Speaker 1: Welcome the prognosis. I'm Laura Carlson. It's day one sixty
Speaker 1: eight since coronavirus was declared a global pandemic. Today's main story.
Speaker 1: An f DA official made a high profile misstatement about
Speaker 1: the efficacy of a COVID treatment this weekend, even after
Speaker 1: he backtracked. The episode has led many to wonder how
Speaker 1: independent the agency really is. But first, here's what happened
Speaker 1: in virus news today. Italy has ruled out imposing a
Speaker 1: new nationwide lockdown despite an increase in coronavirus cases. Today,
Speaker 1: the country recorded its highest number of new cases in
Speaker 1: three and a half months, but the virus and associated
Speaker 1: lockdowns have sent Italy into its worst recession in living memory.
Speaker 1: Italy's Health Minister Roberto Speranza told Bloomberg News that the
Speaker 1: rise in contagion has been limited, with very low impact
Speaker 1: on hospitals. He also said the average age of people
Speaker 1: who have tested positive in the last week is thirty
Speaker 1: and most have mild symptoms or none at all. Authorities
Speaker 1: in Berlin have banned demonstrations that were planned to protest
Speaker 1: COVID related restrictions. Thousands of protesters have clashed with police
Speaker 1: in recent weeks, many of them openly ignore hygiene and
Speaker 1: distancing rules. The city's interior minister said that the ban
Speaker 1: is meant not to limit freedom of assembly, but to
Speaker 1: protect citizens from infection. Separately, the German government is extending
Speaker 1: its coronavirus travel warning for countries outside Europe until September. Finally,
Speaker 1: drug company Moderna presented early data that provides the first
Speaker 1: evidence that its COVID nineteen vaccine stimulates the immune systems
Speaker 1: of older people. In a phase one trial, the vaccine
Speaker 1: produced quote consistently high levels of neutralizing antibodies and older adults.
Speaker 1: According to a statement, antibody levels produced in people older
Speaker 1: than fifty five were comparable to those seen in younger adults.
Speaker 1: The findings are important because those over the age of
Speaker 1: fifty five often don't respond as well to vaccines as
Speaker 1: younger adults. And now for today's main story. This weekend,
Speaker 1: Stephen Hahn, the Commissioner of the US Food and Drug Administration,
Speaker 1: attracted criticism when he substantially overstated the benefits of an
Speaker 1: experimental COVID nineteen therapy at a press conference with President Trump.
Speaker 1: Hans said that a treatment using blood plasma from recovered
Speaker 1: patients could save thirty five of every one hundred people
Speaker 1: who would have died. Those high profile remarks were incorrect,
Speaker 1: and they were repeated by others in the Trump administration.
Speaker 1: Late on Monday, Doctor Han clarified some of what the
Speaker 1: data on blood plasma actually show, but the episode has
Speaker 1: raised questions about how the agency will review a vaccine,
Speaker 1: as well as its overall scientific independence. Senior editor for
Speaker 1: Healthcare Drew Armstrong spoke to Dr Han about the agency's
Speaker 1: role in an increasingly politicized federal virus response. I talked
Speaker 1: to Drew about what his reporting has found. Earlier this week,
Speaker 1: FDA Commissioner Stephen Hahn admitted to overstating the benefits of
Speaker 1: convalescent plasma and treating COVID nineteen. What exactly was incorrect
Speaker 1: about his remarks. The important thing to know is exactly
Speaker 1: what he said at the start and what he said
Speaker 1: at this press conference with President Trump over the weekend,
Speaker 1: was that so plasma is the liquid portion of the
Speaker 1: blood um. That liquid portion contains the natural immunity that
Speaker 1: someone develops in response to an infection, in this case
Speaker 1: COVID nineteen. You can take that and infuse it into
Speaker 1: current patients and hopefully it takes those infection fighting antibodies
Speaker 1: and gives them to the new patient and helps and
Speaker 1: fight off the infection. So around the world this has
Speaker 1: been used by physicians outside of clinical trials. It's always
Speaker 1: been thought of as a promising but unproven therapy for
Speaker 1: COVID nineteen and they've been trying to find out does
Speaker 1: it work and if it works, how effective is it.
Speaker 1: So one of the things that Commissioner Han presented over
Speaker 1: the weekend at the press conference with President Trump was
Speaker 1: a comment that was really really important about how good
Speaker 1: is this thing? And he said, the data continue to
Speaker 1: pan out a hundred people who are sick with COVID
Speaker 1: nineteen thirty five would have been saved because of the
Speaker 1: administration of about plasma. That's a pretty dramatic result. That
Speaker 1: would be one of the most effective treatments we have
Speaker 1: for this disease. Unfortunately, it's not accurate and it's not
Speaker 1: what the data show that FDA have. What the data
Speaker 1: actually show is that the effect of this of the
Speaker 1: highest dose of this blood plasma mu is thirty five
Speaker 1: more effective. It reduces mortality by thirty compared to the
Speaker 1: lowest dose. But we don't have the data to compare
Speaker 1: it to how it works against the standard of care
Speaker 1: of placebo. And that's the gold standard of evidence that
Speaker 1: the f d A really looks at and that physicians
Speaker 1: and patients really want to know when they're assessing does
Speaker 1: something actually work? And that's just something we don't know yet.
Speaker 1: But that Commissioner Hound was really, really, really misleading in
Speaker 1: making that statement in the press conference with President Trump.
Speaker 1: In terms of how this might damage public perception and
Speaker 1: trust of the f d A, particularly during a pandemic.
Speaker 1: What are some of the concerns there. I think there
Speaker 1: are really serious concerns because while these concepts of what
Speaker 1: we call relative risk versus absolute risk are kind of
Speaker 1: technical and maybe a lot of late people don't necessarily
Speaker 1: think about this every day, it's unbelievably important and it's
Speaker 1: incredibly just fundamental if you're a drug researcher or a
Speaker 1: medical researcher. And Steve Hahn over at the fd I mean,
Speaker 1: he's written two hundred and twenty different academic papers, he
Speaker 1: has read thousands. I'm sure he's been in cancer research
Speaker 1: for decades. I mean, this is pretty basic stuff if
Speaker 1: you're in the scientific world, and so it's a pretty
Speaker 1: big screw up, and that's the reason why it's damaging
Speaker 1: to the credibility of the f d A, you know.
Speaker 1: And it also comes at a point when the FDA
Speaker 1: was kind of up there during a political event, you know,
Speaker 1: the administration's um was there with President Trump and his
Speaker 1: re election really hinges on a successful response to this virus,
Speaker 1: and the FDA got dragged into that overstated something that
Speaker 1: wasn't true and about his higher profile setting, as you
Speaker 1: can imagine, and then had to walk it back. That
Speaker 1: is really really not a great place for an agency
Speaker 1: that prides itself on rock solid science and credibility to
Speaker 1: be in Americans, no matter what they're political affiliation, have
Speaker 1: to be able to trust that they have good information
Speaker 1: about the medicine, therapy, medical devices they take. You do
Speaker 1: not want to be in a country where half the
Speaker 1: country doubts whether drug works because of who's in office.
Speaker 1: And let's talk more broadly or generally about the f
Speaker 1: d A in terms of how it does actually function,
Speaker 1: specifically with regard to its independence from political affiliations or
Speaker 1: or who is in office. Yeah, I think the f
Speaker 1: d A has always had a little bit of a
Speaker 1: benefit by being a public health agency and been perhaps
Speaker 1: less susceptible to some of the political pressures that have
Speaker 1: we've seen placed on and you know, other parts of government,
Speaker 1: particularly during this administration. That said, I want to be clear,
Speaker 1: it's certainly not exempt, and it can get hauled in
Speaker 1: front of Congress, criticized by lawmakers, and so it is
Speaker 1: not immune. But one of the Commissioner's real jobs is
Speaker 1: to protect the scientific and professional staff of the agency
Speaker 1: from that so that they can do their jobs. They
Speaker 1: are both a leader and a buffer at the agency.
Speaker 1: And so, turning to the context of the pandemic and
Speaker 1: the concern that politics might actually enter into the f
Speaker 1: d a's reaction or treatments or even vaccines for COVID nineteen,
Speaker 1: I think the worry always is that you have a
Speaker 1: vaccine or a drug or a therapy that is approved
Speaker 1: or allowed out under some kind of emergency program where
Speaker 1: the evidence to support it just asn't there, either because
Speaker 1: of a effectiveness problem or because of an even more
Speaker 1: worryingly a safety problem. One of the things that Commissioner
Speaker 1: hantst in our our lengthy interview this week was that
Speaker 1: he is aware of that. Sure he said that it
Speaker 1: has been uh challenging. He's he's aware that other people
Speaker 1: in the FDA aware of and that he sees one
Speaker 1: of his major jobs to reinforce to the folks at
Speaker 1: the agency that they need to ignore that and and
Speaker 1: do their jobs. He is also very cognizant of the
Speaker 1: unique situation that we're in um with the pandemic in
Speaker 1: the sense that this is urgent, and wants people to
Speaker 1: be able to move quickly, but to move quickly in
Speaker 1: the right way. What kinds of pressure and the Trump
Speaker 1: administration put on the f d A to say, speed
Speaker 1: up the approval process for a COVID nineteen vaccine, Well,
Speaker 1: they can put as much pressure on the f d
Speaker 1: A as the f d A allows them to squeeze.
Speaker 1: It really is up to the f d A. You know,
Speaker 1: the it's a matter of you know, does Commissioner Han
Speaker 1: want to keep his job? Can he take the heat?
Speaker 1: You know? There have been a number of reports out
Speaker 1: there of people in the White House being highly critical
Speaker 1: of the agency. Axios I believe had a report that
Speaker 1: White House Advisor Peter Navarro told some FDA officials that
Speaker 1: you're all deep state and you need to get on
Speaker 1: Trump time. Trump himself put out a tweet over the
Speaker 1: weekend that he had heard some members of the FDA
Speaker 1: were deep staters attempting to slow down work on a
Speaker 1: vaccine or a drug in order to impede his re election.
Speaker 1: UM Commissioner han Um he very definitively said, Um, I'll
Speaker 1: quote from his interview. You said, what I can tell
Speaker 1: you is that I feel very strongly that the seventeen
Speaker 1: thousand plus fd employees are true professionals, and none of
Speaker 1: them wants to delay getting medical products into the hands
Speaker 1: of Americans, and all emphasises, I mean, there is no
Speaker 1: evidence whatsoever, Um that the f d A is slowing
Speaker 1: down work on this. I think everybody in the country
Speaker 1: realizes this is a public health crisis, and the sooner
Speaker 1: there is an effective vaccine UM and additional therapy for
Speaker 1: this disease, the better. And certainly we know from the
Speaker 1: Trump administration that they have their eye on election day
Speaker 1: and there is significant pressure there to have a vaccine
Speaker 1: either approved or even available by that point. And perhaps
Speaker 1: that has led to this question of pressures on the
Speaker 1: f d A and whether or not the FDA needs
Speaker 1: to be even more independent. I was wondering if you
Speaker 1: might be able to go into that of what can
Speaker 1: there be done to ensure this continued independence. I think
Speaker 1: a huge amount of the independence of any agency is
Speaker 1: going to be defined by its leader. You know, there
Speaker 1: are federal agencies and parts of the federal government that
Speaker 1: have more independence. You know, the Federal Reserve is kind
Speaker 1: of a classic example. But it's really up to the commissioner.
Speaker 1: Is the reality and being able to be a strong
Speaker 1: leader who can stand up for the science while being
Speaker 1: cognizant of the real world scenario that they're living in
Speaker 1: is probably at this point in time, I'm the most
Speaker 1: important thing. I asked Commissioner Han, you know, did he
Speaker 1: think that the FDA should be an independent agency instead
Speaker 1: of being a part of the Health and Human Services Department? Um,
Speaker 1: you know, like the Federal Reserve. And you know, he
Speaker 1: said he hadn't really thought about it, but that it
Speaker 1: was worth consideration, um for exactly the reasons we're discussing.
Speaker 1: But he really he backed off on that quite a
Speaker 1: bit and said he didn't really want to rush into
Speaker 1: giving an opinion about it. Uh, it appeared to be
Speaker 1: at least a little bit appealing in that moment. What
Speaker 1: are perhaps the dangers um of this potential political pressure
Speaker 1: on speeding up getting a vaccine out before perhaps it's ready.
Speaker 1: When you're the head of an agency, the reality is
Speaker 1: that you don't have all that many options if an
Speaker 1: administration really does want to pressure your overrule a decision
Speaker 1: that you make. There was a report by Ruters that
Speaker 1: Peter Marks, who is the leader of the group inside
Speaker 1: the FDA that reviews vaccines. The writers reported the HULD
Speaker 1: resign if the agency rubber stamp something. Essentially, our administration
Speaker 1: forced the FDA to rubber stamp something. And I asked
Speaker 1: Commissioner Hot about that, and his response was, you know,
Speaker 1: I'll quote here he said, Peter did not say that
Speaker 1: to me, but it wouldn't surprise me that this is accurate.
Speaker 1: And I asked him the same question. What would he
Speaker 1: do if he was being asked rubber stamp a vaccine?
Speaker 1: And I'll quote again from his answer, it wouldn't be
Speaker 1: okay for me, and I would not participate in any
Speaker 1: decision that was made on anything other than the science.
Speaker 1: So you know, that is kind of the nuclear option
Speaker 1: for an FDA commissioner is to resign or publicly protest
Speaker 1: about a decision where you're either being overruled or forced
Speaker 1: to do something that you don't believe is correct. Hopefully
Speaker 1: we won't be in a situation like that. That was
Speaker 1: Drew Armstrong and that's it for our show today. For
Speaker 1: coverage of the outbreak from one bureaus around the world,
Speaker 1: visit Bloomberg dot com slash Coronavirus and if you like
Speaker 1: the show, please leave us a review and a rating
Speaker 1: on Apple Podcasts or Spotify. It's the best way to
Speaker 1: help more listeners find our global reporting. The Prognosis Daily
Speaker 1: edition is produced by topor foreheads Jordan Gospoure, Magnus Hendrickson
Speaker 1: and me Laura Carlson. Today's main story was reported by
Speaker 1: Drew Armstrong. Original music by Leo Sidrin. Our editors are
Speaker 1: Francesca Levi and Rick Shine. Francesca Levi is Bloomberg's head
Speaker 1: of podcasts. Thanks for listening.