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SUMMARY

A Testimony to Congress

Vijendra K. Singh, Ph.D.

Department of Biology & Biotechnology Center

Utah State University, UMC 4700

Logan, Utah 84322

Today, I will be speaking about the autoimmunity aspect of vaccines in autism, a medical condition that has been largely ignored by the medical community and federal government for a very long time and yet the incidence of autism is increasing at an alarming rate. An estimated one-half of a million Americans, mainly children, and millions more worldwide are known to suffer from autism, a heart-rending disorder that severely impairs higher brain functions: social interaction, communication, language, imagination and cognition. The disorder is a life-long mental disability with devastating consequences for both the patient and his/her family. Thus the financial burden is huge for the families who care for children with autism.

Autism is an idiopathic brain disorder, which simply means that the etiology of the disorder is not known. And there is no single, clear-cut cause for autism. Causally speaking, I tend to think that autism is a complex disorder, in which autoimmunity to brain plays a key role. Today, in spite of virtually no funding available, autoimmunity is the most extensively investigated topic of research in autism. This is by and large due to the fact that autoimmunity is the prime target of therapy that has proven to be quite effective in ameliorating autistic characteristics. Thus the autoimmunity research, unlike the genetic research, has already significantly improved the health and welfare of individuals with autistic disorder. I have recently coined a term “Autoimmune Autism (AA)” to refer to a subset of autism that has autoimmune etiology. Moreover, there are scientific reasons to think that this subset may indeed be a result of vaccine injuries to children who display autistic regression.

Autoimmunity is an abnormal reaction immune reaction, in which the immune system becomes primed to react against body organs. It’s a mosaic of highly complicated interactions and networking between cells and molecules of the immune system. The body makes autoantibodies against itself, resulting in damage to tissues and organs. The “autoimmune” response is what happens in autoimmune diseases such as lupus, and my research showed that a similar response my account for the brain abnormalities found in people with autism.

Autoimmune diseases are identified and characterized by many factors. The hallmark is the “organ-specific autoantibodies” that have also been identified in people with autistic disorder. To that end, I have recently summarized laboratory data of approximately 400 cases (autistic and controls) and found that up to 80% of autistic children have autoantibodies to specific brain structures, in particular a brain protein known as myelin basic protein (MBP) of the myelin sheath, a fatty coating that insulates nerve fibers and absolutely essential for higher brain functions. These autoantibodies are present quite frequently (65-85%) in autistic children, but only rarely (0-5%) in normal children and other disease controls. Accordingly, I postulated that autism involves a specific autoimmune response to MBP -- an immune assault that impairs myelin development in the developing brain, thereby modifying the nerve cell functions of the brain. Ultimately, by way of impaired wiring diagram in the brain, this results into autism.

Autoimmunity is commonly triggered by environmental exposures such as viral infections. Virus serology (or virus antibodies) is an excellent tool for studying virus infections in disease states. However, until recently, such studies had not been performed for autism. Because of my ongoing research, I became interested in examining a virus link with autoimmunity in autism. I recently raised two specific questions: (1) Does autistic children have a hyperimmune response (or increase of antibodies) for a specific virus? (2) Is there a relationship between virus antibodies and brain autoantibodies in autism? I conducted a carefully designed study to address these two questions. Succinctly, I made two very important observations: first, there was indeed a hyperimmune response to a virus and it was specifically for the measles virus (MV), but not for the other viruses tested [human herpesvirus-6 (HHV-6), rubella virus (RV), and cytomegalovirus (CMV)]; and secondly, there was an association between measles virus antibodies and MBP autoantibodies (i.e., the higher the measles virus antibody level the greater the chance of brain autoantibody). Few months earlier in the same year (February, 1998), I had already found that many autistic children had antibodies to a specific protein of the measles-mumps-rubella (MMR) vaccine (MMR vaccine preparation). These viral antibodies were also related to positive titers of brain MBP autoantibodies. This was most probably the first laboratory-based evidence to link measles virus and/or MMR vaccine to autoimmunity in children with autism. Collectively, these observations led me to speculate that autism may be caused by a measles- or MMR vaccine-induced autoimmune response. Unfortunately, due to lack of funding, I have not been able to extend this research and the progress has been hampered.

As I made scientific presentation of my initial findings, a vaccine-autism connection became even more apparent. I compiled a nonscientific, anecdotal survey of vaccine-injured children with “autistic regression” or autistic disorder, as reported by families. Surprisingly, up to 93% of the reported cases had autistic symptoms shortly after vaccinations (52% post-MMR, 33% post-DPT, and 8% post-MMR and/or post-DPT). The remaining 7% of the reported cases were not linked to any vaccination at all. Indeed, if these numbers are reproducible, the data will lead to inescapable conclusion that these vaccines can potentially cause autoimmunity in autism. Quite candidly, this will not be first time that a vaccine has been linked to a disease or disorder. There is quite a bit of literature linking vaccines to autoimmune diseases. Furthermore, an epidemiological study just published in JAMA (March 8th issue) described “extraimmunization” amongst American children and considered it to be a contributing factor for the adverse effects of the vaccines. And I think the vaccines and autism connection is no exception to these adverse effects.

In summary, the rapidly accumulating evidence strongly implicates autoimmunity in autism, which in many may result from a vaccine injury. There is a possibility of an atypical measles infection in autism, but the evidence also suggests a MMR vaccine infection. Without any reservation, I would strongly recommend that this Congressional Committee reviews all the information in bipartisanship, and explore the possibility that drug companies never properly evaluated the safety of vaccines in the first place. If this indeed were true then it becomes imperative that we as a society must pay an immediate attention to this problem; otherwise, an epidemic of autism is a real good possibility. There should be no mistaking about it because autism is on a sharp rise and vaccinations, especially the extraimmunization, could potentially explain this rise. The onset of autism (or autistic regression) post-immunization should no longer be regarded as merely a coincidence with the timing of the vaccinations, as our federal health officials continue to do. We must find new ways to curve adverse effects of vaccines, including autism. Considering a population of 500,000 cases of autism in the United States, the autoimmunity research, but not the genetic research, has already had a great impact on the health and welfare of autistic people. Since brain autoimmunity is found in up to 85% of cases, it can potentially help an estimated 425,000 Americans. Indeed, many of them are already reaping the benefits of the experimental autoimmune therapy. Thus there is an urgent need to promote autoimmunity research in autism. This recommendation is in contrast to the opinions held by the directors of the federal agencies and major private foundations (Cure Autism Now and National Alliance for Autism Research) who are erroneously committed themselves to fund genetic research only. Finally, I urge the Government Reform Committee to provide leadership for new solutions to the existing problems surrounding autism research, and request the Committee Members to be visionary and offer new hope to the people with autism -- The essence of life is to care.

The MMR Vaccine and Autism

Since the MMR vaccine was introduced about 35 years ago,the incidents of autism in children have increased by 1,000 percent - from two or three in 10,000 - to one in 500.

Evidence of a possible link between the MMR vaccination and autism came from the finding of children from villages, within two miles of each other in Scotland, being diagnosed with autism after MMR inoculation.1 The three children from different families in Ayrshire were given MMR vaccine at the same health center within four months of each other. Child neuro-psychologist, Ken Aitken, said that the cluster of cases in Ayrshire indicated the need for further research before the MMR vaccine can be declared safe beyond doubt.

"More children are being diagnosed with autism and clusters like these are deeply worrying", he said. "There is strong circumstantial evidence to point to the MMR ä as the reason, but there has to be much more coordinated research to look into this issue in detail. Research so far hasn't been adequate to address the questions that are being raised about the possible links and there have been a lot of queries about the validity of the conclusions which were drawn."

In the 1980s, one in 2500 children in Britain and America were diagnosed as autistic. Latest figures compiled by researchers revealed a dramatic leap - to one in 146.

The MMR immunisation was introduced in the UK in 1988 with the first dose aimed at children of 12-15 months, a the second dose at 3-5 years. It is designed to protect against measles, mumps and rubella (German Measles) and works by stimulating the immune system to produce antibodies against the viruses without causing harm. It was so well received by both parents and doctors that over 90 per cent of children were being immunised by 1992.

Most children received the vaccine with no obvious serious side-effects, but some became seriously ill within a few weeks. These children began behaving strangely, stopped talking and became socially withdrawn, staring into space for hours on end. Many developed a raging thirst, bizarre eating habits, multiple food allergies, hyperactivity and sleep problems. This was usually accompanied by abdominal pain, bloating and bowel disturbances. Some children became incontinent of urine or feces. Their development deteriorated. Thousands of children now fall into this category of abnormal development only after receiving the vaccine.

Professor John O'Leary, Director of Pathology at the Coombe Women's Hospital in Dublin, told the US Congress in April, 2000, that he had produced compelling evidence of an association between autism and the MMR vaccine. Professor O'Leary found the measles virus in the guts of 24 out of 25 children who had developed autism, after an apparently previously healthy infancy.

His research supported the findings of Andrew Wakefield, of the Royal Free Hospital, London, who claimed there was an etiological implication between persistent measles virus infection or measles vaccination and inflammatory bowel disease (IBD), mainly on the basis of epidemiological and immunohistochemical findings. Dr. Wakefield identified "autistic enterocolitis", an inflammation of the gut in 150 autistic children who became autistic after receiving the vaccine.

Dr. Aitken, based at Edinburgh University, said, "The substantial increase in cases in the US began about three years after MMR vaccine was introduced and the same thing happened three years after MMR was introduced in Britain. There has been a national increase throughout Britain and I find it very surprising that the change is so tightly linked in time with when triple vaccine was introduced."

On February 28, 1998, Wakefield reported in The Lancet a possible connection among inflammatory bowel disease, autism, and viral infection associated with measles, mumps, and rubella (MMR) vaccination. The damage from autism is thought to be provoked by an allergic reaction initiated by the body's reaction to the vaccine. This auto-immune response may also reduce levels of the dipeptidyl peptidase (DPP)-IV enzyme, thereby connecting vaccines to the opioid theory of autism.

Andrew Wakefield did his first colonoscopy on an autistic child, because the anguished mother begged him to find the reason why her son had such terrible gastrointestinal problems. Finding some very specific pathology, Dr. Wakefield proceeded to investigate 11 more autistic children, again finding similar pathology in all children. These children had lost acquired skills, including communication, after a period of apparent normality.

Among eight of the children, the onset of behavioral problems had been linked, either by the parents or the child's physician, with MMR vaccination Five had an early adverse reaction to immunization (rash, fever, delirium, and seizures in 3). The average interval from exposure to first behavioral symptom was 6.3 days (range: 1-14 days).

Among the remaining 4 children, one received monovalent measles vaccine at 15 months, after which his development slowed. A striking deterioration then occurred in his behavior at age 4.5 years, the day after he received an MMR vaccine. A second child received the MMR vaccine at 16 months, developing at 18 months a combination of recurrent, antibiotic resistant, otitis media, along with his first behavioral symptoms (lack of interest in siblings and lack of play). A third child received an MMR at 15 months, experienced recurrent "viral pneumonia" for the next 8 weeks, and developed behavioral symptoms 4 weeks after the MMR ( loss of speech development and deterioration in language skills). The fourth child developed self- injurious behavior 2 month after the MMR.

Urinary methylmalonic acid excretion was significantly raised in all children tested (8 of the 12). Ten of the twelve children showed lymphoid nodular hyperplasia of the terminal ileum on endoscopy. The eleventh child had prominent luteal lymph nodes and the ileum was not reached in the twelfth (who had an ulcer in the rectum along with chronic colitis).

Wakefield, concluded that a subset of autistic people may suffer brain inflammation resulting from infections that began in their intestines after they were inoculated with the measles-mumps-rubella (MMR) vaccine. Theoretically, this condition could occur after naturally-acquired infection as well. The pro-vaccine community would argue, if this is true, that vaccination still reduces the incidence of disease by reducing the number of infections.

Wakefield's studies received enormous press attention in the United Kingdom. The immediate result of Dr.Wakefield's paper was a vitriolic attack from every front. A flood of opposing articles appeared in the same issue of The Lancet, and systematic criticism, nearing persecution, of Dr. Wakefield began, and is still going on. Rates of vaccination against measles fell to about 85 percent last year. Epidemiologists have been predicting a measles epidemic to result. Ireland reported an outbreak of 300 measles cases as of summer, 2000, compared to only 30for all of 1999. Two of the new cases were infants who had to be hospitalized with pneumonia complications.

Distraught parents of affected children have become even more confused, because no one has been able to prove conclusively to them yet, that an MMR vaccine-Autism connection does not really exist.

We know from data reported before the availability of MMR vaccine, that a subset of autistic children suddenly regressed at age 15 months, long before the measles vaccine became available.There have been no safety follow-up studies looking beyond four weeks post vaccination, and many studies quoted, have been partially funded by vaccine manufacturers, with obvious commercial interests.

No serious researcher has looked at a large sample - three to nine months post MMR vaccination, when auto-immune diseases usually would occur. When some parents in England became vocal, the pro-vaccine authorities in the UK reacted forcefully, to protect the MMR vaccination program. The single measles, mumps and rubella vaccines effectively became unavailable, and every effort was made to prove Dr. Wakefield wrong.

Despite the above, Britain's National Health Service's Chief Medical Officer, Sir Kenneth Calman, felt confident enough to say, "I have concluded there is no link between MMR immunisation and autism." Questioned in Parliament in 1997 on the possible link between MMR and autism, then health minister Tessa Jowell reassured Parliament that: "No vaccine is issued in the United Kingdom unless it passes the highest standards for quality, and parents should have confidence that the vaccines that are provided are both safe and efficacious."

In 1999, two studies appeared that the Department of Health claimed "reinforce the conclusion that there is no link" between MMR and autism. The first, by the Committee on the Safety of Medicines, involved examining questionnaires sent to the parents who had suspected MMR as a cause for their child's autism - 1200 questionnaires were distributed and 126 examined in detail. The study concluded: "It is impossible to prove or refute the suggested associations between MMR vaccine and autism" - hardly convincing reassurance.

The second study cited by the DOH looked at one area - north London - and found an alarming increase in autism there. The incidence was running steadily at between four and eight of the children born there each year between 1978 and 1985. Then came a dramatic increase to just under 50 of the children born in 1992 - the last year studied by Professor Brent Taylor and colleagues at University College London. Curiously, however, they concluded: "Our analyses do not support a causal association between MMR vaccine and autism."

The Taylor study was funded by The Medicines Control Agency and The Public Health Laboratory Service and was published in The Lancet, June 1999. Taylor, et al. stated that the age of diagnosis was the same before and after the introduction of the MMR vaccine, and used this finding to conclude that the MMR vaccine did not have a causative role in autism. Dr. Taylor stated: "For age at first parental concern, no significant temporal clustering was seen for cases of core autism and atypical autism, with the exception of a single interval within six months of MMR vaccine associated with a peak in reported age of parental concern at 18 months." Taylor, et al. Could not explain the increase in autism noted in 1992, the last year for which they examined data.

To others, Taylor's failure to explain the massive increase in autism only added fuel to the controversy. Children who were born in the mid-1980s in Britain and the 1970s in the United Sates were the first to receive the MMR vaccine. In California the incidence of autism was running at 150-200 a year until 1980, when it dramatically rose to reach nearly 600 in 1990.

While Taylor argued that MMR cannot contribute to autism, and Wakefield argued that it might, both studies may be correct. What Taylor may have missed is the susceptible child argument. He limits himself to the more typical, reductionistic, one variable theory of disease. In this theory, one agent causes a disease. All individuals exposed to this agent have equal probability of developing the disease.

A more accurate theory of disease posits susceptible individuals who succumb to the disease after multiple contributory insults. Wakefield worked backwards from children who definitely had autism with gastrointestinal symptoms. Taylor worked forward from all children receiving the MMR vaccine. While various authors question his sampling effort and point out potential bias in how he selected his subjects, the much more important problem lies in Taylor's type of study posing no help for the question of whether susceptible children could be more likely to develop autism after MMR vaccine.

We have only begun to speculate about who is susceptible to autism. We know the risk is higher if one or more family members have the condition. But what are the promoting agents that make autism more likely? Not all children with autistic siblings develop autism. The genetic penetration is not 100%. Non-genetic factors must play a role. Could vaccines be one of these promoting agents? Wakefield suggested yes, and Taylor's study did not really address that question.

Some other investigators have not been able to reproduce Wakefield's findings [M.A. Azfal and colleagues]. They could not detect measles viruses in the bowel, brain, or any other tissue of the patients in Wakefield's series.2

Subjectively, we cannot deny that many parents report developmental deterioration following MMR vaccination. Neurological sequelae following MMR are also widely reported. Dozens of heart-rending, anecdotal accounts link permanent neurologic disability or death to vaccine use. One of the leading sites in the anti-immunization field is the National Vaccine Information Centre (NVIC).

Other studies besides Wakefield's have suggested a link between autism and vaccination. H.H.Fudenberg reported that the first symptoms of autism among 15 of 20 children developed within a week of vaccination. S.Gupta commented on the striking association between MMR vaccination and the onset of behavioral symptoms in all the children he investigated for regressive autism.

The MMR vaccine is all live virus. Disintegrative psychosis is recognized as a sequela of measles encephalitis. Viral encephalitis can give rise to autistic disorders, particularly when it occur early in life.

A genetic association for autism is represented by a null allele of the complement C4B gene located in the class III region of the major histocompatibility complex. The C4B-gene is also crucial for protection against viruses. Affected individuals may not handle certain viruses appropriately - even the attenuated ones used in vaccines. In an addendum to the paper, Wakefield, et al. noted that their sample size had increased to 40 children by Jan 28,1998, with 39 of those showing similar findings. The C4b null allele is present on chromosome 6.3

These studies support our view that MMR vaccine may trigger a cascade of events leading to autism in genetically susceptible children, and not affect children who lack susceptibility. Unfortunately, vaccination among public health and medical practitioners has become almost sacred. Questioning the wisdom of vaccination for certain children is seen as professional heresy. Nevertheless, the possibility cannot be ignored.

Could killed (rather than live virus) MMR accomplish the same task? Should measles be administered separately from mumps? We know that the combination of chicken pox and measles dramatically increases the risk for subacute sclerosing panencephalitis. Perhaps other mixed viral infections are also clinically significant.

More important is the science we must use to explore this. Simple correlation analysis and comparison studies will not suffice. If autism is indeed linked to the MMR vaccine in genetically susceptible individuals, unless these individuals are selected from the larger pool, the statistical significance will cancel out in these studies.

Medical research also suffers from a failure to consider interactions and synergy in the disease process. Simple epidemiology will not suffice either, since we are not even sure what the potential genetic defect is in autism - or if autism is one syndrome or many.

The United States' Center for Disease Control (CDC) believes that the current scientific evidence does not support the hypothesis that MMR, or any combination of vaccines, cause the development of autism, including regressive forms of autism.4 CDC argues that the apparent link between MMR and autism is purely coincidental, based upon the fact that the MMR vaccine is usually given between the ages of 12 and 18 months, which is also the most common age at which autism is diagnosed. One could say, "go figure!", or pursue more sophisticated studies.

An extensive study of the evidence was recently conducted in the United Kingdom. The British Committee on Safety of Medicines convened a "Working Party on MMR Vaccine" to conduct a systematic review of reports of autism, gastrointestinal disease, and similar disorders after receipt of MMR or measles/rubella vaccine. The National Childhood Encephalopathy Study (NCES) was examined to see if there was any link between measles vaccine and neurological events.

The CDC noted that no researchers in England had found any indication that measles vaccine contributed to the development of long-term neurological damage, including educational and behavioral deficits (Miller et al. 1997). A more recent epidemiological study also found no association between MMR vaccine and autism (Taylor et al. 1999). This study compared rates of autism between children who received the MMR vaccine and children who did not. The results found no difference in rates of autism between the two groups. On the other hand, such large scale population studies, would not necessarily be expected to identify a small difference in autistic rates, which, as parents argue, is crucial to those affected.

The CDC agreed with an expert committee from the UK Medical Research Council (MRC) who reviewed Wakefield's research and concluded that no link had been demonstrated between MMR vaccine and inflammatory bowel disease in autism.

Wakefield's study was criticized for:

Using too few cases to make any generalizations about the causes of autism; only 12 children were included in the study. The cases were selected by researchers and may not be representative of many cases of autism.

There were inadequate groups of control children. As a result, it is difficult to determine whether the bowel changes were similar to changes in normal children, or to determine if the rate of vaccination in autistic children was higher than in the general population.

The study did not identify the time period during which the cases were identified.

In at least 4 of the 12 cases, behavioral problems appeared before the onset of symptoms of bowel disease; that is, the effect preceded the proposed cause. It is thus proposed unlikely, therefore, that bowel disease or the MMR vaccine triggered the autism.

The CDC argues against any scientific research or data indicating benefit to separating the MMR vaccine into its individual components. CDC argued that splitting the MMR vaccine into three separate doses could be harmful because it would expose children unnecessarily to potentially serious diseases. If the rubella vaccine were delayed, 4 million children would be susceptible to rubella for an additional six to 12 months. This would potentially allow otherwise preventable cases of congenital rubella syndrome (CRS) to occur. Infection of pregnant woman with "wild" rubella virus is one of the few known causes of autism. Thus, by preventing infection of pregnant women, rubella vaccine also prevents autism, asserts CDC.

CDC argues that, due to the general safety of vaccines, and the rarity of serious vaccine adverse events [Ed: although, see information from the US government contained in a Database of Vaccine Injury: The Vaccine Adverse Event Reporting System (VAERS)], it is extremely difficult to study whether a subgroup (e.g., family members) are actually at increased risk compared with the general population.

The one exception, they acknowledge, is an increased risk of neurologic events -primarily febrile seizures - after vaccination with DTP vaccine and measles-containing vaccines (MCV). The risk increases if any of these have previously occurred in immediate family members. Considering the rare occurrence of these events after DTP and MCV vaccination, the generally benign outcome of febrile convulsions, and the risk of pertussis and measles to unvaccinated people and the general population, the Advisory Committee on Immunization Practices concluded that a history of convulsions in siblings or parents should not be a contraindication to pertussis or measles vaccination.

Special care in the prevention of post-vaccination fever could be warranted in children with a family history of seizures, they admit. For instance, oral polio vaccine (OPV) is contraindicated when there is a family member with immune-deficiency, since OPV can spread to family contacts.

CDC argues for evidence of the benefits of childhood immunization, including record, or near record, low rates of vaccine preventable diseases in the United States. Last year, for example, there were fewer than 100 reported cases of measles - and no deaths - in the US, compared with 27,786 cases and 64 deaths in 1990.

Kawashima, et al.5 reported that measles virus could be present in the intestines of patients with Crohn's disease. Responding to Wakefield's data on "autistic enterocolitis (see above), the authors set out to determine if the virus found in Crohn's disease, ulcerative colitis, and autistic enterocolitis came from wild strains of measles or from vaccine strains.

To do this, they found measles RNA from peripheral blood mononuclear leukocytes (PBML) in eight patients with Crohn's disease, three patients with ulcerative colitis, and nine children with autistic enterocolitis. They used healthy children and patients with subacute sclerosing pan-encephalitis and human immunodeficiency virus 1 as controls (eight patients).

RNA was purified from PBML, followed by reverse transcription. The resulting cDNAs were subjected to nested PCR for detection of specific regions of the hemaglutinin (H) and fusion (F) gene regions. Positive samples were sequenced directly, in nucleotides 8393-8676 (H region) or 5325-5465 (from noncoding F to coding F region).

One of eight patients with Crohn disease, one of three patients with ulcerative colitis, and three of nine children with autism, were positive. Controls were all negative. The sequences obtained from the patients with Crohn's disease shared the characteristics with wild-strain virus. The sequences obtained from the patients with ulcerative colitis and children with autism were consistent with being vaccine strains. The results were concordant with the exposure history of the patients. Persistence of measles virus was confirmed in PBML in some patients with chronic intestinal inflammation.

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Deadly Immunity

Robert F. Kennedy Jr. investigates the government cover-up of a mercury/autism scandal

In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood conference center in Norcross, Georgia. Convened by the Centers for Disease Control and Prevention, the meeting was held at this Methodist retreat center, nestled in wooded farmland next to the Chattahoochee River, to ensure complete secrecy. The agency had issued no public announcement of the session -- only private invitations to fifty-two attendees. There were high-level officials from the CDC and the Food and Drug Administration, the top vaccine specialist from the World Health Organization in Geneva and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur. All of the scientific data under discussion, CDC officials repeatedly reminded the participants, was strictly "embargoed." There would be no making photocopies of documents, no taking papers with them when they left.

The federal officials and industry representatives had assembled to discuss a disturbing new study that raised alarming questions about the safety of a host of common childhood vaccines administered to infants and young children. According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the agency's massive database containing the medical records of 100,000 children, a mercury-based preservative in the vaccines -- thimerosal -- appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children. "I was actually stunned by what I saw," Verstraeten told those assembled at Simpsonwood, citing the staggering number of earlier studies that indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity and autism. Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the preservative be given to extremely young infants -- in one case, within hours of birth -- the estimated number of cases of autism had increased fifteenfold, from one in every 2,500 children to one in 166 children.

Even for scientists and doctors accustomed to confronting issues of life and death, the findings were frightening. "You can play with this all you want," Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the group. The results "are statistically significant." Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado whose grandson had been born early on the morning of the meeting's first day, was even more alarmed. "My gut feeling?" he said. "Forgive this personal comment -- I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on."

But instead of taking immediate steps to alert the public and rid the vaccine supply of thimerosal, the officials and executives at Simpsonwood spent most of the next two days discussing how to cover up the damaging data. According to transcripts obtained under the Freedom of Information Act, many at the meeting were concerned about how the damaging revelations about thimerosal would affect the vaccine industry's bottom line. "We are in a bad position from the standpoint of defending any lawsuits," said Dr. Robert Brent, a pediatrician at the Alfred I. duPont Hospital for Children in Delaware. "This will be a resource to our very busy plaintiff attorneys in this country." Dr. Bob Chen, head of vaccine safety for the CDC, expressed relief that "given the sensitivity of the information, we have been able to keep it out of the hands of, let's say, less responsible hands." Dr. John Clements, vaccines adviser at the World Health Organization, declared flatly that the study "should not have been done at all" and warned that the results "will be taken by others and will be used in ways beyond the control of this group. The research results have to be handled."

In fact, the government has proved to be far more adept at handling the damage than at protecting children's health. The CDC paid the Institute of Medicine to conduct a new study to whitewash the risks of thimerosal, ordering researchers to "rule out" the chemical's link to autism. It withheld Verstraeten's findings, even though they had been slated for immediate publication, and told other scientists that his original data had been "lost" and could not be replicated. And to thwart the Freedom of Information Act, it handed its giant database of vaccine records over to a private company, declaring it off-limits to researchers. By the time Verstraeten finally published his study in 2003, he had gone to work for GlaxoSmithKline and reworked his data to bury the link between thimerosal and autism.

Vaccine manufacturers had already begun to phase thimerosal out of injections given to American infants -- but they continued to sell off their mercury-based supplies of vaccines until last year. The CDC and FDA gave them a hand, buying up the tainted vaccines for export to developing countries and allowing drug companies to continue using the preservative in some American vaccines -- including several pediatric flu shots as well as tetanus boosters routinely given to eleven-year-olds.

The drug companies are also getting help from powerful lawmakers in Washington. Senate Majority Leader Bill Frist, who has received $873,000 in contributions from the pharmaceutical industry, has been working to immunize vaccine makers from liability in 4,200 lawsuits that have been filed by the parents of injured children. On five separate occasions, Frist has tried to seal all of the government's vaccine-related documents -- including the Simpsonwood transcripts -- and shield Eli Lilly, the developer of thimerosal, from subpoenas. In 2002, the day after Frist quietly slipped a rider known as the "Eli Lilly Protection Act" into a homeland security bill, the company contributed $10,000 to his campaign and bought 5,000 copies of his book on bioterrorism. The measure was repealed by Congress in 2003 -- but earlier this year, Frist slipped another provision into an anti-terrorism bill that would deny compensation to children suffering from vaccine-related brain disorders. "The lawsuits are of such magnitude that they could put vaccine producers out of business and limit our capacity to deal with a biological attack by terrorists," says Andy Olsen, a legislative assistant to Frist.

Even many conservatives are shocked by the government's effort to cover up the dangers of thimerosal. Rep. Dan Burton, a Republican from Indiana, oversaw a three-year investigation of thimerosal after his grandson was diagnosed with autism. "Thimerosal used as a preservative in vaccines is directly related to the autism epidemic," his House Government Reform Committee concluded in its final report. "This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal, a known neurotoxin." The FDA and other public-health agencies failed to act, the committee added, out of "institutional malfeasance for self protection" and "misplaced protectionism of the pharmaceutical industry."

The story of how government health agencies colluded with Big Pharma to hide the risks of thimerosal from the public is a chilling case study of institutional arrogance, power and greed. I was drawn into the controversy only reluctantly. As an attorney and environmentalist who has spent years working on issues of mercury toxicity, I frequently met mothers of autistic children who were absolutely convinced that their kids had been injured by vaccines. Privately, I was skeptical.

I doubted that autism could be blamed on a single source, and I certainly understood the government's need to reassure parents that vaccinations are safe; the eradication of deadly childhood diseases depends on it. I tended to agree with skeptics like Rep. Henry Waxman, a Democrat from California, who criticized his colleagues on the House Government Reform Committee for leaping to conclusions about autism and vaccinations. "Why should we scare people about immunization," Waxman pointed out at one hearing, "until we know the facts?"

It was only after reading the Simpsonwood transcripts, studying the leading scientific research and talking with many of the nation's pre-eminent authorities on mercury that I became convinced that the link between thimerosal and the epidemic of childhood neurological disorders is real. Five of my own children are members of the Thimerosal Generation -- those born between 1989 and 2003 -- who received heavy doses of mercury from vaccines. "The elementary grades are overwhelmed with children who have symptoms of neurological or immune-system damage," Patti White, a school nurse, told the House Government Reform Committee in 1999. "Vaccines are supposed to be making us healthier; however, in twenty-five years of nursing I have never seen so many damaged, sick kids. Something very, very wrong is happening to our children."

More than 500,000 kids currently suffer from autism, and pediatricians diagnose more than 40,000 new cases every year. The disease was unknown until 1943, when it was identified and diagnosed among eleven children born in the months after thimerosal was first added to baby vaccines in 1931.

Some skeptics dispute that the rise in autism is caused by thimerosal-tainted vaccinations. They argue that the increase is a result of better diagnosis -- a theory that seems questionable at best, given that most of the new cases of autism are clustered within a single generation of children. "If the epidemic is truly an artifact of poor diagnosis," scoffs Dr. Boyd Haley, one of the world's authorities on mercury toxicity, "then where are all the twenty-year-old autistics?" Other researchers point out that Americans are exposed to a greater cumulative "load" of mercury than ever before, from contaminated fish to dental fillings, and suggest that thimerosal in vaccines may be only part of a much larger problem. It's a concern that certainly deserves far more attention than it has received -- but it overlooks the fact that the mercury concentrations in vaccines dwarf other sources of exposure to our children.

What is most striking is the lengths to which many of the leading detectives have gone to ignore -- and cover up -- the evidence against thimerosal. From the very beginning, the scientific case against the mercury additive has been overwhelming. The preservative, which is used to stem fungi and bacterial growth in vaccines, contains ethylmercury, a potent neurotoxin. Truckloads of studies have shown that mercury tends to accumulate in the brains of primates and other animals after they are injected with vaccines -- and that the developing brains of infants are particularly susceptible. In 1977, a Russian study found that adults exposed to much lower concentrations of ethylmercury than those given to American children still suffered brain damage years later. Russia banned thimerosal from children's vaccines twenty years ago, and Denmark, Austria, Japan, Great Britain and all the Scandinavian countries have since followed suit.

"You couldn't even construct a study that shows thimerosal is safe," says Haley, who heads the chemistry department at the University of Kentucky. "It's just too darn toxic. If you inject thimerosal into an animal, its brain will sicken. If you apply it to living tissue, the cells die. If you put it in a petri dish, the culture dies. Knowing these things, it would be shocking if one could inject it into an infant without causing damage."

Internal documents reveal that Eli Lilly, which first developed thimerosal, knew from the start that its product could cause damage -- and even death -- in both animals and humans. In 1930, the company tested thimerosal by administering it to twenty-two patients with terminal meningitis, all of whom died within weeks of being injected -- a fact Lilly didn't bother to report in its study declaring thimerosal safe. In 1935, researchers at another vaccine manufacturer, Pittman-Moore, warned Lilly that its claims about thimerosal's safety "did not check with ours." Half the dogs Pittman injected with thimerosal-based vaccines became sick, leading researchers there to declare the preservative "unsatisfactory as a serum intended for use on dogs."

In the decades that followed, the evidence against thimerosal continued to mount. During the Second World War, when the Department of Defense used the preservative in vaccines on soldiers, it required Lilly to label it "poison." In 1967, a study in Applied Microbiology found that thimerosal killed mice when added to injected vaccines. Four years later, Lilly's own studies discerned that thimerosal was "toxic to tissue cells" in concentrations as low as one part per million -- 100 times weaker than the concentration in a typical vaccine. Even so, the company continued to promote thimerosal as "nontoxic" and also incorporated it into topical disinfectants. In 1977, ten babies at a Toronto hospital died when an antiseptic preserved with thimerosal was dabbed onto their umbilical cords.

In 1982, the FDA proposed a ban on over-the-counter products that contained thimerosal, and in 1991 the agency considered banning it from animal vaccines. But tragically, that same year, the CDC recommended that infants be injected with a series of mercury-laced vaccines. Newborns would be vaccinated for hepatitis B within twenty-four hours of birth, and two-month-old infants would be immunized for haemophilus influenzae B and diphtheria-tetanus-pertussis.

The drug industry knew the additional vaccines posed a danger. The same year that the CDC approved the new vaccines, Dr. Maurice Hilleman, one of the fathers of Merck's vaccine programs, warned the company that six-month-olds who were administered the shots would suffer dangerous exposure to mercury. He recommended that thimerosal be discontinued, "especially when used on infants and children," noting that the industry knew of nontoxic alternatives. "The best way to go," he added, "is to switch to dispensing the actual vaccines without adding preservatives."

For Merck and other drug companies, however, the obstacle was money. Thimerosal enables the pharmaceutical industry to package vaccines in vials that contain multiple doses, which require additional protection because they are more easily contaminated by multiple needle entries. The larger vials cost half as much to produce as smaller, single-dose vials, making it cheaper for international agencies to distribute them to impoverished regions at risk of epidemics. Faced with this "cost consideration," Merck ignored Hilleman's warnings, and government officials continued to push more and more thimerosal-based vaccines for children. Before 1989, American preschoolers received only three vaccinations -- for polio, diphtheria-tetanus-pertussis and measles-mumps-rubella. A decade later, thanks to federal recommendations, children were receiving a total of twenty-two immunizations by the time they reached first grade.

As the number of vaccines increased, the rate of autism among children exploded. During the 1990s, 40 million children were injected with thimerosal-based vaccines, receiving unprecedented levels of mercury during a period critical for brain development. Despite the well-documented dangers of thimerosal, it appears that no one bothered to add up the cumulative dose of mercury that children would receive from the mandated vaccines. "What took the FDA so long to do the calculations?" Peter Patriarca, director of viral products for the agency, asked in an e-mail to the CDC in 1999. "Why didn't CDC and the advisory bodies do these calculations when they rapidly expanded the childhood immunization schedule?"

But by that time, the damage was done. Infants who received all their vaccines, plus boosters, by the age of six months were being injected with levels of ethylmercury 187 times greater than the EPA's limit for daily exposure to methylmercury, a related neurotoxin. Although the vaccine industry insists that ethylmercury poses little danger because it breaks down rapidly and is removed by the body, several studies -- including one published in April by the National Institutes of Health -- suggest that ethylmercury is actually more toxic to developing brains and stays in the brain longer than methylmercury.

Officials responsible for childhood immunizations insist that the additional vaccines were necessary to protect infants from disease and that thimerosal is still essential in developing nations, which, they often claim, cannot afford the single-dose vials that don't require a preservative. Dr. Paul Offit, one of CDC's top vaccine advisers, told me, "I think if we really have an influenza pandemic -- and certainly we will in the next twenty years, because we always do -- there's no way on God's earth that we immunize 280 million people with single-dose vials. There has to be multidose vials."

But while public-health officials may have been well-intentioned, many of those on the CDC advisory committee who backed the additional vaccines had close ties to the industry. Dr. Sam Katz, the committee's chair, was a paid consultant for most of the major vaccine makers and shares a patent on a measles vaccine with Merck, which also manufactures the hepatitis B vaccine. Dr. Neal Halsey, another committee member, worked as a researcher for the vaccine companies and received honoraria from Abbott Labs for his research on the hepatitis B vaccine.

Indeed, in the tight circle of scientists who work on vaccines, such conflicts of interest are common. Rep. Burton says that the CDC "routinely allows scientists with blatant conflicts of interest to serve on intellectual advisory committees that make recommendations on new vaccines," even though they have "interests in the products and companies for which they are supposed to be providing unbiased oversight." The House Government Reform Committee discovered that four of the eight CDC advisers who approved guidelines for a rotavirus vaccine laced with thimerosal "had financial ties to the pharmaceutical companies that were developing different versions of the vaccine."

Offit, who shares a patent on the vaccine, acknowledged to me that he "would make money" if his vote to approve it eventually leads to a marketable product. But he dismissed my suggestion that a scientist's direct financial stake in CDC approval might bias his judgment. "It provides no conflict for me," he insists. "I have simply been informed by the process, not corrupted by it. When I sat around that table, my sole intent was trying to make recommendations that best benefited the children in this country. It's offensive to say that physicians and public-health people are in the pocket of industry and thus are making decisions that they know are unsafe for children. It's just not the way it works."

Other vaccine scientists and regulators gave me similar assurances. Like Offit, they view themselves as enlightened guardians of children's health, proud of their "partnerships" with pharmaceutical companies, immune to the seductions of personal profit, besieged by irrational activists whose anti-vaccine campaigns are endangering children's health. They are often resentful of questioning. "Science," says Offit, "is best left to scientists."

Still, some government officials were alarmed by the apparent conflicts of interest. In his e-mail to CDC administrators in 1999, Paul Patriarca of the FDA blasted federal regulators for failing to adequately scrutinize the danger posed by the added baby vaccines. "I'm not sure there will be an easy way out of the potential perception that the FDA, CDC and immunization-policy bodies may have been asleep at the switch re: thimerosal until now," Patriarca wrote. The close ties between regulatory officials and the pharmaceutical industry, he added, "will also raise questions about various advisory bodies regarding aggressive recommendations for use" of thimerosal in child vaccines.

If federal regulators and government scientists failed to grasp the potential risks of thimerosal over the years, no one could claim ignorance after the secret meeting at Simpsonwood. But rather than conduct more studies to test the link to autism and other forms of brain damage, the CDC placed politics over science. The agency turned its database on childhood vaccines -- which had been developed largely at taxpayer expense -- over to a private agency, America's Health Insurance Plans, ensuring that it could not be used for additional research. It also instructed the Institute of Medicine, an advisory organization that is part of the National Academy of Sciences, to produce a study debunking the link between thimerosal and brain disorders. The CDC "wants us to declare, well, that these things are pretty safe," Dr. Marie McCormick, who chaired the IOM's Immunization Safety Review Committee, told her fellow researchers when they first met in January 2001. "We are not ever going to come down that [autism] is a true side effect" of thimerosal exposure. According to transcripts of the meeting, the committee's chief staffer, Kathleen Stratton, predicted that the IOM would conclude that the evidence was "inadequate to accept or reject a causal relation" between thimerosal and autism. That, she added, was the result "Walt wants" -- a reference to Dr. Walter Orenstein, director of the National Immunization Program for the CDC.

For those who had devoted their lives to promoting vaccination, the revelations about thimerosal threatened to undermine everything they had worked for. "We've got a dragon by the tail here," said Dr. Michael Kaback, another committee member. "The more negative that [our] presentation is, the less likely people are to use vaccination, immunization -- and we know what the results of that will be. We are kind of caught in a trap. How we work our way out of the trap, I think is the charge."

Even in public, federal officials made it clear that their primary goal in studying thimerosal was to dispel doubts about vaccines. "Four current studies are taking place to rule out the proposed link between autism and thimerosal," Dr. Gordon Douglas, then-director of strategic planning for vaccine research at the National Institutes of Health, assured a Princeton University gathering in May 2001. "In order to undo the harmful effects of research claiming to link the [measles] vaccine to an elevated risk of autism, we need to conduct and publicize additional studies to assure parents of safety." Douglas formerly served as president of vaccinations for Merck, where he ignored warnings about thimerosal's risks.

In May of last year, the Institute of Medicine issued its final report. Its conclusion: There is no proven link between autism and thimerosal in vaccines. Rather than reviewing the large body of literature describing the toxicity of thimerosal, the report relied on four disastrously flawed epidemiological studies examining European countries, where children received much smaller doses of thimerosal than American kids. It also cited a new version of the Verstraeten study, published in the journal Pediatrics, that had been reworked to reduce the link between thimerosal and autism. The new study included children too young to have been diagnosed with autism and overlooked others who showed signs of the disease. The IOM declared the case closed and -- in a startling position for a scientific body -- recommended that no further research be conducted.

The report may have satisfied the CDC, but it convinced no one. Rep. David Weldon, a Republican physician from Florida who serves on the House Government Reform Committee, attacked the Institute of Medicine, saying it relied on a handful of studies that were "fatally flawed" by "poor design" and failed to represent "all the available scientific and medical research." CDC officials are not interested in an honest search for the truth, Weldon told me, because "an association between vaccines and autism would force them to admit that their policies irreparably damaged thousands of children. Who would want to make that conclusion about themselves?"

Under pressure from congress, parents and a few of its own panel members, the Institute of Medicine reluctantly convened a second panel to review the findings of the first. In February, the new panel, composed of different scientists, criticized the earlier panel for its lack of transparency and urged the CDC to make its vaccine database available to the public.

So far, though, only two scientists have managed to gain access. Dr. Mark Geier, president of the Genetics Center of America, and his son, David, spent a year battling to obtain the medical records from the CDC. Since August 2002, when members of Congress pressured the agency to turn over the data, the Geiers have completed six studies that demonstrate a powerful correlation between thimerosal and neurological damage in children. One study, which compares the cumulative dose of mercury received by children born between 1981 and 1985 with those born between 1990 and 1996, found a "very significant relationship" between autism and vaccines. Another study of educational performance found that kids who received higher doses of thimerosal in vaccines were nearly three times as likely to be diagnosed with autism and more than three times as likely to suffer from speech disorders and mental retardation. Another soon-to-be published study shows that autism rates are in decline following the recent elimination of thimerosal from most vaccines.

As the federal government worked to prevent scientists from studying vaccines, others have stepped in to study the link to autism. In April, reporter Dan Olmsted of UPI undertook one of the more interesting studies himself. Searching for children who had not been exposed to mercury in vaccines -- the kind of population that scientists typically use as a "control" in experiments -- Olmsted scoured the Amish of Lancaster County, Pennsylvania, who refuse to immunize their infants. Given the national rate of autism, Olmsted calculated that there should be 130 autistics among the Amish. He found only four. One had been exposed to high levels of mercury from a power plant. The other three -- including one child adopted from outside the Amish community -- had received their vaccines.

At the state level, many officials have also conducted in-depth reviews of thimerosal. While the Institute of Medicine was busy whitewashing the risks, the Iowa legislature was carefully combing through all of the available scientific and biological data. "After three years of review, I became convinced there was sufficient credible research to show a link between mercury and the increased incidences in autism," says state Sen. Ken Veenstra, a Republican who oversaw the investigation. "The fact that Iowa's 700 percent increase in autism began in the 1990s, right after more and more vaccines were added to the children's vaccine schedules, is solid evidence alone." Last year, Iowa became the first state to ban mercury in vaccines, followed by California. Similar bans are now under consideration in thirty-two other states.

But instead of following suit, the FDA continues to allow manufacturers to include thimerosal in scores of over-the-counter medications as well as steroids and injected collagen. Even more alarming, the government continues to ship vaccines preserved with thimerosal to developing countries -- some of which are now experiencing a sudden explosion in autism rates. In China, where the disease was virtually unknown prior to the introduction of thimerosal by U.S. drug manufacturers in 1999, news reports indicate that there are now more than 1.8 million autistics. Although reliable numbers are hard to come by, autistic disorders also appear to be soaring in India, Argentina, Nicaragua and other developing countries that are now using thimerosal-laced vaccines. The World Health Organization continues to insist thimerosal is safe, but it promises to keep the possibility that it is linked to neurological disorders "under review."

I devoted time to study this issue because I believe that this is a moral crisis that must be addressed. If, as the evidence suggests, our public-health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American children, their actions arguably constitute one of the biggest scandals in the annals of American medicine. "The CDC is guilty of incompetence and gross negligence," says Mark Blaxill, vice president of Safe Minds, a nonprofit organization concerned about the role of mercury in medicines. "The damage caused by vaccine exposure is massive. It's bigger than asbestos, bigger than tobacco, bigger than anything you've ever seen."

It's hard to calculate the damage to our country -- and to the international efforts to eradicate epidemic diseases -- if Third World nations come to believe that America's most heralded foreign-aid initiative is poisoning their children. It's not difficult to predict how this scenario will be interpreted by America's enemies abroad. The scientists and researchers -- many of them sincere, even idealistic -- who are participating in efforts to hide the science on thimerosal claim that they are trying to advance the lofty goal of protecting children in developing nations from disease pandemics. They are badly misguided. Their failure to come clean on thimerosal will come back horribly to haunt our country and the world's poorest populations.

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VACCINES, MERCURY, AUTISM---THE CHEMICAL CRIMES

JUNE 20, 2005. The article below, written by Robert F Kennedy, Jr., was published in Salon.com and then re-printed in Common Dreams. It concerns the toxic effects of mercury in vaccines and the cover-up of that crime.

Several comments:

This article assumes that vaccines are a good thing. I have disputed that assumption for the last 15 years, and have written much on the subject.

In general, the long-term decline in various so-called infectious diseases is attributable to factors like improved nutrition and sanitation and cleaner water supplies and less overcrowding of populations---not the introduction of vaccines.

There are still vaccines on the market that contain mercury, and there are also drugs that contain mercury.

While it may be polite to say that health authorities overlooked the mercury problem, and while it may be less polite to say they coverered it up, in reality we are talking about a crime. A crime of poisoning. It is one of the most basic and traditional of crimes. It is actually a form of warfare, no matter what rationalizations are offered.

The most often-used rationalization goes this way: "We know that vaccines are miracles of disease prevention. If we scare the public by admitting we have been using a poison in vaccines, they will stay away from all vaccines, they won't trust us, and millions of unvaccinated children will die. Therefore, we must lie."

In fact, vaccines are not miracles. They are multi-faceted poisons. They may induce the formation of antibodies, which are said to be the best protection against future disease, but human immunity from disease is a much more complex situation. Immunity really comes from basic overall health, not from a shot of attenuated and/or live germs plus mercury, aluminum, formaldehyde, and other chemicals.

Medical authorities have no problem saying the public should be the last to know. "We will protect you, but you must leave the method to us. You shouldn't enter into the process, which is really science, about which you know nothing. We're the pros. Trust us. Don't impede us."

Treating the public as a mass of uncomprehending idiots, time and time again, establishes a self-fulfilling prophecy. Walled off from vital information, the public does become more ignorant and less able to think matters through to essential conclusions.

Although it is true that admitting the mercury-autism link would greatly injure the profit picture of pharmaceutical companies and bring down hundreds of class-action suits on their heads, it is more true that a crime is in progress. In other words, if we focus too tightly on the concept that these companies are wrongly trying to protect their money, we don't emphasize strongly enough that they and the government agencies that aid them are engaged in a death-injection program.

Published on Thursday, June 16, 2005 by Salon.com

Deadly Immunity

When a study revealed that mercury in childhood vaccines may have caused autism in thousands of kids, the government rushed to conceal the data -- and to prevent parents from suing drug companies for their role in the epidemic.

by Robert F. Kennedy Jr.

In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood conference center in Norcross, Ga. Convened by the Centers for Disease Control and Prevention, the meeting was held at this Methodist retreat center, nestled in wooded farmland next to the Chattahoochee River, to ensure complete secrecy.

The agency had issued no public announcement of the session -- only private invitations to 52 attendees. There were high-level officials from the CDC and the Food and Drug Administration, the top vaccine specialist from the World Health Organization in Geneva, and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur.

All of the scientific data under discussion, CDC officials repeatedly reminded the participants, was strictly "embargoed." There would be no making photocopies of documents, no taking papers with them when they left.

The federal officials and industry representatives had assembled to discuss a disturbing new study that raised alarming questions about the safety of a host of common childhood vaccines administered to infants and young children. According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the agency's massive database containing the medical records of 100,000 children, a mercury-based preservative in the vaccines -- thimerosal -- appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children.

"I was actually stunned by what I saw," Verstraeten told those assembled at Simpsonwood, citing the staggering number of earlier studies that indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity and autism.

Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the preservative be given to extremely young infants -- in one case, within hours of birth -- the estimated number of cases of autism had increased fifteenfold, from one in every 2,500 children to one in 166 children.

Even for scientists and doctors accustomed to confronting issues of life and death, the findings were frightening. "You can play with this all you want," Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the group. The results "are statistically significant."

Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado whose grandson had been born early on the morning of the meeting's first day, was even more alarmed. "My gut feeling?" he said. "Forgive this personal comment -- I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on."

But instead of taking immediate steps to alert the public and rid the vaccine supply of thimerosal, the officials and executives at Simpsonwood spent most of the next two days discussing how to cover up the damaging data.

According to transcripts obtained under the Freedom of Information Act, many at the meeting were concerned about how the damaging revelations about thimerosal would affect the vaccine industry's bottom line. "We are in a bad position from the standpoint of defending any lawsuits," said Dr. Robert Brent, a pediatrician at the Alfred I. duPont Hospital for Children in Delaware. "This will be a resource to our very busy plaintiff attorneys in this country."

Dr. Bob Chen, head of vaccine safety for the CDC, expressed relief that "given the sensitivity of the information, we have been able to keep it out of the hands of, let's say, less responsible hands."

Dr. John Clements, vaccines advisor at the World Health Organization, declared flatly that the study "should not have been done at all" and warned that the results "will be taken by others and will be used in ways beyond the control of this group. The research results have to be handled."

In fact, the government has proved to be far more adept at handling the damage than at protecting children's health. The CDC paid the Institute of Medicine to conduct a new study to whitewash the risks of thimerosal, ordering researchers to "rule out" the chemical's link to autism. It withheld Verstraeten's findings, even though they had been slated for immediate publication, and told other scientists that his original data had been "lost" and could not be replicated. And to thwart the Freedom of Information Act, it handed its giant database of vaccine records over to a private company, declaring it off-limits to researchers.

By the time Verstraeten finally published his study in 2003, he had gone to work for GlaxoSmithKline and reworked his data to bury the link between thimerosal and autism.

Vaccine manufacturers had already begun to phase thimerosal out of injections given to American infants -- but they continued to sell off their mercury-based supplies of vaccines until last year. The CDC and FDA gave them a hand, buying up the tainted vaccines for export to developing countries and allowing drug companies to continue using the preservative in some American vaccines -- including several pediatric flu shots as well as tetanus boosters routinely given to 11-year-olds.

The drug companies are also getting help from powerful lawmakers in Washington. Senate Majority Leader Bill Frist, who has received $873,000 in contributions from the pharmaceutical industry, has been working to immunize vaccine makers from liability in 4,200 lawsuits that have been filed by the parents of injured children.

On five separate occasions, Frist has tried to seal all of the government's vaccine-related documents -- including the Simpsonwood transcripts -- and shield Eli Lilly, the developer of thimerosal, from subpoenas. In 2002, the day after Frist quietly slipped a rider known as the "Eli Lilly Protection Act" into a homeland security bill, the company contributed $10,000 to his campaign and bought 5,000 copies of his book on bioterrorism.

Congress repealed the measure in 2003 -- but earlier this year, Frist slipped another provision into an anti-terrorism bill that would deny compensation to children suffering from vaccine-related brain disorders. "The lawsuits are of such magnitude that they could put vaccine producers out of business and limit our capacity to deal with a biological attack by terrorists," says Andy Olsen, a legislative assistant to Frist.

Even many conservatives are shocked by the government's effort to cover up the dangers of thimerosal. Rep. Dan Burton, a Republican from Indiana, oversaw a three-year investigation of thimerosal after his grandson was diagnosed with autism. "Thimerosal used as a preservative in vaccines is directly related to the autism epidemic," his House Government Reform Committee concluded in its final report. "This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal, a known neurotoxin."

The FDA and other public-health agencies failed to act, the committee added, out of "institutional malfeasance for self protection" and "misplaced protectionism of the pharmaceutical industry."

The story of how government health agencies colluded with Big Pharma to hide the risks of thimerosal from the public is a chilling case study of institutional arrogance, power and greed. I was drawn into the controversy only reluctantly. As an attorney and environmentalist who has spent years working on issues of mercury toxicity, I frequently met mothers of autistic children who were absolutely convinced that their kids had been injured by vaccines. Privately, I was skeptical. I doubted that autism could be blamed on a single source, and I certainly understood the government's need to reassure parents that vaccinations are safe; the eradication of deadly childhood diseases depends on it. I tended to agree with skeptics like Rep. Henry Waxman, a Democrat from California, who criticized his colleagues on the House Government Reform Committee for leaping to conclusions about autism and vaccinations.

"Why should we scare people about immunization," Waxman pointed out at one hearing, "until we know the facts?" It was only after reading the Simpsonwood transcripts, studying the leading scientific research and talking with many of the nation's preeminent authorities on mercury that I became convinced that the link between thimerosal and the epidemic of childhood neurological disorders is real.

Five of my own children are members of the Thimerosal Generation -- those born between 1989 and 2003 -- who received heavy doses of mercury from vaccines. "The elementary grades are overwhelmed with children who have symptoms of neurological or immune-system damage," Patti White, a school nurse, told the House Government Reform Committee in 1999. "Vaccines are supposed to be making us healthier; however, in 25 years of nursing I have never seen so many damaged, sick kids. Something very, very wrong is happening to our children."

More than 500,000 kids currently suffer from autism, and pediatricians diagnose more than 40,000 new cases every year. The disease was unknown until 1943, when it was identified and diagnosed among 11 children born in the months after thimerosal was first added to baby vaccines in 1931.

Some skeptics dispute that the rise in autism is caused by thimerosal-tainted vaccinations. They argue that the increase is a result of better diagnosis -- a theory that seems questionable at best, given that most of the new cases of autism are clustered within a single generation of children. "If the epidemic is truly an artifact of poor diagnosis," scoffs Dr. Boyd Haley, one of the world's authorities on mercury toxicity, "then where are all the 20-year-old autistics?"

Other researchers point out that Americans are exposed to a greater cumulative "load" of mercury than ever before, from contaminated fish to dental fillings, and suggest that thimerosal in vaccines may be only part of a much larger problem. It's a concern that certainly deserves far more attention than it has received -- but it overlooks the fact that the mercury concentrations in vaccines dwarf other sources of exposure to our children.

What is most striking is the lengths to which many of the leading detectives have gone to ignore -- and cover up -- the evidence against thimerosal. From the very beginning, the scientific case against the mercury additive has been overwhelming. The preservative, which is used to stem fungi and bacterial growth in vaccines, contains ethylmercury, a potent neurotoxin. Truckloads of studies have shown that mercury tends to accumulate in the brains of primates and other animals after they are injected with vaccines -- and that the developing brains of infants are particularly susceptible.

In 1977, a Russian study found that adults exposed to much lower concentrations of ethylmercury than those given to American children still suffered brain damage years later. Russia banned thimerosal from children's vaccines 20 years ago, and Denmark, Austria, Japan, Great Britain and all the Scandinavian countries have since followed suit.

"You couldn't even construct a study that shows thimerosal is safe," says Haley, who heads the chemistry department at the University of Kentucky. "It's just too darn toxic. If you inject thimerosal into an animal, its brain will sicken. If you apply it to living tissue, the cells die. If you put it in a petri dish, the culture dies. Knowing these things, it would be shocking if one could inject it into an infant without causing damage."

Internal documents reveal that Eli Lilly, which first developed thimerosal, knew from the start that its product could cause damage -- and even death -- in both animals and humans. In 1930, the company tested thimerosal by administering it to 22 patients with terminal meningitis, all of whom died within weeks of being injected -- a fact Lilly didn't bother to report in its study declaring thimerosal safe.

In 1935, researchers at another vaccine manufacturer, Pittman-Moore, warned Lilly that its claims about thimerosal's safety "did not check with ours." Half the dogs Pittman injected with thimerosal-based vaccines became sick, leading researchers there to declare the preservative "unsatisfactory as a serum intended for use on dogs."

In the decades that followed, the evidence against thimerosal continued to mount. During the Second World War, when the Department of Defense used the preservative in vaccines on soldiers, it required Lilly to label it "poison." In 1967, a study in Applied Microbiology found that thimerosal killed mice when added to injected vaccines. Four years later, Lilly's own studies discerned that thimerosal was "toxic to tissue cells" in concentrations as low as one part per million -- 100 times weaker than the concentration in a typical vaccine.

Even so, the company continued to promote thimerosal as "nontoxic" and also incorporated it into topical disinfectants. In 1977, 10 babies at a Toronto hospital died when an antiseptic preserved with thimerosal was dabbed onto their umbilical cords. In 1982, the FDA proposed a ban on over-the-counter products that contained thimerosal, and in 1991 the agency considered banning it from animal vaccines. But tragically, that same year, the CDC recommended that infants be injected with a series of mercury-laced vaccines. Newborns would be vaccinated for hepatitis B within 24 hours of birth, and 2-month-old infants would be immunized for haemophilus influenzae B and diphtheria-tetanus-pertussis.

The drug industry knew the additional vaccines posed a danger. The same year that the CDC approved the new vaccines, Dr. Maurice Hilleman, one of the fathers of Merck's vaccine programs, warned the company that 6-month-olds who were administered the shots would suffer dangerous exposure to mercury. He recommended that thimerosal be discontinued, "especially when used on infants and children," noting that the industry knew of nontoxic alternatives. "The best way to go," he added, "is to switch to dispensing the actual vaccines without adding preservatives."

For Merck and other drug companies, however, the obstacle was money. Thimerosal enables the pharmaceutical industry to package vaccines in vials that contain multiple doses, which require additional protection because they are more easily contaminated by multiple needle entries. The larger vials cost half as much to produce as smaller, single-dose vials, making it cheaper for international agencies to distribute them to impoverished regions at risk of epidemics.

Faced with this "cost consideration," Merck ignored Hilleman's warnings, and government officials continued to push more and more thimerosal-based vaccines for children. Before 1989, American preschoolers received only three vaccinations -- for polio, diphtheria-tetanus-pertussis and measles-mumps-rubella. A decade later, thanks to federal recommendations, children were receiving a total of 22 immunizations by the time they reached first grade.

As the number of vaccines increased, the rate of autism among children exploded. During the 1990s, 40 million children were injected with thimerosal-based vaccines, receiving unprecedented levels of mercury during a period critical for brain development. Despite the well-documented dangers of thimerosal, it appears that no one bothered to add up the cumulative dose of mercury that children would receive from the mandated vaccines. "What took the FDA so long to do the calculations?" Peter Patriarca, director of viral products for the agency, asked in an e-mail to the CDC in 1999. "Why didn't CDC and the advisory bodies do these calculations when they rapidly expanded the childhood immunization schedule?"

But by that time, the damage was done. Infants who received all their vaccines, plus boosters, by the age of 6 months were being injected with levels of ethylmercury 187 times greater than the EPA's limit for daily exposure to methylmercury, a related neurotoxin. Although the vaccine industry insists that ethylmercury poses little danger because it breaks down rapidly and is removed by the body, several studies -- including one published in April by the National Institutes of Health -- suggest that ethylmercury is actually more toxic to developing brains and stays in the brain longer than methylmercury.

Officials responsible for childhood immunizations insist that the additional vaccines were necessary to protect infants from disease and that thimerosal is still essential in developing nations, which, they often claim, cannot afford the single-dose vials that don't require a preservative.

Dr. Paul Offit, one of CDC's top vaccine advisors, told me, "I think if we really have an influenza pandemic -- and certainly we will in the next 20 years, because we always do -- there's no way on God's earth that we immunize 280 million people with single-dose vials. There has to be multidose vials." But while public-health officials may have been well-intentioned, many of those on the CDC advisory committee who backed the additional vaccines had close ties to the industry.

Dr. Sam Katz, the committee's chair, was a paid consultant for most of the major vaccine makers and shares a patent on a measles vaccine with Merck, which also manufactures the hepatitis B vaccine. Dr. Neal Halsey, another committee member, worked as a researcher for the vaccine companies and received honoraria from Abbott Labs for his research on the hepatitis B vaccine. Indeed, in the tight circle of scientists who work on vaccines, such conflicts of interest are common.

Rep. Burton says that the CDC "routinely allows scientists with blatant conflicts of interest to serve on intellectual advisory committees that make recommendations on new vaccines," even though they have "interests in the products and companies for which they are supposed to be providing unbiased oversight."

The House Government Reform Committee discovered that four of the eight CDC advisors who approved guidelines for a rotavirus vaccine laced with thimerosal "had financial ties to the pharmaceutical companies that were developing different versions of the vaccine." Offit, who shares a patent on the vaccine, acknowledged to me that he "would make money" if his vote to approve it eventually leads to a marketable product. But he dismissed my suggestion that a scientist's direct financial stake in CDC approval might bias his judgment.

"It provides no conflict for me," he insists. "I have simply been informed by the process, not corrupted by it. When I sat around that table, my sole intent was trying to make recommendations that best benefited the children in this country. It's offensive to say that physicians and public-health people are in the pocket of industry and thus are making decisions that they know are unsafe for children. It's just not the way it works."

Other vaccine scientists and regulators gave me similar assurances. Like Offit, they view themselves as enlightened guardians of children's health, proud of their "partnerships" with pharmaceutical companies, immune to the seductions of personal profit, besieged by irrational activists whose anti-vaccine campaigns are endangering children's health. They are often resentful of questioning. "Science," says Offit, "is best left to scientists."

Still, some government officials were alarmed by the apparent conflicts of interest. In his e-mail to CDC administrators in 1999, Paul Patriarca of the FDA blasted federal regulators for failing to adequately scrutinize the danger posed by the added baby vaccines. "I'm not sure there will be an easy way out of the potential perception that the FDA, CDC and immunization-policy bodies may have been asleep at the switch re: thimerosal until now," Patriarca wrote. The close ties between regulatory officials and the pharmaceutical industry, he added, "will also raise questions about various advisory bodies regarding aggressive recommendations for use" of thimerosal in child vaccines.

If federal regulators and government scientists failed to grasp the potential risks of thimerosal over the years, no one could claim ignorance after the secret meeting at Simpsonwood. But rather than conduct more studies to test the link to autism and other forms of brain damage, the CDC placed politics over science. The agency turned its database on childhood vaccines -- which had been developed largely at taxpayer expense -- over to a private agency, America's Health Insurance Plans, ensuring that it could not be used for additional research. It also instructed the Institute of Medicine, an advisory organization that is part of the National Academy of Sciences, to produce a study debunking the link between thimerosal and brain disorders.

The CDC "wants us to declare, well, that these things are pretty safe," Dr. Marie McCormick, who chaired the IOM's Immunization Safety Review Committee, told her fellow researchers when they first met in January 2001. "We are not ever going to come down that [autism] is a true side effect" of thimerosal exposure.

According to transcripts of the meeting, the committee's chief staffer, Kathleen Stratton, predicted that the IOM would conclude that the evidence was "inadequate to accept or reject a causal relation" between thimerosal and autism. That, she added, was the result "Walt wants" -- a reference to Dr. Walter Orenstein, director of the National Immunization Program for the CDC.

For those who had devoted their lives to promoting vaccination, the revelations about thimerosal threatened to undermine everything they had worked for. "We've got a dragon by the tail here," said Dr. Michael Kaback, another committee member. "The more negative that [our] presentation is, the less likely people are to use vaccination, immunization -- and we know what the results of that will be. We are kind of caught in a trap. How we work our way out of the trap, I think is the charge."

Even in public, federal officials made it clear that their primary goal in studying thimerosal was to dispel doubts about vaccines. "Four current studies are taking place to rule out the proposed link between autism and thimerosal," Dr. Gordon Douglas, then-director of strategic planning for vaccine research at the National Institutes of Health, assured a Princeton University gathering in May 2001. "In order to undo the harmful effects of research claiming to link the [measles] vaccine to an elevated risk of autism, we need to conduct and publicize additional studies to assure parents of safety."

Douglas formerly served as president of vaccinations for Merck, where he ignored warnings about thimerosal's risks. In May of last year, the Institute of Medicine issued its final report. Its conclusion: There is no proven link between autism and thimerosal in vaccines. Rather than reviewing the large body of literature describing the toxicity of thimerosal, the report relied on four disastrously flawed epidemiological studies examining European countries, where children received much smaller doses of thimerosal than American kids. It also cited a new version of the Verstraeten study, published in the journal Pediatrics, that had been reworked to reduce the link between thimerosal and autism. The new study included children too young to have been diagnosed with autism and overlooked others who showed signs of the disease.

The IOM declared the case closed and -- in a startling position for a scientific body -- recommended that no further research be conducted.

The report may have satisfied the CDC, but it convinced no one. Rep. David Weldon, a Republican physician from Florida who serves on the House Government Reform Committee, attacked the Institute of Medicine, saying it relied on a handful of studies that were "fatally flawed" by "poor design" and failed to represent "all the available scientific and medical research." CDC officials are not interested in an honest search for the truth, Weldon told me, because "an association between vaccines and autism would force them to admit that their policies irreparably damaged thousands of children. Who would want to make that conclusion about themselves?"

Under pressure from Congress, parents and a few of its own panel members, the Institute of Medicine reluctantly convened a second panel to review the findings of the first. In February, the new panel, composed of different scientists, criticized the earlier panel for its lack of transparency and urged the CDC to make its vaccine database available to the public. So far, though, only two scientists have managed to gain access. Dr. Mark Geier, president of the Genetics Center of America, and his son, David, spent a year battling to obtain the medical records from the CDC. Since August 2002, when members of Congress pressured the agency to turn over the data, the Geiers have completed six studies that demonstrate a powerful correlation between thimerosal and neurological damage in children. One study, which compares the cumulative dose of mercury received by children born between 1981 and 1985 with those born between 1990 and 1996, found a "very significant relationship" between autism and vaccines. Another study of educational performance found that kids who received higher doses of thimerosal in vaccines were nearly three times as likely to be diagnosed with autism and more than three times as likely to suffer from speech disorders and mental retardation.

Another soon-to-be-published study shows that autism rates are in decline following the recent elimination of thimerosal from most vaccines. As the federal government worked to prevent scientists from studying vaccines, others have stepped in to study the link to autism. In April, reporter Dan Olmsted of UPI undertook one of the more interesting studies himself. Searching for children who had not been exposed to mercury in vaccines -- the kind of population that scientists typically use as a "control" in experiments -- Olmsted scoured the Amish of Lancaster County, Penn., who refuse to immunize their infants. Given the national rate of autism, Olmsted calculated that there should be 130 autistics among the Amish. He found only four. One had been exposed to high levels of mercury from a power plant. The other three -- including one child adopted from outside the Amish community -- had received their vaccines.

At the state level, many officials have also conducted in-depth reviews of thimerosal. While the Institute of Medicine was busy whitewashing the risks, the Iowa Legislature was carefully combing through all of the available scientific and biological data. "After three years of review, I became convinced there was sufficient credible research to show a link between mercury and the increased incidences in autism," says state Sen. Ken Veenstra, a Republican who oversaw the investigation. "The fact that Iowa's 700 percent increase in autism began in the 1990s, right after more and more vaccines were added to the children's vaccine schedules, is solid evidence alone."

Last year, Iowa became the first state to ban mercury in vaccines, followed by California. Similar bans are now under consideration in 32 other states. But instead of following suit, the FDA continues to allow manufacturers to include thimerosal in scores of over-the-counter medications as well as steroids and injected collagen. Even more alarming, the government continues to ship vaccines preserved with thimerosal to developing countries -- some of which are now experiencing a sudden explosion in autism rates.

In China, where the disease was virtually unknown prior to the introduction of thimerosal by U.S. drug manufacturers in 1999, news reports indicate that there are now more than 1.8 million autistics. Although reliable numbers are hard to come by, autistic disorders also appear to be soaring in India, Argentina, Nicaragua and other developing countries that are now using thimerosal-laced vaccines.

The World Health Organization continues to insist thimerosal is safe, but it promises to keep the possibility that it is linked to neurological disorders "under review."

I devoted time to study this issue because I believe that this is a moral crisis that must be addressed. If, as the evidence suggests, our public-health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American children, their actions arguably constitute one of the biggest scandals in the annals of American medicine.

"The CDC is guilty of incompetence and gross negligence," says Mark Blaxill, vice president of Safe Minds, a nonprofit organization concerned about the role of mercury in medicines. "The damage caused by vaccine exposure is massive. It's bigger than asbestos, bigger than tobacco, bigger than anything you've ever seen."

It's hard to calculate the damage to our country -- and to the international efforts to eradicate epidemic diseases -- if Third World nations come to believe that America's most heralded foreign-aid initiative is poisoning their children. It's not difficult to predict how this scenario will be interpreted by America's enemies abroad. The scientists and researchers -- many of them sincere, even idealistic -- who are participating in efforts to hide the science on thimerosal claim that they are trying to advance the lofty goal of protecting children in developing nations from disease pandemics. They are badly misguided. Their failure to come clean on thimerosal will come back horribly to haunt our country and the world's poorest populations.

Robert F. Kennedy Jr. is senior attorney for the Natural Resources Defense Council, chief prosecuting attorney for Riverkeeper and president of Waterkeeper Alliance. He is the co-author of "The Riverkeepers."

end Salon.com article

JON RAPPOPORT www.nomorefakenews.com

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CDC Ignored Autism-Mercury Data

SafeMinds' Report Shows CDC Ignored Autism-Mercury Data

Monday November 22, 12:49 pm ET

Documents Show Agency Discovered Elevated Autism Risks and Withheld From Public/Congress

WASHINGTON, Nov. 22 /PRNewswire/ -- SafeMinds -- America's leading scientific organization investigating the links between mercury and autism -- has released a report showing that government analysts were aware of a potential vaccine-autism link as early as 1999, but hid that information from the public and Congressional inquiry.

The SafeMinds study, "Generation Zero," details these initial findings based on data contained in spreadsheets and related email traffic from former Centers for Disease Control and Prevention (CDC) research fellow, Dr. Thomas Verstraeten. In his analysis, secured by SafeMinds through a Freedom of Information Act (FOIA) request, Verstraeten examined the connection between mercury exposure and childhood disease for the first time. SafeMinds board member and published researcher Mark Blaxill prepared the review and chose the title "Generation Zero" for two reasons: 1) the CDC analysis compared autism risks in children with high thimerosal exposure levels to children with zero exposure levels, a logical approach they abandoned later; and 2) these CDC analyses preceded four subsequent generations of reports that an earlier Safe Minds study designated Generation One through Four.

"Verstraeten's initial analysis reveals two important facts," Blaxill said. "First, CDC official were aware in 1999 of an eleven fold increase in autism risk in children who received vaccines containing thimerosal versus children who received no exposure. Second, in four subsequent generations of reports using this data, the CDC never revealed their initial risk findings to the Institute of Medicine, nor to Congress when called upon to present evidence during relevant hearings."

Thimerosal, a mercury-containing preservative used for years in many vaccines, lies at the center of the vaccine-autism debate. Although the dangers of early childhood mercury exposure have long been recognized, vaccines, including those given to infants, still contain this potent neurotoxin.

"In the most straightforward analysis of the risk of mercury exposure in children, Verstraeten discovered significant extremely elevated risks of autism as well as a range of childhood developmental disorder including ADHD and sleep disorders. In emails accompanying his analyses, Verstraeten invited his colleagues to find ways to explain away these findings. Predictably, his alarming analyses were suppressed by the CDC. Only watered-down reports were ever shared and fourth of these was made public several years late, discounting any autism-mercury link," continued Blaxill.

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"A Dragon By The Tail"- Vaccine Cover-Up Exposed!

Vaccine Cover-Up Exposed!!

A byronchild world exclusive report Release: March 7, 2005 Contact: Naomi Radunski, Marketing and Strategy Byron Publications P/L 7 Palm Avenue Mullumbimby,Australia 61 02 6684 4353“This article may be freely posted, reproduced and distributed with acknowledgement to both Lisa Reagan (author) and byronchild magazine (also list www.byronchild.com).

“A Dragon By The Tail”On the eve of an historic, billion-dollar world vaccination campaign, a leaked transcript ignites questions of vaccine safety and research corruption. Meanwhile, US senators fast-track a bill to protect vaccine manufacturers from litigation. With millions of lives at stake, and billions of dollars to loose, will a merger of philanthropy, big business and compromised science win an epic race between corporate agendas and medical ethics? In this world exclusive report, byronchild exposes how the most powerful medical research bodies in the United States compromise their vaccine safety research for vested interests, as they assist in a global vaccine policy, while a bill looms in the background to protect it all.By Lisa Reagan On January 24, 2005 -- the same day the Global Alliance for Vaccines and Immunization (GAVI) announced the receipt of $750 million for its historic world vaccination campaign -- seven US Senators introduced Senate Bill 3 . The bill is an unprecedented act giving comprehensive liability protections to vaccine manufacturers , restricting Freedom of Information Acts on drug/vaccine safety, and pre-empting states' rights to ban mercury from children's vaccines, all under the bill's official title: ‘‘Protecting America in the War on Terror Act of 2005''. Meanwhile in Texas, after receiving an internal transcript that allegedly proves the Institutes of Medicine's report denying a link between childhood vaccines and autism last year was “predetermined”, a US District Court judge has ordered the worlds' “big five” vaccine manufacturers to “produce any and all documents relating to payments made to, or stock ownership” by the seventeen members of the IOM's Immunization and Safety Review Committee. A court document submitting the IOM's leaked transcript as an exhibit in the first civil juried lawsuit against the vaccine manufacturers states the transcript proves the IOM committee, “predetermined the necessity of not finding causality between vaccines and autism and/or neurological injury” in its official reports on the issue. Judge T. John Ward also ordered the vaccine manufacturers to produce all communications with “members of the World Health Organization, the Center for Disease Control, the Food and Drug Administration, the Institute of Medicine, the Brighton Collaboration, or the Global Alliance for Vaccines and Immunization relating to the issue whether the thimerosal contained in pediatric vaccines causes autism or other neurological disorders.” When the vaccine manufacturer's legal counsel balked at the amount of expense involved in producing such documentation for the court, Judge Ward reassured the defense that the process could be useful for the more than 300 pending lawsuits waiting to be tried in the US . Vaccine manufacturers Aventis Pasteur, Merck, GlaxoSmithKline, Wyeth and Eli Lilly and Co. are cited as defendants in the lawsuit brought by the parents of a child who developed autism after receiving mandatory routine childhood immunizations. The same IOM reports denying a link between vaccines and the country's autism epidemic have been used: • to endorse standardized case definitions for Adverse Events Following Immunizations for “global dissemination”; • as justification for Senate Bill 3's sweeping provisions and protections; • as a cause for no further federal monies to be spent on research of the potential vaccine/autism link; • as a reason to silence media inquiries into vaccine safety issues; • and as a defense for dismissing over 4,500 petitions for vaccine injuries in a federal court. Is it possible that a closed meeting transcript alleged as proof of a ploy to ignore vaccine risks, a near billion dollar grant for a global vaccination campaign, emerging lawsuits for vaccine injuries and a sweeping federal bill to protect vaccine manufacturers are unrelated? Is it possible that in spite of US Congressional hearings and reports citing widespread conflicts of interest between federal policy makers and the vaccine industry that Senate Bill 3 will defy the US Constitution's provisions for state and civil rights in order to shield vaccine manufacturers from liability? And finally, how will a world vaccine policy influenced by allegedly “predetermined” safety reports implemented through a global alliance of international governments and vaccine manufacturers with a fund of billions headquartered in Geneva, Switzerland, support or protect the health and human rights of targeted Third-World country peoples? History of the IOM's Immunization and Safety Review Committee Insight to these questions may lie in the pivotal year of 1999, a year preceded by a decade of declining vaccine sales, major breakups within the manufacturing industry, increased requirements for routine childhood vaccines, a growing autism epidemic, and researchers and media reports questioning the safety of vaccines and their possible link to autism. In 1999, as a US Congressional Government Reform Committee initiated an investigation into the rampant conflicts of interest between federal vaccine policy makers and manufacturers, a global rescue effort of the sinking vaccine industry began with the formation of GAVI. Originally funded by Microsoft billionaire Bill Gates through his Seattle-based Bill and Melinda Gates Foundation, GAVI's partnership of international governments and vaccine manufacturers salvaged lagging sales through an overhauled world vaccination campaign that placed GAVI, headquartered in Geneva, Switzerland, at the center of the reorganized alliance. Also formed in 1999 were the international Brighton Collaboration and the WHO Global Advisory Committee on Vaccine Safety. Brighton's sole purpose was to create standardized case definitions for Adverse Events Following Immunizations for “global dissemination”. Brighton's steering committee members currently hail from the US FDA, CDC, and Aventis Pasteur, a vaccine manufacturer and federal lawsuit defendant. Brighton's website does not include autism among its listed adverse events. The WHO Global Advisory Committee on Vaccine Safety has “ concluded that there is currently no evidence of mercury toxicity in infants, children, or adults exposed to thimerosal in vaccines” and “that current WHO immunization policy with respect to thimerosal containing vaccines should not be changed.” The Brighton Collaboration has been cited as being “fraught with pitfalls and merges regulators and the regulated into an indistinguishable group.” “ I am very concerned about the development of the Brighton Collaboration,” stated US Congressional Representative Dave Weldon, MD, (R-FL) at an Autism One Conference in May 2004. “Particularly troubling is the fact that serving on the panels defining what constitutes an adverse reaction to a vaccine, are vaccine manufacturers. What is even worse is the fact that some of these committees are chaired by vaccine manufacturers. It is totally inappropriate for a manufacturer of vaccines to be put in the position of determining what is and is not an adverse reaction to their product. Do we allow GM, Ford and Chrysler to define the safety of their automobiles?” In 1999, w ith GAVI's international partnership and Bill Gates' billions on the way to rescue the industry, the CDC hired the IOM's Immunizations and Safety Review Committee to examine multiple “vaccine safety challenges”. In its public report, the CDC specifically sited a 1998 British Lancet study recommending more research into a potential link between the Measles, Mumps, Rubella (MMR) vaccine and autism, negative press, public information vaccine conferences, the Rotavirus vaccine recall and seven congressional hearings questioning vaccine safety as impetus to employ the IOM. However, the CDC's ability to objectively and fairly evaluate vaccine risks has been denounced by a three year long US congressional investigation: “To date, studies conducted or funded by the CDC that purportedly dispute any correlation between autism and vaccine injury have been of poor design, under-powered, and fatally flawed. The CDC's rush to support and promote such research is reflective of a philosophical conflict in looking fairly at emerging theories and clinical data related to adverse reactions from vaccinations… “The CDC in general and the National Immunization Program in particular are conflicted in their duties to monitor the safety of vaccines, while also charged with the responsibility of purchasing vaccines for resale as well as promoting increased immunization rates,” states the congressional report. (View the report at www.nomercury.org/science/documents/GRC_6-15-00.pdf ) “They serve as their own watchdog -- neither common nor desirable when seeking unbiased research,” Weldon has stated in describing the CDC. “An association between vaccines and autism would force CDC officials to admit that their policies irreparably damaged thousands of children. Who among us would easily accept such a conclusion about ourselves? Yet, this is what the CDC is asked to do,” Weldon said. When byronchild asked CDC spokesperson Curtis Allen for a copy of the contract that would detail the agreement between the IOM and the CDC, Allen stated that the contract would be available only in a heavily “redacted” or blacked-out format. The IOM stated “no comment” to byronchild about the leaked transcript or its use in the pending civil court case. The Transcript of the First Organizational Meeting of the IOM Committeeclick here to see full IOM transcriptOn January 11, 2001, the IOM's Immunization and Safety Review committee members gathered for its first organizational meeting in Washington, DC. It is this meeting's transcript that has been submitted as an exhibit by Waters and Kraus, a Dallas, Texas law firm. During the IOM's open meeting, Walter Orenstein, MD, the Director of the National Immunization Program at the CDC, charged the committee to specifically address: “the causal relationship between the vaccine and adverse effect; the biologic mechanisms that could account for the adverse effect; and the significance of the safety concern in the context of society at large.” ( Orenstein presided over another leaked CDC transcript from June 2000, see sidebar 1. ) However, according to Gordon Douglas, MD, Director of Strategic Planning for the Vaccine Research Center at the National Institutes of Health (NIH) the IOM committee was hired by the CDC to “rule out the proposed links”. The NIH serves as America's medical research agency. Douglas stated in a Princeton University lecture summary that, “Four current studies are taking place at the CDC in collaboration with the NIH to rule out the proposed links between immunizations and autism, immunizations and possible developmental regression, inflammatory bowel disease and the MMR vaccine, and thimerosal and the risk of autism. In order to undo the harmful effects of research claiming to link the MMR vaccine to an elevated risk of autism, we need to conduct and publicize additional studies, strengthen the program to assure parents of MMR's safety, and further educate pediatricians and primary care physicians.” Formerly Douglas served as the president of vaccine manufacturer and federal lawsuit defendant Merck Vaccines from 1991 to 1999. According to an LA Times story on February 8, 2005, while serving as president of Merck, Douglas received a memo from Maurice R. Hilleman, MD, an internationally renowned vaccinologist, who told Douglas that six-month-old babies who received their vaccines on schedule would receive a mercury dose 87 times higher than the Environmental Protection Agency deemed safe. (The NIH announced a “sweeping ethics reform” on February 1, 2005, see side bar 2. To view the Merck memo: www.nomercury.org/science/documents/LATimes-Merck_Memo_2-8-05.pdf ) From the beginning of the IOM committee's meeting behind the closed doors of the National Academies of Science building on January 12, 2001, committee members repeatedly expressed their “need for reassurance” and concern over their charge, evidence, methodology, and public communication goals, especially to parents. “We've got a dragon by the tail here,” states a committee member in the transcript. “At the end of the line, what we know is – and I agree – that the more negative that presentation [the report] is, the less likely people are to use vaccination, immunization, and we know what the results of that will be. We are kind of caught in a trap. How we work our way out of the trap, I think, is the charge.” Instead of focusing on scientific data which could possibly tarnish the current routine childhood vaccine policy, “The transcript sets forth in significant detail stated biases, preferences and/or predetermination of various committee members in January, 2001, i.e. before any medical or scientific evidence had been presented to the committee (emphasis added),” states t he court document. Specifically sited are statements by the IOM's study director Kathleen Stratton, PhD, and committee chair Marie McCormick, MD. These statements, the law firm says, strongly suggest Stratton and McCormick deliberately railroaded their committee into specific outcomes (all in italics directly from court document): Dr. McCormick, for example, in speaking of the CDC, noted that the agency “wants us to declare, well, these things are pretty safe on a population basis.” (See Exhibit 1 at page 33). “The committee's bias and predetermination of the causality issues presented are found at page 74 in a comment from Dr. Statton: Dr. Stratton: “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 will 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.” Similarly, Dr. McCormick, at page 97 in discussing whether autism could be associated with vaccines, stated that “we are not ever going to come down that it is a true side effect,” despite the fact that the committee had not yet considered any evidence on this issue. At page 123, Dr. Stratton indicated that, despite not having heard any of the evidence, the probable conclusion was going to be that the evidence was “inadequate to accept or reject a causal relation.” “Chances are, when all is said and done, we are still going to be in this category. It is just a general feeling that we probably still are not going to be able to make a statement.” Stratton joined the IOM in 1990 and was later awarded the IOM's Cecil Research Award for her contributions to vaccine safety. McCormick is the Sumner and Esther Feldberg Professor of Maternal and Child Health at the Harvard School of Public Health. Congressmen, researchers and parents petitioned the IOM Committee to delay their final meeting and report last year until an animal study demonstrating a link between mercury and autism by Mady Hornig, MD, an associate professor at Columbia University, could be completed. The IOM refused to delay their final meeting and issued their “no link” report on May 2004. The Columbia University study confirming the link between mercury and autism was completed and presented to the public in June 2004. “This is a perfect example of the scientific findings that the IOM ignored when creating their recent report on the potential of the vaccine-autism link,” stated Lyn Redwood, RN, MSN, NP, president of Safeminds, an independent nonprofit organization. “The IOM was well aware that studies like these were due for release, but chose to ignore them…The findings in this study make clear that the IOM was more interested in regurgitating CDC spin than incorporating hard science like Dr. Hornig's report. Such information would force the government to face the reality of the mercury threat and take definitive action to protect countless children from potential neurological damage.” The US Office of Special Counsel (OSC) – an independent investigative and prosecutorial agency that serves as a channel for whistleblowers -- forwarded hundreds of disclosures “alleging public health and safety concerns about childhood vaccines that include a mercury-based preservative known as thimerosal, and its possible link to neurological disorders, including autism” to the US Congress on May 20, 2004, the day after the IOM issued its “no link” report. The OSC letter requesting congressional action was addressed to US Senator Judd Gregg (R-NH) – who introduced Senate Bill 3 and its provisions for liability protection for vaccine manufacturers on January 24, 2005. The OSC's letter to Gregg stated, “it appears there may be sufficient evidence to find a substantial likelihood of a substantial and specific danger to public health caused by the use of thimerosal/mercury in vaccines because of its inherent toxicity…” “Due to the gravity of the allegations, I am forwarding a copy of the information disclosed to you in your capacity as Chairmen of the Senate Committee and House Committee with oversight authority for HHS. I hope that you will review these important issues and press HHS for a response to this very serious public health danger,” states the OSC letter to Gregg. (To view the OSC letter: www.nomercury.org/science/documents/OSC_Press_Release_5-20-04.pdf ) Conflict of Interest in IOM Governing Council Currently, members of the IOM's governing Council include, among 19 others , Gail H. Cassell, PhD, of Eli Lilly and Company and Helene D. Gayle, MD, from the Bill and Melinda Gates Foundation – the same foundation that donated the world's sixth largest charitable gift of $1.5 billion to create and sustain GAVI. Lilly is the original manufacturer of thimerosal, a mercury derivative used in childhood vaccines as a preservative. The result of a discovery process by law firm Waters and Kraus showed that Lilly knew of mercury's toxicity as early as 1930 but nonetheless “secretly sponsored a human toxicity study on patients already known to be dying of meningococcal meningitis.” “Lilly then cited this study repeatedly for decades as proof that thimerosal was of low toxicity and harmless to humans," states a press release from the law firm. While Lilly ceased the sale of thimerosal in 1991, their licensing agreements demonstrate continued profits from the product until at least 2010. Lilly is the single biggest contributor to the Republican Party from the pharmaceutical industry donating $1.6 million in the last US election. Senate Majority Leader Bill Frist (R-TN), co-sponsor of Senate Bill 3, was the author of a controversial bill that contained a provision that would protect Eli Lilly and other vaccine manufacturers from lawsuits over mercury in the 2002 Homeland Security Act. Frist's other notable tie to Lilly is the fact that the vaccine manufacturer bought 5,000 copies of the senator's book on bioterrorism and distributed them to physicians after September 11, 2001. The basis of the Frist family fortune is the Hospital Corporation of America (HCA), the largest for-profit hospital chain in the country, which was founded by Frist's father and brother. (For more on Senator Frist see sidebar 3). GAVI – Using Corrupt Research to Vaccinate the World? GAVI's public and private sector partners include governments in industrialized and developing countries, UNICEF, the World Health Organization, WHO, the World Bank, non-governmental organizations, foundations, vaccine manufacturers, and public health and research institutions. WHO and GAVI's headquarters are both in Geneva, Switzerland. To date a total of almost $1.3 billion, in addition to the Gates endowment, has been raised from international governments and private sources as well as an additional $1.19 billion in pledges toward GAVI's goal of a 90% routine immunization rate by 2010 for all of its 70 underdeveloped countries/grantees. For vaccine manufacturers, the Gates' billions for GAVI represent a guaranteed pipeline of money. For governments of undeveloped countries, the funds may be used for any aspect of health as long as their country's vaccine rate increases. If the rates drop, so do the funds. According to GAVI figures, 4 million children have been vaccinated for diphtheria, tetanus, and whooping cough; 42 million more children have been vaccinated with hepatitis B; and 991 million single-use disposable syringes have been produced for the program. “ GAVI relies on technical and scientific information and advice from the Global Advisory Committee on Vaccine Safety. Based on the committee's findings, GAVI and its partners will continue to support the use of vaccines that contain thimerosal,” responded Gates Foundation spokesperson Jenny Sorensen to byronchild's inquiry. If the accusation that the IOM “predetermined” the outcome of their reports is true, what does this bode for a worldwide vaccine policy that is now being routinely employed through GAVI's partners and the governments of undeveloped countries who rely on the IOM's vaccine safety information to be accurate? World Economic Forum questions GAVI's Global Vaccine Campaign Is the solution for creating a healthy world a global vaccine campaign? During the World Economic Forum's 2003 Annual Meeting in Davos, Switzerland, GAVI's global vaccine campaign was intensely debated by panelists. WEF panelists were not convinced that GAVI's goals were realistic or a panacea for the complex needs of underdeveloped countries. "There is a strong tendency to see vaccines as a cure-all that can work in isolation," said Geoffrey Foster, Founder and Consultant, International Child Welfare and Health, Family AIDS Caring Trust, FACT, Zimbabwe, and Social Entrepreneur. “Instead, vaccines must be set firmly within a realistic and holistic context. In the past, in Europe, death and disease dropped because of nutrition and education. Vaccines must accompany poverty alleviation or children will be stunted both physically and intellectually.” The World Economic Forum is a global community of business, political, intellectual and other leaders of society. The forum is an independent international organization incorporated as a Swiss not-for-profit foundation and has NGO consultative status with the Economic and Social Council of the United Nations. Autism – An Epidemic Too Big To Ignore During the years that the IOM reports were drafted, 2001 to 2004, more than 4,500 petitions for “vaccine injuries resulting in autism spectrum disorder”, piled up in an Omnibus Autism Proceeding with the US Court of Federal Claims. Currently, autism is the fastest growing developmental disability in the United States, with one in 166 US children diagnosed with Autism Spectrum Disorder, up from 1 in 2500 a decade ago, and over 1.77 million affected. In the last four years alone, the number of cases of autism has nearly doubled in California. “It is growing much faster than the growth of the population and other forms of childhood disabilities,” states Cliff Allenby, director of the State Department of Development Services. A report by the independent Environmental Working Group issued in December 2004 found that autistic children had less glutathione, an antioxidant that helps rid the body of toxic metals, when compared to a sample of healthy children. The study, led by Jill James, PhD, a professor of biochemistry and pediatrics at the University of Arkansas for Medical Sciences, found that a glutathione deficit “may contribute to the development and clinical manifestation of autism." Autism is not a disease but a ‘condition' often characterized by a failure to bond, lack of social interaction, avoidance of eye-to-eye contact, difficulties in language development, and repetitive behaviors known as stimming (self-stimulation). Milder forms of autism are Asperger's Syndrome , Pervasive Developmental Disorder and Attention Deficit/Hyperactivity Disorder . Collectively they are known as Autism Spectrum Disorder, ASD. States Take Matters Into Their Own Hands After multiple congressional hearings on conflicts of interest within the vaccine industry and government, repeated IOM reports stating no link between vaccines and autism, and with no official FDA recall for mercury containing vaccines, US citizens and state legislators took matters into their own hands and in May 2004, Iowa became the first state to ban mercury in vaccines. During the same three-year period the IOM committee reviewed its data on the vaccines and autism link, the Iowa Human Resources Committee reviewed scientific and biological data from independent researchers. ‘After three years of review, I became convinced there was sufficient credible research to show a link between mercury and the increased incidents in autism,' said Iowa Senator Ken Veenstra. ‘The fact that Iowa's 700 percent increase in autism began in the 90s, right after more and more vaccines were added to the children's vaccine schedules, is solid evidence alone…The IOM has not convinced me this action is not needed. I feel strongly we need to pursue a use of alternative vaccines.” US Congressional Representative Dave Weldon, MD, (R-FL), called the IOM reports “heavily biased and unrepresentative of all the available scientific and medical research.” Weldon said the reports discounted the biological evidence presented by US Congressional investigative reports and university studies. It also discounted thousands of parent activists who pointed to the parallel increase in vaccination requirements and the rise in autism rates starting in the early 1990s. California Governor Arnold Swcharzenegger signed his state's mercury ban last year and more than a dozen other states are currently considering their own bans. Senate Bill 3 would seek to repeal the current states bans and to prohibit more states from enacting their own bans on mercury, a violation of the US Constitution's Tenth Amendment . (See side bar 4 for a complete list of the bill's proposals.) Senate Bill 3 – Dissolution of Civil Rights? Sighting the IOM reports' green light to justify the act's proposed sweeping protections for the vaccine industry, the bill states that, “ After considering recent changes in the litigation environment with respect to vaccines as well as recent scientific evidence and reports by the Institute of Medicine (italics added) and others with respect to the safety of vaccines and their components and ingredients, the Secretary of Health and Human Services and the Attorney General shall, not later than 6 months after the date of enactment of this Act, jointly submit recommendations to the appropriate committees of Congress concerning necessary modifications to the Vaccine Injury Compensation Program and Federal rules regarding litigation involving vaccines.” “The war on terror is a different kind of war and requires a different kind of preparedness,” US Senator Judd Gregg (R-NH) said in a press release about the bill. “Specifically, this bill encourages development of products needed to protect the nation against biological, radiological or nuclear agents as well as infectious diseases. It expands the availability and accessibility of vaccines. Finally, it strengthens capacity and coordination, so we can respond effectively during public health emergencies.” “This bill is labeled as an ‘anti-terror' bill, but it is power grab by the federal government and an assault on self-governance and the informed consent ethic. It takes away the freedom of the people to make their voices heard through their elected state representatives and protect themselves from unsafe drugs, such as Celebrex and Vioxx, and unsafe vaccines, such as those that contain high levels of mercury. It gives unprecedented liability protection to the drug industry and broad powers to federal officials to hide the truth from the people about vaccine and prescription drug risks,” said Barbara Loe Fisher, president of America's largest and oldest vaccine safety and consumer watchdog organization the National Vaccine Information Center. “Protecting the public health was not delegated to the federal government and public health laws, including laws governing use of vaccines, have always been under the control of citizens residing in each state,” said Fisher. “The irony of this bill is that it is using the families of citizens who have given their lives to defend our nation's freedom in order to take rights and freedoms away from other families. Military veterans should not be used to protect the drug industry and take away the freedom for all Americans to have their voices heard through their elected state representatives… This bill does not serve justice or freedom.” An internationally renowned bio-ethicist who has previously spoken on vaccine policy issues at the National Vaccine Information Center conference, told byronchild magazine that people should not be surprised by the contents of the IOM transcript or Senate Bill 3. ‘Old paradigms do not die easily,' he said. ‘This is just the nature of the beast.' Side Bar 1: Not The First Leaked Transcript The 2001 IOM transcript is not the first to be leaked to the public. Another closed meeting transcript from June of 2000 recorded 53 scientists from the CDC, FDA, and the vaccine industry at the Simpsonwood Retreat Center in Georgia to review the findings of a statistically significant correlation between mercury-containing vaccines and neurological conditions. The discovery was made by CDC employee Thomas Verstraeten, MD, using the CDC's own data. The meeting was not open to the public or announced in the Federal Register, and the CDC has still not made their findings public. Verstraeten has since left the CDC to work for a vaccine manufacturer in Belgium. He has also not responded to a US Congressional subpoena. However the meeting transcript was included in the “Mercury in Medicine: Taking Unnecessary Risks?” report that was the result of a three year investigation by the US Congress' Subcommittee on Human Rights and Wellness, Committee on Government Reform's Report published in April 2003. The Simpsonwood meeting was presided over by Walter Orenstein, MD, the Director of the National Immunization Program at the CDC. Orenstein presented the public charge to the IOM committee on January 11, 2001, the day before the closed organizational meeting. (To read the Simpsonwood transcript go to: www.nomercury.org/science/documents/Simpsonwood_Transcript.pdf To read the Verstraeten study: www.nomercury.org/science/documents/ThimerosalVSDstudy001.pdf ) Side Bar 2: Sweeping Ethics Reform to End Culture of Corruption? Drug industry influence on medical research and practice and on the prescribing of drugs is pervasive. After a yearlong investigation into the “culture” of conflicts of interest between its scientists and manufacturers, on February 1, 2005, the National Institutes of Health, the US leading agency for medical research, announced a “sweeping ethics reform”. Under the new rules which reversed a 1995 decision that allowed “moonlighting” between the scientists and industry, all NIH employees have been prohibited from engaging in employment with pharmaceutical and biotechnology companies, supported research institutions, including NIH grantees, health care providers and insurers. NIH employees were also required to sell their stock in any of the above. In a “town hall” meeting for employees on February 3, 2005, NIH director Elias A. Zerhouni, MD, announced the need for a summit of government and academic leaders to address conflicts of interest throughout American medical research as part of the ethics reform. The NIH announcement came after a year-long investigation in to conflicts of interest and the “discovery, made by congressional investigators, that more than 100 NIH employees had not disclosed various relationships they had with pharmaceutical and biotech companies, in violation of government ethics rules” according to a Washington Post article on February 3, 2005. "I came to the conclusion that we have a systemic problem," Zerhouni said in an LA Times interview on February 12, 2005. "They were not just isolated events. They reflected the complete set of rules that had been adopted over the years, which had transformed the culture. I said, if that's the case, let's bring back the culture to where it needs to be: That is, public first. "That's the hardest part," he said. "It's easy to come up with regulations. It's not easy to change a culture." To read the NIH report: www.nih.gov/news/pr/feb2005/od-01.htm Sidebar 3: Who is Senate Majority Leader Bill Frist (R-TN), co-sponsor of Senate Bill 3? According to the Center for Justice and Democracy, these are some facts about Senator Bill Frist, MD: • The basis of the Frist family fortune is the Hospital Corporation of America (HCA), the largest for-profit hospital chain in the country, which was founded by Frist's father and brother. • Frist and his wife have $26 million in HCA stock in a so-called “blind trust.” • HCA has agreed to pay the federal government more than $1.7 billion in civil and criminal penalties, the largest health care settlement in history, for massive Medicare, Medicaid and Tricare billing fraud. • Frist has gotten more than $2.3 million from doctors, health insurers, drug companies and others in the health care industry, roughly 20 percent of all the contributions to his two Senate races, raising more cash from health-care interests than 98 percent of his colleagues. • Frist has voted against patients' rights to sue their HMOs for failure to provide adequate treatment while supporting tax subsidies to HMOs and insurance companies to offer prescription drugs to seniors, rather than providing them through Medicare. Frist has received $123,750 in campaign cash from HMOS. • To date, Frist has received $265,023 from the pharmaceutical industry. The pharmaceutical industry was also the largest single contributor to the National Republican Senatorial Campaign Committee that Frist chaired, giving about $4 million — and Lilly was the single biggest contributor to the GOP from that industry, having given $1.6 million in the last election cycle. • In 2002, Frist engineered the insertion of a provision into the Homeland Security bill that would protect Eli Lilly and other pharmaceutical giants from lawsuits over mercury in vaccines. Not long after Frist introduced the legislation, the Pharmaceutical Research and Manufacturers of America, the drug industry's trade group, gave $10,000 to his political action committee. This report from: www.centerjd.org/free/mythbusters-free/Frist.pdf Side Bar 4: Senate Bill 3 – What It Could Do Of major concern to vaccine safety and civil rights advocates are the following provisions in Senate Bill 3: * Eliminates a state's right to more strictly regulate vaccines and drugs and more fully inform their citizens about vaccine and drug risks than does the federal government. Laws already passed in California and Iowa limiting mercury content in vaccines would be repealed. * Gives comprehensive liability protections to drug companies. Eliminates a citizen's right to seek justice in state courts for drug and vaccine injuries and deaths and limits awards in federal courts. Gives tax credits, grants and patent extensions to the drug industry. *Allows the Department of Health and Department of Justice, the defendants in the federal Vaccine Injury Compensation Program, to write the terms of their own defense in order to further limit awards to vaccine injured children. * Creates and funds a mandatory, national electronic tracking system operated by the Centers for Disease Control (CDC) to monitor vital records of citizens relating to both notifiable and non-notifiable diseases and "new trends" and "patterns in public health." Creates penalties for states and health care providers not reporting in a "timely manner" to the national tracking system. There are no provisions for mandatory reporting of serious health problems following vaccine and prescription drug use or punishments for not reporting serious side effects. S. 3 is being promoted by sponsors as a military veteran benefit bill because it raises the death benefits and other financial support for the families of soldiers who lost their lives in the war in Iraq. From the National Vaccine Information Center's website. For a point by point examination of the bill, visit the site at www.nvic.org/ActionAlerts/S3Article.htm . For the actual bill: Senate Bill 3: www.nomercury.org/science/documents/S_3_War_on_Terror_Act_2005.pdf Related articles Autism is treatable – hope that is real treatment that heals - by Lisa ReaganClaiming our Sovereignty – by Kali Wendorf

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A byronchild world exclusive report Release: March 7, 2005 Contact: Naomi Radunski, Marketing and Strategy Byron Publications P/L 7 Palm Avenue Mullumbimby,Australia 61 02 6684 4353“This article may be freely posted, reproduced and distributed with acknowledgement to both Lisa Reagan (author) and byronchild magazine (also list www.byronchild.com). If you do so, please notify byronchild magazine through Naomi Radunski and forward all copies (electronic and printed) to vaccine@byronpublications.com or the above postal address. Click here to download this article in .pdf format

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Autism IS Linked to Vaccines

March 2, 2006

FOR IMMEDIATE RELEASE:

Medical Journal: Autism Rates Decline as Mercury Removed from Childhood Vaccines

Independent Analysis Refutes Institute of Medicine Claims of “No Relationship,” While Mercury Still Used in Flu & Other Vaccines

TUCSON, AZ -- A new study shows that autism may be linked after all to the use of mercury in childhood vaccines, despite government’s previous claims to the contrary.

An article in the March 10, 2006 issue of the Journal of American Physicians and Surgeons (JPandS.org) shows that since mercury was removed from childhood vaccines, the alarming increase in reported rates of autism and other neurological disorders (NDs) in children not only stopped, but actually dropped sharply – by as much as 35%.

Using the government’s own databases, independent researchers analyzed reports of childhood NDs, including autism, before and after removal of mercury-based preservatives. Authors David A. Geier, B.A. and Mark R. Geier, M.D., Ph.D. analyze data from the CDC’s Vaccine Adverse Event Reporting System (VAERS) and the California Department of Developmental Services (CDDS) in “Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines.”

The numbers from California show that reported autism rates hit a high of 800 in May 2003. If that trend had continued, the reports would have skyrocketed to more than 1000 by the beginning of 2006. But in fact, the Geiers report that the number actually went down to only 620, a real decrease of 22%, and a decrease from the projections of 35%.

This analysis directly contradicts 2004 recommendations of the Institute of Medicine which examined vaccine safety data from the National Immunization Program (NIP) of the CDC. While not willing to either rule out or to corroborate a relationship between mercury and autism, the IOM soft-pedaled its findings, and decided no more studies were needed. The authors write: “The IOM stated that the evidence favored rejection of a causal relationship between thimerosal and autism, that such a relationship was not biologically plausible, and that no further studies should be conducted to evaluate it.”

As more and more vaccines were added to the mandatory schedule of vaccines for children, the dose of the mercury-based preservative thimerosal rose, so that the cumulative dose injected into babies exceeded the toxic threshold set by many government agencies. Mercury is known to damage nerve cells in very low concentrations.

The concern about vaccines may actually be underrated, as it is generally acknowledged that the voluntary reporting of such disorders has resulted in vast underreporting of new cases. For example, the Iowa state legislature banned thimerosal from all vaccines administered there after it documented a 700-fold increase in that state alone. California followed suit, and 32 states are considering doing so. Up until about 1989 pre-school children got only 3 vaccines (polio, DPT, MMR). By 1999 the CDC recommended a total of 22 vaccines to be given before children reach the 1st grade, including Hepatitis B, which is given to newborns within the first 24 hours of birth. Many of these vaccines contained mercury. In the 1990s approximately 40 million children were injected with mercury-containing vaccines.

The cumulative amount of mercury being given to children in this number of vaccines would be an amount 187 times the EPA daily exposure limit

Between 1989 and 2003, there has been an explosion of autism. The incidence of autism (and other related disorders) went from about 1 in 2,500 children to 1 in every 166. Currently there are more than a half million children in the U.S. that have autism. This disorder has devastated families.

In 1999, on the recommendation of the American Academy of Pediatrics and U.S. Public Health Service, thimerosal was removed from most childhood vaccines as a "precautionary" measure - i.e. without admitting to any causal link between thimerosal and autism.

The Geiers conclude that mercury continues to be a concern, as it is still added to some of the most commonly-used vaccines, such as those for flu:

“Despite its removal from many childhood vaccines, thimerosal is still routinely added to some formulations of influenza vaccine administered to U.S. infants, as well as to several other vaccines (e.g. tetanus-diphtheria and monovalent tetanus) administered to older children and adults. In 2004, the Institute of Medicine (IOM) of the U.S. National Academy of Sciences (NAS) retreated from the stated 1999 goal of the AAP and the PHS to remove thimerosal from U.S. vaccines as soon as possible…As a result, assessing the safety of TCVs [thimerosal-containing vaccines] is a matter of significant importance.”

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U.S. scientists back autism link to MMR

5/30/2006

The vaccine strain of measles virus has been found in 85% of samples taken from the guts of children with regressive autism, according to a study to be presented in Montreal, Canada, this week by Dr. Stephen Walker of the Wake Forest University School of Medicine in North Carolina.

The study replicates findings made by Dr. Andrew Wakefield, a gastroenterologist, in 1998, and by Prof. John O’Leary, a pathologist, in 2002.

More than 2,000 parents in the UK claim their children suffered damage from the measles/mumps/rubella (MMR) vaccine. They say the children were developing normally before receiving the shot between 12 and 18 months of age, then regressed into autism.

The British Department of Health reiterated last night that MMR is safe (Beezy Marsh and Sally Beck, Telegraph.co.uk 5/28/06).

Additional information:

“Detection of Measles Virus Genomic RNA in Cerebrospinal Fluid of Children with Regressive Autism: a Report of Three Cases,” by JJ Bradstreet, J El Dahr, A Anthony, JJ Karzinel, and AJ Wakefield, J Am Phys Surg , Summer 2004

The Denmark study on MMR and autism: two articles in J Am Phys Surg, Fall 2004

article #2,