May 29, 2020 6:12 PM
The off-label use of drugs is however possible even without a clinical trial, if you are in particular conditions. Already at the end of March, the WHO noted that against covid-19, doctors often prescribed authorized medicines for the treatment of other diseases.
One of the prescribed drugs was precisely hydroxychloroquine. Interest in this molecule was generated in part outside the scientific community, by a series of tweets in mid-March that promoted its use. U.S. President Donald Trump has also endorsed its use. His tweet cited a study published in the International Journal of Antimicrobial Agents. It was a small study, which involved twenty patients for ten days. A possible antiviral effect of hydroxychloroquine would emerge from this study.
In the week of March 15 to March 21, U.S. prescriptions for hydroxychloroquine and chloroquine increased significantly. For example, prescriptions below 28 pills grew 1,977 percent. The prescriptions for larger quantities have also increased.
The Food and Drug Administration (FDA), in the United States, authorized the emergency use of chloroquine and hydroxychloroquine for patients hospitalized for covid-19 on March 28. In a comment published in Jama Internal Medicine magazine on May 19, Mike Zhai, Carolyn Lye and Aaron Kesselheim strongly criticized the decision. The FDA has given the green light on the basis of in vitro data and individual clinical cases, not of extensive trials. “Whether hydroxychloroquine and chloroquine have clinical efficacy against covid-19 or not, there is a great risk of damage deriving from the authorization issued on insufficient data,” they write in their comment. The FDA’s decision can push patients to use the two antimalarials outside of clinical trials, slowing down data acquisition.
Furthermore, while it is not yet known whether the two drugs are effective against covid-19, it is known that they can cause heart problems, even fatal ones. Finally, there is a risk of causing a shortage of the two drugs, which are necessary for other patients, not covid-19. “As the covid-19 pandemic continues, the public, members of the government and the pharmaceutical industry can put pressure on the FDA to issue additional authorizations for emergency use of drugs. Instead of succumbing to these pressures, the agency should ensure that authorizations are issued only when supported by sufficient scientific evidence, and all of this evidence should be made public at the time of authorization, “continue the researchers in their comment.
Following the publication of the study, the World Health Organization suspended testing on hydroxychloroquine. A review of the safety of the treatment is therefore expected.