Thursday, February 14, 2008

Baxter's Heparin Needs to Call Johnson & Johnson's Tylenol

The New York Times reported on a problem with Baxter's heparin drug. The firm suspended production this week after 350 patients suffered harmful effects from the drug. At least four people died.

Yet, the Food and Drug Administration and Baxter knew of the problem months ago. The article reported:

Public health officials noticed a problem with heparin supplies late last year when children undergoing dialysis at a Missouri hospital had severe allergic reactions. As officials investigated, they discovered hundreds of similar cases. Baxter initially recalled some of the product, but the problems persisted.

Recall the Tylenol scare and J & J's reaction? They pulled all inventory off the shelves. They wouldn't sell any product that might be deadly. What happened in this case?

The F.D.A. decided to allow Baxter to deliver heparin that it was in the midst of shipping for fear that a total recall would lead to an immediate and severe shortage of the drug. The F.D.A. cautioned doctors to use as little of the Baxter drug as possible and to infuse it into patients very slowly. The agency also suggested that doctors consider giving steroids or antihistamines along with the Baxter heparin to help prevent possible severe allergic reactions.

This is a prime example of the cost of poor quality, including greater risk of harm to patients and the cost of counteracting medicines. Baxter is responsible for the quality of their heparin ingredients, regardless of where they're manufactured. In this case, one plant is in China and the other, the company would not mention. The FDA plans to inspect the Chinese plant in the near future. One might expect Baxter to have already done so. They've known about the problem for months. What did the company find?

This story hit the wire the same day the SEC voted on relaxing its rules for foreign firms. If the Chinese plant marked their packages in English, would that make it a quality product? Bush's SEC seems to think so. It looks like "buyer beware" all around. I bet you didn't think you'd need your doctor or financial advisor to exercise it on your behalf...