STEPHAN SCHMITZ
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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.
A Science investigation
In 2005, FDA disqualified Philadelphia dermatologist Harold Farber just before he pleaded guilty to two federal crimes: illegal possession of anabolic steroids and (in his role as sole owner of a private practice) “knowingly and willfully” making a “false, fictitious, or fraudulent statement or representation” to the sponsor of a clinical trial. Federal prosecutors found that during the clinical trial, for an experimental cream to treat Sun-damaged skin, Farber delegated patient exams that he claimed to have conducted himself to an assistant. He was sentenced to probation and medical supervision of his practice and paid about $220,000 in fines and restitution, mostly to the sponsor of the skin cream trial. And he was barred from future earnings for conducting trials.
But Farber has since recouped those losses in other ways, thanks to the pharmaceutical industry. From 2013 to 2019 alone, Open Payments data show, he took in about $665,000 from 45 medical research companies—including Actavis, Allergan, Bayer, and Genentech—for consulting and teaching. Pfizer paid him the most, $90,000. He received $169,000 in other fees, food, and travel perks. Asked whether he informed the companies about his FDA disqualification and legal history, Farber declined to 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.”
With reporting by Meagan Weiland.
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