A loved one lies dying, withering away. A new drug shows promise in treating this disease. Shouldn’t it be a “no-brainer” that the dying person can chose whatever therapy they want, including an unapproved drug? Isn’t this a basic human right protected by the U.S. constitution? No, in fact judges in big court cases have argued that dying patients have no such right. This past year, this difficult to comprehend situation may be changing due to “Patient Right to Try Laws” sprinting through state legislatures, but the same powerful forces that have always opposed this concept are still against patients having this right. Why?
The movie The Dallas Buyer’s Club seems to have planted some powerful seeds. In it, an extremely skinny Matthew McConaughey plays AIDS patient Ron Woodroof who decides to go to Mexico to get AIDS drugs which are approved there and not in the U.S. He also brings these back into the country and forms a “buyer’s club” for other AIDS patients, which eventually runs him afoul of the US FDA. While the movie seems like it should be fiction, Mr. Woodroof did sue the FDA and the judge’s decision in the film closely mirrors the conclusion made by Judge Charles Legge in the real-life case. Legge found that, while he personally believed terminally ill patients should be able to purchase unapproved drugs, no right to do so could be found in the Constitution. A much more legally important case was not discussed in the movie. The Abigail Alliance is an organization formed by the father of a college student with cancer to allow terminal patients access to experimental drugs.The group sued the FDA to allow this to happen. In 2006, the DC District court ruled in Abagail’s favor by holding that a patient did have a constitutional right to access potentially lifesaving medical care. The FDA then asked for and was granted an “en Banc” review from all 12 judges of the circuit court. The language of the of the Amicus brief the FDA received from a physician cancer organization is important to understand the opposition to patient right to try bills. The ASCO proposed that the Constitution does not guarantee the right to access unapproved medications, and that the court case threatened the cancer clinical trial enterprise. The panel of DC circuit judges, in an 8-2 decision, threw out Abagail’s claims. Judge Griffith, writing for the majority, said a right to experimental drugs was not deeply rooted in the nation’s history and tradition and that the right of self-defense “cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process.” In a dissent, Judge Rogers wrote that it was “startling” that the “right to try to save one’s life is left out in the cold,” not protected by the due process clause of the Constitution. The Abagail Alliance petitioned the supreme court to hear the case, but the court denied to hear the case.
The language of the ASCO Amicus brief and Judge Griffith’s opinion helps to explain the opposition to these new laws. First, the “clinical trial enterprise” would be adversely effected. While some of this has a kernel of truth, i.e. some terminally ill patients would try drugs on their own outside of a clinical trial, much of this sentiment is commercially driven. The “clinical trial enterprise” is a huge business for universities, clinical research organizations, and physicians involved in research. If Abagail had prevailed, the costs for this enterprise would have gone up (i.e. it would be harder to recruit patients) and profits would have taken a hit. Is it true that the machinery of FDA approved research would come to a screeching halt as many organizations claimed? No, there are no shortage of patients who would clearly choose the safer “FDA approved” pathway rather than turning themselves into an experiment of one. In addition, valuable data could still be gleaned from the patients who did opt out of the FDA system by creating a treatment registry like the one proposed by the Manhattan Institute. This last point shines light on an area of Pharma research that most would like to not discuss-carefully crafted clinical trials are put together to show the drug being tested in the most favorable light. A drug company spending hundreds of millions trying to get a drug approved doesn’t want unfettered use of it’s drug outside of the carefully crafted and very artificial world of a clinical trial. Anything could happen and this could harm the greater commercial push toward FDA approval.
The language of Judge Griffith’s opinion brings up another important point in understanding the opposition to these laws. There is no constitutional right to “assume any level of risk without regard to the scientific and medical judgment”. This of course is Paternalism, here being expressed in the concept that a competent patient isn’t smart enough to assess risks, not even one that’s looking at the ultimate risk: death. For a physician, this is difficult to hear, as I deal with patients everyday who must weigh the risks and benefits of any number of procedures that might cripple or kill them. Based on my experience, I assume it is a basic human right that the individual can assess and assume risk. After all, who in living a long life isn’t faced with life and death risks? For example, should I go on that really shaky looking amusement park ride set up in a parking lot? Should I bungee jump or take up sky diving? Do I really need to spend extra money on that reserve parachute? However, I have many colleagues in university settings who don’t view this the same way. To them, the importance of the university clinical trials process is found in it’s paternalism-using many smart minds to assess the risks that patients can not assess and balance on their own. While I completely disagree with this position, it explains why many university scientists and physicians cringe at these laws, it upsets a worldview that expert opinion should prevail over lay opinion-even when the layperson is looking at his or her own mortality.
The upshot? Three states have approved patient right to try laws and many more are likely on the way. Looking back in history explains why there is any opposition to a movement that just seems to make common sense. Given that the FDA, universities, and drug companies have opposed these laws in the past, I would expect that a major show down is brewing. However, this time, the DC Circuit and Supreme court may find itself in quite a pickle. Rather than just terminal patients being impacted by their decisions, a major state versus federal battle is being positioned. I think anyone who reads this blog knows where I stand on that issue!