CDC Whistleblower

By Eben Plettner - 9/1/2014 11:37 EST

This article is to provide facts surrounding the recent revelations by the CDC whistleblower and to analyze the released documents.

Senior CDC scientist Dr. William Thompson hired a well known whistleblower law office and released a statement on August 27th, 2014 revealing CDC has seen and then omitted data that suggested a “significant risk” of autism in African American boys due to MMR vaccine before 36 months. He also comments on the study protocol not being followed and there is also the question of who made the “Decisions” about which findings to report. There are wide ranging implications to this including the validity of statements made by senior CDC officials in front of congress, under oath, claiming that they never saw a link between vaccines and autism.

The statement also acknowledges that congress is bound to get involved as he has already met with congressman Posy of Florida who is the author of HR.1757 "Vaccine Safety Study Act" 

I am providing information to Congressman William Posey, and of course will continue to cooperate with Congress.“

Whenever congress gets involved you never know what will happen but it will get messy. Already support from several other congressmen/women has been expressed and this is a huge boon for Posey as HR.1757 had a very low chance of getting out of committee and as congressmen join him that increased greatly. The purpose of the bill is

To direct the Secretary of Health and Human Services to conduct or support a comprehensive study comparing total health outcomes, including risk of autism, in vaccinated populations in the United States with such outcomes in unvaccinated populations in the United States, and for other purposes.

The rest of Dr. Thompson's statement states that he would feels vaccinated are safe and that his family is vaccinated. Again that may be tempered by earlier recorded statements he made. That brings up his recorded statements.


DR THOMPSON ON TAPE

During 10 months of conversations with Dr. Brian Hooker many voice recordings of Dr. Thompson were made showing his guilt in not bringing this forward sooner. There is a whole series of recordings on how there is TOP down pressure to make the data work and Dr. Thompson expresses extreme remorse and guilt for his actions and for not coming forward sooner.


“Oh my God, I did not believe that we did what we did, but we did. It’s all there… This is the lowest point in my career, that I went along with that paper. I have great shame now when I meet families of kids with autism, because I have been part of the problem."

Dr. Thompson also talk extensively about  the CDC the ts lost the CDC muchop down pressure on researchers in not find "associated" effects of vaccines and how these last ten years could have been used researching improvements.


 “We’ve missed ten years of research because the CDC is so paralyzed right now by anything related to autism. They’re not doing what they should be doing because they’re afraid to look for things that might be associated.”


On Tuesday September 3rd 2014 text messages between Dr. William Thompson and Dr Andrew Wakefield were released that show Dr. Thompson of the CDC apologizing to Dr. Wakefield. This looks to be Dr. Thompson of the CDC claiming that the hidden data could have vindicated him. 



<-- Stay tuned. More to come -->



SUPPORTING DOCUMENTS

Some documents were allegedly obtained from Thompson and through Freedom Of Information Act (FOIA) requests, some required the help of congressman Daryl Issa as the CDC did not want to release “restricted” data. These documents show serious concern and possible illegal activity.

In 2002 when a US Department of Justice (DOJ) request for information regarding MMR, Thimerisol and autism. Dr. Thompson sent an email to Dr. Melinda Wharton, CDC Director of the Epidemiology and Surveillance Division at the time,  talking about “sensitive result” they were having with the MMR/Autism study. And references

some potential sensitive legal issues”

He goes on to sate that he will provide everything he thinks is appropriate before the final paragraph where he states many serious concern and hints at highly unethical if not illegal activity. When a paragraph starts “I don't think anyone has broken the law but”, something almost always being hidden. It goes on to list several major concerns.

  1. Dr Coleen Boyle testifying before congress regarding MMR and autism

  2. Legal issues regarding MADDSP MMR/Autism study

  3. NCBDDD lawyer proving Dr. Coleen Boyle guidance on what to submit

this was bad enough for him to hire his own lawyer and suggest in writing that he was considering removing him name from the study.

What could these “legal issues” regarding the MMR autism study be? It seems clearer now that Dr. Thompson released his statement about data manipulation, but is there more? That was in 2002.

The next document is a handwritten note on a document from January 28, 2004. It was written by Dr. Thompson and says

IOM Presentation – Unresolved Issues

    1) what should we do about race effect ??

      - Shows large effect for blacks and

      no effect for whites”


The Institute of Medicine (IOM) meeting is he is referring to is at the National academy of sciences and is with the Immunization Safety Review Committee there. At this meeting Dr. Thompson was to present the results of the MMR Autism study. This meeting so bothered Dr. Thompson that he wrote a memo to Dr. Gerberding, the head of the CDC at the time. He talks about how he is suppose to present “several problematic results relating to statistical associations between the receipt of MMR vaccine and autism”.

He then goes on to say he has been talking to people in the National Immunization Program (NIP) about multiple requests from representative David Weldon and has been disappointed by the answers. Remember he is talking to his bosses boss and stating his disappointment with the descriptions. He continues to say that he has presented the material to Steve Cochi and Melinda Wharton (from the other email) and says in a cryptic manner that the science needs advocates to get the “real” message to the people.

Dr. Thompson obviously had serious concerns of presenting before representative David Weldon concerns are addressed.

Imagine for a minute writing your bosses boss and saying what Thompson did, it could easily be taken as he is admonishing her.

" I believe it is your responsibility and duty to respond in writing  ..... and make those letters public" 

He goes on to hint that the leadership was putting politics ahead of the science.

"This is not the time for leadership to act politically. It it a time for our leadership to stand by their scientists and do the right thing."

He was promptly replaced as the presenter at the IOM meeting (February 9th, 2004) that was only 7 days after this memo is dated. Dr. Gerberding did not respond to Representative Weldon before the IOM meeting either, so it is easy to assume that the CDC leadership did not stand by it's scientists. 

INSTITUTES OF MEDICINE

The IOM presentation of the data to be published and some of the numbers were elevated for the "Total Sample (all children), This was compared to the sample of "GA Birth Certificate Sample" which was the set that excluded children. In the "Total sample" group there are elevated numbers as seen in the highlighted numbers on pages 29 and 31,


In the 
"GA Birth Certificate Sample", pages 30 and 32, the increase is not “statistically 

significant”. You may notice that some of the numbers are just as high as in the Total sample, but the reduction of participants means an even higher number is needed to get to "statistically significant". This could be used in any college statistics class as a common example of how to make statistics lie.

One thing missing from this is the breakdown by race. you can see a higher significance with boys than girls, but no slides on race. The original proposal for this study has race listed as the only variable so why was it not presented?

The most disturbing thing is that they showed a possible “significant” risk of autism if the MMR vaccine if it was given before 36 months and presented it to the IOM with differences in sub types. Then they said, this goes away if we exclude this group. At the very least you would expect the CDC to do a follow up study to see if they found the same relationship, but instead they made up a quick assumption to validate their “new” findings.

I don't know what to say...This is the 

vaccine safety group, CDC, the government. How did that go 'Oh we found a link with autism but we also found a way to ignore it'.

The assumption they used to negate any elevated numbers was that parents of children with autism rushed out to get their children vaccinated for a special needs school. The problem is that you only see the effect for boys, so only the parents of boys with autism rushed out? The parents of girls with autism did not ? A deeper look into the data finds it was only for African American boys.


Another interesting thing in the IOM is on pages 31 and 32 where they separated the autistic children a few ways. The first two rows are “pre-existing”(from birth) and regressive autism 
and notice the regressive autism group has elevated numbers. 
Then they separated on who did (with) and did not(without) have Mental Retardation (MR). You may notice that the group of children with autism without MR have a more elevated number. As a side note, the difference in sample size between the total group and birth certificate group plays a lot into the numbers, cutting the sample size in half resulted in several risk factor being larger but due to the small size they were diluted. All these doctors would have known of and seen this effect. They would have seen that the larger sample size with 248 children a 2.45 risk factor was significant, but in the smaller sample, 132 children, a 3.55 was not. 

This should beg the question what if you looked at the children with regressive autism that did not have MR! But it sure looks like they did not want to find something...

In the end the IOM approved the set with no birth certificates and the paper was promptly published. By promptly I mean that same month. The Journal of Pediatrics would have had no time to peer review, they trusted the CDC and IOM.


OMNIBUS AUTISM FINDINGS

With the paper published the CDC claimed no link to autism. This paper was central in the VICP Omnibus which resulted in thousands of cases of autism being rejected from the vaccine injury compensation program. In fact, any question to the reliability of this study should call for a complete reevaluation.


BROKEN PROTOCOL

In Dr. Thompson's official statement he mentioned the protocol not being followed. He said “I believe that the final study protocol was not followed”. The protocol Dr. Thompson is talking about is the research protocol that is first defined in a proposal before a study is begun. That has to outline the What, Where, When, Why, and How of the study and is not to change.

- Hypothesis, what the questions are

- How they are going to collect the data,

- What data they are going to use,

- Where they're getting it from,

- statistical analyses method to be used


Failure to follow the protocol invalidates a study. Changing the protocol after the data is collected and analyzed strongly suggests they did so to hide what they had found.  If these claims do prove to be true, and there is a lot more analysis needed before that happens, it could call into question the nine other studies cited by the CDC as evidence denying a link between vaccines and autism.

This has caused a lot of attention from many people, reporters and even congress.
Through all this it does seem that Dr. Thompson is mainly concerned with making sure the science is done correctly and to have the CDC further research these “sub-types” they have talked about. His concern is evident in one statement he made.

"we've missed ten years of research because the CDC is so paralyzed right now by anything related to autism. They're not doing what they should be doing because they're afraid to look for things that might be associated."



WIDE RANGING IMPLICATIONS
These allegations and documents may even lead to legal charges if proven true as several senior CDC officials have made statements in front of the House of Representative's Oversight committee, under oath, claiming that they never saw a link between vaccines and autism. Some of these statements have been made by people that were involved with or approved this study, including Dr. Coleen Boyle and Dr. Gerberding. Dr Boyle was an author on the paper in question so it would be highly unlikely that she would not have been well aware of the original findings. As for Dr. Gerberding, the document above where Dr. Thompson talks about the "problematic" results shows she was well aware of the report, but whether she was aware what the "problematic" results were will require additional investigation. 


OTHER STUDIES “MANIPULATED”

The MMR vaccine is not the only one Dr. Thompson says was suppressed and “manipulated”. He reveals in the recordings that another study was altered. This one was studying the effect in infants to thymerisol (mercury) containing vaccines given to pregnant mothers. Dr. Thompson says that a serious connection to tics and “autistic-like behavior” was found and hidden. This was so hard to hide that several journals rejected the article when peer reviewing it with harsh complaints. In the tapes Dr. Thompson believes so strong in the problem that he even suggested a mantra for Dr. Hooker and Focus Autism. Yes that would be a senior CDC vaccine researcher giving an autism group a mantra to go after the CDC!

Thimerosal from vaccines causes tics. You start a campaign and make that your manta.”

The original manuscript put forward internally in the CDC by Barille and Thompson looking into thimerosal and pregnant women stated the following regarding the mercury containing preservative thimerosal and tics

In light of these findings, the researchers conclude that greater exposure to thimerosal from vaccines is potentially associated with an increased risk for the presence of tics in boys between he ages of seven to ten.”

and

The study also found that for girls, higher prenatal exposure to thimerosal was associated with higher tic counts during the assessment period.”

Dr. Thompson goes on to explain that when this was submitted to the CDC for clearance the entire manuscript was rejected due to these admissions. Dr. Ed Trevathan, director of the CDC's National Center for Birth Defects and Developmental Disabilities at the time, recommended that the manuscript not be published in an email on April 25, 2009. The paper was then given to Dr. Jonathan Mink of the University of Rochester Medical Center, a tic expert, and he was paid by the CDC to state the paper's conclusions were:

This finding [regarding tics] should be interpreted with caution due to limitation in the measurement of tics and the limited biological plausibility regarding a causal relationship”

Thompson says he was under tremendous pressure from top CDC officials to absolve thimerosal at all costs and was told to run and rerun the analyses to remove any connection between thimerosal and tics. This was not the only or the first time the CDC publish a paper relating thimerosal to tics either. Three other CDC publications already reported an association between thimerosal exposure early in life and tics.

Verstraeten et al. 2003

Andrews et al. 2004

Thompson et al. 2007

When the final apporved study was submitted for publishing, it was first sent to the prestigious New England Journal of Medicine for consideration where it was quickly rejected with several peer reviewers noting serious flaws .

Reviewer 1: In this paper, the authors seem to be hoping for and wanting to determine lack of relationships. When a relationship does emerge, the authors essentially downplay it, even though a) the authors argue for how strong the data set is earlier in the paper and b) the authors explain why SEM is superior to alternative analysis techniques.

Reviewer 2: the authors' conclusions that "thimerosal is not a major causal agent for the disorder (p.13)." is not in accordance with their own data. That is, it is not reasonable, on the one hand, to argue that the use of SEM reduces the probability of Type 1 error and then, on the other hand, to ignore the one significant, positive finding because of "lack of biological plausibility of such a relationship."

Reviewer 3: In general, the arguments presented on page 13 that findings on the tic outcome variable were not seen as sufficiently persuasive to completely dismiss those findings. Only one citation is provided. Further, in the absence of complete heritability [genetically inherited], evidence of heritability does not (as the authors seem to suggest), rule out gene-by-environment interactions or even direct environmental effects. If the authors are to convince skeptical professionals, parents, or public policy makers of their point, they would be well-advised to address the purported mechinisms of the effect that have been proposed.

After that harsh set of criticism, they proceeded to submit to the Journal of the American Medical Association without making any changes. It was rejected from their also. It would be assumes that a researcher would go back and review the research at this point, but instead they were able to successfully submit to the Journal of Pediatric Psychology in 2012. That means they started trying to publish this in 2009 and it took till 2012 to find a journal willing to publish it.

The CDC also funded a fifth (5th) study done on thimerosal and tics which also states "we failed to observe an association with tics...". Dr Thompson himself has said he has extreme doubts regarding the veracity of this study. An independent review of this study showed a "statistically significant relationship between thimerosal and both motor and phonic tics for girls and a statistically significant relationship between thimerosal and phonic tics for boys"

So all 5 CDC studies that considered tics as a consequence to thimerosal exposure show stron, statistically significant relationships despite the CDC's current claims that,

"There is no convincing evidence of harm caused by ther low dose of thimerosal in vaccines, except for minor reactions like redness and swelling at the time of injection."


To put this in context it has been shown that children with autism are 4 times as likely to have tics that the general population. Dr. Thompson has been quoted saying

"There is a biological plausibility right now to say that thimerosal causes autism-like features."

But is not the definition of autism having "autism-like features"?

There is some documentation on  some of the other thimerosal studies that have been provided. Suach as an email from Colleen Boyle to Frank DeStefano in 2000, on a thimerosal and vaccine study entitled Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases. This study is mentioned above and listed as Verstraeten et al. 2003. Dr. Boyle is asking for information on the population being studied, but also  providing suggestion and comments on how to change the population. She comments on "missed cases" and underreporting. Statements in the second item could be taken as she is trying to manipulate data by excluding samples or limiting the study, but more information would be needed to make that conclusion. the big question being, was did the protocol set up initially specify the ages or not.



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