NIH in Chaos; Docs for Oz; Activist Group ‘Helped Torpedo’ Psychedelic Company

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

NIH in Chaos

Amid the second Trump administration, the NIH is in turmoil, NPR reported.

To date, there has been a blackout on communications, banned travel, and cancelled meetings for decisions on important research, generating confusion and fear among scientists and doctors at the NIH and at the institutions dependent on the agency’s funding, NPR reported.

“It’s a huge deal,” Haley Chatelaine, PhD, a postdoctoral fellow studying basic cellular functions at the NIH who helps bargain for the union representing 5,000 fellows there, told NPR. (She was one of just a few NIH employees willing to speak on the record with NPR, the outlet noted.)

“Science moves at breakneck speeds. And requires that all of us in the scientific community work together,” Chatelaine told NPR. “Any gap that we experience sets us back in terms of being able to conduct the cutting edge biomedical research that Americans need to stay healthy.”

Those outside the agency also are paying close attention.

“I have grave concerns,” said Keith Yamamoto, PhD, special adviser to the chancellor for science policy and strategy at the University of California San Francisco, chair of the Coalition for Life Sciences, which advocates for U.S. health agencies. “People are dismayed about the chaos and confusion being sown and don’t really know what to do.”

However, others said the long-term impact could be modest if current prohibitions affecting the NIH are temporary.

“If this all lasts a few more days or a couple of weeks and then gets lifted with some potential reforms then we can evaluate those reforms on their merit and that’s fine,” Ashish Jha, MD, MPH, dean of Brown University School of Public Health, told NPR. “But, boy, at the moment it’s really disruptive and harmful.”

Doctors Among Oz’s Supporters

After leading an operating room and then a television show, Mehmet Oz, MD, MBA, is set to take over CMS — “hardly the standard backdrop for someone now poised to lead a $1.5 trillion federal agency that oversees crucial health care programs for older adults, low-income Americans, and people with disabilities,” STAT reported.

Yet for “all the people who dismiss him as a ‘quack grifter’ and a ‘health care huckster,'” Oz “has a surprisingly large, albeit less vocal, contingent of loyal supporters,” the article stated.

Many of these supporters are heart surgeons Oz trained or worked with at Columbia University, according to STAT. They remember him as a generous mentor and accomplished surgeon. Meanwhile, others who worked with Oz on TV describe him as unusually approachable and fun.

Still, Oz’s financial ties to products he promotes, such as a supplement company and an insurance agency selling private Medicare plans, have become more blatant in recent years, STAT reported. This has garnered criticism from some, though is not disqualifying for a role in the Trump administration, the outlet noted.

Though some consumer advocacy groups have called Oz unqualified and “criticized his promotion of products that don’t work, and characterized his support for privatized Medicare as ‘dangerous,'” STAT reported that, “[a]ssuming no unforeseen scandals, Oz’s Senate confirmation is generally viewed on Capitol Hill as all but assured.”

Former colleagues (doctors and TV producers) the outlet interviewed were unanimous in their support for Oz as CMS administrator, though “may be a self-selecting group, as anyone who does not support a Trump nominee is less likely to respond to a reporter’s inquiry on the subject,” STAT wrote. “They said that not only is Oz a hard worker and fast learner, he surrounds himself with smart people and actually listens to them.”

Oz himself declined STAT’s request for comment through a spokesperson.

Leftist Activist Group ‘Helped Torpedo’ Psychedelic Company

After decades of planning and a $250 million investment, Lykos Therapeutics’ application for an inaugural psychedelic drug was “expected to be a shoo-in,” the New York Times reported.

The company had submitted data to the FDA that its treatment for post-traumatic stress disorder — MDMA plus talk therapy — was significantly more effective than existing treatments, the Times noted. But then came accusations that the company was “a therapy cult,” that its clinical trial practitioners had engaged in abuse of participants, and that it had concealed adverse events.

Seven individuals who spoke at an important public hearing last summer “presented themselves as experts in the field of psychedelics, but none had expertise in medicine or therapy,” the Times reported. Nor had they disclosed their connection to Psymposia — a “leftist advocacy group whose members oppose the commercialization of psychedelics,” the article stated.

Psymposia had been campaigning against Lykos and parent organization the Multidisciplinary Association for Psychedelic Studies, according to the Times.

The FDA rejected Lykos’ application 2 months after that meeting, though the agency did not mention any allegations of misconduct or abuse in doing so, the Times reported. A spokesperson for the agency declined to comment, noting that it does not discuss pending applications.

Ultimately, the “significance of Psymposia’s role in torpedoing Lykos’s bid is unclear,” the Times wrote. But some experts told the outlet that Psymposia’s “incendiary allegations made approval that much harder.”

Neşe Devenot, PhD, a writing instructor at Johns Hopkins University and Psymposia’s most high-profile member, said in an interview that the group was focused on “making things safer” for people who use psychedelics and highlighting abuses in the field others have been unwilling to address, according to the Times.

Recently, Lykos met with FDA officials to discuss a path forward, with executives saying this would most likely include an independent review of its data and another clinical trial that could add years as well as millions of dollars to the process, the Times reported.

  • author['full_name']

    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.

Please enable JavaScript to view the

comments powered by Disqus.