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9486 in the collection
Top Psychiatrist Failed to Report Drug Income
Ohanian Comment: I am
reading Our Daily Meds by reporter
Melody Petersen, who wrote about the
pharmaceutical industry for four years for the
New York Times. It is very detailed with
specific examples of money and resort
vacations with which the pharmaceutical
industry hopes to lure physicians. The book is
a real eye-opener, particularly if your
physician has prescribed pills you are supposed
to take for the rest of your life. These
are the high-stakes prescriptions--high stakes
for the pharmaceutical industry, an industry
that spends more on advertising than on
research.
Most shocking (so far) is the fact that
developmental houses which are the arm of ad
agencies write articles purporting to be
research and then hire physicians to put down
their names as authors--to make the articles
look legitimate.
By Gardiner Harris
One of the nation’s most influential
psychiatrists earned more than $2.8 million in
consulting arrangements with drug makers
between 2000 and 2007, failed to report at
least $1.2 million of this income to his
university, and violated federal research
rules, according to documents provided to
Congressional investigators.
The psychiatrist, Dr. Charles B. Nemeroff of
Emory University, is the most prominent example
to date in a series of disclosures that is
shaking the world of academic medicine and
seems likely to force broad changes in the
relationships between doctors and drug makers.
In one telling example, Dr. Nemeroff signed a
letter dated July 15, 2004, promising Emory
administrators that he would earn less than
$10,000 a year from GlaxoSmithKline to comply
with federal rules.
But on that day, he was at the Four Seasons
Resort in Jackson Hole, Wyo., earning $3,000 of
what would become $170,000 in income that year
from the British drug giant — 17 times the
figure he had agreed on.
The Congressional inquiry, led by Senator
Charles E. Grassley, Republican of Iowa, is
systematically asking some of the nation’s most
prominent researchers to provide their
conflict-of-interest disclosures, and he is
comparing those documents with actual payment
records from drug companies.
The records often conflict, sometimes starkly.
“After questioning about 20 doctors and
research institutions, it looks like problems
with transparency are everywhere,” Mr. Grassley
said. “The current system for tracking
financial relationships isn’t working.”
The findings suggest that universities are all
but incapable of policing their faculty’s
conflicts of interests. Almost every major
medical school and medical society is now
reassessing its relationships with drug and
device makers.
“Everyone is concerned,” said Dr. James H.
Scully Jr., the president-elect of the Council
of Medical Specialty Societies, whose 30
members represent more than 500,000 doctors.Dr.
Nemeroff is a charismatic speaker and widely
admired scientist who has written more than 850
research reports and reviews. He was editor in
chief of the influential journal
Neuropsychopharmacology. His research has
focused on the long-term mental health risks
associated with child abuse as well as the
relationship between depression and
cardiovascular disease.
Dr. Nemeroff did not respond to calls and e-
mail messages seeking comment. Jeffrey L.
Molter, an Emory spokesman, wrote in an e-
mailed statement that the university was
“working diligently to determine whether our
policies have been observed consistently with
regard to the matters cited by Senator
Grassley.
“Dr. Nemeroff has assured us that: ‘To the best
of my knowledge, I have followed the
appropriate university regulations concerning
financial disclosures. I have dedicated my
career to translating research findings into
improvements in clinical practice in patients
with severe mental illness.’ ”
Mr. Grassley began his investigation in the
spring by questioning Dr. Melissa P. DelBello
of the University of Cincinnati after The
New York Times questioned her connections
to drug makers. She reported to university
officials that she earned about $100,000 from
2005 to 2007 from eight drug makers, but
AstraZeneca alone paid her $238,000 during the
period, Mr. Grassley found.
Then in early June, the senator reported to
Congress that Dr. Joseph Biederman, a renowned
child psychiatrist at Harvard Medical School,
and a colleague, Dr. Timothy E. Wilens, had
reported to university officials earning
several hundred thousand dollars apiece in
consulting fees from drug makers from 2000 to
2007, when in fact they had earned at least
$1.6 million each.
Then the senator focused on Dr. Alan F.
Schatzberg of Stanford, president-elect of the
American Psychiatric Association, whose $4.8
million in stock holdings in a drug development
company raised the senator’s concerns.
Mr. Grassley has sponsored legislation called
the Physician Payment Sunshine Act that would
require drug and device companies to publicly
list payments made to doctors that exceed $500.
Several states already require such
disclosures. As revelations from Mr. Grassley’s
investigation have dribbled out, trade
organizations for the pharmaceutical industry
and medical colleges have agreed to support the
bill. Eli Lilly and Merck have announced that
they will publicly list doctor payments next
year even without legislation.
The National Institutes of Health have strict
rules mandating that conflicts of interest
among grantees be managed or eliminated, but
the health institutes rely on universities for
oversight. If a university fails, the agency
has the power to suspend the school’s entire
portfolio of grants, which for Emory amounted
to $190 million in 2005. But this step is so
draconian that the health institutes almost
never take it.
Dr. Nemeroff was the principal investigator for
a five-year, $3.9 million grant financed by the
National Institute of Mental Health for which
GlaxoSmithKline provided drugs. Income from
GlaxoSmithKline of $10,000 or more in any year
of the grant — a threshold Dr. Nemeroff crossed
in 2003, 2004, 2005 and 2006, records show —
would have required Emory to inform the health
institutes and manage the conflict or remove
Dr. Nemeroff as the investigator. Repeatedly
assured by Dr. Nemeroff that he had not crossed
this income threshold, Emory did nothing.
“Results from N.I.H.-funded research must not
be biased by any conflicting financial
interests,” John Burklow, a spokesman for the
health institutes, said in the kind of tough
statement that in the past has rarely been
followed by real sanctions. “Officials at Emory
are investigating the concerns. Failure to
follow N.I.H. standards on C.O.I. is very
serious and N.I.H. will take all appropriate
action to ensure compliance.”
Many medical school deans say that they would
welcome a public listing of payments from
companies because the only way to audit
disclosure statements now is to demand
professors’ tax returns, something no one wants
to do. But even if the Sunshine act passes, the
Nemeroff case suggests that medical schools may
falter.
Emory, for instance, conducted in 2004 its own
investigation of Dr. Nemeroff’s outside
consulting arrangements. In a 14-page report,
the university’s conflict of interest committee
detailed multiple “serious” and “significant”
violations of university procedures intended to
protect patients.
But besides insisting that he reform, the
university took little apparent action against
Dr. Nemeroff and made no attempt to
independently audit his consulting income,
documents show. His violations continued,
documents show.
Asking schools to oversee faculty consulting
arrangements and the conflicts they represent
to patients is fraught since schools benefit
from the fame and money that the deals can
bring. In effect, universities share
professors’ conflicts — a point Dr. Nemeroff
made plain in a May 2000 letter stamped
“confidential” that he sent to the dean of
Emory’s medical school. The letter addressed
Dr. Nemeroff’s membership on a dozen corporate
advisory boards.
“Surely you remember that Smith-Kline Beecham
Pharmaceuticals donated an endowed chair to the
department and that there is some reasonable
likelihood that Janssen Pharmaceuticals will do
so as well. In addition, Wyeth-Ayerst
Pharmaceuticals has funded a Research Career
Development Award program in the department,
and I have asked both AstraZeneca
Pharmaceuticals and Bristol-Meyers [sic] Squibb
to do the same. Part of the rationale for their
funding our faculty in such a manner would be
my service on these boards.”
There was a time when universities looked
askance at professors who consulted for more
than one or two drug companies, but that
changed after a 1980 law gave schools ownership
of patents discovered with federal funds. The
law helped give birth to the biotechnology
industry and is widely credited with spurring
the discovery of dozens of life-saving
medicines. Consulting arrangements soon
proliferated at medical schools, and Dr.
Nemeroff — who at one point consulted for 21
drug and device companies simultaneously —
became a national model.
That Dr. Nemeroff, according to Congressional
documents, broke university and federal ethics
rules and concealed much of his consulting
income from Emory administrators may make him a
model once again — this time for a broad
reassessment of industry relationships. Many
medical schools, societies and groups are
considering barring doctors from giving drug or
device marketing lectures.
In 2003, Dr. Nemeroff failed to state in a
review of experimental treatments for
depression that he had significant financial
ties to three therapies that he mentioned
favorably. He blamed the journal.
Three years later, he blamed a clerical mix-up
for failing to disclose in an article that he
co-wrote, published in a journal he edited,
that he and his co-authors had financial ties
to Cyberonics, the maker of a controversial
device that they reviewed favorably.
The Cyberonics paper led to a bitter exchange
of e-mail messages between Dr. Nemeroff and
Claudia R. Adkison, an associate dean at Emory,
according to Congressional records. Dr. Adkison
noted that Cyberonics had paid not only Dr.
Nemeroff and his co-authors but had also given
an unrestricted educational grant to Dr.
Nemeroff’s department.
“I can’t believe that anyone in the public or
in academia would believe anything except that
this paper was a piece of paid marketing,” she
wrote on July 20, 2006.
Her exasperation may have resulted because,
unknown to the public, Emory’s conflict of
interest committee in June 2004 discovered that
Dr. Nemeroff had made far more serious
blunders, including failures to disclose
conflicts of interest in trials of drugs from
Merck, Eli Lilly and Johnson & Johnson. His
continuing oversight of a federally financed
trial using GlaxoSmithKline medicines led Dr.
Adkison to write Dr. Nemeroff on July 15, 2004,
that “you must clearly certify on your annual
disclosure form that you do not receive more
than $10,000 from G.S.K.”
In a reply dated Aug. 4, Dr. Nemeroff wrote
that he had already done so but promised again
that “my consulting fees from GSK will be less
than $10,000 per year throughout the period of
this N.I.H. grant.”
When he sent that letter, Dr. Nemeroff had
already earned more than $98,000 that year from
GlaxoSmithKline. Three weeks later, he got
another $3,844.56 for giving a marketing talk
at the Passion Fish Restaurant in Woodbury,
N.Y.
From 2000 through 2006, Dr. Nemeroff earned
more than $960,000 from GlaxoSmithKline but
listed earnings of less than $35,000 for the
period on his university disclosure forms,
according to Congressional documents.
Sarah Alspach, a GlaxoSmithKline spokeswoman,
stated in an e-mail message that “Dr. Nemeroff
is a recognized world leader in the field of
psychiatry,” and that the company requires its
paid speakers to “proactively disclose their
financial relationship with GSK, and we believe
that healthcare professionals are responsible
for making those disclosures.”
— Gardiner Harris
New York Times
2008-10-04
INDEX OF OUTRAGES
Pages: 380
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