Alert Consumer Is Best Defense, FDA Chief Says
The U.S. Food and Drug Administration is considering several new actions in its war against criminal tampering with over-the-counter medicines, but an “alert and vigilant consumer” is still the best defense against its perils, FDA Commissioner Frank E. Young said Sunday.
“I’m not convinced there’s any way, unless we put a cop in each person’s house, we can prevent an adulterated bottle from getting there,” Young said in an interview. “If someone takes a bottle and throws in a poison at point of purchase, that’s beyond what the FDA can protect you against.”
He added: “Regretfully, we’ve assumed all our medicines are safe and we don’t look at them. Nothing is absolutely safe, whether it be capsules, tablets or caplets. I’d be misleading the American people if I implied otherwise.”
Angry Over Incidents
Young expressed wrath over the incidents of recent weeks--in which two people died in Auburn, Wash., of cyanide-tainted Extra-Strength Excedrin capsules--as well as the death last February of a New York woman who took cyanide-laced Extra-Strength Tylenol capsules.
“This kind of terrorism is just like a burglary--in this case, the burglar burglarizes our trust,” he said. “I get angry that someone would do this to us as citizens.”
Young said that consumers “should make no assumptions and should examine carefully every dosage form and every tamper-resistant feature before ingesting the product. I do--and I would advise everyone else to.”
He added: “Just because there is a police force out there, we still lock our doors at night. We never assume that no one can get in.”
Young said the FDA is considering asking industry to initiate--and pay for--several new steps to combat further episodes of tampering. They include adding a third layer of tamper-resistance to packages, and placing illustrations on the outside of packages showing a facsimile of the “untampered” dosage form so that consumers “will know what to look for and can tell by comparing whether or not it has been tampered with.”
The agency also is examining ways to enhance the safety of capsules themselves, such as making them transparent or sealing them, or both, so that tampering can be more easily detected.
Capsule Ban Not Considered
Although both Johnson & Johnson, the manufacturer of Tylenol, and Bristol-Myers, the maker of Excedrin, have permanently halted production of all over-the-counter capsule products, Young said the FDA is not considering a ban on capsules.
“I’m not convinced that banning capsules is the appropriate way to go,” he said. “Once you start down this road, you start banning dosage forms until the next tampering incident comes out. Then you don’t have any dosage forms left. My thinking is: We need to have some way of increasing the tamper-resistant packaging and educating the consumer to look at the dosage form.”
He added: “I think that’s the best protection. It’s not a cop-out. It’s a real line of defense.”
The recent pattern of homicide-by-tampering began in 1982 with the still-unsolved killings of seven Chicago-area people who took cyanide-laced Extra-Strength Tylenol.
In the latest poisonings, Sue Snow, 40, a bank manager from Auburn, Wash., died June 11, while Bruce Nickell, 52, a state maintenance worker also from Auburn, died June 5. Both had apparently taken Extra-Strength Excedrin tainted with cyanide. The King County medical examiner’s office announced Sunday that five earlier suspicious deaths it had reviewed for cyanide poisoning were found negative.
In another case still under investigation, Diane Elsroth, a 23-year-old stenographer, died last February in Yonkers, N.Y., after ingesting Extra-Strength Tylenol laced with cyanide.
The Elsroth death was followed by a rash of incidents.
The death of a Pullman, Wash., woman was ruled not a case of tampering, while a cyanide poisoning case in Tennessee was ruled a suicide. Last month, a University of Texas student died from cyanide poisoning that authorities said was linked to a bottle of Anacin-3.
A former stock brokerage clerk was arrested in Los Angeles last month and charged with placing rat poison in capsules of Contac, Teldrin and Dietac. No one was harmed in that tampering episode.
Young said his agency has investigated hundreds of “false alarms” in recent months and has spent $6 million and “135 person-years” on tampering since February.
He acknowledged that the tampering problem was “unsettling,” but added: “The comforting thing is that very, very few cases of tampering actually have occurred when you realize that over 12 1/2 billion analgesic capsules have been sold since 1982. In that sense, the number of tampering incidents has been very low.”