Has there been a drug more vilified during the coronavirus pandemic than hydroxychloroquine (HCQ)? There is a new study out that may vindicate those who touted HCQ as a viable treatment drug for COVID-19. If the study findings hold up after it is peer-reviewed, HCQ taken with azithromycin, improved COVID-19 survival by nearly 200% in ventilated patients. That conclusion would be very good news.
For most of us, the whole controversy over the use of hydroxychloroquine in treating COVID-19 patients seemed mostly political in nature and less so about the drug’s effectiveness. Once Donald Trump came out in support of it, the gloves came off. At least half of the country decided that HCQ was not a scientific treatment for the coronavirus because the bad Orange Man was an anti-science president. Never mind that it was Trump who expedited the vaccine process to historic speed with Operation Warp Speed. He put together a White House coronavirus task force before many people (especially on the left) were willing to acknowledge the pandemic that originated in China. When Trump announced that he was taking HCQ himself, he was roundly mocked. Nevertheless, others in the medical community studied the use of the drug during the pandemic and found some positive results.
Dr. Robin Armstrong treated a nursing home outbreak of COVID-19 in Texas City, Texas with HCQ because it was available and worth a try if it saved patients. While Armstrong doesn’t credit hydroxychloroquine with saving the lives of his elderly patients, he touts the gamble as a success. The State of Texas purchased mass quantities of the drug and that is where Armstrong’s supply came from. He provided tablets to 38 residents who had tested positive but not yet shown symptoms. Three patients died, but 35 no longer showed COVID-19 symptoms. He declared them as “recovered,” though some still tested positive for the virus itself.
The drug remdesivir became a drug of preference in the medical community in the treatment of COVID-19. HCQ is cheap in price (under $10 for the course of a COVID-19 treatment) and has been used for more than 80 years, mostly as an anti-malaria drug. It is taken orally. Remdesivir is “a proprietary, intravenous drug manufactured by Gilead Sciences, costing about $3,500 per treatment, with unknown side effects.” Fauci and others at the National Health Institute of Allergy and Infectious Diseases preferred remdesivir. Why would that be? Let’s follow the money. There is an interesting op-ed in the Washington Times that does just that.
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.
Oh. Gilead quietly moved the study’s endpoint in the middle of the trial. There were clear conflicts of interest among members of the NIH’s COVID-19 Treatment Guidelines panel. Maybe nothing fishy was going on, but it sure looks as though something fishy was going on. It is hard not to notice that Dr. Fauci was the one presumed to be working closely with Gilead and giving the ok to press releases.
A paper was published by Lancet that proved fraudulent, yet it “put the nail in HCQ’s coffin.” The story by Harvard professor Dr. Mandeep Mehra has been debunked and retracted. Its conclusion was that HCQ is not effective and is dangerous. There was speculation that the paper was ghostwritten by Gilead. Mehra attended a conference on COVID-19 co-sponsored by Gilead a month before the paper was published. The damage was done. NIH updated its COVID-19 guidelines. It recommended against using HCQ except for clinical trials. The FDA revoked emergency use of HCQ and remdesivir is the only officially U.S. endorsed drug to treat COVID-19.
You may remember that when Trump was hospitalized with COVID-19, he was treated with remdesivir and did, indeed, experience a speedy recovery. By the way, Gilead spent $2.45 million in the first quarter of 2020 lobbying the federal government.
The results of the latest study showing success with HCQ in patient recovery time for those on a ventilator is very encouraging. Perhaps the Follow the Science people should practice what they preach. How many lives were lost because of tunnel vision?
Always follow the money.