Diabolically dishonest: Lewin Group’s MMR-Autism sibling study
BY J.B. HANDLEY February 8, 2017
FALLS CHURCH, Virginia — Three months ago, the prospects that the first study ever done comparing the health outcomes (both chronic and acute) of vaccinated versus unvaccinated children would be published were looking very, very good. A study from Jackson State University had been accepted by a prestigious journal, Frontiers in Public Health, had passed peer-review, and was days away from being published. As is customary, Frontiers posted an abstract of the study online alerting readers that the study was on its way, and that’s when all hell broke loose.
It’s incredibly difficult to fund and publish a study that potentially indicts a multi-billion dollar industry, and within 24 hours of the abstract being posted online, Frontiers decided not to move forward with the publication of a study they had already put through peer-review and already accepted for publication. The Frontiers paper looked at fully unvaccinated children, and explored many different health outcomes, including autism, allergies, and learning disabilities. Here’s an excellent article from Health Impact News about the study, its outcomes, and its implications.
“A new peer-reviewed study comparing health outcomes of vaccinated and unvaccinated children, provisionally published in the journal Frontiers in Public Health and assigned a DOI number (a digital object identifier given by publishers to identify content and provide a persistent link on the internet), confirmed what parents like Sarah Carrasco have observed: that completely unvaccinated children have less chronic disease and a lower risk of autism than vaccinated children.”
The background and details nobody knows
The science of whether or not vaccines cause autism is incredibly controversial, and someone new to the topic will be instantly struck by the dichotomy of opinions they encounter, depending on where they look:
“Mainstream” narrative: The question of whether or not vaccines cause autism has been asked and answered through dozens of studies all over the world. This question only arose because of a British researcher who faked data, it’s dangerous to keep talking about this myth.
“Alternative” narrative: Scientists have studied one of 38 vaccine ingredients and one vaccine and declared the debate over, which is ridiculous. The British researcher never produced any data to fake, and the simple control group of unvaccinated children has never even been explored.
I hope this chart will prove helpful in simplifying the debate. Column A lists 38 ingredients that are present in 2 or more vaccines in the U.S., according to the Centers for Disease Control. Column B lists the vaccine load that a child in the U.S. receives between the ages of 0–15 months, based on the CDC schedule. Column C shows the downward health progression of my own son over the course of his first 15 months of life that led to an autism diagnosis. My son’s story is shared by hundreds of thousands of parents all over the world — many children with autism are suffering from many other health conditions and are very physically sick.
When I’m able to get friends of mine to this point in the vaccine-autism science debate, they generally don’t believe me — It seems absurd to keep screaming “vaccines don’t cause autism” when this chart shows clearly that the study of this subject has barely begun, as investigative journalist David Kirby explains:
“It is illogical to exonerate all vaccines, all vaccine ingredients, and the total US vaccine program as a whole, based solely on a handful of epidemiological studies of just one vaccine and one vaccine ingredient. It is akin to claiming that every form of animal protein is beneficial to people, when all you have studied is fish.”
— David Kirby, Investigative Journalist
The purpose of this article is to analyze what I think is a deeply dishonest published study on the relationship between the MMR vaccine and autism, but I need you to understand four quick things before I do that which will help you better appreciate the study and the publicity that surrounded it:
- The U.S. vaccine schedule has gone up 15-fold since the early 1960s
The numbers can be very confusing, but this chart accurately shows the difference between the vaccine schedule in 1962, 1983 and 2016 recommended by the U.S. Centers for Disease Control. Please note on the chart that it looks at “doses” rather than “vaccines” so that a single DTaP shot given for three separate illnesses (Diptheria, Tetanus, and Pertussis) is always counted as 3 doses. With that apples-to-apples comparison, we can see that the vaccine schedule in the United States called for 5 total doses in 1962 versus 72 total doses today (that’s not a typo).
2. Today, other first world countries give far fewer vaccines to children than the U.S., and avoid many altogether
The most recent study I could find on this topic was done several years ago, but I think it’s very eye opening. Of 30 first-world countries looked at, no other first world country besides the U.S. recommends Hepatitis A vaccine. Only one other country (of 30) recommends the flu shot, only 2 other countries recommend Rotavirus, and only 3 other countries recommend the Varicella (chicken pox) vaccine. Why doesn’t England vaccinate for chicken pox? Why doesn’t Sweden give babies Hepatitis B? The U.S. is #1 in the world for total vaccines given, and #1 in the world for autism rate (1 in 48 kids), but no one ever mentions this.
3. Vaccines cause brain injury, and the U.S. government knows this
Most people struggle to believe a vaccine can injure a child. The narrative generally used is that vaccines are “safe and effective.” Yet, the Vaccine Injury Compensation Program is very much alive and well and run by the U.S. government, and has paid more than $3.3 billion for vaccine injury. As the program itself explains:
“In very rare cases, a vaccine can cause a serious problem, such as a severe allergic reaction. In these instances, the National Vaccine Injury Compensation Program (VICP) may provide financial compensation to individuals who file a petition and are found to have been injured by a VICP-covered vaccine.”
The Vaccine Injury Compensation Program includes a Vaccine Injury Table that spells out typical injuries by vaccine.
Here’s the table of injuries for just the MMR vaccine. As you can see, vaccine injury “B” is described as “Encephalopathy”:
“Encephalopathy is a general term describing a disease that affects the function or structure of your brain [a brain injury].”
Note that many other vaccines also have “Encephalopathy” as a potential side effect.
“It is important to remember that as a legal matter, all vaccines are considered ‘unavoidably unsafe.’ In other words, all vaccines, like the illnesses that they’re intended to prevent carry inherent risks. People are injured by vaccines. More than 3,800 people have been compensated by the federal government for vaccine injury, including death. So brain damage and death are common side effects of the vaccine, just as they are of the illness.”
My son’s decline coincided perfectly with his vaccine schedule and he developed a myriad of physical symptoms that ultimately ended up with an autism diagnosis, as I showed you in Column C on the chart above. Remember that a side effect of the MMR is “brain injury.” The U.S. Government knows vaccines cause brain injury. My son’s autism is a brain injury.
It’s not that hard to conclude that something that is known to cause a brain injury (a vaccine) and my son’s brain injury (autism) are related.
(Here’s the best article I have read explaining how exactly a vaccine can cause a brain injury for those of you interested in the biology of it all.)
4. A British Researcher never “faked data” on the link between the MMR vaccine and autism
I could write a book about British Gastroenterologist Dr. Andrew Wakefield (here’s a podcast interview I did with him recently), and you can hear from him directly in this excellent article. But, I just want you to see the actual “data” everyone refers to from the study Dr. Wakefield and 12 other colleagues published in 1998 in The Lancet.
The Wakefield study was a very specific study (called a case series) about a novel bowel disease they had discovered in children with autism, called Ileal-lymphoid-nodular hyperplasia. It explored the gastrointestinal health issues of twelve children with autism, as the authors made clear: “We investigated a consecutive series of children with chronic enterocolitis and regressive developmental disorder.” The choice to include the commentary about the possible relationship between MMR and autism was made because either the parents or doctors of the children reported it, and that’s what the study authors chose to do.
There never was ANY data in The Lancet paper about the relationship between the MMR vaccine and autism. There was only a short sentence saying that parents and/or doctors had linked regression into autism and the vaccine, and that it therefore merited further study. This is normal scientific reporting in a case series.
If someone tells you that The Lancet study faked data on the link between vaccines and autism, they are either lying or repeating the lies of others — the “data” has never existed!
Simultaneous administration, control groups, and the narrowing of a hypothesis
It’s almost time to dig into a very dishonest study about the MMR vaccine and autism. I just took you through four important background points about vaccines that most people don’t know: 1. Growth of the U.S. vaccine schedule, 2. Differences between the vaccine schedule in the U.S. and other first world countries, 3. The established fact that vaccines cause brain injury, and 4., The British researcher never faked any data about vaccines and autism because he never had any data to fake. There are three more things I need to explain to you to make this whole analysis clear:
- Simultaneous administration
I have NO idea which vaccine caused my son’s autism. In the United Kingdom (where the Lancet study originated and where all the subjects were from), the MMR vaccine is often given by itself at a single pediatric appointment (the U.K. does not give the chicken pox vaccine, which is always given with the MMR here in the U.S.). This is NOT the case in the United States where as many as six shots may be given on the day the MMR is given, which is what happened with my son (typically somewhere between 12–16 months). Take a look at a blow-up of my chart from above:
By the time my son received his MMR vaccine, he had already received 19 vaccines, and his health was in extreme decline. The day he received MMR, he received 5 other vaccines NOT called MMR — I have no idea which vaccine caused my son’s autism, and really how could I? What I know is that vaccines can cause brain injury, we give way more vaccines than we did 20–30 years ago, that the autism rate has skyrocketed, and that hundreds of thousands of other parents had the same experience with their child that I had with mine. Which brings up the next obvious point…
- Control groups
Everyone understands what a control group is, we all learned it in high school science:
“The control group is defined as the group in an experiment or study that does not receive treatment by the researchers and is then used as a benchmark to measure how the other tested subjects do.”
Smoking cause lung cancer? Compare smokers to non-smokers (the control group) and find out. New drug lowers cholesterol? Compare a group taking the drug to a group not taking the drug (the control group). For some reason, scientists have forgotten this very simple concept of a control group when it comes to vaccine-autism science:
In mainstream vaccine-autism science, the control group is always a group of children who have received slightly fewer vaccines or slightly less mercury in their vaccines. It’s ALWAYS two-pack a day smokers versus one-pack a day smokers, it’s NEVER versus non-smokers (unvaccinated).
I’d argue that this lack of a control group is the least appreciated and the most important point in the whole vaccine-autism science debate. It’s also why that study ALMOST published in Frontiers that I discussed was such a threat to the medical establishment. Behind the scenes, the pressure on Frontiers to NOT publish the study was extreme, and we all know why: The study had a real control group (kids who had NEVER received any vaccines), and the results were devastating.
- Narrowing a hypothesis
I wrote a scathing article about a new spokesperson for the vaccine industry, Dr. Peter Hotez, and a blog post he had written, where he claimed to cite the definitive science that he felt “proves” vaccines don’t cause autism. Dr. Hotez performed a trick that many others are guilty of, which really frustrates me — he narrowed the definition of vaccines and autism down to just three things:
“Dr. Hotez narrows, quite dramatically, his definition of what he means when he says “the science” has shown that vaccines do not cause autism. This is the trick most often used by vaccine promoters. He says that the papers he will be citing, the papers that give him comfort that vaccines didn’t cause his daughter’s autism (and by extension my son’s), really only focus on three “allegations” about autism’s links to vaccines, and to quote him, these three are: 1. the MMR vaccine, 2. trace thimerosal used in some vaccines, 3. the close spacing of vaccines.”
I spelled this out on that same chart I shared with you that I hope makes this extreme scientific dishonesty more clear:
When a scientist chooses to narrow the hypothesis that vaccines cause autism down to one ingredient and one vaccine, they are being dishonest, and disrespecting my son’s experience. Worse, they are falsely reassuring parents that they have studied this issue in a sincere manner, and they engage in almost endless word play:
- Kids who got more or less mercury in their vaccines have same autism rate…so vaccines don’t cause autism.
- Kids who got every vaccine except MMR have the same autism rate as kids who got all their vaccines and the MMR…so vaccines don’t cause autism.
It’s always only been true that a control group will get you a real answer, and scientists (who are more often than not funded by vaccine makers) have been unwilling to tackle this issue in an honest way.
I have only ever seen one mainstream doctor/scientist who really, truly understood what I am trying to tell you about the paucity of actual science done to explore vaccines and autism, and luckily she was a scientist who held the top position in the entire universe of scientific research, Dr. Bernadine Healy, former head of the National Institutes of Health. Knowing what I just told you about the actual science, listen carefully to her words, spoken also in 2009, and you’ll see how right she really was (unfortunately for us all, Dr. Healy has since passed away).
The MMR-Autism Study Heard ‘Round the World, and the misappropriation of the word “unvaccinated”
There have been a lot of studies published over the years looking at a single vaccine or a single vaccine ingredient in relationship to autism that the media has loudly proclaimed to be the final word on the vaccine-autism hypothesis. Frankly, it gets tiresome to sort through all the hyperbole and see what the studies actually did.
When the unvaccinated study in Frontiers was almost published a few months ago, I heard from so many people on the other side telling me that unvaccinated kids had already been looked at, and they all pointed to a study from 2015 published by The Lewin Group.
The publicity surrounding this “Sibling MMR-Autism” study was incredible, and the headlines all said pretty much the same thing, I’ll just show you two of the dozens:
A large study released Tuesday in JAMA, the Journal of the American Medical Association, finds no link between autism…www.nj.com
Siblings of autistic children are at higher risk of developing the developmental disorder, but do vaccines affect that…time.com
The vaccine-autism link is dead. Move on, what more proof do you need? Even more shocking was the pre-lease publicity page from the Journal of the American Medical Association where the study was published. In order to help reporters get ready to write a story, they included some quotes from some “third parties” discussing the findings. Here’s an important quote they provide from Bryan H. King, M.D., M.B.A., of the University of Washington and Seattle Children’s Hospital:
“Taken together, some dozen studies have now shown that the age of onset of ASD does not differ between vaccinated and unvaccinated children, the severity or course of ASD does not differ between vaccinated and unvaccinated children, and now the risk of ASD recurrence in families does not differ between vaccinated and unvaccinated children.”
Ok, wait. Please. Take a deep breath. Please re-read the quote, the quote from Dr. Bryan King that is sitting on the publicity page of the journal that published this study. He claims more than a dozen studies have looked at vaccinated versus unvaccinated children. He claims this study looks at unvaccinated children. I can tell you, in no uncertain terms, that Dr. King’s statement is a blatant lie, and it’s simply unbelievable that JAMA included this quote in their press kit for the study! Don’t take my word for it, CDC scientist Dr. Coleen Boyle had to answer this question under oath:
What happened right after the Sibling-MMR study was released really shook my foundation. I couldn’t believe how much misreporting was going on, because you see there are no unvaccinated children in The Lewin Group’s study, but even Autism Speaks thought it was worthwhile to promote the lie:
In the largest-ever study of its kind, researchers again found that the measles-mumps-rubella (MMR) vaccine did not…www.autismspeaks.org
I mean, you can’t really say it any more directly than that, and reading what Autism Speaks wrote really just takes my breath away, so let’s take a close look at the actual study, and what it did (and didn’t) do. Vaccine Papers, which is a simply incredible website written by an incredibly smart group of scientists, provided further support:
“The Jain study only looked at MMR. Media reports about this study have falsely and deceptively asserted that the Jain study shows that “vaccines” in general do not cause autism. In reality, the Jain study says nothing about other vaccines…The other likely more dangerous aluminum-containing vaccines, given at younger ages, have hardly been studied at all. It is a blatant lie to claim that the science shows “vaccines” generally do not cause autism.”
The Lewin Group’s goal was to see whether or not the MMR vaccine caused autism, but in a very novel way: they would look at the younger siblings of children who already had an autism diagnosis, and see if these younger siblings had higher or lower rates of autism based on whether or not they received the MMR vaccine. As the paper explained clearly its objective:
“To report ASD [autism] occurrence by MMR vaccine status in a large sample of US children who have older siblings with and without ASD.”
The conclusion was highly reassuring for all:
“In this large sample of privately insured children with older siblings, receipt of the MMR vaccine was not associated with increased risk of ASD, regardless of whether older siblings had ASD. These findings indicate no harmful association between MMR vaccine receipt and ASD even among children already at higher risk for ASD.”
Simple enough. Except that I think this is one of the more dishonest and deceptive studies that’s ever been published about this topic, and I will tell you why.
4 reasons the Sibling-MMR study from The Lewin Group was diabolically dishonest
1. The conflict of interest for The Lewin Group was extreme, and never mentioned in the press — their clients are vaccine makers!
This study was written by three employees of The Lewin Group, which is a health care consulting firm that works for pharmaceutical companies. While that alone may not invalidate the findings of the study, this conflict was never reported in any of the press of this study. The Lewin Group’s website reveals that at least four of the companies they consult for are vaccine manufacturers. (If they had found an association between the MMR vaccine and autism, do you think they would have published this study?)
2. The study authors misappropriated the use of the word “unvaccinated”
This to me represents the “diabolical” moment in the creation of this study. In drawing a distinction between children who had received or had not received the MMR vaccine, the authors chose to call the children who had not received the MMR vaccine “unvaccinated.” The term “unvaccinated” is well understood by all to mean a child who has not been vaccinated with ANY vaccines, not just missing one (MMR). The Lewin Group’s choice to misuse the term “unvaccinated” could cause the following to take place in the study, where a child receiving 24 vaccines (Child A) would be called “unvaccinated” while a child receiving one vaccine (Child B) would be called “vaccinated”. Huh?
Moreover, the choice to misuse the term “unvaccinated” in the study is what caused the term to be misused in the press, and on the website of Autism Speaks (although they should read the study for themselves!). The Lewin Group’s misuse of the word created something that I consider to be incredibly irresponsible and dangerous: they created false assurance to parents.
3. The actual numbers of children studied were very small: 23 children drove ALL the study results
This study was heralded as being a “large” study of “unvaccinated” kids. I’ve already shown you that the “unvaccinated” part of that claim was untrue, and so was the “large” part. Yes, the study authors started with over 95,000 kids, and this was the certainly the number used everywhere in the media. But, remember, the power of this study was in looking at younger siblings who had an older sibling with autism. This group is considerably more “at risk” for autism, and it’s therefore their outcome that was of interest to the study authors. Moreover, the real “gem” in the study would be a child who met three separate criteria: 1. Had an older sibling with autism, 2. Had autism themselves, and 3. Had NOT received the MMR. You see, if you met all three criteria, you were the proof the study authors were looking for that MMR had not caused your autism.
How many kids in this large study met the three criteria that mattered? How many had an older sibling with autism, had autism themselves, and had never received the MMR? 23 kids. That’s it.
23 kids is not very much to slam the door on whether or not “vaccines cause autism,” much less the actual question the study considered about MMR’s potential role in autism. And yet, these 23 kids were the proof that MMR couldn’t cause autism, because they had a sibling with autism, had autism themselves, and had never received the MMR vaccine. And, the rest of their vaccination status was completely unknown and never discussed, which leads to the single most critical flaw in the study.
3. The study suffered from a serious case of “Healthy User Bias”
I really can’t say it any better than the devastating analysis of this paper compiled by the brilliant scientists at Vaccine Papers, so I will let them explain this concept further:
A substantial problem with the Jain study is that parents observing developmental delays or autism symptoms will avoid MMR vaccination. Consequently, sick children (e.g. vaccine-injured children) will become concentrated in the “unvaccinated” group, even if the problems are caused by vaccines (i.e. non-MMR vaccines). This of course will conceal an association between MMR and autism. If the effect of parental vaccine avoidance is large enough, it will create a negative association (i.e. the incidence of autism will be higher in the unvaccinated group). Jain etal report such a negative association (since all but one odds ratio is <1.0).
In other words, there are two possible causal links between MMR vaccination and autism, and they interfere with one another:
Causal Link #1: MMR vaccination causes autism (the hypothesis under investigation)
Causal Link #2: Autism (or vaccine injury) causes MMR avoidance (due to parental concern that vaccines may cause autism. Mere indicators suggestive of autism, not enough for autism diagnosis, will also impact parental vaccination decisions)
The idea behind Causal Link #2 is what’s known as “Healthy User Bias”, which can best be explained this way:
“It is common practice in medicine to avoid vaccination of people with pre-existing health problems. Good doctors do not give vaccines to people that already have signs of neurological or immune disorders, for example. Consequently, people with these health problems become concentrated in the unvaccinated control group. Since they have health problems, the unvaccinated have increased risk of adverse outcome, even if they don’t receive the vaccine.”
CDC researchers have been well aware of this phenomenon since at least 1992, when CDC researchers Dr. Robert Chen and Dr. Paul Fine both discussed Healthy User Bias in a study they did on the DTP vaccine and SIDS:
“Confounding…is a general problem for studies of adverse reactions to prophylactic interventions, as they may be withheld from some individuals precisely because they are already at high risk of the adverse event.”
Vaccine Papers includes a helpful decision-tree that explains how an “unvaccinated” (no MMR) baby could get to that point because the parents were very worried about the child’s health outcome:
4. The study authors did nothing to account for this obvious “Healthy User Bias”
You now understand that The Lewin Group’s conclusions were based almost entirely on the results of 23 children who had an older sibling with autism, who had autism themselves, and who had NOT received the MMR vaccine. You also know that nothing else about their vaccination status was reported, so they may have received 24 vaccines other than MMR and we wouldn’t know.
Given that every parent of a child with autism is at least familiar with the possibility that vaccines play a role, this group of children is rife with Healthy User Bias risk, and this risk is very well-known amongst vaccine epidemiologists and has been for at least 25 years.
What’s also known is that you can CONTROL for Healthy User Bias in your analysis, and I consider this choice not to control to be the single biggest flaw of this paper.
The Lewin Group authors noted the risk of Healthy User Bias, but made absolutely no effort to control for it:
“It is possible, for example, that this pattern is driven by selective parental decision making around MMR immunization, i.e., parents who notice social or communication delays in their children decide to forestall vaccination. Because as a group children with recognized delays are likely to be at higher risk of ASD, such selectivity could result in a tendency for some higher-risk children to be unexposed [to the MMR vaccine].”
The scientists at Vaccine Papers re-analyzed The Lewin Group’s data using the Healthy User Bias, and found very different results:
This means that HUB is strong enough to account for the finding of no association by Jain et al. In fact, HUB appears to be so strong as to conceal a positive association between MMR and autism. In other words, when the effect of HUB is removed, the Jain et al study data shows that MMR is associated with autism. However, I am not arguing that Jain et al. provides evidence for a positive MMR-autism association. I think there are too many assumptions for such a claim. Rather, I assert that HUB is strong enough to make the Jain et al study unreliable. The Jain et al results are essentially meaningless. The reason why Jain et al. find no MMR-autism association is simply because of the effect of autism on parental vaccination choices, not the other way around. When parents observe autism or autism traits, they avoid vaccination, and the result is that autistic children wind up in the “unvaccinated” group. Obviously, this is a highly misleading effect that conceals an autism-causing effect of MMR.
Vaccine Papers went on to conclude:
Many vaccines, including MMR, cause autism. Vaccines cause autism if they stimulate interleukin-6 or interleukin-17a production in the brain. The autism effect is not observable in Jain et al due to its failure to control for HUB.
There are profound difficulties in studying health outcomes in a population that is aware of the hypothesis under investigation. Many people are aware of the vaccine-autism controversy and believe in the link. When they adjust their behavior accordingly, the direction of causation is reversed and the phenomenon becomes almost impossible to observe.
HUB [Healthy User Bias] biases every MMR-autism study. Unfortunately, the other MMR-autism studies do not provide the data necessary to calculate the strength of HUB. Jain et al. is the only study I am aware of that provides data sufficient to estimate the strength of HUB.
HUB is a good reason to be skeptical of human vaccine-autism studies, and instead look at controlled animal studies. Animal studies always have better controls and do not suffer from biases due to behavior of study subjects. And many animal studies prove beyond any doubt that activation of the immune system during brain development causes autism, schizophrenia, epilepsy, seizure disorders and other brain injury. Animal studies also prove beyond doubt that aluminum adjuvant in vaccines can cause brain damage, at dosages routinely given to human infants.
I hope this article opened your mind to some of the falsehoods about the science that has — and more importantly has not — been done on the relationship between vaccines and autism. We are still in the first inning, having only considered one vaccine and one vaccine ingredient — calls by doctors and scientists to slam the door on research in this area is both dishonest and dangerous.
By looking at just one study in detail, it’s possible to see how easy it is to manipulate numbers to desired outcomes, as a consulting firm that works for vaccine makers was able to do. In the case of The Lewin Group, things went even farther, with this study incorrectly being called a study of “unvaccinated children,” which most certainly falsely reassured and confused parents. That this study still sits on the website of Autism Speaks and is referred to as a vaccinated versus unvaccinated study is an utter disgrace!
J.B. Handley is the father of a child with Autism. He and his wife co-founded Generation Rescue, Jenny McCarthy’s autism charity. He spent his career in the private equity industry and received his undergraduate degree with honors from Stanford University. He is also the author of “The Only Vaccine Guide a New Parent Will Ever Need” , “An Angry Father’s Guide to Vaccine-Autism Science”, and “7 reasons CDC employees should be “crying in the hallways”
Mr. Handley has started a podcast called “How to End the Autism Epidemic” — you might enjoy his first six interviews: