Say you’ve just been diagnosed with high cholesterol. Would you rather your treatment be more of a guessing game – a doctor putting you on a standard medication, then monitoring and adjusting for weeks or months to figure out a dosage that works for you? Or would you rather start with a treatment already found to be effective for people who are just like you in age, gender, ethnicity, body type and more?
That’s the basic idea behind precision medicine, a healthcare term you’re sure to be hearing more and more in the coming years. It requires creating an enormous treasure chest of diverse patient information for researchers to access and study. And in the U.S., that treasure chest is the All of Us Research Program, a first-of-its-kind project conceived and funded by the National Institutes of Health and partially managed by Scripps Research Translational Institute.
All of Us is working to sign up 1 million Americans to provide health information over a 10-year-period or longer – not just their basic health metrics, health histories and genetic information, but also data tracked on wearable devices, such as Fitbits.
Recruiting the volunteers – especially from under-represented demographics – is where Walgreens comes in. Since the official launch of All of Us in May 2018, Walgreens has been one of three large commercial partners, along with WebMD and the Blue Cross Blue Shield Association, working with Scripps to populate the program, which we do by encouraging customers to sign up for All of Us through our Walgreens Find Care service or at www.joinallofus.org/go.
WBA Stories recently spoke with Scripps’ Julia Moore Vogel, director of research implementation for All of Us, and Greg Orr, Walgreens’ vice president of digital health, to talk about how All of Us has grown (even during a pandemic) and where we’re hoping it all leads.
Let’s talk a little about the genesis of the All of Us program and Walgreens’ early place in it.
Julia Moore Vogel: In 2015, President Obama announced the Precision Medicine Initiative in general – an effort to really improve the way we treat disease in America, which is a pretty big goal. One of the key pillars was this cohort program where we recruit a million Americans to share their information for many, many research studies in the future. That’s now called the All of Us Research Program, and together, Scripps and Walgreens are working on recruiting people all over the country to take part.
Greg Orr: We got involved through Dr. Eric Topol, who leads the Scripps research organization, and if you're in the digital health or “future of medicine” game, you absolutely know who Dr. Topol is. He’s a real thought leader and not only examines the “what could be” in medicine but, in my opinion, pushes the industry away from its old ways into something more like we're starting to see now. He had just written a book called “The Patient Will See You Now” that really studies the whole history of medicine and how, in older times, the doctor was in the middle of everything. Now things are much different – it’s the patient who’s at the center of everything. Walgreens had already been working with and having interesting conversations with Dr. Topol, so when he mentioned this program, it matched up with where we were looking to move ourselves forward in healthcare.
Vogel: From my perspective, what's so great about having Walgreens involved is it really reaches everyone all across the country. Everyone's familiar with Walgreens. It’s a place where people get trusted information, and a great partner to get the word out about this.
In 2½ years, how far are we toward the goal of 1 million people?
Vogel: As of mid-December, we have more than 360,000 who have completed the initial steps to join us, which we’re really excited about. One of the most important goals of the program is to make sure the cohort is representative of the entire U.S. – demographically, geographically, many different ways. And so far, 50 percent of volunteers come from what we call “under-represented” race and ethnicity categories in biomedical research, with 80 percent coming from under-represented demographics overall. That's very important to us, with a taxpayer-funded study, to make sure we’re really reaching everybody and that everybody can be part of the research, so that the discoveries benefit everyone.
Orr: Medicine in general doesn’t have a great reputation for being all-inclusive in terms of the people who are in the studies. And I can't say enough about the All of Us team’s unwavering push to reach these underserved populations. That’s another area where Walgreens fits in very nicely: We have 9,000-plus stores. We’re in neighborhoods where the primary customer base is these under-represented populations. So at the community level, that’s especially where we’ve been able to help engage folks into this program.
How effective is the “direct volunteering” model, with a push from commercial partners, versus how people might have gotten involved in medical research studies in the past?
Orr: Between Walgreens, WebMD and Blue Cross Blue Shield, those three groups, we hit a large swath of America.
Vogel: It’s very different from the traditional research setting, where a volunteer would have to come in person, sit down with someone and only participate in one specific study. Now we’re working with these three big brands and many other community partners across the country to run a really participant-centric study where anybody from anywhere can decide to enroll and add their data to a pool. The enrollment experience is completely online. You can do it on your own time, at your own pace. You’re very carefully taken through the process to make sure you understand everything that's involved so you can decide whether it's for you or not.
Orr: With a traditional cohort, you might sign up for it and forget about it. You might not remember anything except that you answered a bunch of questions in an office somewhere. This program is much different. This, I think, taps into some of the interests people have in their health. As you sign up, it's not just, “Hey, I'm going to donate my data and walk away.” You’re in an experience and you get emails periodically with other questions you can answer. You can look back at your own data. All of Us is constantly looking at how to add more engagement elements to continue to bring people in.
Is it still mostly a data-collecting process at this point, or are researchers already studying and applying some of this information?
Vogel: We’re doing both. Data is already out there for researchers across the country to log in and use. Previously, it could have taken years for a researcher to recruit participants for their own study, collect the data, analyze the data, etc. Now they can access All of Us and get answers to some of their questions right away.
Earlier this month, for the first time, we released a set of Fitbit data that provides information about volunteers’ physical activity, diet, water intake and more, in combination with other data that have already been collected. We also released a big COVID-19 data set from a survey of 80,000 program participants. We’ve been asking our volunteers on a regular basis how the pandemic is affecting them – not just whether they’ve had COVID-19, but how has it affected their employment situation? How has it affected child care? How has it affected their mental health and things like that? So we’re getting a whole picture of the impact of the disease and putting it out there for researchers. And that’s just one example. The more people we recruit into All of Us, the more patterns we can find in all sorts of data, and the more valuable the resource becomes.
Orr: The “wearables” piece Julia mentioned is an important aspect of it. When you go to a doctor, there's an encounter – a point in time that’s recorded and might be used for these types of studies. But what about all the activities and behaviors going on between those doctor visits? Wearables now go beyond just counting how many steps you're taking. They're looking at your resting heart rate and your active heart rate. Some of the new ones are even taking continuous temperature. That's a tremendous amount of data to actually see what's going on with you in your day-to-day life. Precision medicine is more than just when you're talking to somebody in a white coat.
Vogel: Our team recently used Fitbit data in a study of influenza-like illness. They were able to spot local outbreaks based only on Fitbit data and where in the country people were. This type of study has recently been extended to COVID-19 research as well. The more people we have sharing that type of information, the more the researchers can learn.
How do we see All of Us research eventually affecting the average patient who goes to a Walgreens pharmacy?
Orr: At a high level, this is the research that could drive a massive sea change in the way we treat conditions, the way we prevent conditions, or even cure conditions. Today, the traditional method is you're diagnosed and prescribed a pill, similar to other people with a similar diagnosis. This is the research that’s going to start looking at the archetype, the profile, of you, and possibly lead us toward not everybody getting the same pill for a condition.
Vogel: There’s a lot of research that's already been done that shows, based on your genetic makeup, that a specific medicine either may not work for you or is likely to give you a reaction that you don't want. Usually we find that out by taking the medicine and waiting a month and realizing, “Oh, nothing changed. I guess I'll try something else,” or “OK, I had an adverse reaction and now I'm not going to take that medicine anymore.” But there are many medicines we already know you shouldn’t take if we can just look at your DNA sequence. And that's part of the results we're getting ready to return. We’re going to learn much more about this going forward. The million volunteers sharing their information is the first step. We plan to engage the volunteers for many years, running disease-specific sub-studies. Different investigators around the country will be able to run specific disease trials.
Orr: If there's one thing Walgreens has been great at for 120 years, it’s evolving along the way. We do things much differently than we did in 1901. And we will continue to do things differently. So to me, this research is benefiting all of society, and we’re on the forefront of how new treatments are being discovered. It's really one of the most exciting things that's happened in decades.
What do we see as next steps in this relationship?
Orr: I think, from Walgreens’ perspective, we’ll continue to bring awareness to the program and also just make things easier. We have assets that could be valuable that we may explore, including our recently rebranded program, myWalgreens Health Goals, which currently collects wearable data. We also may have an opportunity to use myWalgreens to appeal to people around diseases and conditions that may be relevant to them personally – breast cancer, for example – to encourage them to join the cohort to provide data that could aid in the development of treatments or even cures for those specific conditions. One thing that’s pushing us forward is that a year ago, most people didn’t even know what a clinical trial was. Now, because of the COVID-19 vaccine trials, far more people do. So we have a huge opportunity where people are saying, “Oh, I get it. And if I participate, it's going to contribute to the greater good.”
Have we seen that already – a COVID effect that’s helping All of Us to grow faster?
Vogel: In-person interactions are not happening the way that they were before, where you go into your doctor’s office and someone talks to you about a research study. But with the model we’ve embraced – where you can do it from your couch, completely online, on your own time – I think we actually were set up to be successful during the pandemic. You can submit biosamples – saliva kits sent to your house – without having to interact with anyone. It’s convenient for the volunteers.
Orr: That’s such a great point. It’s much like what we saw this year with the increase in people using telemedicine. COVID hits, and something that was considered sort of just there for convenience all of a sudden becomes a necessity. People are not just more interested in volunteering with All of Us now – they can do it right from the safety of their house, no mask required. That definitely boosted the program.
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