MMR vaccine and the autism epidemic
In a compulsory inoculation program, it is the responsibility of the developers, promoters and enforcers to prove safety and efficacy
Reply to Professor Louis Z Cooper, 6 June 2005
I am grateful to Louis Z Cooper, Professor Emeritus of Pediatrics, Columbia University, New York for his personal account of 1964, albeit anecdotal.  Regrettably it shows official 'estimated' figures are less well grounded in fact than prudence might dictate - illustrating my point. The Orenstein 'estimated' 20,000 congenital rubella syndrome ('CRS') figure  is suddenly an 'estimated' 40,000 - doubled at a stroke. In contrast, the figures I cited  were documented official figures from real reported cases. I cite more here to assist waverers.
A brief literature survey shows varying figures cited with abandon: 12 million, 12.5 million, and from 10,000 to 30,000 miscarriages, stillbirths and CRS. Even if right, and they are not, just as hard cases make bad law, worldwide policy should not be based on uncommon once-in-25-to-50 year epidemics and never on inaccurate wildly varying data.
Further, and obviously an oversight, Professor Cooper's interests were not disclosed. His involvement since 1964 in all aspects of rubella vaccination, including research, commercial, official and political assists in putting his perspective in context. 
Reported US rubella cases prior to vaccination were less than 50,000 per annum. ,  Average US CRS incidence was less than 50 per annum.  One study averaged 80 Japanese CRS cases per annum between 1965 - 1985 . Another notes 39 Japanese CRS babies in 2,000,000 cases in 1975-1977 when notification was operating. 
Contrast the US CDC's official autism spectrum disorders ('ASD') incidence of 24,000 ASD children per annum, with a 500,000 prevalence aged 0 to 21. 
We cannot justify mass vaccination on this basis, particularly where the vaccines are not properly tested or subject to short and long term safety monitoring. No one knows the full extent of all problems vaccines cause because no one is looking or counting - less than 50 CRS cases per annum against 24,000 autism spectrum disorder? All when disease incidence has been falling dramatically irrespective of vaccination.
It seems rubella overestimation might be misdiagnosis. According to Kibrick:
"... illness with features resembling those of rubella may sometimes be due to other causes. Thus, rubella-like illness may be incorrectly diagnosed as rubella ....." 
A paper from one of Professor Cooper's own New York Rubella Project colleagues, John Sever, states:
Evidence that erroneous diagnoses are common in this disease is provided by results of a study on 464 pregnant women wherein attempts were made to correlate the patient's history of rubella with presence or absence of antibody. No correlation was observed. This suggests that the occurrence of rubella as reported by patients cannot be taken as a reliable index of previous exposure. 
As for birth defects, with a low average incidence of CRS, rubella cannot be the culprit (and the following is 2005 published - when indigenous US rubella is claimed eradicated):
"Birth defects affect about one in every 33 babies born in the United States each year. They are the leading cause of infant deaths, accounting for more than 20% of all infant deaths. Babies born with birth defects have a greater chance of illness and long term disability than babies without birth defects." 
Compounding these inaccuracies, 1964 house to house survey data collection methods were questionable, with limited sample sizes (0.00022 fraction of the US population).
As for the varying figures for miscarriage (10,000 to 12,000), two fifths of pregnancies miscarry. 4,000,000 live US births means 1.6 million annual miscarriages in the US, so where the assorted 10,000 to 12,000 figures comes from is anyone's guess (and it seems that is precisely what they are).
Even on the basis of Professor Cooper's own paper there could be no more than 4000 US CRS cases. This assumes his 'Rubella Project' was limited to the cited area of 20 million  (and the population of New York State in 1963 was less than 17.5 million ). Professor Cooper also cites anecdotally 400 women reported to the New York City Department of Health during 1964-5; 300 having terminations. As 92% of rubella cases deliver normal healthy children, adjusting for normal miscarriages, had these run full term they provide a potential figure of CRS births for this cohort of 24. 
excerpt- 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.
excerpt- My primary interest is Regressive Autism, its incidence and its MMR connection.
In the United Kingdom, the issue of MMR remains in the forefront with a David and Goliath scenario unfolding for the last seven years: On one side, the mighty Government, the Prime-Minister personally, the Health authorities, the Press -some of it very ugly- and large useless epidemiological studies and on the other side, Andrew Wakefield with his study of 12 children and a small group of faithful devoted and informed parents.
In the United States, most researchers and the majority of parents with affected children have been more involved with the Thimerosal issue lately. There is enough scientific evidence to show that both the MMR vaccine and Thimerosal in other vaccines precipitate autistic regression in genetically-predisposed children, not withstanding the opinions of biased 'experts,' a misleading IOM special committee report and obviously the CDC.
At any rate, I wrote The Mercury Memo because I thought the story had to be told but fully intended to leave the Thimerosal issue - from there on, to its supporters. That is when a British Red Flag member decided to send me an email with just a URL:
The first and second words seemed interesting enough - so I had a look.
5 April 2005
Supplies of the MMR Vaccine
Stocks of the MMR vaccine held centrally on our behalf by Farillon Ltd are currently at a low level. This is a result of the very high quantities of stock being distributed in recent weeks, largely to carry out local catch-up campaigns to protect older teenagers and students susceptible to mumps.
We are unable to continue to issue stocks of the MMR vaccine at the same high levels. We are working with vaccine manufacturers to see whether additional supplies of MMR vaccine can be purchased. Until sufficient additional stock can be delivered, we need to prioritise the use of the current stock held centrally.
Due to the seriousness of measles, available stocks of MMR vaccine need to be prioritised to protect children against measles. Therefore existing supplies of vaccine need to be used in the routine childhood programme. Surgeries are asked to ensure that the childhood immunisation programme is maintained. In addition it is also important to ensure that those women of child-bearing age who are currently susceptible to rubella also need to be protected, and the MMR vaccine should be offered to susceptible women.
There may be a significant amount of MMR vaccine currently held in GP surgeries, and in PCTs where MMR catch-up campaigns have already taken place.
Each surgery is also asked to review the stocks of MMR vaccine it currently holds for use in infants and pre-school children, and ensure that existing stocks of vaccine are used to protect children according to the routine schedule, and for unprotected women of childbearing age. Before placing orders for additional stock with Farillon, surgeries are asked to see whether other surgeries within the PCT have excess stocks of MMR vaccine that could be shared.
As a consequence of prioritising vaccine use, we are unable to supply vaccine for use in catch-up programmes in students. I realise that that will cause problems in some areas. We are doing everything we can to try to secure additional stocks of vaccine as soon as possible, and I will contact you as soon as additional stocks become available.
I very much appreciate your understanding in this matter.
Please feel free to cascade this information to other colleagues working in immunisation
Yet another epidemiological study, this time from Japan has apparently revealed "no link between MMR and autism". But yet again the findings appear open to interpretation.
The Eye has often pointed the limitations of epidemiological in identifying a possible sub-set of children with regressive autism and gut disease at the centre of the controversy over the triple vaccine. These studies have consistently looked at what happened after MMR was introduced in populations of children, most of whom had the triple jab. But the Japanese study offered something different. It was the first to examine autism trends after the vaccine had been withdrawn and in children who had not had the three-in-one jab. (MMR was withdrawn in Japan in 1993 in a crisis of confidence after the mumps component was linked to meningitis).
As the "nail in the coffin of the MMR controversy" newspaper reports suggested, the Japanese paper found that autism cases continued to rise after vaccine withdrawal. There were 48-86 cases per 10,000 children before withdrawal, which doubled to 97-161 per 10,000 afterwards. It reported a similar trend in children considered to have been developing normally and then regressing - like the ones at the centre of the MMR controversy.
On the face of it "resoundingly negative", as one of the authors, Hideo Honda, of the Yokohama Rehabilitation Center, claimed. They had found a similar trend to what is happening in the UK and US and concluded: "The withdrawal of MMR cannot be expected to lead to a reduction in the incidence of autistic spectrum disorders." But is it so straightforward? Hostility over the MMR controversy is such these days it is very unpopular to mention the name of Andrew Wakefield, the gastro-enterologist at the centre of the storm, let alone report his words. But with Dr Carol Stott, an academic psychologist at Cambridge, he has raised serious questions about the Japanese data and what they purport to show.
Unlike the US and UK, where the autism trend is steadily upwards, the Japanese data shows a strikingly "different" dip at the time that Japanese public confidence fell in MMR and vaccination generally. Autis rates had risen 85.9 per 10,000 for children born in 1990, but then dropped to 55.8 per 10,000 for children born in 1991 when MMR uptake was falling ahead of its total withdrawal. Rates started to ris again at the time when the Japanese public started to accept the notion of three separate vaccines.
Wakefield and Stott suggest that, because the three separate vaccines were given as little as four weeks apart (there is evidence to suggest that some children had all three jabs on the same day), it was the same as being given MMR. Therefore, they argue, the "dip" in autism rated at a time when the children were not receiving measles, mumps or rubella vaccines in any form may indicate the opposite of the conclusion given to (sic) the Japanese paper.
A similar verdict on the Japan paper was also reached by US paediatrician Edward Yazbak, who in a commentary on it said that while MMR vaccination rates were high and rising in the UK, and low to nil in Japan, "autism increased more substantially in the UK".
One of the co-authors of the Honda paper was Professor Sir Michael Rutter, of the Institute of Psychiatry, who had prepared a draft report for GlaxoSmithKline, one of the defendant drug companies in the UK litigation but who was not retained by them. He told the Eye that as he was not an immunologist he could not comment on the suggestion that giving three separate vaccines a short time apart was the same as administering the MMR triple vaccine. But he added that although it was unfortunate there was little relevant material published on any possible interference between vaccine components, immunologists who he had consulted doubted that this was a significant issue.
As to the dip in autism rated highlighted by Wakefield, Stott and Yazbak, Prof Rutter said there was nothing to show it was a statistically significant change and may merely have been a blip.
Prof Rutter said that the one good thing that had come out of Dr Wakefield’s controversial 1998 paper that raised the MMR alarm, which he believed should not have been published in that form in the Lancet, was that it triggered much useful autism research.
Some experts convinced of a real rise in autism across the developed world - rather than, as many still maintain, better diagnosis and detection - were now looking for an unknown environmental trigger that might interact with an unknown genetic risk. He said that while MMR could fit that environmental profile, he claimed his and other researchers work showed it did not fit the pattern.
Meanwhile a team from the department of pediatrics at the New Jersey Medical School (and nothing to do with Dr Wakefield) have published a study in the Journal of Neuropsychology which replicated Wakefield’s findings of immune abnormalities in the diseased guts of children with autism. Further, independent work to see if Wakefield’s and Prof Joh ‘Leary’s discovery of vaccine strain measle virus in the inflamed guts of autistic children with immune abnormalities can also be replicated continues in the US. The debate is not yet over.
The study: "MMR Vaccination And Pervasive Developmental Disorders: A Case Control Study." By Liam Smeeth, Claire Cook, Eric Fombonne, Lisa Heavey, Laura C Rodriques, Peter G Smith, Andrew J Hall. Lancet 2004;364:963-969.
The above paper has many failings. Two in particular are of such significance as to invalidate the conclusion; that MMR vaccine is not associated with onset of autism in children.
On page 967, first column, penultimate paragraph the authors state: "We were not able to separately identify the subgroup of cases with regressive symptoms to investigate the hypothesis that only some children are vulnerable to MMR- induced disease and that this is always regressive (27).
In this single statement the authors make it perfectly clear that they have not conducted an investigation of what has been referred to by the Department of Health and press commentaries as "the Wakefield hypothesis".
This hypothesis has remained unchanged since 1999, when we first described it in detail in a paper that was later published in the Israeli Medical Association Journal (IMAJ;1999:Vol1,1-5). The original hypothesis is restated below in lay form.
There exists a subset of children who are vulnerable to developing a particular form of regressive autism following previously normal development in combination with a novel form of inflammatory bowel disease. Onset may occur over weeks or sometimes months, and is triggered by exposure to a measles containing vaccine, predominantly the measles mumps rubella vaccine (MMR), that is in use in much of the world today. This exposure leads to long term infection with measles virus within key sites, including the intestine where it causes inflammation.
Smeeth and colleagues were aware of the question that needed answering since they had consulted with epidemiologist, Dr Scott Montgomery and Dr Wakefield several years ago, when they were designing the current study. We made it absolutely clear then that they should specifically look at the children with regressive autism. They ignored this explicit advice.
Secondly, epidemiolgists in Sweden and Cambridge have confirmed that even if they had studied the correct group -- regressive autism -- the study would need to have included at least 3,500-7,000 children with autism -- 3 to 6 times the actual number examined -- in order for the study to have any validity at all.
On this basis the paper cannot be said to have concluded anything of relevance to the hypothesis summarised above and has been grossly over-interpreted.
Moreover, in their conduct of the study, the authors do not even meet their own criteria set out in their previous paper ‘A Case-Controlled Study of Autism and Mumps-Measles-Rubella Vaccination Using the General Practice Research Database: Design and Methodology’, published in BMC Public Health (2001)1:2.
In that paper they stated in their abstract that "Children with a possible diagnosis of autism will be identified from their electronic health records. All diagnoses will be validated by a detailed review of hospital letters and by using information derived from a parental questionnaire". The second and third steps were not performed. Only 25% of cases had their records examined and no questionnaire was used. There were other substantial changes in the methodology which were also not explained in the present paper. This paper, therefore, meets neither the criteria for testing the original question nor those laid-down by the authors themselves.
The Government has chosen to rely on a series of epidemiological studies that, when subject to re-analysis, have been comprehensively criticised.
For example, readers should consider the two papers recently published in the Journal of American Physician and Surgeons, one by Dr Goldman and one by Dr Stott. These papers, demonstrated the unreliability of the recent Danish study, which was also heralded by the authorities as demonstrating the safety of the MMR vaccine.
The graph below has been reproduced from the second of these papers. It demonstrates a striking change in the number of children developing autism following the introduction and progressive increase in uptake of MMR in Danish children.
Figure can be viewed here:
Figure 1. Autism prevalence in Denmark by year of birth, 1982-1992. Lines of best fit are shown for birth years 1982-1986 and from 1986 to 1992. Children born in 1986 were first to receive MMR in Denmark. The annual growth before MMR was -0.5% [trend = -15%;95% CI, (-1.06) - (-0.76),ns], compared with +14.98% after MMR introduction (t = 6.94, p<0.001; trend 1.54, 95% CI, ).97 - 2.11).
The Visceral research program involves the meticulous clinical investigation of individual affected children, which is a far more accurate and precise way of investigating the possible relationship between MMR and regressive autism.
Regarding your epidemiology study that said there was no link to autism and the MMR vaccine, here are some critical analysis by F. Edward Yazbak, MD, FAAP, TL Autism Research, Falmouth, Massachusetts:
I'm an accountant by trade and figures don't lie, but liars can figure. You did not do the clinical science such as immune blood panel tests, biopsies of the ileal, etc. Taking numbers and coming to your conclusion that there is no connection to autism and the MMR vaccine is not science.
Also the National Alliance for Autism Research (NAAR) who funded your study has a Centers for Disease Control (CDC) member on their science board and NAAR has been funded by Merck, the manufacturer of the MMR vaccine. The CDC promotes and regulates vaccines at the same time. This is a contradiction. The CDC therefore is only interested in furthering the agenda of the vaccine companies over the health and well-being of the families and their children.
A vaccine safety study of more than 124,000 babies that appears today in the journal Pediatrics concludes there are "no consistent significant associations" between mercury-laced vaccines and maladies such as autism or attention-deficit disorder. However, an advocacy group is accusing federal researchers of finding such a link in "earlier, secret studies" and "manipulating data" to cover it up.
"They found the truth and then swept it under the rug," said Lyn Redwood, the mother of an autistic child and president of Safe Minds, a Cranford, N.J., organization dedicated to removing mercury from medical products. Mercury is known to have toxic effects on the brain. Thimerosal, a mercury-containing preservative, was used for decades to stabilize vaccines. Vaccines today contain little or no thimerosal.
Rep. Dave Weldon, Florida Republican and a physician, sent a letter Friday to Dr. Julie L. Gerberding, director of the Centers for Disease Control and Prevention (CDC), asking for a "thorough, open, timely and independent review" of the study.
"I have reviewed the [Pediatrics] article and have serious reservations about the four-year evaluation and conclusions of this study," Dr. Weldon said. "While most childhood vaccines now have only trace amounts of mercury from thimerosal-containing vaccines, it is critical that we know with certainty if children were injured in the 1990s," he wrote. "I am a strong supporter of childhood vaccinations, and know that they have saved us from considerable death and suffering," he added. However, "[W]e must fully disclose adverse events" to preserve public confidence in vaccines.
The CDC study, led by Dr. Thomas Verstraeten, was based on vaccine and health data from 124,170 infants born between 1992 and 1999 at two health maintenance organizations and 16,717 children born between 1991 and 1997 at another HMO. The researchers found "conflicting results" about links between vaccines and tics or language delays at different sites. However, they found no evidence of significant increased risks for autism or attention-deficit disorder.
Safe Minds leaders say that, according to materials obtained through the Freedom of Information Act, Dr. Verstraeten said during the early stages of the study that he thought he saw a "plausible" link between thimerosal-containing vaccines and autism. But, "once Dr. Verstraeten began working for vaccine manufacturer GlaxoSmithKline, he altered the data, sampling and methodology of the study so that results would point to enough inconsistencies to cast doubt" on the link, the group said.
Specifically, they said, CDC researchers added data from a Massachusetts HMO even though it had data-management problems and the state is believed to have "severely underreported" its cases of autism. This data skewed the findings, the Safe Minds leaders said.
Spokesmen for the CDC said Friday they were reviewing information about these "serious allegations." CDC materials say there are no proven links between autism and vaccines, and American parents and health care workers should continue to immunize babies and young children against disease.
A spokeswoman at GlaxoSmithKline referred questions about the study to the CDC, since it was conducted when Dr. Verstraeten was in an agency fellowship program. GlaxoSmithKline is named as a defendant in lawsuits filed by persons with autism. A spokeswoman for the Pediatrics journal said that the CDC study was "peer-reviewed by multiple experts." Also, Dr. Verstraeten declared that he was a federal employee and had no conflict of interest when the study was performed, the journal said.
A child who developed severe epilepsy after receiving the MMR jab has been found to have measles virus from the vaccine in his brain. The results of tests conducted recently have been revealed by the 13-year-old boy's mother. She says that she has decided to go public in order to push the Government to take the plight of children allegedly damaged by the three-in-one measles, mumps and rubella vaccination more seriously.
Scientists say that the implications of the discovery are difficult to assess without further research. However, it raises new questions about the triple inoculation, which has been dogged by controversy since Andrew Wakefield, a former consultant at the Royal Free Hospital in London, linked it with a new syndrome of bowel disease and autism in children.
The boy's mother, who has asked to remain anonymous, told The Telegraph yesterday that her son had developed an allergic rash eight days after he received the MMR vaccination when he was 15 months old. He then progressed to have 10 to 12 seizures every month. In the summer of 1998, however, he descended into "status epilepticus" - continuous convulsions - and surgeons at a London hospital decided that he needed emergency brain surgery to save his life. It was at this point that a brain biopsy was taken.
The woman, who is suing the manufacturers of the MMR vaccine on behalf of her son, declined to say where the biopsy had been tested for the measles virus but indicated that this had been done in a reputable laboratory. She had been shocked to receive the test results indicating that vaccine-strain measles virus had been found, she said. She had also learnt that samples from her son's bowel, taken in 1997 because he had digestive problems, had tested positive for vaccine-strain virus.
After the operation when he was nine, her son had had to relearn "virtually everything", she said. His personality changed and he was no longer able to attend mainstream school, although he had very recently been free of seizures. "Now with this new information I am very concerned," the boy's mother said. "Is it over for him or not? No one knows and this is why all these children - not just my son - need to be acknowledged rather than have the continuous stream of blanket denials that have been issued by the Department of Health."
British specialists investigating MMR were reluctant to comment publicly on the case last night. One cautioned that it was theoretically possible that the boy had developed a vaccine-related condition that was more commonly caused by a natural measles virus infection. "If this was the case," he said, "then MMR would actually help to protect the wider population from similar infections." However, he added: "We do not know what this result means."
The Academy also recommended, "Infants and children who have received thimerosal -containing vaccines do not need to have blood, urine, or hair tested for mercury since the concentrations would be quite low and would not require treatment." If no testing for mercury was recommended, then how could one know for a fact that there is no "evidence of harm"? (AAP, 1999)
The Department of Health has told parents they have no need to be concerned about MMR - a position supported by leading medical bodies.
The information was compiled from data in the Annual Reports to Congress provided by the US Department of Education, and is posted in tabular format
Over 60 years ago the FDA approved a little known product, thimerosal, to be used as a preservative. Now today, many parents question if this product is responsible for the current epidemic of children diagnosed with learning disabilities and autism.
Current thinking suggests that exposure to mercury is primarily from environmental and dietary sources, dental amalgams and rare catastrophic events. Recently, however, another common and pervasive source of mercury exposure has been identified, thimerosal.
Thimerosal was first approved as an additive by the FDA in the 1930's. It has been utilized as a preservative to prevent bacterial contamination in a number of blood and biological products including vaccines and immune globulins and over the counter eye and nose drops. The danger that thimerosal presents is that it contains 49.5% ethyl mercury by weight.
Thimerosal was first approved as an additive by the FDA in the 1930's. It has been utilized as a preservative to prevent bacterial contamination in a number of blood and biological products including vaccines and immune globulins and over the counter eye and nose drops. The danger that thimerosal presents is that it contains 49.5% ethyl mercury by weight. Mercury is a potent human toxicant, which has long been the source of many serioushealth problems. It is especially toxic to the rapidly developing fetal and infant brain. While acceptable levels for exposure are published by Federal Agencies, mercury is a poison at any level. Chemically, thimerosal is a water soluble-cream colored crystalline powder. In the human body thimerosal is metabolized to ethylmercury and thiosalicylate. The literature on thimerosal metabolism and excretion is old and toxicological information is limited. Therefore, it has been assumed that the toxicity of ethylmercury is equivalent to methylmercury until further information is available. In the past there have been case reports of toxicity and death following inadvertent massive exposures.
In 1997 when the FDA Modernization Act was signed into law there was an attached amendment which required the FDA to compile a list of drugs and food that contain intentionally introduced mercury compounds and to provide a quantitative and qualitative analysis of the mercury compounds on the list. One may ask why FDA did not routinely perform this task. FDA's mission is to ensure purity, safety, potency and efficacy of individual products, and such analysis have never been a required part of the permitting process. In it's review, which took two years to complete, the FDA discovered that infants who receive thimerosal-containing vaccines at several visits may be exposed to more mercury than recommended by Federal guidelines for total mercury exposure.
Infant vaccines that routinely contained thimerosal were DPT, Hep B and HiB. Following the CDC recommended vaccine schedule infants were exposed anywhere from 0 to 187.5 mcg of ethylmercury, depending on the vaccine manufacturer and total exposure through 18 months could be as high as 237.5 mcg. (Table 2). The dose thought to be allowable by EPA is 0.1 mcg per kilogram per day. If an average 5 kg infant received all thimerosal containing vaccines at his 2 month visit the exposure that day would be 62.5 mcg ethylmercury, an exposure that is 125 times above the EPA's guideline.
In its analysis, the FDA multiplied EPS's daily exposure levels of 0.1 per kilogram by 180 days, even though the exposures had occurred on only 4 days during this time period. It is perplexing that FDA chose to average an infant's total exposure to mercury over the first six months of life as though children were being exposed on a daily basis, and reported that amounts were only slightly above one of the Federal guidelines. According to toxicologist, because of the inherent pharmokinetics of mercury and its long half-life in the body, you can not legitimately calculate the effect of a large injected bolus dose as though it were ingested in small amounts over a longer period of time. This method of analysis inaccurately minimizes the levels of exposure. If one were to look at the mercury in thimerosal from a daily dose perspective, no one vaccine containing thimerosal would be able to meet EPA's guidelines for safe exposure. A simple analogy can be made that one may safely consume 4 Tylenol a day in 6-hour intervals for a month but consuming 120 Tylenol in one day would be equivalent dosing. This dose not only defies logic, but sound medical practice.
At the same time the FDA findings were released, The American Academy of Pediatrics published An Interim Report to Physicians on Thimerosal in Vaccine. In this document the AAP and Public Health Service agreed that the use of thimerosal containing vaccines should be reduced or eliminated, stating that any potential risk was of concern. While the document discussed much of the uncertainty regarding the potential effect of mercury exposure in vaccines, it clearly stated that there was no evidence of harm having occurred from this exposure.
The Academy also recommended "Infants and children who have received thimerosal-containing vaccines do not need to have blood, urine, or hair tested for mercury since the concentrations would be quite low and would not require treatment." If no testing for mercury was recommended, then how could one know for a fact that there is no "evidence of harm"? (AAP, 1999)
It is interesting to note that thimerosal was introduced only a few short years before Dr. Leo Kanner described a new mental disorder which differed "markedly and uniquely from anything reported" before. In its early history autism was diagnosed more frequently in affluent families, but became more evenly distributed socio-economically by the 1970's.
This apparent widening in demographics paralleled the increasing availability of vaccines to all children through federally sponsored programs. It has been during this same time period, the 1980's and especially the 1990's, that we have witnessed a tremendous increase in the occurrence of autism spectrum disorders. In the late 1980's and early 1990's the vaccine schedule was amended to include both Hepatitis B and HiB vaccines. Each of these vaccines are administered to infants 3 times during the first six-months of life. Their addition to the vaccine schedule potentially tripled an infant's exposure to mercury, should they receive all thimerosal-containing vaccines.
An additional concern is that these vaccine exposures are occurring on top of prenatal exposures from immune globulin preparations administered during pregnancy to RH- mothers, dietary, dental and environmental exposures.
Information from large epidemiological studies conducted in mercury exposed populations suggests that intermittent large exposures may pose more risk that small daily exposures. In one study, lower scores on memory, attention, language and motor function tests were found years later in children who had been exposed prenatally to intermittent bolus doses of methyl mercury from dietary exposure at levels that had been previously thought to be safe. (Grandjean, 1998)
In a recent investigation, mercury levels were obtained before and after exposure to 12.5 mcg of ethyl mercury in hepatitis B Vaccine in 15 preterm and 5 term infants. (Stajich, 2000). There were no differences between the preterm and term infants with respect to mean pre-vaccination levels although post immunization mercury levels were significantly increased in both groups of infants. Post vaccination levels in preterm infants were 3 times higher than those of term infants, a difference that was statistically significant. Of interest, one preterm infant developed a post vaccinal mercury level of 23.6 mcg/L, which falls within the range known to result in neurodevelopmental dysfunction. (Grandjean, 1994)
At the June 21, 2000 Advisory Committee for Immunization Practices meeting held in Atlanta, Georgia, Dr. Thomas Verstraeten of the National Immunization Program presented a review of vaccine safety data link information on thimerosal containing vaccines. Over 400,000 children participate in the vaccine safety datalink program. From this database 100,000 eligible children charts were reviewed to determine exposure to thimerosal containing vaccines and specific neurodevelopmental outcomes. Key findings were statistically significant associations between cumulative exposure to thimerosal containing vaccines at 2 months of age and unspecified developmental delay; 3 months of age and tics; 6 months of age and attention deficit disorder; 1,3, and 6 months of age and speech and language delay and neurodevelopmental delays in general.
According to a recent report in the Weekly Epidemiology Record, January 2000, which reviewed the use of thimerosal as a vaccine preservative stated that "this safety assessment cannot currently exclude the possibility of subtle neurodevelopmental abnormalities in infants from a cumulative exposure to thimerosal in vaccines" (Wkly Epi Rec, 2000)
There are many unknowns with respect to thimerosal. These include:
Current investigations are underway from both governmental and private agencies in an effort to address these concerns.
Not only are there many unanswered questions concerning mercury exposure from thimerosal in vaccines, but there appears to be no general consensus as to how best proceed to diagnose, or effectively treat elevated mercury levels in children. The effectiveness of chelating agents in crossing the blood brain barrier has become a topic of scrutiny, as well as the ability to treat a long-standing exposure which occurred during a critical time in development.
At a recent conference, a number of physicians who specialize in the treatment of children with autism and developmental disorders reported finding many children with elevated mercury levels who had remarkable improvement in behaviors, speech and cognition when treated with a program to reduce oxidative stress and metal body burden. (DAN, 2000)
What to do?
Despite this information, the FDA has only "encouraged" vaccine manufacturers to reduce or eliminate thimerosal. According to the FDA, there are currently enough vaccine products that are thimerosal-free to meet the immunization needs in the U.S. the first 6 months of life. Therefore, until there is more research available assuring its safe use in infants, it would only be prudent to give preference to all thimerosal-free vaccines. Dr. Neal Halsey, at the Institute for Vaccine Safety, Johns Hopkins, summed up this issue best in a recent article on thimerosal published in the Hepatitis Control Report, Summer 1999 issue. "We can say there is no evidence of harm (from thimerosal), but the truth is no one has looked." (Hepatitis Control Report, 1999).
Currently there are still 30 vaccine products on the market that contain thimerosal. The general public, as well as health care providers, needs to be aware that there are many different vaccine products available, both with and without thimerosal. Parents research the safest car seats and toys for their children, but do not realize that they also need to research vaccines as well. Thimerosal has been eliminated from latex paints, merthiolate and many other over the counter products because of serious toxic effects from these products. Although FDA has only focused on thimerosal in infant vaccines at this time, all vaccines that contain this product should come under scrutiny in the near future.
Is there "Cause for Concern?"
Although there are many unanswered questions about excessive mercury exposures in infants who received multiple thimerosal-containing vaccines, there are many well-documented facts that support concerns that mercury is playing a role in the recent epidemic of learning disabilities and autism spectrum disorders. These include the facts that:
Andrew Wakefield explains why he first warned of a possible link between the MMR jab and autism
"What I'm advocating is that in the presence of this question mark, a question mark that was put there by the parents, which we have corroborated in repeated studies -- while that question mark exists, at the very least, parents deserve a choice of how they protect their children against these infections, whether it be with the MMR vaccine or with the single vaccine.
"There is a very limited body of material bearing on the safety of the vaccine, but those studies were totally inadequate from the beginning. They looked at short-term outcomes three or four weeks after vaccination, but these children regress insidiously over weeks or months, and this is never ascribed to the vaccine by the attending physician.
"I sit across from you as the parent and you say: 'this is what happened to my child, they were developing normally, they had speech, language, social skills, they received their MMR vaccine and they developed bowel symptoms and their behaviour deteriorated, I lost them, the light went out'.
"You listen to that story, you don't buy into it, but you say: 'is there anything I can do to substantiate this in my job as a physician?' You investigate the symptoms and you find that there is an inflammatory bowel disease that has gone unrecognised in these children . So the parents were right. So when they say: 'I believe my child regressed after the MMR vaccine', do you take that seriously? Damn right you do.
"I don't believe that [single vaccinations would lead to a drop in take-up]. I think parents are well informed, they are not inherently anti-vaccine, nor are we. We have advocated throughout that children continue to be protected . But in the light of this evidence there is a question mark, and while that question mark exists, parents must have the choice over how they protect their children.
"What we have done is to show that the parents' story is valid. We have found measles virus highly in excess of developmentally normal controls in the diseased [bowel] tissue of children with autism, and not only in the diseased tissue but in the very cells in that diseased tissue that you would antici pate if it were the cause of the disease. This is a very compelling observation that means, once again, that though causation has not been proven, there is sufficient anxiety that the parents must have a choice.
"What actually precipitated this crisis? What precipitated this crisis was the removal of the single vaccine, the removal of choice, and that is what has caused the furore -- because the doctors, the gurus, are treating the public as though they are some kind of moronic mass who cannot make an informed decision for themselves."
A highly respected and well-published scientist at the Utah State University, Vijendra K. Singh has further linked autism to the MMR vaccine. His study published in New Foundation of Biology, Elsevier Science BV 2001: 447-58 titled Neuro-immunopathogenesis in Autism provides brain autoantibody and virus serology evidence that links autism to MMR and postulates autism as a neuroautoimmune response that occurs at the neuroimmune biological interface.
Singh found that autoantibodies to myelin basic proteins were present in 80% of autistic children but that none were found in the normal children control group and only rarely in all other controls. These autoantibodies attack the basic proteins that constitute myelin, which surrounds the sheaths of nerve fibers. Regarding the virus serology, autistic children had a significantly higher level of measles virus antibodies as compared to controls, which suggests a temporal link of measles virus with autoimmunity in autism.
Furthermore, Singh found a very important serological association between measles antibody level and antiMBP, which showed that the higher the measles antibody titer the greater the chance of autoantibodies to myelin basic protein. The shocking fact is that none of the children had a wild-type measles infection, but they all had the measles mumps rubella (MMR) vaccine.
Singh also offers hope. He notes an open label trial of oral Sphingolin (myelin containing autoantigen) is being assessed. Preliminary results show significant improvement in autistic people, which further support the neuroimmune pathogenesis in autism.
Vijendra K. Singh, Department of Biology and Biotechnology Center, Utah State University, Logan, Utah, USA 84322-5305
|SIDS / SBS|
|Chart used by Dan Burton Congressional Record - November 22, 2002|
|More autism statistics by john at: whale.to|
|Disclaimer / Investigate: The intent of this website is to raise awareness about the controversial aspects of vaccination. Many vaccines still contain thimerosal (49.6% ethylmercury by weight.) While mercury is a highly toxic element second only to radioactive plutonium, when combined with other ingredients, specifically aluminum and formaldehyde, the synergistic effects increase 10,000-fold. Individuals who suffer from chronic mercury exposure will have a unique expression of symptoms. This presentation is not to be construed as medical or legal advice: locate and confer with a trusted physician and lawyer.|