As we entered the final weeks of a presidential campaign held during a pandemic, access to experimental medical interventions played a major role in the Trump campaign’s case for reelection. President Trump regularly boasted about the Right to Try legislation he signed as a major health care achievement. Meanwhile, he has been hyping the availability of experimental treatments for COVID-19.
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With his diagnosis, the president became the living embodiment of how experimental medical interventions have entered the political spotlight. After being hospitalized, Trump received Regeneron’s experimental antibody treatment REGN-COV2 through the FDA’s expanded access pathway. Fortunately for the president, the CEO of Regeneron is a friend and member of his golf club who was “happy to oblige” his request for access to this drug despite the company focusing its limited supply of REGN-COV2 on clinical trials and limiting expanded access to “exceptional circumstances.”
Right to Try and the expanded access pathways are similar in that they allow medical researchers and developers to make experimental medical interventions available to people with serious or life-threatening conditions. These recipients must have no alternative FDA-approved treatment options and be unable to enroll in a clinical trial for their medical condition. In both instances, the sponsor of the intervention must agree to provide it, and may impose a charge to cover the direct costs of doing so.
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Right to Try proponents argue that it is necessary as it removes the FDA from the process of approving requests for access to experimental interventions. Critics have pointed out that the FDA approves nearly all of these requests and has streamlined the application and approval process. Instead, these critics worry, Right to Try is a way to try to reduce the FDA’s role in providing oversight of investigational medical products.
President Trump has spent the two and a half years since signing Right to Try claiming that it will revolutionize the ability of seriously ill Americans to access experimental medical interventions. These claims include saying it will save “hundreds of thousands” of lives and that it is “so incredible and so successful.”
There is, however, little evidence to support even more modest statements that the law has been successful. While there have beenmediareports of a few people accessing treatment, these are very limited and do not include evidence that lives have been saved as a result. The FDA is tasked with collecting yearly reports from treatment sponsors under the new law, but the requirements for doing so have not yet been finalized, and the first information on use of Right to Try will not be reported until after the presidential election.
To get a better sense of how Right to Try has been used in comparison to the preexisting expanded access pathway, Alison Bateman-House, Leigh Turner and I decided to look at crowdfunding campaigns seeking treatment through these pathways. While crowdfunding campaigns will not capture all or even most people using these pathways to access experimental interventions, some people use crowdfunding because the costs of accessing these interventions can be very high and are generally not reimbursed by insurance.
Our results were published in Regenerative Medicineon October 7, 2020, During the period following the passage of the Right to Try law, we found 26 campaigns mentioning expanded access or compassionate use pathways administered by the FDA and 29 referencing the Right to Try pathway that circumvents the FDA. But while 21 of the expanded access campaigns reported being approved to access treatment via this pathway, only one Right to Try campaign did so. This discrepancy may be in part because these campaigns generally showed poor understanding of how that pathway works in practice. This so-called right still requires drug developers to agree to provide the intervention, and recipients have to demonstrate that they aren’t eligible to participate in a clinical trial for the drug, have no other treatment options and have a life-threatening medical condition, among other requirements.
These campaigns tended to treat the “Right to Try” as shorthand for wanting and deserving to access experimental interventions. In this vein, several campaigns read like political statements, expressing support for President Trump for signing the Right to Try law. Others acknowledged the roadblocks to accessing treatment via Right to Try, stating that no sponsor was willing to provide them treatment. One frustrated campaigner facing this issue went so far as to state that the “Right to Try should be relabeled as Right to Die.”
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For both of these pathways, the direct and indirect costs of accessing experimental interventions create a significant barrier. In our research, they ranged from $15,000 to $700,000 in costs for the intervention with more added on in travel and other expenses. This shows that even when expanded access pathways are working well and creating a process to access experimental interventions, they still depend on the willingness of sponsors to provide these treatments and the financial means to pay for them.
Expanded access to experimental medical interventions is an important tool for helping very sick and dying people have every chance to improve their health, especially when they don’t have the option of participating in clinical trials. More can be done to improve this process, especially by addressing inequities in who has the opportunity to pursue this pathway. As the president’s own use of expanded access (notably not Right to Try) shows, it pays to have friends who are the CEOs of pharmaceutical companies and access to the finest medical treatment in the country. The Trump administration’s regular lies about this pathway—claiming that the Right to Try legislation’s sidelining of the FDA is necessary, and, lately, that REGN-COV2 will be 'delivered to every hospital where you have sick people with the COVID”—simply serve to confuse these issues.
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It is unfortunate that the FDA will not provide the exact numbers on Right to Try usage before the November election. But we know enough already to say that President Trump is using expanded access and Right to Try to cover for failures to advance comprehensive health care legislation and to adequately address the COVID-19 pandemic. Sick Americans deserve the truth on these pathways and all Americans should be able to vote with a clear understanding of the impacts of this administration’s actions—and inactions—on access to health care.