Biotech Ditches Life-Saving Drugs for Cosmetics w/ Dr. Shoshana Shendelman

♪ ♪ >>Welcome to American medicine today. I'm Kimberly Bonati. We have a jam packed show. Let's get straight to it. Biotech companies are starting to focus less on discovering major medical cures and more on creating cosmetic products. Why? Because cosmetic products are faster, cheaper and less risky to bring to market. Joining us to discuss is Dr. Shoshana gentlemen, scientist and entrepreneur of numerous biotech companies. Thank you for joining us. >>Thanks for having me. >>Now, can you tell us, first off, why biotech is focusing more on cosmetics than actual medical cures? >>Yeah, I think it has a lot to do with the risk benefit analysis in different spaces right now. And since the first GLP ones were approved several years ago for weight loss, it's become clear that that's a major revenue driver. People are willing to pay for that. And there's a clear regulatory path forward with the FDA, which is responsible for approving any drugs in our country. And so those two things together, it's it's not very risky because you know what to do to get the drug approved. You just follow the roadmap from the last ones that were approved and you can be guaranteed that people will use those drugs and will pay for them. Whereas if we shift to diseases that have no current treatments, it's very risky to develop drugs right now for those diseases because the FDA is a very unpredictable place. And if nothing has yet been approved for a particular disease, you don't have a roadmap to look at. There's a lot of variability. Then when it takes hundreds of millions of dollars, sometimes billions of dollars to bring a drug through the development process, that risk benefit analysis is really important. >>Do you think any of that also has to do with the fact that the government now is holding these companies liable for any damages to patients that receive their treatment? >>I think that's definitely a piece of the equation. That's also factoring in. And I think what you just raised does underscore some of the unpredictability right now that we're facing with development and then, of course, marketing of drugs for for diseases. >>Yeah, well, you know, the obesity market is really, you know, kind of a prime example of that. Can you explain what these Triple G are? They agonist. Triple G agonists are? >>Yes. Yeah, that's correct. So, you know, with GLP one's, which were the first class of drugs to come through, they just hit one of the GS and you know, the next wave of drugs, the next generation hit GLP one but also glucagon and another target. So they're, you know, at least from what we've seen in clinical studies, they deliver more on a greater weight loss than the GLP ones, which was pretty large to begin with. And the market is very clear. We know who will use them, we know who will pay for them. And there's a lot of profit there for pharmaceutical companies. >>Do you think profit is also why the shift is headed more cosmetic? >>I think it's a big part of it because you have to remember biotech and pharmaceutical companies are businesses. It's less than 10% of drugs that are developed even make it through phase three, let alone past the approval process, which is even lower. And with each of those drugs costing hundreds of millions or billions of dollars to develop, you know, the drugs that actually get approved and marketed and are sold to people have to pay not only for their own development, but for all of those drugs in the pipeline that never made it through. >>And so it does cost a lot to develop drugs. I think that there are a lot of things we can do, though, as a country to cut that down so that it costs less to develop. And then maybe companies are willing to take a little bit more risk, but we can also lower the price of drugs in the process. >>I was just going to ask you how we can combat that trend and really incentivize them to start curing disease. So can you elaborate just a little bit more? Absolutely. I think one of the things that's been most concerning in the past year on the biotech side is the lack of visibility and really variability that we're seeing at FDA. John Crowley in Bio put out a statement on this last week that we're really at a tipping point as an industry and we need more consistentcy and less risk on the FDA side. >>Many people don't know this, but right now the way this works at FDA is that they can change their mind throughout the development process. So they could tell you at the start, we want you to do A, B, C, and you do those things and then you come in and they say, We changed our mind. Now we want you to do D. So right now, the way that FDA works, when you go in and meet with them and ask questions, they give what's called non binding advice, which means they don't have to stick through it. So I think that if we kept FDA accountable, if their guidance and their recommendations were binding, I think that would take a lot of the risk out of the equation and people wouldn't be as nervous about politics affecting the FDA. >>Is there any money exchanging hands between the people that are researching and developing these pharmaceuticals and the FDA? Is there money to be made maybe in administrative fees? I think that's why they don't stick to what they say. So they say, oh, you'll need to refile that. Oh, make sure you send your updated check. Yeah. Along with that. >>It's a very good point. Companies do pay what's called user fees to the FDA and you pay them all along the way through development. And then, of course, when you're submitting your your drug for approval. So that is true. It's not a huge amount of money, but it there's nothing there to incentivize them to to sort of be there with the company and care what happens. It's easy enough for, you know, government agencies, bureaucracy to just keep sending you back and forth. They don't feel the pain of that. But if there was a consequence for that or, you know, if the government had to field part of the development cost hundreds of millions of dollars, they might not be so wasteful about it. >>Summarize a little bit more about your work. >>So I founded a few different biotech companies along the way, mostly focusing on rare and underserved diseases. My current company is called Cyan Therapeutics. We're developing cancer treatments and our lead drug is for treatment of solid tumors, things like breast cancer, lung cancer, colon cancer, pancreatic cancer. And that's a place where even though there are a lot of drugs available, there's still a lot of need from patients. There are still, unfortunately, people dying from these diseases. So it's very meaningful to me. >>You are on the path to help many. Thank you so much, Dr. Shoshana Gentleman, scientist and entrepreneur of numerous biotech companies. Thank you for sharing your insight here on American medicine today. >>Thanks for having me. >>Well, that's all the time we have for this segment. Make sure you stay tuned. We'll have more after the break. You were watching American Medicine today. Revolutionary in his field, Dr. Bonati created, perfected and patented the Bonati spine procedures using his genius. Bonati invented the precise tools necessary to minimize surgery, scarring, anesthesia and recovery. So successful are the Bonati spine procedures. They consistently reflect 98.75% patient satisfaction, 80,000 procedures have been performed exclusively at our location. Nearly half our patients have suffered from failed back and surgeries at other facilities. Bonati succeeds where others fail. >>I got my life back because of Dr. Bonati and it's the truth. And I didn't think I was going to. >>Bonnie is happily on her road to recovery now, but to understand how she's feeling, you need to hear how the pain affected her life. >>We were on the beach with our friends and she was sitting like back here and I was talking to her all day and had my head turn. And then I said, That nice guy, my neck hurts, You know, it's just achy. I kept complaining about it. I thought that's what was happening, you know, and it wasn't really nothing big. And then I went out paddle boarding. I went on on Monday. Everything was fine. Did it again on Friday. And I'm like, God, I can't keep up with you girls. What's going on? And what I had done or forgot to do was put my fin, the dorsal fin on my paddle board. And that's daring. That's everything. And so I was pulling, twisting and pulling, you know, just to go for about an hour and a half to get through the mangroves and get back to shore the next morning. My I mean, I went for my walk, which I've done for 15 years, walked three miles every day, pretty much nonstop. And halfway through, I'm like, oh, my God, I'm having a heart attack. I just felt this pain go down my arm. I mean, and it was bad and kept getting worse. So I just was walking with my arm up like this, thinking, Oh, God, I'm having a heart attack. I ended up going to a chiropractor first because I figured out it wasn't a heart attack. >>Bonnie first tried conservative treatments to relieve her pain, but soon realized they weren't going to be the solution. >>And he tried for days to adjust me and do all that and everything. Work day goes. You need I can't help you. You need to go see a orthopedic. And they're like, Yeah, you know, they did. You're going to need an MRI, blah, blah, blah. So I did that and they said, Well, we see a little bit of stenosis and this and that. We're going to make you go to physical therapy. He was just kind of like kind of blew me off a little bit. I was a little disappointed, you know, he says, I just go and get physical therapy. You know, it's just it's not a big deal, really. And it's like, really I'm sitting here dying here. So I got tortured for six weeks of physical therapy. >>Bonnie then learned about the Bonati Spine Institute from a friend. >>And he was telling me, Dr. Bonati, because I had the same exact symptoms as you, and he fixed me with one surgery and I was playing golf a month later, filled out the paperwork online. They immediately called me back and to get a phone call from a doctor on a I think it was a Friday. He called me and talked to me probably for a good 40, 45 minutes, explaining everything. He just sees it in a different way, I think, than a regular orthopedic. >>The exclusive Bonati spine procedures are performed incrementally using conscious I.V. sedation that keeps the patient comfortable while also awake. This technique allowed Bonnie to communicate with Dr. Bonati and to tell him the instant her pain was eliminated right there on the operating table. >>Now what we end up in them. All right? The pain that you had, the here and here. There's nothing on here yet. Okay, Put it back. >>No, I was scared to do this, of course, because, you know, it's your spine. The last thing I wanted to do was have surgery. My husband was in there and wanted him to be in there. And I said, I love you. He said, I love you back. I remember that his to get it on the table the first day was a struggle because it was all in here and in my back because it was like someone was stabbing me. I had two pinched nerves he got he got loose yesterday. Freedom, you know. And I felt it on the table when he did that because the nerves came back to life. So when it happened, it was like electricity went through my hand. >>No pain. >>All right. >>Bonnie, like many patients at the Bonati Spine Institute, was surprised by how quickly she felt relief from her debilitating pain. >>How are you? >>You know, you got my arm back here. >>You get your own back. >>I just I felt better. You know, I know it was fixed. I could tell my arm wouldn't hurt anyone burning anymore. I can walk. And that's all I wanted to do because that's my therapy set is walking in knee high. You win because, you know, if I can walk, I'm happy. >>Bonnie highly recommends the Bonati Spine Institute to anyone suffering with neck or back pain. >>I'm glad I found this happened. I think it was meant to be. My husband would be happy. He didn't have to grocery shop any more. >>To see more stories of recovery. Just like this. Search for the Bonati Spine Institute on YouTube. 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