Let’s start with yesterday’s huge news: Scott Gottlieb, the widely liked commissioner of the Food and Drug Administration, is resigning. After nearly two years in the job, he wants to spend more time with his family, he told the Washington Post.
The unexpected announcement is rocking the world of health and medicine — particularly here on the West Coast, because it creates big uncertainty on issues pivotal to the fortunes of the region’s life sciences companies. Here are three of those issues:
- Curbing teenage vaping: Amid a surge in underage vaping that Gottlieb characterized as an “epidemic,” he made an aggressive push to regulate e-cigarette makers — and repeatedly called out the San Francisco vaping products company Juul Labs. Gottlieb expects the FDA in the next few weeks to release much-anticipated guidance on restricting the sales of flavored e-cigarettes, he told the New York Times. But his other ambitious proposals to regulate the industry will be left unfinished. You have to think the executives at Juul are feeling relieved right now.
- Regulating medical software: Gottlieb’s FDA sought to speed up the process of getting low-risk medical software to market. Most notable was a push to develop a pre-certification program that would shift the agency’s focus from evaluating products to evaluating producers. Among the companies participating in developing the program: Apple, Fitbit, and Alphabet’s life sciences unit Verily. How, or even whether, the program gets widely deployed is now uncertain.
- Streamlining clinical trials: Plenty of Silicon Valley startups are betting on digital technologies designed to make clinical trials faster and easier to run. Gottlieb’s FDA took up the issue, most recently with an expanded partnership with the New York startup Flatiron Health, though it’s been cautious about not sacrificing rigorous evaluation along the way. It’s unclear how Gottlieb’s successor will see the issue.
Now, onto the latest headlines
The Apple Watch, you’ll recall, got FDA clearance last year for a feature to detect atrial fibrillation, an irregular heartbeat that can lead to more serious health concerns. Since then, Apple has been aggressively marketing the feature with an unusual public relations campaign that’s worrying cardiologists, Politico’s Darius Tahir reports.
The FDA’s warning last month about unproven young blood infusions left me wanting to know more about Alkahest. That’s a biotech company that’s doing serious science in the field, including testing a plasma-derived product in Alzheimer’s patients. So I went down to Silicon Valley the other day to sit down with Alkahest’s executives — and ask them about all those vampire jokes. Here’s what I learned.
In the Bay Area and beyond, a booming industry has been built around synthesizing DNA and finding ways to use it to store data. But a new study points to an alarming vulnerability in these technologies. Researchers at UC Irvine and UC Riverside showed that just by recording the sounds of a DNA synthesizer, it’s possible to steal genetic blueprint it’s working from — and reverse-engineer that information for potentially dangerous purposes. The researchers carried out their demonstrative attack on a machine made by Applied Biosystems, a brand sold by Thermo Fisher Scientific, Wired reports.
The past few days brought a few personnel moves of note at the Bay Area biotech bellwether Gilead Sciences: Daniel O’Day finally started his new job as CEO. Meanwhile, the head of the company’s oncology pipeline, Alessandro Riva, is leaving after two years to lead a new New Jersey spinout from an Indian generic drug maker.
San Francisco just added a new biotech company: Maze Therapeutics, which aims to harness genetic modifiers, genes that can alter the effects of a single genetic variant. Endpoints profiled the startup at its launch.
When patients get diagnosed with the most common type of lung cancer, they generally get a traditional biopsy, involving a small amount of tumor tissue removed from the lung. Now, Silicon Valley-based Guardant Health is out with new data supporting an alternative: the blood test it markets to detect fragments of DNA in the bloodstream. My STAT colleague Matthew Herper breaks down Guardant’s results.
Hims, the San Francisco startup pitching online prescriptions for drugs to treat simple health conditions, has launched a new offering: the beta blocker propranolol, for people with social anxiety disorder. Hims joins fellow San Francisco startup Kick, which launched its own propranolol prescriptions in January, in trying to reach anxious public speakers.
The UC system broke up with a major journal publisher. Now what?
In previous editions of this newsletter, I’ve updated you on months of negotiations between the University of California system and the journal publisher Elsevier, centered around their dispute over how open-access research should get paid for. Last week, the UC system announced that it will not renew its subscriptions to Elsevier’s journals. In other words: “The game of chicken has come down to the nuclear option,” as one psychology researcher at UC Davis put it on Twitter.
All of which left me wondering: What does this mean for faculty and students in the UC system?
Nothing, at this point. Elsevier hasn’t yet cut off access to its journals. But the UC system expects Elsevier to do so, though Elsevier has not yet told the UC if or when that will happen, according to Jeffrey MacKie-Mason, a librarian at UC Berkeley who helped lead the UC system’s side of the unsuccessful negotiations.
If Elsevier does cut access, MacKie-Mason told me he anticipates that will mean that UC faculty and students will no longer be able to directly retrieve articles published since the start of this year from the Elsevier server. He also expects UC faculty and students to be blocked from accessing a small fraction of old publications.
In the meantime, the UC has prepared a guide about alternative legal ways for faculty and students to get articles. “We are ready to help anyone on our campuses who asks for help. We will do everything feasible to minimize inconvenience for them,” MacKie-Mason told me.
Elsevier, for its part, maintains that it put forth a reasonable counter offer during the unsuccessful negotiations — and that it still wants to reach a new deal.
Don't miss this essay
Dr. Rahul Desikan is a physician scientist at UC San Francisco who built his career studying degenerative brain diseases. Two years ago, he had recently begun studying the genetics of amyotrophic lateral sclerosis when, at age 38, he was diagnosed with ALS himself. In a new personal essay in the Washington Post, Desikan writes movingly about why he’s continuing his research — even though he’s able to communicate only with his eyes.
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