Podcasts about avandia

Send us a Text Message.In part two of our Truth on Diabetes series, you will understand diabetes treatments as we sit down with Dr. Arpeta Gupta to dissect the latest guidelines and the transformative impact of newer diabetes medications. We will discuss how SGLT2 inhibitors and GLP-1 agonists are not only enhancing glycemic control but also delivering critical cardiovascular and renal benefits. We revisit the troubled history of TZD drugs like Avandia and contrast it with the safety profiles of today's leading medications. Drs. Gupta and Koren dive into the complexities of managing diabetes care across multiple specialties and share actionable strategies to improve interdisciplinary communication for better patient outcomes.Navigating the hurdles of diabetes treatment access is no small feat, and we tackle this issue head-on by examining how insurance policies and cost barriers affect patient care. From the implications of prior authorization and step therapy to the financial strain on patients, particularly those on federal plans, we leave no stone unturned. We also explore the exciting potential of federal drug price negotiations and recent strides in lowering insulin costs. The significance of selecting therapies that safeguard end organs and the advantages of participating in clinical trials for cutting-edge treatments are underscored, ensuring you leave with a comprehensive view of the future landscape of diabetes care.Koren's Key Three Takeaways:Guidelines and Effectiveness of Diabetes DrugsDiabetes treatment access and insuranceChallenges and Future of Diabetes TreatmentRecording Date: June 19, 2024Be a part of advancing science by participating in clinical research.Share with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramTwitterLinkedInWant to learn more checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.comMusic: Storyblocks - Corporate InspiredThank you for listening!

This episode's Community Champion Sponsor is Ossur. To learn more about their ‘Responsible for Tomorrow' Sustainability Campaign, and how you can get involved: CLICK HERE---Episode Overview: Is it possible to revolutionize kidney disease treatment and redefine conventional care? Our next guest, John Erbey, is doing just that as the founder and CEO of Roivios. With over 25 years of pioneering experience in the medical field, John brings a unique blend of analytical rigor, physiological insight, and deep understanding of customer needs, which has driven ground-breaking advancements across the medical device and pharmaceutical sectors. Inspired by personal experiences with kidney disease in his family, John is on a mission to transform patient lives. Join us as we explore how Roivios is reshaping kidney health management, potentially saving billions in healthcare costs, and paving the way for a future where kidney function can be sustained and enhanced. Let's go!Episode Highlights:Embracing discomfort for true innovation in healthcareAddressing kidney disease's $250 billion annual cost in the USTargeting renal impairment during cardiac surgeryDeveloping JuxtaFlow technology with future wearable applicationsEnvisioning implantable devices to prevent kidney disease progressionAbout our Guest: John Erbey, a visionary with over 25 years of experience in the medical field, is the founder and CEO of Roivios. His dynamic leadership and pioneering approaches have led to substantial advancements in therapeutic development and medical devices.At Roivios, John has revolutionized the treatment of kidney disease by introducing an innovative approach that redefines conventional wisdom about kidney filtration. This led to the creation of the groundbreaking JuxtaFlow® Renal Assist Device (RAD), marking a significant evolution in kidney health management.John's leadership extends across the medical device and pharmaceutical sectors, where he has led the launch of CardioMEMS and defined the EU pricing strategy for Ezetrol (Zetia). As a strategist, his mission is to enhance patient lives by providing superior tools to healthcare providers. His unique blend of analytical rigor, physiological insight, and deep understanding of customer needs has enabled him to leverage scientific innovations, creating value for brands like CardioMEMS™, Zetia™, Vytorin™, and Avandia™.Since founding Roivios in 2015, John's personal journey has been a driving force behind his commitment to transformative healthcare solutions. Having witnessed the profound effects of kidney failure within his own family and through poignant stories shared by potential investors, John's resolve to make a positive impact on patients facing similar challenges has only strengthened over time.John holds a Ph.D. in epidemiology from the University of Pittsburgh's Graduate School of Public Health, where his groundbreaking research in this field has earned him induction into Delta Omega, the prestigious National Honor Society for Public Health.Links Supporting This Episode:Roivios Website: CLICK HEREJohn Erbey LinkedIn page: CLICK HERERoivios LinkedIn page: CLICK HERE Mike Biselli LinkedIn page:

HISTÓRIAS CHOCANTES de 5 MEDICAMENTOS que DESTRUÍRAM VIDAS Apesar dos avanços que trouxeram medicamentos salvadores como a penicilina e a adrenalina, é vital reconhecer as falhas que resultaram em tragédias e mortes. Neste vídeo, compartilharei com vocês cinco casos onde medicamentos foram banidos ou severamente restringidos devido a seus efeitos nocivos. Estes exemplos realçam a importância de uma vigilância rigorosa e de uma ética inabalável no campo da medicina. Vamos aprender juntos como a incessante busca por lucro pode comprometer não só a integridade científica mas também a vida de milhares de pessoas. Capítulos: 00:00 Introdução 01:30 Talidomida - O Legado de um "Remédio Mágico” 04:02 Vioxx - Um Escândalo 06:54 Avandia - De Esperança a Desilusão 09:26 Trovan - Experimento Terrível na África

Vicki J. Maniatis is a partner at Milberg Coleman Bryson Phillips Grossman who has worked on mass tort cases involving pharmaceuticals and medical devices for seventeen years. She is a frequent invited lecturer and moderator on a wide variety of pharmaceutical and mass tort cases including, Opioids, Trans Vaginal Mesh, Fosamax, Ortho Evra, Risperdal, Propecia, Avandia, Onglyza, as well as several medical devices. Vicki has been appointed by State and Federal Judges to serve as lead counsel and on Plaintiffs' steering committees. She has significant experience performing all levels of bellwether trial case-specific work up including, plaintiff, spouse and family member depositions, implanting, explanting, treating physicians, sales representative, and expert depositions, for over 30 cases in several mass torts including TVM, Mirena and Propecia cases. Vicki serves as a founding member of Mass Tort Med School, an annual medical seminar for Plaintiffs' attorneys that offers numerous physician speakers and cutting-edge medical issues. In May 2022, along with the Trial Lawyers of Puerto Rico, Mass Tort Med School is hosting Mass Torts Puerto Rico, a first-of-its-kind program where attorneys will have the opportunity to learn from and connect with world-class trial lawyers and experts – the Mass Tort Med School program will be bigger and better than ever. Remember to subscribe and follow us on social media… LinkedIn: https://www.linkedin.com/company/mass-tort-news Twitter: https://www.twitter.com/masstortnewsorg Facebook: https://www.facebook.com/masstortnews.org

I Never Trusted Bill Gates, Nor Should You While leading a Senate investigation, I tracked a corrupt pharmaceutical executive right into the lobby of the much-vaunted Bill and Melinda Gates Foundation—Bill Gates did nothing.   The DisInformation Chronicle,   https://disinformationchronicle.substack.com/p/i-never-trusted-bill-gates-nor-should   The last year has not been kind to Bill Gates.  For two decades, Gates has shoveled out buckets of cash through the Bill and Melinda Gates Foundation to transform himself from despised 1990’s software monopolist to a present-day public health intellectual—a miraculous, money-fueled metamorphosis. But that reputational makeover has stumbled, as a series of critical articles have tarnished Gates’ paid-for golden image and cast doubt on his credibility. However, long before these articles came to light, I already knew that Gates could not to be trusted.  A decade ago, I led a Senate investigation into a multi-billion-dollar diabetes drug sold by GlaxoSmithKline (GSK) that government scientists found to have caused around 83,000 heart attacks. During this federal investigation, I uncovered multiple examples of GSK officials intimidating medical experts who decried the drug’s dangers. A leader in this campaign was GSK’s chairman of research and development, Dr. Tadataka (Tachi) Yamada.  By the time our committee uncovered GSK’s coercion campaign, Yamada had left the company to run Gates’ global health program. And yet, as the media outlets reported on Yamada’s prior role bullying physicians who tried to warn about the drug’s dangers, the Gates Foundation ignored this public outcry and allowed Yamada to maintain his pulpit as global health protector. Twenty years back, journalists scrutinized Gates’ foundation as a vehicle to enrich himself and polish his appearance. But over the years, reporters began to forget Gates’ past and provide him a platform to puff himself up as scientific expert, despite his having no medical or scientific credentials. Bill Gates’ sculpted persona as health policy guru began to wobble last summer, however, precisely because of revelations showing the tools he had used to improve his media cachet. In August 2020, Tim Schwab published an article in the Columbia Journalism Review exposing around $250 million in grants that Gates was throwing at journalism outlets including the BBC, NBC, Al Jazeera, ProPublica, National Journal, The Guardian, Univision, Medium, the Financial Times, The Atlantic, the Texas Tribune, Gannett, Washington Monthly, Le Monde, and the Center for Investigative Reporting.  A later article in The Nation spotlighted Gates’ potential to profit from investments in companies situated to reap a windfall from the COVID pandemic. And another report in The Nation found that Gates’ funding has stifled debate in public health—described as “the Bill chill”—as organizations are reluctant to bite the hand that feeds them. These revelations came as little surprise to me. Back in 2007, I was working as an investigator for the Senate Finance Committee and learned first-hand that Bill Gates does not put the public first. That year, I wrote the Senate Finance Committee’s report showing that, shortly after the GSK diabetes drug Avandia came on the market in 1999, the company attacked and silenced several scientists including Dr. John Buse, a professor of medicine at the University of North Carolina.  GSK began to bully Dr. Buse after he gave talks stating that Avandia might increase cardiovascular problems such as heart attacks. By the time we released the 2007 report, FDA scientists estimated that Avandia had caused approximately 83,000 heart attacks. When Dr. Buse began warning physicians about the drug, Dr. Yamada was at GSK and contacted Dr. Buse’s department chairman to complain. In an email discussing Dr. Buse with GSK’s CEO and other executives, Dr. Yamada wrote:  In any case, I plan to speak to Fred Sparling, his former chairman as soon as possible. I think there are two courses of action. One is to sue him for knowingly defaming our product even after we have set him straight as to the facts—the other is to launch a well planned offensive on behalf of Avandia.... In our report, we released a private email that Dr. Buse later sent a colleague detailing this encounter with GSK: [T]he company’s leadership contact[ed] my chairman and a short and ugly set of interchanges occurred over a period of about a week ending in my having to sign some legal document in which I agreed not to discuss this issue further in public. Dr. Buse ended the email, “I was certainly intimidated by them.... It makes me embarrassed to have caved in several years ago.” Multiple media outlets covered Yamada’s actions, including The Guardian (GSK accused of trying to intimidate critic), NBC News (Diabetes drug probe leads to Gates Foundation), and even Bill Gates hometown newspaper, the Seattle Times (Senate committee turns attention to Gates Foundation official). Months prior to the report’s release, The New York Times also detailed Dr. Yamada’s behavior (Doctor Says He Was Assailed for Challenging Drug’s Safety), as some initial evidence came to light during a hearing in the House.  In response to all this outcry, Bill Gates did... nothing. To put this matter directly under Bill Gates’ nose, I then wrote the Senate Committee’s letter demanding that Dr. Yamada come and brief Senate investigators. Just in case Gates was too distracted with saving the world and playing public health saviour to have noticed the bad press, I had the letter sent directly to the Gates Foundation. When Dr. Yamada showed up for his appointment in Senate Hart, we started with some brief niceties and formalities—typical DC nonsense such as shaking hands, passing out business cards, asking how the plane flight was—before getting down to business. Dr. Yamada’s lawyer then pulled from his briefcase a marked-up copy of a Committee report I had written titled: The Intimidation of Dr. John Buse and the Diabetes Drug Avandia.   We spent about twenty minutes going over the report, as the lawyer explained what Dr. Yamada had done. He then turned the matter over to Dr. Yamada to detail why, many years prior, he had called Dr. Buse's superiors at the University of North Carolina. As Dr. Yamada explained, he wasn't trying to intimidate anyone. Ironically, he even offered up the idea that he had called Dr. Buse's dean at North Carolina, because he was concerned that Avandia might actually be harmful. And if the drug was harmful, Dr. Yamada said, he wanted to know. I almost giggled when he said that. I then asked, "So this is the only time that you can remember calling a university about one of their faculty?" "Yes," he replied. I let him drone on some more, explaining medical research, before I asked him again if he had ever called a university to complain about a professor. Again, he denied doing so, and then started explaining drug development and the regulatory process at the FDA.  I then asked again, "So during all your time at GSK, this is the only incident you can remember where you placed a call to a university about a researcher who raised concerns about one of your products, correct?” I asked. “It was a singular incident in your time at the company?” "Yes," he said. This was the third time that Dr. Yamada had denied making calls to other universities to intimidate academics speaking up about Avandia. I then pulled out copies of GSK emails, showing that Dr. Yamada had called the University of Pennsylvania about physicians there who were worried about drug’s dangers. “Would you like to explain to us about the call you made to the University of Pennsylvania?” I asked. “One of the physicians involved told me, 'It left a really bad taste in my mouth. After that happened, I said that I would never work for a drug company.’ Another physician who was involved told me, 'It’s the kind of thing you imagine happening on TV.'’’ I then slid the emails across the table to him. Dr. Yamada’s attorney jumped up and grabbed the emails saying, “These emails weren't in the report!” “No shit, Counselor,” I thought. “I left these ones out, to see if your client might lie to us. Calm down. Everything's going to be A-O-K....” We then exchanged some more niceties as Yamada “reexplained himself.” Oddly enough, it seems there may have been more than just that one incident at North Carolina, Dr. Yamada said. But I really wasn't interested in listening and started checking my Blackberry. It took a couple more years to go through hundreds of thousands of GSK’s internal documents before we released our final 342-page report in 2010 titled: Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia. But we redacted the names of the scientists at the University of Pennsylvania who Dr. Yamada had harassed for speaking up, because they were still scared about possible retaliation from the drug industry.  After reading the report, Yale cardiologist Harlan Krumholz wrote that it "read like a spy novel.” Analysts at UBS predicted that GlaxoSmithKline could face legal liability of up to $6 billion. The New York Times covered the report on its front page and the CBS News put Yamada in its story’s headline: Meet Glaxo's Fixer -- The Man Who Scuttles Drug Critics With One Phone Call. And still, Bill Gates did nothing. Five months after the 2010 Senate Finance report, GSK agreed to a $460 million settlement with 10,000 Americans who sued the company for withholding Avandia’s heart attack risks. The New York Times editorialized that GSK and its leaders “can’t be trusted to report adverse clinical results fairly.”  Nothing at all happened to Yamada. He remained in his role as global health expert at the Gates Foundation, until he left the following year, in June 2011.  Keeping someone like Yamada to run a global health program has always made me doubt Bill Gates’ commitment to public health. How could anyone have faith in Gates’ judgement after watching him stand idly by as a stream of evidence proved that one of his top lieutenants had a history of corrupt behavior? Since that time, I have never trusted Bill Gates. And neither should you.

Renee Dufault finds traces of mercury in corn syrup. The FDA tells her not to investigate. Rosemary Johann-Liang wants to place a strong warning label on the drug Avandia. Her superiors transfer away her responsibilities on that drug. David Graham says of the deadly Vioxx, “I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless...Vioxx is really a symptom of something far more dangerous to the safety of the American people. Simply put, FDA and its Center for Drug Evaluation and Research are broken.” And that’s just the start. This episode also features the FDA spying, a criminal investigation of the head of the FDA, and even more whistleblowers. What Senator Grassley said kind of says it all. "Secret monitoring programs, spying on Congress and retaliating against whistleblowers -- this is a sad commentary on the state of affairs at the FDA.” Listen to or download the episode here. Show notes, references and more available at https://healthsovereign.com/59/

Renee Dufault finds traces of mercury in corn syrup. The FDA tells her not to investigate. Rosemary Johann-Liang wants to place a strong warning label on the drug Avandia. Her superiors transfer away her responsibilities on that drug. David Graham says of the deadly Vioxx, “I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless...Vioxx is really a symptom of something far more dangerous to the safety of the American people. Simply put, FDA and its Center for Drug Evaluation and Research are broken.” And that’s just the start. This episode also features the FDA spying, a criminal investigation of the head of the FDA, and even more whistleblowers. What Senator Grassley said kind of says it all. "Secret monitoring programs, spying on Congress and retaliating against whistleblowers -- this is a sad commentary on the state of affairs at the FDA.” Show notes, references and more available at https://healthsovereign.com/57/

Finance ethics committee, big pharma with deep pockets, mafia like arrangements, and a patient with a 40% increase risk of ischemia myocardial events have in common? I will say todays podcast was inspired by a tweet, yes a tweet from Dr. john Mandrola and he said “I am embarrassed to have not (really) known the details of the rosiglitazone affair. Teaching this to learners has to be 10x more valuable than the krebs cycle. My gosh – talk about lessons to learn. We have to promote more skeptical priors’ He attached a link to a paper titled The rise and fall of rosiglitazone European Heart Journal, Volume 31, Issue 7, April 2010, Pages 773–776 https://academic.oup.com/eurheartj/article/31/7/773/433556 I also will say I did not know the details of the rosiglitazone affair but after spending the last 3 days digging through this paper and the sources to this paper and the sources to those papers and by the end you will know exactly what Finance ethics committee, big pharma with deep pockets, mafia like arrangements, and a patient with a 40% increase risk of ischemia myocardial events all have in common. This was a wonderful summary about rosiglitazone and the scandal of the mafia like drug company hiding and covering up the evidence in related to cardiac events…. For those of you that don’t know or are not medical roseglitizone is a diabetic drug, it part of the glipizide family and although rarely seen on medication this day in are it is a tragic and sickening story for a drug that was once the largest selling diabetes drug in the world. In 2006 sales of the drug reached over $3 billion. So when study came out in 2007 in the New England Journal of Medicine titled “effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes” which was a meta-analysis that sought to find if cardiovascular morbidity and mortality were decreased by rosiglitazone. Ultimately the results showed that those in the rosiglitazone group compared to those in the control group were 43% more likely to suffer a myocardial infarction ((((odds ratio for myocardial infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98; P=0.03), ))) and a trend towards increase rates of death from cardiovascular causes ((((1.64 (95% CI, 0.98 to 2.74; P=0.06) THAT IS A SHOW STOPPER—the top drug on the market for diabetes bringing in over 3 billion dollars actually causes heart attacks and death Of course GlaxoSmithKline, the maker of the drug came out and said, NO NO NO it is one trial and our drug is just as safe as any other diabetic drug. Hindsight we can all look back and say, “OMG are you kidding me, how did the FDA not step in right away’ and THAT is where the story begins. But in order to get to the beginning of the story to go back to 1998 when troglitazone was the only TZD glitazone on the market. Unfortunately, troglitazone was associated with rare but potentially fatal hepatotoxicity. This is obviously bad publicity in the FDA as well as all diabetics and physicians wanted better option. Insteps rosiglitazone= dysuria over drug was approved by the FDA after 5 trials consisting of just under 3000 patient’s. - https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21071_Avandia_medr.pdf 2 of the studies were placebo controlled that only lasted 26 weeks 1 study was a double blind comparing RSG with glyburide to just glyburide lasted 52 weeks 1 study was a 26week study looking at the effects of either RSG or placebo added to metformin And the last A 26 week double blind study comparing metformin monotherapy vs RSG monotherapy vs RSG + metformin There you have it- the 5 trials that got RSG FDA approval. Just under 3000 patients and a grand total of 3 yrs TOTAL of data. One of the problems is a duration of these trials. A million one week trials is not equal to one trial that is a million weeks long. The hard outcomes need time to develop. It is like a good play action pass, it takes time to develop the play. Death and heart attacks take time to develop and short trials often miss these outcomes PLUS the trials were looking for……..A1C and FBS There are many problems with the A1C and FBS but the main one is the lack of association with A1C and hard end points. High A1C is bad, that seems pretty clear but as long as it is some what controlled the macrovascular risk does not appear to change very much. TO ApprovE diabetes drugs based on glycemic effects is not smart. Who cares if a drug lowers your blood suger but makes you 50% more likely to have a heart attack. Yet, we are obsessed with the number and the patient outcome. ((((((((((((The current SGLT2 inhibitors that are showing cardiovascular benefits change the A1C very little. A1C seems to be a surrogate marker we put way to much strength in when there is likely something else going on since it is clear A1C does not tell the whole picture but lets get back to RSG))))))) Of these 5 trials you will find that when you dig a little deeper into the numbers In 3-5 trials LDL cholesterol was increased by an average of almost 20% PLUS- There is also significant amount of weight gain with rosiglitazone in the 6 months trials those randomized to rosiglitazone gained almost 10 pounds more than those in the control group. Saying that differently, 20% of the patients randomized to rosiglitazone had gained 5-10% of the body weight at 6 months compared to only 2% of the patient’s placebo group and 1% of patients in the metformin group. BUT MAYBE the biggest problem was ---- And when you combine all 5 trials the rates of ischemic cardiovascular events were almost twice as likely in individuals receiving rosiglitazone compared to those randomized to the control arm. BUT good news, remember how I said, troglitazone was associated with fulminent hepatitis? Well it looks like RSG did not share this trait, there were no cases report! This is great news and remember FDA, patients and doctors want another option, they want a better option. And when you scroll down to page 40-41 of the medical officers review of a new drug for RSG you will read “Heart disease due to atherosclerosis is a major cause of morbidity and mortality in patients with type 2 diabetes, and it cannot be assumed that treatment with rosiglitazone will decrease the risk” the go on to say “my concern about deleterious long-term effects on the heart should be addressed by requiring a sponsor to provide adequate information in the label about changes in weight and lipids. A post marketing study to address these issues needs to be a condition of approval.” TWO big things happened right around this time— May 1999, FDA approval rosiglitazone Dr John Buse a diabetic special at UNC was speaking at an American Diabetes Association symposium where he called into question the cardiovascular safety of rosiglitazone Both of these things in and of themselves are not bad things. Sure the FDA hindsight should have required more data but their backs were against the wall so although I do point blame I don’t point a ton of blame. Dr. John Buse he is allowed to question medicine he is allowed to say hey I don’t think this is correct. But for every action there is an equal and oppisite reaction for the action of FDA approval of RGS the reaction was a ton of prescribing of RSG- Drug reps were in the office showing you how great this new drug is that does not cause liver failure and how it lowers your A1C blood test which we have all artificially made as the gold standard compared to any hard outcome. The drug reps would talk about how RSG lowered the CRAP marker….. wait did I just say crap marker?? Oooo sorry, I mean to say it lowered the CRP blood marker, but given the value of CRP I was probably right the first time. Sadly, we as physicians ate from their hands and prescribed a bunch of it. TONS of it. Over 3billion dollars of it. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2099503/ https://www.finance.senate.gov/imo/media/doc/prb111507a.pdf But remember I said for every reaction is equal and opposite well when Dr. John Buse spoke out against rosiglitazone is certainly triggered a reaction from glaxosmithkline… what kind of reaction you ask? Well they went after Dr. Buse with a team of lawyers and per paperwork given to the United states senate committee on finance it was clear that Dr. Buse was bullied into signing in agreement stating that he was no longer worried about cardiovascular risks associated with RGS. And he was barred from probably expressing concerns about safety of the drug in the future. The company was threatening to sue him for damages from his comments which glaxosmithkline was claiming cost them over 4billion dollars because of a stock price drop. Yes- this is 1999 and glaxosmithkline is acting like the mafia. They don’t care about the patients. They care about their 4billion in loss revenue. What is even more discussing is glaxosmithkline used this forced retraction letter to gain a foothold with financial investors. Some of the testimony and documents that were revealed in the senate finance committee will make you never want to prescribe another glaxosmithkline drug every again. Truly sickening. https://www.finance.senate.gov/imo/media/doc/prb111507a.pdf so we have this drug company, glaxosmithkline that knows they have a “bad drug’ or at least a drug that requires further investigation and evaluation but is doing everything they can to cover up or hide what leadership knows to be true. Likely for the world and patient’s everywhere in 2004 glaxosmithkline was sued over their drug paroxtine by the state of NY claiming they had not released or published the results of their unfavorable or negative trials on paroxtine. And I will get back to RGZ but stop me if you have heard this one before GSK runs 2 trial of paroxtine in adolescence, Study 329 conducted from 1993-1996 and at the itme was the largest trial to date for the use of SSRI in the pediatric population. In this study paroxetine didn’t beat placebo. The other study, Study 377, placebo was actually more effective than the antidepressant. However, instead of releasing these results there was an email that was later accidently leaked from within the corporation stated that because the results were “insufficiently robust“ the company needs to “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact” The data was hidden or covered up and in 2003 paroxetine was a 4.9 billion dollar drug https://www.ncbi.nlm.nih.gov/pmc/articles/PMC343848/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC437671/ Luckily for us, when GSK settled this case, they wrote a check for 3 billion dollars, or roughly 9months of income from just the sales of paroxtine in 2003 and they agree to make a clinical registery that has all their data after dec 27 200. Are you asking how is this a good thing when a company that is bringing in deca-billions is hit with a measly 3 billion dollar fine?? Well then you don’t know how it ends, Now that the data was out there in a clinical registry you can do a study of And it turns out that is exactly what happened, a meta-analysis of 42 studies, 35 of which were unpublished. The authors poor over the data and submitted their paper for pubication to the all wonderful and incredibly high impact journal most of you have heard of called the NEJM. Now when you submit an article to a journal it has to undergo peer review process. Basically this is when other experts in the field or individuals with knowledge of the subject at hand review the paper to make sure all the T are crossed and I are dotted. When you peer Review of paper it is supposed to be secretive. He’ll share the document with anyone. Not even your best friend. Unfortunately one of the individuals that reviewed the paper, Dr. Steven Haffner at University of Texas in San Antonio, sent the analysis to GKS. Remember you don’t share this with your best friend let alone the DRUG COMPANY! This is a breach of ethics and every journal has rules on this and it certainly violates those. Why would someone do this??? Oooo maybe because Dr. Steven Haffner was getting paid by GKS, almost a $100,000 in total payment up to that point. This is the mafia, the mafia we see in movies, they cover up information and have every cop or ‘good guy’ in the city on their payroll. This NEJM of medicine article is the same one I mentioned at the beginning of this podcast, the article titled “effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes” which was a meta-analysis that sought to find if cardiovascular morbidity and mortality were decreased by rosiglitazone. And Ultimately the results showed that those in the rosiglitazone group compared to those in the control group were 43% more likely to suffer a myocardial infarction ((((odds ratio for myocardial infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98; P=0.03), ))) with a trend towards increase rates of death from cardiovascular causes ((((1.64 (95% CI, 0.98 to 2.74; P=0.06) THIS PAPER that was a show stopper for GSK they had in their hands 2 weeks prior to publication and they did their own statistical analysis and concluded that the numbers were spot on. They were not surprised by the findings. You may be asking why within not surprised by the findings? Well it’s because in 2006 GSK had already done their own analysis which found a 30-43% increase in ischemic events and this data was shared with the FDA who then did their own analysis and found a similar 40% increase in ischemic events.. However near the FDA nor GSK ever announced this information or released it to the medical community.. why would this happen you ask?? My guess is money but I couldn’t prove this to be true. “Music” How does this story end???? Eventually, 5 months after the meta-analysis published in the New England Journal of Medicine and almost an entire year after the FDA made there own similar conclusions about rosiglitazone they finally added a black box warning for increased risk of ischemic myocardial events. And remember when the drug was bring approved by the FDA and they said in the final analysis “. A post marketing study to address these issues needs to be a condition of approval.” Well it comes at no surprise the GSK knew this would be bad news for them so No well-designed cardiovascular outcome trials were conducted. The RECORD trial was the only cardiovascular outcome trial which look to compare cardiovascular outcomes and it was a seriously underpowered open label study with low adherence to medications, and not completed until 10 years following launch. HOWEVER the FDA mandated the study in 2007 after the release of internal documents and the adversory committee and the metaanalysis showing a 40% increase in ischemic cardiac events. It is no surprise this was big news and the trial struggled with slow enrolled because anyone who watched tv or read the news paper knew this was a bad drug and no provider wants to enroll a pt. on a drug that is knowingly harmful! https://www.nejm.org/doi/full/10.1056/NEJMoa066224 Ultimately the trial was halted in 2010 and I think for good reason, When you are a patient going into a trial hopefully you get a miracle cure drug and at worse you get placebo. In this trial you at best would get a placebo and at worst a harmful drug. Dr. Buse, the physician who made the initial statement and warning in 1999 and was shut up by the drug company?? Well, At a 2007 FDA safety panel meeting on RGS, FDA scientists presented data showing RGS was estimated to have caused approximately 83,000 excess heart attacks since coming on the market. If a scientist was able to speak freely and question medicine it is almost certain SOME of those heart attacks would have been prevented. https://www.finance.senate.gov/imo/media/doc/prb111507a.pdf Luckily, not all bad came from this story – it led a bunch of people to question medicine which I will forever be a fan of, I agree with Dr. John Mandrola we need to promote more skeptical learners. Also because of this in December 2008, the FDA issued a new guidance for development of drugs to treat diabetes, requiring cardiovascular outcomes trials. This is the reason we now have the SGLT2 inhibitors that seem to be working to prevent cardiovascular events. They didn’t know the outcome was going to be a decrease in events they were just hoping there was not an increase in cardiovascular events.

Brian, Katie, and I sit down with Vince Fuoco, a pharmacist from the greater Seattle area. We discuss a wide range of medication-related issues, including Coronavirus, dieting and nutrition, the placebo effect, the opioid crisis, and mental health. We also delve into a few less-scientific topics, drink fantastic beer from Geaux Brewing in Auburn, and much more! Recorded March 7th, 2020 at the TPDM studio in Wenatchee, Washington. Check out Vince Fuoco's podcast: Pick A Topic https://anchor.fm/vincent-fuoco/ Geaux Brewing -- Auburn, WA http://www.geauxbrewing.com/   EPISODE NOTES: Peramivir — an antiviral injection for treating influenza https://www.fda.gov/drugs/information-drug-class/rapivab-peramivir-information The Game Changers (documentary) https://en.wikipedia.org/wiki/The_Game_Changers The Complete Guide to Fasting: Heal Your Body Through Intermittent, Alternate-Day, and Extended Fasting (book by Jason Fung and Jimmy Moore) https://www.amazon.com/Complete-Guide-Fasting-Intermittent-Alternate-Day/dp/1628600012 https://www.dietdoctor.com/intermittent-fasting/guides Angus Barbieri's record-breaking fast https://en.wikipedia.org/wiki/Angus_Barbieri%27s_fast The Placebo Effect https://www.webmd.com/pain-management/what-is-the-placebo-effect Eddy Merckx — Belgian cycling legend https://en.wikipedia.org/wiki/Eddy_Merckx Magic Bullet Effect (medicine) http://broughttolife.sciencemuseum.org.uk/broughttolife/techniques/magicbullet Cure for Hepatitis C https://www.mayoclinic.org/medical-professionals/digestive-diseases/news/most-patients-with-hcv-cured-with-new-drugs-but-at-what-price/mac-20430491 Avandia (rosiglitizone) https://en.wikipedia.org/wiki/Rosiglitazone https://blogs.scientificamerican.com/observations/avandia-restricted-in-u-s-banned-in-europe/ Heroin marketed for children in the early 1900's https://www.narconon.org/drug-information/heroin-history-1900s.html The Pharmacist (documentary) https://www.netflix.com/title/81002576 Cigarette advertisements featuring physicians https://www.healio.com/hematology-oncology/news/print/hemonc-today/%7B241d62a7-fe6e-4c5b-9fed-a33cc6e4bd7c%7D/cigarettes-were-once-physician-tested-approved Washington State prescriptive authority for Narcan https://www.wsparx.org/page/NaloxoneOpioid https://stopoverdose.org/naloxone-law-in-washington/ Supervised consumption services in Switzerland JRE #1250 — Johann Hari https://www.youtube.com/watch?v=CDpjvFn4wgM&t=1722s Medical Heroin program in Norway https://www.theguardian.com/world/2018/aug/10/norway-trials-free-heroin-prescriptions-for-most-serious-addicts Ibogaine Therapy for drug addiction https://maps.org/research/ibogaine-therapy Ibogaine for treatment of alcoholism — clinical trial in Brazil https://www.clinicaltrials.gov/ct2/show/NCT03380728 Jay Greenberg — prolific composer and cello prodigy twice featured on 60 minutes https://en.wikipedia.org/wiki/Jay_Greenberg_(composer) Daniel Tammet — British man who memorized over 22,000 digits of Pi (π) https://www.sciencemag.org/news/2005/04/man-who-memorized-pi Medical Cannabinoids for Cancer Cachexia https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6360413/ Marinol — brand name for dronabinol, a specific type of THC used for chemotherapy-induced nausea/vomitting https://en.wikipedia.org/wiki/Dronabinol https://medlineplus.gov/druginfo/meds/a607054.html Notes from Brian: Lisinopril is not a duretic. It's an angiotensin-converting enzyme (ACE) inhibitor. Furosemide is an example of a duretic which would have a fluid-reducing effect. The New England Patriots started four different quarterbacks in 1992. Hugh Millen, who played for the University of Washington in 1985, led the '92 Patriots in passing yards. Drew Bledsoe played high school football for the Walla Walla Blue Devils, not the Prosser Mustangs. https://www.thisprobablydoesntmatter.com/

Benedict Morelli│Mark Perez v. Live Nation Worldwide, Inc.│$101 Million Verdict   This week, your hosts Steve Lowry and Yvonne Godfrey interview Benedict Morelli of ( https://www.morellilaw.com/ )   Remember to rate and review GTP in iTunes: Click Here To Rate and Review     Case Details: Morelli Law Firm founder Benedict Morelli shares how he secured justice for 30-year-old Mark Perez, a talented graphic designer and DJ who sustained a traumatic brain injury when a forklift operated by a Live Nation employee crashed into his booth at Jones Beach Theater in Wantagh, New York. Despite the defense's attempts to undermine the validity and severity of Mark's physical limitations and continuing, pain and suffering, a New York County jury returned a verdict of $101,798,968 in damages after four weeks of trial.     Click Here to Read/Download the Complete Trial Documents   Guest Bio:   Benedict Morelli Benedict Morelli began his career in 1973 as a law clerk in a personal injury law firm, becoming eligible for the bar exam in 1977. After being admitted to the New York State Bar he became a partner and then senior partner of that firm. Mr. Morelli has a degree from City College, NY 1971 and studied law at New York Law School. He is admitted to the United States Supreme Court, the U.S. District Courts, Southern, Eastern, Western, and Northern districts of New York.   Mr. Morelli has been a partner at his law firm since 1981 and a senior partner since 1990. In June 1998, Mr. Morelli dissolved his firm and started Benedict P. Morelli & Associates, which later became Morelli Law Firm.   Mr. Morelli represents clients in Employment Discrimination cases (including racial discrimination, age discrimination, sexual harassment, sexual discrimination, and gender bias), false arrests, civil rights, complex product liability (including drug product liability – DES, Vioxx, Bextra, Ortho-Evra, and Avandia), auto accidents, premises, labor law, and many other types of cases. In each of these areas, Mr. Morelli has gotten multi-million dollar verdicts. He represents individual plaintiffs against many major corporations including many large investment banks.   For over thirty-five years of trying cases, Mr. Morelli has received numerous multi-million dollar verdicts. In 1995, his $40 million dollar verdict was featured in the National Law Journal as one of the "Top Ten Verdicts" in the United States.   He has tried every kind of civil case – from a person who tripped and fell over a raised door saddle and broke his hip ($2.6 million – the largest verdict in the country for that injury) to complex medical malpractice cases (the largest verdict in the country for blindness in one eye). He has attained the largest verdict for a loss of three fingers (medical malpractice) and the largest verdict for a crush injury to the arm.   In 2010, Mr. Morelli was lead counsel in a polio vaccine case that had been filed thirty years earlier and received a $22.5 million verdict (the largest verdict in Supreme Court in Staten Island, NY history.) It was also the largest vaccine verdict in U.S. history.   In 2011, Mr. Morelli was lead counsel in a sexual harassment trial in Federal Court in the Southern District of Illinois and received a $95 million verdict (the largest single-plaintiff sexual harassment verdict in history.)   Approximately half of the cases the firm handles are for other lawyers or law firms who choose Mr. Morelli and his staff as their trial counsel because of their track record for delivering multi-million dollar verdicts. Over the years Mr. Morelli has always been considered a lawyer's lawyer. He not only has numerous law firms referring clients to him but also has judges recommending clients to him. From the time he was admitted to the Bar through the present, Mr. Morelli has been first and foremost a trial lawyer.   Read Full Bio     Show Sponsors: Legal Technology Services - LTSatlanta.com    Digital Law Marketing - DigitalLawMarketing.com   Case Pacer - CasePacer.com   Harris, Lowry, and Manton - hlmlawfirm.com   Free Resources: Stages Of A Jury Trial - Part 1 Stages Of A Jury Trial - Part 2

The phrase "Cool as a Cucumber" is a Truest Truth as it does in fact cool your body down, on the other hand hot food like jalapeños heat you up and help Clean the river of Life Our Ancestors were close with Nature so they passed on the wisdom and the nuggets of the truth about what they Observed and Experienced and there results from mouth to ear and then they tried to hand their records down, but they were all taken away and destroyed A Quote from Robert Ingersole "The noblest work of man, is to create kind gods" There's no doctor in the world that would ever personally take or give a number of Drugs to their own family but 95% of them will Prescribe them to you and your family The most 8 Common Drugs we know of have over 900 names now for different disease symptoms 1.  Advair - An Asthma drug that creates greater severity to an asthma attack that can lead to death. When this was introduced under another name Fenoterol,  in the 1980's in New Zealand, in less than 1 year the death rate had multiplied 13 times. Asthmatics need to rub 3 drops of Essential Peppermint Oil into your palms until it's warm 6 x twice a day, go for a walk and lay out in the sun for 20 mins a day and eat plenty of Sea Salt for about 28days.  You will not be asthmatic anymore 2.  Avandia - for Diabetes which leads to heart attacks.  Diabetics need to go on nothing but Water and Raw Food for 28days and will no longer be diabetic 3.  Celebrex - The super Aspirin which eats holes in the Stomach and causes Internal Bleeding, destroys the Liver and leads to serious Kidney problems and killed tens of thousands of people 4.  Ketek - A Lung and Sinus Antibiotic which kills the liver and causes heart rhythm problems 5.  Prilosec And Nexium - For Heart Burn which has been linked to more heart attacks and phenomena deaths than any other studied drug.  If you go on just apples and water for 14days you'll be rid of heart burn 6.  Visine - Original eyedrops for redness. Creating more dilation and constriction problems which lead to more redness, ultimately leading to more serious problems known as Glaucoma and Cataracts  It is in Published Studies that they haven't created a new drug since 1974, they repackage, rename and re-prescribe for other Diseases, they never go away 98% of all human Chronic Diseases can be completely remised in 28days of doing nothing but Raw Plant food and drinking Water, getting in the sunshine and taking no Medicines and Supplements Grapes are good for your Lungs, they are also good for your Heart and they  drive the Nutritional Components of themselves through the blood stream to the bronchioles and can heal and repair any condition thats going on there To be Continued….

Today in FirstWord:

Today in FirstWord:

Today in FirstWord:

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Am 23.September 2010 wurde von der Europäischen Arzneimittelbehörde die Zulassung des Diabetes-Medikaments Rosiglitazon ausgesetzt. Metaanalysen haben gezeigt, dass durch Rosiglitazon das kardiovaskuläres Risiko erhöht ist. In den Vereinigten Staaten ist das Medikament weiterhin verfügbar. Billrothhaus-News Experte Univ.-Prof. Martin Clodi erörtert in diesem Statement die Konsequenzen dieser Entscheidung für Ärzte und Patienten. Ca. 6000 Patienten müssen auf andere Präparate wie Pioglitazon, Gliptine oder auf Sulfonylharnstoffe umgestellt werden.

Am 23.September 2010 wurde von der Europäischen Arzneimittelbehörde die Zulassung des Diabetes-Medikaments Rosiglitazon ausgesetzt. Metaanalysen haben gezeigt, dass durch Rosiglitazon das kardiovaskuläres Risiko erhöht ist. In den Vereinigten Staaten ist das Medikament weiterhin verfügbar. Billrothhaus-News Experte Univ.-Prof. Martin Clodi erörtert in diesem Statement die Konsequenzen dieser Entscheidung für Ärzte und Patienten. Ca. 6000 Patienten müssen auf andere Präparate wie Pioglitazon, Gliptine oder auf Sulfonylharnstoffe umgestellt werden.

Avandia users have a 60% higher rate of Heart Failure! The FDA's war on Stevia, the additional beneficial aspects of stevia usage. Flax oil and flax seeds have been shown to lower blood cholesterol and triglycerides, and to help reduce damage to cells.

Avandia is a popular diabetes drug manufactured and marketed by the pharmaceutical company Glaxo Smith Kline. Avandia was approved by the FDA in May of 1999 and has emerged as one of the top-selling drugs in the United States. Several medical reports have linked Avandia to serious side effects including, heart attacks, congestive heart failure and bone fractures.

Avandia is a popular diabetes drug manufactured and marketed by the pharmaceutical company Glaxo Smith Kline. Avandia was approved by the FDA in May of 1999 and has emerged as one of the top-selling drugs in the United States. Several medical reports have linked Avandia to serious side effects including, heart attacks, congestive heart failure and bone fractures.

Guest: David Kliff Host: Larry Kaskel, MD Join host Larry Kaskel interview David Kliff, a diabetic himself and the publisher of the Diabetic Investor. Should you invest in the Diabetes Sector? What drug companies will pick up the Avandia business? Find out in this segment.

Dr. Cooper will explain why.In today's world of media, Internet, and instant information it is sometimes hard to tell whom to trust when it comes to medical news. The prestigious New England Journal of Medicine recently took a tough stand against the diabetes drug Avandia and now many are contending it was done to advance political agenda. Today Dr. Cooper will help separate fact from fiction when it comes to recent news regarding Avandia, folic acid, multivitamins, and calcium and kidney stones. Dr. Cooper takes listeners' calls.

      In today's world of media, Internet, and instant information it is sometimes hard to tell whom to trust when it comes to medical news.     The prestigious New England Journal of Medicine recently took a tough stand against the diabetes drug Avandia and now many are contending it was done to advance political agenda.     Today Dr. Cooper will help separate fact from fiction when it comes to recent news regarding Avandia, folic acid, multivitamins, and calcium and kidney stones.     Dr. Cooper takes listeners' calls.