Big Bucks in Tylenol

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Tylenol (calpol)

http://www.counterpunch.org/gardner06202006.html

June 20, 2006

The Big Bucks in Tylenol

The Long War on Aspirin

By FRED GARDNER

& '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 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 & 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 & '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. 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?

& 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 Easton

and 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 ] 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. " 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.

--------------------------------------------------------

Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines - http://www.wellwithin1.com/vaccine.htm

Vaccine Dangers & Homeopathy Online/email courses - next classes Sept 10, 2008