Wednesday, September 13, 2006

Minimal Disincentives for Conflicts of Interest at the NIH

We have posted a lot about the story of wide-spread conflicts of interest affecting top leaders at the US National Institutes of Health (NIH). After the NIH conflict of interest rules were relaxed in the mid-1990's, some top NIH managers received five- and six-figure consulting payments from pharmaceutical and biotechnology companies. Some failed to disclose these payments, even when writing journal articles favoring the products of the companies for which they worked. Since then, NIH Director Zerhouni made the organization's conflict of interest policies much more stringent, although not without opposition from some of his staff (see post here).

Most recently interest has focused on two cases. Dr Trey Sunderland, a leader within in the National Institute of Mental Health (NIMH), part of the US National Institutes of Health (NIH), provided tissue samples to Pfizer Inc while receiving consulting fees from the drug company. (See posts here and here.) We also posted about Dr Thomas J Walsh, Head, Immunocompromised Host Section, Pediatric Oncology Branch, Center for Cancer Research and the National Cancer Institute (NCI). A Los Angeles Times investigation had suggested that Dr Walsh, while working full-time for the NIH, had received money from several pharmaceutical companies, and also had had spoken for these companies' products at several US Food and Drug Administration (FDA) meetings. An internal NIH investigation just accused Walsh of "serious misconduct." (See post here.)

However, yesterday a report by the Associated Press suggested that while the NIH now may have more stringent regulations, government enforcement of existing regulations on conflicts of interest has been anything but rigorous. To wit,

Only two of the 44 scientists found to have violated rules governing private consulting deals are being investigated for possible criminal activity, and they remain on the government payroll, the National Institutes of Health told The Associated Press this week in the most detailed accounting it has released.

Of the 44 alleged offenders, six left NIH before they could be punished and two had offenses so minor they merited no sanction....

The majority received reprimands or warnings for failing to properly obtain approvals for their outside consulting work, he said. Suspensions ranging from a week to 45 days were meted out to a few who did not get prior approval or did not report their drug company ties....

NIH spokesman John Burklow said his agency wanted eight others reviewed for possible crimes, but those cases were rejected by the investigating office at the U.S. Health and Human Services Department.

The two still outstanding -Drs. Trey Sunderland and Thomas Walsh -both committed "serious misconduct," so grave that they would be fired if they were civilians, NIH internal ethics reports contend.

NIH says it has been unable to act against the two because they are part of the Public Health Service Commissioned Corps, which provides medical help during disasters.

Some scientists whose consultancies were negatively highlighted in 2004 congressional hearings and press accounts left NIH voluntarily. They suffered no repercussions.

Cancer researcher Lance Liotta said he retired in May 2005 with pension and benefits, accepting 'a great opportunity' in research at George Mason University. His consulting activities, though questioned after the fact by Congress, were approved at the time, and he never was sanctioned.

Another former researcher, 33-year NIH veteran Michael Brownstein, had held nearly $2 million in stock with four companies whose boards he served on while he worked at NIH. The agency approved the consulting and never accused him of wrongdoing, said Brownstein, who continues his genetic research at the J. Craig Venter Institute in Rockville, Md.
Some in Congress are not happy,
Rep. Bart Stupak, D-Mich., said he wants to know why it is taking so long to resolve the case of Sunderland, a leading Alzheimer's disease researcher whose request to leave government service has been denied for two years.

'Where's the accountability? Where's the response?' Stupak said. 'This person should be dealt with severely.'

He referred to allegations that Sunderland improperly transferred human tissue samples from NIH patients to the drug company Pfizer.

'These people thought they were helping other people, not some scientist profiting,' he said. Sunderland, through his attorney, denies that his consulting payments from Pfizer were tied to samples he provided in his government capacity.

Rep. Joe Barton, R-Texas, chairman of the House Energy and Commerce Committee, said the case points out deeper problems at NIH.

"In spite of the public changes that have been made at NIH, there really does not appear to be a cultural change where the institution and the members of the institution condemn the kind of behavior that apparently Dr. Sunderland has exhibited. It's really, really disappointing," he said.
Regulating conflicts of interest will not have much effect if violating regulations does not produce much in the way of negative incentives, and if there is no change in the underlying organizational climate. Reprimands or brief suspensions will likely not discourage people from seeking six-figure consulting contracts.

A particularly distressing aspect of this story is the possible violations of the trust of human research subjects. The Nuremberg Code states that in order for a research participant to give truly informed consent
[he or she] should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.
Barton's words, however ungrammatical, have a resonance here: "These people thought they were helping other people, not some scientist profiting." Was their consent obtained without "fraud, deceit, ... [or] over-reaching?" If not, was it really informed?

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