Brainstorm Health Daily: June 16, 2017

And then he asked a question that all of us, at some point in our lives, should have thought to ask: “Why do they put directions on shampoo? I mean, if you don’t know how to wash your hair, should you really be standing naked under hot, running water by yourself?”

This newsletter, as Daily readers know, is dedicated to exploring the great disruption that’s happening in healthcare and medicine, and probing the ever-expanding science of well being. But there’s a dirty little secret it’s time to share: All of the new whiz-bang technology that inventors come up with—and all of the efforts to shape public health policy for the better—won’t amount to much if people don’t have the basic smarts and sense to take care of themselves.

Yesterday, as a case in point, the CDC released an update on the number of American middle and high schoolers who smoke or otherwise use tobacco. That number, happily, went down from 2015 to 2016 (mostly due to a decline in e-cigarette usage). But as the new FDA Commissioner, Scott Gottlieb, pointed out: That still leaves 3.9 million smoking, vaping, and hookah-sparking kids out there. (Not to mention a few weird pipe smokers in the chess club.) Every day, more than 400 young Americans “become daily cigarette smokers,” Gottlieb says.

As for basic smarts about food and nutrition, Americans seem to be starting from an even lower base. Witness a few telling data points that the Washington Post’s Caitlin Dewey scooped up yesterday as well. “Seven percent of all American adults believe that chocolate milk comes from brown cows,” she reported, citing a survey commissioned by the Innovation Center of U.S. Dairy. “If you do the math, that works out to 16.4 million misinformed, milk-drinking people,” Dewey said—or a population roughly the size of Pennsylvania’s.

Previous studies she cited found that rather large shares of teens (and, in some cases, adults) apparently don’t realize that onions and lettuce are plants, that hamburgers generally derive from cows, and that cheese is made from milk. (The full piece is well worth reading.)

All this said, there’s no doubt an ambitious young developer is hard at work on a technofix for this very problem: maybe a smartphone app you can point at a taco supreme and have it tell you exactly what’s in it—and whether it’s animal, vegetable, or mineral.

Until then, however, maybe we ought to do a better job of teaching the basics of health and wellness in fifth grade. And a little primer on shampooing wouldn’t hurt either.

Enjoy the weekend! Sy’s got the news below.

DIGITAL HEALTH

Scott Gottlieb puts forth a plan for digital health. New FDA Commissioner Dr. Scott Gottlieb has a history of arguing against bureaucratic red tape at the agency he now runs. Now, he's taken his first steps toward revamping the way that the Food and Drug Administration approaches digital health and mobile medical apps, announcing upcoming guidance that goes into more specifics than the 21st Century Cures FDA reform bill signed by former President Barack Obama last year. "FDA will provide guidance to clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not," wrote Gottlieb in a blog post. "In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements. Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA’s compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities." In short: Gottlieb doesn't think the FDA has much business regulating every single consumer-facing health app out there. (FDA Voice)

Are genome-wide disease studies problematic? Precision medicine has entranced the biopharmaceutical industry, with significant new research based on genomic studies. One variant of these analyses, genome-wide association studies (GWAS), involve tracking the genetic differences between healthy people and those who have a certain disease. But many of the variations identified here may be pretty useless when it comes to sussing out genetic targets for drugs and pinpointing exactly which genes are linked to an illness, according to new research published in the journal Cell. "The implicit assumption of GWAS has been that when you find hits, they should be directly involved in the disease you’re studying," says Stanford geneticist Jonathan Pritchard, one of the study authors. "When you start to think that all of the expressed genes in a tissue can matter, it becomes untenable that there’s a simple biological story for each one." (Nature)

INDICATIONS

FDA approves a cheaper EpiPen alternative.  The FDA on Thursday approved Symjepi, an alternative to Mylan Pharmaceuticals' popular allergy-buster the EpiPen. Symjepi should be hitting the market later this year and its creator, Adamis Pharmaceuticals, says that it will be cheaper than its major rival, which has come under intense scrutiny over massive list price hikes. The Adamis product will reportedly be priced even cheaper than Mylan's new generic EpiPen version, which retails at $300 before rebates and discounts. Mylan has been losing market share to competitors since the price increase scandal broke but still dominates the field for now.

Checkmate Pharmaceuticals raises $27 million for cancer immunotherapy work. Checkmate Pharmaceuticals has hauled in $27 million in a Series B funding round to support its cancer treatment platform, which the company hopes can boost the effectiveness of an increasingly popular class of cancer immunotherapy drugs called "checkpoint inhibitors." These include Merck's flagship Keytruda, which Checkmate is testing its lead experimental candidate CMP-001 in conjunction with; since checkpoint inhibitors don't work on all cancer patients, Checkmate believes that its products can increase the number of people who respond to immunotherapy treatment. The company is headed by veteran scientist Art Krieg, who was formerly the chief scientific officer at rare disease drug maker Sarepta Therapeutics. (Xconomy)

THE BIG PICTURE

Multiple GOP Senators say they have no idea what their health care bill looks like. Vox conducted a series of interviews with GOP Senators to ask them about the emerging health care bill to dismantle Obamacare. And the general thrust of the arguments seems to be that lawmakers are frustrated at the secrecy with which the process is proceeding. In fact, some, like Alaska's Sen. Lisa Murkowski, explicitly say they can't answer specific questions about the legislation because they're not sure what's actually going to be in the bill. The interviews are worth reading in full. (Vox)

REQUIRED READING

Amazon Is Buying Whole Foods for $13.7 Billion, by Melissa Chan

Dow Chemical and DuPont Have Won U.S. Antitrust Approval to Merge, by Reuters

Bitcoin and Ethereum Crashed, Taking Coinbase Down With Them, by Jen Wieczner

California Tells Volkswagen to Build Electric Charging Stations in Poor Areas, by Reuters