Joshua Stein is a guest blogger at Neuroethics and Law; he is a doctoral student in philosophy at the University of Calgary, with a background in bioethics and philosophy of science.
I checked twitter in the middle of the night, a compulsion shared by many folks my age, and a colleague had posted an article summarizing a recent talk by Eric Lander, the co-chair of the President's Council on Science and Technology and one of the major contributors to Project Moonshot, the current administration's push to "cure" cancer. (Or, on more modest interpretations, make cancer a chronic and manageable condition.)
Lander's work, in particular, focuses on gathering data on the individual genome in order to develop treatments. Now, there are various criticisms of Lander's work as misguided; I'm inclined to think those criticisms are right, but I'm not going to delve into the scientific literature. Hal Burstein and Vinay Prasad (the folks who brought the article into my twitter feed) are better commentators for that discussion.
(A rough summary of the concern advanced by Burstein and Prasad, as I understand it: Having access to more information is not clearly to the advantage of the patient or researcher. There is good reason to suppose that genetic information actually is not particularly useful in studying most cancer, and therefore building a large database like this includes a massive commitment of resources without clear benefit.)
I want to focus on something that I think is ethically problematic (if not downright wrong) with Lander's project.
In the course of the discussion, Karen Weintraub (the reporter who wrote the article) notes that one of Lander's major goals is to create a massive database of genetic information about patients, something that is problematic for a number of reasons. (Hospitals don't want to give up such data; patients have to give consent for data to be shared; etc.) Lander wants patients to give consent for their medical information, particularly genetic information, to be used in medical research; now, this (in itself) is not a problem.
(Weintraub sent me an email to clarify the context and content of Lander's comments; that has been taken into consideration here.)
Patients have a right to control their genetic information. While Lander says, "We should force the liberation of people’s own medical records," this is really just an unfortunate phrasing without context. What he means is that we should get patients to give consent to share their medical information; not "force the liberation" in any coercive sense.
But this is where I change gears, because even on a weak sense of what Lander means here, considered in tandem with the way that his projects have gone about gathering medical data, it is ethically problematic.
The major project cited in the article, and perhaps the largest push for this work, is the Metastatic Breast Cancer Project. The MBCP homepage is a push to convince patients with metastatic breast cancer to send genetic and personal information in for research. Again, this in itself is not morally problematic. If you have a condition and there are reasons to believe that there are genetic components to that condition then genetic information is a sensible part of a research program. The problem is that Lander et al. have not met the conditions to get consent from the patient.
Suppose Sally, a layperson with metastatic breast cancer, visits the homepage for the MBCP. She looks over the information and decides she is going to send material. The standard view of informed consent for research, as articulated by the FDA, requires that "the investigator has not persuaded or influenced the research subject."
Now, MBCP will try and inform Sally (to the best of their ability given her background knowledge) about the research being done, increase her awareness of possible risks and treatment options, etc. And that's all terrific; that is really the best standard we can hope for in medical research, that the process of participating in the research includes educating the patient about what their participating in. (Though there is a practical question about how widely used this genetic information will be, and whether they are genuinely keeping patients appraised of all of the uses; let's be charitable and assume that they're doing all of that well.)
The problem is that the MBCP homepage itself, and the various efforts associated with recruiting individuals and encouraging them to share genetic information is an overt effort to persuade and influence the research subject's decision; it is unethical, eo ipso, to try to convince patients to participate in your research program. Even if we are as charitable as possible to Lander and the MBCP, and even if we assume that all of the research their doing is clearly communicated to patients, it is clear that Lander is persuading and influencing patients to offer up their information for research.
For many readers outside of medical research, or perhaps even researchers themselves, some wonder, "why is this important?" After all, a researcher wants her research program to succeed and is therefore in a position to encourage patients to participate.
I won't delve too much into the historical and more technical concerns, but this is an important question. It seems quite reasonable, superficially, to expect researchers to express excitement and focus on the benefits of their research, actively encouraging patients they interact with to participate. The problem is that medical authority matters, and the presentation of an experimental treatment or program as decidedly beneficial communicated by a doctor and researcher (someone in a privileged position, both from the standpoint of information and as a matter of the social dynamics of treatment) exploits an existing asymmetry with the patient. That is not to say that patients will feel coerced; perhaps they too are genuinely excited about the research! But they're in a position where the influence of the proximate expert (that researcher, doctor, etc.) is really their primary guiding light, and if that expert is influencing the patient to choose one thing or another, it undermines the agency of the patient.