How about Tylenol for your child’s cold or fever? How about Tylenol ADVERTISING to rev up a parent’s anxiety?

April 1, 2008 | By | 6 Replies More

Check out this current website from Tylenol. You’ll see that McNeil (maker of Tylenol) has heroically and voluntarily removed all of these medicines from the market:

Concentrated TYLENOL® Infants’ Drops Plus Cold
Concentrated TYLENOL® Infants’ Drops Plus Cold & Cough
PediaCare® Infant Dropper Decongestant
PediaCare® Infant Dropper Long-Acting Cough
PediaCare® Infant Drops Decongestant (containing pseudoephedrine)
PediaCare® Infant Dropper Decongestant & Cough
PediaCare® Infant Drops Decongestant & Cough (containing pseudoephedrine)

Why remove all these children’s medicines?  According to Tylenol, it’s because:

[W]e have become aware of rare instances of misuse leading to accidental overdose, especially in children under the age of two. Therefore, we are voluntarily withdrawing [these] concentrated cough and cold medicines from the market.tylenol-childrens

Really? Does the manufacturer of Tylenol really believe that it is removing these drugs only because consumers are misusing Tylenol products?  Or could it be something else, perhaps this relatively recent and damning press release by a reputable group of pediatricians:

Cold and cough medicines given to infants and toddlers work no better than dummy pills and can be dangerous, pediatricians seeking to curb their use told government health advisers Thursday.

The doctors told the Food and Drug Administration advisers that the over-the-counter medicines shouldn’t be given to children younger than 6 because they don’t help them and aren’t safe. Such a prohibition would go beyond last week’s drug industry move to eliminate sales of the nonprescription drugs targeted at children under 2.

The group petitioned the FDA seeking in part a government statement saying the medications shouldn’t be used in older children as well. The expert advisers began a two-day meeting to consider the issue. The FDA has yet to act, in part pending a recommendation expected late Friday from the joint panel of outside experts in pediatrics and nonprescription drugs, said the agency’s Dr. Joel Schiffenbauer.

The medicines have been marketed for use in children for decades, with drug companies spending $50 million a year on heart-tugging ads in parenting magazines and elsewhere. Still, it has long been acknowledged there is little or no data from studies in the very young to show the medicines are safe and work. Worse, some studies suggest the medicines are no better than dummy pills in treating cold and cough symptoms in young children, the petitioners said.

“When a treatment is ineffective, its risks — if not zero — always will exceed its benefits,” said Dr. Michael Shannon, a Children’s Hospital Boston pediatrician and Harvard Medical School professor who was another of the petitioners.

It’s quite amazing that the drug companies might be selling chemicals that don’t really do what the drug manufacturers say they do.  It’s most amazing because it happens so incredibly often.

What do I mean?  Consider the recent news regarding the scam regarding Prozac and other modern antidepressants. And remember Vioxx, the “miracle” drug that created 100,000 widows and widowers?   Not only are some of these drugs dangerous; another aspect of the scam is that many of these medical “miracles” don’t function any better than placebos for many patients.

But back to Tylenol.  This isn’t the first time Tylenol has been caught scamming the public.  If you Google “acetaminophen” and “liver,” you’ll see hundreds of sites that talk about the danger of taking a too much Tylenol (which might surprise you, given the common belief that there is considerable tolerance built into the product and given the existence of Extra-Strength Tylenol).  Follow this link to see that the makers of Tylenol have fought hard, at least since 1977, to keep the public from knowing that overdoses of Tylenol can cause liver failure.

How else would you explain that the FDA and the pharmaceutical makers delayed giving liver failure warnings for decades?  Since 2003, Tylenol has carried a liver toxicity warning, but it makes you wonder how many lives it cost when it delayed giving that warning.  It cost more lives when consumers use the cup that comes with Children’s Tylenol (see above photo) with the concentrated formulas of cough and cold concoctions (now discontinued) that should be administered with a dropper. You see, the discontinued formulas had higher concentrations of acetaminopen.  A parent mistakenly using the little plastic cup (that comes with children’s Tylenol)  instead of the dropper (that came with the (now-discontinued infant formulas) could destroy childen’s livers.  According to the manufacturer, it’s the consumer’s faut, even though swapping the cup for the dropper was entirely foreseeable.  But now, the maker of Tylenol can blame the consumers for the need to take these products off the market rather than admit (because the pediatricians were correct) that these products didn’t really work.

Aside from the risk of liver toxicity (which exists only when the consumer more than the recommended dose of Tylenol), isn’t Tylenol an important and effective way to reduce your child’s fever?  Is fever always a bad thing?

Mass marketing has programmed parents to fear all fevers and to feel a deep need to prove their dedication to their children by pouring bright red chemicals into their children’s mouths at the first sign of fever.

I have a different understanding of fever than most American consumers.   I believe that Tylenol’s multi-billion dollar budget (more money is spent per year on Tylenol than on Coca-Cola) is geared to making people needlessly anxious about fevers.   A low grade fever is not always dangerous.   In fact, it is rarely dangerous. Here are some guidelines as to when to treat a child’s fever.

The maker of Tylenol (and those who manufacture other fever-reducing products) have successfully convinced the public that something absolutely must be done to bring down all fevers in young children.  Is that good medical advice?  Usually not.  The pediatrician treating my children made it clear to my wife and me that even a fever that spikes up to 106 is not a problem in a young child as long as that child is hydrating (drinking fluids and peeing regularly).   At some point, of course a sustained fever should give a parent concern.  But a few days of 102 or 103 is usually nothing to be worried about—unless you watch a lot of television commercials that tell you that you MUST get that fever down by pouring those bright red chemicals into your child’s body (chemicals that are potentially harmful to your child’s liver).

Here’s one other thing to consider.  What if fever is not only not a bad thing, but acutally good thing?  What if fevers often serve as the body’s own natural reaction to fighting pathogens?  In fact, research has shown that bringing down a low-grade fever often delays healing.  But they don’t tell you that on the box of Tylenol, though, do they?   For the truth on fever, don’t read Tylenol bottles or watch Tylenol commercials.  Instead, consider things like this article by a Pediatrician named Dr. Greene or this one, entitled “Evolutionary Approach to Medicine”:

Antipyretics are frequently administered without a compelling medical reason.[15] In most febrile illnessess, there is no evidence that fever is detrimental or that antipyretic therapy offers any benefit. Likely exceptions to this principle may include pregnant women, patients for whom a hypermetabolic state could be dangerous, children with a history of febrile seizures, and patients who cannot tolerate a rise in intracranial pressure.

Keeping in mind that bringing fever down by using medication possibly postpones recovery, increases the probability of a secondary infection, deprives one of clues as to the need for further examination or for changes in the therapeutic approach, and may provoke widespread side effects, physicians should treat feverish patients only when the expected benefits outweigh the possible risks.

Consider also this article

Medical researchers have also debunked two commonly held misconceptions about high fever in children: that it can result in dangerous seizures, and that fevers from infection must be controlled before they reach a certain point, often 41°C (I06°F), to prevent seizures and brain damage. Febrile seizures, as they are called, are certainly frightening to watch, but they tend to occur early in the fever process, rather than after fevers have mounted, and a small percentage of children simply seem to be prone to them; administering fever-reducing medicine does not stave off their recurrence. They also do not have permanent ill effects, and although parents are advised to notify the doctor if their child has one, they are not necessarily a cause for alarm.

And while it is true that fevers over I06°F are potentially damaging, such high temperatures are virtually always the result of heatstroke or brain injury, not infection, and so fears of a cold — or flu — caused fever rising to this level are groundless. Michael S. Kramer and Harry Campbell, two child-health experts writing in a document for the World Health Organization, say, “One is left to conclude that the principal rationale for antipyretic [fever-reducing] therapy is to soothe worried parents and health care workers and to give them the sense that they are controlling the child’s illness, rather than it controlling them.

And consider this article:

In summary, what does the evidence seem to indicate? Fever represents a universal, ancient, and usually beneficial response to infection, and its suppression under most circumstances has few, if any, demonstrable benefits. On the other hand, some harmful effects have been shown to occur as a result of suppressing fever: in most individuals, these are slight, but when translated to millions of people, they may result in an increase in morbidity and perhaps the occurrence of occasional mortality. It is clear, therefore, that widespread use of antipyretics should not be encouraged either in developing countries or in industrial societies.

Unfortunately though, just as fever represents an ancient biological response, an emotional effect is embedded deeply. Through the ages, parents have seen that when fever begins to diminish and disappears, the child feels better and recovers from the illness — whatever it was. Thus, the fever has become synonymous with the illness. This flaw in logic has persisted in parents’ and physicians’ minds, and they are seduced by the thought that if they “make the fever go away, the patient will be well.” No amount of scientific discourse will change this attitude . . .

Consider, also, these excerpts from a book by Randolph Nesse, M.D. and George C. Williams, Ph.D.: Why We Get Sick: the New Science of Darwinian Medicine (1995):

Fever results not from any mistaken temperature regulation but from the activation of a sophisticated evolved mechanism.  If you put a rat with a 2° fever into a very hot room, the rat activates its cooling mechanisms to keep its body temperature 2° above normal.  If you put it into a cooler room, it activates heat conservation mechanisms to maintain that 2° fever.  Body temperature is carefully regulated even during fever; the thermostat is just set a bit higher.

We should emphasize that any given expression of a defense need not be adaptive, and that even when it is, it may not be essential.  We would not dream of recommending that people never take drugs to reduce fever…. even if we knew that it would prolong an infection, we would still sometimes want to block a fever.  Maintaining and improving health are, after all, not the only goals of medicine…. the important point, with respect to the adaptive significance of fever, is that we need to know what we are doing before we interfere with it.  At present we don’t.  If discomfort were the whole story, we could always choose to reduce or eliminate it.  But if reducing fever will often delay recovery or increase the likelihood of a secondary infection, we should interfere only when the expected gain is worth the risk.  We hope that medical research will soon produce the evidence to help doctors and patients decide when fever is and is not useful.

In honor of large pharmaceutical companies that do mass marketing directly to consumers for chemicals they don’t really need, I’ve decided to create a new category for DI posts which I will call “snake oil.”  This category is not limited to big Pharma, of course, but it is becoming clear that big Pharma is claiming more than his share of money gained through fraud.  By the way, in case you’re wondering why so many people speak so highly of Tylenol, you might first need to know how many hundreds or thousands of doctors are on the Tylenol payroll, being paid to speak highly of Tylenol.  McNeil (Tylenol’s maker) has formed numerous other strategic partnerships as well.  These PR moves help sell a lot more Tylenol than Americans really need.

I’m not claiming that Tylenol has no uses.  I have used Tylenol on occasion, and it is, indeed, an effective drug for reducing aches and pains and headaches, as well as reducing fever (although I don’t use it to reduce fever).  I’m certain that it brings much relief to people who suffer from arthritis.  My concern is not with Tylenol’s legitimate uses, but with it’s underplayed dangers and it’s over-promotion for reducing fever.

Should you take Tylenol (or some other brand of acetaminophen)?  If you’ve got a headache or pain and you want to feel better, follow the directions on the bottle.  But don’t automatically reach for it to reduce fever just because you’ve been made anxious about fever by the manufacturers of acetaminophen.  Just because acetaminophen is an over-the-counter (OTC) drug, doesn’t mean that it isn’t a powerful and potentially dangerous substance.

The most amazing thing about Big Pharma is that these scams are being revealed with such regularity now.   Here’s an undeniable truth: FDA is owned by the industry it supposedly regulates and we’re a bunch of guinea pigs working to help these guys make a bunch of money, often fraudulently.  Worse yet, a Congress that it bought and paid for is more than happy to make certain that drug companies are not held accountable, thanks to new efforts to allow federal preemption of damage suits against the drug companies.

Thank goodness that there are some drug companies that still make drugs that truly heal.  Shame on the rest of them.

[This post is dedicated to the people who have complained to me that I tend only to pick on alternative medical techniques, such as homeopathic medicine. ]


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Category: American Culture, Evolution, Health, Medicine, Science, snake oil, Technology

About the Author ()

Erich Vieth is an attorney focusing on consumer law litigation and appellate practice. He is also a working musician and a writer, having founded Dangerous Intersection in 2006. Erich lives in the Shaw Neighborhood of St. Louis, Missouri, where he lives half-time with his two extraordinary daughters.

Comments (6)

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  1. Ben says:

    Popular cholesterol drug fails to improve heart disease:

    Millions of Americans already take the drug or one of its components, Zetia. But doctors were stunned to learn that Vytorin failed to improve heart disease even though it worked as intended to reduce three key risk factors.

    The results show the drug had "no result — zilch. In no subgroup, in no segment, was there any added benefit" for reducing plaque, said Dr. John Kastelein, the Dutch scientist who led the study.….

  2. Niklaus Pfirsig says:

    I have also noticed how the drug industry have turned into drug pushers. Recently I've noticed a series of TV ads for Celebrex. Celebrex is a close relative of Vioxx, in a group of chemicals known as cox-2 inhibitors. The medical studies concerning the safety of Cox-2 inhibitors concentrated on the effectiveness at reducing inflammation, while minimizing grastro-intestinal problems. Very little if any research has been published concerning health risks from the side effects of cox-2 inhibitors,

    The current crop of ads for Celebrex, state that all NSAIDs (Non-Steroidal Anti Inflammatory Drug) have side effects, but play up the the reduced incidence of stomach and intestinal problems, and points out that it is still available for prescription therefore implying that the FDA considers it to be safe and effective.

    It boils down to greed. Cox-2 specific inhibitors are protected under patent, and the makers of this class of drugs can charge high prices for them. Other NSAIDs such as naproxen, aminophen. and even aspirin, do not command the high profit margins sought by the big pharma companies. When the patent runs out, they actually have to compete fro price and quality, something they don' like to do.

  3. Erich Vieth says:

    From the NYT:

    For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

    This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

    The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts.

  4. Erich Vieth says:

    Children under 4 should not be given over-the-counter cough and cold remedies, drug companies said Tuesday in a concession to pediatricians who doubt the drugs work in kids and worry about their safety.

  5. Erich Vieth says:

    Here's more on the reason for limit the maximum dosage of acetaminophen, from MSNBC:

    [A]voiding an acetaminophen overdose requires reading medicine bottles scrupulously and doing a little math because acetaminophen is often a hidden ingredient. Popping a few extra pills or mixing Tylenol with other medicines can quickly add up to too much. So can taking any of these drugs while drinking alcohol, which aggravates effects on the liver.

  6. Erich Vieth says:

    “An earlier ProPublica investigation done in collaboration with This American Life examined the toll of acetaminophen in the United States. The investigation found that 1,500 people in the U.S. had died and tens of thousands more had been hospitalized as a result of overdosing on acetaminophen over the past 10 years.
    ProPublica and This American Life also found that the Food and Drug Administration had delayed implementing safety measures for decades. McNeil Consumer Healthcare, the Johnson and Johnson unit that makes Tylenol, had worked to repeatedly block tougher safety warnings on its billion-dollar product.”

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