What happened in health care technology this week – and why it’s important.
Top VCs warn there’s a glut of cancer-treatment startups, and lackluster drugs risk bogging down the field
Allison DeAngelis and Andrew Dunn published an article in Insider on the increased efforts in immuno-oncology to develop new drugs to treat cancers. For the last several years, oncology has been the hottest area for startups and the most prominent recipient of venture capital dollars. About half of all biotechs that went public in 2020 and 2021 are specialized in cancer research, according to Evercore ISI data. But, investors at top firms like Perceptive Advisors, RTW Investments, and venBio are starting to feel there’s an overabundance of cancer startups, particularly ones trying to piggyback on blockbuster drugs like Keytruda.
Treating cancer took a monumental step forward a decade ago by introducing a group of drugs called “checkpoint inhibitors.” Cancer cells can often turn off and hide from the body’s immune system by manipulating “checkpoints” in the system. This group of medications overrides that, allowing the body to better fight cancer cells. But these drugs don’t work on all patients. So, a wave of companies has been developing hundreds of immune system-targeting therapies that can be added to checkpoint inhibitors to boost their effect. Last September, the Cancer Research Institute counted more than 4,700 immuno-oncology drugs in development, with more than 6,200 active clinical studies evaluating these treatments. More than 1,000 clinical trials are testing Keytruda in combination with other medications, according to Merck. The sheer number of treatments being developed has made running clinical trials extremely challenging.
Why it’s important – Because there are so many drugs in development, it’s challenging to find people who aren’t already taking another experimental treatment. Many of these drugs don’t show much impact on their own, breeding wariness among some investors. Trying to find the “signal” among the “noise” has become highly challenging. Whether it’s a proven mechanism like checkpoint inhibitors or a new approach, cancer trials are still risky. While the clinical pipeline is crowded with promising prospects, only a small number of these will likely have sufficiently transformative benefit-to-risk profiles to drive return on investment.
The biggest US healthcare company is jumping into the red-hot direct-to-consumer prescription market
Also, in Business Insider, Shelby Livingston reports on United Healthcare’s move into selling prescription drugs online and expanding their telehealth options. Optum, UnitedHealth’s fastest-growing business, quietly revamped its online pharmacy, called the Optum Store, to sell more than 800 generic drugs at discounted prices to people who forgo using their insurance. Optum is also offering cash-only telehealth services so people can get prescriptions for birth control or medication to treat anxiety, depression, erectile dysfunction, and other common illnesses. Soon it will offer treatment for hair loss, its website said.
Optum’s push into the direct-to-consumer world is a bid to own another piece of the healthcare system and keep its customers’ healthcare dollars in-house, rather than losing them to VC-backed startups or Amazon. As more Americans pay directly for their healthcare, UnitedHealth is now catering to people who use insurance and those who can’t afford to use it.
Why it’s important – Through the Optum Store, it can tap into that more minor but still lucrative market for customers paying cash for prescription drugs. Americans spent $359 billion on medicine in 2020, and patients paying without insurance spent $14 billion, IQVIA found. Optum’s entrance into the direct-to-consumer market brings new competition to online pharmacies and telehealth providers selling their services directly to patients. As copayments and insurance deductibles rise, these startups are also attracting customers who have realized that they can save money on drugs and visits to the doctor by paying without insurance.
Hospitals must be attentive as FDA revokes more authorized devices
An important article in MedCityNews by Elise Reuter provides critical insight to health systems about changes to specific emergency use authorizations that the FDA is rolling back as we continue the struggle to manage the COVID-19 pandemic.
After authorizing a record number of products for emergency use during the Covid-19 pandemic, the Food and Drug Administration has since begun whittling down the pool. Just as the FDA gave emergency use authorizations (EUA) to hundreds of products, it must go through the time-consuming process of deciding which ones to approve and which ones to stop using.
Why it’s important – Hospitals should pay close attention as the agency revokes more authorizations, which could leave them liable if they continue to use those products. For healthcare providers, it’s up to them to make sure they’re no longer using these revoked devices.
“People need to take that as seriously as they would have to take a recall.”
Marcus Schabacker, M.D., CEO, ECRI
Dr. Schabacker recommends that hospitals have a committee in place to keep track of all of the products they’re using that are under a EUA, including an inventory of where they are and how many have been supplied. He also recommends they start considering if there is an approved alternative available and their plan if that EUA gets revoked.
At a leading health tech conference, enthusiasm for machine learning mixes with calls for greater scrutiny
In a follow-up to his HIMSS conference coverage, STAT’s Casey Ross reports on calls for regulation on machine learning and AI algorithm development. Throughout the four-day conference, the largest annual event in health care technology, industry leaders called for better ways to evaluate the usefulness of machine learning algorithms, audit them for bias, and put in place regulations designed to ensure reliability, fairness, and transparency.
Health care organizations and entrepreneurs are collectively spending billions of dollars on developing, implementing, and refining machine learning models in medicine. But several speakers said a lack of standards jeopardizes those investments to evaluate these tools or guardrails to protect patients against errant results and unintended consequences. Even prominent developers of clinical algorithms said the potential harms merit a more stringent regulatory approach. Those concerns run counter to the current hands-off approach to regulating such products, especially those that operate within electronic health records. The Food and Drug Administration, which reviews algorithms used to interpret medical images and data from wearables, does not provide equivalent scrutiny to many tools hospitals use within their record-keeping software to guide diagnosis and treatment.
“But the FDA is probably not the right group to look at efficacy or bias. And I believe that will fall to a public-private collaboration of government, academia, and industry. In 2021 I believe we’ll see these kinds of collaborations come together.”
John Halamka, M.D., President, Mayo Clinic Platform
Why it’s important – Machine learning, a subset of artificial intelligence, is not a new technology. But its initial iterations in the 1950s have been augmented by novel technical architectures and computing power that have allowed them in some realms to surpass the capabilities of physicians and even open a new dimension of medical knowledge. Those capabilities have fueled an explosion of investment and research and implementation of algorithms whose inner workings and potential impacts are not always apparent to clinicians and regulators. Mayo Clinic, Duke, Stanford, and other large institutions have suggested creating a national algorithm certification body and regional testing laboratories that could create greater consistency in the evaluation process.
Digital therapy program for fibromyalgia receives FDA breakthrough device designation
Tech Crunch reporter Emma Betuel reported on the recent FDA decision to grant a breakthrough device designation to Swing Therapeutics for their 12-week smartphone-assisted fibromyalgia management program. This FDA breakthrough designation was awarded to the company’s smartphone adaptation of an acceptance and commitment therapy (ACT) program initially designed and tested at the University of Manitoba.
Swing Therapeutics’ platform is designed to be prescribed by a doctor as a treatment management tool. Once prescribed, the patient would enter a 41-session acceptance and commitment therapy program that’s run entirely on their phone and broken into “daily doses.” A “daily dose” might include a prompt for a mindfulness session or a short writing prompt.
Why it’s important – At the moment, there is no cure for fibromyalgia, but the FDA has approved three drugs that can help manage symptoms. These include Lyrica, which is usually prescribed to treat nerve damage but is also used to treat fibromyalgia; Cymbalta, which was initially developed to treat depression, anxiety, and diabetic neuropathy; and Savella, an SSRI that’s similar to treatments for depression. Outside of the drug world, there’s some evidence ACT can help patients who live with chronic pain (including fibromyalgia). So, if this application performs as well as in the early trials, it provides another tool to help patients manage their chronic pain.
Mayo Clinic Finds Success With Remote Patient Monitoring
Digital Health Wire’s Jason Barry reported on the recently published study by the Mayo Clinic of its remote patient monitoring (RPM) program for ambulatory care of COVID-19 patients (n = 7,074), aimed at reducing acute care utilization and hospital admissions. The program included two care-delivery models based on patient risk, enabling RPM-registered nurses to respond to technology-generated alerts and deliver standardized care for clinical assessments and patient management.
Among all patients, ED visit and hospitalization rates within 30 days of enrollment were 11.4% (low-intensity) and 9.4% (high intensity), with a 30-day mortality rate of 0.4%. The RPM engagement rate was above-average at 78.9%, supporting recent changes to the CMS physician fee schedule to expand reimbursement for RPM services to patients with acute conditions.
Why it’s important – The study provides solid evidence that RPM for management of COVID-19 is associated with “excellent clinical outcomes,” especially among patients at risk for severe illness. Given that Mayo Clinic’s RPM program was part of a retrospective cohort study, it remains unknown how the results compare with “usual care.” Still, a matched case-control study is planned to evaluate the program.
Mass General Brigham is diversifying its innovation process. Here’s how.
In an article on MedCity News, Anuja Vaidya outlines a new initiative at Mass General Brigham to ensure diversity in their innovation efforts. Called the Innovator Community Expansion Initiative, the main goal of the action is to pinpoint and remove obstacles keeping underrepresented groups, like women, out of the innovation process. The initiative will promote networking and education about the path to commercialization.
Launched in October 2019, the initiative will focus on increasing participation among underrepresented groups at Mass General Brigham, starting with women and early career clinicians and scientists.
Why it’s important – Increasing the pool of candidates submitting innovation ideas directly from the frontline clinical perspective will ultimately help impact patient care. Also, they are using a data-driven approach to measure the success of the program. To measure their success, the initiative will focus on the number of invention disclosures filed by Mass General Brigham team members and the demographics of those doing the filing. As the initiative’s efforts ramp up, leaders will track participation numbers and design new programs based on their findings.
Robot Could Operate a Docking Station Inside the Gut – Magnetic drug capsule docks with implant to deliver insulin
An article in IEEE Spectrum reported on research into developing an insulin delivery robot surgically implanted in the abdomen and swallowable magnetic capsules that resupply the robot with insulin. A device the size of a flip phone is surgically implanted along the abdominal wall interfaced with the small intestine. The device delivers insulin into the fluid in that space. When the implant’s reservoir runs low on medication, a magnetic, insulin-filled capsule shuttles in to refill it.
Why it’s important – This kind of delivery system could prove helpful to people with type 1 diabetes, especially those who must inject insulin into their bodies multiple times a day. Insulin pumps are available commercially, but these require external hardware that delivers the drug through a tube or needle penetrating the body. Implantable insulin pumps are also available, but those devices have to be refilled by a tube that protrudes from the body, inviting bacterial infections; those systems have not proven popular.
A fully implantable system refilled by a pill would eliminate the need for protruding tubes and hardware. Such a system could help deliver drugs for other diseases too, such as chemotherapy to people with ovarian, pancreatic, gastric, and colorectal cancers.
Cancer patients’ own cells used in 3D printed tumors to test treatments
An article in Reuters reported on recent research published on Wednesday in the journal Science Advances, where researchers have used brain cancer patients’ own cells in the form of 3D printing material to make a model of their tumor to test the efficacy of potential treatments before using them for real inside the body.
“The more physiological mimicry you create, the better prediction you get in terms of how drug treatments will work on the actual tumour in the patient’s body.”
Ofra Benny, Hebrew University of Jerusalem
The scientists extract “a chunk” of the tumor from the brain of a patient with glioblastoma – an aggressive cancer with an abysmal prognosis – and use it to print a model matching their MRI scans. The patient’s blood is then pumped through the printed tumor, made with a compound that mimics the brain, followed by a drug or therapeutic treatment.
Why it’s important – Researchers have often 3D printed tumor models to plan for surgery. Still, more recent innovations have focused on bioprinting, which uses live cells as a sort of ink to build up the layers. While previous research has used such “bioprinting” to simulate cancer environments, the Tel Aviv University researchers say they are the first to print a “viable” tumor. Since glioblastoma is such a deadly form of cancer, having the ability to test treatment options using these printed tumors allows clinicians to select the most effective therapy earlier, thereby improving the possibility of slowing the progression of the disease.