Marco Cáceres di Iorio

Oh Sanjay…

Sanjay Gupta

Watch the video below. It’s a TV commentary by CNN’s Sanjay Gupta regarding the comments made by Ben Carson, Donald Trump and Rand Paul during the second Republican presidential primary debate on September 16, 2015. Now remember, Gupta is an Emmy-award winning chief medical correspondent for CNN. The man was once offered the post of Surgeon General of the United States in the first Obama administration, but he turned it down. His credentials are so stellar that he actually said no thanks to Surgeon General. Forbes magazine in 2011 named Gupta “one of the 10 most influential celebrities.”

Gupta is extremely charismatic, affable and well-spoken. He comes across as thoroughly knowledgeable and trustworthy—which is no doubt why CNN features him whenever there’s a critical medical or scientific issue to discuss. He has a way of explaining things clearly and concisely so that the average American can understand. He’s good.



In the video, CNN news anchor Wolf Blitzer opens by saying…

So Sanjay, it’s a well known fact that vaccines, at least according to the studies out there, and you can correct me if I’m wrong, there is no correlation with autism. But when you hear this exchange going on, give us the facts. What’s your reaction?

Twelve seconds into the video, Gupta begins…

There is no connection between vaccines and autism. And I’ll just pause there for a second because I don’t want anybody to think there’s any strings attached to that statement. There just is no connection. There hasn’t been. There was a study done earlier this year… one of the largest, 96,000 children they looked at, looked at their history of vaccinations and looked for any correlation with autism. It simply doesn’t exist.

So it’s settled. Gupta proved it. He cited an authoritative, flat out conclusive study—the one done by The Lewin Group earlier this year. There’s just one problem. It’s a bogus study. It’s an interesting exercise, and it may offer some data to help support the mainstream position that there is no correlation between vaccines and autism. But it doesn’t actually prove anything. The same is true with all those studies that the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), countless doctors, media sources, and politicians like to cite to demonstrate to people how silly they are to believe in such a myth and continue insisting on their “pseudo-science” on a vaccine-autism link.

The Lewin Group, based in Falls Church, VA looked at the records of 95,727 children over an 11-year period, and it determined that the kids who had received one or two doses of MMR (mumps, measles, rubella) vaccine did not show any greater risk of developing autism spectrum disorders (ASD) than those who did not receive the vaccine. According to the study abstract published in The Journal of the American Medical Association (JAMA), “Participants included children continuously enrolled in the health plan from birth to at least 5 years of age during 2001-2012…” All of these kids had an older sibling, either with or without ASD.

The epidemiological cohort study—tracking a similar group of people—found that, regardless of whether or not a child had an older sibling with ASD, there was no indication of any harmful association between receiving the MMR vaccine and ASD. No higher risk even for already higher-risk children who had a brother or sister with ASD. The study’s authors wrote, “Consistent with studies in other populations, we observed no association between MMR vaccination and increased ASD risk among privately insured children. We also found no evidence that receipt of either 1 or 2 doses of MMR vaccination was associated with an increased risk of ASD among children who had older siblings with ASD.”

But let’s pause here and do a little analysis regarding the Lewin study. It’s clear CNN has neglected to do so. CNN and countless other media sources featuring “experts” like Gupta have swallowed the study’s findings hook, line, and sinker, and thus have confirmed to the public without so much as a whisper of a question regarding the methodology of the study or the identity of The Lewin Group and any possible conflicts of interests on its part. It’s not like you have to search very hard to find out that the firm has numerous vaccine manufacturers and promoters of vaccines as its clients. Could that possibly influence the design of its study and the findings? How much weight should be given to a study conducted by a firm that is not independent? Should we simply trust The Lewin Group and have faith that the study is significant or even credible?

Furthermore, is it possible that the firm’s retrospective epidemiological cohort study using a single “administrative claims” database from a single commercial healthcare provider could be wildly skewed, or that a retrospective (backward-looking) study may not be nearly as controlled, and thus accurate, as a prospective (forward-looking) one. Think about it. It wasn’t even The Lewin Group’s own data, so the firm has no idea how accurate or representative is the information. This alone should raise lots of red flags. And while the size of the study—the number of records—is impressive, remember that size is only one factor… and it is relatively meaningless if it is not representative of the population as a whole, if it’s not balanced. That’s where having certain controls in place comes in handy.

There is also the matter of whether a cohort study is the best kind of study to use in the first place.

Cohort studies tend to be the study of choice by the CDC, particularly when it comes to vaccines and ASD. But you have to wonder why. If you truly wanted to determine whether vaccines contribute to the onset of ASD, then why not do a large prospective observational study? Take two separate controlled groups of children. Vaccinate one group. Don’t vaccinate the other. Follow each group of kids, and see which one develops the highest rate of ASD. It makes perfect sense. Yet, for all the talk about all the studies it has conducted on vaccines and ASD, the CDC has not performed one full-blown prospective observational study on this issue.

You could also perform biological mechanism studies to understand what happens to the cells and molecules in the body when vaccines are given to an infant or young child and whether there are common genetic variations that make some children more vulnerable to developing ASD following vaccination.

Both the observational and biological mechanism studies would be infinitely more conclusive than the epidemiological cohort studies that have become standard practice at the CDC.

But a more fundamental problem is that epidemiological studies—be they cohort or observational—aren’t the be all and end all of scientific research. First of all, it’s important to note that epidemiology is a basic science, not an applied science. It is not meant to prove anything, merely point the way for further research by fields of applied science that are more capable of solving problems and finding answers.

Freedman Green, MD writes in the National Research Council’s Reference Guide on Epidemiology: “Epidemiology is concerned with the incidence of disease in populations and does not address the question of the cause of an individual’s disease. The question, sometimes referred to as specific causation, is beyond the domain of the science of epidemiology.”

Georgia Ede, MD concurs. She writes: “Even the most rigorous epidemiological studies suffer from a fundamental limitation. At best, they can show only association, not causation. Epidemiological data can be used to suggest hypotheses but not prove them. … Epidemiological studies, at their best, can only  point out a possible connection between two things, but that is only the very first step in trying to figure out whether or not there really is a connection between them.”

Same goes for Richard Farmer of the Department of Epidemiology at the University of Surrey in the United Kingdom: “Epidemiological studies provide a valuable tool for the investigation of the causes of disease. However, such studies alone are rarely able to prove cause. No study is perfect and the evaluation of results must take account of the design and execution of the study, together with the analytic methods used.”

Then, of course, there are those pesky little things that might influence the way an epidemiological study is designed, conducted, and evaluated. Helen Barrat and Maria Kirwan of the Public Health Action Support Team and the UK Department of Health write: “In theory, [epidemiological] research should be driven only by a desire to establish the truth. However, in the real world, other factors often interfere with this aspiration and can result in conflicts of interest. Research has to be funded, carried out and ultimately published, whilst researchers seek to promote their reputations and careers. Research is, therefore often carried out amidst many competing agendas.”

That really does go to the heart of the debate about the credibility of epidemiological studies like that of The Lewin Group. What exactly is the agenda? Then, of course, there’s the question of why the media is so quick to accept the conclusions of these type of studies, instead of asking some hard follow-up questions. One might pardon a common reporter for this oversight, but not a guy who was once considered Surgeon General material.

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3 Responses to “Oh Sanjay…”

  1. tlundeen

    There is an excellent analysis of the Lewin Group study at http://vaccinepapers.org/review-of-jain-et-al-jama-2015-and-comments-on-mmr-autism/ (They call it the Jain study, because Jain was the lead author.)

    The make the point that “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 strongly conceals an autism-causing effect of MMR.”

    In fact, if you could control for the effect of parental choice on vaccination status, the Jain study could well show that MMR vaccine does cause autism (as do all vaccines, as shown by immune activation research).

    All of the work at vaccinepapers.org is worth reading.

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  2. tlundeen

    One more quote from the vaccinepapers.org analysis:

    “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 MMR vaccine is the only vaccine that has been much studied in relation to autism, and most of the MMR-autism studies are flawed, deceptive or associated with criminality. 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” do not cause autism.”

    “The science actually shows the opposite. Controlled animal experiments overwhelmingly prove that immune activation (and interleukin-6 specifically) in the developing brain causes autism. Animal experiments also prove that aluminum adjuvant causes brain damage, at dosages human infants routinely receive from vaccines.”

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  3. drmaryanneshiozawa

    Great post. Thank you. The only issue I have is that although I’d love nothing more than to see a large study done which compares the health of the vaccinated and the unvaccinated. There’s just a problem with that. It can’t be done. Well, not ethically at least.

    You said, “If you truly wanted to determine whether vaccines contribute to the onset of ASD, then why not do a large prospective observational study? Take two separate controlled groups of children. Vaccinate one group. Don’t vaccinate the other. Follow each group of kids, and see which one develops the highest rate of ASD.”

    How can it be well designed, even if observational? There are a lot of questions to ask, and yes it would be very interesting to see a well-designed study like that, but there are too many variables, as well as the ethics in question.

    — MaryAnne.

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