Government agencies are withholding worrying safety information about vaccinations, as secret minutes to key decision-making committee meetings reveal
According to private minutes to meetings of the UK government's Joint Committee on Vaccination and Immunisation (JCVI), members were made aware of a possible link between the MMR vaccine and autism 10 years before Andrew Wakefield published the controversial paper that eventually resulted in his being struck off the medical register.
From 1983 up to just recently, the minutes-obtained under Freedom of Information legislation-suggest that important information about vaccine safety that would almost inevitably have affected the take-up rate needed to achieve 'herd immunity' was not revealed to the public.
The JCVI acts as an advisory service to the UK's health minister, and many of its committee members over the years have had ties to the pharmaceutical companies making vaccinations (see below).
Spin, not science
In an analysis of the private minutes covering monthly meetings of the JCVI between 1983 and 2010-which still contained many redactions and omissions-medical researcher Dr Lucija Tomljenovic from the University of British Columbia, Canada, makes eight serious charges against the committee and the UK's Department of Health.
Charge 1.Instead of re-examining vaccine policies when new safety concerns were raised, the JCVI took no action, or skewed or selectively removed worrying safety data from reports released to the public, or made extensive efforts to reassure the public about the ultimate safety of the vaccines.
As long ago as 1981, the JCVI had extensive information concerning serious adverse reactions to the MMR vaccine, including sudden death and encephalitis, from studies going back to 1970. The JCVI said the high numbers of deaths and injuries were "surprising".
After receiving even more worrying data on adverse reactions, a "commercial in confidence" JCVI subcommittee in 1986 decided to put a positive spin on the safety of two measles vaccines by reporting that "results showed that 70 per cent of children were well after receiving Attenuvax and 61 per cent after receiving Rimevax . . . [and] if children with mild general reactions were added to those who were apparently well, then the numbers associated with Attenuvax were 85 per cent and those with Rimevax 80 per cent."
Another way of interpreting the same data is that between 15 and 20 per cent of children given one of the vaccines would suffer a serious adverse reaction.
The subcommittee agreed to stop the study, and concluded that the vast majority of adverse reactions were probably nothing to do with the vaccines but were, in fact, "temper tantrums".
The same subcommittee was also told of 90 serious adverse reactions to the DTP (diphtheria-tetanus-pertussis, or whooping cough) vaccine, including convulsions, abnormal fever and two cot deaths.
By 1988 the JCVI was becoming concerned by an association in the public's mind between vaccines and death or brain damage. Legal claims began to be brought to the courts, and JCVI members were given secret documents concerning vaccine safety levels on the express understanding that they were never to be made public. One paper on the scientific evidence of harm caused by the DTP vaccine conflicted with the current legal opinion that there was insufficient evidence to demonstrate that the vaccine caused permanent harm, the committee was told-in other words, there was sufficient evidence, but the government was sitting on it.
The following year the committee was given evidence from the National Institute for Biological Standards and Control (NIBSC) that indicated a link between the mumps component (Urabe Am9 strain) of the MMR vaccine and meningitis and encephalitis, an association that would be drawn 10 years later by Andrew Wakefield in his controversial Lancet paper. The NIBSC suspicions were vindicated by 1990 when 10 definite cases of meningitis/encephalitis were established by analyzing cerebrospinal fluid taken from recently vaccinated children.
Despite these findings the JCVI agreed to not make any changes to the then current vaccination policy although, by 1991, reports on adverse reactions from other countries, such as Canada and Japan, were mounting, prompting the committee to seek the guidance of the vaccine manufacturers. The drug companies concurred that the UK government's approach of "surveying adverse events" was the correct one. But by 1992, SmithKlineBeecham, as the company was then known, decided to stop manufacturing the Urabe MMR vaccine on the advice of lawyers, and the JCVI was told that, in light of that sudden decision, it needed to "act quickly".
In secret meetings with their European counterparts in September of that year, UK health officials decided not to revoke SKB's licence to produce the vaccine because it would have "caused a worldwide vaccine crisis".
Despite these growing concerns, the JCVI set aside lb800,000 for a publicity campaign and lb1.4 million to help meet increased vaccine costs, education and the "reprogramming of children's computers".
Charge 2.Health officials reduced the number of contraindications-the circumstances in which a vaccine should not be given-just to increase vaccination take-up rates.
By 1980, public confidence in the whooping cough vaccine (the pertussis element of the triple DTP vaccine) had reached a low point, and only 40 per cent of eligible children were being vaccinated. A new subcommittee was then created by the JCVI to address the problem; it was tasked with relaxing the parameters of defining the 'at-risk' children. The subcommittee had been told that "the right balance had to be struck between the need to keep acceptance rates for vaccination as high as possible and the need to protect groups of children who had an increased risk of adverse reaction to vaccination" (the contraindicated vaccine recipients).
But the emphasis was on the reputation and safety profile of the vaccination and not the wellbeing of the vaccinated child. Respiratory disease was one contraindication that should be removed, some committee members mooted, while others pointed out that the contraindication "protected the reputation" of the vaccine. Respiratory disease was often associated with sudden infant death syndrome (SIDS) and the vaccine could be dragged into the controversy if those children received the vaccine.
A similar argument was put forward to members who wanted epilepsy to be removed as a contraindication. Again the vaccine could be blamed if the child suffered convulsions or seizures. Yet even in healthy children, the vaccine was causing fits, and the child stopped developing. "It is very difficult to assess this as a random event," the committee was told.
However, to fulfil its brief the subcommittee finally agreed that there should be "special consideration", but not necessarily exemption, of children with cerebral damage from birth, with a history of convulsions, with a family history of epilepsy, with developmental delay or with neurological disease. The risk posed by the vaccine in the child with a familial history of epilepsy was "slight", said the subcommittee, while developmental delays and neurological disease were stable conditions and so would not be worsened by the vaccine.
These statements, designed to reassure parents, had little or no basis in fact and were not supported by any evidence.
Although the subcommittee was keen to play down the risks of the DTP vaccine, it had been told of 95 adverse reactions, including one death, in children given the vaccine during the four months leading up to September 1986. The report concluded that "there is reason to believe that the increased relative risk of prolonged convulsions after DTP was a real one".
Not only was it real, the risk was also high, the subcommittee was told after reviewing 12 cases of vaccine-induced encephalopathy, which included two deaths and five cases of long-term impairment.
Despite having these data, the subcommittee issued reassuring statements to parents that downplayed the risks-while also advising the vaccine manufacturers to alter their data sheets to include the risks and so avoid legal action later.
Charge 3.The JCVI worked closely with the vaccine manufacturers to amend the accompanying data sheets even though they often conflicted with its official advice to parents.
From 1987 onwards the JCVI worked closely with the pharmaceutical company M'erieux, which was making a booster MMR vaccine and a DTP vaccine, to encourage it to change the data sheets so that they were in line with forthcoming changes to the Department of Health's own guidelines to doctors. Without that conformity, the JCVI was worried that the UK government would be leaving itself open to damages claims.
But the drug company felt it could not make the changes while litigation, brought by the parents of a child injured after being given the pertussis vaccine, was ongoing. Nonetheless, the JCVI had private meetings with the Association of the British Pharmaceutical Industry and solicitors for the Department of Health to see if some help could be given to M'erieux. The discussions were described as "commercial" and "in confidence".
Presenting a united front became imperative after the JCVI received a report that year from the Committee on Safety of Medicines (CSM), which stated: "No scientifically unassailable link has been established between DTP immunisation and serious neurological illness, but we have come to the conclusion, on the basis of all present evidence, that there is a prima facie case that such a link may exist. We would also agree that the evidence suggests that the vaccine causes convulsions in some children."
Despite its concerns, the CSM supported the JCVI's view that the DTP vaccine was safe. According to Dr Tomljenovic, the JCVI made legal "discovery" of negative reports difficult and so evaded potential legal repercussions.
Charge 4. The JCVI persistently relied on dubious studies, and dismissed independent research, to promote vaccine policies.
To promote the MMR as a safe vaccine, the JCVI always welcomed studies that appeared to support that view while dismissing any that raised concerns. It greeted one population-based study, which could find no link between autism and MMR, as "persuasive" even though it is not the purpose of epidemiological studies such as this to look for causation.1 Indeed, four years later the prestigious Cochrane researchers looked at the same study and concluded that "the number and possible impact of biases in this study were so high that interpretation of the results is impossible".
In the same Cochrane review, which looked at 31 studies of MMR and autism and Crohn's disease, the researchers concluded that the studies were so poorly designed that they were "largely inadequate".2
The JCVI reserved a similar critical eye only for those studies that suggested problems with the MMR. In 2002 its experts reviewed five critical studies, including one that found a direct link between the MMR and autism, and concluded there was "no evidence" of any causation (see below).
Charge 5. The JCVI persistently played down safety concerns while exaggerating vaccine benefits.
The number of legal claims over injury from the pertussis vaccine was reaching a crescendo by 1985, and the JCVI wanted to put a lid on rising public concerns. In one confidential paper issued in 1986, it said it "deprecated" the use of the term 'brain damage' when talking about the vaccine as "the public might consider [it] a permanent entity".
The JCVI clearly didn't want to find out if any damage was permanent as, in the same paper, it stated that it was "unreasonable to ask paediatricians to report for a period of six years". This was a strange decision as one review, known as the Meade Panel Study, reported to the JCVI examples of children "who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development". The length of time that development stopped was not known.
The vaccine also triggered encephalopathy, a disease that damaged brain function, the JCVI was told in a confidential paper, and one-third of these cases resulted in a permanent handicap for at least a year following vaccination.
The JCVI was also told that the DTP vaccine could cause febrile convulsions lasting more than 10 minutes or repeating over a 24-hour period, and that 10 per cent of these could cause "permanent handicap".
Despite these clear descriptions of permanent harm, the JCVI thought it best to keep the facts from the public. The minutes of one meeting recorded that "if the public was given a risk ratio-any ratio-they would see it as a scientifically proven risk. It was therefore preferable not to use insecure figures if possible but to stress the benefits from vaccination."
Charge 6.The JCVI promoted new vaccines of questionable efficacy and safety into the routine vaccination schedule on the assumption that licenses would eventually be granted.
In May 1999 the JCVI met to discuss the introduction of new group C meningococcal vaccines designed to protect against septicaemia and meningitis. Three brands of the vaccine were likely to be adopted as part of the mass vaccination programme, and members were reminded that the issue was "extremely sensitive, commercially and politically". Because of the sensitive commercial nature of the discussions, four of the committee members declared a conflict of interest as they had close ties to the drug companies manufacturing the vaccines, but rather than barring these members, the committee allowed them to stay as "they would be able to provide a valuable input".
The Department of Health and the JCVI seemed determined to introduce the new vaccine as quickly as possible, although there was no evidence that it was effective. "To actually test the efficacy . . . it would be necessary to introduce the vaccine and then conduct a Phase III or Phase IV study to test efficacy; this would be very difficult to do and would delay introduction by three to five years," the JCVI was told.
Moving on, the JCVI then had to decide on the age group that should be given the vaccine. One committee member said "there was very little to choose between the priority age groups" and suggested that infants were easier to target. It was agreed that all infants should receive the vaccine, even though nobody knew if it would work.
Within a year the first safety worries surfaced. Headache and muscle stiffness were common side-effects, although the symptoms were not the result of meningitis since, wrote the JCVI, "the vaccine could not cause this". The committee also noted that "this information would not have been available without the cooperation of the manufacturers. This had given everyone much more confidence in the vaccine programme and was a unique cooperation." The statement suggests this was the first time ever that the drug companies had shared adverse events information with the UK officials.
But confidence was beginning to wane by October 2000, when 14 deaths were linked to the vaccine, including seven SIDS cases and two because of meningitis. Again the JCVI moved to put a lid on public concerns. It felt the statement from the Medicines Control Agency that there was "no evidence that the vaccine caused meningitis" was too mild and instead proposed the statement that "the vaccine categorically did not cause meningitis", although it had no evidence to support that claim.
In fact the JCVI was told there had been 17,000 adverse events reported by family doctors using the 'yellow card' system for reporting adverse reactions, which represented one adverse event per 2,000 doses of the new vaccine. Department of Health solicitors also told the JCVI that the yellow card system was not routinely used by doctors and so the true extent of adverse reactions was probably far higher than that reported.
Charge 7.The JCVI actively discouraged research into vaccine safety issues.
As early as 1985 the numbers of infants who had died immediately after vaccination were beginning to cause concern, and an expert from the London School of Hygiene and Tropical Medicine was asked to review the data. In a letter to the JCVI, he thought that the government's estimates of vaccine-related SIDS were about right-suggesting some causal link, albeit small-but "given the importance of the subject, a more thorough examination of the subject seems appropriate".
But scientists from Nottingham University, who were sent the letter, strongly advised against further investigation. "There is no foolproof method of discrediting the hypothesis [that vaccines cause SIDS]", they wrote, suggesting that they had already made their minds up, and they advised that nobody should look too closely at the issue.
This reluctance in the scientific community was highlighted by the European Medicines Agency's Professor Luigi Matturri, who noted that full post-mortem examinations-including brain-stem analysis-were not carried out on five infants in Germany who had died within 24 hours of vaccination. This prompted a letter from two researchers who asked: "The main problem is that vaccine specialists have failed for decades to establish any tests or other criteria to find out if adverse events are linked to vaccinations or not. To our knowledge they did not even try hard-why?"3
Underpinning this reluctance are apparently two assumptions: that vaccines are inherently a 'good thing', so any suggestion that they could cause harm would reduce the numbers having them, thus impacting on the protective effects of 'herd immunity'; and that vaccines are assumed to be safe. This is perhaps why no one has looked too hard for serious adverse effects; as America's Food and Drug Administration has stated, "Historically, the safety assessment of preventive vaccines has often not included toxicity studies in animal models. This is because vaccines have not been viewed as inherently toxic".4
Charge 8. The JCVI deliberately took advantage of parents' trust in vaccinations to promote a scientifically unsupported immunization programme that could put certain children at risk of severe long-term neurological damage.
In October 2010 the JCVI decided to make fundamental changes to the UK's immunization programme by introducing a six-in-one jab in one visit rather than spreading them out over a few months. At 12 months an infant would receive vaccinations for Haemophilus influenzae and meningitis C, measles, mumps and rubella, and pneumococcal infection, all in one day.
The Department of Health said this simplified policy would streamline the process, while "independent scientific research has shown that providing these vaccines at the same time is safe, effective and more convenient for parents".
The statement isn't true. The 'independent' research was in fact carried out by the Department of Health itself, while the safety of the vaccines was assessed at seven days after vaccination and then only for localized reactions such as swelling and tenderness immediately around the site of injection.
In 2009 the JCVI had started the ball rolling by concluding that there is "no scientific reason to keep the . . . vaccines separate". Again, the statement is untrue. A year earlier the JCVI counterpart in the US, the Advisory Committee on Immunization Practices (ACIP), had recommended dropping a four-in-one jab, which combined the MMR with one for varicella (chickenpox), after it was found to double the risk of febrile seizures compared with the MMR vaccine on its own. In the same year the European Medicines Agency had recommended the withdrawal of a six-in-one (hexavalent) vaccine for safety reasons.
Ignoring these warnings from other countries, the Department of Health thought it was "unwise" to offer parents a choice between the current policy of spreading the vaccines over several months or giving their child the six-in-one. Instead, health professionals should reassure parents that the new strategy was "entirely safe" and that, partly in response to the Wakefield controversy, the "MMR is safe". Yet, just months earlier the UK government had paid out damages of lb90,000 to the parents of Robert Fletcher, who had suffered epilepsy and severe mental retardation following the "entirely safe" MMR jab.
The JCVI also seems to have a short-term memory. In 1974 it was advised that "[as] an interval in the administration of live vaccines [is] advocated in view of the probability of adverse reactions . . . the committee agreed that it would be inopportune to change the guidance that an interval of at least three weeks should be allowed to elapse between the administration of any two live vaccines."
In spite of this, the health professionals had to downplay any risks. The best strategy, the Department of Health advised in a circular to clinics, was to hand out a sheet listing possible adverse reactions to parents "immediately before vaccination so that parents feel they have been given advance warning, but do not dwell on the content to the extent that they begin to worry".
The path to hell
These recommendations were based on market research carried out by the Department of Health among parents to determine how best to implement the new six-in-one vaccine and how to gauge resistance to the MMR vaccine in particular. What came out of this 'attitudinal' research was the vast gap between the trust of parents and the cynical fast-and-loose approach of policy makers.
Typical comments from parents revealed an assumption that vaccines have been thoroughly tested and that policy makers have the best interests of their children at heart.
In a sense the latter statement is true: vaccine policy makers truly believe that vaccinations can save countless lives, although this protective effect can be achieved only through 'herd immunity', when around 95 per cent of the targeted population has been immunized.
It's a belief that surpasses science and takes on more of a religious zeal so that any inconvenient truths-such as adverse reactions up to and including death-are discounted or disbelieved. They just don't fit with the paradigm that vaccines are safe and effective.
Parents don't want religious zeal or the preservation of paradigms. They want to know their children's safety is paramount-and yet it isn't. Vital safety information is being deliberately withheld, which makes the parents' consent to have their children vaccinated not informed-raising the possibility that every vaccination is an illegal act.
1. Pediatrics, 2001; 108: e58
2. Cochrane Database Syst Rev, 2005; 4: CD004407; 2012; 2: CD004407
3. Vaccine, 2006; 24: 5781-2; author's reply 5785-6
4. US DHHS, FDA, Office of Women's Health. Workshop on: Non-clinical safety evaluation of preventive vaccines: Recent advances and regulatory considerations, volume 1. Washington, DC: Miller Reporting Co, 2002
THE MMR AND AUTISM
Andrew Wakefield lost his job as a consultant at the Royal Free Hospital in London, and eventually his licence to practise medicine, after he suggested a possible link between the MMR vaccine and autism. He was found guilty of fraud in preparing the 1998 paper in which he first postulated such an association.
The General Medical Council hearing that struck Wakefield off the medical register in 2010 had been told that no researchers were able to replicate his original findings of a possible connection between a gut disorder caused by the measles component of the MMR vaccine and autism.1
The JCVI jumped on this statement as further evidence of the safety of the vaccine-but, yet again, it wasn't true. In 2002, researchers from Utah State University analyzed blood samples from 125 autistic children and compared them with blood taken from 92 healthy children. In 75 instances in the autism group, antibodies in the blood indicated an abnormal reaction to the vaccine. The antibodies attack the brain by targeting the building blocks of myelin, the insulating sheath that covers and protects nerve fibres. As a result, the nerves fail to develop properly and so possibly affect normal brain functioning. None of the non-autistic children had such antibodies in their blood samples.
Lead researcher Dr Vijendra Singh, an immunologist, said there was a relationship between the abnormal reaction to the vaccine, which happens in some children, and autism.2
1. Lancet, 1998; 351: 637-41
2. J Biomed Sci, 2002; 9: 359-64
Herd, but not seen
Vaccines protect the general population when 95 per cent or more of the targeted at-risk group is vaccinated, according to the concept of 'herd immunity'. This one theory can explain the JCVI's consistent blocking and denial of evidence of adverse reactions, as any 'bad news' like this could affect the take-up rate.
But does the theory hold up? According to the evidence, it doesn't. After one outbreak of measles in Corpus Christi, Texas, in 1985, researchers discovered that 99 per cent of the children affected had received the measles vaccination and at least 95 per cent were supposedly 'immune', according to their blood samples.1
Three years later, there was an outbreak of 84 measles cases at a college in Colorado, and yet 98 per cent of the students had been vaccinated and were still immune, according to blood-serum analyses.2
This was followed by a chickenpox outbreak at a school where 97 per cent of children had been vaccinated. Those who had been vaccinated more than five years previously were especially at risk, the researchers concluded.3
1. N Engl J Med, 1987; 316: 771-4
2. Am J Public Health, 1991; 81: 360-4
3. Pediatrics, 2004; 113: 455-9
Keeping up standards
As with anyone holding public office, the members of the UK's Joint Committee on Vaccination and Immunisation (JCVI) are supposed to meet exacting standards. These are encapsulated in the 'Seven Principles of Public Life', set out by the Nolan committee, which include:
- Selflessness. Holders of public office should take decisions solely in terms of the public interest. They should not do so in order to gain financial or other material benefits for themselves, their family or their friends.
- Objectivity. In carrying out public business, holders of public office should make choices on merit.
- Accountability. Holders of public office are accountable for their decisions and actions to the public and must submit themselves to whatever scrutiny is appropriate to their office.
- Openness. Holders of public office should be as open as possible about all the decisions and actions that they take. They should give reasons for their decisions and restrict information only when the wider public interest clearly demands it.
Turning to the JCVI's own rules about personal financial interest, "if a member has in the last 12 months received, or plans to receive, a financial payment or other benefit from a business or representative body relating to vaccines or any other product or service, including carrying out consultancy or fee-paid work, the member must declare an interest . . . [I]f this interest is specific to an agenda item and the payment or other benefit is connected specifically with the product under consideration, the member will be required to absent him/herself from the discussion and any subsequent vote".
Yet according to the minutes regarding the introduction of the group C meningococcal vaccine, members with a direct link to the manufacturers were allowed to stay as "they would be able to provide a valuable input".
How many other times has this rule been broken?
WDDTY vol 23 no 12