Brainstorm Health: Digital Pill, FDA Kratom Warning, Hypertension Guidelines

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Hello, readers! This is Sy.

The Food and Drug Administration (FDA) on Monday approved the first ever drug-digital tracking tool hybrid for the U.S. market. The digital pill, Otsuka Pharmaceutical Co Ltd’s Abilify MyCite, uses sensor technology developed by Proteus Digital Health in combination with a version of Otsuka’s best-selling mental illness medication Abilify, which is used to treat schizophrenia, bipolar disorder, and depression. The landmark regulatory clearance underscores the high-tech evolution in how drugs are delivered into the body—which in turn presents an opportunity to claw back some of the estimated $300 billion in wasted medical spending caused by patients not taking their drugs.

Here’s how the system works: The sensor inside of the pill is activated by stomach fluids. Once a patient takes his or her medicine, that information is relayed to a patch (also developed by Proteus) worn on the patient’s torso, which then shoots the data over to a smartphone app. Furthermore, doctors and health care providers can get permission from their patients to access the drug tracking data through an online portal.

The FDA is careful to note that there hasn’t been an established association between using the digital pill platform and increased patient adherence to their drug regimens. But the device may be particularly beneficial for certain patients with mental illness since taking medications as prescribed is particularly crucial for these people.

Indeed, making it easier for people to take their drugs—and keep track of their habits—is one of the pillars of the digital health revolution. “Drug pricing is not the problem,” as Andrew Thompson, co-founder and CEO of Proteus, explained during Fortune‘s second annual Brainstorm Health conference in San Diego in May. “The problem is that we’re asking payers to purchase drugs that are prescribed that are not taken or not taken properly.” That reality renders otherwise effective medicines moot.

Digital tracking is just one approach to making sure people stick to their regimens. Companies like Intarcia and Braeburn Pharmaceuticals are pursuing other approaches like creating implantable devices which contain six months’ or one year’s worth of treatments for people with chronic medical needs, such as those fighting opioid addiction.

Read on for the day’s news.


Your wearable may be able to detect hypertension and sleep apnea. A study presented at the American Heart Association’s (AHA) ongoing meeting in Anaheim suggests that Cardiogram’s deep neural network tech, called “DeepHeart,” could allow the Apple Watch to detect high blood pressure with 82% accuracy and sleep apnea with 90% accuracy. The research is part of Cardiogram and the University of California, San Francisco’s eHeart study. (MacRumors)


Johnson & Johnson drops suit against Samsung Bioepis’ Remicade copycat. J&J biotech unit Janssen is dropping its patent suit against Samsung Bioepis, which manufactures a copycat of Janssen’s best-selling anti-inflammatory and autoimmune disease drug Remicade. Samsung Bioepis’ drug, Renflexis, is a “biosimilar,” or a generic version of a branded biologic drug (these treatments tend to be pricey and extremely lucrative for the biopharma firms that sell them). Remicade brought in nearly $7 billion in 2016 sales. (The Investor)

FDA: Don’t use kratom. The Food and Drug Administration (FDA) has issued a stern safety warning against the use of kratom, an increasingly popular herbal substance that has been marketed by some companies as a safe, natural treatment to treat a wide range of conditions. “The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” said the agency in a statement. “Importantly, evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death.” Those risks prompted the FDA’s warning, specifically against using kratom as an add-on treatment or alternative to opioid painkillers. “There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder,” the FDA notes.


New hypertension guidelines mean nearly half of Americans have high blood pressure. Revised hypertension guidelines lower the “danger zone” cutoff for high blood pressure from the previous standard of 140/90 to 130/80. That means that doctors will begin urging patients with blood pressure at that level or higher to make lifestyle changes or begin taking medications to control their blood pressure. And the number of Americans with high blood pressure under these new standards will rise to an estimated 103 million people, or about 46% of the country’s adult population. (Reuters)