Gender Clinic's Political Storm; Nursing Pillow Deaths; Drug Price Cut Concerns

— This past week in healthcare investigations

INVESTIGATIVE ROUNDUP over an image of two people looking at computer screens.

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Small Gender Clinic at 'Center of Political Storm'

A small Missouri gender clinic inside a children's hospital affiliated with Washington University in St. Louis has found itself at "the center of a political storm," the New York Times reported.

The clinic opened in 2017. And earlier this year, Jamie Reed, a former case manager, "went public with explosive allegations," also claiming in a whistle-blower complaint that doctors there had "hastily prescribed hormones with lasting effects to adolescents with pressing psychiatric problems," the Times wrote.

However, "The reality was more complex than what was portrayed by either side of the political battle," the Times wrote, citing interviews with dozens of patients, parents, former employees and local health providers, as well as more than 300 pages of documents shared by Reed.

For instance, many patients of the clinic -- and their parents -- told the Times that the clinic provided essential care, with some even saying, "they were lifted out of grave depression."

At the same time, as demand grew, more patients arrived at the clinic with complex mental health issues, the Times reported. And the clinic turned to external therapists, including some with little experience in gender issues.

Doctors prescribed hormones to patients who obtained approvals, including adolescents whose medical histories "raised red flags," the Times wrote. "Some of these patients later stopped identifying as transgender, and received little to no support from the clinic after doing so."

At the state level in Missouri, civil rights groups are now challenging a ban on gender treatments for minors, the Times noted. Reed has testified in favor of the ban.

As for Washington University, an investigation by the school claimed that none of the clinic's nearly 600 patients on hormonal medications reported "adverse physical reactions," the Times reported. And, in a statement provided to the Times, Washington University said that it would not address specific allegations due to patient privacy, and that, "physicians and staff have treated patients according to the existing standard of care."

All the while, "doctors in St. Louis and elsewhere are wrestling with evolving standards and uncertain scientific evidence -- all while facing intense political pressure and an adolescent mental health crisis," the Times wrote.

Safety Requirements for Nursing Pillows After Infant Deaths

Consumer Product Safety Commission (CPSC) staff recommended the first federal requirements to make nursing pillows safer, citing dozens of infant deaths associated with the product, NBC News reported.

"Because infants frequently fall asleep during or after feeding, nursing pillows are foreseeably misused for infant sleep, which creates a potential hazard for the infant," the draft proposal stated, in part.

The recommendations closely follow an NBC News investigation that found, since 2007, at least 162 infants have died in incidents involving nursing pillows, the outlet reported.

"Most of the infants died after they were placed to sleep on or with the pillows," NBC News wrote.

In 2020, the most recent year for which the CPSC had complete data, there were 38 deaths associated with nursing pillows, NBC News reported, citing the commission.

Commissioners are slated to decide whether to adopt the recommendations next month, NBC News reported. And the public would have the opportunity to provide feedback before the proposal is finalized.

However, the proposal is "likely to face opposition from an industry that has defended the safety of its products, arguing that nursing pillows pose no risk when they are used as intended: while babies are awake and supervised," NBC News wrote. Manufacturers have instead advocated for voluntary safety standards that are currently under development.

Drug Price Scrutiny Worries Rare Disease Patients

For people with cystic fibrosis, including Sabrina Walker, a 37-year-old mother from Erie, Colorado, taking a drug called Trikafta "has been a life-changer," KFF Health News reported.

These days, Walker "runs and hikes in the thin Colorado air and works a full-time job," KFF Health News wrote. "Other patients have seen similar gains with the drug therapy, allowing many to resume regular lives and even take themselves off waiting lists for a lung transplant."

However, Walker and many other Colorado patients with cystic fibrosis are concerned they could lose access to the medication, KFF Health News reported.

A state board working to address the affordability of high-priced prescription drugs has selected Trikafta as one of the first for review, KFF Health News reported. And the board could move to slash the medication's average in-state annual price of roughly $200,000, accounting for insurers' contributions and patients' out-of-pocket costs.

As a result, drug makers like Vertex Pharmaceuticals, the company behind Trikafta, have said that such payment limits "could hurt innovation and limit access, stoking panic among patients that the drug might no longer be sold in Colorado," KFF Health News wrote.

Ultimately, "State officials contend that the high cost of prescription drugs puts them out of reach for some patients, while patients worry that they'll lose access to a life-changing therapy and that fewer dollars will be available to develop breakthrough medications," KFF Health News wrote. "And with affordability boards in other states poised to undergo similar exercises, what happens in Colorado could have implications nationwide."

"It just puts Trikafta as a whole at risk," Walker told KFF Health News. "It would start here, but it could create a ripple effect."

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    Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.