Is the liver damage risk associated with Tylenol real?
J&J's dirty little secret - Despite bad publicity and costly legal settlements, Johnson & Johnson refuses to put ample warnings on its Tylenol labels.
By Thomas Easton and Stephen Herrera
IT WAS JUST AFTER the 1989 winter holidays. Lacy Keele, a 5-year-old living in rural Louisiana, was given a common remedy for the common flu: Tylenol. Only she got too much: four extra strength tablets in one day, her mother said, or twice what a child should receive. The overdose destroyed Lacy's liver. Within a week she was dead.
A jury found Tylenol to be a cause in her death, but it let Tylenol's manufacturer, Johnson & Johnson, off because her parents were adequately informed of the risks. Risks with Tylenol? The product's advertising slogan, after all, was: "Nothing's safer."
J&J won the legal skirmish-but the war is not over. In the eight years since Lacy died, there have been hundreds of fatalities and serious liver injuries attributed to acetaminophen, the active ingredient in Tylenol. J&J has paid out millions of dollars in legal settlements. A handful of these cases have drawn coverage in newspaper and television stories. The word is beginning to get out that, safe though it is in proper doses, Tylenol can be very dangerous indeed in doses not much greater.
Sophie Regosin-Hodges was 14 months old when an overdose of Tylenol almost killed her. Sophie's mother gave her Tylenol infant drops-but, acting under instructions from a pediatrician, used the dosage for a different product, Tylenol children's suspension liquid. You'd never know it from looking at the packages (see photo, p. 44), but the infant drops are three times as potent as the children's formula.
Sophie is 4 years old now. She survives by dint of a transplant of liver tissue from her father. She will be on immunosuppressant drugs all her life.
Mary Rose Palmison was a moderate drinker and regularly took Tylenol for back pain. In late 1993 she checked into a hospital suffering from nausea. A month later she was dead. According to the complaint in a case that J&J has settled for an undisclosed sum, Tylenol poisoning caused her liver to fail.
Antonio Benedi, then a 37-year-old aide to George Bush, drank wine with dinner on a Saturday night in 1993 and over the next four days took ten extra strength Tylenol tablets, hospital records show. He went into a coma and was saved only by a liver transplant. He sued and won $8 million from J&J.
We could go on. Our point is not that Tylenol is too dangerous to sell-Americans take billions of doses a year without suffering ill effects. The question is simply one of disclosure. Has Johnson & Johnson done all it could to publicize the hazards? Shouldn't the label, which is full of boilerplate about consulting physicians, be more explicit?
J&J has made grudging concessions, strengthening the warning label, a little at a time. After the Keele case, J&J added to the extra strength package: "Not for use in children." In 1994, after Benedi, it added a warning about using any pain reliever if you drink. It is planning to redo the confusingly similar packages on the two very different versions of Tylenol for young patients.
Still, J&J resists writing the kind of label that would really wake people up to the dangers of stepping over the line between permissible and impermissible doses.
Why not warn about possible liver failure? J&J says that "organ specific" warnings would confuse people. Why not talk about the risk of death? That would promote suicides, says the company: If people knew that acetaminophen was potentially deadly, they might find it a convenient means for departing this world.
When you've got an ache Tylenol rules the market for branded nonprescription headache, fever, allergy and cold remedies. These figures cover retail U.S. sales in only certain outlets.
Acetaminophen, a chemical vaguely similar to aspirin in molecular structure, has all of aspirin's ability to quell fevers and relieve pain, but without aspirin's tendency to upset the lining of the stomach. It also lacks a side effect that makes aspirin unsuitable for children: the one-in-a-million chance that a child taking aspirin during a spell of flu or a cold will come down with the potentially fatal nervous system complication known as Reye's syndrome.
The Johnson & Johnson subsidiary McNeil Consumer Products Co. has been selling Tylenol since 1955. It has brilliantly marketed the limited advantages of acetaminophen over aspirin. J&J has no patent on the chemical, which was first used in Germany almost a century ago. Yet it has made Tylenol into a stunning moneymaker. Wall Street analysts estimate J&J's revenue for Tylenol at $1.3 billion a year. The fact that generic acetaminophen is available at about half the price suggests J&J's small profit margin is pretty hefty.
J&J spends a lot of that gross profit to strengthen the brand. Advertising Age estimates the company's domestic ad budget for Tylenol at $250 million, more than Coca-Cola spends on Coke. The money hasn't been wasted. Tylenol holds an overwhelming share of the acetaminophen market, and a 30% share of the combined market for branded sniffle, headache and fever remedies.
Which perhaps explains J&J's reluctance to make people more aware of Tylenol's dark side. At least 100 suits have been filed against Johnson & Johnson over acetaminophen poisonings, half in the past three years. In four cases we know of-in Pennsylvania, Texas and Ohio-the company has made out-of-court settlements under agreements that require the plaintiffs to keep mum about the terms.
Damning evidence was dredged up during the trial over Benedi's near-death experience. In 1986 J&J polled several hundred people, including doctors, on their reaction to a hypothetical alcohol warning. Some 70% of the respondents said they wouldn't recommend use of the product for drinkers. In short, an alcohol warning might have threatened J&J's market share. Benedi's lawyers got a lot of mileage out of that point.
In response to studies tying liver damage to the use of acetaminophen and alcohol, Johnson & Johnson drafted damage-control memos that also came out in court. One told the company's sales representatives: "Do not initiate discussions with your physicians on this issue." The second advocated: "diffusing media interest"-i.e., muddy the waters.
It's a tricky business to keep your customers from hurting themselves but not scare them away. Here's a useful idea: Tell customers to keep a log of doses taken. It's the cumulative dose over the course of an illness that matters. With the help of a log, a patient or a parent might notice that he has gone too far and call a poison control center in time to get help (see box, p. 42).
No, the log is not our idea, but J&J's. It is making the recommendation in a patient education brochure being sent to doctors. But the label says nothing about keeping track of doses.
The fact is that people do tend to use Tylenol in a casual fashion. Think about the circumstances: You have a headache and take a few pills. It still hurts so you take more. It's even worse with a child whose fever may be stretching the outer numbers on the thermometer at 3 a.m.
Under the circumstances, it just might make sense for the manufacturer to do everything possible to keep its customers on the safe side of the line. In a study cited at a Food & Drug Administration committee meeting in September, parents were given a choice of measuring devices for acetaminophen, the product label and the correct weight of their child. Still, 70% measured out the wrong dosage.
So what is on the label? A red-letter warning about avoiding the product if the package has been tampered with. This is a throwback to that infamous episode in 1982 when a murderer stuffed cyanide into Tylenol bottles.
Johnson & Johnson's adroit response to the tampering incident became a classic business school case study on corporate responsibility and crisis management. A tamper-proof container was introduced; J&J's then-chief executive James Burke visibly took responsibility for public safety. Burke brought a badly shaken consumer brand back to life.
Contrast this forthrightness with J&J's inch-by-inch concessions on label warnings about liver damage. The cyanide killed seven people. The American Association of Poison Control Centers counts about 100 deaths a year from acetaminophen alone or in combination.This figure understates the total, since hospitals are not required to report cases.
Burke's successor, Ralph Larsen, has a painful choice. He can rewrite the label, putting on it the verbal equivalent of a skull and crossbones. Or he can go on paying off victims, and hope for the best.
Which is the moral choice? Which, in the long run, is the best business decision?