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FDA Suspends Gene Therapy Tests


For the second time in four months, a child treated with an experimental gene therapy in France has developed a form of leukemia apparently caused by the treatment.

The new cancer case, in a boy who was given new genes to cure a severe immune system deficiency, undercuts scientists’ initial hopes that the first case was a fluke, and calls into question the value of the radical treatment, which had been touted as the first successful use of DNA to cure a disease.

In response, the Food and Drug Administration Tuesday suspended as “a precautionary measure” more than two dozen U.S. gene therapy studies that involve techniques similar to those in the French experiment. Three U.S. gene therapy studies that even more closely resemble the French experiment had already been on hold since the first leukemia case came to light in September.

The new cancer case is a serious blow for an experimental field that has struggled for a dozen years to produce its first cure and which suffered a terrible setback in 1999 with the death of an American patient, Arizona teenager Jesse Gelsinger. The approach involves the delivery of new genes to take over missing or broken ones.

Alleged ‘Dirty Bomber’ Has Nothing To Tell U.S., Lawyer Says


In her strongest challenge yet to the government’s case, the attorney for alleged “dirty bomber” Jose Padilla said Tuesday that the American-born captive being held as an enemy combatant is not a terrorist and that he “has no information to provide” military interrogators.

Donna R. Newman, a New York lawyer who is seeking to meet with her client, also alleged that authorities are merely engaged in “foot dragging” in trying to keep her from fashioning a defense that might get him released if prosecutors never file criminal charges.

“Although the government presents facts showing Padilla had contact with and was acting on behalf of al-Qaida, there is nothing to indicate that Padilla in particular was trained to transit information in the way the government suggests, or that he had information to transmit,” she said in a court filing in New York.

She and prosecutors are to meet Wednesday with U.S. District Judge Michael Mukasey to sort out their differences about whether the attorney-client meeting should be held.

Indeed, prosecutors asserted, more than 100 terrorist threats have been thwarted by information picked up in interrogations with numerous captives since the Sept. 11 attacks on the World Trade Center and the Pentagon.

High Court Hears Defense of HMO Limits on Choice of Doctors


Saying the very future of managed health care may be at stake, an attorney for a group of HMOs on Tuesday urged the Supreme Court to strike down state laws that give patients more power to choose their own doctors.

At issue in the case is a Kentucky “any willing provider” statute, which, like similar laws in more than a dozen states, requires HMOs to let patients see any doctor willing to meet the health insurer’s conditions for participation in its network, whether the HMO selected that doctor for the network or not.

Such laws were passed to address the common complaint that HMOs excessively restricted patients’ choices, but the attorney, Robert Eccles, said they create “uncertainty” in the industry and run afoul of a 1974 federal law that gives the U.S. government exclusive power to regulate employee benefit plans.