Originally published on blog of Union of Concerned Scientists.
by Anita Desikan
The Trump administration’s claim that two anti-malarial drugs, hydroxychloroquine and chloroquine, should be regarded as treatment options for COVID-19 may be one of its most dangerous forms of misinformation yet. For weeks, the Trump administration has claimed that these drugs can act like a panacea for the disease and, while the administration has recently gone quiet on this messaging, the damage has already been done.
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— Union of Concerned Scientists (@UCSUSA) April 23, 2020
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Trump administration dismisses leading vaccine expert
Dr. Rick Bright, a vaccine expert, has recently alleged that his refusal to conform to the Trump administration’s misinformation about two drugs for COVID-19 treatment, hydroxychloroquine and chloroquine, led to his dismissal from his post at the Department of Health and Human Services. First reported on April 21 by STAT News, Dr. Rick Bright was abruptly dismissed from his job as the director of the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), where he was responsible for vaccine development, and was then reassigned to a lower position at the National Institutes of Health (NIH).
More than any other agency, CDC respondents reported White House interference as a top barrier to science-based decisions—an alarming finding in the midst of a global pandemic where CDC scientists’ ability to conduct science is an immediate matter of life and death. pic.twitter.com/oRMdUVkmMT
— Gretchen Goldman, PhD (@GretchenTG) April 23, 2020
Dr. Bright told the New York Times that the reasons for his dismissal appear to be due to his efforts to resist the “broad use of chloroquine and hydroxychloroquine, promoted by the administration as a panacea, but which clearly lack scientific merit.” Dr. Bright added that he “rightly resisted efforts to provide an unproven drug on demand to the American public,” which “have potentially serious risks associated with them, including increased mortality … in COVID-19 patients,” and that “rushing blindly towards unproven drugs can be disastrous and result in countless more deaths.”
Dr. Bright’s words get to the heart of why the Trump administration’s promotion of hydroxychloroquine and chloroquine as some sort of a cure-all to the pandemic is so troubling and potentially dangerous. Science is like a conversation, a series of topics tackled and expanded upon by top experts in the field which, together, can paint a picture of the probable reality of how the world works.
The Trump administration, on the other hand, is threatening to derail the scientific conversation on what drugs can be effective against COVID-19 in a way that is already leading to fear, illness, and even deaths.
The science does not justify the promotion of hydroxychloroquine as a COVID-19 treatment
It is very dangerous to say that a drug can treat COVID-19 without a series of well-established, robust clinical trials. Already, we’ve seen this misinformation by the administration leading to hydroxychloroquine poisonings and deaths in Nigeria and the US; a mass public scramble for the drugs such that lupus and rheumatoid arthritis patients, who depend on hydroxychloroquine for pain management, are unable to obtain it; and some pharmaceutical companies have hiked the price up by 350 percent for a component used to make the hydroxychloroquine drug.
While the anti-malarial drugs hydroxychloroquine and chloroquine have been approved for human use since the 1950s and 1930s, respectively, it very well established that these drugs can prove deadly to a subset of people with heart problems like arrhythmias. In fact, a Brazilian study looking at chloroquine as a possible treatment for COVID-19 had to be stopped midway because multiple participants developed irregular heart rates, of which 11 patients died. And considering that people with underlying heart conditions often face some of the worst symptoms of COVID-19, the ability of hydroxychloroquine and chloroquine to act as an effective treatment during the pandemic may be further in question.
The science behind whether these drugs can treat COVID-19 is mixed. Some early laboratory studies and small-scale human studies in China and France have showed some promise, but several of the human trials have faced intense criticism for poor methodology or a lack of peer review.
A recent nationwide study of 368 patients in US veterans hospitals, released in a preprint form prior to peer review, looked at the effectiveness of hydroxychloroquine, with or without the antibiotic azithromycin, for treating COVID-19. The researchers found that hydroxychloroquine made no difference in quelling the symptoms severe enough to require a ventilator, and that patients who only took hydroxychloroquine had a higher risk of death than those who did not take the drug.
The National Institute of Allergy and Infectious Diseases (NIAID), the agency headed by Dr. Anthony Fauci, recently conveyed a panel of experts that weighed the evidence and recommended against using a combination of hydroxychloroquine and azithromycin for the treatment of COVID-19 patients because of potential toxicities. The expert panel concluded that there was “insufficient clinical data to recommend either for or against” the use of hydroxychloroquine or chloroquine alone for the treatment of COVID-19.
At the same time, several high-profile research institutions and pharmaceutical companies consider the preliminary evidence for hydroxychloroquine and chloroquine promising enough to launch large-scale robust clinical trials which will likely put us on firmer ground as to the drugs’ effectiveness against COVID-19.
Some of the most promising clinical studies include the National Institutes of Health’s (NIH) blinded, placebo-controlled randomized clinical trial of 500 patients for hydroxychloroquine; Novartis’ 450-person trial for hydroxychloroquine using the “gold standard” of a randomized, double-blind placebo-controlled study; and the World Health Organization’s SOLIDARITY trial of four treatment options, including chloroquine and hydroxychloroquine in combination, for thousands of patients in dozens of countries.
Robust clinical trials matter
It is still an open question as to whether hydroxychloroquine and chloroquine has some potential benefits for treating COVID-19. For instance, it is possible that the drugs may be promising in certain drug combinations but not others; the drugs may prove to be beneficial for some patients at certain stages of a disease but not others; or the drugs could provide benefits for people with certain demographic or underlying health conditions but not others.
There are simply too many unknowns to tell. This is why we conduct clinical trials with robust methodology. The history of science and medicine are littered with examples of people excited about certain treatment options that later proved to be detrimental under randomized clinical trials. There is a bitter lesson here: touting miracle cures without proper scientific evidence can led to heartbreaking situations for patients.
The Trump administration — an administration with a three-year history of censoring scientists, disbanding scientific advisory committees, and burying scientific studies — and its attempts to promote unproven drug treatments for COVID-19, against the advice of its own scientists, is more than just irresponsible. It is misinformation that will likely compromise the health of thousands of people in the middle of the most deadly pandemic experienced in our lifetimes.
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