Brainstorm Health: ‘All of Us’ Enrollment, Theranos Investor Losses, Gottlieb Vs. Drug Rebates

As I mentioned yesterday, the National Institutes of Health (NIH) is launching public enrollment in its ambitious genetic and health data collection project. The initiative, the “All of Us” research program announced by former President Barack Obama back in 2015, has a pretty out-there goal: to guide the development of personalized medicine by collecting samples from one million American volunteers.

Such a broad project necessitates widespread participation. And academic institutes are pushing it hard ahead of the official “All of Us” enrollment drive which begins this Sunday, May 6. “All of Us is an unprecedented effort to gather genetic, biological, environmental, health, and lifestyle data from 1 million or more volunteer participants living in the United States,” wrote the University of California system in a blog post Thursday. “A major component of the federal Precision Medicine Initiative, the program’s ultimate goal is to accelerate research and improve health.”

The hope is that the project (which, by the way, you can learn more about in case you’re interested in participating here) could theoretically help spur better medical research and better drugs by recruiting a far larger and more diverse swath of participants than traditional studies or clinical trials do.

Private companies, including consumer genetic testing firms like 23andMe and Google parent Alphabet—have similar ambitions through research partnerships and programs like Alphabet subsidiary Verily’s “Project Baseline.” But the scale of NIH’s program, and the approach taken by “All of Us,” may set it apart in some ways—including the fact that it makes its request for data transparent upfront, and that whatever information is gleaned from it would be available in a public database to researchers.

More than 25,000 people have already signed up for the project in its early stages. Congress has authorized nearly $1.5 billion toward the effort over the next 10 years.

Read on for the day’s news, and have a wonderful weekend!

DIGITAL HEALTH

Theranos investors lost a lot of money. The Wall Street Journal is out with yet another eye-opening report of the Theranos' debacles downstream effects: Prominent government and business officials lost more than $600 million investing in the blood testing startup, which has now faced multiple regulatory smackdowns and galvanized investor lawsuits. The family of Education Secretary Betsy DeVos alone invested $100 million in Elizabeth Holmes' now-hobbled unicorn, according to the Journal. Other prominent investors include the heirs to Walmart founder Sam Walton and Mexican businessman Carlos Slim.(Wall Street Journal)

INDICATIONS

FDA chief Gottlieb calls out drug rebate protections. In another signal that upcoming Trump administration may—may—have more bite than bark when it comes to drug pricing reform, FDA Commissioner Dr. Scott Gottlieb on Thursday publicly took aim at the behind-the-scenes rebates negotiated between drug makers and health insurers, questioning whether they should continue to be protected by federal safe harbor laws. "What if we took on this system directly, by having the federal government reexamine the current safe harbor for drug rebates under the Anti-Kickback Statute?" said Gottlieb. "Such a step could help restore some semblance of reality to the relationship between list and negotiated prices, and thereby boost affordability and competition."(Reuters)

THE BIG PICTURE

WHO: Cut out those saturated fats! The World Health Organization (WHO) has issued new guidance on saturated and trans fats, recommending that both adults' and children's diets should contain a maximum level of 10% of saturated fats (the kinds you get from foods like butter) and one percent of trans fats. Sticking to those levels can help reduce the risk for heart disease, the global health agency says.(Reuters)

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