US National Academy of Sciences Hearing on Vaccine Safety

US National Academy of Sciences

Institute of Medicine

Washington, DC

Immunization Safety Review Committee Hearing

Monday - February 9, 2004 8:30AM – 5:00PM

Out of 15 speakers polled:

60% (9) felt there IS a link to Autism etc. (This represents all those with NO conflicts of interest)

26% (4) felt there is NO link to Autism etc. (This represents all those WITH conflicts of interest)

14% (2) were noncommittal. (This group likely to have conflicts of interest)

100% of those with no conflicts of interest are convinced there is a massive problem.

(See Stats on Consensus)

In Order of Appearance….

Marie McCormick, MD, Committee Chair, introduced Congressman Dave Weldon, (R-FL). In addition to an explanation of the committee’s duties, she defended the committee’s knowledge base by showing the audience a 6-inch binder of collected data and stating information was copied on “both sides and the committee has read them…Believe me they have read them.” (See Video)

Congressman Dave Weldon, (R-FL), (also a physician) indignantly delivered a scathing address riddled with a long list of how the CDC, along with other agencies like them, have been less than forthcoming - citing instance after instance of the CDC’s “appearance of conflicts of interest”. (See Video)

Dr Mady Hornig, MD, Associate Professor, Columbia University shared a study on mice who were introduced to the same ratio of mercury, per body size that humans are exposed to. “The exposed mice had abnormal behaviors compared to the control group including aggressive tail biting, self mutilating, wildly self-grooming, frantically grooming his partner eventually grooming through his partner’s skull, thus killing his own partner.”

Possible Conflicts of Interest - Although she has had funding from a variety of pharmaceutical manufacturers who produce vaccines and the NIH, she has no specific funding for looking at safety in vaccines. She has also received funding from Safe Minds.

Opinion on Safety - Dr. Hornig has serious concerns with accumulative mercury exposure through the use of thimerosal, mercury in vaccines, and other applications in the many other products in which it is contained.

(See video)

Dr. Kumanan Wilson MD MSc, of the Toronto General Research Institute, Canada, reviewed over multitudes of case studies, some with significant association between thimerosal and autism and some inconclusive.

Possible Conflicts of Interest - Dr Wilson could not and did not verify any conflict of interests of his own or within the many studies he reviewed.

Opinion on Safety – Dr. Wilson did not reach any definitive conclusions. (See video)

Dr. Frank DeStefano, MD, Centers for Disease Control and Prevention and one of the co-authors along with another scheduled speaker, Dr. Robert Davis, of the infamous and controversial Verstraeten study, presented another study he co-authored initially for mental retardation, Cerebral Palsy, hearing loss and visual impairment. Autism Spectrum Disorder was added in 1996.

Possible Conflicts of Interest - The Verstraeten study in February 2000 found a definitive and causal connection between thimerosal and autism, speech delays and ticks with 110,000 children from two HMOs. Dr. Verstraeten presented at a hearing in this committee in 2001.

At a secret review hearing held at the Simpsonwood Meeting Center in Atlanta, Georgia in June of 2000, 50 some experts, all personnel from the CDC, NIH, FDA and affiliated groups, spent the weekend reviewing the alarming data. This information was embargoed from the public.

In November of 2003, three years later, a watered down version of the same study, this time claiming no connection between thimerosal and autism, appeared in peer - reviewed publication, Pediatrics, where it was immediately attacked by peers for manipulation. It sparked a series of claims of fraud and an investigation into the CDC from members of Congress that not only remains unresolved but also is escalating at an explosive rate.

The study’s main author, Thomas Verstraeten, has been working for GlaxoSmithKline since July of 2000 and is unavailable in Belgium. The information that Verstraeten and his co authors worked for pharmaceutical manufacturers was apparently not disclosed to the publishers of Pediatrics when the new revised version of the study was submitted. (See Peer Reviews in Pediatrics) -

DeStefano claims at this hearing none of his co-authors have conflict of interests on the study he presented however, his states the CDC provided all the support for the study he presented.

Critics claim the CDC is collaborating with vaccine manufacturers when they are supposed to act in an oversight position.

Opinion on Safety – DeStefano seemed to mix categories of his study groups, cohorts, to the degree that many in the audience, including committee members, appeared confused as to what his position really is. (See video)

Dr Elizabeth Miller, Head Immunization Division, Public Health Laboratory Service, Communicable Disease Surveillance Centre, London, UK, well known in research circles and the UK alike for her abrasive style and lead in the concerted and unprovoked attack on Dr. Andrew Wakefield who expressed his concerns on the possible autism link to thimerosal on the UK television program Panorama several years ago. (See Panorama)

Wakefield has been an undaunted thorn in the side of the UK government authorities since he went public in 1998 with his concerns in that vaccines may be related to autism. These aggressive attacks by Miller and others affiliated with funding from pharma, were the subject of Congressman Weldon’s welcome address at this NOM hearing. Dr. Wakefield’s research was one of the first alarms that riveted through the medical community and has been largely validated by many other researchers.

Possible Conflicts of Interest - Her disclosures do not appear to be totally forthright of her close ties with vaccine manufacturers. (See More Elizabeth Miller)

The serendipitous appearances of experts in the field who response to questions of safety with anger and misdirection instead of facts that appear, by design, to mislead the medical community and the public has been the subject of an explosion of “conflicts of interest” allegations.

Public reaction to these open attacks appears to be one of cynical sentiment and a growing movement by the US and the UK populations alike to question the credibility of their own governmental agencies. The use of “alternative” medicine in both the UK and the US is on a rapid rise leaving the pharmaceutical market share dwindling.

Pharma’s aggressive response to this situation has been the subject of much press in their attempts to gain control of the supplement industry through quiet purchasing of preferred brands and pressuring for FDA and CDC control of the supplement and alternative industry through congressional bills to change these agencies’s authority.

Critics claim pharma’s fight to control the sales of pharmaceuticals outside the US is only a symptom of a desperate pharma to reclaim a disenchanted market share. This has created much furor in congressional circles and the senate alike as pharma flexes its well-financed lobbying mercenaries against a growing and passionate grassroots movement to protect the public who threaten campaigns to recall those who throw a deaf ear to public safety.

Opinion on Safety – Despite many other experts claims to the contrary, Dr. Miller feels there is no evidence that increasing exposure to thimerosal at a young age increases the risk of autism.

During much or the day, a hostile Miller spent an unusual amount of time defending her position that thimerosal was safe during the Q&A of experts who did not subscribe to her position. In some cases she contradicted herself. Critics question what is rational about getting hostile over a concern of safety and thus question her credibility. (See video)

Dr. Robert Davis, MD MPH University of Washington, Group Health, Cooperative Dept. of Pediatrics, Center for Health Studies and Epidemiology, and one of the co-authors along with another scheduled speaker, Dr. Frank DeStefano, of the infamous and controversial Verstraeten study, presented and reviewed some of the Verstraeten study at this hearing. Dr. Verstraeten presented at a hearing in this committee in 2001.

The study’s main author, Thomas Verstraeten, has been working for GlaxoSmithKline since July of 2000 and has been unavailable in Belgium. The information that Verstraeten and his co authors worked for pharmaceutical manufactures was apparently not disclosed to the publishers of Pediatrics when the new revised version of the study was submitted. (See Peer Reviews on Pediatrics)

At this hearing, Davis reveals numerous and deeply disturbing conflicts of interest at this meeting but apparently not all of them. An investigation reveals $5 -$7 million in pharm funding alone. Critics allege he has not disclosed his financial involvement with the financial melting pot - Brighton Collaboration that appears to be a money-laundering vehicle for a who’s who of government agencies such as the FDA, NIH, CDC and pharmaceutical companies collecting additional income under the claim of tracking vaccination adverse effects.

Davis’s own curriculum vitae on the Internet states six plus million from pharmaceuticals cartels. (See Davis on line CV disclosures). (See Funding)

Opinion on Safety – Although Davis states autism is primarily diagnosed at around 10 months, (44+ weeks), he then concludes there is no evidence of dose response at three different ages, 1 month, 3 months and 7 months, ages where autism is rarely diagnosed. Critics allege this is deliberately misleading.

During his presentation at this hearing, when reviewing the IOM recommended in 2001, he appears to have left out the specific recommendation that called “for the removal of thimerosal from vaccines as a precautionary step in the effort to minimize children’s exposure to mercury.” (See 2001 NOM Committee recommendations) (See video)

Anders Peter Hviid, MSc, Department of Epidemiology Research, State Serum, Institute, Copenhagen, Denmark presented a study of the association of Thimerosal-containing vaccine and autism in Denmark or the “Denmark study” mentioned by several others during the day.

Possible Conflicts of Interest - During his disclosures of possible conflicts of interest, he did not mention the work he has done for private vaccine manufacturers who supply the vaccine for his government agency that he also works for.

Opinion on Safety – Hviid states his study shows no relationship between Thimerosal and autism although the data he presented showed a clear difference in:

· Denmark protocols of lesser exposure at later ages, versus

· US’s protocols of more exposure at earlier ages.

· It is well known in scientific circles that Danish rates of autism are under 5 per 10,000, and

· US rates are dramatically higher at 60 per10,000.

Because it appears Hviid’s study did not account for these significant differences in protocols and rates, any standardized applied statistic would be skewed and render the Danish findings useless.

Attention to these inconsistencies came up during the Q&A when Dr. Haley asked Hviid what the relative rates per 10,000 in Denmark were versus the US rates, Hviid acted nervous, seemed to falter and did not answer. It was these statistical flaws that precipitated Dr. Haley’s comment later in the conference that comparing the Denmark stats to the US stats, was like “comparing apples to cows.”

Another recent Denmark research, Madsen et al, (Go to study), shows Denmark’s incidence of autism was less than .4 per 10,000 before 1992 but that it has increased 7.5 times to 3/10,000 in 2000 seemingly supporting Hviid’s findings.

Madsen’s paper, along with Hviid, also claims there can be no correlation between thimerosal causing autism because autism appears to have increased while authorities were removing the mercury containing, (thimerosal), vaccines.

Since it is fairly absurd to imply the removal of thimerosal, a well-known potent neurotoxin, somehow correlates, as preventative for autism, (because in Madsen’s study autism increased between 1992 and 2000 during the removal), critics claim the next most likely hypothesis for the differences is poor record keeping at the time.

Poor tracking would result in a fatal flaw in comparisons. It would also make sense authorities would have employed more reliable tracking as they became aware of a potential issue. If these critics are correct, the Denmark <. 4 figure, before 1992, is much more likely to have been comparable to the US figures in 2000 at 60/10,000.

If critics claims were applied, the Denmark calculations would sync with other alarming autism trends around the world this and look like the following:

Some allege this Danish issue may be an issue of some within the Danish government to attempt to cloud the issue, not only in the US, but also internally in Denmark. (See Video)

Dr. Mark R Geier MD PhD, President, The Genetic Centers of America and David Geier, President of MedCon are part of the research team commissioned by Congress to review the CDC’s Vaccine Adverse Effects Research database. Geiers are also part of the congressional authority who were denied access for the most of part of the past two-years by the CDC to this database. Rep. Weldon referred to this in his opening statements.

Possible Conflicts of Interest -They have been summoned and reported to Congress as expert witnesses many times and have been called as expert witnesses in other actions. They disclosed no conflicts of interest.

Opinion on Safety – Given that their presentation consisted of countless studies showing alarming findings of massive exposures. The IOM choose not give them any extra time to review the data for the committee as they did in for another presenter earlier. As a result they were not able to go into depth on any of them. There was no doubt about their position that if this exposure is not addressed immediately “that this society is going to be in big trouble – we cannot have a whole generation of people damaged the way this is happening.” (See video)

Breaking News: Immediately after Geier’s presentation at the NOM, in a letter dated February 13, 2004, the acting Assoc. Dir. For Science at the CDC, Jeanne Santoli, MD, shut down their access to extract data from the CDC database stating “potential breaches in confidentiality.” This set off a chain reaction of outrage through the Congressmen who commissioned the research and others than has yet reached critical mass.

(See CDC/Geier letters)

NEW! (See Geier Response )

Dr. H. Vasken Aposhian, PhD, Professor, Molecular and Cellular Biology, University of Arizona presented a toxicologist’s view of Thimerosal and autism. Dr. Aposhian reviewed over science available and the US standards of what is considered safe and determined that there is a definitive causal connection between over accumulative thimerosal and autism.

Possible Conflicts of Interest - Dr. Aposhian disclosed no conflicts of interest.

Opinion on Safety – “It is this toxicologist’s view that the link between thimerosal and neuro development disorders in children has become more plausible… Thimerosal appears to add organic mercury to the mercury burden of the mercury of children with mercury efflux disorder.” (See video)

Dr. David Baskin, MD Professor of Neurosurgery and Anesthesiology, Baylor College of Medicine did a presentation of neurotoxic effects of thimerosal to autism.

Possible Conflicts of Interest - Dr. Baskin disclosed funding in relationship to his studies in his field and appeared to be related to research unrelated to vaccine manufacturers.

Opinion on Safety – Baskin clearly feels there is an issue referring to replicated studies at MIT “is at least alarming and is of concern.” (See video)

Dr. Polly Sager, Assistant Director for International Research, National Institute of Allergy and Infectious Diseases under the National Institutes of Health, presented evaluations of mercury in infants after thimerosal containing vaccines and examines several possibilities. She reminded the audience that their studies were done on the maternal hair not from maternal blood levels using the studies on damaged children in Iraq as an example. She reviewed over a study that looked at safety standards thimerosal exposure form vaccines and ethyl mercury accumulation in non-human primates. She states the study itself is fairly incomplete and not as useful for this hearing as it might be in the future.

Possible Conflicts of Interest – Sager disclosed some of her previous funding and believes she has no conflicts of interest. Sager’s primary employer is the National Institute of Allergy and Infectious Diseases under the NIH.

The NIH has been the subject of numerous and recent US Senate hearings alleging conflicts of interest within the National Institutes of Health and large pharma.

Some critics allege that any insinuation that a reaction to mercury as an allergy is misleading and the legitimacy of granting funding through the NIH and the National Institute of Allergy and Infectious Diseases is thus inappropriate.

The National Institutes of Health, (where the National Institute of Allergy and Infectious Diseases resides), have been the subject of some critical scrutiny due to their open policies on personnel accepting outside sources of funding including pharmaceutical interests. Coverage on recent US Senate investigating these allegations by the LA Times - (See LA Times) (See additional LA Times Story) http://pqasb.pqarchiver.com/latimes/483567461.html?MAC=cfb1287b70ba5bfebbabb7536276bd7f&did=483567461&FMT=FT&FMTS=FT&PMID=&printformat=&desc=Stealth+Merger:+Drug+Companies+and+Government+Medical+Research%3b+Some+of+the+National+Institutes+of+Health%27s+top+scientists+are+also+collecting+paychecks+and+stock+options+from+biomedical+firms.+Increasingly,+such+deals+are+kept+secret

Opinion on Safety – This presentation reviewed over where mercury was found in the brain and blood of primates and no conclusion was addressed as to safety issues because of the incomplete status of the study.

(See video)

Dr. Boyd Haley PhD, Chairman and Professor, Department of Chemistry, University of Kentucky is one of the premiere world experts on mercury exposure. Haley presented numerous studies. One study was done on mercury in the birth hair of children and the relationship between the amount of amalgam fillings in the mother and the birth hair where the mercury burden of the fetus could be correlated to the amount of dental amalgam fillings in the mother.

Another study was done on the effects of testosterone combined with mercury on brain neurons and the effects of estrogen combined with mercury on brain neurons where it was found that testosterone exacerbated the toxic affects of mercury on the brain neurons and estrogen seemed to protect the brain neurons.

Haley discussed the role of mercury in other medications including Idiopathic Dilated Cardiomyopathy, (IDCM), where young athletes die suddenly and have been found with massive amounts of mercury in their heart tissue. Haley states it is a ”very distinct possibility” these young athletes are injecting testosterone containing Thimerosal in an attempt to enhance performance thus dangerously increasing their bio-accumulative mercury burden.

Possible Conflicts of Interest – Haley disclosed some funding from private sources. Haley has received no funding from pharmaceutical interests.

Opinion on Safety – Haley believes there is an alarming amount of exposure of an accumulative amount of mercury in the population from amalgam and vaccines as well as environmental.

Referring to Haley’s statement that he is “baffled” how there can be “such different results from people using the same database,” one committee member asked, “Are you implying the epidemiologists lied?” Haley responded, “I’m implying that some epidemiologists lied, yes.”

“There appears to be a subset of the population that cannot effectively excrete mercury and are at greater risk to exposures to mercury than are the general population. Genetic susceptibility is critical. Presence of other heavy metals enhances susceptibility…Estrogen decreases thimerosal toxicity where testosterone enhances toxicity. Gender effects are involved.”

(See video)

Dr Jeff Bradstreet, MD FAAFP, Adjunct Professor, Neurosciences, Stetson University, Director of Clinical Programs, International Child Development Resource Center, Florida.

Possible Conflicts of Interest – Disclosed sponsors CRC Stetson University. Bradstreet asked the committee to give an opportunity to have the Wakefield and Dr. Oleary team present their information and believes it critical to their information.

Opinion on Safety – “Is very concerned about mercury in general…and I’m even more concern after 600,000 children were added to the at risk group of mercury from dietary exposure from fish eating… Exposing children to a neurotoxin, even at a theoretical level is an unwise practice.” (See video)

Dr. Vijendra k Singh, PhD, Research Associate Professor, Utah State University presented autism, vaccines, and immune reactions. His studies show consistent finding of measles virus in autism children.

Possible Conflicts of Interest – Singh states he has no conflict of interest from anyone.

Opinion on Safety – Singh believes his studies show that the measles virus is a serious player in the neurological epidemic seen in autistic children. He thinks it is time to re-evaluate vaccine safety and the manner in way we practice vaccines today. (See video)

Highlights and Interesting Remarks –

Dr. Elizabeth Miller seems to say to Dr. Haley that the UK vaccination schedule has the same exposure as the US with no incidence of autism. Earlier she states the UK does not vaccinate for Hepatitis B and flu, (like the US), and there is no incidence of autism.

(See video)

Geier interview with CNN.

(See video)

Stats:

(Back to top)

	Is there a link to Autism etc and vaccines?	Conflicts of Interest?
Weldon	YES	NONE
*Hornig*	*YES*	*NONE*
*Wilson*	*Could not say*	*Not definitive*
*Destefano*	NO	*YES*
*Miller*	NO	*YES*
*Davis*	NO	*YES*
*Hviid*	NO	*YES*
*Geier*	*YES*	*NONE*
*Geier*	*YES*	*NONE*
*Aposhian*	*YES*	*NONE*
*Baskin*	*YES*	*NONE*
Sager	*Possibly*	*Possibly*
*Haley*	*YES*	*NONE*
*Bradstreet*	*YES*	*NONE*
*Singh*	*YES*	*NONE*

Media and for more in depth information on this developing story contact:
UnInformed Consent - 425 487 2358 or visit:
www.uninformedconsent.com

E-mail UnInformed Consent: qci@oz.net

Weldon

YES

NONE

Sager