Prominent among the achievements listed by the Trump administration, as the president seeks a second term, is the Right to Try Act he signed into law in May of 2018. The act was intended to let dying patients try experimental treatments, but it has not lived up to that promise.
Trump and his allies invoke right to try often because the policy is, like apple pie, popular to red, blue, and purple audiences across America. Yet behind the appealing name are some not-so-sweet facts. First and foremost, there is no “right” to try. Patients, through their doctors, may ask companies developing new drugs or devices for early, nontrial access to them, but no law requires these companies to provide them.
Second, Americans have had the ability to request access to experimental medical products for decades. The Right to Try Act merely repackaged this existing option, called expanded access, under a flashier name and stripped out the Food and Drug Administration oversight that protects patients from exploitation and requires prompt reporting of serious harms resulting from a product’s use. Right to try proponents claimed that FDA’s involvement meant that patients were being blocked from accessing drugs promptly, but the data show that the FDA quickly approves the vast majority of expanded access requests.
The act also includes a liability shield barring anyone involved in the provision of experimental products from being held accountable for bad outcomes, except under narrow circumstances. Though not a bad idea in principle, the protection is too broad. It also is unnecessary; there has never been a lawsuit for injury or death occurring under expanded access. This does not mean that bad things can’t happen when trying an experimental treatment—they can and do—but it suggests that patients understand the risks they face. That’s why reporting bad outcomes is crucial to inform others who might use the experimental treatments of the possible risks.
While Trump and his inner circle have wrongly claimed that the Right to Try Act has saved hundreds of thousands of lives, the law has actually been rarely used. Thus, regardless of what its backers claim, right to try is not an improvement on expanded access, which continues to be used by more than a thousand patients annually.
Whomever wins the election must focus on the mundane, but very real issues that need to be addressed to help seriously and terminally ill patients who have run out of therapeutic options. We propose three actions that would make a world of difference. First, clinical trials are the best, most efficient way to access an experimental medical product, but they are often needlessly difficult to learn about and participate in, and patients may be charged for trial-related expenses. Passing the Clinical Treatment Act would fix the financial barrier to trials and help far more patients access experimental treatments than has right to try.
Next, for patients who cannot join a clinical trial, there’s expanded access. One thing apparent from right to try was that many Americans didn’t know that preapproval access to experimental medicines was already possible. Clinicians, patients, and caregivers need to be educated about all the options. A pilot “concierge” service at the FDA called Project Facilitate guides doctors through the expanded access process, but it is a temporary program without permanent staff or budget, and is only for oncologists. It should become permanent and expanded to cover all serious or life-threatening medical conditions.
Finally, there needs to be a national conversation about how to cover the costs of making experimental treatments available to patients. Cost prevents many patients from joining trials, and it’s frequently a reason why companies deny expanded access requests. This program cannot and should not supplant clinical trials, but it could provide an option for patients unable to participate in these studies. But simultaneously running trials and providing access requires more drugs and more employees, and thus more expenses. Simply put, spending money to provide an unapproved product to patients is a difficult sell to shareholders, who often want all the company’s effort devoted to getting new products on the market. Who should pay for expanded access and how remain open questions.
The combination of increasing access to clinical trials, expanding Project Facilitate, and determining who should pay for expanded access will help patients achieve what the Right to Try Act hollowly promised. The playbook is there. The next administration simply needs to run with it.
Alison Bateman-House is assistant professor in the Division of Medical Ethics at the New York University Grossman School of Medicine in New York City and co-chair of the NYU Working Group on Compassionate Use and Preapproval Access.
Arthur Caplan is the Drs. William F. and Virginia Connolly Mitty professor and founding head of the Division of Medical Ethics at the NYU Grossman School of Medicine.
Lisa Kearns is a senior researcher in the Division of Medical Ethics NYU Grossman School of Medicine.
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November 03, 2020 at 08:13PM
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The Right to Try Act Has Failed America's Terminally Ill Patients - Barron's
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