Forbes reported about a study of acetaminophen (Tylenol) published in the journal, Hepatology (December 2005) noted that “Overdosing on acetaminophen is now the most common cause of acute liver failure in the United States, accounting for at least 42 percent of all cases seen at liver centers.” This is up from 28% in 1998.Of those who develop acetaminophen-related liver failure, 30% die. http://www.forbes.com/lifestyle/health/feeds/hscout/2005/12/01/hscout529427.html
Acetaminophen is best known by the brand name Tylenol, but many consumers don’t realize the drug is found in more than 100 over-the-counter products including cold and cough remedies such as Benadryl, Contac, Robitussin and Sinutab, and medications for menstrual cramp such as Midol and Pamprin, as well as Nyquil, DayQuil, Theraflu, Excedrin, Coricidin D, Triaminic, Dristan, and prescription painkillers, including Vicodin and Percocet. The profusion of products containing acetaminophen explains unintended overdosing.
The marketing strategy for Tylenol is a primary case example of pharmaceutical industry deceptive marketing: "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." http://www.counterpunch.org/gardner06202006.html
In the 1970s, Counterpunch reports, "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." http://www.counterpunch.org/gardner06102006.html
J & J failed to warn about its own product’s lethal risk while succeeding in scaring the public by making exaggerated misleading claims about aspirin lethality. The claim was picked up by Ralph Nader (Public Health Research Group) which pressured the government to issue warnings about aspirin, but not about Tylenol. In 1982 the Surgeon General issued a warning based on J & J’s false claim, and in 1986 the FDA required all aspirin products in the U.S. 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."
Meanwhile, the number of Tylenol related casualties is mounting. Counterpunch reports that according to the National Institutes of Health, last year there were approximately 2,000 acute liver failure cases, resulting in about 500 deaths according to William M. Lee, MD, of the University of Texas Southwestern Medical Center.
“Acetaminophen overdose is the leading cause for calls to Poison Control Centers (more than 100,000 /year); it accounts for some 60,000 emergency room visits annually.”
Yet, these devastating Tylenol-related statistics have been effectively concealed from the public by a media wall of silence and, according to Counterpuch, by J & J buying silence in sealed settlements: "Johnson & Johnson has paid out countless millions of dollars over the years to settle suits by Tylenol victims and minimize adverse publicity.”
Indeed, Media silence about hazardous drug effects has provided a shield enabling drug manufacturers—of both prescription and over-the-counter-drugs—to reap multi-billion dollar profits from the sale of hazardous, even lethal drugs.
The marketing of Tylenol (since the early 1950s) is an example of the drug industry’s “norm and practice.” This industry’s financial success is not linked to bringing life-saving or safe and effective medicines to market, but rather to this industry’s clever, albeit corrupt marketing practices. The FDA is demonstrably asleep at the helm as drug manufacturers regularly conceal lethal risks.
See also: Amanda Gardner, Acetaminophen Overdose a Growing Threat, Forbes, Dec. 2005: http://www.forbes.com/lifestyle/health/feeds/hscout/2005/12/01/hscout529427.html
Contact: Vera Hassner Sharav
Tylenol Toxicity Terror
June 10, 2006
By FRED GARDNER
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, the active ingredient in Tylenol, is about 2:1 -and even lower if your liver has been compromised by hepatitis or alcohol. 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.
The active ingredient in Tylenol, acetaminophen, had been known to have anti-fever and anti-pain effects since the end of the 19th century, but no drug company saw fit to manufacture it until McNeil Consumer Healthcare began marketing Tylenol Elixir for Children in 1955 as a safer alternative to aspirin.
Johnson & Johnson acquired McNeil in 1959. In the 1960s J&J pushed Tylenol forcefully after aspirin was associated by an Australian pediatrician named Reye (pronounced "Rye") with a very rare, potentially fatal condition involving the liver and ultimately the brain of infants and children who, Reye found, had been treated with aspirin in response to upper respiratory infections.
Acetaminophen is 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.
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.
For those with liver damage from hepatitis and/or heavy alcohol a smaller amount of acetaminophen than the recommended "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 a paper in Hepatology 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. 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. Last year there were approximately 2,000 such cases, resulting in about 500 deaths, according to Dr. Lee. Acetaminophen overdose is the leading cause for calls to Poison Control Centers (more than 100,000/year); it accounts for some 60,000 emergency room visits annually. 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 in the current 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. (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 OTC painkiller market. It generated almost 20% of J&J’s profits during the first three quarters of 1982. 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 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 the find themselves on the brink of losing everything," says a typically admiring text used in a Defense Department communications course. Actually, the terrorist’s attack in Chicago gave Johnson & Johnson an opportunity to conflate safety with purity (just as the terrorists’ attack on 911 enabled the Bush Administration to conflate safety with conquest abroad and repression at home). Johnson & Johnson reintroduced Tylenol with great fanfare "in new triple-safety seal packaging," writes the DoD analyst a glued box, a plastic seal over the neck of the bottle, and a foil seal over the mouth of the bottle." The label carried a warning not to use if the package had been tampered with -and nothing about liver damage. The unspoken message, etched heavily into consumer consciousness, was that the synthetic compound inside the bottle is perfectly safe as long as it’s pure.
James Burke, master salesman of Tylenol, has been selling the marijuana prohibition for decades. Bill Clinton gave Burke the Presidential medal of honor in 1996, when he was chairman emeritus Partnership for a Drug-Free America, the private-sector partners of the drug czar’s office. The Robert Wood Johnson Foundation helped launch and has been the major backer of another prohibitionist propaganda project the Community Anti-Drug Coalitions of America. Less than two weeks after Prop 215 passed in November 1996, the Drug Czar convened a meeting at which prohibitionist tacticians from the private and non-profit sectors, along with California and federal officials, discussed steps to block its implementation. Paul Jellinek of the Robert Wood Johnson Foundation said, according to notes taken by a government attorney, "The other side would be salivating if they could hear [the] prospect of feds going against the will of the people." This is an unusually frank acknowledgment of bias, conspiracy, and projection on the part of a man who thinks it’s all a game, who doesn’t understand the magnitude of the crisis.
There are some parallels between Johnson and Johnson’s public relations strategy with respect to Tylenol and the Prohibitionist ideology Burke et al have helped to frame. A misdirection play is involved. In the case of Tylenol, they made it seem as if safety was simply a function of sealing out adulterants In the case of marijuana, "the crude plant" can’t be defined as a medicine. False safety measures now abound. Drug testing has replaced good goggles in many a workplace.
The Big Bucks in Tylenol The Long War on Aspirin
June 20, 2006
By FRED GARDNER
Johnson & Johnson’s Acetaminophen is the active ingredient in Tylenol. McNeil Laboratories first marketed it (in combination with a barbiturate) in 1953 as a safer alternative to aspirin. The big selling point was that aspirin, then the best-selling 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 the 1970s 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. (Ralph Nader’s Public Health Research Group received credit in the media for pressuring the government to act.) In 1986 the FDA required all aspirin products in the U.S. 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 there were 172 cases reported 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.
In 2004 an Australian government committee evaluated the Reye’s warning statement on aspirin in a report that noted numerous inconsistencies in the diagnosis itself. "The viral illness which proceeds Reye’s Syndrome varies" from country to country, the report said. 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. "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 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," according to the Australian report, whose authors 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 -the body couldn’t make enough of a certain enzyme. 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 that "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."
More Americans probably fear aspirin as a cause of Reye’s syndrome than fear acetaminophen as a cause of severe liver damage. Yet, as discussed in a previous column there are approximately 2,000 cases of acute liver failure annually in this country, 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). The mechanism of action is not mysterious: 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. Recently Dr. William Lee presented data at a conference showing that one in eight cases of acute liver failure attributed to hepatitis B also involves acetaminophen poisoning.
Your correspondent asked Dr. Lee why manufacturers combine -"bundle"- acetaminophen with synthetic opiates, as in Percocet and Vicodin. (Tylenol with codeine is ubiquitous, while most U.S. pharmacies don’t even stock aspirin with codeine.) 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. There are people in DC who 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?
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, "[CEO James] Burke’s successor 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." Richard Cowan posted the Forbes piece on Marijuananews.com, with a commentary contrasting the safety profiles of Tylenol and cannabis. That was about 2,500 deaths ago.
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