Science  28 Sep 2001:
Vol. 293, Issue 5539, pp. 2367
  1. Court Asked to Reconsider

    Several academic groups are asking the Maryland Court of Appeals to reconsider part of a recent decision that they say could halt “virtually all” research involving children.

    The 16 August ruling, which concerned a study of home lead cleanup by the Johns Hopkins University (JHU)-affiliated Kennedy Krieger Institute, says no child or legally impaired adult should be allowed to participate in “nontherapeutic” studies involving “any risk” (Science, 31 August, p. 1567 and 14 September, p. 1997). This sweeping wording “would have a devastating impact” on research by barring standard procedures such as needle sticks and the use of placebos, says an amicus brief filed by JHU, the Association of American Medical Colleges, the Association of American Universities, and the University of Maryland Medical System. The groups ask the court to rescind this portion of the decision. An AAMC spokesperson says the court has indicated it may hear the appeal in October.

  2. West Nile Watch

    The West Nile virus keeps popping up in more U.S. states. In the last month, health authorities in Maine, Illinois, Wisconsin, Iowa, Kentucky, Alabama, and Tennessee reported detecting the agent in birds or other animals for the first time.

    West Nile, which had never been found in the Americas until it hit New York City in 1999, has now been reported in 24 states and the District of Columbia, and “we need to assume that it's going to spread throughout the country,” says Duane Gubler, head of the Centers for Disease Control and Prevention's arthropod-borne virus lab in Fort Collins, Colorado. Gubler suspects that migratory birds transported the virus to southern states such as Florida and Louisiana in the fall of 1999 or 2000; from there, it probably hitched a ride to the northern Midwest this spring.

    So far, the human toll has been relatively low: Early this week, there were 26 reported or suspected cases, including one fatality, compared to 62 cases in 1999 and 18 last year. And even if it conquers the rest of the country, good surveillance, prevention, and control measures should prevent the virus from becoming a major public health threat, says Gubler: “This is a virus we can deal with.”

  3. Self-Policing

    Clinical researchers at the University of Michigan (UM) are taking steps to keep ahead of ethics regulators. In a “proactive” move, says spokesperson Kara Garvin, a review of genetic and molecular medicine this year resulted in stepped-up oversight of all clinical protocols and a 3-year suspension of research privileges for Alfred Chang, a top cancer investigator.

    The self-initiated audit, according to the university, turned up inadequate or late documentation of informed consent, noncompliance with protocols, and improper reporting of adverse events. Chang's suspension and a decision to quadruple spending on clinical oversight, announced several weeks ago, are designed to reinforce “the importance of the rules governing clinical research trials, particularly those protecting human volunteers,” said UM vice president Gilbert Omenn.

    In a Web posting (∼newsinfo/Releases/2001/Aug01/chang.html), Chang argues that many patients had benefited from his studies but acknowledges the need for better compliance with the rules.

  4. Stem Cell Fight

    The Wisconsin Alumni Research Foundation (WARF), which holds the patent on human embryonic stem cells, has gone to court again in a bid to curb efforts by biotech company Geron to expand its claims over WARF's cell lines. The California company has an exclusive commercial license to use six types of cells derived from the Wisconsin stem cells, but it is claiming it still has an option for more.

    WARF says no, it doesn't want all its cells tied up by Geron and unavailable to other researchers, and it filed suit on 13 August to get a federal court to back up its reading of its agreement with the company. This week, WARF added a stipulation to the complaint: It wants the court to declare that Geron—contrary to the company's claim—has no exclusive rights to “research products” of the stem cells, such as cell-based screening assays, except where they have been combined with Geron's own patented technology.

    “We're anxious to be able to license other companies to make research products … without the cloud of Geron claiming that we've breached the agreement,” says WARF managing director Carl Gulbrandsen. A Geron spokesperson says the company doesn't comment on pending litigation.

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