Jun 11, 2019

The rise of unproven billion-dollar health care industries

Caitlin Owens, author of Vitals

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, NY Times 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 two 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.

Go deeper: FDA plans to discuss legally marketing CBD products

Go deeper

Updated 27 mins ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 8 a.m. ET: 6,294,222 — Total deaths: 376,077 — Total recoveries — 2,711,241Map.
  2. U.S.: Total confirmed cases as of 8 a.m. ET: 1,811,277 — Total deaths: 105,147 — Total recoveries: 458,231 — Total tested: 17,340,682Map.
  3. Public health: Nearly 26,000 coronavirus deaths in nursing homes have been reported to federal health officials —Coronavirus looms over George Floyd protests across the country.
  4. Federal government: Trump lashes out at governors, calls for National Guard to "dominate" streets.
  5. World: Former FDA commissioner says "this is not the time" to cut ties with WHO.
  6. 🎧 Podcast: The virus didn't go away.

More than 1 in 6 black workers lost jobs between February and April

Adapted from EPI analysis of Bureau of Labor Statistics data; Chart: Andrew Witherspoon/Axios

As is often the case, the staggering job losses in the coronavirus-driven recession have been worse for black workers.

By the numbers: According to a report from the Economic Policy Institute, titled "Racism and economic inequality have predisposed black workers to be most hurt by coronavirus pandemic," more than 1 in 6 black workers lost their jobs between February and April.

Coronavirus could lower GDP by $15.7 trillion

Reproduced from Congressional Budget Office; Chart: Axios Visuals

The CBO released projections on Monday for U.S. nominal GDP to be lower by $15.7 trillion over the next decade than its estimate in January as a result of the coronavirus pandemic.

What they're saying: It predicts that when adjusted for inflation GDP will be $7.9 trillion lower over the next decade and down by $790 billion in the second quarter of this year — a 37.7% quarterly contraction.