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Listening to Tylenol

At the March 12 meeting of the Society of Cannabis Clinicians, Bonni Goldstein, MD —in the course of an extremely informative talk on cannabis in the treatment of autism and epilepsy— remarked that she was “mortified” that she had prescribed so much Tylenol in her years as a pediatrician. For those who have not yet heard the news…

The active ingredient in Tylenol, acetaminophen, is the most widely used drug in the US —and it has the narrowest therapeutic ratio of any drug sold over the counter. The “therapeutic ratio” of a drug compares the amount required to produce harmful effects with the amount required to provide benefit. The therapeutic ratio of acetaminophen is about 2:1.

An Extra-Strength Tylenol contains 500 milligrams of acetaminophen. The recommended daily maximum is eight pills —4,000 mg, or four grams. A person taking twice that much can incur severe liver damage —and people in pain sometimes lose perspective and gulp a handful. “Seven to eight grams a day for three or four days can be fatal,” according to William M. Lee, MD, of the University of Texas Southwestern Medical Center.

Acetaminophen was known to have anti-pain and anti-fever effects when it was synthesized in 1909, but no drug company saw fit to manufacture it until 1953, when McNeil Laboratories brought it out (in combination with a barbiturate) as a safer alternative to aspirin. McNeil’s big selling point was that aspirin, the then-ubiquitous painkiller, is hard on the stomach. Preceding the launch, McNeil had hired a leading critic of aspirin, a gastroenterologist named James Roth, and organized a conference. “In 1951,” the company history recounts, “the safety and efficacy of acetaminophen was described at a scientific symposium in New York City sponsored by the Institute for the Study of Analgesic and Sedative Drugs. According to the research reported at this symposium, acetaminophen was found to be as effective as aspirin for pain relief and fever reduction, but without the side effects of aspirin such as stomach irritation, gastrointestinal bleeding, and impairment of the blood to clot normally.”

McNeil launched Tylenol Elixir for Children —pure acetaminophen— in 1955. The company history says, “The outstanding success of Tylenol was attributed to a unique marketing strategy: to inform health care professionals of the undesirable effects of aspirin and ask them to recommend Tylenol to patients susceptible to these effects.”

After Johnson & Johnson acquired McNeil in 1959 the safer-than-aspirin pitch was complemented by a massive giveaway of the product to doctors and hospitals, creating market share by irresistible financial force. In 1980 J&J sales reps began solemnly informing healthcare professionals that aspirin had been associated with “Reye’s syndrome” (pronounced “Rise”) a potentially fatal condition involving the liver and ultimately the brain of infants and children following viral illness. In 1982 the Surgeon General issued a warning to this effect. In 1986 all aspirin products were required to carry a warning label stating “children and teenagers who have or are recovering from chicken pox, flu symptoms or flu should NOT use this product.” A second sentence was added in 2003: “If nausea, vomiting, or fever occur, consult a doctor because these symptoms could be an early sign of Reye’s Syndrome, a rare but serious illness.”

It is a tribute to Johnson & Johnson’s marketing effort that so many people have heard of Reye’s and its association with aspirin, given how extremely rare it is. In ’86 there were approximately 100 cases in the U.S. In the UK, where better statistics are kept, there were 172 cases between 1986 and 1999 —only 17 associated with aspirin use. Aspirin (an extract of willow bark) is not as benign as cannabis, but it, too, has been on the receiving end of a corporate disinformation campaign. J&J has whipped up exaggerated fears of lethality —”Aspirin Madness,” you might say.

In 2004 an Australian government committee evaluated the Reye’s warning statement on aspirin in a report that noted, “The viral illness which proceeds Reye’s Syndrome varies” from country to country. In the US almost all Reye’s cases involve varicella or influenza A or B; but in the UK and Australia, gastrointestinal and other viruses are involved. “Another difference between Reye’s Syndrome cases in the UK and the US is the median age of the cases. In the US, the cases are usually over five years of age, with a median age of six-seven years. In the UK the median age of cases was 10-15 months… These differences between Reye’s Syndrome as it is commonly seen in the US and the UK (and, apparently, Australian) cases, have led to questions About whether the term Reye’s Syndrome refers to the same disease in both countries or, in fact, whether it refers to a single disease at all, or a heterogeneous group of disorders. “Despite over 20 years of study, there is still debate about the nature of the association between aspirin and Reye’s Syndrome,” states the report, which reviewed all the relevant studies.

In many cases it turned out that the symptoms attributed to Reye’s were actually manifestations of inborn errors of metabolism. In 1987 a researcher named Orlowski at the Children Hospital in Camperdown —Reye’s old hospital— reviewed the records of 20 patients diagnosed with Reyes, and found that only one had been administered aspirin (and “this patient had a zero salicylate level when admitted hospital after severe vomiting”). In 1999 Orlowski reevaluated 26 surviving Reye’s Syndrome patients [who had been assessed in 1990] and found that 18 had been diagnosed in the intervening years with other conditions, 15 of them with inborn metabolic disorders. “Orlowski also reanalyzed the records of all 49 patients in the 1990 study and determined “six had probable Reye’s Syndrome, two had possible Reye’s syndrome, 23 were unlikely to have had Reye’s Syndrome, and Reye’s Syndrome was excluded in 18 patients.”

The report notes that “A number of studies have been conducted to investigate how aspirin could be involved in Reye’s Syndrome. However, no clear mechanism of action has been defined. It is clear from the epidemiology studies that other factors apart from viral illness and aspirin exposure are involved… The data available does not confirm a specific or causal role for aspirin. It is likely that, if aspirin is involved in Reye’s syndrome, it acts to compound injuries to an already stressed metabolism.”

Acetaminophen turns out to be not as benign as Tylenol’s slogan, “Nothing’s safer,” alleged (and aspirin may not be as dangerous as the pharmaco-medical establishment now alleges). Acetaminophen poisoning has become the leading cause of acute liver failure (ALF) in the U.S. Some of the cases are suicide attempts, some are unintentional (“therapeutic misadventures”). Many consumers don’t realize they’re overdosing on acetaminophen because they don’t know it’s an ingredient in hundreds of over-the-counter drugs —Nyquil, DayQuil, Theraflu, Excedrin, Coricidin D, Triaminic, Dristan, Midol, Pamprin, etc.- and prescription painkillers, including Vicodin and Percocet, the two most widely used.

The liver, as it breaks down acetaminophen, makes a toxic compound, N-acetyl-para-benzoquinoneimine, which is then transformed to a benign one. In cases of overdose, the liver can’t fully process the toxin, which accumulates. For those with liver damage from hepatitis and/or heavy alcohol use, a “therapeutic” dose can lead to acute failure. In May Dr. Lee presented data at a conference showing that one in eight cases of acute liver failure attributed to hepatitis B also involves acetaminophen poisoning. Lee summarized: “If you are sick with acute viral hepatitis and taking acetaminophen, you are more likely to go into acute liver failure… even if you take therapeutic doses.”

Given acetaminophen’s known effects on the liver, Lee commented, “I am surprised that it’s still on the market.” He elaborated to a Reuters reporter: “I don’t think that any drug with this amount of (use) and length of time on the market will ever be taken off the market, but there should be labeling change.” Lee noted that the FDA doesn’t require that over-the-counter medicines containing acetaminophen so state on the front of the package -although it’s been four years since an FDA advisory committee recommended that the agency impose such a requirement.

Last November Lee co-authored a paper in Hepatology that described a study led by Anne Larsen of the University of Washington Medical Center analyzing data gathered at 22 U.S. liver-transplant centers on 662 patients suffering acute failure over the course of five years. Forty-two percent of the cases had been caused by acetaminophen. “The annual percentage of acetaminophen-related ALF rose during the study from 28% in 1998 to 51% in 2003,” according to Larsen et al. “Median dose ingested was 24 g (equivalent to 48 extra-strength tablets). Unintentional overdoses accounted for 131 (48%) cases, intentional (suicide attempts) 122 (44%), and 22 (8%) were of unknown intent. In the unintentional group, 38% took two or more acetaminophen preparations simultaneously, and 63% used narcotic-containing compounds. Eighty-one percent of unintentional patients reported taking acetaminophen and/or other analgesics for acute or chronic pain syndromes.”

The National Institutes of Health tracks acute liver-failure cases. In 2000 there were approximately 2,000 such cases, resulting in about 500 deaths. Acetaminophen overdose is the leading cause for calls to Poison Control Centers (133,000 in ’04, more than half required a trip to the ER or doctor’s office). Johnson & Johnson is putting out a blame-the-victim line, i.e., it’s your fault for not using as directed, or drinking alcohol, or inadvertently taking in combination with other drugs that contain acetaminophen. “If you’re not going to read the label, then don’t buy our products,” says a J&J spokesperson, haughtily, in the 2006 ad campaign. This may be a pre-emptive strike aimed at jurors who, in the days to come, will be weighing how much to award the families of Tylenol victims. It’s a totally hypocritical pitch. For years Johnson and Johnson has been manipulating the supine FDA to stall and soften any warnings that might put a dent in Tylenol sales.

The marketing of Tylenol is one of the all-time triumphs in the annals of corporate public relations. By the start of the ’80s, Tylenol had surpassed aspirin and had a 37% share of the over-the-counter painkiller market. By 1982 it was generating almost 20% of J&J’s profits. But then came a national recall of all Tylenol products, occasioned by a whacko terrorist in Chicago who laced some bottles with cyanide and killed seven people. CEO James Burke’s handling of the situation is held up in the business schools to this day as a model of genius p.r. It is the subject of many learned articles, theses, even books. “Johnson & Johnson’s handing of the Tylenol crisis is clearly the example other companies should follow if they find themselves on the brink of losing everything,” says a typically admiring text used in a Defense Department communications course. The terrorist’s attack in Chicago gave Johnson & Johnson an opportunity to conflate safety with purity (just as the terrorists’ attack on 911 would enable the Bush Administration to conflate safety with repression).

Burke held a press conference less than six weeks after the recall to reintroduce Tylenol in its new “triple-safety-seal packaging.” It was the number-one story throughout the country in all media. Here’s Howard Goodman in the Kansas City Times: “The package has glued flaps on the outer box, which must be forcibly opened. Inside a tight plastic seal surrounds the cap and an inner foil seal wraps over the mouth of the bottle… The label carries the warning ‘Do not use if safety seals are broken.’” The unspoken message, etched deeply into consumer consciousness, is that the synthetic compound inside the bottle is perfectly safe. All we have to do is keep faceless evildoers from doing evil… The label did not warn that overdose could lead to acute liver failure.

James Burke’s/J&J’s misdirection play on behalf of Tylenol was widely imitated and has resulted in every commodity known to man being shrink-wrapped. It’s likely that many more people have been fatally stricken by acetaminophen in the last 24 years than would have died from terrorists slipping adulterants into Tylenol bottles. A macabre equation… And how do you factor in environmental damage from the production and application of x tons of plastic? What about the frogs with their permeable skins? What about the workers involved —all that human effort wasted on gratuitous packaging?

Burke went from selling Tylenol to selling marijuana prohibition. “When Burke retired [in 1989] after almost forty years with J&J,” states his Harvard Business School bio, “he quickly found a new mission as chairman of the Partnership for a Drug-Free America, a coalition of communications professionals dedicated to persuading children to reject substance abuse. The result was the creation of the largest public service media campaign in the history of advertising -an endeavor that led President Clinton to award him in 2000 the Presidential Medal of Freedom.” The Robert Wood Johnson Foundation, J&J’s non-profit arm, has been the major financial backer of the Community Anti-Drug Coalitions of America (CADCA), another Prohibitionist propaganda network.

Paul Jellinek of the Robert Wood Johnson Foundation and Jim Copple of CADCA were among the strategists who met with California and federal officials less than two weeks after Prop 215 passed to discuss steps to block its implementation. They both pledged money for legal challenges to Prop 215 and a p.r. campaign to maintain Prohibition in other states. According to notes taken by an attorney from the Drug Czar’s office, Jellinek said, “The other side would be salivating if they could hear [the] prospect of feds going against [the] will of the people.” What a frank acknowledgment of bias and conspiratorial involvement! Fortunately, a California law-enforcement lobbyist was taking notes that got turned over to “the other side” in the Conant v. McCaffrey proceedings. Journalist Pat McCartney obtained them and wrote an exposé for O’Shaughnessy’s/

There are some parallels between Burke’s/J&J’s strategy to sell Tylenol and their strategy to sell marijuana prohibition. Both involve a relentless stigmatizing of a plant-based compound (acetylsalicylic acid in aspirin, THC in cannabis). Both involve a misdirection play and promote a cult of purity. In the case of Tylenol, the marketers convinced American consumers that safety was a matter of sealing out adulterants. In the case of marijuana, the “crude plant” is denied status as a medicine because it contains hundreds of compounds and is smoked. Drug testing is the workplace equivalent of the plastic seal on the bottle, keeping out the potentially harmful element. It’s a false safety measure. (In recent years, manufacturers and mining companies have cut back on safety equipment while stepping up their drug testing of employees.) Johnson & Johnson has paid out countless millions of dollars over the years to settle suits by Tylenol victims and minimize adverse publicity.

Occasionally the wall of silence by the corporate media gets breached, but the message that Tylenol causes liver damage has yet to reach the masses. A 1998 article in Forbes by Thomas Easton and Stephen Herrera critiqued J&J’s strategy: “J&J has made grudging concessions, strengthening the warning label a little at a time… Why not warn about people 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.” The Forbes piece concluded, “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.”

Tylenol with codeine is ubiquitous, while most U.S. pharmacies don’t even stock aspirin with codeine.)Asked why manufacturers combine —”bundle”— acetaminophen with synthetic opiates as in Percocet and Vicodin. William Lee replied, “The point of the bundling from the physician’s standpoint is that you do not need a triplicate form to fill in which most of us use very rarely have, but keep in a bottom drawer and (like me yesterday) cannot find… when we are on the run and trying to get someone relief. These compounds are the only ones that can be called in and written on a plain scrip. Not sure how it got enacted, however.”

If the rationale for making the acetaminophen-opioid drugs available by “plain scrip” is regulatory rather than medical, we suspect that J&J lobbyists had a hand in establishing it. This is not a conspiracy theory, it’s a conspiracy hypothesis. Many people in DC should be able to substantiate or disprove it. The question is: which lobbyists working for which corporations fixed which codes so that “bundling” drugs would facilitate prescription writing?

Listening to Tylenol At the March 12 meeting of the Society of Cannabis Clinicians, Bonni Goldstein, MD —in the course of an extremely informative talk on cannabis in the treatment of autism and