The Tylenol Mafia (12 page)

Hayes was brought in as the commissioner of the FDA in 1981 at the recommendation of Donald Rumsfeld, who needed an ally to help him gain FDA approval for aspartame, an artificial sweetener developed by Chicago-based, G.D. Searle. Rumsfeld had been named the CEO of G.D. Searle in 1977, a position he held until 1985. Previously, Rumsfeld was the U.S. representative from the 13th district of Illinois from 1962 to 1969. He served in a cabinet position under President Nixon from 1969 to 1975, and then served for two years as secretary of defense under President Gerald Ford.

In the fall of 1980, an FDA advisory board - the Public Board of Inquiry (PBOI) - met to consider Searle’s application for aspartame. The board issued its decision on October 1, 1980, stating: “The evidence suggested aspartame ‘should not be approved for marketing until further animal testing is conducted to resolve the brain tumor issue.’”

Rumsfeld, undaunted by this setback, stood up at a national sales meeting in 1981 and told the Searle representatives that he would “call in his markers” to get aspartame approved. Twenty days later, Ronald Reagan was sworn in as president. Rumsfeld immediately sought payment for the markers he believed Reagan owed him for reneging on his promise to nominate him for vice president, nominating George H.W. Bush instead. Reagan named Rumsfeld to his transition team that nominated Hayes to the position of FDA Commissioner.

One day after Reagan’s inauguration, Searle re-applied for approval to use aspartame as a food sweetener, submitting ten “new” studies to the FDA. On that very same day, President Reagan appointed Arthur Hayes as the commissioner of the FDA. Reagan knew it would take months to get Hayes into the position; too late for him to overrule the Board of Inquiry, so Reagan wrote an Executive Order making the FDA powerless to do anything about aspartame until Hayes got there. When Hayes took over as the FDA commissioner in April, he appointed a 5-person scientific commission to review the Board of Inquiry’s decision. It soon became clear that the panel would uphold the ban by a 3-2 decision. But Hayes then installed a sixth member on the commission, and the vote became deadlocked. Hayes personally broke that tie, and aspartame was approved in July 1981.

*****

On October 5, 1982, during an emergency meeting of the Joint Committee on Product Security (JCPS) in Washington, D.C., Arthur Hayes and J&J Company Group Chairman, Wayne Nelson, met with other FDA and pharmaceutical industry officials to develop tamper-resistant packaging. JCPS was a joint venture between the FDA and the Proprietary Association, a Washington, D.C.-based lobbying group for the OTC pharmaceutical industry. Almost all OTC manufacturers, including Johnson & Johnson, belonged to the Proprietary Association. Congress later enacted the Anti-Tampering Act based on the tamper-resistant packaging guidelines developed by the JCPS for OTC drugs.

Hayes left the FDA in September of 1983. Two months later he took the post of senior medical consultant for Burson-Marsteller; the public relations firm for G.D. Searle and Johnson & Johnson. Hayes was hired under a ten-year contract that paid him $1,000 for each day he worked. Burson-Marsteller Vice President, Buck Buchwald, stressed that Hayes was not involved in aspartame issues and worked but 10 to 15 days a year. However, a former Burson-Marsteller employee, who requested anonymity, said Hayes was hired precisely because of his decision on aspartame and other issues affecting company clients.

Hayes was later named to top executive and director positions at several pharmaceutical companies. He was the president and CEO of EM Pharmaceuticals from 1986 to 1991. He served on the Board of Directors at
Napro
Biotherapsutics
,
Celgene
, and
QuantRX
Biomedical, and he also received lucrative jobs from former Johnson & Johnson Company Group Chairman, Wayne Nelson.

Nelson, a graduate of Northwestern University in Evanston, Illinois, is credited with launching the Tylenol programs that made it the top selling analgesic in the United States. In September 1982, Nelson, then the chairman of McNeil, was named chairman of Johnson & Johnson International.

Nelson founded Nelson Communications in 1987. The company provided professional personal selling services to pharmaceutical companies through dozens of shell companies that offered a wide variety of marketing and advertising programs for promoting the drugs of major pharmaceutical manufacturers to doctors and consumers. Nelson brought Arthur Hayes into his company in July 1991 as the chief operating officer of
MediScience
Associates, a Nelson Communications subsidiary. Nelson later appointed Hayes as vice chairman and medical director of Nelson Communications.

For the first decade of Nelson Communications’ existence, its revenue came primarily from Johnson & Johnson. The company’s reliance on J&J gradually decreased as it gained business from other pharmaceutical manufacturers. Nevertheless, in 1996, nine years after the company was founded, J&J still accounted for 39 percent of Nelson Communications’ annual revenue of $86 million.

The connection between Johnson & Johnson and Arthur Hayes actually goes back to 1966 when Hayes was a captain in the United States Army. In addition to his role in overseeing the testing of mind-altering drugs for the CIA, Hayes was working on at least one experiment being conducted by Dr. Albert Kligman on behalf of the Army and Johnson & Johnson.

Since 1962, Dr. Kligman had been paid by the Army, Dow Chemical, and Johnson & Johnson to conduct experiments on inmates at Holmesburg Prison in Philadelphia. One of these experiments was a study on “the effects of poisonous vapors on the skin,” in which researchers dropped nitrogen mustard on “a limited area of [the inmates’] skin.” Nitrogen mustards are cytotoxic, and powerful and persistent blister agents. In principle, these compounds can also be deployed as chemical warfare agents. “This is a program for national defense,” Kligman proclaimed at the time, “…for once such vapors get through the skin they can destroy the nerve system and the central function of the brain.”

From 1964 to 1967, the University of Pennsylvania and the Ivy Research Lab Inc., which Kligman owned, received $326,840 ($2.25 million in 2012 dollars) from the U.S. Army, and an unknown amount of money from Johnson & Johnson to test the effects of nitrogen mustard on the skin. The tests were carried out on twenty Holmesburg Prison inmates who were issued up to $20 per week in commissary credit for their participation as research subjects. The Army’s contract project officer overseeing this experiment was none other than Captain Arthur Hull Hayes Jr.

Out of Kligman’s experiments at Holmesburg Prison, came Retin-A - a drug that would generate billions of dollars in revenue for Johnson & Johnson.

Hayes was sharply criticized for taking handouts from companies in the pharmaceutical industry while he was at the helm of the FDA. In May 1983, Jack Anderson, a Pulitzer Prize winning journalist and syndicated newspaper columnist, described the affinity Hayes had for accepting gifts from the companies he was supposed to regulate. “The slight, bespectacled Dr. Hayes, on his frequent travels around the country to speak to industry groups, had been mighty relaxed about accepting free plane trips and hotel accommodations from companies doing business with the FDA,” wrote Anderson.

When investigators for the Inspector General informed Hayes that he had violated ethics guidelines, “Dr. Hayes said that he is now being told that he violated rules he did not know existed.” One report stated, “He [Hayes] does not recall ever being briefed concerning the standards of conduct.” Yet in 1981, reported Anderson, Hayes told Congress of the need for these very standards, saying, the “FDA has made a major effort on a continuing basis to ensure that all employees are properly notified of the standards of conduct expected of them. We provide every new employee with an orientation to conflict-of-interest rules.” Though Hayes was never charged criminally for taking money from the industry he was supposed to regulate, the investigation into those payments did cause Hayes to resign under a cloud of impropriety.

13

________

No one from the Tylenol task force ever talked about the middlemen that actually distributed Tylenol to the Chicago area stores and pharmacies. Tom
Dulan
, of the
Daily News Record
in Harrisonburg, Virginia, did, however, dig up some information about the distribution of Tylenol that did not match the distribution model described by J&J and the FDA.

The Daily News Record
reported on Saturday, October 2, 1982 that several bottles of Tylenol from a batch implicated in the Tylenol poisonings had been sold at an IGA supermarket in Bridgewater, Virginia. One of the store’s customers had reported Friday that a bottle she purchased on Wednesday, September 29
^th
, bore lot number MC2880, the same lot number that was on the Kellerman and Janus Tylenol bottles. Jim Liptrap, the assistant manager of the Bridgewater IGA store, said another woman had also returned a bottle with that same lot number Thursday night. Liptrap said he then checked the store’s shelves and discovered more bottles from Lot MC2880, though he was not sure how many of the bottles from that suspect lot had been on the shelf and had no way of knowing how many bottles were sold.

“
Sav
-A-Stop,” a nationally known mass merchandiser, takes care “of the ordering and stocking,” said Liptrap. “We don’t keep an inventory of that,” he explained.
Sav
-A-Stop’s main warehouse for this area was in Richmond, Virginia, but the company maintained a small “receiving station” in
Weyers
Cave, near Harrisonburg, Virginia.

Ann Saylor, the manager of the IGA store in Grottoes, Virginia, said representatives from
Sav
-A-Stop, a “national receiving company” that orders Tylenol products for the store, had told her that none of the stock sent to Grottoes was from the suspect batches. Nevertheless, when employees checked their inventory, she said they found ten bottles with the MC2880 lot number. The suspect Tylenol bottles came from
Sav
-A-Stop’s warehouse in Salem, Virginia.

On Monday, October 4
^th
, the general manager of
Sav
-A-Stop’s Salem warehouse, Howard
Quoss
, spoke to the
Daily News Record
.
Quoss
said he “would not have any idea” how many bottles from the lots implicated in the Tylenol poisonings have been supplied to area stores. “Lot numbers are not listed on supply invoices that
Sav
-A-Stop receives from McNeil,”
Quoss
said. He then added, “We’re not shipping any more [Tylenol] until this is over.”

Sav
-A-Stop had annual sales of $250 million and was one of the nation’s largest “rack jobbers,” supplying some 18,000 health and beauty care products to 9,500 supermarkets and convenience stores nationwide. Companies referred to as “rack jobbers” rent space in retail stores and supermarkets to display and sell products. The people who actually restock the display-shelves are also called “rack jobbers,” or alternatively, merchandisers. As the job title implies, a rack jobber may bring in his or her own rack to display products. Retailers also allow rack jobbers to use store shelf space if it is available. Some rack jobbers work exclusively with one store or chain, while others do business with many retailers.

IGA, Kroger, and Safeway all contracted with
Sav
-A-Stop to deliver Tylenol and other healthcare-related products to their stores.
 
Officials from Kroger said they found 14 bottles from lot number MC2880 in the chain’s Roanoke, Virginia stores. A spokesperson for Safeway said Safeway Stores in North Carolina and central Virginia had sold an unknown number of bottles from Lot MC2880.

The distribution of Tylenol by rack jobbers exposes yet another problem with the “approved theory” of the Tylenol murders. The industry-wide use of rack jobbers to restock stores with OTC drugs like Tylenol certainly did not align with the version of reality espoused by spokespersons from Johnson & Johnson and the FDA. They had claimed that full cases of 72 bottles of Tylenol capsules were shipped unopened directly from the McNeil manufacturing plants to the retailers’ warehouses. According to
Newsweek
, many experts thought it was unlikely that any tampering occurred along the distribution chain, since the packages of Tylenol were “shrink-wrapped” in plastic in groups of six at the factory, and adulterating individual bottles before they reached retail stores would be readily apparent from the broken wrapping.
Newsweek
failed to name any of their “experts,” but one must have been FDA Deputy Commissioner, Mark Novitch.

Novitch had said that the Tylenol bottles were wrapped in plastic and put in cartons as they left the factory and remained that way until the retailers received them. “If a retailer had received an open package in which a bottle had been removed and tampered with, it would become immediately obvious,” said Novitch. But that simply wasn’t true. In reality, the cases of Tylenol bottles were typically opened and the plastic-wrap torn off the six-packs of Tylenol bottles before rack jobbers delivered the Tylenol bottles to retail stores.

In 1982, Safeway and Kroger were the two largest supermarket chains in the nation, and IGA represented the largest group of independent supermarkets in the nation. Tylenol was not delivered to these retailers in full un-opened cases. Instead, third-party rack jobbers ordered Tylenol for the retail stores and then restocked the stores’ shelves one bottle at a time. This process was nothing at all like the distribution process Mark Novitch had described.