As unprecedented challenges to societies come, history often reveals two outcomes: the uniting of a people to overcome that challenge or the downfall of cultures resistant to necessary adaptation.

The global coronavirus pandemic is one such challenge that impacts not just one civilization, but our entire global society, forcing humanity to adapt. Despite the separation of our planet’s populations by borders and languages, the scientists of past millennia have led us to a unique position - one where we are capable of communicating with each other at an instant.

We’ve used this capacity well, gathering the research of scientists and fostering discussion among countries as to the best way to handle the crisis. However, the United States, the wealthiest nation in humanity’s history has chosen another route. This road, laden with politicization and miscommunication, has undeniably increased both social confusion and suffering.

I want to recount a particular instance, among many, in which both the decisions and the words of leadership can cause harm to a society that said leadership purports to protect.

Hydroxychloroquine

Over the past 6 months, the President of the United States, Donald Trump, has been challenged in his role of protecting the people of the United States. In the midst of this role, seemingly out of desperation, he mentioned an anti-malarial drug, hydroxychloroquine, as a potential solution to those afflicted with COVID-19. Google Trends shows that the popularity of hydroxychloroquine spiked in March when the president voiced the drug’s apparent promise, proving that many, reasonably, take the words of the president seriously.

This in itself is not a problem - providing hope for people you are responsible for is reasonable. What is a problem is the lie that followed:

“And we’re going to be able to make that drug available almost immediately. And that’s where the FDA has been so great. They — they’ve gone through the approval process; it’s been approved. And they did it — they took it down from many, many months to immediate. So we’re going to be able to make that drug available by prescription or states. ”

— President Donald Trump

The Food and Drug Adminsitration, or FDA, at that point, had not approved hydroxychloroquine (nor have they to this day), never mind its use as a prescription. By voicing that they had, people, who still have a high opinion of science and scientists, would have taken Trump’s words as having the backing of the relevant scientific authorities. In reality, the FDA did not allow the administration of hydroxychloroquine until March 28, 2020, when they issued an Emergency Use Authorization, a highly restrictive authorization, 9 days after his announcement.

Despite this 9 day distance between the president’s first comments and the FDA’s official, emergency approval, he continued to speak on it, even contradicting the Director of the National Institute of Allergy and Infectious Diseases (NIAID) and member of his own Coronavirus Task Force, Dr. Anthony Fauci.

“Question: Dr. Fauci — this was explained yesterday — there has been some promise with hydroxychloroquine as potential therapy for people who are infected with coronavirus. Is there any evidence to suggest that, as with malaria, it might be used as a prophylaxis against COVID-19?

Dr. Fauci: No. The answer is no. And the evidence that you’re talking about, John, is anecdotal evidence…the information that you’re referring to specifically is anecdotal; it was not done in a controlled clinical trial. So you really can’t make any definitive statement about it.

Question (to Trump): For clarity, Dr. Fauci said there is no magic drug for coronavirus right now, which you would agree…

Pres. Trump: Well, you know, I think we only disagree a little bit…I disagree. Maybe and maybe not. Maybe there is, maybe there isn’t. We have to see. We’re going to know. We’re going to know soon.

Question: Is it possible — it possible that your impulse to put a positive spin on things may be giving Americans a false sense of hope, and misrepresenting the preparedness right now?

Pres. Trump: No. No, I don’t think so.”

— Remarks by President Trump, Vice President Pence, and Members of the Coronavirus Task Force in Press Briefing [2]

Putting aside that we now know that Donald Trump did “put a positive spin on things” to “avoid causing panic”, this is a crisis that requires effective and deliberate science communication. The idea that you can just simply disagree with a career scientist that specializes in infectious diseases, with no scientific basis for that disagreement, is tantamount to believing that your knowledge (or lack there of) is sufficient to suppress the coronavirus - hubris at best, negligence at worst.

The Emergency Use Authorization

The FDA’s EUA was strict and certainly not available to every American. In a letter by Rear Admiral Denise Hinton, Chief Scientist of the FDA, she listed several criteria for the administration of hydroxychloroquine, including that it must be administered:

By a healthcare provider pursuant to a valid prescription of a licensed practicioner.
To treat adult and adolescent patients who weigh 50 kg (110 lbs) or more that are hospitalized with COVID-19 for whom (1) a clinical trial is not available or (2) participation is not feasible.

This letter also notes that hydroxychloroquine was not FDA-approved - the EUA is not a substitute for approval given only after the required testing is done. Given that, personally, I wonder why the FDA issued the EUA. I can’t confidently state why, but, if I had to make a guess, it was a combination of pressure from the president’s announcement and politicization of the situation through governmental scientific institutions like the US Department of Health and Human Services (charges I will explore in a future article).

Dr. Anthony Fauci (left) and Dr. Rick Bright (center)

In fact, the target of that letter, Dr. Rick Bright, lends some credence to that hypothesis. Dr. Rick Bright was the Director of the Biomedical Advanced Research and Development Authority (BARDA), the division of the US Department of Health and Human Services responsible for securing the US from emerging infectious diseases, before he was ousted from his position on April 20th.

Afterward, Dr. Bright prepared a statement, voicing what he feels are the reasons for his dismissal. He states:

“…Contrary to misguided directives, I limited the broad use of chloroquine and hydroxychloroquine, promoted by the Administration as a panacea, but which clearly lack scientific merit. While I am prepared to look at all options and to think “outside the box” for effective treatments, I rightly resisted efforts to provide an unproven drug on demand to the American public.”

— Dr. Rick Bright [3]

Dr. Bright also filed a whistleblower report, which the United States Office of Special Counsel, one of the whistleblower agencies that protect whistleblowers, found was legitimate.

Of course it was. Dr. Bright was the one responsible for reasonable regulations on the use of an unapproved drug after all.

The Unofficial Clinical Trials

Despite the efforts of Dr. Bright to restrict the use of hydroxychloroquine, it is still a drug that hadn’t been used or tested for patients that are not afflicted with malaria. Therefore, its emergency use here was watched closely, as though they were advanced clinical trials with human test subjects.

Doctors affiliated with the American Heart Association, American College of Cardiology and Heart Rhythm Society were the among the first to raise an alarm. On April 8th, they issued a joint statement on the use of the anti-malarial drug for patients with heart disease or other cardiac problems. They warn that this drug has a multitude of heart-based secondary effects, like an increase in the speed of heartbeats (long QT syndrome), a change the heart’s ventricular rhythm (Polymorphic VT and arrhythmia) or even sudden death.

Brazil, one of the nations with coronavirus death rates that rival the United States, attempted to perform official clinical trials gauging hydroxychloroquine as a treatment. However, preliminary findings on their studies, which found that higher doses of hydroxychloroquine led to a higher lethality rate, led to them recommending that the drug not be used as a COVID-19 treatment and halting patient recruitment for their trial.

As a response to the increasing reports of heart problems in patients that were taking the drug, the FDA reminded us, on April 24, that the only instances in which this drug should be used in are within “clinical trials settings or for treating certain hospitalized patients under the EUA”.

But, despite all of these warnings by the global scientific community, President Trump still tried to push hydroxychloroquine, even mentioning on May 19th that he was taking the drug.

Why did the words of the scientific community and the risks to hydroxychloroquine not prevent Donald Trump from taking the drug? We can only speculate, but, objectively, we can say for certain that the president ignored those warnings and acted on his own instinct, for better or for worse.

The Politicization of Hydroxychloroquine

A mere month later, on June 15th, as might have been predictable to anyone that was paying attention, the FDA revoked the Emergency Use Authorization of hydroxychloroquine reporting that “based on the ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.”

I would like to note that it was BARDA, the same organization that Dr. Rick Bright headed, that asked for this revocation (which brings even more credibility to Dr. Bright’s initial caution).

Five days after the FDA’s first statement on the National Institute of Health (NIH), the primary institution within the US for biomedical and public health research, stopped their clinical trial of hydroxychloroquine, finding that “the drug was very unlikely to be beneficial to hospitalized patients with COVID-19”.

The FDA, on July 1st, put out an analysis of safety issues due to taking hydroxychloroquine or chloroquine, finding that one third of their patience had “a serious cardiac adverse event” - a result that mirrored several other institutions’ findings in the past.

In other words, two of our foremost public health institutions found that hydroxychloroquine was ineffective at helping COVID-19 and, in the case of the FDA’s studies, found that there was even adverse effects to taking it. Consequently, hydroxychloroquine was not offered to patients.

Yet, the president continued to push hydroxychloroquine. Watch this segment citing his remarks on August 3.

This is disturbing. Putting aside the disagreement with Dr. Fauci (again), how do you have all of this information on hand, still push a drug that was never approved and then, following months of research, was collectively unsupported?

I don’t know how this could be explained except by saying that the president doesn’t take the word of scientific experts, all of whom he has access to, seriously. In cases like these, one has to ask what is the priority?

An answer can be deduced from that last video; the president believes that hydroxychloroquine has become political, a charge agreed to by FDA Commissioner Stephen Hahn. But it hasn’t been politicized by scientists; it’s been politicized by the president himself. The evidence of this comes from two facts: (1) that he was the first to announce its possible promise and (2) that hydroxychloroquine went through its clinical paces in the same way that most drugs are tested. In good faith, I have to say that his support of the drug may not have begun as a political position in March, but it is highly likely, the more hydroxychloroquine was questioned, it evolved into one.

We have to be careful of the hidden dangers to this situation (that drove me to writing this article). For President Trump to say that hydroxychloroquine has been politicized is to say that scientists are disagreeing with the use of hydroxychloroquine because of some political ramification or influence.

Scientists and scientific organizations, in this country, have conducted themselves honorably in coming to the conclusions they did. To suggest otherwise would be a grave blow to the integrity of the United States’ scientific community. It goes without saying that this is dangerous for a multitude of reasons, not the least of which includes a wrench to our public’s collective trust in science communication.

The Consequences of Poor Science Communication

At some point, we have to come to conclusions and take stock of our situation. Let’s summarize the facts:

March 19, 2020 - The President was the first high-level figure to push hydroxychloroquine to an American audience, driving public interest.
March 20, 2020 - Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases (NIAID) and a member of Trump’s Coronavirus Task Force, disagreed with the idea that hydroxychloroquine had promise, noting that all evidence that pointed to that conclusion was anecdotal and no clinical trials had been done. Donald Trump openly disagrees.
March 28, 2020 - The Food and Drug Administration (FDA) issued an Emergency Use Authorization on an unapproved drug, with Dr. Rick Bright using his position to put restrictions on its use, citing that it should only be administered by a healthcare provider when a patient has a valid prescription and used for hospitalized patients for whom clinical trials were not available or feasible and administered.
April 8, 2020 - Doctors affiliated with the American Heart Association, American College of Cardiology and Heart Rhythm Society released a joint statement of warning due to adverse cardiac effects.
April 16, 2020 - Brazil concludes a clinical trial, noting that lethality rate for participants rises as more hydroxychloroquine is provided and that hydroxychloroquine has no positive impact for the treatment of COVID-19.
April 20, 2020 - Dr. Rick Bright was ousted from his position as Director of the Biomedical Advanced Research and Development Authority (BARDA).
April 24, 2020 - The FDA reminds us that hydroxychloroquine is unapproved and should only be used for the restrictions that Dr. Rick Bright authorized in the original Emergency Use Authorization.
May 19, 2020 - President Donald Trump states that he has been taking hydroxychloroquine.
June 15, 2020 - The FDA revokes its Emergency Use Authorization.
June 20, 2020 - The National Institute of Health (NIH) concludes its clinical trials after finding that it was unlikely to be effective for the treatment of COVID-19.
July 1, 2020 - The FDA reveals documented safety issues associated with taking hydroxychloroquine, corroborating previous findings that there are adverse cardiac effects in a third of the participants.
August 3, 2020 - Trump triples down on his support for hydroxychloroquine, citing that he’s finished his two week hydroxychloroquine treatment.
August 4, 2020 - FDA Commissioner Stephen Hahn remarks that he thinks that “we can all agree that the issue of hydroxychloroquine has become politicized.”

In each step of the way, there have been individual scientists or scientific organizations that have stalled the widespread dissemination of hydroxychloroquine as a response to the president and the president alone. The first disagreement came a mere day after he first revealed the drug, but continued behind the scenes as Dr. Bright worked to limit how hydroxychloroquine was used.

But how many people knew this? Dr. Fauci has had many interviews since he took his place as the president’s advisor, yet the subjects of many of these interviews were never repeated in following interviews. We never got acknowledgment that the FDA was internally debating issuing the EUA. He never talked about the cardiac issues with taking hydroxychloroquine. He kept parading the drug as if there were no potential issues.

How many people took hydroxychloroquine for COVID-19 and suffered lasting cardiac damage? How about cardiac arrest? How many people died? We’ll never hear these numbers; we’ll never get the accountability of the president for trumpeting an unapproved drug.

Despite the six months of potential disaster, there is a silver-lining in this saga. Awareness of the secondary effects of hydroxychloroquine has led to a new wave of study to assess the safety of those drugs. This could lead to the evolution of the drug to something that is far healthier to use in the coming years.

However, as I voiced in an article that I wrote in the beginning of this pandemic, in situations like these, when the president is not amplifying the voices that we need to hear, you must seek out those voices. They are there for us. They - we - have always been.

Flux Science was recently named 112th on a list of curated science blogs at Feedspot. I’d like to personally thank them for the honor. Check their website out to see other fantastic science blogs.

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Citations

1. Remarks by President Trump, Vice President Pence, and Members of the Coronavirus Task Force in Press Briefing. (2020, March 19). Retrieved from https://www.whitehouse.gov/briefings-statements/remarks-president-trump-vice-president-pence-members-coronavirus-task-force-press-briefing-6/

2. Remarks by President Trump, Vice President Pence, and Members of the Coronavirus Task Force in Press Briefing. (2020, March 20). Retrieved from https://www.whitehouse.gov/briefings-statements/remarks-president-trump-vice-president-pence-members-c-oronavirus-task-force-press-briefing/

3. Statement from leader of federal vaccine agency about his reassignment. (2020, April 22). Retrieved from https://edition.cnn.com/2020/04/22/politics/read-whistleblower-vaccine-development/index.html

Hydroxychloroquine - A Case Study on Poor Science Communication

Abstract (TL;DR)