Scientific Fraud and Vaccines
Here is a recent letter written by Congressman Dave Weldon, MD, to Julie Gerberding, Director of the CDC, regarding a fraudulent CDC-sponsored study purporting to show no link between mercury-laced vaccines and autism:
Dave Weldon, M.D.
15th District, Florida
Congress of the United States
House of Representatives
Washington DC 20515
October 31, 2003
Julie L. Gerberding, M.D., M.P.H.
Director, Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Atlanta, GA 30333
Dear Dr. Gerberding:
I am writing to follow up on our conversation about the article (Verstraeten et. al.,) that will be published in the November 2003 issue of Pediatrics. I have reviewed the article and have serious reservations about the four-year evolution and conclusions of this study.
Much of what I observed transpired prior to your appointment a year ago as the Director of the Centers for Disease Control and Prevention (CDC). I am very concerned about activities that have taken place in the National Immunization Program (NIP) in the development of this study, and I believe the issues raised need your personal attention.
I am a strong supporter of childhood vaccinations and know that they have saved us from considerable death and suffering. A key part of our vaccination program is to ensure that we do everything possible to ensure that these vaccines, which are mandatory, are as safe as possible. We must fully disclose adverse events. Anything less than this undermines public confidence.
I have read the upcoming Pediatrics study and several earlier versions of this study dating back to February 2000. I have read various e-mails from Dr. Verstraeten and coauthors. I have reviewed the transcripts of a discussion at Simpsonwood, GA between the author, various CDC employees, and vaccine industry representatives. I found a disturbing pattern which merits a thorough, open, timely, and independent review by researchers outside of the CDC, HHS, the vaccine industry, and others with a conflict of interest in vaccine related issues (including many in University settings who may have conflicts).
A review of these documents leaves me very concerned that rather than seeking to understand whether or not some children were exposed to harmful levels of mercury in childhood vaccines in the 1990s, there may have been a selective use of the data to make the associations in the earliest study disappear. While most childhood vaccines now only have trace amounts of mercury from thimerosal containing vaccines (TCVs), it is critical that we know with certainty if children were injured in the 1990s.
Furthermore, the lead author of the article, Dr. Thomas Verstraeten, worked for the CDC until he left over two years ago to work in Belgium for GlaxoSmithKline (GSK), a vaccine manufacturer facing liability over TCVs. In violation of their own standards of conduct, Pediatrics failed to disclose that Dr. Verstraeten is employed by GSK and incorrectly identifies him as an employee of the CDC. This revelation undermines this study further.
The first version of the study, produced in February 2000, found a significant association between exposure to thimerosal containing vaccines (TCVs) and autism and neurological developmental delays (NDDs). When comparing children exposed to 62.5 ug of mercury by 3 months of age to those exposed to less than 37.5 ug, the study found a relative risk for autism of 2.48 for those with a higher exposure level. (While not significant in the 95% confidence interval for autism, this meets the legal standard of proof exceeding 2.0.) For NDDs the study found a relative risk of 1.59 and a definite upward trend as exposure levels increased.
A June 2000 version of the study applied various data manipulations to reduce the autism association to 1.69 and the authors went outside of the VSD database to secure data from a Massachusetts HMO (Harvard Pilgrim, HP) in order to counter the association found between TCVs and speech delay. At the time that HP's data was brought in, HP was in receivership by the state of Mass., its computer records had been in shambles for years, it had multiple computer systems that could not communicate with one another (Journal of Law, Ethics and Medicine Sept. 22, 2000), and it used a health care coding system totally different from the one used across the VSD. There are questions relating to a significant underreporting of Autism in Mass. The HP dataset is only about 15% of the HMO dataset used in the February 2000 study. There may also be significant problems with the statistical power of the HP dataset.
In June of 2000 a meeting was held in Simpsonwood, GA, involving the authors of the study, representatives of the CDC, and the vaccine industry. I have reviewed a transcript of this meeting that was obtained through the Freedom of Information Act (FOIA). Comments from Simpsonwood, NJ meeting include: (summary form, not direct quotes):
* We found a statistically significant relationship between exposures and outcomes. There is certainly an under ascertainment of adverse outcomes because some children are just simply not old enough to be diagnosed, the current incidence rates are much lower than we would expect to see (Verstraeten);
* We could exclude the lowest exposure children from our database. Also suggested was removing the children that got the highest exposure levels since they represented an unusually high percentage of the outcomes. (Rhodes)
* The significant association with language delay is quite large. (Verstraeten);
* This information should be kept confidential and considered embargoed;
* We can push and pull this data anyway we want to get the results we want;
* We can alter the exclusion criteria any way we want, give reasonable justifications for doing so, and get any result we want;
* There was really no need to do this study. We could have predicted the outcomes;
* I will not give TCVs to my grandson until I find out what is going on here.
Another version of the study - after further manipulation - finds no association between TCVs and autism, and no consistency across HMOs between TCVs and NDDs and speech delay.
The final version of the study concludes that "No consistent significant associations were found between TCVs and neurodevelopmental outcomes," and that the lack of consistency argues against an association. In reviewing the study there are data points where children with higher exposures to the neuortoxin mercury had fewer developmental disorders. This demonstrates to me how excessive manipulation of data can lead to absurd results. Such a conclusion is not unexpected from an author with a serious, though undisclosed, conflict of interest.
This study increases speculation of an association between TCVs and neurodevelopmental outcomes. I cannot say it was the author's intent to eliminate the earlier findings of an association. Nonetheless, the elimination of this association is exactly what happened and the manner in which this was achieved raises speculation. The dialogue at the Simpsonwood meeting clearly indicates how easily the authors could manipulate the data and have reasonable sounding justifications for many of their decisions.
The only way these issues are going to be resolved - and I have only mentioned a few of them - is by making this particular dataset and the entire VSD database open for independent analysis. One such independent researcher, Dr. Mark Geier, has already been approved by the CDC and the various IRBs to access this dataset. They have requested the CDC allow them to access this dataset and your staff indicated to my office that they would make this particular dataset available after the Pediatrics study is published.
Earlier this month the CDC had prepared three similar datasets for this researcher to review to allow him to reanalyze CDC study datasets. However when they accessed the datasets - which the researchers paid the CDC to assemble - the datasets were found to have no usable data in them. I request that you personally intervene with those in the CDC who are assembling this dataset to ensure that they provide the complete dataset, in a usable format, to these researchers within two weeks. The treatment that these well-published researchers have received from the CDC thus far has been abysmal and embarrassing. I would also be curious to know whether Dr. Verstraeten, an outside researcher for more than two years now, was required to go through the same process as Dr. Geier in order to continue accessing the VSD.
You have not been a part of creating this current situation, but you do have an opportunity to help resolve this issue and ensure that confidence and trustworthiness in the CDC and our national vaccination program is fully restored. I would ask that you work with me to ensure that a full, fair, and independent review is made of the VSD database to fully examine this matter. I would like to meet with you at your earliest convenience to move this process forward.
Thank you for your consideration. I look forward to working with you on this urgent matter of great importance to our nation's most precious resource, our children.
Dave Weldon, M.D.
Member of Congress
Here is some correspondence Thinktwice! recently received from a research analyst who spent 7 years working for the CDC to assess the benefit/risk ratio of the chickenpox vaccine. This analyst quit in disgust when he found that his data proving serious problems with this vaccine was suppressed.
Q. Dear Editor, I have read with great interest various items on your website. First of all, please let me introduce myself. I have served as Research Analyst on the Antelope Valley Varicella Active Surveillance Project, one of three sites supported by a grant from the CDC, for the past 7 years. I recently resigned from this position as I encountered deleterious effects of the varicella vaccine (including increasing incidence of Herpes Zoster among children with prior wild-type varicella experience) which appeared to be suppressed by my supervisors and the CDC; while all positive results were published.
I have three manuscripts that have much technical merit, however, like other manuscripts that support increased incidence of HZ among adults by Brisson et al and Thomas et al, the major U.S. journals (such as Journal of the American Medical Association and New England Journal of Medicine) will not consider them for publication. Do you have any recommendations on other journals, even European ones that might be more objective?
Is there an appropriate manner in which to have the manuscripts objectively peer-reviewed and published in a peer reviewed journal. Dr. Philip R. Krause, head research scientist of the Biologics Lab of the FDA, had done a preliminary review of one of my manuscripts and suggested there was indeed some merit to the hypotheses presented.
I have also, unbelievably found great manipulation of data by CDC suggesting "no increases in herpes zoster at this time." Yet, they utilized a study that had insufficient power and too small of a sample size to detect increases in incidence less than 400%.
Thank you in advance for any assistance you can provide.
A. Dear ----, As you must know by now, it will be very difficult to have your papers accepted in mainstream medical journals. We would be interested in publishing your research online.
Q. Dear Editor, I have completed three manuscripts which were submitted to major U.S. journals and which were rejected. The reasons for rejection were just amazing. For example, I was told I needed additional years of data to show a trend. Interestingly, Dr. Hope Simpson's manuscript was published, including his figure on herpes zoster incidence based on 6 cases of herpes zoster encountered during 16 years in a town of 510 children in Cirencester, England. My study had 15 times greater the observation time of this study and was on par with most other studies of herpes zoster incidence.
Recognizing that the U.S. journals might not publish, I have currently submitted them to another prestigious peer-reviewed journal and the manuscripts are being reviewed at this time. I have just completed a 4th manuscript, Why herpes-zoster incidence among school age children is paradoxically high despite seven years of universal vaccination: Preliminary Data and Hypotheses. Should I receive a negative response regarding publication in the journals I would consider online publication that you kindly mention. Why did you seem so certain that major U.S. journals were not going to publish the paper?
[Furthermore,] I have worked at one of the three varicella active surveillance sites in the nation for the past 7 years. While all my positive results were published, the negative results appeared to be suppressed -- thus, due to ethical concerns I resigned as Research Analyst. I have specific, quantified details concerning, for example, the VAERS reporting [the Vaccine Adverse Event Reporting System jointly operated by the FDA and CDC] and how the published data of herpes zoster indicates 2.6 cases per 100,000 doses. The actual figure that was measured during active surveillance for herpes zoster during a two year period in a community of 320,000 residents was approximately 44 per 100,000 doses, thus, the VAERS rate represented only a little more than 5% of the true value.
I could provide many other details to you and am pursuing publication of 4 manuscripts in peer-reviewed journals.
There is something with which you can help me. I recently wrote a manuscript entitled, Why herpes-zoster incidence among school age children is paradoxically high despite seven years of universal vaccination: Preliminary Data and Hypotheses. Would you have any experiences of school nurses and or other healthcare professionals who have actually noted and increase in the number of herpes-zoster (shingles) cases in recent years relative to the prelicensure era? Will be back in touch with you soon. I will check out the reference you have provided.
A. Dear ----, If you'd like, I'll send you a complimentary copy of our booklet on chickenpox. It includes a few case histories and other pertinent information on chickenpox and its vaccine. Tell me where to send it.
Major journals generally support vaccination programs. Therefore, they often reject papers that show vaccines in a poor light.
Q. You are so very right about publishers accepting research with a positive bias. All I was attempting to do is be very objective -- presenting both the postive aspects of vaccination (which were all published) along with the negative aspects (which were suppressed for one to two years). I am an objective researcher, neither for or against vaccination. I only report numbers and analyze data. I do this very well and attempt to make a balanced presentation based on solid facts with appropriate confidence intervals!
Thank you very much for sending the case histories concerning chickenpox and shingles (herpes zoster). I will keep you informed of additional details -- especially if my manuscripts are published.
Here is some correspondence Thinktwice! received from a high level employee working for the State Health Department. He read a secret CDC bulletin acknowledging that flu shots from 1993 to 1996 were "dirty." When he tried to get a copy of this Bulletin, his efforts were met with great resistance.
Q. My family has been in crisis mode for the better part of 5 1/2 years. My wife has been diagnosed as the worse Myasthenia Gravis patient in New Mexico -- besides one other man who tried to treat himself by overdosing on steroids after getting his diagnosis. [We believe the flu vaccine caused her condition.] Our situation is particularly complex, as my wife has been the state medical director for Children's Medical Services for over 17 years, and continues to try and hold onto her job by working at home a few hours a week. I work in the Office of Epidemiology for the state, and have a rather high level technology position. So you see, both of our jobs could be jeopardized immediately by political forces if confidentiality was breached. I was privy to a bulletin put out by the CDC around 1998, or 1999, stating that they had acknowledged that the flu shots from 1993 to 1996 were considered 'dirty'. When I went back to get a copy of this bulletin last year (so that my wife could take an early retirement), no one admitted to the existence of such document. Believe me, I have contacts all over the country, including Atlanta. I realize now that the ranking members of CSTE are privy to information that not even EIS Officers in Atlanta know about. We are looking for ways to get a copy of that bulletin, or any related documents, just so that my wife can retire...not for any other purpose. I look forward to hearing from you, and would like to get whatever information you can provide. Thanks.
A. Thanks for the brief explanation of your situation. Apparently you believe that your wife's condition resulted from a flu vaccine. I would be interested in hearing more of the details. I would also like to see that bulletin. If others in your field suspect that you and your wife blame vaccines for her condition, they will remain cautious around you and will not provide you with information. We publish a small booklet documenting hazards of the flu vaccine. I can send you a copy if you'd like. Please email me with a mailing address. Best wishes.