Waffling on Avandia

11/24/2007- When it comes to ensuring that prescription drugs are safe, the buck is supposed to stop with the U.S. Food and Drug Administration.

But, in a case that can only be described as a dangerous form of waffling, the agency has abandoned its leadership role and is leaving it up to patients and doctors to decide who should take Avandia, the controversial drug for diabetics.

The FDA could have taken the route of Canada, which is keeping the drug on the shelf while narrowly restricting its use, but here in the United States, all that's being required is that the drug's container carry an advisory that is itself muddled.

For months, there's been growing concern that Avandia - manufactured by GlaxoSmithKline PLC - increases the risk of heart attacks in diabetic patients. Since then, some doctors no longer prescribe it, and some patients have refused it.

The newly required warning, in a black box, states that the "available data" on the drug's risk are "inconclusive." Doctors and their patients are forced to guess whether that means it is safe and, if not, why it's on the market.

The advisory also states that the drug could be associated with "myocardial ischemic events such as angina or myocardial infarction." If you are a doctor, you know that means a heart attack. If not, well, maybe you'll ask your pharmacist about the terms or look them up in a medical dictionary or online.

But, in that case, why do you need a watchdog agency like the FDA? Canada's health-care system isn't perfect, but at least its health agency, Health Canada, is willing to take a stand for its citizens. It says Avandia may only be used in combination with certain other drugs in patients with hard-to-control blood sugar levels.

Restricting the drug's use removes needless worry. Dr. Thomas Pickering, an advisor to the FDA and a cardiovascular disease expert at Columbia University Medical Center, says most doctors are as much in the dark as their patients. He isn't convinced of the heart attack risk, but suggests trying other drugs first.

Dr. Steven Nissen, of the Cleveland Clinic, who was first to warn about the potential risk for heart attack with Avandia, said the FDA's approach is imprecise, and he's right. The agency has called for a major study, but it won't end until 2014. Meanwhile, patients and doctors will muddle along, but that's not safe public policy.

The FDA should take the drug off the market or restrict its use to certain hard-to-treat diabetic patients. Either way, the agency must show some leadershi