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Best podcasts about neupogen

Latest podcast episodes about neupogen

Fitness Confidential with Vinnie Tortorich
Making Progress & Giving Answers - Episode 2493

Fitness Confidential with Vinnie Tortorich

Play Episode Listen Later May 27, 2024 49:55


Episode 2493 - On this Monday's show Vinnie Tortorich and Anna Vocino chat about Vinnie's cancer protocol making progress, giving answers to listeners' questions, and more. https://vinnietortorich.com/2024/05/making-progress-giving-answers-episode-2493 PLEASE SUPPORT OUR SPONSORS YOU CAN WATCH ALL THE PODCAST EPISODES ON YOUTUBE - Making Progress & Giving Answers There's some fun with Sam Elliott voiceovers. (2:00) When this episode airs on May 27, 2024, Anna will have a birthday discount code, “Birthday10” until the end of May. (6:00) Vinnie's cancer update (11:30): Vinnie is an N=1 experiment. His protocol has changed a bit. He thought they were using a smaller amount than 17 years ago, but they are just administering at a different rate. He mentions some of the side effects he was having, especially with the Neupogen. CBD (not THC) has helped him control some of the pain. He's getting bored—he hasn't been able to do some of the things he hoped to do to occupy his time, like archery. Vinnie has great health care—better than he had in California. (22:00) Questions from listeners. (27:00) What are NSNG® foods for mouth/jaw damage, especially for getting good protein? There's a great question about various exercises, and Vinnie gives his top 5 exercises. He adds some exercises if you want to push yourself further. Sets to failure are as effective as multiple sets; however, you may need help with sets to failure. The “Dirty Keto” documentary landing page should be up by May 30th. When it comes out, make sure you watch and rate it. There's a new NSNG® Foods promo code you can use! (53:00) The promo code ONLY works on the NSNG® Foods website, NOT on Amazon. Anna's upcoming Eat Happy Italian book is on the way. You can go to: —upload your receipt and get bonus content.  You can preorder it from . [the_ad id="20253"] PURCHASE BEYOND IMPOSSIBLE (2022) The documentary launched on January 11! Order it TODAY! This is Vinnie's third documentary in just over three years. Get it now on Apple TV (iTunes) and/or Amazon Video! Link to the film on Apple TV (iTunes):  Then, Share this link with friends, too! It's also now available on Amazon (the USA only for now)!  Visit my new Documentaries HQ to find my films everywhere: REVIEWS: Please submit your REVIEW after you watch my films. Your positive REVIEW does matter! FAT: A DOCUMENTARY 2 (2021) Visit my new Documentaries HQ to find my films everywhere: Then, please share my fact-based, health-focused documentary series with your friends and family. The more views, the better it ranks, so please watch it again with a new friend! REVIEWS: Please submit your REVIEW after you watch my films. Your positive REVIEW does matter! FAT: A DOCUMENTARY (2019) Visit my new Documentaries HQ to find my films everywhere: Then, please share my fact-based, health-focused documentary series with your friends and family. The more views, the better it ranks, so please watch it again with a new friend! REVIEWS: Please submit your REVIEW after you watch my films. Your positive REVIEW does matter!  

Fertility Wellness with The Wholesome Fertility Podcast
EP 283 Why Acupuncture & Herbs are Game-changing for Fertility Health

Fertility Wellness with The Wholesome Fertility Podcast

Play Episode Listen Later Apr 30, 2024 36:49


In today's episode of The Wholesome Fertility Podcast, Mike Berkley shares his personal journey with acupuncture and herbal medicine in fertility treatment. He highlights the value of integrative medicine in fertility enhancement. Mike explains how acupuncture and herbal medicine improve fertility by increasing blood flow to the ovaries and testes, enhancing egg and sperm quality. He also discusses the importance of preparing for IVF and the timing of treatment.    Mike Berkley, LAc, FABORM, is a licensed and board-certified acupuncturist and a board-certified herbalist. He is a fertility specialist at The Berkley Center for Reproductive Wellness in the Midtown East neighborhood of Manhattan, New York. Infertility can be a daunting journey for couples longing to start a family, which is a reality Mike faced with his wife. Luckily, she sought the guidance of an acupuncturist and herbalist who possessed some knowledge of reproductive issues. Despite initial disappointments, after undergoing acupuncture and herbal medicine treatments for seven months, the couple became pregnant and carried the child to term without any complications. Their once seemingly elusive dream had become a beautiful reality thanks to the remarkable effects of acupuncture and herbal medicine. This experience led Mike to obtain his degree in acupuncture from the Pacific College of Oriental Medicine's New York campus and his National Board Certification in herbal medicine. Equipped with the necessary license and fueled by an insatiable thirst for knowledge, Mike studied Western medical approaches and the ancient wisdom of Chinese medicine about infertility treatment. Through rigorous study and invaluable clinical experience, he developed unique acupuncture protocols and proprietary herbal formulas, tailoring them to each individual or couple seeking his assistance. Mike is also a member of several organizations, including the Acupuncture Society of New York and the American Infertility Association. He is writing a book on reproductive disorders and Chinese medicine and hosts his groundbreaking seminars nationwide. Mike has witnessed firsthand the life-changing potential these ancient practices hold for couples struggling with infertility. Together, he can help transform your dreams into reality and create a world where the joy of parenthood knows no bounds.   Website: www.berkleycenter.com Instagram: https://www.instagram.com/mikeberkley56/   For more information about Michelle, visitwww.michelleoravitz.com   Click here to find out how to get the first chapter of "The Way of Fertility" for free.    The Wholesome FertilityFacebook group is where you can find free resources and support: https://www.facebook.com/groups/2149554308396504/   Instagram: @thewholesomelotusfertility Facebook:https://www.facebook.com/thewholesomelotus/         Transcript:   Chapters   00:00 Introduction and Personal Journey 00:30 Discovering Acupuncture and Herbal Medicine 05:16 The Limitations of Western Reproductive Medicine 06:33 The Value of Integrative Medicine in Fertility Treatment 08:59 How Acupuncture and Herbal Medicine Improve Fertility 20:16 Living in Accordance with Nature and the Impact on Fertility 26:11 The Mind-Body Connection and the Importance of Mental and Emotional Health 28:48 The Impact of Acupuncture on Blood Flow 32:35 The Heart and Uterus Connection 33:49 Contact Information     Michelle (00:00) Welcome to the podcast, Mike. Yeah, I'm actually really happy to have you. And mike berkley (00:02) I'm thrilled to be here. Thank you for having me.   Michelle (00:07) read about your story and I find it fascinating that you guys started out as patients, kind of like how I was. I was working in New York, really close to you, for doing architecture. So completely different life, completely different world. So I went in for my menstrual irregularities and then everything started getting resolved.   for the first time with acupuncture. And I know you guys were also moved by it with your own journey. So I'd love for you to share your story and how you got into this type of work.   Mike berkley (00:39) Sure, I'd be happy to. So, while I was in acupuncture school, my wife and I were trying to have a baby. And we couldn't. And I had, she had anti -sperm antibodies and I had, I don't remember, motility issues or morphology issues or something. And she went to a...   She didn't go to a reproductive endocrinologist. She went to a gynecologist and he wanted to do some IUIs. And then she met or heard about an acupuncturist and herbalist in New York. And she went to this one.   And the woman gave her herbs and acupuncture and gave me some   then two months later, I was I think I was working and going to school. I can't remember so long ago, but she called me. My wife called me and said that she was pregnant and I didn't know anything about medicine in any way, shape or form. And I said, how do you know?   And she said, well, I peed on the stick. And I said, well, that's all well and good, but I don't believe in that. You better go to the doctor and get a blood test. And she did. And now I have a 29 year old son. Yeah. So I got very inspired at that time to pursue knowledge in the realm of reproductive medicine.   Michelle (02:03) amazing.   Mike berkley (02:17) And so I spent many years studying Western reproductive medicine. I don't mean officially, I didn't go to medical school, but on my own, I studied a lot of Western reproductive medicine and a lot of acupuncture and a lot of herbs. And I've been treating fertility cases exclusively. Like I won't treat a neck or a back or a headache. I've been treating fertility cases exclusively for 27 years.   Michelle (02:29) Yeah. Amazing.   So that's awesome. I mean, I personally love working with fertility. I first started, it was more general, but I just love it. And the rewards are like insane. You know, when you get the positive pregnancy pictures sent to you and it's really incredible and people are shocked. Oftentimes, because they're like, there's no way. I mean, sometimes five years of nothing like Western medicine. And I think one of the common things is that people think that IVF is a guarantee. Do you find that?   Mike berkley (03:17) Of course, of course. I mean, it's, you know, our lives as acupuncturists and herbalists are very interesting, gratifying and ungratifying. I'll give you an example. This has happened to you. It's happened to any acupuncturist listening. Patient does four failed IUIs and three failed IVFs.   Michelle (03:18) Yeah.   Right. Right, or it helped me relax through the process.   Mike berkley (03:43) And then you work with the patient for three months and she does an IVF and she gets pregnant and has a baby. And then I've had patients more than one say, well, you know, it's possible that that what you did helped me. And I'm like, yeah, it's possible, you know.   Exactly, exactly. I love that one. You know, it helped me relax. So I think that I'm I think more and more individuals more more couples more women more men are becoming aware of the the efficacy and the value of You know complementary medicine or integrated medicine acupuncture herbs You know diet In the context of fertility enhancement   Michelle (04:16) Mm -hmm.   Mike berkley (04:34) And I often say to patients, I say, listen, you can go to the best reproductive endocrinologist in the world. I don't care who it is, but that person cannot improve your egg quality. They cannot improve your lining quality and they cannot rectify your husband's sperm DNA fragmentation. I can. So therefore,   Michelle (04:37) Mm -hmm.   Mm -hmm. Right.   Mike berkley (05:03) We should work as a team. And I'm saying this to the patient, but I'm also saying it to society. And I'm saying it to reproductive endocrinologist. The best type of medicine is integrative medicine. You can do something I can't. I can do something you can't. Let's do this. Let's try again.   Michelle (05:05) Right, 100%. Everybody has their blind spots, you know, and their strengths. I mean, we don't have the technology, we can't go in there and extract eggs. Right.   Mike berkley (05:32) That's right, but who cares? You know, a good car mechanic can fix an engine, but it doesn't mean he can make an engine. So it doesn't matter that we don't have the technology. It doesn't matter that we're not reproductive endocrinologists. What matters is, is that for an IVF to work, you need four things. You need a good egg, a good sperm.   Michelle (05:36) Right.   Mm -hmm. Right.   Mike berkley (06:00) And so the reproductive endocrinologist cannot offer a patient good eggs and good sperm and good line. In fact, there are patients that come to me and they say they have a five millimeter lining and the doctor will give them either transvaginal Viagra or something called Trentol and Neupogen. And these medications will thicken the lining and they still have implantation failure. Why? because a thick lining or within normal limits lining, a 10 millimeter lining doesn't convey that it's a good lining.   Michelle (06:31) Definitely. And of course I've asked this question a lot. I love asking questions that I can answer them too, but obviously every acupuncturist says it in a different way. So,   Mike berkley (06:38) So I think that as acupuncturists and herbalists, we have a lot to offer a patient suffering with infertility for sure.   Michelle (07:00) I'd love for you to talk about how acupuncture and herbals can help somebody who's trying to conceive.   Mike berkley (07:08) Sure. So I'm gonna kinda speak around a little bit, but it'll all make sense in the end. So blood is nothing other than a taxicab. Blood is nothing other than a messenger service. When we inhale, the oxygen gets into the blood and the body is oxygenated through blood flow.   When we eat food, our nutrient products get into the bloodstream and nutrients are disseminated through the blood. FSH and LH coming from the pituitary get to the ovaries via the blood. And so I'm gonna step back for a second and say what I say to patients.   You have a heart that's beating. It's disseminating blood throughout your body. But there are two things that are happening. Number one, that dissemination of blood is generalized. And number two, you're 40 years old. And your blood flow is not as good as it was when you were 20. And if you're not 40, you're 37 or you're 36. Same case. Your blood flow is not as good generally as it was when you were running around in the playground at nine years old. You exercise less, you do less in general, I'm speaking.   And so now to acupuncture, what acupuncture does is it improves and elevates hemodynamics, which means blood flow. And when a patient says, well, my heart is doing that, though that's true, with the utilization of acupuncture, you're improving hemodynamics to a specific area, which is the ovaries.   Michelle (08:57) Mm -hmm.   Mike berkley (08:58) Blood, therefore, is you're increasing the delivery of oxygen, electrolytes, nutrients, and hormones to the ovarian milieu. Not only that, but you know when a taxi cab takes a passenger to the airport and the passenger gets out, the taxi cab doesn't want to drive back to the city empty. They want to take a passenger back to the city.   It's a 45 minute trip from JFK to New York City to Manhattan. So they don't want to go back without a passenger. Well, blood is the same thing. So when you're increasing blood flow to the ovaries, you're delivering these essential products, but the blood is also picking up debris. What is debris? Debris are dead cells. Now, of course, during this conversation, both of us have lost a billion cells. They've died and they've regenerated. But what happens to the cells that die? Well, they get emitted through the sweating, exhalation, urination, defecation. This is how we get rid of toxins in the body. But again, because our digestive functions are not necessarily great, because our hemodynamics are not necessarily what they could be, by stimulating blood flow to the ovaries, you're delivering the good and helping to take back the bad which is the dead cells. So you're actually taking this garden that's not getting a lot of rain and it's not getting a lot of sunshine because the trees are like this over the garden. So when you're doing acupuncture herbs, you're cutting down the tops of these trees and you're going like this. So the garden is now getting all this sunshine and the rain is able to hit the flowers. And in a month, the flowers are joyous, beautiful, smiling, looking at everybody and winking at them and saying, hey, I'm a beautiful rose, look at me.   And so that's kind of, I think that the analogy or the metaphor is to how acupuncture improves egg quality. And the same is true with sperm quality. You're causing improved and increased hemodynamics to the testes and the same thing happens as with the ovaries. So it's the testes and the ovaries are really homologues. They both do the same thing. One creates eggs, one creates sperm and...   Michelle (11:09) Mm -hmm.   Mike berkley (11:23) …stimulating blood there, we're improving the quality of the contents. Now let's talk about herbal medicine. So herbal medicine is much more sophisticated, in my humble opinion, than acupuncture. Acupuncture is very sophisticated and very effective in all areas, whether you have pain or infertility. But the thing about herbal medicine is that you can construct an herbal formula that specifically deals...with the overall presentation of the patient, in my opinion, in a more powerful, efficacious manner. So for example, if you have a patient with polycystic ovarian syndrome who's five foot five and weighs 250 pounds and she's 40 years old, and then you have a PCOS patient who's five foot five and she's 29 years old and she's 110 pounds, they're both suffering with...   Michelle (11:56) you   Mike berkley (12:23) lack of proper menstruation, they're both suffering with infertility. So when you use herbal medicine on those patients, you're not just treating PCOS, treating this woman who's 250 pounds, this woman who's 120 pounds, this woman who's 40 years old, this woman who's 29 years old. So the herbs are very pinpoint accurate in what they do and how they work. And...   The beauty of herbal medicine is that one can create a very specific formula for this patient. So this patient is suffering with infertility, but she also has constipation and chronic headaches and...   Michelle (12:56) you   Mike berkley (13:05) She's got low back pain. So you can give her herbs to deal with all of that stuff. And so acupuncture is efficacious in the same manner. So really, what's the difference? So there's a couple of differences. As I said earlier, in the perspective of herbal medicine, you're taking it orally. It's internal medicine. It's having an effect on the organs, on the follicles.   Michelle (13:16) you   Mike berkley (13:34) the ovaries, on the testes, et cetera, et cetera. But I'm going to say something that's even more interesting. Let's say that you or I had a really bad headache. And we said to our partners, honey, I have a splitting headache. Could you please massage my shoulders and massage my head? It would really make me feel better. And our partners say, of course, of course. And they stand. I'm sitting in this chair and my wife comes.   Michelle (13:46) you   Mike berkley (14:03) me and starts to massage me and she's massaging my head and maybe in a half an hour I feel better. Let's retell that story. The same exact scenario except before my wife starts to work on me I take three Advil. Now what happens is instead of my headache dissipating in 30 minutes it dissipates in 15 minutes. Why?   Michelle (14:22) you   Mike berkley (14:32) because I'm being treated from the outside in, which is the massage, and I'm also being treated from the inside out, which is a three Advil. And so when you use these together, you're increasing the efficacy of the treatment. And so I think using acupuncture nerves together, they do similar things, but they also do different things, and they certainly potentiate each other's efficacy and power.   Michelle (15:00) Yeah, for it's very complimentary. Now, typically somebody comes to you and says, I'm starting IVF in a month. Sometimes I'm like, okay, I kind of wish you came here a couple of months before. So for people who are listening, if they want to prepare for IVF or really just prepare their body and their egg quality, how early...   should they come to you? Like how long does it take really for everything to take effect?   Mike berkley (15:30) So it's a great question. So again, I'm going to talk about sperm and egg. Again, the similarity is quite fascinating. It takes three months for a spermatogonia, an immature sperm, to reach a mature sperm. And it takes three months for a primordial follicle, which is...speck of dust to turn into a 20 millimeter follicle. It is the 20 millimeter follicle that the egg is retrieved from. So three months before a transfer is the, you know, is the gold standard. It's the best thing to do. But what I will say to patients, because I get this kind of situation all the time, is listen, you're having a cycle, you're having a transfer next month. That's okay. Let's start tomorrow.   Yeah, but you just told me it takes three months. No, no, no, no, I understand. But let's start tomorrow. I'm going to tell you why. If you do the transfer and it works, you've thrown out a couple of hundred dollars on some sessions. So what? I'm going to continue to treat you twice a week for 13 weeks to help prevent miscarriage. Why for 13 weeks? Because 90 % of miscarriages occur viable for the 12th week. In the event, in the most unfortunate event,   Michelle (16:29) you   Mike berkley (16:52) that the cycle fails. We've already started treating you now. So then in the subsequent cycle or the cycle subsequent to that, you'll have much better egg quality. You know, I don't know if you know Warren Buffett. Warren Buffett is one of the greatest investors in the history of America. And somebody said to him one time, Mr. Buffett, when is the best time to invest in the stock market? And he said, today.   And the point of the story is you can't really time the market. Invest if it's high, invest if it's low, dollar cost average. Invest 100 bucks every month for the rest of your life and you'll be okay. And so that's kind of like this. Invest in the treatment even though your transfer isn't a month. Doesn't work out? Okay, we've still improved follicular quality. Does work out? It's all good. I'm gonna continue to treat you twice a week for 13 weeks. You're gonna have a baby.   Michelle (17:47) Yeah. That's a good perspective for sure. yeah, I mean, what are some of the things that you see? Cause cause I feel like the way we're living right now is impacting our bodies in so many ways. And Chinese medicine, really the heart of it is living in accordance with nature, living in accordance with our own nature. And what happens is when we live outside of that and against our normal flow, that's when we start to get patterns and symptoms. So living in New York, I remember having a lot of really kind of like climbing an uphill battle because it is go, go, go. And so some of the things that I tell people who are not close to here, wanted to get coaching calls is even getting a grounding matter somehow finding ways to living in more flow. And what are some of the things that you see?   Mike berkley (18:43) So I think everything that you just said is true, real and valid. However, I'd like to say that unfortunately, and remember, this is to the listening audience. This is my opinion only. I do feel it's next to impossible to get to one's nature. I do think it's next to impossible to be really settled, really like, able to exhale. Why do I say this? I say this because the world is at war, because there is intense poverty, there's joblessness, there's crime, there's all kinds of negative things. Of course there's many beautiful things, but there's many negative things. And so how can people possibly exhale?   So it's very difficult to become kind of, you know, one with nature and one with yourself and this kind of thing. I do think, however, that even though it's difficult to achieve, that the achieving is not the goal. The trying is the goal. The journey is the goal. One will probably never reach the destination, but it's okay because through the journey one's psychic and mental and emotional and physical health can improve. So even though I don't see a path to ultimate improvement, I don't see a path to ultimate health, I do think that there is a mind -body connection for sure. It's completely unassailable. And I think that people, I don't really get involved with this kind of thing too much in my own practice. I'm very, very clinical, but that doesn't mean that I don't totally embrace what you're saying. I think people should do yoga. I think they should meditate. Listen, I'll tell you an example of exactly, I'll put a patient in the room and I'll come to take the patient out and she's laying on the table with the cell phone.   You know, this is terribly destructive to the patient and he or she doesn't understand that. And I'll say to them, listen, you have 30 minutes of your entire life that you cannot be bothered by anybody. You can just be free. You're in this room on this table with beautiful music and it's a lovely room and you're taken care of here.   Michelle (20:53) yeah.   Mike berkley (21:22) put the phone down, man, and B, and it's really hard because people need that constant stimulation. I need it. The first thing I do when I wake up is I check my phone at 6 .15 in the morning. You know, it's mental illness. It's mental illness. It's craziness. But I do think that trying to be at peace is very important, not only for fertility,   Michelle (21:26) Yeah.   It's an addiction for sure. Yeah.   Mike berkley (21:49) but for life, for happiness, for joy. And so, as I say, I don't have meditation classes here or yoga classes here, but I strongly recommend that patients do engage in those activities. And I also think people should go to the gym. I think people should work out three days a week.   Michelle (22:09) yeah.   Mike berkley (22:10) and work out pretty hard. I don't mean hard like a professional athlete, but you know, don't get on the treadmill for five minutes. Like work. You know, listen, we have this thing called liver -chi stagnation, right? It means that, you know, the chi is stuck and people are stuck. And as a result of being stuck, inflammation occurs and they're angry and they get headaches and they're bitter. Guess what happens to the stuck chi when you move, when you exercise, the chi becomes unstuck and the   Michelle (22:37) Right, yeah.   Mike berkley (22:39) Exercise makes you feel better psycho -emotionally and when you feel better psycho -emotionally, you'll be better off physically   Michelle (22:47) 100%. I remember, so when I was in New York in the craziness just over firm, you know, that's the only way you can really survive there. You have to like show that you're a good quality employee. And I remember I found Acupuncture and what I found that it gave me is this flow.   in my life where I was able to still withstand and have that pressure, but I felt more resilient. It like, it increased my ability to adapt more than anything else has. And that was one of the things that I was so amazed by. But then it really made me realize whole beings that have so many different aspects to ourselves and how one...   part, if we work on our own energetic frequency and chi, it impacts our life and it impacts our how we can think and how we feel.   Mike berkley (23:47) I agree with you. You know, another problem that I see quite frequently is, you know, there were two kinds of patients. There are patients that are very self -aware, and they exercise and they meditate and they do yoga and they eat properly.   And then there are patients that they may not be overweight, but they don't eat well. You know, they drink Coca -Cola and they eat French fries and listen, guess what? There's nothing wrong with drinking a Coca -Cola and having French fries, you know, once every two months, once a month. It's all good. Chinese medicine is about yin and yang. What does yin and yang mean? Balance. It's all good. But when you have French fries and burger and ice cream tonight, you smoke a joint tomorrow and you, you know, you don't go to the gym for three days. You know, this just...   Michelle (24:07) Mm -hmm.   Mike berkley (24:36) it's just going to have negative attributes. It's going to create negative outcomes, certainly physically. So I try to encourage patients to eat properly and I try to give them some type of helpful diet plan if I think they need it. But I think nutrition and diet are very important for health in general. And certainly in the world of infertility, many of the   Many of the causative factors can really be, I don't want to get too technical, but they can kind of originate with what's called free radicals, reactive oxidative species, and these things cause inflammation in the body. And if you have inflammation in the uterus or inflammation in the testes, inflammation in the testes kills sperm. Inflammation in the uterus is going to kill an embryo. So we need to be careful about what we're eating from the inflammatory point of view.   You know, the inflammation point.   Michelle (25:37) Right. Yeah. Gut health is everything. interesting how the spleen and stomach are center. That's their location. The direction is center because, and it really is, it's such a symbol of how important it is in creating blood. And actually speaking of blood flow that you were talking about before, did you ever see, there was something on Instagram, somebody took a sample of blood before and after acupuncture.   it was shocking. Like you could see it literally move everything that you learn in textbook about how it improves chi and flow. You could see the blood cells being a little bit more stuck together from the before. They're a little more stuck together and very slow moving. The after the blood cells not only are not stuck together, but they're more round.   Mike berkley (26:30) Interesting.   Michelle (26:30) They're more round and they're moving fast and flowing. They're not right next to each other. It's crazy. And that was mind boggling. And I actually, so I shared it on my Instagram. I'll forward you the link. And I shared it on my Instagram. And interestingly enough, I had a lot of acupunctures, because we all learn this in theory. That's the theory. We don't really often see this with our own eyes. So I think that a lot of   Mike berkley (26:45) Please.   Michelle (27:00) acupuncturists that saw this were like blown away. They're like, my God, this is exactly what it says in the textbook. And to actually see it with your own eyes is amazing.   Mike berkley (27:09) So I'm going to share a little story with you that's completely apropos of the story that you just told   I'm going to tell you a story that's a little bit different than what you told me, but it's the exact same outcome. So about 10 years ago or 12 years ago, there was a study done. First of all, let me talk about the uterine artery impedance index. The uterine artery impedance index is an index that determines the flow through of blood through the uterine artery.   Uterine artery at its end point has branches that come out and enervate the ovaries. So the ovaries are getting their blood through the uterine artery. And so the more patent and effective the uterine artery is, the more blood will get to the ovaries. And so there was this little study done.   where they did a transvaginal ultrasound with a color doppler. And for the listeners who don't understand that, you know, when you have an ultrasound and the doctor looks at the monitor, it's all black and white and gray. But with a color doppler, the monitor is color. You can see all color. It's not just gray. And so they did these transvaginal ultrasounds with a color doppler to determine the uterine artery impedance index. The higher the index,   the lower the amount of flow through of blood through the uterine artery. So they took a bunch of women, they did this and they wrote down the uterine artery impedance index numbers. and by the way, when they did the transvaginal ultrasound, you could either see no blood or just a little blood in the uterus, in the uterine lining. Then acupuncture was given to the patient and...   Michelle (28:37) Mm hmm. Mm hmm.   Mike berkley (29:00) 25 minutes after acupuncture was done, they repeated the transvaginal ultrasound with a color Doppler and two things happened. The uterine artery impedance index dropped like three or four points and you could actually see a red line right across the uterus. So you could actually perfectly well see evidence of enhanced blood flow into the uterine environment which   you know, really I'm talking about the ovarian environment, but you don't see it on the ovaries, you see it on the uterus. And it was fantastic. So it's exactly what you're saying, a little bit of a different study, but the same outcome.   Michelle (29:43) more specific to fertility. Yeah, that's amazing. Wow, incredible. So fascinating. I mean, it is really fascinating when we get to see with our own eyes, something that has been, you know, taught for thousands of years, and to actually see science and you know, I look also housing the mind   Mike berkley (29:45) Absolutely. Yeah. Pardon.   Michelle (30:04) that also reflect that in modern science, but the heart math and the heart -brain coherence that they're finding is pretty much proving the whole idea of the heart housing the mind.   Mike berkley (30:04) you   So I don't even, I don't know anything about this. This is all brand new news to me, but it sounds really fascinating. I love.   Michelle (30:22) Yeah.   It is. And this is why I love talking to acupuncturists. Cause you just told me something that I did not, I thought I heard about it, but I didn't hear it in that detail. And I'm learning so much talking you. So this is why I love coming together with fellow acupuncturists because I always, always learn something new.   Mike berkley (30:44) as do I from you, thank   Michelle (30:46) of course I could talk to you for   But I would love for you to   can people find you or find more about you?   Mike berkley (30:53) Yeah, thank you so course, I'm Mike Berkeley and my website is berkeleycenter .com, which is B -E -R -K -L -E -Ycenter .com. And I'm happy to speak to anybody, answer anybody's questions. There's no charge for that. And I'm a plain, simple, down to earth guy. And I'm just here to help people.   Michelle (30:55) Yeah.   Yeah. You got the New Yorker mentality that I miss that I'll be honest, the culture of New York, I really miss since I've moved. So it kind of brings me back home to like, you know, the accent and all that. So Mike, it was great meeting you. I really enjoyed our conversation and thank you so much for coming on today.   Mike berkley (31:35) Well, I want to say it was an absolute pleasure and an honor to meet you. I enjoyed our conversation so much and thank you so much again for having me as a guest. I'm grateful.

What The Fertility
A Persistent Thin Lining with Katie Griffith

What The Fertility

Play Episode Listen Later May 8, 2023 36:31


Katie details all the methods she tried to increase her thin lining. From estrogen priming to a Neupogen wash, Katie details the struggles of women with thin lining. Tune in to hear how Katie's conception journey has unfolded. Follow Katie on IG: kgriffith18Surrogacy & Gestational Carrier Information:@circlesurrogacy

Cancer Stories: The Art of Oncology

"Good Genes," by Kaitlin Demarest: a resident searches for answers after genetic testing.   TRANSCRIPT Good Genes, by Kaitlin Demarest, MD1 (10.1200/JCO.22.00871) My mother was diagnosed with breast cancer when I was 5. I accompanied her to a handful of chemotherapy sessions and filled the time with MadLibs and word searches. The drive to the hospital became familiar; the diner where I celebrated my fifth birthday was on the way, as was the dairy bar and the Chi Chi's that shut down. I grew accustomed to her wearing wigs and remember vividly the time one almost flew off her head on a windy day at Rockefeller Center. I learned that vomit could be green and what a computed tomography (CT) scan was. This is not to say that I knew what was going on or what all of it meant. When she was first diagnosed, my dad explained that there was something scary growing inside my mom and her doctors needed to take it out. He drew an arrow coming out of a finger instead of breast tissue to help my young mind better grasp the concept. I was not sure why the cancer picked her breast to start growing in but that mattered little to me as my kindergarten logic figured it would be simple enough to take out. However, after “trying to get the cancer out” with surgery and chemo, she only seemed to get sicker. She would spend days on the couch after treatments, nauseous but not wanting the Coke syrup she would give me when I was sick. Eventually, she returned to work, her new head of hair much curlier than before, and things seemed normal again for a brief time. I can recall multiple times, almost yearly, that I believed she was cancer-free, but then I would overhear her telling someone over the phone that she needed to start treatment again. I clung to the belief that everything would be okay without a second thought, but then one day the summer after fourth grade, she told me and my brother that she would not be getting better. Soon she was in hospice care, and then she was gone. Losing her at 10 years old, there was so much I did not understand. I decided I wanted to become a doctor and tried to start my medical education as soon as possible to fill in these gaps. I wrote research papers on cancer topics in middle school, took as many science classes as possible in high school, and majored in molecular biology as an undergrad. I even spent a summer shadowing oncologists, including one of my mom's. He called me by her name a few times, which mostly warmed my heart that he still thought of her and reminded me that he had known her too. He was very kind, clearly doing the best for his patients. Watching him, I began to appreciate the rocky road of disclosing setbacks and poor prognoses as a provider. Despite a week of shadowing my mother's oncologist and countless visits with my aunt and uncle, both doctors, who had helped her navigate the treatment process and even took care of her when she was home on hospice, I refrained from asking about the genetics of my mother's cancer. Perhaps due to wishful thinking, I was under the impression that my mom had been tested for hereditary breast cancer syndromes while she was alive and that she was negative for BRCA mutations. But finally, at the end of my first year of medical school, over the karaoke music at a bar after my cousin's college graduation, my aunt told me that she had never been tested; I would need to be tested soon. I had been scared to receive the results of my genetic testing. I had faced mortality but avoided thinking about my own. I remember my heart pounding as I listened to my genetic counselor, trying to discern any doom or gloom in her tone. After she carefully explained that I carried no mutations known to be associated with cancer, I caught my breath and relief did wash over me. Then it was all over. Years of questioning, asking what if, bargaining, avoiding, wondering, hoping all tied up. “Take care of yourself, Kaitlin,” she said, “Don't study too hard tonight.” It was almost as if she knew. The sudden silence, the finality, and the lack of solace in my solitude; I felt panicked and empty. There would be no sticky little mutation to act as scapegoat for all my pain, no genetic alteration on which to pin her loss. I would not have to think so much about prophylactic mastectomies, only early screening. But I was devastated. I thought knowledge would mean power, but it turned out that ignorance was almost bliss. I secretly hoped for an answer, written in our DNA, a molecule I had come to understand so well, that would explain why I had lost my mom so prematurely. As a kid, I felt helpless against my mother's illness and these results only exacerbated that feeling. Studying molecular biology and human physiology granted me some sense of control, but my heart ached not knowing what happened inside of her organs, tissues, and cells. I knew a lot about cancer but virtually nothing about hers. I could not let cancer have any secrets. There are a lot of things I know and remember about her. Her love of grocery store–related game shows. Her frustration over untangling my hair each morning before school. Her Armenian way of dancing; her arms twirling along to Santana on the radio at a traffic stop. But it made me feel so far away from her to learn about the histology, diagnostic workup, and treatment of breast cancer and not know anything about her experience. Our time was cut short, so many stories left untold. Any morsel of information I could remember of her was proof of our time together and that our relationship was special, despite how young we both were when we were separated by her death. If I could not ask her about her hobbies growing up, her social life in college, or what it was like being pregnant with me, I was going to learn about what made that impossible. I remember hearing that my aunt and uncle still had her medical records and, after asking them, they arrived in the mail along with old Mother's Day cards and letters to Santa. The woman kept everything. It took me a few nights, locked in my room, chasing the grief with episodes of The Marvelous Mrs. Maisel, but I made it through every page. She had a modified radical mastectomy and a transverse rectus abdominus muscle flap reconstruction, an echocardiogram prior to doxorubicin, and required Neupogen to keep her white count up. Other things I had already known: menarche was at age 11 years, she wore a sleeve to improve the lymphedema in her left arm after her lymph node dissection, she had two c-sections, and she smoked cigarettes for a brief period. Also documented was my parents' divorce and the fact that they had me and my brother, our ages swapped. Everyone always thinks he is the older one. It was satisfying and heartbreaking. Now I knew the type of cancer and its stage and size at diagnosis. I knew that she had surgery followed by many cycles of chemotherapy then radiation and tamoxifen. After all of this, according to an office note, she was “basically doing extremely well.” But I read on and on as her tumor markers kept rising. 52. 94. 178. 145. 375. Scan after scan showed no evidence of metastatic disease, until they finally did. One year, three CT scans, three bone scans, and a positron emission tomography CT later, she was found to have bilateral pleural effusions, liver metastases, and omental caking. She had been on estrogen deprivation therapy with Zoladex which was not working, so it was decided to perform a laparoscopic oophorectomy. The oophorectomy converted to an open procedure due to adhesions, bilateral Krukenberg tumors, and extensive carcinomatosis. Mostly lab sheets remained after that, with platelet counts and international normalized ratio checks after she was placed on warfarin for a blood clot. The very last page was a list of information requested by the cancer center at which she was to start another round of chemotherapy to control her progressive disease. On it, she wrote a note to remind herself to have the office reach out to my physician aunt with questions. Even at this stage, she had hope chemotherapy would prolong her life. As painful as it was, I got my answers, which showed me just how powerful and therapeutic it can be to feel informed. I had harbored so much grief for so long because not understanding my mother's cancer made her feel that much farther away. Many would expect the relief but not the heartbreak from hearing my negative results. The truth is, good news is good but it is also new. It does not erase the pain, worry, and loss that may have preceded it, and it does not necessarily indicate a clear path forward. New information can anchor us, quench our anxieties, or it can be an unpleasant surprise. My experience has taught me that you cannot predict how news will land on the ears and hearts of someone else. This makes it so important to leave one's own expectations behind and to give patients the time and space that they need to process. As healthcare providers, we always want to be the bearers of good news, but we must remember that every patient has an undocumented history and any conversation can be a delicate one. As I write, my internal medicine residency training quickly approaches. I am still shaking down cancer's secrets but feeling closer to my mother than before. As a physician, I will meet patients and their families on some of the scariest days of their lives. I cannot take away all of their fear, but I can walk with them through all of the knowing and not knowing and make space for relief and grief alike. I hope I will always remember that my every day could be the longtime culmination of loss, worry, and anticipation for someone else. I am grateful for the good genes, good memories, and good purpose in life my mom gave me, and I will do my best to make her proud. Dr: Lidia Schapira: Welcome to JCOs Cancer Stories: The Art of Oncology, brought to you by ASCO podcasts, which offer a range of educational and scientific content and enriching insight into the world of cancer care. You can find all of the shows, including this one at podcast.asco.org. I'm your host, Lidia Schapira, Associate Editor for Art of Oncology and Professor of Medicine at Stanford. And with me today is Dr. Kaitlin Demarest resident at the University of Pennsylvania. We'll be discussing her Art of Oncology article, 'Good Genes'. Our guest has no disclosures. Kaitlin, welcome to our podcast. Dr. Kaitlin Demarest: Thank you so much for having me. Dr: Lidia Schapira: It is a pleasure. I just like to start the conversation by asking authors to tell us what they're currently reading or what they recently enjoyed and would recommend to a colleague, what could I find on your night table? Dr: Kaitlin Demarest: I recently finished a book called Middlesex. It's not a very recent book, but it's actually one of the books that I remember my mom reading when I was a kid, and I've wanted to read it since then. It's incredibly beautifully written and it has a medical thread through it as well, I would absolutely recommend it. Definitely one of my favorites. Dr: Lidia Schapira: I really enjoyed that book. It's one of my favorites, too. So, you're currently a medical resident, correct? At Penn? Dr: Kaitlin Demarest: Yes, this is my second week. Dr: Lidia Schapira: And how's it going? Dr: Kaitlin Demarest: It's been so great. I started in the outpatient setting. So it's been nice to step into that PCP role. Dr: Lidia Schapira: Fantastic! Well, maybe we can even interest you in pursuing a career in cancer medicine. Dr: Kaitlin Demarest: Absolutely. Dr: Lidia Schapira: But let's turn to your essay, 'Good Genes'. You share with us that your mom was diagnosed with breast cancer when you were 5, and that you lost your mom when you were 10. Tell us a little bit about what motivated you to write the essay and then send it to us at JCO. Dr: Kaitlin Demarest: Sure! It actually was when I was writing my personal statement for residency applications. My mom's experience with cancer is very much linked to why I want to be a doctor. And so, I think that's why it came up when I was writing that personal statement. I think I just had a lot to put down on paper after I'd gone through her medical records. And it was really therapeutic actually, to write it all down. And a friend encouraged me to send it in. Dr: Lidia Schapira: There's an interesting comment there and one that I want to unpack a little bit. Writing to process an important emotional experience is therapeutic, but then the decision to share it, and in this case, perhaps share it with your future colleagues and attendings in medicine, requires sort of an additional step. What made you want to share the story with a broader community of cancer clinicians? Dr: Kaitlin Demarest: I think I was really comforted by my genetic counselor who probably hasn't read something like this, but she just seemed to be so in tune with the range of responses that someone can have when they get genetic testing results. And I wasn't even expecting the reaction that I had and I thought that maybe it could be helpful both to people who undergo genetic testing, but also to any provider who's delivering those results. Dr: Lidia Schapira: So, let's talk a little bit about the theme of your essay, sharing important medical news, in this particular case, the results of a genetic test. Tell our listeners a little bit about what made you want to be tested? And then how did you receive the news of the genetic test? Dr: Kaitlin Demarest: I knew I was going to need to be tested for a while because my mom was so young when she was diagnosed. So, it was indicated for me. And I understand how it can be a daunting decision for a lot of people. But I hold fast to the notion that knowledge is power. I'm very grateful that I underwent the testing and it really set me up with a great plan to get screening done very regularly. It's sort of a setup for that process. It honestly has brought me a lot of resolve knowing that I'm doing what I need to do in order to best protect myself for the future. Dr: Lidia Schapira: I'm very happy to know that you feel this resolve and you feel good about it. But you write in the essay and share with us that initially, it was devastating to hear that you did not have an inherited susceptibility that we could name. My interpretation of that statement and I want you to react to that was that in a way it made your mother's cancer more mysterious, not knowing the cause, not knowing what the danger was made the threat of the potential genetic susceptibility more vague and diffuse. Tell us a little bit about what it was for you. Dr: Kaitlin Demarest: Exactly. When I found out that I didn't inherit susceptibility, it did make it seem a bit mysterious, both for my mom and for myself. She didn't have genetic testing done, which makes it a little bit more confusing as well. But I think I was really hoping for an answer to explain why she was diagnosed so young, although that would have been difficult news to receive as well knowing that I had inherited something that could lead to cancer. Dr: Lidia Schapira: I found your insights incredibly powerful about the idea that news is just news, and the lens through which somebody receives the news may be different from that of the person who's sharing the news. You make this reflection that you hope that as a physician, you will sort of listen to what's happening with your patients. Tell us a little bit about this idea that even good news that you had good genes wasn't necessarily experienced by you in the moment as good? Dr: Kaitlin Demarest: Definitely news is new and it takes time to process that, even if it's expected to be good. And like you said before, I feel like it is good news now, but when I originally heard that information, I really needed to process what that meant, for me, but also, it just made me realize that there was more processing of my mom's death that I needed to do. Every time we deliver news to a patient, we have no idea what brought them to that space and what is going to come up when they receive that information. Dr: Lidia Schapira: I admire the genetic counselors. Their training is specific to their discipline, but they're also trained in communication skills. I think that is so incredible because, as you say, they can't anticipate how the news is going to land. They have that moment, that sort of teachable moment, to help people begin to process what they've just heard. So, let's talk a little bit about the other piece of the essay, which is that you sought to connect to your mother or you needed to understand the details of your mom's history. And so, you found her records when you were in medical school and sort of able to read through them. I have this image of you locking yourself up in your room instead of listening to Fabulous Mrs. Maisel and even getting some snacks and just pouring your heart and soul into reading this. Can you tell us a little bit about that experience? Dr: Kaitlin Demarest: I think, I would have loved to have processed this a lot sooner, but I think going through the medical records in medical school was a good time to do it because I had a better understanding of what I was reading. It took me probably three nights. I don't think they were three consecutive nights because it was definitely heavy. It was really difficult to read how things progressed and to understand the weight of it all. And not only to read what was happening in her records but to think back and remember those times and being able to look back at those memories with new knowledge filled in a lot of gaps for me, but it was definitely difficult. I feel like I have more to say but I'm struggling to find the words. Dr: Lidia Schapira: Reading your essay, I have the impression that there were many adults who tried to help you as you were developing your own ideas about what had happened to your mom - your aunt, your uncle, your mom's oncologist who allowed you to shadow him in the clinic, which I found very endearing. Can you tell us a little bit about what was helpful, and which ones of these experiences actually were helpful to you? Dr: Kaitlin Demarest: I remember when I received the results, and I was very upset. I called my dad and my stepmom. I think it was my dad who told me that my aunt would probably have her medical records. She sent them right away. Just knowing that my aunt and uncle who are both physicians helped her so much through this process has been incredibly helpful and just very touching. They've been so helpful to me and inspiring to me as I move forward through my medical career. They are the ones who helped me set up a time to shadow my mom's oncologist. And he taught me a lot about breaking news to patients. It was really amazing to get to work with him because I could see how much he cared for his patients and knowing that he was one of the people caring for my mom felt really good. Everyone in my family has been so encouraging of me since I said I wanted to be a doctor when I was 8 years old and they've never made me feel pressured to pursue anything in particular, but they never made me second guess this purpose. Dr: Lidia Schapira: As oncologists, we often tell our patients who are not going to be able to see their kids grow up that their kids are going to be alright and I hope your mom had that feeling that you were going to be alright. Listening to you now I can only imagine how proud she would be of the doctor that you've become and planned to be. What message would you like the readers of your essay and listeners of this podcast to take away from the story? Dr: Kaitlin Demarest: I hope that readers will not shy away from daunting news, whether that means they're the ones hoping to pursue testing or screening, or whether they are providers who are nervous about these kinds of conversations because while they can be very uncomfortable and they can be emotional, they're so, so worth having because they can really protect the health of a lot of people and it's a really great opportunity to form a very trusting relationship that can have a really positive impact for the long term. Dr: Lidia Schapira: And it gives meaning to our work as well. Dr: Kaitlin Demarest: Of course. Dr: Lidia Schapira: It's one of the reasons that many of us get up and go to the clinic every day or every week. It's been lovely to hear your story, Kaitlin. You're a terrific writer. Your insights are very powerful. I thank you for sharing your story with us and I sincerely hope that you consider a career in medical oncology. Dr: Kaitlin Demarest: I'm very much considering it. Thank you so much for having me. Dr: Lidia Schapira: Until next time, thank you for listening to this JCOs Cancer Stories: The Art of Oncology podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple podcasts or wherever you listen. While you're there, Be sure to subscribe so you never miss an episode of JCOs Cancer Stories: The Art of Oncology podcast. This is just one of many of ASCO's podcasts, you can find all of the shows at podcast.asco.org.   The purpose of this podcast is to educate and inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.    

SCOTUScast
Sandoz, Inc. v. Amgen, Inc. Post-Decision SCOTUScast

SCOTUScast

Play Episode Listen Later Aug 11, 2017 14:52


The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated pathway for obtaining Food and Drug Administration (FDA) approval of a drug that is biosimilar to an already licensed biological product. Among other things, BPCIA provisions require applicants for approval of a new biosimilar to provide the manufacturer of the already licensed product with a notice of commercial marketing and certain information about the biosimilar. Failure to comply permits the manufacturer to pursue infringement litigation against the applicant on an accelerated basis. -- Amgen claims to hold patents on methods of manufacturing and using filgrastim--a biologic used to stimulate the production of white blood cells--and markets one such product, Neupogen. Sandoz sought FDA approval to market a biosimilar called Zarxio. When the FDA accepted Sandoz’s application for review, Sandoz notified Amgen that Sandoz intended to market Zarxio upon receipt of FDA approval. Sandoz also indicated that it would not share with Amgen the relevant application and manufacturing information as required by the BPCIA and invited Amgen immediately to sue for infringement. Amgen did so, and further asserted claims for “unlawful” conduct in violation of California’s unfair competition law. The basis for the latter claims was Sandoz’s alleged failure to comply with the BPCIA requirements that Sandoz (a) share the application and manufacturing information pertaining to Zarxio, and (b) provide a notice of commercial marketing prior to obtaining FDA licensure. Amgen sought injunctive relief in federal district court to enforce both requirements against Sandoz, which counterclaimed for declaratory judgments that Amgen’s patent was invalid and not infringed, and that Sandoz had not violated the BPCIA. -- While the litigation was pending, the FDA licensed Zarxio, and Sandoz provided Amgen with further notice of commercial marketing. The district court thereafter granted partial judgment in favor of Sandoz on its BPCIA counterclaims and dismissed Amgen’s unfair competition claims with prejudice. A divided U.S. Court of Appeals for the Federal Circuit affirmed in part, vacated in part, and remanded the case. The Federal Circuit held that Sandoz had not violated the BPCIA disclosure requirements and that Amgen could not pursue state law remedies to enforce the BPCIA. The court also held that an applicant may provide effective notice of commercial market only after FDA licensure and therefore enjoined Sandoz from marketing Zarxio until 180 days passed after Sandoz’s second notice. -- By a vote of 9-0, the Supreme Court unanimously vacated in part and reversed in part the judgment of the Federal Circuit and remanded the case. In an opinion by Justice Thomas, the Court held that the BPCIA’s requirement on sharing application and marketing information is not enforceable by an injunction under federal law, but that the Federal Circuit should determine on remand whether a state-law injunction is available. The Supreme Court further held that an applicant may provide the requisite notice of commercial marketing before obtaining FDA licensure; therefore Sandoz fully complied with this requirement through its initial notice, the Federal Circuit erred in enjoining Sandoz from marketing Zarxio on this basis, and Amgen’s state law unfair competition claim predicated on the view that the BPCIA forbids pre-licensure notice must fail. Justice Breyer issued a concurring opinion. -- And now, to discuss the case, we have Erika Lietzan, who is Associate Professor of Law at the University of Missouri School of Law.

Teleforum
Courthouse Steps: Amgen, Inc. v. Sandoz, Inc.

Teleforum

Play Episode Listen Later Apr 28, 2017 26:33


The Biologics Price Competition and Innovation Act of 2010 (42 U.S.C. § 262) created an abbreviated pathway for FDA approval of biological products determined to be “biosimilar” to a reference product. The Act outlines a patent resolution and information exchange scheme, with litigation safe harbors during this “patent dance.” -- Subsection (l)(2)(A) provides that not later than 20 days after the application is accepted for review, “…the subsection (k) applicant – shall provide to the reference product sponsor a copy of the application…and other information that describes the processes used to manufacture the biological product…” Subsection (l)(8)(A) provides “[t]he subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” -- In 2015, Sandoz filed a subsection (k) application based on Amgen’s filgrastim (Neupogen®), but refused to provide its (l)(2)(A) disclosure and claimed that pre-FDA approval notice satisfied (l)(8)(A). Amgen sued in federal court on state law claims of unfair competition and conversion, and patent infringement, and requested a preliminary injunction. The district court granted Sandoz’ motion for partial summary judgment, holding that (l)(2)(A) disclosure was optional and that Sandoz did not have to wait for FDA approval before providing (l)(8)(A) notice. -- In a fractured opinion, the Federal Circuit affirmed on the (l)(2)(A) issue, holding that subsection (l)(9)(C) provided a remedy for the reference product sponsor to bring an immediate declaratory judgment action if the subsection (k) applicant failed to provide its (l)(2)(A) information, showing that disclosure was optional. The court reversed on the (l)(8)(A) issue, holding that notice before the FDA approved the subsection (k) application was ineffective under the statute. The Court granted certiorari on both issues. -- This case presents intriguing questions of statutory interpretation, as the boundaries of the BCPIA are explored. -- Featuring: Mr. Andrew A. Hufford, Intellectual Property Attorney, Brinks Gilson & Lione.

FirstWord Pharmaceutical News
FirstWord Pharmaceutical News for Thursday, Sep 3, 2015

FirstWord Pharmaceutical News

Play Episode Listen Later Sep 3, 2015 1:42


FirstWord Pharmaceutical News
FirstWord Pharmaceutical News for Tuesday, July 21, 2015

FirstWord Pharmaceutical News

Play Episode Listen Later Jul 21, 2015 2:08


Today in FirstWord:

FirstWord Pharmaceutical News
FirstWord Pharmaceutical News for Thursday, January 8, 2015

FirstWord Pharmaceutical News

Play Episode Listen Later Jan 8, 2015 1:43


Today in FirstWord: