WASHINGTON — Scientists at the National Institutes of Health who are fighting new rules that would end their financial ties to the drug industry have hired, at a favorable rate, a law and lobbying firm that also represents the companies.
The hiring has added firepower to the government scientists' campaign, which already is getting results: Senior aides to NIH Director Elias A. Zerhouni now are discussing whether to soften a requirement that employees sell any stock they hold in a biomedical company, according to an agency spokesman.
The divestiture requirement -- scheduled to take effect in October -- was part of a package of reforms announced by Zerhouni on Feb. 1. The new rules also immediately prohibit all NIH scientists from taking fees, stock options or any other compensation from pharmaceutical or biotechnology companies.
In an e-mail to NIH employees on Tuesday, a group of dissident agency scientists said that it had "mounted a legal and government relations campaign to challenge the new conflict-of-interest rules."
The dissidents, called the Assembly of Scientists, contend that the new restrictions impose unfair financial burdens on them and will harm NIH's ability to recruit and retain top talent. In addition to rescinding the stock-divestiture requirement, they want most agency researchers -- including laboratory directors and branch chiefs -- to again be allowed to take consulting fees from the companies.
The Washington firm they hired, Arent Fox, has ties to the industry that has been employing the moonlighting NIH scientists as consultants. According to its website, Arent Fox represents the makers of pharmaceuticals, medical devices, and dietary supplements. One of its longtime clients is the Biotechnology Industry Organization, which last year urged the NIH to allow agency scientists to continue serving as private, paid consultants.
Arent Fox attorneys earlier this month filed a petition asking the U.S. Circuit Court of Appeals for the District of Columbia to review the new conflict-of-interest rules, arguing that they were imposed before the scientists had enough opportunity to comment.
Last week, Rep. Chris Van Hollen (D-Md.) sent a letter to Zerhouni asking him to delay implementation of all the new rules for at least three months. Van Hollen, whose district encompasses the NIH complex in suburban Bethesda, is a former Arent Fox partner. He said Wednesday that he began assisting the dissidents early this year before he learned about the firm's involvement.
The chairman of Arent Fox, Marc L. Fleischaker, said in an interview that his firm was providing lobbying and legal services to the dissidents at a discount. He declined to elaborate, but said that none of the companies that Arent Fox represents had paid for the firm's services on behalf of the NIH employees.
Fleischaker said his firm was seeking "a more reasonable conflict-of-interest standard which will not result in the loss of current scientists or the inability to recruit future scientists. We hope to do that through discussions and conversations.... And if we have to litigate, we will."
The new conflict-of-interest rules stemmed from revelations that hundreds of NIH scientists took fees and stock from the industry totaling millions of dollars, and that most of the payments were hidden from public view. The payments raised questions about the scientists' impartiality in overseeing clinical trials or making public recommendations on the use of new drugs or other commercial treatments.
In some cases, NIH scientists worked for drug companies that directly benefited from their recommendations to doctors and regulators. In other cases, agency scientists appeared at public forums and commented on or endorsed treatments or drugs without revealing that they were on the payroll of companies making the products.
Zerhouni, working with the Office of Government Ethics and the Department of Health and Human Services, announced the tougher rules after months of public discussion during which comments were sought from NIH employees. In the spring of 2004, a blue-ribbon committee appointed by Zerhouni held public hearings. Also last year, four congressional hearings -- one in the Senate and three in the House -- were convened to examine conflicts of interest at NIH.
Yet two weeks ago, Zerhouni told a Senate Appropriations subcommittee that he generally favored relaxing the new requirement that senior agency scientists divest holdings of stock in individual companies.
Two senators who led the hearing, subcommittee Chairman Arlen Specter (R-Pa.) and Tom Harkin of Iowa, the panel's ranking Democrat, questioned whether the stock-divestiture provisions would hurt the NIH's ability to retain talented scientists.
