clinical trials, the company says, GSK stands firmly behind the safety of Avandia when used appropriately and we believe its significant benefits continue to outweigh any treatment risks.

Richter, however, said that even a tiny risk associated with a drug such as rosiglitazone, prescribed to millions of people, will eventually translate into grave consequences.

In view of the potential cardiovascular risks and in the absence of evidence of other health advantages, except for laboratory measures of glycemic control, the rationale for prescribing rosiglitazone at this time is unclear, say public health experts Bruce Psaty, M.D., and Curt Furberg, M.D., in a New England Journal of Medicine editorial published June 14. The journal published the initial analysis of Avandia.

Rosiglitazone represents a major failure of the drug-use and drug-approval processes in the United States, Psaty and Furberg write, comparing the situation to the withdrawal of the painkiller rofecoxib (Vioxx) from worldwide markets in 2004.

The Cochrane reviewers concur, saying, Current drug approval for antidiabetic medications and possibly all new drugs needs to be changed. However, they also question whether new studies with rosiglitazone will be ethical given the fact that less-dangerous therapeutic alternatives exist.

Lisa Esposito at (202) 387-2829 or hbns-editor@cfah.org.


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