The French virologist Dr. Didier Raoult, who early in the pandemic successfully treated COVID-19 patients with hydroxychloroquine, has issued an “expression of concern” excoriating the prestigious New England Journal of Medicine for publishing dubious studies.
In trenchant terms, Raoult calls out the journal for publishing studies with such egregious flaws that the practices would not pass muster at his teaching hospital in Marseille. He highlights, for instance, the most obvious limitation of a widely touted study claiming to show that hydroxychloroquine treatment does not prevent COVID-19: Less than 3 percent of the study participants had a confirmed diagnosis.
The RECOVERY trial, published in the journal and celebrated for showing that dexamethasone improves survival in hospitalized patients, was no major breakthrough. Anti-inflammatory steroids help patients in respiratory distress, and hospital protocols that include steroids in COVID-19 treatment were already the norm elsewhere.
Why even run such a study, asks Raoult, let alone withhold treatment from patients in the control group? Scandalously, in another arm of the study, these investigators overdosed patients with toxic levels of hydroxychloroquine, then dismissed the drug as useless.
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Failures of Remdesivir
Contrast that to the receptiveness to Remdesivir. Following the journal’s publication of preliminary findings, the experimental drug was declared a “game changer.” The trial, however, showed only modest results. When the main outcome measure, a reduction in deaths, failed to reach statistical significance, a secondary outcome, time to hospital discharge, was elevated as a measure of recovery. Hospital stays were shortened from 15 to 11 days on average.
A companion study of patients treated with Remdesivir for either five or 10 days, however, should give pause. A four-fold higher rate of acute kidney injury occurred with the longer treatment, an outcome not readily discerned when major and minor adverse events are reported in aggregate.
Did the journal editors or peer reviewers express any concern? One hears nothing of this finding from the medical establishment, the regulatory agencies, nor the news media. By contrast, an observational study of severely ill hospitalized patients, in which hydroxychloroquine statistically halved the death rate even after correcting for factors such as steroid use, was pronounced “flawed.”
Thus Remdesivir, a failed Ebola drug repurposed for COVID-19, is declared the standard of care by a National Institutes of Health (NIH) panel, the members of which have financial ties to the manufacturer, Gilead Sciences. The same panel duly notes the hydroxychloroquine study results yet “recommends against” using the drug except in clinical trials.
Sadly, this phenomenon is not new. Fifteen years ago, a survey of 200 expert panels that issued practice guidelines found that a third of the members had a financial interest in the drug under consideration.
Effectiveness of Hydroxychloroquine
Antiviral drugs such as Remdesivir and hydroxychloroquine work best early in the disease, as they block cell infection, viral replication, or both. Although Remdesivir should stop the virus from replicating, one study found it failed to reduce viral loads. By contrast, hydroxychloroquine (ideally given with zinc) reduces viral loads and helps prevent COVID-19 from developing into a serious illness.
Moreover, the hysteria over hydroxychloroquine’s safety is hyperbole: Decades of evidence indicate safe use under a doctor’s care. A hospital study to address this specific issue found the drug to be safe for COVID-19 patients with cardiovascular disease, the very patients for whom there may be a concern.
Suppressing early treatment with hydroxychloroquine based on the lack of randomized prospective trials is unwarranted. Dr. Thomas Frieden, former head of the Centers for Disease Control and Prevention, argued against excessive reliance on such data while discounting other worthwhile and sometimes superior evidence.
If the need for a large prospective trial on hydroxychloroquine is the main roadblock, why hasn’t the NIH already sponsored one? Multinational coalitions have called for such a study. No doubt the American public would consider this a worthy use of taxpayer money.
Few people recognize that most of the funding for clinical trials comes from the pharmaceutical industry and that the industry deeply influences their conduct. Nor is it widely known that two-thirds of the Food and Drug Administration’s (FDA) budget for evaluating prescription drugs comes from the industry it regulates.
Even less apparent is that federal legislation allows institutions supported by federal grants to patent and license new products. Investigators are handsomely remunerated through consulting fees, equity in the pertinent companies, and patent and royalty agreements.
Follow the Money
The National Institute of Allergy and Infectious Diseases, a branch of the NIH led by Dr. Anthony Fauci, sponsored the multicenter trial of Remdesivir. Remdesivir is experimental, expensive, scarce, and administered by intravenous injection. Hydroxychloroquine is off-patent, cheap, widely available, and taken orally. Yet the FDA granted an emergency use authorization for Remdesivir but revoked such authorization for hydroxychloroquine and will not allow the hospitals that saved patients to keep using it.
Why stymie a treatment that is pragmatic, affordable, helps ill patients, and could reduce the need for hospitalization? Spurred by such obvious considerations, a current lawsuit demands that the FDA remove its hydroxychloroquine restrictions. Three U.S. senators now request that the FDA provide evidence to justify its apparent conclusion that the drug is unsafe or ineffective when used early under a doctor’s care.
Pharmaceutical giants such as Gilead Sciences have major stakes in the global financial industry. Drug companies are known to promote their products and marginalize naysayers by covertly controlling the public narrative. Independent journalist Sharyl Attkisson attempted to examine the controversy in depth, but Fauci and Gilead Sciences declined her interview requests.
What to make of this state of affairs? Dr. Marcia Angell, former editor of the New England Journal of Medicine, offers this sobering assessment:
It is simply no longer possible to believe much of the clinical research that is published, or to rely on trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.
When will we witness unblemished science, probing journalism, and a true commitment to the common good? Alas, Dr. Raoult, they abuse our patience indeed.