Sunday afternoon, President Donald Trump joined Food and Drug Administration chief, Dr. Stephen Hahn, to firmly endorse the use of convalescent plasma as a miracle treatment for COVID-19. In the press conference, Hahn gave a statistic that has now been proven to be false to justify the rush to approve the drug.
The use of plasma was put "on hold" last week after researchers and doctors at the FDA found that there wasn't enough data to confirm the effectiveness. The Washington Post reported Monday that when Hahn cited 35 percent cure-rate of COVID-19 with plasma, the data wasn't exactly accurate.
"It wasn’t difficult to see how overeager Trump was for another coronavirus quick fix — a political win even — by hyping the treatment," said the Post. "And what was particularly notable was the degree to which the health officials next to him, including FDA Commissioner Stephen Hahn, played along."
Citing a Mayo Clinic study, Trump said the plasma "has proven to reduce mortality by 35 percent. That's a tremendous number. Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective."
Hahn was more cagey with his answer, but he did repeat the 35 percent number, he just didn't say that plasma had a 35 percent cure rate.
"I just want to emphasize this point because I don't want you to gloss over this number," the doctor explained. "We dream in drug development of something like a 35 percent mortality reduction. This is a major advance in the treatment of patients. This is a major advance. Many of you know I was a cancer doctor before I became FDA commissioner. And a 35 percent improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — 100 people who are sick with COVID-19, 35 would have been saved because of the admission of plasma."
Trump was asked about the contradictions in what was said by the FDA just days ago, and the cautious statements by Hahn. He asked the doctor to answer and then abruptly rushed out of the briefing.
Trump incorrectly stated that the treatment is "proven to reduce mortality by 35 percent," and Hahn refused to back it up.
"The Mayo study, while finding a statistically significant effect, was not a randomized clinical trial, the gold standard for such studies, nor has it been peer-reviewed yet," the Post reported. "Even the FDA in its news release and an accompanying memorandum Sunday said merely that the treatment "may be effective" — and that the possible benefits outweigh the risks — rather than that it's been proven to be very effective, as Trump claimed."
It was just days ago that the FDA said that it was pausing the plasma with coronavirus task force's Dr. Francis Collins and Dr. Anthony Fauci warning against the FDA rushing to approve it. While it hasn't officially been approved, the FDA has "authorized" its use, just as they did with Trump's other miracle cure, hydroxychloroquine, which was found to cause heart problems in users.
The data doesn't exactly show that 35 out of 100 people would have been saved using plasma, however.
"The vast majority of people who get the virus will recover with or without plasma," the report said. "The 35 percent figure comes into play among these who die. The data [Hahn] and Trump were apparently referring to showed 11.9 people out of 100 died without the treatment, while 8.7 percent died with it."
I think Dr Hahn misspoke here. I think he meant to say something to the effect of: "if the preliminary analysis of… https://t.co/e3HO2jLx6E— Robert M Califf (@Robert M Califf)1598229400.0
@ScottGottliebMD In this statement, @SteveFDA claims 35 per 100 people treated with plasma would be saved. The Mayo… https://t.co/e6GBfoTLiT— Eric Topol (@Eric Topol)1598231422.0
Hahn’s statement that if “100 people were sick, 35 would be saved by plasma” is shockingly wrong. The risk reductio… https://t.co/vjLN1cDYq5— Jonathan Reiner (@Jonathan Reiner)1598226885.0
After Trump attacked the FDA for being a "deep state" plot to block any coronavirus drugs' progress to hurt him in the election, the FDA approved the treatment on the Sunday before the Republican convention.
Treatments can be helpful, but one concern is that because everyone will now be asking for the plasma and randomized studies to chart its effectiveness will be more difficult to achieve, .
The data shows the lives saved are a little closer to 3 people out of 100, not 35. More Americans are saved by wearing a mask. Three people aren't anything to scoff at, and it's important that as many lives as possible be saved, but it's a far cry from the miracle cure Trump is claiming it is. While it is helpful, it's yet another example of Trump putting politics before science in making important decisions about the pandemic. All his tweets and press conferences do is create the appearance that he's doing something. There will likely be a Congressional hearing to uncover whether the FDA was forced to cave to Trump's tweets in authorizing the treatment.
"Health officials are generally very careful with their claims, especially about unproven treatments," the Post explained. "And it's difficult to divorce this from what has preceded it. Trump has applied tremendous public pressure on the FDA — both on hydroxychloroquine, for which he has sought another reversal to again allow for emergency use, and now on convalescent plasma."
In the end, there could be a plasma shortage as a result of Trump's press conference, which could stop lives from being saved in other situations. There's also a fear that Trump will demand the FDA rush to approve a vaccine that hasn't been proved to work. If that happens, the concern is that people will take the vaccine and still get sick, or worse die, because they're given a false sense of security. If the vaccine doesn't work, people might also be resistant to take the one that ultimately does work because the one previously was ineffective.