Brainstorm Health: Athersys Stem Cell Treatment, Alexa in Medicine, Oklahoma Opioid Suit

The world of stem cell-based medicine has had its fair share of disappointments and regulatory recriminations over wildly inflated claims. But Athersys CEO Gil Van Bokkelen says the stem cell field isn’t getting a fair shake.

“It’s a misconception to say stem cells haven’t really delivered,” he tells Fortune in an interview. “This is a very hot field right now, and things have really changed.”

Van Bokkelen points to his own company’s recent achievements, including a number of cell therapies in mid- or late-stage clinical trials. Just two weeks ago, Athersys’ experimental MultiStem treatment received the Food and Drug Administration’s (FDA) coveted fast track designation in a devastating lung-wasting disease called acute respiratory distress syndrome (ARDS). These designations speed the regulatory process and is typically granted for products that treat disorders with a dearth of available treatments.

And devastating ARDS surely is. It’s a consequence of trauma to the lungs in patients who are typically already in the hospital for some kind of severe injury or illness, and it results in fluid leaking in to the lungs, making the very act of breathing even more difficult (or impossible) in patients who are already extremely sick, according to the American Lung Association.

Athersys’ studies of MultiStem found that patients who received the treatment “within several days after being diagnosed with ARDS and being placed on a ventilator experienced lower mortality, increased ventilator-free days, and increased ICU-free days” compared to a placebo group. Those preliminary results led to the FDA fast track.

What makes the MultiStem platform intriguing is, well, what puts the “Multi” in the name. Van Bokkelen says that Athersys is trying to avoid the main problem many stem cell upstarts face: Scaleability and multi-faceted uses. Rather than requiring an individual, perfect donor match, Athersys is attempting to create a product that’s an “off-the-shelf” version of regenerative stem cell treatment that can help repair tissue.

“The drug isn’t just doing one thing, it’s doing a bunch of different things,” says Van Bokkelen. For instance, it’s being tested out in late-stage trials for ischemic stroke patients (yet another program with FDA fast track designation). “Market opportunity is way bigger in this space than pretty much any other one,” he adds.

We should find out soon enough whether Athersys can succeed where so many others have failed.

Read on for the day’s news.

DIGITAL HEALTH

Alexa is getting into medicine. But is that a good thing? Guest contributor and health reporting vet Elisabeth Rosenthal has a piece up for Fortune detailing the ways in which Alexa's new foray into medicine - and the very field of virtual medicine itself - could present its own host of problems. "But when I returned from [Fortune's] Brainstorm Health [conference], I was confronted by an alternate reality of virtual medicine: a $235 medical bill for a telehealth visit that resulted from one of my kids calling a longtime doctor’s office," she writes. "It was for a five minute phone call answering a question about a possible infection." Elisabeth's thoughts on this issue are worth mulling over. (Fortune)

INDICATIONS

Oklahoma's opioid lawsuit is underway. A seminal, and potentially historic, trial against opioid makers is officially underway in Oklahoma. Unlike federal district lawsuits against companies like Purdue Pharma and other opioid painkiller manufacturers, Oklahoma's state suit is levied against Johnson & Johnson's pharmaceutical unit Janssen. And the state is pursuing damages for communities it says have been decimated by aggressive marketing of the addictive products. (Politico)

THE BIG PICTURE

Supreme Court upholds certain parts of controversial Indiana abortion law. The Supreme Court on Tuesday left certain portions of a controversial Indiana abortion law (signed by then-Governor and now-Vice President Mike Pence) in place while upholding a lower court's rejection of other measures. The Justices struck down a part of the law that would bar women from seeking abortions due to specific fetal characteristics such as sex or disability; however, abortion clinics will still have to bury or cremate fetal remains rather than dispose of them as medical waste, as most states do. (Fortune)

Why can't drug stores quit cigarettes? My colleague Phil Wahba asks a pretty good question: Why the heck has it been so hard for some drug stores to get out of the tobacco game? The answer, shockingly, appears to have something to do with money. "Cigarettes are a modest and declining business for U.S. drugstore chains—total sales of about $1.6 billion based on Euromonitor International data—but they’re a desperately needed source of foot traffic for Walgreens and Rite Aid," Phil writes. "Both chains have seen comparable non-pharmacy sales fall in the past four quarters." Go figure. (Fortune)

REQUIRED READING

Some Just Paid $1.3 Million for a Laptop Infested With Malware, by Chris Morris

Why the U.S. Should Embrace 'Green China Inc.', Not Fight It, by Jeffrey Ball

Keep Your A.I. Buzzwords Straight, by Jonathan Vanian

Chip Wars 2019, by Aaron Pressman