WASHINGTON, DC – The Association of American Physicians and Surgeons is suing the Food and Drug Administration saying the federal agency is withholding the much needed Hydroxychloroquine from patients infected with COVID-19.
“While more than 100,000 American deaths have been attributed to COVID-19, 150 million doses of hydroxychloroquine, donated by manufacturers, are deteriorating in government warehouses. There is an aggressive campaign to portray HCQ at first as “unproven” and now as also “unsafe.” Following the lead of the Food and Drug Administration’s Emergency Use Authorization (EUA), which prohibits use of HCQ being stored in the Strategic National Stockpile (SNS) outside of hospitals, most states have placed unprecedented restrictions on physicians’ ability to prescribe HCQ “off-label” for COVID-19 (tinyurl.com/y7oc65gn),” the Asssociation said. “In its lawsuit (http://aapsonline.org/hcqsuit), filed in June in federal court in the Western District of Michigan, AAPS asks the court to enjoin the enforcement of the restrictions in the Mar 28 EUA; to make available and distribute promptly, for the benefit of the public, HCQ from the SNS; and to enjoin FDA, the Biomedical Advance Research & Development Authority (BARDA), and HHS from impeding the distribution, sale, or purchase of HCQ by members of the public during the COVID-19 pandemic.
Press Release from AAPS:
Through a biased, improper process, FDA officials from prior administrations acted contrary to the wishes of President Donald Trump by arbitrarily limiting use of HCQ. Rick Bright, Ph.D., former head of BARDA, who is an outspoken critic of President Trump and is personally opposed to making HCQ widely available, distorted the agency process to unjustifiably limit access.
Bright is also biased by his pre-conceived opinion in favor of an expensive, proprietary antiviral medication developed by Gilead Sciences, remdesivir. He repeatedly advised HHS officials to acquire the existing doses, to secure future doses as they were produced, and to “on-shore” all steps of the remdesivir supply chain. These actions should have caused his recusal from the decision-making process about HCQ.
According to Bright’s whistleblower complaint against the Trump Administration, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, also played a pivotal role in pushing for the EUA. Woodcock simultaneously occupied a top position in a public-private operation designed to approve new vaccines for COVID-19, and she reportedly communicated with a Wall Street analyst concerning such development.
Safety
HCQ has been approved as safe by the FDA for 65 years, and is safer than numerous medications that are widely available over-the-counter (OTC), including anti-depressants, sleeping pills, bronchodilators, Tylenol, and even aspirin.
The “safety profile” with respect to new uses of a medication previously approved by the FDA is virtually never studied, and there is no rational basis for delaying new uses of previously approved medication by requiring such studies.
Harvey A. Risch, professor of epidemiology at the Yale School of Public Health and Yale School of Medicine, stated: “Hydroxychloroquine+azithromycin has been used as standard-of-care in more than 300,000 older adults with multicomorbidities, with estimated proportion diagnosed with cardiac arrhythmias attributable to the medications 47/100,000 users, of which estimated mortality is <20%, 9/100,000 users.” He noted that 10,000 Americans are dying each week from COVID-19. Five studies, he writes, including two controlled clinical trials, have demonstrated significant major outpatient treatment efficacy. He concluded that “these medications need to be widely available and promoted immediately for physicians” (Am J Epidemiol, May 27, 2020, https://tinyurl.com/y9yfb2h9).
Dr. Jon Giles, an epidemiologist and rheumatologist at Columbia University Department of Medicine, told National Public Radio (NPR) that HCQ is a “very, very safe drug; it’s been used for over 75 years. When I give someone [HCQ], I don’t get an ECG or do blood monitoring” (tinyurl.com/y7enya9w).
More than 25 articles since 1982 published in peer-reviewed medical journals have reported on the safety of HCQ, and these articles are included in the PubMed database.
Harms of Restricting Access to Prevention
Dr. Risch states that “an outpatient treatment that prevents hospitalization is desperately needed [for COVID-19].”
In addition to the preventable mortality and morbidity, devastating harm results from lockdowns and fear of acquiring an untreatable illness. The AAPS complaint states that irrational interference with the use of HCQ as a prophylaxis interferes with the political process, for example, national political conventions, and with rights to associate, assemble, and attend religious services.
Defendants violate the equal protection guarantee implicit in the Due Process Clause of the Fifth Amendment to the U.S. Constitution by discriminating based on a patient’s hospitalization status, illness status, and access to clinical trials.
Defendants lack the authority to override the discretion of a medical professional to prescribe off-label uses of FDA-approved drugs. The decision-making underlying the EUA was tainted by bias, and thus it is arbitrary and capricious. The Administrative Procedure Act directs courts to “hold unlawful and set aside agency action…found to be … contrary to constitutional right, power, privilege or immunity.” 5 U.S.C. § 706(2)(B).
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