Category: patients

  • How consumer tech company Whoop is building for Medicare patients

    How consumer tech company Whoop is building for Medicare patients

    Whoop has never been known for marketing to an older population. Performance athletes headline ads for the wearable company, which aims to turn continuous streams of physiological data into useful insights for behavior change — mostly, for a young, fit customer base.

    But this year, Whoop became one of the first consumer wearable companies to be accepted into Medicare’s ACCESS program, making it available at no cost to many traditional Medicare patients ages 65 and up. On Wednesday, at the STAT Summit in Boston, Whoop’s newly appointed chief medical officer Ami Bhatt spoke about how the company is moving to build experiences — and demonstrate outcomes — for a very different population.

    “Number one on our roadmap — and I think I’m allowed to say this, if I’m not, I’m saying it — is simplification of the app,” said Bhatt, who previously chaired the Food and Drug Administration’s digital health advisory committee and served as the American College of Cardiology’s chief innovation officer. Surveys suggest, said Bhatt, that even members of the Silent Generation, who are older than 80 today, trust their clinicians with their data. “It’s not that they’re averse to giving data,” she said. “It’s how easy can we make it for that population to be able to share their data.” 

    Bhatt said that Whoop, which recently raised $575 million from investors including Mayo Clinic and the sovereign wealth fund of Qatar, is working with the National Council on Aging and AARP to think about how to personalize the product to older adults’ individual priorities. “For each of us, how we feel, how we perform, how we age, we have our own goals,” said Bhatt. “The thing is, we don’t want to decide for you what that is.”  

    The goals are less diffuse for the 10-year pilot ACCESS program, which published a directory of initial participants last month. Through those 55 companies, Medicare patients can access chronic condition management for little or no cost — Whoop serves patients with high blood pressure, high cholesterol, obesity, and prediabetes — and Medicare will pay the companies based on their health outcomes. Whoop will provide patients with a wearable, a 12-month subscription to its app, and access to clinicians who can help them make sense of their data and offer advice.

    “The goal is, how do we bring technology closer to the patient, but not put the cost on the patient — rather, put the demand on the company,” said Bhatt. “Whoop takes responsibility for, in 12 months, I am going to make these people better. I’m going to show you outcomes in the Medicare population who have these risk factors to demonstrate that my technology can help them engage in their own health.” To receive full payment under the ACCESS model, Whoop will be required to show that it improved or controlled measures tied to its patients’ chronic conditions, including blood pressure, hemoglobin A1C, and low-density lipoprotein cholesterol.

    Bhatt said it was her role to help the company — which until recently focused on selling a product intentionally binned in the wellness category — develop and demonstrate those kinds of outcomes that bring them closer to clinical practice. The company just this year announced the ability for users to discuss their wearable data with clinicians, shortly before the FDA closed its warning letter that had initially said Whoop’s blood pressure-estimating feature qualified as a medical device — not a wellness feature. 

    While Whoop demonstrates good patient engagement, said Bhatt — users check the app eight times a day, on average — research into the original “wearable” for diabetes, continuous glucose monitors, suggests that engagement doesn’t necessarily translate to better health outcomes. 

    “In order to actually create personalized health at a population level, you need to start thinking about outcomes,” said Bhatt. “Can we show that we decrease blood pressure by five millimeters of mercury in individuals on Whoop — which, by the way, we have shown — so that we can say, hey, the outcome of cardiovascular disease and stroke, we know that outcome is better.” 

    At the same time, Bhatt said, the utility of continuous data is limited within the traditional health care system. As a practicing physician, “I had some really great patients who would print out binders of their wearable data,” she said. “This is me: I love this data. And I’d be like, ‘Oh, God.’” Despite her interest and the patient’s engagement, it was impossible to handle in a 20-minute visit.

    Ultimately, Bhatt imagines Whoop could help solve that problem, perhaps by delivering contextualized reports to clinicians that summarize a patient’s continuous data along with key points from their own journaling entries and interactions with their Whoop app coach. “When you put that together and you actually have a comprehensive report you can give to a clinician, now your clinician says, ‘Oh, that’s what I needed.’” 

  • Breast cancer can behave differently in older women. This physician is making more tailored treatments a reality

    Breast cancer can behave differently in older women. This physician is making more tailored treatments a reality

    Of all the factors that can increase a person’s risk of breast cancer, age is among the most significant. Almost half of people diagnosed with breast cancer are at least 65, and about 20% are 75 or older. Despite these rates, older women are frequently excluded from clinical trials; one study of breast cancer trials found that only 9% of participants were 65 or older, leaving physicians with a poorer understanding of how drugs behave in older adults and fewer guidelines with which to treat them.

    There’s increasing evidence that these patients could benefit from more tailored treatments. Neil Carleton, a cancer biologist and first-year resident physician at Brigham and Women’s Hospital, said that breast tumors can develop and grow differently in older patients than in younger ones because of hormone levels and inflammation. 

    “It can be a very heterogeneous disease,” Carleton said. But “historically, we’ve kind of treated all breast cancer the same,” he added — in a way that’s “age-agnostic.” 

    Carleton, who was recently named a STAT Wunderkind, wants to change that. After an M.D.-Ph.D. spent studying how clinicians can better treat tumors in older adults, he is now working to ensure that these patients receive care that is right for them, whether that means dialing back treatment or increasing it.

    “We typically think an older adult may be a little bit more frail” or less able to tolerate standard surgeries and therapies, he said. “But I don’t even think it’s about that. I think it’s more about appropriately treating.”

    Crafting the ‘nudge’

    As an undergraduate at Carnegie Mellon University, Carleton spent two summers working in a Johns Hopkins prostate cancer lab and was surprised to see surgeons making a point to attend the department’s journal club. On Wednesday mornings, as the urology group — basic scientists and physicians alike, in all stages of their careers — filed into the conference room to discuss scientific papers in the field, Carleton began to see how medicine and research were intertwined. 

    He’d been thinking about medical school since high school in Pittsburgh, when a formative biology teacher veered his lessons away from photosynthesis and toward anatomy, physiology, and new biotechnology — the kind of science that explained how human health really worked. The idea of a physician-scientist was completely new, and it felt like the right fit.

    “I knew you could be a doctor, and I knew you could do research. I had no idea that you could kind of do both,” Carleton said.

    When he started his M.D.-Ph.D. at the University of Pittsburgh in 2018, Carleton began working in the lab of Adrian Lee and Steffi Oesterreich, a husband-and-wife team of breast cancer biologists who were enthusiastic about new ideas and had a robust track record of translational research. Lee remembers the intensity with which Carleton wanted to be involved in that kind of work. “We can go on doing basic research forever, but we would like to eventually impact patient care,” Lee said. “And you could tell that he wanted to do that.” 

    At the time, there were reports from surgeons and in the scientific literature that older women with breast cancer were being overtreated. The three started talking about the patients that would come to launch Carleton’s career and a body of work in Lee and Oesterreich’s lab. In 2020, under the guidance of Lee, Oesterreich, and surgeon Priscilla McAuliffe, Carleton set out to quantify how many patients were receiving a surgery called a sentinel lymph node biopsy. 

    When removing a tumor from a patient’s breast, surgeons sometimes make an incision in the armpit and take a small amount of lymph node tissue to see if the cancer has spread there. Though professional society guidelines recommended against performing this biopsy on women 70 or older with early-stage cancer, other groups had reported that it was still being done.

    In data from the university medical center, Carleton found that about 65% of patients were still receiving biopsies. Rates actually continued to increase after the Society of Surgical Oncology adopted the guidelines in 2016, even though patients who received the biopsy were not more likely to survive or avoid recurrence. But “it can be very hard for surgeons to stop doing a surgery that’s kind of been ingrained in the paradigm for a while,” Carleton said.

    How, then, could he and his colleagues convince surgeons to reconsider? They designed a “nudge” within the electronic health record — a pop-up that would appear in a provider’s schedule for a qualifying patient that would remind them to consider omitting the biopsy. They implemented the nudge in eight clinics across the community and, in a clinical trial, tracked biopsy rates. The year after the nudge, they decreased by almost half.

    McAuliffe, now a breast cancer surgeon and clinical investigator at Emory University, said that surgeons encounter a lot of extraneous information in the electronic health record — but the nudge was simple. “I think that it reminded them without being a burden to them,” she said.

    One surgeon, when surveyed, said that the nudge “did exactly what its job was,” urging physicians to think about biology rather than reflexively recommending the biopsy. “I had to keep in mind that complete care doesn’t always equate with better care,” they said.

    The science behind a paradox

    While in the clinic, Carleton began studying a years-old question in the lab. Most breast cancer cases in older women are estrogen-receptor positive (ER+), meaning that tumor cells have receptors that bind to estrogen and trigger cancer growth. By 85, 91% of women with breast cancer have ER+ disease, even though postmenopausal women have lower levels of circulating estrogen. Carleton wanted to know how those tumors managed, seemingly paradoxically, to thrive.

    Looking at the gene expression in tissue from patients and healthy controls, Carleton and his colleagues found that the patients produced more of an enzyme involved in converting estrone — a form of estrogen that circulates in the bloodstream in postmenopausal women — to estradiol, its more potent version, within the tumor’s environment. 

    Scientists had known for 20 years that tumors made their own estrogen but didn’t know how it was done, Lee said. The enzyme Carleton identified was more than a mechanistic insight — it created a druggable target. In 3D models the lab made from patient cells, inhibiting the enzyme blocked estrogen conversion.

    Currently, doctors often treat postmenopausal women with ER+ tumors with inhibitors of a different enzyme. The drugs cause side effects like fatigue and joint pain, which lead many patients to stop treatment prematurely. Though the work is still early, Carleton hopes that drugs targeting the process they identified, administered through a gel or patch, could treat or even prevent breast cancer with fewer side effects. “I think it opens up possible therapeutic interventions,” he said.

    ‘Refining what we do’

    When looking through patient data early in his degree, Carleton noticed that some women ages 70 and older were forgoing surgery — not only the biopsy, but also a procedure to remove the main tumor in the breast. In this group, only 3% died of breast cancer after six years, and about 91% had their tumors controlled with primary endocrine therapy, which blocks estrogen receptors on ER+ breast cancer to prevent its growth. 

    If you could identify those patients for whom endocrine therapy might be enough treatment and monitor them, both the patient and their surgeon might be more comfortable with scaling back surgery, Lee said. “Precision medicine doesn’t mean doing more,” he said. “It means refining what we do, and sometimes refining what we mean we do means doing less.”

    While others might have missed the dozens of patients that hadn’t had any surgery among the thousands that did, Lee said, Carleton has a knack for noticing small details. And in September 2021, he uncovered a way to potentially track disease in patients who might not need surgery.

    Sitting in a talk at a local conference, Carleton learned about circulating tumor DNA (ctDNA), which cancer cells release into the bloodstream and can be measured to survey tumor growth. Natera, a molecular diagnostics company, had designed an assay that seemed perfect for older patients who’d declined surgery in favor of endocrine therapy: It required only a blood sample and could be done through a mobile blood-drawing service that came to their homes. Carleton and Lee approached Natera and, in the months afterward, designed a clinical trial to test whether they could use ctDNA to watch and identify patients at risk of progression.

    “It’s not an easy trial to recruit to — to say to someone, ‘Hey, you have breast cancer, but we’re not going to cut it out,’” Lee said. 

    But Carleton “has an amazing ability to kind of get the message across and encourage people,” Lee said, and put in hours with patients and physicians to earn their trust. Carleton was surprised by how many older adults were thrilled to join a trial that would guide not only their care, but the treatment of others going forward. “I think it was kind of one of the first times they were even approached to join a study,” he said.

    Over the next few years, the team studied patients who decided against surgery with Natera’s assay and ultrasound imaging. Patients with detectable ctDNA at six months were 30 times more likely to progress in their disease during the study, suggesting ctDNA was a marker of potential progression. And indeed, no patients with undetectable ctDNA before endocrine therapy progressed.

    The ‘closer’

    Today, as a first-year resident in Boston, Carleton spends most of his time treating patients. But he stays engaged with research: with the students in Lee and Oesterreich’s lab continuing to study the estrogen-converting enzyme, and with projects like designing a larger ctDNA trial. Lee and Oesterreich, with whom he still has regular check-ins, call him a “closer” — someone who takes on projects and sees them through to completion, synthesizing complex data from basic science and clinical practice into an understandable whole. “He has the complete package,” Lee said.

    Ultimately, Carleton hopes this work can help patients receive care without frequent trips to the clinic — turning breast cancer “into more of a chronic disease,” he said, where a patient might just take a daily pill and have regular imaging or ctDNA tests.

    Of course, Carleton said, not every patient will want that, and people with aggressive disease may need every intense treatment, test, and appointment. But better tools can help doctors identify: Who can be the patient they send home?

  • STAT+: Why this startup is taking its AI to predict breast cancer risk directly to patients

    STAT+: Why this startup is taking its AI to predict breast cancer risk directly to patients

    Waiting on doctors and insurers to get on board would have taken too long, Clairity says

    Adobe

    Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer telehealth. Confidential tips can be sent on Signal at palmer.01.

    You’re reading Part 5 of Paying for AI, a series examining how new clinical artificial intelligence tools influence the affordability of health care and patients’ long-term health. Here’s Part 1, Part 2, Part 3, and Part 4.

    “Don’t wait. Choose to be informed.” 

    That’s the call to action that patients will find on the site for digital health company Everlywell, which has offered at-home lab tests directly to consumers for a decade. But last week, it wasn’t marketing a prick to measure blood glucose or screen for celiac disease: It was launching one of a new generation of AI-based risk prediction algorithms for medical images. 

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    1. Health Tech Correspondent

      Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer telehealth. Confidential tips can be sent on Signal at palmer.01.

  • STAT+: Utah plows ahead with more health AI pilots for prescriptions, women’s health

    STAT+: Utah plows ahead with more health AI pilots for prescriptions, women’s health

    Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

    Utah regulators on Monday announced a plan to allow an artificial intelligence product to evaluate patients for acne treatment and write new drug prescriptions without prior human review. 

    A startup called Nolla Health will launch an AI-powered service in the state that will assess a patient for mild-to-moderate acne treatment using a structured intake and by analyzing photos of their skin. The product may determine whether one of a list of low-risk drugs is appropriate. In the first stages of the pilot, the decisions of the AI will be reviewed by a licensed clinician who will sign off on prescriptions, but Nolla may eventually be allowed to prescribe drugs without this review. The company last year announced it raised $4.5 million from investors including General Catalyst, and Nolla aspires to direct treatment for a host of conditions using AI.

    The new pilot is part of a significant expansion of a closely watched “AI sandbox” program that allows Utah’s Office of Artificial Intelligence Policy, or OAIP, to waive regulations, including around the practice of medicine, for companies that want to test AI products under state supervision. 

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