Much controversy surrounds whether or not hydroxychloroquine is effective in preventing or treating infection with COVID-19. While much of the data so far suggests that hydroxychloroquine is not effective at treating COVID-19, and perhaps that it might even be harmful, multiple clinical trials focusing both on prevention and treatment are ongoing. The controversy around hydroxychloroquine led the FDA to issue a statement advising against the use of hydroxychloroquine for COVID-19 outside of the hospital setting or a clinical trial.
In a joint statement between the United States of America and the Federative Republic of Brazil issued on May 31, 2020, the two countries announced that the United States government had delivered two million doses of hydroxychloroquine to the people of Brazil. The statement designates that the drug is to be used both for prophylaxis against COVID-19 among health care workers and treatment of those already infected. It also announces a joint United States-Brazilian research effort to evaluate the safety and efficacy of hydroxychloroquine for the prevention and treatment of COVID-19. Along with hydroxychloroquine, the United States also sent 1,000 ventilators to Brazil.
The ethical issue with sending hydroxychloroquine to Brazil is that the medication’s benefit in preventing or treating COVID-19, and its potential for harm, are unknown and unproven. A very basic requirement of both the World Health Organization (WHO) and the Food and Drug Administration (FDA) is that medications donated for humanitarian aid be safe and effective. The donation of hydroxychloroquine to Brazil directly violates the FDA’s policy, as well as the WHO’s policy, on medicine donations. Beyond that, the donation is contrary to the moral foundations on which medicine is based: to do good and avoid harm. Providing a medication whose safety and efficacy is unproven to vulnerable populations is not what anyone should call humanitarian. Of further concern is how the medication will be distributed and used in Brazil where, according to one publication, the country’s COVID-19 response is “caught between denialism and technocratic hubris.”
Regardless of how they estimate their authority, presidents cannot prescribe medications; only doctors and advanced practice clinicians can do this. The reason is based not only on training and education, but also the recognition that medications can be used both for benefit and for harm. The privilege to prescribe entails a moral obligation that medication be used for the good of the patient and not for their harm. Take, for instance, the decision of President Trump’s physician, Dr. Sean Conley, to prescribe the president hydroxychloroquine. Notwithstanding the fact that Dr. Conley and the President “concluded the potential benefit outweighed the relative risks,” the decision is ethically ambiguous. Patients often request medications and interventions that physicians know to be nonbeneficial, and even potentially harmful. Saying “no” can be one of the most difficult parts of the job. It is not just our professional judgment, but also our moral obligation.
Based on the joint statement from the United States and Brazil, one may argue that the medication is being given to Brazil not as humanitarian aid, but as part of a research study. Had the purpose been to enlist international participation in a study of hydroxychloroquine, a far more ethical solution would have been to encourage participation in an already existing study. Doing so would assure Institutional Review Board (IRB) oversight, a robust informed-decision-making process, standardized criteria for participation, safety monitoring, and all the other elements on which scientifically grounded, ethically sound clinical research is carried out. Furthermore, the medical community is unlikely to trust any conclusions that are not the result of a well-designed and scientifically respected study.
The donation of hydroxychloroquine, in contrast to the accompanying donation of 1,000 ventilators, is unethical as either humanitarian aid or as a “research study.” The United States has a moral responsibility for any human harm that results. We cannot simply send medications off to potentially vulnerable populations without regard for the lives that could be negatively affected. It is not enough to intend to do good and avoid harm; we must ensure it.
Charles E. Binkley is a bioethicist and general surgeon.
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