A vaccinated vs unvaccinated study

6 Jun

For as long as I can recall, this has been one of the clarion calls of the autism/antivaccine/pro-disease groups – that the only way to know if vaccines cause autism is to do a ‘simple’ study of vaccinated vs unvaccinated populations. Indeed, Generation Rescue carried out an ill-fated phone survey that in reality meant absolutely nothing so badly was it put together and carried out. But even if it _had_ been well designed and carried out the results were not good for pro-disease anti-vaccine autism believers:

Number of boys and girls with Aspergers
Unvaccinated: 1% of total
Partially vaccinated: 2% of total
Fully vaccinated: 1%
Fully and Partially combined: 2%

Conclusion: you are 1% more likely to have Aspergers if you have been partially vaccinated than unvaccinated. If you are fully vaccinated your chance of being Aspergers is no greater than if you were unvaccinated.

Number of boys and girls with PDDNOS
Unvaccinated: 2% of total
Partially vaccinated: 2% of total
Fully vaccinated: 1%
Fully and Partially combined: 1%

Conclusion: you are 1% more likely to have PDDNOS if you are unvaccinated. If you are fully vaccinated your chance of being PDDNOS is 1% less than if you were unvaccinated.

Number of boys and girls with Autism
Unvaccinated: 2% of total
Partially vaccinated: 4% of total
Fully vaccinated: 2%
Fully and Partially combined: 2%

Conclusion: you are 2% more likely to have autism if you have been partially vaccinated. If you are fully vaccinated your chance of being autistic is no greater than if you were unvaccinated.

Number of boys and girls with all ASD’s
Unvaccinated: 4% of total
Partially vaccinated: 6% of total
Fully vaccinated: 3%
Fully and Partially combined: 3%

Conclusion: you are 2% more likely to have an ASD if you have been partially vaccinated. If you are fully vaccinated your chance of being autistic is 1% less than if you were unvaccinated.

Overall conclusion: the best way to avoid being diagnosed with an ASD is to be fully vaccinated according to the CDC schedule.

And in September of last year, you may recall the announcement of yet another study that demonstrated there was no link between MMR and autism. During the press conference that launched that study David Kirby asked the lead author – Ian Lipkin – what his thoughts were about a vaccinated vs unvaccinated study. His answer was:

http://webjay.org/flash/dark_player

Very difficult if not impossible.

Given that, the US NVAC vaccine safety group released a draft of their latest thinking on the issue of vaccine safety which touched on the idea of doing this sort of study. The entire section related to this is quoted in full below:

Feasibility study of Vaccinated/Unvaccinated/Alternatively Vaccinated Children

Members of the public, stakeholders, and the Interagency Autism Coordinating Committee (IACC) have articulated interest in a study of vaccinated vs. unvaccinated children to determine if there are differences in health outcomes between groups with varying exposures to vaccines. The Working Group considered drafting a recommendation for an IOM review of the science, epidemiology and feasibility of studies of unvaccinated, vaccine delayed, and vaccinated children. The Writing Group Draft Document on Gaps in Research Agenda further developed this idea. The Working Group wishes to clarify several points on this topic. *First, the Working Group believes that the strongest study design, a randomized clinical trial that includes a study arm receiving no vaccine or vaccine not given in accord with the current recommended schedule, is not ethical, would not pass IRB review, and cannot be done*. The type of study that is being suggested would be an observational study of populations looking at natural variation in vaccination schedules including some children where vaccination is declined through parental intent. All children in the study should be recommended to receive the standard immunization schedule. The Working Group endorses the Writing Group’s recommendation for an external expert committee, such as the Institute of Medicine, with broad methodological, design, and ethical expertise to consider “strengths and weaknesses, ethical issues and feasibility including timelines and cost of various study designs to examine outcomes in unvaccinated, vaccine delayed and vaccinated children and report back to the NVAC.

The Working Group does not necessarily agree with all of the language in the Writing Group’s statement, but with its general intent. The process should be open and transparent, engaging individuals from a broad range of sectors. Considerations as outlined by the Writing Group and modified by the Working Group are as follows:

- This review should consider strengths and weaknesses, ethical issues and feasibility including timelines and cost of various study designs and report back to the NVAC

- Consideration should be given to broad biomedical research including laboratory studies, and animal studies.

- Consideration should also be given to study designs comparing children vaccinated by the standard immunization schedule with unvaccinated children (by parental intention), and possibly partially vaccinated children or children vaccinated by alternative immunization schedules

- Outcomes to assess include biomarkers of immunity and metabolic dysfunction, and outcomes including but not limited to neurodevelopmental outcomes, allergies, asthma, immune-mediated diseases, and other developmental disabilities such as epilepsy, intellectual disability and learning disabilities.

- The inclusion of autism as an outcome is desired. This review should also consider what impact the inclusion of Autism Spectrum Disorders (ASD) as an outcome would have on study designs and feasibility, as referenced in the IACC letter to NVAC.

- This review should be conducted expeditiously, in a transparent manner, and involving broad public and stakeholder input.

So, as per a straight ‘vaccinated vs unvaccinated’ study, Ian Lipkin and NVAC Working Group agree that it can’t be done in the most scientifically accurate way and even if it could, it wouldn’t be ethical due to the requirement of excluding children from vaccination.

What they are saying is that a group like the IOM therefore should write up a feasibility study as to how such a study _could_ be done. Without this, its extremely unlikely that a vax vs unvax study will ever fly.

Amusingly, the way that the NVAC Working Group words a possible solution – vaccinated vs unvaccinated via parental choice – sounds pretty much like the Generation Rescue phone survey. And we know how that ended up.

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21 Responses to “A vaccinated vs unvaccinated study”

  1. jefflegweak June 7, 2009 at 00:09 #

    You need some help with your math. If 1% of people who are vaccinated get a disease, and 2% of people who are not vaccinated get a disease, this means you are 100% more likely (twice as likely) to get the disease if you are not vaccinated, NOT 1% more likely…. quite the difference.

  2. autismfamilyonline2 June 7, 2009 at 04:12 #

    whether or not vaccination increases the chances of autism, we still have the condition and have to learn to communicate and live with our circumstances. It is like is the glass half empty or half full. It is easy to be angry and hard to learn how we can live peacefully with a loved one who has autism. This video will bring a tear to your eye and help comfort your heart and move toward peace instead of anger.

  3. Kev June 7, 2009 at 07:34 #

    Fair enough Jeff – maths was never my strong point – the points and overall conclusions remain the same however.

  4. passionlessDrone June 7, 2009 at 13:51 #

    Hi Kev –

    Amusingly, the way that the NVAC Working Group words a possible solution – vaccinated vs unvaccinated via parental choice – sounds pretty much like the Generation Rescue phone survey. And we know how that ended up.

    Does this mean that you feel the recent study ‘Parental Refusal of Pertussis Vaccination Is Associated With an Increased Risk of Pertussis Infection in Children’ study that got so much attention in various places a few weeks ago is of such poor design that we can learn nothing from it? Because it was a retrospective study of children who were vaccinated versus those whose parents made the choice not to vaccinate their children.

    Once the study had been performed, and the results were published, the problem of the health care bias confound were apparently, not sufficient to keep us from learning things. I never would have guessed the confounds only worked in one direction.

    – pD

  5. jharris2004 June 7, 2009 at 15:25 #

    oh boy: You need some help with your math. If 1% of people who are vaccinated get a disease, and 2% of people who are not vaccinated get a disease, this means you are 100% more likely (twice as likely) to get the disease if you are not vaccinated, NOT 1% more likely…. quite the difference

    1% is not that big of a difference. If I had to groups of people, 100 in ea group. All have terminal cancer. One group gets sugar pill, other get brand new drug. At the end of the study, the sugar pill group has 1 person alive, the drug group has 2 people alive. This would be consired a failor, not “a 100% increase in survival rate”.

  6. jharris2004 June 7, 2009 at 15:27 #

    sorry* failure, not failor (what ever that means)

  7. Joseph June 7, 2009 at 16:22 #

    I believe we went over this already. The “partially vaccinated” group is indicative of poor survey design, because a lot of autistic children are partially vaccinated because they are autistic (not the other way around.) That obviously skews the figures.

    The interesting part of the survey is the prevalence of ASD among the completely unvaccinated (3.73%) vs. the prevalence among the fully vaccinated (3.01%). The (non significant) risk ratio is 0.81.

  8. Kev June 7, 2009 at 16:49 #

    pD – I’m simply saying that to me the NVAC seems to be recommending a similar type of study to the GR phone survey. As it hasn’t even gone through a required feasibility study, let alone been done or published its hard to compare it to any sort of published science don;t you think?

  9. rosenfeld.mikey June 7, 2009 at 19:27 #

    I’ve read an interesting post about so called “Oprah effect” regarding vaccination and Autism… worth reading as well.
    maybe someone should send her this link.
    http://blog.biodata.com/2009/6/4/austism-vaccines-and-the-oprah-effect

  10. Kev June 7, 2009 at 20:16 #

    Yeah I just linked to that. It’s a good piece.

  11. me.yahoo.com/a/lOLb0ixovdEUnvJNPkVQQfPv June 16, 2009 at 21:08 #

    “1% is not that big of a difference. If I had to groups of people, 100 in ea group. All have terminal cancer. One group gets sugar pill, other get brand new drug. At the end of the study, the sugar pill group has 1 person alive, the drug group has 2 people alive. This would be consired a failor, not “a 100% increase in survival rate”.”

    Yesterday I found Kev’s original article about the phone survey and read all the comments. Several people wrote that Kev was wrong when he wrote that the difference is 1% or 2% and they explained (as jefflegweak in this thread) that the risk is respectively 100% or 200%. But Kev is right! Obviously many people are used to see the way in which newspapers report study-results. They very often indicate the RELATIVE risk as this sounds much more sensational than the ABSOLUTE risk. Jharris2004 explained the difference between the relative and the absolute risk perfectly! Generation Rescue has an interest to impress with a high percentage, but this is just sand in the eyes, and doesn’t reflect the reality. Obviously in this case the “dates” of the survey itself are worthless…

  12. Lauren August 22, 2009 at 19:53 #

    I’m researching to see if there is any reliable published information or research to suggest whether vaccination is in fact or is in fact not correllated with autoimmune disorders, like diabetes or cancer, perhaps autism. What I know for certain is that I could NOT EVER inject my children with a substance that has not been tested to this ends in a way that I am comfortable with. Testing in children (as the CDC cites as the reason they believe vaccines to be safe) is positively cruel. People even boycott products tested on animals! Somehow they reason in favor of testing on children!!!

    Why would we NOT want to have information such as the number of children in the hospital for cancer who had received vaccines vs. the number of children in for cancer who were never vaccinated? You don’t even have to make an excellent study! Just let the numbers speak for themselves!!

  13. Dedj August 22, 2009 at 20:28 #

    Not making a study that accounts for all confounders would be pointless, as the numbers would certianly not speak for themselves, but would be grotesquely misquoted, as already happens with IDEA and VAERS data.

    If we didn’t account for confounders, the data would be useless as we would have no way on knowing whether it’s vaccines or better access to healthcare or poorer diet or living in cities or……..and so on and so on, that would account for the difference (if any).

    So far all of the scientific discussion about ‘how to put on a study’ has been completely originating from people other than the movement to ‘put on astudy’ – this is the total opposite to how science usually works. Until we get some actual data and ideas from the ‘put on a study’ people they’re just voices in the wind.

  14. passionlessDrone August 22, 2009 at 20:51 #

    Hi Dedj –

    Not making a study that accounts for all confounders would be pointless, as the numbers would certianly not speak for themselves, but would be grotesquely misquoted, as already happens with IDEA and VAERS data.

    Haha. No study ever takes into consideration all confouning effects, and in fact, many studies go to great lengths to detail the limitations of the studiy, up to and including confounding effects which could not be controlled for.

    Perfect is the enemy of very good.

    So far all of the scientific discussion about ‘how to put on a study’ has been completely originating from people other than the movement to ‘put on astudy’ – this is the total opposite to how science usually works.

    Studies with known limitations including potential confounding effects are written, published, and provide valuaable insight all of the time, if you don’t understand that, the notion that you have a clue how science works is pretty funny.

    Until we get some actual data and ideas from the ‘put on a study’ people they’re just voices in the wind

    How about more direct analysis of immunological markers other that seriopositivity How about analysis that takes into consideration time dependent effects of vaccination? What about studies that analyze immunological impact on children genetic markers known to associate with immune function, autism and/or autoimmunity?

    The idea that we’ve done all we can in terms of vaccine research demonstrates a lack of critical analysis of the issue.

    – pD

  15. Dedj August 22, 2009 at 21:29 #

    “up to and including confounding effects which could not be controlled for.”

    Which means they recognised what they were, or that they at least existed – even if only theorectically. It’s one of the signs of a well-researched paper.

    Remember – my post was in reply to a person who thinks raw numbers are the be all and end all in themselves. You should not have expected each and every caveat to have been explained to them.

    “Studies with known limitations including potential confounding effects are written, published, and provide valuaable insight all of the time, if you don’t understand that, the notion that you have a clue how science works is pretty funny.”

    Indeed I do know that and there’s nothing in my comment that indicates otherwise, you contradict me by mentioning the very thing I was getting on at. The post was in response to a simplistic assertion and was thus written simplistically. I may have confused you by using the term ‘accounts’, although I expected the context to indicate that it was being used in it’s broader meaning (i.e. the meaning likely to be understood by the person I was writing to).

    “The idea that we’ve done all we can in terms of vaccine research demonstrates a lack of critical analysis of the issue.”

    Indeed, and at no point did I say we should stop researching.

    Although your reply is not incorrect – it’s ‘correcting mistakes’ that weren’t even made. When reading replies, please read the post they were in reply to. This helps avoid mistakes by providing context which informs correct interpretation.

    I do not disagree with the points you have made, nor did my comment indicate such. I hope you agree that this is the end of this exchange as there is no purpose responding to a person who it appears I may not actually disagree with.

  16. dr treg August 22, 2009 at 22:41 #

    Would a thorough study of children with autism who when immunised appeared to the parents to have an immunisation reaction resulting in autism be worthwhile to assess whether the children share some predisposition e.g.
    1. Abnormal genotype
    2. Abnormal mitochondrial function.
    3. Abnormal immunogenic response to the immunisation.
    4. Abnormal MRI head scan appearances.
    rather than just comparing them to normal children.
    i.e. is there some underlying reason why some children may respond in this way as it seems that some parents seem to describe this temporal association..

  17. David N. Brown August 23, 2009 at 01:11 #

    It seems to me that what the GR data shows is that of children identified AS autistic (rather than the sample as a whole), 66.6% had received at least one vaccine and 33.3% had not.
    I think the most significant conclusion is that the autistic sample was unvaccinated at a much higher rate than the general population. (300-600%, if 90-95% of the population vaccinates.) The net implication is that it is more likely that autism is caused by NOT vaccinating than that it is caused by vaccines!

  18. Chris August 23, 2009 at 04:31 #

    Well that was a rambling incoherent bit of spam!

    • Sullivan August 23, 2009 at 06:50 #

      Chris,

      you are correct. In case anyone wonders–the comment has been removed.

  19. David N. Brown August 23, 2009 at 05:21 #

    As far as the correlation of autism and vaccination, the important point to drive home is that as long as the very large majority of the population is vaccinated (and even the British autism/MMR scare could not drive vaccination under 70%) there will be a strongly positive correlation between vaccination and autism even if the two things have nothing to do with each other.

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  1. Vaccinated Versus Unvaccinated Studies: Slim Chance Of Approval - June 8, 2009

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