Source: O;Shaughnessy’s

Andrew Wiggins, 26, the Golden State Warriors smooth small forward, had a valid reason to fear the Covid-19 vaccine. He had once had an allergic reaction to Tylenol so severe that he started carrying an Epipen. Presumably this was known to the Warriors front office.

After Wiggins’s unwillingness to get vaccinated became known to the media in late September, he was criticized relentlessly. On October 4, after he yielded and got his shot, Rusty Simmons of the SF Chronicle quoted Wiggins explaining, “’I had a bad reaction a few years ago to Tylenol and from there I never really like to take anything. Let stuff heal naturally. That was a little fear factor.” Simmons may not have grasped the significance of the comment, which was buried in his article.

Having once had a strong, adverse drug reaction is grounds for a medical exemption to the Covid-19 vaccination mandate. If the Warriors’ well-paid media staff had explained and publicized Wiggins’s valid reason for not getting the shot, the dignified young athlete would have been spared a lot of nasty criticism. By not citing Wiggins’s allergic reaction to Tylenol, the Chase-Centered flacks were instinctively or consciously protecting the image of Johnson & Johnson and Capital-M Medicine. You can bet that if the Warriors refusenik had been assistant general manager Kirk Lacob, the owner’s son, the PR people would have publicized his valid excuse.

As I send this off on October 7, Wiggins’s severe reaction to Tylenol has been totally ignored by the media. This morning the front page of the Chronicle’s Sporting Green featured a piece berating Wiggins. The writer, Scott  Ostler had been woke for a while by Colin Kaepernick, but this was the Ostler of old, the scold who regularly ridiculed a “knucklehead of the week” (usually a young black man caught smoking marijuana). Today he wrote, “Before Wiggins got vaxed, he grumbled to the media that this was a personal issue. Even though his refusal to get the shot had negative implications for his team and his league, he said it was none of anyone’s business… Once Wiggins was vaccinated, he used his platform to veer into new and troubling territory. He scattered a sackful of dangerous ideas, like a misinformed Johnny Appleseed. He rambled about his doubts and concerns, including a fear that the vaccine might do long-term damage. Wiggins’ expressed fears are unsubstantiated by a shred of medical or scientific evidence. For those still weighing the pros and cons of the vaccine, the only thing worse than no information is false information…” And so forth. There was even a borderline-racist line about LeBron James heeding the wisdom of “a stranger in the barbershop.”

Does Scott Ostler not read his colleague Rusty Simmons? Did he and everyone else on the sports desk think Wiggins’ severe reaction to Tylenol was insignificant trivia from the irrelevant past? It was obviously of great significance to Wiggins and led to the “doubts and concerns” he expressed about the Covid-19 vaccine. His concerns were not clearly expressed, but they are not groundless. He was lied to about the safety of Tylenol. We all were.  (“Toadstools and Tylenol” is what UCSF medical students used to call their Pathology rotation at San Francisco General because the only cases of severe liver damage encountered were caused either by Johnson & Johnson’s painkiller, or poisonous mushrooms that Asian immigrants mistook for ones that were edible back home.)

Tod Mikuriya, MD, founder of the Society of Cannabis Clinicians, wanted case reports in O’Shaughnessy’s to always note the pharmaceutical alternatives to marijuana. His goal was to document the relative benignity of the herb. As a result I have many Tylenol clippings to forward to the Andrew Wiggins Defense Committee.

The active ingredient in Tylenol, acetaminophen, is the most widely used drug in the US, and it has the narrowest therapeutic ratio of any medication 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, as quoted in the NY Times.

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, was 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 and concluded that “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 poisoning has become the leading cause of acute liver failure 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. Dr. William Lee has shown 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 told the NY Times, “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.”

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 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.

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.”

Add items from O’Shaughnessy’s archive:

• From the British Medical Journal 3/3/15:

 “…The true risks of taking the drug [paracetamol in England,  acetaminophen in the US, brand name Tylenol] may have been underestimated, a UK team of researchers writes in the Annals of the Rheumatic Diseases.

“Philip Conaghan, professor at the Leeds Institute of Rheumatic and Musculoskeletal Medicine, and colleagues carried out a systematic literature review to assess the adverse event profile of paracetamol… The researchers found a dose related link between paracetamol and increasing incidence of mortality and cardiovascular, gastrointestinal, and renal adverse events…”

• From a case report by Lisa Sanders, MD, in the November 19, 2017 New York Times Magazine:

“Acetaminophen is the most common cause of acute liver failure in the United States. Half of all patients with liver failure, and one-fifth of all patients who need a liver transplant, sustained their injury using this common over-the-counter medication.

“When acetaminophen passes through the liver, some of the drug is broken down into toxic chemicals. A healthy liver can dispose of these dangerous components. But the liver needs nutrients to do this, and because she was so sick, this woman wasn’t taking in much in the way of nutrients. In addition, because she was pregnant, she was sharing her nutrients with her fetus.”

• From an article by Christie Aschwanden in the NY Times 12/9/11:

The sharp worldwide increase in childhood asthma over the past 30 years has long perplexed researchers, who have considered explanations as varied as improved hygiene and immunizations. Over the last decade, however, a new idea has emerged.

The asthma epidemic accelerated in the 1980s, some researchers have noted, about the same time that aspirin was linked to Reye’s syndrome in children. Doctors stopped giving aspirin to children with fevers, opting instead for acetaminophen. In a paper published in The Annals of Allergy and Asthma Immunology in 1998, Dr. Arthur Varner, then a fellow in the immunology training program at the University of Wisconsin School of Medicine, argued that the switch to acetaminophen might have fueled the increase in asthma.

Since then, more than 20 studies have produced results in support of his theory, including a large analysis of data on more than 200,000 children that found an increased risk of asthma among children who had taken acetaminophen. In November, Dr. John T. McBride, a pediatrician at Akron Children’s Hospital in Ohio, published a paper in the journal Pediatrics arguing that the evidence for a link between acetaminophen and asthma is now strong enough for doctors to recommend that infants and children who have asthma (or are at risk for the disease) avoid acetaminophen.

Dr. McBride based his assertion on several lines of evidence. In addition to the timing of the asthma epidemic, he said, there is now a plausible explanation for how acetaminophen might provoke or worsen asthma, a chronic inflammatory condition of the lungs. Even a single dose of acetaminophen can reduce the body’s levels of glutathione, a peptide that helps repair oxidative damage that can drive inflammation in the airways, researchers have found.

“Almost every study that’s looked for it has found a dose-response relationship between acetaminophen use and asthma,” Dr. McBride said. “The association is incredibly consistent across age, geography and culture.”

A statistical link between acetaminophen and asthma has turned up in studies of infants, children and adults. Studies have also found an increased risk of asthma in children whose mothers who took acetaminophen during pregnancy.

For instance, a study published in The Lancet in 2008 examined information collected on more than 205,000 children from 31 countries as part of the International Study of Asthma and Allergies in Childhood, known as the Isaac study. The 2008 analysis found that children who had taken acetaminophen for a fever during the first year of life had a 50 percent greater risk of developing asthma symptoms, compared with children who had not taken the drug. The risk rose with increasing use — children who had taken acetaminophen at least once a month had a threefold increase in the risk of asthma symptoms.

A study published by British researchers in 2000 using data from the Isaac study found that the prevalence of asthma increased in lock step with sales of acetaminophen in the 36 countries examined. The more acetaminophen used in a country, the greater that country’s prevalence of asthma.

A meta-analysis published in 2009 calculated that children who had taken acetaminophen in the past year had nearly double the risk of wheezing compared with those who had not taken the drug. “We know that acetaminophen can cause increased bronchial constriction and wheezing,” said Mahyar Etminan, a pharmacoepidemiologist at the University of British Columbia and lead author of the study.

Fred Gardner is a former editor of Scientific American. He got his booster shot today.

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