(5.d. Comments on Professor Stewart’s letter)
“The meeting then considered Professor Stewart’s paper on deaths from whooping cough in Great Britain (JCVI(81)12). Dr Williams, referring to page 5 of the paper, said that deaths from whooping cough tended to be under-notified…On the other hand, at times of outbreaks of whooping cough the disease tended to be over-notified; this had the effect of lowering fatality ratio.”
In the ensuing discussion:
“The Chairman concluded that it would probably not be wise for the Committee to make a formal reply to this paper. (Members also thought that controversial replies to correspondence to the medical journals might not add support to the whooping cough vaccination campaign.)”
In the following years, the members of ARVI continued to “express anxieties” over eroding confidence of the public in pertussis and other vaccines. In a Joint Sub-Committee ARVI meeting on 8th March 1988, the members recommended that a monitoring system for vaccine reactions should be set up, which would cope with any vaccine related “adverse publicity” (item 7, Adverse Reactions Surveillance; http://www.dh.gov.uk/en/
FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306; note that this meeting was incorrectly noted as March 1998 rather than March 1988).
While the public appeared to have lost the confidence in the safety of the pertussis vaccine by the mid 80s, in 1989, the JCVI was still debating on whether or not the pertussis vaccine caused permanent brain damage. Referring to the NCES report it was generally accepted by the JCVI that if the vaccine led to severe neurological outcomes, it did so very rarely (JCVI meeting on 3rd November 1989; http://www.dh.gov.uk/ab/DH_095169). Finally, it was agreed that the statistical data of attributable risk should be removed from the Memorandum since, according to Dr Salisbury:
“If the public was given a risk ratio — any ratio — they would still 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.” (12.1 Whooping cough – article by Dr A H Griffith in Vaccine etc JCVI (89)32)
Regarding the alleged overall “benefits from vaccination”, it is worth mentioning that in a
discussion about Diphtheria outbreaks in immunised populations on 22nd April 1988 (http://www.dh.gov.uk/ab/DH_095169), the JCVI acknowledged that these do in fact:
(16.1)
“occur in well-immunised populations…”
In addition, the decision to include mumps in the routine vaccination schedule with the
introduction of the MMR in 1988 goes against JCVI’s own past advice, as evidenced by a discussion about the usefulness of the mumps vaccine in the JCVI meeting on 11th December 1974 (http://www.dh.gov.uk/ab/JCVI/DH_095052):
(10.)
“The Committee agreed that there was no need to introduce routine vaccination against
mumps.”
because
“complications from the disease were rare.”
Granted, opinions can change with time as new scientific evidence becomes available. Even so, the arguments are against routine mumps vaccination. Mumps in adults but not in children can cause mumps orchitis, a serious condition which may result in male sterility. Mumps outbreaks in older individuals increased in frequency since the introduction of the MMR into the routine schedule, most likely because of the poor effectiveness of the mumps component of the vaccine.
In a comprehensive assessment on mumps orchitis in the post-vaccine era, which included epidemiologic, clinical, therapeutic, and follow-up studies and outcomes of 609 patients, Ternavasio-de la Vega et al. [15] reported:
“Mumps orchitis is the most common complication of mumps infection in young postpubertal males. Testicular compromise is characterized by an abrupt onset of unilateral or bilateral marked scrotal swelling and pain, accompanied by constitutional symptoms and fever. Immunization programs against mumps have reduced the number of reported cases and influenced their age distribution. Since the introduction of mumps vaccine in 1967 (the year the first mumps vaccine was licensed in the United States), a shift in the age of peak incidence of mumps from children aged 5-9 years, in the prevaccine era, to children and young adults aged 10-24 years has been observed. Serious complications have appeared as a consequence because of the higher rate of sequelae among the older age-group. The principal complication of acute mumps orchitis is the atrophy of germinal epithelium with spermatogenesis arrest, which in turns leads to male sterility.”
The evidence for the poor effectiveness of the mumps vaccine has recently been reported by Castilla et al. [16]:
“This study adds to the literature showing moderate effectiveness of the mumps vaccine containing the Jeryl Lynn strain, which seems to be related with early and progressive waning immunity. This effect, seen in children vaccinated with both one and two doses, makes it difficult to control the disease even when high vaccination coverage is achieved, and leaves open the possibility that outbreaks will occur when the infection is reintroduced.”
“Our results indicate that this effect of waning immunity begins early, as seen in the fact that 3 or more years after the second dose of MMR vaccine, the risk of mumps was 10 times higher. This increased risk does not appear to be linear, but rather is accentuated over time.”
Hence, routine mumps vaccination has shifted a childhood disease to adolescents and young adults, groups with a higher incidence of adverse long-term complications and sequelae. By contrast, the benefits of naturally acquired immunity against mumps in early childhood are life-long protection against mumps and its serious complications later in life.
Curiously, at the meeting held on 17th September 1990 (http://www.dh.gov.uk/ab/JCVI/
DH_095294), the JCVI also acknowledged the consequences of shifting mumps infections to older age groups:
(6.5)
“It was noted that the introduction of mumps immunisation could in theory shift the age specific infection rates to the older age groups in whom the complications were greater;”
However, the Committee concluded:
“…nevertheless, the gains from the progressive reduction in mumps illnesses outweigh such concerns.”
It would appear that in following the JCVI’s line of reasoning, one must conclude that the alleged benefit of eradicating mumps in young males where the illness is mild and “complications are rare”, outweighs the risk of male sterility.
Similar to mumps, the complications from rubella early in childhood are minimal, hence it may be argued that vaccination against both rubella and mumps are of little clinical benefit to a child. Serious complications from rubella may occur in a developing foetus of a pregnant woman who has contracted rubella during her first trimester. In such cases a child may be born with congenital rubella syndrome (CRS), involving multiple congenital abnormalities. The risk of CRS can be reduced either by making sure all women have caught rubella as children or by vaccinating those who have not prior to puberty. Hence, the current JCVI’s policy of vaccinating every child, male and female, against rubella does not appear to be justified.
Finally, apart from “no need to introduce routine vaccination against mumps” , the decision to introduce the MMR into a routine schedule was in conflict with the JCVI’s past concerns about risks associated with simultaneous administration of multiple live vaccines. Curiously, the MMR vaccine developed by MSD was first licensed in the UK in 1972, but not marketed until 1988. An indication as to why it took 16 years to introduce it in to a schedule may be found in the same meeting which discussed the usefulness of the mumps vaccine (JCVI meeting, 11th December 1974; http://www.dh.gov.uk/ab/JCVI/DH_095052):
(11 Simultaneous administration of live vaccines (CHCS(VI)14))
“The Chairman refereed to the 3 vaccines which had been licensed for Merck Sharp and Dohme and asked for comments on the company’s claim that these could be administered simultaneously with live poliovirus vaccine. This use of the vaccine appeared to conflict with the Committee’s published advice and they had to consider (a) whether this advice should be changed and (b) if the vaccine concerned viz MMR, Biavax and Measles and Rubella virus vaccine and live MSD could be given with live poliovirus vaccine. Professor Dick and Dr Warin pointed out that an interval in the administration of live vaccines had been advocated in view of the probability of adverse reactions and because of the recent publicity surrounding adverse reactions. The Committee agreed that it would be inopportune to change the guidance that an interval of at least 3 weeks should be allowed to elapse between the administration of any 2 live vaccines whichever came first.”
Perhaps unknown to most lay people as well as medical professionals is the issue of vaccine contaminants which is somewhat inherent to the vaccine production process. In this regard, one particular item discussed under the section 3.4. Ruminant and Human Materials used in Vaccine Manufacture, at the JCVI meeting on 4th May 2001 (http://www.dh.gov.uk/ab/JCVI/DH_095044), deserves special emphasis:
(3.4.1)
“This report was provided for information. The Committee asked by which date the vaccines already distributed would no longer include any whose production process may have involved the use of potentially BSE [Bovine spongiform encephalopathy] infected Category 1 or 2 material. The Committee was told that Category 1 material was only used at the master seed/working seed stage of the manufacture of a very few vaccines, not in routine vaccine production itself. Many vaccines are produced from master seeds which were manufactured many years ago…Master seed material often antedated the BSE epidemic in the UK, and was diluted many fold to the extent that any exposure to infected material, if ever present, would be remote.”
How many people would feel comfortable with taking medicinal products derived from potentially BSE-contaminated material? As to why such vaccines continued to be used:
(3.4.1)
“There is reluctance to establish new master seeds for vaccines which have long history of use because such a change could possibly change the vaccine characteristics which may adversely impact safety and efficacy.”
Indeed, removing sources of possible BSE contamination from vaccine manufacture would have no doubt “impacted safety”; it would have made vaccines safer.
Curiously, when asked by the JCVI:
(3.4.3)
“…to consider whether it would be possible to put the information it had summarised on vaccine manufacturing and excipients in vaccines into the public domain; the MCA would consult their lawyers on this point.”
If there was no risk of contracting BSE from a vaccine, then why did the MCA have to consult their lawyers “on this point”?
At the same meeting, on 4th May 2001 (http://www.dh.gov.uk/ab/JCVI/DH_095044), the Committee discussed:
(4.5.1)
“… suspected adverse reactions categorised as serious to DTP/Hib, polio, BCG, hepatitis A and B vaccines over the last three years. The data was based on Yellow Card reports received by the MCA.”
and it showed the following:
“i. DTP/Hib – the overall pattern and type of suspected reactions in 2000 were similar to previous years, with the exception of an increase in the number of respiratory reactions. Most of the increase appeared to be due to an increase in number of SIDS (5) and apnoea type reactions (14) being reported.
ii. Polio – The types of suspected reactions reported in 2000 were on the whole similar to previous years. The only differences appeared to be an increase in the number of cardiovascular, eye and respiratory reactions reported.
iii. BCG – Overall the types of suspected reactions reported were similar with the exception of an increase in number of cardiovascular reactions in 1999 and musculo-skeletal reactions in 2000.
iv. Hepatitis B – The types of suspected reactions reported on the whole had been similar, with a notable decrease in the number of serious cardiovascular, eye, immune system, musculo-skeletal and neurological reactions being reported.
v. Hepatitis A – The types of suspected reactions being reported were on the whole fairly similar. However, there were three notable differences: a significant increase in the number of cardiovascular and musculo-skeletal reactions reported in 2000, and a significant increase in the number of immune system disorder reactions reported in 1999. All these type of reactions were recognised side effects of this vaccine.”
(4.5.2)
“Overall, there were no new safety issues identified.”
Perhaps these were not new issues, just old persisting ones. Nonetheless, in all but one case (Hepatitis B), the number of serious adverse reactions appeared to have increased and in some cases this was not only significant but also a “recognised side effect of this vaccine” (Hepatitis A). In spite of this:
(4.5.2)
“The Committee was not persuaded given all the inherent uncertainties of spontaneous reporting that there were significant problems developing.”
If anything, the Committee previously appeared to have acknowledged that there were problems with underreporting of adverse reactions to vaccines. In a Report of North Herts Immunogenicity Study on the 1st May 1992 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050), it was noted that “the report of a cluster of CSF mumps virus positive cases in Nottingham had caused concern that national surveillance may have been underreporting the incidence of cases…”
As noted in the following Section (6), the Yellow Cards are a passive surveillance system, not routinely used by the GPs and hence, data on adverse reactions obtained through Yellow Card reports are likely to be an underestimate of the true rate of these events.
Finally, since the principal rationale for shaping vaccine recommendations and policies according to the JCVI was to keep vaccination rates as high as possible so that presumably, “herd immunity” would be achieved, it would seem fair at this point to question exactly how well has this concept been established? The theory behind vaccine-mediated “herd immunity” appears sound, it maintains that vaccination of a significant portion of a population (herd), will provide a measure of protection for individuals who have not developed immunity. Obviously, transmission of a disease to the point where it would reach an epidemic is expected to be countered in a population where most individuals are thought to be immune. However, the concept of vaccine-mediated “herd immunity” is based on the assumption that vaccines are effective in conferring immunity to the individual. If this were so, then how does one explain outbreaks of infectious diseases in populations where over 95% of individuals have been vaccinated?
Gustafson et al. [17] “An outbreak of measles occurred among adolescents in Corpus Christi, Texas, in the spring of 1985, even though vaccination requirements for school attendance had been thoroughly enforced. Serum samples from 1806 students at two secondary schools were obtained eight days after the onset of the first case. Only 4.1 % of these students (74 of 1806) lacked detectable antibody to measles according to enzyme linked immunosorbent assay, and more than 99 % had records of vaccination with live measles vaccine…After the survey, none of the 1732 seropositive students contracted measles. Fourteen of 74 seronegative students, all of whom had been vaccinated, contracted measles. In addition, three seronegative students seroconverted without experiencing any symptoms. We conclude that outbreaks of measles can occur in secondary schools, even when more than 99 percent of the students have been vaccinated and more than 95 percent are immune”
(Note that if the measles vaccine was effective in providing herd-protection, then the <5% of children in this study who did not seroconvert would still have had protection from contracting measles. The whole premise on achieving high vaccination rates rest on the assumption that the herd will protect those vulnerable individuals who have not been vaccinated, or do not seroconvert.)
Hersh et al. [18] “In early 1988 an outbreak of 84 measles cases occurred at a college in Colorado in which over 98 percent of students had documentation of adequate measles immunity (physician diagnosed measles, receipt of live measles vaccine on or after the first birthday, or serologic evidence of immunity) due to an immunization requirement effect since 1986.”
Tugwell et al. [19] “A chickenpox outbreak occurred in a school in which 97% of students without a prior history of chickenpox were vaccinated. Students vaccinated >5 years before the outbreak were at risk for breakthrough disease.”
It would thus appear that these vaccines only provide waning immunity, not herd immunity, as already well established in the case of the mumps vaccine by Castilla et al. [16] This often has the effect of shifting a relatively mild childhood disease to older age groups of children or young adults, in whom complications and sequelae from the disease are much more severe [15].
6) Promoted and elaborated a plan for introducing new vaccines of questionable
efficacy and safety into the routine paediatric schedule, on the assumption that
the licenses would eventually be granted.
On 7th May1999 (http://www.dh.gov.uk/ab/JCVI/DH_095050), the JCVI met to discuss the use of the new conjugate Group C meningococcal vaccines. At the beginning of the meeting, Professor Hull, the Chairman:
“…reminded members that the minutes and proceedings of the JCVI were confidential. Politically and clinically sensitive material was dealt with by the Committee…”
It was further emphasised:
(8. Meningococcal meningitis, i.)
“This was the main agenda item for the meeting. Much information had been made available and important decisions were required of the Committee, particularly about the introduction of meningococcal Group C conjugate vaccine, of which three brands would soon become available. Any decision would be dependent on the granting of product licenses and the wording of those licenses and, during the discussion, the Committee had to act on the assumption that licenses would be granted. The MCA was responsible for the safety, efficacy and quality of vaccines. The question for consideration by the Committee was how it would recommend that the vaccine should be introduced.”
The Committee members were also once again:
“…reminded that this issue, and the papers presented, was extremely sensitive, commercially and politically. It was requested that confidentiality be maintained.”
The Chairman had then asked for any declarations of interest:
“Professor Cartwright was involved in manufacturers’ studies on the vaccines, including health trials. Dr Goldblatt was involved in one company-sponsored study and had provided a clinical expert report to the MCA for one manufacturer. Dr Jones was involved in trials for two of the companies involved. Dr Schild said that NIBSC was evaluating the vaccines.”
In spite of these substantial conflicts of interests:
“There were no objections to these members continuing to take part in the meeting and it
was agreed that they would be able to provide a valuable input to the discussion in
common interest.”
We are only left to speculate as to what such “common interest” might have been,
between the JCVI and the pharmaceutical industry, bearing in mind several past instances
where the Chairman of the JCVI met with the Association of British Pharmaceutical
Industries to discuss:
“…the availability of scarce vaccines and the introduction of new vaccines into more
regular use. The question of financial support for training members of the health service in
immunisation was also discussed.” (18. Meeting of the Chairman of the JCVI and the
Association of British Pharmaceutical Industries, JCVI meeting on 23rd October 1987; http://
http://www.dh.gov.uk/ab/DH_095169)
or where:
“The Chairman said that Departmental officials had recently met vaccine manufacturers who were keen to be informed, in confidence, of the outcome of JCVI discussions which might affect their own plans.” (2.iv. JCVI meeting on 4th May 1990 (http://www.dh.gov.uk/ab/DH_095169)
The apparent close ties between the pharmaceutical industry, JCVI and the DH perhaps explain why the DH funded studies were not adequately designed to detect long-term vaccine-related adverse outcomes. In discussing 8.4.1 Meningococcal C Conjugate (MCC) Vaccine Evaluation Programme, at the 7th May1999 JCVI meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050), Dr Elizabeth Miller reported:
(i.)
“Papers providing data on the new vaccines’ safety and efficacy and data from the Department of Health funded studies were looked at; no other country had conducted similar studies. The Medicines Control Agency had also gathered lots of information and NIBSC was evaluating the vaccines. The data provided to the Committee related to the Wyeth product, which would be the first to become available. All available ADR [adverse reactions] data was included; the follow-up of ADRs had been up to the end of 4 to 6 weeks.”
It should be obvious that long-term adverse reactions cannot be identified if a study is not designed to detect them (and quite predictably there were none, since the DH funded studies showed that the MCC vaccines were well tolerated, section 8.4.1. vii., 7th May1999 JCVI meeting; http://www.dh.gov.uk/ab/JCVI/DH_095050). The reason for such omissions in study design are bewildering, given the past safety issues with the measles vaccine, where several children “were left one year later with severe handicap.” (7. Suspected adverse reactions to measles vaccine: recent reports to the CSM, JCVI meeting on 17th of June 1983; http://www.dh.gov.uk/ab/JCVI/DH_120115)
Not only did the safety of the new, soon-to-be introduced MCC vaccine remain questionable, but also:
(ii.)
“There was no good evidence for the efficacy of the meningococcal Group C conjugate vaccine, only the surrogate of antibodies compared with those known to be protective against invasive disease. To actually test the efficacy on the conjugate vaccine 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 3-5 years.”
In the ensuing discussion we are told that the JCVI:
(iii.)
“…felt that it was important to plan the programme now and confirmation that the vaccines were equally effective could follow.”
In other words, the JCVI and the DH were actively working on a plan to introduce a vaccine with no demonstrable safety or efficacy into a routine paediatric schedule. Apparently, those responsible for sound safe and effective immunisation policies concluded that it was “very difficult” to conduct the necessary trials and they felt that this would unnecessarily delay the introduction of the MCC vaccine into a routine immunisation schedule.
What should have been considered by the JCVI is that vaccines represent a special category of drugs, generally given to healthy individuals and often to prevent a disease to which an individual may never be exposed [1]. Because of this, according to the US FDA, significant emphasis should be placed on vaccine safety [1]. Thus, If there are uncertain benefits from a vaccine, only a small level of risk of adverse effects may be acceptable. If the benefits are certain, then a greater risk of side effects may be tolerated. However, neither of these two points would have applied in the case of the MCC introduction programme, since there is absolutely no clinical benefit to a child from a vaccine that has neither been proven to be safe nor effective. The only “benefit” from such a programme would have been more in line with certain “common interests” rather than public health.
What followed at the 7th May 1999 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050), was a discussion on priority groups to whom the MCC vaccine should be offered, in which Dr Smithson made a following remark:
(ix.)
“…there was very little to chose between the priority age groups but suggested that
infants were easier to target.”
Finally, the Committee concluded that:
(x.)
“…if sufficient vaccine was available, all children should have it…”
In the following meeting, held on 21st January 2000 (http://www.dh.gov.uk/ab/JCVI/DH_095050), in section 6.4 Meningococcal C Conjugate (MCC) Vaccine Evaluation Programme, Dr Elizabeth Miller reported that several safety studies indicated that the new vaccine was not a cause for concern. Although,
(6.4.4)
“… headache, particularly if it was associated with muscle stiffness inevitably raised fears of actual meningitis, although the vaccine could not cause this.”
Furthermore:
(6.4.6)
“The Committee 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 co-operation.”
In the following meeting, on 9th October 2000 (http://www.dh.gov.uk/ab/JCVI/DH_095050), the Committee was given an update on the safety profile of the MCC vaccine:
(7.6.2)
“The Working Party had received data available and had concluded that an association between MenC vaccine and seizures had not been proven. There had been 14 deaths reported. (2 further deaths had since been reported: 7 of the deaths were SIDS, 2 were meningitis B, 3 were in children with underlying conditions 1 was pneumococcal septicaemia, 1 was infantile encephalitis, 1 bronchiolitis and 1 child collapsed one month after immunisation with no cause of death being found).The Working Party believed that the deaths were all explained by other causes and that the vaccine was most unlikely to be implicated. By 21 September 2000, there had been 8.300 reports of 17,000 ADRs (1 ADR per 2,000 doses). The profiles were the same for each brand of vaccine.”
Note that the Working Party “believed” that the vaccine was not implicated. An even firmer
belief in MCC vaccine safety was held by the JCVI:
(7.6.3)
“The Committee did feel that the MCA statement that there was “no evidence that the vaccine caused meningitis” was far too light: the vaccine categorically did not cause meningitis. The MCA Meningitis Working Party would consider this issue further…”
How the JCVI could claim with such definite certainty that the newly introduced and poorly tested MCC vaccine could not cause meningitis is not clear from the transcript. Amongst those who did not share similar views with regards to vaccine safety are Alexander Harris Injury and Accident Solicitors and their clients, families whose children appear to have suffered severe long-term health problems following MCC vaccination. From their website (http://www.alexanderharris.co.uk/OurWork/ProductLiability/MeningitisCVaccine/Pages/default.aspx), we learn that safety concerns about MCC vaccine were first raised by the media (and not the UK health authorities) and that:
“Some 16,527 adverse reactions from 7,742 patients had been reported by GPs to the Medicines Control Agency through the Yellow Card reporting system. As well as reactions at the site of the injection such as swelling and soreness were other long-term reports which included seizures and 12 deaths.”
This appears to be consistent with the data reported at the JCVI 9th October 2000 meeting. Further, the Solicitors made an important observation:
“The Yellow card reporting system is not routinely used by most GPs and healthcare professionals and as such the figures for adverse reactions are likely to be an underestimate. Despite the known under-reporting, the number of adverse reactions reported for Meningitis C vaccine is the highest for any vaccine within the UK immunisation programme.”
7)
8) Actively discouraged research on vaccine safety issues.
On 14th October 1985 a letter was issued to Dr Derek Zutshi (DHSS), from a member affiliated with the London School of Hygiene and Tropical Medicine at the University of London, whose name was erased from the copy of the letter prior its FOI release (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4140359.pdf):
“Dear Derek
Enclosed are comments on the estimates of vaccination-associated SIDS as presented at the recent ARVI meeting. I hope they prove helpful.
Let me add that this is a complicated problem, but one that I would be interested to pursue
in the future.”
In three pages, the author of the letter made several comments on “Tabled Paper 1, (Appendix to ARVI/85/34)”, titled “Note on the estimation of sudden infant deaths expected to occur by chance after immunization”, authored by Paul EM Fine from the London School of Hygiene and Tropical Medicine. A balanced critical overview was given on three key points relevant to Paul EM Fine’s estimation of SIDS: “method used”, “data used” and “assumptions made”, outlining both strengths and limitations. In a final note, the author concluded:
“These brief comments indicate a number of problems which arise in estimating the number of SIDS deaths expected to arise by chance, within 24 hours of vaccination, if there were no causal association between them. Some of these problems favour overestimation and others favour underestimation by the methods used in the DHSS note. Given the nature and direction of the biases, it is probable that the estimates presented in the DHSS note are of the correct order of magnitude. On the other hand, given the importance of the subject, a more thorough examination of the subject seems appropriate.”
Copies of this letter appear to have been forwarded to Dr M Graveney (DHSS) and Professor RW Gilliatt (JCVI).
Two months later, on 13th December 1985, on the University of Nottingham, Department of Child Health’s letterhead, a member whose name was erased from the copy of the letter released under FOI (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4140362.pdf), also wrote to Dr Derek Zutshi, to express his grave concerns about potential further investigations into the relation between vaccination and SIDS:
“Dear Derek
I showed the Tabled Paper 1, (Appendix to ARVI/85/34) to Richard Madeley [Department of Community Medicine and Epidemiology, University of Nottingham Medical School] and he kindly prepared the enclosed observations. I agree with everything that he has said. As you know, at the meeting I had grave misgivings about the exercise and of the assumptions that were made.”
In the following section, “Re: Note on the estimation of sudden infant deaths expected to occur by chance after immunisation”, apparently from the author of the “enclosed observations”, Richard Madeley, several reasons are given for his own misgivings “about the exercise”, some of which appear to be sound, such as:
(3. The hypothesis that immunisation may cause SIDS)
“c. Most deaths from SIDS occur before the age of four months2, when first immunisation takes place.”
(note, this still does not exclude the possibility that some cases of SIDS may be vaccine-related)
while others appear not as sound:
“d. There is no foolproof method of discrediting the hypothesis by statistical or epidemiological methods. On the contrary, there is a danger of getting drawn into a lengthy argument about numbers which neither side could win, thus giving more credibility to the hypothesis than it deserves.”
(it ought to be noted that in the realm of science, a hypothesis can only be proven or disproven by experimental evidence and not by personal opinions)
In his “Final Comments and Conclusions” the author stated:
“For those reasons, I think it would be extremely unwise for the DHSS to get involved in any type of epidemiological work on this hypothesis. The hypothesis seems most unlikely on grounds of basic scientific reasoning, and such evidence as already exists points in the opposite direction.”
“To go ahead in these circumstances would endow upon the hypothesis a respectability which it does not deserve. It is impossible to disprove through numbers. To try to do so, using flawed assumptions, as in the memorandum of the DHSS Statistics Division, weakens the position.”
Indeed, epidemiological work would not be the most appropriate way to address the possibility that SIDS could be causally related to vaccination given that epidemiological studies only test for “association” and not “causation”. However, case control studies as well as post-mortem lab analysis should have been considered as viable alternatives to further research. Such as:
Ottaviani et al. [20] “Herein we report the case of a 3-month-old female infant dying suddenly and unexpectedly shortly after being given a hexavalent vaccination. Examination of the brainstem on serial sections revealed bilateral hypoplasia of the arcuate nucleus. The cardiac conduction system presented persistent fetal dispersion and resorptive degeneration. This case offers a unique insight into the possible role of hexavalent vaccine in triggering a lethal outcome in a vulnerable baby. Any case of sudden unexpected death occurring perinatally and in infancy, especially soon after a vaccination, should always undergo a full necropsy study according to our guidelines.”
“The identification of a possible pathological basis of reflexogenic mechanisms in sudden, unexpected infant death necessarily requires examination of the brainstem nuclei and of the cardiac conduction system on serial sections.”
The senior author of this study, Professor Luigi Matturri is a member of the European Medicines Agency (EMEA) Pathologists Panel for evaluation of SUD (sudden unexpected death) cases reported for hexavalent vaccines. In a review by EMEA cited in the Introduction of the study, of five reports of unexplained deaths in children which occurred within 24 hours of vaccination with a hexavalent vaccine, panels of experts (including pathologists with the experience in the field of vaccines and SIDS), investigated whether there might have been a link between the vaccines and the deaths observed:
“The EMEA’s conclusions were that the causes of death remained unexplained. SIDS, viral infection, metabolic disorders, allergic reactions or airway obstruction were plausible but were not definitely proven to have been the cause of death [4]. However, to the best of our knowledge, during the mentioned post-mortem investigations, little, if any, attention was paid to examination of the brainstem and the cardiac conduction systems on serial sections, nor was the possibility of a triggering role of the vaccine in the lethal outcome considered.”
In addition, in responding to numerous criticisms of their study Unexplained cases of sudden infant death shortly after hexavalent vaccination [21] Zinka et al. noted [22]:
“(ad 6) The main problem is that vaccination 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?!”
“(1) A precise description of the mechanism leading to serious adverse events after hexavalent vaccination is not the task of forensic pathology. This would be the job of vaccination specialists, and actually this job should have been done before phase 1 and phase 2 studies in order to get valid data on the drug safety.”
In summary, it may be inferred from here that the real reason why causality is rarely (if ever) established by scientific investigations into vaccine-related serious adverse outcomes is because it is assumed that: a) they don’t happen and b) the study is not designed to detect them. This may further suggest that vaccines are not proven to be safe but are only assumed to be safe. Indeed, according to the US FDA “Historically, the non-clinical safety assessment for preventive vaccines has often not included toxicity studies in animal models. This is because vaccines have not been viewed as inherently toxic” [1].
9) Deliberately took advantage of parent’s trust and lack of relevant knowledge on
vaccinations in order to promote a scientifically unsupported immunisation
program which could put certain children at risk of severe long-term neurological
damage.
Recently the DH announced that there would be a significant change in the current UK
immunisation schedule, following the October 2010 meeting at which the JCVI recommended that children be vaccinated against six diseases at the same time. This would be through receiving three vaccines (Hib/MenC, MMR and pneumococcal) in one visit rather than getting the first vaccine at 12 months of age and the second two at 13 months of age. According to a letter sent by the Chief Medical Officer Professor Dame Sally Davies to local GPs (http://www.dh.gov.uk/en/
Publicationsandstatistics/Lettersandcirculars/Professionalletters/Chiefmedicalofficerletters/DH_121748), this new “simplified” immunisation policy is to be implemented “as soon as
practicable”. Furthermore, according to a BBC news report on 22nd November 2010 (http://www.bbc.co.uk/news/health-11809967), the purpose for vaccinating against 6 diseases at one single appointment is “to boost vaccine uptake”, which has apparently been low ever since safety concerns regarding the MMR vaccine had been raised in public following the study of Wakefield et al. in 1998 [3]. Despite continued public concerns on the overall safety of the MMR and its possible link to autistic regression and other severe neurological outcomes, the DH spokesperson stated (http://www.dh.gov.uk/en/MediaCentre/Statements/DH_122026):
“Independent scientific research has shown that providing these vaccines at the same time is safe, effective and more convenient for parents.”
I have requested from the UK DH to show me these independent data. The request was granted, and much more than that. First to the independent data: they are not independent.
The study by Miller et al. [23], referenced by the DH states in the acknowledgments:
“This is an independent report funded by the Policy Research Programme in the Department of Health, UK, grant 039/031.”
As for the safety assessment:
“For safety, proportions of children with erythema, swelling or tenderness at site of injection, or fever or other systemic symptoms for 7 days after immunization were compared between regimens. No adverse consequences for either safety or immunogenicity were demonstrated when MCC/Hib was given concomitantly with PCV and MMR at 12 months of age or separately at 12 and 13 months of age.”
Thus the vaccine was “demonstrated safe” based on a 7 day follow-up and monitoring for largely local reactions. Not only is this an appalling example of a vaccine safety study, it is the only study quoted by the DH and JCVI in support of their decision to implement a new vaccine schedule. This is evident from a Possible simplification of the childhood vaccination schedule report (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_121799.pdf), issued by the JCVI Secretariat in October 2010, which states:
“In June 2009, JCVI considered a pre-publication clinical trial paper from Miller et. al. that showed that co-administration did not adversely affect the immune response elicited by the vaccines. In addition, no safety concerns around co-administration were identified.”
The JCVI report further states:
(Annex A, Background)
“In June 2009 the Joint Committee on Vaccination and Immunisation concluded that there is no scientific reason to keep the combined Hib and Meningitis C vaccine (currently given at 12 months) and the MMR and pneumococcal vaccines (given at 13 months) separate.”
The “no scientific reason” is grossly misleading. Once again, it should be obvious that safety concerns cannot be identified if the study is not designed to detect them. Autistic regression is known to occur gradually over periods of weeks to many months. In spite of this, the vast majority of studies which are presumed to provide conclusive evidence on the safety of vaccines, have short follow ups and focus almost exclusively upon acute near-immediate events [23-29].
In addition, the fact that in 2008 The US federal Advisory Committee on Immunization Practices (ACIP) voted to withdraw their initial recommendation for the use of measles, mumps, rubella, and varicella vaccine (MMRV, marketed by Merck & Co., Inc. as ProQuad) as the vaccine of choice for vaccination of infants, because it was associated with double the risk of febrile seizures when compared to the MMR, shows that there is indeed solid reason for concern over simultaneous administration of multiple vaccines. Proquad contains only four vaccines in combination, not six. The research from The Vaccine Safety Datalink (VSD), considered by the ACIP, evaluated the incidence of febrile seizures in 43,000 children between the ages of 12 and 23 months who had been vaccinated with ProQuad and 315,000 who had received two separate MMR and varicella vaccines. Within 7 to 10 days after vaccination, those given ProQuad suffered twice as many seizures (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5710a3.htm):
“The preliminary results indicated a rate of febrile seizure of nine per 10,000 vaccinations among MMRV vaccine recipients compared with four per 10,000 vaccinations among MMR vaccine and varicella vaccine recipients.”
The multivalent vaccine Hexavac was also recently withdrawn following a recommendation from the EMEA (http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2009/12/WC500017695.pdf) “as a precautionary measure“, due to its poor effectiveness. Safety concerns have also been raised over administration of hexavalent vaccines by Ottaviani et al. [20] and Zinka et al. [21] the latter, following five cases of infant deaths in Germany in 2005 (all occurring within 48 hrs of vaccination). The post-mortem analysis of six children aged 4-17 months (5 of whom were vaccinated with Hexavac and one with another hexavalent vaccine, Infanrix Hexa) reported by Zinka et al. [21], revealed abnormal pathologic findings particularly affecting the nervous system. Although there is no conclusive proof that these deaths were directly caused by vaccination, the authors felt it was:
“…important to inform vaccinating physicians and pediatricians as well as parents about such possibly fatal complications after application of hexavalent vaccines.”
In spite of these relevant findings, no mention of these two studies is found in the DH and the JCVI reports regarding the introduction of the new “simplified” and “improved” schedule.
Other than the paper by Miller et al. [23], the DH also provided me with the official report on their research on parents’ attitudes to the possibility of administering the Hib/MenC, PCV and MMR vaccines on a single occasion. Following their initial consideration of the draft paper by Miller et al., in 2009, the JCVI did recognize the need to seek parent’s opinion on the proposed “6 in 1” program before making any changes to the current schedule. In February 2010, the DH initiated this research and subsequently published it in a document Childhood immunisation programme: Attitudinal research into combining 12 and 13 month immunisations which is now available on the DH website at:
http://www.dh.gov.uk/en/Publichealth/Immunisation/Marketresearch/index.htm
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/
digitalasset/dh_122329.pdf
What the Attitudinal research found was that parent’s knowledge on childhood’s current
immunisation timetable, particularly around 12 and 13 months, was generally low and apparently, the DH and the JCVI are content with keeping it that way, in order to preserve the national vaccination program. The DH and the JCVI concluded that informing parents of the changes would be “unwise” because it would create unnecessary panic. In order to prevent this, the health officials need to be instructed on how to “reassure” parents in the safety of vaccines, especially the MMR.
According to the Attitudinal research report, parents generally trusted the schedule and the NHS, however, some had reservations about the MMR, particularly if it was to be combined with other vaccines. Specifically, the Research Management Summary on Behalf of the DH from a Possible simplification of the childhood vaccination schedule report (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_121799.pdf), issued by the JCVI Secretariat, states that:
“While the principle of combining vaccinations and/or giving more than one at the same time appeared largely to be accepted, if one of these is MMR, views can change.” (Conclusions and Recommendations: 2.)
In light of this explicit concern, the DH report noted:
“The combined schedule at 12 and 13 months was regarded with mixed feelings; if it is introduced, the way in which it is communicated will have a significant impact on how it is received. Given low awareness of the immunisation schedule, parents are unlikely to notice the change until informed about it.” [their emphasis added-italicised] (Conclusions and Recommendations: 3.)
They further elaborated on this particular finding:
“When the combined schedule was presented to parents first (before seeing the current schedule), very few identified the appointment at a year of age as different or worthy of comment. Parents’ problems and worries only came to the surface when the combined option was explicitly presented as a change to the schedule. Those in areas where the combined schedule is apparently already being given accepted it without question. When parents were told that the new schedule involves giving MMR and PCV at the same time as another vaccine, some changed their views, including some of those who were otherwise accepting of MMR.” (Conclusions and Recommendations: 4.)
On the basis of the above observations the DH concluded that it is best to keep parents ignorant of the proposed changes, in order to avoid what they deemed as “unwarranted anxiety”, as this would most likely lead to reduced immunisation rates:
“Offering parents a choice between the two schedules could generate more questions than answers, and seems unwise. It might also risk compromising current understanding of the vaccination schedule as ‘just what happens’, and reframing it as optional, which could reduce vaccine uptake.” (Conclusions and Recommendations: 5.)
Consistent with their past legacy that apparently puts priority on the preservation of the vaccination program rather than the safety of an individual, the British Health Authorities consider it “unwise” that parents should have a choice as to how immunisations are to be carried out. So much so that special action is needed to assure that their efforts in promoting vaccination are not hampered. In particular, to the DH it “seems sensible” to, somehow, camouflage the change in the vaccination schedule in order to prevent what they deem as “unwarranted anxiety”.
“It is also clear that offering parents detailed information, and flagging up changes, can generate anxiety where it is not warranted. In light of this, it seems sensible to introduce the combined schedule as far as possible without announcing it explicitly as a change.” (Conclusions and Recommendations: 6.)
Indeed, the DH offers an elaborate strategy for addressing parental concerns about the “improved” and “simplified” vaccination program:
“If the combined immunisation is introduced, some parents will have questions about it, and health professionals, especially health visitors and practice nurses, will be their first port of call for information. Health professionals will have an important part to play in informing and reassuring parents, and they will need to provide consistent answers; any variation between what they say is likely to create a sense of unease among parents.” (Conclusions and Recommendations: 7.)
In revealing further details on how the health staff should approach those parents who may have concerns over the safety of the MMR vaccine, the DH advises:
“Health professionals will need to be ready to reassure parents that…
• combining vaccinations into one appointment and giving three at a time is entirely safe
• the fact that MMR is one of these makes no difference, because MMR is safe
• there is a good reason for the change: though the current system is effective and safe, changing it will be an improvement
• there are significant benefits to baby and parent in having one fewer appointment and reduced distress”
It should be obvious that any a priori exclusion of possible adverse effects from vaccines which is not based on valid scientific evidence but rather, a belief system is not by definition scientific. Rather, it reflects a disturbing trend to view anything associated with vaccines and vaccine policy as sacred and beyond scientific scrutiny. The need to protect the UK government-mandated vaccination program against any reasonable doubt, in the absence of any truly independent scientific evidence and despite a) CSM/JCVI/ARVI’s own records discussed under Sections 1)-3) & 5) which show that vaccines, including measles and the MMR are not “entirely safe” and b) the government’s own concession that the MMR can in fact cause permanent brain damage (in the case of Robert Fletcher who in August 2010 received £90,000 payout for epilepsy and severe mental retardation that he suffered following the MMR jab; http://www.bbc.co.uk/news/uk-englandmerseyside-11125343), is even more disturbing.
If vaccines are indeed entirely safe as the DH and the JCVI claim, why do they feel they need to hide information from parents and health professionals?
Perhaps “combining vaccinations into one appointment and giving three at a time is” not “entirely safe”.
As a reminder (JCVI meeting, 11th December 1974; http://www.dh.gov.uk/ab/JCVI/DH_095052):
(11 Simultaneous administration of live vaccines (CHCS(VI)14))
“Professor Dick and Dr Warin pointed out that an interval in the administration of live vaccines had been advocated in view of the probability of adverse reactions and because of the recent publicity surrounding adverse reactions. The Committee agreed that it would be inopportune to change the guidance that an interval of at least 3 weeks should be allowed to elapse between the administration of any 2 live vaccines whichever came first.”
The above would explain the need to censor certain information as well as why the JCVI went to great lengths in devising a special strategy with which such a task would be achieved:
“Given continued sensitivity about MMR, any negative news coverage will have a significant impact. Health professionals will be the front line in combating this, and will need to be kept fully informed on the latest information from JCVI and DH to prevent any contradictions or confusion, and to ensure that they are equipped to reassure parents.” (Conclusions and Recommendations: 9.)
The choice of words is rather peculiar here, it appears as if the DH and the JCVI are preparing for war. Their choice of weapons includes “educating” health professionals with what appears to be highly censored information, since numerous truly independent studies which raised safety concerns in the scientific community (particularly about the MMR vaccine), were simply dismissed by the JCVI (see Section 4). Both the JCVI and the DH opted instead for the methodologically dubious study by Miller et al. [23] as their only evidence to promote the new “improved” and “simplified” immunisation program. This obvious information bias is to be promulgated by the JCVI/DH to the health profession.
Furthermore, according to the DH, it is not only important to censor information given to both parents and health professionals, the way in which this information is to be communicated is also very important.
“It is important that the information given by health professionals is pitched at the right level. The JCVI information prompted questions among many respondents, but was useful for reassuring some, particularly those with a more pragmatic view of immunisation. Information at this level needs to be carefully tailored by health professionals according to the attitudes of individual parents.”
The corresponding section from the Attitudinal research report (http://www.dh.gov.uk/
prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_122329.pdf) adds:
“If in doubt, we would suggest keeping it simple, as outlined above.” (D Conclusions; 3. Dealing with questions about the change to a combined schedule)
Since some disclosure to the parents on adverse events associated with the combined schedule is necessary, it is further regarded that in spite of some:
“…diverging views on when the sheet should be given to parents; on balance it seems wise to hand it out 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.” (D Conclusions; 4. The tear-off sheet on side effects)
The idea of “keeping it simple” was also welcomed by the health professionals. Indeed, as already discussed in Section 5), the public may not understand correctly the significance of febrile convulsions. Nor would anyone want the public to dwell extensively on associations between the words “vaccine” and “death” or “permanent brain damage”.
One has to wonder whether parents who to this day continue to trust the British Health Authorities on matters of immunisation, would still have the same opinion if crucial facts on vaccine-associated adverse events discussed in “commercial” and “in confidence” CSM/JCVI/Joint Sub-Committee ARVI meetings were fully disclosed to them:
From the Attitudinal research report (pg 22):
“To my eyes these things have all been tried and tested, the
medical people studied for years, they tried all of this stuff. They obviously know getting these things correctly so my trust is in their hands really at the end of the day.”
From a discussion on a proposal for the surveillance of severe neurological disorders in infancy and their relationship to pertussis vaccine, 7th February 1986, CSM/JCVI/Joint Sub-Committee ARVI ( h t t p : / / w w w . d h . g o v . u k / e n / F r e e d o m O f I n f o r m a t i o n /Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):
(6.5.1)
“It was considered unreasonable to ask paediatricians to report for a period of six years.”
“No attempt would be made to study serious neurological disease arising from pertussis and other infectious diseases.”
From Miller et al. [23]
“For safety, proportions of children with erythema, swelling or tenderness at site of injection, or fever or other systemic symptoms for 7 days after immunization were compared between regimens.”
From the JCVI meeting held on 3rd November 1981 (http://www.dh.gov.uk/ab/DH_095169):
(5.d. Comments on Professor Stewart’s letter)
“Professor Gilliatt observed that in the Meade Panel Study one-third of children with brain damage were not admitted to hospital. In both the Meade and Dudgeon studies there were 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. It was very difficult to assess this as a random event…The Chairman concluded that much was not known about the natural history of brain damage in the young.”
From the Attitudinal research report (pg 22):
“…the diseases must be serious and pose a risk – ‘the NHS wouldn’t put children through it [so young] if it wasn’t necessary.”
From the JCVI meeting on 11th December 1974 (http://www.dh.gov.uk/ab/JCVI/DH_095052):
(10.)
“…mumps vaccine was unnecessary because complications from the disease were rare. The Committee agreed that there was no need to introduce routine vaccination against mumps.”
From a discussion on a proposal for the surveillance of severe neurological disorders in infancy and their relationship to pertussis vaccine, 7th February 1986, CSM/JCVI/Joint Sub-Committee ARVI ( h t t p : / / w w w . d h . g o v . u k / e n / F r e e d o m O f I n f o r m a t i o n /Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):
(6.5.1)
“No attempt would be made to study serious neurological disease arising from pertussis and other infectious diseases.”
From the Attitudinal research report (pg 23):
“They’re in the book and they say you should do them, I think if I don’t do them then that’s wrong. They know what they’re doing.”
From the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting, held
on 5th October 1984 (http://www.dh.gov.uk/ab/JCVI/DH_095294):
(9.)
“Fetal damage after accidental polio vaccination of an immune mother. Barton AE et al.
Journal of the RCGP 1984: 34: p. 390-394
Dr Smith observed that the termination of the pregnancy at 20 weeks in this case report was not related to the administration of oral poliovaccine (OPV).”
Note: how such conclusion could be reached remains unclear since:
“However, the foetus was reported to have signs of infection with poliovirus in the nervous system although no similar event had been previously seen after vaccination.”
From the Attitudinal research report (pg 23):
“I don’t think they would put something into a child that is not good for them.”
“I put my hands in the medical profession and they do a good enough job for me and I trust them.”
“Surely they wouldn’t give these injections if they felt they would harm?”
“I do think it’s a good thing. You want to try and protect your children so if that’s what they’re suggesting they have to have done you should trust your health professionals.”
“Because they’re recommended you kind of trust the doctors to guide you.”
From the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting, held
on 6th July 1987 (http://www.dh.gov.uk/en/FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):
(6.1 Whooping cough)
“He explained that in February the CSM had called for ARVI’s advice about updating the statement made in the 1981 report on Whooping Cough (HMSO) about a possible link between DTP immunisation and serious neurological illness. It had been hoped that by this means ‘discovery’ of all the relevant JCVI, CSM and ARVI documentation on whooping cough vaccine could be avoided.”
From the JCVI/Joint Sub-Committee ARVI “commercial in confidence” meeting on 6th
February 1987,
section “7.1 Whooping cough vaccine –CSM advice” (contents of the statement that CSM wished to modify; http://www.dh.gov.uk/en/FreedomOf Information/
Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):
“No scientifically unassailable link has been established between DTP immunisation and serious neurological illness but we have come to 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.”
From the CSM/JCVI/Joint Sub-Committee ARVI “commercial in confidence meeting on 3rd October 1986 (http://www.dh.gov.uk/en/FreedomOfInformation/
Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):
(5.1.3.c.)
“From the above there is reason to believe that the increased relative risk of prolonged convulsions after DTP was a real one.”
From the JCVI meeting on 3rd November 1989 (http://www.dh.gov.uk/ab/DH_095169):
(9. ARVI Committee – Minutes of meeting 6 October 1989 (JCVI (89)25)
“Dr Schild reported that NIBSC was now able to distinguish clearly the wild strains from each of the two vaccines, and isolates from CSF clearly showed Urabe in all three cases believed to be associated with vaccine-although it should not be assumed that Jeryl-Lynn is not capable of the same result.”
From the JCVI meeting on 7th May 1999 (http://www.dh.gov.uk/ab/JCVI/DH_095050):
(8. Meningococcal meningitis, i.)
“Committee members were reminded that this issue, and the papers presented, was extremely sensitive, commercially and politically. It was requested that confidentiality be maintained. The Chairman asked for any declarations of interest. Professor Cartwright was involved in manufacturers’ studies on the vaccines, including health trials. Dr Goldblatt was involved in one company-sponsored study and had provided a clinical expert report to the
MCA for one manufacturer. Dr Jones was involved in trials for two of the companies involved. Dr Schild said that NIBSC was evaluating the vaccines.
“There were no objections to these members continuing to take part in the meeting and it was agreed that they would be able to provide a valuable input to the discussion in
common interest.”
From a discussion of the 8.4.1 Meningococcal C Conjugate (MCC) Vaccine Evaluation
Programme, at the 7th May1999 JCVI meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050):
(ii.)
“There was no good evidence for the efficacy of the meningococcal Group C conjugate vaccine, only the surrogate of antibodies compared with those known to be protective against invasive disease. To actually test the efficacy on the conjugate vaccine 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 3-5 years.”
(iii.)
“It was felt that it was important to plan the programme now and confirmation that the vaccines were equally effective could follow.”
Standards of Conduct
Finally, a reader may wish to assess the presented data on JCVI vaccination policies against the JCVI’s own Code of Practice (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_115363.pdf) which states:
(Responsibilities of Committee and Sub-committee members):
(30)“All members of the Committee and its Sub-committees (‘members’) must demonstrate high standards of conduct.”
(31)“In exercising their duties, members must observe the ‘Seven Principles of Public Life’ set out by the Committee on Standards in Public Life (the Nolan Committee):
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
Integrity: Holders of public office should not place themselves under any financial or other obligation to outside individuals or organisations that might influence them in the performance of their official duties.
Objectivity: In carrying out public business, including making public appointments, awarding contracts, or recommending individuals for rewards and benefits, 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.
Honesty: Holders of public office have a duty to declare any private interests relating to their public duties and to take steps to resolve any conflicts arising in a way that protects the public interest.
Leadership: Holders of public office should promote and support these principles by leadership and example.”
(Conflicts of Interests)
(39) Personal pecuniary8 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 that could be under consideration by JCVI or a Sub-committee including:
• holding a directorship, or other paid position
• carrying out consultancy or fee paid work
• having shareholdings or other beneficial interests
• receiving expenses (e.g. travel to, or registration for, conferences) and hospitality the member must declare this interest.
If 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.”
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