When the Food and Drug Administration (FDA) wields its ultimate penalty, disqualification, against clinical researchers who it determines have violated the law, falsified data, or committed grave errors or misconduct, they can no longer run human trials in the United States. But that doesn’t always sever their financially rewarding relationships with big pharma.
In 2008, FDA filed a public notice that it had disqualified Texas urologist James Vestal after its inspectors discovered egregious problems in clinical trials he had led of an experimental hormonal treatment for advanced prostate cancer. The agency said Vestal admitted to fabricating medical exams, faking signatures, enrolling ineligible patients, and other actions that “exposed [his] subjects to unnecessary risks.”
Yet a Science examination of corporate compensation disclosures from the federal Open Payments database showed that from 2013 to 2019, 27 drugmakers—including heavyweights Bayer, the Johnson & Johnson subsidiary Janssen, and Sanofi—paid Vestal about $422,000, including $340,000 for consulting and teaching. (The system only began to record pharmaceutical compensation to physicians in 2013.) Vestal did not respond to requests for comment.
Science asked 33 drug companies why they paid Vestal or Farber to teach or consult after FDA expelled them as clinical investigators. The 22 that responded all said the two remain qualified physicians who were not hired for clinical trials. None would say whether they knew about the FDA sanctions, or Farber’s criminal conviction, when they made the payments.
Among the 42 other physicians FDA disqualified since 2005, data from 2013 to 2019 show five others took in about $10,000 to $36,000 in drug company payments after their bans.
One was Miami internist Farid Marquez, barred from research in 2015 after FDA found what it said were phony documents in his work for drug giants Boehringer Ingelheim and Eli Lilly. But those companies seem to have no hard feelings. Although Marquez no longer gets their research money, Boehringer Ingelheimhas treated him to at least 168 meals since his disqualification; and Lilly, 17. Marquez declined to comment.
“The most favorable sort of interpretation is that the companies’ internal vetting process is deeply broken,” says Vinay Prasad, a hematologist-oncologist at the University of California, San Francisco, who studies how drug industry funding influences research and medical practice. “The more pessimistic interpretation is that they turned a blind eye because the investigators were not disqualified for something that hurts the companies’ bottom lines.”