Facts, not Fantasy

Thursday, March 24, 2011

9 Questions that Stump every Pro-Vaccine Advocate and their Claims

Earlier this week I came across this article written in the inappropriately named Baby Centre website. It is a reposting of another article but the original site is down. In it is a series of questions posed by David Mihalovic; ND. These questions are allegedly meant to stump “medical professionals”.

It was reposted by an individual called alaskaiscold. If these are a common cross-section of anti-vaccine arguments, let us dissect them. Certainly as a medical student I have heard some of these. As a denizen of the internet some of these seem “rather out there”.

I think one of the reasons why the anti-vaccine movement is so strong is that doctors often argue from unfathomable knowledge. The knowledge that goes into the making of a doctor or a nurse is colossal and well out of the ken of most normal people who spent their post teenage years getting degrees that take 3 years unlike the medical students who spend anything from 5 years to 7 years merely to acquire a degree that they must then prove they deserve in the crucible of a real hospital. Clinical rotations soften the blow but as I see in my seniors, it is like being thrown to the wolves with the instruction manual on how to build a spear. Not only must you fight off the wolves, but you must also do better than your peers.

Naturally this is stressful and it causes a bit of exasperation. What you read here is a product of that exasperation. It is hard to remain lucid when your opponents are for all intents and purposes, daft buggers. People look at the argument differently, a person with a minor medical background would look objectively and find logical arguments. I have tried to do that but quite frankly every time I hear these questions I just want to say “Shut up and do as I say. I have spent x amount of years studying and quite frankly you have not. You aren’t being intelligent or savvy; you are being incredibly stupid and dangerously so since you are playing with the lives of your children”. But then it hit me that this is precisely what kind of response they are angling for.
 1. Could you please provide one double-blind, placebo-controlled study that can prove the safety and effectiveness of vaccines?

A simple search using key words of “vaccine efficacy” and “placebo controlled” on Pub Med finds more than a 100 articles, which is more than one. A more apt question would be if there are any double blinded studies showing the efficacy of naturopathy, or a comparative between naturopathy vs. Medicine.

2. Could you please provide scientific evidence on ANY study which can confirm the long-term safety and effectiveness of vaccines?

No vaccine is a 100% safe. No medicine is a 100% safe. Your body runs via homeostasis, anything you put inside that alters the homeostasis makes you sick. Even too much water can cause side effects. The effects of excess sugar are well known in diabetics. If you consume enough to overcome your homeostatic control of sugar you get the same symptoms.

Unlike water, your immune system remembers antigens. The way vaccine’s work is by increasing your resistance to the disease by sensitising your immune system. Each subsequent exposure to the disease is fought off re-sensitising individuals to the disease causing their immune systems to react faster to the disease. Even if your resistance is overcome and you do get a disease, your body responds a lot faster and you are sick for a shorter amount of time with less severity.

Nothing in medicine is perfect. If someone is offering you a perfect cure, be wary. Long term studies in medicine chart development from a few weeks to a few years. This is probably insufficient for the anti-vaccine movement who would simply shift the goalpost till it was outside the research range.

3.  Could you please provide scientific evidence which can prove that disease reduction in any part of the world, at any point in history was attributable to inoculation of populations?

Now do you see why doctors just get angry and swear a lot at these people? Smallpox is extinct and that was killing people like HIV is now. If that existed now we would have a giant epidemic of unbelievable proportions since HIV would increase the fatality rate of smallpox.

Medicine is a multi-factorial science. I have always stated that our first line of medicine are two things we take for granted. Sewage and Garbage are the first lines of disease control and a hallmark of low life expectancy. The flushing toilet and the garbage truck have done more to increase life expectancy than any single other invention in public health. (Give them a big hug next time!)

Now onto the nitty gritty, there are plenty of studies from the USSR into the Measles vaccine program. The stats are quite astounding as the rates plummet within 5 years. In the place where I work? The polio drives have reduced polio’s occurrence by 93%. But don’t take my word for it, there is plenty of research from the JAMA on this for you Americans who won’t listen to the words of a dirty foreigner or a dirty communist.

4. Could you please explain how the safety and mechanism of vaccines in the human body are scientifically proven if their pharmacokinetics (the study of bodily absorption, distribution, metabolism and excretion of ingredients) are never examined or analyzed in any vaccine study?

The pharmacokinetics of a drug are studied in Phase 1 trials, Phase 2 trials are what the vaccine studies are all about. In order for us to inject vast numbers of people, we would need to know the pharmacokinetics anyways.

And the mechanism of how vaccines work, is an understanding of how the body fights disease. Via antibody/antigen reactions, the idea being that if you present the antigen or just use a less virulent pathogen, you would end up sensitising the body rather than triggering a disease.

5. Could you please provide scientific justification as to how injecting a human being with a confirmed neurotoxin is beneficial to human health and prevents disease?

This is easy. There are plenty of drugs that are technically neurotoxins. This has nothing to do with vaccination by the way.  Many drugs such as curare are neurotoxins themselves and have many uses such as in open heart surgery. Atropine is also a toxin and was used for optometry testing (the drops that make your pupils look like saucers is a nerve toxin).

I have heard of people who work with snakes using minute doses of venom to inoculate themselves with it. This is second hand information from my vet uncle so I hope that any zoology majors who do work with poisonous snakes will confirm this.

If this is about Mercury and Aluminium, then the amount of mercury and aluminium within a dose of vaccine is minute. You get the same kind of doses or higher eating anything from the ground such as root vegetables or using an aluminium foil to cover your food. And the presence of these as ions or as compounds is what is important. Hydrogen, Nitrogen and Carbon make up our amino acids but they also make up cyanide. Chemistry is important too.

Perhaps the issue is that this argument is usually brought up by homeopaths and their views on chemistry are based on the concept that the lower the concentration the greater the effect. Thus the minute concentrations of these metals would be of greater fear to them.

6. Can you provide a risk/benefit profile on how the benefits of injecting a known neurotoxin exceeds its risks to human health for the intended goal of preventing disease?

The treatment for myasthenia gravis is palliative. Neostigmine is given (which has neurotoxic effects) as a method of prolonging muscle use and improving quality of life. The drug in normal musculature would have terrible effects, however as a therapeutic agent for a disease where the muscular receptors are lost, this anti-cholinesterase effectively increases the half-life of acetylcholine increasing the strength of muscle contraction.

In terms of vaccination, plenty of studies look into the number of lives improved by reducing the lethality of various flu strains (contains aluminium).
From eight trials, the protective efficacy of the Hib conjugate vaccine was 84% (OR 0.16; 95%CI 0.08-0.30) against invasive Hib disease, 75% (OR 0.25; 95%CI 0.08-0.84) against meningitis, and 69% (OR 0.31; 95%CI 0.10-0.97) against pneumonia. Serious adverse events were rare.

7. Could you please provide scientific justification on how bypassing the respiratory tract (or mucous membrane) is advantageous and how directly injecting viruses into the bloodstream enhances immune functioning and prevents future infections?

To my knowledge not a single vaccine is provide via venous route. Every single one is subcutaneous bar some flu vaccines (nasal) and polio (oral).

It actually does not matter how vaccines are administered, if the conditions are met. It is just that most vaccines must be kept cold. Vaccines are maintained from creation to admin at a specific temperature via something called a cold chain. If administering via a different route the dosages need to be increased and the dose may not work perfectly as your lungs have a variety of cell mediated defences. What we wish to trigger is avoid that cell mediated defences and trigger the humoural immunity. Also by the logic of this question one would have to administer the tetanus vaccine by coating it onto a rusty blade or apply it to a ragged open wound. 

8. Could you please provide scientific justification on how a vaccine would prevent viruses from mutating?

No I cannot. Mutations in viruses (also in bacteria, while we are at it) are not linked to our immunities. We have no control over that.

Yes, the vaccine can act as a selection pressure for some strains of the virus or bacteria but quite frankly if one is immune to 9 out of 10 strains of a disease then surely that is better than not being immune to any of them.

However that is probably only the case in antigen only vaccines, in vaccines using either killed or live pathogens, there are multiple antigens involved and the immune response may actually prevent the outbreaks of mutations by dealing with mutations to one antigen via a different antigen.

9. Could you please provide scientific justification as to how a vaccination can target a virus in an infected individual who does not have the exact viral configuration or strain the vaccine was developed for?

It is not all or nothing. Resistance is a percentage, if you have a high resistance to a disease, you can still carry the disease without any of the associated disease issues. You may even fall sick but will recover faster. The flu vaccine actually provides a partial protection to future flu infections but the flu has a high mutation rate.

The terrifying thing about these arguments is that they are from a Doctor of Natural Medicine/Naturopathy. These individuals have rights to treat equivalent to a doctor where I am studying (and it greatly scares me that one day I will have to go back home to the UK and that the reputation of my education will be tarnished by such crummy thinking).  These individuals can tell patients what to do and where I live patients aren’t educated enough to make the choice between them and real medicine.

To close I leave you with some choice statements from David Mihalovic, ND.

I have never encountered one pro-vaccine advocate, whether medically or scientifically qualified, who could answer even 1 let alone all 9 of these questions. One or all of the following will happen when debating any of the above questions:- They will concede defeat and admit they are stumped- They will attempt to discredit unrelated issues that do not pertain to the question.- They will formulate their response and rebuttal based on historical arguments and scientific studies which have been disproved over and over again. Not one pro-vaccine advocate will ever directly address these questions in an open mainstream venue.

I think anyone with a few minutes of Google Time can find out these answers. The studies are extremely indicative and as one can see I have specifically answered questions.

I am willing to debate these questions. They aren’t particularly hard ones to answer. However I would suggest producing double blinded proof that natural medicine is indeed better than a placebo and indeed superior to actual medicine. Until then, it’s vaccination till I die (yo!).

Sunday, March 20, 2011

Greg Laden: The Measles Vaccine is Safe and Effective

Greg Laden just posted a quick blurb about the measles.  I encourage you to read it.  And to think that yet again someone is sick because of the irresponsible actions of those around them.

The Measles Vaccine is Safe and Effective

Posted on: March 17, 2011 4:35 PM, by Greg Laden

As we speak, several children lie gravely ill in Minneapolis, struck down by a preventable but sometimes fatal childhood disease.

One of the children is an infant who was too young to have been vaccinated, but caught the disease, apparently, from someone old enough to be vaccinated but who was not.

Get your children vaccinated. 

Learn about measles here. Read about vaccination here.
 Since this is such a short entry, the entire article is reposted here.  CLICK HERE TO READ COMMENTS FROM THIS POST.  And there are many interesting comments, so you need to head over there.

Saturday, March 19, 2011

Just the Vax: Dr. Bob Sears' Alternate Reality or Everyone is a Pharma Shill

Today I read another article that I think all should read.  This is the oft touted, but 100% wrong, idea that there is a "Big Pharma" covering up the autism/vaccines link...  Normally I w9ould do a teaser, and then have you "CLICK HERE TO READ THE REST OF THE STORY" bit, but this is important.  Over and over again there are studies that totally debunk (dare I say destroy) the lie spread by these irresponsible shysters, yet they keep trotting out the same old tired lies.  They are exhibiting the classic hallmarks of denialism.  Sadly, those sort of minds are very hard to reach.  However, anyone that actually values evidence needs to read this entire article.

Dr. Bob Sears' Alternate Reality or Everyone is a Pharma Shill

On 17 February, 2010 Dr. Bob Sears appeared on The Dr. Oz Show; the topic was "What Causes Autism". Dr. Oz packed the audience with mainly those who believe autism is caused by vaccines thus setting up all of the legitimate panel members (paediatricians) to be on the defensive. It was a live viewing, however, of how "alternative" practitioners get to play by their own rules enticing the audience, leaving those who remain true to the facts appearing unsympathetic and cold. One particular statement that Dr. Bob made was rather sensational and undoubtedly meant to be:

"Most of the vaccine studies that show no link between vaccines and autism are funded by the pharmaceutical companies."
Audience applause then:
"In fact, if you look at the 23 major studies that have shown no link, 18 of them are funded by big pharma."
Yes, he really did say "big pharma". Needless to say, I found this claim rather intriguing so I asked Dr. Bob which studies was he referring to:
On the Dr. Oz Show about autism a couple of weeks ago, you stated that most studies exonerating vaccines as the culprit for autism were pharma-funded, 18/23 to be exact. I'm very curious as to which 23 studies you were referring to.
 He kindly replied:
Not counting studies labeled as “commentary,” since that isn’t original research, I count 18 out of 23. There may be some studies I didn’t include here, but these are most of them:

Studies that compared children who received vaccines with mercury with children who did not and found no association between vaccine mercury and autism:

1.) Association between thimerosal-containing vaccines and autism, Hviid A, et al., JAMA 2003;290(13):1763-66. Pharma-funded. http://jama.ama-assn.org/content/290/13/1763.long

2.) Mercury concentrations and metabolism in infants receiving vaccines containing thimerosal: a descriptive study, Pichichero M, et al., Lancet 2002;360(9347):1737-41. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/12480426

3.) Thimerosal and autism? Nelson K and Bauman M., Pediatrics 2003;111:674-79. Commentary. http://pediatrics.aappublications.org/cgi/content/full/111/3/674

4.) On-time vaccine receipt in the first year does not adversely affect neuropsychological outcomes, Smith M. and Woods C. Pediatrics 2010;125(6):1134-41. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/20498176

Studies that show autism continued to increase even after mercury was removed from vaccines:

5.) Thimerosal and the occurrence of autism: negative ecological evidence from danish population-based data, Madsen K, et al., Pediatrics 2003;112:604-606. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/112/3/604?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=madsen&searchid=1&FIRSTINDEX=0&volume=112&issue=3&resourcetype=HWCIT

6.) Continuing increases in autism reported to california’s developmental services system, Schechter R, Grether, J., Arch Gen Psychiatry 2008;65(1):19-24.http://archpsyc.ama-assn.org/cgi/content/full/65/1/19

7.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al., Pediatrics 2006;118:e139-e150. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/118/1/e139

Studies that examined the rates of autism compared to the cumulative levels of mercury in vaccines and found no association:

8.) Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism, Price C. et al., Pediatrics 2010;126:656-64. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/20837594

9.) Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization database, Verstraeten T. et al., Pediatrics 2003;112:1039-48. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/112/5/1039

10.) Neuropsychological performance 10 years after immunization in infancy with thimerosal-containing vaccines, Tozzi A, et al., Pediatrics 2009;123:475-82. http://pediatrics.aappublications.org/cgi/content/full/123/2/475

11.) Autism and thimerosal-containing vaccines: lack of consistent evidence for an association, Stehr-Green P., Am J Prev Med 2003;25(2):101-106. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/12880876

12.) Thimerosal exposure in infants and developmental disorders: a prospective cohort study in the united kingdom does not support a causal association, Heron J, et al., Pediatrics 2004;114:577-83. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/114/3/577

13.) Early thimerosal exposure and neuropsychological outcomes, Thompson W, et al., N Engl J Med 2007;357:1281-92. Pharma-funded. http://www.nejm.org/doi/full/10.1056/NEJMoa071434#t=articleTop

14.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al., Pediatrics 2006;118:e139-e150. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/118/1/e139

Research comparing autism rates in children who did and did not receive the MMR vaccine and found no increased risk of autism:

15.) A population-based study of measles, mumps, and rubella vaccination and autism, Madsen KM, et al. N Engl J Med 2002;347(19):1477-82. Pharma-funded. http://www.nejm.org/doi/full/10.1056/NEJMoa021134#t=articleTop

16.) No effect of MMR withdrawal on the incidence of autism: a total population study, Honda H, et al., J Child Psychology and Psychiatry 46:6 (2005); 572-79. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/15877763

Research that duplicated Wakefield’s study and found no association between MMR and autism:

17.) Lack of association between measles virus vaccine and autism with enteropathy: a case-control study, Hornig M, et al., PLoS ONE 2008;3(9):e3140. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2526159/?tool=pubmed

Studies showing no evidence of a temporal relationship between MMR vaccine and autism:

18.) MMR vaccination and pervasive developmental disorders: a case-control study, Smeeth L, et al., Lancet 2004; 364:963-69. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/15364187

19.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al., Pediatrics 2006;118:e139-e150. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/118/1/e139

20.) No evidence for a new variant of measles-mumps-rubella-induced autism, Fombonne E and Chakrabarti S, Pediatrics 2001;108:e58. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/11581466

21.) No evidence for links between autism, MMR, and measles virus, Chen W. et al., Psychological Medicine 2004;34(3):543-53. http://www.ncbi.nlm.nih.gov/pubmed/15259839

22.) Neurologic disorders after measles-mumps-rubella vaccination, Mäkelä A, et al., Pediatrics 2002;110:957-63. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/110/5/957

23.) Association of autistic spectrum disorder and the measles, mumps, and rubella vaccine, Wilson K. et al., Arch Pediatr Adolesc Med 2003;157:628-34. Commentary. http://archpedi.ama-assn.org/cgi/content/full/157/7/628

24.) Vaccines for measles, mumps and rubella in children, The Cochrane Database of Systematic Reviews 2005; issue 4. Commentary. http://www.ncbi.nlm.nih.gov/pubmed/16235361

Studies that show no link between MMR and autism or gastrointestinal disease:

25.) MMR vaccine and autism: an update of the scientific evidence, DeStefano F., Thompson W., Centers for Disease Control, Expert Review of Vaccines 2004;3(1):19-22. Commentary. http://www.ncbi.nlm.nih.gov/pubmed/14761240

26.) Measles vaccination and antibody response in autism spectrum disorders, Baird G, et al., Arch Dis Child 2008;93:832-37. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/18252754

27.) Unintended events following immunization with MMR: a systematic review, Jefferson T. et al., Vaccine 2003;21(25-26):3954-60. Commentary. http://www.ncbi.nlm.nih.gov/pubmed/12922131

28.) A case-control study of measles vaccination and inflammatory bowel disease, The East Dorset Gastroenterology Group, Feeney M. et al., Lancet 1997;350(9080):764-66. http://www.ncbi.nlm.nih.gov/pubmed/9297995


29.) Immunization Safety Review: Vaccines and Autism, Immunization Safety Review Committee, Washington, DC: Institute of Medicine of the National Academies, 2004. Commentary. http://www.ncbi.nlm.nih.gov/books/NBK25344/

Research can be funded in numerous ways, for example, government institutions such as the NIH or CDC, special interest groups such as Autism Speaks or Autism Science Foundation, charitable/philanthropic organisations such as The David & Lucile Packard Foundation or Wellcome Trust and of course, industry such as pharmaceutical or agricultural companies.  When Dr. Bob states, "funded by pharmaceutical companies", that has a very specific meaning, that the study was funded by pharmaceutical companies.  Let's look at the funding sources for those he tagged as "pharma-funded":

1.) Association between thimerosal-containing vaccines and autism, Hviid et al.
Author Affiliations: Danish Epidemiology Science Centre, Department of Epidemiology Research (Messrs Hviid, Wohlfahrt, and Dr Melbye) and Medical Department (Dr Stellfeld), Statens Serum Institut, Copenhagen, Denmark.
Funding Statement: This study was supported by grant 11 from the Danish National Research Foundation and grant 22-02-0293 from the Danish Medical Research Council.

The Danish System is unique in that they have universal healthcare; Statens Serum Institut (SSI) is a public enterprise that operates under the Danish Ministry of Health.  SSI has a division which develops vaccines and is essentially, a non-profit.  SSI also has divisions which operate much like the CDC in the U.S.  These divisions are where the authors of this study are employed.  A comprehensive explanation of SSI's structure can be read here.  This is not "big pharma" by any stretch of the imagination.

2.) Mercury concentrations and metabolism in infants receiving vaccines containing thimerosal: a descriptive study, Pichichero M, et al.
Author Affiliations: Department of Microbiology/Immunology, University of Rochester, Rochester, New York, NY, USA.
Conflict of Interest: None declared.
Funding Statement: The investigation was funded by the US National Institutes of Health (NIH), Bethesda, MD, under contract 1 AF-45248.

4.) On-time vaccine receipt in the first year does not adversely affect neuropsychological outcomes, Smith M. and Woods C.
Author Affiliations: University of Louisville School of Medicine, Division of Pediatric Infectious Diseases, 571 S Floyd St, Suite 321, Louisville, KY 40202, USA.
Conflicts of Interest: Drs Smith and Woods are or have been unfunded subinvestigators for cross-coverage purposes on vaccine clinical trials for which their colleagues receive funding
from Wyeth, Sanofi Pasteur, GSK, MedImmune, and Novartis; and Dr Woods has received honoraria for speaking engagements from Merck, Sanofi Pasteur, Pfizer, and MedImmune and has received research funding from Wyeth and Sanofi Pasteur.
Funding Statement: This study was conducted without funding from any company (e.g., vaccine manufacturer) or agency (e.g., the CDC). We conducted this study on our own after requesting and receiving the publicly available data that were used for the analyses. Our unrelated interactions with vaccine manufacturers have been appropriately disclosed for full transparency in accordance with our own ethical standards as well as formal guidelines from the Academy of Pediatrics and the University of Louisville.

This is what Dr. Bob had to say about the study when he was asked (he also copied a communication from Dr. Rosen included in the preceding link):
Major flaws by Dr. Bob Sears - posted on 5/25/2010
Let me first say I haven't read it yet. Too busy in office last few days. But here are three observations: 1 - they excluded kids with autism from the study (DUH! - that's the type of kids you'd want to include in this!)
2. Hugely funded by pharmaceutical companies - the list of conflict of interest is quite long. Publishing a study like this with pharma funding is 100% worthless - the only people who will believe it are those who don't mind conflicts of interest.
3. Here's a comment from one of a doctor in the AAP who heads up one of the AAP divisions: this is the letter he wrote the journal:

"Dear Sirs,

I read with great interest Smith and Woods article, "On-time Vaccine Receipt in the First Year Does Not Adversely Affect Neuropsychological Outcomes." This issue is of paramount importance in clinical primary care practice today. However, I was dismayed by two factors within minutes of reading the piece. One, of perhaps lesser importance, in the Results Section, the numbers, simply put, do not add up. If all of the subjects are added as listed, a total of 1037 (not 1047) is obtained. Furthermore, the percentages are incorrect as listed. The final group (311) is in fact 30% of the incorrect total, not 20% as listed. It always concerns me and forces me to question the validity of the other findings when a mistake like this is notable. In any case, the finding that approximately 50% (depending on the true numbers) received an alternative vaccine schedule, even as long ago as 1993-1997 is of interest.

Of greater concern to me, personally, is the Financial Disclosure listings. It is very difficult in this day and age to review the authors' conclusions without considering their considerable potential biases given where their funding comes from. I believe every known vaccine manufacturer is listed on the payroll. Until we have well-done, conflict- free published research on this topic, both the public and skeptical physicians must continue to look for honest answers."
Dr. Bob didn't even read the study, let alone read the response that Dr. Rosen received about funding sources (self-funded) from the authors and absolutely no pharmaceutical funding.  He doesn't even grasp that Dr.s Smith and Woods used the data set from Thompson et al. (13), which specifically excluded autism and explained why. This is just Dr. Bob being intentionally misleading so he doesn't have to confront any evidence that is antithetical to his "trademark alternative vaccine schedule".

5.) Thimerosal and the occurrence of autism: negative ecological evidence from danish population-based data, Madsen K, et al.
Author Affiliations:  Danish Epidemiology Science Centre, Department of Epidemiology and Social Medicine, University of Aarhus, Denmark
Institute for Basic Psychiatric Research, Department of Psychiatric Demography, Psychiatric Hospital in Aarhus, Risskov, Denmark
National Centre for Register-Based Research, University of Aarhus, Aarhus, Denmark
State Serum Institute, Department of Medicine, Copenhagen, Denmark
Funding Statement: The activities of the Danish Epidemiology Science Centre and the National Centre for Register-Based Research are funded by a grant from the Danish National Research Foundation. This study was supported by the Stanley Medical Research Institute. No funding sources were involved in the study design.

7.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al.
Author Affiliations: Department of Psychiatry, McGill University, Montreal Children's Hospital, Montreal, Quebec, Canada
Lester B. Pearson School Board, Montreal, Quebec, Canada
Conflicts of Interest: In the United Kingdom, Dr Fombonne has provided advice on the epidemiology and clinical aspects of autism to scientists advising parents, to vaccine manufacturers, and to several government committees between 1998 and 2001. Since June 2004, Dr Fombonne has been an expert witness for vaccine manufacturers in US thimerosal litigation.
Funding Statement: None of his research has ever been funded by the industry.

8.) Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism, Price C. et al.
Author Affiliations: Abt Associates Inc, Cambridge, Massachusetts;
National Center for Chronic Disease Prevention and Health Promotion, Immunization Safety Office, and Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia;
Division of Research, Kaiser Permanente Northern California, Oakland,California;
Department of Psychiatry and Behavioral Sciences, Kaiser Permanente ASD Center San Jose Northern California Region, Stanford University, Palo Alto, California;
Department of Population Medicine, Harvard Pilgrim Health Care Institute, Harvard Medical School, Boston, Massachusetts;
Southern California Kaiser Permanente, and Center for Vaccine Research, University of California, Los Angeles, California; and
Center for Health Research Southeast, Kaiser Permanente, Atlanta, Georgia
Funding Statement: This work was supported by a contract from the CDC to America’s Health Insurance Plans and via America’s Health Insurance Plans subcontracts to Abt Associates Inc; Department of Population Medicine, Harvard Pilgrim Health Care Institute, Harvard Medical School; Southern California Kaiser Permanente, and Center for Vaccine Research, University of California Los Angeles; and Division of Research, Kaiser Permanente Northern California.

Ironically, this is the study that Dr. Bob's colleague, Sally Bernard of SafeMinds participated in.

9.) Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization database, Verstraeten T. et al.
Author Affiliations: Epidemic Intelligence Service Program, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia
Vaccine Safety and Development Activity, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia
University of Washington and Group Health Cooperative of Puget Sound, Seattle, Washington
Center for Child Health Care Studies, Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care and Harvard Medical School, and Division of General Pediatrics, Children’s Hospital, Boston, Massachusetts
Kaiser Permanente Vaccine Study Center, Oakland, California
Funding Statement: None declared.

Ironically, this study group invited Dr. Bob's colleague, Lyn Redwood of SafeMinds to review the findings.

11.) Autism and thimerosal-containing vaccines: lack of consistent evidence for an association, Stehr-Green P. et al.
Author Affiliations: Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle, WA, USA.
National Board of Health and Welfare (Tull), Stockholm, SwedenStatens Serum Institut (Stellfeld), Copenhagen, Denmark
National Centre for Register-Based Research (Mortenson), Aarhus, Denmark
National Immunization Program, Centers for Disease Control and Prevention (Simpson), Atlanta, Georgia, USA
Funding Statement: Financial support for the compilation of the data used in this investigation and the preparation of this report was provided by the National Immunization Program, Centers for Disease Control and Prevention. We are grateful to Victoria Romanus of the Swedish Institute for Infectious Disease Control, Ingrid Trolin of the Swedish Medical Products Agency, Anne-Marie Plesner and Peter Andersen of the Danish Statens Serum Institut, and Roger Bernier and Susan Chu of the Centers for Disease Control and Prevention for their contributions in the design and conduct of this investigation, and in the preparation and review of this manuscript.

12.) Thimerosal exposure in infants and developmental disorders: a prospective cohort study in the united kingdom does not support a causal association, Heron J, et al.
Author Affiliations: Unit of Paediatric and Perinatal Epidemiology, Department of Community-Based Medical Sciences, University of Bristol, Bristol, United Kingdom
Funding Statement: Financial support for the establishment of the ALSPAC cohort was provided by the Medical Research Council, the Wellcome Trust, the UK Department of Health, the Department of the Environment, and DfEE, the National Institutes of Health, and a variety of medical research charities and commercial companies. Funding for this study was provided by the Department of Health (Ref VIE 134/1).

13.) Early thimerosal exposure and neuropsychological outcomes, Thompson W, et al.
Author Affiliations:  From the Influenza Division and Immunization Safety Office , Centers for Disease Control and Prevention, Atlanta;
Abt Associates, Cambridge, MA;
Group Health Center for Health Studies, Seattle;
the Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care and Harvard Medical School, Boston;
Kaiser Permanente Division of Research and Vaccine Study Center, Oakland, CA;
UCLA Center for Vaccine Research, Torrance, CA;
Southern California Kaiser Permanente, Los Angeles;
RTI International, Atlanta; and
Stanford University, Palo Alto, CA.
Conflicts of Interest: Dr. Thompson reports being a former employee of Merck; Dr. Marcy, receiving consulting fees from Merck, Sanofi Pasteur, GlaxoSmithKline, and MedImmune; Dr. Jackson, receiving grant support from Wyeth, Sanofi Pasteur, GlaxoSmithKline, and Novartis, lecture fees from Sanofi Pasteur, and consulting fees from Wyeth and Abbott and serving as a consultant to the FDA Vaccines and Related Biological Products Advisory Committee; Dr. Lieu, serving as a consultant to the CDC Advisory Committee on Immunization Practices; Dr. Black, receiving consulting fees from MedImmune, GlaxoSmithKline, Novartis, and Merck and grant support from MedImmune, GlaxoSmithKline, Aventis, Merck, and Novartis; and Dr. Davis receiving consulting fees from Merck and grant support from Merck and GlaxoSmithKline. No other potential conflict of interest relevant to this article was reported.
Funding Statement: Supported by the CDC.

14.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al.
Author Affiliations: Department of Psychiatry, McGill University, Montreal Children's Hospital, Montreal, Quebec, Canada
Lester B. Pearson School Board, Montreal, Quebec, Canada
Conflict of Interest: In the United Kingdom, Dr Fombonne has provided advice on the epidemiology and clinical aspects of autism to scientists advising parents, to vaccine manufacturers, and to several government committees between 1998 and 2001. Since June 2004, Dr Fombonne has been an expert witness for vaccine manufacturers in US thimerosal litigation.
Funding Statement: None of his research has ever been funded by the industry.

15.) A population-based study of measles, mumps, and rubella vaccination and autism, Madsen KM, et al.
Author Affiliation: Danish Epidemiology Science Center, Department of Epidemiology and Social Medicine, Århus, Denmark;
Danish Epidemiology Science Center, Department of Epidemiology Research, Statens Serum Institute, Copenhagen, Denmark; and
National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta.
Funding Statement:  Supported by grants from the Danish National Research Foundation; the National Vaccine Program Office and National Immunization Program, Centers for Disease Control and Prevention; and the National Alliance for Autism Research.

16.) No effect of MMR withdrawal on the incidence of autism: a total population study, Honda H, et al.
Author Affiliations: Yokohama Rehabilitation Center, Yokohama, Japan;
Institute of Psychiatry, London, UK
Funding Statement: None declared.

18.) MMR vaccination and pervasive developmental disorders: a case-control study, Smeeth L, et al.
Author Affiliations: Department of Epidemiology and Population Health;
Department of Infectious and Tropical Diseases ;
London School of Hygiene and Tropical Medicine, London, UK;
Department of Psychiatry, McGill University, Montreal Children’s Hospital, Canada;
and Institute of Psychiatry, Kings College, London, UK
Conflicts of Interest: L Smeeth, C Cook, L Heavey, L C Rodrigues, and P G Smith have no conflicts of interest. E Fombonne has provided advice on the epidemiology and clinical aspects of autism to scientists advising parents, to vaccine manufacturers (for a fee), and to several government committees. A J Hall received a financial contribution from Merck towards research on hepatitis B vaccination in 1998. He is also a member of the Joint Committee on Vaccines and Immunisation (2002–present).
Funding Statement: The study was funded by the UK Medical Research Council. L Smeeth is supported by a Medical Research Council Clinician Scientist Fellowship.

19.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al.
Duplicate of (14)

20.) No evidence for a new variant of measles-mumps-rubella-induced autism, Fombonne E and Chakrabarti S
Author Affiliation:  Institute of Psychiatry, Department of Child and Adolescent Psychiatry, King’s College London, London, United Kingdom;
Child Development Center, Central Clinic, Stafford, United Kingdom.
Funding Statement: None declared.

22.) Neurologic disorders after measles-mumps-rubella vaccination, Mäkelä A, et al.
Author Affiliations:  Hospital for Children and Adolescents, Helsinki University Central Hospital, Helsinki, Finland
Department of Infectious Disease Epidemiology, National Public Health Institute, Helsinki, Finland.
Funding Statement: Dr Mäkelä was partially supported by a grant from Merck & Co.

26.) Measles vaccination and antibody response in autism spectrum disorders, Baird G, et al.
Author Affiliation: Newcomen Centre, Guy’s & St Thomas’ NHS Foundation Trust, London, UK;
Biostatistics Group, Division of Epidemiology & Health Sciences, University of Manchester, Manchester, UK;
Department of Child and Adolescent Psychiatry, Institute of Psychiatry, King’s College London, UK;
Behavioural and Brain Sciences Unit, UCL Institute of Child Health, London, UK;
Department of Paediatrics, John Radcliffe Hospital, University of Oxford, Oxford, UK;
School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK;
Chatswood Assessment Centre, Sydney, New South Wales, Australia;
National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK;
Virus Reference Department, Centre for Infections, Health Protection Agency, London, UK
Conflicts of Interest: MA and DB have given unpaid advice to lawyers in MMR and MR litigation. GB has acted as an occasional expert witness for the diagnosis of autism. AP receives royalties from SCQ and ADOS-G instruments. PBS has acted as an expert witness in the matter of MMR/MR vaccine litigation. All other authors have no conflicts of interest.
Funding Statement: he study was funded by the Department of Health, the Wellcome Trust, the National Alliance for Autism Research (NAAR) and Remedi. The sponsors of the study had no role in study design, data collection, data analysis, data interpretation or writing
of the report. The corresponding author had full access to all the data in the study and final responsibility for the decision to submit for publication.

Of the 18 studies that Dr. Bob declared are pharma-funded, 1 (22) is partially funded by Merck, three studies (9, 16 and 20) don't have funding statements and 1 (19) is a duplicate of (14).  That leaves 13 studies with no pharmaceutical funding whatsoever, confirmed.  I already knew this so I offered Dr. Bob the chance to rectify his "mistake":
I really do wish to thank you for answering me. In doing so, I would like to extend you the courtesy of retracting your statements that, "Most of the vaccine studies that show no link between vaccines and autism are funded by the pharmaceutical companies" and, "In fact, if you look at the 23 major studies that have shown no link, 18 of them are funded by big pharma." before I write about this.
However, instead of making the honest gesture to retract his demonstrably false statements, Dr. Bob "clarifies":
Clarification by Dr. Bob - posted on 3/10/2011

A quote from the beginning of the Fombonne study:
Since June 2004, Dr Fombonne has been an expert witness for vaccine manufacturers in US thimerosal litigation.

The qualifications I use to determine if a study is pharma-funded is 1. The research is directly funded by pharma, or 2, the researchers involved have received money from pharmaceutical companies for services rendered, or 3. The researchers in the past have had other studies funded by pharma (I'm don't think this last one applies anywhere here, but I don't remember now).

Because Dr. Fombonne has been an expert witness in defense of the pharmaceutical companies, this creates a clear financial and professional conflict of interest.

I know that none of this would matter to some of you on this board, but I think it matters to most parents in general.

And this goes both ways. Some of the doctors who HAVE found a link between autism and vaccines in their research have testified AGAINST pharma on behalf of vaccine injury claimants. I also consider that a conflict of interest in their research.
But of course!  Create an overreaching, blatantly dishonest, weasel-worded definition for what he meant; pure truthiness.  He devises an alternate rendering in order to set up the premise should "big pharma" even fart in the general direction of an investigator, he can label their study as "pharma-funded".  Even by his own tortured criteria, he can't claim that the three studies with no funding declaration are "pharma-funded" but yet he does.  He doesn't even read these studies; he doesn't know how but only knows that they don't concur with his pre-conceived notions (and his bread and butter).  How does he explain that these so-called "pharma-funded" studies' results are concordant with those that he hasn't deemed "pharma-funded"?  He can't.

As for this statement:
And this goes both ways. Some of the doctors who HAVE found a link between autism and vaccines in their research have testified AGAINST pharma on behalf of vaccine injury claimants. I also consider that a conflict of interest in their research.
It's a right load of bollocks.  His Vaccine Book is rife with "studies" by the Geiers, Wakefield, Classen, Goldman, Yazbak and Bradstreet, all with conflicts of interest, businesses that profit from "vaccine damage", and/or appearances as "expert witnesses" for petitioners in the NVICP.  Why he still considers Andy (Wakefield) a close friend and stands behind his research, not to mention Dr. Bob's own flagrant conflicts of interest.  As a DAN! doctor, he thrives on hawking "vaccines cause autism" and promoting fear about vaccines helps to keep his books, products and services selling.  He clearly has a financial and personal investment in denying the legitimacy of any studies that don't support his paradigm.

Do some authors have conflicts of interest?  Yes they do and their declarations allow the readers of their studies to properly assess their value and consider replication of other studies.  Had Dr. Bob stated that some of these authors have conflicts of interest, he would have made a factual statement, but he also wouldn't have made the same impact on the audience and I believe he knows that, which is why he defers to truthiness.  It is a predictable tactic for the deceptive "vaccine safety" party line pushers to take.  Furthermore, he only includes about half of the list of studies that cannot find a vaccine-autism association; hand-picking only those he believes he can apply his crooked standard to.

It is also worth noting Dr. Bob's dishonest/incompetent labelling of studies 3, 23, 24, 25, 27 and 29 as "commentaries".  Again, a word with a very specific meaning when referring to scientific publications.  For example, Pediatrics defines commentaries as follows:
Abstract length: no abstract
Article length: 400 to 800 words
Commentaries are opinion pieces consisting of a main point and supporting discussion. These contributions usually pertain to and are published concurrently with a specific article; the commentary serves to launch a broader discussion of a topic. Commentaries may address general issues or controversies in the field of pediatrics.
Nearly all medical/scientific journals will have a commentary or editorial section and they are rather consistent.  What Dr. Bob labelled as "commentaries" are actually reviews, systematic reviews or meta-analyses and only one actual commentary and it is positively cloddish that he either doesn't know this or is too morally bankrupt to care.  A review, as the name implies is an article that provides a more generalised, critical review of a specific topic.  They are almost always solicited and peer-reviewed in the same manner as original research.  They are very useful, mostly written by top experts in their respective fields (the quality, of course, depends upon the quality of the journal) that provide a good overview although can still be subject to author bias.  Systematic reviews and meta-analyses can be very powerful study designs as explained in this study module by The Cochrane Collaboration.  I doubt Dr. Bob has the desire to actually learn something contrary to his witless dogma by reading this, but "systematic review" in the titles of the damn studies should have tipped him off.  For him to try and pass off an Institute of Medicine - Immunization Safety Review as a commentary just begs for a rhetorical drubbing.

Dr. Bob is nothing more than a self-styled marketeer, a medico last.  He has managed to parlay some business acumen, M.D. credentials and family name into a business that obfuscates his mediocre medical skills and complete oblivion of science.  He is influencing public health and has absolutely no competence to do so.

Paediatricians need to be more proficient at countering his fabrications when both dealing with parents and confronting him in the media.  Parents' fears can be acknowledged without being validated and sadly, paediatricians have to make an effort to undo the damage that the likes of Dr. Bob have done on their own time while he makes a living off of generating fear with patently false information.

Friday, March 18, 2011

Vaccine Times: Vaccinated vs. Unvaccinated Study

Well, it seems that I finally managed to beat Vaccine Times to the publishing of a story.  But I think it's important enough that I will also post their story and a link to it here.

I have previously reported on a newish trend in anti-vaccine propaganda, the “vaccinated vs. unvaccinated study” gambit. The anti-vaccine proponents have retreated to this new position after the thimerosal, MMR-autism and other hypotheses of theirs were shown to be worthless. This …..strategy is well known to anyone with a basic understanding of logic as moving the goal post. Superficially, the request does not sound unreasonable. Why not compare the non-vaccinated with the vaccinated and see if there is any increased risks with vaccination?

To be clear, I am not against such research being done, to the limit it can practically be done. There are a few things to keep in mind though. For starters, the problem is presented by the anti-vaccine proponent as a make-it-or-break-it thing. They behave as if the mountain of evidence in support of the use of vaccines is worthless, until and unless such vax vs. unvax study is done. They also act as if the whole vaccination issue hinges upon this one study. However, nothing could be further from the reality. One study doesn’t prove anything, one way or another. We have a ton of science on vaccines, a literal mountain of scientific papers and that will no be overthrown by one study.

Secondly, the unvaccinated population is quite small and dispersed. As we will see, the German Study had over 13,000 participants, and under 100 fell into the unvaccinated category. This hinders considerably the ability to design a study that would include enough non-vaccinated children, and at the same time be able to control for the myriad factors that could affect the results.

Thirdly, this study could not be done prospectively. Current ethical standards of study design would not permit randomly assigning a large number of children not to receive vaccines, when risk of pain, suffering, and even death is so high with vaccine-preventable diseases.  That means that the only kind of study we can do is a retroactive study, looking at existing non-vaccinated populations and trying to match the control group as much as possible. That has its own pitfalls, randomization would be impossible, and the point of randomization is precisely to control for all those variables that the scientist didn’t, or can’t, think off on his own. By definition, the non-vaccinated group would be a self-selected group, which may exhibit biases or other behaviors that can affect the results in a non-intuitive way, so that it would be impossible for the researchers to control for said behaviors.

So, we are caught in a Catch 22: we cannot design a prospective, randomized, double blind test due to ethical considerations, and any retrospective studies are inherently limited due to the small numbers of unvaccinated children and the impossibility of randomization. Clearly, any results we may get will need to be analyzed carefully, taking into account all the shortcomings we just went over.

Keeping that in mind, let us look at th German Study.
Schmitz R, Poethko-Müller C, Reiter S, Schlaud M:
Vaccination status and health in children and adolescents—findings of the German health interview and examination survey for children and adolescents (KiGGS). Dtsch Arztebl Int 2011; 108(7): 99–104.DOI: 10.3238/arztebl.2011.0099

Summary – The authors utilized data collected through the German Health Interview and Examination Survey for Children and Adolescents (Kinder- und Jugendgesundheits survey, KiGGS) which collected health data on 17,641 children and teenagers aged 0-17 years of age, selected at random in 167 German locations. The data was collected over 3 years, between May 2003 and May 2006. Of these, useful data existed for 13,453 subjects which made up the study population. Any child for which no record existed showing receipt of even a single dose of vaccine was classified as unvaccinated. Any child who had received at least one dose of vaccine was classified as vaccinated. There were a total of 94 unvaccinated children and over 13,000 made up the vaccinated group.

At the time, the recommended German vaccine schedule included the DTaP, MMR, Hib, HepB, and Polio vaccines which were all included in the study. For girls 12-17 the HPV vaccine was also recommended. Lifetime prevalence calculations were done for pertussis, measles, mumps, and rubella (diseases that the vaccines protected against) and also for other infectious diseases outside of the vaccine preventable ones. Atopic (allergies) disease rates were also calculated. Prevalence rates were then compared between vaccinated and unvaccinated children.

Results -The study showed that for pertussis, measles, mumps, and/or rubella, unvaccinated children had on average triple the number of infections when compared with sufficiently vaccinated children. Specifically:
  • Pertussis: Unvaccinated 15.8% – Vaccinated 2.3%
  • Measles:   Unvaccinated 15% – Vaccinated 5.2%
  • Mumps:    Unvaccinated 9.6% – Vaccinated 3.1%
  • Rubella:    Unvaccinated 17% – Vaccinated 6.8%

Furthermore, no differences were found in rates of other infectious diseases whose burden was similar on each group, thus providing contradictory evidence to the claim that vaccines “overload” the immune system and make vaccinated children more vulnerable to other diseases. The same held true for medically diagnosed atopic disorders.

Tuesday, March 15, 2011

An interesting study of vaccinated vs unvaccinated children

A blog I follow called A Photon in the Darkness posted this.  I want to repost the entire thing for your benefit here, but please take some time to visit them and even follow them.  I will highlight something that struck me as particularly interesting/relevant.  I wonder if unvaccinated children also lead vaccinated kids in another important metric: death!?

An interesting study of vaccinated vs unvaccinated children

March 14th, 2011

Vaccinated children aren’t as sick as some people think.
The 18 February 2011 issue of Deutsches Aerzteblatt International had an interesting study [1] looking at the prevalence of allergic disease, asthma and non-specific infections (i.e. “colds”) in children ages 1 - 17. The interesting part was that they compared children who were completely unvaccinated to those who were vaccinated.

The study was carried out in Germany (some of you might have already guessed that) and looked at 13,359 children who had received at least one vaccination and 94 children who had received not a single vaccination. For those keeping score, the percentage of completely unvaccinated children was 0.7%. The subjects came from children covered in the Kinder- und Jugendgesundheitssurvey (Health Interview and Examination Survey for Children and Adolescents) carried out between 2003 and 2006.

What they found was that the unvaccinated kids led in one important metric: they had significantly more pertussis, measles and mumps than the vaccinated kids.

As for allergic disease (atopy), asthma and susceptibility to “colds”, there was no significant difference between the two groups.

So much for the “unvaccinated children have less allergic disease, less asthma and are sick less often than vaccinated kids” canard, eh?

No, I don’t actually think that the “true believers” in the virtues of communicable diseases will be convinced by this study. On the other hand, it is certainly “grist for the mill” for anyone who has an open mind.

So, what does this have to do with autism?
Now, I know that some of my faithful readers who have stuck with me through weeks and months of inactivity (’blog inactivity - I’ve been busy as heck doing other things) are wondering “What has this got to do with autism?” Well, the numbers are instructive for those who are proposing (or insisting on) a “vaccinated vs unvaccinated” study of autism. Even in Germany, which has a relatively homogeneous population, socialised medicine and centralised record-keeping, it was difficult to find very many completely unvaccinated children.
Still, the researchers managed to come up with statistically significant results, so what’s the problem? If they can do it with allergies, colds and asthma, it shouldn’t be that much of a stretch to do the same with autism, right?


Actually, no. It isn’t that easy.

Here’s the problem - problems, in fact.

First, the most obvious problem is that the small but hyper-vocal “horde” screaming for a “vaccinated vs unvaccinated” study in autism won’t be satisfied with any study that doesn’t find a correlation. We’ve seen this too many times before: a study shows no statistically significant correlation between autism and [fill in the blank] and the “horde” screams “Foul! Corruption! Conflict of interest!” etc.

To my mind, this is the single most significant reason to not do a “vaccinated vs unvaccinated” study: the only people who want one won’t be satisfied with the most probably outcome.

Secondly, there is the problem of statistical power. The statistical power (1 - β error) of a study is its probability of finding a real difference (i.e. rejecting the null hypothesis) when a real difference exists. The power of a study depends on a number of things:

[a] The α error probability threshold (often referred to as the “significance” level). This is typically set at 5% in medical and biological studies by consensus. The α error represents the probability of “finding” a difference when once doesn’t really exist. The more stringent the α error threshold, the lower the statistical power of the study will be (i.e.  the more likely it is to “find” no difference when one exists), given the same sample size.

[b] The size of the effect. When the effect is small or when there is a small difference in effect between the two groups, it is harder to detect. This should seem intuitive.

[c] The size of the sample. Because of random chance, it is always possible to select a sample from any larger group that is not representative of the group. Larger sample sizes give smaller β error, thus greater statistical power. This is because larger samples have a lower probability of being misrepresentative. For example:
If you have a bag containing 50% red marbles and 50% green marbles and only take two as your sample, there is a 50% chance that the two marbles you pick will both be the same color, giving you a false impression of the “population demographics” of the bag. If your sample is four marbles, your chance of getting all red or all green is less (12.5%).  
For the effect sizes and sample sizes used in the Schmitz et al study, the statistical power runs from 42% (allergic rhinoconjunctivitis 1 - 5 yrs) to 99% (pertussis). As expected, in the comparisons which failed to find a difference (i.e. all but the vaccine-preventable diseases), the statistical power was lower, primarily because the difference between the groups was small.

Let’s “run the numbers”!
To put this into the autism perspective, let’s “run the numbers” and see how the same samples would have fared in detecting any difference in autism prevalence between vaccinated and unvaccinated children.
If we assume that the prevalence of autism in the vaccinated population is 1% (given the small proportion of completely unvaccinated individuals in the general population - 0.7% in this study - that is a reasonable assumption), the sample in Schmitz et al is too small to detect a difference unless the unvaccinated group has a higher autism prevalence than the vaccinated group. This is because, with only 94 unvaccinated subjects and a general population prevalence of 1%, there are better than even odds that zero unvaccinated subjects would have autism, even if the prevalence was the same in both groups.

Why not just go out and beat the bushes looking for unvaccinated kids? The problem with that approach (similar to that tried in the past (and being tried today) by a number of anti-autism advocacy groups) is that the sample of unvaccinated children won’t be random.  So, what’s the problem with non-random selection? Let me explain.

In this case, soliciting for unvaccinated children, especially by or through groups researching autism or advocating for/against autism, could be expected to draw more attention from parents with autistic children. Moreover, those parents with unvaccinated non-autistic children would probably be more motivated to enter the study than those with autistic unvaccinated children. Thus, the sample would be skewed towards unvaccinated children without autism.

Possibly more concerning to those who desperately want to find a “vaccine-autism connection” is the possbility that, because they will be recruiting disproportionally among families with an autistic child, the prevalence of autism will be artificially high, even among the unvaccinated children.

The only ways to accurately determine the correlation of autism and vaccination are either to do a large random population sample (as in Schmitz et al) or to compare cases (autistic) to matched controls (non-autistic) for vaccination status.

Do want to win or do you want the correct answer?
Now, I’m sure that there are a lot of people in the “vaccines cause autism” camp that would welcome any result suggesting that vaccines cause autism, even if it was false. This is because they have confused science and sports. In sports, the most important thing (the only thing, if you listen to some fans) is winning. In science, however, the most important thing (again, some might say the only thing) is getting the correct answer.

To me, it is more important that we know whether or not vaccines cause autism than any personal preferences I have for any particular result. I may strongly suspect that vaccines don’t cause autism (based on data available to date), but I am perfectly willing to change my mind if the data go that way.

Bis später,


[1] Schmitz R, et al. Vaccination Status and Health in Children and Adolescents. Dtsch Arztebl Int (2011); 108(7): 99–104

Sunday, March 13, 2011

New Link

I received a very nice email today, and have added a new link to the links page.

At LessonCorner our goal is not only to create the best collection of worksheets and lesson plans on the web, but also to make it free. Our freemium business model allows all users to access many of the site's features. In addition, users can receive a free 1 year premium membership by sharing their lessons and worksheets with the community.
I encourage anyone who is an educator to give this site a look.  As we all know, many states are systematically limiting teacher's access to good material on teaching evolution.

Grades of 50 states and the District of Columbia evaluated on the inclusion of evolution in state science standards. The darker the state is shaded, the worse grade it received. Graphic courtesy of the National Center for Science Education.

Although, I must express my surprise at the grade Kansas got. Maybe because they have done so much dumbtardery in the past, they realize they are under scrutiny?

Thursday, March 10, 2011

Vaccine Times: Japan panel finds no link to vaccines, deaths

Vaccine Times found this, which seems to go along with everything that has been said.  Yet another study to add to the pile that already indicates that vaccines are much safer than the alternative.  It IS tragic that there were four (well seven when you add in the Netherlands cases) deaths that were in close proximity to receiving vaccines, and the age would make some sort of statistical anomaly flag go up.  However, as Lisa Simpson is fond of pointing out, correlation is not causation.  I sincerely hope that the anti-vax pro-disease nutters don't start to think this is some sort of conspiracy.

TOKYO — A panel of experts at Japan’s health ministry found no direct link between vaccines made by Pfizer Inc and Sanofi-Aventis SA and the deaths of children, but said further checks were needed, Kyodo news agency reported on Tuesday.

Japan will keep its suspension on the use of the vaccines that prevent meningitis and pneumonia, a health ministry official said after the safety panel’s meeting, but declined to comment further.

The ministry halted the use of Pfizer’s Prevenar and Sanofi’s ActHIB vaccines in response to the deaths of four children shortly after receiving the vaccines.

U.S. health officials have said they were aware of the deaths in Japan but have not seen any such safety concerns in the United States.

In February last year health authorities in the Netherlands said no relation was found between Prevenar and the deaths of three infants who had received the vaccine.

Three of the children that died in Japan were administered Prevenar together with ActHIB. In addition, three of the children also received a mixed vaccine against diphtheria, whooping cough and tetanus on the same day they received the other vaccines.

Tuesday, March 08, 2011

Anti-Vaccine stance or a cost saving device?

I am deeply disappointed in you.

Children under five were not included in this year's flu vaccination programme because of medical and not cost grounds, the government says.

 The flu epidemic is particularly bad in children, and much as I loathe to say this. I am on the side of Labour with this one (I am a Lib Dem supporter for what it's worth. Sadly...). 

I am of the opinion that this is indeed a cost cutting measure that my government has sadly put together. The reduction in advertising for the vaccine seems to correlate with the additional influx of influenza sufferers. 

Not targetting children appears on paper to be a cost saving measure since children are (for want of a better description) little buggers who run around rubbing snot on each other for fun. I know I used to do that as a kid... The flu practically has ideal conditions for spread amongst children since they tend to sit around in large groups and wipe their noses on their sleeves (again... guilty!).

I wonder if someone will calculate the price of such a decision, however in the mean time the Anti Vaccine groups have leapt on this.

Vac Truth Article

- Avicenna

Saturday, March 05, 2011

Andrew Wakefield: An Explanation from a Medical Standpoint

A doctor is inherently regarded as a trustworthy individual. The field provides legitimacy. It has real power. In a world where money rules everything the MBBS (or MD or MuDr or what ever combination of letters makes up your standard medical degree) still has a kind of immense power. People still assume we are rich (we are well paid and don’t want for much but the vast majority of doctors do not earn incredibly large salaries. We won’t starve but if we wanted to make money we would be lawyers. Or Homoeopaths)

So a doctor has legitimacy. But we are not infallible. History has repeatedly shown doctors being on both sides of the spectrum of good and bad. In order to give legitimacy to torture many Japanese and German concentration camps hired doctors to do the torture. A doctor gone wrong receives the same respect from the common man and hence is requested to such things
With this in mind we come to Mr Wakefield. No longer is a doctor but his legacy is entrenched in anti-vaccine culture. He is now the centre of a conspiracy theory his ardent defenders insisting that we have initiated a witch hunt.

That we have altered his results in order to ostracise him and denounce him. We forget that he legitimised the anti vaccine movement. Normally powered by quacks, here was a real doctor to give them a leg to stand on. Unique amongst anti-vaccine movements this is the first one to gain an incredible amount of support from the western public. We normally consider anti-vaccine theories to be the hallmark of third world nations where the rumour is powered by a lack of education and the superstitions of people.

And again we forget what a tragedy this is. Autism is not a joke. These parents are angry because we don’t yet know the cause and the pathology of the disease. So we cannot venture cures. They need a scapegoat, a villain and vaccines provided a handy moustache twirling unnatural villain filled with god knows what.
Vaccinations provide that villain. It’s part of the whole idea that organic food is somehow superior to modern agriculture.

The sheer irony of the anti-vaccine movement is that it exists because of vaccines. Only in a society where there is no fear of such disease can people stand up and say that measles is not that dangerous.

Andrew Wakefield was struck off the medical register of the GMC. The trial was well publicised and a lot of weird things come into the light. As a medical point before we begin to deconstruct his research, autism is a real disorder and occurs either as a regressive disorder where the child simply degenerates socially or as a disorder that is expressed from a really young age where the child fails to develop. Another thing to worry about is that a lot of high grade fevers can cause this kind of behaviour in babies because the brain is still developing and the fever affects it quite spectacularly.  

These are the following reasons why the study is flawed and indeed incorrect. All of these are verifiable by a variety of sources. Even by the very same natural medicine advocates who parrot anti-vaccine information.

Altered Data

  • Andrew Wakefield’s study was from a cohort of 12 children. 12 children does not make a study. A hundred children would be more appropriate study case to declare something as ground breaking as this. This is due to chance.  
  • There was no control, the individuals recruited were “people who thought their kids had mental issues after the administration of the MMR vaccine”. Normally you would see the stats of autism in a population that was being vaccinated and see if they increased or not.
  • One cannot claim a disease was caused by MMR vaccines by recruiting people whose kids had autism and have had MMR. Correlation does not imply causation.
  • Mr. Wakefield was working on a lawsuit. He was being paid a fair amount of money for his research and his role as a witness into suing MMR vaccine providers. The payments were surreptitious and heavily influenced his research as the bias was monetary and the amount worked out to nearly half a million pounds.
  • Individuals in the study turned out to have autistic like behaviour prior to the injections. In one subject the child started regression a month prior to the vaccination. This strongly indicates that either the vaccine had no effect or the MMR vaccine is capable of time travel.
  • Another child was regarded to have a behavioural anomaly in Mr. Wakefield’s paper. The secondary analysis showed that he had a chest infection as did the original hospital report
  • It is true that some of these children were autistic and Mr. Wakefield took advantage of them to run incredibly pointless and invasive procedures as he attempted to link both the autism and the bowel disorders to the vaccine. These included spinal taps and colonoscopies.
  • In many cases parents were not adequately interviewed. One mother claimed the child developed symptoms immediately. Under review, immediately turned out to mean 6 months. Many of the other parents indicated that their children had suspected developmental disorders prior to this but were unsure of them. Not all children develop at the same age and many children often miss developmental stages quite normally. This mother was already of the belief that vaccines caused her child’s autism and so was manipulated to provide a false testimony that came apart under more rigorous questioning. 
  • Under heavy GMC scrutiny the patients were reviewed via looking through the primary diagnosis of various hospitals. Of the 12 strong cohort only one had regressional autism. The rest were not regressive autism but classical autism. 3 out of the 12 didn’t even have either regressional autism or bowel disease. The individual with regressional autism suffered it a full 6 months after the vaccine. There is therefore a severe misrepresentation of data.
  • Two of the children were brothers who exhibited fits and bowel disorders (common in convulsions). The older was not thought to have autism, the younger was regarded to have Asperger’s syndrome. Brothers would have ruled them out in the study because it would have brought up a genetic element. In addition fits are not regarded to be a behavioural disorder as the child’s behaviour is often normal. A lot of these children’s behaviours can be attributed to the frustration and the pain brought on by the convulsions and bowel issues which were alleviated on defaecation only to return within a day.  
  • When you write a prescription or a request for a test, you often specify what your conditional diagnosis is. For eg. If an individual arrived with drooping eyelids and facial weakness, I would write “Bell’s palsy?” or “Myasthenia Gravis?” Followed by what tests I would wish to run. Andrew Wakefield deleted the question marks turning conditional diagnosis into an actual one. Tampering with diagnosis files is a serious breach of trust.
  • All the recruitment of his cohort was done via anti MMR campaigns with the promise of a class action lawsuit against MMR manufacturers.
And these are just issues of what he did wrong research wise notwithstanding the serious allegation that his so called control were children at his son’s birthday party.

So it’s not merely a case of “he is wrong because it’s nuts” but a case of him being wrong because his research is incredibly faulty or worse biased on purpose in order to make money at the cost of a pharmaceutical company. His research is incredibly flawed even without the onus of the money.

We blindly panicked. No one stopped to think for a second how the individual vaccines never caused this issue but the combined one did.

Lest we forget, even vaccines do have side effects. Almost all medication does. It’s a cost benefit analysis that we can save countless amounts of money and grief by taking a small risk now than a huge risk with the actual disease. Post publishing the UK’s inoculation rate dropped to around 75% and we started seeing outbreaks of Measles, Mumps and Rubella in the population.

Vaccination has always provided people with the cheapest and most effective way of controlling a disease. Mr. Wakefield is responsible for some of the deaths and permanent injuries due to his lackadaisical attitude to medicine and his greed as are the people who funded him

- Avicenna.