Could Tylenol be linked with neurodevelopmental disorder, Attention Deficit Hyperactivity Disorder?
A recent study in The Journal of The American Medical Association Pediatrics (JAMA Pediatrics) has suggested a link between ADHD in children and mothers taking Tylenol while pregnant. This has been widely covered by the news media. The study is a correlational statistical evaluation. Of course correlation is not causation. Yet the study has been widely reported as an open ended question. Should pregnant mothers taking Tylenol be worried that they are giving their child ADHD? Given what is known about ADHD I found the premise improbable. I decided to take an intensive look at this research and try to tease out the facts.
Tylenol(AKA Acetaminophen and Paracetamol) is a widely used over the counter as a pain medicine. In my opinion it is just about the safest pain reliever available. Like all medicines it has known risks. It commonly causes liver failure due to overdosing, both accidentally and intentionally( Suicide Attempt). The most common source of overdose is taking multiple over the counter medicines. People are unaware that Tylenol is often an ingredient in many cold and flu remedies. They fail to read the boxes and end up overdosing themselves. If you have a normally functioning liver and you limit yourself to 2-3 grams per day it is probably the safest medication that you can take bar none. It is given to newborns and pregnant mothers. So it is quite a surprise that there is correlation between ADHD and intra-partum tylenol dosing.
The Actual Research:
Layman’s Synopsis- It was a large Danish study. Involving 64000 children and their mothers. They had multiple lines of evaluation. Parent response questionnaires, the danish hospital registry, and ADHD medication prescriptions were all tracked. At least half the mothers took tylenol while pregnant. They found a signficant correlation with first trimester usage of tylenol, and frequent dosing throughout all three trimesters with higher rates of ADHD. They tried to control for maternal inflammatory disease, infection during pregnancy, the mother’s mental health problems, or other potential confounders.
There are problems with this study but I think they did a reasonable evaluation. One question that plagues me is, why did they look at this aspect of ADHD? In the abstract they cite concerns over Tylenol and hormone regulation. Sure there are some theoretical models that predict that problem, and some high dose animal studies that duplicate that. They are making a complicated and precarious assumption to even come up with this study. They make two complicated assumptions to look at this. Namely that hormone changes from Tylenol affect brain development and that in turn relates to ADHD. They are drawing a lot of lines together that do not have a solid foundation. In my estimation the only true link is the reverse. They looked at Tylenol because it is one of the few drugs thought to be relatively safe intra-partum(pregnant) therefore widely taken. Even that doesn’t answer my question. Out of all the neurodevelopmental issues in childhood why is ADHD the one that is correlated with Tylenol? That makes me suspicious of an agenda but it does not invalidate the work.
There are real problems with their methods. Self reporting tools are a consistent problem with ADHD or Hyper kinetic disorder studies. Although they used a standardized tool, its benefit as a diagnostic tool is weak. Also tracking prescriptions as a measure of disease incidence(frequency) is also problematic. Ritalin in particular can be over utilized and has been criticized as being used as a diagnostic tool. Meaning, I give your kid Ritalin and he/she gets better therefore he/she has ADHD. Successful medication treatment is not truly a comprehensive way to diagnose this condition. ADHD is a behavioral disorder which by its nature is a very difficult diagnose even in expert hands. Using ADHD medication prescriptions as a method for determining prevalence of ADHD is very flawed.
The study tried to control for maternal mental health issues. Their methods were self reporting, intra-partum eval, and statistical controls. This is a relatively weak control for a large confounding variable. Research clearly shows that there is a genetic/environmental link in ADHD. How much is environment and how much is genetic is unclear. One thing is clear, home parental mental health is a large variable to exclude and this study has not done that very stringently.
My final significant objection is statistical. Although using large numbers is very good to generalize results, it causes a problem. The P value to big to fail problem. Meaning, with a very large sample, the standard error becomes extremely small, so that even minuscule distances between the estimate and the null hypothesis become statistically significant. TO laypersons- The more subjects you have the more likely you will produce a statistical anomaly that falsely positive.
So am I ready to call BS on this bit of widely reported research?
No I am not. It has some very compelling evidence. It was a large study and even though there are a lot of confounding variables, they did a reasonable job trying to control them.
The most compelling evidence is in the dose dependent response. Seeing a correlation with dose and disease is fairly compelling. Although compelling in is not causation. It is a argument to do more research. It is not compelling as a basis for deciding drug safety. Especially given decades of safe use and the complete uncertainty about the causes of ADHD.
This is not a study that should be creating the type of fear mongering I have already begun to see on the naturopath/Alt.Med crank blogs and websites.
This study is interesting, and it is strong enough to recommend a more controlled and focused study. It is not impossible that Tylenol is some how affecting brain development, and that the exposure results in long term behavioral issues. It is just improbable.
It is improbable because ADHD and other Hyper Kinetic disorders are not a single source disease. There seem to be many environmental, and genetic links. It is a improbable chain of reasoning to say that Tylenol affects brain development intrapartum, and that the change is long lasting, and that it results in specific behavioral changes years later with no other discernible cognitive effects.
Improbable not impossible.
So when you have a weak study correlating(not causing) a complication from a medication used in pregnancy, you always take a look at it. You do not jump to blanket warnings or label changes, especially if the drug has a generational history of safety. I recommend you look at this using a Bayesian anaylysis (in my opinion far more accurate). You will see that this study cannot possibly outbalance the prior evidence of safety. More research is needed to define if this is even a problem.
A common argument would be to err on the side of caution, but that can have unintended negative consequences as well.
Mothers may falsely believe that Tylenol is dangerous. Causing everyone to start thinking that taking OTC NSAID’s are safer. Hysteria could easily develop and people would start avoiding Tylenol for all pediatric conditions, not just pregnant mothers. NSAID’s are not dangerous either, but clearly they have a higher risk profile for the very young compared to Tylenol.
Plus, blaming a mother’s need for a pain control medication in the past may result in maternal guilt over a child’s current problems. By assuming that Tylenol caused a child’s ADHD you are pointing at the mother, as the cause. Resulting in many negative secondary effects for a family dealing with a behavioral disorder. You are making current and future pregnant women struggle with severe pain without any medication options.
Just a few ways reactionary fear could damage people. All to “err on the side of caution.”
Rule of thumb for pregnant moms. There is a chance that everything you do may affect the future development of your child. It is not limited to medication. That is a very heavy responsibility, so take it seriously. Don’t go it alone, and don’t fall for the naturalistic/alt med fallacy. Medications are tested and researched. Yes we find the occasional proverbial “warts” on the treatment. At least we are looking. What you don’t see in the Alt. med research is any indication of any problems. They expect you to assume that everything they do is perfectly safe because it is “Natural”. Utter nonsense, no treatment is perfectly safe.
My advice for pain control. Avoid medications if you can, not just Tylenol, all medications. Try to use massage therapy, and physical therapy to deal with most general pain complaints. Check with your OB before taking any treatment. Never take any supplement, vitamin, or medicine unless it is under you OB doctor’s direct advice. Always take the smallest dose for the shortest time. Stay away from untested/regulated/and poorly researched alternative medicine. I can tell you what the risks are for your baby with proven medical care. I cannot even guess what the risks are with Alt. Med. Please don’t treat a pregnant mom like she is a selfish murderer because she took some Tylenol in front of you. Tylenol and its generic versions are still the safest pain treatment that can be offered to a pregnant mommy. Pregnant mothers, do not under any circumstances take a Non Steroidal Anti-Inflammatory like OTC ibuprofen. That medicine has proven risks to your unborn child.
Most risks for pregnant women are well known. Some are overblown fear mongering. This study is interesting, but as tool to determine cause and effect it is useless. Warnings that you may hear about Tylenol and ADHD amount to no more than Fear Mongering and are not medical science.
Disclaimer: This post is my personal opinion, it does not reflect the opinion of: my practice, my partners, hospital affiliations, Brian Dunning or my academic affiliations. It is for informational/educational purposes only. It is not intended to replace personal medical evaluation and discussion with your healthcare provider.
A skeptoid writer brought to my attention to a webpage about the flu vaccine. After reading the blog post I found myself thinking about the TV show Seinfeld. Specifically a few lines from the episode called The Bizarro Jerry. Where the comeidian Jerry Seinfeld says “Superman’s exact opposite, who lives in the backwards Bizarro world. Up is down, down is up, he says hello when he leaves, goodbye when he arrives“.
This article was written by Bill Sardi. He is a well known anti-vaccine/conspiracy crank and has tons of ludicrous posts. It is not surprising that he can take data about influenza in California and twist it in Bizarro like fashion to suit his quack ideas. Not surprising at all. I think it is a wonderful demonstration of how self motivated reasoning can come up with the exact opposite of reality.
- Lewis Carroll’s Mad Hatter
Lets take a little trip down the “Rabbit Hole”, and reveal the difference between logic and motivated reasoning.
Bill Sardi published the web article “The Flu Death Trap” on March 5 2014 (Although it is referenced at the bottom I am not directly linking since I do not want to enhance his readership in any way). He hits the usual highlights for the anti-vax crowd fear mongering and anti-corporate warnings, the standard fare. He does deliver it with a twist. Using statistics that demonstrate the risks of poor vaccination rates, he then cherry picks them to “prove” how the flu vaccine is deadly. Not a revolutionary approach in the Anti-Vax crowd. Just another good demonstration that arguing with the Anti-Vaccine crowd is pointless. Bill has devised an interesting maze of illogical thinking to explain deaths from Influenza. Artfully dancing around the real findings to fit his world view.
“There just has to be a reason for the unusual rash of flu-related deaths in California. Even after the peak of the flu season has passed and a steep decline in hospitalizations signaled the flu season was almost over, reports of flu-related deaths keep coming in. If public health authorities know the reason for these deaths they certainly aren’t saying anything.”
I believe the term “Flu related Deaths” is self explanatory but lets continue to explore his thinking.
“California mandates all health insurance plans must go through a health exchange and that puts many of the preventive health services mandated by the Affordable Care Act into play including free flu shots — not even copayments. But ironically the number of flu deaths in California this season has skyrocketed 17-fold, from 14 deaths last year at this time to 243 deaths, mostly among adults age 25-64 years of age.And long past the date when hospitalization rates from the flu peaked in mid-January, flu-related deaths soared to 302 in news reports dated March 1, 2014.”
This is a complete misrepresentation of the facts and it omits the most significant findings. Yes there has been a prolonged and severe flu season in California as well as the Northeast. Yes there have been an increase in deaths compared to last year. He is trying to draw a link with the vaccines and the deaths. I will address his very purposeful massaging of the data to produce the opposite of what the data really indicates.
Influenza always changes from season to season. Comparing single season data is not useful, especially when we are still in the collecting phase. These deaths are assumed from the Flu but the final data may be much different. For arguments sake lets assume that the deaths are all related to Influenza. First of all with a few minor exceptions all the deaths were in un-vaccinated individuals. The few exceptions had severe complicating health issues. Almost all of the deaths in the 25-65 age group had complicating health issues of some kind. Respiratory, Auto-immune conditions, organ transplant, and coronary conditions. Older people have had fewer problems with this disease. Not because they haven’t been vaccinated(his unspoken premise). Rather, it is believed that this H1N1 strain is similar to one that afflicted that generation when they were young. So they have had this strain of Flu before and have some protection now. People who have had the pandemic H1N1 supplement 3 years ago seem to be better protected as well. That is why the age curve seems unusual this year. Nationwide, Flu deaths are down this year. It is only when you select for California do you see this anomaly of increase. I would point out that the health care initiative he derides has slightly increased vaccination rates in the northeast (traditionally higher than California), with a subsequent decline in flu fatalities all ages.
That does not stop Bill from determining the opposite.
“By this time last year only 34 flu-related deaths had been reported among adults under age 65. A total of 106 deaths in that under-65 age group were totaled by the end of the 2012-13 flu season. So one wonders if the total flu-related deaths in California will rise over 1000 by the end of the flu season. Is a so-called “hot-lot” flu vaccine to blame? Or is the vaccine failing altogether? Given that any revelation flu shots aren’t working or may be attributed to raising flu-related mortality, one can anticipate public health officials will be less than forthcoming. They are the guardians of the vaccine industry.”
He goes straight to the Anti-Vax playbook. Draws unsupported conclusions, and poisons the well, “one can anticipate public health officials will be less than forthcoming. They are the guardians of the vaccine industry.”
Nice, so when the officials point out that the vaccine is the best tool to blunt the disease they are corporate shills. Bill doesn’t stop there. He then tries the gish-gallop approach to support his conclusions and further fear monger about the vaccine. That may work in a public debate but in writing it just doesn’t work. I will break down this nonsense one piece at a time.
“Consider the fact a toxic flu vaccine administered under a newly announced nursing home vaccine campaign resulted in so many preventable deaths in 1993 that the life expectancy in the U.S. declined for the first and only time since the 1918 flu pandemic. This fact remained hidden till this journalist pored through reports published in Morbidity & Mortality Reports to uncover this hidden vaccine catastrophe. Is a repeat of the same underway?”
Just an allusion to another ridiculous article he wrote pro-porting that an uptick in death rates in the US coincided with a new flu vaccine in 1993. Long story short, 1993 was the peak mortality for the AIDS epidemic. The death of so many statistically young people skewed the data for average life expectancy. There was a sharp rebound beginning in 1996 when anti-viral therapy became wide spread. Whatever he “Pored Through“, obviously was not the facts.
“Simultaneously health authorities are avoiding announcement of an outbreak of Reye’s Syndrome in California, caused after children with the flu use a fever-reducing medicine like aspirin. They are calling these childhood cases “mysterious” when its limb paralyzing symptoms are obvious signs of Reye’s syndrome.”
At this point what caused the polio like cases is thought to be a virus. There is no evidence that this is some form of Reye’s Syndrome. Which is linked to a drug not a vaccine.
“Of the 405 reported cases of fatal or severe influenza (requiring hospitalization in an intensive care unit) influenza (Morbidity & Mortality Weekly Reports) as of Jan. 18, 21% had been vaccinated with the current vaccine at least two weeks prior to their diagnosis.”
This is an out and out lie or he has no ability to read the data. Out of the 405 reported cases only 28 had a known vaccination status. Of those 28 people only 6 had been vaccinated. That is 21% of 28 people not 21% of 405 people.
- “Usually the very young (under 3 years of age) and the very old (over age 65) comprise most flu deaths, so the fact that 61% of hospitalizations were 18-64 years of age is of alarming concern. Persons age 41-64 were 600% more likely to die of the flu than other age groups.
- The very young and the very old have undeveloped and used-up immune systems. But these presumably well-fed young to middle-aged adults don’t fit the typical mortality profile.
- All cases for which complete records were available succumbed to the pH1N1 strain of the flu virus.”
As I pointed out above elderly had previous exposure to this strain, so age lowered risks with this flu. The majority of fatalities however were not “healthy”. I have no idea what his description “well-fed young to middle-aged adults” means. Morbid obesity is a risk factor for mortality not a prevention. The high rates in younger people is an anomaly, for the most part they were not “Healthy.” Not coincidentally, the high rates of unvaccinated adults in California are in the affected age group. Changing the bell curve to the middle follows the pattern of unvaccinated persons. Usually fatality leans towards the elderly because they have increased susceptibility and poor response to the vaccine. Not “used-up immune system.” Although the personal exemption rule has raised the risk for children in California, they still have high enough vaccination rates to prevent widespread outbreaks. It is true that the very young are at high risk for severe flu complications. Fortunately despite declining vaccination rates the number of flu related deaths have stayed stable. Probably due to sufficient herd immunity.
“Is it adult Reye’s?”
He donates a whole paragraph to this improbable and foolish concern that tylenol can somehow induce Reye’s syndrome in adults. It doesn’t, Reye’s syndrome is strictly pediatric and aspirin related. More useless comparisons and fear mongering. He doesn’t stop there.
“Flu shots administered from retail pharmacies rather than at doctors’ office and clinics is a relatively new practice and it places three mortal flu factors under the same roof – acetaminophen, sugar and the flu virus itself.”
Meaning less fear mongering. He call this the “deadly Flu Triad”. Up is down, Down is up again. Next is the Piece de resistance, of Bizzaro world.
“The very idea of giving a flu shot (a little bit of the flu itself) to sick high-risk (diabetic, overweight, asthmatic) customers who arrive at pharmacies and already have evidence of weak immunity and selling them a vitamin C-depleting drug (acetaminophen) at the same time may explain the current rise in flu-related deaths among adults younger than age 65. Once hospitalized, these very ill now flu-sickened patients are likely to receive medications (steroids, acetaminophen) that further deplete vitamin C, leading to their early demise.”
There is zero reputable data linking vitamin C deficiency and flu virulence. It is an science-y sounding load of nonsense.
The facts of this data is apparent to me. A fairly virulent strain of the flu in California affected a younger population. Due to virulence, lack of vaccinations and co-morbid health issues there is a one year statistical bump middle age mortality. Isolated to one US state. The elderly were not affected as strongly due to a remote past exposure to a previous strain of the flu. Unfortunately kids still suffered deaths, at least no more than usual.
What this data says to me is that California needs to promote more Flu Vaccination clinics. That the strong anti-vaccine sentiment in the state of California is having a deleterious effect upon public health and stronger measures need to be taken. There is no evidence that a Deadly Flu Vaccine is being given. In fact the opposite is represented in the data. The best protection is the flu vaccine.
Like I said a Bizarro world, Down is Up, Up is Down. All I have to say is…..
- Bizarro DC comics
I am a staunch proponent of vaccines and vaccinations, normally. When I learned of the meningitis outbreak at Princeton University I reacted positively to the report that they were offering vaccinations for an outbreak of meningitis. My graduate work involved the epidemiology and treatment of meningitis. Given my(admittedly dated)knowledge of meningitis the news details gave me cause for concern. So I took a long hard look at what is known about this outbreak and what are the plans. I begrudgingly have to say that I wouldn’t recommend this particular vaccination plan for the meningitis outbreak. In my opinion Princeton is trying to mollify students and possibly parents, not practicing good medicine. This plan may have a disastrous outcome for both the future of the vaccine, and the students of Princeton university.
I am not advocating in any way that approved vaccines are a problem, or useless. Vaccines are always a small risk and a large benefit. In my opinion, this plan fails to be effective with this vaccine because of incomplete data and the epidemiological specifics of this disease. The plan has the flavor of a feel good move, not a proper public health initiative. Realistically it will be offered to provide anxious students with a anxiety reducer. It will not be an effective epidemic treatment as outlined and it may actually have a negative effect on the situation. To explain I will have to do a short layman’s meningitis primer and a review of this situation’s specifics.
Meningitis is actually a description of disease not truly a single “Disease agent”. Meningitis is caused by many organisms. For this discussion I will use the term Meningitis to mean an infection of the meninges by the organism found in the Princeton University cases Neisseria meningitidis (meningococcus).
Meningitis is dangerous, it has a 10% mortality rate, and even among survivors there can be permanent disabilities. Brain damage, loss of limbs, kidney damage, major organ failure to name a few. Antibiotics can treat the infection but it is often not effective in preventing the complications. The organism infects a protected section of your body, and by the time you begin experiencing symptoms the disease is advanced. It progresses rapidly and can be fatal in as little as 24-72 hours from onset of first symptoms. The organism has an endotoxin that can be released on mass when antibiotics are introduced causing a cascading inflammatory reaction. The disease and what makes it lethal is actually far more complicated than I have the time to review here. It affects healthy and infirmed alike, yet the lethal illness is usually in the young and healthy. Meningococcus is spread through the exchange of saliva and other respiratory secretions during activities like coughing, sneezing, kissing, and in small children chewing on toys. It infects the host cell by sticking to it using Trimeric Autotransporter Adhesins (TAA). Though it initially produces general symptoms like fatigue, it can rapidly progress from fever, headache and neck stiffness to coma and death. There are different “Strains”, A, B, C, W135, X, and Y. All can be spread easily, yet A seems to be the most contagious. In the Princeton cases the B strain is involved. That is unusual in the U.S. B strain is commonly a European strain, A is in the middle east(so called meningitis belt). A, C strain predominates in US, with a disproportionate number of Y strain involved in college dormitory outbreaks.
There are currently three vaccines available in the U.S. to prevent meningococcal disease for people aged 2 or older. All three vaccines are effective against the same serogroups: A, C, Y, and W-135. Two different meningococcal conjugate vaccines (MCV4) are licensed for use in the U.S. The first conjugate vaccine was licensed in 2005, the second in 2010. Conjugate vaccines are the preferred vaccine for people 2 through 55 years of age. A meningococcal polysaccharide vaccine (MPSV4) has been available since the 1970s and is the only meningococcal vaccine licensed for people older than 55. MPSV4 may be used in people 2–55 years old if the MCV4 vaccines are not available or contraindicated. Information about who should receive the meningococcal vaccine is available from the Centers for Disease Control and Prevention (CDC). What is Glaringly missing from current vaccines in the U.S. is serotype B vaccine.
The school has decided to allow students to receive injections of a Novartis vaccine, which has been approved in the European Union and Australia but not by the U.S. Food and Drug Administration. It is specifically for Serotype B Meningitis. Novartis and FDA officials “have not yet come to an agreement on a pathway to licensure” for Bexsero, said Liz Power, a spokeswoman for the Swiss-based drugmaker. The U.S. Centers for Disease Control and Prevention received permission last week from the FDA to import the vaccine because of the New Jersey outbreak. Princeton will have the first of two doses of the vaccine ready in early December, with the second available in February; Two doses are needed for the greatest protection, the school said in a statement: “Students who already received a meningococcal vaccine are not currently protected against serogroup B, the bacteria causing the outbreak at Princeton.” The university said it will pay the costs of the vaccines for students who want to receive it.
Meningitis is a scary and contagious disease, so how could a vaccine be bad? Anti-Vax supporters have a dis-proven laundry list of why vaccines are terrible. Yet like a bad marksman they miss the target in this scenario. The Vaccine is not the problem, it is the administration.
In my opinion, the Novartis vaccine should be required for all students not currently immunized unless it is contraindicated due to a pre-existing condition. Failing that, voluntary immunization may not halt the disease and could have unintended negative consequences.
My opinion is based upon the limits of the vaccine, the complicated nature of the disease, and the unknown risks of the vaccine.
There is a reason that the vaccine for this strain has been difficult to design. Developing vaccines against Neisseria meningitidis serogroup B (MenB) has been a challenging aim for decades and was hindered by the close relationships between serogroup B capsule and the human antigen the neural-cell adhesion molecules (NCAM)2. The huge efforts made by the pharmaceutical industry in this field have led to a pioneer approach/concept called the reverse vaccinology that opened the way to develop not only a vaccine against MenB but also against many other diseases, that are otherwise difficult to be developed using conventional approaches. More than 15 years of intense research has led finally to the licensure of the Bexsero, the first vaccine against MenB. It should be undelined here the licensure of meningococcal vaccine is based on serum bactericidal assays and on the correlate of protection4,5 and no clinical efficacy studies have been required for the licensure of meningococcal vaccines. The Bexsero vaccine may offer a potential unique strategy against meningococcal disease (not only due to MenB) as the antigens targeted by the vaccine are conserved among meningococcal isolates regardless their serogroups.
Layperson summary: It is a novel approach that has a great deal of evidence supporting efficacy but it has not been thoroughly field tested. It was used with success to control a French outbreak last summer. It is not an experimental treatment but widespread use has not occurred even in Europe. You cannot experimentally infect people to test vaccines. All new vaccines are licensed and distributed based on laboratory testing. Additionally it is a two dose vaccine, meaning that it may be weeks to months for full immunization.
It is not just the “newness” or the schedule of the vaccine that is of concern. The nature of meningitis itself, overcomes the vaccine. Meningitis is spread through close human contact. In 9-20% of the human population, at anytime, meningitis can benignly colonize your Nares (Nasal Passages). Vaccines do not get rid of the colonization, it just prevents the internal infection. In meningitis there is no benefit of herd immunity. Meaning that in other communicable diseases like measles the un-immunized are protected when enough of the “herd” is immunized. The disease is stopped because it lacks the necessary carriers to keep spreading the infection. This is not the case with meningitis. Even the immunized can be carriers, infecting the unprotected.
In summary, immunizing a small voluntary population in this case has several major medical flaws.
The Vaccines primary efficacy in a large populations is untested.
The revolutionary nature of the vaccine makes the complications and risk/benefit profile a little more unpredictable than standard vaccines.
There is no Herd Immunity, so partially immunized groups will not make a major impact on halting an epidemic.
The complicated nature of sharing information about the vaccine’s limits may give newly immunized and un-immunized alike a false sense of security. This may result in a drop in traditional exposure precautions. More likely explaining the complicated issues to people will make them avoid the vaccine.
Bottom line: If Princeton is going to obtain FDA permission to import, buy, and administer this vaccine they better make sure everyone gets it, or it may fail spectacularly. Harming people and damaging the perceived public usefulness of the vaccine. You cannot undertake halfway measures with this disease and make it work. You must be “in for a penny in for a pound.”
For epidemic control this is shades of a placebo, to prevent a panic without substance. I am not recommending that your son/daughter at Princeton avoid the vaccine if it is available. What I am saying is that Princeton needs to go “all in” or kids will still get sick. Plus if your son/daughter is not immunized they may feel falsely secure about transmission. Worse current carriers may lose caution and continue to spread the disease. They hopefully will continue current practice of antibiotic prophylaxis in exposed adults. If they don’t it will be an even bigger failure.
Public health is not individual choice and privilege. Public health is using good science, and medicine to protect the public. Public health is what is good for the public not for the individual. A hard pill to swallow, but it only works if you really do what needs to be done. If you act like the “Wizard of Oz” all show and no substance you are really left with nothing worthwhile. This disease has the power to “pull back the curtain” and expose you as a charlatan.
Disclaimer: This post is my personal opinion, it does not reflect the opinion of: my practice, my partners, hospital affiliations, Brian Dunning or my academic affiliations. It is for informational/educational purposes only. It is not intended to replace personal medical evaluation and discussion with your healthcare provider.
Chemtrails are all over the internet, and purported to be part of a government conspiracy to poison or control populations. This is complete psuedoscience and fear mongering debunked in skeptoid episode 27. Major news outlets are reporting today that science has produced a link with jet aircraft and heart attacks. No it is not a chemtrail story, it is another example of thrill science publishing and reporting.
“Exposure to Aircraft noise may increase the risk of hospitalizations for heart problems“. When I first read the story, I immediately assumed reporter error and twisted exaggeration. Not at all. It is the BMJ that is at fault here.
I am dismayed by the conclusions of the actual study. I have to give the media a partial pass because analyzing the complicated double speak is difficult. The conclusions of this study are on such shaky ground that my initial impression is that this is one of the well known BMJ “Joke” studies that it publishes annually in the Christmas holiday edition. As far as I can tell the paper seems serious and not a spoof.
The title of the paper is”Aircraft noise and cardiovascular disease near Heathrow airport in London: small area study“. It proposes that having controlled for the confounding factors as best they can, the authors see a statistically significant link between exposure to aircraft noise; coronary artery disease, stroke and mortality.
My Opinion, I am stunned that this pile of tripe got published. It is a very nice statistical exercise but what it really says about anything is unclear. There is so much wrong methodologically that I hope the conclusions from this data cannot be serious. It may have been done on purpose. Either to expose poor science reporting, study poor science reporting, or to try to drum up public support financially for their research. That can explain the author’s fail. It completely escapes me why the BMJ would publish it as a serious paper.
Here are a few of the major methodological error highlights making the stated conclusion impossible to determine.
- They retroactively took chart data from hospital admissions and compared it to airline noise plots based on time of day and location. The data controlled for air pollution, and some patient demographics. It did not remove exclude or analyze any other noise sources for the patients. Meaning that the authors in metropolitan London assumed that all other noise sources were irrelevant compared to airline noise.
- They included no data on the following confounding cardiovascular risk factors: Body mass index, serum lipid profile, family history, exercise tolerance or frequency, employment, interior personal environment(IE:smoke filled lounge), driving or not, traffic or not, amount of sleep, psychiatric stressors, caffeine intake, alcohol or illicit drug use(there is more for brevity I will stop). What they did they control for? “adjusted for age, sex, ethnicity, deprivation, and a smoking proxy (lung cancer mortality) using a Poisson regression model”
- They used a statistical expansion model increase actual data points to more than they collected. It is a statistically valid technique but not for this type of study.
- They even noted that their population was heavily laden with biases, loading a group of distinct ethnic groups into one group “south Asian”
- For the premier fail of the study “We were able to adjust at small area level for ethnicity, deprivation, and a smoking proxy (and additionally for particulate air pollution and road traffic noise for a subset of 2.6 million people), but we did not have access to individual level information on confounders such as smoking; therefore results at the area level may not be applicable to individuals (ecological fallacy). ” Meaning they did not know if they were smokers or not. They averaged it out based on population grouping. I would term that a major confounding factor. How can you possible consider cardiovascular mortality factors without knowing if the patient is an active smoker? Answer: YOU CAN’T!
Just a stunning pile of research fail. This study is so loose that I am not even sure you can depend on any of the statistical findings. It is absolutely false to say that they can correlate airline noise with heart disease. It would be like publishing a paper about car accidents and drinking water. Primarily concluding in that paper that drinking a glass water in the 72 hours before a car accident causes it.
Utter and complete rubbish, shame on the BMJ. The study is slick and well done I can only fault the reporting to a point. If science reporters just called anyone with medical expertise and asked for a medical opinion on this study it wouldn’t be the lead medical story for the day. That is also probably why media outlets don’t do that.
This week on Twitter Brian has thrown down the science blog gauntlet about an Indegogo start-up. Specifically a spray on “energy drink”.
I accept the challenge.
Energy Drinks are a broad category of stimulant drinks. Some energy drinks have ingredients that are useless, dangerous, or a completely unknown. The common active ingredient in energy drinks is caffeine. There can be a carbohydrates but not always. There can be a broad range of additives mostly for marketing generally pseudoscience. The investors assert that their spray is superior, cheaper, safer and lasts longer than conventional energy drinks. At this point they have raised nearly 10 times their goal of 15,000 usd for their start-up. Lets take a look at their claims and apply our “Skeptical Eye”.
“Sprayable Energy Welcome to the end of tired. We’ve developed a liquid you spray on your skin to get the energy you would from energy drinks”
Caffeinated Products Currently Suck
They are too expensive, too inconvenient, too filled with calories and questionable ingredients, and in many cases taste terrible.
You also have to buy them multiple times a day, store them at the right temperature, and in 20%+ of the population they can cause nausea, headaches, and a feeling of being overly wired.
We hated making all these unfair compromises and developed a solution.
I don’t have a problem with most of this claim. My objection is that many of those side effects are due to the caffeine. Ironic that the energy spray originators object to the calories in the energy drinks, since it is the only actual energy. I would also disagree that all caffeine products “Suck”.
“Sprayable Energy is the world’s first caffeine based topical energy spray. It can be taken in seconds, doesn’t make you crash, is way more affordable than current products, and isn’t full of mystery ingredients.
Sprayable is a colorless, odorless liquid you spray on your skin to get a steady stream of energy for hours. Our patent-pending technology (described below) enables us to deliver just one active ingredient, caffeine, to give you the energy you need without the side effects or safety risks.
Sprayable is way safer to use than the cocktail blends of current energy products. Never be concerned for your health when using caffeinated products again.”
Many problems with the previous statement.
Changing the delivery of an active ingredient rarely diminishes risk. There is no energy in this spray, there are no calories. It is a stimulant spray. They are claiming longer lasting effects than oral caffeine. Why? how? Transdermal does not automatically mean extended release. Nicotine transdermal is designed to be slowly released. If this formulation is extended release then multiple applications would be dangerous, possibly deadly. High dose caffeine can induce, hallucinations, muscle fasiculations, heart arrhythmia, hypertensive crisis or stroke. Dumping the energy drink woo ingredients is safer, but the active ingredient is still dangerous. By eliminating the drink part of the energy drink you have removed a barrier to overdosing. The volume of the drink is protective to an extent. If you drink a 100 cups of coffee you will wash it out quicker than you can overdose yourself. Plus if you consume that much fluid the bloated full feeling will slow you down. A topical spray could be dosed and dosed and dosed until you pass out from an arrhythmia. That is the primary reason why pill caffeine is dangerous and caffeinated beverages are usually not. Finally it is absolute fallacy to claim that delivery method will give all the positives without any of the problems. That is an out and out lie.
It is not energy it is a caffeine spray.
At this point, you’re probably wondering how Sprayable works and we don’t blame you.
Our active ingredient is caffeine, which can actually naturally enter your body through the skin by passing through cell membranes (caffeine is very structurally similar to nicotine – which also easily passes through cell membranes, if you’ve ever seen a nicotine patch).
So what’s our great breakthrough? Well, it turns out caffeine isn’t very soluble in water, and so it’s difficult to transport enough caffeine in a spray to have a significant effect. After months of research, we discovered we could increase caffeine’s solubility five-fold by using a simple derivative of a naturally produced amino acid, tyrosine.
Thus, our patent-pending technology opens up a whole new realm of possibilities when it comes to energizing as effectively as possible without all the drawbacks and side effects.
This is mostly nonsense revealing the investors complete lack of pharmacological and chemical knowledge about their own product. Nicotine is not the same as caffeine except that they are both atypical stimulants from plant evolved pesticides.
“Well, it turns out caffeine isn’t very soluble in water, and so it’s difficult to transport enough caffeine in a spray to have a significant effect”
Caffeine is hydrophilic it is soluble in water. It is dissolved in soft drinks all the time. Your skin is water repellent so dissolving it in water is the opposite of what you want.
“Our active ingredient is caffeine, which can actually naturally enter your body through the skin by passing through cell membranes” “caffeine is very structurally similar to nicotine – which also easily passes through cell membranes”
Caffeine pharmacological action is extracellular it does not need to cross cell membranes. Caffeine is believed to work by blocking adenosine receptors in the brain and other organs. This reduces the ability of adenosine to bind to the receptors, which would slow down cellular activity. The stimulated nerve cells release the hormone epinephrine (adrenaline), which increases heart rate, blood pressure, and blood flow to muscles, decreases blood flow to the skin and organs, and causes the liver to release glucose. Caffeine also increases levels of the neurotransmitter dopamine. What is the benefit to intracellular caffeine? I don’t know but considering it is unlikely it is probably nothing to worry about.
Using tyrosine, an amino acid, as a transdermal transport agent? In vivo transdermal caffeine experimentation found the best results with a lipid agent. Simply put the fat based system worked best in the lab. The spray uses an amino acid, the building blocks of proteins. In my opinion, they probably chose tyrosine based on guesswork and because it sounds jazzy. Plus who would buy spray on fat. In any case there is no research so pure speculation.
“Thus, our patent-pending technology opens up a whole new realm of possibilities when it comes to energizing as effectively as possible without all the drawbacks and side effects.” Energizing, again there is no energy involved. I suppose you could call it feeling energized.
Bringing this all together.
- Previous in-vitro studies show poor transdermal absorption of caffeine. There is no published research by the inventors, or anyone using a protein as a enhancer.
- Despite the excessive use of the word energy. There is no human usable energy in caffeine.
- It is complete speculation if not outright confabulation to say that transdermal caffeine results in longer or sustained effect comparative to oral.
- It is a lie to say that caffeine through the skin will result in effect without any side effects/rebound. If you get enough into your system to have an effect you will have a similar scale side effect. No way around that.
- The mode of delivery is not safer than drinking a caffeinated beverage. In fact it is more dangerous due to easy overdosing.
- Their proposed mechanism of action is unfounded and probably useless.
- They demonstrate a lack of basic knowledge about the chemical properties of the drug that they are selling.
- It is not an energy drink substitute. It is not a drink and it contains no energy. It is a spray on drug.
- It is an untested unknown. How much caffeine do you absorb per spray? What are the side effects? What is the dermal effects? What are the problems?
- I think they may have FDA troubles since this is a drug delivery system not a supplement or food. Caffeine is ok as an additive, here it is the only ingredient. I suspect that the tyrosine is necessary to get around FDA and call it a ingredient. Making it legal to distribute without testing or safety checks. Even though they mentioned an FDA approved manufacturer about 20 times. That does not make this an FDA approved item, but they are desperately trying to get you to draw that connection.
So if you have been dying to dump your energy drinks for a untested, unknown dosage caffeine cologne. This may be the item for you. It would be more effective and definitely safer just to take a caffeine pill and have a bottled water. On thing is certain no matter how many times you spray it there will only be caffeine no energy.
Personally I rather have a good coffee with skim milk.
1. Trauer S, Patzelt A, Otberg N, Knorr F, Rozycki C, Balizs G, Büttemeyer R, Linscheid M, Liebsch M, Lademann J. Permeation of topically applied caffeine through human skin – a comparison of invivo and in vitro data. Br J of Clin Pharmacol 68(2): 181-186.
2. Int J Pharm. 2011 Dec 12;421(1):34-44. doi: 10.1016/j.ijpharm.2011.09.014. Epub 2011 Sep 19.Investigation of microemulsion microstructures and their relationship to transdermal permeation of model drugs: ketoprofen, lidocaine, and caffeine.
You could write a blog post twice a day about dietary pseudoscience and never come close to keeping up with the flood of bad reporting. This post is not about the study rather it will be a primer for a Dietary BS Detector. Teach you to fish rather than give you a fish yaada yaada. Plastic residue causing obesity was widely and credulously reported from multiple news media outlets this week. Skeptoid Episode #60 is a good example of this type of BS. There are variations on the story but one common theme emerges. Plastic residue is making children obese. My favorite example from the Daily Mail “Are chemicals in food packaging making children fat? Experts warn they expand waistlines and increase the risk of diabetes” So take out your skeptical tools (logic/science) and we will work through this pile of bad reporting together.
The first question you must ask about any dietary claim. Does it violate any laws of physics? I find this question weeds out a lot of useless claims immediately and allows you to move on. This article claims that eating plastic encapsulated food makes children obese. Basic laws of physics conservation of mass. You cannot gain a pound of weight without consuming at least that much weight in food or fluid. Since our bodies are not 100% efficient we have to consume much more than a pound to gain a pound. Calorie dense items translate a higher % of mass but it still cannot come close to 100% of mass or exceed it. There is no way that you could become obese by eating plastic since we have no real ability to metabolize it. If it was slowly impacted in our intestines without killing us you might gain a little weight. You would die from intestinal obstruction long before you would gain any real weight. It is physically impossible to gain significant weight by ingesting food packaging residue without killing yourself. Dietary pseudoscience often overplays the effects of nutrients/additives and how much it affects your body weight. You cannot gain 5lbs because you consumed an 12oz slice of cake no matter how calorie laden it is. You are not a plant you cannot absorb light and make more carbohydrates. Humans are not 100% efficient you will always eat or drink much more than you will gain. Simple equation burn more mass than you ingest you will lose, eat more than you burn you will gain. So plastic residue cannot affect your weight directly. This reporter’s claim fails to abide physics. That said, could it affect you indirectly by metabolism or satiety?
The plausible question is, does plastic residue affect metabolism? This article claims a link between insulin resistance and the chemical phthalate in the urine. It assumes that insulin resistance results in obesity(chicken or egg argument). Possibly true but not probable. This research is correlational not causal. Lets put on our logical fallacy caps here. What do we know about correlational studies? “Correlation does not imply causation. It is a phrase used in science and statistics to emphasize that a correlation between two variables does not necessarily imply that one causes the other Many statistical tests calculate correlation between variables. A few go further and calculate the likelihood of a true causal relationship. Correlation proves causation is considered a questionable cause logical fallacy in that two events occurring together are taken to have a cause-and-effect relationship. This fallacy is also known as cum hoc ergo propter hoc, Latin for “with this, therefore because of this”, and “false cause”. A similar fallacy, that an event that follows another was necessarily a consequence of the first event, is sometimes described as post hoc ergo propter hoc (Latin for “after this, therefore because of this”). Causation requires multiple independent lines of differing correlation research to draw any conclusion. A single correlational study says nothing about causation. The reporter and the researchers are drawing conclusions. The researcher’s are tentative and the reporter’s are definitive.
In this case, it is equally plausible to say that insulin resistance in children elevates phthalate in the urine. I don’t think that is true either, but given the findings it is just as plausible.
Question one-fail, question two singular correlation research. You could stop here. It is prudent to use one more skeptical tool. I use Occam’s razor. Is there a simple much more likely reason for obese children to have phthalate in their urine? Obese children have high rates of insulin resistance. How did they get high rates? Current consensus in pediatrics is there may be a genetic component, but obesity is the predisposing factor. How do children get to be obese? Conservation of mass again, they eat a lot of calorie dense food.
Pre-packaged food like cupcakes and snack cakes are wrapped in plastic. Prepared food such as bologna, processed cheese, even minimally processed meat and dairy have relatively high levels of phthalate. Obese children do not favor lean meat fresh fruits or vegetables.
Soooo if an obese kid has phthalate in his urine what is more likely as the cause of the obesity? Is it the food or the packaging? The food no question. The food doesn’t violate any law of physics. Doesn’t conflict with the findings of the study. It is the simplest best answer. Bing! BS detected. Three strikes and you are out in my book.
See you didn’t even have to critically review the study to figure this one out. Nailing dietary pseudoscience is as easy as 1 2 3.
What is implied by the reporter is that pizza doesn’t make you fat, the pizza box does.
FYI the researchers did not draw the same conclusions that the reporters did.
“The researchers said their findings don’t prove that eating food packaged with phthalates causes insulin resistance.
For example, it’s possible children who are already insulin-resistant have unhealthier eating habits and eat and drink more packaged products – thus the higher phthalate levels in their urine.”
This week’s Skeptoid podcast about Muzak showed how things become embedded in “popular knowledge”. Pop culture quotes are a paraphrase of a cultural ideas. They become a common social references. Memorable quotes become a place holder for cultural knowledge. Cultural knowledge, like our brain’s memory, is unreliable and subject to fluid interpretation. Pop culture quotes often are distorted or incorrect variations on the original. Here is a short list of a few that make me cringe whenever I hear them. They are often heard but rarely correctly. Continue reading →
The patriot act. Another government power over us that circumvents the constitution and the liberties we enjoy. Employing high tech surveillance of domestic citizens with the hope that we can stop terrorists attacks. Yet it doesn’t work. As evidenced by the Boston Marathon bombing. Terrorists know where we are looking and learn to avoid methods. Electronic surveillance is not helpful enough, given the tremendous amount of data that is available. Historically governments can not be trusted with unlimited power. Yet because of fear over 9/11 people willingly surrendered their privacy in the hope that we would be protected. A flawed concept and the wrong answer.
The patriot act is an excuse to be able to oversee someone’s every move. Ostensibly to “protect us”. We are expected to believe that the government will be able to restrain themselves and not abuse that power. History says impossible. Worse surrendering our privacy is based on a flawed concept. If we give law enforcement and intelligence bureaus unlimited data we will be safer. Wrong, and not supported by historical precedents. Think about this. Prisons in the US are the most monitored restricted section of our society. Yet we can appreciably stop anything from happening there? Humans are inventive destructive creatures. If you tighten the surveillance you naturally select for “the best of the best” they get better at hiding. In my opinion the stated goal of catching terrorist cells in the US is impossible. No matter how much data they have someone will find a way. How well did the US do in Vietnam, Afghanistan, and Iraq. In the 90’s they bombed the world trade center still we had no idea they would attack it again. Ridiculous to think that personal privacy was the major barrier to protection. Russia has oppressive surveillance compared to US. Still Chechen rebels attack all the time. It is a flawed premise that just doesn’t work. Except as a tool of intimidation and information gathering for your own law abiding populace. That has a direct negative effect on freedom. Have I brought unwanted attention just by writing this. Maybe I could end up being an FBI focus. Just by exercising my freedom of speech.
Somehow we are supposed to believe that FBI will be able to pull produce terrorists out of an even bigger pile of data, everyone’s phone records. I call BS on this. Yes, if you want to catch someone and you have a idea who it is and what they want this would be helpful. Why not make them get a warrant instead of fishing. If you assume guilt then the patriot act makes sense. That is the opposite of the US justice system that I was taught.
Ok surrender my freedom, but does it work? I am not an expert but look at the record. How many big cells in the US have been caught? They roll out examples of terrorist idiots with x-ray machines as examples of “50” plots thwarted. Yet two kids detonated two bombs in the middle of Boston. They were caught in 72 hours because of the video from the phones they were monitoring. How helpful is that?
It sounds good to law enforcement and government agencies. It is not worth the loss of privacy. We are but a few steps away from what the founding fathers feared most monolithic government oppression.
I am of the opinion that fear is what drives this. Not reality. We are afraid so we give up freedoms. One little bit at a time. We keep letting people in power get more and more power. All in the name of “Terrorism”, “health” “the children”. For a concept, not an enemy. You will never stop terrorism, just individual terrorists. Each small liberty surrendered is 10 times the effort to regain. Historically can people in power be trusted? NO. Should we stop this march towards Orwellian dystopia? YES.
With each small link the chain is forged, until we wake up in irons. That is the nature of power and people. It must be stopped. People need to wake up. Make your outrage heard. Stop this before we lose the ability to challenge those in power.
Did medieval serfs know that by working for landowner they would eventually end up virtual slaves? Probably not. We should. The federal government becomes more and more monolithic everyday. They dictate healthcare, education, the military, and money. How far are we away from serfdom? Some would say we are there now. You don’t own your home you rent it from the state. They take it away if you don’t pay your taxes. That is not ownership, it is serfdom to the state.
Forced DNA test and checks are now law of the land thanks to the Supreme court. The federal government can essentially track your every move. All in the name our safety. It is an illusion. Surrendering you freedom to feel safer is not a fair trade. Well fed complacency and fear is ending liberty. One little bit at a time so we don’t feel it and don’t complain. All in the name of the common good. Which history teaches us is “their” good and our common toil.
What can you do? Well if enough people; write, email, and call enough of their representatives then this can end. Either that or let your children have to deal with a country that mouths words like “land of the free” with irony rather than pride.
A new paper by Professor Qing-Bin Lu PhD is purporting to demonstrate that chlorofluorocarbons, not carbon dioxide, are behind global warming. Since CFC production has tapered off, he therefore predicts that we’ll see global cooling for the next 50 years or so.
CFC’s or Chlorofluorocarbons were widely used as refrigerants until it was phased out for the ozone friendly R-410A due to the Montreal protocol. CFC’s do in fact have high global warming potential as do all halogenated molecules. As much as 10,000 times the global warming potential of CO2. So this theory has plausibility. I think it is reasonable to turn the colloquial “Skeptical Eye” of Skeptoid toward this claim and the science involved.The findings of Professor Lu’s paper – “Cosmic-Ray-Driven Reaction and Greenhouse Effect of Halogenated Molecules” would be dramatic and ground breaking. Like most extraordinary claims I require extraordinary evidence. Lets review the paper, the claims, it’s author, and the publisher.
The CFC paper (PDF) originated from University of Waterloo Ontario Canada. I am no chemist nor physicist, still on quick evaluation the math appears appropriate. In addition there does appear to be a correlation between CFC’s and global temperature. I quickly find glaring flaws even to a lay person. There does not appear to be any consideration for ocean based warming. The temperature figures are for land based temperatures only. Secondly he makes claims that the global temperatures have been cooling for the last decade. This is not supported by the temperature measurements from multiple lines of evidence. This makes me suspicious that there are more subtle but significant errors in the paper that I lack the expertise to find.
I also have concerns about the author, related to his expertise. He is a physicist not a climatologist. This is a red flag in science for pseudoscience. He is working outside his field. It is unlikely that a physicist can suddenly trump a generation of climatologists research. The Galileo gambit is another red flag for pseudoscience. People from outside a complex field of science suddenly coming up with a simplistic answer to complicated problem is likely bogus.
The publisher International Journal of Modern Physics B is not a peer reviewed climatology journal. Frankly another red flag. Getting your trauma surgery study published in Nature and not in The Journal of trauma and acute care surgery usually means that it has no real basis for surgical publication. Journals are like all publications, sensation sells, and publishing a controversial paper with good physics in it makes a lot of sense. That does not mean that there is any basis for guiding climate science.
For me the final “nail in the coffin” is that the author published a similar paper in 2010 with the same theory and it was roundly criticized then. “Cosmic-ray-driven electron-induced reactions of halogenated molecules adsorbed on ice surfaces: Implications for atmospheric ozone depletion and global climate change. Qing-Bin Lu.” In Physics Review.
So from a non-climatologist perspective. We have a physicist publishing a paper in a physics journal about climate change. Who ignores ocean temperatures, indicates that the planet is cooling when it is not, and bucks what 97% of experts in that field say.
In my opinion implausible and unlikely to pan out. That does not mean I think that CFC’s have no effect on climate. It is part of a global picture of climate change. AGW is multi-factoral. The science and the experts indicate that CO2 is still king. All other factors deforestation, CFC’s, methane, albedo changes, water vapor et al… All play a role but CO2 is still the major player.
It is a pleasant fantasy to think that the problem is already fixed and going away on its own. Unfortunately it is fantasy not science.