NIH chief seeks changes in new ethics regulations

He tells Senate panel that rules OK'd in Feb. have led to defections

April 07, 2005|By Susan Baer | Susan Baer,SUN NATIONAL STAFF

WASHINGTON -- Two months after announcing strict ethics regulations he said were necessary to restore public trust in the National Institutes of Health, Director Elias A. Zerhouni said yesterday that he would seek changes in the sweeping set of rules that have rocked the NIH campus and caused several high-level defections.

Zerhouni told a Senate panel it was "very clear" to him that a new rule requiring divestiture of health-related stock for all NIH employees would have a "deleterious impact" on the nation's premier health research facility.

As an example, he pointed to James F. Battey, a highly regarded NIH official who testified yesterday that he plans to leave in September because of that requirement.

At a wide-ranging hearing, Zerhouni also said that "from a purely scientific standpoint," disease research could be advanced if NIH scientists had access to more embryonic stem cell lines than President Bush's policy allows. Several NIH officials, in testimony and letters, were more direct in their opposition to the president's policy.

Divesting stocks

The new ethics regulations, developed by the Department of Health and Human Services and the Office of Government Ethics in consultation with NIH, require stock divestiture of any health-related holdings by the agency's 17,500 employees and their families. They also prohibit employees from outside work with biomedical companies, scientific organizations, trade associations and academic institutions.

Zerhouni said he was still committed to the ban on consulting work until NIH has a better system in place for monitoring such arrangements. But he said he agreed with the growing chorus of scientists who believe the stock divestiture requirement is inappropriate.

"The philosophy of the ... regulations is, in my view, one that would be more appropriate for a regulatory agency rather than a scientific agency," Zerhouni said.

HHS has postponed implementation of that rule, and Zerhouni told senators he believed the measure would be modified.

The uncertainty over the rules alone, Zerhouni said, "can be damaging to morale, damaging to recruitment and retention."

Zerhouni pointed to examples of damage done since February, when the strict ethics rules were announced.

David Schwartz, a renowned Duke University scientist who was supposed to take the reins of the National Institute of Environmental Health Sciences next week, has decided to delay accepting the job because of his concerns over the ethics rules, Zerhouni said.

Battey, director of the agency's deafness institute for the last eight years and chief of the NIH stem cell program until last month, told the senators that he was leaving "the greatest job in the world" because the cost of selling his health-related stock was too great.

The outcry from NIH employees, and much of the larger scientific and biotech community, has succeeded in rolling back some of the provisions. Along with the 90-day delay of the July deadline for stock divestiture, the rules now grant exemptions to the 5,000 clinical and research fellows who rotate through the agency for several years at a time.

In the years preceding the ethics rules, when some scientists were discovered to have engaged in lucrative outside consulting work that was not approved by NIH officials, Zerhouni had opposed such blanket restrictions, worrying they would impede science. But in announcing the far-reaching regulations in February, in the face of mounting pressure from a House committee and the Office of Government Ethics, he said he felt they were necessary to restore public trust in the agency.

Yesterday, Zerhouni reiterated his earlier concerns, saying the broad regulations seem to "restrict academic interchange. I do believe we should not restrict interactions that are purely scientific or academic in any way, shape or form."

Pennsylvania Sen. Arlen Specter, who received a fourth round of chemotherapy for Hodgkin's disease last Friday and has lost most of his hair, chaired the hearing and asked a series of questions to Zerhouni and the director of the National Cancer Institute, Andrew C. von Eschenbach, about progress in curing cancer.

"What will it take to win that war?" the Republican asked.

Stem cell limits

Grilling Zerhouni on embryonic stem cell research, Specter, an advocate of such research, told the NIH director there was a strong sentiment in Congress to broaden Bush's policy.

Zerhouni has never divulged his personal feelings about Bush's policy, which limits NIH research to the 20 or so lines that were created from embryos already harvested at the time the president announced his policy in 2001. But he often states, as he did repeatedly yesterday, that from a scientific standpoint, research could be advanced with more available stem cell lines than Bush is permitting.

Asked by Specter what ethical purpose is being served by not allowing federally funded research on frozen embryos that would otherwise be discarded at fertility labs, Zerhouni said, "I think you have to ask that of those who hold that view."

But several NIH officials were more direct in their criticism of Bush's policy. Battey, who chaired the NIH stem cell task force for the last three years, said the state of the science was moving "very rapidly" and that the limits created by Bush's policy were becoming more apparent. He said scientists were concerned about the long-term stability federal funding for the cell lines.

In a letter to Specter, Elizabeth G. Nabel, director of the National Heart, Lung and Blood Institute, said "progress has been delayed" by the president's limits.

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