Tylenol Toxicity Terror

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.


Angel Raich Gets Support From Her Son

Angel Raich sent an email to her friends June 9, “My son Tad has in the past not wanted to speak out about medical cannabis or about how it has affected him and his life growing up. Now at the age of 20 Tad wants to speak out in support of medical cannabis, and his mom. He asked me to send to you all. In June 2005 Tad joined the US Army. After being away from home and after working for the US government for almost a year and he is now stationed in Korea since January 2006. After seeing how the government treats medical cannabis patients for years and now seeing the way some of the higher ups treat some of the soldiers including him. He decided to make a statement to post on my website so people would know what it is really like growing up with a parent that using cannabis as a medicine and how it affects the children, the truth about medical cannabis through the eyes of a child, or when he was a child. I am proud of my son.”

Angel has posted Tad’s letter, which was written in April, on her webpage along with a picture of him graduating from boot camp on Sept. 1, 2005.

To the U.S. Government:

My name is Tad, I am 20 years old. This letter is about my mother and medical cannabis.

My mother first became disabled when I was 8 years old. She was confined to a wheelchair for several years and had a difficult time just getting out of bed. She could never make it to my basketball games or golf tournaments and barely made it to my 6th grade graduation. I was completely devastated — my own mother couldn’t go to any of my events because she couldn’t get out of bed. Then one day she told my younger sister and me that she started using medical cannabis. My sister and I were in complete disbelief. We couldn’t believe what she was telling us and we were completely against it. Then after a short while, my mom started moving around more and eventually started walking again. She was able to make it to more of my and my sister’s events. I have seen with my own eyes over the past 9 years that cannabis is a miracle drug.

You know, you call people who attack the United States terrorists, but what do you call yourself for attacking innocent civilians for trying to stay alive? TERRORISTS! That’s what you are. You are terrorists and I can tell you right now that I hate terrorists. So guess what that means? You are nothing but hypocrites. You can’t call MY mother a criminal or a terrorist for using medical cannabis to stay alive. She’s not harming anyone or attacking anything. She’s fighting for her life, so how the hell is she a criminal!

My mom has tried many prescription drugs and each and every one of them made her severely ill. Prescription medication approved by the Federal Government can cause patients severe side effects and possibly kill them. Medical cannabis hasn’t killed anyone! I am always hearing about recalls on prescription drugs because of the dangerous side effects, yet what deadly side effects does medical cannabis have? NONE!!!

They say this is the “Land of the Free.” How is it the land of the free when we have you TELLING US what to do with our bodies? Last time I checked, you don’t own our bodies. I can tell you that I am going to do whatever I want to my body because it’s mine and not yours, and NO ONE OWNS IT BUT ME!

I am going to do what I can to stand by my mom. I look at the flag and see nothing but hypocrisy. You are waging war against innocent civilians. You need to stay out of our private lives and let us do what we need to do to stay healthy and alive. We American citizens have the right to use whatever medication works to ease our pain and keep us alive. If it weren’t for medical cannabis I would have grown up without a mother. My mom is a mother who cares for her children and her life. I don’t see any harm or terrorism in that. So take a good long look at yourself and stay away from innocent civilians. All you are doing is causing a civil war against sick Americans, and in THAT war I will fight to protect my mother.”

FRED GARDNER is the editor of O’Shaughnessy’s Journal of the California Cannabis Research Medical Group. He can be reached at: fred@plebesite.com




Fred Gardner is the managing editor of O’Shaughnessy’s. He can be reached at fred@plebesite.com