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U.S. FDA revokes hydroxychloroquine emergency approval as a Covid-19 treatment

By Lev Facher

The U.S.  Food and Drug Administration on Monday said it had withdrawn an emergency approval for use of the malaria drug hydroxychloroquine as a Covid-19 treatment.

Credit: George Frey / Getty Images

Almost since the beginning of the novel coronavirus pandemic, U. S. President Donald Trump and other world leaders have touted hydroxychloroquine as an effective treatment based on scattered anecdotes, not reliable scientific studies. But the FDA said Monday that the drug, along with chloroquine, is “unlikely to be effective in treating Covid-19,” and highlighted “serious side effects.”

The FDA’s withdrawal of the emergency use order, which Politico first reported, appears to formally close the door on U.S. officials’ willingness to use the drug to prevent or treat Covid-19, the disease caused by the novel coronavirus.

In recent weeks, an increasingly conclusive body of research showed the drug was not effective at treating Covid-19 or at preventing the respiratory disease from developing in individuals who’d been exposed to the virus.

The controversy has pitted Trump and his high-profile allies against the country’s scientific establishment. Rick Bright, a prominent government scientist, has alleged he was ousted from his vaccine-development role after he opposed the initial emergency approval for hydroxychloroquine. At a March press conference, Trump said his belief in the drug was “just a feeling,” contradicting Tony Fauci, the country’s top infectious disease researcher, who told reporters minutes before there was no reliable evidence supporting hydroxychloroquine’s use.

Despite the lack of evidence supporting the drug’s use, Trump continued to tout it as a promising tool to treat and prevent Covid-19, even announcing last month that he had taken a regimen of hydroxychloroquine as a safeguard.

Asked for comment, an FDA spokesman directed STAT to an online list of current emergency use authorizations for Covid-19 medical products. The list no longer includes hydroxychloroquine.

In a letter to Gary Disbrow, the acting director of the Biomedical Advanced Research and Development Authority, a top FDA official said the withdrawal of the hydroxychloroquine approval was based on recent science that showed the drug to be ineffective.

“Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat [Covid-19] and that the drug’s potential benefits for such use do not outweigh its known and potential risks,” wrote Denise Hinton, the FDA’s chief scientist.”

The FDA had previously expressed concerns about broad use of hydroxychloroquine, issuing a pointed warning in late April that cautioned against use of the drug outside the setting of a hospital or clinical trial.

While the hydroxychloroquine saga largely pitted politicians against scientists, the science underpinning the debate also proved, at times, surprisingly unreliable. Earlier this month, the Lancet, a leading medical journal, retracted an influential study that suggested hydroxychloroquine wasn’t just ineffective but also potentially unsafe for use as a Covid-19 treatment.

Nicholas Florko contributed reporting.

14 thoughts on “U.S. FDA revokes hydroxychloroquine emergency approval as a Covid-19 treatment

  1. Never a doubt that the FDA is a captive of Big Pharma. I listened to 2 doctors that say it can still be prescribed off label, though.

    1. The FDA is also a captive of Donald Trump so you can figure the evidence is pretty strong that the stuff doesn’t work.

      1. Just can’t resist taking a swipe at the President, can you? Let’s show some respect for whoever’s in the Whitehouse. Are you willing to dismiss the extensive research & trials by Dr. Rault in France, as well as others as to saving lives with hydroxychloroquine? The FDA is no more a captive of the current president than it is of any other president in office.

        1. Dr. Rault in France is doing research, but not saving lives. …” it wasn’t long before experts were raising serious problems with the way these results had been presented.

          In all, 26 patients were given hydroxychloroquine, of whom six were also given azithromycin. And yet only 20 of these people made it into the results. Three were transferred to intensive care; another died. One more decided to stop taking the drug because it made them nauseous, and another simply left the hospital. Since the study relied on being able to test the presence of the virus via daily nasal swabs, these patients were left out of the final data.

          This was problematic enough, but the trial had other major design flaws too. “The biggest one was the lack of randomisation,”

    2. Yes, that’s true, 2 MDs in my family in NYC have prescribed it, and so have many of their colleagues. It will be in use for a long time. Works better than “opiods,” er, I mean, “opioids.” There is an MD here, from a steel mill in Honolulu, who will get the tree bark remedy for you here. Down the street from Jackie Schweigert.

      1. Thanks. I read recently of severe penalties for harvesting the tree bark that quinine comes from. Too much bark removed kills the tree. I know someone that has some of the bark.

    3. Let’s be honest, Judy. If Trump said the drug was worthless, there would be the same people replying that the drug works fine, saved lots of lives, and as usual Trump lies.

  2. the American College of Physicians and Surgeons have provided the correct interpretation of the FDA ‘order’. HCQ works quite well in the early stages of this CV thing as reported by thousands of doctors across the world. It is less helpful in end stages. Here is the ACPS announcement:

    “””””In fact, the EUA (emergency use auth) was put in place to improperly restrict use of the donated drugs to only hospitalized patients. The now infamous “whistle-blower” Rick Bright, PhD, admits that he pushed for the EUA to impede use (not expand it).

    The Trump Administration wanted to make the donated HCQ available for early treatment outside of hospital settings, but Rick Bright pushed for an EUA to restrict use to hospitals where it is often too late for the treatment to be beneficial.

    Today’s revocation of the EUA by the FDA is, in a sense, an admission that the agency erred by limiting the supply in the NSS to use in hospitalized patients.

    A good outcome of today’s FDA order is that it states that the NSS supply of HCQ “can be distributed in interstate commerce.” This means it could be available for off-label early treatment, instead of limited to only hospitalized patients.

    So rescinding the EUA does NOT meant that HCQ cannot be used for early treatment of COVID-19 patients. It means that the supply of the drug stuck in the stockpile is now free from the EUA’s retractions (restrictions), once it is released into the consumer supply chain.

    Will it then be shown that HCQ does not kill people as reported by the MSM, did Trump just setup the biggest lawsuit ever””””””

    1. Thanks for the details that were skipped over in the interviews I listened to. The main thing is that somebody who needs it can get it in the U.S. I know someone who got the pills here recently. So it’s available in EC.

  3. It is my understanding that the drug DOES work and IS effective, but not so much on patience that are too far gone. This article is so biased.

  4. HCQ and chloroquine have been used for years in treating auto immune disorders and is a FDA approved drug. If it is so dangerous why was it approved by the FDA which is a very corrupt organization and an offshoot of the drug cartel.

  5. The FDA is covering for the drug companies since it gets a lot of “contributions”. The drug companies can’t make the billions they hope to if hydroxychloroquine is approved. That’s the reason they’re scrambling to be the first to get their own drug approved. Yes, no, maybe ??

  6. Are talking here about the FDA who approves drugs that kill over 100,000+ people a year? Who is behooven to the FDA for their egregious and fatal decisions? The pharmaceutical companies of course.

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