

When cold medicine containing a poison made in China killed nearly 120 Panamanians in 2006 and early 2007, Americans could take some comfort in the belief that a similar epidemic could never happen here, not with one of the best drug regulatory systems in the world.

Then last spring, hundreds if not thousands of pets died or were sickened in the United States by a Chinese pet food ingredient that contained lethal levels of melamine, an industrial product used to artificially boost protein levels. That was followed quickly by the discovery that Americans were brushing their teeth with Chinese toothpaste containing a poisonous chemical used in antifreeze.

Still, no Americans died from the chemical.

And then came heparin.

A hugely popular blood thinner used in surgery and dialysis, heparin turned out in some cases to contain a mystery substance that sophisticated lab tests earlier this month determined to be a chemically modified substance that mimics the real drug. The United States Food and Drug Administration has linked it to 19 deaths and hundreds of severe allergic reactions, though the agency is still investigating whether the contaminant was the actual cause.

What a difference a year makes.




Congressional Democrats are talking about authorizing more money so the F.D.A. can do more overseas inspections, particularly in China, where more and more drug ingredients are made. The agency is also completing a plan to permanently station employees in China for the first time.

“Just focusing on the borders of the United States does not work,” said Dr. Murray Lumpkin, a deputy commissioner at the F.D.A. “In order for us to do our job better domestically, we have to work better internationally.”

Chinese drug regulators have also begun to take small steps toward plugging some of the country’s gaping regulatory holes, particularly with the thousands of chemical companies that sell pharmaceutical ingredients without a drug license. Regulators have much to do and many obstacles to overcome in trying to adapt to changes brought on by globalization.

The way heparin is made and distributed illustrates the challenges they face. The drug’s raw material comes from mucous membranes in the intestines of slaughtered pigs. Those membranes are mixed together and cooked, a process that in China often takes place in unregulated family workshops.




“Advanced technology and global manufacturing outlets have made fake drugs a big and illicit business that is literally poisoning patients,” said Alan C. Drewsen, executive director of the International Trademark Association.

And since supply chains often pass through more than one country, there is no government agency with the power to police all of it. The World Health Organization runs a program that helps track counterfeit medicine, but it has no regulatory authority.

Manufacturers also need to do a better job of testing imported ingredients, drug experts say.

For example, tests failed to detect the heparin-like contaminant because it was so similar to the real thing. And that worries Dr. Roger L. Williams, chief executive of the United States Pharmacopeia, which sets quality standards for medicine and supplements.

“What you are seeing here is the tip of the iceberg,” Dr. Williams said. “How do we know what else has gone wrong?”

He said, for example, that melamine was missed because “we have a bad test for protein.” Other tests should also be improved, he said. To help companies identify diethylene glycol, the inexpensive poison that ended up in Panamanian cold medicine and in Chinese toothpaste, USP recently came up with a better way of determining if that poison is present.

Some leading members of Congress don’t want to rely so heavily on manufacturers to protect the public, particularly afterreports said poor management and scientific inadequacies have weakened the F.D.A.

More than 500 plants in China export drug ingredients to the United States but the agency inspected only 13 of them last year.

One of the plants not inspected was the one that made the contaminated heparin ingredient. That plant, Changzhou SPL, blames someone else further upstream in the supply chain for selling tainted raw materials.

The F.D.A. is continuing to investigate.

“We can blame the Chinese for this stuff as much as we want, but the truth of the matter is we are the people who are buying,” said Joseph G. Acker, president of a chemical trade association.

And Mr. Acker points a finger at the F.D.A., adding, “I think that organization needs a total overhaul.”