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How Scientific is the FDA?

Summary:
Not as much as  you might think. The Food and Drug Administration claims to follow the science. So why is it attacking ivermectin, a medication it certified in 1996? Earlier this year the agency put out a special warning that “you should not use ivermectin to treat or prevent COVID-19.” The FDA’s statement included words and phrases such as “serious harm,” “hospitalized,” “dangerous,” “very dangerous,” “seizures,” “coma and even death” and “highly toxic.” Any reader would think the FDA was warning against poison pills. In fact, the drug is FDA-approved as a safe and effective antiparasitic. Ivermectin was developed and marketed by Merck & Co. while one of us (Mr. Hooper) worked there years ago. William C. Campbell and Satoshi Omura won the 2015 Nobel Prize for

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How Scientific is the FDA?

Not as much as  you might think.

The Food and Drug Administration claims to follow the science. So why is it attacking ivermectin, a medication it certified in 1996?

Earlier this year the agency put out a special warning that “you should not use ivermectin to treat or prevent COVID-19.” The FDA’s statement included words and phrases such as “serious harm,” “hospitalized,” “dangerous,” “very dangerous,” “seizures,” “coma and even death” and “highly toxic.” Any reader would think the FDA was warning against poison pills. In fact, the drug is FDA-approved as a safe and effective antiparasitic.

Ivermectin was developed and marketed by Merck & Co. while one of us (Mr. Hooper) worked there years ago. William C. Campbell and Satoshi Omura won the 2015 Nobel Prize for Physiology or Medicine for discovering and developing avermectin, which Mr. Campbell and associates modified to create ivermectin.

These are the opening 3 paragraphs of David R. Henderson and Charles L. Hooper, “Why Is the FDA Attacking a Safe, Effective Drug?,” Wall Street Journal, July 28, 2021 (electronic) and July 29 (print.)

I’ll post the whole piece in 30 days. We found out last night, in response to some feedback, that one of the studies we quote was retracted earlier this month due to questionable data. We immediately drafted a letter last night to the Wall Street Journal stating that we retract our cites of that study.

The Wall Street Journal editor was quite responsive, adding this correction at the bottom:

Correction
This article has been edited to remove a reference to a study of 200 healthcare workers by Ahmed Elgazzar of Benha University in Egypt. Messrs. Henderson and Hooper relied on a summary of studiespublished in the American Journal of Therapeutics. They learned after publication that this study has been retracted because of charges of data manipulation.

Because we cited multiple evidence, though, we stick by the rest of the piece. Also, our main point, that, contrary to the FDA, ivermectin is incredibly safe, stands.

David Henderson
David R. Henderson (born November 21, 1950) is a Canadian-born American economist and author who moved to the United States in 1972 and became a U.S. citizen in 1986, serving on President Ronald Reagan's Council of Economic Advisers from 1982 to 1984.[1] A research fellow at Stanford University's Hoover Institution[2] since 1990, he took a teaching position with the Naval Postgraduate School in Monterey, California in 1984, and is now a full professor of economics.[3]

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