I’m completely fascinated by ResearchKit, Apple’s new program for encouraging people to contribute their data to clinical trials. This program was announced at the same time as the Apple Watch and, it seems to me, was a total scene-stealer. An expensive watch that allows you to track your steps and use your watch like Captain Kirk? Kind of cool if you live in the 650/415 area code. A program that makes it possible to sign up over 5000 Parkinson’s patients and collect their data in a consistent way in a couple of days? That’s freaking amazing. Note that a good reference point is it took five years and $60mm to get 800 patients to participate in an old-fashioned pharma trial for Parkinsons, according to the Michael J. Fox Foundation.
In similar fashion, over 11,000 people signed up in 24 hours for a healthy heart study to be conducted by Stanford in conjunction with the American Heart Association. Getting 11,000 people to sign up for anything, besides free money, is damn near impossible.
In total, five research apps were announced at the ResearchKit launch dealing with major areas of clinical challenge; in addition to the heart and Parkinson’s studies noted above, apps to study breast cancer, asthma and diabetes were launched. These are all high cost areas of medicine where existing treatments are of mixed value and cures are elusive at best.
I think it is so interesting how rapidly people are rushing to contribute their data to these initiatives. On the one hand, why wouldn’t one offer up their data? It is easy to enroll and you don’t have to do much, relying on the iPhone (and perhaps ultimately Apple Watch) sensors to do most of the work while you are not paying attention. This is perfect for real people who definitely don’t want to pay attention to their health, much less take an active role in tracking things. Make sensing easy and passive and voila! One can contribute the greater good while sitting on the couch watching The Voice.
On the other hand, I can’t help thinking about the ramifications of this downstream. I don’t mean the privacy and accuracy risks or even the fact that this is pretty much an exercise in tracking the health metrics of the One-Percenters. Those are real issues and I’m sure we will hear a ton about them in the months and years to come.
What I’m fascinated by is the profit thing. If you have ever read the book The Immortal Life of Henrietta Lacks–and if you haven’t you absolutely should…totally fascinating—you know that sometimes research leads to the actual discovery of stuff and that leads to the development of products that make a bunch of money. At what point will those who contributed their data for free wake up and say, “hey wait a minute, that new drug that made a gazillion dollars this year, they did that with my data; how do I get a piece of that action?”
It’s one thing to agree to contribute to research, it’s another to contribute to some big drug company’s corporate jet. It would be awfully nice if Apple had figured out a way for those who contribute data to this incredible research effort also have a way of receiving royalties, or at least free iPhone minutes or iTunes downloads or 1 hour on the Merck corporate jet.
Apple’s marketing slogan for ResearchKit is “Now everyone can do their part to advance medical research.” Surely this is an awesome public health and public policy goal. But after you have consented to contribute your data, you don’t own it anymore; someone else does. And I can assure you that this someone else hopes to use it to make products that will, if they are lucky, make money. Thank god for that, because we need better treatments. The ones we have now are constantly disappointing us and even those that appear to make a positive difference are later found to be a mixed blessing. I think, for instance, about recent announcements about Lipitor, the drug that has been amazingly effective at lowering cholesterol, which has also now been found to dramatically raise the risk of acquiring Type II diabetes. Crap, I hate that when that happens.
I find it really interesting that a recent study, done at the University of Nottingham, which is apparently a real place and not just a forest where Robin Hood lived, found that 60% of people are willing to donate their medical data for one of two reasons: for the greater good of mankind or for personal benefit. It’s those latter people that fascinate me. Will we be hearing from them later when they say that the consent they signed was intended to facilitate non-profit research, but was not meant to convey the rights to profit from that research? On the one hand, what good is it if research never turns into cures, and cures are, almost always, delivered by for-profit corporations. On the other hand, one of the top reasons that those 60% of people would agree to donate their data is because they know and trust the place to which they donated their data. What are the dynamics when that known, trusted place then turns around and licenses the data to big pharma, big medtech, big anyone?
It makes perfect sense to me that one of the results of the Nottingham study is this: “We suggest that self-benefit and other-regarding dimensions of motivation should be accounted for when prompting people to provide their personal data for public good.” This is a particularly prescient statement, I think, when combined with the perceived importance of the familiarity and trustworthiness of the recipient of one’s personal health data.
This week we also saw 23andMe announce that they intended to use the data to which they have access to create their own homegrown biopharmaceutical products. Many 23andMe users have already, prior to this announcement, agreed to donate their data back to the company. I do not know whether the company is going to go back and ask those prior donors if it’s ok to use that data for the creation of profit-making drugs or not, but they probably should, even if they earlier consented to allow licensing of data to others. Would those same people have donated their data for free to the company if they believed it would be used to create potentially massive profits at the company? Or would they have asked to be cut in if they had that knowledge? Perhaps they should be. 23andMe could easily establish a fund to take a percentage of profits that is redistributed to those data donors. I’m not sure that they will do this or have even considered it, and it will likely be many, many years before the research turns into commercial products, but still.
To me there is a real parallel between this issue and the issue of using people’s external likenesses for profit without their consent. You are allowed to use a photo of Elvis within the fair use laws on your non-commercial blog, but the minute you want to sell a pillow with his picture on it, you gotta pay the King, or at least Priscilla. So should that rule be the same for the insides of people’s bodies as for the outside? Or at a minimum, should data donation agreements explicitly state that the data may be used in a for-profit manner some day and you are explicitly signing away your right to your piece of the rock? I think so. I have to believe that Elvis would agree.
Jonathon Feit says
Hey Lisa — I’m really glad you posted this, and in particular, the Lipitor story. That news (which somehow I missed, or is it just not getting enough attention?) is incredibly and personally important: my doctor prescribed statins to me many years ago for familial hypercholestorolemia, but I stopped taking it when we found I was experiencing the muscle-catalysis side effect. Now I’m thanking my lucky stars that I stopped, and spreading the word to my family. Thanks!
Lisa Suennen says
Jonathon, Well no one should stop taking their Lipitor without a doctor discussion, as the benefits are also really good. Really depends on the individual situation of course. L
Bettina Experton says
Another thought-provoking blog from the Venture Valkyrie and my fellow “2015 Disruptive Woman of the Year!” With Apple ResearchKit and mHealth innovation, consumers are indeed poised to revolutionize medical research. They are already transforming healthcare as they become more engaged and begin taking advantage of the ability to use their own mobile devices to gather the health data their physicians are too often missing, helping them to render the right diagnosis and treatment. One of the worst epidemics in search of a “personal data cure” is that of preventable medical errors, which are responsible for over 400,000 deaths a year in the U.S., many of which are caused by a lack of information at the point of care. After $27 billion of federal incentive payments dispersed to-date to physicians and hospitals to digitize medical records and make them available wherever we get care, electronic health records (EHR) remain siloed in each healthcare organization. To cure this “lack of data” epidemic, should we also rethink public payment incentives to now reward consumers for contributing their personal data with their own mobile devices wherever they receive care? Consumer rewards with shared savings could also be part of new healthcare payment systems, and consumers could also be rewarded for their contribution to new drug development.
Lisa Suennen says
Bettina, you know we agree! Lisa
David Harlow says
Great post, Lisa. I’ve been thinking about the “pay me for my data” argument for years. Every time I talk about data collection or research someone pipes up with the notion that patients should be paid for their data. As you know, the Henrietta Lacks story is one that predated the Common Rule (informed consent, etc.) and while perhaps there should have been different ideas at play at the time, there weren’t. What we’re talking about here is different, because most of the value is likely to come from the aggregated, analyzed data (yes, ResearchKit might turn up another Henrietta Lacks, but if we want to we could craft consents to cover aggregate data but not the one-in-a-million super organ or tumor or whatever). The Moore v. Regents of UC case held that a patient (even when not informed that his cells were getting someone tenure and $$) had no right to $$ proceeds from the cells. My hesitation to go down the path of agreeing to payouts to patients is the fact that the profits, if any, are attributable to the gathering and analysis (and more) rather than to the raw material contributed by each of the 11,000 patients in one of the ResearchKit studies (or more). How much is each individual participant’s data worth? You could set up a system where folks could be paid for their contributions, but how much is the raw data for one study worth, divided by 11,000? Are we really thinking about sharing long-term profits from patented drugs with data subjects? If we are, it would be a relatively small dollar figure, divided by many data subjects, and tracking patient identities and contact info in order to send them Starbucks gift cards is probably counterproductive in the long run. And, yes, the one percenter issue raises the question of the utility of this data in the first place. Let’s wait for the analog on the Android platform before we get too excited.