While Covid-19 continues to kill thousands of Americans each week and devastate the national economy, President Donald J. Trump and his allies are trying, against all reason, to portray him as a successful commander in chief of the pandemic response. Last month, during a press conference to promote convalescent plasma as a potential new Covid-19 treatment, Health and Human Services Secretary Alex Azar branded Trump as the “Right to Try President” for aggressively pushing for new coronavirus treatments. In truth, the president has repeatedly misrepresented the Right to Try law and other coronavirus efforts in an apparent attempt to exploit the public’s hope for medical miracles. His stream of unsupported claims threatens to erode trust in government health agencies just when that trust is needed the most.
The Right to Try law, signed by President Trump in May 2018, aims to increase access to experimental medical treatments by allowing patients diagnosed with a life-threatening disease to receive experimental treatments that have yet to be approved by the U.S. Food and Drug Administration. Eligible treatments must have completed a phase one clinical trial to establish their safety, must not be approved for any other use, and must still be under active investigation. A sponsor — typically the company that makes the treatment — must then agree to provide the treatment to the patient at cost.
As critics have rightly pointed out, Right to Try did not clearly address a problem with accessing experimental treatments. The FDA already administers an expanded access pathway that allows ill Americans to obtain these treatments outside of clinical trials. While this process has been criticized as too slow, in recent years the FDA has sped up and streamlined the expanded access application process and approves nearly all applications. In actuality, the Right to Try law appears to be aimed largely at reducing FDA oversight over the drug approval process.
In practice, the restrictions in Right to Try — designed to ensure that the law protects patient safety and doesn’t impede medical development — have meant that very few people have accessed treatment via that pathway. There have been very few news reports of people successfully using Right to Try, and these reports are often countered with stories of companies abandoning plans to sponsor treatments. While the FDA has proposed a rule that would require Right to Try sponsors to submit annual reports to the agency, it has not yet been finalized. Nonetheless, in a recent announcement the agency indicated that it expects to receive only up to six such reports annually.
But these facts haven’t stopped the president from portraying Right to Try as a major health care success of his first term. At his campaign appearances, Right to Try is commonly held up as a key highlight of an otherwise thin health care track record. “The lives saved have been really incredible,” Trump has argued, adding that “now they sign a very short, simple document, and they have the right to try, and it’s given them hope, and in many cases, it’s given their life back.”
Right to Try was also hailed at last month’s Republican National Convention. One of the featured speakers of the convention’s opening night was Natalie Harp, who has claimed that she was able to access lifesaving treatment for terminal bone cancer via Right to Try. In her speech, she claimed that before Trump signed the law into effect, doctors “didn’t give me the right to try experimental treatments.” Without Trump, she said, “I’d have died waiting for them to be approved.”
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But Harp’s story doesn’t seem to be an actual case of Right to Try providing access to an experimental treatment. According to Harp’s own statements, she received “an FDA-approved immunotherapy drug for an unapproved use” to treat her cancer. The federal Right to Try law, however, cannot be used for FDA approved drugs. Rather, the off-label use of FDA approved drugs has been allowed for many years, long predating President Trump’s administration.
The same pattern of deceit emerged with the FDA’s recent announcement of its emergency use authorization of convalescent plasma to treat Covid-19. Emergency use authorizations are a mechanism by which the FDA can allow use of an unapproved medical product or allow unapproved use of an approved product for treatment during a public health emergency. To be eligible, a treatment must have produced evidence that it “may be effective in diagnosing, treating, or preventing” the target disease.
While there is some debate over whether convalescent plasma meets this standard, it is clear that the administration massively overstated the known ability of the treatment to save the lives of patients infected with Covid-19. In last week’s press briefing, President Trump claimed that convalescent plasma “has proven to reduce mortality by 35 percent. It’s a tremendous number.” His comments were echoed by FDA commissioner Stephen Hahn.
In reality, the observed improvement in mortality rate — that is, the reduction in the number of deaths in a given patient population — was likely no more than 5 out of 100. Moreover, the study Trump cited was based on a small subgroup of patients and did not include a control group, and has not yet been peer reviewed, making it difficult to assess its actual impact on mortality. While Hahn has now acknowledged that the comments were misleading, the president has not followed suit.
It is clear that the administration massively overstated the known ability of the treatment to save the lives of patients infected with Covid-19.”
Although convalescent plasma has been used in other contexts and is generally thought to be safe, hyping the known efficacy of the treatment for Covid-19 is irresponsible. If convalescent plasma turns out not to be effective, or not as effective as the president claimed, it could erode trust in the FDA and other arms of the government as they try to battle Covid-19. Moreover, these claims make it difficult to run the kind of high quality, placebo-controlled trials that will help physicians more precisely determine the effectiveness of convalescent plasma. This is because people who have been told that the treatment saves one in every three lives are unlikely to risk receiving a placebo through a clinical trial when they can be guaranteed access to convalescent plasma through the emergency use program.
In this sense, then, Secretary Azar is correct to call President Trump the Right to Try President as he oversees the U.S.’s coronavirus response. Just as Right to Try is an overhyped and underperforming policy that misleads the public, Trump is now actively misrepresenting the status of potential coronavirus treatments. These statements don’t just mislead the public, they make it harder for scientists to gather the information they need to determine if the treatments are effective and how best to use them. And there is good reason to fear that the president’s pattern of overhyping medical treatments will extend to any potential announcement of a Covid-19 vaccine as well.
Right to Try and convalescent plasma do, as the president says, give people hope. But it is largely false hope that the president exploits for his political purposes. The country needs leadership based in truth. The government must trust that the American people can build hope based on facts and a real understanding of what is needed to contain and eventually eliminate Covid-19. The public has a right to be told the truth and the president and his administration must try to give it to them clearly and consistently.
Jeremy Snyder is a bioethicist and professor in the Faculty of Health Sciences at Simon Fraser University. His book “Exploiting Hope” will be available from Oxford University Press in September.