Suffer the little children: null link between tylenol and asthma

When little ones hurt, have a high fever and are crying and too miserable to rest or eat, their parents have been able to help them feel better with a few drops of tylenol or panadol. It’s the most-used analgesic around the world and used by parents for more than 50 years. This weekend, parents were frightened by 442 worldwide news reports of a study on more than 205,000 children just published in Lancet, claiming to find a link between acetaminophen use during infancy and asthma in childhood.

All the information was there to recognize that this study actually found no cause for concern, but how many parents understood that? How many babies will be left without pain relief, or worse, how many parents may go back to baby aspirin (putting their baby at risk for Reye’s syndrome) because, sadly, they got caught up in fear?

Per readers’ requests, let’s take a brief look at this study.

See those baloney words: linked to, associated with, correlated to…

Bottom line, this was a data dredge through a massive database of the International Study of Asthma and Allergies in Childhood (ISAAC) looking for correlations. In fact, the huge numbers of children included may have sounded impressive, but was our first clue that this study was most likely done in a computer rather than to have been a clinical trial on real children. Our second clue was the title of the paper, which reported on the association between paracetamol (known as acetaminophen in the United States) use in infancy and the risk of asthma…

These are our quickest and easiest baloney alerts that this report doesn’t warrant any reaction on our part. As we come to understand correlations and what risk factors mean, this study needs no more than a glance before going to line the bird cage.

These epidemiological studies were never meant to be used for anything more than the most preliminary-type of exploration for researchers to search for strong links among data that can be used to begin to form hypotheses that can be later tested in the laboratory and eventually in human clinical interventional trials. As we’ve seen again and again, no matter how “significant” any correlation, doesn’t mean it means anything or will ever hold up to later actual research that’s a fair test of a hypothesis. The only purpose served by publicizing the bazillions of — often meaningless, nonsensical and contradictory — correlations these data dredges scour up, is to provide daily fodder for media sensationalism and special interest groups. Sadly, the public is left to suffer from epidemiological whiplash, as one day’s scare is likely to be reported as good for us the next day, and bad for us again the day after.

Imagine how much less stressed and healthier we’d all feel if the media only reported actual clinical research that had scientific merit and was news we could really use. Since that’s not likely to happen, let’s look more closely at this study because its weaknesses offer additional examples of why this wasn’t a fair test of anything.

Overview of methodology

ISAAC is a database created in 1991, when Phase One began by sending out questionnaires to the parents (or primary caregivers) of 721,601 children in 56 countries. Questionnaires were translated into the local language with back-translated into English. This latest study published in Lancet was led by Richard Beasley, DSc, at the Medical Research Institute of New Zealand, Wellington, on behalf of the ISAAC Phase Three Study Group. It used data from Phase Three of the ISAAC project, which had sent out additional questionnaires asking parents (or primary caregivers) of 6-7 year olds and 13-14 year olds to think back to their child’s first year of life and symptoms of asthma, rhinoconjunctivitis (rhinitis with watery, itchy eyes) and eczema.

The questionnaires also asked the parents about 28 select environmental factors that the ISAAC authors wanted to examine as possible risk factors for asthma and allergies. As the authors explained: “Questions were about age, sex, family size, birth order, antibiotic use in the first year of life, breastfeeding, birthweight, diet, heating and cooking fuels, exercise, pets, socioeconomic status, immigration status, parental tobacco smoke, traffic pollution, and paracetamol use in the first year of life and in the past 12 months of children aged 6–7 years.”

Professor Beasley and colleagues said that they “used parent-reported symptoms [of asthma] rather than doctors’ diagnose [sic] to avoid major diagnostic differences related to access to medical care, language, and medical practice in populations worldwide.”

Already, the quality of the data going in is problematic. Not only was it restricted just to the information the ISAAC authors chose to examine, but it was retrospective and self-reported, subjective information. There was no attempt to validate the information with clinical examinations or examinations of the children’s medical records. Nor were any dosages of the medication recorded or included in the analysis. This is the very weakest of information and is at the greatest risk for recall bias.

As even Dr. R. Graham Barr, M.D., DrPH, assistant professor of epidemiology at Columbia University Mailman School of Public Health in New York wrote in a commentary in the same issue of Lancet:

[A] cross-sectional survey with a retrospectively ascertained primary exposure is not a design on which we prefer to make therapeutic decisions. Recall bias (parents of children with asthma might better remember giving paracetamol in the first year of life) and reporting bias (parents more attuned to their children’s maladies might be more likely to give paracetamol and report the current wheeze) could account for the findings.

Nearly every child on the planet has received this analgesic. As the ISAAC authors also commented in their Discussion Section, fever is common in infants, so most babies would likely have received paracetamol for fever on more than one occasion during their first year of life. But since respiratory illnesses during early childhood (especially respiratory syncytial virus infection) is associated with increased problems with wheezing in children, these infants would also have been more likely to have received paracetamol for their accompanying fever and discomfort than typical little ones.

In other words, respiratory infections and other illnesses accompany the use of acetaminophen in babies. Had the researchers asked about other comfort measures, such as use of humidifers, favorite cuddly toys, or popsicles, the correlations to asthma might have been every bit as significant. Repeated respiratory problems, however, have considerably more biological plausibility for a potentially meaningful link. The tylenol connection just came along for the ride.

As Dr. Barr wrote, underlying respiratory disease, differences in hygiene and the use of other fever medications could also explain the findings.

Epidemiological studies have linked asthma to hundreds of things, but this type of data is not very reliable Dr. Richard Lockey, M.D., professor of Medicine, Pediatrics and Public Health and director of the Division of Allergy and Immunology at the University of South Florida College of Medicine, told ABC News. Dr. Lockey is a past President of the American Academy of Asthma, Allergy and Immunology and former director of the Board of Allergy and Immunology. He said he seriously doubted there is anything to this link.

When enough data is thrown into a computer, odds are it will pull out all sorts of meaningless correlations, just like a popsicle. But no one would try to claim a popsicle causes asthma. Yet, like all such databases, this one has been the source of countless other links with asthma, many of which contradict each other or make no sense at all. Authors from New Zealand, for example, dredged ISAAC and reported children who ate a hamburger more than once a week had a 65% odds ratio of having a history of wheeze and if it was from a fast food restaurant, the odds went up to 141%. But no one would really believe that a hamburger causes asthma. Turkish authors used the database to report a 154% higher odds ratio of asthma among those whose family incomes were below $ 300/month; whereas Brazilian authors used it to report higher risks for asthma associated with wealthier families.

This weekend’s Lancet study, also suffered from exceedingly high attrition rates. Of the original cohort, 89,514 babies (46%) who’d received tylenol for fever during 1^st year of life were lost in follow-up and their parents didn’t complete the questionnaire. Only data on about half (105,041) of the original group of babies who’d received acetaminophen at least once during infancy were included in the multivariate analysis. Were the parents of children with asthma more likely to have completed the questionnaires, seeking answers to their children’s illnesses?

The ISAAC researchers then loaded all this questionnaire data into a computer and applied several different computer models to identify links, calculate odds ratios and adjust for specific confounders. They adjusted for these covariates: maternal education, antibiotic use in the first year of life, ever breastfed, parental smoking, current diet and siblings.

As they stated: “The primary outcome measure was the association between paracetamol use for fever in the first year of life and asthma symptoms at 6–7 years of age, expressed as odds ratios, as measured by the multivariate analysis.”

Results

From their multivariate analysis, they reported a 46% odds ratio (OR=1.46) associated with acetaminophen use in the first year of life and risks of asthma symptoms at age 6-7 years.

Of course, this is an untenable correlation, made even moreso by the use of odds ratios rather than relative risks. This computer-derived correlation, like others under at least 200%, is no better than what might have surfaced for this type of study by a random error or chance, and most likely explained by co-factors. The relative risks derived from epidemiological studies that later prove out in clinical trials to be real, are considerably higher — by several hundred percent! Forty-six percent may sound like a lot, but it’s still a null finding. It’s even less than a hamburger.:-)

In other words, there was no valid link found between acetaminophen usage in infancy and childhood asthma. Without even a tenable link, it’s not a viable avenue to look for a cause, of course.

Professor Beasley and colleagues admitted that their odds ratio “may be overestimates of the risk” because of confounding factors likely to have been present. The authors didn’t report the odds ratios from any of the other 28 questions in the questionnaire, nor did they provide any of the actual (absolute) numbers of children with asthma, to enable us to put these odds into any credible perspective. [Providing only odds ratios, instead of actual numbers, is not valid medical reporting. If 1 child among 1,000 who"d not been given tylenol developed asthma compared to 2 children among 1,000 who"d received tylenol, the risk is double, but clinically meaningless.] By comparison, authors at the Isra University Hospital in Hyderabad reported in the July issue of the Journal of the College of Physicians and Surgeons Pakistan an association between asthmatic children and a parental history of asthma, with an odds ratio of 26.8 — 1,800% the risks associated with acetaminophen in this week’s study.

BTW: The only clinical research the ISAAC authors referenced as support for a potential medical link between tylenol use and asthma was found: “in one randomized controlled trial, paracetamol use for fever in childhood was associated with an increased risk of hospital outpatient attendance for asthma when compared with ibuprofen.” This study had been conducted by doctors from the Slone Epidemiological Unit School of Public Health, Boston University School of Medicine and published in the February 2002 issue of Pediatrics. It was a randomized, double-blind trial where 1,879 asthmatic children were prescribed either low doses of acetaminophen or two different doses of ibuprofen for fever control as needed. The children’s outpatient medical visits and hospitalizations over the next four weeks were obtained from parental questionnaires. A total of 18 children had been hospitalized for asthma during those four weeks, two more in the acetaminophen group compared to the higher ibuprophen dose group, but “there were too few hospitalizations to permit computation of stable dose specific risk estimates.”

The ISAAC authors said “causality cannot be established from a study with this design” and the “evidence is insufficient to advise parents and healthcare workers of the risk-benefit of taking paracetamol in childhood.”

Aubrey Grayson, Medical writer for ABC News, reported on doctors issuing much stronger statements about this ISAAC study, telling parents to not worry or react to it. Dr. Anita Gewurz, M.D., professor of allergy and immunology at Rush University Medical Center, said the study contains serious methodological flaws and the findings should be taken with a grain of salt. Several doctors urged parents not to deny their children relief because of scary news reports:

“Don’t panic or go back to aspirin,” said Dr. N. Franklin Adkinson, Jr., professor in the division of allergy and clinical immunology at the Johns Hopkins Asthma and Allergy Center in Baltimore. “Continue to use acetaminophen until further research is done.”

Parents should also remember that other painkillers are not without their risks. In 1982, the government issued a warning to avoid giving young children aspirin to relieve cold and flu pain. Aspirin use in young children has been linked to the development of Reye’s syndrome — a rare but serious children’s disease that can lead to brain damage, liver failure and death. Acetaminophen has never been linked with the development of Reye’s syndrome, and doctors have since urged parents to choose acetaminophen-based pain relievers to give to their feverish children.

But some doctors worry that many parents may read about the new findings and begin denying their sick children any form of pain relievers. Even worse, parents might begin to choose aspirin over acetaminophen once again — thus possibly placing their children at risk for Reye’s.

“Misrepresenting this will cause unnecessary panic,” said Dr. Peter Catalano, chairman of the department of otolaryngology at the Lahey Clinic in Burlington, Mass. “The science is absent.”

© 2008 Sandy Szwarc

More information

Tylenol has long been the standard remedy for fever and pain in children and to be safe and effective when used as directed. However, like everything, overdoses can be harmful and tylenol overdoses can result in serious liver damage. More information on how much tylenol to give your child and other precautions is available at the Tylenol Dosage Calculator.

More information on paracetamol is available here, and on acetaminophen here.

Study Disclosures:

Funding The BUPA Foundation, the Health Research Council of New Zealand, the Asthma and Respiratory Foundation of New Zealand, the Hawke’s Bay Medical Research Foundation, the Waikato Medical Research Foundation, Glaxo Wellcome New Zealand, the New Zealand Lottery Board, Astra Zeneca New Zealand, and Glaxo Wellcome International Medical Affairs. Richard Beasley received honoraria for lectures and participation in advisory boards, and grant support from GlaxoSmithKline, the manufacturer of paracetamol. All other authors declare that they have no conflict of interest.

Can Children Outgrow Asthma?

Perhaps the most common question a parent asks me about asthma is whether the disease is life long.  This question is hard to answer and it is risky to assume that children may “outgrow” their condition.  SS

Patients can’t outgrow breathing illness

It’s not the news parents want to hear, especially those who have watched their children gasp for every breath.

   But the reality is that you can’t outgrow asthma.

   Sure, the symptoms might ease, especially during teenage years. And, yes, getting a handle on any triggers that might worsen the problem — mold, pollen, dust mites, smoke, pollution and strong odors chief among them — can help.

   Still, “Asthma is a chronic disease, not a temporary condition,” said Dr. Jonathan Parsons, a pulmonologist and associate director of the Asthma Center at Ohio State University’s Wexner Medical Center.

   “It’s like high blood pressure or diabetes. There’s waxing and waning of the symptoms, but you have to be aware that you have it, and you have to know how to manage it.”

   Doctors say that asthma is most often diagnosed in children, and of those, about 90 percent experience a recurrence of symptoms, Parsons said.

   Managing the condition becomes a way of life. Asthma occurs when airways are narrow and swollen, impeding the flow and speed of air intake.

   “That’s a wheeze,” Parsons said.

   But sufferers don’t have to huff and puff all the time to have the problem. Asthma can manifest itself as a cough or an uncomfortable feeling or tightness in the chest or can masquerade as a runny nose attributed to a sinus problem or allergies.

   The only way to really diagnosis it is to undergo pulmonary-function tests, which measure airflow.

   Parents often don’t want to accept the diagnosis, said Dr. Karen S. McCoy, chief of the Division of Pediatric Pulmonology at Nationwide Children’s Hospital.

   “An asthma diagnosis is perfect for making a parent as worried and apprehensive as they can be,” McCoy said. “They don’t want to think that their child would have something ongoing or chronic, and the potential for ongoing and long-term medications is a concern for them.”

   She said childhood asthmatics often get a respite during their teenage years mostly because teens aren’t as prone to viral infections, which trigger symptoms, and because a change in the size of the airways means that a little bit of swelling doesn’t affect breathing as much.

   But as those kids grow older, they must remember to watch for the signs again.

   Xandula Gaitor said she wishes her two sons were so lucky.

   Her boys, now ages 20 and 10, have long struggled with severe asthma. Her older son, Alwyn Burns, caught a break in his teen years, but that was largely because his condition was so severe that the family relocated to Phoenix for its drier climate, she said.

   To help her younger son, Isaiah Burns, manage his asthma, they relocated to Alabama for a time.

   Now they are back in Westerville to be closer to family, and Isaiah’s symptoms remain severe.

   Gaitor said that when Alwyn was 5 months old and doctors diagnosed his asthma, she was scared yet relieved to know why he suffered terrifying breathing episodes.

   “I just said, ‘OK. Tell me what we need to do and how we can get him better.’”

   Alwyn’s asthma is so severe that the smell of cleaning supplies can trigger an attack. So can a whiff of smoke. And his linens must be washed often in extra-hot water to kill dust mites.

   “It has altered our lifestyle in so many ways,” Gaitor said.

   Treating childhood or adult asthma is largely the same — a maintenance dose of inhaled steroids to reduce inflammation in the airways and a rescue inhaler or breathing machine (called a nebulizer) for serious episodes.

   While childhood patients typically don’t outgrow asthma, some adults end up developing the breathing disorder. It’s called adult-onset asthma, but Parsons said it’s virtually impossible to tell whether the inflammation is new or had always been there.

   Genetics and family history play a role, and exposure to mold or chemicals can make a difference. hzachariah@dispatch.com  

http://www.dispatch.com/content/stories/local/2012/03/25/health/Patients-cant-outgrow-breathing-illness.html

National Health Interview Survey, United States, 1998--2009: Percentage of Children Aged less than 18 Years with Reported Food, Skin, or Hay Fever or Respiratory Allergies

I am copying the image and wording directly from the CDC’s website.  Households were randomly contacted and asked three questions: “During the past 12 months, has your child had any kind of food or digestive allergy?” and “During the past 12 months, has your child had eczema or any kind of skin allergy?” and a positive response to either “During the past 12 months, has your child had hay fever?” or “During the past 12 months, has your child had any kind of respiratory allergy?”

“From 1998–2000 to 2007–2009, the percentage of children who were reported to have a food allergy during the preceding 12 months increased from 3.5% to 4.6%, and the percentage who were reported to have a skin allergy increased from 7.3% to 10.7%. The percentage of children reported to have hay fever and/or respiratory allergy was 16.6% during 2007–2009, a level that did not differ substantially from earlier years.”   Food and skin allergies are increasing.

Helping Children Deal With It

Posted by BOdy on 16:46

Some say that there are no short cuts in how to treat asthma especially for very young children and they are right. However, there is always an answer as to how you, especially if you are a parent, can help in alleviating the effects of asthma on your child. Luckily, the best way to treat the asthma condition of your child is through natural methods. Doctors and other medical practitioners would agree with this. In fact, even if they give prescriptive medications to their patients, they still recommend that their patients and the parents of children diagnosed with asthma to subject the asthmatic person to a healthy diet and regular exercise.

However, experts say that if you want to know how to treat asthma, you need to remember the top four factors on how you could control asthma using natural ways and that means not being dependent on prescriptive medications and this include: Environment, Diet, Breathing and Exercise. In almost all the sites that you check out online, you will be able to read about natural ways of treating asthma but most of them forgot to emphasize the need to really engage in what is natural because this is the basis of whether or not the patient will survive an asthma attack. These four factors play an essential role in ensuring that the child is healthy and in tip top shape to engage in all the activities that children their age should be doing.

Since asthma is a disease that can be triggered by pretty much everything that you can find in the environment, it is very important that you as a parent ensure that you know what could trigger the asthma attacks of your child. Your knowledge of this will lessen the frequency of the attacks allowing your child to live a normal life just like other kids without asthma. If you think adults are having a difficult time dealing with asthma and controlling its effects, then perhaps children diagnosed with asthma are dealing with something seemingly impossible. Not only will they suffer from difficulty in breathing but their young fragile bodies will also be exposed to a lot of stress and anxiety and children who are very young might not be able to survive without proper care.

Perhaps one of the biggest challenges that children with asthma have to deal with is the change in the diet that they have been used to. Children find it more difficult to make a shift in their diet plan particularly because they are still young and because they still do not understand why they could not eat chocolates or chicken. It is important that parents understand the foods and drinks that could trigger the asthma attack of their children particularly those that they are allergic too. Allergic reactions of asthmatic patients can be very serious that sometimes it can be fatal.

It has been an accepted fact that parents play a major role in the survival of their children especially those with asthma. It is important that parents understand what their child is up against so that they can prepare themselves and their child for whatever they might suffer form. Moreover, their knowledge of what could trigger allows them to explore the possibilities of treating asthma. Nothing beats parents who are prepared and ready for whatever task may come their way.

Call for action: Sign petition to prevent US compulsory prescription of psychiatric drug to children

Founded in 2002 by former president Bush The New Freedom Commission on Mental Health was supposed to “…promote successful community integration for adults with a serious mental illness and children with a serious emotional disturbance.” as it is at the commission’s site.
But this is one of the health politics this commission propose:
The Ron Paul Parental Consent Act


“The New Freedom Commission on Mental Health has recommended that the federal and state governments work toward the implementation of a comprehensive system of mental-health screening for all Americans. The commission recommends that universal or mandatory mental-health screening first be implemented in public schools as a prelude to expanding it to the general public. However, neither the commission’s report nor any related mental-health screening proposal requires parental consent before a child is subjected to mental-health screening. Federally-funded universal or mandatory mental-health screening in schools without parental consent could lead to labeling more children as “ADD” or “hyperactive” and thus force more children to take psychotropic drugs, such as Ritalin, against their parents’ wishes.

Already, too many children are suffering from being prescribed psychotropic drugs for nothing more than children’s typical rambunctious behavior. According to Medco Health Solutions, more than 2.2 million children are receiving more than one psychotropic drug at one time. In fact, according to Medico Trends, in 2003, total spending on psychiatric drugs for children exceeded spending on antibiotics or asthma medication.

Many children have suffered harmful side effects from using psychotropic drugs. Some of the possible side effects include mania, violence, dependence, and weight gain. Yet, parents are already being threatened with child abuse charges if they resist efforts to drug their children. Imagine how much easier it will be to drug children against their parents’ wishes if a federally-funded mental-health screener makes the recommendation.

Universal or mandatory mental-health screening could also provide a justification for stigmatizing children from families that support traditional values. Even the authors of mental-health diagnosis manuals admit that mental-health diagnoses are subjective and based on social constructions. Therefore, it is all too easy for a psychiatrist to label a person’s disagreement with the psychiatrist’s political beliefs a mental disorder. For example, a federally-funded school violence prevention program lists “intolerance” as a mental problem that may lead to school violence. Because “intolerance” is often a code word for believing in traditional values, children who share their parents’ values could be labeled as having mental problems and a risk of causing violence. If the mandatory mental-health screening program applies to adults, everyone who believes in traditional values could have his or her beliefs stigmatized as a sign of a mental disorder. Taxpayer dollars should not support programs that may label those who adhere to traditional values as having a “mental disorder.” 

This is from the petition congressman Ron Paul wrote explaining very well the absurd.


What The New Freedom Commission on Mental Health is proposing, and is already being done, is nonsense for many reasons and one of them is the impossibility of diagnosing mental disease by any physical or psychological test or by taking a quick look at a person.
Surely the US government will not spend loads of money to have groups of psychiatrists being at schools all over US for at least six months observing the behavior of each child. How will these screenings will be accurate?
What they really want is to put more children taking Ritalin and other psychiatric drugs whose harms are explained at the petition.
What they want is prescribing drugs to healthy children but they have to pretend that these children were diagnosed and as in psychiatry nothing is detectable easily, worse, any behavior can be considered abnormal, even excess of happiness or mild happiness, “Let’s drug them. We want the money.”
Sometimes I think that some of the mental health politics being done by USA government with the help of the corporate-elite that is ruling the world, and they affect the world, makes US eugenicists, that inspired Hitler, look like philanthropists. And if we go back in history in 1926 the Rockefeller Foundation has donated money for the Kaiser Wilhelm Institute for Psychiatry which was a great help in the construction of facilities to the “scientific experiments” done by Nazi scientists.  
Funny that they started by killed those who were considered mentally ill.
This is unacceptable.
Sign the petition HERE

Nazi propaganda for their compulsory euthanasia” program: 

“This person suffering from hereditary defects costs the community 60,000 Reichsmark during his lifetime. Fellow German, that is your money, too.”

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