Thanks for your $1B gene. Now go home.

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  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.”

4 thoughts on “Thanks for your $1B gene. Now go home.

  1. Ok, I’ll bite. What do you mean by include them in our work and it what ways beyond the remuneration they frequently receive should they be rewarded?

    • In DNA banking studies, we don’t provide compensation for patients that participate. Maybe taking a tissue sample does not involve a lot of time so it hasn’t come up. Rather than a single payment, people who agree to participate in clinical trials should be given benefits over time, reduced co-pays for example, and also access to what is being done with their data. In the rare case, like that in the article, where there is a big research payoff, the patients that helped that happen should get extra benefits.

      • It is up to patients and researchers to define these contractual relationships, i.e. “extra benefits” could be anything. IMO best would be to provide support for better medical coverage. Under ObamaCare there will be tiers of coverage plans, e.g. gold, silver, platinum, and participants and possibly relatives could be upgraded as an “extra benefit.” I like this idea because it could send the message, “we will take care of you.”

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