Why did the FDA try to block the study and use of Ivermectin for Covid?

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Why did the FDA try to block the study and use of Ivermectin for Covid?

Imagine if a company like Pfizer had a product that would make the company billions but we're going to be unable to market it if there was another product already in the market... It would be easily conceivable that a company like Pfizer could use the revolving door arrangement with the FDA to benefit their agenda....

Pharma-giant Pfizer announced on June 28 that the former US Food and Drug Administration commissioner Scott Gottlieb would be joining its board of directors. The move fell in line with a troubling pattern: After their tenure at the FDA, commissioners tend to go on to advise private companies in the pharmaceutical industry.

In fact, 9 out of the last 10 FDA commissioners—representing nearly four decades of agency leadership—have gone on to work for pharmaceutical companies. The lone exception, David Kessler, joined the ranks in academia before eventually settling in his current position as chair of the board of directors at the Center for Science in the Public Interest, a non-profit nutritional science advocacy group. On its own, Gottlieb’s move from FDA commissioner to Pfizer board member isn’t necessarily a problem for the FDA. There’s nothing illegal about the move, Kessler told Quartz in an interview. However, when it happens again and again—as it has for the past 38 years—it raises the specter of conflict of interest. The perception of a so-called “revolving door”—a chummy agreement between big drug companies and the regulators who approve their products for sale—undermines trust in the FDA.

https://www.google.com/amp/s/qz.com/1656529/yet-another-fda-commissioner-joins-the-pharmaceutical-industry/amp/

A group of doctors has filed a lawsuit against the Biden administration claiming it unlawfully attempted to block the use of ivermectin in treating COVID-19. It names the Department of Health and Human Services, HHS Secretary Xavier Becerra, the Food and Drug Administration, and FDA Commissioner Robert M. Califf as defendants. In the filing, plaintiffs Mary Talley Bowden, Paul E. Marik, and Robert L. Apter argued that by publicly ordering health professionals and patients to avoid ivermectin, the FDA both acted outside of its authority and inhibited the doctors’ ability to practice medicine. Though the FDA has approved ivermectin to treat certain infections, the department has urged the public not to use the drug to treat COVID-19. “Moreover,” the filing continues, “if the FDA is allowed to interfere with the practice of medicine now under cover of a pandemic, this interference will metastasize to other circumstances, destroying the carefully constructed statutory wall between federal and state regulatory powers, and between the FDA and the professional judgment of health professionals.”

https://boydengrayassociates.com/complaint-in-apter-v-hhs-no-322-cv-184-s-d-tx-june-2-2022-2/

Initially the only FDA approved treatment for covid was Remdesiver. Pfizer has an agreement with Gilead, the owners of Remdesiver to manufacture the drug. October was a good month for Gilead Sciences, the giant manufacturer of antivirals headquartered in Foster City, California. On 8 October, the company inked an agreement to supply the European Union with its drug remdesivir as a treatment for COVID-19—a deal potentially worth more than $1 billion. Two weeks later, on 22 October, the U.S. Food and Drug Administration (FDA) approved remdesivir for use against the pandemic coronavirus SARS-CoV-2 in the United States—the first drug to receive that status. The EU and U.S. decisions pave the way for Gilead's drug into two major markets, both with soaring COVID-19 cases. But both decisions baffled scientists who have closely watched the clinical trials of remdesivir unfold over the past 6 months—and who have many questions about remdesivir's worth. At best, one large, well-designed study found remdesivir modestly reduced the time to recover from COVID-19 in hospitalized patients with severe illness. A few smaller studies found no impact of treatment on the disease whatsoever. Then, on 15 October—in this month's decidedly unfavorable news for Gilead—the fourth and largest controlled study delivered what some believed was a coup de grâce: The World Health Organization's (WHO's) Solidarity trial showed that remdesivir does not reduce mortality or the time COVID-19 patients take to recover. Science has learned that both FDA's decision and the EU deal came about under unusual circumstances that gave the company important advantages. FDA never consulted a group of outside experts that it has at the ready to weigh in on complicated antiviral drug issues. That group, the Antimicrobial Drugs Advisory Committee (AMDAC), mixes infectious disease clinicians with biostatisticians, pharmacists, and a consumer representative to review all available data on experimental treatments and make recommendations to FDA about drug approvals—yet it has not convened once during the pandemic.The European Union, meanwhile, decided to settle on the remdesivir pricing exactly 1 week before the disappointing Solidarity trial results came out. It was unaware of those results, although Gilead, having donated remdesivir to the trial, was informed of the data on 23 September and knew the trial was a bust. “This is a very, very bad look for the FDA, and the dealings between Gilead and EU make it another layer of badness," says Eric Topol, a cardiologist at the Scripps Research Translational Institute who objected to remdesivir's FDA approval.

https://www.science.org/content/article/very-very-bad-look-remdesivir-first-fda-approved-covid-19-drug

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