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President Trump has been a cheerleader for the drug hydroxychloroquine, pointing in a tweet and in person to a French study as evidence that one particular drug combination might be one of the biggest game changers in the history of medicine.

But now the medical society that published the French research has issued a statement saying theyre reviewing the study again and a correction to the scientific record may be considered.

Dr. Kevin Tracey, president and CEO of the Feinstein Institutes for Medical Research in New York City, gave an even more pointed assessment of the French research.

The study was a complete failure, he said.

It was pathetic, added Art Caplan, head of the division of medical ethics at the New York University School of Medicine.

The small French study of 20 people found that taking hydroxychloroquine was associated with the viral load reduction/disappearance in COVID-19 patients, noting that the effect was reinforced with azithromycin, an antibiotic better known as a Z-pack.

Tracey and Caplan pointed out that several patients who took the drug, and ended up faring poorly, dropped out of the trial, and their outcomes were not factored into the studys final conclusions.

The International Society of Antimicrobial Chemotherapy published the study online in its journal, the International Journal of Antimicrobial Agents, on March 20.

The society and the publisher of the journal, Elsevier, issued a joint statement that concerns have been raised regarding the content, the ethical approval of the trial and the process that this paper underwent to be published within International Journal of Antimicrobial Agents.

According to the statement, the study authors had been contacted to address concerns, and that additional independent peer review is ongoing to ascertain whether concerns about the research content of the paper have merit.

One of the studys co-authors, Jean-Marc Rolain, is also editor-in-chief of the journal.

The statement noted that Rolain was not involved in the peer review of the manuscript.

The statement from the society and Elsevier is dated April 3, but a previous statement with the same date was on the same webpage and has since been removed.

That statement by Andreas Voss, president of the society, said the study does not meet the Societys expected standard and that 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.

Voss, Rolain and Didier Raoult, a lead study author, did not immediately respond to CNN emails seeking comment.

Rarely does one unproven drug make such headlines, but hydroxychloroquine did due to Elon Musk, conservative media and Trump.

A recent article in Vanity Fair laid out the sequence of events.

On March 16, Musk, the Tesla CEO, tweeted that it maybe worth considering chloroquine for C19. Hydroxychloroquine is a derivative of chloroquine, and C19 is Covid-19, the medical term for the disease caused by the coronavirus.

Two days later, Breitbart and The Blaze wrote glowing articles about chloroquine.

The day after that, Trump said chloroquine was possibly a game changer at a White House briefing.

Two days later, on March 21, Trump referred to the French study in a tweet, saying that the combination of hydroxychloroquine and azithromycin have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains Thank You!

Trumps enthusiasm for hydroxychloroquine hasnt waned with time, even though its one of many drugs being studied to prevent or treat coronavirus, and none of them have been proven to be safe or effective.

We have some very good results and some very good tests. Youve seen the same test that I have, he said at an April 5 briefing. In France, they had a very good test.

In its statement, the society that published the paper mentioned concerns about the lack of better explanations of the inclusion criteria in the study, which took place at the Mditerranne Infection University Hospital Institute in Marseille, France.

The study started out with 26 patients taking the hydroxychloroquine, but six were lost in follow up during the survey because of early cessation of treatment, according to the study.

Three left because they ended up in the intensive care unit, another patient died, and a fifth stopped treatment due to nausea. It turned out the sixth patient didnt actually have coronavirus.

Leaving out the five patients who took the drug and didnt fare well is cherry picking, said Caplan, the bioethicist.

Thats not science, he said. Youve got your thumb on the scale.

The remaining 20 patients took hydroxychloroquine, some with the antibiotic azithromycin and some without, and their outcomes were compared with patients who did not take either drug.

The study authors wrote that 100% of patients who took the drug combination were virologically cured compared to 57.1% of the patients who took hydroxychloroquine alone and 12.5% of the control group. The authors did not fully explain what they meant by virologically cured.

Caplan added that even without the cherry picking issue, a study with such a small number of patients is basically meaningless.

Its just a jumbled mess, he said.

Several centers are doing clinical trials on hydroxychloroquine to prevent or treat coronavirus, including Harvard, Columbia, New York University and Henry Ford Health System in Detroit.

Tracey, the researcher at the Feinstein Institutes in New York City, is also conducting a study on the drug. He said despite the French study being seriously flawed, its still worth looking at hydroxychloroquine to see if its safe and effective for a subset of coronavirus patients.

First, he noted that hydroxychloroquine has anti-inflammatory properties. The US Food and Drug Administration has approved its use against lupus and rheumatoid arthritis, both diseases that involve inflammation.

Hydroxychloroquine might help coronavirus patients who experience whats called a cytokine storm, a potentially deadly inflammatory process.

And small studies other than the seriously flawed French one have shown that the drug might work, he added.

Theres a lot of small studies in humans and in the lab that frame an appropriate question thats never been answered in a clinical trial, he said. Its important to know if it works and if its safe in some people with coronavirus.

Originally posted here:
Publisher of hydroxychloroquine study touted by Trump says the research didn't meet its standards - KVIA El Paso

This entry was posted on April 12, 2020 at 11:51 pm and is filed under Arthritis. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |