The charges were related to the methods employed by Dr Wakefield in obtaining their research data, includ-ing the use of "high-risk" methods such as lumbar punctures, and paying lb5 to children attending a party for samples of their blood. All three doctors are expected to have their licenses to practise medicine taken away within the next few months.
But the hypothesis that the MMR vaccine could cause autism was not on trial at the GMC's 20-month hearing, the longest in its history. In his 1998 paper, Wakefield found that 12 autistic children-examined at the request of their parents-had persistent entero-colitis and inflammation of the colon, among other intestinal abnormalities. He later discovered that eight of the 12 had been given the measles vaccine, which led him to consider the possibility that the vaccine might be a cause (Lancet, 1998; 351: 637-41).
Despite the furore that followed, Wakefield has never been any more emphatic than that as to any possible link between the vaccine and the gastrointestinal conditions. Indeed, at a press conference following the public-ation of the paper, he confirmed that his research had not proven any association between the MMR vaccine and autism.
Yet, bizarrely, journalists at the press conference appeared to infer from that statement that Wakefield and his team were suggesting a causal link between the vaccine and autism-and this became the story that has since spread far and wide over the past 12 years, during which time, the MMR take-up rates in the UK fell to around 80 per cent (Thompson G. Measles and MMR Statistics, 2008. London: House of Commons Library). Worryingly, for an already cash-strapped UK government, any further decline in take-up would have triggered automatic compensation payments to the vaccine manufacturers.
But all that ended with the GMC's verdict. Finally, the journalists, doctors and scientists alike were able to disassociate the MMR vaccine from autism once and for all-that is, until new evidence came to light, gleaned from tests on 14 monkeys.
Hear no evil, speak no evil . . .
The primates had been tested by Wakefield and other researchers at the University of Pittsburgh School of Medicine, in Pennsylvania, to look for any early developmental problems when given vaccines according to the numbers and scheduling order that is followed by the vaccination programme in the US. Ten of the monkeys were given a hepatitis B vaccine-the first jab in the long, comprehensive vaccine programme required for American children-and, almost immediately, all the monkeys lost the reflexes that are critical for survival. They also suffered brain-stem damage.
These results were part of the second phase of a study that had been started in 2002 as a collaboration between the University of Pittsburgh and the Thoughtful House Center, the autism research unit set up in Austin, TX, by Dr Wakefield. He resigned from the centre after the GMC verdict.
Led by Dr Laura Hewitson from the university, the study claimed to be one of the first to investigate the synergistic effects of the entire American vaccination programme, as well as its impact on neurological development, and on the immune and gastrointestinal systems.
Dr Hewitson presented the study's initial findings at a conference on autism in London in 2008. In her talk, she announced that the "vaccinated animals exhibited progressively severe chronic active inflammation in gastro-intestinal tissue whereas unexposed animals did not. We have found many significant differences in the GI tissue gene expression profiles between vac-cinated and unvaccinated animals."
In fact, the results virtually replicated the findings made by Wakefield and his colleagues in 1998, when they examined those 12 autistic children at the Royal Free Hospital in London. All had displayed a new form of GI inflammatory infection.
. . . and see no evil
In October of last year, the prestigious journal Neurotoxicology accepted for publication the paper from Wakefield et al., entitled 'Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing hepatitis B vaccine". The paper had been duly peer-reviewed, it had been approved by the journal's editor Joan Cranmer, and it was available to be read on the journal's website before being published in the journal.
However, on February 12-two weeks after the GMC verdict on Wakefield and his British colleagues-the report mysteriously disappeared from the Neurotoxicology website. In fact, Cranmer had been under pressure to remove the paper as early as November of last year, but had rebutted the complainant with the response that Wakefield's paper had been "subjected to rigorous independent peer review according to our journal standards", according to Age of Autism on 2 March 2010 (see www.ageofautism.com).
However, by February of this year, her position-along with that of the journal-appears to have changed dramatically. The journal's publisher, Elizabeth Perill, told Lyn Redwood of SafeMinds-a non-profit pressure group that is working to have thimero-sal removed from vaccines and which partly funded the monkey study-that the research was "not suitable" for publication. The decision mirrors the response of The Lancet journal, which retracted Wakefield's original 1998 paper immediately following the GMC verdict. The word 'Retracted' is now plastered in large red capital letters over each page of the study, making it impossible to read.
Changing the story
Censorship and the manipulation of data appear to be the modus operandi of health authorities and most researchers when attempting to disprove any causal link between vaccines and autism whereas, all along, what parents have wanted was merely an open-minded debate, and to be given the known facts concerning the safety of the MMR and other vaccines that their children are required to have.
Every health authority stands by the claim that numerous studies have conclusively established that the MMR vaccine does not cause autism. The US Institute of Medicine is one of the many authoritative bodies to make these reassuring claims to parents, and has relied on several published papers as supportive evidence. One report, prepared by Eric Fombonne and his colleagues at the Children's Hospital in Montreal in Quebec, Canada, demonstrated that pervasive develop-mental disorders, such as autism, continued to increase in Montreal between 1987 and 1998, during a period that MMR vaccine coverage had decreased (Pediatrics, 2006; 118: e139-50). In passing, Fombonne mentioned that the vaccine data had been obtained from five-year-olds attending kinder-garten during 1993 to 2004 in Quebec City.
However, as Dr F. Edward Yazbak, a researcher for the TL Autism Research in Falmouth, MA, has pointed out, Quebec City is around 160 miles (265 kilometres) from Montreal. "The rates of autism in Montreal have as much to do with MMR vaccination rates in Quebec City as pollution in Los Angeles has with diesel buses in Chicago," he says. However, data on vaccination rates in the city of Montreal itself is available, and the statistics demonstrate that they have been increasing in line with the rise in cases of pervasive developmental disorders: MMR rates rose from 85.1 per cent in 1983 to 88.8 per cent in 1996, and to 96 per cent in 2003.
Fombonne had attempted to disprove Wakefield in an earlier paper, which was also published in the journal Pediatrics. In that report, he stated that there was "no evidence for a new variant of measles-mumps-rubella-induced autism" (Pediatrics, 2001; 108: e58). However, this paper was eventual-ly discredited by the prestigious and independent Cochrane Collaboration in a review that found that "the numbers and possible impact of biases in this study are so high that interpretation of the results is impossible" (Cochrane Database Syst Rev, 2005; 4: CD004407).
One of the most significant papers on the subject was prepared by researchers from the Danish Epidem-iology Science Centre at the University of Aarhus in Denmark, and is now referred to as 'the Danish study'. This retrospective study, which tracked the numbers of autism cases recorded by the Danish Psychiatric Central Research Register from 1971 to 2000, and all outpatients cases seen by psychiatric departments since 1995, demonstrated that thimerosal could not have been a cause of autism because the preservative had been removed from vaccines in Denmark in 1992 and, yet, the rates of autism continued to rise during the years thereafter (Pediatrics, 2003; 112: 604-6).
However, critics of the report were quick to point out that the Central Research Register added data from outpatients clinics only from 1995 onwards and, yet, that is where 93 per cent of Danish children with autism go to have their diagnosis confirmed. Thus, for 14 of the 29 years of the study period, the principal source of autism data was excluded-and adding it so late in the study would obviously demonstrate a sudden increase.
In addition, it was also not revealed at the time that the Danish Centre had been hired by the US Centers for Disease Control (CDC) "to prepare a series of studies that would exonerate thimerosal . . . and the MMR vaccine from any role in causing autism" (The Copenhagen Post, 11 February 2010).
The media massages
Concerned parents cannot obtain clarity from their newspapers and newscasters either. One reassuring voice has been American paediatrician Ari Brown, whose pronouncements are published by the Immunization Action Coalition, which is funded by the CDC and by the vaccine manufacturers. According to the Immunization Action Committee, in her 2008 report entitled 'Clear Answers and Smart Advice About Your Baby's Shots', Brown leans heavily on studies prepared by the CDC that demonstrate that thimerosal "had no significant effect on either intelligence or developmental delays in kids aged seven to 10". In particular, one CDC study put 1047 children through a series of 42 neuropsychological tests that showed that they had not been developmentally impaired by vaccines (N Engl J Med, 2007; 357: 1281-92).
Nevertheless, the researchers' conclusion is not supported by the evidence. Many of the boys had developed facial tics, one sign of neuro-psychological disturbance, and the reading skills of some of the girls was well below normal. The study group was also self-selecting, as only 30 per cent of the families invited to participate actually did so. But most concerning of all, the researchers were not looking for autism in the first place. In fact, these limitations were revealed by one of the study's own panel members, who disassociated herself from the findings the following year (N Engl J Med, 2008; 358: 93-4).
What's more, the CDC itself doesn't always follow its own official 'party line'. Its former director, Julie Gerberding, who resigned in January 2009 after the election of President Obama, told CNN's Sanjay Gupta that the MMR vaccine could cause autism in children born with mitochondrial disease, a condition in which cells fail to properly convert food and oxygen into energy. She reckoned this could happen in one in 50 children-or 2 per cent-so it wasn't a rare condition. Yet, despite this departure from the party line, Gerberding is now heading up Merck's vaccine division.
However, Gerderding's calculations are wrong. Around 20 per cent (or one in five) of all autistic children have mitochondrial disorders (Dev Med Child Neurol, 2007; 49: 726-33), and around half of the 4800 cases of post-MMR autism filed for possible compensation claims in the US include some degree of mito-chondrial dysfunction (Medical Veritas, 2009; 6: 1907-24).
In the UK, the anti-Wakefield faction has been spearheaded by investigative journalist Brian Deer, whose articles in The Sunday Times sparked the GMC hearing. Since its conclusion, Deer has revealed that he was instructed by the newspaper in 2003 to "find something big" on the MMR controversy. By then, vaccine rates had fallen away in the UK as parents were concerned over the safety of the MMR and other childhood vaccines and, especially, by the possible link with autism. In 2007, Deer's immediate superior left the newspaper to take up a lucrative post as head of the UK's National Health Service website and, in 2009, James Murdoch, who has been heading up the UK and European division of News Corpora-tion, which publishes The Sunday Times, became a board member of the drug giant GlaxoSmithKline (GSK), which manufactures the MMR vaccine (www.ageofautism.com, 3 March 2010).
The Sunday Times newspaper has not been alone in discrediting any doubts over the safety of the MMR vaccine. Many publications and TV channels have also done so, and it's virtually been open season on Wakefield since the GMC hearing began. But, according to a House of Commons select committee report, this is only to be expected. In its report, the health committee reveals that "considerable resources are invested [by the pharmaceutical industry] into building long-term, sustainable relationships with stakeholders and key opinion leaders and journalists. These relationships are used to promote the use of certain brands and counter concerns relating to safety. Efforts to undermine critical voices in particular were identified, under terms of issue management" (House of Commons Health Committee. The Influence of the Pharmaceutical Industry, Fourth Report of Session 2004-05, 2005; section 221, page 60).
Such a conclusion resonates with that of Dr Peter Fletcher, former Chief Scientific Officer at the UK Depart-ment of Health, who declared that if it is ever proven that the MMR vaccine causes autism, then "the refusal by governments to evaluate the risks properly will make this one of the greatest scandals in medical history".
He also said, in the Mail on Sunday (22 March 2006), that he has seen a "steady accumulation of evidence" that the vaccine is causing brain damage in certain children, but added: "There are very powerful people in positions of great authority in Britain and else-where who have staked their reputa-tions and careers on the safety of MMR, and they are willing to do almost anything to protect themselves".
The case for autism
So, what is the evidence to which Dr Fletcher alludes? It's now established that many children with autism or autism-spectrum disorders (ASD) also have chronic gut inflammation, as Wakefield noted in 1998. Scores of studies have since witnessed the phenomenon, and one from the New York School of Medicine, which studied 143 autistic and ASD children, is only the latest to confirm these findings (Autism Insights, 2010; 2: 1-11).
But where's the evidence that the MMR vaccine-and especially thimer-osal-may have triggered such inflammation? One important study from Vijendra Singh at Utah State University found antibodies in blood samples from 75 of the 125 autistic children tested that indicated an abnormal reaction to the measles component of the MMR vaccine. These antibodies attack myelin, the insula-ting tissue sheath that protects nerve fibres, thereby preventing the nerves from developing properly which, in turn, can affect brain function. Singh concluded that an abnormal immune response to the vaccine could be the cause of many cases of autism (J Biomed Sci, 2002; 9: 359-64).
In a later study, Singh confirmed that the measles element of the MMR vaccine was associated with increased antibodies in children with autism. He concluded that "autistic children have a hyperimmune response to measles virus, which, in the absence of a wild type of measles infection, might be a sign of an abnormal immune reaction to the vaccine strain or virus reactivation" (Pediatr Neurol, 2003; 28: 292-4).
Researchers at Tokyo Medical University made similar discoveries when they examined children with Crohn's disease, ulcerative colitis or autism, and found that some had signs of the measles virus in their gastro-intestinal system. In the cases of autism and ulcerative colitis, the virus had to have come from vaccines on the basis of genomic RNA studies of the viruses (Dig Dis Sci, 2000; 45: 723-9).
Other earlier evidence of a possible link-or a coincidental association-between MMR and autism also came out of Japan, which stopped using the vaccine combination in 1993. The data showed a rise in autism cases with the introduction of the triple vaccine that was followed by a decline as it was replaced by single shots (J Child Psychol Psychiatry, 2005; 46: 572-9).
Parents know best
Perhaps the most compelling evidence so far is from the parents themselves, who have witnessed the sudden, and catastrophic, decline in the development of their child immediately following an MMR vaccination. Typically, they report sudden fits and seizures, high fevers, gastrointestinal problems, and the loss of motor and verbal skills; their previously happy and outgoing child often becomes withdrawn and starts behaving strangely.
A survey of around 9000 parents in California and Oregon found a strong association between the vaccination and a range of neurological disorders such as ADHD (attention-deficit and hyperactivity disorder) and autism. According to a telephone survey that targeted the families of both vaccinated and unvaccinated boys, those who had been vaccinated were, on average, two-and-a-half times more likely to have some neurological disorder compared with the boys who had not been vaccinated; also, they were 224-per-cent more likely to have ADHD, and 61-per-cent more likely to be diagnosed as autistic (Generation Rescue, 25 September 2007; www. generationrescue.org/studies.html).
It had also been the parents who, suspecting that the MMR vaccine had caused autism in their children, approached Dr Wakefield at the Royal Free Hospital in 1998 to investigate.
It was no coincidence that they chose Dr Wakefield, as he had already expressed concerns over the MMR vaccination by writing to Dr David Salisbury, head of the UK's vaccination and immunology unit, as early as in 1993. He had noticed a number of adverse reactions to the vaccine in children who came to his surgery at the Royal Free, and he feared that there could be a public-health crisis.
The official line remains that vaccines in general, and the MMR in particular, don't cause autism. Yet, despite this widely held view, the US National Vaccine Injury Compensation Scheme has made 925 compensation payments to parents between 1998 and 2008 for claims that a vaccine was the cause of their child's autism. Some of the more public examples include the cases of Bailey Banks, whose parents, in 2007, were compensated after he developed autism following a vaccination, and Hannah Poling, whose parents were compensated after she developed autism after the MMR vaccine. However, in the latter case, doctors have argued that Hannah was susceptible to autism because she had the preexisting condition of mitochondrial disorder. Her mother has the same condition, but with no ill effects. Writing in The New York Times in 2008, her father pointed out: "Our daughter, Hannah, developed normally until receiving nine vaccines at once. She immediately developed a fever and encephalopathy, deteriorating into autism".
Despite this public acceptance of culpability in the US, the UK's own compensation scheme, the Vaccine Damage Payments Unit, continues to refuse to pay out on any autism cases, as it continues to maintain that a causal link has not been proven.
But what does it mean to be proven? In an authoritative report, Donald Miller, a professor of surgery at the University of Washington School of Medicine, and Clifford Miller, a commercial lawyer, together argue that the evidence from parents should be enough to establish proof. America's drugs regulator, the Food and Drug Administration (FDA), is willing to accept the evidence from just one case that a drug causes a specific adverse effect as long as it is well documented and, yet, similar cases concerning the MMR vaccine are ignored. Instead, doctors want clinical evidence, which they regard as being 'scientific', but even this evidence can be biased, partial and manipulated, and can be as far away from being 'scientific' as an individual case study (J Am Phys Surg, 2005; 10: 70-5).
Pity the parent who is trying to get to the simple truth about the MMR vaccine and autism. Following the GMC's verdict on the Wakefield case, the media was, as a chorus line, crowing that the autism argument was dead. In fact, the autism hypothesis was never on trial, and the principal defendant had never claimed it in the first place.
Worse, governments have been deliberately concealing evidence, scientists have been manipulating data and everyone seems to be trying to mislead the parents-all of which adds up to suspicious activity that suggests that there may well be something to the MMR-autism hypothesis after all.
It's true that the evidence suggests a link, but it has not yet been established beyond reasonable doubt. The respected autism researcher Bernard Rimland says that "substantial data demonstrate immunity abnormality in many autistic children consistent with impaired resistance to infection, activation of inflammatory response, and auto-immunity". But he then sums up by saying: "We are far from certain that vaccines help trigger autism, but we are farther still from certain they do not" (Lab Med, 2002; 33: 708-17).
However, one thing is certain: demonizing Andrew Wakefield isn't helpful, and doesn't bring us any closer to the truth that we all have the right to hear.
WDDTY VOL 21 NO 1