Op-Ed: Blindly Endorsing Hydroxychloroquine Is Medical Malpractice

The President and his enablers are diluting science and putting American lives at risk

Jonathan Zenilman
Elemental

--

A general view of hydroxychloroquine sulfate medication, which President Donald Trump touted as a potential treatment for Covid-19. There is currently no proven treatment. Photo: John Phillips/Getty Images

The use of unproven medical therapies was widespread for generations, often with catastrophic outcomes. The era of unrestrained quacks ended with establishment of the U.S. Food and Drug Administration (FDA) in the early 1900s, and its implementation of regulations that require data on a drug’s effectiveness and safety before it can be used or marketed. Our system is not perfect, but it has become respected worldwide.

During the initial stage of any drug development, everyone involved is optimistic. Most of the time scientists are ultimately proven wrong. But even failed clinical trials provide important insights to guide the next steps. This is how science works.

In the 1980s, during the AIDS crisis, Anthony Fauci, MD, now the director of the National Institute of Allergy and Infectious Diseases, was pilloried by advocates such as ACT UP for not rapidly approving drugs thought to have potential. He responded by actively engaging the HIV community, educating on the importance of well-conducted trials and the potential danger of uncontrolled studies, and partnering with them in developing the required studies. It was a two-way street, as physicians and clinical researchers learned to work with patient groups as true partners. Concurrently, Robert Redfield, MD, now the director of the Centers for Disease Control and Prevention (CDC), and Deborah Leah Birx, MD, now the coordinator of the U.S. Covid-19 response, studied a therapeutic HIV vaccine candidate that had tremendous promise — but ultimately the trials showed it was ineffective. These HIV clinical trials — conducted by all three of the President’s coronavirus medical advisors — were part of a large research effort that was careful and deliberate, and eventually yielded spectacular results with the development of highly effective treatments for the disease and for its prevention.

When the President asks, “What do you have to lose?” in some cases, the answer could be your life.

Contrast this work with the spectacle of President Donald Trump touting hydroxychloroquine for Covid-19 and saying, “there are signs that it works on the coronavirus, some very strong signs.”

Hydroxychloroquine, which the President has said he might take himself, has some serious side effects, like the potential for cardiac arrhythmias and heart failure, a host of blood, eye, and skin side effects, and even occasional deaths. When used as indicated for malaria or severe rheumatological diseases, the benefits of the drug clearly outweigh the risks. For the novel coronavirus, this calculus is unknown. Furthermore, we have learned over the past months that underlying cardiac disease and hypertension are risks for developing severe Covid-19 symptoms, and people with these conditions are the same groups who are at risk for adverse effects from the drug.

Defining the value or risks of using a drug like hydroxychloroquine is impossible without a controlled study. When the President asks, “What do you have to lose?” in some cases, the answer could be your life. To make things worse, there is clear evidence of political pressure on the CDC to recommend hydroxychloroquine treatment for Covid-19, even though its effectiveness is speculative. This insertion of politics into drug development was exacerbated on April 22, when Richard Bright, PhD, a vaccinologist and former director of the Department of HHS Biomedical Advanced Research and Development Authority (BARDA), was reassigned because he called for careful studies of hydroxychloroquine. This occurred amid reports of serious side effects and questionable efficacy of the drug in medical literature.

If I, as a physician, stated that a drug is unequivocally effective against Covid-19, ignored the side effects, and stated that there was “nothing to lose” by taking it, I would be conflict with the Hippocratic oath dictum.

Widespread use of hydroxychloroquine could have a ripple impact. There are a large number of clinical trials for treatments and vaccines that are being developed with incredible speed. Nearly all clinical trials require that people take no other therapies due to the risk for confounding the results. If people are already being treated indiscriminately with hydroxychloroquine, it makes it harder for scientists to ascertain which therapies really work.

If I, as a physician, stated that a drug is unequivocally effective against Covid-19, ignored the side effects, and stated that there was “nothing to lose” by taking it, I would be conflict with the Hippocratic oath dictum, primum non nocere (do no harm), and working contrary to the medical standard of care which is expected of me. If I did not carefully balance the risk and benefits, I would be potentially liable for medical malpractice.

What we learned from AIDS, and other subsequent medical crises, is that solutions are found in sound science, performed deliberately. Promoting unproven therapies may be politically expedient, but is unethical, will result in harm and unanticipated consequences, could delay our ability to find out what is effective, and could be a tragic coda to this epidemic.

The President and his enablers have committed wanton public health malpractice. This is a result of ignoring the clear warnings of this pandemic, silencing leaders in medicine and science, and dismantling the infrastructure for pandemic preparedness and drug and diagnostic test regulation. It continues with the interference of proper drug testing and by abetting states and cities to “liberate” themselves from social distancing orders — contrary to the advice of medical experts and what would be considered “standard of care” for a population. By promoting unproven medical therapies with serious side effects, the President is encouraging medical malpractice as well, and the consequences could be American lives.

--

--

Jonathan Zenilman
Elemental

Jonathan is an infectious diseases and public health physician in Baltimore, and has been on the faculty at Johns Hopkins since 1989.