AMERICAN FRAUD and The Tylenol Murders
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WILLIAM GRIGG, FDA Public Information Officer
 
 
 
 
 
FDA: Poisoning Does Not Mean Tampering Precautions Awry
 
February 12, 1986
 

WASHINGTON (AP) - The death of a 23-year-old New York woman after swallowing poisoned Tylenol capsules does not signal a flaw in anti-tampering regulations developed after the 1982 poisonings of seven people in Chicago, government and industry observers said Tuesday. William Grigg, a spokesman for the Food and Drug Administration, said the agency has found no evidence of tampering among other Tylenol bottles from the same store or factory batch as that which killed Diane Elsroth of Peekskill.N.Y.

 

He also said the Extra-Strength Tylenol capsules involved in Ms. Elsroth's death are among the most protected in the industry, with three separate barriers to tampering — a cardboard box that must be ripped open to get at the bottle, a plastic neckband seal on the outside of the bottle and a foil diaphragm seal on the bottle mouth. "It's one of the most tamper resistant packages in existence," Grigg said.

 

John T. Walden, senior vice president of the Proprietary Association, the trade group for non-prescription drug manufacturers, said the incident appeared to be "a single, isolated case of poisoning."

 

"There's no evidence that this was the kind of random tampering on the store shelf as was the case in Chicago in 1982," Walden said. "We don't have a national health and safety crisis here like we had for a time in 1982."

 

Dr. Frank Young, the FDA commissioner, said three out of 21 capsules left in the bottle Ms. Elsroth used were found to have been tainted with cyanide. But Grigg said other bottles on the shelf of the A&P grocery where it was bought showed no signs of tampering, although the batch has been on store shelves since last August.

 
 
FDA: Evidence Points Away From a Widespread Problem
 
February 13, 1986
 

Tests conducted on two of three poisoned capsules found in the botUe used by Elsroth showed that the cyanide had a different chemical profile from the chemical used in Chicago in 1982,. FDA spokesman William Grigg said Wednesday in a call from his Washington area office. The poisons used in both killings also differed from the cyanide used for testing and quality control in the Johnson & Johnson plant that produces the painkiller, Grigg said.

 

The FDA inspected the factorywhere the pills were made in in Fort Washington. "Pa., and determined that "there were no indications that it (the contamination) could be the result of the manufacturing," he said.

 

Grigg said the determination that the type of cyanide in the latest death differed from that found in Chicago or at the manufacturing plant constituted "two more pieces of informationthat continue to point away from a widespread problem."

 
 
 
 
FDA: Capsule Ban Not Right Response
 

NEW YORK (AP) — A ban on sales of over-the-counter drugs in capsule form is premature, despitethe scare over the death of awoman who swallowed Extra-Strength Tylenol capsules taintedwith deadly cyanide, federal officialssay.

 

The ban was suggested Sunday by Andrew P. O'Rourke, elected executive of Westchester County, the New York suburban area where Diane Elsroth, 23, died last week. Investigation also turned up a second bottle containing tainted Tylenol in the same town where, the bottle containing the fatal dose was purchased.

 

O'Rourke suggested the federal government control production and sale of all drugs in capsules, but federal Food and Drug Administration spokesman William Grigg said the government is not advocating such a ban.

"We think it's premature, until we know what the problem wasand have discussed it thoroughly,to propose solutions," he told TheAssociated Press.

Grigg said he expected representatives of the over-the-counter drug industry to discuss the issue during a meeting of the Proprietary Association in Washington this week. James A. Burke, chairman of Johnson & Johnson, which manufactures Tylenol, also disagreed with O'Rourke's suggestion. He said selling the drug from behind store counters "would deprive the public of the freest system in the world in terms of marketing consumer products."

 

O'Rourke, interviewed with Burke and FDA head Frank E. Young on ABC's "This Week With David Brinkley," said a bottle of tainted TyJenol capsules found in a Woolworth's store in the Westchester community of Bronxville came from a batch different from others around it. "That would appear to be reverse shoplifting, somebody came in and actually put it on the shelf," O'Rourke.

 

Capsules from a bottle bought at an A&P Food Store two blocks from the Woolworth's killed Elsroth. Sunday night, FBI spokesman Jack French had no comment on O'Rourke's information about the Woolworth's bottle, and Grigg would neither confirm nor deny whether it was true. But Bronxville police confirmed the bottle was the only one ofits lot on the shelf.

 
 
 

GROUP URGES BAN OF A PAINKILLER, CITING REPORTS OF KIDNEY DAMAGE

September 26, 1986
 
REUTERS
 

A private group that monitors the drug industry charged today that Suprol, a non-narcotic painkiller approved for sale last December, caused kidney damage and asked that it be taken off the market.

 

Dr. Sidney Wolfe, head of the watchdog organization, the Health Research Group, said in a letter to Frank Young, Commissioner of Food and Drugs, ''The unique kidney-damaging properties of Suprol, which lacks evidence of being any more effective than aspirin or other such drugs, demand its immediate removal from the market.''

 

More than 500,000 people in the United States have taken the drug, the group said.

 

A spokesman for the Food and Drug Administration, Bill Grigg, said in an interview that the agency had received 270 doctors' reports of kidney damage linked to the drug, made by McNeil Pharmaceutical.

 

Mr. Grigg said that in every case the damage was reversed after the drug was discontinued. ''If we began seeing cases of permanent damage, we certainly would consider further restrictions,'' he said.

 

Robert Andrews, a spokesman for McNeil, a subsidiary of Johnson & Johnson of New Brunswick, N.J., said the drug was safe so long as doctors followed cautionary guidance supplied by the company.

 

The private group said hospitalization had been necessary for about 25 percent of the more than 100 cases of reported kidney damage cited in its letter.

 

In April the drug agency announced that McNeil had received 16 reports of decreased kidney function and side and back pain in patients taking Suprol. It said McNeil had written doctors asking them to prescribe the drug with caution or consider alternative medications until it investigated.

 

''We will continue to share information with physicians and the F.D.A. on a timely basis,'' Mr. Andrews said in a telephone interview, ''but we know of no reason why removal of the drug from the market is appropriate as long as physicians have proper prescribing information.''

 

Dr. Wolfe said Suprol bore a ''remarkable'' similarity to Selacryn, banned in 1980 after it was found to cause liver and kidney damage.

 

Speaking to a charge raised by Dr. Wolfe, Mr. Grigg of the FDA said the agency discovered several years ago that four doctors had submitted false data in connection with research they performed on the drug for McNeil and other concerns. As a result, Mr. Grigg said, McNeil resubmitted its application for approval of Suprol after deleting the data supplied by the four doctors.

 

Suprol, as was Selacryn, is a nonsteroidal anti-inflammatory drug, a class of drug widely used in the treatment of arthritis symptoms and as a painkiller. Such drugs include ibuprofen and Feldene.

 

Correction: September 27, 1986, Saturday, Late City Final Edition

 

A Reuters dispatch from Washington yesterday, on a proposal to remove a non-narcotic painkiller from the market, incorrectly described another drug, Selacryn, that was banned in 1980. Selacryn is a diuretic used to treat hypertension, not a painkiller.

 
 
 
 
 
 
 
 

A spokesman for the Federal Food and Drug Administration, William Grigg, said the Yonkers death and two in the Seattle area last June that were traced to cyanide-laced Extra-Strength Excedrin capsules caused a wave of reports of tampering - 1,692 in the fiscal year that ended in October, compared with 129 the previous year.

 

Although the majority were unfounded, he said, ''they cause a great deal of difficulty for manufacturers and consumers, and we have to investigate each incident.''

 

The F.D.A. has developed radio spots and other announcements encouraging consumers to ''check the integrity of packages before purchasing them, just as we've learned to look left and right before crossing a street,'' he said. Under anti-tampering regulations imposed by the F.D.A. after the Chicago deaths, manufacturers ''must have a tamper-resistant feature and notification on the package of what it is,'' Mr. Grigg said. Those precautions have not been materially changed since the Yonkers death, he added, although stronger safeguards may be imposed.