Drug Industry Defends Packaging Safety : Admits Little Can Be Done to Enhance Tamper-Resistant System
Drug industry officials, stung by the latest Tylenol poisoning, conceded Tuesday that there is little they can do to further enhance the safety of packages already designed to thwart tampering.
“We’re not giving up on trying to do more, but there’s no guarantee that we can,” said John T. Walden, a spokesman for the Proprietary Assn., an industry trade group. “We have found no breakthroughs, no magnificent new ways--no miracle systems.”
Walden said that drug industry officials, after meeting with Food and Drug Administration technical experts here, “feel absolute confidence in the system they developed in 1982,” after cyanide-tainted Tylenol capsules killed seven persons in the Chicago area.
Additional Controls
He said that the industry would try to develop some additional packaging controls “to make it impossible to get into (a container) without leaving tracks,” but “everyone feels the basic system is in place, and they see no reason to throw it away.”
FDA spokesman William Grigg said agency officials would continue meeting with representatives from trade, consumer and medical groups, as well as state officials, in the next few days to discuss the situation. But “it’s difficult to forecast what recommendations may emerge,” he said.
On Feb. 8, cyanide-laced Tylenol capsules killed Diane Elsroth, a 23-year-old Peekskill, N.Y., woman who died at the home of her Yonkers, N.Y., boyfriend. Several days later, a second bottle of poisoned Tylenol was found in a store less than two blocks from where the first bottle had been purchased. Both the FDA and the company immediately confiscated thousands of capsules in Yonkers and outlying areas.
Grigg said that, as of Tuesday, the agency had examined 270,400 capsules and found no further cyanide contamination.
Following the Chicago cases more than three years ago, experts from industry and government designed the current tamper-resistant packaging.
Walden, whose group represents 83 companies that make nearly all over-the-counter medications sold nationwide, said there is “no hope” of designing a package that is absolutely tamper-proof.
“You can’t make anything tamper-proof,” he said. “You can’t even make a vault tamper-proof. Burglars prove it all the time.”
Walden dismissed the suggestion that other companies follow the decision Monday of Tylenol’s manufacturer, Johnson & Johnson, and remove all capsule products from the market.
‘No Need for It’
“This industry sees no reason to entirely give up capsules,” Walden said. “There is no need for it in the name of public health. It is the preferred method of taking medicine.”
He said medications in capsule form are easier to swallow than uncoated tablets and are an effective way to administer timed-release formulations. In addition, he said, capsules tend to sustain less damage during shipping than uncoated tablets, which chip and break.
In a related development, Felicia Elsroth, the mother of Diane Elsroth, told wire service reporters Tuesday that Johnson & Johnson’s decision to remove its capsules from the market was “three years too late.”
Elsroth described her daughter as “too good for this Earth” and said her remarks were “not the ravings of a mad mother.” Her daughter loved her boyfriend, Michael Notarnicola, and his family “very much,” she said.
Not a Suspect
Notarnicola opened the suspect bottle and gave Elsroth the capsules when she complained of feeling ill. Authorities have said that he is not considered a suspect.
Westchester County Medical Examiner Millard Hyland said Tuesday in White Plains, N.Y., that his office has begun reviewing all deaths and autopsies in the county since Jan. 1 to look for evidence of cyanide that may have been overlooked.
“In light of the events of the past week, it bears a second look,” said county spokesman Marc Moran.
In Tyler, Tex., police and federal officials continued to investigate an East Texas man’s claim that Tylenol contaminated with cyanide caused his poisoning three weeks ago but said they had no evidence that tainted Tylenol had caused his illness.
