Right Wing AAPS Sues FDA over Hydroxychloroquine

The FDA granted Emergency Use Authorization (EUA) for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) for the treatment if COVID-19 back in late March 2020. However, the EUA was revoked in mid-June 2020, due to concerns of efficacy and evidence of cardiac adverse events. The drug was approved by the FDA for use against malaria in 1955, and the CDC (Centers for Disease Control and Prevention) “has no limits on the use of hydroxychloroquine for the prevention of malaria,” as stated on the Center’s website.

The Association of American Physicians and Surgeons (AAPS), a politically active, conservative non-profit that has previously promoted several scientifically discredited ideas, such as the link between vaccination and autism, filed a lawsuit against the FDA in June, even before the EUA was revoked, claiming that the FDA was still blocking access to the drug for Americans. The organization later asked a court to issue an injunction to force the FDA and Department of Health and Human Services (HSS) release to the public nearly 100,000 doses of the drug which had been donated to the agencies.

Along with the injunction, the AAPS provided a chart that shows the fatality rate of COVID-19 in countries that “allow and encourage” HCQ use, such as South Korea and Israel, compared with countries that “banned or discouraged” HCQ use, which include the U.S. and several European nations. There is a clear divide on the chart showing the former group with fatality rates below 4.0% and the latter with rates over 5%. Only 15 countries were included in the chart and statistics were not provided, making it difficult to determine the causality of discrepancy in fatality rates.

Even before the revocation of the EUA, on June 4, 2020, 2 large studies published in The Lancet and the New England Journal of Medicine were retracted. These studies had found increased rates of cardiac adverse events, but the data was later found to lack veracity. A New York Times article, published on July 27, 2020, found that the source of the data was unable to be verified after independent review.

Early in June 2020, a double-blind, randomized, placebo-controlled trial found no significant benefit of the drug compared with placebo as a postexposure prophylaxis for COVID-19.

However, a large, retrospective, observational study, that we reviewed in a recent posting at OTW found that treatment with HCQ resulted in 50% reduced mortality. The AAPS has cited this study as new evidence in its suit against the FDA. “Countries with underdeveloped health care 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 group wrote in its filing. It is clear that the studies are conflicting, which make drawing a conclusion on the efficacy and safety nearly impossible. The pollical injection by the President and his Advisor, Peter Navarro, Ph.D., only increases the potential sources for bias on both sides of the discussion.