Dark Side of MDMA's Journey to FDA; Fake Studies Shutter Journals; H5N1 Turf Wars

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

Dark Underbelly of MDMA's Journey to FDA

For decades, Rick Doblin has been at the forefront of efforts to mainstream psychedelics, Business Insider reported.

When the federal government made MDMA -- also known as molly or ecstasy -- a Schedule 1 substance, the activist "sprung into action, founding a nonprofit called the Multidisciplinary Association for Psychedelic Studies [MAPS] in 1986," Business Insider noted.

"In 2014, MAPS launched a public benefit corporation to focus on legalization, and this February, that entity, recently renamed Lykos Therapeutics, announced that the Food and Drug Administration had accepted its application to use MDMA to treat PTSD and granted it an expedited review," Business Insider wrote.

Should the FDA rule in its favor, Lykos "could become a multibillion-dollar company," the outlet reported, citing an investor.

However, "[c]onversations with more than 50 former and current MAPS employees, investors, and industry peers over the past few months suggested an organization that, having almost won its battle for mainstream respectability, is increasingly at war with itself," Business Insider wrote.

"While most of the former employees say they still believe in MDMA's therapeutic potential," the outlet added, "some have begun voicing concerns about possible ethical lapses in the way Lykos conducted its clinical trials and questioning whether MAPS and the pharmaceutical company it birthed are the right stewards to bring it into the future."

At the same time, supporters told Business Insider that, regardless of what happens with medicalization, Doblin has largely achieved his goal of changing the narrative when it comes to psychedelics.

Doblin also isn't giving up, Business Insider noted. "The reason that I could work for 38 years and not get burnt out," he told the outlet, is "that I didn't get ahead of myself."

Fake Studies Forcing Journal Closures

Fraudulent studies have infiltrated top scientific journals, "leading to thousands of retractions and millions of dollars in lost revenue," the Wall Street Journal reported.

"Although this large-scale fraud represents a small percentage of submissions to journals, it threatens the legitimacy of the nearly $30 billion academic publishing industry and the credibility of science as a whole," the article stated.

Wiley, a 217-year-old publisher based in Hoboken, New Jersey, which is slated to close 19 journals, has taken the largest hit, WSJ reported.

The problem is due to paper mills -- entities that, "for a price, will list a scientist as an author of a wholly or partially fabricated paper," WSJ noted. The paper mills then submit the work, "generally avoiding the most prestigious journals in favor of publications such as one-off special editions that might not undergo as thorough a review and where they have a better chance of getting bogus work published."

And, on the other side, there are motivating factors at play, WSJ noted.

"World-over, scientists are under pressure to publish in peer-reviewed journals -- sometimes to win grants, other times as conditions for promotions," WSJ wrote. "Researchers say this motivates people to cheat the system. Many journals charge a fee to authors to publish in them."

At Wiley, closures are due to multiple factors, WSJ reported. Though a spokesperson for Wiley confirmed to WSJ that some of the journals were affected by paper mills, they declined to provide an exact number.

Agency 'Turf Battles' Hampering U.S. Outbreak Response?

Turf battles between the U.S. Department of Agriculture (USDA) and FDA have the potential to hamper responses to outbreaks, STAT reported.

More than 20 former agency officials and independent experts cited these issues as a basis for their concern regarding H5N1 bird flu, STAT reported.

"In the past, the fragmented responsibilities between the FDA and sub-agencies within the USDA led to inefficient investigations and stunted surveillance testing in cases involving E. coli, salmonella, and tuberculosis," STAT wrote.

More recently, if the FDA "wanted to enter farms to test livestock products and better understand how the disease might spread into human foods, it couldn't," STAT reported. Instead, it tested pasteurized milk in grocery stores.

"Several experts and former federal officials argued that bringing food regulation under one agency would clearly improve public health," STAT wrote, "but industry interests and political power grabs make it a utopian, unlikely reality."

The USDA did not respond to questions from STAT.

A spokesperson for the FDA told STAT that the agency "continues to work steadfastly toward its goal of reducing foodborne illness, but it is true that access to data and information can present challenges for the agency in its response -- as well as prevention -- efforts."

Comment