Tuesday, February 01, 2005

Ban on Federal Scientists' Consulting Nears

An article in the NY Times today on a forthcoming ban on consulting arrangements for NIH employees.

Whether hard action occurs and is strictly enforced over the long haul remains to be seen. These type of scandals tend to burn brightly for awhile, then turn to more lukewarm efforts once out of the public spotlight.

February 1, 2005
Ban on Federal Scientists' Consulting Nears


The National Institutes of Health and the Office of Government Ethicsare expected to announce a ban today on private consulting arrangements between scientists at the institutes and pharmaceutical and biotech companies.

The ban comes in the wake of damaging revelations that some government scientists leveraged their positions at the institutes to gain lucrative consulting contracts with such companies, arrangements that sometimes overlapped with their government work.

Dr. Elias Zerhouni, director of the institutes, emphasized in an interview last year that only 369 of the institutes' 6,000 scientists had consulting arrangements with such companies from 1999 to 2004. More than 80 percent of these scientists received $5,000 or less from outside consulting, Dr. Zerhouni said.

"I want to dispel the notion here that every scientist at N.I.H. has consulting arrangements with 10 companies," he said in the interview.

Dr. Zerhouni had hoped for months to preserve scientists' right to engage in some of these activities, saying a ban would turn the institutes into "a convent," which, he said, was not in keeping with Congress's insistence that its research lead to cures.

But a series of articles in The Los Angeles Times detailing the conflicts between some N.I.H. scientists' public and private work and several hearings by the House Energy and Commerce Committee forced Dr.Zerhouni to retreat and finally propose late last year a ban on outside consulting activities. Since the ban was a change to government policies, it required approval from the Office of Government Ethics. That office is expected to announce today that it has approved such a ban.

Representative Diana DeGette, a Democrat from Colorado and a member of the House Energy and Commerce Committee, released a statement yesterday saying that the institutes' new consulting guidelines would be "a major step toward restoring public confidence in our nation's premier research institution."

Studies show that researchers who accept money from private companies are less likely than others to share the results of their work with their colleagues. Such researchers are also more likely to focus on commercially applicable studies, said Dr. David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospitalin Boston.

Mildred Cho, associate director of the Center for Biomedical Ethics at Stanford University, said that academic researchers increasingly collaborated with drug and biotech companies, and that the growing number of consulting relationships between N.I.H. researchers and companies had simply reflected that trend.

"What's different about this," Dr. Cho said, "is that it involves the government, government research and government funding of research. That represents a crossing of a line that hadn't been crossed before."

The number of cases that have come to light so far are wide-ranging and include top-level administrators and working researchers alike.

Dr. Bryan Brewer Jr., for instance, is chief of the National Heart,Lung and Blood Institute's molecular disease branch. In 2003, he wrote an article promoting the benefits of Crestor, a cholesterol-lowering medicine from AstraZeneca.

The article was published in a medical journal "supplement" that was paid for by AstraZeneca, and Dr. Brewer's N.I.H. title was prominently displayed.

The article failed to mention potentially serious safety problems with Crestor.
In the interview last year, Dr. Zerhouni distanced himself from Dr.Brewer's Crestor article, saying that it was a "marketing effort" and "a product-driven endorsement" that should be banned.

Dr. P. Trey Sunderland, a senior researcher at the National Institute of Mental Health, received more than $500,000 in consulting fees from Pfizer at the same time that he was collaborating with it in his government capacity of studying patients with Alzheimer's disease. Despite rules requiring that government scientists disclose their consulting arrangements to the health institutes, Dr. Sunderland failed to make such a disclosure.

Dr. Zerhouni has described Dr. Sunderland's case as "a way outlier" that is being closely investigated.

Private consulting arrangements between N.I.H. researchers and drug and biotech companies were relatively rare until the 1980's, when they slowly started to grow. They grew quickly after Dr. Harold Varmus, who was the institutes' director in the 1990's, decided to lift the limits on outside income, and administrators loosened disclosure rules about these activities.

When the House began investigating, it asked Dr. Zerhouni to produce a list of agency researchers who were consulting for companies and the amounts they made. At first, Dr. Zerhouni said such a list would be impossible to produce. The committee asked pharmaceutical companies to disclose a list of their consultants at the agency. Finally, Dr. Zerhouni produced a list of consultants.

But the lists produced by the drug companies included dozens of researchers who had not been listed by the institutes. Dr. Zerhouni said some of those names were errors. But, he said, the agency is investigating "30 or 40" people whose outside consulting arrangements were unknown to the institutes, and among them is Dr. Sunderland.

Neither Dr. Sunderland nor Dr. Brewer could be reached. An institutes spokesman also declined to comment.

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