Hydroxychloroquine and President Trump’s obsession with it has been something of a running joke during the COVID19 Crisis, to the extent jokes are possible in such a dismal climate. But I want to flag your attention to this new study published in The Lancet, which has dire findings about the impact of hydroxychloroquine and the hydroxychloroquine in combination with the class of antibiotics the President has repeatedly endorsed. Here’s the study and here’s a write-up of the study in The Washington Post. Let me start with an arresting quote: “for those receiving hydroxychloroquine and an antibiotic — the cocktail endorsed by Trump — there was a 45 percent increased risk of death … ”
That is, to state the obvious, a very bad number.
There are important caveats. This is an observational study rather than a double blind controlled study, which is the gold standard for clinical research. In the latter case you have a group of subjects with some condition or disease, with one half given the real drug and the other a placebo on a random basis. Neither the patients nor the doctors knows who’s getting what. Then you see whether outcomes were meaningfully different between those who got the drug and those who didn’t. In an observational study like this you are basically reviewing records of outcomes. That introduces a range of potential biases in the results. The most significant one is that hydroxychloroquine may have been prescribed to patients who were sicker in the first place, thus biasing the sample toward increased mortality.
But the researchers who produce such a study are aware of these pitfalls and make efforts to account for them. Significant in this case is the sheer size of the group analyzed. The study looked at 96,032 patients treated in 671 hospitals on six continents from the beginning of the epidemic in late December through the middle of April.
A drug regimen that increases mortality by say 10% while providing no measurable benefit is a big problem and certainly something no one should be using. A 45% increased chance of death is just off the charts. Only controlled double-blind studies could give us definitive proof of the harm caused by using this drug for this purpose. But I would be curious to hear from researchers, doctors, ethicists and epidemiologists among TPM Readers whether it would be ethical start or even continue such trials (at least two are underway) given significant evidence of harm to study participants.
This would be a topic of interest mainly to clinicians and researchers if politics had no so brazenly intruded on it. President Trump didn’t start the hydroxychloroquine mania. But there’s no question most of the interest in it has been driven by him. There is abundant evidence that the federal government’s push to purchase, push it into the hardest hit parts of the country and approve it for emergency use have been driven by the President personally. Indeed, indeed we have a high ranking whistleblower who claims he was booted from his job running the Biomedical Advanced Research and Development Authority because he wouldn’t fall into line about pushing hydroxychloroquine. After the President started pushing it, Trump appointees started pushing the drug on career officials and local public health authorities because the White House “really want[ed] to flood Ny and NJ” with hydroxychloroquine, according to emails reviewed by Vanity Fair.
Medical research is unpredictable – miraculous findings, great disappointments. That’s all the more so in the scramble to find treatments in the midst of a historic global outbreak of a novel disease. But here we have a case where the whole push was uniquely and overwhelmingly driven by a man with no clinical expertise whatsoever, in the face of varying degrees of resistance by medical experts and for reasons that remain significantly unclear. I will leave it to clinicians and health researchers to make sense of what level of proof we need to establish the risks of using this drug or combination of drugs for this purpose. But how many Americans took it under the FDA-emergency approval? If this study is even broadly accurate it seems quite likely that a non-trivial number of Americans were harmed or lost their lives because of this treatment regimen.
Again, life is full of risk and in the climate of an epidemic disease with no known cure it is appropriate to lean more aggressive into risk to find some treatment. But pressing a medicine on a whim and against the advice of medical experts puts this into the realm of negligence if these studies are borne out in further research.