To better understand how using hydroxychloroquine (HCQ) to treat COVID-19 patients last year became a scientific quagmire, it’s always best to follow the money.
HCQ is cheap (costing under $10 for the course of a COVID-19 treatment), well-understood by physicians having been prescribed for more than 80 years, and can be taken orally. Yet, Dr. Anthony Fauci and others at the National Health Institute of Allergy and Infectious Diseases preferred remdesivir, a proprietary, intravenous drug manufactured by Gilead Sciences, costing about $3,500 per treatment, with unknown side effects. And as to not make Big Pharma mad — and possibly threaten invites to cocktail parties, board seats and threaten grant monies — Dr. Fauci and his cohorts did everything possible to promote remdesivir and downplay HCQ, possibly costing millions of lives around the globe.
Although, many doctors around the world were finding success with HCQ, in February 2020 NIH started enrolling patients for a remdesivir COVID-19 trial, with Dr. Fauci overseeing its progress. He had the final say on all the press releases, and presumably was working closely with Gilead. On April 16 something funny happened with the trial — the endpoints of it were quietly changed and updated on the clinicaltrials.gov website. Instead of evaluating remdesivir’s ability to prevent death from COVID-19, the study was redesigned to evaluate how fast a patient recovered from remdesivir.
It was an interesting change because a leaked World Health Organization study of remdesivir showed there was no statistically significant clinical benefits in using the drug on COVID-19 patients and that it had severe side effects. However, it did show some promise in reducing recovery time. When the news broke of this study to the public, on April 23, Gilead shares fell.
Drs. Dennis Bier at the Baylor College of Medicine and Arne Astrup, from the University of Copenhagen wrote in the BMJ Medical Trade Journal, NIH’s decision to move its study’s endpoints in the middle of the trial is generally frowned upon because the trial design is not drafted to focus on secondary endpoints, can produce data that’s unreliable, and can “introduce bias into a trial and creates opportunities for manipulation.”
Yet, on April 29, the NIH enthusiastically rolled out its results. During an appearance alongside former President Donald J. Trump in the Oval Office, Dr. Fauci said there was reason for optimism, the study achieved its primary goal, which was to improve the time to recovery, which was reduced by four days for patients on remdesivir. He failed to mention the study’s endpoint was changed mid-way through the trial. Still, the media tour was started, with Dr. Fauci at the lead, praising remdesivir and simultaneously bashing HCQ for its lack of a similar clinical trial. Gilead’s stock soared.
On May 1, the NIH’s COVID-19 Treatment Guidelines panel members granted emergency use of remdesivir and stated HCQ could only be used in hospitals or in studies. Investigative journalist Sharyl Attkisson found 11 members of that panel had financial ties to Gilead. Two were on Gilead’s advisory board, others were paid consultants or received research support and honoraria. None of the members, however, had ties to HCQ, which is made by numerous generic manufacturers, and “is so cheap, analysts say even a spike in sales would not be a financial driver for the companies,” Ms. Attkisson reported.
Ms. Attkisson also found one of the authors of a small Veterans Administration trial that claimed HCQ caused increased deaths received a $247,000 grant from Gilead in 2018.
On May 22, a fraudulent paper published by Lancet put the nail in HCQ’s coffin, claiming to show HCQ was not effective and was dangerous. The lead author of the now-debunked and retracted study was Dr. Mandeep Mehra, a Harvard professor, who attended a conference co-sponsored by Gilead a month before to discuss COVID-19. Many have speculated whether Gilead ghostwrote the study, as Surgisphere the company that spearheaded the effort, had only a handful of recently hired staff that reportedly included a science fiction writer and an adult-content model.
Yet, the damage was done. On June 11, the NIH updated its COVID-19 guidelines recommending against the use of HCQ except for in clinical trials. Days later, on June 15, the Food and Drug Administration revoked emergency use of HCQ, with remdesivir being the only officially U.S. endorsed drug to treat COVID-19.
The $2.45 million Gilead spent in the first quarter of 2020 lobbying the federal government was well spent. Meanwhile, a new, not yet peer-reviewed study of HCQ released this month found it, taken with azithromycin, improved COVID-19 survival by nearly 200% in ventilated patients.
If only there were money in the drug. Imagine the lives that could’ve been saved.
• Kelly Sadler is commentary editor at The Washington Times.