May 8, 2019

Axios Vitals

The stories about Purdue Pharma — maker of the opioid painkiller OxyContin — just keep on coming: "Abusers aren't victims; they are the victimizers," Richard Sackler, Purdue's former chief executive, wrote in a 2001 email, Bloomberg reports.

1 big thing: 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 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."
2. Insurers are thriving in the individual market
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Reproduced from Kaiser Family Foundation; Chart: Axios Visuals

Insurers on the individual market are expected to pay a record total of about $800 million in rebates to enrollees, a result of setting their premiums too high last year, according to a new Kaiser Family Foundation analysis.

  • Insurers raised premiums in 2018 by an average of 26% — a response to political uncertainty surrounding the Affordable Care Act.
  • But instead of market chaos, insurers saw their best financial performance yet under the ACA, as per-person claims rose by only 7%.
  • Utilization also remained steady in 2018, meaning healthy people didn't flee the marketplace.

The big picture: The analysis suggests that the ACA marketplaces are stable and profitable for insurers, even if individual market enrollees tend to be sicker than they were pre-ACA.

  • Despite all of the worrying about the Trump administration's policies, this is "not exactly a market that’s collapsing," Kaiser's Larry Levitt tweeted.
3. A $2 million drug is on its way

A new gene therapy made by Novartis is about to come to market with a potential price tag of $2 million, the Wall Street Journal reports.

  • The drug, Zolgensma, has the potential to cure spinal muscular atrophy, an inherited disease that often kills babies before their second birthday.
  • Between 400 and 500 babies are born each year in the U.S. with the disease.
  • The 12 babies treated in Zolgensma's first clinical trial have survived past their second birthday and are hitting key developmental milestones.

The imminent arrival of the drug is, unsurprisingly, creating new concerns about cost.

  • Drug companies, including Novartis, say that alternative payment models — like paying in installments or tying payment rates to value — could smooth out costs over time.

My thought bubble: The situation is emblematic of our future. With the development pipeline full of innovative drugs designed to treat or cure gut-wrenching diseases, the question of whether a baby's life is worth $2 million — and whether we as a society can afford that — is going to become a familiar one.

4. Most pregnancy-related deaths are preventable

Three out of 5 U.S. deaths from pregnancy-related complications are preventable, the CDC announced yesterday.

  • There are still stark racial disparities: Black and American Indian/Alaska Native women were 3 times more likely to die than white women.

Why it matters: Public health officials have been grappling with the knowledge that the U.S. continues to have one of the highest maternal death rates despite being one of the biggest economies in the world, my colleague Eileen Drage O'Reilly reports.

Details: 700 American women die every year from pregnancy-related deaths, according to the CDC.

  • Between 2011 and 2015, these included 31% during pregnancy, 36% during delivery or the week after delivery and 33% after that week and up to a year after birth.
  • Overall, heart disease and stroke led to more than one-third of the deaths.

Go deeper: "Every year, thousands of women suffer life-altering injuries or die during childbirth because hospitals and medical workers skip safety practices known to head off disaster," USA Today reported in March, in an investigation that is worthy of your time.

5. The rising cost of getting sick
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Data: Kaiser Family Foundation; Chart: Axios Visuals

It has always been expensive to get sick, but it's becoming an even worse problem in a way that hasn’t really gotten our attention, the Kaiser Family Foundation's Drew Altman writes in today’s column.

The big picture: A survey by the Kaiser Family Foundation and the Los Angeles Times shows that a strikingly large share of people with serious medical conditions are struggling to pay their medical bills, often wreaking havoc with their family budgets and causing them to cut back on care.

  • Six out of 10 people in this group report that they or a family member skipped or postponed medical care or prescription drugs they needed because of costs, or tried a home remedy instead.
  • High deductibles can make things worse: among those with chronic conditions whose deductibles are at least $3,000 for an individual or $5,000 for a family, three-quarters report skipping or postponing some type of care.

Read the column.

6. Online medicine site Hims' new hire

Hims, an online seller of prescription health care products for such conditions as erectile dysfunction, recently hired former Lyft executive Melissa Walters as its first chief marketing officer, Axios' Dan Primack reports.

Why it matters: This comes shortly after a well-traveled New York Times story about "restaurant-menu medicine" companies like Hims, which operate in something of a regulatory blank space — connecting patients with doctors who prescribe without conducting in-person exams.

  • Walters will be tasked with telling the story in a more positive light.

Hims founder and CEO Andrew Dudum told Axios that the NYT story "didn't really articulate anything we felt was out of clinical protocol and outside standards."

  • He also doesn't believe that the industry needs federal regulation, instead believing that state medical boards are doing an "incredible job."

Editor's note: The fourth story of Vitals yesterday was corrected to show that 47.4% of physicians work as employees of a hospital system or as employees of a practice owned by other physicians.