Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.
Psychedelic Therapy Probe Expands
After rejecting Lykos Therapeutics’ psychedelic therapy for post-traumatic stress disorder (PTSD) earlier this month, the FDA is deepening its investigation into key trials, according to the Wall Street Journal.
According to sources familiar with the matter, the FDA’s Office of Regulatory Affairs has spoken with four people who have knowledge of the trial.
One of those people was Nese Devenot, PhD, a writing professor at Johns Hopkins University and a board member of Psymposia, a nonprofit critical of Lykos. Another was a person treated by Lykos therapists, WSJ reported.
One of the sources “shared information on the conduct of the trials, including the suicidal thinking of a study subject that didn’t get reported,” the article stated. A source also spoke with FDA’s Biomedical Research Monitoring Program.
Lykos said it was cooperating with investigators, and the FDA told WSJ it couldn’t comment on ongoing investigations.
Why Therapists Leave Networks
Not enough therapists take insurance, but it’s not for lack of trying. More than 500 therapists, psychiatrists, and psychologists who spoke with ProPublica detailed myriad factors that led them out-of-network.
These providers explained how insurers interfered in patient care and created a dysfunctional system full of red tape. In the end, providers who often have hefty loans from their advanced degrees simply couldn’t afford to stay in-network, the outlet reported.
Industry insiders told ProPublica that mental health patients “whose disorders can be chronic and costly, are bad for business,” the article stated.
Of the interviewees, 44 left the network after insurers questioned the necessity of patient care — even in instances when patients were on the brink of suicide. More than a hundred left after being tangled in red tape and facing low reimbursement rates. Another 60 cited delayed payments as the reason they left.
“The interviews underscore how the nation’s insurers — quietly, and with minimal pushback from lawmakers and regulators — have assumed an outsize role in mental health care,” the article stated.
The piece details dozens of stories from providers about reaching their breaking point in the web of dysfunction.
Pandemic Program Fizzling Out
A government program focused on antiviral development will be dismantled before it fully begins, leading to very little return on investment of taxpayer dollars, a STAT investigation revealed.
Back in June 2021, the Biden administration announced the Antiviral Program for Pandemics (APP), a $3.2 billion program to develop new COVID drugs and infrastructure to make it so the U.S. won’t be caught unprepared for future pandemics. As a whole, the field of antiviral research is underfunded and often neglected until an outbreak stirs panic and frenzy, the article stated.
But just 5 months after APP was announced, the White House diverted some of the APP funds to tackle the newly emerged Omicron variant.
Still, the NIH created 9 antiviral drug discovery centers (AViDDs) with APP money. Funding for all of these centers is set to run out on April 30 of next year — and the research and drug development is still in its early stages, meaning projects will have to wind down and staff will have to be laid off before any real progress is made.
“Instead of a medicine cabinet of new compounds, capable of being deployed against any viral threat, the Biden administration’s grand plan may lead to only a few papers and a small handful of interesting molecules,” the article stated.
STAT also detailed how the ramp-up to distributing APP funding was slow and the limited timeline of funding was barely enough to scratch the surface of new antiviral research.
“The taxpayers will have spent $577 million on essentially nothing, which is heartbreaking, to say the least,” computational chemist John Chodera, PhD, of Memorial Sloan Kettering Cancer Center in New York City, told STAT.
