Brainstorm Health: FDA and Blood Plasma, Intercept NASH Data, Tide Pods

I’d guess that at least a slice of our readers regularly watch, or at least have seen, HBO’s biting television satire of Silicon Valley (aptly titled Silicon Valley). I only bring this up because the Food and Drug Administration (FDA) on Tuesday issued a warning that evokes memories of one of the show’s most ridiculous (and yet entirely-too-real) episodes, wherein an SV billionaire has a young “blood boy” who regularly supplies him with infusions to stay healthy.

The crux of the FDA’s message: No, you probably shouldn’t dole out thousands of dollars to infuse young people’s blood plasma into your veins in the hopes of staving off serious diseases like dementia, Parkinson’s, and Alzheimer’s.

“Plasma is not FDA-recognized or approved to treat conditions such as normal aging or memory loss, or other diseases like Alzheimer’s or Parkinson’s disease,” wrote FDA Commissioner Scott Gottlieb in a statement, going on to note that such unproven treatments can be dangerous and cause a host of side effects.

“Moreover, reports we’re seeing indicate that the dosing of these infusions can involve administration of large volumes of plasma that can be associated with significant risks including infectious, allergic, respiratory and cardiovascular risks, among others,” he said.

This isn’t to say that certain forms of blood plasma treatment will never prove effective for certain diseases; there just isn’t any solid clinical evidence along those lines to date. And there certainly isn’t any proof that injecting “young blood” can serve as some kind of biomedical fountain of youth.

These plasma infusions’ high price tags—reports peg them at anywhere between $8,000 and $12,000—also raise a broader question about the psychology of public health: How is it that pricey, but questionable and unproven, medical technologies sometimes appear to draw more hype than existing, proven, and cheap ones like basic vaccinations?

In any case, the FDA’s warning already led Ambrosia, the main firm that markets such blood-based treatments, to state it will “cease patient treatments” on Tuesday.

Read on for the day’s news.

DIGITAL HEALTH

Could CRISPR make vaccines more effective? STAT News' Sharon Begley has an excellent report on the potential for CRISPR gene editing to make vaccines more effective—in come cases, by bypassing the whole "vaccination" process altogether. Begley points to the many hurdles facing the early-stage research (including the fact that immune B cells would have to be modified individually in the process). The tech, though, is worth checking out. (STAT News)

INDICATIONS

Intercept's mixed bag on a pernicious liver disease. Intercept Pharmaceuticals shares rose 6% in Tuesday trading following mixed data on what's been on of the most flummoxing fields in the life sciences: NASH, or nonalcoholic steatohepatitis, a form of fatty liver disease that can lead to permanent damage and cirrhosis. Larger companies such as Allergan and Gilead have set out to treat the same condition but have yet to achieve major successes; even Intercept's modest results in a phase 3 trial could therefore signal an eventual FDA approval.

Bob Hugin gets back into biotech. Bob Hugin, former CEO of Celgene, jumped from the fraught (but lucrative) field of biotech to the fraught (but not nearly as lucrative) field of politics last fall, mounting a challenge for a U.S. Senate seat in New Jersey. Having lost that race, Hugin is now returning to his roots, taking up a board role at Botox maker Allergan while the company reportedly seeks a leadership restructuring, according to Endpoints News. (Endpoints News)

THE BIG PICTURE

The public health danger of Tide pods—and what P&G did about it. My colleague Jake Meth has a must-read on the mini public health crisis bred by, of all things, laundry detergent pods. "Too often, it appears, young children and seniors with dementia mistake them for candy and try to eat them. And when that happens, they’re more likely than other detergents and other household cleaning products to cause serious injury," writes Jake. "Laundry pods’ threat to public safety became apparent immediately after their North America launch in 2012. Between 2011 and 2013, the number of annual emergency-department visits for all laundry detergent-related injuries for young children more than tripled, from 2,862 to 9,004." Jake goes on to explore how manufacturer Procter & Gamble and other detergent makers have tried to address the safety issues of these increasingly popular products—and how they still have a long ways to go. (Fortune)

REQUIRED READING

Amir Husain Is Building the Future of AI, by Dinah Eng

Why It's Time to Radically Redesign the Smartphone, by Aaron Pressman

Wall Street's Incredible Shrinking Earnings Outlook, by Shawn Tully

What Happens Next in the Case of Trump vs 16 U.S. States, by Grace Dobush