Trump and COVID-19: Population Health Neglect, Hydroxychloroquine Hype, and a Gambler’s Fallacy

William M. London

Cover Image Courtesy of Flickr


 

I am wary of anything offered with a sales pitch of “What do you have to lose?” I wonder about undisclosed risks that are difficult to anticipate. I wonder how good the prospects are for gain. I wonder whether the pitchman is trying to take advantage of people who struggle to find answers under difficult circumstances. I wonder how desperate the pitchman is to have the offer accepted.

I first noticed accomplished pitchman Donald J. Trump making a “What do you have to lose?” pitch in 2016. I noticed a second pitch from him again this year. I had good reasons to be wary both times.

Trump’s “What Do You Have to Lose?” Pitch in 2016

During his 2016 presidential campaign. Trump asked “What the hell do you have to lose?” in his pitch to African American voters to try something new, namely Trump. The Congressional Black Caucus replied that African Americans had a lot to lose. Only six percent of black voters chose Trump in 2016, according to the Pew Research Center

It turned out that many black people have had their lives to lose in the Trump administration. According to the COVID Tracking Project, more than 32,000 deaths among black people in the United States are attributable to COVID-19, and the COVID-19 death rate among black people is 2.5 times that of white people.

In July, one of Trump’s few ardent African American supporters, former presidential hopeful Herman Cain, died of COVID-19 complications. Cain, who had been cochair of Black Voices for Trump, had attended Trump’s indoor campaign rally in Tulsa, Oklahoma, on June 20, where there was little social distancing, few masks were worn, and attendees had to sign a digital waiver releasing the campaign and the president of any liability if they got sick. Cain tested positive for coronavirus infection on June 29 and was hospitalized July 1 with serious symptoms. 

Cases of COVID-19 had been increasing in Tulsa County the week of the event. The Trump campaign announced on the day of the event that six of its staffers working the rally had tested positive for COVID-19.

Trump has claimed that he has done more for African Americans than any president other than Abraham Lincoln. That claim is hard to reconcile with his recent actions that are likely to disproportionately harm African Americans. 

Last month, the Trump administration dismantled Obama-era rules designed to promote fair housing and Trump said:

Yo know, the suburbs, people fight all of their lives to get into the suburbs and have a beautiful home. There will be no more affordable housing forced into the suburbs. It’s been going on for years. I’ve seen conflict for years. It’s been hell for suburbia. We rescinded the rule three days ago so enjoy your life, ladies and gentlemen, enjoy your life.

As noted by Los Angeles Times business columnist Michael Hiltzik, Trump with Republican support in Congress:

Every benefit under the CARES Act elapsed on July 31st including the eviction moratorium, which places renters suffering financial hardships related to the pandemic at risk of losing their homes.

Trump’s “What Do You Have to Lose?” Pitch in 2020

In mid-March, Trump started touting the drug hydroxychloroquine as a potential “game changer” against COVID-19. In April, Trump announced:

We have purchased and have stockpiled 29 million pills of the hydroxychloroquine, 29 million. A lot of drugstores have them by prescription and also and they’re not expensive. Also we’re sending them to various labs, our military. We’re sending them to hospitals. We’re sending them all over. I just think it’s something. You know the expression I’ve used it for certain reasons. What do you have to lose? What do you have to lose? And a lot of people are saying that and and and are taking it.

Yes, it was second time I noticed a “What do you have to lose?” pitch from him. Again, I was wary. While hydroxychloroquine is an evidence-based treatment in selected patients who have lupus or rheumatoid arthritis, it is at best an experimental treatment for COVID-19. 

On April 20, Rick Bright, PhD, an immunology and virology expert, was involuntarily transferred to a position of narrow responsibility at the National Institutes of Health after being dismissed as the U.S. Department of Health and Human Services’ director of the Biomedical Advanced Research and Development Authority and deputy assistant secretary for preparedness and response. He attributed his demotion to his being insistent that government funds be spent on “safe and scientifically vetted solutions” to address COVID-19 and not on “drugs, vaccines and other technologies that lack scientific merit.” He said: “Specifically, and 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.”

In early May, Bright filed a whistleblower complaint alleging a range of government wrongdoing in responding to the COVID-19 pandemic. Bright blasted the Trump administration’s COVID-19 response in testimony on May 14 before the House Committee on Energy and Commerce’s Subcommittee on Health and in an interview on the CBS 60 Minutes program that aired on May 17. In his testimony, Bright said that the Trump administration rushed out recommendations for hydroxychloroquine for COVID-19 and attempted to bypass rigorous scientific vetting. On 60 Minutes, he disagreed with the notion promoted by President Trump that hydroxychloroquine has a “real chance to be one of the biggest game changers in the history of medicine.”

Widespread interest in hydroxychloroquine was initially generated by Didier Raoult, the senior author of a paper first published online in March reporting a small, substandard, uncontrolled clinical study of the drug used alone and in combination with the antibiotic azithromycin on COVID-19 patients. The paper purported to show the treatments reduced the presence of the novel coronavirus in the body, but the study design was inadequate for demonstrating that drug treatment was helpful and has been harshly criticized. Raoult’s reputation as a scientist has since suffered.

Some scientists thought that hydroxychloroquine can act to both keep the virus from entering cells of the body and disrupt viral protein production. Several rationales have been proposed for using azithromycin, but its effectiveness against COVID-19 remains unsubstantiated. Over 100 relevant clinical trials were started. But serious concerns about the safety and effectiveness of hydroxychloroquine in treating COVID-19 soon emerged.

Hydroxychloroquine is an approved drug for either prevention or treatment of certain types of malaria. Its anti-inflammatory action makes it effective in treating patients with lupus, rheumatoid arthritis, and some other health problems. The promotion of hydroxychloroquine for COVID-19 has threatened supplies of the drug for patients who rely on it to manage their inflammatory diseases.

Hype for hydroxychloroquine and the similar drug chloroquine led to a tragic mistake in March. The Centers for Disease Control and Prevention (CDC) reported that two individuals consumed non-pharmaceutical chloroquine phosphate, a chemical for aquarium use that is commercially available for purchase at stores and through internet websites:

One of the individuals died shortly after arrival to the hospital. The second individual was critically ill with severe gastrointestinal symptoms and cardiac conduction abnormalities. Upon recovery, the surviving individual reported to the media that they ingested the product to prevent infection with SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19), after seeing information on the medical use of chloroquine on television. The product in their possession was in powder form inside a 2.2-lb. container and labeled “for Ornamental Fish Use Only.”

Hydroxychloroquine has not been approved by the U.S. Food and Drug Administration (FDA) for treating COVID-19, but in April it was granted an emergency use authorization (EUA) for its use to treat adults and adolescents who weigh at least 110 pounds and who are hospitalized with COVID-19 but are unable to participate in a clinical study. That EUA was later revoked as new, discouraging evidence emerged.

On May 18, 2020, President Trump announced that he had been taking hydroxychloroquine every day for about a week despite having tested negative for the coronavirus and having no symptoms. A statement from Trump’s physician Sean P. Conley, D.O., released that day noted that, two weeks prior, one of the president’s support staff had tested positive. Dr. Conley wrote:

After numerous discussions [President Trump] and I had regarding the evidence for and against the use of hydroxychloroquine, we concluded that the potential benefit from treatment outweighed the relative risks.

On May 24, President Trump announced that he had finished his hydroxychloroquine regimen. If Dr. Conley had prescribed the drug for him and President Trump had taken it as he said he did, we would still have no way of knowing from his anecdote whether the drug made any difference for him. Before concluding that hydroxychloroquine is evidence-based medicine against COVID-19, favorable findings from well-designed, properly conducted clinical trials would be needed.

On June 15, the FDA revoked the EUA because the legal criteria for initiating it were no longer met. It announced:

Based on its 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. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.

Moreover:

Recent results from a large randomized clinical trial in hospitalized patients, a population similar to the population for which chloroquine and hydroxychloroquine were authorized for emergency use, demonstrated that hydroxychloroquine showed no benefit on mortality or in speeding recovery. This outcome was consistent with other new data, including data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19. The totality of scientific evidence currently available indicate a lack of benefit.

In a separate announcement on June 15, the FDA warned that co-administering either hydroxychloroquine sulfate or chloroquine phosphate with the investigational antiviral drug remdesivir may result in reducing remdesivir’s antiviral activity. Remdesivir has received an EUA for treating hospitalized COVID-19 patients with severe disease.

The FDA’s chief scientist wrote on June 15:

FDA has concluded that … it is no longer reasonable to believe that oral formulations of [hydroxychloroquine] and [chloroquine] may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.

The FDA has cautioned against use of hydroxychloroquine and chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of potentially life-threatening heart rhythm problems.

In June, the World Health Organization announced that its ongoing Solidarity Trial’s hydroxychloroquine treatment arm had been discontinued based on disappointing interim findings, signals of safety problems, evidence from the UK’s Recovery Trial, and a Cochrane Review of other evidence about the drug.

A guidelines panel of the Infectious Diseases Society of America (IDSA) recommended (updated as of June 18) that among patients with COVID-19:

  • Hydroxychloroquine or chloroquine be used only in the context of a clinical trial.
  • Hydroxychloroquine or chloroquine in combination with azithromycin should not be used outside of the context of a clinical trial (due to concerns about toxicity).

On June 20, the National Institutes of Health announced that a clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with coronavirus disease 2019 (COVID-19) had been halted because a Data Safety Monitoring Board had determined that drug was very unlikely to be beneficial to hospitalized patients with COVID-19.

In late July, NBC News reported that Facebook, YouTube, and Twitter each removed a forty-five-minute video that violated their standards by falsely claiming that business and school closings, social distancing, and masks were not needed because the drug hydroxychloroquine could both prevent and cure COVID-19. The claims were made by a group presented as “America’s Frontline Doctors” at a July 27 event in front of the U.S. Capitol with a small audience that had been livestreamed by the far-right website Breitbart News. The Tea Party Patriots, a right-wing nonprofit group, hosted and funded the event.

Donald Trump Jr.’s Twitter account was temporarily suspended after he tweeted the video stating “This is a must watch!!! So different from the narrative everyone is running with.” President Trump retweeted a clip of the video and later defended doing so, saying that one of the doctors, Stella Immanuel, was impressive and that he thought her voice was “important.”

Dr. Immanuel, a pediatrician and religious minister in Houston, Texas, has a history of making bizarre medical claims. She has repeatedly attributed gynecological problems to people having sex in their dreams with demons and witches. She claims that alien DNA is used in medical treatments. Investigators of the featured doctors found that “none of the most vocal members have practices that would place them on the actual front lines of the COVID-19 pandemic. Some don’t currently practice at all.”

On July 31, the Texas Medical Board issued a press release objecting to “a widely published claim of a ‘cure’ for COVID-19.” It stated in part:

A physician must provide full disclosure of treatment options, side effects, obtain informed consent, and there cannot be false, misleading or deceptive advertising or statements made regarding any therapies, including a cure for COVID-19.

President Trump has also touted a journal paper published in July about a retrospective observational study of 2,541 hospitalized patients with COVID-19 that found reduced mortality among those who received hydroxychloroquine alone or in combination with azithromycin. Such a study cannot control for confounding factors the way properly designed randomized clinical trials can. Letters to the editor of the journal identified multiple flaws, errors, and biases in the study.

On August 3, President Trump continued to hype the use of hydroxychloroquine against COVID-19. He said that it has tremendous support despite contrary views from his own experts. He claimed that his support for it is “politically toxic.” It seems to me that promoting treatments with baseless claims ought to be politically toxic.

Trump’s enthusiasm for hydroxychloroquine is inconsistent with recommendations from the National Institutes of Health’s COVID-19 Treatment Guidelines Panel. The panel’s guidelines include these summary statements:

  • The COVID-19 Treatment Guidelines Panel (the Panel) recommends against the use of chloroquine or hydroxychloroquine for the treatment of COVID-19, except in a clinical trial. [The panel characterized this recommendation as strong and based it on one or more well-designed, nonrandomized trials or observational cohort studies.] (This recommendation is part of a statement last updated June 16, 2020.)
  • The Panel recommends against the use of high-dose chloroquine (600 mg twice daily for ten days) for the treatment of COVID-19. [The panel characterized this recommendation as strong and based it on one or more randomized trials with clinical outcomes and/or validated laboratory endpoints.] (This recommendation is part of a statement last updated June 16, 2020.)
  • The COVID-19 Treatment Guidelines Panel recommends against using hydroxychloroquine plus azithromycin for the treatment of COVID-19, except in a clinical trial. [The panel characterized this recommendation as strong and based it on expert opinion.] (This recommendation is part of a statement last updated July 17, 2020.)

We’ve had much to lose from hydroxychloroquine hype beyond adverse reactions to the drug. As inspired by Trump and Dr. Immanuel, we’ve seen widespread complacency about the need to apply inconvenient public health measures to combat the pandemic. We’ve seen wasted resources on poorly designed and poorly conceived COVID-19 research studies. We need to be wary of the nothing-to-lose fallacy.

A Gambler’s Fallacy

On several occasions, my mentor, the late William T. Jarvis, referred to the notion that there is nothing for a terminally ill patient to lose by trying a questionable remedy as “The Gambler’s Fallacy. Perhaps it would be better to call the fallacy the nothing-to-lose fallacy or the Jarvis fallacy rather than the gambler’s fallacy, since that term is widely applied to a different fallacy: failing to correctly identify separate events of chance such as the results of separate coin flips as independent of each other.

Jarvis wrote that cancer quacks exploit the fallacy. He wrote that threats of questionable therapies even to terminally ill patients include incompetent practitioners, hazardous clinical conditions, and interfering with proper clinical management that can lead to reduced quality of life. Since then, researchers have found “alternative medicine” use to be associated with shorter survival time for cancer patients. Refusal of standard treatment has also been found to be associated with shorter survival time for breast cancer patients.

I suggest that it’s prudent to consider any poorly considered response of “nothing” to a WDYHTL (What-do-you-have-to-lose?) pitch as the nothing-to-lose fallacy. Examples include concluding that African Americans had nothing to lose by getting Trump elected and concluding that hydroxychloroquine effectively treats, cures, or prevents COVID-19.

Preventing Further Losses

Trump seems unwilling to acknowledge that the United States now has one of the highest cumulative case counts taking into account population size and the highest COVID-19-specific mortality rates among nations of the world. Trump didn’t cause the COVID-19 pandemic, but his response to it has been slow and haphazard. Poll data now indicate that most Americans disapprove of Trump’s response to the crisis

Trump’s overconfidence, arrogance, unwillingness to admit making mistakes, unwillingness to take responsibility, priority to blame others, science denialism, distrust of real expertise, reliance on untrustworthy sources of information, disregard for getting the facts straight, mendacity, penchant for claiming more than he can deliver, disregard for evidence, embrace of conspiracy theories, wishful thinking, ignorance, diverted attention, and lack of concern for others have been barriers to a successful response.

According to a new report from the Center for Health Security at the Johns Hopkins Bloomberg School of Public Health on how the United States must reset its response to the pandemic: “Unlike many countries in the world, the United States is not currently on course to get control of this epidemic.” The Association of American Medical Colleges has also issued a report providing a roadmap to reset the U.S. response to COVID-19. Both reports call for implementation of sound public health practices. Neither report mentions hydroxychloroquine.

Trump said that the United States is in the process of crafting a strategy to combat the pandemic. That was three weeks ago—not in February when the spread of the coronavirus could still be contained. I’m still waiting for Trump to reveal his strategy.

 


 

Articles, reports, reviews, and letters published on skepticalinquirer.org represent the views and work of individual authors. Their publication does not necessarily constitute endorsement by CSI or its members unless so stated.

William M. London

William M. London is a professor of public health at Cal State LA, the editor of the free weekly email newsletter Consumer Health Digest, and the developer of CFI’s Dubious COVID-19 Treatments and Preventives page from which most of the discussion of hydroxychloroquine in this essay is derived.