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New Web site will summarize select drug trials

/ Source: The Associated Press

An association that represents the nation’s leading drug manufacturers said Tuesday it has created a Web site where companies can list clinical trials they sponsored for drugs approved by the Food and Drug Administration.

Unlike the FDA’s, the Pharmaceutical Research and Manufacturers of America site will not list trials that are still enrolling patients. Nor will the PhRMA site post details of every clinical trial that companies sponsor, as drug makers GlaxoSmithKline PLC and Merck & Co. have promised to do.

Beginning Oct. 1, the site will summarize results from selected trials completed since Oct. 1, 2002, on FDA-approved drugs. No details will be listed from clinical trials for drugs that fail to gain FDA approval.

'Too little too late'

The announcement precedes a congressional hearing that will examine when the industry minimizes trials with negative results. At least seven drug makers are scheduled to testify Thursday at a hearing prompted by the discovery that unpublished data linked antidepressants to suicidal behavior in children.

Caroline Loew, PhRMA vice president for scientific and regulatory affairs, said the group’s announcement was “not a direct response to the congressional environment.” Loew is among the witnesses scheduled to testify during the House Energy and Commerce subcommittee session.

Dr. Jeffrey Drazen, editor in chief of The New England Journal of Medicine, dismissed PhRMA’s proposal as “too little too late.” Because PhRMA’s registry remains voluntary, drug companies won’t feel compelled to include studies that reflect negatively on their products.

Dr. Catherine DeAngelis, editor in chief of The Journal of the American Medical Association, said doctors and patients should have access to all results from medical studies because such data may affect treatment decisions.

AMA calls for government-run registry

The American Medical Association has called for a government-run registry to ensure that consumers and physicians can read details of industry-sponsored trials that question a drug’s safety.

Later this week, editors of leading medical journals are expected to announce they will reject papers unless researchers include clinical trials in such a public registry as patients are first enrolled, The Wall Street Journal reported Tuesday.

Alan Goldhammer, PhRMA associate vice president for regulatory affairs, said his group knew about the editors’ plans. The group will take a “hard look” at the journals’ formal announcement, he said, and remains open to suggested improvements.

Still, Goldhammer said, PhRMA remains committed to its own Web site’s mission. The PhRMA site aims to help physicians find drug information offered, bit by bit, through conference abstracts, posters and unpublished studies that didn’t sufficiently pique the interest of journal editors, he said.

Elsewhere in Congress, Sens. Chris Dodd, D-Conn., and Edward M. Kennedy, D-Mass., said they will propose legislation within the coming days to make such clinical trial listings mandatory.

“Voluntary measures are fine — to a point. But what is needed is federal legislation that will require all of the companies to do this,” said Jim Manley, press secretary for Kennedy.

Loew said the industry has a good record of compliance, and government mandates often take years to implement.

“We don’t believe this needs to be mandated,” Loew said. “We believe that (companies) will be posting data. But it’s out there. It’s open for people to see. We would welcome the public and the media to look at it and to, you know, hold our feet to the fire.”