Podcasts about mhra

 In this episode, we dig into the shifting landscape of botanical supplements in the UK — and what every practitioner needs to know to stay compliant, confident, and consumer-focused.With evolving guidance from the MHRA, FSA, ASA, and changes across the EU and post-Brexit UK context, natural health practitioners are under increasing pressure to ensure their product recommendations and content meet both regulatory and ethical standards. But where's the line between education and advertising? What counts as a compliant health claim? And how can you talk about botanicals without crossing the line?

The government's health agency, the MHRA, is warning women that they shouldn't use weight loss jabs while pregnant and that the drugs can also affect the reliability of the pill, which has led to a rise in so-called "Ozempic babies".   On today's Sky News Daily Niall Paterson talks to Dr Nikita Kanani, a GP and former medical director for primary care at NHS England, about the risks, whether there are other concerns about using them and if there should be tighter restrictions on online sales of the jabs.  Producer: Emily Hulme Editor: Wendy Parker 

FREEDOM - HEALTH - HAPPINESSThis podcast is highly addictive and seriously good for your health.SUPPORT DOC MALIK To make sure you don't miss any episodes, have access to bonus content, back catalogue, and monthly Live Streams, please subscribe to either:The paid Spotify subscription here: https://creators.spotify.com/pod/show/docmalik/subscribe The paid Substack subscription here: https://docmalik.substack.com/subscribeThank you to all the new subscribers for your lovely messages and reviews! And a big thanks to my existing subscribers for sticking with me and supporting the show! ABOUT THIS CONVERSATION: In this episode, I speak with Cheryl, who brings insider experience from the pharmaceutical world and a deeply analytical mind to everything that's unfolded over the past few years.We dive into the role of the MHRA, the UK's drug regulator, and explore whether it's truly serving public health or merely rubber-stamping products handed to it by pharmaceutical companies. Cheryl shares her concerns about the lack of transparency, the failures of pharmacovigilance, and how freedom of information requests have revealed troubling gaps in regulatory oversight, especially in relation to the COVID-19 vaccine rollout.We talk about mRNA technology, gene therapy, and the disturbing trend of pushing products to market without adequate long-term safety data. Cheryl also highlights the yellow card system, supposedly in place to track adverse effects, which is shockingly underused and almost unknown to most doctors.See my substack for more information.I hope you enjoy this episode.Much love, as always.Doc MalikLinksWebsite https://substack.com/@cherylgrainger IMPORTANT INFORMATIONCONSULTATION SERVICEIn a world of rushed 7-minute consultations and endless referrals, I offer you something rare: time, context, and clear guidance.As your health advocate, I can help you:Understand your diagnosis and decode medical jargonDecide who to see: GP, specialist, osteopath, physio, accupuntcurist, homeopath etc?Break down treatment plans in plain, easy to understand non jargon EnglishPrepare for surgery, understand your risks, obtain true informed consent, and optimise yourself pre-op Recover from surgery, advise you how to heal faster and quicker and minimise post-op complicationsManage chronic illness with lifestyle, mindset, and dietary changesExplore holistic options that complement conventional careImplement lifestyle changes like fasting, stress reduction, or movementAsk better questions, and get real answersGet an unbiased second opinionReady to Take Control?If you're navigating a health concern, preparing for a big decision, or simply want to feel more confident in your path forward, I'd love to support you.Book here https://docmalik.com/consultations/ Because it's your body, your life, and your future. Let's make sure you're informed and heard.WaterpureI distill all my water for drinking, washing fruit and vegetables, and cooking. If you knew what was in tap water, so would you!https://waterpure.co.uk/docmalik BUY HERE TODAYHunter & Gather FoodsSeed oils are inflammatory, toxic and nasty; eliminate them from your diet immediately. Check out the products from this great companyhttps://hunterandgatherfoods.com/?ref=DOCHG BUY HERE TODAYUse DOCHG to get 10% OFF your purchase with Hunter & Gather Foods.IMPORTANT NOTICEIf you value my podcasts, please support the show so that I can continue to speak up by choosing one or both of the following options - Buy me a coffee If you want to make a one-off donation.Doc Malik Merch Store Check out my amazing freedom merch

On this week's episode, Lisa Moneymaker (SVP, Head of Strategic Customer Engagement, Medidata Solutions) and Adam Aten (Legislative & Regulatory Policy Lead, Verily) join the podcast to discuss how the clinical research industry must use insights from the past to better prepare our AI models and other technologies to meet the needs of patients in the present and future. They dive deeper into the role that collaboration between technologists and clinical scientists can play in helping to reduce bias in our AI models, what legislators and regulators should be keeping top of mind as they write new rules of the road for AI and ML, and ACRO's ongoing efforts to promote the responsible use of AI in clinical research.

Welcome to Health Check, the podcast that takes the temperature on regulatory developments affecting the life sciences and healthcare sector in the UK, and offers a prescription to these challenges. In this episode, Osborne Clarke's regulatory lawyers Anna Lundy and Peter Rudd-Clarke, explore regulatory reform in the AI and healthcare world, compare events in the UK with the EU approach, and ask how has the new UK government and MHRA are supporting innovation.

In this final episode of our mini-series on the AstraZeneca Covid vaccine, Investigations Editor Claire Newell explores whether the MHRA, the regulatory agency for drugs, has protected patients. She hears from families about the long-term consequences of a rare adverse reaction to the jab, and whether they have received enough support from the Government.Written by: Claire NewellProducer: Jack BoswellExecutive Producer: Adélie Pojzman-Pontay Hosted on Acast. See acast.com/privacy for more information.

Rare condition research is evolving, and patient communities are driving the breakthrough. In this special Rare Disease Day episode, we explore the challenges and opportunities shaping the future of rare condition therapies. From groundbreaking gene therapy trials to the power of patient-driven research, our guests discuss how collaboration between families, clinicians, researchers, and regulators is paving the way for faster diagnoses, equitable access to treatments, and innovative approaches like nucleic acid therapies and CRISPR gene editing. With insights from Myotubular Trust, we follow the journey of family-led patient communities and their impact on advancing gene therapy for myotubular myopathy - showcasing how lived experience is shaping the future of medicine. However, while patient-driven initiatives have led to incredible progress, not every family has the time, resources, or networks to lead these research efforts. Our guests discuss initiatives like the UK Platform for Nucleic Acid Therapies (UPNAT), which aims to streamline the development of innovative treatments and ensure equitable access for everyone impacted by rare conditions. Our host Dr Ana Lisa Tavares, Clinical lead for rare disease at Genomics England, is joined by Meriel McEntagart, Clinical lead for rare disease technologies at Genomics England, Anne Lennox, Founder and CEO of Myotubular Trust and Dr Carlo Rinaldi, Professor of Molecular and Translational Neuroscience at University of Oxford. "My dream is in 5 to 10 years time, an individual with a rare disease is identified in the clinic, perhaps even before symptoms have manifested. And at that exact time, the day of the diagnosis becomes also a day of hope, in a way, where immediately the researcher that sent the genetics lab flags that specific variant or specific mutations. We know exactly which is the best genetic therapy to go after." You can download the transcript, or read it below. Ana Lisa: Welcome to Behind the Genes.    [Music plays]  Anne: What we've understood is that the knowledge and experience of families and patients is even more vital than we've all been going on about for a long time. Because the issue of there being a liver complication in myotubular myopathy has been hiding in plain sight all this time, because if you asked any family, they would tell you, “Yes, my son has had the odd liver result.”  There were some very serious liver complications but everybody thought that was a minor issue, but if we are able to engage the people who live with the disease and the people who observe the disease at a much more fundamental level we may be able to see more about what these rare genes are doing.  [Music plays]  Ana Lisa: My name is Ana Lisa Tavares, I'm Clinical Lead for Rare Disease research at Genomics England and your host for this episode of Behind the Genes. Today I'm joined by Anne Lennox, Founder and CEO of the Myotubular Trust, Dr Meriel McEntagart, an NHS consultant and Clinical Lead for Rare Disease Technologies at Genomics England, and Dr Carlo Rinaldi, Professor of Molecular and Translational Neuroscience at the University of Oxford.    Today we'll be hearing about the importance of involving the patient community, particularly as new rare therapies are developed, and discussing the forward-facing work that's happening that could have potential to unlock novel treatments for many rare conditions.  If you enjoy today's episode we'd love your support. Please like, share and rate us on wherever you listen to your podcasts. Thank you so much for joining me today.  Please could you introduce yourselves.   Anne: I'm Anne Lennox, I'm one of the founders of the Myotubular Trust, a charity that raises research funds for and supports families affected by the rare genetic neuromuscular disorder myotubular myopathy.  Meriel: I'm Meriel McEntagart, I'm a consultant in clinical genetics in the NHS and I have a special interest in neurogenic and neuromuscular conditions.  Carlo: Hi, I'm Carlo Rinaldi, I'm Professor of Molecular and Translational Neuroscience at the University of Oxford. I'm a clinician scientist juggling my time between the clinic and the lab where we try to understand mechanisms of diseases to develop treatments for these conditions.  And I'm also here as a representative of the UK Platform for Nucleic Acid Therapies, UPNAT. Thanks for your invitation, I'm very pleased to be here.  Ana Lisa: Thank you. Meriel, I'd love you to tell us a bit about your work and how you met Anne, how did this story start?  Meriel: Thank you. Well prior to being a consultant in clinical genetics, I spent 2 years as a clinical research fellow in neuromuscular conditions, and as part of that training I worked on a project where the gene for myotubular myopathy had just been identified, and so there was a big international effort to try and come up with sort of a registry of all the genetic variants that had been found as well as all the clinical symptoms that the affected patients had, and then do kind of a correlation of the particular variant mutation with symptoms.   I worked when I was training to be a clinical geneticist because of my interest in neuromuscular conditions so when I eventually became a consultant at St George's Hospital I was actually interviewed by the Professor of Paediatrics and he knew Anne and her son, when Anne was looking for more information about the condition he suggested that perhaps I might be a good person for Anne to talk to.  Ana Lisa: Thank you. Interesting connections. Anne, can you tell us your story and how this led you to found the Myotubular Trust?  Anne: Yes, thanks Ana-Lisa.  Well, as many families will tell you when they're newly diagnosed with a rare disease, you go from knowing nothing about a condition to being one of the few deep experts in that condition because there are so few deep experts. So this happened to us in 2003 when our son, Tom, was born, and when he was born he was floppy and his Apgar scores, the scores they do on new-born babies, were pretty poor, and before long we knew that it was more than just momentary issues at birth.  And, cutting a very long story short, 5 weeks later he was diagnosed with this very rare neuromuscular genetic disorder that we didn't know we had in the family.  We were told that this was a very serious diagnosis.    At that time – more than 20 years ago – over 80% of those boys didn't make it to their first birthday and the stark statistic we had in our head a lot was that only 1% made it past the age of 10. And that has changed due to better ventilator and breathing equipment, etc, but at the time we expected that he might not make it to his first birthday.    We were very lucky, we had Tom longer than one year, we had him for nearly 4 years, 4 very lovely years where it was tough, but he was a really lovely member of our family.  Despite being really weak he managed to be incredibly cheeky and bossy, and he was a great little brother for his big sister. We were also very lucky that he was being looked after by Professor Francesco Muntoni, who is Head of the Paediatric Neuromuscular Service at Great Ormond Street. And, like Carlo, he is a clinical researcher and actually that I found to be amazing as a family member because you knew what was happening out there and Professor Muntoni, other than living with the reality day to day you want to know where things are going.    We began to realise that back then 20 years ago the more common rare neuromuscular diseases were finally beginning to get some fundamental research funds, like Duchenne, spinal muscular atrophy, and Professor Muntoni was very good at explaining to lay non-scientific parents like us that one day the technologies that would lead to a cure, that would re-engage proteins for other conditions and would translate down eventually into the possibility of replacing myotubularin, which is the protein not being produced or not being produced enough in myotubular myopathy. And then we began to understand actually what the barriers to that would be, that translating developments in more common, or let's say more prevalent conditions, would be hard to do without some translation research being done; you could not just not lag years behind, you could lag decades behind if you haven't done some other work.    So, I met Wendy Hughes, another mother, of a boy called Zak who was a few years older than Tom, and these were the days before social media, and it was amazing to be in contact with another family going through something similar and we had great conversations. But then they were also looked after by Professor Muntoni and we particularly began to develop the idea as 2 families that we might be able to raise some research funds towards this concept of keeping pace with the scientific developments.  And then we discovered there was no charity we could channel those funds through. Even the umbrella body for neuromuscular diseases who were covering 30 to 40 conditions, frankly, they just couldn't trickle their funding down into investing in every neuromuscular disease, and slowly but surely it dawned on us that if we did want to make that difference we were going to have to set up our own charity.   So that's what we eventually did and back in 2006, we founded what was actually the first charity in Europe dedicated to myotubular myopathy – luckily, more have come along since – and we were dedicated to raising research funding. In fact, it wasn't our goal to set up another charity but around that time, about a year in, we happened to go to a meeting where the Head of the MRC, the Medical Research Council, was giving a talk and he said that in the last few years the MRC had begun to really realise that they couldn't cure everything, that they couldn't cure the diseases that would be cured in the next millennium from a top down perspective. There had to be a trick, there had to be a bottom up as well, because that was the only way this was going to happen. And I have to say that that was a really reassuring moment in time for us to realise that we weren't just chasing pipe dreams and trying to do something impossible, that there was a role for us.    Ana Lisa: I think it would be really interesting for people to hear your story and the amazing set-up and fundraising that you've done, and at the same time it would be really good for us to reflect on how this isn't feasible for every patient and every family and how we're going to need to work cooperatively to move forwards with rare therapies.  Anne: When we explored the idea with Professor Muntoni and Meriel and others about setting up a charity one of the really reassuring things that Professor Muntoni got across to us was that this wasn't about raising the millions and millions it would take to fund clinical trials but the issue in the rare disease space was funding the proof of principle work, the work where you take a scientist's hypothesis and take it over the line, and the rarer the disease, the less places there are for a scientist to take those ideas. And the example he gave us was a piece of research like that might cost a hundred to a couple of hundred thousand, if you fund a piece of work like that and if it is successful, if the scientist's principle gets proven, then behind you it's much easier for the bigger muscle disease charities to also invest in it. It's harder for them to spread their money across all the very rare diseases hypothesis out there, but if you've helped a scientist get over the line they'll come in behind you and then they won't be the ones who fund the tens of millions that it takes to run a clinical trial.    If it's got potential, then that's where the commercial world comes in, and that's where the biotechs come in. So he'd given the example of if you spent £ten0,000 on a piece of research and it actually is proven, in behind you will come the bigger charities that would put in the million that takes it to the next phase, and in behind them will come the bio-checks that'll provide biotechs that'll provide the tens of millions.    And then, you know, a lot of what happens relies on serendipity as well, we know that, and you could easily run away with the idea that you made everything happen but you don't, you stand on the shoulders of others. And our very first grant application in our first grant round, which received extraordinary peer review for how excellent the application was, was a £100,000 project for a 3-year project that had gene therapy at the core of it by a researcher called Dr Ana Buj Bello at Généthon in Paris. This piece of research was so promising that 18 months in she and another researcher were able to raise $780,000 and, as Professor Muntoni predicted, from the French muscle disease charity AFM and the American muscle diseases charity MDA.  And 18 months into that 3 years it was so promising that a biotech company was started up with $30 million funding, literally just on her work.    So that doesn't always happen but, as Professor Muntoni explained, our job was not that $30 million, our job was that first £100,000, and our job was also to make ourselves known to the people in the neuromuscular field.  If you have lab time, if you have research time and you have a choice where you're putting it there is a place you can go to for a myotubular myopathy related grant application, so it's not just that this will come to us out of the blue, people will have done prior work, and our existence makes it worth their while, hopefully, to have done that prior work.  Ana Lisa: That's an amazing story how you've set up this charity and how successful that first application for gene therapy was. I'd love to hear more about that gene therapy and did it get to the clinic and to hear that story from you.  Because I think there are a lot of learnings and it's really important that the first patients who are treated, the first families that are involved, the researchers who start researching in this area, the first treatments lead the way and we learn for all the other treatments for all the other rare conditions that we hope and that together as a community we can share these learnings.  Anne: Yeah. I sometimes describe it a bit like going out into space. When you see a rocket going off look at how many people are behind and the amount of work that's been done, the degree of detail that's managed, and then you go out into space and there are a whole load of unknowns, and you can't account for all of them.  Who knows what's out there in this sphere.  But the amount of preparation, it feels similar to me now, looking back.  We were so idealistic at the beginning.  Our grant to Dr Buj Bello was 2008 and actually it is a really fast time in, the first child was dosed in the gene therapy trial in September 2017.  Ana Lisa: So, we're talking less than 1 years.  Anne: Yeah. And in the meantime obviously as a charity we're also funding other proof of principle research. One of the founding principles of the charity was to have a really excellent peer review process and scientific advisory board so that we wouldn't get carried away with excitement about one lab, one research team, that everything would always come back to peer review and would be looked at coldly, objectively. I don't know how many times I've sat in a scientific advisory board meeting with my fingers crossed hoping that a certain application would get through because it looked wonderful to me, and then the peer review comes back and there are things you just don't know as a patient organisation. So, yes, in those 9 years we were also funding other work.  Ana Lisa: You've just given an interesting perspective on sharing the learnings between the scientists, clinicians, the experts in a particular condition, if you like, and the families, and I'd be really interested to hear your views on what's been learnt about how families and the patient community can also teach the clinical and scientific community.  Anne: So, the first child was dosed in September 2017 and by the World Muscle Society Conference 2 years later in October 2019 the biotech had some fantastic results to show. Children who had been 24-hour ventilated were now ventilator-free, which, unless you know what it's like to have somebody in front of you who's ventilator-dependent, the idea that they could become ventilator-free is just extraordinary.    However, one of the things we've learnt about gene therapy is that we are going out into space so there are extraordinary things to be found, and extraordinary results are possible, as is evidenced here, but there is so much that we don't know once we are dealing with gene therapy. So unfortunately, in May, June and August of 2020, 3 little boys died on the clinical trial. So we have a clinical trial where the most extraordinary results are possible, and the worst results are possible, and both of those things are down to the gene…  What we discovered and what is still being uncovered and discovered is that myotubular myopathy is not just a neuromuscular disorder, it is a disorder of the liver too, and these children didn't die of an immune response, which is what everybody assumes is going to happen in these trials, they died of liver complications.    And one of the things that has come out of that, well, 2 sides to that. Number one is that it is extraordinary that we have found a treatment that makes every single muscle cell in the body pick up the protein that was missing and produce that protein, but also what we've understood is that the knowledge and experience of families and patients is even more vital than we've all been going on about for a long time. Because the issue of there being a liver complication in myotubular myopathy has been hiding in plain sight all this time, because if you asked any family they would tell you, “Yes, my son has had the odd liver result, yes.”    We could see something that looked like it was not that relevant because it was outside the big picture of the disease, which was about breathing and walking and muscles, but actually there was this thing going on at the same time where the children had liver complications. There were some very serious liver complications but everybody thought that was a minor issue but if we are able to engage the people who live with the disease and the people who observe the disease at a much more fundamental level we may be able to see more about what these rare genes are doing.  Ana Lisa: Yeah, thank you very much for sharing such a moving story and with such powerful lessons for the whole community about how we listen to the expertise that families have about their condition, and also I think the really important point about how we tackle the research funding so that we're including and sharing learnings from the conditions that are initially studied in greater depth, and we hope that many more conditions will be better understood and more treatments found and that actually the learnings from these first gene therapy trials will really help inform future trials, not just for gene therapies but also for many other novel therapies that are being developed.  [Music plays] If you're enjoying what you've heard today, and you'd like to hear some more great tales from the genomics coalface, why don't you join us on The Road to Genome podcast. Where our host Helen Bethel, chats to the professionals, experts and patients involved in genomics today. In our new series, Helen talks to a fantastic array of guests, including the rapping consultant, clinical geneticist, Professor Julian Barwell, about Fragile X syndrome, cancer genomics and a holistic approach to his practice - a genuine mic-drop of an interview. The Road to Genome is available wherever you get your podcasts. [Music plays] Ana Lisa: Carlo, I would really like to come to you about some of the initiatives that are happening in the UK, and particularly it would be really interesting to hear about the UK Platform for Nucleic Acid Therapies as a sort of shining example of trying to do something at a national scale across potentially many different rare conditions.    Carlo: Thanks, Ana-Lisa. Thanks very much, Anne, for sharing your fantastic story. I mean, I just want to iterate that as clinician scientists we do constantly learn from experiences and constantly learn from you, from the patient community, and this is absolutely valuable to push the boundary. And I really liked your vision of a rocket being launched in space and I would imagine that this is a similar situation here. So, we are facing a major challenge. So, there is over 7,000 rare diseases in the world and with improvements of genetic diagnosis this is only increasing. So, in a way rare diseases is the ultimate frontier of personalised medicine and this poses incredible challenges.   So, you mentioned the bottom-up approach and the top-down approach and in a way, both are absolutely necessary. So your story is a fantastic story but also makes me think of all the other families where they don't share perhaps the same spirit, you know, they are in areas of the world that are not as well connected or informed, where patient community simply cannot be ‘nucleated', let's say, around the family. So, there is definitely an issue of inclusivity and fair access.    So, what we're trying to do at UPNAT, which is the UK Platform for Nucleic Acid Therapy, is to try to streamline the development both at preclinical and clinical level of nucleic acid therapies. So, we'll start with antisense oligonucleotides just because those are the molecules of the class of drugs that are most ‘mature', let's say, in clinic. So, there are several antisense oligonucleotides already approved in the clinic, we know that they are reasonably safe, we understand them quite well, but of course the aspiration is to then progress into other forms of gene therapy, including gene editing approaches, for example.   And one of the activities that I'm involved, together with Professor Muntoni, is to try to streamline the regulatory process of such therapies and in particular curate a registry of, for example, side effects associated with nucleic acid therapy in the real world, and you would be surprised that this is something that is not yet available.  And the point is exactly that, it's trying to understand and learn from previous mistakes perhaps or previous experiences more in general.    And this is very much in synergy with other activities in the UK in the rare disease domain.  I'm thinking of the Rare Disease Therapy Launchpad, I'm thinking of the Oxford Harrington Centre, I am thinking of the recently funded MRC CoRE in Therapeutic Genomics. These are all very synergistic. Our point is we want to try to amplify the voice of the patient, the voice of the clinicians working on rare disease, and we want to systematise. Because of course one of the risks of rare disease therapies is the fragmentation that we do all these things in isolation. And I would argue that the UK at the moment leveraging on the relatively flexible and independent regulatory agencies, such as the MHRA, on the enormous amount of genetics data available through Genomics England, and of course the centralised healthcare system, such as the NHS, is really probably the best place in the world to do research in the rare disease area, and probably I'm allowed to say it because I'm a non-UK native.       Ana Lisa: Thank you, that's a brilliant perspective, Carlo, and across all the different therapeutic initiatives that you're involved with. And, Carlo, presumably - we're all hoping - these different initiatives will actually lead to ultimately a bigger scaling as more and more novel therapies that target both our RNA and DNA and actually are working, I guess further upstream in the pathway.    So classically in the past it's been necessary to work out all the underlying biology, find a druggable target somewhere in that pathway and then get a larger enough clinical trial, which can be nearly impossible with many of the rare and ultra-rare conditions or even, as you've said, the sub-setting down of more common condition into rarer subtypes that perhaps can be treated in different ways.  And with the many new different treatments on the horizon, ASO therapies, as you've said, is a place that's rapidly expanding, and also crisper gene editing. I'd be really interested to hear your reflections on how this might scale and also how it might extend to other new treatments.  Carlo: Yeah, that's exactly the right word, ‘scaling up'. I mean, there will be of course very unique challenges to every single rare disease but I would argue that with genetic therapies, such as ASOs or crisper gene editing, the amount of functional work that you need to do in a lab to prove yourself and the scientific community that this is the right approach to go for can be certainly very important but can be less just because you're addressing very directly because of the disease.    And then there are commonalities to all these approaches and possibly, you know, a platform approach type of regulatory approval might serve in that regard. You know, if you are using the same chemistry of these antisense oligonucleotides and, you know, similar doses, in a way the amount of work that you need to produce to again make sure that the approach is indeed a safe approach and an effective approach might be also reduced.    I would say that there are also challenges on other aspects of course, as you were saying, Ana-Lisa. Certainly the typical or standard randomised placebo control trial that is the standard and ultimate trial that we use in a clinical setting to prove that a molecule is better than a placebo is many times in the context of rare diseases simply not possible, so we need to think of other ways to prove that a drug is safe and is effective.   This is something that we all collectively as a scientific community are trying to address, and the alliance with the regulatory agencies, such as the MHRA, and you said that you have found your interaction with the MHRA very positive, and I can tell you exactly the same. So we are all trying to go for the same goal, effectively, so trying to find a way to systematise, platformise these sort of approaches. And I guess starting with antisense oligonucleotides is really the right place to go because it's a class of drugs that we have known for a long time, and we know it can work.  Ana Lisa: Meriel, can you tell us a little about the National Genomic Research Library at Genomics England and how this could link with initiatives to find many more patients as new treatments become available for rare and ultra-rare conditions?  Meriel: Yes, I think what's wonderful now is actually that what we're really trying to do is give everybody the opportunity to have their rare condition specifically diagnosed at the molecular level, and the way in which that is being done is by offering whole genome sequencing in the NHS currently in England but to all patients with rare diseases.    And so, it's about trying to establish their diagnosis. And as well as that, even if the diagnosis isn't definitely made at the first pass when the clinical scientists look at the data, because the whole genome has been sequenced, actually all that information about their genome, if they consent, can then be put into the National Genomics Research Library.  And that is a fantastic resource for national and international researchers who get approved to work in this trusted research environment to make new disease gene discoveries and identify these diagnoses for patients.  What's also offered by Genomics England as well is when the National Genomics Library data results in a new publication, the discovery of a new gene or perhaps a new molecular mechanism that causes a disease we already know about, that feeds back into the diagnostic discovery pathway within Genomics England back onto the diagnostic side of all the data.    So, patients who may have had genetic testing previously using whole genome sequencing where they've, if you like, had their sequencing done before the diagnosis was sort of known about, will also be picked up. And so, what this is really doing is trying to kind of give this really equal platform for everybody having testing to all have the same opportunity to have their diagnosis made, either on the diagnostic side or with research.  Ana Lisa: So, sort of on a cohort-wide scale as new discoveries are made and published you can go back and find those patients that may actually have that diagnosis and get it back to them, which is brilliant.  Meriel: Exactly. And this speeds up the whole process of getting these diagnoses back to people. So on a regular basis in the NHS, we will get feedback from the Diagnostic Discovery Pathway about “Here's some patients who you requested whole genome sequencing from a number of years ago and actually now we think we know what the particular molecular condition is.”  And so, it's key of course for our patients with rare conditions to make that molecular diagnosis because then we're able to have them identified for our colleagues who are doing this ground-breaking research trying to bring therapies for these rare conditions.  Ana Lisa: Thank you. And I hope that, as currently, if a novel genetic mechanism, as you've just described, is identified that could explain a rare condition that those patients can be found and they can receive that diagnosis, even many years later, and hopefully as novel treatments become available and say there's a chance to individualise ASO therapies, for example, to start with, that one could also go and look for patients with particular variants that could be amenable potentially to that treatment. And that's really sort of exciting that one could look for those patients across England, irrespective of which clinic they're under, which specialist they're under, and I think that could be really powerful as new treatments develop. I suppose, Meriel, if somebody comes to see you now in clinic are things different?  Meriel: Well, I think one of the things for me when patients come to clinic now is we might have an idea about what we think their condition is, maybe even we think it's a specific gene. And we can offer whole genome sequencing and so it's not just the way we used to do things before by looking just at the coding regions of the gene, we can find more unusual ways in which the gene can be perturbed using whole genome sequencing.  But let's say we don't make the diagnosis. I encourage my patients, if they're comfortable with it, to join the National Genomics Research Library, because really it's been incredibly productive seeing the new genetic discoveries that are coming out of that, but as well I say to them, even if we don't get the diagnosis the first time round when we look at the data, actually this is a constant cycle of relooking at their data, either if they're in the NGRL or as well on the Diagnostic Discovery Pathway side of the service that's run by Genomics England. So yeah, I feel like it's a very big difference; they don't have to keep coming every year and saying, “Is there a new test?” because actually they've had an excellent test, it's just developing our skills to really analyse it well.  Ana Lisa: Yes, and our knowledge, the technology and the skills keep evolving, certainly.  And I think one of the things that I'm sort of hearing from this conversation is that balance of hope and realism, Carlo we were talking about earlier how you need all the pieces of the puzzle to be lined up - so the regulatory agency, the clinicians, all the preclinical work has to have been done, monitoring afterwards for side effects - every piece of the puzzle has to be lined up for a new treatment to make it to a patient.    And, Anne, I'd like to come back to you because we've talked about this before, how one balances these messages of optimism and hope which are needed for bringing everybody together as a community to crack some of these very difficult challenges highlighted by treatments for rare and ultra-rare conditions and at the same time the need for realism, a balance conversation.  Anne: Yeah, that was one of our big learnings through the gene therapy trial and other trials we've had in the condition. As a rare disease charity, you do everything. You know, my title is CEO, but I tell people that's Chief Everything Officer because there's only a few of you and you do everything. So, you go and you lead the London Hope Walk and you also are a layperson on the Scientific Advisory Board and you also send out the emails about grants... And so, you could easily as a small rare disease charity conflate different communication messages because you're in a certain mode.  And so we have been from the early days in the mode of raising hope for people to say, “Look, we can make a difference as a patient community, we could raise funds, we might be able to move things forward, you've got the power to make a difference if you want to.” That's one set of hope.  And it's not dreamlike hope, we're linked to the reality of there are great breakthroughs.  So, you know, in the world of spinal muscular atrophy these clinical trials have led somewhere very quickly, so we're not selling false hope, we're talking about the difference we can make.    But then as soon as you flip into “There's a clinical trial being run” that's a completely different type of communication and you cannot conflate that message with the previous message.  And we always say to everybody, “We're your team, we're a family, we're a team, we all help each other.  When you are considering joining a clinical trial your team is the clinical trial team.    The other team does other things for you but the people you need to work with and ask hard questions of and listen hard to, that's your clinical trial team led by the principal investigator because then you're in that with them. And, you know, the reality of the fact that many, many clinical trials don't work as we wish they would be and the decision you make for your child, your baby, your little one, to join a clinical trial… because that's what it comes down to in our disease, has to be made with that team, not the team that's selling you a fundraising event. It's worth reminding rare disease patient organisations we're wearing different hats and the hope and the realism are different tracks you have to go down.    But at the same time as being realistic you also have to keep remembering that there is still grounds for hope, we are moving forward. And 21 years ago, when Tom was born the idea that you would be able to get all of the muscles in the body to switch back on – putting it in lay terms – seemed like a bit dream. Well, that is what has happened in the gene therapy clinical trial, we just have to now make it safer and understand more about what we're dealing with. So, the 2 things, the hope and the realism, do exist side by side.  Ana Lisa: I think that perfectly encapsulates a lot of the messages around rare disease therapies where there's such hope that novel treatments will really target directly the DNA or RNA to potentially correct the problem across many different rare conditions and therefore actually making treatments one day suddenly available to a much, much bigger population of people with rare conditions than we could've dreamt of 20 years ago or perhaps now, and at the same time this massive need to work cooperatively to all make this as fair, as equitable. Not everybody is going to have the opportunity to fundraise massively to be an expert about their condition, and the importance of sharing these learnings and also really, really listening to the patient community and really, as Carlo was saying, keeping track of side effects, having registries/databases to share these is going to be incredibly important.  [Music plays]  Ana Lisa:  Anne, can you tell us a little about your reflections on equity from the patient community perspective?  Anne: Well I mentioned serendipity early and one of the aspects of serendipity that played into our favour for setting up the Myotubular Trust was that by hook or by crook Wendy Hughes, who set up the charity with me, and I were both able to devote time at that period of our lives to setting up a charity. When my husband, Andrew, and I were told that Tom would more than likely die before his first birthday, one of the decisions we made as a family was that he would never not be with a parent, we would always have someone around, and that kind of meant someone had to give up a full-time job and that was me.  We thought, “If Tom has a few scarce months on the planet, we'll be with him.” And then when Tom lived to be nearly 4, as a family we got used to living on one salary and we were very lucky that we could pay the mortgage that way and run our family that way and eventually that meant I had the time to run the charity.    That doesn't happen that easily, that's a tall order, particularly when you have somebody in the family who has such high needs. And one of the things that I have often thought about is that in the rare disease space we could do with a different funding model for rare disease charities, we could, in an ideal world I have this nirvana that I imagine where there's a fund that you can apply to that is contributed to by the people who make profits out of finding rare disease cures - so the pharmaceutical companies and the biotechs - and there's a fund that they contribute to and that if you have a rare disease and you are willing to set up an organisation that supports families, that raises research funds, that provides a way of hearing the patient voice, then you could apply to that for running cost funds and then you'd be able to run this charity. And then you wouldn't have to rely on whether you live in an area where people will raise money for you or…  We were very lucky that we came across a few great benefactors who would give us money for running the charity, which is actually how we fund it.    All the research money we raise goes 100% into research, not a penny of it goes towards running costs because we have serendipitously found people who will be benefactors for the charity, but we're relying on a lot of good luck for that kind of model to work. And when you look at how much profit is made from developing rare disease treatments and cures – which is fine because that's what puts the passion and that gets people working on it – then why not have an advance fund to run rare disease charities? One of my nirvana dreams.  Ana Lisa: It's good to dream. Indeed, my hope is that there will be some amazing shining examples that lead the way that open doors, make things possible, prove that something can work and how and that then that will enable many other treatments for many additional rare conditions to be added in so that if you've learnt how this particular treatment modality works for this rare condition and there was funding behind it and everything else that's needed that then you can, the learning from that, I'm going to use the word ‘tweak', which sounds minor and could be very major but actually the concept that you can then tweak all those learnings and findings so that that same type of treatment modality could be adapted to treat somebody else with a different rare condition in a different location would be absolutely incredible and really powerful, given that if something like 85% of rare conditions affect less than one in a million people it's not going to be feasible to use the same strategies that have been used in the past for very common conditions.    One of the other big barriers is the cost of developing treatment for ultra-rare conditions.  Where it's a small number of patients that you have and therefore all the challenges that come with monitoring, checking for efficacy, monitoring safety and ultimately funding the challenges are much greater, however if some of these treatment modalities are also going to be used to treat common conditions it might be that actually there's a lot more cross-talk between the nano-rare, ultra-rare, rare and common conditions and that we can share a lot of that learning. I'd love to hear from each of you where you hope we will be for rare disease and rare therapies.  Carlo: Well my dream is that in 5 to 10 years' time an individual with a rare disease is identified in the clinic, perhaps even before symptoms have manifested, and at that exact time the day of the diagnosis becomes also a day of hope in a way where immediately the researcher, the centre, genetics lab, flags that there are the specific mutations, we know exactly which is the best genetic therapy to go after, antisense oligonucleotides as opposed to CRISPR editing, and a path forward, both at the preclinical and clinical level, to demonstrate and to cure these patients eventually is already laid out in front of the patient.  So, transforming the day of their diagnosis as a day of hope, this is my dream with the next ten years.  Ana Lisa: Thank you, that's a wonderful dream. Meriel, can I come to you?  Meriel: Yes, I think I just want to echo Carlo.  We've had great developments and progress with getting whole genome sequencing into the NHS for testing but what we really need is for it to be fast and efficient and getting those diagnoses established quickly. And we have had that set up now and we're really getting there in terms of speed, but then what we need is exactly what's the next step and actually structure like UPNAT that are developing these processes that we can then say to the patient, “And from there, now that we've established your diagnosis, this is what we have options to offer.”  Ana Lisa: Brilliant. And presumably that if the diagnosis isn't achieved now there is a hope that it will be achieved in the future as well. Anne...  Anne: Well, stepping one hundred per cent into the patient's shoes rather than the scientific side that we don't so much influence....  stepping in the patient's shoes, in 5 years' time I would absolutely love it if we were in a situation where all the parties that have come to the table looking at a therapy or in the earlier research genuinely want to bring the patient voice into the room. As Carlo talked about, there's even going to be more and more and more of these rare diseases, then those voices, those few people who have experience of it, they may be able to shed light on something. Maybe even sometimes don't even know it's a fact that they know but that were brought to the table as passionately as everything else is brought to the table.  [Music plays]  Ana Lisa: We'll wrap up there. Thank you so much to our guests, Anne Lennox, Carlo Rinaldi and Meriel McEntagart, for joining me today as we discuss the collaborative power of working together and look to the future of rare therapies that could have the potential to unlock treatments for many rare conditions. If you'd like to hear more like this, please subscribe to Behind the Genes on your favourite podcast app.  Thank you for listening.  I've been your host, Ana-Lisa Tavares. This podcast was edited by Bill Griffin at Ventoux Digital and produced by Naimah Callachand.  

In this final episode of our mini-series on the AstraZeneca Covid vaccine, Investigations Editor Claire Newell explores whether the MHRA, the regulatory agency for drugs, has protected patients. She hears from families about the long-term consequences of a rare adverse reaction to the jab, and whether they have received enough support from the Government.Listen to the first two episodes of The Daily T Investigates: The AstraZeneca vaccine hereListen to 'The Lockdown Files: The Forgotten Victims' hereWritten by: Claire NewellProducer: Jack BoswellExecutive Producer: Adélie Pojzman-Pontay Hosted on Acast. See acast.com/privacy for more information.

The treatment of Geographic Atrophy (GA) or late stage dry age-related macular degeneration as it's also known, is proving to be a pretty tough nut to crack. Hopes had been high that a treatment available in the USA would also be approved for use here in the UK. However, the Medicines and Healthcare products Regulatory Agency (MHRA) has rejected the application. Ed Holloway, Chief Executive of the Macular Society and Bill Best who has lived with GA for many years join us to discuss the MHRA decision.Optomap is an imaging system which produces significantly more detailed information about the retina than had been available before. This can lead to earlier diagnosis of many eye conditions and accordingly a better chance of preventing sight loss. Dr Peter Hampson, Policy and Clinical Director of the Association of Optometrists and John Hopcroft, Clinical Services Manager at Boots join us to discuss the system and how public access to it is being improved by bringing it to the high street. Presenter: Peter White Producer: Fern Lulham Production Coordinator: David BaguleyWebsite image description: Peter White sits smiling in the centre of the image, wearing a dark green jumper. Above Peter's head is the BBC logo (three individual white squares house each of the three letters). Bottom centre and overlaying the image are the words "In Touch"; and the Radio 4 logo (the word Radio in a bold white font, with the number 4 inside a white circle). The background is a bright mid-blue with two rectangles angled diagonally to the right. Both are behind Peter, one of a darker blue and the other is a lighter blue.'

hVIVO PLC CEO Yamin 'Mo' Khan talked with Proactive's Stephen Gunnion about the company's involvement in a world-first Phase 3 human challenge trial for a pertussis (whooping cough) vaccine candidate. The trial, in partnership with ILiAD Biotechnologies, is expected to start in the second half of this year. Khan highlighted the importance of this milestone for hVIVO, noting that it will be the company's largest challenge trial to date and its first bacterial challenge trial. The trial data aims to secure FDA marketing authorisation, marking a pivotal moment for the utility of human challenge trials in vaccine development. According to Khan, "The goal is to get a better vaccine to patients faster. Pertussis is a severe disease, particularly for infants, and there's an urgent need for new vaccines." He further explained that hVIVO's state-of-the-art Canary Wharf facility will play a critical role in supporting this trial, equipped with expanded laboratory capabilities for bacterial analysis. The trial comes as cases of pertussis are on the rise, increasing sixfold between 2023 and 2024. ILiAD Biotechnologies has also secured FDA fast-track status and an MHRA innovation passport for this vaccine candidate. Khan emphasised the partnership's goal of addressing this unmet medical need and delivering an effective vaccine to patients worldwide. Visit Proactive's YouTube channel for more videos, and don't forget to like, subscribe, and enable notifications for future updates. #hVIVO #VaccineDevelopment #WhoopingCough #Pertussis #ClinicalTrials #FDAApproval #BiotechInnovation #Phase3Trial #HumanChallengeTrials #HealthcareResearch

The latest episode of Digital Health Unplugged features Holly Coole, senior manager for digital mental health at the Medicines and Healthcare products Regulatory Agency (MHRA), talking about the regulation of digital mental health technologies (DMHTs). Tammy Lovell, news editor at Digital Health News, chats to Coole about the three-year Digital Mental Health Project, which aims to improve outcomes for people with mental health conditions by ensuring that both medical professionals and the public have safe and effective access to DMHTs. In the podcast they discuss how the project, led by the MHRA in partnership with the National Institute for Health and Care Excellence, aims to provide clarity around the key considerations for the regulation and valuation of DMHTs.   They also talk about the challenges of regulating this area and why it is so important to protect patient safety, and ensure access to effective products for mental health.  Coole, who is a registered mental health nurse, co-authored a paper on the project, published in The Lancet Digital Health in January 2025. Listen to this episode to discover what this project means for the future of mental health technology in the UK. Guest: Holly Coole, senior manager for digital mental health at the MHRA  

 HO HO HO, MERRY FISMAS!!!On the Third & Final Pod of FISmas these ID:IOTS have for you… 6 golden topics! Listen to hear about:1. Personalised approach to invasive fungal infection2. Agricultural anti-fungals and One Health3. Candida auris4. NTM standards of care5. Narrative reporting 6. Fluoroquinolones and the MHRA warnings Jame and Callum attended the Federation of Infection Societies 2024 annual meeting in  Liverpool; here they share their reflections on the sessions  they attended on:  a wide mix of topicsWe hope these episodes have been ADVENTatious to your learning.Notes for this episode here Send us a text Support the showQuestions, comments, suggestions to idiotspodcasting@gmail.com or on X/Threads @IDiots_podPrep notes for completed episodes can be found here (Not all episodes have prep notes).If you are enjoying the podcast please leave a review on your preferred podcast app!Feel like giving back? Donations of caffeine gratefully received!https://www.buymeacoffee.com/idiotspod

In today's episode of AI Lawyer Talking Tech, we delve into the dynamic and sometimes challenging role of artificial intelligence in the legal industry and beyond. From digital platforms enabling modern-day exploitation to innovative tools streamlining contract management and legal research, AI's impact is far-reaching. We discuss how AI is revolutionizing client acquisition, assisting OSHA inspections with smart glasses, and helping firms improve efficiency and governance. At the same time, we explore the ethical and regulatory challenges emerging alongside these advancements, highlighting the need for transparency, accountability, and robust AI policies. Tune in to discover how AI is simultaneously empowering legal professionals and reshaping the landscape of human rights, innovation, and business practices. Updating human rights law necessary to combat “digital forced labor” in age of GenAI11 Dec 2024Thomson Reuters InstituteBest of 2024: Investing in Legal Tech and the Ingredients of a Successful Start-Up (Zach Posner, The LegalTech Fund)11 Dec 2024Technically Legal - A Legal Technology and Innovation PodcastDouble Whammy: SixFifty's AI Tool + Epiq's New AI Abilities10 Dec 2024Artificial Lawyer360 Business Law launches AI contract review triage service10 Dec 2024Legal IT InsiderWe Get AI for Work: Establishing AI Policies and Governance Part 111 Dec 2024Jackson LewisWe Get AI for Work: Establishing AI Policies and Governance Part 211 Dec 2024Jackson LewisWelcome to Lowenstein AI: A-I Didn't Know That10 Dec 2024Lowenstein Sandler PCJPM2025: AI integration into UK's MHRA's processes presents opportunities, and challenges for regulating medicinal product development10 Dec 2024Hogan LovellsOSHA Inspectors to Use AI-Driven Smart Glasses to Inspect Workplaces: What Employers Should Do to Protect Privacy Rights10 Dec 2024Fisher & Phillips LLPDLA Piper recognized as one of the Most Innovative Law Firms in North America by the...10 Dec 2024DLA PiperPower moves: Data center deals are heating up in EMEA10 Dec 2024White & CaseNew Expectations for AI: Governance is Key for AI Success in Health Care10 Dec 2024Frost Brown ToddDisrupting the Legal Industry: How Viribuz is Revolutionizing Client Acquisition and Intake with AI11 Dec 2024Grit DailyTransforming legal workflows with customized AI models10 Dec 2024Thomson ReutersSpeed up litigation prep with AI-Assisted Research10 Dec 2024Thomson ReutersThe Business of Law: What Junior Associates Should Know About Firm Economics10 Dec 2024Firsthand.coLegal departments meet budget challenges with strategic spend management10 Dec 2024Thomson ReutersHow It Works: Our Walkthrough of ShareFile's Document Collaboration Tools10 Dec 2024LawSitesFive ways law firms can use digital tools to grow10 Dec 2024Law SocietySixFifty Launches AI-Powered Tool to Provide Plain-English Answers to Employment Law Questions10 Dec 2024LawSites

Faron Pharmaceuticals Limited (AIM:FARN) CEO Dr Juho Jalkanen talked with Proactive's Stephen about the significant fast-track designation awarded to their cancer immunotherapy, bexmarilimab, by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This milestone aligns with prior FDA acknowledgments, marking critical progress in addressing relapsed refractory Myelodysplastic Syndrome (r/r MDS). Faron also announced MHRA approval to expand its BEXMAB trial to UK sites. Jalkanen explained, “UK is like a second home for us,” emphasising the importance of extending treatment access to UK patients. He also detailed how the Innovation Passport streamlines regulatory interactions, rolling submissions, and early drug access opportunities. Looking ahead, Dr. Jalkanen shared that a confirmatory Phase 3 study is being planned for high-risk MDS patients globally, in collaboration with major regulatory authorities. The global trial underscores the company's dedication to delivering groundbreaking therapies to patients in need. For more insightful interviews, visit Proactive's YouTube channel. Don't forget to like this video, subscribe, and turn on notifications for updates! #faronpharmaceuticals #CancerImmunotherapy #Bexmarilimab #MDSResearch #BiotechInnovation #ClinicalTrials #MHRA #FDAApproval #GlobalHealthcare #ProactiveInvestors #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

FREEDOM - LIBERTY - HAPPINESS SUPPORT DOC MALIK To make sure you don't miss any episodes, please subscribe to either: The paid Spotify subscription here: ⁠https://podcasters.spotify.com/pod/show/docmalik/subscribe The paid Substack subscription here: ⁠https://docmalik.substack.com/subscribe Thank you to all the new subscribers for your lovely messages and reviews! And a big thanks to my existing subscribers for sticking with me and supporting the show! ABOUT THIS CONVERSATION: In this chat, I sit down with Dr Liz Evans to discuss why we need a medical freedom movement here in the UK, especially after everything we've seen during the COVID-19 pandemic. We talk about the ethical concerns around vaccine safety and informed consent. Liz opens up about her background as a former NHS doctor, her shift into complementary medicine, and how her Christian faith plays a huge role in her commitment to medical ethics. We also discuss how the UK Medical Freedom Alliance came to be and the worrying changes in public health legislation (Scotland, Canada, and now Northern Ireland) that could lead to government overreach. The conversation highlights why public resistance is so important and why we all need to take a stand. Ultimately, it's about fighting for a society that respects individual freedoms and upholds medical ethics. Ahmad x Links Website UK Medical Freedom Alliance X UKMFA X Proposed Public Health Bill Consultation Link UKMFA Open letter to JCVI, MHRA and Matt Hancock, in Nov 2020, urging them not to authorise or roll out the Covid vaccines due to serious safety & ethical concerns IMPORTANT INFORMATION AFFILIATE CODES Hunter & Gather Foods ⁠Hunter & Gather Foods Use DOCHG to get 10% OFF your purchase with Hunter & Gather Foods. IMPORTANT NOTICE Following my cancellation for standing up for medical ethics and freedom, my surgical career has been ruined. I am now totally dependent on the support of my listeners, YOU. If you value my podcasts, please support the show so that I can continue to speak up by choosing one or both of the following options - ⁠Buy me a coffee⁠ If you want to make a one-off donation. Join my Substack To access additional content, you can upgrade to paid from just £5.50 a month Doc Malik Merch Store⁠ Check out my amazing freedom merch To sponsor the Doc Malik Podcast contact us at ⁠hello@docmalik.com⁠ Check out my website, visit ⁠www.docmalik.com

In this podcast recorded in early August, James Cave (Editor-in-Chief) and David Phizackerley (Deputy Editor) talk about the September issue of DTB. They discuss the editorial (https://dtb.bmj.com/content/62/9/130) that highlights some of the challenges associated with NHS England's national medicines optimisation measures for Integrated Care Boards. They talk about the MHRA's recent safety alert on the risk of an interaction between tramadol and warfarin (https://dtb.bmj.com/content/62/9/131), which was prompted by a coroner's prevention of future deaths report (summarised in a DTB article in March https://dtb.bmj.com/content/62/3/36). The main article reviews the evidence for icosapent ethyl for cardiovascular risk reduction (https://dtb.bmj.com/content/62/9/135).   Please subscribe to the DTB podcast to get episodes automatically downloaded to your mobile device and computer. Also, please consider leaving us a review or a comment on the DTB Podcast iTunes podcast page. If you want to contact us please email dtb@bmj.com. Thank you for listening.

Justice for Reyzl: Standing up to LGBTQ Workplace Discrimination Host: Noah Parrish, Gender Justice Communications Director Guest: Brittany Stewart, Gender Justice Senior Staff Attorney In August 2024, Gender Justice and co-counsel Wanta Thome PLC filed a discrimination lawsuit against the Academy of Holy Angels, a Catholic high school in Richfield, Minnesota, and the Archdiocese of St. Paul and Minneapolis after they effectively terminated Reyzl Grace, a staff librarian, when she came out as trans. Reyzl Grace's story highlights the importance of ensuring that no employer in Minnesota has carte blanche to discriminate against employees simply because of who they are.   We believe the school violated the Minnesota Human Rights Act (MHRA) by refusing to allow Grace, who served as a secular librarian at the school, to reapply for her position on the basis of gender identity and sex. While the MHRA does permit limited exemptions on religious grounds, the Legislature never intended for these exemptions to apply to secular employees. In this episode of The Gender Justice Brief, Reyzl Grace's attorney, Brittany Stewart, outlines our case seeking justice for her: Background and context on Reyzl Grace's case Grace v. Academy of Holy Angels — Fact Sheet Read the complaint here Sign up to stay informed on Reyzl Grace's case ### Visit the "Gender Justice" Website ⁠here⁠ and "Unrestrict Minnesota" ⁠here⁠. The GJB is produced by Michael at ⁠www.501MediaGroup.com⁠ & Audra Grigus.

Pharmacogenomics plays a critical role in personalised medicine, as some adverse drug reactions are genetically determined. Adverse drugs reactions (ADRs) account for 6.5% of hospital admissions in the UK, and the application of pharmacogenomics to look at an individuals response to drugs can significantly enhance patient outcomes and safety. In this episode, our guests discuss how genomic testing can identify patients who will respond to medications and those who may have adverse reactions. We hear more about Genomics England's collaboration with the Medicines and Healthcare products Regulatory Agency in the Yellow Card Biobank and our guests discuss the challenges of implementing pharmacogenomics into the healthcare system. Our host Vivienne Parry, Head of Public Engagement at Genomics England, is joined by Anita Hanson, Research Matron and the Lead Research Nurse for clinical pharmacology at Liverpool University Hospitals NHS Foundation Trust, and Professor Bill Newman, Professor of translational genomic medicine at the Manchester Center for Genomic Medicine, and Professor Matt Brown, Chief Scientific Officer at Genomics England.   "I think we're moving to a place where, rather than just doing that one test that might be relevant to one drug, we'd be able to do a test which at the same price would generate information that could be relevant at further points in your life if you were requiring different types of medicine. So, that information would then be available in your hospital record, in your GP record, that you could have access to it yourself. And then I think ultimately what we would really love to get to a point is where everybody across the whole population just has that information to hand when it's required, so that they're not waiting for the results of a genetic test, it's immediately within their healthcare record."   To learn more about Jane's lived experience with Stevens-Johnson syndrome, visit The Academy of Medical Sciences' (AMS) YouTube channel. The story, co-produced by Areeba Hanif from AMS, provides an in-depth look at Jane's journey. You can watch the video via this link: https://www.youtube.com/watch?v=v4KJtDZJyaA  Want to learn more about personalised medicine? Listen to our Genomics 101 episode where Professor Matt Brown explains what it is in less than 5 minutes: https://www.genomicsengland.co.uk/podcasts/genomics-101-what-is-personalised-medicine  You can read the transcript below or download it here: https://www.genomicsengland.co.uk/assets/documents/Podcast-transcripts/Can-genomic-testing-prevent-adverse-drug-reactions.docx   Vivienne: Hello and welcome to Behind the Genes.  Bill: What we've seen is that the limited adoption so far in the UK and other countries has focused particularly on severe adverse drug reactions. They've been easier to identify and there's a clear relationship between some drugs and some genetic changes where that information is useful. So, a good example has been the recent adoption of pharmacogenetic testing for a gene called DPYD for patients undergoing cancer treatment, particularly breast and bowel cancer. And if you have an absence of the enzyme that that gene makes, if you're given that treatment, then you can end up on intensive care and die, so it's a really significant side effect. But as you say, the most common side effects aren't necessarily fatal, but they can have a huge impact upon people and on their wellbeing.  Vivienne: My name's Vivienne Parry and I'm head of public engagement at Genomics England, and today we'll be discussing the critical role of pharmacogenomics in personalised medicine, highlighting its impact on how well medicines work, their safety, and on patient care. I'm joined today by Professor Bill Newman, professor of translational genomic medicine at the Manchester Centre for Genomic Medicine, Anita Hanson, research matron, a fabulous title, and lead research nurse for clinical pharmacology at the Liverpool University Hospital's NHS Foundation Trust, and Professor Matt Brown, chief scientific officer for Genomics England. And just remember, if you enjoy today's episode, we'd love your support, so please like, share and rate us on wherever you listen to your podcasts.  So, first question to you, Bill, what is pharmacogenomics?  Bill: Thanks Viv. I think there are lots of different definitions, but how I think of pharmacogenetics is by using genetic information to inform how we prescribe drugs, so that they can be safer and more effective. And we're talking about genetic changes that are passed down through families, so these are changes that are found in lots of individuals. We all carry changes in our genes that are important in how we transform and metabolise medicines, and how our bodies respond to them.  Vivienne: Now, you said pharmacogenetics. Is it one of those medicine things like tomato, tomato, or is there a real difference between pharmacogenetics and pharmacogenomics?  Bill: So, people, as you can imagine, do get quite irate about this sort of thing, and there are lots of people that would contest that there is a really big important difference. I suppose that pharmacogenetics is more when you're looking at single changes in a relatively small number of genes, whereas pharmacogenomics is a broader definition, which can involve looking at the whole genome, lots of genes, and also whether those genes are switched on or switched off, so the expression levels of those genes as well would encompass pharmacogenomics. But ultimately it's using genetic information to make drug prescription safer and more effective.  Vivienne: So, we're going to call it pharmacogenomics and we're talking about everything, that's it, we'll go for it. So Matt, just explain if you would the link between pharmacogenomics and personalised medicine. And I know that you've done a big Genomics 101 episode about personalised medicine, but just very briefly, what's the link between the two?  Matt: So, personalised medicine's about using the right dose of the right drug for the right individual. And so pharmacogenomics helps you with not only ensuring that you give a medication which doesn't cause problems for the person who receives it, so an adverse drug reaction, but also that they're actually getting the right dose. Of course, people's ability to metabolise, activate and respond to drugs genetically is often genetically determined, and so sometimes you need to adjust the dose up or down according to a person's genetic background.  Vivienne: Now, one of the things that we've become very aware of is adverse drug reactions, and I think they account for something like six and a half percent of all hospital admissions in the UK, so it's absolutely huge. Is that genetically determined adverse drug reactions?  Matt: So, the answer to that is we believe so. There's quite a bit of data to show that you can reduce the risk of people needing a hospital admission by screening genetic markers, and a lot of the very severe reactions that lead to people being admitted to hospital are very strongly genetically determined. So for example, there are HLA types that affect the risk of adverse drug reactions to commonly used medications for gout, for epilepsy, some HIV medications and so on, where in many health services around the world, including in England, there are already tests available to help prevent those leading to severe reactions. It's likely though that actually the tests we have available only represent a small fraction of the total preventable adverse drug reactions were we to have a formal pre-emptive pharmacogenomics screening programme.  Vivienne: Now, I should say that not all adverse drug reactions are genetic in origin. I mean, I remember a rather nasty incident on the night when I got my exam results for my finals, and I'd actually had a big bee sting and I'd been prescribed antihistamines, and I went out and I drank rather a lot to celebrate, and oh my goodness me, I was rather ill [laughter]. So, you know, not all adverse drug reactions are genetic in origin. There are other things that interact as well, just to make that clear to people.  Matt: Yes, I think that's more an interaction than an adverse drug reaction. In fact frankly, the most common adverse drug reaction in hospitals is probably through excess amounts of water, and that's not medically determined, that's the prescription.  Vivienne: Let me now come to Anita. So, you talk to patients all the time about pharmacogenomics in your role. You've been very much involved in patient and public involvement groups at the Wolfson Centre for Personalised Medicine in Liverpool. What do patients think about pharmacogenomics? Is it something they welcome?  Anita: I think they do welcome pharmacogenomics, especially so with some of the patients who've experienced some of the more serious, life threatening reactions. And so one of our patients has been doing some work with the Academy of Medical Sciences, and she presented to the Sir Colin Dollery lecture in 2022, and she shared her story of having an adverse drug reaction and the importance of pharmacogenomics, and the impact that pharmacogenomics can have on patient care.  Vivienne: Now, I think that was Stevens-Johnson syndrome. We're going to hear in a moment from somebody who did experience Stevens-Johnson's, but just tell us briefly what that is.  Anita: Stevens-Johnson syndrome is a potentially life threatening reaction that can be caused by a viral infection, but is more commonly caused by a medicine. There are certain groups of medicines that can cause this reaction, such as antibiotics or anticonvulsants, nonsteroidal anti-inflammatories, and also a drug called allopurinol, which is used to treat gout. Patients have really serious side effects to this condition, and they're often left with long-term health complications. The morbidity and mortality is considerable as well, and patients often spend a lot of time in hospital and take a long time to recover.   Vivienne: And let's now hear from Jane Burns for someone with lived experience of that Stevens-Johnson syndrome. When Jane Burns was 19, the medicine she took for her epilepsy was changed.  Jane: I remember waking up and feeling really hot, and I was hallucinating, so I was taken to the Royal Liverpool Hospital emergency department by my parents. When I reached A&E, I had a temperature of 40 degrees Celsius. I was given Piriton and paracetamol, and the dermatologist was contacted. My mum had taken my medication to hospital and explained the changeover process with my epilepsy medication. A decision was made to discontinue the Tegretol and I was kept in for observation. Quite rapidly, the rash was changing. Blisters were forming all over my body, my mouth was sore and my jaw ached. My temperature remained very high. It was at this point that Stevens-Johnson syndrome, or SJS, was diagnosed.  Over the next few days, my condition deteriorated rapidly. The rash became deeper in colour. Some of the blisters had burst, but some got larger. I developed ulcers on my mouth and it was extremely painful. I started to lose my hair and my fingernails. As I had now lost 65 percent of my skin, a diagnosis of toxic epidermal necrolysis, or TEN, was made. Survivors of SJS TEN often suffer with long-term visible physical complications, but it is important to also be aware of the psychological effects, with some patients experiencing post-traumatic stress disorder. It's only as I get older that I realise how extremely lucky I am to have survived. Due to medical and nursing expertise, and the research being conducted at the time, my SJS was diagnosed quickly and the medication stopped. This undoubtedly saved my life.  Vivienne: Now, you've been looking at the development of a passport in collaborating with the AMS and the MHRA. Tell me a bit more about that.  Anita: Yes, we set up a patient group at the Wolfson Centre for Personalised Medicine approximately 12 years ago, and Professor Sir Munir Pirmohamed and I, we wanted to explore a little bit more about what was important to patients, really to complement all the scientific and clinical research activity within pharmacogenomics. And patients recognised that, alongside the pharmacogenomic testing, they recognised healthcare professionals didn't really have an awareness of such serious reactions like Stevens-Johnson syndrome, and so they said they would benefit from having a My SJS Passport, which is a booklet that can summarise all of the important information about their care post-discharge, and this can then be used to coordinate and manage their long-term healthcare problems post-discharge and beyond. And so this was designed by survivors for survivors, and it was then evaluated as part of my PhD, and the findings from the work suggest that the passport is like the patient's voice, and it really does kind of validate their diagnosis and raises awareness of SJS amongst healthcare professionals. So, really excellent findings from the research, and the patients think it's a wonderful benefit to them.  Vivienne: So, it's a bit like a kind of paper version of the bracelet that you sometimes see people wearing that are on steroids, for instance.  Anita: It is like that, and it's wonderful because it's a handheld source of valuable information that they can share with healthcare professionals. And this is particularly important if they're admitted in an emergency and they can't speak for themselves. And so the passport has all that valuable information, so that patients aren't prescribed that drug again, so it prevents them experiencing a serious adverse drug reaction again.   Vivienne: So, Stevens-Johnson, Bill, is a really scary side effect, but what about the day to day benefits of pharmacogenomics for patients?  Bill: So, what we've seen is that the limited adoption so far in the UK and other countries has focused particularly on severe adverse drug reactions. They've been easier to identify and there's a clear relationship between some drugs and some genetic changes where that information is useful. So a good example has been the recent adoption of pharmacogenetic testing for a gene called DPYD for patients undergoing cancer treatment, particularly breast and bowel cancer. And if you have an absence of the enzyme that that gene makes, if you're given that treatment, then you can end up on intensive care and die, so it's a really significant side effect. But as you say, the most common side effects aren't necessarily fatal, but they can have a huge impact upon people and on their wellbeing.   And it's not just in terms of side effects. It's in terms of the effectiveness of the medicine. Because if a person is prescribed a medicine that doesn't or isn't going to work for them then it can take them longer to recover, to get onto the right medicine. That can have all sorts of detrimental effects. And so when we're thinking about introducing pharmacogenetics more broadly rather than just on a single drug or a single gene basis, we're thinking about that for common drugs like antidepressants, painkillers, statins, the drugs that GPs are often prescribing on a regular basis to a whole range of patients.  Vivienne: So, to go back to you, Anita, we're really talking about dose here, aren't we, whether you need twice the dose or half the dose depending on how quickly your body metabolises that particular medicine. How do patients view that?  Anita: Well, the patient in question who presented for the Academy of Medical Sciences, I mean, her take on this was, she thinks pharmacogenetics is wonderful because it will allow doctors and nurses to then prescribe the right drug, but also to adapt the dose accordingly to make sure that they get the best outcome, which provides the maximum benefit while also minimising any potential harm. And so from her perspective, that was one of the real benefits of pharmacogenomics. But she also highlighted about the benefits for future generations, the fear of her son taking the same medicine and experiencing the same reaction. And so I think her concerns were, if we have pharmacogenetic testing for a panel of medicines, as Bill mentioned then, then perhaps this would be fantastic for our children as they grow up, and we can identify and predict and prevent these type of reactions happening to future generations.  Vivienne: And some of these drugs, Bill, are really very common indeed, something like codeine. Just tell us about codeine, ‘cos it's something – whenever I tell this to friends [laughter], they're always completely entranced by the idea that some people don't need nearly as much codeine as others.  Bill: Yeah, so codeine is a drug that's very commonly used as a painkiller. To have its real effect, it needs to be converted in the body to a different drug called morphine, and that is done by an enzyme which is made by a gene called CYP2D6. And we all carry changes in CYP2D6, and the frequency of those variants, whether they make the gene work too much or whether they make it work too little, they vary enormously across the world, so that if you go to parts of Africa, about 30 percent of the population will make more of the CYP2D6, and so they will convert the codeine much more quickly, whereas if you go to the UK, maybe up to ten percent of the white population in the UK just won't be converting codeine to morphine at all, so they won't get any benefit from the drug. So at both ends, you have some people that don't respond and some people that respond a little bit too much so that they need either an alternative drug or they need a different dose.  Vivienne: So, all those people who say, you know, “My headache hasn't been touched by this painkiller,” and we say, “What a wimp you're being,” actually, it's to do with genetics.  Bill: Yeah, absolutely. There's a biological reason why people don't – not for everybody, but for a significant number of people, that's absolutely right, and we can be far more tailored in how we prescribe medication, and get people onto painkillers that work for them much more quickly.  Vivienne: And that's so interesting that it varies by where you come from in the world, because that means we need to give particular attention – and I'm thinking, Anita, to working with patients from different community groups, to make sure that they understand the need for pharmacogenomics.  Anita: I think that's really important, Vivienne, and I think we are now having discussions with the likes of Canada SJS awareness group, and also people have been in touch with me from South Africa because people have requested the passport now to be used in different countries, because they think it's a wonderful tool, and it's about raising awareness of pharmacogenomics and the potential benefits of that, and being able to share the tools that we've got to help patients once they've experienced a serious reaction.  Vivienne: So, pharmacogenomics clearly is important in the prevention of adverse drug reactions, better and more accurate prescribing, reduced medicines wastage. Does this mean that it's also going to save money, Bill, for the NHS?  Bill: Potentially. It should do if it's applied properly, but there's lots of work to make sure that not only are we using the right evidence and using the right types of tests in the laboratory, but we're getting the information to prescribers, so to GPs, to pharmacists, to hospital doctors, in a way that is understandable and meaningful, such that they can then act upon that information. So, the money will only be saved and then can be reused for healthcare if the whole process and the whole pathway works, and that information is used effectively.  Vivienne: So, a lot of research to make sure that all of that is in place, and to demonstrate the potential cost savings.  Bill: Yes. I mean, there are very nice studies that have been done already in parts of the world that have shown that the savings that could be accrued for applying pharmacogenetics across common conditions like depression, like in patients to prevent secondary types of strokes, are enormous. They run into hundreds of millions of pounds or dollars. But there is an initial investment that is required to make sure that we have the testing in place, that we have the digital pathways to move the information in place, and that there's the education and training, so that health professionals know how to use the information. But the potential is absolutely enormous.  Vivienne: Matt, can I turn now to the yellow card. So, people will be very familiar with the yellow card system. So, if you have an adverse reaction, you can send a yellow card in – I mean, literally, it is a yellow card [laughter]. It does exactly what it says on the tin. You send a yellow card to the MHRA, and they note if there's been an adverse effect of a particular medicine. But Genomics England is teaming up with the MHRA to do something more with yellow cards, and we're also doing this with the Yellow Card Biobank. Tell us a bit more.  Matt: So, yellow card's a great scheme that was set up decades ago, initially starting off, as you said, with literally yellow cards, but now actually most submissions actually come online. And it's important to note that submissions can come not just from healthcare providers, but majority of submissions actually come from patients themselves, and that people should feel free, if they feel they've had an adverse drug reaction, to report that themselves rather than necessarily depending on a medical practitioner or the healthcare provider to create that report. So, Genomics England is partnering with the MHRA in building what's called the Yellow Card Biobank, the goal of which is to identify genetic markers for adverse drug reactions earlier than has occurred in the past, so that we can then introduce genetic tests to prevent these adverse drug reactions much sooner than has occurred previously.   So, what we're doing is basically at the moment we're doing a pilot, but the ultimate plan is that in future, patients who report a serious adverse drug reaction through the Yellow Card Biobank will be asked to provide a sample, a blood sample, that we then screen. We do a whole genome sequence on it, and then combine these with patients who've had like adverse drug reactions and identify genetic markers for that adverse drug reaction medication earlier, that can then be introduced into clinical practice earlier. And this should reduce by decades the amount of time between when adverse drug reactions first start occurring with medications and us then being able to translate that into a preventative mechanism.  Vivienne: And will that scheme discover, do you think, new interactions that you didn't know about before? Or do you expect it to turn up what you already know about?  Matt: No, I really think there's a lot of discovery that is yet to happen here. In particular, even for drugs that we know cause adverse drug reactions, mostly they've only been studied in people of European ancestry and often in East Asian ancestry, but in many other ancestries that are really important in the global population and in the UK population, like African ancestry and South Asian ancestries, we have very little data. And even within Africa, which is an area which is genetically diverse as the rest of the world put together, we really don't know what different ethnicities within Africa, actually what their genetic background is with regard to adverse drug reactions.  The other thing I'd say is that there are a lot of new medications which have simply not been studied well enough. And lastly, that at the moment people are focused on adverse drug reactions being due to single genetic variants, when we know from the model of most human diseases that most human diseases are actually caused by combinations of genetic variants interacting with one another, so-called common disease type genetics, and that probably is similarly important with regard to pharmacogenomics as it is to overall human diseases. That is, it's far more common that these are actually due to common variants interacting with one another rather than the rare variants that we've been studying to date.  Vivienne: So, it's a kind of cocktail effect, if you like. You know, you need lots of genes working together and that will produce a reaction that you may not have expected if you'd looked at a single gene alone.  Matt: That's absolutely correct, and there's an increasing amount of evidence to show that that is the case with medications, but it's really very early days for research in that field. And the Yellow Card Biobank will be one of many approaches that will discover these genetic variants in years to come.  Vivienne: Now, Matt's a research scientist. Bill, you're on the frontline in the NHS. How quickly can this sort of finding be translated into care for people in the NHS?  Bill: So, really quickly is the simple answer to that, Viv. If we look at examples from a number of years ago, there's a drug called azathioprine that Matt has used lots in some of his patients. In rheumatology, it's used for patients with inflammatory bowel disease. And the first studies that showed that there was a gene that was relevant to having bad reactions to that drug came out in the 1980s, but it wasn't until well into this century, so probably 30-plus years later that we were routinely using that test in clinical medicine. So, there was an enormous lot of hesitancy about adopting that type of testing, and a bit of uncertainty. If you move forward to work that our colleague Munir Pirmohamed in Liverpool has done with colleagues in Australia like Simon Mallal around HIV medicine, there was this discovery that a drug called abacavir, that if you carried a particular genetic change, that you had a much higher risk of having a really severe reaction to that. The adoption from the initial discovery to routine, worldwide testing happened within four years.   So, already we've seen a significant change in the appetite to move quickly to adopt this type of testing, and I see certainly within the NHS and within other health systems around the world, a real desire to adopt pharmacogenetics into routine clinical practice quickly and at scale, but also as part of a broader package of care, which doesn't just solely focus on genetics, but thinks about all the other parts that are important in how we respond to medication. So, making sure we're not on unusual combinations of drugs, or that we're taking our medicine at the right time and with food or not with food, and all of those other things that are really important. And if you link that to the pharmacogenetics, we're going to have a much safer, more effective medicines world.  Vivienne: I think one of the joys of working at Genomics England is that you see some of this work really going into clinical practice very fast indeed. And I should say actually that the Wolfson Centre for Personalised Medicine, the PPI group that Anita looks after so well, they've been very important in recruiting people to Yellow Card Biobank. And if anyone's listening to this, Matt, and wants to be part of this, how do they get involved? Or is it simply through the yellow card?  Matt: So at the moment, the Yellow Card Biobank is focusing on alopurinol.   Vivienne: So, that's a medicine you take for gout.  Matt: Which I use a lot in my rheumatology clinical practice. And direct acting oral anticoagulants, DOACs, which are used for vascular disease therapies and haemorrhage as a result of that. So, the contact details are available through the MHRA website, but I think more importantly, it's just that people be aware of the yellow card system itself, and that if they do experience adverse drug reactions, that they do actually complete a report form, ‘cos I think still actually a lot of adverse drug reactions go unreported.  Vivienne: I'm forgetting of course that we see Matt all the time in the Genomics England office and we don't think that he has any other home [laughter] than Genomics England, but of course he still sees some patients in rheumatology clinic. So, I want to now look to the future. I mean, I'm, as you both know, a huge enthusiast for pharmacogenomics, ‘cos it's the thing that actually, when you talk to patients or just the general public, they just get it straight away. They can't think why, if you knew about pharmacogenomics, why you wouldn't want to do it. But it's not necessarily an easy thing to do. How can we move in the future, Bill, to a more proactive approach for pharmacogenomics testing? Where would we start?  Bill: Yes, so I think we've built up really good confidence that pharmacogenetics is a good thing to be doing. Currently, we're doing that predominantly at the point when a patient needs a particular medicine. That's the time that you would think about doing a genetic test. And previously, that genetic test would only be relevant for that specific drug. I think we're moving to a place where, rather than just doing that one test that might be relevant to one drug, we'd be able to do a test which at the same price would generate information that could be relevant at further points in your life if you were requiring different types of medicine. So, that information would then be available in your hospital record, in your GP record, that you could have access to it yourself. And then I think ultimately what we would really love to get to a point is where everybody across the whole population just has that information to hand when it's required, so that they're not waiting for the results of a genetic test, it's immediately within their healthcare record. That's what we'd call pre-emptive pharmacogenetic testing, and I think that's the golden land that we want to reach.  Vivienne: So for instance, I might have it on my NHS app, and when I go to a doctor and they prescribe something, I show my app to the GP, or something pops up on the GP's screen, or maybe it's something that pops up on the pharmacist's screen.  Bill: I think that's right. I think that's what we're looking to get to that point. We know that colleagues in the Netherlands have made some great progress at developing pathways around that. There's a lot of public support for that. And pharmacists are very engaged in that. In the UK, the pharmacists, over the last few years, have really taken a very active role to really push forward this area of medicine, and this should be seen as something that is relevant to all people, and all health professionals should be engaged with it.  Vivienne: And on a scale of one to ten, how difficult is it going to be to implement in the NHS?  Bill: So, that's a difficult question. I think the first thing is identifying what the challenges are. So I have not given you a number, I've turned into a politician, not answered the question. So, I think what has happened over the last few years, and some of our work within the NHS Network of Excellence in pharmacogenetics and some of the other programmes of work that have been going on, is a really good, honest look at what it is we need to do to try to achieve pharmacogenetics implementation and routine use. I don't think the challenge is going to be predominantly in the laboratory. I think we've got phenomenal laboratories. I think we've got great people doing great genetic testing. I think the biggest challenges are going to be about how you present the data, and that data is accessible. And then ensuring that health professionals really feel that this is information that isn't getting in the way of their clinical practice, but really making a difference and enhancing it, and of benefit both to the healthcare system but more importantly to the patients.  Vivienne: Now, when I hear you both talk, my mind turns to drug discovery and research, and Matt, I'm quite sure that that's right at the top of your mind. Tell us how pharmacogenomics can help in drug discovery and research.  Matt: So, pharmacogenomics, I think actually just genetic profiling of diseases in itself just to start off with is actually a really good way of identifying new potential therapeutic targets, and also from derisking drug development programmes by highlighting likely adverse drug reactions of medications that are being considered for therapeutic trials, or targets that are being considered for therapeutic development. Pharmacogenomics beyond that is actually largely about – well, it enables drug development programmes by enabling you to target people who are more likely to respond, and avoid people who are more likely to have adverse drug reactions. And so that therapeutic index of the balance between likely efficacy versus likely toxicity, genetics can really play into that and enable medications to be used where otherwise they might have failed.  This is most apparent I think in the cancer world. A classic example there, for example, is the development of a class of medications called EGFR inhibitors, which were developed for lung cancer, and in the initial cancer trials, actually were demonstrated to be ineffective, until people trialled them in East Asia and found that they were effective, and that that turns out to be because the type of cancers that respond to them are those that have mutations in the EGFR gene, and that that's common in East Asians. We now know that, wherever you are in the world, whether you're East Asian or European or whatever, if you have a lung adenocarcinoma with an EGFR mutation, you're very likely to respond to these medications. And so that pharmacogenomic discovery basically rescued a class of medication which is now probably the most widely used medication for lung adenocarcinomas, so a huge beneficial effect. And that example is repeated across multiple different cancer types, cancer medication types, and I'm sure in other fields we'll see that with expansive new medications coming in for molecularly targeted therapies in particular.  Vivienne: So, smaller and more effective trials rather than larger trials that perhaps seem not to work but actually haven't been tailored enough to the patients that are most likely to benefit.  Matt: Yeah, well, particularly now that drug development programmes tend to be very targeted at specific genetic targets, pharmacogenetics is much more likely to play a role in identifying patients who are going to respond to those medications. So, I think many people in the drug development world would like to see that, for any significant drug development programme, there's a proper associated pharmacogenomic programme to come up with molecular markers predicting a response.  Vivienne: We're going to wrap up there. Thank you so much to our guests, Bill Newman, Anita Hanson, Matt Brown, and our patient Jane Burns. Thank you so much for joining us today to discuss pharmacogenomics in personalised medicine, and the benefits, the challenges and the future prospects for integrating pharmacogenomics into healthcare systems. And if you'd like to hear more podcasts like this, please subscribe to Behind the Genes. It's on your favourite podcast app. Thank you so much for listening. I've been your host, Vivienne Parry. This podcast was edited by Bill Griffin at Ventoux Digital and produced by the wonderful Naimah. Bye for now. 

Topic: Malcolm, Carol, and Joe Sherman celebrate Back to School Week at MPB with a visit from Elaine Trigiani before she heads home to Italy. They talk about Elaine's online classes, travel, and olive oil. And then, the Executive Director of the Mississippi Hospitality and Restaurant Association, Pat Fontaine, and culinary arts instructor from Clinton High School, Chef Catherine Bruce, talk about MHRA and the ProStart program for Mississippi high schoolers.Guest(s): Elaine Trigiani, Pat Fontaine, and Catherine BruceHost(s): Malcolm White, Carol Palmer, and Joe ShermanEmail: food@mpbonline.org Hosted on Acast. See acast.com/privacy for more information.

The Medicines and Healthcare products Regulatory Agency better known as the MHRA, rearranges to spells HARM and they now prefer to be Enablers not Regulators.

On this episode, Dr. Tala Fakhouri (Associate Director for Data Science and Artificial Intelligence Policy, FDA) and Stephen Pyke (Chief Clinical Data & Digital Officer, Parexel) join the podcast to discuss how the FDA and regulators around the world are thinking about the use of AI in clinical research.They dive deeper into the FDA's evidentiary standards for AI, what organizations should consider about methodological transparency in submissions, and AI's potential as a tool that can help bring medicines to market more efficiently.For more information on ACRO's AI/ML Principles Statement, visit ACRO's website: https://www.acrohealth.org/initiatives-hub/ai-ml-in-drug-development/

The Data Product Management In Action podcast, brought to you by Soda and executive producer Scott Hirleman, is a platform for data product management practitioners to share insights and experiences. In Season 01, Episode 002, host Frannie Helforoush (Senior Digital Product Manager at RBC Global Asset Management) chats with Deepti Surabattula (Principal Data Product Manager and AI Delivery & Support Workstream Lead at Pfizer). They discuss the importance of user and stakeholder involvement in data product management and effective relationship management. Deepti shares experiences and challenges with different implementation processes and how to enjoy and find reward in creating valuable data products. About our host Frannie Helforoush: Frannie's journey began as a software engineer and evolved into a strategic product manager. Now, as a data product manager, she leverages her expertise in both fields to create impactful solutions. Frannie thrives on making data accessible and actionable, driving product innovation, and ensuring product thinking is integral to data management. Connect with Frannie on LinkedIn. About our guest Deepti Surabattula: Deepti is a product leader with a strong engineering background. She has proven success across Life Sciences, Aerospace, and Medical Devices, leading AI, data, and regulatory-compliant products from inception to delivery. Deepti is an expert in regulatory guidelines for data integrity and product compliance (21 CFR part 11, GDPR, MHRA, ICH, EMA) and is passionate about strategy, technology innovation, and quality solutions to improve human lives. Connect with Deepti on LinkedIn. All views and opinions expressed are those of the individuals and do not necessarily reflect their employers or anyone else. Join the conversation on LinkedIn.  

As AstraZeneca forges on creating more ‘vaccines', what about those left behind who have lost everything? Blocked on social media by the UK's medicines regulator and reported to a government agency for ‘misinformation', Adam tells what life is like when you are vaccine-injured or bereaved. Read the write-up at: https://www.ukcolumn.org/video/blocked-by-the-mhra-reported-to-the-health-security-agency-a-day-in-the-life-of-vaccine

Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA's advisory committee reform effort (:32), the agency's efforts to help the clinical trial modeling and simulation industry (16:22), and the UK's MHRA plan to use artificial intelligence to assist in drug application reviews (21:05). More On These Topics From The Pink Sheet US FDA Adcomm Reform: Does Listening Session Suggest No Major Near-Term Changes?: https://pink.citeline.com/PS150167/US-FDA-Adcomm-Reform-Does-Listening-Session-Suggest-No-Major-Near-Term-Changes US FDA Wants Advice About Advisory Committees: Try Having Some?: https://pink.citeline.com/PS154644/US-FDA-Wants-Advice-About-Advisory-Committees-Try-Having-Some US FDA Developing Model Master File System To Grow Modeling, Simulation Field: https://pink.citeline.com/PS154647/US-FDA-Developing-Model-Master-File-System-To-Grow-Modeling-Simulation-Field UK's MHRA To Use AI In Regulatory Review Process & RWD Analysis: https://pink.citeline.com/PS154643/UKs-MHRA-To-Use-AI-In-Regulatory-Review-Process--RWD-Analysis

How many medicines can you think of created for just one person? The likelihood is none - which is why the world hasn't heard of milasen yet. But its creation, and the efforts behind it, could build a pathway towards some of the greatest advances in genomic medicine, and a new initiative being trialled in Britain has a huge role to play in making this happen. At the age of seven, Mila Makovec became the first person in the world to be treated with a medicine created just for her. A bubbly young girl from Colorado, Mila suffered from a very rare genetic disorder called Batten disease, which leads to a painful early death in children. Mila's mother, Julia Vitarello, resolutely sought out scientists to try to discover a way to save her daughter. After relentless efforts, one doctor, Timothy Yu from Boston Children's Hospital, imagined a possible treatment for Mila. The challenge was it involved making a completely unique treatment for Mila's specific genetic mutation. It would be novel and very expensive - but it was her only option. Julia raised the millions of dollars required through a charity she set up in her daughter's name, and in 2018 Mila became the one patient in the world to receive the drug milasen. Initially, it worked, and Mila's condition stabilised and improved. However, the treatment was given after the disease had done a great deal of damage to a small child, and Mila died when she was ten years old.There are an estimated 7,000 rare diseases in the world, affecting more than 400 million people - and most are genetic. The majority have no effective treatment. New medicines for these conditions can't be put through clinical trials on groups of patients because they are so rare. So, currently, such novel therapeutics can only be legally given after lengthy and costly work that is uncommercial for drug firms. Having got so achingly close to saving her daughter, Mila's mother is now leading efforts to make these new genetic medicines available to other children with rare diseases - and Britain is where her campaign is about to take a huge step forward. The launch of the Rare Therapies Launch Pad is bringing together efforts from Mila's Miracle Foundation, the UK medicine's regulator the MHRA, Genomics England and Oxford University in an world leading attempt to build a new streamlined regulatory pathway to allow one-off drugs to be designed and approved for use in individual patients with rare diseases. Natasha Loder, Health Editor at the Economist, tells this very personal story of how one mother's determination to try and save her daughter could lead to a revolution in personalised medicine - one that has the potential to bring hope to millions of families. Producer: Sandra Kanthal

Cheryl Grainger joins Mike, Debi and Ben for further discussion on the MHRA withholding data on vaccinated pregnant women. Extra is normally members-only, but we feel this topic should be available to everyone. Please share this link: www.ukcolumn.org/video/uk-column-news-extra-12th-april-2024

Grab your trainers, your dog lead or a cuppa and join us for some free CPD as we have another relaxed round up of recent Red Whale primary care Pearls of wisdom. This month, Nik and Caroline discuss: Acute aortic dissection. What would you do if you suspected it?The limping child. Who goes in to hospital? Who might be able to be managed in primary care?Soluble tablets. Are you aware how much sodium is in the average soluble pill?Quinolones… just say no to systemic fluroquinolones! Why have the MHRA released a drug safety update?All of the above questions, and more, will be answered during the episode. Listen as soon as you can to ensure you have full access to all the free resources. And hear about how some home grown tomatoes brought a primary care team together, but left an unpleasant taste in the mouth!!Send us your feedback podcast@redwhale.co.uk or send a voice message Sign up to receive Pearls here Pearls are available for 3 months from publish date. After this, you can get access them - plus 100s more articles - when you buy a one-day online course from Red Whale OR sign up to Red Whale Unlimited. Find out more here. Follow us: XFacebookInstagramLinkedIn Disclaimer We make every effort to ensure the information in this podcast is accurate and/ correct at the date of publication, but it is of necessity of a brief and general nature, and this should not replace your own good clinical judgement, or be regarded as a substitute for taking professional advice in appropriate circumstances. In particular, check drug doses, side-effects and interactions with the British National Formulary. Save insofar as any such liability cannot be excluded at law, we do not accept any liability for loss of any type caused by reliance on the information in this podcas...

GET HEIRLOOM SEEDS & NON GMO SURVIVAL FOOD HERE: https://heavensharvest.com/ USE Code WAM to save 5%! GET ORGANIC COFFEE, MANUKA HONEY AND MUSHROOM TINCTURES HERE: https://madtravnutrition.com/ Use Code "Josh" and save 10%! Support the work of Jaymie Icke & Ickonic! HELP THE WAM LEGAL DEFENSE FUND HERE: https://gogetfunding.com/wam-legal-defense/ BUY GOLD HERE: https://firstnationalbullion.com/schedule-consult/ GET YOUR APRICOT SEEDS at the life-saving Richardson Nutritional Center HERE: https://rncstore.com/r?id=bg8qc1 Josh Sigurdson reports on the news of congressional Republicans introducing "The LIABLE Act." The act is meant to hold vaccine manufacturers like Pfizer, Moderna and Johnson & Johnson responsible for vaccine injuries and crimes against humanity. The LIABLE Act stands for "Let Injured Americans Be Legally Empowered Act" and so far has a lot of support after vaccine manufacturers were essentially given full immunity in the fact of their massive global eugenics exercise. While it's good news, it's yet another example of "hopium." It's too little, too late. Of course these corporations should be held liable for the mass death and the injuries, but once again, we're offloading responsibilities on government, the same entity that forced these deadly injections into people's arms. Everything needs to be overhauled, not just big pharma which pays the government to force people to their graves with mandates and insane regulations. Former Governor Andrew Cuomo has also been subpoenaed in a GOP led investigation into nursing home deaths in 2020 in New York. More good news, but again... Are we really trusting government to hold themselves in check? The MHRA, The UK's Medicines and Healthcare Regulatory Agency is also under fire as millions demand answers after they openly admitted they used "circular reasoning" with their claims that the increase in vaccine injuries is only due to more public awareness. The CDC just released 148 pages on myocarditis and the covid shots and all pages were redacted. We're ruled by anti-human psychopaths and many are actually expecting these anti-human psychopaths to make things right. Give your head a shake my friends. The solution is YOU. In this video, we break down this latest news and why we shouldn't hold too much hopium but we should also not feel hopeless. Let's be reasonable and apply real solutions to these problems individually instead of extrapolating the issues into the government's hands. Stay tuned for more from WAM! ORDER QUALITY MEAT TO YOUR DOOR HERE: https://wildpastures.com/promos/save-20-for-life/bonus15?oid=6&affid=321 Save 20% and get $15 off your FIRST order! Support your local farms and stay healthy! HELP SUPPORT US AS WE DOCUMENT HISTORY HERE: https://gogetfunding.com/help-wam-cover-history/ GET AN EXTENDED FREE TRIAL FOR ICKONIC WHEN YOU SIGN UP HERE: https://www.ickonic.com/affiliate/josh10 BUY YOUR PRIVATE CLEARPHONE HERE: https://www.r1kln3trk.com/3PC4ZXC/F9D3HK/ LION ENERGY: Never Run Out Of Power! PREPARE NOW! https://www.r1kln3trk.com/3PC4ZXC/D2N14D/ GET VITAMINS AND SUPPLEMENTS FROM DR. ZELENKO HERE: https://zstacklife.com/?ref=WAM GET TIM'S FREE Portfolio Review HERE: https://bit.ly/redpilladvisor And become a client of Tim's at https://www.TheLibertyAdvisor.com STOCK UP ON STOREABLE FOODS HERE: http://wamsurvival.com/ OUR GOGETFUNDING CAMPAIGN: https://gogetfunding.com/help-keep-wam-alive/ OUR PODBEAN CHANNEL: https://worldaltmedia.podbean.com/ Find us on Vigilante TV HERE: https://vigilante.tv/c/world_alternative_media/videos?s=1 FIND US on Rokfin HERE: https://rokfin.com/worldalternativemedia FIND US on Gettr HERE: https://www.gettr.com/user/worldaltmedia See our EPICFUNDME HERE: https://epicfundme.com/251-world-alternative-media JOIN OUR NEWSLETTER HERE: https://www.iambanned.com/ JOIN our Telegram Group HERE: https://t.me/worldalternativemedia JOIN US on Rumble Here: https://rumble.com/c/c-312314 FIND WAM MERCHANDISE HERE: https://teespring.com/stores/world-alternative-media FIND OUR CoinTree page here: https://cointr.ee/joshsigurdson JOIN US on SubscribeStar here: https://www.subscribestar.com/world-alternative-media We will soon be doing subscriber only content! Follow us on Twitter here: https://twitter.com/WorldAltMedia Help keep independent media alive! Pledge here! Just a dollar a month can help us alive! https://www.patreon.com/user?u=2652072&ty=h&u=2652072 BITCOIN ADDRESS: 18d1WEnYYhBRgZVbeyLr6UfiJhrQygcgNU World Alternative Media 2024

29 February marks Rare Disease Day. This day is an opportunity for the rare community to come together to raise awareness of the common issues affecting those living with rare conditions. A rare condition is a condition that affects less than one in 2,000 in the population, and although rare conditions are individually rare they are collectively common. It is estimated that there are over 7,000 rare conditions. Around 80% of rare conditions have an identified genetic origin. In this episode of the G Word, our host Julia Vitarello, Founder and CEO of Mila's Miracle Foundation, is joined by Rich Scott, Interim CEO for Genomics England, and Ana Lisa Tavares, Clinical Lead for Rare Disease Research at Genomics England, as they discuss challenges for those living with a rare condition and the work being carried out across the genomics ecosystem to support them. Julia is the mother of Mila, a young girl who was diagnosed with a rare genetic condition called Batten Disease, and in this episode Julia takes us through Mila's story, and how she hopes to help many more families access treatments for their children.   "So when parents, children, are diagnosed whether it's a fatal or life-longing debilitating or difficult disease, if you know that what's being learned from your child both from just the genomics to the potential treatments that's helping the next child, that helps parents like me be able to continue living."   You can find out more about Mila's story in our previous podcast episode with Rich Scott, Julia Vitarello and Dr Tim Yu.   You can read the transcript below or download it here: https://files.genomicsengland.co.uk/documents/Podcast-transcripts/Rare-Disease-Day.docx  Julia: Welcome to the G Word So my life at that point seemed to just disappear in that moment, all the things that had mattered to me were gone; I knew there was something wrong with my daughter but I had absolutely no idea that a typical child who was outgoing and active and verbal and had friends could suddenly lose all of her abilities and die. My name is Julia Vitarello, and I'm your host for today's episode. Today joining me in conversation is Rich Scott, Interim CEO for Genomics England, and Ana Lisa Tavares, Clinical Lead for Rare Disease Research, also at Genomics England. Today we'll be discussing challenges for those living with a rare condition and the work being carried out across the genomics ecosystem to support them. If you enjoy today's episode, please like, share and rate the G Word on wherever you listen to your podcasts. The 29th of February marks rare disease day. This day is an opportunity for the rare community to come together to raise awareness of the common issues affecting those living with rare conditions. A rare condition is a condition that affects less than one in 2,000 in the population, and although rare conditions are individually rare they are collectively common. It is estimated that there are over 7,000 rare conditions. Around 80% of rare conditions have an identified genetic origin. Before I get into speaking with Rich and Ana Lisa, I wanted to share my story and my daughter, Mila's, story. My life as a mother started really like anyone else's, my daughter was perfectly healthy, her name is Mila. For the first three or four years of her life she was like any other kid. I live in Colorado in the United States, my daughter was a skier, she was a hiker, she was rock climbing, she was incredibly active and singing songs and swimming and riding bikes. But around four years' old she started tripping and falling, she started pulling books and toys up closely to her face; she started being covered in bruises, getting stuck on words and repeating her sentences and I brought her to about 100 different doctors and therapists around the United States to try to figure out what was going on with her. Around four years' old I started speaking with orthopaedic surgeons, with ophthalmologists, with neurologists, with speech therapists and each one of them, you know, told me pretty much that I was a crazy mom and that my daughter was typical and normal and that she would grow out of these sort of strange symptoms that she was having.      By the time that she was six years' old, I had had enough and I was crying on a regular basis, no doctor could help me and I was tired of lugging my daughter, who was now covered in bruises and tripping and falling and stuttering, together with my newborn son at the time, kind of around the country only to be told that I was crazy. And at that point at six years' old I brought her into the emergency room in the Children's Hospital Colorado, near where I live. She was in there for about a week and underwent a battery of tests and at the end of that week I was told that my daughter had a rare genetic condition called Batten Disease and that she would lose all of her abilities and die in the next few years. So my life at that point, first four years of my life seemed to just disappear in that moment, all the things that had mattered to me were gone. I knew there was something wrong with my daughter but I had absolutely no idea that a typical child who was outgoing and active and verbal and had friends could suddenly lose all of her abilities and die. After crying on my closet floor pretty much most of the day for a few weeks I picked myself up. I started to read white papers, I started to go online and learn about other rare conditions. I started to speak with parents that had fought for their children with physicians, with researchers, and did everything I could to kind of figure out if there was even a glimmer of hope. And what I was told at the time at the end of 2016 was that there is almost nothing that could be done and very little was known about my daughter's form of Batten Disease. But that there was a tiny glimmer of hope that we could maybe stop genetic disease, and that's all I needed. I started Mila's Miracle Foundation, which is a non-profit organization. I started telling Mila's story and taking care of my kids by day and trying to fight and learn and raise money by night and I started a gene replacement therapy because it was the only option that I could take on as we didn't know much at all about the disease, and by replacing it, it was kind of the only thing that I could do, but it was going to take many years and millions and millions of dollars and I knew that it wouldn't be in time for my daughter. Along the way, there was something a little bit unusual which was that my daughter had an auto recessive disease which meant that she needed to have a mutation in the same Batten causing gene from her mom, myself, and her father, and they could only find one of these two. That led me to learn about whole genome sequencing, which was kind of the most extensive way of looking at Mila's genome to figure out where this missing mutation was. And in that search I crossed paths with a Dr Timothy Yu at Boston Children's Hospital, and he volunteered with his lab to help me find this missing mutation that no other lab could possibly find. And within a few months and a lot of work, a lot of late nights and weekends and staring at screens, through whole genome sequencing, the team was able to find Mila's missing mutation and finally diagnose her fully with this rare form of an already rare Batten disease. That is where Mila's story changed and turned direction. At that point, a recently approved drug for spinal muscular atrophy was on all neurologists' minds at that moment because it had just been approved in the US by the FDA and in other countries, and it was a game changer, these children were dying and on respirators and in wheelchairs you know at the age of two and with this new drug they were actually living, many of them were living long lives and were active and happy and healthy and going to school. And Mila looking her whole genome sequence was able to kind of fit that same criteria, and so the doctors, including Dr Yu said, “What if we did the same thing for these children? What if we made a drug like this for Mila?” This drug called Antisense Oligonucleotides, or ASO seemed to be a good fit for Mila's mutation. And so a drug was made for Mila and named after her called Milasen and it was a race against time for an entire a year with a team of honestly hundreds of people across academics and industry, I was fighting to try to raise the money and awareness and working with a scientific team. And one year after Mila was diagnosed when she turned seven years' old, we moved to Boston and Mila began receiving Milasen, which was named after her, and only in that moment in time did I realise not only what a big deal this was for me as her mother, but what a big deal this was for science. She was the first person in the world to receive a medicine that was tailored just to one person and it was named after her because there was no-one else in the world they could find that shared that same mutation. When Mila began this, you know, I didn't know what to expect but I knew that she was going to lose all her abilities and die if she didn't receive this. And so once she started receiving this within just a few months, her 30 seizures a day went down to nothing; she had occasional small tiny seizures that were barely visible but her quality of life was incredibly you know improved, not to mention our family's because she was no longer thrashing and smashing her arms and legs up against walls and tables. She had been slumped and could no longer sit up. She could no longer hold her body up and take steps with my support from behind and after Milasen she started being able to do that even walk up the stairs with alternating feet with me supporting her from behind. She also had received a G-tube and was receiving all of her nutrition through the G-tube and after Milasen she started eating by mouth, it wasn't perfect, but she was eating pureed foods, and being able to swallow better and probably most importantly she was able to smile and laugh at the funny parts in the books and the stories that I had been reading and singing to her and that she had kind of really not been responding to as much before Milasen and some of that came back. So, a year into this everyone was quite shocked that Mila had done so incredibly well in this first year despite how progressed she was, progressed her condition was. Unfortunately in the second year it was during COVID and it was unclear whether or not Mila's disease had kind of stopped or whether it was slowly progressing and in the third year Mila started having problems associated with her rare condition and I was faced as a mother with the most horrible decisions anyone should ever, never, never, never have to face to decide what Mila would want if she were able to talk and tell me whether or not this was a life that she felt like she would want to live. And after three years on Milasen, which was three years ago almost this week, Mila died and in many ways my life as I knew it was kind of over. I'm a very positive happy person and I have a son and I continue getting up every day and pushing through the day but I'm not sure how any parent makes it through days, weeks, months and their whole life without their child physically there with them. Ana Lisa: We can really hear the perseverance that you had to get a diagnosis through whole genome sequencing eventually for Mila. Can you tell us a little bit more about that process and what that diagnosis, what did it mean for Mila and for your family? Julia: When Mila was first diagnosed with Batten Disease, one of the missing mutations could not be found by any lab. I did research and found out that whole genome sequencing which at the time was very, very hard to find a lab that would do it or anyone that would do it in the United States, I did learn that that was really what was needed in order to try to really get down to find the underlying genetic cause of Mila's disease and give her a full diagnosis. So once we managed to have Dr Yu's lab at Boston Children's Hospital carry out the whole genome sequence, obviously we were able to then find exactly where the broken, underlying broken kind of genetic mutation was and why that was important was for two reasons: 1) was so that we could actually have a diagnosis and even though it was the worst diagnosis we could have ever asked for, at least there was an answer and for so many years I didn't have an answer and there is nothing worse than seeing your child, you know, having all of these different symptoms and problems and having you know tens, if not hundreds, of different doctors and therapists tell you that they don't know and maybe you're just a little bit over-worked and over-worried about things, and having no answer and no idea what's wrong is like living in this limbo that's just terrible. And so whole genome sequencing allowed for us to have a full diagnosis for Mila, and it also allowed us to use that data since it was truly the precise place where, you know, we could find the precise plan where her gene was broken. It allowed the researchers to then also think about what could be done about it as well, which is the second thing a parent thinks about after they have the kind of relief in some ways, which is a strange word to use but it's true, of knowing what is wrong and then thinking, “What could I do about it now?” And so for me I would say that's how, Ana Lisa, that's how I reacted to that, is there was enormous relief initially, which is just the weirdest word ever to use for that but at least I felt like I wasn't crazy and that there was an actual reason and that it allowed us, allowed me and others to think what kind of action can we take now. Rich: One of the things that often strikes me, I'm a clinical geneticist by background, just like Ana Lisa, is how often particularly several years ago when we were in a different situation, it depended on families and parents pushing and pushing and pushing and asking, that's something I think in the UK we're really lucky that there have been changes in terms of availability of testing. Julia, as you know, we were set up ten years ago initially to run a project, a research project in partnership with the NHS called ‘The 100,000 Genome Project' asking the question about whether whole genome sequencing could be used in a diagnostic setting. Whole genome sequencing had just emerged as a thing that could even be conceived of as affordable in a healthcare system back then, and we worked with the NHS and tens of thousands of families with rare conditions and people with cancer to ask that question and again, we're really proud of what that work and our partnership with the NHS has led to, which is now in the UK. There is the availability nationally of whole genome sequencing to test in certain settings including in rare conditions that are hard to solve in this sort of way and it's one of the things which has really changed the way we can go about this, but we also know that there's still, it's still hard often to identify who should be seen by a specialist who might do a test and so on. But it has really changed things and I think it's hearing from families like yours about how challenging it is and thinking about how we turn, looking across all of the story that you told us of everything you went through, how we can make that be something where we can make it be more systematically available and work for many more people, and I know your phrase from Mila to millions really strikes a chord with me, and I know with the NHS mind-set here in the UK where it's about equity of access and I think that mind-set that you bring is so important. Julia: Yes, Rich, I think it's a really good point you know, because a lot of parents like myself, we're talking about probably millions around the world and tens of thousands just in the UK alone, spend so much time going from one physician to another and to a therapist and it takes an enormous amount of energy and time in a family that's already dealing with pain and confusion and not understanding what's going on, not to mention usually that child, in my case, Mila, is having problems that it's not easy to leave the house and get in the car and go to all these appointments. And the more we can push towards whole genome sequencing as one of the first places to go, if not the first place to go, the more it's going to cut that sort of diagnostic odyssey down to the very bare minimal. And so of course a dream would be is that any child that has, I like to think of it as soon as you kind of have more than one symptom that shouldn't normally go together, that sort of has a little red flag that goes off and in most parts of the world right now no physician wants to scare a parent like me, it's happened a number of times to me where a physician has said, “Well, you know, there is this rare condition but I'm not going to bring that up because it's so rare that the likelihood that your daughter has that, I wouldn't want to scare you.” But the more we can move towards whole genome sequencing right away to help with that answer that could cut months and very often years from that odyssey, and that is where we need to be, we can't have the tapping on the knee and stacking up blocks and running down the hall for months and years just to figure out what's going on. Ana Lisa: And I think Rich also there said a power of having a national healthcare service where patients who are having whole genome sequencing can also decide whether they wish to consent to be part of research and combining that with a national genomic research library and then the ability to work so closely with the NHS and go back to patients if there is a new diagnosis that could benefit them is really powerful I think, and that's definitely one thing that we've also learnt from these big whole genome sequencing efforts is that our knowledge is continuing to develop and some people will get a diagnosis from that immediately and we've got amazing colleagues working on diagnostic discovery looking at whole cohorts of patients now who are having whole genome sequencing and that's also been really informative and allowed a lot of new diagnoses identified also through research and through these efforts to be found. Julia: Absolutely and I think that the UK is incredibly well suited to have such widespread sort of country-wide whole genome sequencing project like what Genomics England has done because you have one system where all of the clinical and genetic data can all come in and kind of be analysed both for like you said diagnostics but also it could be, if families and patients are interested, right, in contributing to the research which then comes full circle and helps the entire system benefit from better treatments you know and better understanding of diseases. Rich: And that point of sort of thinking about how to move things forward, so the NHS has a service based in Exeter which is addressing the question where children are on intensive care, where often intervention is needed really rapidly to make a difference, so that's one of the examples where sort of thinking about making sure that service is available early and rapidly is being set up and that's been really successful and identifying a cause where that really changes the care of that child on intensive care. The other area where we're working really closely with the NHS at the moment, as you know, Julia, and in fact I think this was probably one of the reasons we first came to talk to you was thinking about our newborn genomes programme where if you like, the big question there is saying we know that there are a few hundred conditions that are within that longer list of rare conditions where there is a treatment available routinely if the diagnosis is made, and saying could we use whole genome sequencing alongside existing newborn heel prick testing which in the UK currently looks for nine, shortly to be ten, conditions. So we're just about to launch that programme and that will sequence the genomes of 100,000 babies born at maternity hospitals, not selected for children where there's something, a concern, raised, but any baby at that hospital would be eligible for the family to choose to join that research programme and really to ask that question about whether this is something that we should offer to all babies developing the scientific evidence around it, learning about how you might implement it in practice, and also having conversations about how one might do that, what public attitudes are to it and so forth, developing evidence that can move us forward in that area too. And back to Ana Lisa's point about improving knowledge, we know that today there are a certain number of conditions that one might think are comparable to those nine that are currently looked for in the UK on the heel prick that we could use genetics as a way in. We also know that through the sort of innovation and the new knowledge that you mentioned that was relevant to Mila, that list might grow quite considerably in the coming years, so it's thinking about how we set ourselves up to make sure that we're able to take advantage of that to its full. Julia: Yeah, and I think it's a great, I'm glad you brought this up Rich because the UK really is leading the world in this, there is no-one else that is doing whole genome sequencing at birth, and ultimately, that's where we need to be. You know it's not going to happen overnight and like you said, the purpose of this is really to learn a lot about how and if to roll this out maybe in a larger scale way across the UK. But ultimately, you know, as Mila's mom, I think all the time about you know how incredible what I saw at a very progressed state for Mila with this treatment and the only way to actually really truly help Mila and other Milas is to get to these children early enough so that they're diagnosed before they have symptoms and they're treated before they have symptoms. And the way to move towards that is to at least have efforts like the project, you know, the newborn screening project so that we can get to children, find them before they have symptoms, treat them before that and from what I saw from Mila I feel pretty strongly that if Mila had received Milasen at birth she might never know the effects of Batten Disease, and we as a family might never know what it's like living with a rare condition, and this is a step in that direction to help. Effie Parks: Hi there, I'm Effie Parks, mom to Ford, who lives with a rare neurodevelopmental disorder called CTNNB1 and the host of the Once Upon a Gene podcast. Our show connects families facing rare diseases, offering stories from parents, insights from experts and discussions on everything from navigating grief to exploring genetic advances. It's a space for understanding, connection and empowerment. For support and inspiration on your rare disease journey, subscribe to the Once Upon a Gene podcast on your favourite podcast app and let's navigate this path together. Ana Lisa: Julia, I'm interested to hear what you think the development of individualised medicines like the N1 treatment Mila had what that means for the sort of collaboration that's required across the genomics ecosystem to achieve that. Julia: Yeah, that's a really good question. It's been seven years that I've been thinking about this kind of individualised medicine concept, you know, as Mila kind of became the pioneer in this field and I'm not a scientist, I'm not a physician, but I've learned a lot because I've been fortunate enough to be part of thousands and thousands of conversations, including with all of you and others, Genomics England, and around the world and I think what I learned and what I've learned so far is that when you have a genetic condition most genetic conditions are individually rare and unfortunately that doesn't make them very suited to have anyone go after a treatment for them because really the only way to connect a patient, a child like Mila, to a science or technology is if they're lucky enough, and I hate to use the word ‘lucky' but they're lucky enough to be part of a large kind of cohort of people, and that allows them to be, you know, commercially viable, so a company will be maybe develop if they're lucky, a treatment for that, for those people. The only other option is this sort of like Herculean effort of which myself and Dr Yu and others went through, we had to raise millions of dollars and get hundreds of people to get on board and develop a novel medicine for one person – now how scalable is that? How many times can we do that, right? And so the only people that really have access to medicines today with genetic conditions are those that are fortunate to be part of one of these two groups, but what about everyone else which is 95% of the people? And so I think what the field is learning is that we kind of have the patients and we're finding them, especially thanks to Genomics England and others, we're starting to find them more rapidly earlier, more of them, and we have these technologies to be able to not only find them but to also treat them but we just do not have the infrastructure and the processes to connect them, we have clinical trials and we have these sort of named patient route but we don't have anything else. And so I think the genomics community, especially in the UK because it's so well suited with all the efforts that we've just brought up, is really well suited to kind of try to work together to allow for access kind of no matter how many people could benefit, it's not only one, it could be six or 20, or 200 or 500. Right now there is no access for them. So I think that the UK is really well suited, starting with whole genome sequencing, that's where it begins, it begins by identifying patients early enough and getting the data that's needed in order to diagnose them and also to help with the treatment you know, and so this is how I think the UK is really leading the world right now, including in the recent announcement of the rare therapies launch pad, which Genomics England is part of, I am part of, others are part of, Oxford Harrington Rare Disease Centre, the MHRA, others are all part of really trying to be dedicated to building the infrastructure and resources and processes that are needed to connect the patients to these technologies that exist today. Rich: I've been really inspired by the conversations and the drive that you, Julia, personally have given to those conversations. And I think what's really interesting and I think it's relevant more broadly than just in rare therapies particularly, but I think that challenge of recognising the need for the system to change to be able to respond to evidence and make the response proportionate to the expectations of various people, the patients or the families who are receiving it, the system as a whole, these sorts of therapies and rare conditions as well, are just not the shape that works well with existing paradigms, but I think it's relevant you know, in other settings as well. I'm really interested in some of the conversations that I've had with you before about balancing risk and understanding how to get that right and the fact that that really needs an open discussion in public to also understand the journey and the situation that families find themselves in. I wonder if you could tell us a bit about your perspective on getting that risk balance right? Julia: Thanks for bringing that up, Rich. I think it's really, really important because to me the way we think of risk and benefit and the risk tolerance maybe is a better way to put it is the foundation of the house that we're building. So, you know, the regulatory process and everything behind that are built on top of how we think about risk. And one of the things that I regularly think about is children that have end stage cancer, and that we as a society have accepted an enormous amount of risk for a child at end-stage cancer that has no other options that's going to die no matter what, probably very rapidly and that if they don't respond to kind of some of the main line treatments then to turn to an experimental cancer treatment which carries a very high risk is considered very acceptable by our society and that everyone, the clinicians, the families, the regulators, everyone is willing to take that risk for that child because they're going to die otherwise. And they're willing to spend money and they're willing to take the risk and often perhaps to buy that child maybe three or six months of life. So then if you look at Mila and if I tell you that instead of having a rare condition that she has an end-stage genetic disease, and I use the words from cancer, from oncology, is now suddenly the discussion changes a little bit, so Mila's going to die no matter what, no child has ever lived with her form of Batten Disease and she's going to lose all of her ability, so we know the risk of not treating Mila. The risk of treating Mila in this case was an antisense oligonucleotide, which is a modality that's been around for 30+ years, tested in animals and more frequently in numerous humans across different sort of trials. And the labs that worked on Mila's medicine felt that it was safe enough and hopefully efficacious enough. And at that point why is the hurdle so exponentially higher than what it would be for a child with end-stage cancer? The way that we are thinking about these children with end-stage genetic disease and end-stage cancer, is drastically different, so we need to first, to your point Rich, we need to start realising we've already set that precedent, we don't need to be having this discussion again. We know the risk we're willing to take for a dying child when there's no other therapeutic, no other option and they're going to die no matter what. So the risk of treating Mila, versus the risk of not treating Mila is black and white and we need to do our best and then we need to not only treat Mila but we need to learn from the treatment of Mila. We need to collect those learnings, they must be iterative learnings so that the next child that's treated with an individualised different ASO or different medicine that they don't happen in silos, but that all of this knowledge comes together so that the second and the third and the fourth and the tenth and the twentieth, the process gets better and faster and eventually cheaper so that it's accessible. Rich: Yes, and that's very much back to Ana Lisa's point on the link and for diagnostics too on continuing to learn and creating a system that recognises that that's crucial to offering the best care today but also in the future and being able to make proactive decisions more confidently if you're a policymaker, knowing that you'll continue to learn, you don't have to pretend you know everything today. Julia: It's very meaningful for parents. So when parents, children, are diagnosed whether it's a fatal or life-longing debilitating or difficult disease, if you know that what's being learned from your child both from just the genomics to the potential treatments that that's helping the next child, that helps parents like me be able to continue living. And so you know, research is this kind of generic word, I wish there were a better word for it. Really what it is, is it's learnings and it's what can be learned from my child that can help the next child? Ana Lisa: And then that learning requires a lot of collaboration, which is the super important part I think of your story. Julia: Yes, it does, it requires a lot of people starting with those diagnosing the children with whole genome sequencing all the way through just to the clinicians who are in the NHS, not to mention the researchers who are then looking at the data and bettering their understanding. Ana Lisa: I think there are also, maybe one can extend some of those parallels as well, in that I think currently we sometimes think of an individualised therapy of NF1 as being something that takes a lot of time and benefits an individual, and actually if we can really collaborate we can really set up processes that work across the ecosystem and keep learning, then I'd love to dream that actually this could help many, many different patients, with many, many different types of rare conditions because actually we've learnt how to target a little bit more at source, perhaps a particular type of genetic variant, and so a bit like cancer, we're not thinking about breast cancer, we're thinking about what sub-type, what genetic causes there are and targeting those, and if we can apply that one day more broadly across rare conditions then it might be that actually once you've learnt a certain amount, that you could scale up and treat many, many different conditions, not dependent on their frequency in the population. Julia: Yeah, that's a great dream, I share that dream. Rich, what is your, you've been in this for many years, what's your dream for the next five, ten years? Rich: I guess I have, I think there's two aspects to it. I think there's two, I think there's a lot of distance left to run for us improving on the diagnostics and I think thinking back to your conceptualisation of it Julia, of sort of thinking about how we can bring that earlier, whether that is that for example we're able to sort of more proactively flag when children have you know, more than one visit to a particular type of doctor or something that makes that happen much earlier in the process. So the tooling that we now know works whether it's whole genome sequencing or something more targeted can be used earlier in the process, or whether for example in our newborn genomes programme we get that evidence that we can look for a broader range of conditions in a screening context right at the beginning of life. And I think in five to ten years we should be in a substantially different place, we'll know whether or not we think whole genome sequencing should be there but offered for every baby at birth, and we can be much more proactive also when symptoms arise. I would also hope that on the side of therapies and intervention, we're in a substantially different position and I think, I've been amazed the last five years how my level of hope has increased. I believe we should now be in a position in five to ten years where those with a therapy that is potentially there to benefit them, should at least be able to be aware of it and there will be a clear pathway by which either that is available if it's proven, or there's a pathway that we all understand about how that can be trialled. And I think we're at the beginning of that journey and I now feel it's a responsibility of ours to work through how we can bring the right pieces into place, we can't prejudge the science, but we can set up the system that makes us be able to respond to it. Julia: Yeah, I remember Rich when you and I were speaking a number of months ago and maybe you could share the story because you talked about your hope kind of changing over time as a clinician I thought that was really powerful to me. Rich: Yeah, I remember it's probably now maybe 15 years ago being asked by a family about what my advice would be to them on the likelihood of there being a treatment for their child's particular condition being available and in fact they asked me to do it in a way that I sort of provided a formal written report to them that I spent a lot of time thinking about and agonising over and was very honestly you know saying it was highly unlikely that something would become available. If I had to write that same report today it would be very different. Julia: That's so promising to hear that. I don't know, Ana Lisa, have you had any experiences like that in the past that you feel differently now of how you would approach a family like mine? Ana Lisa: I think it's a real balance between having that hope ourselves, sharing that hope with other people and not giving false hope and it's such a balance when right now more than 95% of rare diseases don't have a treatment and I think that's such a difficult position to be in right now. And everything we've been talking about gives me massive hope for the future and a lot of what we're pouring our energy and efforts into is both the diagnostics so that we're not trying to make a puzzle with missing pieces in the dark and that's mission-critical, and then the real hope that actually this will drive therapies, which is what we really want for everybody who needs a therapy to have a therapy that's effective, whether they've got a common condition, a rare condition and that's our driving ideal. So I think I'm full of hope and optimism and I hope that it will accelerate, that's what I really hope, the momentum will build and we'll get to a certain level of knowledge, we're learning the processes, we're learning the evidence, we're learning the collaborative models that are needed to really suddenly explode our ability to treat rare conditions. Julia: Yeah, you know when Mila was, I guess when I look at newborn screening in the United States and Batten CLN7, which is Mila's kind of sub-type of her condition is not on newborn screening tests because there is no treatment for it, but the whole genome sequencing that was done for Mila was the data that we got from that was what was needed to create a treatment for her and so it's an unusual case where she was sequenced and a child and a baby, a newborn in the UK could be sequenced and not only told that they have a disease, so they have time to kind of understand the disease more but also potentially kind of prepare for a treatment that might be in the pipeline, but that data is also going to help scientists and researchers create new treatments that may not be available when that child is born but that's the data that's needed to create the treatment. Right now you guys are you're really at the forefront of solving both halves of the what I consider like a rare condition, you know, global health crisis with tens and hundreds of millions of people that have you know families like mine, like my story sounds unique, it sounds impossible but there are tens of millions of other people like me, like my story sounds unique, it sounds impossible but there is tens of millions of other people like me and so to have the UK kind of leading this effort to solve both halves of the problem, the diagnostic half, you know, what disease does a child have and find it in time and also kind of the treatments, here's where we're headed, and if we don't solve both of those problems then there is no such as access, you know to a better life, so I'm really grateful for the fact that you've set a precedent for other countries because now finally there are other countries that are looking towards you and kind of really trying to do the same thing that you're doing. Rich: Yeah, well I think we feel we're uniquely placed; the NHS in the UK and for Genomics England our partnership with the NHS, together with a number of other factors and I think the recognition from government as well as the NHS over a long period that the importance and the power of genomics and the importance of for example, making changes to regulation to get it right mean that it's something that I think we feel really privileged to be in the position to even be able to ask these big questions. Julia: yeah, I think the UK is really uniquely suited to have hung their hat on genomics so that the topics you're taking on are very central, they're not kind of on the sideline, they seem whenever I'm in the UK they say that what Genomics England is doing is at the forefront and in the middle of all the discussions with academics and companies and regulators and government. What do both of you think are the, what are the biggest kind of hurdles we have coming a few years in the newborn programme or you know, any of your other initiatives? Rich: I guess all of these are big questions and I think we need, it's back to that sort of point from Ana Lisa sort of balancing the hope and expectation, I think we're uniquely placed to develop the evidence really clearly and one of the things that we again think is so important is having this conversation in the public about it and developing a shared view, almost you know, it drives policy but it's also something which I think the whole of society needs to sort of think about how we address and what we want to do collectively. I wouldn't place it as a barrier but I would highlight it as a strength that we've had and I think we're hopeful that we'll continue is that long-term commitment in terms of government and the NHS and I think that's really powerful in this space to maintain the UK's position as being able to ask these questions and to show that leadership. Ana Lisa: And to bring together, we need to work really closely across the ecosystem. So in my mind one of the challenges is if one part is missing then that person is not going to get the treatment and how we keep joining up these really important dots across the whole ecosystem to make sure that most people will one day be able to get a treatment. Julia: And all those dots honestly, those dots can never even start unless you have a diagnosis and it's in time. And so there are so many people around the world working on each of those dots that connect a child or a patient to a treatment, but if you can't even be diagnosed or if you're diagnosed too late, which is what the reality is in the world of rare conditions right, then you know, then it's a little bit futile to race to a treatment or even think if that's possible. So I think the very, very first thing is: can we find children and patients, like can we find children like Mila in time? And I love hearing the word ‘hope' that's the word that keeps me going and doing what I'm doing because if there isn't any hope it's pretty hard to keep fighting, so I'm really glad, thank you both for having hope. Okay, we'll wrap up here. Thank you to Ana Lisa and to Rich for joining me in this conversation today as we shed some light on the challenges you know that those with rare conditions are facing. We touched on the work being carried out across the Genomics ecosystem in the UK to support those living with rare conditions. If you'd like to hear more of this, please subscribe to the G Word on your favourite podcast app. And thank you so much for listening. I've been your host, Julia Vitarello. This podcast was edited by Mark Kendrick at Ventoux Digital, and produced by Naimah Callachand.  

What did the MHRA know before the roll out of the Covid–19 vaccines? Has Dame June Raine bare-faced lied to us all? Where have all the missing people gone? Stolen lives, stolen data, and stolen time. Read the write-up at: https://www.ukcolumn.org/video/big-pharma-organised-crime

In January we saw experts from across the genomics ecosystem, including patients and those with an interest in genomics, gather at the Festival of Genomics - the UK's largest annual life sciences event. In this episode, our host, Vivienne Parry, Head of Engagement at Genomics England, speaks to Louise Fish, CEO of Genetic Alliance UK, and Professor Matt Brown, Chief Scientific Officer at Genomics England, to discuss the event and emerging future trends in genomics.  In this episode you'll also hear some exciting future advances in genomics research from some eminent speakers at the Festival: Harold Sneider, Professor of Genetic Epidemiology, University Medical Center Groningen sheds light on the "Identification of methylation markers for Type 2 diabetes up to 10 years before disease onset." Nagy Habib, Professor of Surgery, Imperial College London, delves into "The future of saRNA therapeutics and its potential for treatment".  Lennard Lee, National Clinical Advisor on innovation and cancer vaccines, presents his perspectives on "The Future of Cancer Vaccines," offering a glimpse into the promising advancements in this critical field. "The scientific breakthroughs that are being made are absolutely incredible and they're really exciting, but from the point of someone living with a genetic condition, what they want to see is those scientific breakthroughs making a real difference in the clinics...For some conditions, it's about treatments, but it's also about being able to get a diagnosis faster, to be able to understand what condition is impacting on you, how it might affect you over your lifetime and your wider family, and to be able to work with NHS services to understand and plan for the care and treatment that you'll need throughout your lifetime."   You can read the transcript below or download it here: https://files.genomicsengland.co.uk/documents/Podcast-transcripts/Insights-from-the-Festival-of-Genomics.docx   Vivienne Parry: Hello and welcome to the G Word. Vivienne Parry: The Festival of Genomics is the UK's biggest genomics event, and it's become an essential part of our year. It's free for 90% of its delegates, it's in person, and with more than 5,000 people expected, it's now so big that it's had to move to ExCel's cavernous Dockland Halls. It's the place to hear top science and to spot new trends, but actually for me the joy of the festival is the people you meet. Of course, it's great to catch up with old friends, but it's the new collaborations sparked by random encounters at the festival which I think are the lifeblood of the genomics ecosystem, and everyone with an interest in genomics is here, patients, clinicians from the NHS, researchers, industry, policymakers, and the G Word. What we thought we'd do is bring you a flavour of this great event from the floor of the ExCel halls, and give you a quick soundbite from three of the speakers that we felt best exemplify the future of genomics. With me to discuss the event and future trends in genomics, Professor Matt Brown, Genomic England's chief scientific officer, and Louise Fish, CEO of the Genetic Alliance UK, which as its name suggests, is an alliance of over 200 organisations reflecting the needs and concerns of those affected by genetic conditions. My name's Vivienne Parry, I'm head of public engagement at Genomics England, and I'm delighted to be your host for today's pod from the Festival of Genomics. Welcome to you both. So, let's start with you, Matt. How important is the Festival of Genomics for genomics in the UK? Matt Brown: Well, the Festival of Genomics has become a really key meeting for the genomics community in the UK, and I think increasingly in Europe as well. It's a really large, high quality event that brings together commercial and academic and biotech companies in the one forum, and I think it's a really exciting programme. Vivienne Parry: And of course, Louise, it's open to patients as well, which makes it an unusual event. Louise Fish: Absolutely, and it's brilliant to have patients and families here. So, people living with genetic conditions clearly need to be part of the debate when we're talking about developing new services, and developing new treatments and diagnostics, so it's absolutely fantastic to be able to come together in one room with people from the NHS and the broader sector. Vivienne Parry: And it's grown enormously, and I guess that reflects, as much as anything else, just how exciting genomics is. Matt, I'm going to pin you to the ground [laughter] and say, why is it so exciting in genomics at the moment? Matt Brown: Look, the field's really hitting its tracks. We're seeing advances in technology, analytics, application in the clinical space, and of course booming commercial activity associated with that. But from a situation ten years ago, where we had research capability for using genomics to assist in diagnosis and cancer profiling, now we're in a situation where we have multiple different approaches to assist with both of those things, transcriptomics, proteomics, spatial, single cell methods, optical mapping, a whole monopoly of different technologies that have developed out of the research world but are pretty close to being ready for clinical application. Of course, in analytics, the rise of AI and the potential that has for improving interpretation of genomes and improving personalised medicine prediction in cancers and in multivariant data, those are absolutely massive things. But aligned to that, there's also, you know, the growing worldwide application of genomics in clinical spaces, of course led through the UK and the NHS Genomic Medical Service, which has really shown the way for the world about how this might make a difference. Vivienne Parry: And Louise, that's the really exciting thing is we're now seeing not just talk about therapies, we are seeing the therapies for rare disease actually going into clinical trials and into services even. Louise Fish: Yeah, absolutely, and that's why people living with genetic conditions and their families want to see the change. The scientific breakthroughs that are being made are absolutely incredible and they're really exciting, but from the point of someone living with a genetic condition, what they want to see is those scientific breakthroughs making a real difference in the clinics. And that's sometimes about treatments, you know. For some conditions, it's about treatments, but it's also about being able to get a diagnosis faster, to be able to understand what condition is impacting on you, how it might affect you over your lifetime and your wider family, and to be able to work with NHS services to understand and plan for the care and treatment that you'll need throughout your lifetime. So, treatment's one part of it, but actually that ability to better understand what the future will hold for you, and to plan ahead for the care and support that you will need to live your life to the full is what really excites people living with genetic conditions and their families. Vivienne Parry: Now, let's hear the first of our three clips. The programme is absolutely vast, but these were three presentations that we just thought were terrific. Let's hear the first one. Nagy Habib: My name is Professor Nagy Habib. I'm a consultant surgeon at Hammersmith Hospital, Imperial College, London. We are going through a very exciting time, where we know what is the problem with the diseases, and so far we couldn't do anything about it, but suddenly the door is opening and it all came with the RNA vaccine, because we had to go very fast to get a vaccine for covid, to protect the population, and that pushed the science to go very fast, and now we can apply it to other areas apart from covid, like cancer and rare genetic diseases. And these therapeutics are what you and I and everybody else have received during vaccination. There has been six billion injections around the world, so you can imagine that everybody had an RNA injection. And RNA is that molecule between our genome, the DNA, and the protein. For anything to happen in our body, it requires the protein, but there must be an RNA in between. In the past, it was all about DNA, but now it is RNA. Why can't we get a vaccine against cancer? And so now the field is growing very fast for a vaccine for cancer. Now, the way we think about it is that we can have an injection so that we don't develop cancer of the prostate or cancer of the breast and so on, but in actual fact today what we can say is that if we take out a tumour with surgery, and we can take the RNA from the tumour and inject it in the patient, the early clinical trials tell us that this might work, and to stop the tumour coming back. It is very important to make sure that, once the tumour is out, it doesn't come back. And I think there is hope that we can have RNA vaccines in cancer. Now, to treat cancer without surgery, still we have some way to go, but again, now we know that the problem with cancer is that some of our immune cells that are there to defend us from cancer, they change their mind and suddenly they collaborate with the enemy. So instead of helping us, they are destroying our immune system, and we are developing drugs that can stop that from happening to our immune systems. Now, when you really think about what are the diseases that kill people, cancer is definitely very high up. The second one, not in a particular order, but cardiovascular system, we get heart attacks and we die from heart failure, or we get stroke and we die from stroke, and that's because we eat too much. The food is very tasty [laughter]. So, now we have injections, and the injection can make us lose weight, and we lose weight very fast. The problem is again it's very expensive. Who can afford £600 a week? And when you stop the injection, you put on weight again. So, now we are working again with RNA, and we have found a way where you inject only once every six months. And then the final thing, which is really the dream of everybody, is to stop Alzheimer's disease. So, Alzheimer's disease, as we get old, there are toxic materials that are accumulating in our brain cells, and only this year we've got two drugs coming along that can help stopping Alzheimer's disease at an early stage. Now, what we need to do is to bring that it works on all types, even the advance type of Alzheimer's disease, and now there are [inaudible 0:09:26] where we can take it from the nose. So, you inhale it from the nose and it goes straight to the brain, because there is sort of a motorway that connects the roof of the nose with the base of the brain, which is very simple. It doesn't even need an injection in the arm vein. So, it's all very, very exciting. Vivienne Parry: That is so fascinating. It's real future casting. Matt, I mean, I say it's future casting, but tell me a bit about the Rare Therapies Launchpad, because, you know, that picks up some of what Nagy has outlined. Matt Brown: Yeah, so DNA and RNA therapeutics are absolutely booming, and that's one of the big excitements is that we're not only being able to diagnose people, but we're coming up with new ways of actually providing treatments for patients with rare diseases and cancers through nucleic acid therapeutics. For rare diseases, the type of clinical trials that are involved are really quite different, and you can't just basically translate what was used for common diseases into the rare disease space. It just doesn't work, and that's really held back the field a lot. So, to try and enable rare therapies to actually make that leap from a research setting into actual clinical practice, Genomics England, in partnership with the Medical Health Regulatory Authority and others, have set up a Rare Therapies Launchpad, to provide an end to end solution for people to be able to run clinical trials for rare and ultra rare diseases, particularly focusing on nucleic acid therapies, and linking that with both the regulatory authorities and health funding authorities so that we can get these ultimately into clinical practice. I think we need these sorts of initiatives so that we don't continue to see rare therapies falling over because they're being assessed and made to go through the hurdles that common therapies do nowadays. Vivienne Parry: So Louise, we really are in the area of what people call N of 1 medicines. Louise Fish: Yeah, absolutely. So, these are medicines that are made specifically for one person and will help that one person, and obviously that brings a whole heap of possibilities for people living with genetic conditions, but also a load of challenges that we understand for decision makers within the MHRA and NICE and the NHS. And so I think there are some real challenges that we're really aware of from the decisions that are already being made by those decision making authorities about treatment. Obviously, putting it at the most basic level, you don't have the same evidence base for treatment that's just available for one person that you do from a clinical trial, where thousands of people will have taken part in a trial to understand how it affects a whole host of people. So, we know that the decision making bodies are going to need to take a different approach to evidence, so are going to need to be willing to look at evidence that is just from a trial involving one person. They're going to need to be able to extrapolate the benefits of that treatment across someone's lifetime, and that can be challenging, and we've seen that before in rare disease medicines and the new treatments that have come along in recent years. So, there are definitely some challenges, and we're really glad to see those challenges being acknowledged upfront by Genomics England, the MHRA and others, and being debated and discussed, and trying to find solution now rather than waiting for those treatments to come along later, and then trying to retrofit and decide how to manage them. So, it's great to see this debate taking place early, and we're really keen to make sure that the voices of people living with rare conditions and their families are part of that discussion. Vivienne Parry: And the really cheering thing that we're hearing from Professor Habib is that he thinks that the cost is going to be much less, because some of these things, you know, have million pound price tickets, so to have something that will be cheap is really going to be I think the gamechanger.   Louise Fish: One of the challenges with that is understanding the lifetime costs of someone living with a genetic condition and all of the complexities that are involved, and not just the medical care that they need, but the social care and the wraparound care that they'll need, the extra support from schools and colleges, the extra support from employers if they're able to go in employment. So, I think we're constantly trying to help the government and decision makers have a better understanding that those lifetime costs of living with a genetic condition are the things that should be taken into account when they're making decisions about a new treatment that could be totally game changing for someone's health and their future. Vivienne Parry: Cheaper treatments on the way, Matt? Matt Brown: So, I think we absolutely need to work on reducing the costs of these treatments, because at the moment the costs are so high that, were we to extrapolate that out to try and treat the thousands to tens of thousands of different rare diseases that there are out there, we couldn't possibly afford it. I think it's very promising that we will get cheaper treatments. This might come about through reducing the development costs, in particular reducing the clinical trial programmes, and the level of safety and efficacy evidence that you require before you can actually make these treatments available. I think that will make a massive difference, if we can simplify that. And another thing is, by better collaboration between the different rare disease communities and genetic medical services around the world, to make sure that what might be an N equals 1 condition in the United Kingdom, when you consider it around the world, might actually be an N equals 100 people, and then basically the cost per patient drops substantially. To achieve that, we need much better coordination between the national genomic medical services. Vivienne Parry: At the end there, you heard talk of using RNA therapies for obesity and Alzheimer's, and we principally talk, particularly in Genomics England, not just about cancer and rare disease. But I wanted to present to you another presentation, which I just thought was extraordinary, which comes from the Netherlands, and it's about picking up signs of diabetes using genomics ten years in advance. Just listen to this. Harold Sneider: Hi, I'm Harold Sneider, I'm a genetic epidemiologist working at the University Medical Centre in Groningen in the Netherlands, and my focus is on cardiometabolic disease, and I have a great interest in hypertension, for example, obesity, but also type two diabetes. So, one of my major interests is to try and identify genes for common complex, mostly cardiometabolic diseases, so our approach is to do genome-wide association studies using genetics, but also epigenetics. And epigenetics can be screened for so-called methylation markers, and those methylation markers have an effect on expression of the genes, and we can look at this all over the genome. Then a very interesting question came up, whether these types of epigenetic signals or methylation markers could actually be used to predict disease in people that are still healthy. So, the goal of this type of work always consists of two parts. First, it's that we try to find out which genes are highlighted by these DNA methylation markers, because they are located at certain positions on the genome, so we know which genes are involved in those regions and we can learn more about the underlying biological mechanisms that play a role in the development of the disease. Because we found those signals up to ten years before the disease occurred, so that tells us something about changes that already happen at an early stage. It's like an early detection mechanism. At the same time, a combination of these markers together lets you calculate what's called a methylation score that can be used for the prediction of the disease, and the ultimate goal here is that even in healthy individuals, when you have those measurements, you can calculate such a score to improve the prediction and identify people with a higher probability to develop such a disease. I definitely think we can apply this general approach also to other – for example, cardiometabolic diseases, such as coronary artery disease or also hypertension. Vivienne Parry: Harold Sneider there from Groningen. And extraordinary, the idea that you might be able to pick up not just diabetes perhaps ten years in advance, but also he was talking about potential for other lifestyle diseases, like cardiovascular disease, for instance. What are your thoughts about that, Matt? Matt Brown: Look, I think it's always been an aspiration of the clinical community to move treatments from treating patients with established disease to actually working in really early or preclinical spaces, where you've got a much better chance of preventing end organ damage, and secondly you've got a much better chance of actually inducing remissions or potentially actually curing diseases. And I think not just in diabetes, but also in a range of immune mediated diseases, there's pretty good evidence now that you can, by intervening early, really make a massive difference to the natural history of diseases, and new methods are coming about to identify those patients, be it polygenic risk scores or other biomarkers, to enable us to sort of flip the approach of medicine from being reactive to pre-emptive. Vivienne Parry: And rare conditions, as they do so often, Louise, are leading the way in understanding the issues, which will then spill out into a much wider area of the population. Louise Fish: Yeah, absolutely, and rare conditions obviously is the space that we work in. So, Genetic Alliance UK, as you say, is an alliance of around 230 charities that support people largely with rare genetic conditions, and many of those charities are condition specific or look after groups of conditions, like metabolic rare diseases. So, that's the kind of space that we come from, and obviously in our space, the excitement is around the work that we're doing with Genomics England around the Generation Study, and trying to use that to understand whether it's possible to screen babies to understand whether they have a rare genetic condition, and if so to identify that condition and intervene early. And again, excitingly, that's not just about treatment, it's about whether there's a way of helping that child and their family, if you can identify very early to help really improve their lifestyle choices. And one of the best examples we have is identifying children with brittle bone disease, where if you pick them up through screening, you'd be able to teach their parents to handle them safely, so they didn't have breaks in their bones as babies, which is what we see now. So from our perspective, it's obviously different to the polygenic risk scoring, but again it's that idea of using genomics as a way of identifying conditions very early, and intervening before signs and symptoms start, to try and improve the life chances of the person living with that condition, and help their wider family to help them, which is really exciting from our perspective. Vivienne Parry: But the experience and knowledge that you've gained as rare disease organisations actually is enormously valuable to other people. I mean, rare has always been at the forefront. I mean, in cancer, for example, it was chronic myeloid leukaemia, which was a rare cancer, that kind of unlocked cancer targeted treatments for everybody else. And it always seems to me that rare is at the forefront. Although it's often seen to be behind, it actually is the key to unlocking so many other things, and the experiences that you have all had are so valuable for much wider populations. Louise Fish: Yeah, absolutely, and one of the reasons we run Genetic Alliance UK is so our member organisations can learn from one another, ‘cos there's always one of the rare patient organisations which is surging ahead in a particular space, doing something really exciting, doing something really new, and we try and make sure that our members can learn from one another and don't have to kind of reinvent that wheel. But I know that spills out into the wider cancer space and beyond, which is fantastic. Vivienne Parry: And Louise, do you think there are particular conditions which, if I can put it like this, are on a roll at the moment, where genomics is really advancing fast for them? Louise Fish: Oh goodness, that's a really good question. There are lots of conditions where genomics is making a significant difference really quickly. For us, I think we go back to the Generation Study, and at the moment we only screen in this country for nine conditions, soon to be ten with the addition of a new condition, but the Generation Study's looking at 200 conditions and whether it's possible to screen for them. And for all of those 200 conditions, it's a really exciting opportunity to see if we can learn more, both about the potential to understand and develop treatments early, but also just about the chance to understand the natural history of that condition so much earlier than we do at the moment. And I think that's it, it's that understanding of the natural history of the condition really early, and understanding how a family can be helped through all the aspects of the condition, which is giving people most excitement, I think, alongside the potential to develop treatments. And I know we talk about treatments a lot, but at the moment only five percent of rare diseases have a condition specific treatment available, so we really try and balance, within Genetic Alliance UK, that hope for the small number of conditions that do have treatments, which is really exciting, or have treatments in development, and actually making sure that the scientific breakthroughs in genomics are something that all conditions can benefit from, whether there's a treatment or not. The potential for early identification of people with a condition, understanding the natural history better, and wrapping a package of support and care around people that is not just about a drug itself, is really important to us and to all of our members. Vivienne Parry: Matt, are you seeing any particular areas where there's a really rapid success? Matt Brown: Look, I think there have been some absolute standout successes in nucleic acid therapies in recent years. So, one is the treatment of familial hypercholesterolemia, with siRNAs for PCSK9, so the Inclisiran type approach, which has absolutely revolutionised management of that disease. In recent times, I'd highlight, for example, the treatment of sickle cell disease, an absolutely massive global problem, and now we've got a therapy which can really control sickling crisis and make a big difference to a disease which isn't just a disease of developed countries, in fact it's particularly a disease of Africa, of course. On a global level, that's just going to have a huge effect. But I think, yeah, I just would like to come back to that comment you made about things starting with rare diseases. So, in genomics, rare disease genomics has taught us a heck of a lot about what drives common diseases as well, and to my mind, gold dust for drug development companies is where you have genes that are associated with both rare and common forms of the same type of disease. And that tells you that basically you're very likely, through your treatment, to be able to actually influence the disease, and that it will influence a large proportion of patients with the disease. So, I'm really enjoying seeing this division between rare diseases and common diseases broken down a little bit, and a lot more learning in therapies going from one to the other. Vivienne Parry: Let's move to a completely different area, one that's very important to Genomics England and less important, Louise, at the Genetic Alliance UK, which is cancer. We're going to hear from Lennard Lee about cancer vaccine. Lennard Lee: I'm Dr Lennard Lee, I'm a medical oncologist, so I practice as an NHS doctor, treating cancer, and I'm an associate professor at the University of Oxford. We've come to a position whereby vaccines can be developed quicker than anyone thought. In the last few years, we've realised that the technology has moved on rapidly, MRNA technology, and you can make vaccines and update them really, really quickly. We've now come to a situation where vaccines can be made against cancer, and this is where genomics is really starting to supercharge this technology. If you can sequence a cancer then what we're finding now is that the technology now exists for you to print off an MRNA vaccine for that patient, a truly personalised product. And it's amazing because the genetic basis of the cancer, what the genomics sequencing shows then becomes a vaccine itself. The vaccine is designed based on that sequence, and that's why genomics has really supercharged this field of vaccinations for cancer. One of the possible things we just need to clarify and be aware of is that when people talk about cancer vaccines, they mean a number of things. Ultimately, what it involves is getting a new treatment for people with cancer, because it's based on their genetic sequence, so it's used to treat people with cancer. The future's an exciting one, truly personalised medicine based on genomics. Genomics is going through so many different phases in the field of cancer. Firstly, we were starting to understand why cancer happened and what patients outcomes were. The second phase started to kick off where genomics would help patients select the right drugs at the right time for them, which is amazing. And now we've entered the final evolution of genomics, where it now becomes the actual drugs that we treat people with. And cancer vaccine is one of the first potential areas where genomics will start to form the basis of the treatments going ahead. In five years' time, we're going to know if it works or not, where an individual vaccine based on the genomic abnormality seen in that cancer is going to give better outcomes for patients than an off the shelf product. We know that every cancer's different, so genomics has showed us this, but all of a sudden that sequence could become that vaccine, which then primes that immune system, truly personalised therapy. And it is so exciting that we're going to be talking about this in this festival, and it's being driven as from the UK, which has got so much strength in terms of genomic capabilities as we're developing vaccines. Vivienne Parry: So Lennard Lee there, absolutely confident of the importance of cancer vaccines. Matt, what are your thoughts on that?  Matt Brown: I think it's a tremendously exciting field. The early data on cancer vaccines with melanoma, for example, showed that for a cancer which previously had been resistant to virtually all of our approaches, is actually quite responsive to novel cancer vaccine approaches. We are yet to see across what diversity of cancers this is actually going to work, so there's clearly a huge clinical trial programme that's going to be required to drive this, and the UK is playing a really central role through the Cancer Vaccines Launchpad that Lennard's involved with running, in creating the evidence base about whether these are going to achieve the promise that they hold. I also think that they've got a lot of possibility for inherited cancer types. For example, I think the programme's looking at cancer vaccines for Lynch syndrome, to try and prevent colorectal cancer in that group of patients. So, I think they've got lots and lots of opportunities, and it's nice to see something positive actually coming out of the pandemic like this, for what was a pretty bleak episode worldwide otherwise. Vivienne Parry: They are a small part, I know, of your organisation, Louise, but in some ways, those people with inherited cancers in their families are seeing the benefits of genomics on both sides, both in that earlier diagnosis, picking up right from the very beginning, and of course in the promise of these new treatments. Louise Fish: Yeah, absolutely, and you're right, it's a small part of our remit. We do have some organisations in our membership who specifically support people with rare inherited cancers, and we work very closely with an organisation called Cancer 52, who also represent organisations with rare cancers. I'll just give them a quick shoutout in case anyone listening is not aware of them and their amazing work. But you're right, I think there are a couple of things going on that are really exciting in the cancer space. It's that ability to better understand why some people are likely to inherit cancers, how that pattern works within families, and to support those families and help them understand like the risk that they have, and to make informed decisions about their own treatment and care in the future. And also about whether they want to have children, and if they do want to have children, kind of how they want to approach that to try and reduce the risk of passing on that heritability. So, that's a really important part for everybody. I think there's also potential to develop new treatments, which is absolutely amazing and really exciting, and it is really exciting to hear about the potential for cancer vaccines. The other area where I think people living with inherited cancers are interested to find out more is what impact it might have on better understanding which treatments will work for which people. And we know, for example, that there are some cancer treatments that only work for one in four people with that particular kind of cancer, but it's been really hard to understand why that's the case. And I think the potential for genomics to identify which people could benefit from a particular cancer treatment would have two huge benefits. A, cancer treatments, many of them are really horrible, you know. They're horrible things to go through, and if you had a better confidence that a particular treatment was going to work for you because of your genetic makeup, that would make you a lot more confident about deciding to try that treatment, and taking on board the side effects of the treatment and how it's going to impact on you. That would also obviously massively impact on the cost effectiveness of that treatment. At the moment, we might give it to four people and only one of them would benefit, but you're paying for the cost of giving it to all four people. If you could identify in advance which people were more likely to benefit then you'd give it to fewer people, they'd be more likely to benefit, and the cost would come down. So, I think that there is real potential in this field of genetics and genomics to help in all kinds of ways that people living with these conditions are really excited to see and explore. Vivienne Parry: So Matt there, it's not of course simply about identifying, you know, what the cancer is like and its genomic makeup, but actually it's that wider field of pharmacogenomics, which is a big feature of the programme at the Festival of Genomics this year. And we're very much involved in that, aren't we? Matt Brown: Yeah, we are. So, pharmacogenomics is one of those areas where genomics is about to make a big difference in clinical practice. What we're hoping to get to is the point where we have people who are not yet treated with a medication actually already have the genetic profiling done, so that when they go to a general practitioner or a physician and be prescribed a medication, the data will already be there to say what the appropriate dose should be, and whether they're at risk of getting adverse reactions to those medications, so we could avoid them or use alternate medications. So, that sort of pre-emptive pharmacogenomics is just over the horizon, and if we can achieve that, we're going to significantly improve patient care and reduce the risk of adverse drug reactions, which are a major cause of morbidity and hospital admissions not just in the UK but worldwide. Vivienne Parry: So Matt, perfect segue into our next question, which was, you've already identified one area which you think is going to be big in the next few years. You're both absolutely in the centre of the genomics ecosystem. What do you think we're going to be seeing at next year's Festival of Genomics? What do you think is going to be the big thing that's coming up on the inside rail? Matt Brown: So look, I'd like to say what I think's going to be in next year and what I think's going to be in ten years. Next year, I think the big things are going to be advances in AI and genomic analytics. That's really ramping up fast, and I think we're going to see it in clinical implementation a lot more next year. I think the cancer therapy vaccines are going to be really big next year, as are nucleic acid therapies. Multiomics for rare disease diagnosis and cancer personalised medicine, I think is also ramping up very fast. In ten years' time, the two areas that we've not discussed so far where I think genomics is going to make a big difference are going to be in infectious diseases and in pathology services. In infectious diseases, genomics I think has a fair chance of replacing to a large extent culture based practice, or serology based diagnosis of infectious diseases, which will be done by sequencing instead. And that will be a massive change to the practice there, because you'll be able to rapidly work out, even if people have been treated with antibiotics already, what the infections are and what the likely treatment responses are going to be. Louise Fish: So from my perspective, next year what I hope to see is people getting just as excited about the differences that some of the technology we hear about this year are actually making when they're being applied in clinical practice. So I think from my perspective, it's all about that move from being excited about the science to seeing people just as excited about the difference that science is actually making when it's benefiting people living with rare conditions and their families through clinics across the UK and the NHS. Next year, I'd like to hear that excitement when people are talking about how it's actually affecting real lives. In ten years' time, I hope we'll be talking about the massive difference that some of the amazing techniques we've heard about here this year have made to the lives of people living with genetic and rare conditions. So, you know, in ten years' time, I hope that some of the treatments and the opportunities and the tests we hear about today, we can see how they've affected the natural history of the condition across ten years of lives, and that we can really see that people are living their lives to the full as a result of the fantastic technological breakthroughs that we're hearing about today. Vivienne Parry: Fantastic. It's been great to talk to you both, and it has been a fantastic festival. Vivienne Parry: So, thank you to you again, and also thank you to Frontline Genomics, who organised the Festival of Genomics, because it really has been a wonderful, wonderful event. And if you're interested in things genomic, you can subscribe to the G Word on your favourite podcast app, and if you're new to our podcast, and we always welcome our new listeners, do check out our back catalogue. You'll find it's really extensive. There's a wonderful set of genomic listening available to you, in which even spatial transcriptomics gets explained. I've been your host, Vivienne Parry. This podcast was edited by Mark Kendrick at Ventoux Digital, and produced by Naimah Callachand, and it's very good to have had you with us. Bye for now, and hope to see you at the Festival of Genomics next year.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Today we have a packed episode with news from various sectors of the industry. Let's dive in!## SnapLVV: Overcoming bottlenecks in LVV productionSnapLVV, a new offering powered by Resilience, aims to overcome bottlenecks in the production of lentiviral vector (LVV) for cell therapy. LVV is a critical component in therapy development, but creating the necessary material can take up to two years, causing delays. With SnapLVV, users can secure a batch of LVV with the specific material they need for phase I of their therapy. Resilience offers expert understanding and streamlined processes for LVV manufacturing. To determine if SnapLVV is a good fit, users can connect with Resilience and discuss their vector needs.## Apple's smartwatches redesign and other industry updatesApple is redesigning its smartwatches to avoid a ban on sales due to a patent dispute with Masimo. The new versions will not have a pulse oximetry feature. In other news, Integer has acquired Pulse Technologies for $140 million. Pulse specializes in micro machining components for medical devices. EssilorLuxottica is integrating technology into glasses to target the hearing loss market. ResMed's magnetized masks have been linked to patient injuries, according to the FDA. The UK's MHRA has shared a roadmap for a new regulatory framework for medtech.## Allakos announces restructuring plan and IPO filingsBiotech company Allakos plans to cut its workforce by 50% after the failure of its lead inflammatory candidate in two Phase II studies. The company will focus on other product candidates. In other news, Alto Neuroscience and Kyverna Therapeutics have filed for IPOs, joining the growing number of biotech companies seeking to go public. Orion Group has announced a $415 million investment in Legochem Biosciences, securing a majority stake. Several significant deals were secured during the J.P. Morgan Healthcare Conference.## Insights into the biotech industry and upcoming trendsDespite setbacks, the biopharma industry is cautiously optimistic about a rebound in 2024. Increased dealmaking and a stock market run have boosted the sector. However, fewer biotechs are going public, and investors are focusing on drugs in advanced testing. Women's health companies are seeing growing opportunities, and real-world data is playing a critical role in shaping pharma's strategies. The industry is aware of the challenges and lessons from the past.## Webinar on cfHPV-DNA biomarker for HPV+ OPSCCA webinar will discuss the potential of cfHPV-DNA as a prognostic biomarker for HPV+ OPSCC. It aims to explore how this biomarker can enhance clinical research and drug development. The webinar will cover historical limitations in biomarker testing and provide real-world data behind cfHPV-DNA. It will inform sponsors and CROs on leveraging cfHPV-DNA in drug development.## Summary of biotech industry articles and newsInvestors and executives at the J.P. Morgan conference are optimistic about the sector but stress the need for leaner operations and focus on first medicines. The formation of Arena Bioworks, a new biomedical institute blending academic and venture capital research models, is discussed. AI's impact in biotech is explored through a Q&A with Chris Gibson from Recursion. Other topics from the J.P. Morgan conference include Novartis' head start in radiopharma, Pfizer's challenges, and the building of biotech platforms. The industry has regained some optimism due to recent deals and stock market momentum.And that's all for today's episode! Thank you for tuning in to Pharma and Biotech Daily. Stay informed and have a great day!

In this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder, Regulatory Compliance Associates'® (RCA) Regulatory Expert. Kinga Demetriou, an Expert Certifier at BSI, and Nathan Shipley, a Global Certification Manager at BSI to discuss the current trends and challenges with Regulatory Requirements US and EU while focusing on personal protective equipment.Listen in as we cover the current trends in the industry, the challenges companies face in relation to the trends, and how companies can address and prepare in this evolving landscape. We cover things like market access, product category changes, as well audience diversification with personal protective equipment (PPE), and why the regulatory requirements are changing in these areas. About BSIBSI enables people and organizations to perform better. They share knowledge, innovation and best practice to make excellence a habit – all over the world, every day. Their solutions and services improve performance and support the United Nations Sustainable Development Goals. At BSI, our mission is to share knowledge, innovation and best practice to help people and organizations make excellence a habit. This is underpinned by our role as the national standards body and through our prestigious Royal Charter. About Regulatory Compliance AssociatesRegulatory Compliance Associates (RCA) provides regulatory compliance consulting to the following industries:Life SciencesPharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceLab TestingWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.Founded in 2000Expertise backed by over 500 industry subject matter expertsAcquired by Sotera Health in 2021

Join us for a relaxed round up of recent Red Whale primary care Pearls of wisdom. This month, Nik and Caroline discuss: Healthy ageing: adding quality to years? What does ‘healthy ageing' look like? What are the 3 trajectories of ageing? How can we work as a primary care team to promote the basics that increase the chance of healthier ageing?Preventing breast cancer: what's our role? The MHRA are now licensing anastrozole for primary prevention of breast cancer in postmenopausal women at moderate to high risk. We discuss our article on Breast cancer: genetic risk, and explore how to assess risk, the evidence for preventative medication and some of the side-effects people taking it may experience.  Acute retention: sort the catheter… then think: why?  A Danish study showed that those who go into acute retention are at an increased risk of being diagnosed with genitourinary cancers in the following 12 months. How much should we worry about this?Self-harm: creating a safety-plan. The UK has one of the highest rates of self-harm in Europe and whilst it can occur at any age, it is most common in young people and females. The 2022 NICE Guidelines on self-harm recommend that whilst we are waiting for CAMHS support and assessment, we can help by encouraging the young person to develop a safety-plan. Would you feel confident to do this? And hear about a colleague's car-tastrophe…NICE patient information leaflet - familial breast cancer:https://www.nice.org.uk/guidance/cg164/ifp/chapter/About-this-informationWe'd love to hear your feedback by email - podcast@redwhale.co.uk or leave us a voice message - Send a voice message to RedWhalePrimaryCarePod (speakpipe.com) If you don't already receive our weekly Pearls email then you can sign up to these herePearls are available to read for 3 months from the date they are first published. After this time, you can get access to any Pearls - along with ALL of the rest of our online written resources - either when you buy a one-day online course from Red Whale OR if you purchase a membership to GPCPD.com here: https://gpcpd.com/subscribe-to-gpcpd Follow us on:TwitterFacebookInstagramLinkedInDisclaimerWe make every effort to ensure the information in this podcast is accurate and/ correct at the date of publication, but it is of necessity of a brief and general nature, and this should not replace your own good clinical judgement, or be regarded as...

The world's first approval of a CRISPR-based gene editing therapy, granted by the U.K.'s MHRA, was a milestone for the technology that was just discovered about 12 years ago. On the latest BioCentury This Week podcast, BioCentury's editors discuss the implications of the landmark and the challenges that still face partners Vertex Pharmaceuticals and CRISPR Therapeutics in launching and scaling the rollout of Casgevy exagamglogene autotemcel (exa-cel) in the U.K. and beyond. The editors also discuss the unintended consequences of the Inflation Reduction Act (IRA) on the development of orphan drugs and new legislation that aims to address the problem by providing an exemption to price negotiations for therapies that are approved only for orphan indications, regardless of how many. The team also reflects on the legacy of FDA's Janet Woodcock ahead of her planned retirement next year; the sentiment coming out of last week's Jefferies Healthcare Conference in London; and the aftermarket performance of two market debuts last week from antibody-drug conjugate CMO WuXi XDC Cayman and Mural Oncology.Music for the 24th Bio€quity Europe promo produced by:Thomas de Paula Eby, Andreas Unge, Epidemic Sound via Getty Images

Christian Schneider is the Chief Medical Officer of Biopharma Excellence, and was formerly the Chief Scientific Officer at the UK's MHRA. He was the Medical Head for Licensing at the Danish Medicines Agency, and a member of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. In this podcast, we discuss the continuing challenges to Europe's Biopharma competitiveness, and how an improved regulatory environment could be a benefit. Christian also highlights both the risks and opportunities of the EU's proposed revision of the general pharmaceutical legislation. This podcast was supported by The European Federation of Pharmaceutical Industries and Associations (EFPIA) and has been recorded in collaboration with PharmaLex GmbH.  It is not meant to serve as legal advice and may contain certain marketing statements. PharmaLex and its parent, Cencora, Inc. strongly encourage listeners to review all available information and to rely on their own experience and expertise in making decisions with regard to the information discussed today.   00:00:01 Introduction  00:01:05 What's your day like as a regulator?  00:09:48 Patient access to novel and effective treatments and patient engagement with the EMA.  00:11:40 Availability of data and clinical trials.  00:14:12 Clinical Trials Regulation.  00:15:19 Europe's loss of competitiveness and its role as an innovator.  00:16:36 The importance of Scientific Advice.  00:17:28 Revision of the EU Pharmaceutical legislation: Fostering innovation and streamlining the regulatory process.  00:20:32 Europe losing ground vis-à-vis the USA: Regulatory assessment.  00:27:37 The use of drug-device combinations.  00:32:30 Reimbursement and pricing decisions and criteria for (High) Unmet Medical Needs.  00:41:02 Revising EU Pharmaceutical legislation and creating a future-proof framework for clinical trials and R&D investments.  00:44:15 Ability of Member States to access all medicines.  00:46:27 Recommendations to the European Commission and the EMA on the EU Pharmaceutical package. See omnystudio.com/listener for privacy information.

In this solo episode entitled “Tried Everything, yet You Still Have Acne” I will be discussing “Acne: The Good, The Bad & The Ugly”In part 2, I'll be discussing, “What really causes acne” as it's very misunderstood by mainstream medicine, and I will also explain why I believe that to be the case.If you're someone who has never suffered or isn't suffering from acne, I invite to listen in, as I believe you will not only find it very interesting, but ultimately very useful in your own health pursuits.I explain in this episode why the traditional medical approach doesn't work for most people. I also explain why many people believe they have tried everything, yet nothing has worked to resolve their acne problem..I discuss:1:05An Introduction to the Episode16:38Why the traditional medical approach doesn't work22:46Risks and benefits of traditional treatments38:55Why the medical approach is allowed even though it is so ineffective and harmful45:50SummaryLeigh's NEW BOOK:"Eliminating Adult Acne for Good" https://bit.ly/eliminatingadultacneforgood References:Demasi, M. (2022, June 29). From FDHA to MHRA: are drug regulators for hire? BMJ, 377. DOI: https://doi.org/10.1136/bmj.o1538Leading Lobbying industries in the United States in 2022, by total lobbying spending(in million U.S. dollars). (2023). Statista. https://www.statista.com/statistics/257364/top-lobbying-industries-in-the-us/Support the showDon't forget to leave a Rating for the podcast!You can find Leigh @:Leigh website - https://www.bodychek.co.uk/Leigh's books - https://www.bodychek.co.uk/books/ Eliminate Adult Acne Programme - https://skinwebinar.com/HEAL THEM Education Programme - http://healthemeducation.vhx.tv/ Radical Health Rebel YouTube Channel - https://www.youtube.com/@radicalhealthrebelpodcast

Show notes and Transcript At long last it has happened. Andrew Bridgen MP (Reclaim Party) secured a debate on excess deaths in the UK Parliament.  Nearly twenty requests were turned down but Andrew simply would not give up.  His courage and determination to find out the truth won in the end.  Andrew gave a 25 minute presentation of all the data and facts which show a shocking rise in excess deaths since the covid jab rollout.  The fact that many people have died after receiving an injection appears to be the very reason every government wants total silence on this issue.  As you watch Andrew speak, be inspired to speak truth in the circles you find yourself in.  Use the information in the speech to arm yourself with the facts.  We now await a much longer 3 hour debate on excess deaths which Andrew is requesting. *This episode contains a background of the debate, the full speech by Andrew Bridgen MP, his message afterwards to the supporters gathered outside in Parliament Square and Peter catches a few words with the man himself. Andrew Bridgen  Member of Parliament for North West Leicestershire since 2010https://www.reclaimparty.co.uk/andrew-bridgen  Some Key Points Made During the Speech... - Ambulance calls for life-threatening emergencies ranged from a steady 2,000 calls per day until the vaccine rollout, from then it rose to 2,500 daily and calls have stayed at this level since.   - The surveillance systems designed to spot a safety problem have all flashed red, but no one's looking. - Payments for Personal Independent Payments (PIP) for people who have developed a disability and cannot work, have rocketed with the vaccine rollout and have continued to rise ever since. - The trial data showed that one in eight hundred injected people had a serious adverse event, meaning the risk of this was twice as high than the chance of preventing a Covid hospitalisation. - There were just over 14,000 excess deaths in the under 65-year-olds, before vaccination, from April 2020 to the end of March 2021. However, since that time there have been over 21,000 excess deaths in this age group alone. - There were nearly two extra deaths a day in the second half of 2021 among 15 – 19-year-old males,  but potentially even more if those referred to the coroner were fully included. Recorded 20.10.23 *Special thanks to Bosch Fawstin for recording our intro/outro on this podcast. Check out his art https://theboschfawstinstore.blogspot.com/ and follow him on GETTR https://gettr.com/user/BoschFawstin and Twitter https://twitter.com/TheBoschFawstin?s=20  To sign up for our weekly email, find our social media, podcasts, video, livestreaming platforms and more... https://heartsofoak.org/connect/ Support Hearts of Oak by purchasing one of our fancy T-Shirts.... https://heartsofoak.org/shop/ Please subscribe, like and share!   Subscribe now Transcript (Hearts of Oak) Hello, Hearts of Oak. Today we are here with Andrew Bridgen at a debate in Parliament, the first debate in this Parliament, on excess deaths. There's been very little debates, very little discussions on vaccine harms here. Of course, this is the issue that Andrew Bridgen MP was thrown out of the Conservative Party, the Tories, for beginning to raise the issue of vaccine harms and now raising the issue of excess deaths was simply is not discussed in this place. I've seen discussion in other parts of the world, especially Germany, with the AFD. But Andrew Bridgen has made this the hill that he will fight and die on. And he has been thrown out of the Conservative Party. He's lost that position he had for many years. Andrew Bridgen, of course, is one of the original Brexiteers, well known to any of us involved in the Brexit movement, in the UKIP movement. And Andrew has been fearless. He's one of those strange beasts in Westminster. He is led by conviction. He is led by courage and led by a desire to do what is right. And he had no desire to climb up the greasy pole. He's traditionally been a backbencher. So has stood his ground, kept his position as a lowly MP and not wanted to rise to the ministerial level, because that gives him the freedom to discuss what he wants. He's not held, he's not restricted by government restrictions, but he can say what he thinks and do what is right for his constituents, for those who vote for him, and realise that he is the servant of the people and he is not the servant of the government. So today there will be a debate led by Andrew Bridgen, I assume he will be one of maybe very few, one of one, who will actually speak on this. I'm really curious to see. I've seen a couple of Conservative, MPs who have touched on this, who have spoken a little bit about this, sometimes on GB News, but they have not gone as far as Andrew Bridgen. And Andrew Bridgen has gone this far. He has lost his job over it, and he doesn't care, because this is the right thing to do when a jab when an experimental vaccine, so-called vaccine, was rolled out and everyone was coerced and more or less forced to take it. Andrew was in that, he also took it, now regrets that and wants to keep raising the alarm on the ongoing effects of this and of course to challenge this government overreach that wants to force this upon everyone. This of course is a conservative government supposedly that stands up for freedom of speech, personal responsibility, rights, and yet all those traditional understandings of a conservative party have been completely upended and is no longer a party of freedom and liberty but is now a party of coercion and control. A number of MPs I assume will come in and speak after Andrew will present his position on excess deaths and ask the question, why is this? It seems to correlate to the rollout of the jab. You and I know that. We've seen the data. Andrew will be careful in how he puts it forward. He will use parliamentary language. He's skilled enough in this chamber to know what to say, what not to say, what connects with those in the chamber, and to win them over. Because ultimately, politics is about the art of persuasion. It is about winning the public over. And today, it is not necessarily the public is winning over, although you will watch the debate in a few moments, but actually is winning over MPs. And that also is crucial. Whatever you think, we still have 650 individuals and many of us mistrust absolutely, many of us detest. Many of us have had a traditional understanding of politics where there was a level of trust with our institutions and that included those in the building behind me. That is gone. I think for all of us, that is completely gone. And to have an individual who is a champion on the issue of curtailing that government overreach, asking questions, following the money, saying, was this just a push by big pharma for profits? Was this something darker? There are a whole load of areas we can go into, but Andrew has, wisely stayed within the areas he can understand. He has read papers, he has, understood them and he has presented those and I think he has been extremely wise on how far he has gone on this because it is a case of winning people over. That's what we have faced, all of us, over the last three years of winning friends, family, colleagues, connections over to persuade them that this is a dangerous experiment on not only the UK population but on the world population. We have a police car. I hope they don't want to arrest Andrew before his debate. I don't think even our government would do that, would they? Anyway, I will let you watch the debate, watch Andrew speaking, and then after I will try and catch up with a number of the people who have been here to support Andrew. I saw, Mike Yeadon earlier heading into the debate and I saw Matt Le Tissier earlier, I saw Fiona Hines earlier, I saw a big group of people who are here to support Andrew as he speaks truth and to let him know that he is not alone because it must feel very alone in that chamber. No one to back you, no one to support you and you feel as though you are a lonely voice crying out in the wilderness and yet. Many people have come to show Andrew that there are many people behind him who are indebted to him for actually speaking truth in this place and are standing with him shoulder-to-shoulder. So we'll hopefully talk to a few of those people after the debate. (Andrew Bridgen MP) Thank you, Mr Deputy Speaker. We've experienced more excess deaths since July 2021, than the whole of 2020. Unlike the pandemic, however, these deaths are not disproportionately of the old. In other words, the excessive deaths are striking down people in the prime of life. But no one seems to care. I fear history will not judge this House kindly. Worse still, in a country supposedly committed to free and frank exchange of views, it appears that no one cares that no one cares. Well, I care, Mr Deputy Speaker, and I credit those members here in attendance today who also care. And I'd also like to thank the Honourable Member for Lincoln for his support, and I'm, sorry that he couldn't attend today's debate. It's taken a lot of effort and more than 20 rejections to be allowed to raise this topic, But at last we're here to discuss the number of people dying. Nothing could be more serious. Numerous countries are currently gripped in a period of unexpected mortality, and no one wants to talk about it. It's quite normal for death numbers to fluctuate up and down by chance alone, but what we're seeing here is a pattern, repeated across countries, and the rise has not let up. I'll give way to my Honourable Gentleman.  (Phillip Davies MP) I'm very grateful and can I commend him for the tenacious way he's battled on this particular, issue. I certainly admire him for that. I just wonder where he found the media was in all of this, because of course during the Covid pandemic, every day, the media, particularly the BBC, couldn't wait to tell us how many people had died in that particular day without any context of those figures whatsoever. But they seem to have gone strangely quiet over these excess deaths now. (Andrew Bridgen MP) I thank the gentleman for his intervention. He's absolutely right. The media have let the British public down badly. There will be a full press pack going out to all media outlets following my speech with all the evidence to back up all the claims I'll make in that speech. But I don't doubt there'll be no mention of it in the mainstream media. You might think that a debate about excess deaths is going to be full of numbers. This speech does not have that many numbers because most of the important numbers have been kept hidden. Other data has been oddly presented in a distorted way, and concerned people seeking to highlight important findings and ask questions have found themselves inexplicably under attack. Before debating excess deaths, it's important to understand how excess death is determined. To understand if there is an excess, by definition you need to estimate how many deaths it would have been expected. The Organisation for Economic Co-operation and Development used 2015-2019 as a baseline, and the Government's Office of Health Disparities and Improvement used its 2015-2019 baseline modelled to allow for ageing, and I've used that data here. Unforgivably, the Office of National Statistics have included deaths in 2021 as part of their baseline calculation for expected deaths, as if there was anything normal about the deaths in 2021. Exaggerating the number of deaths expected, the number of excess can be minimized. Why would the ONS want to do that? There's just too much that we don't know and it's not good enough Mr. Deputy Speaker. The ONS published promptly each week the number of deaths that were registered and while this is commendable it's not the data point that really matters. There's a total failure to collect, never mind publish, data on deaths that are referred for investigation to the coroner. Why does this matter? A referral means that it can be many months and, given the backlog, many years before a death is formally registered. Needing to investigate the cause of a death is fair enough. Failing to record when the death happened is not. Because of this problem, we actually have no idea how many people actually died in 2021. Even now, the problem is greatest for the younger age groups, where there's, a higher proportion of deaths are investigated. This date of failure is unacceptable. It must change. There's nothing in a coroner's report that can bring anyone back from the dead and those deaths should be reported. The youngest age groups are important not only because they should have their whole lives ahead of them. If there is a new cause of excess mortality across the board, it would not be noticed so much in the older cohorts because the extra deaths would be drowned out amongst the expected deaths. However, in the youngest cohorts, that is not the case. There were nearly two extra deaths a day in the second half of 2021 among 15 to 19 year old males, but potentially even more if those referred to the coroner were fully included. In a judicial review of the decision to vaccinate yet younger children, the ONS refused in court to give anonymised details about these deaths. They, admitted that the data they were withholding was statistically significant and I quote they said, the ONS recognises that more work could be undertaken to examine the mortality rates of young people in 2021 and intends to do so once more reliable data are available. How many more extra deaths in 15 to 19 year olds would it take to trigger such work? Surely the ONS should be desperately keen to investigate deaths in young men. Why else have an independent body charged with examining mortality data? Surely the ONS has a responsibility to collect data from the coroners to produce timely information? Let's move on to old people, because most deaths in the old are registered promptly and we do have a better feel for how many older people are dying. Deaths from dementia and Alzheimer's show what we ought to expect. There was a period of high mortality coinciding with COVID and lockdowns, but ever since there have been fewer deaths than expected. After a period of high mortality, we expect, and historically have seen, a period of low mortality because those who have sadly died cannot die again. Those whose deaths were slightly premature because of COVID and lockdowns, died earlier than they otherwise would have. This principle should hold true for every cause of death and every age group, but that's not what we're seeing. Even for the over 85-year-olds, according to the Office of Health Improvement and Disparities, there were 8,000 excess deaths, 4% above the expected levels, for the 12 months starting in July 2020. That includes all of the autumn 2020 wave of COVID, when we had tiering, the second lockdown, and it includes all of the first COVID winter. However, for the year starting July 2022, there have been over 18,000 excess deaths in this age group, 9% above expected levels, more than twice as many in a period when there should have been a deficit. And when deaths from diseases previously associated with old age were actually fewer than expected. Mr Deputy Speaker, I have raised my concerns around NG163 and the use of midazolam and morphine, which may have caused and may still be causing premature deaths in the vulnerable, but that is sadly a debate for another day. There were just over 14,000 excess deaths in the under 65-year-olds before vaccination from April 2020 to the end of March 2021. However, since that time there have been over 21,000 excess deaths, ignoring the registration delay problem, the majority, 58% of these deaths, were not attributed to Covid. We turned society upside down before vaccination for fear of excess deaths from Covid. Today we have substantially more excess deaths, and in younger people, and there's complete and eerie silence, Mr Deputy, Speaker. The evidence is unequivocal. There was a clear stepwise increase in mortality following the vaccine rollout. There was a reprieve in the winter of 2021-22 because there were fewer than expected respiratory deaths, but otherwise the excess has been incessantly at this high level. Ambulance data for England provides another clue. Ambulance calls for life-threatening emergencies were running at a steady 2,000 calls per day until the vaccine rollout. From then it rose to 2,500 daily and calls have stayed at this level since. The surveillance systems designed to spot a safety problem have all flashed red but no one's looking. Claims for personal independence payments for people who've developed a disability and cannot work rocketed with the vaccine rollout and it's, continued to rise ever since. The same was seen in the USA, also started with the vaccine rollout, not with Covid. A study to determine the vaccination status of a sample of such claimants, would be relatively quick and inexpensive to perform, yet nobody seems interested in ascertaining this vital information. Officials have chosen to turn a blind eye to this disturbing, irrefutable and frightening data, much like Nelson did, but for far less honourable reasons. He would be ashamed of us, Mr Deputy Speaker. Furthermore, data that has been used to sing the praises of the vaccines is deeply flawed. Only one COVID-related death was prevented in each of the initial major trials that led to authorisation of the vaccines and that is taking their data entirely at face value, whereas a growing number of inconsistencies and anomalies suggest we ought not to do this. Extrapolating from that means that between 15,000 and 20,000 people had to be injected to prevent a single death from COVID. To prevent a single COVID hospitalisation, over 1,500 people needed to be injected. The trial data showed that 1 in 800 injected people had a serious adverse event, meaning they were hospitalised or had a life-changing or life-threatening condition. The risk of this was twice as high as the chance of preventing a COVID hospitalisation. We're harming 1 in 800 people to supposedly save 1 in 20,000. This is madness. The strongest claims have too often been based on modelling carried out on the basis of flawed assumptions. Where observational studies have been carried out, researchers will correct, for age and comorbidities to make the vaccines look better. However, they never correct for socio-economic or ethnic differences that would make the vaccines look worse. This matters. For example, claims of high mortality in less vaccinated regions in the United States, took no account of the fact that this was the case before the vaccines were rolled out. That is why studies that claim to show the vaccines prevented Covid deaths also showed a marked effect of them preventing non-Covid deaths. The prevention of non-Covid deaths is always a statistical illusion and claims of preventing Covid deaths should not be assumed when that illusion has not been corrected for. And when it is corrected for, the claims of efficacy for the vaccines vanish with it. COVID disproportionately killed people from ethnic minorities and lower socioeconomic groups. During the 2020, during the pandemic, the deaths among the most deprived were up by 23%, compared to 17% for the least deprived. However, since 2022, the pattern has reversed, with 5% excess mortality amongst the most deprived, compared to 7% among the least deprived. These deaths are being caused by something different. In 2020, the excess was highest in the oldest cohorts and there were fewer than expected deaths amongst the younger age groups. But since 2022, the 50 to 64 year old cohort has had the highest excess mortality. Even the youngest age groups are now seeing substantial excess, with a 9% excess in the under 50s since 2022 compared to 5% now in the over 75 group. Despite London being a younger region, the excess in London is only 3%, whereas it is higher in every more heavily vaccinated region of the UK. It should be noted that London is famously the least vaccinated region in the UK by some margin. Studies comparing regions on a larger scale show the same thing. There are studies from the Netherlands, Germany and the whole world each showing that the highest mortality after vaccination was seen in the most heavily vaccinated regions. So we need to ask, what are people dying of? Since 2022, there has been 11% excess in ischemic heart disease deaths and a 16% excess in heart failure deaths. In meantime, cancer deaths, only 1% above expected levels, which is further evidence that it is not simply, some other factor that affects deaths across the board, such as a failing to account for an aging population or a failing NHS. In fact, the excess itself has a seasonality with a peak in the winter months. The fact it returns to baseline levels in summer is a further indication that this is not due to some statistical error or an ageing population alone. Dr Clare Craig from the Heart Group first highlighted a stepwise increase in cardiac arrest calls after the vaccine rollout in May 2021 and Heart have repeatedly raised concerns about the increase in cardiac deaths and they have every reason to be concerned. Four participants in the vaccine group of the Pfizer trial died from cardiac arrest compared to only one in the placebo group. Overall there were 21 deaths in the vaccine group up to March 2021 compared to 17 in the placebo group. And there are serious anomalies about the reporting of the deaths within this trial, with the deaths in the vaccine group taking much longer to report than those in the placebo group. And that's highly suggestive, Mr Deputy Speaker, of a significant bias in what was supposed to be a blinded trial. An Israeli study clearly showed an increase in cardiac hospital attendances, among 18 to 39 year olds that correlated with vaccination, not with COVID. There have now been several postmortem studies demonstrating a causal link between vaccination and coronary artery disease leading to death up to four months after the last dose. And we need to remember that the safety trial was cut short to only two months. So there's no evidence of any vaccine safety beyond that point. The decision to unblind the trials after two months and vaccinate the placebo group is nothing less than a public health scandal. Everyone involved failed in their duty to the truth. But no one cares, Mr Deputy Speaker. The one place that can help us understand exactly what caused this is Australia. Australia had almost no Covid when vaccines were first introduced, making them the perfect control group. The state of South Australia had only a thousand cases of Covid across its whole population by December 2021, before Omicron arrived. What was the impact of vaccination there? For 15 to 44 year olds there was historically 1,300 emergency cardiac presentations a month. With vaccine rollout in the under 50s this rocketed to 2,172 cases in November 2021 in this age group alone, a 67% more than usual. Overall there were 17,900 South Australians who had a cardiac emergency in 2021, compared to only 13,250 in 2018, a 35% increase. It is clearly the vaccine that must be the number one suspect in this and it cannot be dismissed as just a coincidence. Australian mortality overall has increased from early 2021 and the increase is due to cardiac deaths. These excess deaths are not due to an ageing population because there are fewer deaths in the diseases of old age. These deaths are not an effect of COVID because they've happened in places where COVID have not reached and they're not due to low statin prescriptions or under-treated hypertension, as Chris Whitty would suggest, because prescriptions did not change and in any effect would have taken many years and been very small. The prime suspect must be something that was introduced to the population as a whole, something novel. The prime hypothesis must be the experimental COVID-19 vaccines. The ONS published a data set of deaths by vaccinated and unvaccinated. At first glance, it appears to show that the vaccines are safe and effective. However, there were several huge problems with how they presented that data. One was that for the first three-week period after injection, the ONS claimed, there were only a tiny number of deaths. The number the ONS would normally predict to occur in a single week. Where were the deaths from the usual causes? When this was raised, the ONS claimed that the sickest people did not get vaccinated, and therefore people who were taking the vaccination were self-selecting for those least likely to die. Not only is this not the case in the real world, with even hospices heavily vaccinating their residents, but the ONS's own data showed that the proportion of sickest people was equal in the vaccinated and unvaccinated groups. This inevitably raises serious questions about the ONS's data presentation. There were so many problems with the methodology used by the ONS that the Statistics Regulator agreed that the ONS data could not be used to assess vaccine efficacy or safety. That tells you something about the ONS. Consequently, Hart asked the UK Health Security Agency to provide the data they had on people who had died and therefore needed to be removed from their vaccination dataset. This request has been repeatedly refused, with excuses given, including the false claim that anonymising this data will be equivalent to creating it even though there is case law that, anonymization is not considered creation of new data. Mr Deputy Speaker I believe if this data was released it would be damning. That so many lives have been saved by mass vaccination that any amount of harm, suffering and death caused by the vaccines is a price worth paying. They're delusional, Mr Deputy Speaker. The claim of 20 million lives saved is based on now discredited models which assume that Covid waves do not peak without intervention. There have been numerous waves globally that now demonstrate that is not the case, and it was also based on there having been more than half a million lives saved in the UK. That's more than the worst-case scenario predicted at the beginning of the pandemic. For the claim to have been true, the rate at which Covid killed people would have to have taken off dramatically at the beginning of 2021 in the absence of vaccination. This is ludicrous and it bears no relationship to the truth. In the real world, Australia, New Zealand and South Korea had a mortality rate of 400 deaths per million up to the summer of 2022, after they were first hit with Omicron. So how does that compare with the Wuhan strain? France and Europe as a whole had a mortality rate of under 400 deaths per million up to the summer of 2020. Australia, New Zealand and South Korea were all heavily vaccinated before infection. So tell me, where was the benefit? The UK had just over 800 deaths per million up to the summer of 2020. So twice as much. But we know that Omicron is half as deadly as the Wuhan variant. The death rates per million are the same before and after vaccination. So where was the benefits of vaccination? The regulators have failed in their duty to protect the public. They've allowed these novel products to skip crucial safety testing by letting them be described as vaccines. They've failed to insist on safety testing being done in the years since the first temporary emergency authorisation. Even now, no one can tell you how much spike protein is produced on vaccination and for how long. Yet another example of where there is no data for me to share with the House. And when it comes to properly recording deaths due to vaccination, the system's broken. Not a single doctor registered a death from a rare brain clot before doctors in Scandinavia forced the issue and the MHRA acknowledged the problem. Only then did these deaths start to be certified by doctors in the UK. It turns out that doctors were waiting for permission from the regulator and the regulators were waiting to be alerted by the doctors. This is a lethal circularity. Furthermore, coroners have written Regulation 28 reports highlighting deaths from vaccination to prevent further deaths, yet the MHRA said in a response to an FOI that they had not received any of them. The system we have in place is clearly not functioning to protect the public. The regulators also missed the fact that the Pfizer trial, in the Pfizer trial, the vaccine was made for the trial participants in a highly controlled environment, in stark contrast to the manufacturing process used for the public rollout, which was based on a completely different technology. And just over 200 participants were given the same product that was given to the public. But not only was the data from these people never compared to those in the trial for efficacy and safety, But the MHRA have admitted that they dropped the requirement to provide the data. That means there was never a trial on the Pfizer product that was actually rolled out to the public. And that product has never been compared to the product that was actually trialled. The vaccine mass production processes use vats of Escherichia coli and present a risk of contamination with DNA from the bacteria as well as bacterial cell walls which can, cause dangerous reactions. This is not theoretical, Mr Deputy Speaker, this is now sound evidence that has been replicated by several labs across the world, and the mRNA vaccines were contaminated by DNA which far exceeded the usual permissible levels. Given that this DNA is enclosed in the lipid nanoparticle delivery system, it is arguable that even the permissible levels have been far too high. These lipid nanoparticles are known to enter every organ of the body, as well as this potentially causing some of the acute adverse reactions seen, there is a serious risk that this foreign bacterial DNA is inserting itself into human DNA. Will anybody investigate? No, they won't. I'll give way on that point.  (Danny Kruger MP) I am conscious that time is tight. I recognise that the hon. Gentleman is making a very powerful case. Does he agree that the Government should be looking at this properly and should commission of review into the excess deaths, partly so that we can reassure our constituents that the case he's making is not in fact valid and that the vaccines have no cause behind these excess deaths. (Andrew Bridgen MP) I thank the Honourable Gentleman for his support on this topic and of course that is what exactly any responsible government should do. I wrote to the Prime Minister on the 7th August 2023 with all the evidence of this but sadly Mr Deputy Speaker I still await a response. What will it take to stop these products? Their complete failure to stop infection was not enough and we all know plenty of vaccinated people who have caught and spread Covid. The, mutation of the virus to a weaker variant, Omicron, that wasn't enough. The increasing evidence of the serious harms to those of us that were vaccinated. That's not enough. And now the cardiac deaths and the deaths of young people is apparently not enough either. It's high time these experimental vaccines were suspended and a full investigation into the harms they've caused initiated. History will be a harsh judge if we don't start using evidence-based medicine. We need to return to basic science, basic ethics immediately, which means listening to all voices and investigating all concerns. In conclusion, Mr Deputy Speaker, the experimental Covid-19 vaccines are not safe and they're not effective. Despite there only being limited interest in the chamber from colleagues, and I'm very grateful for those who have attended, we can see from the public gallery there is considerable public interest. I would implore all members of the House, present and those not. Support calls for a three-hour debate on this important issue. And Mr Deputy Speaker, this might be the first debate on excess deaths in our Parliament. Indeed, it might be the first debate on excess deaths in the world, but very sadly I promise you won't be the last. (Parliament Square Speech Andrew Bridgen MP) But without further ado let's welcome to the stage Mr Andrew Bridgen. Thank you ladies and gentlemen, thank you for coming down here to support the debate today, and thank you for supporting me and the cause. More? I just spoke for 25 minutes. Blood. It's been quite a week. Start of the week, get attacked from behind by a blunt instrument. But what an ending to this week. We have made history today. Nine months, more than 20 refused attempts to get a debate on excess deaths, the first debate on excess deaths in the UK, Parliament, the first proper debate on excess deaths in the world and I promise you, I absolutely promise you, it won't be the last. We will get a three hour debate in the next few weeks now on excess deaths. We've got two democracies under challenge all over the world. We're hanging over and using what we've got to make sure we get our message out there. On Tuesday next week I'm, I'm bringing in a bill, a ten minute rule motion, a bill called the Sovereignty and Referendums Bill. I'm going to put it to the House. That would stop, if we could bring that in, that would stop the WHO power grab of the people of the UK. I've been invited to speak as well next week on Zoom to some African political leaders, to try and persuade them to resist the WHO power grab, because it doesn't matter where we break this, we can break it in the UK, we can break it anywhere else in the world. This is a worldwide problem, an absolute assault on humanity, and we've all got to stick together. I've been an MP for nearly 14 years. I've given a lot of speeches in that chamber. That I was a bit nervous today because I knew there was never going to be a more important, speech I've ever given. I've never been in a more important speech than the one I was giving today. Can't you hear at the back? Turn up the PA. So, here we go. There was never going to be a more important speech than the one I was giving today, and, even after 14 years as an MP I was a little bit nervous standing up. But what really got me was, OK, there wasn't as many MPs in the chamber as I'd liked, but, the public gallery was full and the support from there was absolutely incredible. And they always say the politicians, that place over there, is in the Westminster bubble. We are going to burst the bubble in Westminster. Absolutely. Ultimately, my message to send you away with is that your determination, your cheerfulness, your resilience will deliver us victory. Thank you very much for coming today. (Hearts of Oak) Andrew, we've just been in on the debate on vaccine harms. Tell us about the process, because it's been a long, hard battle, which you talk about in the chamber. (Andrew Bridgen MP) Yeah, I've been putting in since January every week for a backbench business debate. That was refused. I've put in for a Westminster Hall debate on a weekly basis and I've put in for an adjournment debate. Eventually, after nine months and more than 20 rejections, we had the first debate on excess deaths in the UK Parliament. I think it's the first one in the world, but I promise you it won't be the last. I think the dozen or so MPs who attended today's debate, I'm hoping I'll be able to get a get them to sign up that we can have a three-hour debate well before Christmas and then it's going to grow from there because ultimately the data that I imparted in the chamber today, it's all backed up with the science. Every MP is going to be getting a copy of my Hansard speech and the full data pack of all the evidence that backs up everything I've said. There's no excuses now. So this goes to law because it's a no-brainer really to have these conversations because we've all seen excess deaths across Europe. Ask yourself in a democracy why don't they want to have a conversation about anything? I mean, I'm aware that in the Australian Senate four or five senators asked for a debate on excess deaths they ended up having a debate on whether you should have a debate on excess deaths and the consensus of the Australian Senate was they didn't want to have a debate on excess deaths. Well, I mean that's a red flag straight away, isn't it? (Hearts of Oak) Last question, I assume you believe that there are some MPs that can be won over, that public figures have kept quiet a further reputation, which you don't care about and you've walked away from the party. Tell us about those who you think you can possibly win over and then support you publicly on this. (Andrew Bridgen MP) Well certainly some of the ones that were there today, I know of some who weren't there today who will support calling for a much bigger debate on excess deaths. And ultimately it's the pressure of the electorate, the people, and you could see that although the House wasn't very full of members, the public gallery was full and that shows you that public opinion is they want this issue debated, they want to know what's gone on, and it's their right to have it happen. And that will become an irresistible force for politicians. That's how democracy works. (Hearts of Oak) Well, we've just had the debate in Parliament, a debate that I actually, to be honest, didn't think would happen. I thought that it would be stopped and held off. Only one member of 650 MPs in that place was willing to stand up and have this conversation, on vaccine arms as on excess deaths. He spoke for 24 minutes, presented everything in a measured calm manner, no emotion. One of the many things Andrew is great at, that he just lays it out gently, softly, step by step, that he doesn't raise the hyperball that maybe some others will rise to. And he laid it out in 24 minutes. And of course, the government's response is, Well, excess deaths are other factors, lifestyle factors, like smoking, like cholesterol, even fatty foods. So the government are blaming all the excess deaths over a period of a sudden spike in, smoking and a spike in eating fish and chips. That's what the government. Wow. Like ostriches with their heads in the sand. So Andrew presented his figures. The great thing is that we expect now there to be a much longer debate in Parliament. That was a short motion, a short debate, a 30 minute session. Andrew is hopeful that this can now go to a three hour fuller debate and that will be really interesting to see whether that gets tabled and whether it actually does go ahead and I would like to see other MPs backing Andrew and I think the more he speaks the more courage they will get. Andrew is someone with courage, with conviction, with a backbone, with a determination to speak truth and often, that is a rarity across there, it really is, really people want to, keep their heads down, they want to climb up the greasy pole and attain those higher levels of political achievement. So we obviously will watch this, follow Andrew. He is a hero. There's no one else in that Parliament across the way that's a hero like Andrew. And what else? I mean, it's the hill that he's chosen to die on. It's the hill that he has chosen to fight on. It's the hill that he has lost his career in the Conservative Party. And why? Because people are dying and no one is talking about it. What more important issue is there apart from life and death? And if something has been introduced and it's killing people, you need to look at it, you need to address, you need to understand it, to analyse it and then see what you do with that. So we have won here amongst 650. We will follow this and watch this closely as we see this move towards a fuller debate in Parliament and certainly my hope and prayer is that many other MPs stand up and speak, and that this happens across the world. We've seen a debate happening, I know, in the German Parliament with the AfD. I know we've seen debates happening in the Australian Parliament and the One Nation Party with Pauline and Malcolm are doing a fantastic job there. And here is one individual. Obviously, the Reclaim Party is behind Andrew Bridgen. He's a member of that of Lawrence Fox's party. And Andrew will continue to speak. And as he speaks, I believe that we will see ripple effects across the world because the world watches what happens here. This is called the mother of parliament and I believe that as Andrew continues to speak and continues to speak within this chamber that we will see other parliaments around the world address this issue. But this doesn't affect future debt, I mean, the damage is done, the deaths are happening. But at least you have to hold people to account. And for me, this is about justice. It's about honesty. It's about clarity. It is about truth, which is something that's been in short supply over the last couple of years during the COVID tyranny. So keep an eye on this space for Andrew to continue to push this. And when that longer three hour debate does happen, we will be here reporting on us and reporting on those who have come out to support Andrew today. Matt Le Tissier was here, Le God was in the chamber watching Andrew, Mike Yeadon was here speaking, Fiona Hine has done a great job in pulling people together. There is massive support and I think the parliamentarians in the government want individuals like Andrew Bridgton to feel they are alone, but they are not alone. They are backed by masses of the population and today was a small subset, of that, but Andrew knows he is not alone. Make sure and post this video, let others see what has happened here in the UK Parliament and have hope, because I think often that's also in short supply and I think what has happened today is a day of hope, is a day of reckoning and is a day of moving forward to actually presenting the truth and holding people to account.

Show notes and Transcript Andrew Bridgen MP is one of those rare individuals in UK politics.  He is driven by convictions and critical thinking as opposed to fame and power which is the norm in Westminster (or on Capital Hill I assume).  He was an absolute Brexiteer and led part of that campaign for The UK to have freedom from the EU.  He joins Hearts of Oak to discuss how he fought for Brexit all through his political life, but his biggest battle has been against the Covid Tyranny imposed on us by the UK government.  Andrew spoke up for all who have been vaccine injured and for that he was thrown out of the Conservative party and vilified in the media.  But the Conservatives loss was the gain of The Reclaim Party as he now represents them as the MP for North West Leicestershire. His bravery and boldness is plain for all to see and as long as we have people like Andrew Bridgen in Parliament, we have a glimmer of hope in the UK. Andrew Bridgen was elected in 2010 after spending 25 years running his successful family business, AB Produce, based in the constituency at Measham. Prior to this Andrew attended local state schools and Nottingham University. He has also trained as an officer in the Royal Marines. During his time in Parliament, Andrew has been a prolific speaker and has campaigned on a variety of local and national issues in Parliament. Locally Andrew campaigned for grant funding to bring all of NW Leics District Council housing up to the Decent Homes Standards. Andrew has also campaigned for better transport infrastructure which led to the duelling of the A453 and the planned electrification of the midland mainline. He has also worked with business and community groups to bring down the rate of unemployment in the District, as well as holding a jobs fair. On a national level, Andrew led the successful campaigns to decriminalise non-payment of the TV Licence and to scrap Air Passenger Duty for Children. He has also used his business experience to serve on the Regulatory Reform Committee as well as the Deregulation and the Enterprise Bill committee. Connect with Andrew... X: https://x.com/ABridgen?s=20 The Reclaim Party: https://www.reclaimparty.co.uk/andrew-bridgen Interview recorded 22.9.23 *Special thanks to Bosch Fawstin for recording our intro/outro on this podcast. Check out his art https://theboschfawstinstore.blogspot.com/ and follow him on GETTR https://gettr.com/user/BoschFawstin and Twitter https://twitter.com/TheBoschFawstin?s=20  To sign up for our weekly email, find our social media, podcasts, video, livestreaming platforms and more... https://heartsofoak.org/connect/ Support Hearts of Oak by purchasing one of our fancy T-Shirts.... https://heartsofoak.org/shop/ Please subscribe, like and share! Transcript (Hearts of Oak) Andrew Bridgen, it is wonderful to speak to you today. Thank you so much for your time. (Andrew Bridgen MP) Yeah, you're welcome.  Andrew Bridgen, of course you can find him @ABridgen on Twitter and he has served as Member of Parliament for North West Leicestershire since 2010, re-elected 2015, 2017 and 2019 with a whopping 62% off the vote, one of the few MPs with anywhere near that. Obviously, thrown out of the Conservative Party, the whip removed, and then that was in April 2023 for raising concerns on the Covid jab, and Andrew now represents the Reclaim Party in Parliament as an MP. Andrew, may I ask you first, what got you into politics? You entered Parliament in 2010. What made you think it would be a good idea to get into politics? Frustration, Peter, and I've been running a business for 22 years, which would start it up the thousand pounds. So I've been I've been MD and chairman of the company and we built it up to 25 million turnover company employing 300 people by 2006. And I'd give, I'd been interested in politics. I joined the Conservatives in 1983 at Nottingham University. And I'd been chairman of the Institute of Directors and on the council of the IOD in Pall Mall, and through working during the Blair years with the East Midlands Regional Assembly as a business member. Obviously I'd met a lot of ministers and I can't say that I was impressed. Well, it was pretty clear they were going to bankrupt us. So a group of friends, most, they were all really sort of small and medium-sized business people and their wives, we used to meet in a pub locally and every Friday night it was sort of a groundhog day, so they always moaned about the state of the country. I'd given a reasonable donation to the Conservative Party in 2005 and I think we had a half a percent swing to the Conservatives so worked out at that rate we're never going to get rid of Tony Blair. And so they moaned every Friday night and it eventually it got to me but I mean by that time I was running a business that was making about three million pounds a year across the group. I've got a good management team and no debt whatsoever and one pint of Marston's Pedigree on a Friday night too many and I said to this group of collected individuals, that's it then. It's no good relying on anybody else. There's only us. So in North West Leicestershire was supposed to be a rock solid Labour seat. The council I don't think had ever been conservative controlled properly. I think they may have had control for about three months once out of 40 years after a by-election. So I said well you all stand for the council, the district council, I'll stand for MP, we'll take over and we'll get it sorted and to a man and a woman every single one of them agreed. And so I put most of the money up for the, I put the money up for the campaign and I got the nomination. Nobody really wanted to be the MP for North West Leicestershire, well the candidate for North West Leicestershire because no one, the Conservatives told me we can't win North West Leicestershire, 83rd target seat. They also said they weren't giving me any money but I said that's fine, I've got my own money and my factory was in the, in the, so I actually did have a payroll vote. So 300 people plus their families in the constituency and the District Council elections came round first in 2007 and I was already selected as the parliamentary candidate. I ran those elections and put the money up and it was the first time the Conservatives had put a full slate up in the seat and they said I was running them too thin but I always thought basically if you didn't put a candidate up at an election it's very difficult to see how how they're going to vote for somebody aren't they? So we put a full slate of candidates up and took Labour down to five councils out of 38 in one night, the biggest swing in the country in the District Council elections in 2007. We took control of the council obviously, and I had the second biggest swing in against Labour in 2010, so I turned a rock-solid four and a half thousand Labour majority with a much loved Labour MP, who sadly died, into seven and a half thousand Conservatives at one, so that's like a 12.5% swing. The seat's my home and, you know, I'm very comfortable in North West Leicestershire. And we moved it to, in 2015, it went up to 11,200 majority. And despite Theresa May's best efforts in 17 with her manifesto, which was appalling, I moved it up to 13,300 majority. Then in 19, I led the leave campaign in the referendum for the East Midlands. I told my seat that if they didn't back me I would have to resign as their MP because we didn't agree on the big issues but to be honest Peter I was fairly sure they would. So the East Midlands voted 59-41 to leave and my own seat voted 61 39 and I'm actually the MP who persuaded Boris Johnson to back leave. He was no way that he was a natural Brexiteer and also if you look back on YouTube you'll find that on the eve of the referendum Boris Johnson came to my seat and we went round Ashby de la Zouch. That's when I told him we were going to win and you should have seen his face when I told him we were going to win. I don't think that that wasn't actually part of the plan Peter and in fact he tried to talk me out of it he said no no it's going to be close but we're not going to win. I said no no we're going to win tomorrow. No, it's going to be close. I said, well, maybe I said, but certainly not around here, not around here. It's not going to be close. You know, the bit we're running. So, and then in 19, on the get Brexit done election, which now seems so much happened since 19. It feels like a very long time ago, more than four years away. And I got a 20,400 majority, it was 62.8% of the vote. And the BBC, I had no sleep that night, the next morning the BBC interviewed me and they said, Mr Bridgen, you must be delighted, this is your fourth election victory, each time you've increased your vote, you've increased your majority, your percentage of the vote, you must be delighted. I said, no, it's terrible actually. They said, why is it terrible? I said, well, I've, you know, it's nine years since I was first elected as the MP, I've delivered the highest economic growth in the country. We've taken the poorest constituency in Leicestershire and made it the richest, the only part of Leicestershire with above-average UK salaries and wages. We've got the happiest place to live in the Midlands now, Colville, which was the most deprived town in Leicestershire. I said one in three of the electorate are still not voting for me. I'm gonna have to work much much harder.  Tell me about that whole Brexit battle. I mean my time was UKIP and UKIP was easy because 100% of Kippers were on board. The Conservative Party have always had that tension and division over Europe. What was that like actually in the Conservative Party pushing something that wasn't necessarily what the Conservatives wanted?  Well it wasn't what the establishment wanted, all the established parties were backing Remain. I think it was interesting that the Conservative Party was like, a very civilized internal war, and there were probably only a quarter to 30 percent of conservative MPs who were for leave, so still the majority were, remain, or indifferent, and some of them maintaining indifference, which I mean, I don't know what you're into politics for. If a big question like whether we should remain or leave the European Union, they say, I don't want to get involved in this. I'll just sit down and see what my people say. I mean, that's not exactly leadership, is it? I mean, I think that should be pretty much automatic deselection, if you can't make your mind up on that sort of issue. And what comes back to mind is that the Conservative Party, we used to, when I was in the Conservative Party, before they threw me out, well, first I'll tell you this, Conservatives have never been encouraged in the Conservative Party, they're only ever tolerated. And the Conservative Party, Parliamentary Party, had something called an away day every two years, and they pay for them in advance to get a good deal. So despite the fact that there was this internal schism over the referendum that was coming, the party had paid for an away weekend in Oxfordshire at this basically hotel that's like a Bond villain's hideout, with an underground lecture theatre, which is a very weird place, and because we paid for it, we were told we'd all got to go there, and this is only sort of three months before the referendum, and we had a very civilised weekend of talking about policy, but no one mentioned the EU and no one mentioned the referendum over the whole two and a half days and the dinner, but I do remember that Craig Oliver sat with me at the final dinner he sat next to me on my table at the final dinner and I told him, I said have you got yourself another job lined up for when you lose, and he said to me he said that's fine he said if we win by one vote that's it settled and that's that's it done. I said well I'll be honest I'll take though I'll take that on as as it cuts both ways, you know, if we win by one. And I knew we were going to win, Peter, because, I'd been around the East Midlands and I could tell we were definitely going to win. But it's about driving the vote up because it wasn't just winning by a seat, all the votes were cumulative, so every vote counted. And what I'd sussed out is in my seat and in the East Midlands is that people who didn't normally vote were going to come out and vote. They weren't, those people who didn't normally engage with politics, they weren't coming out to, they weren't coming out to vote for the status quo, they were voting for change. So I concentrated my campaigning efforts the last six weeks. And did a lot of campaigning and also I was running a load of field operatives who were, 90% of it, they were UKIP. The Remain campaign had nobody on the ground willing to deliver leaflets, hardly at all, for them. We were destroying them on the ground battle. Obviously, in the air campaign we could only be responsive because they got all the media, they got all the established parties, and we were the insurgents. So that was more of a struggle, but on the ground we were doing very, very well. And what I'd sussed out was that people were going to come out and vote who didn't normally vote and every time I saw the polls I was not disappointed because I knew that we were probably, we probably got five or six percent better than the polls were saying because these people who were going to come out and vote and they told me they were and I believe they were, They're not engaged in politics, they're not on YouGov's polling panel, and when Com Res or somebody else rang them up and they said, oh, I'm going to vote to leave the European Union, they'd say, well, did you vote in the last general election? No. Did you vote in the local? No. Did you vote in the one before? No. Have you ever voted? No. And they'd put them down as zero chance of voting. Well, I knew as long as we got those people out, it was all going to come as a bit of a surprise to the Remain campaign. In North West Leicestershire, and we counted our votes, so I know it's fine, I know exactly what the vote was in North West Leicestershire, but you could terminate my seat of North West Leicestershire until the next boundary changes. I think it was a sort of 70-75% turnout to get me in in 2010, important election. And then ever since then, as my majority had gone up, the turnout had gone down and it dropped to sort of 68.5% or something in 19. But I mean, it was a stonking massive majority. And obviously the referendum, I was very encouraged when it was nearly 80%. And I'd spent all my time in Northwest Leicestershire and across the East Midlands. In my villages, I mean, it's a general election, they turn out 85 percent anyway. I'm not going to squeeze much more out of those people. You know, it's very hard to squeeze that they're on the second, third pressings of the pips. So I went to all the areas that normally turn out 50, 55, 60 percent because there was plenty of low-hanging fruit and you know it was that turnout in North West Leicestershire and across the East Midlands some people who didn't normally vote and that's why we won and that's why the polling was so wrong and that's what people like David Cameron who'd come to my seat in 2008 when he was leader of the opposition and he really upset me Peter so I'm a a candidate. We've just taken the council with the biggest swing in the country for the first time in living memory and Cameron told me in front of constituents that my seat was a dump and it should never be conservative. And they weren't giving me any money and I said I don't need your money and to be honest David if that's your view, never ever come to my constituency again and I will with it. And to be honest, David Cameron is a man of his word, he never came, he never came again. So that's fine. And I think now my majority is bigger than Whitney, so I mean what a dump the Cotswolds must be. North West Leicestershire. And we've gentrified. So people used to say Coalville was a very poor place and it didn't have a chance and now it's Coalville and proud. In fact I'm speaking to you from Coalville today.  I want to get on to the COVID discussion situation, but just you, you talked at the beginning about having a business and I guess part of your reason for getting into politics was you wanted the government to butt out, you want local businesses to be able to get on, to have, not to have restrictions on them actually doing well, making money, employing people. What kind of other kind of interests or passions? Well, I've actually cut my teeth in politics when I was chair of the Institute of Directors, which they didn't like particularly because they were fairly pro-EU, is that I got involved as a businessman in the,business for sterling in the no campaign to keep the pound so 25 years ago and thank goodness we didn't join the euro otherwise I mean it'd be much much more difficult to extract ourselves. Yes and Simon Wolfson the chairman of Next we used to meet at Enderby in his boardroom and plot business for Sterling in the No campaign. So I suppose that's where I got involved. And a chap called Chris Eaton Harris, who's gone on to great things, apparently, he was an MEP. And his father had a fruit and vegetable wholesale pitch in Covent Garden Market. And since I was into washing, packing, and distributing vegetables, mostly potatoes, nothing sexy. Chris was one of my customers. I used to buy from Mark Potatoes from Mark Spencer. And Philip Dunn as well. They're farmers. So we had the whole supply chain between us, do you know what I mean? But I made most of the money.  Which is just as well because they're not in parliament. Just as well. So yeah, I wanted to put something back and yeah, that's where we ended up. Obviously being a Brexiteer, there was backlash in the media, there was probably some pushback within the party itself. But I guess none of that even prepared you for the backlash whenever you addressed COVID tyranny. Is that a fair assessment?  Well I know that the two years under Theresa May were purgatory quite honestly. I mean I was a Spartan so I voted three times against Theresa May's deal which you know it wasn't, you know, some colleagues were conflicted and there was Steve Baker crying his eyes out. Well I mean there's nothing to cry about because I've already voted against it twice, it hasn't got any better and once you've come to the conclusion, which was the correct conclusion, that Theresa May's deal was constitutionally and democratically worse than being in the European Union. I mean at least if you're in the European Union you have a chance of leaving whereas Theresa May's deal we would be in vassalage forever and there's no way of leaving. Well I mean that's not a deal, not in my name and that vote on the third time Theresa May's deal came up before the Commons I was pretty convinced that there were probably going to be 28 Conservatives in the no lobby. The rest of Parliament would vote yes and that we would have been slung out of the Conservative Party within a few days. That was where I thought we were. Thank goodness. I mean we always criticise Jeremy Corbyn but he is a man of principle and he is secretly a Brexiteer really I think and he marched the Labour Party in behind us and the rest, as they say, is history. But I mean, a politically savvy Keir Starmer would never, would have taken Theresa May's deal and consigned us to EU vassalage. So thank goodness it was Jeremy Corbyn. But he did win the Conservatives the 19th election. That wasn't, down to Boris, it was pure fear of Jeremy Corbyn.  Yeah, no, it was, you don't want Corbyn, 100% I remember that well.  Well, I actually had two, during that 19 election, I can remember when I was going around the doorsteps, two members, two paid-up locally members of the Labour Party came to me and said I'll be voting Conservative, I can't vote for Jeremy Corbyn.  And they actually told me they were paid up members of the Labour Party locally. Well I mean if you, I mean that is your core, ultra core vote. They weren't even voting for him. Wow. On to the COVID. I've never seen anything and I mean I've loved politics, forever with Northern Ireland parties, the DUP and we've had Ian Paisley and Sammy Wilson on before and then conservatives then over to UKIP, but nothing has divided people like what we've had in the last three years with the COVID tyranny. But you spoke a step, it wasn't just on the restrictions that we had, that civil liberty, but you also saw what was happening with harms and went on that. Tell us about that, how you worked that out, because that was a big step and that was an unacceptable step.  I think there's an element of destiny about all of this Peter. When I was 18 and I'm the only member of my family that's been to university, I had a foreground because my parents weren't very wealthy, they were poor. So about two and a half percent of people went to University when I went in the 80s and I went to Nottingham locally but I studied biological sciences with biochemistry specializing in genetics, virology and behaviour. Oh dear! And I don't know why, just they were things I found quite fascinating so I've tried to keep my knowledge up so I mean in February when we'd had the 19 election and then we had a sort of six weeks period and then we had then we had COVID and everything changed. Well in the February I was sent and I looked through the scientific papers for the efficacy of hydroxychloroquine, its effectiveness against coronaviruses and it was compelling. They were scientific papers and because I've got, my degree a very long time ago in those subjects I mean I can read them and I can understand the papers and I sent the papers to Mark Spencer, Chief Whip, and said the government need to look at this urgently, this could be could be very useful and also sent them to Jeremy Hunt who was at the time, Chair of the Health Select Committee, and I didn't get anything back from Spencer. And I also told Spencer, I said, you realise that I've got qualifications in all the areas that'll be useful, if you want some help in the number 10, with someone who can actually read the papers and understand it and put it across politically, I'll be quite happy to help. They never, Mr Stewart never asked me to help, and I rang up Jeremy Hunt a week later, and this shocked me, Peter and it will shock your listeners. So I rang him Hunt up and said Jeremy I sent you these papers, have you have you looked at them? And he said Andrew he said don't send me scientific papers he said I don't understand them and I said but Jeremy you're chairman of the health select committee and you were health secretary for seven years. I said what? You don't understand scientific papers, and what you have no access to anyone who does understand them he could actually explain them to you and he put the phone down and that was it and so my suspicion, so I hadn't got a great deal of confidence I did support the first lockdown because I don't think anybody knew, well somebody knew what was going on it certainly wasn't me, you know was it three weeks to flatten the curve. Anyway, so, and I was, from then on, things just didn't seem to stack up. The masks, I couldn't see the sense behind the masks. I mean, those paper masks, they are to stop saliva from the doctors and nurses going on to the patient's wounds and to stop blood and other bodily fluids squirting into the medic's mouths, which they don't really like, they don't like that. That's what they're there for. So not to stop viruses and the gaps around the edges And I was briefly in the military. And if you had a full nuclear biological chemical suit, you've only got an 80% chance of keeping a virus out. Well, I mean, that's not what these paper masks are. And I guess, I hated putting them on anyway. They're horrible. So I was on that. And then the continuous lockdowns, and Northwest Leicestershire was chucked in with Leicester. And so we were locked down as much as anywhere in the country. It was completely unprecedented and unwarranted. I also really objected to the schools being closed. And I objected. I mean, they were making the children wear masks. And even some schools were making the children wear masks when it wasn't mandated. And none of this seemed right. And there are some, speaking to some scientists who were speaking out about their concerns, And the fact that they were silenced, and they said all the science is all settled, I mean we've heard that one before several times, I'm sure we'll hear it again, but I mean science is never settled. It's a bit like politics, there's always another view, and if you can't defend your position, then there's something wrong. You know, every scientific thesis is open to challenge, or should be able to challenge, and most of them, I mean half of everything that doctors are taught in medical school within 10 years will be proved to be completely wrong. That's a fact, I mean that's just a fact. So, you know, the only constant is the evolution of science and new theories to supersede old ones and saying that, you know, we're not having any debate about this and cancelling eminent scientists. Then my concerns grew and grew and grew but I didn't want to believe the worst of the government. I actually am double vaccinated. They will call me an anti-vaxxer so which is difficult when I'm vaxxed. I'm more the sort of concerned vaxxed and I had two shots of AstraZeneca, I wish I had none, and I had a bad reaction after the second jab, which really, really hurt me. So I'd bitten my tongue, that also uncovered a lot of corruption around PPE. My whistle-blower was sacked. We uncovered £860 million worth of PCR tests that had disappeared from stock at Kuehne & Nagel were the distributor. We traced some of the unique barcodes and they turned up in Berlin. They'd been resold. So nearly a billion pounds. And my whistle-blower could only go back 12 months on his computer. And he was only in one of the three channels. He was in the channel to do with bulk. So it was only sort of prisons, schools, hospitals, things like that. But 860 million pounds worth of PCR tests had gone missing the taxpayer paid for. We took it to the government and the civil service. My whistle-blowers computer was switched off on the day and he was sacked within seven days, no investigation. I was pretty annoyed. And I mean, the corruption of the Boris Johnson regime was the first one I'd, and he was the he'd been the first Prime Minister I'd actually voted for and I was feeling very betrayed. So I hadn't voted for David Cameron, obviously, I voted for David Davies, and Cameron got in and I didn't vote for Theresa May. She got in. And so then Boris turned out to be as crooked as all the rest of them. So that wasn't good. And then my pretty view on the vaccines and the mRNA technology, the messenger ribonucleic acid technology. I was working behind the scenes and obviously Matt Hancock had to go and we had, Sajid Javid became health secretary. But there are about five Conservative MPs who are qualified doctors. Well Matt Hancock, not a good man, but he had said in the House of Commons that these vaccines were for adults, they weren't for children, so no one under 18 was going to have them. I know that every one of the doctors, qualified doctors, went to see Sajid Javid and told him not to use the experimental vaccines on under-18s and he listened to all of them and then approved it. It's interesting that these two health secretaries are both leaving the Commons at the next election, isn't it? I wonder where they'll land, you know what I mean? I suspect Peter, there'll be earning a lot more money than MPs get paid, let's just put it that way.  And then when the MHRA came out in November last year and wanted to extend the experimental vaccines to babies, down to six months of age, and I'll declare an interest, I've got a five-year-old and I thought now, I've got to speak out and I knew there'd be a huge backlash from the party, politically and I knew the vested interests that were involved in it but I also knew that it was probably going to cost me my position in the Conservative Party because they were so committed, but that I could win, that I'm pretty sure I thought, well there's no point doing it for nothing, you've got to win and I was pretty sure that I could put the science over that there were no healthy child of that age had died anywhere in the world of COVID-19 so there was minimal, minuscule risk from the virus but there was a risk from the vaccine. I thought even the most pro-vaccine person I could persuade that since the manufacturers still had immunity from prosecution that there had to be a risk. But there was no risk for those children. I thought I could get that message across and we could actually do some good and so I'd spoken out in a Westminster Hall debate, in I think it was October and then on November 13th I secured an adjournment debate and and blew the lid off the childhood vaccines, vaccination with the experimental mRNA. And that night, my life changed. I was basically immediately cancelled by the mainstream media. And from that moment onwards, I had hundreds of thousands of emails from around the world from people who were telling me about the vaccine harms and the vaccine deaths that they were seeing and that was it really. So after that, although the government will say that I'm a conspiracy theorist and anti-science, anti-vax, and all the people who call me anti-science and everything, I mean they haven't got any science degrees between them and the fact is that the government, our government was never able to approve those vaccines for healthy under fives, whereas all the other countries around the world did. So despite the fact that they said that I was talking absolute rubbish, they never bought the policy and every other country did. And then we got round to sort of January and the infamous tweet, which was actually, I mean, yes, so I retweeted, I actually didn't do it, but it was retweeted on my Twitter, a tweet from Dr. Josh Guetzkow of the Hebrew University of Jerusalem and it's fair to say that Mr. Guetzkow is a Jewish gentleman, that he'd been told by a top cardiologist that the rollout of the vaccine was the biggest crime against humanity since the Holocaust, and the party seized on that, the Conservative Party seized on that, to say I was an anti-Semite, and suspended me immediately from the party. I had a meeting at that time with a Conservative Party grandee who'd clearly been briefed by the party. We had an hour together in his office and I told him all of my concerns around the vaccine harms, the midazolam and morphine, the creation of the first wave of deaths by moving people out of care homes and then putting them onto the death pathway, putting them down, treating them with respiratory suppressants to give them the symptoms of COVID-19 which will appear on their on their death certificate and they were pretty much all cremated very shortly afterwards so there was no autopsies and we had an hour of that. I also knew that the person I was meeting with, because I'd done my research and I've got plenty of informers, he knew full well all of my concerns because he'd been told them. I also know that his sister had had to go into hospital after the second Pfizer jab with chest pains, but I didn't tell him any of this. And at the end of the meeting this grandee turned around to me, obviously with the party line, I've been suspended and said that there is currently no political appetite for your views on the vaccine, Andrew. They may well be in 20 years time and you're probably going to be proved right but in the meantime you need to bear in mind you're taking on the most powerful vested interest in the world with all the personal risk for you which that will entail, and at that point I said well the meeting's over then isn't it? I'm not, don't ever threaten me and I don't like being threatened by public school boys. You know, as a comprehensive school boy, if they had been at my school, they'd have spent most of their time with their head down the toilet. It was a very comprehensive education.  So we basically called it a day at that and then they just fast-tracked the investigation and found me guilty and permanently expelled me from the Conservative Party, which is interesting because in their investigation what they didn't discover is I never put the tweet out myself anyway. I've never ever had the codes to my own Twitter. It was actually posted by my association chairman who remains in the Conservative Party.  Can I ask you about... I need to ask you about the conversations with colleagues and obviously not breaking confidentiality of that, but working with Lord Pearson I'm always amazed people come to him after a debate and says well done. I could never say that but well done you said that. Did you have any kind of similar?  Yes, it's coming up to a year since I first spoke out so yeah I've probably had 20, I probably had 30 backbenchers have come up to me and said you're definitely onto something with these vaccine harms, keep going but that's a million miles from standing in the chamber and saying anything. I've had senior members of the Conservative Party have come to me and said that they're going to speak out. I've had a very senior MP came to me before summer recess and said he'd been approached by a constituent representing 1,100 vaccine-harmed people and he'd have to speak out, but he hasn't, and I had a very senior minister who came to me and said that they're, I mean this is all in private in parliament, no witnesses, so I mean they can deny it if they want to, but you have my word it's the truth, and come to me and said you do realize that my sister's just taken the Moderna booster and now she's paralyzed from the neck down. And I said well that's that's that's terrible news but clearly you're going to have to speak out now aren't you? and they said no, well she doesn't want any publicity and they think they're going to get her to walk again. I said well you don't have to name names I mean you know, you've got to speak out you know and the minister said I'm not speaking out and walked off. And I don't know what to go, I mean, we're supposed to speak without fear or favour, you know, I think the job of an MP is to, certainly I see the job as being to represent, the people, start with my people in North West Leicestershire, against the government and the establishment. And now what we seem to have is a lot of MPs who represent the government and the establishment against the people. That's an inversion of the job of a Member of Parliament. They said to me, you know, why are you willing to die on the hill of vaccine harms, you know, of an issue? And I said, well, because that's the hill you're killing my people on. No completely. I want to add two things to finish. One, you're in the Reclaim Party because that seemed to be the only option. Course you could do as an independent, that doesn't really happen in the UK, but also you're continually asking the government questions. One of the latest questions is did the MHRA inform the Minister of the Pfizer COVID-19 vaccine had been switched? Tell us about Reclaim and I'm assuming you're yet to receive an answer to that government question.  Well Reclaim are a political party, they didn't have any MPs but they're well funded and they've got some lovely premises and they've got great people and they're also aligned with something called the Bad Law Project, so I have access to lawyers and solicitors and so I'm taking Matt Hancock to court for defamation and we have a very strong case. I'm probably going to take the Conservative Party to court for the way they handled my dismissal from the party, which is unbelievable. I'm on my fifth subject access request to the Cabinet Office. I mean, Peter, I've put in for all the information they're holding on me, and even when I'm over four, this is the fifth one going in now, I keep cutting down the number of keywords and compressing the time, and every time they come back and say, I mean, they must have a library on me. They haven't got a black book, they've got a whole library on me. And every time they come back and say, it's too much work. I mean, the last one was about 10 key words. And I said, it's only from 1st of January, 2017. I'll publish all the papers one day and it'll be fascinating, but goodness knows what they're hiding. They're certainly not willing to release any documentation. So I think we're going to have a massive, massive, massive bust up with the government over that. And if they're doing it to me, it won't be just me, will it? There'll be. Yeah, I mean, if there is any mitigation of my colleagues, and I'm not thinking of any any mitigation at all for their inactivity when so many of them, I mean, what you've got to understand, Peter, is people say to me, So there was a lovely female Conservative MP who will remain nameless, but she was elected in 19. And she came up to me a few months ago and said, Andrew, I'm really worried about you. You speak in the chamber on your own. You have all your meals on your own. You sit on your own table in the tea room and the dining room. No one talks to you. You seem really isolated. I'm really worried about you. I said, well, that's very touching. I said, but you've got to remember, 4,000 real people work in Parliament. The cooks, the cleaners, the waiters, the security guards, the police, I said, and they all come to me and 80% of those agree with me. So I'm not really isolated at all, am I? I said, actually, you're isolated, you just don't realise it. So it's not been that bad in Parliament. As far as the Pfizer data, it was again Dr. Josh Guetzkow sent me some from the Hebrew University, sent me some evidence and he's not a scientist, he's a criminologist but he's a specialist in fraud and he went through the Pfizer papers and discovered how they'd switched the vaccines. There were two batches in the initial batch, one that they basically made a Rolls-Royce vaccine up which they gave to 22,000 individuals and they had 22,000 in the placebo group who got a saline shot and that's what they got approval for with the MHRA and every other regulator around the world. But that wasn't the vaccine, that wasn't the Pfizer vaccine that was rolled out. And the smoking gun for the switch of the vaccines is the fact that the MHRA changed the protocols on day two of the mass rollout of the vaccination in the UK, and said that everyone got to stay at the vaccine centre for 15 minutes after day two because of the risk of anaphylactic shock and you only get anaphylaxis if there's endotoxins in the vaccines and you only get endotoxins in the vaccines if they're cultured up in bacteria such as Escherichia coli and the MHRA hadn't expected anaphylaxis because that is not how the vaccine that was given approval for was manufactured, it wasn't manufactured in bacteria with all the contaminants that would go with it. Now, you can't, to get approval for a drug, you have to use the same mechanism of production. You can't change anything because then you've got a different drug with different side effects. So basically, what my allegation is, supported by 44 pages of evidence supplied to me by a doctor of criminology from the Hebrew University of Jerusalem, the government will not answer or even acknowledge, is that the vaccine that was rolled out in the UK and around the world was effectively completely untested and it also explains why the, I mean that the harms from the Pfizer trials of the very best vaccine they could make in in a very small, basically a bespoke vaccine that they made for 22,000 doses, I mean that was horrific enough and that should never have had approval but it was nothing like the harm profile we've seen in actuality through the VAERS system and the yellow card system and the fact that the vaccine is a different vaccine basically explains that as well. If they were doing that with Pfizer, I mean I have no doubt that Moderna and the same and of course I had the AstraZeneca vaccine which which was actually that bad. It was just quietly withdrawn, wasn't it? And it's interesting that the Johnson & Johnson vaccine, which is the AstraZeneca vaccine is not a messenger RNA. It's a DNA strand in an adenovirus vector. So it's different technology to the Pfizer and the Moderna. It's because obviously the DNA then will code for the messenger RNA. And so it's one step further back. It's interesting also that the, I asked for an urgent question in Parliament a few months ago because the Johnson & Johnson vaccine was withdrawn in America and I saw the FDA, the Federal Drugs Agency guidelines and it said stop basically, stop injecting the Johnson and Johnson and all stocks are to be destroyed. And the Johnson and Johnson that was also, a DNA strand not a messenger RNA strand and also in an adenovirus vector to get it into the into the cell. So it's interesting that basically both the vaccines, experimental vaccines were using the DNA adenovirus vector method, they were, both withdrawn and destroyed. But it is interesting that India are still producing effectively AstraZeneca under license. They call it Covishield in India. And of course they didn't stop the Australian version of the AstraZeneca vaccine until only a couple of months ago, so there's going to be a big kickoff there as well. So that's it. I sent it to the Attorney General because one of the questions I did ask was did the MHRA tell the Minister that they'd switched the vaccines, in which case if they didn't then the MHRA are guilty of potentially a crime which is I think it's a two-year prison sent us an unlimited fine, but if they did tell the minister, then how could the minister go out and say they're safe, effective, and tested when they knew that they weren't? I don't understand why the prime minister doesn't want to come back to me. I'm afraid the letter I sent him was a bit of a, do you still beat your wife question. There isn't a good answer, because either I'm going to nail the MHRA, or I'm going to nail the ministers. And it's also interesting, I think, you know, so many health ministers are deciding to not stand at the next general election. No, 100%. Andrew, I've watched your many speeches in the Commons and followed those written questions and I think for our UK viewers and listeners who are very frustrated at UK politics, I think as long as there remains someone like you speaking this truth, then there is hope. So thank you for what you do and thank you for your time today. Thank you very much for having me on. I'm sure we'll speak again in the future.

Pleibéricos - Presentación de estudios ibéricos online. Para marcar el inicio de nuestro cuarto año en activo y nuestro evento 25, el 6 de septiembre de 2023 celebramos nuestro primer evento híbrido en el marco del Congreso Anual (44) de ACIS (Association of Contemporary Iberian Studies) en Oporto. Libros presentados: Memory, Transition, and Transnationalism in Iberia (Cambridge Scholars, 2023). Editores: Mark Gant, Susana Rocha Relvas and Siân Edwards. Matilde de la Torre. Sex, Socialism and Suffrage in Republican Spain (MHRA 2022). Autora: Deborah Madden. Leyendas negras, marcas blancas. La malsana obsesión con la imagen de España en el mundo (Contexto, 2022). Autor: Sebastiaan Faber. Novedades de la serie ‘Constelaciones‘ (Comares, 2022-23). Conversación con la editora de la serie: Cristina Moreiras Menor. Encounters with Jazz on Television in Cold War Era Portugal 1954–1974 (Routledge, 2022). Autor: Pedro Cravinho.

On this episode, I was joined by Janine Jamieson, European Editor at International Pharmaceutical Quality. In this episode, Janine walks through: -Medical Device vs. Medicinal Product Reviews in the EU -Working at MHRA as a Pre-Market Reviewer on Devices with an Ancillary Medicinal Substance -Notified Bodies, EU MDR and Article 117 -European Commission, Member States and European Member States Structure -Writing about combination products in the EU Janine is European Editor at IPQ (International Pharmaceutical Quality) Publications, living in Sweden and writing about the regulatory dialogue at biopharma conferences. She writes about quality/CMC issues, innovation and reliance, and drug-device combination products. Between 1997 and 2016, Janine was a pharmaceutical assessor at the UK MHRA, where she focused on device-drug combination products, working with several EU notified bodies, and with MHRA colleagues on drug-device combination products and borderline classification issues. She helped with training, set up a cross-agency combination product working group, and was involved in horizon scanning and innovation office activities at MHRA and EMA. She has also been an enthusiastic contributor to TOPRA, The Organization for Professionals in Regulatory Affairs, from special interest networks to training and chairing conference sessions.

Show notes and Transcript... Dr David Cartland joins Hearts of Oak once again to discuss his ongoing battles as a wide awake doctor.  For over 2 years he has had to fight, not only for his credibility in the NHS but for his continued employment.  He shares his ongoing battle with the GMC (General Medical Council) who seek to destroy GP's on the basis of random complaints about their social media posts.  In the middle of this skirmish, David finds himself 'persona non grata' and struggles to find locum jobs as a doctor in a country that is in desperate need for medical professionals.  We end with Dr Cartland sharing the many stories he hears each day of horrific vaccine injuries. Dr David Cartland (MBChB MRCGP) is a fully qualified doctor and GP. He is also one of the most censored professionals in the UK. Dr Cartland has a 1st class degree in Biomedical science including a year of specialist immunology and microbiology/virology training that included statistical analysis, and it is this area of expertise that has had particular relevance and value in allowing him to professionally assess the mass of government, NHS, MHRA, pharmaceutical and ONS data on Covid-19 and Covid-19 Vaccine Adverse Reactions, which has been published since the declaration of the ‘pandemic' in UK. Between his two degrees David worked for a year in the angiogenesis research group at the University of Birmingham and he is a published author in angiogenesis research. At his graduation he recited the Hippocratic oath. Part of this powerful oath is a vow. A vow to ‘Primum non nocere'- first do no harm. After years of training and sacrifice, followed by many happy years in a professional practice as a highly respected doctor, in February 2022 David took the difficult decision to resign as a GP. Follow and support Dr Cartland at the following links.... WEB: https://drcartland.com/ X: https://twitter.com/CartlandDavid?s=20 GETTR: https://gettr.com/user/DrCartland TRUTH: https://truthsocial.com/@drdavidcartland DONATE: https://www.buymeacoffee.com/drcartland PEOPLES HEALTH ALLIANCE: https://the-pha.org/  WORLD COUNCIL FOR HEALTH: https://worldcouncilforhealth.org/  DOCTORS FOR PATIENTS UK: https://doctorsforpatientsuk.com/ Dr Cartland's original testimony titled ‘Breaking the Silence' can be read here....https://metatron.substack.com/p/breaking-the-silence  Interview recorded 19.8.23 Audio Podcast version available on Podbean and all major podcast directories...  ⁣https://heartsofoak.podbean.com/ Transcript available on our Substack...https://heartsofoak.substack.com/ To sign up for our weekly email, find our social media, podcasts, video, livestreaming platforms and more... https://heartsofoak.org/connect/ Please subscribe, like and share! Transcript (Hearts of Oak) Hello, Hearts of Oak, and welcome to another interview coming up in a moment with Dr. David Cartland, who's back with us again. And David joins us to discuss his experiences of being investigated over two years now by the General Medical Council, the GMC. It is the regulatory body that investigates doctors' malpractice or failures. And because of initially anonymous reports complaining about a social media profile, he has been investigated. He discusses that process and the GMC have absolute power, they can remove a doctor's ability to practice medicine in the UK. So it is, they are judge and jury, court martial. We also go into how the NHS silences whistle-blowers. He shares some of the stories of his patients that he has seen vaccine injuries and we also discuss his difficulty of simply getting a job as a locum in surgeries.  Dr. David Cartland, it's wonderful to have you back with us. Thank you so much for your time today.  (Dr David Cartland) No, thanks for having me, Peter. It's always a pleasure to chat.  Good to chat. I think last time you were with me is probably our last video at the end of last year. Time flies past, but it's good to have you back. Lots to cover, not only about you but what you see professionally. But if I can @CartlandDavid on Twitter, that's where you can follow David's many pieces of information put out regularly. So if you're not already following him, do. Although, David, you've become quite high profile. Maybe just touch on that and then before we get onto of the GMC stuff and some of the cases you see. But what is it like to be kind of the voice of reason? Because I guess when you go into profession, you're there as part of the system. You put your head down, you do the good that you've been trained to do. It's quite different for you because a lot of doctors now in the media, in the public sphere, are talking about. What has it been like over the last three years?  It's really strange because I get a lot of feedback that I've kind of stuck my head above the parapet and I'm brave and I've got balls of steel or whatever they say, but you know I see it as simply my duty to do what I've done. You know I've said this many times, you know, I've stuck my neck on the line but really not because I've spoke out about ethical principles of consent, bodily autonomy, not coercing patients to take medical treatments that they aren't being fully informed about number one, but you know, that we haven't got any safety data for, you know, defending children and pregnant moms, you know, there was never any roll out data for both cohorts. And so that's the two easy wins, I thought I picked, you know, the ethical issues and the pregnancy safety, lack of safety data and the children and vaccine injuries and speaking out about lockdowns and masks and for doing so, you know, the NHS supposedly supports whistle blowing, they call it a learning culture, a no-blame culture, let's talk about these things without any blame until you whistle blow. And then, like I found out, to my detriment in a couple of arenas, really, as soon as you whistle blow about concerns that you've got. Concerns that still to this day remain unanswered. That's the other thing. You could easily shut me off with some data. Very easy to do. Correct my blasphemous views on all of this, just sit me down and show me the error of my ways and hasn't happened for two and a half days. It's been a full two and a half years, should I say. It's been a cancel culture as other people in the arena have found, you know, you look at Andrew Bridgen, all he did was ask questions and asked to take a closer look at the data. You look at footballers, Matt Le Tissier, you know, speaking out and saying, look, we need to look at this, footballers are collapsing left, right and centre, let's stop, let's investigate this. Similar to me, I'm just saying like this isn't ethically right, this isn't safe, we're not following evidence-based practice here, but yeah to somehow out of all of this become, I googled myself the other day because I said a third's really let me go because they said they'd googled me, so I thought let's. Have five minutes and see what you can come up with when you google Dave Cartland. One thing that comes up is internet personality, so that's the surrealness of where we are at the moment in that for somehow doing the job, following my Hippocratic oath, following principles of safety evidence based practice and ethics and these are all GMC guidance's as well you know I keep reminding on Twitter my fellow colleagues of the guides the guidelines that we have you know about the duty of candour whistleblowing ethics you know making sure you know we're gaining informed consent these are all enshrined in the GMC and as we'll talk about later on in the discussion the GMC they've got some slightly double standards when it comes to who to go after.  I guess there was some point where it went from criticism within the profession, so disagreements with fellow doctors, fellow professionals, to a, more bigger investigation and checking up. I mean how did that step change come? Yeah, where to start with that? So yeah, I mean, it has been kind of, it started off as kind of anonymous reporting. So the first I ever heard of the GMC, being involved in me was, I found it in my junk email box from my NHS mail account, saying that there'd been some sort of hearing about me about spreading COVID misinformation, and that a decision had been made that there was no case to answer for. This was in April, I think, 2021, it goes all the way back to that. That was without your input, you just...  So that was without my knowledge, my input, but even though they found there was no case to answer, they escalated it to NHS Performance Advisory Committee. And so you'll see on Twitter, I posted a reflective piece they asked me to do at that point to explain how I got to my position. I actually got to present to the GMC at the time as well, not the GMC, NHS PAG committee and their six doctors. I had the floor for about an hour, went through data, my concerns, and with specific reference to the reflective piece that I posted. And, you know, at the very end, I just said to them, any comment, any information on what, you know, any rebuttal to what I presented? And they just said, look, we're not here to discuss the content of your views on COVID. We're here to discuss, and it was a really strange comment they made. They said, we're here to discuss your mental health, your fitness to practice, and your fitness for purpose. I always remember that comment, fitness for purpose. And it kind of all fizzled out after that. They closed the case, and then pretty much, you know, every month or two, I'd get a dumping from the GMC saying we've had these 15, mostly anonymous complaints from various characters, either from Twitter or ex-colleagues I used to work with saying, we've had these 15, 20 complaints just to let you know, FYI, this is the content that's sending you the redacted complaints. And you'd just been told that you were getting this flurry of complaints about COVID misinformation, conspiracy theories, and all the rest of it. And some of them are quite comical. I was called a dangerous individual, I've been called Harold Shipman 2023. And all the rest of it and so you know they were throwing them out which is good but then it kind of got a little bit more nefarious in that you know, firstly the council culture in my own community, so I've been you know, I've been I moved down to Cornwall for the work life balance, I didn't wake up one morning and say I tell you what I'm going to be a crazy anti-vaxxer and conspiracy theorist and commit career suicide. I said what I saw I had genuinely held and still unrebutted concerns as previously mentioned on safety ethics and an evidence-based medicine and not being followed. And for that, I've received a cancellation, blacklisting. I've applied recently for, in Cornwall, we've got a lack of doctors. We've got a massive issue with GPs in particular. I'm an ED-trained GP, so I'm kind of dual-trained, and I teach medical students. I've got background in science. I'm a published scientist, did a degree with quite heavy weighting in immunology. And we've got somewhere around 25 jobs out there all the time, consistently. Whenever you look at the website advertising for GP jobs, there's always 25 jobs. So I applied for 25 jobs about six, seven months ago, and I got three responses. The rest just ignored me. Their jobs are still being advertised, by the way. And the three letters that I got back were essentially we don't employ anti-vaxxers or your views on vaccines don't align with the ethos of our vaccine centre, for example. So it started off like that. And even now, I mean, I've been let go from locum surgeries now because I retweeted an Andrew Tate video six months ago. That's a genuine example of why I've just been let go from three weeks worth of work, you know, and I didn't really know who Andrew Tate was. If I'm honest, I must've just seen something on Twitter, retweeted it without doing a full, you know, biography check on the person. And then that was enough cause for the GP surgery to let me go. And that was actually a surgery that had massively positive feedback from the work that I'd done. And then the other surgeries then, you know, putting the phone down on agencies they mentioned the name Dr Cartland, literally putting the phone down on them saying and then the agency would get back to them and say was that technically correct. Was that a technical issue with the line? I said, no, no, no. You mean Dr. David Cartland from Cornwall? Oh, no, no, we don't employ anti-vaxxers at our surgery. We'd rather not employ a doctor. We would rather have no doctor than have him. And there's been several examples across the last six months where surgeries have gone without a medic for a whole day than have me, who's offered my services to them. And I've got email confirmation of that. So it started off a little bit like that, cancellation in my locality. I mean, cancellation by the village that I live in, the town I live in. Literally bizarre because as you mentioned earlier you know outside of Cornwall, I'm quite, there's a profile there you know people know who I am people recognize me but not in my home village they think I'm a leper and they treat me like a leper so very odd and then the GMC stuff started a bit more insidiously then with with the usual suspects on Twitter..  So okay tell us what the GMC the General Medical Council there'll be many watching not in the UK so what exactly is that body what does it do? So the GMC are there, General Medical Council are there to kind of oversee doctors conduct, doctors you know any issues around their abilities practice safely, you know so clinical negligence etc so they've got kind of lots of overreach into into what doctors do but I mean the way you complain about a doctor is you can literally go on to an online page completely you can say anything you want and I've seen this in action, like literally you can say, Dr. Cartland tweeted this. And this was what a lot of the complaints were that I was getting. It was about social media activity. But I did come across, you know, I had the devil in me at some point in the past, about seven or eight months ago. And I decided to do a sort of feature on Twitter where I went into some of the TV doctors. And I thought, I'm going to out some of the outrageous statements that Van Tam, Chris Whitty, Matt Hancock. I did a week of going after the politicians and just quoted what they said in their own press conferences and, you know, the next slide, please, conferences that they were doing. And then I moved on to the TV doctors. And I went to Dr. Ranj, Dr. Amir Khan, Dr. Sarah Kayat, Dr. Hilary Jones, and I basically published the biggest whoppers that they'd ever told, you know, like, Dr. Ranj said, you know, take one COVID-19 vaccine, and you're 100%, 100%, it's always 100% safe and effective of avoiding hospital or going, becoming unwell, or dying of COVID-19. That's what he said, or worse. And I just posted it. And that's been taken now by the GMC to be examples of my bullying. The charges against me at the moment are bullying, incitement of hatred to fellow professionals, and online harassment. So they've tried the misinformation, they've tried the mental health, they've tried the conspiracy theories on professional behaviour, social media guidance, and now they've moved on to what can only be described as a coordinated complaint. I've got evidence of all the complainants collaborating together in chat rooms, and making this an effort to get me struck off. So as we stand today, you know, I've been all of the complainants, for example, have been given the chance to give an oral statement against me. You know, Dr. Ranj gave a 110 page victim statement in inverted commas. And it was like reading a fantasy novel. Honestly, I've read it, it's an embarrassment really to the GMC, but they've took it seriously on the lines of bullying and harassment. And what have I done? I've posted 'This Morning' interview where he made outrageous claims that misled a lot of people, you know, nothing's 100% RSA, you know, this cup of tea, it's not 100% safe, I could choke on it, I could drop the cup on my foot, I could drop, you know, the hot liquid on my crotch, you know, and it's not, it's not 100% safe, is it? So all of these doctors made the claim of 100% safety. One particular complainant said it was 100% safe to vaccinate pregnant women, and then went on to say that the vaccine reduced miscarriage rates, and then went on to equally tell a whopper around what technology was used in the vaccine, saying it was identical to the influenza vaccine, without naming names for this particular doctor. But, you know, they've been able to formulate that my retweet of, you know, their false claims has been labelled as, what did they say in the one complaint, I've set my anti-vax mob upon them, and, you know, they're all playing the mental health card now, saying that because of Dr Cartland, they're suffering with their mental health and anxiety and all the rest of it playing the victim beautifully. Very strange goings on and to me I mean it's a big overreach really GMC are they there to comment on my twitter feed? you know that's what it seems to have come down to. But well, what is the the process do you get an email or letter through to say you need to appear in front of somewhere, just being told you're under investigation and you said you were before them so what input do you have with that? That's a really good question, so in all in all of this you get kind of, you get I'm infamous at GMC now so I've got my own complaints member of staff so I've been allocated my own member of staff for the inundation that they've had. But essentially that person will then update me on the process. And the process has been the three complainants have been given the oral witness statements. And they've gone to town on me really and dug back into my timeline. There's clear collaboration between them. Meaning one particular complaint, the GMC have actually helped the complainant go through my Twitter feed and look at interviews to look for examples of alleged transphobia. So there was a period about three months ago where I went in heavy on the strange things that we're seeing in the sexualization of children, sex trafficking. There's the drag queen story hour that we've had in Cornwall. Some of the videos I'm seeing online about inappropriate things going on in front of children. People clad in gimp suits with kids stroking them. You've probably seen the images. Men clad with sex toys all over them, multi-coloured sex toys, making a complete fool of themselves really in front of children. And calling that out, and again, charge number eight on the GMC charge list is I've showed hostility towards the LGBTQ community. I've had lots of input from LGBTQ people, show me a lot of support, actually, because they're fed up of it. They're fed up of this kind of leaning into the agenda and the overreach of it, this minor attracted persons, the, we need to start having sympathy for paedophilia, we need to start looking deep into the psychology, normalizing it and then going off on things like, you know, in schools now we've got kids in our locality identifying as cats. I mean, how on earth have we ended up with that? You know, when we've got people being referred off a puberty blockade at the age of 12 and genital mutilation, that to the GMC there is evidence of my hostility towards LGBTQ and they're jumping on anything at the moment. Clearly I've got a target on my head. So none of it has to do necessarily with your medical understanding or ability or giving someone the wrong drugs. It's simply your views, what's in your head. And it's strange how a tweet can affect how you actually carry out, listen to a patient diagnosing them. It's, their opposites. They're saying it just affects confidence in the profession, so another colleague, I won't mention the name at the moment, is having a case reopened for bringing the profession into disrepute. Affecting public confidence with their conspiracy theories in inverted commas. But I mean, I'll tell you what's happened, just to finish off what I meant to say just about the GMC proceedings. So all three complainants got the chance of an oral statement. They've been either to the building in GMC HQ or they've given a Zoom, you know, face-to-face. I've not been afforded that privilege so basically what they've done is clumped all three complaints together into about 600 pages of evidence and I mean the evidence is pathetic, simple as that it's not it wouldn't you know if it was a murder case it would be thrown out, you know it's absolutely embarrassing but all the way through this I've got a clear evidence of all three complainants colluding, inciting against me, getting people to and they've done it for other doctors like Aseem Malhotra, please report this doctor to the GMC, well that's incitement isn't it. And I've got evidence of this. In fact, one of the complainants has been, is a very notorious chap on Twitter. Again, I can't name his name, but a notorious bully, troll, spreader of misinformation. And this guy has been bullying me for two years and has had the audacity to accuse me of bullying. I said to the GMC, I've got pages and pages of information where he's called me Harold Shipman or he's had me arrested or I've been struck off. I'm dangerous, I'm dodgy, I'm unsafe to practice, I'm a liar. I've got all of these screenshots. He's even questioned my mental health, publicly saying I should be sectioned, I'm mentally unstable. He's been speaking to my family and they're all increasingly concerned about my mental health. I've got all this, but can you show it to the GMC? Do they want to see it? No, they don't. not letting me give, you know, get beyond the administrative system to speak to a decision maker. So it's been very much guilty till proven innocent and they backed that up by, about a month ago, they demanded of me my full, you know, who I work for as a locum, what surgeries, which hospitals I work in and they wanted me to go back six months to name what surgeries I work at and the reason for that was they wanted to send out a letter before I've even had a chance to give evidence to say Dr. Cartland has been accused by some high profile TV doctors of bullying, harassment and online incitement and that's gone out to every surgery that I've either worked for or currently worked for and I absolutely begged them not to do that. I said look, this is clearly a guilty till proven innocent approach to the situation, please let me at least give my chance of defending myself. I mean to be fair to them, they've been clear in the letter that, you know there is no fitness to practice hearing here and it's not, you know, they haven't even made a decision on that they're just collating so what's the point of sending the letter. I said to them this is only going to give me financial and reputational damage, they still sent it and since then the three surgeries have not offered me a single locum shift, so as predicted they want to wait till the investigation's over and that's natural of course, why would you want to employ a doctor by choice that, you know, it's hard enough for me to get a surgery to take me for half a day when they're absolutely desperate, you know, it's it's such a waste but can't explain that. Guilty to all, even innocent.  How long has the process with the GMC, how long has that been going on for and how long does it, is there a fixed time period, can they keep it open for indefinitely, what's the process? Yeah that's a great question as well, I don't know, I've not been very transparent through the whole time, it's been, I've been dangled by a piece of string since like I say April two years ago, with various different, you know, aspects, like I say I first found out about investigation from a junk email. It's just the communication has been terrible as well. They've not kept me up to date really. They keep telling me they dropped a lot of the charges against me without informing me that they dropped a lot of charges against me. What GMC like to do as well is they send you emails that are quite anxiety inducing about five to five in the evening, and they're all knocking off at five o'clock. So even in that approach it's like well. There's method in that, they're doing that on purpose, you know, to send an email at 10 to 5 with, you know, this is the witness statement for Dr. X and then you're going into the weekend and you can't fight your corner and, you know, all they've done along in terms of pastoral care, you know, at the end of the day this is very stressful, you know, I'm going into the next month not knowing if I'm going to be in front of a fitness to practice hearing for the crimes of promoting evidence-based practice ethics and safety. And I don't know where my next pay check's coming from. It's just, it's bizarre. And all they've done is they've given me a Samaritan's number and to contact the BMA 24-hour helpline, completely separate to them. There's been no pastoral support. In fact, there's been no pastoral support at all. I've tried all through the last year to reach out. It's hard enough to do that as a doctor, reaching out to other doctors, and I've ended up passed from pillar to post. No one can offer me any support, any help. I even went to my own GP at a time when I was having a lot of stress, I wasn't sleeping. GP essentially, in a nutshell, signed me off work for six months with stress and depression. Sent me bucket loads of antidepressants, sleeping tablets and anxiolytics and then zero point during that, I've still got the boxes by the way, I never used them, but the point I was trying to make is not one single doctor or nurse spoke to me in that six months and assessed me and gave me copious amounts of drugs during that time and signed me up and made a diagnosis actually based upon e-consults, which is what doctors are doing now. They're not even seeing patients to this day. They're still doing telephone consults, you know, triaging everything out, you know, only seeing on the day emergencies and this is what's contributing in a way to some, only a small amount of the excess mortality that we see and they're just not seeing patients hence, not diagnosing or processing and doing their job, still hiding behind the COVID. I worked at a surgery a few weeks ago and the doctors are all still masked up. They've got two, three masks on some of them, gloves on, aprons on, visors, they change between every patient and they've had five or six jabs at each of these doctors. So we've created this bizarre kind of germ OCD phobia kind of mentality. I can't explain it.  It is. Maybe four months ago, five months ago, I went to the hospital with one of my kids and I went in and the doctor said, I'm sorry, you'll obviously need to wear a mask. I said, I'm exempt. He goes, no, no, no, you can't be exempt. I said, yes, I'm exempt, I can show you, the government. And he goes, oh well, it's too dangerous. If you refuse to wear a mask, we'll have to have the consultation in the corridor. So we moved out of his room and we were in the corridor of a busy hospital and he carried out the consultation in the corridor, because the corridor was safe, but his room was not. And I thought, you don't even argue when you're with children, you just...  And this is in 2023, Peter, isn't it? The insanity continues and now we've got the old... Eris, is it? Eris, the variant, and they're trying to stoking up the fear porn. The goddess of destruction, they've named this one after all, chaos or something like that. So they're really working on getting the anxiety levels up and people will fall for it. The doctors have fallen for it, hook, line and sinker. Absolutely easy meat it's been to con the doctors. I mean, how to explain what happens to you there? You know, you've been taken out to a corridor. It's just insane. You know, if you see a doctor in a mask, I would go and ask to see another doctor. I'd go so far as to say that, you know, It's an instant IQ assessment for me. The data's out there about damage. Not only is it pointless, I keep trying to explain, you've got eyes as well. If you sneeze into somebody's eyes, you still can contract. So unless you've got goggles on. Doesn't matter what you wear on your face. There are studies that show it's dangerous to your blood gas. You can become hypercapnic, hypoxic. Quite swiftly, I have to put in one arm. Spoke to a lady at my son's optician appointment last week, and you could see she was struggling to breathe. You're speaking and she's and you can see it bellowing out and just like you don't need to put that on, it doesn't work, but her excuse to me was it just makes the older patients feel safer, but it's fraud isn't it, it doesn't it doesn't do what it says on the tin but that's just a small cog in this deception isn't it.  One last question on the GMC and then maybe touching some of the cases you have seen what powers do the GMC have?  They've got the power to end your career, literally, so that's where we are with my particular cases, that they're going to, two people get to decide, one's a lay person and I don't get to speak to these people. I've got the opportunity to write a written rebuttal and they turn the sand timer off 14 days ago so I've left it for a few days and I've got 14 more days to respond and then that goes to a decision maker which is a doctor, a lay person to decide is it fitness to practice or not and that's where the fun begins if it is a fitness to practice and in a kind of dark way. I hope they do because I hope to air my facts and figures to them in public and I think this is the reason they haven't taken some of the higher profile doctors to fitness to practice because it goes on public record. We come out with all of our data, we talk about excess mortality, we talk about our clinical experiences and it all comes out in the open and I don't think they want that. That's why they go for things like bullying and online harassment and breaking the social media guidance or there's a new guidance come out on LGBTQ+ now, all you need to do is offend, that's the measure now you have to leave your faith for example at the door and if the level of being able to report the doctor to the GMC is just merely offending somebody with your view and again at that fitness to practice that literally is what it says on the tin, are you fit to practice or not and we see it now in some of the cases of people being struck off, it's very nefarious, people are, and it's not based on safety, it doesn't seem to be harming patients that brings about the charges are being struck off anymore it can be what you're offending somebody or you know your twitter feed or retweeting an Andrew Tate video for example, it's just bizarre I mean what what jurisdiction should the GMC have over my private, where's that private, public social media. I've got freedom of speech, you know, I'm a lot of these views and they're quite you know within their rights to debate me but I'm two and a half years in now, not a single doctor, no one from the LMC, no one from the GMC, no one from the NHS, the chief medical officer runs away from me down here, the MP runs away from me down here. No one wants to have the conversation and so we all know what that is. But it's just so dark, isn't it, that, you know, a good doctor here is not able to work in one of the most under doctored areas of the NHS. And, you know, it's only patients that suffer. It's not me. I'm doing okay with my private work, you know, so, you know, it's one of those. Well, actually, let's touch on that, the private work side on your website. Let people know what they can find because this is, I think, a way forward and what you're offering is essential and exciting that's happening, it's sad to see it has to happen. But tell us what people, is it people in the local area that they can basically connect with you and have a diagnosis? Yeah, so the service has been set up with a deliberate eye on what the GMC have been up to. So I've kind of called it a kind of off-grid, off-matrix kind of medical experience. So I don't know anyone else who's doing it, really. So it's kind of novel in its approach. So I've had to be careful what I call it. Obviously, I am a GP, I'm a doctor, so I'm allowed to use those titles. But I've had to kind of draw a line as to what needs to be regulated and what I can do in an unregulated fashion. So for example, if I prescribe a drug, that needs to be regulated. You need a GMC license to practice, CQC registration. Now, if I keep patient notes, I need GDPR regulation. So I've had to pitch it, the model, at where I can be unregulated, like a life coach, for example. So I call what I do health coaching. I call it clinical navigation, clinical signposting. I call it health advocacy. And that's what I do. I'm a voice of reason. I'm a medically trained person, ex-scientist, that is there for patients to come to and listen. One of the key things I get is as to why people book in with me is, A, that they trust me for standing up against all of this this nonsense, so it's a trust issue and that trust has been lost. These people you're never gonna trust doctors ever again. And they come to me because they value my opinion and I listen. It's a simple case of having an hour, you know, I charge in a very ethical price, you know, it's far below what, you know, the standards for a private GP appointment would be. It's a quarter of that. And I sit with the patient for an hour and I listen and I take the history. And even this very morning, I had three cases of vaccine injured patients that just, they were quite emotional, really, both the two younger girls, because they just got heard. They were listened to and acknowledged instead of being gas lit and told it was all in their head and there was absolutely no chance of that. But going back to the service, it's growing month on month. It's going really well. I work from this office. I work every morning seven days a week, 363 days a year. So accessibility is there. You get the same doctor twice. You actually get a doctor, which is a bonus. In general practice, if you actually get a doctor, you've struck gold, haven't you? So they're the USPs really, and you'll get an honest opinion. Sometimes I do have to direct people back into the NHS to take our blood tests, for example. But that's what I'm there for. I'm a health advocate. And so like one of the patients this morning, I've written what I call a kick the doctor up the backside letter to get the doctor to do some basic investigations with a girl that's been having chest pain and palpitations within a week of the vaccine. And they haven't even done an ECG. They've done their blood tests. a referral for 24-hour ECG monitoring. They've not done a referral for an echocardiogram. Just basics. You know, we're seeing a lot of clinical and criminal negligence now in the patients that I see, particularly from the vaccine injury community. So that's what you get in a nutshell. So yeah, go to drcartland.com and have a peek. Tell us more about what you're seeing because I'm assuming that you may see people that have gone to their doctor, nothing's happening, the doctor refuses to even consider this could be vaccine injury and therefore they come across you and speak to you. But tell us kind of how that's worked and what are some of the stories that you've heard from patients?  Yeah so the stories are quite classic actually. So what I would say from the outset is I've not spoke to a vaccine injured patient that has got the same story. So there's different kind of severities of symptoms, there's different timelines, there's some are immediate, some are sort of medium term, some are slightly longer term. But the one thing that's really consistent with these patients is that temporal relationship to the vaccine. They're in good health, the two patients this morning. In good health, fit and healthy. One was an 18 year old and within two days of having the vaccine and the second patient was within two weeks having some heart pain, chest discomfort. They then venture off to their doctor and every case is the same. The doctor will immediately, as soon as the patient mentions the vaccine word, that's it. It's almost like crucifix comes out at that point. The room changes, the mood changes, the aggression levels of the doctor change and they dismiss the patient with immediate effect and just say, look, this is absolutely 100% nothing to do with the vaccine whatsoever. But these are the same doctors, if you remember, that had, you know, they were putting down COVID-19 for every death. You know, you can have a positive test and get struck by lightning the day after. And they put COVID-19 as a death certificate, they'll put in COVID-19 as 1A when people have died of cancer. And it was quite extraordinary. But what they're telling these people is, either it's in their head, the amount of people who've got bizarre symptoms, and some people have got some really eclectic, strange, medically unexplainable symptoms. So they come and they've got a bit of this and a bit of that, and it doesn't fit into a conventional diagnosis or criteria to diagnose things like MS, for example. They get brain fog with numb left arm with weakness of the right calf and incontinence of urine, for example. That doesn't fit into any conventional neurological diagnosis. I'm hearing of cases where neurologists are seeing the patients. Telling them it's absolutely not 100% nothing to do with the vaccine. They're not even touching the patient with a tendon hammer. They're not examining them and just dismissing them as functional neurological disorder, aka they're making it up. It's in their head, despite you know, coming on two days after the vaccine. The latest thing I'm hearing is they're telling vaccine injury patients that it's from long COVID, everything's long COVID. So these doctors who deny a day after the vaccine, somebody, you know, going into fits, is anything to do with the vaccine, are the same doctors who were saying, oh, actually, the latest one is even more dark, asymptomatic long COVID. So I'll give you a real life example of a 31 year old who I saw about a month ago at surgery, who had two AstraZeneca's. After each AstraZeneca, she had a blood clot on her leg, one on each leg. Then they went on to booster with a Moderna in December this year, just gone. And this was a 31 year old girl. She had a mini stroke a week later and then she had a full-blown stroke. And when she had to have surgery, a bilateral stroke, blood clots on the brain. And she was told, and I saw this in the neurological letters, that she'd been, this was from an asymptomatic COVID-19, long COVID infection, that had caused a stroke and this was all within a month of a Moderna booster. Absolutely incredible and then, you know, I tell patients, you know, it's highly likely but the issue we've got here is really that we can't ever prove it. There isn't really a way of absolutely proving it. We're looking at ways of really nailing this correlation, causation thing now. So there is a way of finding out antibodies, if you've got antibodies, for example, to nucleocapsid protein and the S-protein, and if you've got both, then there's an equal argument that it could have been the COVID infection. But what we have got now is patients that are just measuring for antibodies for the S-protein, which is a spike protein, and not the nucleocapsid protein. So that completely knocks out the possibility that it can be long COVID-related, because there's no evidence of the nucleocapsid protein. So we need to find that test that really is that eureka moment in helping these patients. And a lot of work I do is around spike protein detox. And we're all, whether you believe in shedding or not, that's up for discussion, but we really need to get detoxifying our bodies and I've really turned myself around in the last eight or nine weeks because I've been vaccinated as you know, and it's really messed with me, it's messing my cognition, my memory, lots of brain fogs, lots of mental fatigue, obviously there's a lot of confounders here about all the stress going on, but at the same time, I felt like I was going into dementia at 41 years of age and really turned it around. So anyone who's got any concerns about spike protein, obviously not just me, don't just contact me. I'm not just selling my service. There are lots of protocols out there now from World Council for Health, People's Health Alliance. You've got the FLCCC, I Recover Protocol. My protocol is publicly available on Twitter for free. It's all about detoxification of the spike protein. That's the pathology here. And that's common across the board. It really was a flawed thing to do, get the body to produce this non-human spike protein through the mRNA. Surprise, surprise, it's causing autoimmunity, it's causing cancers, it's causing inflammation in the body, it's causing immune system destruction, it's causing micro-plotting, endothelial dysfunction. It really is poisonous stuff. So yeah, anyone who's had a jab needs to look at, for themselves and for their relatives and loved ones, what we can to get rid of the spike protein. Lots of literature out there. Yeah, PHA, certainly World Health Alliance, fantastic work. So what you're basically pointing out is they are providing solutions. Absolutely, yeah. And these are grassroots organizations picking up momentum with each passing month. Both of the aforementioned, they're grassroots, they're run by people that give a lot of time for free to help set up an alternative to the NHS. And, you know, honesty is at the centre of it all, you know, being open, being honest, and not for profit. None of these people are here to make money. They're here to provide a service. And if you go, for example, to the PHA website, you'll see that there's a whole directory of people that can help. It's not just the NHS. It's not, you don't have to go with the Stockholm syndrome, of going through the primary care system and being gaslit, you know, go contact people. There's directories of people that are, Naturopathic is the best way to put it. It doesn't have to be drugs. My own protocol's got one medicine on there, the rest is all plant-based. Anti-inflammatories, supplements, things like that. Things like keto diets, paleo-ketogenic diet, carnivore diets, that can really help get your body detoxed from anything from spike protein to heavy metals and all the crap that's in our food. We're toxic people now because it's everywhere. It's in the food chain, it's in the water, it's in the sky. So we're getting, you need to detox. 100%. Can I just ask you about doctors, whenever a patient goes to a doctor, are doctors kind of given information they go by, or is it purely in their head? Because obviously when someone comes in they refuse to accept it's vaccine harm. Is that simply because they're in, I guess, in some ways the pocket of the pharma industry, or because they just are too busy, they haven't looked, or because they're following guidance from elsewhere? A bit of everything, really. I think when I do get to chat to it, and I do all the time, I get told not to talk about COVID in surgeries. I make it my business to enlighten the staff that are vaccinating people. So I worked in a room last week with a lady who was jabbing pregnant moms and kids with the COVID vaccine, so she was enlightened by me. So what I would say is the combination of doctors have got egos, number one, egos and God complexity, thinking they are the powers that be. Number two, they're complicit. They've been putting these jabs into people's arms. What's more concerning is people who've been jabbing through the last two and a half years don't even know that it's a novel technology. You completely lose them when you talk about gene therapy and immunomodulatory therapy. MRNA, a paramedic last week said, what's MRNA? And she'd been jabbing it into people's arms for the last two and a half years. And really that's not acceptable. The only defence I do have, and again, I've been dabbling a little bit back into the NHS the last few months, is that your just run ragged. You start your day at eight o'clock, you finish at six. Your halftime break's a home visit, where you're driving around, particularly in Cornwall, like there's quite distance the homes are from the surgery. And so you're driving with your sandwich in your mouth and your crisps while you're driving around, and you get back and you start again. It's like eat, sleep, repeat, and you don't have time. That's my only slight defence is that you run ragged and I think deliberately so. So doctors just haven't got the energy. You know, those days I did a few weeks ago, I haven't got time to get up and read the Lancet Journal or the evidence data for excess mortality. And it's not a good enough excuse, but you know, it's a factor in the equation that needs to be considered, that people are run ragged. And hence they don't know the Pfizer data, you know, the Pfizer documents that I've read cover to cover. These people haven't even heard of the Pfizer documents because they're that frazzled at the end of the day. And then the money, you know, it's been a big money maker for the whole of primary care hospitals. You know, they've cleared their debts from all of this. So I'll never understand why doctors aren't putting two and two together when you've got somebody that in a very short timeframe after a novel gene therapy, you know, has developed X, Y, and Z symptoms and how it can't be in the differential diagnosis at the least, that's just clinical negligence. You know, it's, this whole denial of the timeframe, you know, these well healthy young people. I've had some harrowing stories in the last few months of people that have lost legs, lost the use of the legs, you know, becoming incontinent, transverse myelitis, MS cases, turbo cancers, blood clots at the age of 18, all in proximity to the vaccine. All of them have one thing in common, it's absolutely nothing to do with the vaccine, according to their medical professional. It's just not good enough because we have to start helping these people. One thing's for sure, I've never jabbed a single individual. I've not given an mRNA jab to a single human, but I'm the only one seeming, along with a small pocket of UK doctors, trying to find answers and solutions. And we work day and night, and we're the bad boys of the profession, working day and night, often for nothing, to try and find solutions to what will be looked back on as the biggest crime against humanity. Of that, I'm certain.  100% agree with you. Dr David Cartland, I really appreciate you coming on, giving us an update on what's happening with you and what you're seeing as a professional. I'm assuming the best place is on your Twitter. They can follow what's happening with the GMC and whenever you're coming, as you're going through that process, you'll keep your followers up to date on @CartlandDavid.  That's the one. There are a few imposters, nice to be popular, but if you type in David Cartland into Twitter, you'll see there's about 25 versions of me, but that, you've got the twitter tag right there on the screen, so look out for the imposters because they are asking people for money personal details and you try to report to twitter to stop them but no, if they put parody in their profile they're allowed to say what they want, it's incredible, the amount of bullying I've had Peter is just, it's incredible, and yet I'm in the dock for being a bully, it's so bittersweet really to accept.  Hmm, no completely. Well yeah, @CartlandDavid, make sure and get it right. Nowhere else but there.  David, thank you so much for your time today. No, thanks for having me. It's always good to share what I'm seeing.

On today's show, the Perseus Group members discuss the failures of UK medicines regulation and what needs to change at the MHRA. GUEST OVERVIEW: The Perseus Group is a multidisciplinary team of experts from medicine, pharmaceutical regulation, and safety management.

Whistleblower Report – mRNA gene therapy shots, deceptively called “Advanced Therapies” to hide the experimental and gene-altering design of these injections, are seen as the next “Gold Rush” for Big Pharma's push for profits over people. Leading the way, the UK government and MHRA officials seek to dominate the mRNA gene therapy market as a global leader, drawn to profits and political power...

Whistleblower Report – Yellow Card biobank is a collaboration between the MHRA and Genomics England. Its goal is to improve understanding of how a patient's genetic makeup may increase their risk of harm from side effects. They are collecting your data but not presenting the methods to be used to correlate drug side effects with people's genetic makeup. Another journey into fantasy...

In this week's Trending News EU episode, Jack, Ollie, and Will discuss a few recent newsworthy items on UK Life Sciences policy including what the latest spring budget means for Life Sciences (1.00), future pricing of branded medicines in the UK and differences with other countries (6.10), and how Life Sciences policy is working to attract investment and talent to the UK (18.55).  Podcast Tags: healthcare, healthcare news, NHS, life sciences policy, healthcare policy, government budget, life sciences, brexit, life sciences regulation, healthcare regulation, medicine pricing, VPAS, healthcare costs, healthcare investment Source Links:  Spring Budget 2023 (HTML) - GOV.UK (www.gov.uk) MHRA to receive £10m from HM Treasury to fast-track patient access to cutting-edge medical products - GOV.UK (www.gov.uk)Chancellor gives boost to medical innovation and life sciences industry in Spring Budget | BIA (bioindustry.org)ABPI response to the BudgetIndustry reacts to approvals and R&D tax credit changes in Budget - Med-Tech Innovation (med-technews.com)Voluntary Scheme on branded medicines (abpi.org.uk)Comparing International Prescription Drug Prices | RANDLeading global pharma firms exit UK drug pricing agreement (abpi.org.uk)Life Sciences Innovative Manufacturing Fund (LSIMF) (closed to Expressions of Interest) - GOV.UK (www.gov.uk) Life sciences companies supercharged with £277 million in government and private investment - GOV.UK (www.gov.uk)  UK government, private investors dole out $340M+ to drug, diagnostic manufacturers – Endpoints News (endpts.com) For additional discussion, please contact us at TrendingHealth.com or share a voicemail at  1-888-VYNAMIC. Jen Burke, Director  Jen.Burke@vynamic.com Jack Young, Director jack.young@vynamic.com Oliver May, Senior Manager  oliver.may@vynamic.com   Will Turnbull, Senior Manager Will.turnbull@vynamic.com 

Richie is joined by Dr. Ahmad Malik.Ahmad Malik is a London based consultant orthopaedic surgeon. Last year, he began hearing from patients, family members and neighbours who believed they had been injured by a Covid-19 mRNA jab. Dr. Malik began to question why the government and the MHRA were not looking into this. He took to social media to raise the alarm. He was advised by his manager and by colleagues that he should keep quiet. He refused, believing that it his duty as a clinician to tell the truth. Ahmad discusses this and more with Richie including, how taking more care with what we eat and when we eat it, can have a hugely positive effect on our health. Follow Dr. Ahmad Malik here:https://twitter.com/DocAhmadMalik

This week Rich and Gaz discuss the most WTAF moments of the past two weeks, including Zelensky getting Times "Person Of The Year' Award which makes sense when you see that Hitler and Starlin both got it in decades gone by. Also Pfizer are still jabbing kids like lunatics and paying the MHRA to look the other way and in Oxford they want you to get a Token to Drive 15 minutes outside you designated area! .WATCH THE VIDEO VERSION FOR FREE AT https://ickonic.com

Documentary. Safe and Effective: A Second Opinion (2022) Oracle Films Safe and Effective: A Second Opinion shines a light on Covid-19 vaccine injuries and bereavements, but also takes an encompassing look at the systemic failings that appear to have enabled them. We look at leading analysis of pharmaceutical trials, the role of the MHRA in regulating these products, the role of the SAGE behavioural scientists in influencing policy and the role of the media and Big Tech companies in suppressing free and open debate on the subject. OracleFilms Published September 28, 2022  53,343 Views   HELP ACU SPREAD THE WORD!  Please go to Apple Podcasts and give ACU a 5 star rating. Apple canceled us and now we are clawing our way back to the top. Don't let the Leftist win. Do it now! Thanks. Forward this show to friends. Ways to subscribe to the American Conservative University Podcast Click here to subscribe via Apple Podcasts Click here to subscribe via RSS You can also subscribe via Stitcher FM Player Podcast Addict Tune-in Podcasts Pandora Look us up on Amazon Prime …And Many Other Podcast Aggregators and sites   Please help ACU by submitting your Show ideas. Email us at americanconservativeuniversity@americanconservativeuniversity.com Please go to Apple Podcasts and give ACU a 5 star rating. Apple canceled us and now we are clawing our way back to the top. Don't let the Leftist win. Do it now! Thanks.

In this 144th in a series of live discussions with Bret Weinstein and Heather Heying (both PhDs in Biology), we discuss the state of the world through an evolutionary lens.This week, we discuss the prestigious scientific journal Nature, and its promotion of an anti-scientific perspective on sex and gender. We also discuss the not-so-prestigious journal Transgender Studies Quarterly, and its take on species concepts, and also on the “Trans*-Ness of Blackness.” We discuss the new research that finds that covid vaccines do affect women's menstrual cycles, and also the shortcomings both in that research, and in the Washington Post's reporting on it. Bret offers pro bono marketing help to Pfizer. And we talk about Great Britain's medical regulatory agency (MHRA) moving from its role as “watchdog” of outside entities, to that of “enabler.”Our store:  https://www.darkhorsestore.orgOur book: A Hunter-Gatherer's Guide to the 21st Century: https://www.amazon.com/Hunter-Gatherers-Guide-21st-Century-Challenges/dp/0593086880/). Signed copies available here: https://darvillsbookstore.indielite.orgOur Patreons: https://www.patreon.com/heatherheying, https://www.patreon.com/bretweinsteinHeather's newsletter, Natural Selections (subscribe to get free weekly essays in your inbox): https://naturalselections.substack.comOur sponsors:Vivo Barefoot: Shoes for healthy feet—comfortable and regenerative, enhances stability and tactile feedback. Go to www.vivobarefoot.com/us/darkhorse to get 20% off, and a 100-day free trial.Ned: is a CBD company that uses USDA certified organic full spectrum hemp oil, and creates specialty blends to help with stress and sleep. Visit www.helloned.com/darkhorse to get 15% off.Public Goods: Get $15 off your first order at Public Goods, your new everything store, at https://www.publicgoods.com/darkhorse or with code DARKHORSE at checkout.Mentioned in this episode:Currah, Paisley, 2022. To set transgender policy, look to the evidence. Nature, 9-27-22: https://www.nature.com/articles/d41586-022-03036-5Transgender Studies Quarterly, main site: https://read.dukeupress.edu/tsqTrans Species: https://read.dukeupress.edu/tsq/article/1/1-2/253/91865/Trans-SpeciesHasenbush et al 2019. Gender Identity Nondiscrimination Laws in Public Accommodations: a Review of Evidence Regarding Safety and Privacy in Public Restrooms, Locker Rooms, and Changing Rooms. Sex Res Soc Policy 16: 70–83. https://link.springer.com/article/10.1007/s13178-018-0335-zLivestream of protest of “Outright Vermont,” from 10-1-22, on the YouTube channel of the Disaffected Podcast: https://youtu.be/OBk5hWxPe4IWashington Post article (by Amanda Morris, 9-27-22): Women said coronavirus shots affect periods. New study shows they're right. https://www.washingtonpost.com/wellness/2022/09/27/covid-vaccine-period-late/Edelman et al 2022. Association between menstrual cycle length and covid-19 vaccination: global, retrospective cohort study of prospectively collected data. BMJ Medicine, 1(1). https://bmjmedicine.bmj.com/content/bmjmed/1/1/e000297.full.pdf?with-ds=yesThe Digger, Phil Harper's Substack: https://philharper.substack.comDr. June Raine's talk at Oxford in March 2022, “From Watchdog to Enabler: Regulation in Covid and after”: https://youtu.be/xUQfzTqPUm4?t=1818Timestamps:(00:00) Welcome and announcements(04:00) Sponsors(11:53) Nature on Trans(26:05) Trans gender studies quarterly(36:32) Another research article from TGSQ(39:45) Nature's responsibility(50:18) WaPo on menstrual cycle length and COVID vaccination(01:04:20) Uptake of new bivalent booster(01:08:23) MHRA from watchdog to enabler(01:26:00) Wrap upSupport the show