Top medical org demands FDA make COVID treatment hydroxychloroquine more widely available.
The Association of American Physicians & Surgeons (AAPS) has submitted additional evidence to the U.S. Department of Health & Human Services (HHS) and Food & Drug Administration (FDA) in hopes of compelling the agency to relax its restrictions on the use of hydroxychloroquine (HCQ) to treat COVID-19 among the general public.
Last month, AAPS filed a motion for a preliminary injunction to compel HHS and CDC to release more of the tens of millions of doses in the government’s possession to the public. The FDA has not officially cleared the drug for COVID-19 treatment (it has long been approved for malaria, autoimmune conditions, and arthritis), but has allowed it “to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.” (At the same time, the FDA warns not to use it outside of trials or hospitals.)
This week, AAPS followed up by submitting to the court additional evidence of the drug’s safety and effectiveness.
“As confirmed by another recent study of thousands of patients at the Henry Ford Health System in Michigan, HCQ is both very safe and highly effective in treating COVID-19, reducing mortality by 50 percent,” the group argued. “Countries with underdeveloped healthcare systems are using HCQ early and attaining far lower mortality than in the United States, where (HHS and the FDA) impede access to HCQ.”
“The mortality rate from COVID-19 in countries that allow access to HCQ is only one-tenth the mortality rate in countries where there is interference with this medication, such as the United States,” AAPS general counsel Andrew Schlafly said, citing easier access to the drug in Philippines, Poland, Israel, Turkey, and even Venezuela.
Yet the group laments that 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.”
In the early days of the COVID-19 outbreak, scientists began researching HCQ’s potential applications in treating the new virus – a development that was quickly promoted by President Donald Trump, after which partisans in media and government began a push to discredit the drug, from outlandish stories about a man who died after drinking fish tank cleaner to a junk study falsely claiming HCQ killed Veterans Administration patients.
Several early studies showed promise as a COVID-19 treatment, but a May study published in The Lancet purported to not only find “no benefit” to using HCQ, but instead finding “decreased in-hospital survival and an increased frequency of ventricular arrhythmias,” leading several countries to ban it. However, that study was retracted upon the discovery that the company that provided its data was very likely fraudulent.
“The interference with public access to hydroxychloroquine is disrupting our political processes,” Schlafly said. “Perhaps that is what some want, in order to deter Americans from attending political conventions and even voting, but it is unconstitutional for the FDA to infringe on these constitutional rights by blocking access to this safe medication.”
