Doctors' group: HCQ-hoarding FDA cares more about power than Americans' lives

The American Association of Physicians and Surgeons contends the Food and Drug Administration cares more about its power over drug stockpiles than the lives of Americans.

The AAPS has sued the FDA for withholding from its Strategic National Stockpile supplies of hydroxychloroquine, a drug that many studies show reduces the impact of coronavirus.

"[Defendants] care more about their power over the HCQ Stockpile than the lives being lost daily without access to it: 'the injunction plaintiff seeks would irreversibly overturn the status quo, by compelling the government to disburse the hydroxychloroquine in the Stockpile—a step that, once taken, cannot be undone,'" the AAPS is arguing in its latest court filing in the case.

The group said "it is the loss of life that 'cannot be undone.'"

In its court filing, the AAPS said the FDA holds 60 million doses of HCQ donated for the purpose of treating COVID-19 patients. Experts such as Yale Professor Dr. Havey Risch believe the release of HCQ could save 50,000 to 100,000 lives.

Further, the drug has been approved as safe by the FDA since 1955 and the CDC officially declared it is safe today.

The FDA argues its decision are not reviewable by a federal court.

The AAPS reasons that according to that view, the agency "could dump the entire HCQ Stockpile into the Potomac River and there would be no legal accountability."

The AAPS is asking the 6th U.S. Circuit Court of Appeals to enjoin the FDA to "make available and distribute promptly, and for the benefit of the public holding valid prescriptions, the HCQ being stored in the [Strategic National Stockpile]."

The case began when the agency denied a request for the use of the drug after a clinical trial showed it to be effective.

The FDA "continues to obstruct the use of a long-established antimicrobial that can also be used in outpatients, to prevent the need for hospitalization," said the organization's executive director, Dr. Jane Orient.

Orient noted a research team with the Henry Ford Health System in Detroit filed a request with the FDA for emergency use authorization for preventive and early treatment of COVID-19 with hydroxychloroquine. The request came after the researchers found hospitalized patients showed a 51% reduction in mortality.

"Because of FDA's negative statements about HCQ (hydroxychloroquine), patients are having great difficulty in obtaining HCQ," Orient said.

The lawsuit was filed in June.

Hydroxychloroquine is an FDA-approved medicine, used commonly for malaria and autoimmune diseases such as rheumatoid arthritis. The legal case argues physicians have the authority to prescribe it for other indications.

Elizabeth Van Vliet, M.D., wrote recently hydroxychloroquine with zinc "works during the first five days to stop viral entry into our cells and to block the virus from multiplying."

"Without HCQ and zinc, by day six or seven the viral load explodes and then triggers an exaggerated inflammatory response. This 'cytokine storm' can severely damage critical organs: lungs, kidneys, heart, brain, liver and intestines and is often fatal," she said.

"Why don't Americans have the freedom to use HCQ here as in other countries? The FDA's misleading statements about HCQ have led to dangerous, unprecedented restrictions on physicians' off-label prescribing rights imposed by state governors, medical boards and pharmacy boards. The supply of HCQ has been ramped up to handle its use in early treatment of COVID. The Strategic National Stockpile has millions of doses deteriorating in government warehouses that are not being distributed because doctors are prevented for political reasons from prescribing for outpatients with COVID-19."

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