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Old 08-11-2004, 09:15 PM   #1 (permalink)
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Default FDA Warns of Terrorist Drug Tampering

Posted on Wed, Aug. 11, 2004

FDA Warns of Terrorist Drug Tampering

DIEDTRA HENDERSON

Associated Press


WASHINGTON - Tampering with prescription drugs could be a way for terrorists to launch an attack on Americans, acting Food and Drug Administration Commissioner Lester M. Crawford said Wednesday.

Crawford said in an interview with The Associated Press that possible action by terrorists was the most serious of his concerns about the increasing efforts of states and cities to import drugs from Canada to save money.

Would-be terrorists need only poke around the Internet to learn how Tylenol, then the nation's leading painkiller, was removed from shelves, filled with cyanide and returned to stores to kill unsuspecting consumers two decades ago.

"I would think that's something they would be looking at," Crawford said of terrorists. "Nothing like that has happened," he added. "But it is a source of continuing concern."

A spokesman for the Homeland Security Department said it has received "no specific information" of such a threat.

"We do acknowledge that al-Qaida and other terrorist groups have studied agroterrorism techniques and have probably considered that tactic with regard to destabilizing the United States," said Brian Roehrkasse, spokesman for the Homeland Security Department. "While we must assume that such a threat exists generally, we have no specific information now about any al-Qaida threats to our food or drug supply."

FDA is under mounting pressure - and faces a lawsuit filed by the state of Vermont - to soften its stance on Canadian drug importation, seen by some state and city officials as a way to shave thousands to millions from drug bills.

The FDA has held fast, citing concerns about the safety and effectiveness of the illegally imported drugs. So far, however, the agency has done little more than issue warning letters. And Crawford said the agency has not yet decided whether to vigorously defend itself against the Vermont lawsuit.

The agency's concerns about Canadian prescription imports are many. According to Crawford, some drugs are shipped without proper refrigeration, some have the wrong potency and some are counterfeit, lacking active ingredients.

Crawford's top concern: Terrorists could strike at drugs.

He said he was recently briefed about the stream of previously unknown al-Qaida terror threats yielded by recent arrests and raids. Asked whether the briefing covered potential terror strikes involving products the agency regulates - including food and drugs - Crawford declined further comment.

Two recent product tampering episodes the agency faced this summer ended with no injury or death.

Baby food, which he said was probably singled out for its shock effect, was laced with ground castor beans in Irvine, Calif. The contamination source is unclear; no suspect has yet been arrested. Ricin, a deadly toxin, is made from castor beans.

And a shipment of lemons from Argentina - alleged to be impregnated with an unknown "harmful biological substance" - was barred from entry at the Port of Newark on Aug. 6. The U.S. Coast Guard, Department of Homeland Security and the FDA worked in tandem on the investigation, freezing the lemons to preserve the contaminant.

"There was nothing we could find in there," Crawford said.

The agency, however, can't pin its hopes on terrorist missteps, he said.

"The public-health implications of a terrorist attack using anything we regulate would be greater. It would be immediate. It would be problematic. I mean, not all terrorist attempts are going to be botched like the (baby food tampering)," he said. "But I would say terrorism would be at the top of the list. And, I think that's where it ought to be."

On other issues, Crawford said:

_A second review links antidepressants with higher suicide rates among children. While outside observers who have read both reports say they contain enough detail for the FDA to recommend Prozac as the first drug of choice for depressed youths, Crawford said the agency will wait until its advisory committee meets in mid-September to give the FDA an expert basis for action.

_Before year's end, the agency will provide regulations that define what is and what is not a low-, reduced- or carb-free item. The FDA is leaning toward educating the public about the health benefits of food by, perhaps, highlighting healthier foods with a "starburst" tag or color-coded label.

_New risk-management rules will reduce the chances of people getting seriously ill from salmonella enteritidis, which can thrive in egg yolks without sickening the laying hens. A small number of eggs are tainted but, because of egg-farm consolidation, contamination in a single outfit can quickly blossom. "If there's a problem with a farm, it would be closed down until it got decontaminated."


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