Angus Files and John Stone Speak at Public Petitions Committee - Scottish Parliament
Stone files parliament
Age of Autism's John Stone and Angus Files (live video is below)
NOTE: Advocacy for vaccination rights is taking place on both sides of the pond. Age of Autism's UK Editor John Stone and valued contributor Angus Files spoke at the Public Petitions Committee - Scottish Parliament: 8th December 2015.
From Scottish Parliament TV:
This is the full annotated text of Angus File's presentation:
"The Chair explained that it was important for the Committee to be independent and to be seen to be independent when providing advice to government. This mean not only being separate from the influence of industry, but also being independent from the Department of Health as the recipient of the Committee's advice"
Professor Andrew J Pollard JCVI minutes ,12th February 2014, item 6
Thank you for the invitation to speak on the subject of Scotland’s reliance for vaccine policy on the advice of the United Kingdom’s Joint Committee on Vaccination and Immunisation.(JCVI) In the brief space allocated, I would like to focus on the initial statement in Rachel Smith’s letter to me of 29 October:
“Scottish Ministers are confident in the independence of the JCVI"
If the prime reason for trusting the advice of the JCVI is that it is an independent body then ministers have failed to do their research. A number of its members including the chairman have a concerning catalogue of links to the pharmaceutical industry.
Professor Pollard the present chair is, among his other appointments, head of the Oxford Vaccine Group, which owes its continuing existence to accepting contracts for research and clinical trials from pharmaceutical companies and other agencies trying to promote vaccine products. (1, a, b and c)
Although he states in his declaration of interests that he does not receive personal remuneration from the industry, he is the Director of an enterprise which acknowledges participation in a significant number of drug trials following on from which he has co authored numerous papers on the outcomes(2a,b,c) Very recently, he co authored a paper in respect of trials associated with an Ebola vaccine where he acknowledged a "research grant and research support" from Janssen, a pharmaceutical division of Johnson & Johnson(3). His European Medicines Agency (EMA) declaration for 2015 however where he is asked for details for "grant/funding to an institution" has "no interest declared".(4+8)
When appointed chairperson of the JCVI in October 2013, (5) he had significant on going links to the pharmaceutical industry as "principal investigator" to a number of clinical trials, however he stated ambiguously in his EMA declaration that he wasn't “planning” to take on any new grants for clinical trials and research,(6) In June of this year his JCVI statement noted that "Since taking up his role with JCVI he no longer takes on research grants from industry sources. (7)This is confusing since his EMA 2015 declaration includes a clinical trial funded by Pfizer commencing in November 2013, a month after he took up office (8 and 4)
With that background he has now chaired the JCVI for two years.
His June 2013 his EMA declaration of interests, indicates that he was working as "Principal Investigator" from October 2012 for Novartis’ rMenB + OMV NZ (Bexsero) vaccine, a trial which was at the time, described as “current” and had previously done so in a number of trials involving Bexsero Meningitis B vaccine, between 2008 and 2012.(9)
Under his chairmanship the JCVI recommended the inclusion of Bexsero vaccine into the UK immunisation scheme in March 2014 having previously decided against it in July 2013 (10) before Professor Pollard took up office. However, in a paper published in Clinical and Vaccine Immunology dated February 2014, which he co authored, he has declared that he is "named on patents in the field of group B meningicoccal vaccines"(11)
The JCVI revised Code Of Practice (12) demands that the Chair “cannot have any interests that may conflict with his or her responsibilities to JCVI” and also that “the JCVI Chair and Sub committee chairs cannot have interests that could conflict with the issues under consideration by the JCVI or Sub Committee respectively”.
The JCVI Minutes of the meeting on 12th February 2014 where Bexsero was discussed do not include a declaration of members interests so it is impossible to know what conflicts of interest were declared but it is clear from the Minutes that Professor Pollard took declarations and that members with specific interests were excluded from voting. There is nothing in the text to indicate that the chair absented himself.(13)
Five days after this meeting a clinical trial was lodged involving Bexsero with Professor Pollard as "Principal Investigator" which was partially funded by Novartis vaccines. It is currently described as "ongoing" and not expected to terminate until December 2015.(14) In June 2014, whilst Chairing the JCVI and acting as principal investigator for the trial, he co signed a "Study Information Booklet" on behalf of the Oxford Vaccine Group inviting families with children approaching routine vaccinations to participate in the Bexsero trial! (15)
His JCVI declaration of interests from June of this year acknowledges that "other investigators" in his department were undertaking trials in respect of a men B vaccine funded by Novartis which are said to have "ended".(16) There is no indication that this is Bexsero but if it is not, one wonders where Professor Pollard noted his involvement in the ongoing Novartis Bexsero trial not expected to conclude until December of this year. If it is the Bexsero trial which is referred to, then according to the clinical trial register it is still "ongoing" and not "ended" as stated in his declaration.
In February 2014 the committee agreed that "any conflict of interest should continue to remain for one year after it ceased" and it follows that professor Pollards association with Novartis will not be expunged until December 2016.(17)
Of the remaining members on the JCVI, three have declared financial input from pharmaceutical companies to their places of employment. It follows that although they are not personally in receipt of monies paid directly from the industry it is the case that their earnings are recovered from that source. That their employment continues is somewhat dependant on pharmaceutical companies continuing to invest money in clinical trials etc for their products to be carried out by their institutions. Members have additionally benefited by advancing their careers as co authors of numerous publications which are published following trials. It is also critical that the chair should be free of conflicts since it his job to “appraise” other members of the committee annually. Although, the JCVI Code of Practice dated June 2013 at item 39 includes how the "minutes of each meeting will include interests that are declared and how they have been handled", only once in the last two years and seven meetings have any declarations been published (3rd June 2015).
It is troubling that the actions of the committee could have wider commercial and political implications. In the case of Bexsero negotiations between GSK and Novartis began for the transfer of Novartis’s vaccine division the month after the JCVI recommended the vaccine(18). The government agreeing a price for the Bexsero vaccine was also part of Conservative window-dressing for the recent General Election.
Ministers must surely have concerns that the recommendations circulated by the JCVI promoting the inclusion of vaccines into the immunisation schedule is not done by a committee which is entirely devoid of influence from the manufacturers. At the same time it is hard to understand how officials in the Department of Health and Health England could, for instance, have been completely unaware of any of Prof Pollard’s entanglements.
In recent years there have been a number of serious adverse reactions uncovered following receipt of JCVI advocated vaccines, to include Pandemrix and Fluenz both of which caused narcolepsy/cataplexy in some recipient children(19)Cervarix and Gardasil the HPV vaccines(20) now the subject of thousands of Yellow Card ADR reports of serious lasting conditions in our young women and Rotarix (21 a,b) with an unacceptable risk of intussusception of the bowel, has already been removed the schedule in France. Fluenz place immune compromised people and people with asthma at unnecessary risk by continuing to shed for weeks.
The JCVI have an established history of permitting it's membership to not only hold consultancies and shares in pharmaceutical companies but to accept remuneration for lecturing and carrying out clinical trials spanning decades.(22 a, b) The members are appointed by the Secretary Of State, via the Department of Health senior Responsible officer in consultation with PHE Public Health Directorate, the Sub committees invite industry representatives to their meetings. (23)
It looks as if on its own terms of reference the JCVI has failed miserably to maintain its independence. It is not good enough simply to state that it is independent when there is much evidence to counter this.
I respectfully submit to Ministers that they should not be complicit in such practices. As an “independent” appointment Professor Pollard was more unqualified than the chief executive of a pharmaceutical company – being tied as he was to several of them. I therefore request that consideration be given to the formulation of a Scottish JCVI to serve the best interests of the Scottish people.
As presented to the Scottish Executive by Mr Angus Files
Tuesday 8th December 2015, 10.00 am
FOOTNOTES
1a. Characterizing vaccine responses using host genomic and transcriptomic analysis
AJ Pollard and Daniel O' Connor, Clinical Infectious Diseases Advance Access published May 31, 2013
b. Administration of ASO3B-adjuvanted A (H1N1) pdm09 Vaccine in Children Aged < 3 years enhances Antibody Response to H3 and B viruses Following a single dose of Trivalent vaccine One Year Later
Katja Hoschler , Andrew Pollard et al, Clinical Infectious Diseases Advance Access published December 4, 2013
c. Effect of quadrivalent meningococcal ACWYglycoconjugate or a serogroup B meningococcal vaccine on menningococcal carriage: an observer-blind, phase 3 randomised clinical trial
Robert C Read, David Baxter, Andrew Pollard et al
Published on line August 19, 2014 www.thelancet.com
2 a. Immunisation errors reported to vaccine advice service : intelligence to improve practice Sarah Lang, Andrew J Pollard et al, Quality in Primary Care 2014; 22; 139- 46
b. Comparison of two-dose priming plus 9-month booster with standard three-dose priming schedule for a ten-valent pneumococcal conjugate vaccine in Nelales infants: a randomised, controlled, open label, non-inferiority trial. Lancet Infectious Diseases, 2015 ;15 (4) : 405-14 Hamaluba M, Pollard AJ et al
c. Persistance of Bactericidal Antibodies following early infant vaccination with a serogroup B menigococcal vaccine and immunogenicity of a preschool booster dose
Mathew D. Snape, Andrew J. Pollard et al. CMAJ 2013 Oct 15 185 (15) E 715 - E724
3 ID WEEK October 7-11, San Diego CA
4 and 8 European Medicines Agency Public Declaration of Interests, Professor Andrew J Pollard, 20th October 2015
5 Minutes of JCVI Meeting dated Wednesday 2nd October 2013 item 1, "Welcome"
6 European Medicines Agency Public Declaration of Interests, Professor Andrew J Pollard, 31st May 2014
7 Declaration Of Interests, Professor Andrew J Pollard June 2015
8 AS NUMBER 4
9 European Medicines Agency Public declaration of interests, Professor Andrew Pollard, 6th June 2013
10 GP's to administer meningitis B vaccination following JCVI U-Turn 21 march 2014, Alex Mathews-King, Caroline Price
11 Neisseria meningitidis Native Outer Membrane Vesicles Containing Different Lipopolysaccharide Glycoforms as Adjuvants for Meningococcal and Nonmeningococcal Antigens, Jerry C. Nagaputra, Andrew J Pollard et al, Clinical and vaccine Immunology February 2014 Volume 21 p234-242
12 JCVI Code of Practice June 2103 item 40
13 JCVI Minutes of meeting 11th/12th February 2014 item 29
14 Clinical Trials.gov Investigating the Immune Response to 4CMenB in infants
15 Oxford Vaccine Group Study Information Booklet 9th June 2014
16 Declaration Of Interests, Professor Andrew J Pollard June 2015
17 JCVI Minutes 11th/12th February 2014 Item 5
18 GlaxosmithKline and Novartis change shape to focus on core business Nils Pratley 22nd April 2014
20 MHRA paper provided to JCVI August 2011, "vaccine - associated suspected adverse reactions reported via the yellow card scheme during 2010"
21 a."Vaccination against Rotavirus-the use of Rotarix vaccine" NHS national Services Scotland, Draft updated July 2015
b. A Jab in the Dark 18th August 2012 BMJ volume 345, Nigel Hawkes
22 a. JCVI Members declaration of interests 2005
b. FLINT August 2004
23 JCVI Code of Practice June 2103, item 16
ABBREVIATIONS
EMA European Medicines Agency
JCVI Joint Committee On Vaccination and Immunisation
MHRA Medicines and Healthcare products Regulatory Agency