Since March 2020, we have been bombarded each day with an overload of statistics. Charts,…
Autonomy, our right to make decisions for our own bodies, is the most powerful of all principles in medical ethics. Autonomy is what drives focus on advance care planning: considering, communicating and documenting end of life care preferences.
Dying is draining, both physically and emotionally. A key stressor is the seeming lack of control over one’s destiny. Are there choices for the dying or is it about acceptance? Are there options for those who want to keep trying, no matter what the decision to “try” entails?
“Right to Try” laws are now in effect in 40 states, allowing patients with terminal illnesses to try any drug that has passed its Phase One clinical trial under FDA rules.
Federal legislation was just signed by President Donald Trump and now standardizes rules across every state.
Contentious debate continues between those for and against federal “Right to Try” legislation. While it’s challenging to isolate real arguments from political posturing about harm to the desperately ill, it is worth a brief review of what “Right to Try” would mean nationwide.
According to a report in the Journal of the American Medical Association, “most of the drugs that succeed in Phase One trials turn out to be too unsafe or ineffective for clinical use.” Two-thirds fail in Phase Two, and even more fail in Phase Three, the last trial hurdle before a drug receives approval for marketing.
Authors contend that these laws “dissolve away any semblance of legal, financial or medical protection for the patients and their families, not to mention fairness in the administration of healthcare.”
In addition, many state laws absolve insurers of any responsibility for covering further medical expenses once a patient decides on the “Right to Try” route.
According to medical myth-buster David Gorski, insurance companies aren’t required to pay for care resulting from any patient complication. He also explains that most “Right to Try” patients lose their hospice benefit.
Opponents point to the already available expanded access program or the FDA’s “compassionate use” for access to investigational therapies.
Others cite the dietary supplement industry, Laetrile, Compound Q and off-label promotion as examples of the exploitation of desperate patients who need protecting, likening these debacles to snake oil salesmen.
The FDA approves more than 99 percent of its roughly 1,000 expanded access requests per year, adding whatever changes are needed to ensure additional safeguards. The FDA also retains oversight of physicians authorized to offer expanded access treatments. The results of these treatments can be used to judge the safety and effectiveness of the experimental therapy.
Those opposing “Right to Try” say there is already an effective, accessible alternative for patients with an irreversible terminal illness. This alternative also comes with the oversight of a federal agency commissioned to protect patient safety.
However, advocates cite flaws in the state of affairs. Dr. Roger D. Klein, a member of the Regulatory Transparency Project on Health Care, points out that as recently as 2016, the FDA required a physician to spend 100 hours filling out a form before she or he could help patients wanting a last-ditch effort to extend their lives.
Adding to the complexity, the FDA considers such doctors researchers. Even though the FDA has attempted to streamline the application for expanded access, the agency mandates that petitioners obtain time-consuming institutional review board approval before prescribing potentially life-extending drugs. As a result, this process stifles an already burdened physician’s appetite to begin.
Dr. Klein asks: “is coercing anguished patients into becoming subjects of studies from which others will profit solely to obtain possible cures morally justified?”
Recognizing the shortfalls of state legislation, will federal law improve upon the framework already in place? Will consumer protections be explicitly spelled out so that anyone opting into a “Right to Try” program has truly informed consent? What are the differences between the expanded access program and “Right to Try”? Who benefits most from each? Is it the consumer or the special interest group?
Can expanded access and “Right to Try” co-exist in order to expand patient choices at end of life?