June 6, 2007 -- The controversy surrounding GlaxoSmithKline'sdiabetes drug Avandia mounted Wednesday as a medical expertprepared to tell lawmakers executives threatened him with legalaction when he first raised questions about the treatment's safety.
Dr. John Buse was contacted by SmithKline Beecham in 1999 afterdrawing attention to a trend in heart problems among patients usingAvandia, according to testimony he was prepared to give a Housecommittee. Buse says the representatives from SmithKline, whichcombined with GlaxoWellcome in 2000, mentioned that some in thecompany wanted to hold him accountable for hurting sales of thedrug.
Buse, soon to become president of the American DiabetesAssociation, said he eventually signed a clarifying statement withthe company that was used to ease concerns from investors.
One year later, Buse sent a letter to the Food and DrugAdministration raising the same concerns.
Glaxo's head of research, Moncef Slaoui, and the head of the FDAwill also testify before the House Committee on Oversight andGovernment Reform.
Rep. Henry Waxman, D-Calif., a frequent critic of FDA and thechair of the oversight committee, announced the hearing after ananalysis in the New England Journal of Medicine concluded Avandiacould raise patients' risk of heart attack by more than 40 percent.
In his opening statement, Waxman said FDA officials failed toact on warnings from Buse and others in the eight years sinceAvandia was approved.
"Despite additional warnings from outside experts, despite themillions of patients who rely on Avandia to control their bloodsugar, and despite the potential risks involved, FDA never requiredthe manufacturer to conduct a thorough post-market study of itsheart risks," Waxman said.
Waxman is among a group of House Democrats who want to give FDAmore powers to regulate drug companies. The Senate recently passeda version of a bill that makes major changes to FDA's drug safetysystem, though companion legislation has not yet appeared in theHouse.