CEO and co-founder of Arivale, Clayton Lewis (left), and Co-Founder Leroy Hood, are sold on “scientific wellness” as a new medical frontier.

Arivale

‘Scientific wellness’ study—and a famed biologist’s spinoff company—divide researchers

Leroy Hood knows a thing or two about disruptive technologies. One of biology’s living legends, the now 78-year-old scientist played an influential role in the development of the first automated DNA sequencer. He pioneered systems biology, the study of interactions of molecular networks, and still leads an institute devoted to it in Seattle, Washington. His latest vision is “scientific wellness,” which aims to improve health and prevent disease by combining personalized behavior coaching with DNA and blood testing, activity tracking, and other measures.

Hood unveiled the concept 3 years ago, but a pilot study attempting to back it up has only now appeared. He and colleagues have compiled what Hood calls “personal, dense, dynamic data clouds” for 108 people after tracking them for 9 months. Included in the data clouds are their full genome sequences; blood, saliva, urine, and stool samples taken every 3 months that measured levels of 643 metabolites and 262 proteins; and physical activity and sleep monitoring. The massive data set may have helped people avoid diabetes and other health issues, the researchers suggest. Indeed, Hood intends to move forward with his previously proposed 100K Wellness Project, for which he hopes to recruit 100,000 people for by 2020. The study also spurred Hood to co-found a company called Arivale, which now offers similar services coupled to monthly coaching, with a first-year membership price of $3499.

Yet not all researchers see the pilot study as a rousing success, or justification for people to spend such sums. They are taking the collection of personal physiological information “to new heights, or depths, depending on how you look at it,” says Eric Topol, director of the Scripps Translational Science Institute in San Diego, California. Atul Butte, a computational biologist and director of the Institute of Computational Health Sciences at the University of California, San Francisco, notes a “lack of sparkling findings” in the study. “All of these tests cost a lot of money, and it’s not exactly clear what we are getting out of them yet,” he says. 

In the pilot project, reported this week in Nature Biotechnology, monthly coaching sessions aimed to help the participants understand the data and create plans to address any concerns. For instance, 95 people had low vitamin D levels, 81 had high mercury levels, and 52 were considered prediabetic. Of all the participants’ measured traits, those three improved most significantly across the study, as individuals were coached to change diets, take vitamin supplements, exercise, or consult their doctors for medical advice.

The study also gave participants a Fitbit to track activity and sleep patterns. But only 64% of participants used their devices for 40 days or more, mirroring the dropoff seen in many studies. “This is the best possible cohort of early adopters, and even they couldn’t comply,” Butte says. He adds that’s a potentially foreboding indication of difficulties that lie ahead for the U.S. Precision Medicine Initiative, a National Institutes of Health study that will try to similarly track and analyze 1 million people.

When you see a study like this, it is thrilling. But when you link it to companies offering this as a service, that is where we start getting into trouble.

Jonathan Berg, University of North Carolina School of Medicine

Hood and colleagues identify a single participant that most obviously benefitted significantly from the study. The tests revealed that then 65-year-old Tayloe Washburn, who reported impaired mobility during his family’s hiking trips, had high blood levels of the iron-containing protein ferritin and a genetic risk for developing hemochromatosis, where high iron levels can damage cartilage in joints. Washburn was referred to his physician who linked his cartilage damage to the disease.

Though Hood’s study deserves credit for taking “oodles of data” across multiple time points, the results are “a little soft” to conclude such tracking actually helps many people, because there is no control group to compare to, Topol says. He pointed out similar concerns with the battery of medical tests, including genome sequencing and a full-body MRI scan, done on presumably healthy people recently described in a study posted online from J. Craig Venter’s Health Nucleus company.

Among the 108 participants in Hood’s study was Clayton Lewis, a friend of Hood’s who works at the venture capital firm Maveron. While monitored, Lewis was training for a triatholon. Although he expected “to be the healthiest person in this study,” the data indicated he was prediabetic, which his personal study coach linked to his metabolism genes and his training diet—low in carbs and high in fats and proteins. He also had the highest blood mercury level in the study, due to his decades-old dental filling. Lewis, who is now 58, resolved both issues by incorporating complex carbohydrates into every meal and getting his filling replaced. He went on to place 10th in his age group in the race. Seeing how the study participants loved “that the data was all about them,” Lewis joined with study leaders Nathan Price and Leroy Hood to launch Arivale, with Lewis as CEO.

Now 2 years old, Seattle-based Arivale has already enrolled 2500 individuals for tracking and analysis similar to the pilot study, with 96% of these participants opting in to let their data be used in research, which Hood’s Institute for Systems Biology can pay to access through a licensing agreement. Arivale charges $3499 for the first year, which gets participants’ genomes sequenced; 30-minute monthly coaching sessions; plus blood, saliva, and microbiome (a tally of microbes in stool samples) tests—read every 6 months, instead of every 3 as in the pilot study—plus a Fitbit. Jennifer Lovejoy, Arivale’s chief translational science officer, describes the company as “a bridge to the medical community” that specializes in analyzing the data so that the personal coaches—all registered dieticians, certified nutritionists, or registered nurses—can create lifestyle and wellness recommendations. “Our coaches do not diagnose or treat. We are not providing medical care,” she says. As such, the company has not asked the Food and Drug Administration to review or regulate its offerings.

The company’s formation has concerned some original fans of the 100K Wellness Project. “When you see a study like this, it is thrilling. But when you link it to companies offering this as a service, that is where we start getting into trouble,” says Jonathan Berg, a physician scientist that studies cancer and genetics at the University of North Carolina School of Medicine in Chapel Hill. “We don’t have any idea at all how this information should be used clinically,” he says, adding that scientists should be just as ready to reject their hypotheses as prove them.

Such comments don’t deter Hood from his latest disruptive vision. “I think scientific wellness is here to stay,” he says. “And I think it is going to be a key part in the tipping point that is utterly going to transform the practice of health care and take it from a focus of disease to a focus of wellness.” Hood contends that the project’s value will increase with time as more data from a scaled-up study will uncover new signposts for forecasting disease.

But Butte says more data alone is not enough. “We need the informatics people to come up with better ways to analyze it,” he says. Whether or not you are convinced such digital data sets will improve health and wellness, though, there’s no denying, Topol says, that “this whole deep dive into human information is really blossoming.”