麻豆传媒

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

Steward CEO Made $250M

While Steward Health Care System was losing hundreds of millions of dollars a year, the company paid chief executive officer Ralph de la Torre, MD, at least $250 million over 4 years, according to a .

In May, Steward became the largest health system to fail in decades after filing for bankruptcy. While the financial health of the company waned, the conditions its hospitals were even more dire, according to the WSJ.

As those conditions worsened, de la Torre came under scrutiny from officials over his reportedly lavish lifestyle. Officials noted that he owned two large boats, including a $40 million, 190-foot yacht, and a $15 million, 90-foot sport-fishing boat. He reportedly also owns a $7.2 million, 500-acre ranch in Waxahachie, Texas.

A Senate committee has launched an investigation into de la Torre and subpoenaed him to testify before the committee next month. Massachusetts Gov. Maura Healey (D) also called for de la Torre to be federally investigated after Steward announced it would close two hospitals in the state. The announcement came while de la Torre was attending "Paris Olympics equestrian events at the Palace of Versailles," according to the WSJ.

Healey said de la Torre "basically stole millions out of Steward on the backs of workers and patients and bought himself fancy yachts, mansions, and now apparently lavish trips to Versailles."

WSJ reported that de la Torre declined to be interviewed and, in a statement, claimed the value of his assets had been inflated by the Senate committee. A spokeswoman for de la Torre also told the WSJ that "he was regrettably on a family vacation that was planned and paid for last year" when the company announced the hospital closures.

FDA Device Chief's Conflicts

The FDA's top official for regulating medical devices reportedly oversaw products from companies that his wife represented as a lawyer, according to .

Allison W. Shuren worked for the Washington D.C.-based law firm Arnold & Porter and represented several medical device makers during her husband's tenure, according to the investigation.

Jeff Shuren, MD, JD, that he's stepping down as director of the agency's Center for Devices and Radiological Health after 15 years. He reportedly signed an ethics agreement barring him from involvement in matters involving Arnold & Porter, but the law firm refused to publish a client list, making it difficult for the FDA to enforce that agreement, the Times reported.

In one example, Shuren reportedly did not recuse himself from decisions around an FDA inspection of the discredited blood testing company Theranos, which was represented at the time by his wife's law firm.

Shuren also reportedly did not initially push Allergan to recall its breast implants, which were tied to a rare cancer, while his wife's firm was working on a $63 billion acquisition of the company in 2019.

In response to these alleged conflicts, an FDA spokeswoman acknowledged there were some cases where Shuren "should have either recused himself or sought ethics authorization to participate to avoid any potential appearance of bias." The agency also said that Shuren never requested or received any waiver to participate in any matters related to his wife's employment.

Nonetheless, the spokeswoman said there was no indication that any regulatory decisions were impacted by Shuren's wife's employment.

Psychedelic Founder 'Unleashed'

Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies (MAPS) and recently departed member of Lykos Therapeutics' board, blasted the FDA's rejection of midomafetamine (MDMA) in an interview with .

Doblin -- who said he was "unleashed" after stepping away from the board -- said Lykos was "completely surprised" that the agency asked for an additional trial and accused the agency of "changing the goal posts."

"When you spend years and millions of dollars on research, and you've agreed on a trial design with a special protocol assessment, the FDA needs to be trusted that it'll stick by these agreements," Doblin told STAT.

He also criticized the advisory committee, which voted overwhelmingly against approval in June. He said committee members were "mostly out of their depth," lacked specific expertise, and were "more swayed by the media than their briefing packages."

Ultimately, Doblin said he thinks FDA "is not really responding to the science, or upholding its agreements."

He added that the Lykos and MAPS teams have "never been so vilified, demonized, downtrodden, rejected, retracted."

Since the decision, Lykos announced it would cut 75% of its staff, while MAPS announced it would cut 33% of its staff and redirect its resources toward decriminalization efforts and increasing global access to MDMA.

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