Terminally Ill Patients and Access to Experimental Drugs
Should terminally ill patients be allowed access to experimental drugs, outside the boundaries of the clinical trial process?
No, said the U.S. Court of Appeals for the District of Columbia Circuit on Tuesday, turning down a suit against the FDA filed in 2003 by the Abigail Alliance for Better Access to Developmental Drugs, and the Washington Legal Foundation.
"Terminally ill patients desperately need curative treatments," Judge Thomas B. Griffith wrote on behalf of the court’s majority. But "their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit."
Judge Judith W. Rogers, writing in dissent, noted that courts have established the right "to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private, and to control one's own body even if it results in one's own death or the death of a fetus… But the right to try to save one's life is left out in the cold despite its textual anchor in the right to life."
If ever there was an issue fraught with emotion, this is it. We’re talking about life and death situations–literally. You may have watched a friend go through the long, emotionally eviscerating process of dying. Perhaps you’ve sat beside a family member whose life was ended by cancer or another killer illness, way before it should have been. If there was anything that could have been done to potentially stop that person’s death–experimental drugs, cutting-edge technology, healing earth from a sacred site in South America–you would have wanted it done it–right? At first glance, it seems like a no-brainer; if someone’s dying anyway, why not try anything to prevent that death?
It’s not that simple. What if drugs undergo only the most basic of trials–say, Phase I clinical trials, which involve a tiny number of participants and basically prove only that a drug won’t kill the patient outright–before being released to the public? Since many clinical trials are funded by the drug companies themselves, what would be the incentive to continue on through the long and laborious Phase II and Phase III trials, the trials where the rubber really hits the road and the drug is tested, at length, on hundreds or thousands of patients?
The entire drug development process, including trials, can cost up to a billion dollars. Think the drug companies would like to eliminate as much of that expense as they possibly could?
And what about the FDA’s reliance on a strong clinical trial system, a system that admittedly takes year, but that seems to work (with only occasional mistakes) by allowing the public access to only those drugs that have been proven both safe and effective?
And then there’s your son, dying of leukemia… your dad, with terminal prostate cancer… or you, with stage IV breast cancer, desperately researching ongoing clinical trials to try to find something, anything, that might kill the cancer that’s about to kill you. The Abigail Alliance, in its suit, noted the “different risk-benefit trade-off facing patients who are terminally ill and have no other treatment options.” In other words, desperate situations require desperate measures, measures that may not adhere to a governmentally mandated process.
Frank Burroughs is founder and president of the Abigail Alliance, named after his daughter, who died at age 21 of head and neck cancer after being denied access to drugs that were later approved by the FDA. “The Abigail Alliance is dumbfounded that most of the justices tragically missed the merits of the case,'' said Burroughs in an interview with the Associated Press. “We are going to appeal to the Supreme Court.''
If you were sitting on the Supreme Court, how would you rule?