The Drug Scare That Exposed a World of Hurt
[2008-4-9]
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.
After many near misses and warning signs, the heparin scare has eliminated any doubt that, here and abroad, regulatory agencies overseeing the safety of medicine are overwhelmed in a global economy where supply chains are long and opaque, and often involve many manufacturers.
“In the 1990s governments were all about trying to maximize the volume of international trade,” said Moisés Naím, editor in chief of Foreign Policy magazine and author of “Illicit: How Smugglers, Traffickers and Copycats Are Hijacking the Global Economy.” “I’m all for that, but I believe this decade is going to be about maximizing the quality of that trade, not quantity.”
Mr. Naím said the heparin scare is already having a “huge” impact, fueling worldwide anxiety over imported medicine and a growing demand for consumer protection.
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.
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.
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.
After many near misses and warning signs, the heparin scare has eliminated any doubt that, here and abroad, regulatory agencies overseeing the safety of medicine are overwhelmed in a global economy where supply chains are long and opaque, and often involve many manufacturers.
“In the 1990s governments were all about trying to maximize the volume of international trade,” said Moisés Naím, editor in chief of Foreign Policy magazine and author of “Illicit: How Smugglers, Traffickers and Copycats Are Hijacking the Global Economy.” “I’m all for that, but I believe this decade is going to be about maximizing the quality of that trade, not quantity.”
Mr. Naím said the heparin scare is already having a “huge” impact, fueling worldwide anxiety over imported medicine and a growing demand for consumer protection.
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.
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.
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