steveh_131
Grandmaster
I came across an interesting study from 1999.
Thomas Verstraeten brought this report to the CDC. The original research paper read as follows:
I later found out that this study was not published in this form. It was published several years later, in 2003. The 2003 revised version was substantially different:
This piqued my curiosity. What happened between 1999 and 2003 that caused a complete reversal in the results of this study? This is what I found:
3. Some interesting emails took place between several of the researchers discussing how changes in the research criteria yield different results.
4. Safe Minds did an analysis of the data discrepancies, the changes that took place in the statistical analysis and how it affected the outcome.
5. Dr. Verstraeten, the lead researcher had an interesting career change. In between the time of his first analysis of the data and his final published data, he went to work for one of the main vaccine manufacturers: GlaxoSmithKline.
Thomas Verstraeten brought this report to the CDC. The original research paper read as follows:
Methods: We categorized the cumulative ethylmercury exposure from thimerosal containing vaccines after one month of
life and assessed the subsequent risk of degenerative and developmental neurologic disorders and renal disorders before the
age of six. We applied proportional hazard models adjusting for HMO, year of birth, and gender, excluding premature babies.
Results: We identified 286 children with degenerative and 3702 with developmental neurologic disorders, and 310 with renal
disorders. The relative risk (RR) of developing a neurologic development disorder was 1.8 ( 95% confidence intervals [CI] :::
1.1-2.8) when comparing the highest exposure group at 1 month of age (cumulative dose> 25 ug) to the unexposed group.
Within this group we also found an elevated risk for the following disorders: autism (RR 7.6, 95% Cl = 1.8-31.5), non organic
sleep disorders (RR 5.0, 95% Cl = 1.6-15.9}, and speech disorders (RR 2.1, 95% (1=1.1-4.0). For the neurologic degenerative
and renal disorders group we found no significantly increased risk or a decreased risk.
Conclusion: This analysis suggests that high exposure to ethyl mercury from thimerosal-containing vaccines in the first month
of life increases the risk of subsequent development of neurologic development impairment, but not of neurologic degenerative
or renal impairment. Further confirmatory studies are needed.
I later found out that this study was not published in this form. It was published several years later, in 2003. The 2003 revised version was substantially different:
METHODS: A 2-phased retrospective cohort study was conducted using computerized health maintenance organization (HMO) databases. Phase I screened for associations between neurodevelopmental disorders and thimerosal exposure among 124 170 infants who were born during 1992 to 1999 at 2 HMOs (A and B). In phase II, the most common disorders associated with exposure in phase I were reevaluated among 16 717 children who were born during 1991 to 1997 in another HMO (C). Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 micro g of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life.
RESULTS: In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.05-3.38). At HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13; 95% CI: 1.01-1.27) and 7 months (RR: 1.07; 95% CI: 1.01-1.13). In phase II at HMO C, no significant associations were found. In no analyses were significant increased risks found for autism or attention-deficit disorder.
CONCLUSIONS: No consistent significant associations were found between TCVs and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes. For resolving the conflicting findings, studies with uniform neurodevelopmental assessments of children with a range of cumulative thimerosal exposures are needed.
This piqued my curiosity. What happened between 1999 and 2003 that caused a complete reversal in the results of this study? This is what I found:
- A clandestine meeting took place in 2000. It involved members of the CDC, WHO Vaccine division, FDA, and representatives from the various vaccine manufacturing companies. There is a complete transcript available, thanks to the Freedom of Information Act. A few pertinent quotes:
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Dr. Verstraeten - "Now it turns out that other people also thought that this study was not the right thing to do, so what I will present to you is the study that nobody thought we should do.”
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Dr. Bernier (NIP - National Immunization Program of the CDC) - "We have asked you to keep this information confidential. We do have a plan for discussing these data at the upcoming meeting of the Advisory Committee of Immunization Practices on June 21 and June 22. At that time CDC plans to make a public release of this information, so I think it would serve all of our interests best if we could continue to consider these data. The ACIP work group will be considering also. If we could consider these data in a certain protected environment. So we are asking people who have a great job protecting this information up until now, to continue to do that until the time of the ACIP meeting. So to basically consider this embargoed information. That would help all of us to use the machinery that we have in place for considering these data and for arriving at policy recommendations."
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Dr. Clements (WHO Official Representing the Expansion of their Vaccine Program) - "And I really want to risk offending everyone in the room by saying that perhaps this study should not have been done at all, because the outcome of it could have, to some extent, been predicted, and we have all reached this point now where we are left hanging, even though I hear the majority of consultants say to the Board that they are not convinced there is a causality direct link between Thimerosal and various neurological outcomes."
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Dr. Clements - "So I leave you with the challenge that I am very concerned that this has gotten this far, and that having got this far, how you present in a concerted voice the information to the ACIP in a way they will be able to handle it and not get exposed to the traps which are out there in public relations. My message would be that any other study, and I like the study that has just been described here very much. I think it makes a lot of sense, but it has to be thought through. What are the potential outcomes and how will you handle it? How will it be presented to a public and media that is hungry for selecting the information they want to use for whatever means they in store for them?"
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Dr. Bernier - "I don’t think we can set a rule here because some people have gotten these documents. For example, some of the manufacturers were privileged to receive this information. It has been important for them to share it within the company with the experts there, so they can review it. Some of you may have questions. You may have given a copy, but I think if we will all just consider this embargoed information, if I can use that term, and very highly protected information, I think that was the best I can offer."
2. Dr. David Weldon, a member of the U.S. House of Representatives, wrote a letter describing some of what took place. Some interesting quotes:
[*=1]The actions of the CDC regarding their November 3, 2003, article in
Pediatrics raise serious concerns about the objectivity of the CDC’s top
vaccine safety officials and the value of their input on this issue.
[*=1]On the day the Pediatrics study was released, a top CDC researcher and a
coauthor of the study was quick to declare in news articles that appeared
across this nation, "The final results of the study show no statistical
association between thimerosal vaccines and harmful health outcomes in
children, in particular autism and attention-deficit disorder."
Unfortunately, the study does nothing of the sort, and when called to account
eight weeks later, this CDC official was forced to recant. When asked if the
children in the study were too young to have received an autism diagnosis,
this coauthor stated that yes they were too young. He went on to admit that
the study also likely mislabeled young autistic children as having other
disabilities thus masking the number of children with autism. There are a
host of other flaws in the study that are raised in the attached articles and
letters to Pediatrics, which I urge you to personally review.
[*=1]It appears to me not only as a Member of Congress but also as a physician
that some officials within the CDC’s NIP may be more interested in a public
relations campaign than getting to the truth about thimerosal. At present, I
have lost confidence in the ability of officials at the CDC to give an honest
evaluation of the matters at hand. It is not just me raising these concerns
about public confidence, but also Dr. Neal Halsey who in his letter conveys
his concerns about loss of confidence in the NIP.
3. Some interesting emails took place between several of the researchers discussing how changes in the research criteria yield different results.
4. Safe Minds did an analysis of the data discrepancies, the changes that took place in the statistical analysis and how it affected the outcome.
5. Dr. Verstraeten, the lead researcher had an interesting career change. In between the time of his first analysis of the data and his final published data, he went to work for one of the main vaccine manufacturers: GlaxoSmithKline.