Over Here & Over There By F. Edward Yazbak , MD , FAAP

For many U.S. parents of children lost to regressive autism, February 9, 2004 was a Day of Infamy. On that fateful day, the ninth meeting of the Immunization Review Committee of the Institute of Medicine (IOM) was held. One hour of the meeting was spent on the review of MMR-autism related research and six hours were spent on the Thimerosal issue.

On May 18, 2004 a press release proclaimed that “ MMR Vaccine and Thimerosal-Containing Vaccines Are Not Associated With Autism”.

“ Based on a thorough review of clinical and epidemiological studies, neither the mercury-based vaccine preservative thimerosal nor the measles-mumps-rubella (MMR) vaccine are associated with autism, says a new report from the Institute of Medicine of the National Academies. Furthermore, the hypotheses regarding how the MMR vaccine and thimerosal could trigger autism lack supporting evidence and are theoretical only. Further research to find the cause of autism should be directed toward other lines of inquiry that are supported by current knowledge and evidence and offer more promise for providing an answer.” http://www.iom.edu/report.asp?id=20155

On May 11, 2005 , I wrote to IOM President Harvey V. Fineberg, MD, PhD, respectfully requesting that he withdraw the report of the Immunization Safety Review Committee Meeting 9 of February 9, 2004, f orm a new committee under a new chairman and reconvene a meeting on vaccines and autism as soon as possible in order to ensure that all independent research is reviewed and considered. (1)

Fineberg never bothered to answer me.

To others he stated “The Immunization Safety Review Committee produced eight reports over the course of 3.5 years on vaccine safety-related topics. A list of the topics is available online at: http://www.iom.edu/imsafety. The IOM conducted this work at the request of the Centers for Disease Control and Prevention and the National Institutes of Health. The scope and sponsorship of the committee is, and has always been, a matter of public record. Other than publicly posing the scope of study to the committee and delineating the specific hypotheses to be explored, the sponsoring agencies had no relationship with the committee other than when invited to present scientific information to the committee, either in public sessions or in written submissions that were placed in a publicly available file.”

http://www.safeminds.org/pressroom/press_releases/2005-07-01-IOM-Response.pdf

The undeniable fact is that the shameful conclusions of Meeting 9 of the IOM Immunization Safety Review Committee could have been safely predicted in January 2001, when the very first meeting was held. http://www.nomercury.org/iom.htm

During the closed session of the 2001 meeting, Chairperson McCormick stated among other things “[CDC] wants us to declare, well, these things are pretty safe on a population basis” and “…we are not ever going to come down that it is a true side effect”

Kathleen Stratton , Ph.D ., an IOM Staff member and Study Director of the Immunization Safety Review Committee stated at the same closed meeting “We said this before you got here, and I think we said this yesterday, the point of no return, the line we will not cross in public policy is to pull the vaccine, change the schedule. We could say it is time to revisit this, but we would never recommend that level. Even recommending research is recommendations for policy. We wouldn't say compensate, we wouldn't say pull the vaccine, we wouldn't say stop the program.” http://www.nomercury.org/iom/iom.pdf

After review of available data and research, committees of the Institute of Medicine usually reach one of the following five conclusions:

1. No evidence bearing on a causal relation.

2. The evidence is inadequate to accept or reject a causal relation.

3. The evidence favors rejection of a causal relation.

4. The evidence favors acceptance of a causal relation.

5. The evidence establishes a causal relation.

During the same January 2001closed meeting, Stratton said “Chances are, when all is said and done, we are still going to be in this category.”

Thus the study director made it crystal clear and from the very first meeting: There will never be a change of classification and there will never be evidence to accept a causal relationship between vaccines and regressive autism. Never!

For three and half years, the committee spent a lot of money and may have appeared to be “examining the evidence” but in fact the conclusions of the February 9, 2004 meeting that were announced on May 18, 2004 were reached, very obviously, in January of 2001.

There is a very good chance that an encore is starting to be played across the pond.

In a lead article in the Telegraph on Sunday June 18, 2006, titled “ Ministers agree to MMR autism inquiry” Beezy Marsh reported that “ An inquiry into whether the MMR jab has caused autism and bowel disorders in children is to be launched by the Department of Health… It is understood that David Salisbury, the Head of Immunisation and a passionate defender of MMR, gave the green light to the Department of Health to launch the study”. (2)

Having the United Kingdom Department of Health order an inquiry and research into the MMR-Autism connection at this late stage is as promising as having the CDC fund Madsen and other Danish researchers to look into MMR and autism and then include a CDC epidemiologist as a co-investigator/author.

Expecting an unbiased opinion in London from an inquiry board commissioned by the DOH would be as likely today as having Madsen and Co decreeing in 2003 that MMR did indeed cause autism in Danish children.

Calling David Salibury a passionate defender of MMR is somewhat of an understatement. Since 1998, Salisbury not only “defended” the MMR [and ruled out the use of the single vaccines] but he actually joined Brent Taylor and Elizabeth Miller in the original Anti-Wakefield Tag Team.

In December 2000, Wakefield and Montgomery published “ Measles, mumps, rubella vaccine: through a glass, darkly” in the Adverse Drug Reaction and Toxicology Review.

On January 22, 2001 , the Independent published an article entitled "MMR Scare Is Based On Flawed Research: The case for MMR" by the then head of the immunization program of the Department of Health David Salisbury. The Independent also published a reply by Andrew Wakefield in the same issue.

At the time, I wrote a point by point response to Salisbury 's allegations. (3)

Salisbury : "Dr Wakefield is on a crusade. In the past, he has asserted that the measles vaccine causes bowel disease and linked MMR to autism, and now that MMR was licensed without proper safety studies."

Yazbak: True so far.

Salisbury : "Before we look at his recent claims, we need to remember that he has been wrong before"

Yazbak : When? Where?

Salisbury : "and his views have no support from experts in vaccines."

Yazbak : One must qualify ‘experts on vaccines'; Is Dr. Salisbury referring to the body of professionals who have conflicts of interest (on the vaccine manufacturers' payrolls) or those who wish to preserve the status quo, because of fear of losing face. The experts who reviewed Dr Wakefield's article before publication certainly seemed impressed.

Salisbury : "We also need to recognize that this is not a problem faced by the UK alone. MMR is used all over the world"

Yazbak : This statement will not convince concerned parents that the MMR is safe.

Salisbury : "and it is likely that the US , Canada , Australia and other countries made their decisions on the same data. So were they all wrong?

Yazbak: It is certainly possible that they were and are all wrong, and that these governments based their support of this vaccine on ‘safety' studies funded by the vaccine's manufacturers or the vaccine authorities and which did not look at long-term autoimmune effects.

Salisbury : "or is Dr Wakefield wrong?"

Yazbak: No serious, convincing evidence so far has proved Dr Wakefield wrong.

Salisbury : "The evidence points to MMR having an excellent safety and efficacy record in use, with hundreds of millions of doses used."

Yazbak: Both Dr. Wakefield's and my studies ("An Unconvincing Finnish Study") have shown why the government touted studies should not be taken seriously in reference to autism and IBD.

Salisbury : "In his new paper, Dr Wakefield appears not to know the facts, and fails to report all the evidence. He gives the wrong dates when vaccines were licensed, he misleads readers over just how long follow-up studies really took place, and he uses wrong statistical analyses."

Yazbak: One date, 30 years ago, is in question. The first MMR vaccine was licensed in 1971 in the United States . The vaccine now used, the MMR II was released several years later. The two follow up studies mentioned by Dr Salisbury were never published or peer-reviewed. Criticizing the statistical methods used by Dr Montgomery is simply naïve.

Salisbury : "He raises scares about MMR safety, such as possible problems from giving three viruses together."

Yazbak: Dr. Salisbury should have an old pediatrician describe to him how ill a toddler with measles, chickenpox and roseola all at the same time can be. He also should show us evidence that combining the three live virus vaccines in MMR is safe. It is the lack of such evidence that is causing the present crisis.

Salisbury : "Here he uses the example of the rare but terrible brain-damaging condition SSPE that results from measles – possibly made worse if another infection occurs with it. But the evidence is clear: measles vaccine protects against SSPE, and U.S. and U.K. data show the condition became even rarer after the switch to MMR. Parents should be reassured that even if this scare had a theoretical basis, in reality the evidence supports MMR."

Yazbak: Dr Salisbury should ask the thousands of parents of children with autism if they would have rather taken their chances with measles and its extremely rare SSPE complication. He should speak to a family whose life has changed because of MMR. Besides as he said "Measles vaccine protects against SSPE". All that parents want is the “measles vaccine” . They should be given that choice.

Salisbury : "When Dr Wakefield sent us his paper challenging MMR safety we asked our two independent expert committees to review it. The Joint Committee on Vaccination and Immunisation concluded that "reports from Dr Wakefield's group did not give grounds for concern over the safety of the vaccine", and noted inconsistencies, the lack of rigorous logic and the failure of confirmation by a wide range of independent investigators. The committee concluded that the analyses carried out by Drs Wakefield and Montgomery were intrinsically flawed." The Committee on Safety of Medicine also looked at the paper, especially to check that the licensing had been sound. It concluded that the process was properly conducted and that the licensing followed normal procedure and was based on robust studies"

Yazbak: I would like to challenge Dr Salisbury to name ONE researcher other than Dr Wakefield who would have given the vaccine authorities such a long advance notice to have them prepare for his paper's fall-out. Dr Wakefield deserves gratitude for doing so, not criticism. As far as the reaction of the members of the committees to Dr Wakefield's paper, it was exactly as expected. None of them was likely to "break ranks" and risk losing his or her job.

Salisbury : "Dr Wakefield wants more research. Independent researchers have not replicated his studies on vaccines across the world."

Yazbak: That is absolutely correct. "Independent researchers have not replicated his studies on vaccines across the world." If they had, they would have found ileal-lymphoid-nodular hyperplasia in children with autism and would have isolated persistent measles virus from vaccine in their gut wall. Thousands of parents of children with autism have asked for more research. To date none was ordered and instead millions of pounds are allocated to an MMR propaganda campaign.

Salisbury : "In Japan , measles and rubella vaccines are given separately. From 1992 to 1997, there were 79 deaths from measles. Here, there were none."

Yazbak: The number of deaths from measles in Japan is of significance ONLY if it can be proved that every island and every hamlet in Japan was perfectly well vaccinated with the single measles-antigen vaccine and that the victims were otherwise healthy and had no other serious concomitant illnesses. Japan eliminated the MMR because of thousands of serious reactions. Of the 3,969 medical compensation claims relating to vaccines in the last 30 years in Japan , one quarter had been made by those badly affected by the measles, mumps and rubella vaccine.

In fact, the Japanese experience with the MMR is the ONLY epidemiological study we MUST believe . Dr Hiroki Nakatani, director of the Infectious Disease Division at Japan 's Ministry of Health and Welfare said that giving individual vaccines cost twice as much as MMR, 'but we believe it is worth it'". It is tragic to hear that there were 25 deaths a year from measles in Japan, but this is not because the measles rather than the MMR vaccine is used there. Significant outbreaks of measles are occurring in many countries where MMR vaccination is nearly 100%.

There are thousands of children with autism in the western world. NO ONE has given the parents—who witnessed their perfectly developing child slide into autism, bowel disease and immune dysfunction after their MMR—proof that the MMR is not responsible for their children's tragedy.

Entire families lives are being ruined while the vaccine authorities are playing this media game.

Salisbury : "Yet Dr Wakefield wants us to risk children's lives without a shred of evidence. Children's health is too important to become a victim to his crusade."

Yazbak : The lives of children in the UK are at risk BECAUSE of the vaccine authorities' illogical stubbornness, not because of Dr Wakefield. To the parents who are asking for a choice the authorities are saying "No, it is either the MMR or nothing". This is a dangerous gamble.

Children's health is too important indeed.

Finally, the following statement by the vaccine manufacturer should be noted: "If the prevention of sporadic measles outbreaks is the sole objective, revaccination with a monovalent measles vaccine should be considered" (PDR 2000, page 1748).

***

On January 23, 2001, it was revealed that A Peter Fletcher, MB BS PhD, a former
Principal Medical Officer in the Medicines Division of the Department of Health, a former Medical Assessor to the Committee on Safety of Medicines and one of the reviewers of the Wakefield/Montgomery paper had stated: "With all the benefits of hindsight … Being extremely generous, evidence on safety was very thin. Being
realistic there were too few patients followed up for insufficient time.
Three weeks is not enough… Did the available evidence on the trivalent vaccine support the belief that benefit would outweigh risk? On the basis that effective monovalent
vaccines were available the CSM could be confident that delay in granting a
license would not result in a catastrophic epidemic of measles, mumps and
rubella...The granting of a Product License was premature."
http://www.whale.to/v/mmr16.html

More recently, the authors of the 2005 MMR Cochrane Review stated in their press release “In a process of ‘systematic reviewing' researchers searched international databases and found 139 articles about MMR use. Because many of them referred to studies that had been conducted in a way that could not rule out bias or error, the researchers discarded all but 31 of them. Using rigorously established methods, the researchers then synthesized the findings from these pieces of higher-quality research to create the most authoritative assessment yet available.”

In their abstract, the authors concluded “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate...”

***

Fast-Forward to 2006

Wakefield 's MMR-Autism research has been duplicated.

Similar gastro-intestinal findings have been identified, the presence of vaccine-strain measles virus genomic RNA in the gut and cerebrospinal fluid has been confirmed and serological evidence of vaccine involvement abounds.

An honest inquiry and an open-minded review can and should easily verify all that.

Whether it will be allowed to do so, is another story.

References

  1. F. E. Yazbak Withdraw the Report of the February 9, 2004 IOM Immunization Safety Review Committee Meeting 9: Vaccines and Autism http://www.taap.info/Fineberg.pdf
  2. B. Marsh, Ministers agree to MMR autism inquiry, The Telegraph- Filed 18/06/2006 . Available at http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2006/06/18/nmmr18.xml
  3. F. E. Yazbak. Dr. Salisbury: You Are Wrong On Every Point. January 26, 2001 Available at http://www.whale.to/v/yazbak1.html

 

F. Edward Yazbak , MD , FAAP

TL Autism Research

Falmouth , Massachusetts , USA

June 2006

 















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