The Food and Drug Administration is responsible for assuring the safety and efficacy of any new medical treatment. But Donald Trump and FDA Commissioner Dr. Stephen Hahn have destroyed the agency’s credibility. In fact, drug manufacturers are now reassuring the public that they won’t even submit any COVID-19 vaccine for FDA approval unless they believe it is safe and effective.
That’s upside down.
For Dr. Hahn, a Washington outsider who worked his way up the ranks of academic medicine, the slide down has been swift.
#1: Dr. Hahn’s Hydroxychloroquine Debacle
Mar. 19, 2020: Trump tells the public that the FDA has approved hydroxychloroquine and chloroquine to treat COVID-19 when, in fact, it has not.
Mar. 21: Trump tweets that the FDA should “MOVE FAST” to put hydroxychloroquine and azithromycin “in use IMMEDIATELY. PEOPLE ARE DYING.”
Mar. 25: The Mayo Clinic warns physicians that some patients taking hydroxychloroquine as an experimental COVID-19 treatment are at increased risk for sudden cardiac death.
Mar. 28: Despite growing concerns from physicians about the drugs’ safety and efficacy, the FDA authorizes their emergency use on a limited basis for COVID-19 patients.
Mar. 30: Appearing onFox & Friends, Trump boasts that he pressured Dr. Hahn into approving the treatment: “[H]ydroxychloroquine is something that I have been pushing very hard. I got the very early approval from the FDA. It was going to take a long time, and Dr. Stephen Hahn, the head of the FDA, gave us an early approval, a very quick approval, a 24-hour approval.…And I got it done, because I said: ‘Look, some of these people are very sick and they’re not going to make it. Let’s do it. Let’s get it done.”
Apr. 24: The FDA cautions against using hydroxychloroquine and chloroquine due to potential heart problems, stating that the drugs “have not been shown to be safe and effective for treating or preventing COVID-19.” (Emphasis supplied)
June 15: The FDA revokes the emergency use authorization for the drugs, stating that they are unlikely to be effective in treating COVID-19 and have potentially fatal side effects.
#2: Dr. Hahn’s Reluctance to Expose Trump’s Lies
July 4: Trump makes the dangerously false claim that 99 percent of COVID-19 cases in the US are harmless.
July 5: Appearing on CNN, Dr. Hahn is asked about Trump’s bogus “99 percent harmless” claim. “I’m not gonna get into who’s right and who’s wrong,” he says.
#3: Dr. Hahn’s Convalescent Plasma Disaster
July 30: Trump urges patients who have recovered from COVID-19 to donate blood for use in a Mayo Clinic study of convalescent plasma as a potential treatment for the virus. “It’s had tremendous response so far,” Trump says.
Aug. 12: Prior to peer-review of their plasma study, Mayo Clinic researchers post the results online. They suggest only potentially slight improvement in some patient outcomes — about five out of every 100, or five percent — and include critical caveats:
Even so, the White House presses the FDA for emergency approval, which remains on hold because Dr. Anthony Fauci and Dr. Francis Collins, director of the National Institutes of Health (NIH), argue that the data are too weak to support treatment for COVID-19.
Aug. 19: Asked about reports that the FDA was on the brink of approving convalescent plasma until the NIH said the evidence was sufficient, Trump says that he is surprised:
“Well, I hear great things about it…And it could be a political decision, because you have a lot of people over there that don’t want to rush things because they want to — they want to do it after November 3rd…But I’ve heard fantastic things about convalescent plasma. And I’ve heard numbers way over 50 percent success. And people are dying, and we should have it approved if it’s good. And I’m hearing it’s good. I heard from people at the FDA that it’s good…I’m going to check that right after this conference.”
Aug. 23: Announcing the FDA’s emergency use authorization for convalescent plasma and referring specifically to the Mayo Clinic study, Trump says, “[I]t has proven to reduce mortality by 35 percent. It’s a tremendous number.”
Trump’s claim is false. The mortality reduction was five percent, not 35 percent. Nevertheless, Health and Human Services (HHS) Secretary Alex Azar repeats it: “I just want to emphasize this point because I don’t want you to gloss over this — this number. 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.”
Then Dr. Hahn joins the chorus: “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 administration of plasma.…if you’re one of those 35 out of 100 people who these data suggest or show survive as a result of it, this is pretty significant for that person and their family.”
The FDA promotes the lie on Twitter.
Aug. 23: Dr. Hahn receives withering criticism from the medical community for misleading the public about the Mayo Clinic’s findings. Trump’s false claim perplexes even the scientists who worked on the study.
Aug. 24: In an obscure tweet, Dr. Hahn tries to walk back the 35 percent claim: “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”
Aug. 25: “I can assure the American people that this decision [to approve convalescent plasma for COVID-19] was made based upon sound science and data,” Dr. Hahn says.
Sept. 1: Based on the Mayo Clinic study, the NIH finds, “There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.…[It] should not be considered standard of care for the treatment of patients with COVID-19.”
Sept. 4: Undaunted by the NIH’s conclusion, Trump insists, “The convalescent plasma has had a tremendous impact already.”
And Now Comes a Potential Vaccine
Any new vaccine that doesn’t work and/or generates harmful side effects can undermine public confidence in all vaccines. That’s why the FDA approval requires a series of phased evaluations culminating in a Phase 3 clinical trial that enrolls thousands of individuals. Some are treated, others get a placebo, and all are monitored during a process that typically requires years. Ending trial early is possible where the preliminary outcomes are overwhelmingly positive, but it can leave insufficient time to reveal all adverse effects that may not become apparent until millions have already received the vaccine.
July 27: Pfizer and Moderna begin Phase 2/3 trials of their potential COVID-19 vaccines. Each trial seeks up to 30,000 volunteers who will get two shots spaced 21 or 28 days apart.
July 30: Trump’s chief of staff Mark Meadows tells House Speaker Nancy Pelosi (D-CA) and Senate Minority Leader Chuck Schumer (D-NY) that the FDA would probably give emergency approval to a COVID-19 vaccine before the end of Phase 3 trials in the US, perhaps as early as late September, according to later reporting by The New York Times. Senior administration officials claim that Meadows was misunderstood or being misrepresented.
Aug. 6: Trump asserts that it’s possible to have a vaccine before Election Day.
Aug. 22: In a tweet tagging Dr. Hahn, Trump attacks: “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. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA.”
Aug. 26: Moderna reports that it has enrolled 15,239 volunteers for its trial. Pfizer has also crossed the 50 percent enrollment threshold only recently.
Also on Aug. 26: The Infectious Disease Society of America warns Dr. Hahn that approving a vaccine before completing Phase 3 trials “could significantly undermine COVID-19 vaccination efforts and seriously erode confidence in all vaccines in the current atmosphere of vaccine hesitancy.” (Emphasis in original)
Aug. 30: Dr. Hahn tells the Financial Times that the FDA could consider emergency use authorization or approval for a COVID-19 vaccine before Phase 3 trials are completed.
Sept. 3: At a campaign rally in Pennsylvania, Trump says that a vaccine “will be delivered before the end of the year, in my opinion, before the end of the year, but it really might even be delivered before the end of October.”
Sept. 4: Trump says that he has spoken to the head of Pfizer and “it expects to have the results of its trial very, very shortly — next month — but very shortly. We remain on track to deliver a vaccine before the end of the year and maybe even before November 1st. We think we can probably have it sometime during the month of October.” Trump says that Pfizer, Moderna and Johnson & Johnson have potential vaccines that are all “doing very well. They’re all in final stages, and I think you’re going to see results that are shockingly good.”
Also on Sept. 4: Pfizer, Moderna and Johnson & Johnson are preparing an unusual joint public statement pledging not even to seek FDA approval of any COVID-19 vaccine until it is proven to be safe and effective.
Sept. 8: Along with six other drug manufacturers, Pfizer, Moderna and Johnson & Johnson issue a joint pledge that they would “stand with science” and not seek approval of a vaccine until it had been thoroughly vetted for safety and efficacy. They do not rule out seeking emergency authorization, but promise that any potential COVID-19 vaccine would be based on “large, high quality clinical trials.”
Dr. Hahn’s Short Leash
The next step is October 22, when NIH’s Data and Safety Monitoring Board (DSMB) reviews the “development, authorization and/or licensure” of a coronavirus vaccine. Board members are not government employees. Typically, they are experts in vaccine science and biostatistics who teach at major medical schools. So Dr. Fauci says that he’s “not concerned about political pressure” in the process.
But he should be. DSMB guidance isn’t binding on Dr. Hahn or his boss, HHS Secretary Azar. Neither of them has committed to follow it.
And Trump’s heavy hand is everywhere. Dr. Hahn is not allowed to speak to the press unless Azar’s deputy, Michael Caputo, is on the line. Caputo has no background in health care, but he has known Trump since the 1980s, when he worked briefly for a lobbying and political consulting firm started by Paul Manafort, Charlie Black and Roger Stone — whom Caputo considered a mentor. During Trump’s impeachment, Caputo wrote a book and produced a documentary, both titled The Ukraine Hoax. As Trump began to distrust Azar, Caputo became HHS’s principal spokesperson on April 15.
Acknowledging the pressure to move quickly, Dr. Hahn was asked on September 1 whether he would resign if pushed to approve a vaccine based on politics rather than science.
“I think all options are on the table,” he said. “I hope we won’t be in that position.”
When Dr. Hahn has been in a similar position, he’s caved. Repeatedly. So now he has the biggest problem of his professional life. Even if medical science supports accelerated approval of a COVID-19 vaccine, many Americans still won’t trust the decision because he made it. That means they won’t get the vaccine.
Trump doesn’t care, but Dr. Hahn should.