Amid Avandia doubts, diabetics consider alternatives

Like many diabetics, pharmacist Ben Briggs was eager to see his blood sugar drop when he began taking his new medicine.

But within two weeks, his ankles started swelling. His weight surged eight pounds, and he felt short of breath. "I was feeling awful," said Briggs, who runs the Lionville Natural Pharmacy & Health Food Store in Chester County. The symptoms stopped after he went off the drug, he said.

Briggs wasn't taking Avandia, the GlaxoSmithKline drug caught in a media firestorm in recent weeks because of its alleged links to higher heart-attack risk. The 59-year-old diabetic was trying Januvia, a competing pill from Merck & Co. Inc. that has benefited mightily from Avandia's problems. Many doctors are switching patients to other drugs, including Januvia, after a prominent researcher challenged Avandia's safety in the May 21 issue of the New England Journal of Medicine.

Yet, as Briggs' experience shows, patients and investors may need to tread carefully. Even newer than Avandia, Januvia has been on the market for only eight months, and prominent critics are already questioning why patients should take it when more proven choices, such as metformin and insulin, are available.

Experts say the questions swirling around diabetes drugs underscore a greater weakness in the drug-approval system. Many diabetes drugs are approved for improving a dimension of care, such as lowering blood sugar. But no one knows whether many of those new drugs can go further and help prevent the bad outcomes that really matter: heart attack, stroke, blindness, and amputation. Proving that can take years and add hundreds of millions of dollars to a drug's development.

Merck, based in Whitehouse Station, N.J., is pressing ahead to broaden the testing of Januvia and to monitor any side effects. The firm has seen no evidence of more heart or ankle-swelling problems in patients taking Januvia than in those not taking the pill, said John Amatruda, Merck's vice president of clinical research for metabolic disorders.

Merck has seen an uptick in nasal inflammation, he said, "but these events are, for the most part, transient." He noted that other diabetes drugs had many side effects and called Januvia "a major advance."