Monday, August 26, 2013

The Fate of a Scientist Who Reveals Drug-Related Harms? The Bennett Case

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.
I hope Dr. Bennett will have his day in court and have a chance to defend himself against these charges and that we’ll eventually find out the truth. Meanwhile, as we tally up what happens to scientists’ reputations later in life, it seems much safer to put your name on a ghostwritten article for a drug company, than to earn their ire by exposing the toxic effects of drugs that could be harming patients.

1 comment:

Bernard Carroll said...

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.