Konstantin Monastyrsky – Pseudoscience of Nutrition (Part 2)

Last week I wrote about the Konstantin Monastyrsky and the poor application of science and the use of mostly anecdote in his ideas as to what the human diet should be. Through most of my research on his ideas, it didn’t have much basis in science, although it didn’t seem like he was purposely being misleading. It also didn’t seem his ideas had much harm, as the diet he proposes is one that would be more or less healthy from what I can tell. However, Mr. Monastyrsky seems to have an agenda of anti-science when one looks deeper into his website.

The piece on his website that really shocked me with its misleading information was one claiming MiraLAX is causing neuropsychiatric events. MiraLAX is a mild laxative made from Polyethylene Glycol 3350. The compound is sold by many companies, with MiraLAX being the most common or at least the most recognized brand name. The appeal is it is a non-stimulant and works by drawing water into the colon and is passed out rather than being absorbed into the body. Although not approved for use in children, it is very commonly prescribed to children with problems with constipation because it is effective and the low occurrence of side effects. However, much like other things we give to kids to improve their health, the hysteria has started and some parents are looking for any reason to panic about giving it to their kids. Mr. Monastyrsky seems to have bought into feeding the hysteria.

Mr. Monastyrsky subtitles the article with the following quote:

Getting mad or forgetful after taking a laxative? Well, according to the US Food and Drug Administration that’s exactly what certain best-selling laxatives can do to you.

This is wrong! The FDA did put MiraLAX on its watch list after receiving reports of a possible reaction. It is the FDA’s job to look at those events and decide what should be done about them. Their investigation revealed no connection could be found, and thus the FDA found no action was necessary (Mr. Monastyrsky conveniently ignores this part). Connecting symptoms to a drug which has not shown to be connected in any way is not only wrong, it could actually be harmful in that you could scare people from taking a drug which otherwise would bring them relief for symptoms they are having.

Mr. Monastyrsky continues by explaining how polyethylene glycol (PEG) is a polymer chain made up of ethylene glycol. From there the article is either conjecture or completely fabricated. While using the term fabricated is strong, I have no other way to describe it. While explaining how PEG is made, he links to the OSHA information on the monomer ethylene glycol which states:

Ethylene glycol is chemically broken down in the body into toxic compounds. It and its toxic byproducts first affect the central nervous system (CNS), then the heart, and finally the kidneys. Ingestion of sufficient amounts can be fatal.

This is true. Here’s what is misleading about it: when one ingests PEG, you are not ingesting ethylene glycol. So the effects of the monomer have nothing to do with the polymer. Although not a polymer, salt is a compound which is made of constituents that would be dangerous to ingest in their separate form. Compounds and polymers have properties different than their constituents. It is misleading to try to claim otherwise. Mr. Monastyrsky also injects within that quote a dose which he claims causes these effects. The dose he claims is “as little as 30 mL.” However, according the the MSDS for ethylene glycol, the lowest published toxic dose for humans is 15 mg/kg. This means to be toxic at 30 mL, the human would have to weigh just over 5 pounds.

The article then goes on to try to explain “neuropsychiatric events.” He defines them as “neurologic disorders of the central and peripheral nervous systems such as autism, dementia, depression, schizophrenia, multiple sclerosis, Alzheimer’s and Parkinson’s diseases, and similar others,” and then links to Merck’s list of neurological disorders which doesn’t even include some of those on the list. Also a huge red flag – listing autism first. Don’t worry, we will get to his audacious claim that PEG is causing autism in a moment. He then states:

These conditions result from PEG’s direct (through cellular damage) and indirect (through malnutrition of essential micronutrients) neurotoxicity. No surprise there considering the quotation above [referring to the quotation on ethylene glycol, the monomer].

There is no evidence of either of these results.

He does cite complications with PEG outside of neurotoxicity. He first cites nephrotoxicity, which is damage to the kidneys. However, the link provided as evidence is one that explains how ethylene glycol (again, the monomer) causes kidney damage, not the polymer PEG. He also cites examples of urticaria, which is an allergic reaction. However, these reactions have not showed up in formal studies, but in case studies of patients who were ingesting a solution of PEG and electrolytes in preparation for  surgery. The molecular weight of the PEG used is often different in these solutions, and none of the case studies I looked at seemed to point out the PEG as the issue. He also points out esophageal perforations, which again stemmed from the PEG-electrolyte solution, and only in case studies. Surely these would be areas to study, and have been since the early 1990s. There are no widespread occurrences in either case.

This is probably a good point to interject the safety studies that have been done on PEG. PEG comes in a number of forms, designated by their molecular weight. The one used as a laxative is PEG 3350. However, many other forms exist and are used in a variety of ways, including in skin creams, toothpaste, and as an anti-foaming agent in food. It is also used in gene therapy applications, blood banking, and many other uses. It has been well studied. A 2007 look at the studies done on various PEG molecules concluded:

Literature data indicate that the polyethylene glycol (PEG) associated with a biological molecule should provide no extra concern because the exposure-toxicity relationship of PEG in animals and humans has been thoroughly investigated and metabolism/excretion of PEG is well understood.

The studies show that even if administered intravenously, the higher molecular weights has a high percentage that passed out through the urine unchanged. Orally, various weights were absorbed differently through the intestine:

The absorption of PEG by the oral route is molecular weight-dependent. Urinary recovery data for PEG400 indicate that 50 to 60% of PEG with this molecular weight is absorbed from the intestine. For PEG1000, oral absorption in humans is approximately 10%. The oral absorption of PEG6000 is very low, because no PEG could be found in urine after oral administration.

Thus, again, absorption is molecular weight dependent. Based on these studies, far less than 10% of PEG 3350 will make it into the blood. It is important to also note that the metabolism of PEG compounds happens mostly on lower weight compounds, and the pathway is well known. The study says:

The metabolism of PEG itself is simple and involves the oxidation of the alcohol groups present on the PEG to a carboxylic acid…Evidence from studies with PEG400 indicate that ethylene glycol is not formed as a metabolite of PEG in humans.

PEG cannot be connected to its monomer in any way when ingested. Very little makes it out of the intestine, and very little of that little is metabolized. Any of it that is metabolized is not metabolized into its monomer form. So any attempt to connect it to that cause is not science – it is bogus.

As we progress past the isolated cases, Mr. Monastyrsky takes some very large leaps to try and connect MiraLAX and autism. Here is his first statement on how he thinks they are connected:

Technically, PEG is an osmotic laxative. Because of this property, it blocks the absorption of nutrients in the small intestine. Its extended use may result in severe malnutrition-related disorders, particularly in young children and older adults. Autism is one such disorder. It may take only two weeks of an acute iron or iodine deficiency to cause autism in a child younger than two.

This raises a couple of interesting points. First, if as he earlier claimed that somehow PEG is blocking all nutrients. Second, he is making the claim that autism is caused by an iron or iodine deficiency in young children. His first claim of blocking some nutrients is true. But not to a great extent. Eating fruits and vegetables can also “block” some nutrients to a certain extent. The “blocking” in either case is not to an extent where it would cause malnutrition, except perhaps in a case where there is a more serious underlying disease. That’s why it is important to talk to your doctor about this issue before starting you or your children on a treatment – to check for a more serious cause of your digestive issues.

The autism link is one that just baffled me. Mr. Monastyrsky links to a couple of studies in this claim, so I looked at them to see if the science is sound. It turns out, at least from the abstract, the science is good. However, it has no connection to giving a child MiraLAX. Instead, it was a study on thyroid hormones during pregnancy and a possible connection to  autism. It looked at animal models where changes to the brain development of a fetus  happened when thyroid function was decreased in the mother, and then correlated higher incidence of autism with higher rates of thyroid disrupting compounds in the environment. Even the abstract points out the shortcomings, and instead points out a possible direction for further research. How Mr. Monastyrsky equates the first trimester of pregnancy with a child having constipation problems is simply mystifying. Someone with his educational background should not be prone to such a mistake, and it would seem to me he is championing his cause and purposely making these bad scientific connections to do so. It goes beyond an honest mistake.

His second connection he tries to make is with autism and iron. Again, the abstract tells us all we need to know. The study wasn’t if iron deficiency caused autism. It showed that autistic kids had a higher than normal incidence of iron deficiency and anemia. The kids already were diagnosed as autistic. Having an autistic child myself, I know that there are times when he gets engrossed in something he can forget that he is hungry or that he needs to eat. This is just anecdotal, but I can see where an autistic child could easily become deficient in various nutrients just on that account alone. But we now know autism has a strong genetic component, and has little to do with any exposures once the child is born.

He continues with this claim:

The use of laxatives is particularly common throughout pregnancy. It’s entirely possible that ethylene glycol molecules penetrate the placenta and cause neurological damage in fetuses. Infants may be equally affected via breast milk, or milk supply may be poor quality or too low. And that’s on top of the maternal malnutrition and neurological damages I’ve described above.

Notably, MiraLAX was introduced back in 1999, about the same time the epidemic of autism began sweeping across the United States in earnest. It doesn’t take a PhD in epidemiology to infer a possible connection between these two happenings.

Again, we know ethylene glycol is not a by-product of the metabolism of PEG. Very little of PEG 3350 is metabolized because of the molecule’s size. Secondly, we should all be familiar with the notion that correlation does not equal causation – as many saw in this graphic showing the correlation of organic food sales and autism. It is bogus to make such a ludicrous claim.

Finally, Mr. Monastyrsky spends a few paragraphs making an emotional plea to “spread the word” about the “evil drug companies” and the “terrible effects of this drug.” He begs people to link to his article. Oh, and by the way…he just happens to have a “safe and natural” alternative in a diet you can follow by buying his books! In his words:

Adding insult to injury, after getting nuked with an abdominal CT scanto “diagnose” constipation and, then hooked on MiraLAX by the very doctors expected to protect [a child's] health, [a child] may end up autistic and cancer-prone for the rest of her life.

All that said, I am not yelling “fire” here for the sake of making a point. To the contrary — this site provides safe, effective, and natural solutions for resolving the nastiest kinds of “constipations,” and I hope you’ll use them.

Now he throws in cancer on top of autism just to be extra scary. He really is willfully ignoring what science has told us.

PEG has been around for 60+ years, and the studies on its safety date back to the 1950s. Certainly we should always exercise caution and investigate possible links to harm any time we are willfully ingesting large amounts of any product. We also should always weigh out any risks to the benefits. PEG 3350 has been shown to be safe and effective. Certainly check with your doctor before starting a treatment for a digestive issue to make sure you don’t have a more serious problem. Provided it is just a typical constipation, PEG 3350 might be one solution to discuss with your doctor.

Mr. Monastyrsky should be ashamed to publish such an article on his site. Not only is it false and misleading, it seems almost willful in its negligence of reporting connections of PEG to its monomer, a connection to autism, and using an emotional plea to sell his own products. Hopefully in some way, I can reduce the harm he is doing.

About Eric Hall

My day job is teaching physics at the University of Minnesota, Rochester. I write about physics, other sciences, politics, education, and whatever else interests or concerns me. I am always working to be rational and reasonable, and I am always willing to improve my knowledge and change my mind when presented with new evidence.
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55 Responses to Konstantin Monastyrsky – Pseudoscience of Nutrition (Part 2)

  1. XKJ says:

    I am normally very against the use and advocacy of punishment for philosophical reasons, but one of the legal reasons for requiring qualifications is not just for the knowledge it implies. One of the prominent other reasons is that there is a greater legal exposure for people who are certified, and they are putting their livelihoods on the line when they speak.

    For example, it is okay for a person to DIY their house’s electrical systems, but the resultant system needs to be checked by a certified engineer, so that, in the event of a fire, said certified engineer gets called up if the electrical circuits were simply dodgy.

    For an example closer to what a physicist would know, MIT’s Walter Lewin describes the inevitability of watching the Tacoma Narrows bridge as long as one is on the engineering and physics course at MIT. It is inevitable because the resultant engineer will be held accountable if resonance is neglected.

    So, it is a bit funny why medically trained personnel are not sued for being completely wrong. Somebody should really make a point with this crank.

  2. Yuri says:

    Eric,

    What is your background? Do you have a medical degree. As far as I understand physics is not exactly relatec to medicine

    • Eric Hall says:

      I do not have a medical degree. Neither does Mr. Monastyrsky. That doesn’t nullify either of our arguments, it just means we should be more careful in reviewing the science.

      As a physicist, I do have to have an understanding on a wide range of topics, including chemistry. In fact, medicine is a significant area of study in physics, with many physics majors going into medical physics specifically. I also worked as a safety officer for a small company, which required me to know about all of the substances used in our plant and read the MSDS information as well as research new materials for production, etc. I also have a basic understanding of science and the process, so I feel I can point out errors in scientific reasoning.

      As a scientist who is also human, I can make mistakes. I would hope someone would discuss with me mistakes I make on anything I might write or say. Mr. Monastyrsky is wrong on several areas of his research conclusions, and that is what I am pointing out here. He is welcome to contact me if he would like to discuss those conclusions further.

      • Stephen Propatier says:

        Dead on Eric.
        This is nothing more than an shorter extrapolation of the nonsense associated with Aspartame. IE: that your body metabolizes a tested substance into a toxic one. With ominous sounding sci-ency words. Not a scintilla of evidence just fear. Since I am part of the “medical Industrial complex”, I will be dismissed as a shill for big pharma. Whereas you are accused of lacking the expertise to question. Ridiculous and a nice little nonsense tautology. The mainstay of fear driven quackery marketing.
        No glaring errors.
        I would like to point out if he was right about it blocking all nutrients. Great! Stop giving it to kids and sell it as the greatest diet product ever. Instant billionaire. Eat whatever you want and absorb nothing.

  3. rockney says:

    Eric – You are admittedly not a doctor. Then you have no business spewing an opinion, regardless of how smart you think you are. The fact is you are wrong in several things. Are you aware of the FDA warning on the absorption and overuse of polyethylene glycol 3350? That when metabolized it creates toxins in the body? The fact that polyethylene glycol 3350 is an industrial plastic that the chemical and medical industries want you to accept, along with the risks? Just because something has been used for a while does not make it safe. So do you and the other deniers here work for chemical companies?

    • Eric Hall says:

      I will try to address each of your points.

      I am not a doctor. I do usually run my medical posts by my friends in the medical field, including doctors. Mr. Monastyrsky is not a doctor either. Credentials certainly are piece of the puzzle when evaluating someone’s advice. I think this puts us on equal footing. And besides, the evidence should be the largest piece of the puzzle when evaluating something.

      I did address the FDA warning. I quote my blog above here:

      The FDA did put MiraLAX on its watch list after receiving reports of a possible reaction. It is the FDA’s job to look at those events and decide what should be done about them. Their investigation revealed no connection could be found, and thus the FDA found no action was necessary…

      As far as the metabolites of polyethylene glycol 3350 – I also linked to the evidence. I quote:

      The metabolism of PEG itself is simple and involves the oxidation of the alcohol groups present on the PEG to a carboxylic acid…Evidence from studies with PEG400 indicate that ethylene glycol is not formed as a metabolite of PEG in humans.

      Plastic is a slippery word. Plastic can be broadly defined as any organic polymer. That alone does not mean it is harmful. Each substance must be weighed on its own.

      I wish I worked for the chemical companies. I wouldn’t have to do a super long commute every day!

    • Magnanamous Dinoflagellate, says:

      Thanx for the cobblers on all fronts there rockney, this is pretty simple stuff Eric is talking about.

      But you arent a regulator are you rockney? Then you have no business spewing an opinion.on recommendations..

      The last two sentences indicate your clear reticence in commenting on an issue you havent had the trainng to cope with. I applaud your bravery in the matter.

      10 out of 10 for borrowed style, no marks for preparation.

      • Anne says:

        Until you are a parent who has experienced the death of your child when Miralax was the only drug your child was taking, none of you will understand. Until your child exhibits unexplainable anger or tics or his little hands are so stiff he can no longer play the piano you will not understand. Until a parent experiences first hand what thousands of parents already know about Miralax, you will all continue to bury your heads in the sand. I think all of you boasting your blind brilliance is laughable. The truth is slowly being revealed.
        I applaud Konstantin Monastyrsky. His wisdom and foresight far excels the rest of you simpletons so entrenched in your closed minds.
        Talk to any parent at Miralax@yahoogroups.com.
        Get down from your Ivory Tower and take a stroll with those who have lived and suffered from the tremendous woes of Miralax.
        It is POISON!

        • Eric Hall says:

          Was the death linked to Miralax? Any tests done to prove it? I bet you also rode with your child in a car almost every day – maybe that was the cause?

          I’m sorry about the death of your child. However, your tragic anecdote does not constitute science.

    • I resist intuitively, the recommendation of my G. I. licensed MD to take pg3350, and so I am scouring the net for helpful data. I find that despite all the science waffle, which like political rhetoric, is full of fillers, and ‘harmless’ hypothesis or lab tests.. I lean towards your comment and agree. Polyethylene is a chemical plastic. Why do tests on dogs and cats to try and find some justification for it’s safety.

      Also, that men who call themselves scientists with pride still stick to belief that aspartame is ok, for instance, scares me.

      I will avoid ingesting chemicals unless it is an element that is required to stimulate or save life in emergency. I choose also to avoid mainstream medicine, and perhaps have to croak naturally, when its dying time, laying out in the snow some winter. Otherwise we compromise self care when we give authority to FDA and AMA which has lost credibility due to deceit and greed— is a sinking ship, a wolf in sheep’s clothing. Now that’s a fact.

      • Eric Hall says:

        Hi Joyce -

        Please don’t take what I am saying as mean – but as many others who comment here at Skeptoid saying we are wrong then easily show a gross misunderstanding of science as you did above. What I am going to do is point out a few of those errors.

        The first is the ingestion of “chemicals.” Everything is a chemical. Even if you drink distilled water, you are still taking in a chemical made of 2 hydrogen atoms and one oxygen atom. When you eat food, you are eating more chemicals. In fact, take a look at the chemicals in a banana and egg at this link.

        As for your aspartame comment – what do you see as dangerous about aspartame? Aspartame is made up of two common amino acids. The body breaks it back down into these 2 amino acids. IN fact – look at the egg ingredient list above. The same 2 amino acids (Aspartic acid and Phenylalanine) are both found in a “natural” egg. These can than further break down into methanol, and finally into formaldehyde and formic acid. However, the same thing happens when you eat fruit. In fact, it would take at the minimum 12 cans of diet soda to equal 1 pear’s worth of formaldehyde. That is science. There is no pride involved. It is pretty simple chemistry one can learn as an undergraduate.

        Even the very chemical in question here, polyethylene glycol and the base ingredient ethylene glycol, do occur naturally, though in pretty low amounts. We as humans have the hang of making polymers pretty well, and use them to our advantage. In fact, with milk and some vinegar, you can make plastic. All it means is you use some other chemical assistance to cause another chemical to form chains. We classify them as “plastics” because they have some similar properties – much like we classify magnesium, sodium, and zinc to be metals. Yet they all have some properties unique to them as well. So to say all plastic is bad is another basic misunderstanding of the scientific terms.

        I also find a bit of irony in your idea of self-care. You don’t trust the doctors with volumes of scientific knowledge backing them up, but you trust these communication devices which form the internet which also has volumes of science behind it to make it work.

        Science isn’t about pride. It is about evidence. Sometimes that evidence comes down to statistics. I will stick with the science.

  4. Brooke says:

    I have taken Miralax – almost daily – to combat severe IBS with constipation for the past nine years. In fact, I had a prescription for Miralax before it went over the counter. Six years ago, I was diagnosed with Multiple Sclerosis. Aside from IBS, I was a normal, healthy 23 year old girl, until I woke up one morning unable to move my left side. My family does not have a history of MS and I just considered myself unlucky. Perhaps unsurprisingly, my MS has yet to be managed. I have failed every MS drug on the market (failed = preventing new lesions) and only found Monastyrsky’s article while Googling for Miralax coupons! I may indeed be an unlucky coincidence, but either way, no more Miralax for this chick.

    • Eric Hall says:

      Many people without a family history are being diagnosed with MS in the last couple decades. Certainly it is concerning – and medical scientists are looking into possible reasons for this increase. However, many of those with MS are not on Miralax and have the same situation as you. It is highly unlikely the two are unrelated. It would be a little like trying to blame it on the fact you ride in a car every day.

  5. Anne says:

    Anecdote almost always precedes science.

  6. Anne says:

    Do any of these symptoms sou d like your MS?

    MIRALAX SIDE EFFECTS
    reported to the FDA by parents of children who were given Miralax

    Anxiety
    Phobias
    Extreme nervousness
    Obsessive-Compulsive behavior
    Scratching, biting (self and others)
    Nightmares
    Hysteria
    Memory loss
    Sleeplessness
    Irritability
    Mood swings
    Bipolar disorder
    Withdrawal
    Communication loss
    Loss of concentration
    Vertigo while lying down
    Anger
    Tantrums
    Metabolic acidosis
    Clawing sister’s eyes
    Sensitivity to sound
    Motor skills affected
    Fearfulness
    Confusion
    Inability to focus
    Mumbled speech
    Gait disturbances
    Obsessive finger licking
    Feelings of something dripping down face
    Compulsive bad thoughts
    ‘Meltdowns’ over homework
    ‘Meltdowns’ over trivial things
    ‘Panic’ behavior
    ‘Dr. Jekyll & Mr. Hyde behaviors
    ‘Wave pool feeling’ when trying to go sleep
    Tics
    Tremors

    Seizures:
    life threatening with 3 fatal cases documented and more suspected

    Violent behavior
    Suicidal thoughts (age 6)
    Paranoia/bizarre hiding
    Anti-social behavior
    Slurred speech, whispering
    Staring
    Skin disorders
    Keratosis pilaris

    Homicidal ideation
    Homicide

    I believe this is a short list, as I am sure many others have symptoms to add.

    Call 1-800-FDA-1088

    • Eric Hall says:

      Again – as I stated in the blog – these are self-reported symptoms for which the FDA has closed the case and determined Miralax to be safe.

      Parents often report their children to be “more hyper” after consuming sugar. Studies have since shown this is confirmation bias. Parents who thought their children consumed sugar in a controlled environment reported their children to be more hyperactive, even though half had been given a non-sugar drink.

      There are hundreds of drugs for which parents report side-effects that when studied have been found to be safe. Self-reporting is a very poor method to investigate pretty much everything.

      • rose says:

        The case was not closed. Its been in the fda’s hand since june 12 2012. The previous petition they said there was not info information to go on.

        • Eric Hall says:

          I looked through the entire database of the FAERS and a general search of the FDA website. The latest thing I can find on there is: “FDA decided that no action is necessary at this time based on available information.” Other drugs in the FAERS have statements like: “FDA is continuing to evaluate this issue to determine the need for any regulatory action.” – which tells me the FDA doesn’t see any problem with Miralax like other drugs.

          If you can show me where this information is as well as what the information is, I will be glad to evaluate it and update the post if necessary.

        • Stephen Propatier says:

          There is no case closed or case open for the FDA. It continually monitors complaints by consumers and medical providers. It compiles that data, it is utilized to look for trends to adverse reactions as well as overall effectiveness. Current data related to miralax is representative of the general populations rate of these problems. Meaning the rate of expressed incidents of patients taking this is no more than the population at large who are not taking the medication. This is consistent with no relation to the medication.

  7. rose says:

    You can say this but have you been this horrific experience. Miralax made my daughter have autistic like symptoms and her mental status declined, and it almost killed her. Until you been through it then you can say this. Miralax is pure poison!

    • Eric Hall says:

      You are starting with the conclusion and working backwards. Think of all of the things we do daily – by your logic any of those things could be the cause of your daughter’s condition – riding in a car, getting dressed, drinking milk, drinking water, reading a book, watching TV…and on and on. Unless there is some plausible reason, it is difficult to connect Miralax to your daughter’s condition. There is none.

      I am sorry about your daughter’s health problems. I will say if it were my own child, I would do whatever I could to find the true cause and not just place blame to have someone or something to blame. Don’t stop looking for the true cause based on your “hunch.”

      • rose says:

        Explain to me why all of her symptoms disappeared weeks after stopping. Get your head out of the sand! Its pure POISON!!!

        • rose says:

          I just got off the phone with the fda and they said there still investigating. You need to call yourself. Your press is sickning!

          • Eric Hall says:

            I just called the FDA and spoke to them. Anyone can report anything they think is a side-effect of a drug without any proof or justification. Depending on the frequency and severity, the FDA will investigate the side effect claims and if any action is taken, then they publish that action. The only way to actually see the reported reactions is to file a FOIA request with the FDA.

            I suppose you are technically correct since the FDA will “investigate” every reported side effect, what you say is technically true. But they do not put alot of resources towards small numbers of events when they are such a tiny ratio to the number of doses given with no side-effects.

            Put it this way – I took some Aleve this morning. It just so happens my foot itched pretty badly about an hour after taking it. I could report that as a reaction and the FDA would at least acknowledge my submission. That doesn’t mean that any action will take place due to my report.

            The FDA still considers Miralax safe. This makes sense both from the chemistry standpoint, and from the number of doses given.

        • Eric Hall says:

          My question – again – to you is was this treatment monitored by a doctor? Were the symptoms observed by a doctor? Were any other treatments done simultaneously to going off Miralax? You are reporting a simple anecdote, which when taken from a parent’s perspective, can be biased. It happens. I’m not in any way saying you are stupid, I am saying that parents are bad resources for information on their own children.

          • rose says:

            It doesn’t take a rocket scientist to observe that once we stopped weeks later the symptoms dissapeared. It wasn’t a miracle! I will spread the word about this POISON!

          • Eric Hall says:

            Was there any other medications started or stopped? What about other treatments? It doesn’t take a rocket scientist, but to objectively determine the cause of your daughter’s condition requires the application of some basic logic and at least a loose application of the scientific method.

            My daughter took MiraLax for 2 years, with none of your claimed side effects. If it was “poison” – 100% of people would experience similar symptoms. I guess you could say my anecdote cancels yours.

        • Sarah Locatelli says:

          Rose. Thank God. I found you. My son has the autistic symptoms and mental decline. He started with anxiety, paranoia, the first week. I called his GI and they said keep going with the Miralax. Then mental decline and autistic tics, and finger flicking. The only prescription he was on was Miralax. Otherwise grass fed beef, eggs, fruits and cooked vegetables. 3 months of Miralax and all the symptoms anxiety, depression, anger, threats and finger flicking. I thought it must be the miralax. Once I found all the other stories, I stopped instantly, 7 days ago. Thank god. Bless you. Bless you. I have hope that my son might recover like your daughter.

          Scary thing is that 24 hours after stopping his symptoms got worse and peaked! With an acute autistic roll of the eyes with head to the side. I took him to Stanford ER to make sure he was not going to die that night. I believe as it leaves the body it presents itself.

          This in a little 8 year old boy. That KNOWS whats going on. He says every night before he goes to sleep. “Mommy, I don’t feel myself, I feel sad and scared. He says, “I just want to feel like I did before the tummy aches.”

          Eric Hill NEED NOT RESPOND

          • Eric Hall says:

            Being this is my blog, and you commented, I believe I reserve the right to respond.

            Obviously something made you consider the miralax in the first place. You wouldn’t give it to your son simply because you just wanted to. So have you considered that his issues are due to what led you to miralax in the first place? In fact, I would say you need to consider that and get your son some medical attention if he is having all those symptoms. Especially if he got worse, that should be a clear sign it is something else.

            I hope science can help your son. Please – don’t let an anecdote give you false hope you found the answer.

          • rose says:

            Sarah you can email me @ rosemarygutierrez289@yahoo.com

  8. As I’ve discussed elsewhere on this blog, my wife was diagnosed with MS in 2005. She’s never been on Miralax, at least not to my knowledge, and has no family history of the disease. Her neurologists made it clear that her diagnoses wasn’t a result of anything she knowingly did or ate or didn’t do or didn’t eat.

    As much as we want to blame something or someone for her MS, it really is just bad luck.

  9. Anne says:

    Perhaps reading the FDA Citizen Petition to investigate Polyethylene Glycol 3350 Product Safety for use with Pediatric Patients might shed a little more light on a topic you are not well versed in:

    http://www.elsevierbi.com/~/media/Supporting%20Documents/The%20Tan%20Sheet/20/28/Polyethylene_glycol_citizen_petn_120603.pdf

    • Eric Hall says:

      The concerns in your link have already been addressed in this blog as well as other studies. For example, the study cited from the University of Georgia states the LD 50 for rats as over 50 g/kg. If this directly translates to humans, that means a human would need to take in 3000 grams to hit that ratio, which is 176 times the recommended dose. Even for a child, it would be almost 30 times the dose. We get much closer to the LD50 in the recommended dose of ibuprofen than we do with Miralax.

      The petition also states the actual range of molecular weights is unknown. Actually, it is known. The range is 90-110% of the 3350.

      The petition then tries to connect creams to Miralax is high auspicious. The study comes from 3 patients over 30 years ago. It also is referring to a much lower molecular weight than what is used in Miralax – and is actually different in chemical structure (the bonds are of a different shape). Thus it is not analogous to PEG 3350 in most ways.

      I would again ask – if there is a high degree of certainty that the path for these adverse effects is due to ethylene glycol poisoning, then a blood test should be able to easily confirm this.

      It would be a little like saying salt causes chlorine poisoning – a compound is much different than its components. While it is possible in conjunction with other factors (other meds, chemicals, etc) that a compound could separate back to its components, it is not likely under normal conditions.

      Let us remember a citizen petition does not in any way represent the scientific process. While I wouldn’t ask anyone to take MiraLax based on my advice alone – I think if one were to ask medical professionals, a very high percentage would agree the level of safety for the product is very high.

      • Anonymous says:

        You are very fortunate that your child did not have any indicated side effects from miralax. I wonder how you would have felt if they did? In our case our 8 year old daughter was not on any other meds and over time 4 months for us, basically turned into a different person, with angry outbursts, talking suicide, ocd behaviors I can go on. After she went off miralax all of those crazy behaviors have gone away. Maybe it doesn’t effect all children but it is not approved for children or even adults for lon ger than 7 days,
        Drs , from what i understand are prescribing miralax for long periods of time to children as young as 2 months. When I looked up peg and saw the fda adverse effects and when those behaviors went away after she stopped using it, that was my confirmation. In hind sight these extreme wild eyed crazy behaviors occured shortly after she took a dose of miralax.
        I wouldn’t touch that stuff. Maybe you should take it for a couple of months just to test on yourself if you feel it is so safe. To hear about so many other families experiencing the same side effects I don’t need anyone’s professional opinion or doctorate, I use my comon sense and get myself and anyone who wants to listen to take an alternative laxative why even risk it. I don’t want anyone’s family to go through what we did even if there’s a slight chance. Somehow it metabolized in her to cause these reactions. Lets try to work together here for our future and the sake of our children and families. You said you change your opinion with evidence well i have all the evidence everyday when I see our daughter back to her sweet self after a summer of thinking we had a severely mentally ill child in our home. We are so thankful we discovered what was the toxin in our environment that was effecting her behavior. I don’t need any articles or medical opinions I have the evidence.

        • Eric Hall says:

          What many of the commenters are leaving out is a complete idea of medical history. For example, many psychological and neurological drugs have constipation as a side effect. Is it possible that these children started on some other medication which does affect brain chemistry started causing constipation, but the brain effects from the psychological/neurological drugs were not seen until after the administration of miralax?

          After Dr. Wakefield’s fake study on the MMR and autism, many parents suddenly saw their kids change after getting the vaccine. This is a classic case of confirmation bias. Does this make the parents bad people? No. But it does mean they are not applying logic, reason, and science to the situation. It is understandable, but also potentially harmful. That is why I advocate for the science.

          • Anonymous says:

            Whats interesting is our daughter just had stomach aches never took any medications, in fact we thought miralax was a fiber product, like metamucil when dr. Recommended it because of her stomach aches he said lets try this she may be constipated., We never gave her anything else or tried any other medications not even sure she was constipated, did help stomach aches but caused all sorts of other problems. Went off miralax and has not had constipation problems.

  10. Anne says:

    Eric Hall says:
    October 18, 2013 at 8:17 am
    Wrong. Observation is usually the first step in science – which is much different than anecdote.
    Reply

    But you don’t give credence to the observation of parents.
    Just a little unfair and biased, don’t you think?

  11. Anne says:

    Here is a neurologist who chimed in:

    http://www.regulations.gov/contentStreamer?objectId=090000648103b46d&disposition=attachment&contentType=pdf

    More and more pediatric neurologists are believing parental reports of atypical and unexpected behavior once children are prescribed Miralax with an undesired outcome.
    Miralax is not FDA approved for the use in children under age 17.
    The manufacturer warns against use for anyone longer than 7 days.

    Central nervous system irritability is a problem for some, not all…

    Neuropsychiatric effects do not affect everyone.

    That is part of the problem…who is vulnerable?

    We know many children are…

  12. Stephen Propatier says:

    @anne, Anonymous, rockney, rose.
    2 young girls began to have fits seizures screaming episodes. Adults reported that the children felt they were being pinched or stuck with pins over their body. Adults were stymied, over time there were 5 young girls with varying complaints and the adults were at a loss. More and more young women were affected and the symptoms worsened. The adults searched for a cause, eventually they found evidence of the source. The children were being exposed to “factor X”, more and more the adults saw the undeniable relationship with factor X. When factor x was removed the children improved. Still the adults found it increasing impossible to prevent exposure to factor X. Even criminal charges were brought against the adults who were continuing to distribute factor X. Nothing made the children better, several people died as a direct result. 19 in all were killed. In the end the court closed the case with no satisfactory explanation and factor X disappeared into history. Very similar to all your stories.
    Only difference is Factor X is witchcraft and the town was Salem Massachusetts.

    Your mind is an unreliable source for deciding if something is related to something else. It is not a personal weakness it is the way the human mind works. When you let yourself become convinced of something when multiple independent lines of evidence tell you something is not happening it most likely is wrong.
    My aunt suffers from MS she is disabled and wheelchair bound. Nothing is served by telling her that a laxative did this to her, any more than any other environmental exposure. Do children who have mental illness get better when medical and parental attention is payed to them? Do you feel better when you are sick and your loved ones give you TLC. Of course, but you are convincing yourself falsely that a removal of a certain factor instead of your attention is what caused the improvement. Then there is regression to the mean, the fact that some people get better on their own. Even some people survive the untreatable and mostly fatal pancreatic cancer. You do not have the ability to properly exclude confounding variables in medical cause and effect. Sometime it is because you lack the medical knowledge, but mostly because humans are precondition to see connecting lines where there is none. Then humans always purposefully seek out more evidence to confirm what “we already know”.
    Some of you have made argument against Eric’s expertise, yet he is correct. There is no credible evidence that Polyethylene Glycol 3350 causes any neurological problems. No plausible physiologic mechanism for the supposed side effects. Despite decades of common and widespread use for inpatient constipation in hospitals no plague of neurological patients.

    Scientific method is out only security against the failings of our own mind and experience, other wise we degrade to witchcraft trials.

  13. johnny says:

    you do realize that the FDA is run by the industry it is supposed to be regulating, right?

    • Eric Hall says:

      Even if your statement were true, you will notice that is only one of my sources. If that is your only complaint, I can assume you found nothing else wrong with the science I reported in this post?

  14. Yumad says:

    My god, the number of ridiculous people in this comment thread is a little frightening. You always hear that much of the population consists of poorly educated people who will believe anything you say if you say it the right way but to see it in action is just shocking.

  15. Margaret says:

    The site you criticize, Eric, is deeply flawed, and I share your skepticism about it. That said, I think you are too quick to dismiss all evidence that is “anecdotal” as inherently flawed or inaccurate — not a fully scientific position: anecdotal evidence is observational evidence, albeit collected from a limited number of data points. You essentially say that nothing a parent observes about a reaction to Miralax can possibly be accurate, a priori dismissing the possibility that, for some children in some circumstances, there could be side effects of the drug for which it is not yet labeled. That position is flawed too (albeit more understandable than claiming that autism is caused by iron deficiency — yikes!).

    I speak as a parent who does not believe Miralax is evil — I’ve seen plenty of kids who have used it with no problem, who depend on it and are happy and healthy. I don’t think it’s poison, and I’d never advocate someone stop using it if it’s working well, as I suspect is the case for a good majority of users. But my young child was prescribed Miralax on three different occasions, and in each case I had to discontinue the use of the drug because it severely effected her behavior — erratic mood swings, loss of impulse control, increased aggression. In each case, her behavior returned to normal after discontinuing the medication. She is a child with severe food sensitivities, and my suspicion in her case is that whatever is causing her food sensitivities (perhaps damaged gut lining?) could be affecting how her body handles Miralax.

    I am certain that her situation is very much the exception, but there may be some other exceptions out there, too. And I think that you would probably avoid Miralax for your own child if she had displayed the kind of symptoms my daughter did, on three separate occasions. I think it’s fine to remain open to the possibility that parents who are describing instances of drug reactions might at times not be getting it right — maybe I’m not either. (I’m willing to stay humble. But I’m not willing to put my daughter back on Miralax, under the circumstances.) But I think you also need to remain open to the possibility that at times they might be getting it right. My suspicion is that within 10 or 15 years we’ll see neurological issues added to a list of very rare side effects that can affect a small percentage of people who take Miralax — it will take that long for the observational evidence to become strong enough. And, for those of us who are in that small minority, having access to information indicating that there is such a possibility would be extremely useful.

    • Eric Hall says:

      An anecdote, or many anecdotes, are not evidence. They are observations, which can serve an important purpose in science – which is to help a scientist form a hypothesis. Then one collects data in a consistent, repeatable, and controlled manner. Then after analyzing that data, one can conclude as to whether that data is evidence for the hypothesis.

      I have said here and in many other places on this blog that an anecdote is not evidence. Anecdotes can be important to the process of science, but in no way can one make a conclusion based on it.

      In your last paragraph, what you are giving is a hypothesis based on your observation/anecdote, but are presenting it as a conclusion. Let me propose another possibility. One possibility could be the increased frequency of bowels movements and the water retaining properties of Miralax caused a deficiency in a certain nutrient or set of nutrients which in turn caused the symptoms? We know Vitamin B deficiencies, for example, can cause fairly severe neurological symptoms. Being it is a water-soluable vitamins, perhaps more was retained in the bowel, enough so the body then became deficient.

      I don’t doubt your observation. It is good to do so. But it is not evidence Miralax is bad, but rather a starting point for a number of hypotheses. I can think of several reasons Miralax and the symptoms were correlated in your case – and that is why anecdotes are not evidence – because there is no control to help separate correlation and causation.

      • Margaret says:

        I never stated that Miralax is bad — I rather stated that, under certain circumstances that depend on observation, there may be reason to believe that the drug is creating problems for an individual. Whether the correlation between Miralax intake and health problems in my daughter’s case is caused by a reaction to the Miralax per se or by her body losing nutrients due to the reasons you suggest is, to me, immaterial: either would mean that this drug, for this person, may not be a safe, good choice. (Incidentally, she has done fine on several other laxatives.) And, no, I also did not present it as a “conclusion”: I say myself that I may not be getting it right — I’m aware that it is a hypothesis. But I don’t see that as a reason not to take an action based on that hypothesis: the lack of a large-scale study firmly identifying causation does not preclude the possibility of causation. (It may simply mean that reactions are extremely rare and/or have been poorly documented.)

        I do understand, well, that correlation doe not equal causation. On the other hand, to suggest that correlation can tell us nothing is to buy the line that the cigarette industry for decades tried to sell us: “just because there is a correlation between smoking and lung cancer doesn’t mean it causes it, right?” Correlation is a weaker form of evidence than randomized controlled trials when it comes to making broad decisions about the effectiveness and overall safety of drugs. But randomized controlled trials are actually fairly poor as spotting individual variation in reaction to particular substances, which is why it periodically happens that people have unexpected reactions to medication (and why medication initially cleared for use sometimes gets taken off the market or gets additional labeling requirements). A friend of mine recently got liver damage from a prescribed medication she was taking. Clearly not something that happens to many people with that drug, but it happened to her, and her doctors also acknowledge that fact — not on the basis of randomized controlled trials, but on the basis of reported observations from a very small number of other patients who had had a very similar unfortunate reaction to that particular drug. So, yes, small-scale observation is absolutely vital, even if it is not foolproof. Could it have been that something else very suddenly caused my friend’s liver to be damaged? Theoretically possible, sure. But not particularly likely — and it’s certainly not worth continuing to use the medication just to be sure. Even if there were no prior cases of liver damage with this medication, I might add. If there is no other likely cause that is identifiable, and a patient is experiencing liver damage & related symptoms that appear to coincide temporally with when the medication was started, it would be prudent to discontinue the medication. Someone, after all, has to be the first case observed, and randomized controlled trials don’t always pick up those rare cases. There remains some possibility that the medication wasn’t the problem at all (though, in my friend’s case, going off the medication coincided with considerable improvement in her physical condition). But to suggest that, as an individual, one should not act on this “anecdotal evidence” because it’s not based on a study that involves consistent, repeatable, controlled behavior would be highly irresponsible, I think. (Also irresponsible would be a call to remove a drug from the market because one person appeared to have a terrible reaction to it. One needs to carefully document such cases; in some situations one may amass enough evidence to warrant pulling a drug, or prompting a further rigorous review of its safety. Or it might be that the anomalies are anomalous enough that that isn’t necessary.)

        In everyday life, it is simply not practical or possible to wait for a scientific study to make all my decision-making clear. Suppose I have noticed that I break out with a rash whenever I use a particular laundry detergent. Clearly it’s a detergent that most people don’t react to, and it’s generally safe. There have probably even been studies on the substances involved indicating they are safe for skin contact, and there may have never been a study indicating that this detergent causes this problem. But whether hypothesis or conclusion that the detergent is/could be at fault, I’m going to discontinue the use of the detergent rather than waiting for a large-scale study that would validate the hypothesis/conclusion. We use observational evidence in our everyday lives all the time, and it can be useful. If we meet an acquaintance several times and find that that individual says many things that are obnoxious/irritating each time, we probably won’t keep hanging out with that person. If we find that an adolescent child is surly every time after they hang out with a particular friend or engage in a particular activity, we are going to make parental decisions based on what we’ve observed — not because a scientific study tells us something, but because we’ve noticed patterns, and those patterns are the best available data (and, yes, observations are ONE form of data) on which we have to make a decision. It doesn’t mean our decision is guaranteed to be the best one available. But we have to make a decision on the basis of what we have to go on (there are no randomized controlled trials available for figuring out if hanging out with Joey is contributing to my son’s surliness, or for determining whether the obnoxious comments the acquaintance made were outliers completely unrepresentative of who that acquaintance really is). Saying large-scale decision-making about drug availability shouldn’t be based on anecdote makes sense to me, but to suggest that individuals who make decisions on the basis of observations they have made are inherently misguided remains an unnecessarily rigid and unhelpful position. I think it is great to expand the conversation with people who have come to conclusion or hypothesis by introducing other possibilities and other evidence — and, at its best, your site does some of that — but I think you can do that without dismissing the observations others bring to the table as wrong a priori. Isn’t there at least the possibility that someone might see or experience something that isn’t accounted for by what the large-scale studies have — thus far — been able to tell us?

        • Eric Hall says:

          Sure, correlation tells us something. I am not saying it has zero value. But if a correlation is found, one then needs to strengthen that position with a causation – and one that makes sense.

          Any time we ingest something there is a chance of an adverse reaction. We could choke on whatever we are ingesting. There could be impurities. Your friend anecdote – of course many drugs have these small numbers of reactions because many drugs are processed by the liver – thus it is perfectly reasonable to assume a drug may trigger a reaction – perhaps because of an already weakened liver, or some genetic fluke that wouldn’t have necessarily appeared in a clinical trial.

          Why I wrote these posts on Konstantin Monastyrsky is because of his gross errors in science and logic. His claims have low plausibility, nor does he have data to backup his claim MiraLax is harmful in all or even in most cases. Aspirin has been used for a century with good results, but can cause bad reactions in kids with chicken pox, and can cause stomach problems for a small number of people. Like most things in medicine, we go by the data. A few people are injured by vaccines each year, but we save thousands of lives and prevent thousands of injuries. A few people are injured by OTC pain medications, but we save plenty of people stress, anxiety, etc – and NSAIDs can help heal minor injuries – so we have much more good than harm. Airbags kill a few dozen people every year, but save thousands.

          I would never make a claim something is 100% safe. Feynman was very clear at expressing that isn’t how science works. But we have degrees of certainty. Konstantin Monastyrsky is wrong in saying MiraLax is dangerous. He is wrong in how it is processed in the body. He purposely uses misleading statements and incorrect information to support his agenda. That isn’t science. My post shows MiraLax is very safe for most people. I also showed it is easy to be misled by people making claims not based in science.

          • Margaret says:

            I agree with your critique of Monastyrsky, and with what you say in this last post. I simply don’t want the public discourse to exclude the possibility of exceptions and occasional bad reactions, precisely because science needs to honor those in order to make updates and qualifications to its assumptions across time. Cheers.

          • Eric Hall says:

            Thanks – that’s a good point. I tend to get a bit heated on that topic because too often people want to accept anecdote and/or exceptions as the rule – and they should be put in their proper context. But yes, we shouldn’t ignore anecdotes, but study them (if necessary).

  16. PEGgy says:

    http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-14-002.html. It looks like the FDA jury is still out on the topic of PEG 3350 for kids. No, this call for proposals doesn’t amount to the FDA saying “it IS dangerous”. However it seems they’re sufficiently concerned by accumulated case studies/anecdotal evidence to initiate more systematic observations.

    Margaret is bang on with her arguments and is, i’m going to guess, an experienced scientist. No offense but your own maturation as a scientist would benefit from a few careful re-reads of her posts.

    • Eric Hall says:

      This is pretty common practice. It is part of the problem with the FAD is it is at the whim of public and political pressure.

      If you look at the proposal, they state at the high end children could be exposed to .005 mg/kg/day. Because of the common industrial and commercial use, several other government agencies have studied and set safe limits for acute and intermediate exposure at rates 50x higher than that level.

      And again, if you notice my response to Margaret – she is making reasonable scientific hypothesis and using the proper process in thinking. Maybe PEG will turn out to cause mild harm to kids. But not in the ways described by KM. The point of the post is his method is not proper science.

  17. macguyincali says:

    Very interesting thread and the original article was quite enlightening. Thanks Eric for taking up this cause of debunking this hysteria-based quasi-science. I am glad to have heard a reasoned analysis of this Monastyrsky article especially since my daughter IS on miralax and has had some “personality issues” lets just say, recently. It is tempting to make that connection and Monastyrsky’s article sent me searching for a science-based analysis of his claims. So thanks for that.

    And I will say, you’re willingness to address your commenters is laudable. However, Margaret did make some very solid points regarding the practicality of having to make decisions absent large-scale studies to guide us. She sheds some light on your outright dismissal of any observation however anecdotal, always seeking another plausible scenario instead of considering the potential that the observation might be potentially valid. This semi-absolutism does flirt with being dogmatic, which I’m sure is not what you are intending.  Sometimes, anecdotes are all we have. She reminds us to have some humility about the ability of science to answer all our questions and to guide all our decisions in a timely manner. Sometimes (actually a lot of the time) we have to go with the incomplete information we have at our disposal. That being said, thanks for what you do and keep up the good work.

  18. Sharon Weil-Chalker,MD says:

    Thank you,Eric, for your thoughtful and scientifically sound article. This hysteria pops up from time to time in the on-line communities in which I am a member. I am both the mother of a child with a severe neurodevelopmental disorder who takes Miralax daily and a pediatrician. The only flaw I see in your article has to do with Ethylene Glycol (which, obviously has nothing to do with PEG). Ethylene glycol is highly toxic in very small amounts and fatal in slightly larger amounts. I see you quote the chemistry literature, and I don’t have the energy right now to compare the mg/ml/molar amounts on the chemist’s shelf vs. the product in people’s garages, but here is medical information about the commonly available liquid. Again, nothing to do with PEG/Miralax. http://www.nlm.nih.gov/medlineplus/ency/article/000774.htm

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