Free Trade in Dangerous Drugs

Article excerpt

When the news broke about poisonous pet food and lead-laden toys from China, I asked my local pharmacy to give me a letter stating that it is not selling me any prescription drugs imported from China. The reply was, "We do not buy any drugs from China."

I said, "I know you do not, but I want you to check with your suppliers and verify that they don't buy from China." That request was met by thunderous silence.

Now we know why. The Government Accountability Office (GAO) reported that 80 percent of the drug substances used by United States manufacturers to produce prescription drugs is imported. The majority come from Communist China.

That means most of our medicines and medical products are manufactured in thousands of unregulated, unsupervised plants run by managers who have no moral code that imposes an obligation to use ingredients that are safe in preference to those that are cheaper but poisonous or at least dangerous. As Walter Cronkite would say, that is the way it is.

One of China's largest pharmaceutical companies that export to the United States, Shanghai Hualian, has just been exposed to have marketed contaminated leukemia drugs that paralyzed or otherwise harmed 200 Chinese cancer patients. This is the latest in a string of tainted medicines. Manufacturers who have such little regard for the safety of their own countrymen are not likely to care about the safety of American patients.

Like so many scandals, the problem is not merely the crime but the cover-up of violations; the company refuses to tell what drugs it has exported to the United States. Chinese government authorities have arrested the C.E.O. [Chief Executive Officer]; maybe he will face the same fate as China's top drug safety official who was executed, but that does not solve the problem.

We do know that Shanghai is the sole supplier to the United States of the abortion pill, mifepristone, known as RU-486. Our F.D.A. [Food and Drug Administration] had previously concealed the source of RU-486, and its U.S. distributor, Danco Laboratories, does not list an address on its Web site or return press calls.

Criticism of the F.D.A. is mounting along with demands that the agency be given huge emergency injections of taxpayers' money to do a better job of inspecting imports. But the G.A.O. investigation leads us to believe it is unlikely that the F.D.A. could protect us from contaminated Chinese drugs even if it had ten times its current budget.

The F.D.A. is so overwhelmed by the flood of cheap drug imports that it is simply incapable of protecting the public from unsafe drugs and medical devices as well as food. …