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SCIENCE sciencemag.org 2 OCTOBER 2020 • VOL 370 ISSUE 6512 25
F
or nearly a decade, the Food and
Drug Administration (FDA) cited
osteopath Michael Harris for egre-
gious errors in clinical trials he was
overseeing. Agency inspectors found
a litany of problems at Harris’s pri-
vate firm, Aspen Clinical Research
in Orem, Utah, which had contracts
to evaluate many drugs, including
ones aiming to treat postoperative pain, pe-
diatric schizophrenia, and migraines. FDA
found there were serious lapses in obtain-
ing informed consent from trial volunteers,
unqualified staff made medical assessments,
and Harris failed to properly report abnor-
mal lab test results. He also did not disclose
that trial participants were taking opioid,
antidepressant, or antipsychotic drugs—
which could have skewed results or posed
safety concerns. The agency said Aspen’s re-
cords were disorganized, contradictory, and
sometimes backdated in a way that “begs the
question of the authenticity and veracity of
data collected.”
Those “serious, ongoing deviations”
might constitute “fraud, scientific mis-
conduct,” and “significant human subject
protection violations,” according to FDA
documents obtained by Science through the
Freedom of Information Act (FOIA). Inspec-
tors told Harris he could be subject to fines,
permanent disqualification from clinical re-
search in the United States, and legal pros-
ecution. Repeat problems and a raft of new
ones emerged during inspections in 2014,
2015, and 2019. Each time, in responses to
FDA, Harris admitted some transgressions,
strenuously disputed others, and promised
to improve.
Through all that, FDA never formally
sanctioned Harris or pursued other penal-
ties. The agency never made public the al-
leged offenses or told trial participants they
might have been put at risk. Nor did it tell
companies sponsoring some of the trials
that their data might have been compro-
mised. (The documents Science obtained
were heavily redacted, making it impossible
to know which trials were in doubt and,
thus, which volunteers might have been
harmed or endangered.) Meanwhile, phar-
maceutical and medical device companies
continued to contract with Aspen. Since
2011, they have paid the firm millions of dol-
lars for work on at least 65 trials, and Aspen
is now recruiting people for nine new trials
on Alzheimer’s disease, autism, depression,
and other serious disorders.
Harris declined to comment on the FDA
reports and the agency refused to discuss
its dealings with him. Wayne Croft, Harris’s
business partner at Aspen, also would not
reply to questions, but he describes FDA’s
treatment of Harris as bureaucratic harass-
ment that drove away business. “Anytime he
hears about the FDA,” Croft says, Harris ex-
periences “post-traumatic stress.”
Scrutiny of the agency’s clinical trial
oversight for the past 11 years suggests its
interactions with Harris and Aspen are
commonplace. FDA’s enforcement of clinical
research regulations is often light-handed,
slow-moving, and secretive, Science has
found in an investigation that included a
review of some 1600 agency inspection and
enforcement documents for other trials that
FDA said violated rules and law. Almost all
were acquired via FOIA requests, including
many made by FDAzilla, a commercial ser-
vice that tracks the agency.
The period examined covered former Pres-
ident Barack Obama’s administration and
the first 3 years of President Donald Trump’s
term. Clear corrections of inspector-reported
dangerous or unlawful clinical trial prac-
tices were the exception, even amid signs
that trial participants were harmed and that
data underpinning evidence-based medicine
were corrupted. On the rare occasions when
FDA formally warned researchers of findings
that they had broken the law, the agency of-
ten neglected to ensure that fixes occurred,
