Michael Joyce is a writer-producer with HealthNewsReview.org and tweets as @mlmjoyce
Something huge, expensive, arguably controversial and allegedly revolutionary happened on Sunday to modest fanfare.
Three years after it was announced by President Barack Obama, the ambitious precision health initiative — now rebranded as the “All of Us” research program — was launched by the National Institutes of Health (NIH) in 7 cities across the United States.
The goal? Convince one million Americans to give the NIH access to their electronic medical records (EMRs), blood and urine tests, and answers to lifestyle questionnaires.
Why? Because it could accelerate advances in what’s come to be known as “precision medicine” (aka “personalized” or “individualized” medicine) which we’re told will lead to advances in the prevention, treatment — and even cure — of a host of diseases.
How? Good question. No one, including the NIH, knows the answer to that. Certainly a solid case can be made for using our increasingly sophisticated understanding of genetics, along with EMR’s, to crowdsource as much “human data” as possible to search for an answer.
But it’s not the merits of the $1.5 billion research program critics take issue with. It’s the framing. In other words, how this program is being pitched to the American public. And does it raise expectations beyond what the program can realistically hope to achieve?
The NIH is expected to be a trusted and neutral arbiter of evidence-based medical research.
But the marketing video for “All of Us” — not unlike the news release from NIH — promises benefits and impacts as almost foregone conclusions. With no supporting evidence this oddly patriotic video — appealing to our “honor and compassion” — calls the research program a “landmark in history” that will “heal the sick and eradicate disease” and promises that “the next great breakthrough will be found in each and every one of us.”
“I’m not against publicizing research, or using innovative and ethically appropriate strategies to recruit research participants,” says Tim Caulfield, a lawyer and professor of health policy and law at the University of Alberta.
“But this video contains a lot of extreme language. And if it’s a recruitment tool — and I think it is — one would assume it would need to satisfy the research ethics policies for public advertisements. While most of the institutional review board (IRB) guidelines for recruitment are focused on clinical trials, the general vibe is that advertisements should not overpromise in order to increase recruitment.
“For example, the FDA guidelines explicitly say that ‘any advertisements to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest.’ Clearly, this video goes further than that. Although there is exciting and valuable research happening in this space, this feels more like a commercial for precision medicine. Does the research community think that’s OK? If so, why?”
It’s a question I posed to Stephen Thibodeau, PhD, co-director of the Molecular Genetics Laboratory at the Mayo Clinic. Two years ago, NIH awarded Mayo $142 million to be the primary biobank for the All of Us blood and urine samples. Thibodeau is one of the leaders of that biobank.
“We certainly don’t want to overpromise, but we do want to capture the imagination of people. We need to enroll a large number of people because it’s definitely a numbers game. The size and scope of this program is novel, and it needs to be large in order to accelerate progress in precision medicine.”
But there are already over 50 such studies around the world that have each enrolled over 100,000 people. Most notably, the Precision Medicine Databank of the Veteran’s Administration that’s enrolled well over 500,000 participants. So what’s different about this $1.5 billion dollar program?
“We are capturing a very diverse population that’s historically been underrepresented,” said Thibodeau, alluding to the fact that most research subjects have traditionally been white and male.
“A more diverse population will help us generalize our findings to the larger population. We’ll also have the ability to follow peoples’ health records over time, not just a one-time contact.”
Thibodeau is referring to the fact that volunteers for the study provide what NIH director, Francis Collins, MD, PhD says is: “pre-consent for re-contact for participation in clinical studies of all sorts by industry, by academics … maybe about prevention, maybe about devices, maybe about drugs.” It’s what the NIH news release touts as “a rich and open data resource for traditional academic researchers as well as citizen scientists — and everyone in between.”
But Mike Joyner, MD — a frequent contributor to HealthNewsReview.org and also a researcher at the Mayo Clinic — is more guarded.
“I have three concerns. First, their cohort — which consists of recruited, not randomized subjects — may not be all that representative. Second, there are good studies which support questioning outcomes that come from EMRs. They’re not the same grade as the research results we get from randomized, controlled trials. Finally, I wonder about the claims of using the results to ‘revolutionize’ or ‘transform’ health. What’s going to be their definition of success? Fewer disparities in health care? Increased life expectancy? Decreased health costs? It seems a little vague.”
Leigh Turner, PhD, a bioethicist at the University of Minnesota, shared some similar concerns about the study methodology. But there were other things he found worrisome.
“My primary concern is the hyperbolic claims [the video] makes about precision medicine. We need less hype and more honest accounts of the very serious challenges involved in developing highly tailored therapies for patients. Second, this is a costly program and it’s questionable whether it can achieve its desired results. We need an informed public debate about that, not an ‘anthem’ selling a program. Such a large-scale, high-profile initiative attracts a lot of attention, but that doesn’t mean there will now be an inevitable and swift march toward the development of precision medicine.”
The modest news coverage of the “All of Us” rollout was more cautious — and informative — than the NIH news release.
The Washington Post opted to focus on a very relevant concern: privacy. Something the news release didn’t address at all.
Wired gave a very thorough look into the scale and costs of the project, as well as who will have access to the data, and how.
And Fortune should be commended for using very cautious language in discussing how the project “could theoretically help spur” medical research and treatments.
It’s important to acknowledge that the NIH and its partners have embarked on an ambitious project with a legitimate chance of impacting our health care. Trying to recruit one million people to that end is commendable, can not be easy, and most certainly requires some degree of promotion.
However, equally important is its historic reputation as a neutral arbiter focused on evidence-based science. Some might argue that if the video is wildly successful in driving recruitment for this project, than the ends justify the means. But the video and its hyperbolic appeal could also compromise the NIH’s role as a respected scientific organization. Could that lead to an erosion of public trust? Or, at the very least, could their promotional message cross a very fine line and mislead not just a million people, but many more than that?