May 8, 2019

The unproven, unregulated, $2 billion stem cell industry

Illustration: Rebecca Zisser/Axios

The stem cell industry is booming in the U.S., and while some legitimate medical uses have been discovered, there's also a thriving shadow industry offering poorly understood products without much regulation, ProPublica and the New Yorker report.

The big picture: The number of specialized clinics offering unproven stem cell treatments has grown from 12 in 2009 to more than 700 in 2017, according to one tally.

  • Globally, unproven cellular therapies are a $2 billion enterprise, according to a recent study.

Why it matters: Patients are paying thousands of dollars for care that is unproven and largely unregulated.

  • Sometimes, that's just a waste of money. But in some cases, patients who have turned to these clinics for help have walked away harmed.

One trend is doctors touting the (unproven) healing power of amniotic stem cells, which don't have to be harvested from a patient's own body.

  • Instead, they're conveniently obtained via donation after women give birth.
  • An amniotic stem cell injection into a joint can cost between $5,000 and $10,000. Intravenous administration may cost more than $10,000 per session.
  • There's not much data or research on these treatments, because they don't undergo the clinical trials required for approval from the Food and Drug Administration.

The bottom line: The investigation "found disgraced doctors who were recast as salespeople, manufacturers that cloaked themselves in pseudoscience and had few scientists on staff, and clinics that offer to treat conditions like multiple sclerosis or kidney disease without specialized training," ProPublica’s Caroline Chen writes.

  • "Unscientific methods, deceptive marketing, price gouging and disregard for patients' well-being were rampant across the amniotic stem cell therapy industry."

Go deeper: Unregulated stem cell therapies listed on government database

Go deeper

Mark Cuban opens door to 2020 run

Photo: Axios Events

Businessman and Dallas Mavericks owner Mark Cuban revived talk of an improbable 2020 presidential bid during an Axios virtual event on Friday.

  • "Everything's a reset right now," Cuban told Axios CEO Jim VandeHei. "If this would would've been a month ago, I would have said absolutely not. But obviously things are crazy, things are changing. So I'll keep an open mind. But I seriously doubt it."

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 2 p.m. ET: 1,066,706 — Total deaths: 56,767 — Total recoveries: 223,697Map.
  2. U.S.: Total confirmed cases as of 2 p.m. ET: 258,214 — Total deaths: 6,605 — Total recoveries: 9,408Map.
  3. Business latest: Mark Cuban criticizes "arrogant" 3M on respirator production — The wartime mobilization effort to produce ventilators and medical supplies got started too late.
  4. Politics latest: Lawmakers on both sides of the aisle are worried about the difficulties of delivering the $2.2 trillion in stimulus aid.
  5. Jobs update: The U.S. lost 701,000 jobs in March, but the new report doesn't reflect the height of the virus' impact on the economy.
  6. World update: About half of the deaths worldwide are in Italy and Spain, with fatalities exponentially increasing across Europe.
  7. What should I do? Answers about the virus from Axios expertsWhat to know about social distancingQ&A: Minimizing your coronavirus risk.
  8. Other resources: CDC on how to avoid the virus, what to do if you get it.

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Mark Cuban criticizes "arrogant" 3M on respirator production

Photo: Axios Events

Businessman and Dallas Mavericks owner Mark Cuban said during an Axios virtual event Friday that 3M is "arrogant" for not speaking up about respirator production in the midst of the coronavirus outbreak.

What he said: Cuban criticized the company for "making more globally than domestically," echoing a similar line from President Trump now that the U.S. is the epicenter of the pandemic. "You can't ghost the American people," he told Axios CEO Jim VandeHei from Dallas.