A NYTimes piece yesterday on the discovery of a rare mutation in families with hypercholesterolemia and the race to find drugs based on this discovery http://www.nytimes.com/2013/07/10/health/rare-mutation-prompts-race-for-cholesterol-drug.html?hp reminded me of the ethical imperative to include patients as full participants in the research process. I wrote about this in a review article a few years ago:
The Absence of Patient Rights: The Privacy Rule and informed consent requirement codify ethical norms that govern human subject research, but patients in tissue banking and analysis studies are provided no specific rights.155 Researchers will require more participation and access to more detailed PHI, with the hopeful goal of developing useful (and profitable) diagnostic tests, but patients have no ownership rights to their own tissue, regardless of its potential value. The patients who provide informed consent and agree to participate in research studies are told that they will neither profit nor benefit from their participation, and they may incorrectly assume the same is true for the doctors and scientists performing the research. Greenberg v. Miami Children’s Hospital involved a group of parents with children afflicted with Canavan disease. The parents were stunned to learn that researchers, using tissue samples taken from the children, developed a diagnostic test for Canavan disease and obtained the exclusive patent rights, thereby restricting its availability. The court held that the families had no ownership stake or control over the IP of the test whose creation they had facilitated. Tomasson M. Legal, ethical, and conceptual bottlenecks to the development of useful genomic tests. Ann Health Law. 2009 Summer;18(2):231-60.
So, there is a race to capitalize on this gene discovery for the good of patients, certainly, but let’s be honest: this race would not be going on if there were not billions of dollars to be made. And while this research could not have been accomplished without patient participation, the patients that donated their tissue to make this fortune possible will not see any of that money. The patients have no legal basis on which to complain about this. But as physicians and scientists, I feel we have an ethical obligation to include our patients in this work and to consider ways to reward them for their participation. Otherwise, we wind up repeatig the mistakes so well described in Rebecca Skloot’s “The Immortal Life of Henrietta Lacks.”