A conservative physician group opposed to government interference in medicine is trying to use litigation to free up millions of doses of hydroxychloroquine in government stockpiles, joining other plaintiffs who hope to convince courts to reverse COVID-19 policies they oppose.
The Association of American Physicians and Surgeons is suing the Food and Drug Administration, accusing it of interfering with access to hydroxychloroquine, a decades-old drug widely used to treat malaria and lupus. Doctors prescribed large quantities of HCQ early in the Covid-19 epidemic because it showed some effectiveness against SARS, an earlier communicable lung disease, and they had no other viable treatments.
The drug became a political football after President Trump called it a potential “game changer,” leading critics to accuse him of touting an unproven treatment with side effects that include heart and liver failure. Trump supporters accused the FDA of politics after it revoked an Emergency Use Authorization on June 15, citing the dangerous side effects and a lack of evidence the drug is effective in treating the symptoms of COVID-19.
In its lawsuit and subsequent filings in federal court in Michigan, AAPS accuses the FDA of relying upon flawed studies and ignoring data showing HCQ is effective when prescribed early in the disease. By first restricting HCQ to hospitalized patients only and then revoking the authorization to use it at all, the FDA is preventing doctors from prescribing a potentially lifesaving drug, the organization says.
“A perfect storm of politics in this presidential election year, along with conflicts of interest at the Defendant federal agencies, has resulted in unjustified obstacles to access to HCQ, an inexpensive medication having a track record of more than 75 years of safety," AAPS wrote in a June filing seeking a preliminary injunction against the FDA. The group, whose lawyer is Andrew Schlafly, son of the late antifeminist activist Phyllis Schlafly, compares its lawsuit to similar cases by left-wing groups that have resulted in numerous nationwide injunctions blocking Trump administration policies on immigration and deregulation.
Other groups and individuals are suing the government over coronavirus policies in an attempt to end restrictions on HCQ or to lift shelter-in-place and quarantine regulations. A collection of patients, doctors and unrelated businesses filed a class action in Nevada to block various state orders including restrictions on the use of HCQ. And the New Civil Liberties Alliance, which opposes many forms of government regulation, has asked the Massachusetts Supreme Court to hear its challenge to Gov. Charles Baker’s state of emergency order, saying it arbitrarily categorized businesses and organizations as “essential” and “nonessential.” There has been no further action in either case. There are thousands of similar cases around the country challenging governors' executive orders..
The AAPS claims several thousand members and has mounted several high-profile cases including a successful challenge of the secrecy surrounding Hillary Clinton’s health care task force during her husband’s administration. The organization says it sues to preserve the physician-patient relationship and the independence of doctors from government control.
The government, in a response to the AAPS suit last month, said AAPS doesn’t have standing to sue over its decision to revoke the emergency use authorization because it “raises nothing more than a generalized grievance about federal policy.” The anonymous Dr. John Doe cited as the lead plaintiff doesn’t have any legal interest in government medical supplies and the original premise of the suit became moot after the FDA revoked the EUA on June 15, the FDA claims.
The physician group sued on June 2, seeking access to donated hydroxychloroquine the federal government had distributed to state and local health authorities. Instead of amending its complaint to reflect the revocation of the EUA, AAPS sought a preliminary injunction on July forcing the release of the drug and requiring the FDA to retract “disparaging statements” about hydroxychloroquine.
“AAPS has no right to force the deployment of supplies in the Stockpile for private ends and this Court has no cause to interfere with decisions of public health officials and scientists responding to COVID-19,” the government said in its July 10 response.
The physician group, in its own response, says it will reveal the identity of Dr. Doe if he can be protected against retaliation and says virtually anyone exposed to COVID-19 has standing to challenge FDA policy on the drug.