COVID-19: FDA’s Negativism on HCQ Is Unfounded

Share:

I hope that if you get sick, your doctor doesn’t refuse to treat you for COVID-19, saying that he is following the FDA.

The FDA has stated that “There are currently no drugs or biological products approved or licensed for the treatment of COVID-19 in the United States.”

This is quite true. The approval process takes years or decades, and COVID-19 has been recognized for less than a year. The FDA also acknowledges that physicians have the legal right to prescribe already approved drugs “off label” as they deem appropriate.

So, physicians can prescribe, but they usually don’t. The FDA has asserted that hydroxychloroquine has no clinical effect or may be harmful in COVID-19. This statement has been used by regulatory agencies to restrict access to HCQ in most states.

On Aug 18, Sen. Ron Johnson (R-Wis.), Sen. Mike Lee (R-Utah), and Sen. Ted Cruz (R-Tex.) asked the FDA to provide any studies and data that informed its extremely influential negative statement. A reply was requested by Aug 25. One finally arrived on Oct 6.

This reply cites no studies or data demonstrating harmful effects in outpatients receiving HCQ or CQ for COVID under a doctor’s supervision. The letter lists 22 studies, at least six of which were in hospitalized patients, and the majority of which showed a favorable effect.

Apparently, the FDA’s negativism, which has deprived thousands of Americans of access to a cheap, safe drug that might have saved their lives, has no scientific foundation whatsoever.

The website c19study.com summarizes more than 130 studies of HCQ, which are overwhelmingly positive particularly when HCQ is used early, as well as studies of other drugs and vitamin D. If you can’t get HCQ or it hasn’t made you well, there are other treatments besides the highly touted, expensive, mostly unavailable REGN-COV2 Antibody Cocktail from Regeneron or Gilead’s remdesivir.

As we should have learned from President Trump’s experience, early treatment is key.

Dr. Peter McCullough of Baylor and colleagues has presented a lecture and a treatment protocol developed from experience treating patients in the US. and Italy. (See figure below.)

If you or a loved one—or your readers—are ill or exposed to risk of COVID-19, pass along this information to their doctor. It is published in the respected American Journal of Medicine , but is not being disseminated by most medical societies or public health authorities. [An updated protocol is available as is a video explanation by Dr. McCullough.]                 For further information, see AAPS compendium of articles.