Vioxx study's publication derailed by FDA queries

WASHINGTON -- Government questions about ''basic data integrity" derailed publication of a report raising safety concerns about arthritis drug Vioxx on the eve of a contentious congressional hearing, according to an e-mail exchange.

Without a clear agency go-ahead, Food and Drug Administration safety reviewer David Graham withdrew the paper from consideration for publication in The Lancet medical journal. The paper said high doses of Vioxx tripled the risk of heart problems compared with a rival painkiller.

The whistle-blower told Congress on Nov. 18 that drug regulators fumbled on safety with Vioxx. Graham said the agency left America virtually defenseless against the next Vioxx debacle and he named five other problematic drugs on the market.

The Lancet's editor, Richard Horton, had already pointed to ''lethal weaknesses" in the FDA's regulatory oversight regarding Vioxx in a scathing editorial published in early November.

Graham's paper was a peer-reviewed version of research he presented this summer in France. It would have noted that heart attacks and sudden cardiac deaths were higher among Kaiser Permanente patients taking high or low-dose Vioxx, compared with Celebrex.

The FDA said yesterday it didn't try to thwart publication of the article, but at the same time noted that Vioxx already had been withdrawn from the market. Merck & Co. cited an increased risk of heart attack and stroke when it pulled the drug Sept. 30.

According to the e-mails, FDA superiors peppered Horton with last-minute concerns about the article's scientific accuracy. USA Today published a story on the exchange yesterday.

Graham's study examined the records of 1.4 million Kaiser Permanente patients taking typical doses of Vioxx as well as daily doses greater than 25 milligrams.