Episode 126: The FDA's chaotic week, Trump's effect on science, and Musk's big reveal

Automatic TRANSCRIPT

Welcome to this week's episode of the read out. Loud but weekly biotech podcast from stat I'm Damian Gardai social distancing from the borough of Queens. I'm an importer scene still isolating in Cambridge Massachusetts and Rebecca Robbins off today. It's Thursday August twenty seven, and here's what we're going to talk about this week I it has been a chaotic week at the FDA between accusatory. Trump tweet and a controversial press conference. We'll break down what happened next. Our colleague left faster joins us to discuss trump's war on the FDA and what it means for the agency's future, and finally this podcast has long missed Elon Musk angle. We are fixing that this week with an in depth look inside Musk's brain science tech startup first a word from our sponsor. RNA Therapeutics treat the root cause of disease rather than the symptoms by silencing the expression of the genes that make disease causing proteins. L. Nylon has pioneered RNA Therapeutics by translating the Nobel Prize winning discovery of RN. into an innovative new class of medicines, which we believe has limitless possibilities learn more del nylon com slash stat news. That's ail ny L. A., M., dot com forward slash stat news. Damian it's been a tumultuous week at the FDA and like so many DC dramas these days it started with trump tweet. That's right. So on Saturday morning, a lot of us woke up to see that the president had accused the Food and Drug Administration of delaying the development of Crow Virus Vaccines and drugs for political reasons I won't do an impression of the president at the tweet read the deep state or whoever over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Are. Hoping. To delay the answer until after November third must focus on speed and saving lives exclamation point. Yeah you know. So I was so looking forward to. Sing weekend away from work. But of course, this tweet drops like a bomb on Saturday morning. So a bunch of us. It's dad had to scurry and get a story about it get reaction from the industry. Now obviously, there's no evidence to support trump's nation and the industry people that we spoke to you over the weekend were quick to condemn trump's tweet and you. Know, and they also raised a lot of concerns about the FDA's independence. You know it's really important that decisions that are made at the FDA regarding covid nineteen treatments. You know whether those be drugs or vaccines are based on science and the data and not about politics and I think actually that reaction just sticking to Saturday alone before things escalated is kind of interesting in illustrates. How the FDA has a different relationship with the industry, it regulates I think a lot of other regulators in the united. States when you talk to people at biotech companies and specifically biotech investors, they rely on what they would call a strong FDA because that establishes a gold standard by which they can base their business their investments etcetera the idea of a super lenient cutting the red tape food and drug. Administration. Is Not really something desired by by at least most of the. People that we talked to who actually regulated by the FDA I think that might be different for you know I. I don't cover for example, the beef industry but I assume they have their gripes with the USDA but at least in drug world, there's there's kind of idiosyncratic relationship and of course. Damian. This all comes at a time when drug makers are rushing to develop covid nineteen vaccines, right so this would be alarming I think to people just in general, but it's it's ratchet up. The pressure in that, there is at least in my lifetime really never been more attention paid to the drug development process and the FDA's role in it. So as this is all swirling around in that tweet that we mentioned Donald Trump tagged Steven Hahn, the head of the FDA who is at Steve FDA on twitter and that kind of I think shine the light on on what's going on in and around there the FDA has insisted that it will uphold the agency standards for. Vaccines and drug approvals for Covid nineteen, and I think notably earlier this week Peter Marks, who is the vaccine regulator told Reuters that he would resign if he were asked to approve a vaccine that hadn't demonstrated the safety and efficacy that would normally be required, and so that was our crazy Saturday and I don't know about you Damian but you know try to go to bed at a reasonable hour. But of course, at about eleven twenty, two PM on Saturday night trump's press secretary. Puts out another tweet in which she teased a news conference that was going to be held on Sunday evening at which trump would announce a quote major therapeutic breakthrough on the the China virus and joining trump at that announcement would be h secretary Alex as our and FDA Commissioner Steven Hahn Right. So that led all of this to bleed into Sunday, and when eventually that press conference came about the announcement was related to convalescent plasma, which is blood plasma, take it from people. Who have recovered from covid nineteen that would then be infused into people who are sick with the disease with the hope of treating them and more accurately with the hope of them not dying. So the announcement which was supposed to be a breakthrough is not exactly a breakthrough. It was the announcement that there would be an emergency use authorization for plasma, which you know we we can get into this later may not really change much about the availability of that treatment, but there's a prologue. To this, which is that a lot of big name scientists at Nih and elsewhere had expressed concern that there might not be enough evidence supporting convalescent plasma to justify an emergency use authorization. Yeah. Your trump touted the benefit of plasma Then we heard that the NIH had opposed this emergency use authorization, and now here we have the FDA announcing the very same thing and raising questions whether or not the FDA, the agency had bowed to trump's pressure. So there's the debate over whether this. Authorization was justified by the data You know reasonable parties can disagree where things got problematic. However was how the White House but especially how Steven Hahn characterized the benefit we've seen from this in a large clinical trial that that we report on a couple of weeks ago. Here's what Hans said at the podium on Sunday thirty five percents. Improvement in survival is a pretty substantial clinical benefit. What that means is if the data continue to pan out one hundred people who are sick. With covid nineteen, thirty five would have been saved because of the administration of Plasma Yeah and I think that just sort of ratcheted this whole thing up to like eleven because what Han said there at the White, house on Sunday evening was just plain wrong. I don't WanNa get deep into the weeds here but the actual benefit of lesson plasma is far less perhaps may be three or or five people out of one hundred would have been saved by this kind of treatment based on the data that they. Actually. You know made the decision on you know and as I said on twitter over the weekend and Kinda reiterated in a column that a colleague Matt Harper, and I wrote You know I've spent twenty years as a journalist listening to writing about biotech CEOS who oftentimes make nonsensical inflated claims about the benefit of their drugs and it was really weird disconcerting to hear the FDA commissioner do the exact same thing like you said, Damian haunt could've made a case for granting Andy Way to plasma you know without. The data you know. So it just kind of ratcheted this whole thing up higher, right. So in the days that followed Stephen went on what I guess is not an apology tour, but but he he walked back that statement he acknowledged that he should have been more nuanced in his description of the data and he eventually got around to disputing this notion that his employees are part of deep state operation to sink President Trump which I'm sure they appreciate it however late might be but to a lot of people who were paying attention externally, it was very much too little too late I mean it's it's if you do your misstatement on live possibly. Global. Television. As the world is awaiting a treatment for this horrible disease, and then you do your walk back of in a series of interviews with wire services and other media. You know the first thing is probably gonNA speak the loudest and resonate the most with with people who are paying attention. So the big picture implications to all this is whether trump's assault on the FDA and Hans Response to date will do lasting damage to the agencies all important reputation with the American public our stat colleague left Faster Ross story this week on that very topic and he joins us now to talk about it. Love welcome back to the podcast. Thank you guys what a week. So, there's long been this trope that the FDA is an organization that exists sort of outside of American politics and I think we know that's never been one hundred percent true. But what makes the trump White House's relationship to the agency different from administrations past? Yeah. The FDA, it's not an independent agency and it's not technically in a political agency. It's run by a political appointee other top officials within the agency are political appointees but there is a longstanding culture at the FDA of trying to make decisions in advance policies based on science and based on data and I think what's most different? About trump administration's approach to the FDA is really this overt belief on the part of president trump and many of his senior as that. The FDA essentially serves them their hopes and desires on things as specific as emergency use authorizations for specific drugs that those things should take place at the direct whims of the administration in some cases regardless of whether there's data to support those decisions. So we've seen this over the course of the past several months with the emergency use authorization for hydroxy chloroquine. We saw it in the rollout of the BLOOD PLASMA UA we've even seen it with a couple of. Top trump aides pushing for FDA to sanction the use of Leandra, which is a totally unproven plant extract as Cova Cure, and all of these things have been cast as breakthrough. So this isn't the first time at the broader attitude and the broader tone with which the trump administration speaks about. The FDA is just a completely different animal and it has longtime agency insiders who are currently there who used to work there scientists on the outside, a lot of people in Bio Pharma just very, very alarmed. So love furthering this point your reporting suggests that FDA staff, we're kind of already alarmed by some. Of the recent appointments at the agency, tell us about these new people who are working at the FDA so I want to highlight to recent hires. The most prominent is that of Emily Miller as the assistant commissioner for Media Affairs. So essentially, the FDA's top spokeswoman, she's filling a role that is traditionally non-political traditionally filled by a non-political civil servant, but she's a political appointee, which is itself odd. What's more odd she is a former reporter for one America News Network. If you're not familiar, it's a far right cable channel openly allied with. President. Trump that frankly very frequently espouses complete conspiracy theories. She has long track record as a Republican operative and is a conservative media personality. She's written a couple things that I think have really alarmed folks at the FDA, who of course want their spokeswoman to have roots in medicine and science or just at least in. Presenting government data in good faith So some of her works include a book called Emily gets her gun Bama wants to take yours. It's about gun rights and her struggles to buy a firearm in DC. She's written a couple of Washington Times columns here are the headlines Apart in the language in one of them Maryland's bathroom bill benefits. Few transgenders puts all girls at risk from pedophile 's I should actually say pardon the language in both because the second is new obamacare ads make young women look like sluts so This is a very unorthodox appointment at FDA to say the least and it has people at the agency concerned about how the data that they're agency analyzes and presents uses to make decisions is being spun essentially to the general public. We saw that, of course on Sunday with Stephen Hans dubious claims about the blood plasma mortality reductions and Emily Miller, subsequent defense of him one other higher I'd like to highlight is that of David Gort gorter. Who has worked at FDA previously, but is coming off a stint at the heartland institute, which is a conservative think-tank. He's written that The FDA essentially is in need of a mass firing and it's funny because he's worked at the agency since I believe June but the heartland institute only trumpeted his appointment there in the wake of all this controversy and in a press release, you know how? Great Gertler is how great it is that he works at Fda they called the agencies sclerotic and they. said that the FDA essentially has come to serve as a barrier to Americans accessing the most up-to-date biotechnology. So there are folks coming into the agency who clearly have some extremely controversial views, many of which are just out of step with how a lot of the career scientists at FDA view their role and their job, and it's really shaken people up. Because as I say, you know is very, very atypical. So at the center of all, this is the aforementioned FDA, Commissioner Steven Hahn, who has been on the job for for less than a year, you and are calling Nicholas Forego wrote a story about his approach to leadership at the agency. How is he different from his predecessors I? Think the two big differences are one. He is not a political person. He is not someone who has kind of come up through the system, of DC, and worked at various federal agencies and worked in government even at all. Before at any level, he's a career cancer doctor and beyond that beyond his status. As a political outsider without these kind of deep deep roots routes in connections, he does not have a lot of experience around him. The senior leadership at FDA for the most part is very green. There has been a lot of major departures since for Commissioner Scott Gottlieb left in early twenty nineteen. So there's a view of Han within the agency that I think people view him as a good guy as a qualified scientists, but they also just don't see him as having the capability forcefully push back. Against these attacks from President Trump, and as we saw on Sunday, he's even been willing to play into them directly in kind of further the political messaging of the trump administration and you know the trump administration's effort to essentially. Use the FDA as a as a campaign tool just a couple of months out from the president's reelection. So all the stuff is foreground to something that really scares the public health world you know, and that's the possibility that trump will compel the FDA to approve a covid nineteen vaccine that is either unsafe ineffective or both now have you spoken to lots of people in and? Around the FDA, how realistic do they think that possibility is people at FDA view it as a distinct possibility that there would be an emergency use authorization for code vaccine before the election and the FDA's even convening a vaccine advisory. Committee on October twenty second about two weeks before the election. That's GonNa look at some data that's going to discuss many of the underdevelopment vaccines. I don't know that. Anyone will view a recommendation they issue as as finding there's no guarantee that anything will come of that meeting. And it's also an open question even if there is an easy way before election day whether that will be a causal link or whether there will just be a decision made that the data is there at won't be You know as a result of interference from president trump at of course, it's a it's a very, very deep fear and president trump has repeatedly hinted at a forthcoming vaccine approval. And it's also worth noting I think that a lot of people closest to trump mark meadows, his chief of Staff Peter Navarro, one of his top trade advisors they've just taken these openly antagonistic and very public anti FDA stances where they support the president's deep state rhetoric than they talk about things not wanting to get bogged down in bureaucracy. So you know there is an overt push on the part of. The trump administration to make the if FDA move faster on all fronts. There's a degree to which I think people see that as appropriate were on a pandemic one, hundred, seventy, five, thousand, or so Americans have died. But yeah, the the fear of a politicized vaccine approval has only I think grown stronger as a result of the last two weeks of total FDA chaos lead. Thanks for joining us. Thanks for having me. Is a neuro science technology company founded by Elon Musk that is attempting to fuse human brains with computers. It's also a company grappling with chaotic internal culture where a rush to meet some ambitious project timelines has conflicted with the sluggish pace of science earlier this week stats Aaron Rodwin Rebecca Robbins published the story that offers the first revealing look inside the pretty secretive work going on at neural link Aaron Join Today to talk about it Aaron Welcome back to the PODCAST. Thanks for having me. So most people know that Elon Musk has made his career building, electric cars and rockets, but perhaps fewer no neural link can you explain to us what the brain machine interfaces are designed to do? So. There is a whole history of brain machine interfaces largely used to help people with spinal cord injuries and policies and other forms of brain injury walk and regain some mobility. For example, There are certain things that help them operate you know mechanical prosthesis. So you can be able to pick up a Coffee Cup by thinking about picking up a Coffee Cup with your mind an Elon Musk with neural link is also trying to create a brain machine interface that would help. People with prowse same type of injuries but Elon Musk has ambitions that are much farther ranging than just helping people with disabilities and injuries to regain mobility and I imagine we'll get into some of those shortly. So in the course of your reporting spoke to former neural employee's and some independent experts. So what did they tell you about the company? So I was not entirely surprised to learn that never links company culture sounds a lot like the company culture out a lot of Elon. Musk's other startups which includes spacex and Tesla where there's a rush and a real sense that you know engineering will kind of solve everything that if the you have a project that is starting to become really really difficult that you abandon it and start a new project and basically it's just you know throw a lot of things at the wall see what sticks and like let's get this done and while that's worked really well for SPACEX and for Tesla it's a little. Less clear whether or not that will work in the case of a company that target is the human brain. So just over a year ago in July twenty, nineteen yuan organized the flashy invented San. Francisco where he said that human testing of new links brain machine interface in people with paralysis would start at the end of twenty twenty is the company on track to meet that goal. Yeah. That's a really great question. So one of the things that I was saying at the beginning. I'm sure we'll get into some of the other ambitions that Elon Musk has an and some of those ambitions include things like I. Think he's tweeted about perhaps on Friday revealing the quote Unquote Matrix in the Matrix, which is a cool Sifi reference for all the signers nerds out there. But basically saying that he's going to use this technology to reveal the nature. Of, Our Reality Aka, the red pill to end all red pills and it's a little less clear whether that is actually going to happen on Friday or not. It appears at least from the interviews that I conducted that that they are not quite on track to do that because they are not on track to test their product in humans yet and in order to. Deliver the Red end-all, red pills I think that you would probably have to migrate from testing your early devices in rats, which I believe they've done to primates which I also believe that they've done into humans but from the interviews that I conducted, they are nowhere near ready to start. Testing in humans, of course, the interviews that we conducted our with employees. So who knows perhaps they've. Progressed by leaps and bounds and some of the employees were at the company I think the jury is is pretty out on exactly what's going to happen on Friday but from what I could dig up testing in humans is not something that's on track for Friday. So Erin beyond a red pilling people what are neuro links other concrete ambitions Yay. So the first one that we talked about is helping people with paralysis and other forms of brain injury to regain some mobility and the idea would be putting a device inside the brain that. is able to allow people to control computers, prostheses, and other forms of assistance with their thoughts. So Aaron as you mentioned before, this is all kind of in the foreground of a big announcement expected Friday, August twenty eighth, and we're recording this the Thursday before. So we don't know what neuro link is going to reveal to the world about its research, and as you mentioned before, you know it's kind of anyone's guess what neuro link is going to announce but you know having spoken to independent scientists working in the same field who were watching. From. Afar what's their impression of the company and what do they think is coming on Friday. Yes. The majority of experts that we talked to I'd say they're kind of split into two camps. There are the experts who are brain machine interface experts who've been studying and looking at things like brain gate as I mentioned at the beginning for years and years, and those kinds of technologies like brain gate have out for decades. So their impression of link and what is going to present on Friday they come to this with a lot of skepticism understandably. So because they're like, okay, you know you're working on something that we've been working on for decades and then the other camp of. Experts that I talked to people who say, for example, you know what norling is doing is amazing. They are working on something super super hard, and there for the first time perhaps bringing all of this hard academic work to a semi public stage where lay people can potentially learn about it That said the majority of people that we spoke to think that what Elon Musk and erling might present on Friday is probably going to be focused around showing some of the research that he's done in primates and showing for example, that the technology that he constructed can be used, which includes this pretty fancy cool. Robot called a sewing machine robot which implants the electrodes into people's brains at once. They think he's going to basically unveil a demonstration of the electrodes recording brain activity and potentially seeing primate, for example, control video screen with brain using neural links technology. So I'm sure you'll be watching elands presentation and maybe he'll be popping that red pill. Thanks for joining us. Yeah. Thanks for having me. I am looking forward to it. That does it for another episode of the read out. Loud. Thank you to heison tip another and crystal milner who produced this week's episode. Alex Hogan. Is Our senior producer and Rick Burke is our executive producer and we love to hear from you tell us about what you like about this week's episode what you didn't like and whether or not Damian should get a brain machine implant. You can do all that by sending us an email at read out loud at Stat News Dot Com. We really appreciate the feedback, and if you like what we do, leave a review or rating on Apple podcasts or whichever platform you used to get your podcasts. See you next week.

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