By: Dr. Brent Schillinger, Guest Contributor
Last year Florida passed a law that gives terminally ill patients access to experimental drugs, products, or devices without Federal Drug Administration approval. Known as a patient “Right to Try” law, similar measures have been passed in twenty three other states. At first read, this seems to me to make perfect sense. Why not give a dying patient, and his or her doctor, legal access to all of the potential therapeutic options? While the measure sailed through both branches of the Florida legislature and was signed into law by the governor, it is still fraught with controversy.
There are economic factors. For example, part of the law requires drug companies to be willing to give or sell these not-yet-approved interventions to patients or their doctors. This stipulation has created tension for the pharmaceutical manufacturers who generally are not so keen to take on the added liability involved in providing such drugs or devices to a patient who is already in an advanced stage of a disease. And even if these manufacturers conceded to make their products available, health insurance is not mandated to cover the cost and the drug companies are not compelled to provide the medications for free.
Yes, the FDA already has a compassionate use program that connects appropriate patients with these experimental approaches. The agency will cite statistics that last year 99% of the 2000 or so applicants were approved. A hindrance, though, is that the program’s application process is quite cumbersome. The new laws are intended to relieve some of this burden. The FDA application process takes almost 100 hours to complete. Thanks to Right to Try laws the process reportedly takes less than one hour.
In addition to the economic and paperwork logistics, there are bioethical issues that cannot be ignored. Providing access to unproven and or potentially harmful therapies can create false hope for otherwise desperate patients. Without any expert safeguards while patients are being subjected to these experimental approaches, all kinds problems can arise, including a multitude of adverse patient events. Even worse if a patient should suffer a complication from a Right-to-Try drug or treatment his insurance company can argue that it doesn’t have to pay for the resulting care to treat the complication. In other words such a patient could be financially on the hook for everything subsequent to that treatment. Never mind that the specific Florida Right to Try law provides protection from disciplinary or legal action for a physician who makes such treatment recommendations.
Recently I had the opportunity to treat a patient who developed a recurrence of advanced stage malignant melanoma. I was able to refer this gentleman to a melanoma research center affiliated with Harvard Medical School at the Massachusetts General Hospital. He was started on a novel yet unproven combination of anti-melanoma drugs. Six months later, in spite of suffering a barrage of horrible side effects from the drug regimen, this patient is feeling great and the melanoma seems to be at bay.
This method of treating a patient is the traditional way of managing an otherwise hopeless case, keeping everything within the confines of a top-notch research institution. With the advent of Right to Try laws physicians may be tempted to take a non-traditional route, randomly suggesting long shots for desperate patients, something that might not be the best approach. The Right To Try laws are touted as compassionate health policy. However patients with terminal illness have enough things to deal with never mind being given false hope through a legal manipulation that is clinically and ethically flawed.