Did Donald Trump and his enablers contribute to the unnecessary deaths of 5,600 Americans?

A new French study suggests that the answer is yes

“What do you have to lose?”

That was a question asked repeatedly by President Donald Trump in the spring of 2020 as he promoted the use of an anti-malaria drug called hydroxychloroquine for the treatment of COVID-19. We now know the answer to President Trump’s question, thanks to a new preliminary study, presented this week at a conference in France.

What do you have to lose? Well, your life.

The researchers sought to attribute deaths to taking hydroxychloroquine — a drug which poses risks due to its side effects on heart function — in eight countries (Turkey, Brazil , Belgium, France, the United Kingdom, Spain, Italy and the United States). According to a French news report, in their research,

the scientists were able to establish that approximately 5,645 deaths would be linked to the drug in the United States , and 9,485 in all of the eight countries studied. With hydroxychloroquine prescription rates plummeting after the first wave, the researchers ended their study there. According to them, the deaths are attributable to the adverse cardiac effects of the treatment, while Covid-19 itself can weaken the heart.

The new analysis was presented at the congress of the French Society of Pharmacology and Therapeutics, and it is unclear if it has yet been peer reviewed. It does however reinforce and extend the findings of a 2021 analysis of the efficacy of hydroxychloroquine for treating COVID-19, which concluded, “treatment with hydroxychloroquine is associated with increased mortality in COVID-19 patients, and there is no benefit.”

The story here is not just that President Trump used his bully pulpit to advocate the taking of a drug that wound up killing people – as incredible as that is. It is also a story of scientific leaders and scientific institutions that failed to do their jobs in overseeing the drug approval process that has long and well-served the citizens of the United States. It is also a story of policy failure.

In March, 2020, in the very early days of the pandemic, President Trump was looking for something, anything to rescue him from the unfolding coronavirus disaster that was enveloping the United States and the world. He latched onto hydroxychloroquine. On March 19, 2020 President Trump took the podium at the White House press room, flanked by the commissioner of the Food and Drug Administration (FDA), Stephen Hahn, and one of his top advisors on the pandemic, Deborah Birx (both pictured at the top of this post).

Here is what the President said that day:

Now, a drug called chloroquine — and some people would add to it “hydroxy-.”  Hydroxychloroquine.  So chloroquine or hydroxychloroquine.  Now, this is a common malaria drug.  It is also a drug used for strong arthritis.  If somebody has pretty serious arthritis, also uses this in a somewhat different form.  But it is known as a malaria drug, and it’s been around for a long time and it’s very powerful.  But the nice part is, it’s been around for a long time, so we know that if it — if things don’t go as planned, it’s not going to kill anybody.

When you go with a brand-new drug, you don’t know that that’s going to happen.  You have to see and you have to go — long test.  But this has been used in different forms — very powerful drug — in different forms.  And it’s shown very encouraging — very, very encouraging early results.  And we’re going to be able to make that drug available almost immediately.  And that’s where the FDA has been so great.  They — they’ve gone through the approval process; it’s been approved.

Not surprisingly, Trump’s claim that the drug had been approved by the FDA was an outright lie. It hadn’t been approved. In fact, it hadn’t even been considered by the agency for approval.

In early 2021, Katherine Eban writing at Vanity Fair observed that looking back, despite FDA Commissioner Hahn’s commitment that day to strictly follow FDA procedures for ensuring the safety in drug approval, “that press conference now seems like an upmarket hostage video, with [FDA Commissioner] Hahn not yet fully understanding that he was sharing the stage with his captors.”

According to Eban, in an incredibly detailed investigation, the day before the press conference, the head of the Department of Health and Human Services (HHS) Alex Azar promised the president at a White House meeting that he could “short-circuit FDA review and unilaterally approve the drugs.” Perhaps this explains why President Trump felt comfortable stating falsely that the drug was approved.

Azar was also Hahn’s boss. Hahn, who also attended the White House meeting sat by silently. On the phone was Scott Gottlieb, head of the Food and Drug Administration, and Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, who both reportedly pushed back on the proposal to subvert the FDA drug approval process.

The pushback was to no avail. Just 9 days after Trump’s “no one will die” press conference, on March 28, 2020 the FDA issued an “Emergency Use Authorization” (EUA) for hydroxychloroquine for the treatment of COVID-19. Soon thereafter, multiple studies were published on the drug’s effectiveness and quickly indicating a robust consensus, “By early June, virtually every published study reported that hydroxychloroquine was not effective in reducing either mortality or morbidity.”

Not surprisingly, given the emerging research, on June 15, 2020, the FDA revoked its Emergency Use Authorization for hydroxychloroquine and cautioned against its use outside of hospitals due the risk of causing heart problems. The experience underscores why it is important to conduct relevant research before making important decisions, and not vice versa.

The deaths attributable to the use of hydroxychloroquine are at least in part (and maybe even mostly) due to Donald Trump’s misguided promotion of the drug from the White House podium and via his Twitter account. But some degree of responsibility also lies with the political appointees, career scientists and institutions that broke down and allowed Trump’s political agenda override longstanding and effective science advisory processes. We now know that the hydroxychloroquine debacle was not an isolated incident.

The thousands of deaths from the inappropriate use of hydroxychloroquine are not just of historical interest. It is conceivable that in a few years Donald Trump, or someone very much like him, will again occupy the White House. That makes it imperative that Congress and President Biden act swiftly to strengthen the legal foundations of drug approval processes and the institutions that oversee them, to reduce the chances that another president can steamroll the FDA.

Several close observers offer some concrete recommendations to improve the drug approval process in the face of intense political pressure. These include:

[T]he hydroxychloroquine EUA suggests that the FDA should clarify evidentiary standards for EUAs. This could increase consistency, the likelihood of sound EUA decisions, and public confidence, as well as decrease the risk of political intervention. The FDA could further create differentiated standards, higher standards for therapeutic products than diagnostic tests, and higher standards for widely used therapeutics like vaccines than for products that may be used only by select subpopulations. New guidance could clarify that evidence underlying authorization and revocation will be made public. The FDA could also issue public health emergency–specific process and standards guidance for EUAs, as it has for the development and licensure of COVID-19 vaccines.

The thousands of deaths from failed drug approval policies should be a powerful warning that expert advisory processes and related federal agency decision making is incredibly consequential. What’s the worst that can happen? People can die who didn’t have to die, that’s what. The integrity of such processes and the institutions which oversee them are too important to be left exposed to the whims of incompetent and malevolent leadership.

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