Science - USA (2020-10-02)

(Antfer) #1
SCIENCE sciencemag.org 2 OCTOBER 2020 • VOL 370 ISSUE 6512 27

ILLUSTRATION: STEPHAN SCHMITZ


Disgraced researchers can still reap drug industry payouts


W


hen the Food and Drug Adminis-
tration (FDA) wields its ultimate
penalty, disqualification, against
clinical researchers who it de-
termines 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 compensa-
tion to physicians in 2013.) Vestal did not
respond to requests for comment.
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 pharma-
ceutical 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 convic-
tion, 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 re-
search 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 Ingel-
heim has treated him to at least
168 meals since his disqualification; and
Lilly, 17. Marquez declined to comment.
“The most favorable sort of interpreta-
tion 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’ bot-
tom lines.” — C. P.
Free download pdf