Initially, our friend Dr. Roy Poses blogged about this on
Health Care Renewal:
I was tempted also to blog about this but held off at the
time because I was concerned that the facts were not all available, and it was
just possible that I would be defending someone who was, in fact, guilty of
fraudulent behavior—a concern Dr. Poses shared because he called for more
investigation.
Dr. Poses has meanwhile posted again:
--and in turn referenced an article by Paul Goldberg in The Cancer Letter of Aug. 9:
--which now seem to provide enough factual background to at
least raise some serious concerns. Let’s see if I can tell this tale the right
way around for our purposes, even though it’s a convoluted story.
Let’s go back to the debate over drugs like epoetin that are
used in kidney dialysis and cancer care to treat anemia by stimulating the
production of red blood cells:
Companies like Amgen, that manufactured these lucrative
drugs, were quite upset when studies began to show that higher doses of the
drugs increased blood counts by too much and led to life-threatening clotting
complications. The problem was that both cancer docs and dialysis centers were
being paid on commission, meaning if they used higher doses, they got more
money, and so had a strong financial incentive (which of course also benefited
the drug’s manufacturer) to use the higher doses. Dr. Charles Bennett of
Northwestern University med school played a role in reporting both on the
scientific evidence of harm from too-high doses, and later on the role of the
drug firms in trying to hide this information—for example:
Dr. Bennett eventually created a unit at Northwestern, the
Research on Adverse Drug Events and Reports project, specifically to study
serious adverse drug reactions; and it is not too much of a stretch to suggest
that his work helped to create the climate in which Amgen pleaded guilty to
charges that it misbranded its epoetin drug Aranesp and paid a settlement of
$762M in 2012. When Dr. Bennett left Northwestern in 2009, it was to take the
offer of $6M in startup funds to study the safety of drugs in South Carolina.
Now let’s look at issues at Northwestern regarding the
administration of research grants.
As Goldberg recounts, Northwestern has previously had
problem in this area, and a decade ago had to repay the NIH $5.75M that it
obtained through inflated reimbursement for faculty effort. Just recently,
Northwestern agreed to pay the Feds a settlement of about $3M due to
questionable payments on another grant, in this case one whose principal
investigator was Dr. Bennett.
Just before this recent Federal settlement was announced, a
former Northwestern employee, Feyifunmi Sangoleye, pleaded guilty in U.S.
District Court to embezzling $86,000. She worked in the Northwestern cancer
division’s grants administration office and set up a phony account, into which
she proceeded to divert grant monies that she eventually used to pay for a
wedding in Europe.
The statements issued by the Feds and by Northwestern
regarding their recent settlement focus on the allegations that Dr. Bennett
used NIH grant funds illegally to pay for consulting jobs for family members
and for personal travel unrelated to the grant. The whistleblower credited with
exposing this wrongdoing, and who as a result takes home a nearly
half-million-dollar share of the award, is Melissa Theis, who was a temp
employee at Northwestern in 2007-8. What Goldberg finds intriguing about her
role is that she apparently never worked directly in the cancer center, so it’s
unclear how she obtained information about Dr. Bennett’s grant.
In the normal course of events (as Dr. Poses stressed) Dr.
Bennett could not simply pay himself money out of his grant and do whatever
with it. He had to submit the expenses to the administration, and they had to
approve that the costs were justified before any payment could be issued. The
people who would have had to sign off would have been first, the administrator,
the recently convicted felon Sangoleye, and the director of the cancer center,
Dr. Steven Rosen. Dr. Rosen was initially listed as a co-defendant but his name
was dropped as the Federal settlement proceeded.
Dr. Bennett told Goldberg that he did not do any of the
things alleged regarding inappropriate payments, that he noted irregularities
in the way Northwestern was handling grant funds, and that he duly reported
these concerns to his superiors before leaving Northwestern.
The publicity surrounding the Federal settlement was what
first attracted Dr. Poses’ attention. The Chicago newspapers jumped on the
charges against Dr. Bennett, but completely ignored the Sangoleye guilty plea.
Both Northwestern and the Feds seemed primarily interested in alleging that it
was all Dr. Bennett’s fault and specifically in clearing Dr. Rosen of any
wrongdoing, even though officially he was the person where the buck stopped in
approving payouts from the grants.
Goldberg talked with several colleagues of Dr. Bennett who
testified that he was not the sort of person one would expect to commit fraud
with grant money, and was in fact a scientist dedicated to sniffing out the
truth about adverse drug reactions.
Goldberg hints broadly in the article that Dr. Bennett
collected his share of foes due to his work on epoetin drugs and their dangers,
and that it would not be that strange if at least some of all this recent
scandal reflected an effort to smear his reputation. And given that the
administrator who oversaw his grant is now a convicted felon, if anyone played
fast and loose with money from his grant, it might well not have been Dr.
Bennett. And, finally, if there was lax supervision of grants at Northwestern,
it would seem that Dr. Rosen and not Dr. Bennett should be answering for it.
1 comment:
Smearing is not unknown in the higher echelons of psychiatry. During the run-up to DSM-5, Allen Frances and Robert Spitzer were critical of what they saw developing. They were more or less told to butt out and, when they persisted, they were viciously smeared in print by David Kupfer (in charge of DSM-5) and Alan Schatzberg (American Psychiatric Association President). The contemptible, ad hominem, allegation was that they were trying to defend the flow of royalties to them from previous editions of DSM. In the end, the reputations of Allen Frances and Robert Spitzer fared better than those of Kupfer, Schatzberg, and the APA itself.
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