The Wall Street Journal ran a disturbing story today about a clinical trial that ran low on funding and has depended on payments by patients to continue.
The clinical trial in question is an amyotrophic lateral sclerosis ("ALS") study run by James P. Bennett Jr., director of the Center for the Study of Neurodegenerative Diseases at the University of Virginia.
Is this ethical? According to The Wall Street Journal:
[S]eeking funds directly from patients. . . raises a number of ethical and economic questions — questions that any research effort considering such a solution would have to face. It means soliciting patients at a very vulnerable time, when they may be desperate for hope. With ALS, for instance, there is no cure; the disease attacks the nerves that control movement and usually leads to death within five years. Already struggling to pay for aspects of their own care, patients could quickly find themselves tapped out.
There is also less accountability for how money is spent when it is donated directly to a study rather than through a grant-giving nonprofit. And while Dr. Bennett has no financial interest in his ALS drug, investigators in other trials may financially benefit from their research role, causing potential conflicts of interest.
Clearly, this story is not the norm. But I can’t help but wonder how often this scenario is arising today. How often are patients funding their own trials? And is that really any different than starting your own foundation and funding it to do the same thing? Certainly, there may be more oversight in the case of a foundation, but in both scenarios, a patient is taking his health in his own hands and taking a risk in the hope of finding a cure or even a treatment for his illness.
On the other hand, when the patient is acting directly to fund a trial, there is an increased risk that such patient will be taken advantage of or even coerced into paying for a treatment that has not yet been proven to work.
Of course, how often do patients go bankrupt paying for treatments that have only a small chance of working? You hear stories in the news each day like this, and I even know a few people who have personally experienced such a fate. Luckily they are still around to share their experiences. This story is troubling on a number of levels and raises some difficult ethical issues that we should definitely be discussing, but I think that we also have to put it into its proper context before condemning what has taken place here. What is ethical when it comes to a clinical trial, particularly in the case of a terminal disease such as ALS? And what would you be willing to do yourself if you were the one with the unfortunate diagnosis?
