ScienceScope

Science  17 Jun 2005:
Vol. 308, Issue 5729, pp. 1725
  1. House Targets Conflicts at FDA

    1. Jennifer Couzin,
    2. Genevra Ornelas

    The U.S. House of Representatives last week tackled conflicts of interest at the Food and Drug Administration (FDA) head on, approving a bill that would set new restrictions on who can advise the agency. Voting 218 to 210, with most Democrats in favor, the House passed a measure that aims to end a common FDA practice: waiving conflicts of interest for potential panel members, such as accepting consulting fees from a company whose drug is under FDA consideration.

    FDA has been under pressure to crack down on possible conflicts in its advisory committees, which guide drug approvals. Earlier this year, for instance, The New York Times reported that 10 of 32 panel members examining COX-2 inhibitors had recent ties with companies producing the drugs.

    But politicians worry that the change could erode the quality of the panels. “The effect would be that the top experts … would not be able to advise the federal government about vaccines, biological products, medical devices, and drugs,” says Tom Latham (R-IA), who opposed the amendment.

    Longtime FDA critic Sheldon Krimsky of Tufts University in Medford, Massachusetts, called the measure “an important signal to the FDA to get its act together.” Now the Senate will consider the bill.

  2. Supreme Court on Drug Research

    1. Eli Kintisch

    Drug researchers cheered a Supreme Court ruling this week that a scientist may use a competitor's patented invention during early investigations related to government approval of drugs. But it remained silent on the larger question of whether all basic research with patented materials is exempt from infringement suits. Now the onus is on Congress to consider that blurred area.

    In reviewing a 9-year-old patent- infringement case between Merck KGaA of Germany and New Jersey-based Integra, the court reversed a lower court ruling that had narrowed a legal exemption from infringement for “preclinical” studies. Now the lower court will re- review the case in light of the high court's decision. “This is a big win for discovery drug companies,” says attorney Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP in Chicago.

  3. Cancer Trials Revamp

    1. Jocelyn Kaiser

    A panel convened by the National Cancer Institute last week recommended a sweeping restructuring of NCI-funded clinical trials.

    Among the most far-reaching of the group's 22 recommendations is to create scientific steering committees to coordinate all phase III trials for major cancers. “That's a huge change,” says panel member Richard Schilsky of the University of Chicago, noting that the varied ways trials are currently reviewed can lead to redundant studies.

    The 77-page report also calls for a central database of trials with summary results, and it sets aside new funds for molecular medicine. Total costs of the restructuring plans are estimated at $113 million over 5 years. NCI Director Andrew von Eschenbach, who called for the review 18 months ago, said on 7 June that the reorganization “will change the future of clinical research.”

  4. Want Ads Go Up at NASA

    1. Andrew Lawler

    The new NASA chief is wasting no time sweeping out the old to make way for the new. Last week, a number of senior managers said they would leave the agency in the coming months; other departures were confirmed by agency and industry sources. Those leaving include NASA science chief Al Diaz and his deputy Ghassem Asrar, space-flight chief William Readdy and his deputy, and exploration directorate head Craig Steidle, a retired Navy admiral brought on board last year. To the surprise of many space insiders, Steidle's deputy Steve Isakowitz, a longtime influential insider, will also resign. Expect replacements to be named after NASA returns the space shuttle to flight, now scheduled for mid-July.

  5. U.K. Space Program Criticized

    1. Daniel Clery

    A committee of the British House of Commons slammed the U.K. space program in a report last week, charging that it doesn't properly assess the risks of projects or analyze whether they achieve their goals. Particular criticism was leveled at the failed Beagle 2 Mars lander. Mass constraints, a tight timetable, and poor management gave the mission “no real prospect of success,” the report charged, adding that uncertain funding was a factor. Beagle 2 chief Colin Pillinger of the Open University says the government has learned its lesson and has “already put aside money for the next flight opportunity.”

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