鶹ý

'Shambolic' Medical Meeting; DaVita Whistleblower Suit; FDA Mum on MDMA

— This past week in healthcare investigations

MedpageToday
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.

A 'Shambolic' Medical Conference

A Nature reporter went , an experience described in the investigation as "shambolic."

The reporter attended the "25th Global Nephrology, Urology and Kidney Failure Congress" alongside a postdoctoral researcher in molecular biology. It was supposed to be at a four-star hotel near London's Heathrow airport, but there was no conference signage.

Eventually, they found a "flustered" young organizer who said the nephrology congress was being held in conjunction with other events. The first two talks were about ophthalmology, and subsequent talks covered drug toxicity, dentistry, and antibiotics, Nature reported.

The event was supposed to run until 5:30 p.m., but it wrapped at 12:30 p.m., according to the investigation. "People who were supposed to give poster presentations -- including one who had shepherded hers on two flights -- left with their posters still wrapped," the article stated.

Nature reached out to conference organizer OMICS International, but didn't hear back.

Predatory conferences, which are similar to predatory journals, often draw attendees and speakers by promising to publish research or fulfill academic requirements for a fee, Nature reported. They often involve "weak or no peer review for presentations, poor organization, and a focus on making the organizers money."

Experts suspect the number of predatory conferences is growing, and that they operate on a spectrum, from outright deceit and fraud -- when organizers collect registration fees for a conference that never takes place -- to those that run but with questionable quality, Nature reported.

One organization, the InterAcademy Partnership, said predatory conferences are particularly rife in medicine and dentistry.

DaVita Settles Another Whistleblower Suit

DaVita will pay more than $34 million to settle claims that it paid kickbacks to doctors in exchange for referrals to its dialysis clinics, according to .

Federal prosecutors alleged that DaVita provided management services to vascular access centers owned by doctors who could refer patients to DaVita, and paid "improper remuneration" to a large nephrology practice to induce referrals to its clinics.

DaVita was also accused of paying kickbacks to induce referrals to DaVita Rx, a former subsidiary that provided pharmacy services to dialysis patients.

The lawsuit was originally brought by a whistleblower, Dennis Kogod, the former chief operating officer of DaVita Kidney Care.

According to (CPR), DaVita has paid roughly $1 billion in whistleblower settlements since 2012, which included a $350 million settlement over alleged physician kickbacks, and a $450 million settlement for allegedly billing federal insurers for dialysis drugs it threw away.

DaVita hasn't admitted wrongdoing in any of the cases, CPR reported.

FDA Hasn't Spoken to MDMA Trial Participants

Despite voicing concerns about Lykos Therapeutics' MDMA clinical trials, the FDA had not spoken with patients or others who have alleged misconduct and data suppression during the trials, according to .

from the Institute for Clinical and Economic Review (ICER) alleged that the company did not properly report adverse events during its two phase III trials, and discouraged volunteers from participating in a follow-up study. The agency is scheduled to decide whether MDMA will be approved for treating post-traumatic stress disorder (PTSD) by August 11, but David Rind, chief medical officer for ICER, told STAT he hasn't yet heard from FDA.

Several clinical trial experts told STAT that in order to properly investigate these concerns, the agency would need to speak with trial participants directly. Some of those participants reportedly experienced extreme distress, including suicidal ideation, during the trial.

STAT said the agency has not responded to questions about whether it has reached out to any of these groups for its investigation, but a spokesperson said the agency can't discuss investigations until they're completed.

Lykos claims the allegations are false.

  • author['full_name']

    Michael DePeau-Wilson is a reporter on 鶹ý’s enterprise & investigative team. He covers psychiatry, long covid, and infectious diseases, among other relevant U.S. clinical news.