Sunday, July 01, 2007

The Ongoing NIH Conflicts of Interest Story: The Case of the "Footloose and Fancy-Free" Institute Director

My apologies for being off the air. I was on the road, and then my lap-top decided it no longer wanted to communicate with the internet. Of course, while I was incommunicado, health care's problems continued.

For example, a while back we posted quite a bit (recently here) about conflicts of interest affecting top US National Institutes of Health (NIH) officials. In 2005, the NIH director reinstated strict rules about conflicts of interest.

Yet last week the Washington Post reported that the issue has not gone away. The most recent story was about "David Schwartz, a physician and researcher recruited from Duke University to great fanfare in 2005 as chief of the National Institute of Environmental Health Sciences...." "Schwartz, an expert in environmentally related lung diseases, was hired in 2005 just three months after [NIH Director Elias] Zerhouni imposed strict new conflict-of-interest rules in the aftermath of a scandal involving agency scientists who failed to disclose lucrative consulting deals with pharmaceutical companies." "In an internal NIH investigation he "was found to have spent modest amounts of institute money for personal purposes but was cleared of other allegations of wrongdoing...." However,

several members of Congress have demanded more details, saying they have evidence that the NIH report is incomplete. And scores of e-mails reviewed by The Post confirm that ethics officials in NIH and in the Health and Human Services secretary's office have grown increasingly frustrated with Schwartz's repeated insensitivity to conflict-of-interest rules.
Schwartz allegedly had several kinds of conflicts of interest. One kind involved his personal investments. Schwartz reportedly did not see that his personal investments should not be limited by any petty federal rules and regulations.

In one exchange, when officials learned that Schwartz had not fully divested all his biotechnology and drug company stocks as required, Schwartz wrote to the NIH ethics office that the divestiture 'seems totally unreasonable. . . . I'm simply not willing to limit my investments in this way.'

The ethics officer, who later complained that she had 'lost patience . . . a long time ago' with Schwartz, responded, 'It may appear to be unreasonable, but it is the law.'
Another kind of conflict of interest involved Schwartz's activities as a paid expert witness.

Also raising alarms were Schwartz's growing commitments to give expert testimony in multimillion-dollar asbestos injury cases -- of concern because he might be perceived as profiting personally from his status as head of the nation's premier environmental toxicology program.

Schwartz said he earned about $150,000 from asbestos-related expert testimony and clinical exams from mid-2005 through fiscal 2006.

A third kind of conflict of interested involved Schwartz's position at Duke University.

Schwartz brought more than a dozen Duke researchers to his federal lab, despite a requirement that he recuse himself from matters involving Duke. He also overspent his lab budget by millions of dollars. Those actions led agency officials to take the extremely unusual step of banning Schwartz from his own lab for nearly three months, putting it into receivership and sending the researchers back to Duke in what one official called a 'de-Duking' process.

The lab was recently placed under the budgetary control of another NIH institute to prevent further problems....

And in March, Schwartz -- who had retained his faculty status at Duke, a few miles from the institute's headquarters in Research Triangle Park, N.C. -- separated himself from the university.

All this has attracted the attention of Congress.

Last Thursday, Sen. Chuck E. Grassley (R-Iowa), ranking minority member of the Finance Committee, which has been investigating Schwartz for months, sent an eight-page letter to NIH Director Elias A. Zerhouni with a host of new questions to be answered by July 10.

'The National Institutes of Health conducts important research for the public good, and individuals who hold high-level positions there ought to understand that they hold the public trust and demonstrate respect for it with their actions,' Grassley said.

Schwartz denied any wrong-doing.

In a telephone interview yesterday, Schwartz said he made mistakes, which he blamed on "misunderstandings" about institute rules and "poor communication," for which he said he takes "full responsibility."

Schwartz denied any deception on his part, however, and said he has taken corrective actions to prevent future problems.

The Post found that Schwartz's actions were taking their toll on those he supervises.

In interviews this week, various current and former NIEHS employees called Schwartz 'brilliant' and an 'excellent scientist' but also 'patriarchal,' and 'footloose and fancy-free with the rules.'

Since his arrival, three top institute officials have left, and many employees have expressed dismay at Schwartz's leadership.

'Morale is just horrible,' one said speaking on the condition of anonymity for fear of retribution.

This story seems significant first because it demonstrates that there are continuing conflict of interest problems at the NIH, even after the rules were stiffened in 2005. Such conflicts should be of particular concern because the NIH is one of the world's foremost biomedical research organizations. Having conflicted people in its top leadership positions, particularly as full Institute directors, raises concerns about whether their actions are meant to serve science and the public, or their private financial interests.

This story also seems significant because it shows how multi-faceted conflicts of interest may be. Schwartz's conflicts included not only his pharmaceutical and biotechnology company stock-holdings, but his role as an expert witness, and his continuing relationship with a university that gets millions of dollars in NIH funding. Clearly, solving the conflict of interest problems at the NIH is goint to require ongoing vigilance.

Finally, at the end of the story is a reminder that conflicted leaders tend to demoralize their subordinates, an effect that is particularly important given the pervasive nature of conflicts of interest in health care.

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