Requiem for hydroxy hype

Beyond the curve: Dr. Peter Lurie's COVID-19 blog

You could see the train wreck coming from a mile down the track. The moment President Trump used a briefing of the Coronavirus Task Force to tout the purported benefits of hydroxychloroquine, one knew it wasn’t going to end pretty.

There was the reference to anecdote and a French study[1] , subsequently discredited[2]. Later came the claims that it was working: indeed, that it was “one of the biggest game changers in the history of medicine.” And then the claim that the President was himself indulging⁠—the ultimate celebrity endorsement.

Despite the hype and the false hope it engendered, the Food and Drug Administration’s revocation today of the Emergency Use Authorization (EUA) for hydroxychloroquine and chloroquine is unquestionably in the best interests of patients. And it is to FDA’s credit that it was able to take a fresh look at the data and recognize the error of its ways. Ultimately, the combined force of two randomized controlled trials, numerous observational studies and a slew of adverse cardiac events reported to the agency, including 25 deaths, proved too much to resist.

But the underlying question remains why FDA authorized the product on such skimpy evidence in the first place, and why it caved in to pressure from the White House in doing so. We must also ask ourselves how many promising drugs for COVID-19 went unstudied as researchers across the globe pivoted to address the latest evidence-free pronouncements emanating from the White House podium. And how many patients with lupus and rheumatoid arthritis, for whom the drug actually is effective, had to go untreated as the drug was used to futilely treat COVID-19 or went into limbo in the medicine cabinets of the physicians who hoarded it for themselves and their families?

At the end of this sorry debacle, the lesson is the same it always is in science: answers to difficult research questions do not come from wishful thinking or from the recommendations of television hosts or the President’s pals; they come from the painstaking efforts of committed researchers using time-tested clinical trial methods. Had we done that, this spectacle would have been avoided, and a number of COVID-19 patients who apparently died from hydroxychloroquine cardiac toxicity would still be with us.

[1]Gautret P, Lagiera J-C, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. International Journal of Antimicrobial Agents. DOI : 10.1016/j.ijantimicag.2020.105949 (in press March 17, 2020). Available at: https://www.mediterranee-infection.com/wp-content/uploads/2020/03/Hydroxychloroquine_final_DOI_IJAA.pdf (accessed April 11, 2020).

[2]Voss A. Official Statement from International Society of Antimicrobial Chemotherapy. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Available at: https://www.isac.world/news-and-publications/official-isac-statement (accessed April 11, 2020).