Senate Mulls Curbs on FDA Financial Ties
The full Senate on Wednesday may vote on a measure that would restrict the Food and Drug Administration�s ability to hire outside advisers with financial ties to regulated companies. The amendment, sponsored by Senators Richard Durbin (D-IL) and Jeff Bingaman (D-NM), would limit conflict-of-interest waivers to one per meeting; prohibit that person from voting; and spell out procedures for the FDA to follow to identify non-conflicted experts for its more than 30 outside panels, whose advice the agency usually follows. About a quarter of all appointees in recent years have had some financial involvement: owning stock; consulting agreements; serving on speakers bureaus' with firms with a stake in the outcome of the advisory committees' proceedings. Readers who wish to contact their Senators to support the Durbin-Bingaman amendment can find email links here.
The amendment is being offered to a bill that reauthorizes prescription drug user fees, which now account for nearly half of the FDA's budget for approving new drugs. Critics of the overall bill, including a group of more than 30 physicians and scientists who signed this letter, letter, say the faster approvals tied to the industry user fees have led to greater drug safety problems and shortchanged the agency's safety surveillance system.
However, the user fee reauthorization bill, sponsored by Sen. Ted Kennedy (D-MA) and Michael Enzi (R-WY), does devote additional resources to monitoring the safety of drugs once they're on the market; gives the public greater access to clinical trial data; requires companies to come up with plans for monitoring the side effects and adverse events from drugs once on the market; and gives scientists at the FDA more freedom to raise objections to agency decisions or publish their findings in the medical literature. On the other hand, the Senate rejected allowing Americans the right to import cheaper medicines from abroad. And a last-minute amendment limiting the FDA's ability to restrict direct-to-consumer advertising, which had been pushed by broadcasters and publishers, passed with bipartisan support.
Stanford and UC May Kick Big Tobacco Off Campus
Stanford and the University of California later this month may institute a ban on researchers taking money from tobacco companies or their affiliated non-profits. The University of California Board of Regents will consider a system-wide ban on May 17. The Stanford faculty will vote on a similar resolution the same day. If adopted, the measures will mark the first time an entire research institution has cut its ties to the tobacco industry. Medical schools at Harvard and Johns Hopkins have adopted similar bans.
According to the San Jose Mercury News, only one Stanford researcher still takes money from Big Tobacco. John P. Cooke, director of vascular medicine and biology at the medical school, receives several hundred thousand dollars annually from the Philip Morris Foundation to study nicotine’s enhancement of blood vessel growth or angiogenesis. Though it accounts for 20 percent of his research budget, Cooke has agreed to stop taking money from the foundation in June when the current grant expires. All U.C. branches receive a total of $15.9 million from 19 grants.
Last August, federal district court Judge Gladys Kessler in the District of Columbia forced the dissolution of two of the industry’s long-time research foundations, the Council for Tobacco Research and the Center for Indoor Air Research, which were identified as part of a 40-year conspiracy to obscure the health risks of tobacco. Philip Morris has reinstituted a direct grants program to continue funding academic research, according to anti-tobacco activists
Interior Official Who Fed Industry Inside Info Resigns . . .
The Interior Department's Julie MacDonald has resigned one month after the agency's inspector general issued a scathing report alleging that she leaked sensitive information to industry and bullied environmental scientists into making their research fit her policies. MacDonald resigned on the same day that Sen. Ron Wyden announced that he would block the White House's nominee to run the Fish and Wildlife Service, Lyle Laverty, until allegations against MacDonald were addressed. Environmental advocates expressed fears that MacDonald's resignation would not end industry's control over the agency's enforcement of the Endangered Species Act. "MacDonald was the administration's attack dog, not its general," a Center for Biological Diversity staffer told the New York Times.
. . . While Scientists Protest Interior’s Endangered Species Rule
More than three dozen environmental scientists are protesting a Bush administration interpretation of the Endangered Species Act that will sharply curtail its enforcement, the Associated Press reports. Interior Department solicitor David Bernhardt recently ruled that a species will only be considered endangered if its numbers are significantly declining in currently inhabited areas. The ruling will allow the department to claim it is obeying the law if it keeps the remnants of a species intact somewhere. It would put the government out of the business of returning endangered species to areas where people drove them out, according to John Vucetich, a wildlife biologist at Michigan Technological University who helped organize the protest letter.
Odds and Ends
A federal judge says the First Amendment trumps privacy rights in voiding a 2006 New Hampshire law that made physicians' prescription-writing habits confidential. The ruling by Judge Paul J. Barbadoro came in a suit brought by IMS Health and Verispan, which collect the data and sell it to drug manufacturers. . . Eli Lilly & Co. has released a detailed report on the grants the drug maker gives to nonprofit groups and educational institutions.
Cheers and Jeers