Eight years and seven million patients later, we still don’t know whether the diabetes drug, Avandia, is safe or effective. This is largely because the manufacturer, GlaxoSmithKline, failed to vigorously pursue questions about cardiac safety and the Food and Drug Administration acquiesced in its feeble efforts. Both either ignored or tried to silence scientists who raised the alarm.
Avandia was approved for use in 1999 based on studies showing that it lowered blood glucose levels in patients suffering from Type 2 diabetes. At the time, the F.D.A.’s medical reviewer called for a postmarketing study to address cardiovascular risks. The company’s response was a study that looked primarily at long-term control of blood sugar — a potential plus in marketing the drug — and only glancingly at cardiac risks. Only because European regulators insisted on a more comprehensive study did the company start one. But experts believe even that study — which is still under way — isn’t well designed to provide meaningful answers.
So what’s going on here? One disturbing possibility is that Glaxo has designed tests that have the effect of meeting the company’s marketing objectives while minimizing risks. The F.D.A. may have allowed itself to be outmaneuvered, approving designs that won’t fully answer key safety questions.
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