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FDA to Consider Pricier Alternative to COVID-19 Early Treatment Drugs

By Kenneth Artz, Heartland Institute

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 treatment to fight COVID-19 that is an oral antiviral drug.

Merck is the original developer of the drug, ivermectin, an antiparasitic,  which 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).

According to the New York Times on October 1, the U.S. government has already ordered 1.7 million courses of molnupiravir, at a cost of $700 per patient. The average retail price of ivermectin is $109, according to GoodRx.

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 [the] 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, the 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,” he continued. “For example, half of all cancer treatments, for example, 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 in San Antonio who is 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.”

Blocking Known Treatments, Again

An October 7 article in The Defender noted that Merck accepted $10 million from the U.S. Department of Defense (DOD) and $19 million from the National Institutes of Health (NIH), both in taxpayer-funded grants to develop molnupiravir.

Robert F. Kennedy, Jr., the founder and chairman of Children’s Health Defense noted the collusion between drug companies and the federal government to increase profits during the COVID-19 crisis.

“One analyst predicted COVID boosters alone will bring in $26 billion in global sales next year for Pfizer and BioNTech — and around $14 billion for Moderna if the shots are endorsed for nearly all Americans,” tweeted Kennedy on September 27.

Kennedy’s tweets reveal a lot about what Fauci is up to, says Paul Buckingham, a U.K. member of Doctors for COVID Ethics (D4CE), a group of doctors and scientists from 30 countries seeking to uphold medical ethics, patient safety, and human rights in response to COVID-19.

“RFK Jr’s comment is particularly relevant as to why Fauci is blocking known treatments (again), and we have to keep in mind that if there are known treatments, then no EUA can be issued, and hence the reason why treatment protocols that are now well established by the likes of Dr.  Peter McCullough (one of our members) are being intentionally ignored,” Buckingham said.

“When you have a system where the taxpayer pays for the development (not a very good one at that) and then charges exorbitant prices to manufacture, then you know you are dealing with what is essentially a ‘racketeering’ operation,” he said.

The Vaccine Strategy

The blocking of existing safe, proven, effective, and fully FDA-approved generics, namely ivermectin and hydroxychloroquine, by Fauci through NIH and FDA, was initially to create the market for the COVID vaccines, says Joel Hirschhorn, author of Pandemic Blunder.

“Now their same morally corrupt thinking is pushing rapid EUA for the new pills based on very limited testing; as with the vaccines there is no long-term testing for adverse effects,” said Hirshhorn. “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?” Hirshhorn asks.

An independent body needs to look at the effectiveness of molnupiravir carefully, says Hirschhorn, as “…the new pills that are surely just copies of IVM.”

 


Kenneth Artz (KApublishing@gmx.com) writes from Dallas, Texas.