Axios Vitals

A briefcase with a red cross on the front.

June 11, 2019

Good morning. Today's word count is 875 words, <4 minutes.

1 big thing: The rise of unproven billion-dollar industries

Former FDA Commissioner Scott Gottlieb

Former FDA commissioner Scott Gottlieb. Photo: Astrid Riecken For The Washington Post via Getty Images

The FDA has its work cut out for it as it tries to rein in unregulated and unproven industries that are racking up public attention and billion-dollar profits.

Why it matters: "I think the FDA is taking on industries where there is a potent political constituency trying to resist regulation. And that's hard," former FDA commissioner Scott Gottlieb said.

Driving the news: A judge sided with the FDA earlier this month, in a ruling that will stop stem-cell treatments at a Florida clinic, NYT reports.

  • The clinic injected patients with extract made from their own stomach fat, claiming it contained stem cells that could treat a range of illnesses. Some patients went blind after the fat extracts were injected into their eyes.
  • The ruling may influence similar cases, but many other stem cell clinics may continue operating, hoping the FDA doesn't broaden its crackdown. The agency can't go after every clinic, so instead it goes after the most risky actors.
  • One recent study found more than 700 stem cell clinics in the U.S., but the author called that a substantial undercount.

The agency is also just beginning to wade into the discussion around CBD, which is being marketed as a therapy for a huge number of ailments.

  • "It's a remarkable phenomenon going on now with this particular chemical ... being presented as pretty much magic — as curing everything. It's commercially driven with massive amounts of money promoting this," said Robert DuPont, president of the Institute For Behavior and Health.

Yes, but: The risks of these 2 unproven areas aren't comparable.

  • Stem cell clinics have badly harmed their customers.
  • CBD regulation is more comparable to dietary supplements — looking out for unproven claims or companies that aren't safely manufacturing products, former FDA commissioner Mark McClellan said.

2. Speaking of unregulated services...

Religious organizations in which members pay each other's medical bills are increasing in both membership and controversy, WSJ reports.

  • More consumers are complaining about about bills that weren't paid or were paid late, and states are upping their scrutiny of the cost-sharing groups.

How it works: Members pay a set amount to the organization or to those with medical bills, and they also submit their own medical bills to be paid.

  • But these sharing ministries aren't regulated by state insurance commissioners and aren't required by law to pay members' bills. They also don't have coverage requirements.
  • More than 1 million people have joined the groups, a surge that followed the passage of the Affordable Care Act. The ACA exempted members of such groups from the law's individual mandate.

The ministries say that the increase in complaints tracks with the increase in membership, and that they tell members ahead of time that they're not buying insurance. They also have an appeals process for denied claims.

3. Opioid tracking group's Big Pharma ties

A truck with a Purdue logo

Photo: Drew Angerer/Getty Images

A small yet influential group called Researched Abuse, Diversion and Addiction-Related Surveillance, or RADARS, monitors how opioids are misused across the nation. It also accepts money from the companies that make those opioids, Axios' Bob Herman reports.

How it works: RADARS tracks opioid misuse and abuse by collecting phone call information from poison control centers and patient survey data from addiction treatment programs.

Details: Purdue Pharma, the maker of OxyContin, founded RADARS in 2001 after concerns of prescription painkiller addictions started to rise.

  • But having an opioid company track misuse of its own products gave the perception that the fox was guarding the hen house, so Purdue sold RADARS to Denver Health, a publicly owned hospital system in Colorado that also houses a poison and drug center.

RADARS still has close connections to the pharmaceutical industry.

  • RADARS and its affiliated poison center brought in more than $25 million of revenue last year for Denver Health — most of which is subscription fees, from opioid manufacturers and others, to get access to its data.
  • Researchers paid by RADARS have written articles that line up with industry views.
  • Richard Dart, the head of RADARS, received more than $112,000 from Purdue Pharma in 2014 for his consulting work on the company's opioids, and he has received tens of thousands from other opioid manufacturers.

What they're saying: Dart referred all questions to lawyers at Denver Health. A Denver Health spokesperson submitted written responses, which acknowledged the system had contracts with Purdue and other manufacturers, but did not respond to follow-up questions.

4. An important FDA opioids powwow begins

The FDA today starts its 2-day meeting to hash out whether it should limit or even remove high-dose opioids from the market, Bob reports.

The big picture: The Centers for Disease Control and Prevention says "higher dosages of opioids are associated with higher risk of overdose and death," and people really shouldn't take painkillers that exceed a certain limit.

  •  Some opioids, like the OxyContin 80 mg tablet, vastly exceed the CDC's suggested limit with just 1 pill.

Yes, but: Patients battling chronic pain are worried they will be worse off if they have taper to lower doses.

Guess who’s presenting: RADARS, which has advocated against restricting prescriptions of high-dose painkillers. Ted Cicero, a paid researcher for RADARS, will talk about "understanding opioid trajectories."

Watch the FDA's webcast.

5. The search for $1 million, and a miracle

Two-year-old Maxwell Freed has a rare genetic disease, and his mother is trying to raise $1 million to fund research for a cure, HuffPost reports.

  • Only about 50 people in the world are known to have the same condition, meaning drug companies aren't spending much to research a cure.
  • While Maxwell's parents are raising money for research, they hope that a biotech company will then fund drug development after they reach their goal.

The bottom line: "[W]hile Maxwell's disease is far from common, the Freed family is facing the same problem as everyone who gets sick in the United States: Health care is very expensive, and we’re all on our own to figure out how to navigate [the] labyrinthian health care system and afford care," HuffPost's Jeffrey Young writes.