San Diego Scientists Call Out FDA Commissioner Over 'Cherrypicked' COVID-19 Plasma Data

Speaker 1: 00:00 Many scientists say the federal government and the scientific community appear to be butting heads on many COVID-19 related issues, whether that's on the importance of daily and rapid Corona virus testing to what types of antivirals or other treatments ought to be authorized in late August yet another one of these incidences where scientists and government officials appear to disagree occurred KPBS science and technology reporter Shelina chatline. He spoke with two San Diego scientists about it, and she's here to give us the background. Hi, Shalina Hey Mark. So let's jump in. What happened here Speaker 2: 00:35 On August 23rd, the U S food and drug administration, commissioner Steven Hahn and president Donald Trump held a press conference where Han announced approval for emergency use authorization of convalescent plasma. As a coronavirus therapy emergency use is sort of a fast tracked approval that lasts during the pandemic. So during the press conference, Trump characterized plasma as a quote, very historic breakthrough. Speaker 1: 01:01 This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection, set an incredible rate of success Speaker 2: 01:17 And commissioner Han back this up Speaker 1: 01:19 Optimal treatment. The optimal patients as described by secretary are treated with convalesce and plasma at the highest titers. There was a 35% improvement in survival, which is a significant clinical benefit. Now we're waiting for more data. We're going to continue to gather data, but this clearly meets the criteria that we've established for emergency use authorization. And we're very pleased with these results. And where is the data that Han is basing this on? Speaker 2: 01:48 Han says this data comes from looking at the results of Mayo clinic unpublished and uncontrolled study of plasma use in about 20,000 patients. And he says scientists at the FDA reviewed the data and looked at other published studies, but the statement and the 35% figure still caught the attention of other scientists like Eric Topol of scripts research Topol in fact, wrote an open letter to commissioner Hahn asking for a correction because he says those results are grossly overestimated. And based on thin data analysis, I spoke to him about it. Speaker 1: 02:20 There were no data to support that with any breakthrough. There was a preprint that had a retrospective data, dredging cherry picking analysis that raised a hypothesis that there might be some benefit of complice and plasma, but to call it a breakthrough, it was preposterous because we know that the antibodies that people may after an infection, most of the antibodies are of no value. Only a tiny fraction are truly neutralizing, potent antibodies. So to make this declaration and to make this pronouncement of saving 35 lies per a hundred, who are sick, you know, it's absurd Speaker 2: 03:04 To the emergency use authorization, the convalescent plasma what's next. I mean, Speaker 1: 03:11 Yeah, if it had been get rented this EUA without the fanfare and grandstanding, that might've been so bad because you know, at least it's something out there for an emergency use as when you do that. And you say it is this, you know, miracle treatment. We don't even know if it works. And moreover, uh, it could still have side effects, issues concerned, but mostly we can't do trials anymore. Now that's interesting with Topol said there, what does he mean by there can't be any more clinical trials. Speaker 2: 03:45 What he means is that to do clinical trials, you have to have the question of whether something works or not. And he says, the administration basically undermine that by coming on and saying, Hey, this has lifesaving properties. So there's this sort of contradiction between the FDA saying, Hey, we need more data. And also this works. That's why he's asking Honda, correct what he said at the conference. Now I asked the FDA about the science community's concerns and they directed me back to press releases where they essentially say that emergency use was based on the totality of available scientific data. But about a week later after this press conference, the national institutes of health released a statement saying there's not enough well controlled, adequately powered randomized clinical trial data results to show that plasma is safe and effective enough for COVID-19 patients. They say like Topo, that the data was cherry picked. Speaker 1: 04:39 No we've seen government officials and health experts butt heads before like dr. Anthony Fowchee of the CDC carefully correcting some statements from president Trump regarding the pandemic. But what about this? Why is this causing so much stir from the scientific community? Speaker 2: 04:54 I think a good way to think about this as a sort of straw that broke the camel's back because it's not just hopeful. Who's concerned. Twitter was a buzz with scientists and some supporters going back and forth on a conference. And I spoke to virologist, dr. Suma Trenda, the Sanford Burnham previs medical discovery Institute. Who's had following what he called the FDA's premature support and emergency use authorization of antiviral hydroxy chloroquine, which the FDA had to revoke this supportive plasma with limited data was too much for him to stay quiet. Speaker 1: 05:26 Our entire medical treatment strategy relies on our trust in the FDA, right? Nobody is looking at the clinical trial data gone, Hey, should I take this drug or not? Right. We trust that the FDA is not using anything but the best science, right to come up with their recommendation. And that's no longer happening at the FDA and the CDC. And I feel that as scientists, we have an obligation to hit it in rate and say, Hey, listen, this is fundamental to our way of life. Uh, and, and our health and safety while. So what does he think had happened? Next? Speaker 2: 06:08 Chanda is very concerned of a fast tracked approval by the FDA and CDC for a company to develop and distribute a vaccine. The CDC has already sent letters to stay governors, to be ready to distribute a vaccine by November 1st, just before election day. But Shonda says that's not a safe timeline. Most vaccines are still in clinical trials. And that data has to be reviewed for safety, which could take until at least the end of the year. Speaker 1: 06:33 I'm not saying that look getting a vaccine out as quickly as possible is not the right thing to do. Right. But as quickly as possible means doing the right types of studies, right? So you are more, more light. You're going to do more harm than good. If you fast track a vaccine that either isn't efficacious, which is best case scenario for a vaccine that doesn't work right. Um, or that has heart that has side effects, right? But giving a drug to somebody who's not sick, that you don't understand what the safety and efficacy profile is, is ethically unapproachable. And now there's the report today that major drug companies, including Pfizer or Johnson and Johnson that are working on a COVID-19 vaccine, they issued a public letter volleying, not about a political pressure from president Trump. They say any vaccine will go through rigorous trials necessary to ensure safety and effectiveness. And then Trump on Monday reiterated his belief that vaccines will be on the market before November based on what the scientists are saying, how can we trust what the government is putting out? Speaker 2: 07:41 So I think most scientists would say believe in the health institutions and health experts, but Trenda and Topol say there have been serial incidents that have raised some alarm and it's important for the science community and the public to demand that our health not be politicized and to stand up for correct information to be disseminated. Speaker 1: 08:03 I've been speaking with KPBS science and technology reporter Shalina Chet Lonnie. Thanks. Shelina glad to be here. A link to a letter from dr. Eric Topol, asking for FDA commissioner Steven Han to tell the truth about the data on convalesce, a plasma or resign is on our website, kpbs.org.