Healthy Skepticism Library item: 792

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Publication type: news

Harris G.
Agency Scientists Divided Over Ethics Ban on Consulting
THE NEW YORK TIMES 2005 Feb 2

Full text:

New rules prohibiting outside consulting arrangements by researchers at the National Institutes of Health have been welcomed by some scientists, with the agency’s director saying that group has “said that we needed this.” But others, said the director, Dr. Elias Zerhouni, have threatened “to walk across the street” to work for organizations that do not have such a ban.

The rules, formally announced at a news conference on Tuesday, ban consulting arrangements by scientists at the agency and pharmaceutical and biotech companies.

“There’s no doubt that among the majority of the 5,000 scientists who never did anything wrong and never broke any rules, they see this as being taken into a tsunami of regulations,” Dr. Zerhouni said.

Dr. Sheldon Krimsky, a researcher at Tufts University who specializes in science policy and ethics, said the changes were welcome, albeit overdue. “Imagine if someone working for one of the economic agencies of government made a deal with a company involved in forecasting and gave them privileged access to government data,” Dr. Krimsky said. “It would never have flown, but somehow biomedical scientists got away with it.”

The rules, which will take effect in a few days, grew out of revelations over the past year that some of the agency’s leading scientists had lent their names to drug industry marketing efforts.

Under them, N.I.H. scientists will be banned from working in either a paid or an unpaid capacity for drug and biotechnology companies, health care providers, insurers, trade associations and educational institutions that apply for money from the agency.

The rules will also ban top scientists from owning shares in drug or biotechnology companies. Lower-level employees will be able to own as much as $15,000 in company shares. Gifts of greater than $200 will be banned. Scientists will be prohibited from accepting many academic prizes.

“Nothing is more important than preserving the public trust,” Dr. Zerhouni said.

Banning consulting arrangements between government scientists and private companies is the only way to avoid such conflicts, Dr. Krimsky said.

For much of last year, Dr. Zerhouni insisted that some N.I.H. scientists should be allowed to continue their consulting arrangements, not only to prevent them from leaving the agency for more lucrative jobs elsewhere but also because such arrangements sharpened their skills. He derided calls for complete bans as “ivory tower” proposals that flew in the face of the agency’s need to work toward cures.

But revelations that some agency scientists had lent their names – and thus the name of the institution – to drug industry marketing efforts made him change his mind, Dr. Zerhouni said. He added that less strict proposals that simply banned consulting by top agency administrators would not have stopped lower-level scientists from being “a marketing tool for the outside party.”

Dr. Zerhouni said the rules would remain in effect until the agency decided to change them. But some said that such a change was unlikely in the foreseeable future.

Among the cases that Dr. Zerhouni has condemned is that of Dr. Bryan Brewer Jr., chief of the National Heart, Lung and Blood Institute’s molecular disease branch. In 2003, Dr. Brewer wrote an article promoting the benefits of Crestor, a cholesterol-lowering drug from AstraZeneca. The article was published in a medical journal “supplement” 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. Dr. Zerhouni has described Dr. Brewer’s Crestor article as “a product-driven endorsement.”

Cases like Dr. Brewer’s were revealed in a series in The Los Angeles Times as well as in hearings held by the House Energy and Commerce Committee. The committee’s investigation uncovered 30 to 40 N.I.H. scientists who were consulting for drug and biotechnology companies but who had failed to inform the agency or get permission for these arrangements.

Dr. Zerhouni said that many of the cases were still under investigation, and that some of those employees could be disciplined. Sanctions could vary from counseling to dismissal, another official said.