Friday, February 15, 2008

Government Drowning in the Bathtub

The dream of Grover Norquist was to make the government small enough for that, as you may remember. But a government unable to carry out some of those essential tasks is not such good news for us ordinary chumps:

A Chinese factory that has not been inspected by the Food and Drug Administration is the source for the active ingredient of a critical blood-thinning drug whose production was suspended this week after 350 patients reported ill effects from it.

At least four people died after being given the drug, heparin.

An F.D.A. spokeswoman, Heidi Robello, said Wednesday that the agency was making plans to inspect the Chinese factory as well as a finishing plant in New Jersey "as soon as possible."

She said that "it was yet to be determined" if the Chinese plant was the source of the problem that led to the spike in reports of problems with the drug's use.

Heparin is made from pig intestines. Ms. Robello said that she did not know whether the pigs used to produce the suspended product, made by Baxter International, came from China.

Heparin is used widely in dialysis, heart surgery and chronic care hospitals. Baxter manufactures half of the nation's supply of the drug, and the company's suspension of its production of multiuse heparin vials is expected to lead to shortages.

A Baxter spokeswoman, Erin Gardiner, said her company bought the active ingredient for the drug from another concern, which she would not identify. She said that company had plants in the United States and China.

The Government Accountability Office recently reported that at its current inspection pace, the F.D.A. would need at least 13 years to inspect every foreign drug plant that exports products to the United States. The office, an independent arm of Congress, also found that the F.D.A.'s computer systems were deficient and it had little idea how many plants had been approved for exports to the United States.

How do you like that struggle in the tub, Grover? Note that people needing heparin are usually quite fragile already.

There are two separate issues that trouble me here. The first is the fact that the FDA's ability to protect us from dangerous drugs appears to be close to nil. Remember when we were told that buying medications from Canada might endanger our health because who knows what their quality might be? Now it turns out that the quality control of the U.S. delivered drugs is sorely lacking. We'd probably be much better off with all Canadian drugs.

The second issue of concern is how most everything these days is manufactured in China. I have nothing against the Chinese, but it's not a safe policy to have one country specialize in the production of the majority of the foods we eat and of the drugs we take, especially when countries outside China have very little ability to affect the quality control inside that country. We urgently need some internationally enforceable rules about quality control, environmental protection and worker safety.