By Gary Evans
While the federal Right to Try law passed in 2018 has thus far resulted in little activity, bioethicists expect oncology will be on the frontlines of an anticipated increase in requests for investigational new drugs.
There is concern that increasing patient demand for investigational cancer drugs could lead to an increase in federal Right to Try requests, favoring that route over the longstanding expanded access pathway that includes FDA and IRB review.
“At a minimum, oncologists who are considering certification of patient eligibility should not make themselves available for doctor-shopping or as a rubber stamp,” the authors of a recent paper emphasized.1 “[C]ompanies may emerge to offer the services of physicians willing to certify Right to Try eligibility for a fee. The idea of physician mercenaries is problematic because it makes a farce of the gatekeeping role that Right to Try preserves for certifying physicians.”
Lead author of the paper is Holly Fernandez Lynch, JD, MBE, assistant professor of medical ethics and health policy at the University of Pennsylvania. “The question of mercenaries came up in the context of what we have seen in these online pharmacies, where you can get a prescription from some nameless, faceless physician who doesn’t really know the patient,” she tells IRB Advisor. “For Right to Try, you have to have a physician certify the eligibility criteria. It’s possible that could be some physician who doesn’t know the patient.”
Under such conditions, physicians may not be able to steer patients toward the established expanded access path, which should occur whenever possible, Lynch says.
“I think that physicians have a professional obligation to make sure patients are only pursuing Right to Try if it really is a reasonable pathway for them,” she says. “If you have a personalized relationship with the patient, you can help them understand why it may be a bad idea. If you are just signing off on anybody who has the eligibility criteria, I’m not sure you are satisfying your professional responsibilities.”
The paper includes several recommendations for oncologists on Right to Try issues, including considering the FDA’s Project Facilitate call center, to speed access to investigational new cancer drugs. (For more information, see the July 2019 issue of IRB Advisor.)
“The first point they should consider is, can you get your patient in to a clinical trial?” Lynch says. “If you can’t, can you pursue expanded access rather than Right to Try?”
Other recommendations by Lynch and colleagues for oncologists include:
• Understand that Right to Try may be inappropriate for a patient even when eligibility criteria are satisfied. Physicians can say no;
• Seek guidance from FDA and others regarding the risks and benefits of unapproved products;
• Collect and report information about patient outcomes if certified for Right to Try;
• Counter misinformation, and do not overpromise;
• Engage in shared decision-making with patients. Consider whether pursuing unapproved interventions is likely to advance their goals.
IRB Oversight Role
As opposed to expanded access, neither FDA nor IRB oversight is required with Right to Try.
“There has been some debate about whether IRB oversight is even necessary in the context of expanded access, given that you have FDA involved,” Lynch says.
A recently published survey of IRB members found that 78% of respondents agreed that it is important for IRB review of single-patient expanded access requests. Eighty-seven percent of respondents said their IRB is prepared to review expanded access cases.2
“IRBs also do things that FDA is not doing,” Lynch says. “They take a close look at the informed consent to make sure that the patient really understands what is going on in expanded access. They are able to oversee the physician to make sure they are not conflicted and to make sure they have the right expertise with the particular drug product.”
Likewise, the IRB can ensure that their institution has the right capabilities, resources, and support to oversee such cases. “You can debate whether their role is duplicative with expanded access, but with Right to Try I think the role of IRB review is important because you are losing FDA oversight,” Lynch says.
No such involvement is required under the law, but institutions and IRBs are free to set their own conditions if they are asked to take on a Right to Try case, she says.
“Institutions can decide whether they want to engage in Right to Try at all,” Lynch says. “They also are permitted to add whatever additional protections they think are appropriate.”
REFERENCES
- Lynch HF, Sarpatwari A, Vonderheide RH, et al. Comments and Controversies. Right to Try requests and oncologists’ gatekeeping obligations. J Clin Oncol Oct 15, 2019. Available at: https://bit.ly/33NOf4J.
- Chapman CR, Shearston JA, Folkers KM, et al. Single-patient expanded access requests: IRB professionals’ experiences and perspectives. AJOB Empir Bioeth 2019;10:88-99.
While the federal Right to Try law passed in 2018 has thus far resulted in little activity, bioethicists expect oncology will be on the frontlines of an anticipated increase in requests for investigational new drugs.
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