FDA Considers New COVID-19 Early Treatment Drugs

The original developer of an existing drug being used to treat COVID-19 is seeking approval for a new, early treatment drug much higher in price.

Merck and co-developer Ridgeback Biotherapeutics said on October 1 they were seeking emergency use authorization (EUA) for their experimental COVID-19 treatment, molnupiravir. If approved, the new drug, which cuts the risk of death or hospitalization by 50 percent, would be the first oral antiviral drug to treat COVID-19.

Merck is the original developer of the drug, ivermectin (IVM), an antiparasitic that is currently being used off-label by patients to prevent COVID-19 or to stop it in its tracks early. Ivermectin, however, is off-patent and there was no financial incentive for Merck to perform expensive efficacy trials to win favor for expanded use by the U.S. Food and Drug Administration (FDA) (see related article, page 21).

The U.S. government has already ordered 1.7 million courses of molnupiravir, at a cost of $700 per patient, the New York Times reported on October 1. Ivermectin is available as a generic drug and the lowest price for twenty 3 mg tablets is under $30, according to GoodRX. Doses vary depending on weight and whether the drug is being used to prevent infection or to treat after viral exposure, according to the Front Line COVID-19 Critical Care Alliance.

News of the EUA request sent Merck stock soaring more than 9 percent. Quartz reported on October 1 the company expects to produce 10 million courses of the drug before the end of 2021 and that it could make as much as $7 billion from molnupiravir, which would make it one of the most lucrative drugs ever.

Bureaucrats Like Reducing Risk

Big Pharma is not the only group that will benefit from molnupiravir’s recognition by the FDA; the bureaucratic state also has a lot at stake, says Merrill Matthews, Ph.D., a resident scholar with the Institute for Policy Innovation.

“Dr. (Anthony) Fauci has been a bureaucrat for decades,” said Matthews. “And most bureaucrats tend to embrace process and shun risk. The longer and more complex the process, the more most bureaucrats like it—because doing so appears to reduce risks, especially for them and their jobs.”

“Double-blind, placebo-controlled clinical trials are considered the gold standard in assessing a new drug’s safety and efficacy,” said Matthews. “But they are also the epitome of process, which is one reason why getting the FDA to approve new drugs, or a new use for an existing drug, can take so long. Even emergency use authorization for drugs follows the process, just an expedited version.”

There’s a Pattern Here

When Big Pharma and bureaucrats win, the health care market loses, says John C. Goodman, president of The Goodman Institute and co-publisher of Health Care News.

“The federal government in general, and Dr. Fauci in particular, have been very derelict in not promoting promising early treatments for COVID-19,” said Goodman. “The official view seems to be that we should not promote a treatment until it has been subjected to rigorous (FDA-type) testing.

“This ignores the fact that off-label drug uses (uses that have never been formally tested) are quite common in medicine, based on the experience of doctors and patients,” said Goodman. “For example, half of all cancer treatments are off-label and millions of cancer patients would have died prematurely if doctors were forced to follow Fauci’s view of medicine.”

Fauci did the same thing with AIDS—he limited the use of Bactrim and other cheap drugs while testing and pushing his own drugs, says Martha Leatherman, M.D., a geriatrician affiliated with South Texas Veterans Health Care System-San Antonio.

“It would be good to know whether Merck will get immunity for any adverse reactions,” Leatherman said.

“Lastly, it’s important to remember that Merck developed ivermectin, yet hasn’t defended its efficacy in early Covid treatment,” she said. “This is likely because they would not make money since the patent has ended.”

Another question involves EUA. According to section 564 of the Federal Food, Drug, and Cosmetic Act, the FDA can authorize EUE when certain conditions are met, including “no adequate, approved, and available alternatives.”

“What I find perplexing is this: If the new pills address COVID just like the vaccines do, then how can the EUA be justified since we already have the vaccines as treatment for COVID?” asks Joel Hirshhorn, author of Pandemic Blunder.

An independent body needs to look at the effectiveness of molnupiravir carefully,” Hirshhorn, tells Health Care News, as “…the new pills are surely just copies of IVM.”

Bad Incentives to Blame

One reason Merck downplayed IVM and even discredited its use for COVID-19 treatment is the FDA’s drug approval process.

“The FDA judges all drugs as guilty until proved, to the FDA’s satisfaction, both safe and efficacious,” writes David R. Henderson and Charles L. Hooper, in an article posted on the American Institute for Economic Research website, on October 18. “Merck could spend millions of dollars to get a COVID-19 indication for ivermectin and then effectively get zero return. What company would ever make that investment?”

While we can all be happy that Merck has developed a new therapeutic that can keep us safe from the ravages of COVID-19, we should realize that the FDA’s rules give companies an incentive to focus on newer drugs while ignoring older ones. Ivermectin may or may not be a miracle drug for COVID-19. The FDA doesn’t want us to learn the truth,” write Henderson and Hooper.

Kenneth Artz (KApublishing@gmx.com) writes from Dallas, Texas. AnneMarie Schieber (amschieber@heartland.org), the managing editor of Health Care News, contributed to this article.