NIH is Off and Running
NIH would seem to be wasting no time in getting President Obama’s Precision Medicine Initiative off the ground. Having begun planning in February, it announced just two days ago, the formation of a panel of precision medicine experts to lead initial steps towards designing the project. Notably absent in any of the announcements to date is how the government will succeed in engaging Americans. Perhaps these experts will propose engagement strategies behind these closed doors? Even if so, are they the right folks to create the ticket to success? There is, after all, no initiative without Americans’ enthusiastic support. So, engagement is of vital importance.
Wherefore Public Engagement?
Citizen science and crowd sourced funding have proven successful strategies for engaging/exciting average folk in/about scientific research But they can’t hold a candle to what celebs have done for public awareness of genetics. And yes, of course I’m thinking about Angelina Jolie, who isn’t? She certainly has been credited with doing ‘ a lot’ to raise awareness about the clinical benefit of BRCA testing and preventative actions. Face it, if you want to get something noticed, America’s beloved celebs –perhaps- do it best. Well, maybe not because they’re so genius at it but because when they talk we pay attention. And so, how will the government grab enough attention to get its million DNA donors?
Will Engaging Be Fun?
While commentators have questioned the government’s technological ability to successfully undertake the project, the challenge of recruiting a million folks- I mean regular folks-to complete the project is a timely manner is a bit, dare I say, thought provoking. Clinical research is serious business, to be sure. Yet, the American appetite for fun and fluff suggests that a successful engagement strategy will need to appeal to this appetite.
I can well imagine the public’s imagination being captivated by Apple announcing that all I phone 7 (for example) purchasers will get, free of charge, a spit cup to submit a DNA sample along a finger print protected new app that contains their genome sequence, on the condition that purchasers share their genome, albeit it encrypted and secured, with government researchers. New IPhone 7 users would then –literally- have their genome at their fingertips, but so too would the initiative. I can also imagine great public interest resulting from a Justin Beiber public service announcement saying he’ll give away a million (of the same) spit cups to fans so they can see if they have predispositions to Beiber- like reckless behavior, so as to encourage young people to behave engage sensibly, while giving his image a more mature make over.
And so, in the context I just sketched, I’m wondering what the government will come up with to engender public enthusiasm-that is enthusiasm which converts to participation. I admit I don’t recall any federal efforts to engage the public, save for the military marketing, replete with catchy jingles. Remember ““Uncle Sam wants YOU for the U.S. Army”?
(The 1917 poster was used to recruit soliders for both WW I and WW II). Or, the catchy jingle “Be all you can be: Join the Army”? So, does NIH need a genome slogan and a genetic jingle? Maybe. Perhaps they should hire Jon Stewart can write the slogan and Jay Z the jingle…
Let’s Talk Ethics
Sarcasm aside, engaging the public will be more challenging than in countries with universal health insurance and a national health service, like the UK or Iceland. Yes, our fragmented health care system poses obvious technological complexities that must be solved to enable access to clinical-phenotypic- data. Arguably, equally, if not more important, is the issue of how access to the project participation will be ferreted out given the that there are people who do and don’t have insurance, those whose medical records are and aren’t digitized, who are or aren’t proficient in English, who do or don’t believe that their genetic risks are preordained by God, etc. In other words, the million-person cohort needs to be diverse. The project needs to collect data from people who live in all types of different geographical places, and situations. But how will diverse be defined? What will be inclusion/exclusion criteria? Will the inclusion criteria exclude persons whose medical record is not digitized? That is, those with a paper record can’t participate? Will those without health insurance be ineligible? What database biases could ensue from the implementation of said criteria?
Difference is important to democracy. It’s also vital for genetics research. So, integral to study design, are some important ethical considerations. For one, is excluding individuals who lack an EHR or even health insurance from participating fair or even ethically defensible??
Thinking More Globally
Many have worried about personalized medicine becoming available only to the rich. This argument is based on the high cost of new diagnostics and therapeutics. A more fundamental issue is whether it’s ethically defensible to interject certain exclusion criteria, and interject bias dataset. As I’ve argued elsewhere the principle of beneficence may require maximal data sharing to permit genomic benefit sharing amongst all persons, not just an entitled few. If the initiative’s data set excludes persons lacking an EHR or lacking insurance, we will be faced, in my view, with the unfortunate consequence that not only will enthusiastically engaged persons will be ineligible to participate, but also a bias that could limit generated knowledge in some important ways. If true, such a bias lead to some adverse impacts. That said, for a western industrialized country, this would be an unfortunate consequence because it will evince the possibility that the principles of democracy, and social justice, will not extend to precision medicine.