Monday, December 11, 2006

Sunderland Pleads Guilty to Criminal Conflict of Interest

We have posted frequently about allegations of conflicts of interest affecting top scientists and managers at the US National Institutes of Health (NIH). The most striking case has been that of Dr Pearson "Trey" Sunderland III, who formerly lead the Geriatric Psychiatry Branch of the National Institute of Mental Health (NIMH). Sunderland was just indicted for criminal conflict of interest, based on charges that the worked as a highly-paid consultant for Pfizer Inc while he did related research as a full-time NIMH employee. He also allegedly furnished Pfizer Inc with tissue samples he obtained during his NIHM work. (See most recent post here.)

Sunderland has just entered a guilty plea in this case. Per the Los Angeles Times, reported by David Willman:

A senior government scientist from the National Institutes of Health who took about $300,000 in unauthorized payments from a drug company pleaded guilty Friday to a federal charge that he committed a criminal conflict of interest.

The admission by Dr. P. Trey Sunderland III came after years of denials by his attorneys and six months after the scientist had asserted his constitutional right against self-incrimination to a congressional subcommittee.

The prosecution was the first of an NIH scientist under federal conflict-of-interest laws in 14 years.

Sunderland, 55, admitted that he failed to get required authorization for taking $285,000 in consulting fees and $15,000 in expense payments from the drug company Pfizer Inc. from 1998 to 2003. During the same period, he provided Pfizer with spinal-tap samples collected from hundreds of patients as part of a research collaboration approved by the NIH.

After the hearing Friday, U.S. Atty. Rod J. Rosenstein told reporters that Sunderland's actions were a breach of the public trust.

A plea agreement calls for Sunderland to pay the government the $300,000 he took from Pfizer, perform 400 hours of community service, and submit to two years of probation. [Judge] Motz set sentencing for Dec. 22.

Under the collaboration with Pfizer, Sunderland's staff provided Pfizer with spinal-tap samples they had collected from patients who had Alzheimer's disease or were at risk of developing it. Drug companies prize the material because it could contain genetic clues for finding a breakthrough treatment.

Sunderland at no point from 1998 to 2003 sought permission from his NIH bosses to take the personal payments from Pfizer, and he did not disclose the income on annual financial reports.

Also, as reported by The Scientist, the Geriatric Psychiatry Branch of the NIMH has been dismantled. But
despite Sunderland's plea, Pfizer Inc. denied any wrong-doing:

Sunderland 'received honoraria for consulting and educational activities that were reasonable and customary for an expert of his stature and expertise,' Pfizer spokesman Stephen F. Lederer told The Scientist in an email. 'We believe our actions complied with applicable laws and ethical standards. We are not aware of any allegation that we violated any law or regulation.'
In my humble opinion, the only way to start beating back the tide of conflicts of interest that has enveloped health care is to start assuring negative incentives that will outweigh the personal gain or business profits afforded by such conflicts. The conviction of Sunderland is a small, but important step in this regard.

On the other hand, it is unclear how Pfizer can maintain that its actions met "ethical standards" after a recipient of the payments the company made has been convicted of criminal conflict of interest for accepting these payments.


Alone said...

For what this is worth, I understand that he allegedly gave Pfizer tissue samples. This would explain why they picked on him, because let me assure you that $30k / year from Pharma is at the extreme low end for NIH directors.

Anonymous said...

Have you seen the pharmaceutical drug reps, can you really blame the guy?

Egan Allen said...

Here is an update on the story:

NIH can't fire him

Anonymous said...

Pfizer will not admit any guilt, in this or any other scandal, since it would set a precedent and open them up to other claims. Remember all drug companies are sales organizations and as such they believe what they say at the time they say it. To make a presentation and two day later pull a drug is a normal part of this mind set.

We also find in the Dec. 8, 2006 WSJ an article by David Armstrong concerning an FDA action involving Atricure:

"Investigators from the Food and Drug Administration found "objectionable conditions" and "several serious violations" of regulations designed to protect patients when reviewing two clinical trials overseen by Randall K. Wolf, according to a copy of a warning letter sent to Dr. Wolf on Sept. 28."

The article goes on:

"The violations found by the FDA include failing to obtain proper consent from patients and not following study protocols. The FDA also cited discrepancies in documents tracking the health of patients in one of the studies. The agency ordered Dr. Wolf to take corrective action to prevent future violations.

The FDA inspectors also found that Dr. Wolf failed to fully disclose his numerous financial ties to AtriCure, including a royalty agreement that guarantees him at least $200,000 a year, stock options and monthly consulting payments. Dr. Wolf, through a spokesman for the medical school, declined to comment."

Once again we find the lure of money outweighs patient responsibility and off label use of a procedure can go unchecked.

Steve Lucas

Anonymous said...

In response to Alone's comment that the tissue samples were a factor in this case, I can state that I was in the courtroom on the day that Dr. Sunderland was sentenced and I heard the prosecutor tell the Judge that there was no evidence of improprieties in the issue of the tissue samples. It is interesting to me that this information has not been widely reported

Anonymous said...

To expand on the above: both the lead prosecutor and the judge expressed their sentiment that this was an unfortunate situation. No malice was intended, nor proven to have occured, by Trey Sunderland.
He is an honest man and a superior researcher and doctor.

Anonymous said...

Actually I agree with anonymous too. I understand that the tissue samples were intended to help develop a new diagnostic for Alzheimer's disease. Pfizer does not sell any diagnostics so would have made no direct revenues if this had been successful. The nature of the work was something that the NIH would have been proud of - and they got a bargain having somebody else pay for the work. The crime was non disclosure and failure of form filling. The ethics of the project itself were superb.