Doctors go to war with feds for 'irrational' limits on coronavirus drug

The Association of American Physicians and Surgeons has sued the federal government, alleging "irrational interference" with doctors' efforts to prescribe hydroxychloroquine for COVID-19 patients.

The AAPS complaint argues that various restrictions and limits interfere with due process.

"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," the organization contends.

"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 j[Emergency Use Authorization] 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.'"

The organization of physicians said there have been more than 100,000 American deaths attributed to coronavirus while there are 150 million doses of hydroxychloroquine, donated by manufacturers, in storage in government warehouses.

The doctors point out the doses are "deteriorating."

"There is an aggressive campaign to portray HCQ at first as 'unproven' and now as also 'unsafe,'" the doctors said. "Following the lead of the Food and Drug Administration’s Emergency Use Authorization, which prohibits use of HCQ being stored in the Strategic National Stockpile outside of hospitals, most states have placed unprecedented restrictions on physicians’ ability to prescribe HCQ 'off-label' for COVID-19."

The lawsuit, in the Western District of Michigan, asks for a court order halting the enforcement of restrictions and to make the drug available.

"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," AAPS said. "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."

The Gateway Pundit blog said, "Never in history have we seen such a determined effort by the scientific community and pharmaceutical industry to downplay and lie about the use of a successful drug to treat a deadly disease.

"Hydroxychloroquine is the first choice in a study of 6,000 doctors treating the coronavirus. In the field and in independent testing hydroxychloroquine displayed amazing results in treating the COVID-19 virus. But there was great pushback against hydroxychloroquine for two reasons. The first reason was because it was safe and very inexpensive. The second reason is because Donald Trump promoted its use.

"It is not a stretch to say the Democrat establishment would rather see people die than see President Trump be proven right."

The doctors point out that hydroxychloroquine has been approved as safe by the Food and Drug Administration for 65 years. It's "safer than numerous medications that are widely available over-the-counter, including anti-depressants, sleeping pills, bronchodilators, Tylenol, and even aspirin."

AAPS cited Harvey A. Risch, professor of epidemiology at the Yale School of Public Health and Yale School of Medicine.

"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 said.

Risch said five studies, 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."

AAPS said, "In countries that started using HCQ for prophylaxis and early treatment, death rates soon began to decrease, and the ratio of recoveries to deaths increased dramatically, e.g. in Cyprus, Costa Rica, Russia, Monaco, Algeria, Turkey, Israel, Italy, Peru, Honduras, Indonesia, United Arab Emirates, South Africa, and Portugal."

The criticism of the drug "stems largely from a heavily publicized Lancet article that failed to confirm benefit and claimed decreased in-hospital survival and increased ventricular arrhythmias with CQ or HCQ," AAPS said.

But they noted the Lancet's "politics" include "about 40 tweets by editor Richard Horton that appear to be anti-Trump, pro-China, or pro-WHO."