Image credit: Chip Somodevilla/Getty Images.
For many professionals in the science and healthcare communities, the return of hydroxychloroquine to public discussion came as a shock.
Hydroxychloroquine is an antimalarial drug that researchers initially hoped could be a potential treatment for COVID-19. Over the last few months, scientists have extensively studied hydroxychloroquine in multiple randomized controlled trials.
All of the randomized controlled trials came to the same conclusion: There was, unfortunately, no demonstrated benefit in the use of hydroxychloroquine as a treatment for COVID-19.
As a result, most healthcare providers have moved on from hydroxychloroquine. Instead, the medical community has looked at other therapies with proven benefits, such as remdesivir and steroids.
However, surprisingly, we now find ourselves discussing hydroxychloroquine again in the press and on social media.
Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.
One pivotal event appears to be an opinion piece on Newsweek promoting hydroxychloroquine based on early flawed observational studies written, inexplicably, by a professor of epidemiology at Yale.
Soon after, a YouTube video appeared, which promoted hydroxychloroquine as a “cure” for COVID-19 based on anecdotal experiences. A group of doctors claiming to be “America’s Frontline Doctors” made this video. However, people have questioned their “frontline” credentials.
Together, these pieces of content fueled conspiracy theories claiming that the scientific community has unfairly discredited hydroxychloroquine in an attempt to hurt the Trump administration.
Social media is now awash with people stating that they will demand hydroxychloroquine from their doctors. The governor of Ohio has successfully pressured the state’s board of pharmacy to reverse a ban on hydroxychloroquine for treating COVID-19.
Republican Texas Rep. Louie Gohmert, who recently tested positive for the novel coronavirus, also publicly declared his intention to take hydroxychloroquine.
This is problematic for a number of reasons. Scientists have shown that hydroxychloroquine is ineffective in treating COVID-19. Prescribing a treatment that research has proven does not work is contrary to the ethics of modern medicine.
Hydroxychloroquine also has the potential to cause significant side effects, the most troubling of which are fatal cardiac arrhythmias.
Despite this, the drug has real uses, mostly for the treatment of rheumatological diseases. Wasting this medication on ineffective COVID-19 treatments has led to drug shortages.
In addition, promoting an ineffective treatment as a “cure” instills a dangerous false sense of security. It is troubling that “America’s Frontline Doctors” also claim that the public does not need to wear face coverings.
Finally, the time spent reexamining and refuting these claims distracts from efforts to develop effective treatments for COVID-19.
In examining how we got to this point, it might be enlightening to discuss the fundamentals of evidence-based medicine as it relates to hydroxychloroquine.
Evidence-based medicine is simply the concept of applying a scientific process to the practice of medicine.
It is common for an investigation into a potential treatment to start with observational studies.
In these studies, researchers passively observe a group of participants receiving a therapy (the treatment group) and compare them with a group of participants who do not receive the treatment (the control group).
These observational studies are inherently limited because there is no randomization over who gets placed in each group. This naturally introduces bias and confounding factors, which can prevent the results of observational data from being conclusive.
Although often limited and flawed, observational studies are cheap and easy to complete. Their real value is to drum up interest in performing larger randomized controlled trials.
Randomized controlled trials are scientific experiments in which the researchers randomly assign subjects to either the treatment group or the control group. This randomization hopefully reduces bias and confounding factors.
If a randomized controlled trial is well-designed and large enough to be statistically relevant, then people may consider it conclusive enough to dictate patient care definitively.
This is the essence of evidence-based medicine.
Life-and-death decisions in medicine cannot be left to simple observational studies or, even worse, anecdotal evidence. Instead, the decisions that we make as healthcare providers are of such importance that we must try to use the best type of evidence when it is available. Randomized controlled trials are the gold standard.
In the case of hydroxychloroquine, the initial promising data were, in fact, from small observational studies in France. Recently, a larger positive observational study took place at Henry Ford Health.
Predictably, these studies all had major flaws, including bias and confounding factors. However, these studies produced intense interest in hydroxychloroquine.
Researchers have also carried out multiple large randomized controlled trials. All, unfortunately, showed no evidence of benefit for people with COVID-19.
Other research confirmed this, finding no benefit for people with mild or severe COVID-19. Hydroxychloroquine also showed no benefit as either an early treatment or a prophylactic therapy.
Understandably, these results were disappointing, but this happens routinely in evidence-based medicine. We investigate potential treatments, and some do not work out. We move on and try other things.
Only in this case, we did not move on.
Politics got in the way.
President Trump expressed early support of hydroxychloroquine based on the initial small and flawed observational studies. Since then, his detractors have used the failure of subsequent hydroxychloroquine randomized controlled trials to ridicule his handling of the COVID-19 crisis.
Others have sounded the alarm about so-called dark money political organizations supporting the use of hydroxychloroquine.
Trump’s supporters have surmised that there is an attempt to suppress hydroxychloroquine research as a way to spite the Trump administration. This dynamic has kept an unnecessary focus on hydroxychloroquine, even after strong evidence of its ineffectiveness.
Trump’s early enthusiasm for hydroxychloroquine was an understandable human reaction. Many healthcare providers shared in this initial excitement. Doctors around the world had begun ordering, and sometimes hoarding, supplies of hydroxychloroquine.
The difficulty in accepting that hydroxychloroquine has failed more rigorous trials is, likewise, rooted in human psychology. Hope taps into the emotional self rather than the rational mind.
Also, the concepts of evidence-based medicine may be unclear to the public. Indeed, learning to interpret and conduct this type of research is an important part of physician training.
The difficulty in understanding the nature of evidence-based medicine can lead to news outlets highlighting flawed observational studies but ignoring more conclusive randomized controlled trials.
Seemingly conflicting research can confuse the public. More troublingly, this can result in political leaders making decisions based on faulty information.
The cultural current that promotes flawed studies and anecdotal evidence based on political affiliation is emblematic of the infiltration of misinformation in our war against COVID-19.
And by now, it has become obvious that in losing the war against medical misinformation, we are losing the war against COVID-19.
Pervasive skepticism toward public health recommendations and the parallel rise in conspiracy theories have led to our current situation: America is the only developed country in the world that has failed to control COVID-19.
Frankly, this is embarrassing.
We can turn the tide of this battle, but it requires empathy and active engagement.
Science and healthcare professionals must engage with the public on a personal level and, yes, on social media as well. The purpose of this engagement must be to educate the public on the more challenging concepts of evidence-based medicine.
At the same time, we must remain empathetic to the position of those not trained in medical science. This stuff can seem confusing and bewildering. Patience and clarity are key to sincere communication.
I would also ask that the public be empathetic of science and healthcare professionals.
On a very deep level, healthcare professionals yearn for effective therapies for COVID-19. This is why we took such a long and hard look at hydroxychloroquine, even when the evidence was looking grim.
We really want to have effective treatments for our patients.
On a more existential level, those of us actively treating people with COVID-19 understand that it is likely that we will become patients ourselves. Many of us have written our wills for the first time or drawn up advanced directives.
We desperately hope that something will be available to treat us when we fall ill, too. We have no agenda to “hide a cure” or discount promising therapies.
On a national level, we must find some way of taking politics out of the equation when discussing medical research. The whole idea that medical science has become politicized is simply ludicrous.
Biology does not respond to politics. Pharmacology does not respond to politics. And this virus, surely, does not respond to politics.
We likewise must remain unmoved by our personal politics in our management of this pandemic.
In a year or two, it will matter little who was right and who was wrong. Instead, we will be measured by how many of us experienced death, disability, or destitution.
We are all equally vulnerable to this disease, no matter at what end of the political spectrum we may find ourselves. The virus sees no difference among us, so we, too, should strive to acknowledge our shared humanity.
For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.
