Virus Update: The FDA & The War Over HC

Judicial Watch readers have been closely following President Trump’s efforts to promote hydroxychloroquine (HC), the anti-malaria drug that has shown promise in the fight against Covid-19. Trump has encountered fierce blowback from the media, the medical community, and even from within his own administration. Still, he persists. “I happen to be a believer in hydroxy,” he told reporters on July 29. “I used it. I had no problem. I happen to be a believer.”

There are other believers too. The Second Opinion Project today will deliver to the White House a letter from over 700 doctors asking that HC be made widely available. The doctors target the Food and Drug Administration’s erratic regulation of HC availability to medical professionals and the public.

“You do not need initials after your name to understand that if you restrict a life-saving medicine, more patients will die,” the doctors write. “And then, if you un-restrict it, fewer patients will die.”

As in-depth clinical studies of the drug grind on, so does the war over HC. Sources tell Judicial Watch that resistance to HC inside the Trump Administration is strong, with ongoing battles between the White House and several government agencies—particularly the FDA.

A look at the FDA timeline on HC shows why it is coming under fire.

On March 28, weeks after the president began promoting HC, the FDA issues an Emergency Use Authorization, allowing doctors to use HC to treat patients with Covid-19.

On April 9, with pushback from the media and medical community mounting, the Centers for Disease Control remove from their website guidelines indicating HC has some success in treating Covid-19.

On April 24, as rushed early studies raise questions about HC but anecdotal reports continue to suggest some success, the FDA warns against its use outside of a hospital setting.

On May 22, the prestigious medical journal Lancet publishes a blockbuster study of more than 96,000 patients saying HC does not help in the fight against Covid-19 and might increase patient deaths. News of the study reverberates around the globe.

On June 5, the Lancet retracts the HC study, citing serious flaws in the data. “We deeply apologize,” the Lancet writes.

On June 15, the FDA revokes its Emergency Use Authorization. Curiously, one of the reasons for the revocation appears to be the discredited Lancet study, which the FDA refers to as “recent data from a large randomized controlled trial show[ing] no evidence of benefit for mortality.”

On July 1, the FDA again warns against the use of HC outside a hospital setting.

On July 29, the FDA chief backs away from a definitive HC warning. There is “some risk” associated with HC, Dr. Stephen Hahn tells NBC. But that’s “a decision between a doctor and a patient.”

The 700 doctors signing the Second Opinion Project letter aren’t claiming that the drug is a miracle cure—and neither is Trump. They want clarity from the FDA and wide access to the drug.

Second Opinion is also promoting a second, similar letter from everyday Americans supporting HC access. Americans should “have access to a safe, generic, widely-available drug that is routinely given to pregnant women, breastfeeding women, children, the elderly and the immune compromised since it was FDA-approved 65 years and billions of dosages ago,” the letter states. “In order to clarify the public perception of HC and to restore the doctor-patient relationship, the FDA should immediately authorize an [Emergency Use Authorization] stating that doctors are allowed to prescribe HC for outpatient use to treat or prevent Covid-19.”

Read the full letter here.

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Micah Morrison is chief investigative reporter for Judicial Watch. Follow him on Twitter @micah_morrison. Tips: [email protected]

Investigative Bulletin is published by Judicial Watch. Reprints and media inquiries: [email protected]