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Regulation

Politics & plasma: a BioCentury podcast

Aug 25, 2020 | 1:30 AM GMT

Ex-FDA officials are mixed on the merits of an agency decision to grant an EUA for COVID-19 convalescent plasma, but there is widespread agreement that the process was marred by political posturing, including statements by President Donald Trump and top HHS officials exaggerating the strength of the supporting evidence. On the latest edition of the BioCentury This Week podcast, BioCentury’s editors discuss the ramifications of the decision to grant the Emergency Use Authorization, as well as PhRMA’s drug pricing proposal and Merck’s selection of London for its newest discovery hub.

Washington Editor Steve Usdin, Editor in Chief Simone Fishburn and Executive Editor Jeff Cranmer discuss the takeaways from BioCentury’s conversations with former senior FDA officials, many of whom say that FDA Commissioner Stephen Hahn’s decisions and comments have put politics ahead of science. Usdin says that Trump’s accusations that FDA has delayed COVID-19 regulatory decisions to harm his election chances has created a stain on the agency that could be difficult to erase (see “Ex-FDA Officials: EUA May Be Merited, But FDA Put Politics Ahead of Science”).

Usdin also provides details on PhRMA’s proposed package of drug cost control measures that are intended as an alternative to the Trump administration’s “most favored nation” Executive Order. Negotiated with White House Chief of Staff Mark Meadows, the plan would create $135-$150 billion in savings over 10 years (see “Proposal to Fend Off ‘Most Favored Nation’).

Fishburn says a decision by Merck & Co. Inc. (NYSE:MRK) to build its new Discovery Research Centre in London underscores the U.K.’s growing importance as a global hub for life sciences innovation even in the face of Brexit (see “Merck’s North London Pick”).

A transcript of the episode follows.

[00:00:00] Jeff Cranmer: The biopharma Twitterati nearly broke Twitter last night in the wake of FDA's announcement that it had granted an EUA for COVID-19 convalescent plasma...

[00:00:11] President Trump: "Well, I think that there might've been a holdup, but we broke the log jam over the last week. To be honest, I think that there were people, in the FDA and actually in your larger department that can see things being held up and wouldn't mind so much. It's my opinion. Very strong opinion. And that's for political reasons."

[00:00:30] Jeff Cranmer: That was President Trump speaking yesterday at a press conference to announce the authorization of convalescent plasma for COVID-19. Welcome to BioCentury This Week, I'm Jeff Cranmer, Executive Editor and I'm joined by my colleagues...

[00:00:46] Simone Fishburn: Simone Fishburn, Editor in Chief

[00:00:49] Steve Usdin: and Steve Usdin, Washington Editor.

[00:00:50] Jeff Cranmer: Welcome back, Steve, it's good to have you after a few weeks away and you didn't miss anything. Tell us what's going on in Washington, Steve.

[00:00:59] Steve Usdin: As you heard from President Trump, there's a tremendous amount of attention to the emergency use authorization that FDA granted to COVID-19 convalescent plasma. And a lot of the attention is focused, not so much on the authorization, but on all of the politics that accompanied the decision.

[00:01:22] Part of that involved President Trump accusing FDA officials and officials at the Department of Health and Human Services of putting their political beliefs ahead of their mission for protecting public safety and public health. Some of the people who I spoke with, former FDA officials, were outraged at that. And I've actually also heard off the record from serving FDA officials, who are also outraged at the accusation that they're delaying COVID-19 therapies for political reasons... when in fact the entire federal government and industry is moving at an unprecedented speed to advance therapies and vaccines for COVID-19.

[00:02:05] I also heard an interesting account, a backstory of Trump's Tweets accusing FDA officials of being part of a "deep state conspiracy" against him and it really revolves around kind of confusion in the White House and apparently, in President Trump's mind, between the responsibilities of the FDA and the NIH. And the differences between vaccines and monoclonal antibodies.

[00:02:37] So the story that I heard from several people who have been in touch with the White House on this is that President Trump was outraged by Francis Collins intervention last week to hold up the EUA for convalescent plasma. And somehow his anger about that got redirected to Steven Hahn and the FDA and that's what led him to tweet about the "deep state" and to urge Steven Hahn to move faster on the EUA.

[00:03:09] Simone Fishburn: So one of the things that I think is really frustrating, among scientists in the industry and in public health agencies is this clouding of politics -- and let's be very clear -- it's not just the US, it actually harks back to what we talked about with Russia last week. So industry is working really around the clock to come up with therapies and preventive vaccines and they're trying to do this in a way that is rigorous, is robust, is science driven and produces answers that may beat the general timelines, but certainly do not compromise the standards that the industry has held to. And so having pressure to create authorizations, or last week it was approve a vaccine, when there are things clouding the data, is very frustrating. It's absolutely no statement on whether those therapies themselves work. They may work, but they just haven't been properly tested and the evidence really isn't that robust.

[00:04:12] Steve Usdin: That's the point. The thing with convalescent plasma is that something like 90,000 Americans have taken this therapy, but there still hasn't been a properly conducted randomized controlled trial to determine if it's safe and effective and if it is how effective it is and in which patients. And that's really an indictment, I think, of the FDA, of NIH and of HHS more broadly that they promoted the use of convalescent plasma in expanded access settings, without conducting proper randomized control trials to determine whether it works or not.

[00:04:47] Simone Fishburn: And we've heard this from the beginning and this is the frustration that we're hearing, in that people have to spend their time worrying about the hype of whether it's hydroxychloroquine, we weren't going to get away without a mention of that, whether it's convalescent plasma, whether it's the Russian vaccine, maybe, some of them will work in some of them won't, but having to fend off these sort of exuberant and politics-driven, intrusions is really a distraction.

[00:05:15] And the real cost of that distraction is that if they don't work, then you lose the public's confidence in this now and into the future.

[00:05:27] Steve Usdin: It's not only that... look, if the public believes that convalescent plasma really works and based on the press conference last night, I'm sure that a lot of people do. The president, the Secretary of HHS and the FDA Commissioner all said that there's a 35% reduction in mortality in patients who take convalescent plasma.

[00:05:50] Simone Fishburn: To be clear, that is incorrect.

[00:05:52] Steve Usdin: Of course it's incorrect and there are a lot of reasons why it's incorrect, we could go into them... we've written a story about that, people can look at it on our website, but the point is if you believe that, then why would you agree to be enrolled in a placebo control trial or trial where you might get another active agent that hasn't been proved.

[00:06:10] So they're really compromising the ability to test agents which may end up being far more effective than convalescent plasma.

[00:06:23] Simone Fishburn: And just one postscript to that, there are also other products or uses of convalescent plasma where you fractionate them down, you get what's called a hyperimmune globulin fraction -- which many pharma and biopharma players feel scientifically is a more robust and likely chance. And so if there's only so much plasma, if the plasma is being used one way, it's not being used in other. And so it actually complicates other kinds of therapies. So I think there's really a lot of mess here.

[00:06:55] Jeff Cranmer: Yeah.

[00:06:55] Steve Usdin: I want to emphasize something that you alluded to also, this perception that FDA is acting based on political pressure, rather than on its independent evaluation of the scientific merits of the EUA application, really underpins the foundation of all biomedicine. Because in the past there've been plenty of instances when people disagree with decisions FDA has made, that happens all the time... but those are disagreements about the science. Here we have a situation where people believe that the disagreement is about the politics and once you've created that perception, it's a stain and it's a stain that's going to be very difficult to rub out. In the future when people disagree with FDA's decisions on controversial decisions, for example, around women's reproductive health or around, drugs for rare diseases where there's very thin evidence that they have to make decisions on... this is going to come back to haunt them. It's going to come back to haunt FDA, it's going to come back to haunt the American people, because there will be accusations that those decisions have been made based on politics.

[00:08:08] Jeff Cranmer: Yes, Steve when I was editing your piece last night, there was one quote that just stopped me in my tracks and it was from Luciana Borio, who was the former acting FDA Chief Scientist and she said "at this moment in time, the FDA can no longer call itself an independent and science based regulatory agency".

[00:08:30] Simone Fishburn: I want to just add one word here, because there's actually been a lot of positive feeling on Twitter about this that we're not talking about the agency staffers. The agency staffers are working hard, they are science driven and it really does them a disservice for all their work to be put in this light.

[00:08:48] And I think if that doesn't get fixed, then they're going to have an even bigger problem recruiting, it's really not a good situation.

[00:08:56] Jeff Cranmer: Yeah, that's so true, Simone. Steve, you've got another story out today, you've had a busy morning, pharma's board has approved a proposal to fend off the most favored nation policy by the president. Can you fill us in here, Steve?

[00:09:14] Steve Usdin: If you recall back a little while ago, President Trump signed a series of executive orders related to drug pricing issues and one of them, he held back and said that he wasn't going to put it into effect until today. And to give pharma time to propose an alternative that would create just as much savings and that proposal that he held back on was based on an original proposal that was called, IPI -- international pricing index -- which would set a reference price for drug purchases under Medicare part B. And that referenced price will be based on a basket of prices that are paid, in other countries around the world. The Most Favored Nation twist on that is that it would mandate that Medicare would pay less than the lowest price that was paid in any one of the countries that are used for reference pricing. What I've heard from pharma CEOs and from lobbyists, who are working for pharma companies, is that the industry believes there's a very good chance that they could challenge Most Favored Nation in court and win, but it's not a hundred percent.

[00:10:29] So they've taken Trump up on his offer. They've created a basket of proposals that altogether add up to about $135-$150 billion in savings, over 10 years. And those were presented to the white house, in final form, today.

[00:10:47] And so far, nobody knows as far as I know, whether President Trump is going to accept them or not. The speculation is that he might make an announcement about that at the Republican national convention.

[00:11:02] Jeff Cranmer: Alright. something to look out for there for sure. It was a very busy week, last week, with yesterday's news spilling over today, we don't have enough time to dig into all the stories that we covered at BioCentury, but, I'm wondering Simone if there's anything else that caught your eye last week.

[00:11:19] Simone Fishburn: Yeah. I want to have a non-COVID conversation. I thought it was really interesting, Merck has unveiled plans to, in the best it's going to vet a billion pounds... That's these days about $1.3 billion, to build a center and UK headquarters near King's cross and St. Pancras in London. Why do I care about this other than my accent? The UK is becoming a really important hub in biotech, it's what they call "The Golden Triangle": London, Oxford, Cambridge. I think it's now the third hub after Boston and San Francisco for new company formation. And what we're really seeing, we have the Francis Crick Institute there, the Cancer Research UK and Wellcome, University College Hospital. and those of us who have been around a little bit might remember, this is what Boston started to look like as the pharmas started to say, "Oh, I need to be there, I need to put a center there, I need to put actual boots on the ground" and the word has come up, "knowledge quarter". I'm sure there are literary parts of London round Bloomsbury that think that they might be the knowledge quarter. But that aside, right, I think this is important... I think it's important for the UK and important for London. And, globally important.

[00:12:34] And I think it's one that we should watch as we have seen, pharmas put footprints in Shanghai, after San Francisco and Boston. And I think we may see more of this, so it'll create jobs in London, and it will create another opportunity.

[00:12:51] Steve Usdin: How does it play into the whole Brexit dynamic?

[00:12:53] Simone Fishburn: The Brexit question. The people I'm speaking to don't really feel that Brexit is going to have a huge impact on biopharma, itself. There are some situations where financing of companies might be at risk because of the rules around, if a fund has taken money from an EU based organization. So there are some restrictions, but the idea is that there's actually a fair amount of momentum and I think this is really frankly, a leap of faith in that direction. I think they're basically saying the UK has got its own talent pool. The UK has got its own hospital system and there are advantages to doing it there. And in a way you could see this as a vote of confidence that Merck doesn't see Brexit as really dragging down on the ability of the UK to do its science. That said, there have been questions around whether Brexit would influence the talent pool, because if people can't go freely and so on, we know everywhere that immigration is really important for our industry. And, I don't know, maybe this influences more people to stay.

[00:14:04] Jeff Cranmer: Two other stories that, if you're keen on catching up on the big deals of last week you could go to our website, biocentury.com... we had Johnson and Johnson buying Momenta for $6.5 billion. That deal came about two years after Momenta de prioritized it's complex generics and biosimilars business in order to focus on it's innovative pipeline. And we also saw Sanofi take out Principia for $3.4 billion, the two companies had already been partnered on a BTK inhibitor for multiple sclerosis. The deal is going to let Sanofi move quickly to explore that compound in other diseases.

[00:14:53] Alright that's all we have time for. All of BioCentury's podcasts are available on our website. As well as Spotify, Stitcher, Apple, and Google.

Sponsorship opportunities: Sponsorship and Underwriting packages are available for webinars, podcasts and surveys. For more information, please contact Eric Pierce and Josh Berlin at conferences@biocentury.com.

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