Scientists criticise new NIH rules to cut employees' ties to industry
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《英国医生杂志》
The US National Institutes of Health (NIH) has strictly limited its employees?ties to pharmaceutical and biotechnology companies. A group of leading NIH scientists, called the Assembly of Scientists, has complained that the new rules should be relaxed so as not to discourage scientists from working at the institutes.
The rules, announced by the NIH director, Dr Elias Zerhouni, say that senior scientists (about 5000 people) must not consult for pharmaceutical or biotechnology companies and must sell any shares or stock options that they or their families hold in such companies. They may not receive awards of more than $200, although the Lasker and Nobel awards are acceptable, and they may continue to teach, write textbooks, and review papers. Other NIH employees, such as clerical workers and lift operators, must sell shares worth more than $15 000 in any company in the pharmaceutical or biotechnology industries.
The rules came into effect when published in the Federal Register on 3 February, an NIH said. However, employees have up to 150 days from publication to comply. The rules were developed jointly by the NIH, its parent body the federal Department of Health and Human Services, and the Office of Government Ethics. They are similar to regulations for employees of the Food and Drug Administration. The rules may be reviewed in a year, and comments are being received.
The Assembly of Scientists says that although restrictions on financial interests are needed "to protect the public trust in and integrity and professionalism of the NIH and its staff ? regulations substantially overreach and will severely and irreparably compromise the NIH抯 mission." The assembly argues that the new rules will discourage scientists from working at the NIH, where they earn less than in private industry or in universities, where consulting is permitted. It also says the rules will inhibit free exchange of scientific information between NIH scientists and those at universities, professional societies, and advocacy groups. Furthermore, the rules affect NIH employees who have no possible conflicts of interest. However, about a third of the assembly抯 scientists have ties to industry, according to the Los Angeles Times.
In articles by David Willman beginning in December 2003 the Los Angeles Times showed that scientists at NIH could do lucrative consulting work for the industry (BMJ 2004;329:10). Prohibitions on consulting had been relaxed by the NIH抯 former director, Dr Harold Varmus, in November 1995. Dr Varmus, a Nobel prize winner, is now president of the Memorial Sloan-Kettering Cancer Center in New York.
Scientists who did consulting work were supposed to file financial disclosure forms with the NIH, but some did not, even while consulting for companies related to their NIH work. After publication of the Los Angeles Times articles the House of Representatives?Energy and Commerce Subcommittee on Oversight and Investigations asked 20 pharmaceutical and biotechnology companies about ties to NIH researchers. The committee received the names of about 100 scientists who were said to have violated guidelines on conflicts of interest. However, an NIH review showed that more than half, and perhaps 80%, were wrongly named. They had received NIH approval for their consulting work, or there was a clerical error in reporting their names.(Janice Hopkins Tanne)
The rules, announced by the NIH director, Dr Elias Zerhouni, say that senior scientists (about 5000 people) must not consult for pharmaceutical or biotechnology companies and must sell any shares or stock options that they or their families hold in such companies. They may not receive awards of more than $200, although the Lasker and Nobel awards are acceptable, and they may continue to teach, write textbooks, and review papers. Other NIH employees, such as clerical workers and lift operators, must sell shares worth more than $15 000 in any company in the pharmaceutical or biotechnology industries.
The rules came into effect when published in the Federal Register on 3 February, an NIH said. However, employees have up to 150 days from publication to comply. The rules were developed jointly by the NIH, its parent body the federal Department of Health and Human Services, and the Office of Government Ethics. They are similar to regulations for employees of the Food and Drug Administration. The rules may be reviewed in a year, and comments are being received.
The Assembly of Scientists says that although restrictions on financial interests are needed "to protect the public trust in and integrity and professionalism of the NIH and its staff ? regulations substantially overreach and will severely and irreparably compromise the NIH抯 mission." The assembly argues that the new rules will discourage scientists from working at the NIH, where they earn less than in private industry or in universities, where consulting is permitted. It also says the rules will inhibit free exchange of scientific information between NIH scientists and those at universities, professional societies, and advocacy groups. Furthermore, the rules affect NIH employees who have no possible conflicts of interest. However, about a third of the assembly抯 scientists have ties to industry, according to the Los Angeles Times.
In articles by David Willman beginning in December 2003 the Los Angeles Times showed that scientists at NIH could do lucrative consulting work for the industry (BMJ 2004;329:10). Prohibitions on consulting had been relaxed by the NIH抯 former director, Dr Harold Varmus, in November 1995. Dr Varmus, a Nobel prize winner, is now president of the Memorial Sloan-Kettering Cancer Center in New York.
Scientists who did consulting work were supposed to file financial disclosure forms with the NIH, but some did not, even while consulting for companies related to their NIH work. After publication of the Los Angeles Times articles the House of Representatives?Energy and Commerce Subcommittee on Oversight and Investigations asked 20 pharmaceutical and biotechnology companies about ties to NIH researchers. The committee received the names of about 100 scientists who were said to have violated guidelines on conflicts of interest. However, an NIH review showed that more than half, and perhaps 80%, were wrongly named. They had received NIH approval for their consulting work, or there was a clerical error in reporting their names.(Janice Hopkins Tanne)