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Hiding behind junk science

MagazineApril 2009 (Vol. 20 Issue 1)Hiding behind junk science

In early February 2008, the medical profession and the media gleefully announced that the final evidence was in

In early February 2008, the medical profession and the media gleefully announced that the final evidence was in. A new study had proven-with "no doubt", according to the London Times-that the measles-mumps- rubella (MMR) vaccine does not cause autism. That same month, another study purported to offer definitive evidence that thimerosal, the mercury-based preservative in numerous vaccines, could not be implicated in autism.

Barely a month later, it was revealed that an American court begged to differ. After reviewing the first of three test cases involving a 12-year-old girl who'd developed autistic-spectrum disorder (ASD) as a toddler, a US Federal Claims Court concluded that the booster vaccina-tions that the child had received when she was 18 months of age had aggravated an underlying cellular disorder, which ultimately mani-fested as autism.

The three-member panel of Spec-ial Masters (the presiding justices of the court), concluded that the girl had been developing normally until she received, at 18 months, nine vac-cinations: the tetanus-diphtheria- acellular pertussis (Tdap) triple jab; the haemophilus influenza type B meningitis vaccine; the triple MMR; the varicella chickenpox vaccine; and the inactivated polio vaccine.

After a series of episodes of encephalopathy (brain inflamma-tion), the child's health deterior-ated. Eventually she was diagnosed because of symptoms that were consistent with ASD.The girl's lawyers attempted a broad-brush approach, arguing that her autism was caused by the combination of the MMR jab along with other vaccines that contained thimerosal, as one of two such test cases claiming that it was the combination of vaccine agents that caused the damage. Furthermore, a paediatric gastroenterologist testi-fied that the child had a persistent measles virus in the lymphoid tissue of her bowel.

In fact, subsequent tests found that the girl had a 'defect' in cellular metabolism, and it was concluded that she had oxidative phosphoryla-tion disease, a disorder of cell mitochondria that affects their ability to process energy (see box, page 7).

Writing on behalf of the Depart-ment of Health and Human Services, US Assistant Attorney General Peter Keisler and other Justice depart-ment officials recommended that compensation be awarded to the family.

A chink in the armour

This landmark decision marks the first time that any court anywhere has ruled that vaccination can bring on autism.

This not only effectively counters the position adopted by governments and the medical profession-that vaccination has nothing to do with the epidemic of autism around the world-but it also leaves the door wide open for many more thousands of such families with autistic children, in America and across the globe, to seek compensation for damages as a result of vaccination.

This case is only the first of approximately 4900 autism cases, collectively termed the Omnibus Autism Proceeding, now pending before the US 'Vaccine Court', which reviews whether or not individuals are entitled to a share of the Vaccine Injury Compensation Fund, a pool of money built up by a special tax on vaccines, and distributed by the US government to children found to have been damaged by vaccines.

In the 17 years since the Vaccine Court and fund were created, it has paid out nearly $2 billion in damages to American parents whose children were damaged by one of the child-hood vaccines (N Engl J Med, 2007; 357; 1275-9).

Of some 7000 families who have filed claims of an adverse reaction with the Vaccine Injury Compensa-tion Program (VICP), approximately 2000 families-or slightly less than one-third-have won their cases, receiving individual compensation

at an average of $850,000. Up until now, the VICP has rejected some 300 claims of autism resulting from vaccination, largely because the medical establishment was refusing to recognize the existence of any such link.

Nevertheless, all this could change with the court's recent ruling on this first case-leaving the US govern-ment and the vaccine industry holding its collective breath.

Awarding similar damages to just the families in the autism Omnibus alone would amount to $3.7 billion. And, assuming that just a tiny percentage of the other families of the hundreds of thousands of autistic children in the US comes forward, it would not only bankrupt the vaccine fund, but also leave the American vaccination programme in tatters.

All major studies flawed

But how could the court have ruled in the girl's favour, when medicine has so long claimed that its studies definitely prove otherwise?

The answer is simple: junk science. Close examination of the evidence to date reveals major flaws in the major studies used to argue against a link between autism and vaccination-particularly the new studies considered to have dealt a knockout blow to any possible connection between the vaccine and autism.

The evidence also reveals a concerted cover up initiated by the US's leading agency against preventable disease and a deliberate policy by the top US government agencies charged with protecting the public health to conceal data that could undermine public confidence in vaccination (see Viewpoint, p 3).

The most recent study of the MMR vaccine-the one held up by the press as the final nail in the coffin for theories of the vaccine as a cause of autism-claimed to find no association between it and ASD (Arch Dis Child; 5 February 2008; doi: 10.1136/ adc.2007.122937). Researchers from the UK's Health Protection Agency, in partnership with various universities in the UK, examined a community sample of vaccinated children aged 10 to 12 years who had ASD, and compared them with two control groups: one made up of those who had special educational needs, butno ASD; the other was composed of those who had developed normally. These children were all then examined via blood tests for either the measles virus or an antibody response to it in the blood.

The study claimed that there was no difference between the cases and controls in terms of measles anti-body response, nor any relationship between the severity of autism and levels of measles antibody. What's more, only one child-and this was

in the control group-had symptoms of an inflamed gut.

A central tenet of gastroenterol-ogist Andrew Wakefield's theory is that the live measles virus from the vaccine, either alone or in combina-tion with two live viruses (as in the MMR vaccine), can cause persistent enterocolitis and gut damage, allowing undigested proteins to 'leak' through the gut membrane and, eventually, to make their way to the brain.

However, even a cursory look at the study reveals basic problems in the study's design. There were 735 children 'lost' to the study by the second phase and, of the remaining 155 children who had special educa-tional needs or ASD, 100 of them

did not produce satisfactory blood samples. Consequently, the study's conclusions rested upon the blood samples of just 55 children, a sample too small to be definitive in any significant way.

The authors ruled out any gut problems in the ASD children on the basis of criteria that required five "current and persistent" symptoms: diarrhoea; vomiting; weight loss; abdominal pain; and blood in stool or past persistent diarrhoea of more than two weeks' duration. Current constipation was ruled out as a symptom.

Writing from the US, where he now lives and works, Dr Wakefield wrote an impassioned reply.

"Over the last 10 years, we have evaluated several thousand children on the autistic spectrum who have significant gastrointestinal sympt-oms," he wrote. "Upper and lower endoscopy and surgical histology have identified mucosal inflamma-tion in excess of 80 per cent of these children. Almost none of these children with biopsy-proven entero-colitis would fit the criteria set out above."

As Wakefield pointed out, all these thousands of children he examined almost never had vomiting or current weight loss, or passed blood via the rectum.

The criteria set out in the study reveal a "singular lack of under-standing of the episodic, fluctuating and alternating [diarrhoea/ constipation] symptom profile experienced by these children", he added. Moreover, none of the studied children was examined by any test, such as endoscopy, to definitively reveal the kind of mucosal damage he routinely records.

In other words, the study used symptom criteria that were utterly at odds with the symptoms published by Wakefield (Histopathology, 2007; 50: 380-4).

The fact that the study moved the goalposts on gut symptoms is particularly surprising, given that one of its authors routinely acts as an expert witness in British MMR litigation for the defence (drug companies).

As Wakefield points out, this author would have had frequent access to the clinical records of autistic children, together with all of the relevant intestinal symptoms.

Wakefield also claims that it was a "major error" to presume that using peripheral blood cells was just as valid as studying gut mucosal tissue when looking for the presence of a persistent virus such as measles.

The mercury connection

Several months before the British MMR study, America was doing its own share of junk science.

A team of scientists from the Vaccine Safety Datalink Team at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA, published a study that supposedly demonstrated-once and for all-that thimerosal, the mercury-derived preservative, had nothing to do with autism (N Engl J Med, 2007; 357: 1281-92).

In this study, 1047 children, aged 7 to 10 years, were given stand-ardized tests measuring 42 neuro-psychological parameters. The researchers assessed each child's exposure to mercury (in the form of thimerosal) from immunization and other medical records, as well as from their parents' records and interviews. Their neuropsychol-ogical findings were then compared with their mercury exposures prenatally, and in the first and seventh months of life.

The study found only a few significant associations between exposure to mercury and effects on the brain-some positive and some negative. However, none was related to autism-largely because no neurological tests were performed for autism.

The researchers claimed to have found only one relevant association between the preservative and neuropsychological disturbance: nervous tics in boys. Otherwise, in some cases, claimed the study, mercury exposure was associated with improved performances in fine motor coordination, and attention and executive functioning.

In other words, exposure to one of the best-known toxins on earth might even be good for you.

However, in January of this year, Sallie Bernard, one of the panel members of external consultants for the study, had a letter published in The New England Journal of Medicine (2008; 358: 93-4) in which she publicly challenged its conclusions.

The study cohort, she wrote, had been deliberately skewed to include only those children who were the least likely to exhibit neuro-psychological impairment. Also, once again, 70 per cent of those recruited ultimately dropped out, leaving too small a sample upon which to hang any meaningful scientific conclu-sions with certainty.

But perhaps most remiss of all, the study did not find autism because the question was never asked.

In addition, according to David Kirby, author of Evidence of Harm (St Martin's Press, 2005), the study authors failed to connect the dots: tics among boys is a well-recognized presentation of ASD.

Studies from other countries have produced their own versions of junk science. A study from Hong Kong measured mercury levels from the hair and blood of children with autism, and compared them with a matched control group of normal children. These children were, on average, seven years of age (J Child Neurol, 2004; 19: 431-4). These investigators could find no differ-ences between these two groups of children, and so concluded no causal relationship between environmental mercury and autism.

However, Catherine DeSoto and Robert T. Hitlan, two doctorates at the department of psychology at the University of Northern Iowa, re-analyzed the data reported in this Hong Kong study and found numerous computational errors. Using the corrected figures, DeSoto and Hitlan showed a significant relationship between blood levels of mercury and a diagnosis of ASD.

"Moreover, the hair-sample analysis results offer some support for the idea that persons with autism may be less efficient and more variable at eliminating mercury from the blood" (J Child Neurol, 2007; 22: 1308-11).

However, the biggest mountain of junk science is the database used as the source for the latest New England Journal thimerosal study and the five large-scale population studies showing that the agent is not dangerous to children. It was also the basis of the US Institute of Medicine's 2004 report that ruled against a connection between thim-erosal and autism. In fact, the Vaccine Safety Datalink (VSD) has been the source of more than 75 scientific articles, all claiming no association between thimerosal and autism.

The VSD project is a collaboration between the CDC's Immunization Safety Office and eight large managed-care organizations (MCOs). The project was launched in 1990 to monitor immunization safety and to gather data on vaccinations, including medical status. The VSD gathers data on the types and numbers of vaccinations, and the types of visits and medical outcomes, including urgent-care visits, and birth and census data. Most of the children in the database reside in California, where managed care more or less originated.

In late 2006, a National Institutes of Health panel, led by NIH director Dr Elias A. Zerhouni, signed a statement, submitted to Congress, that answered a query from a group of senators as to whether the VSD could be relied upon to compare autism rates in children before, during and after the gradual removal of thimerosal from US vaccines, which began in 2000.

The NIH's response was that the database could not be relied upon because it had an enormous number of "weaknesses" and other "limita-tions". Such an analysis would prove "uninformative", even "misleading".

First, some 25 per cent of children born during the VSD's existence were not included. Also, the database had no information on the thimerosal-containing drugs given to the mothers, nor on the cumulative exposure of individuals to other sources of mercury, to arrive at a total mercury burden. The panel also expressed concern over the method by which autism was diagnosed and how accurately it had been recorded. These and other issues would certainly contribute to an "under-ascertainment" of the true number of autism cases.

Non-reporting may be a factor. As David Kirby says in his book, theVSD rate of autism was 11.5/10,000 children before thimerosal was ban-ned from vaccines, whereas the rate of autism in California was 30-40 /10,000 children-nearly four times as many.

The NIH panel might have received plaudits for this rare example of governmental whistleblowing except for one disturbing fact. The CDC, who were the very architects of the database, has been using every means at its disposal to avoid the public release of these data after the autism connection was first revealed (see Viewpoint, page 3). So, the database was good enough until it was found to contain damning evidence against vaccination.

Whether or not the government or the medical profession plays fair no longer matters. The implications of the Vaccine Court's findings are extraordinary. The court didn't care what caused the autism-thimerosal, MMR or the combined insult of nine vaccines. It took the commonsense approach-the kind you and I take. If a healthy child is knocked over by a hit-and-run driver and left crippled forever, it is reasonable to conclude that the car caused the damage, even if the driver never comes forward.

The effect of this first court ruling goes far beyond the MMR jab or a preservative. The rates of autism have dropped in the US now that thimerosal has been removed, but the numbers are still far higher than for generations past.

However, given the enormous commercial, political and legal ramifications of any evidence that vaccines are indeed responsible for destroying an entire generation of children, it is unlikely that any scientist will have the temerity to look for other culprits.

Nevertheless, and thankfully, this ruling of the court has revealed one simple, commonsense truth. A legal precedent has established that there is reasonable doubt that we can pump scores of foreign proteins loaded with toxins into our infants with impunity and not expect disastrous outcomes.

Lynne McTaggart

The vaccine or the damaged cell: which came first?

The doctor of the girl in the test case concluded that she had evidence of a 'mitochondrial disorder' that predisposed her to autism. The court concluded that the vaccines made this latent genetic tendency an actuality.

But which came first? Was oxidative damage inherent in her or was it created by the vaccine? The proponents of the oxidative theory argue that, as autism runs in families, the genes involved in autism may be those that relate to mitochondrial function.

Mitochondria are the tiny powerpacks of the cell, providing cells with the energy to do their jobs. Doctors in the case testified that the girl's cells do not metabolize energy properly. But one study of 159 patients with autism discovered that nearly half had abnormal cell-energy metabolism. This could be relevant to autism, as the central nervous system is highly dependent upon mitochondrial function, or it may have to do with wireless radiation (see WDDTY vol 18 no 9), which effectively shuts down the cell, preventing it from excreting mercury and other heavy metals.

More junk science

All of the major studies claiming to refute the autism connection with vaccination are flawed. In fact, evidence obtained by various groups via the Freedom of Information Act reveals that the CDC spearheaded a major worldwide movement to find studies that would bury the thimerosal connection.

- Danish researchers were responsible for the near-simultaneous release of four studies, three of which showed no link between autism and thimerosal (JAMA, 2003; 290: 1763-6; Pediatrics, 2003; 112: 604-6; Am J Prev Med, 2003; 25: 101-6). They were shopped by the CDC as having the best data to partner with (see www.putchildrenfirst.org/media/4.16.pdf).

Nevertheless, Danish autism records have changed so frequently

that they may have falsely decreased the actual number of children who have the condition. Outpatients clinics, where most cases of autism are diagnosed, were only added in the last few years of the 30-year review, making it appear that autism went up after thimerosal was removed. As PutChildrenFirst notes,it is like studying 'Divorce Rates in North America' but using only figures from Mexico and Canada, adding those from the US in the last few years, and then claiming that divorce rates went up.

- Sweden limited itself to examining only those autism cases diagnosed

in hospitals, which tends to underreport the true figures (Am J Prev Med, 2003; 25: 101-6).

- Great Britain reported a study based on data from more than 14,000 children in the Avon area, and managed to show that mercury was actually good for children, offering a "beneficial effect" (Pediatrics, 2004; 114: 577-83).

Another British study purporting to show the lack of association between MMR and gut problems restricted its analysis to hospital emergency admissions (BMJ, 2005; 330: 1120-1). As lawyer Clifford

MMR and mercury detox

The latest views about children with autism is that it is a multifactorial problem, due to a combination of vaccination, heavy-metal exposure and even to microwaves, as generated by mobile phones. Typically, a child exhibits gut conditions, problems with detoxification and heavy-metal poisoning. Here are a few basic ways to regularize these symptoms.

- Make sure your child receives good supplements of vitamins, minerals and essential fatty acids, including trace minerals such as zinc and selenium.

- Remember, gut health can be enhanced with probiotics and digestive enzymes.

- Fix any Candida problems (see The Candida and ME Handbook. London: WDDTY, 2001).

- Supplement with glutathione and products that boost its uptake, which helps with mercury detox. Children exposed to thimerosal have lower cellular levels of glutathione (NeuroToxicology, 2005; 26: 1-8). A number of companies offering such support suggests that the products should be sodium benzoate-free to support clearing of metals and other toxins.

- Support the rebuilding of gut cellular barriers with the use of glycosa-minoglycans. These gut-protective barriers are often impaired when a child is exposed to the MMR shot or heavy metals.

- Chelate heavy metals naturally or with homeopathic methods. One such agent is zeolite, a natural volcanic mineral that claims to chelate heavy metals more gently than do chemicals such as DMSA.


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