Brainstorm Health: Alzheimer’s Definition, At-Home DNA Tests, UnitedHealth’s Reach

Hello there, readers! This is Sy.

Alzheimer’s has long been one of the heaviest therapeutic albatrosses slung round drug developers’ necks. The memory-eating disease, expected to afflict 15 million Americans by 2060 (and tens of millions more around the world as life expectancy increases), has no cure; a new drug for the condition hasn’t been approved in well over a decade; initially promising experimental treatments seem to be failing with clockwork regularity; and there’s not even a definitive consensus on what, exactly, biopharma companies should focus on while developing Alzheimer’s medicines.

A major new proposal from top Alzheimer’s groups may, at least in part, help shift this landscape. The Alzheimer’s Association and the National Institute on Aging released the proposed research framework on Tuesday—and it aims to focus more on prevention rather than treating people once they’re already grappling with Alzheimer’s devastating effects.

Here’s how the groups put it in their official release on the guidelines, dubbed the NIA-AA Research Framework: Towards a Biological Definition of Alzheimer’s Disease: “This evolution of the previous diagnostic criteria is in line with most chronic diseases that are defined biologically, with clinical symptoms being a… consequence… The goal of much of medicine is to identify and treat diseases prior to overt symptoms. The [NIA-AA Research] Framework is intended to provide a path forward to… prevention trials of Alzheimer’s disease among persons who are clinically asymptomatic.”

In plainer terms, the researchers are arguing for a preventive approach that’s based on changes in internal biology rather than the behavioral and physical symptoms which plague Alzheimer’s patients and are visible to the non-clinical world, including friends and family members. As the Alzheimer’s Association notes, until recently, “clinical trials were conducted where up to 30% of participants did not have the Alzheimer’s disease-related brain change targeted by the experimental drug.”

So what does that mean for drug makers, practically speaking, if this framework is officially adopted? For one, it would give them three specific biological markers to home in on: The buildup of beta amyloid and tau proteins, which cause brain plaques associated with Alzheimer’s, and brain nerve cell death. Picking up on these potentially tell-tale signs early on may help biopharma firms recruit a wider swath of patients at risk for developing the downstream symptoms of Alzheimer’s and create more treatments that help prevent that kind of progression—or at least that’s what the hope is.

The new Alzheimer’s framework may not be much of a surprise given numerous, high-profile late-stage clinical trial failures in the field by companies like Eli Lilly and Merck, and the decision by other companies (such as Pfizer) to back away from the risk prone field.

Read on for the day’s news.

Sy Mukherjee

@the_sy_guy

sayak.mukherjee@fortune.com

DIGITAL HEALTH

Are at-home DNA kits comparable to pregnancy tests? Consumer genetic testing star 23andMe's CEO, Anne Wojcicki, has some provocative thoughts on what she thinks about at-home DNA test kits' place in society after the company's recent, landmark Food and Drug Administration (FDA) authorization to market, without a prescription, at-home genetic tests for a number of BRCA gene variants associated with cancer: "I was disappointed to see that some of the initial reaction to this FDA authorization had a similar tone as the early reaction to at-home pregnancy tests. Some critics believe that people can’t handle this kind of information on their own, and that learning about a genetic cancer risk should be conveyed only by medical professionals," Wojcicki wrote in an op-ed for STAT News. "I disagree." Wojcicki has been a consistent and vocal advocate for consumer genetic testing, which she believes empowers patients and defies the conventional wisdom that genetic counselors and the official medical system should serve as bottle necks for consumers' access to their own health data; but her comparison of DNA tests to pregnancy tests drew some strong rebukes from critics who feel it's an apples-and-oranges juxtaposition. (STAT News)

INDICATIONS

Bayer contraceptive gets a "unique" FDA restriction. The FDA is restricting sales of Bayer's Essure birth control implant in a "unique" move by the regulatory agency following thousands of reports (and lawsuits) over the years by women claiming injury caused by the device. On Monday, the FDA said it had received nearly 27,000 reports of adverse events associated with Essure since the device was approved in 2002; under the agency's new order, Bayer would have to restrict sales to medical providers that detail these potential risks to women in full. (New York Times)

THE BIG PICTURE

UnitedHealth's mighty reach. Bloomberg has an illuminating piece up on UnitedHealth Group, the medical giant that's dominating, not just the health insurance business as America's largest private insurer, but also fields like pharmacy benefit management and running huge doctors' groups. UnitedHealth's Optum unit already controls about 30,000 physicians across the country—and could soon control thousands more following the close of UNH's acquisition of DaVita Medical Group, writes Bloomberg. (Bloomberg)