Category Archives: Uncategorized

Post-Holiday Cleansing Diets

Every year the holidays put stress on our health sensibilities. We indulge ourselves, we overeat, drink alcohol and generally take liberty with our bodies. Invariably we can develop a sense of guilt over our excesses. Then there are the traditional New Year’s resolutions and the attempt to negate the past month’s indiscretions. I have noted personally and professionally an increase in health-conscious people using cleansing diets. Friends, students, and even colleagues are using them as a recovery method for this extended period of less-than-healthful behaviors. I decided to take a skeptical look at the so-called cleansing diets. What are cleansing diets and are they a good method to get yourself back into shape? Does a cleanse actually do anything and could it be a health panacea or is it another in a long line of marginal health claims?

Simplifast detox diet beverages. Via Wikimedia.

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Vampirism: The New (Old) Fountain Of Youth

If you read the medical reporting online you can become convinced that we will soon be living like the fictional marvel comics character Blade, “Day Walker”. An immortal that needs human blood to keep himself/herself rejuvenated. They give the mostly false impression that recent research is the first step to immortality. Although there is recent research, confirming prior evidence, of a benefit to older mice from younger mice blood. This is by no means the “key” to immortality. That has not prevented any news media outlets from reporting that it is age reversal in mice. Nor has it stopped them from extrapolating the same benefit to humans.

That may sound familiar since this is a common pop culture theme and has some historical precedent as well. There are early documented references to the use of blood, for what can be at best described as ‘medicinal’ purposes. One of the first of these relating to a ‘transfusion’ is contained in the seventh book of the Metamorphoses, by Ovid, who wrote in 43BCE, describing how (the witch) Medea rejuvenated Jason’s aged father Aeson as follows:

Medea took her unsheathed knife and cut the old man’s throat letting
all of his blood out of him. She filled his ancient veins with a rich elixir.
Received through his lips and wound, his beard and hair no longer
white with age, turned quickly to their natural vigour, dark and lustrous;
his wasted form renewed, appeared in all the vigour of bright youth“.

Almost 2000 years of scientific advancement cannot stop current science reporters from falling for the same story.

Here are just a few of the dramatic headlines you can find online…

  • Young Blood Restores Old Mice
  • Swapping Young Blood for Old Reverses Aging
  • (My Personal Favorite) Vampire’ blood transfusions could cure Alzheimer’s and even be the secret to eternal youth

Could this possibly be true? Is there immortality in the blood freezer at the local blood bank? Well the short answer is……aaaaah no!

These articles are an exaggeration of the salient facts, married to a misunderstanding of a complex science. Small exaggerations allow writers to produce an attention grabbing sound bite and/or headline.

Eternal youth from blood is an irresistible story for both the writers and the readers. Realistically, it as a unsupported conclusion based on some recent research. Lack of probablity does not seem to prevent science reporters from promising eternal youth or pop culture fictional imaginings like vampires.

The actual research makes much smaller claims; although the principal investigators have taken full advantage of pop culture imaginings to promote their research (this is becoming more and more common in promoting research and unfortunate in my opinion).

The actual research is actually three separate lines of good evidence.

  1. Young blood reverses age-related impairments in cognitive function and synaptic plasticity in mice.
  2. Vascular and Neurogenic Rejuvenation of the Aging Mouse Brain by Young Systemic Factors
  3. Restoring Systemic GDF11 Levels Reverses Age-Related Dysfunction in Mouse Skeletal Muscle

The most recent paper Number #1 is making the rounds in the news. Injecting old mice with blood from younger mice improved their cognitive abilities along with promoting new neuron growth in their spinal cords. This is a further  line of evidence that some factor in blood keeps regenerative processes going for a time, but then disappears with aging. The older research done by the same group at the University of California San Francisco (UCSF) and Stanford University in Stanford, Calif., can be found in the journal Nature Medicine. That research involves “heterochronic parabiosis,” which connects the vascular systems of young and old mice so that the young animals’ blood circulates through the older animals. That research had also demonstrated a systemic rejuvenation effect. However, it is still not certain whether GDF11 is the factor underlying these findings.

Multiple lines of convergent evidence in medicine is usually very convincing. As you may have guessed, this evidence is magnitudes removed from being able to make the types of conclusive statements present in the media reports.

The research is duplicating an effect but the conclusions are at best a stretch. There are many factors that are not being controlled for. Even if you assume that the conclusions are 100% accurate there is no guarantee that this effect automatically transfers to humans.

For example, there is a list of studies showing successful spinal nerve regeneration with stem cell treatments in rodents. Everyone is trying to find a way to regenerate the spinal cord after an injury. Despite tons of limited success in rodents it just doesn’t work in other animals especially humans. It is well known that rodents have regenerative properties that we just don’t share. The stem cell treatments just don’t seem to translate to humans like they do in rodents. A common flaw in the conclusions “is it the rodent or the treatment”. It is very likely that this research will run into the same “Human Barrier”. We are not rodents and what works for them doesn’t commonly work for us.

The GDF11 factor is significant because we share this factor with rodents. In truth the researchers have failed to properly isolate this factor. So is the effect from the factor or is it something else?

Additionally there are many many confounding factors. Could it be some hormonal factor in the blood, or something specific to mice in general.

Finally plausibility is an issue for this conclusion. Blood transfusion has been around since 17th century, it is not new med. tech. If there was a large effect from youthful blood transfusion it would have been noted. I am sure since this has been a consistent folk legend surrounding blood. I am certain that real or not it would have been noticed given the millions of blood transfusions that have taken place. More damaging to plausibility is the totality of what we know about the aging process. There is no one factor. Aging is multi-factoral and it is far too complicated of a process to be blunted by one particular blood factor.

I think that the research is worth pursuing. That said, when you evaluate this using a Bayesian model you will see that it is highly unlikely that GDF11 will be a panacea for eternal youth, never mind a cure for Alzheimer disease.

Like many science/medicine stories this news cycle is another good example of why science writers need to consult experts before writing stories. Headline editors are good at writing headlines but they are lousy journalists with absolutely zero science chops.

References:

  1. http://www.mirror.co.uk/news/weird-news/harvard-university-alzheimers-cure-vampire-3499246
  2. http://news.nationalgeographic.com/news/2014/05/140504-swapping-young-blood-for-old-reverses-aging/
  3. http://www.nbcnews.com/health/aging/young-blood-restores-old-mice-n95816

Should Pregnant Mothers Avoid Tylenol?

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.

Acetaminophen

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:

“Acetaminophen Use During Pregnancy, Behavioral Problems, and Hyperkinetic Disorders”

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.

References:

http://archpedi.jamanetwork.com/article.aspx?articleid=1833486#Abstract.

http://www.tylenol.com/safety-dosing

http://www.cdc.gov/ncbddd/adhd/facts.html

http://www.cdc.gov/pregnancy/

DisclaimerThis 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.

Deadly Flu Vaccine and the Bizarro World View.

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…..

Hello 🙂

Bizarro DC comics

References:

http://www.lewrockwell.com/2014/03/bill-sardi/the-flu-death-trap/

http://www.reuters.com/article/2014/02/01/us-usa-flu-california-idUSBREA1004820140201

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6307a

Spray On Energy

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”.

The Pitch-

“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 fasiculationsheart arrhythmiahypertensive 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.

  1. 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.
  2. Despite the excessive use of the word energy. There is no human usable energy in caffeine.
  3. It is complete speculation if not outright confabulation to say that transdermal caffeine results in longer or sustained effect comparative to oral.
  4. 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.
  5. The mode of delivery is not safer than drinking a caffeinated beverage. In fact it is more dangerous due to easy overdosing.
  6. Their proposed mechanism of action is unfounded and probably useless.
  7. They demonstrate a lack of basic knowledge about the chemical properties of the drug that they are selling.
  8. It is not an energy drink substitute. It is not a drink and it contains no energy. It is a spray on drug.
  9. 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?
  10. 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.

References:

http://www.indiegogo.com/projects/sprayable-energy

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.

Plastic Making Your Kids Fat?

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.”

10 Pop Culture Quotes That Never Were.

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 →

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