The Tylenol Mafia (9 page)

On March 3, 1983, several nonfatal anaphylactic reactions were reported by a local television station in Syracuse, NY. The report featured a Syracuse physician’s account of his own life-threatening reaction to Zomax. This was the first bad publicity about Zomax to appear in the lay press. It was now clear that J&J could no longer effectively suppress the growing body of evidence on the dangers of Zomax, so Burke decided to recall the drug from the U.S. market, but only until the labeling could be rewritten. An FDA memo uncovered later stated that the “FDA and the manufacturer, McNeil Pharmaceutical, have been working on a stronger warning for the drug.” J&J continued to sell the drug abroad well into 1984.

The combined effort of J&J and the FDA to get Zomax back on the U.S. market ended abruptly when documents were publicized during Congressional hearings held in 1983 by the Intergovernmental Relations and Human Resources Subcommittee to investigate dangerous drugs approved by the FDA. Subcommittee Chairman, Ted Weiss, dismayed by the cooperative effort between J&J and the FDA to remarket Zomax, lambasted the FDA. “In view of Zomax’s higher risks, FDA had testified during the subcommittee’s hearings in April that it would not permit Zomax to be remarketed unless studies showed that there was a patient population for whom Zomax was better than other drugs in its class. Yet, in August, the FDA asked the advisory committee to decide whether to recommend that drug’s remarketing even though the agency had received no evidence proving the existence of such a patient population. In fact, one FDA official had urged the advisory committee to recommend remarketing without such evidence.”

“In seeking an advisory committee recommendation on the Zomax marketing issue,” wrote Chairman Weiss, “FDA totally disregarded its sworn testimony before the subcommittee.”

James Burke told
The Washington Post
that he was proud of his company’s handling of the Zomax problem. “I think we did a good job,” he said, “I don’t see how you could do it any faster.”

McNeil’s Associate Medical Director, Dr. James Dale, felt differently. “They were avoidable side effects. . . . I feel guilty. . . . We met and had the opportunity to take action. . . . We could have done something sooner.”

FDA spokesperson, William Grigg, shared none of Dr. Dale’s remorse. Regarding J&J’s handling of the Zomax issue, Grigg said, “This is a company that bends over backwards for safety.”

McNeil’s longtime head of regulatory affairs, Dr. Patrick Seay, disagreed with Grigg. Commenting in an internal memo about the delay in strengthening the warning in Zomax’s package insert, Seay wrote, “We resisted too much and waited too long.” Seay faulted the company for allowing its marketing division to gain “a greater role in the content and changes of the package insert,” an area traditionally left to the medical side.

McNeil used protective orders to bury damaging information that it had been compelled
to turn over to plaintiffs’ attorneys in more than 600 Zomax product-liability lawsuits that had been filed. As of October 1988, McNeil had taken only three cases to trial, choosing instead to settle the other cases outside of court without admitting any liability. As part of these settlements, J&J obtained confidentiality agreements that prohibited opposing lawyers and their clients from revealing what they had learned about Zomax.

Larry Foster defended the manner in which J&J executives handled the Zomax situation, stating that they handled both the Tylenol poisoning deaths and the Zomax-related deaths in a similar manner. “As we demonstrated in response to the Tylenol poisonings and again in the way we managed Zomax, our first responsibility under our credo is to our customers,” proclaimed Larry Foster. “Anybody who manages a business for the long term, as we do, knows that putting the customer first is the only way to increase sales.”

Not long after Johnson & Johnson took Zomax off the market, another McNeil painkiller came under fire. In October 1986, the FDA disclosed that
J&J scientists had deliberately falsified research test results to win approval for a new arthritis drug. The fake data was detected by FDA officials in reports on Suprol, an analgesic from the same class of drugs as Zomax. A leaked memo from the head of the FDA team that reviewed applications for licenses on arthritis drugs commented on the Suprol application: “I would be remiss if I did not comment on the quality of the data in this (application). It has been plagued from beginning to end with bad data. Some of it was deliberate falsification. Much of it has been the result of poor workmanship.”

In the last two months of 1985, the Institute for Clinical Pharmacology (IPHAR) in West Germany performed two more studies commissioned by Johnson & Johnson’s Swiss subsidiary. These studies showed clear evidence of Suprol’s adverse effect on the kidneys, but J&J did not submit that data to the FDA. On December 24, 1985, knowing nothing about the IPHAR studies, the FDA approved Suprol.

Johnson & Johnson suspended the sale of Suprol on May 16, 1987, after Congress had learned that 270 patients in the U.S. had suffered kidney damage while taking the drug. This suspension came just three days after the European Community had acted to halt sales of Suprol, and four days after Congressman Ted Weiss had scheduled a hearing for later that month to review Suprol’s approval by the FDA. Weis said, “The subcommittee’s 16-month investigation raised serious questions about why the Food and Drug Administration approved Suprol for marketing.”

J&J spokesperson, James Murray, said the decision to suspend sales of Suprol was not made because of the charges of kidney damage, but rather because of lagging sales.

It was standard practice at McNeil, before and after Johnson & Johnson acquired the company in 1959, to cover up dangerous adverse events linked to its drugs. Long before Zomax and Suprol - there was Flexin, a muscle relaxant with deadly side effects that were also kept hidden by McNeil. FDA Commissioner George Larrick testified in 1964 that mistakes by his agency and the withholding of information by Johnson & Johnson subsidiary, McNeil Labs, kept a harmful drug, Flexin, on the market for five years. Larrick said that in 1955, when McNeil Laboratories submitted Flexin as a drug to relieve muscle spasms, the company had a report that one test patient who used the drug had died from hepatitis. This information was not relayed to the FDA, which approved the drug in 1956.

In 1958, while asking the FDA to allow Flexin to be used in the treatment of gout, McNeil Labs stated: “Flexin has produced no irreversible toxic reactions to patients when administered daily for periods of over six months.”

Larrick testified otherwise. “The facts are that at that time the firm had received reports of seven deaths from hepatitis of patients who were also taking Flexin,” said Larrick. “In 1959, the firm then knew of 39 cases of hepatitis in patients taking Flexin, including 11 fatalities, and that 20 of these cases, including 6 deaths, had been directly ascribed to Flexin by the reporting physicians.” Larrick said the FDA reported the withholding of information by McNeil to the Justice Department. Yet the Justice Department took no action against McNeil or Johnson & Johnson.

In subsequent years, Johnson & Johnson did receive a couple of noteworthy slaps on the wrist
. One very public embarrassment came after Johnson & Johnson had repeatedly ignored internal warnings by employees of J&J subsidiary,
Lifescan
, about their
blood glucose-monitoring
device that gave inaccurate readings. On March 31, 1998, the FBI raided the headquarters of
Lifescan
.
J&J’s CEO at the time, Ralph Larsen, clearly remembers getting the news. “I was at a speaking engagement in Phoenix,” he remembers. “I got a phone call that said, ‘Ralph, you’re not going to believe this, but
we
just had a raid at our LifeScan headquarters by 30 or 40 armed federal agents. They’ve cordoned off the building and are serving a search warrant.’”

The raid came after two whistleblowers filed a claim with the government alleging that LifeScan was knowingly manufacturing and selling to the general public a faulty blood glucose monitoring system. The monitoring system erred by sometimes giving extremely low readings. It also improperly displayed an “error” message when the user’s blood glucose level was abnormally high, rather than indicating that the level was in fact high. The whistleblowers also said that LifeScan had sought to conceal these problems.

After a three-year investigation, the Justice Department intervened in the case and reached a settlement that required LifeScan to plead guilty to criminal violations and pay $60 million in fines and civil penalties. LifeScan acknowledged that they had introduced an adulterated and misbranded medical device, failed to provide appropriate notifications and information to the FDA, and submitted false and/or misleading reports to the FDA.

“Mistakes were made in the LifeScan situation,” said Larsen. “There were errors in judgment. We did too little, too late.”

Another notable sanction was handed out to Johnson & Johnson in 1995 when U.S. District Judge William
Bassler
levied a fine of $5 million on J&J subsidiary, Ortho Pharmaceutical, for destroying documents when a regulatory investigation into its marketing of Retin-A intensified. Ortho admitted its executives had ordered workers to shred thousands of documents on how it marketed Retin-A. J&J also
paid an additional $2.5 million in legal fees
and Ortho Pharmaceutical pleaded guilty to obstruction of justice and corruptly persuading others to destroy the material. Judge
Bassler
said in his ruling that the company “had absolutely no right to interfere with federal investigations of those activities.” He said the company tried to put itself “above the law.”

10

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Illinois Governor Jim Thompson described the Tylenol killer as a “madman.” Thompson complained that the State of Illinois was pouring millions of dollars into the “hunt for the mad Tylenol killer, a killer or killers who is putting a state, indeed a nation, into fear.”

In a similar vein, Health and Human Services Secretary Richard Schweiker said the poisoning of the Tylenol capsules appeared to be the work of “a maniac.”

After the Tylenol murders investigation had gone cold, Illinois officials admitted that they had only referred to the killer as a madman in an effort to draw him out. How exactly that strategy would have drawn out the killer was never explained.

On the one-year anniversary of the Tylenol murders, IDLE Commander Thomas Schumpp dismissed any suggestion that the killer was a madman. “We’ve got a person here who can operate in normal society,” he said. “I think this person used good planning. The person obviously doesn’t want to get caught, probably hasn’t discussed it with anyone.”

Tyrone Fahner said on the one-year anniversary of the murders, “I don’t think
it’s
some whimpering, simpering fool, but a cold, calculated, deadly person.”

Dr. Robert Reifman, Director of the Cook County Psychiatric Institute, theorized that the killer was a sadistic, well-organized loner. He suggested the killer was of above-average intelligence and predicted that authorities were “going to have a tough time” finding the culprit.

Dr. Daniel Faisal, a psychiatrist at Forest Hospital in Des Plaines, Illinois, said the Tylenol killer probably was not psychotic because his methods were too rational.

The FBI brought in John Douglas to develop a psychological profile of the Tylenol killer. Douglas, according to the biography on his web site, is the legendary head of the FBI Support Unit and a pioneer in developing profiles for some of the most notorious and sadistic criminals of our time, including the “Tylenol poisoner.” At the time of the Tylenol murders, however, Douglas admittedly had no experience in this type of case.

In his book,
Mind Hunter
, Douglas says, “Despite the fact that this was early in my career and I’d never done a product tampering case before, nor had I ever interviewed a convicted tamperer in prison, it seemed to me that the killer would likely fit the development models we’d observed for other types of cowardly predators.” Douglas said the Tylenol killer had not targeted a specific person or store, and there appeared to be no motive. “The country was witnessing a form of terrorism; someone, somewhere, could contaminate almost anything they bought and they would innocently consume it and die.” Douglas said the Tylenol tampering was, therefore, a crime involving psychological distance.

Douglas said he believed that the killer was a man with a long history of failures in all areas of life who would probably have a record of complaints of injustices against him. He would have gravitated toward positions of authority, but would have had trouble keeping a job and likely had a psychiatric record. He would have had periods of depression and hopelessness explained Douglas, and likely experienced some stressful event around the time when the deaths occurred late in September. He would also be talkative about the news story to anyone who would listen.

Dawn Hobbs, a journalist who covered the criminal justice system in the 1980s
, said
the profile constructed of a Tylenol terrorist was criticized by some as being too general to be of any assistance in the investigation. In a criminal case that lacks evidence and involves a random selection of victims, like those in the Tylenol murders, the chances of constructing an accurate profile significantly diminish, said Hobbs. Nonetheless, she said a profile is often an essential tool that can assist investigators, at least to a certain degree, in their search for the perpetrator.
On the other hand, said Hobbs, a criminal profile also has the ability to mislead an investigation.