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Thursday, April 9, 2020

French COVID-19 study touted by Trump discredited

The publisher of that paper says it “does not meet the Society’s expected standard”
By Will Collette

Trump's promotion of the drug hydroxychloroquine to fight ...First, I’d love to see researchers come up with an effective treatment for COVID-19 and it would be OK with me if it was Donald Trump’s magic hydroxychloroquine tablets. Or something else – that’d be OK, too. And also a vaccine.

But wishing doesn’t make it so.

Neither does Trump’s Big Lie tactic of saying something is true so often that people believe it. Like repeatedly referring to a French study that has been thoroughly rebuked by the scientific community.

We still don't know if hydroxychloroquine is a viable solution to COVID-19. 

The International Society of Antimicrobial Therapy, the folks who published the controversial paper have issued a statement on April 3 essentially blaming itself for publishing a report that failed to meet proper research standards. That statement appears verbatim at the end of this article.

When Dr. Tony Fauci says that the science behind hydroxychloroquine and COVID-19, so far, is “anecdotal,” he was at least indirectly talking about this study.

International experts unloaded on this study. Among its many flaws was it only reported on results from 20 patients who did well. That’s too low a sample. Plus, the study excluded results from patients who did not do well on the drug and dropped out of the study.

Further, the results were not peer-reviewed, a process considered necessary before any research can be taken seriously.

Dr. Kevin Tracey, president and CEO of the Feinstein Institutes for Medical Research in New York City, told CNN "The study was a complete failure."

The Centers for Disease Control withdrew its initial, optimistic guidance to doctors on how to prescribe it. They replaced it with a new guidance that leads with the warning that There are no drugs or other therapeutics approved by the US Food and Drug Administration to prevent or treat COVID-19. 

The FDA has not approved the drug for use on COVID-19 patients despite Trump’s insistence that it is a miracle cure.

Cardiac problems

Among the patients at highest risk of dying from COVID-19 are people with pre-existing heart disease. They are among those ICU patients struggling to stay alive.

Thus, it’s a terrible irony that one of the side effects of the hydroxychloroquine cocktail is the heightened risk of cardiac arrest.

Dr. Michael Ackerman, a genetic cardiologist who is director of the Mayo Clinic's Windland Smith Rice Genetic Heart Rhythm Clinic, has been trying to rein in expectations.

"What disturbed me the most was when I was seeing not political officials say these medications are safe but seeing on the news cardiologists and infectious disease specialists say ‘hydroxychloroquine’ is completely safe without even mentioning this rare side effect…That's inexcusable."
He is far from alone in criticizing the rush to hydroxychloroquine.

The Canadian Medical Society listed an urgent warning about that and other serious side effects, noting that for a drug with little proven effectiveness against COVID-19, patients are being exposed to some potential life-threatening risk.

The University Hospital Center of Nice ended its trial of the drug, citing the cardiac risk.

Again, I’d like researchers to come up with good treatments and vaccines but I understand that takes time. Donald Trump doesn’t have the attention span or intellectual capacity to grasp that concept.

So besides maintaining social distancing and washing your hands, remember to NEVER listen to Donald Trump.

Here’s the disclaimer issued by the International Society of Antimicrobial Therapy

Statement on IJAA paper, Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial” (Gautret P et al. PMID 32205204)

ISAC shares the concerns regarding the above article published recently in the International Journal of Antimicrobial Agents (IJAA). The ISAC Board believes the article does not meet the Society’s expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety.

Despite some suggestions online as to the reliability of the article's peer review process, the process did adhere to the industry's peer review rules. Given his role as Editor in Chief of this journal, Jean-Marc Rolain had no involvement in the peer review of the manuscript and has no access to information regarding its peer review. Full responsibility for the manuscript's peer review process was delegated to an Associate Editor.

Although ISAC recognises it is important to help the scientific community by publishing new data fast, this cannot be at the cost of reducing scientific scrutiny and best practices. Both Editors in Chief of our journals (IJAA and Journal of Global Antimicrobial Resistance) are in full agreement.

Andreas Voss
ISAC President 
 April 3rd-2020