Dr. Andrew McCabe Interviews Dr. Toni Bark
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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

19 http://www.dailymail.co.uk/health/article-2439408/Narcoleptic-schoolgirl-Chloe-Glasson-hopes-swine-flu-vaccine-payout.html

http://www.dailymail.co.uk/news/article-3224953/Schoolboy-11-left-unable-smile-laugh-without-suffering-narcolepsy-fits-given-nasal-spray-flu-vaccine-government-scheme.html

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

 

 

ABREVIATIONS

EMA European Medicines Agency

JCVI Joint Committee On Vaccination and Immunisation

MHRA Medicines and Healthcare products Regulatory Agency

ADDENDUM

The following account of proceedings and proposed actions has been published on Scottish Government website:

http://www.scottish.parliament.uk/S4_PublicPetitionsCommittee/Meeting%20Papers/20151208_Papers.pdf


PPC/S4/15/21/1
Public Petitions Committee

21st Meeting, 2015 (Session 4), Tuesday 8 December 2015
PE1584 New Scottish Vaccine and Immunisation Advisory Committee

Note by the Clerk
PE1584

– Lodged 7 October 2015
Petition by Angus Files calling on the Scottish Parliament to urge the Scottish Government to set up an advisory committee within NHS Scotland to provide advice
on immunisation and vaccination policy.


Purpose

1. This is a new petition that was not opened for collecting signatures. The petitioner has been invited to speak to the petition and a SPICe briefing has been provided. The Committee is invited to consider what action it wishes to take on the petition.
Background

2. Members are provided a SPICe briefing with their papers from which much of the following information is taken.

3. The Joint Committee on Vaccination and Immunisation (JCVI) issues guidance to the four UK health departments on the use of vaccines. The JCVI has a statutory basis as a Standing Advisory Committee in England and Wales. However the JCVI has no statutory basis within Scotland and, although the
matter falls within devolved competence, the Scottish Government and previous administrations have chosen to receive its advice. Nevertheless, it is entirely up
to the Scottish Government whether or not it accepts the JCVI’s advice and chooses to implement it within Scotland.

4. Scotland does not have membership of the JCVI but it does have observer status. There are two Scottish observers (from Health Protection Scotland and
the office of the Chief Medical Officer) who attend committee meetings and receive papers. Observers do not have voting rights but can contribute to meetings in order to, for example, clarify points of fact, provide additional
information or offer an interpretation of data.

5.Once the JCVI issues a recommendation, the Scottish Government and Health Protection Scotland consider it within a Scottish context and decide whether or
not the recommendation should be adopted in Scotland. Decisions are usually issued via a letter from the Chief Medical Officer.

PPC/S4/15/21/1

Membership of the JCVI
6. Membership of the Committee normally consists of academics, practicing clinicians and lay members. Members are usually appointed for a period of three years but, subject to satisfactory annual appraisals and attendance, may be reappointed for a second or third term. Members cannot serve on the Committee for more than 10 years.

Conflicts of Interest

7.The petitioner is concerned that the JCVI is not sufficiently transparent.

8.The JCVI Code of Practice sets out that appointments are made on merit and in accordance with principles of the
Code of Practice for Scientific Advisory Committees
and the Code of Practice issued by the Commissioner for Public Appointments. In exercising their duties, JCVI members must observe the seven principles of public life set out by the Committee on Standards in Public Life.
These are:

1.Selflessness
2.Integrity
3.Objectivity
4.Accountability
5.Openness
6.Honesty
7.Leadership
8. Under the principle of ‘Honesty’ the JCVI’s Code of Practice says that 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”. The JCVI’s Code of Practice also states that members of the
JCVI must declare any conflicts of interest at the time of their appointment and promptly notify the Committee secretariat of any changes.
9.The Code of Practice describes declarable interests as pecuniary and non-pecuniary interests of the Committee member or a family member that have been received in the last 12 months. All registered interests are appended to the minutes of the Committee meetings (see minutes from the meeting of June 2015
for the most recent register of interests).

Action
9.The Committee is invited to consider what action it wishes to take. Options include –
(i) To write to the JCVI to ask how potential conflicts of interest are dealt with during considerations by the JCVI and whether it would consider publishing the register more prominently;
PPC/S4/15/21/1
(ii) To write to the Scottish Government seeking its opinion on what the petition seeks;
(iii) To write to, Sir David Normington GCB, the Commissioner for Public Appointments (England and Wales) to ask whether he is content that the practices of the JCVI comply with the Code for which he has
responsibility and offer a suitable degree of transparency..
(iv) To take any other action it considers appropriate.

 

 A draft transcript of the session is now available (12 Dec).

 

Comments

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angus files

Grace Green .
As I am only a parent and not a scientist, or a lawyer, or much of anything , I just have to plug away as I do..

Take some heart though ...Scottish petition article below from UOU

http://www.niassembly.gov.uk/globalassets/documents/procedures/inquiries/public-petitions-procedures/6.-professor-derek-birrell---university-of-ulster.pdf

3.3 Outcomes and Influence
The Petitions Committee will produce its final recommendations after taking and considering the evidence. The recommendation may include taking no further action.
The Petitions Committee has carried out major inquiries which have been high profile and led to policy changes following their recommendations. The report on child sexual exploitation was conducted over eight months and made 28 recommendations, was debated in parliament and led to a ministerial statement. Also influential was a petition on NHS cancer treatment and on mandatory sentences for persons found carrying knives, a petition initiated by a father whose son was stabbed to death. The recommended action by the Petitions Committee can be diverse. It may ask a public body to review a decision, recommend a debate in parliament, ask a body to keep a matter under review, often try to incorporate evidence into an ongoing policy process or legislative process. Even if petitioners do not achieve their declared aim they may be satisfied with the publicity and attention given to their cause.

MMR RIP

Grace Green

Thanks John, I remember now - the postman versus the professor! One wonders who IS allowed to be independent these days.
Angus, maybe the Scottish government shows signs of being more open to public opinion. Lets hope something comes of your petition.

angus files

It’s hard to gauge whether Government Policy is changed given the vagaries of any political system and the less than linear nature of ‘political time’. It is not possible in all cases to determine if a petition or an individual such as Dr Nutt directly led to a particular political outcome. It is possible that a petition or Dr Nutt could have encouraged the bringing forward of a policy. Sometimes the classic ‘chicken or egg’ problem is applicable. The JCVI is different, in that the entrenchment of vaccines as we know left alone things were/are just fine. It’s fair to say ,that Scotland has changed its view point on Cannabis where on the spot fines and warnings are going to be issued from next week .Whether this is due to petitions,Dr Nutt et-al giving advice who knows, but in Scotland some influence is being allowed by its citizens…hard to find elsewhere in the world.

http://www.heraldscotland.com/news/14135085.Cannabis_users_to_be_given_on_the_spot_warnings_to_free_up_police_time/

MMR RIP
.

John Stone

Grace

I believe it was Alan Johnson who rejected Nutt's advice. I wrote to BMJ at the time:

--------------------------------------------------------

http://www.bmj.com/rapid-response/2011/11/02/independent

Independent?

"David Colquhoun writes [1]:

""In the House of Commons Mr Johnson said, "I asked Professor Nutt to resign as my principal drugs adviser, not because of the work of the council but because of his failure to recognise that, as chair of ACMD, his role is to advise rather than to criticise government policy on
drugs." But Mr Johnson had it wrong. Nutt, unlike, for example, the chief scientific adviser, is not a civil servant. He is an academic. It is his job to be independent. He is paid nothing for all his hard work on the
ACMD. He has a day job to do as well. It is his job to criticise whatever he thinks it right to criticise."

"In this post Blairite era it may seem strange to point out that Civil Servants are paid to be independent. On the other hand academics are expected as things are to seek out the direct patronage of industry. In the case of David Nutt he states in a article [2]:

""The author has received grants, speaker’s honoraria or consulting fees from all of the pharmaceutical companies that have developed and marketed the antidepressants discussed in Cipriani et al. (2009)."

"The article reproduces a chart from Cipriani et al which includes in alphabetical order (I have added the names of associated manufacturers):

"Bupropion (GlaxoSmithKline), Citalopram (Forest Laboratories),
Duloxetine (Eli Lilly)
Escitalopram (Lundbeck and Forest Laboratories),Fluoxetine (Eli Lilly),
Fluvoxamine (Solvay), Milnacipran (Cypress Bioscience), Mirtazapine
(Organon International), Paroxetine (GlaxoSmithKline)),Reboxetine (Pfizer)
andVenlafaxine (Wyeth)

"In his controversial lecture (Eve Saville Lecture, for Centre of Crime and Justice Studies at King's College, London', as recalled by Colquhoun, Nutt spoke favourably of the safety of the recreational drugs cannabis and ecstasy:

""This furore arose simply because Nutt said that cannabis was less dangerous than tobacco and alcohol (true) and that more people were killed and brain damaged from riding accidents than from ecstasy (also true)."

"But it should also be pointed out that the use of these drugs, particularly cannabis, has been linked with depression. For instance, the Royal College of Psychiatry website tells us [3]:

""A study following 1600 Australian school-children, aged 14 to 15 for seven years, found that while children who use cannabis regularly have a significantly higher risk of depression, the opposite was not the case - children who already suffered from depression were not more likely than
anyone else to use cannabis. However, adolescents who used cannabis daily were five times more likely to develop depression and anxiety in later life."

"Another relevant question might be, in the event of these
recreational drugs ever being legalised, who might manufacture them for the mass market?

[1] David Colquhoun, 'The highs and lows of policy based evidence',
BMJ 4 November 2009 http://www.bmj.com/cgi/content/full/339/nov04_1/b4564

[2] David J Nutt, 'Prescribing anti-depressants post Cipriani et al'
Journal Psychopharmacology 2009,
http://jop.sagepub.com/cgi/reprint/23/8/865

[3] Royal College of Psychiatrists, 'Cannabis and mental health',

http://www.rcpsych.ac.uk/mentalhealthinformation/mentalhealthproblems/al...

-------------------------------------------------

Really no scientist in academic life has the opportunity to be independent anymore: in theory civil servants are but in practice "go with the flow". In the case of the JCVI the advisers are scarcely independent but Alan Johnson amended the law in 2009 to oblige the Secretary of State for Health to follow the committee's recommendations, an anti-democratic and probably illegal move which was nevertheless never debated and entered the statute book unopposed by a single member. So really politicians should ignore the JCVI when it does stupid things (mostly it only does stupid things) but at the moment the British government are in principle not allowed to unless someone challenges this stupid and probably unprecedented law.

Grace Green

Regarding the comments of the Chairman, I'm further remembering that a few years ago the pharmacologist Dr. David Nutt, a government science advisor, told the government that cannabis was less harmful than alcohol (or was it horse riding?) and should be declassified. The home secretary at the time, Jackie Smith, chose to ignore his advice, which of course was her prerogative, although it would have been better if she had admitted that her decision was despite expert advice, and was made for purely political reasons. It just shows they can ignore scientists' advice when it suits them, so why not in the case of vaccines?

angus files

Exactly Grace Green stitched up...As Kenny said he is sure he is still on the hit list of at least a couple in Congress...sorry I digress a bit from my topic.

http://lockerbiecase.blogspot.co.uk/2015/09/al-megrahi-was-not-lockerbie-bomber.html

MMR RIP

Grace Green

Angus, you mean the stitched-up "Lockerbie bomber"!

angus files

Thanks Seonaid, time will tell, as the saying goes.Kenny Mac Askill, the man, the Justice Minister, who freed the Lockerbie bomber, was to my left side, a man not scared of taking controversial decisions. Fingers crossed and who knows what might happen.


MMR RIP

Seonaid

I am in awe of the hard work and research that has gone into the presentation of this petition. Thank you both for calling ‘the powers that’ be to task. It will be interesting to see the eventual outcome. Interesting to note that already it has had impact in that “……..draft JCVI minutes for 7 October were re-posted yesterday with the declarations at the end, however inadequate, added. When the document was viewed on 4 December there were no declarations,….”. So they are watching and listening. A huge thank you to both Angus and John for ‘rattling cages’which needed rattling.

angus files

Your welcome Benedetta my inspiration comes from the likes of you and all on here.We might get recalled to answer further questions so watch this space as they say.

MMR RIP

Benedetta

Thank you both for being there, putting yourself out there, and for trying everyday to make a difference. I mean that.

John Stone

It is amusing to note that the draft JCVI minutes for 7 October were re-posted yesterday with the declarations at the end, however inadequate, added. When the document was viewed on 4 December there were no declarations, but they still have a lot of catching up to do to include the fulll range of Prof Pollard's activities.

angus files

Thanks for the posts Jenny. Smoke and mirrors being used by the Scottish Government that is what has been put in place but they haven’t sought to change it yet.. A bit of me thinks they are willing to change from the JCVI because they did not have to listen John and me and all the documentation supplied by us and others. They gave me the chance of a petition I applaud them, when was this ever done in Westminster or is ever likely to be done in Westminster, I cannot recall, apart from cursory lip service and that covers all the leading Political Parties of the UK as they have all been in power over the past 15 years.

As John has shown what the speech and evidence provide is conflict after conflict of interest and that’s just the chair, the leader, we know the foot soldiers take command from the top. The more you look the more you find about Pollard I wonder what his catch 22,get out of Jail card is? Because if hasn’t one that’s where he should be heading.

MMR RIP
.

John Stone

Another troubling document has come to light, an event on 30 September 2015 sponsored by GSK and hosted by the Royal College of Child Health and Paediatrics - the programme appears with GSK's logo at the head.

http://www.rcpch.ac.uk/sites/default/files/course/Evening%20of%20Evidence%20programme%20Vaccination%20Science%20to%20Policy%20UPDATED.pdf

The event is entitled:

"Evening of Evidence
"Vaccination Science to Policy

"Introduction of new vaccines to the UK vaccine schedule with limited evidence of efficacy (sic): Meningococcal Group B and maternal pertussis vaccination"

Among the speakers are Prof Pollard:

"JCVI decision-making process informing the recommendation for the introduction of Bexsero to the UK vaccination schedule"

and Dr Andrew Riordan, deputy chairman of the JCVI:

"Evidence considered by the JCVI to recommend antenatal pertussis vaccination in the UK"

Other speakers are from Public Health England, the MHRA and various NHS Trusts, and the drinks interval is labelled "Refreshments and Networking".

The hospitality is not noted for either man in the minutes of the JCVI meeting a week later (7 October 2015) draft published 10 December, even though they were using it to discuss JCVI business.

https://app.box.com/s/iddfb4ppwkmtjusir2tc/1/2199012147/46319285265/1

Jenny Allan

From the official account of the Scottish Petitions Commitee proceedings (posted by John Stone below):-

"4. Scotland does not have membership of the JCVI but it does have observer status. There are two Scottish observers (from Health Protection Scotland and the office of the Chief Medical Officer) who attend committee meetings and receive papers. Observers do not have voting rights but can contribute to meetings in order to, for example, clarify points of fact, provide additional information or offer an interpretation of data.

5.Once the JCVI issues a recommendation, the Scottish Government and Health Protection Scotland consider it within a Scottish context and decide whether or not the recommendation should be adopted in Scotland. Decisions are usually issued via a letter from the Chief Medical Officer."

The Chief Medical Officer is presently Dr Syed Ahmed, who seems to have 'carte blanche' on vaccine policy in Scotland. This is the same man who pointed the finger at Dr Wakefield over the shocking increase in mumps cases in our Scottish colleges and universities; the vast majority had received mumps vaccine, mostly via MMR, in infancy. (My own grandson reported no less than FIVE of his 'mates' at uni contracted mumps; they were all warned about possible sterility). The following is extracted from a letter to Shona Robison, Cabinet Secretary for Health, Wellbeing and Sport,The Scottish Parliament, 6th March 2015:-

".....the mumps prevalence situation in our colleges and universities is UK wide.

Of course, no blame attaches to the recent SNP administration for historical UK vaccine decisions taken many years ago. However, the Scottish Daily Mail’s Health Reporter, Victoria Allen, has quoted Dr Syed Ahmed, Clinical Director at Health Protection Scotland, who stated, “Certainly the MMR scare has contributed to the cases we are seeing.” I’m sure Dr Ahmed is well aware Dr Wakefield is NOT to blame for any MMR mumps vaccine component failure, and the main reason for the increase in mumps cases in Scotland is the admitted waning efficacy of the mumps vaccine component. Dr Ahmed laments the difficulties in persuading ‘teenagers’ to submit to any so called ‘catch up’ MMR vaccinations. I would respectfully suggest Scottish teenagers are perfectly capable of researching their own vaccine choices. They will also know their own vaccination status. They only have to ask their mothers.

The situation with fully vaccinated adult mumps cases, should not be permitted to continue. If the MMR vaccine mumps component is ineffective, then it is surely time to warn parents and young adults about this problem. Sooner or later, large numbers of very angry young men, fully MMR vaccinated as children, will discover mumps in adulthood, has reduced or destroyed their chances of fathering children. The court cases in the US could take years, and Merck has already spent $thousands on legal fees, in failed attempts to have the mumps fraudulent malpractice case against them thrown out. They can well afford the best defence attorneys, who will drag this out, challenge the evidence, and argue all kinds of mitigating circumstances.

Scotland can take a ‘lead’ here. I am not suggesting abandoning the MMR vaccine, but instead give new parents a proper NHS choice of single vaccines for measles and rubella if they so wish,(available privately, but expensive). There is no licensed single mumps vaccine presently available, but parents should be counselled about the desirability of contracting natural mumps in childhood, conferring lifelong immunity. Perhaps employers can be asked for understanding, allowing mothers a few days off work to nurse their children through the disease, which in up to a third of cases is so mild it passes unnoticed. Rubella, is a mild fleeting illness in childhood. There is no need to vaccinate boys at all. Girls, with no acquired immunity pre puberty, can receive rubella vaccine, to protect future unborn children from damage during any future pregnancies.

It takes bravery to innovate, although giving parents in Scotland the NHS choice of an alternative to MMR vaccine, using a ‘tried and tested’ measles and rubella vaccination schedule, previously in UK use for more than 20 years, is hardly innovation. There is no question MMR vaccine manufacturers, their paid medical spokespersons, and their sponsored press and media outlets, will vilify anything which looks like denting their obscene vaccine profits, but corporate interests, however loudly they scream and shout, should never prevail above the health and wellbeing of our Scottish citizens."

It's all too easy for our political leaders to play 'silly buggers', relying on so called 'experts' who are all too often, hopelessly biased and conflicted, but for the sake of our children and future generations, we MUST hold them to account.


angus files

I also note a book worth buying for Christmas..


Vaccination Policy and the U.K. Government: The Untold Truth Paperback – December 9, 2015

by Christina A. England (Author), Dr. Michael D. Innis (Foreword), Lucija Tomljenovic PhD (Contributor

http://www.amazon.com/gp/product/1518832369/ref=ox_sc_act_title_1?ie=UTF8&psc=1&smid=ATVPDKIKX0DER


MMR RIP

angus files

Your right Jenny, a convenient half truth, the head scratcher moment is why? If Scotland is serious about independence and separation from the UK Government , divorce is divorce, and you cant say, but we will just keep this part of our break up? divorce is divorce.

Putting all the conflicts aside it would be very fair to say the Scottish Goverment haven't seriously considered the divorce in any depth.

Possibly they are now, time will tell.

As John has posted below plenty of the boys club running the JCVI show at the top ..no prizes for guessing what the reply will be to the petition, from "To write to, Sir David Normington GCB, the Commissioner for Public Appointments "

The Sir bit is the clue...

MMR RIP

John Stone

The following account of proceedings and proposed actions has been published on Scottish Government website:

http://www.scottish.parliament.uk/S4_PublicPetitionsCommittee/Meeting%20Papers/20151208_Papers.pdf


PPC/S4/15/21/1
Public Petitions Committee

21st Meeting, 2015 (Session 4), Tuesday 8 December 2015
PE1584 New Scottish Vaccine and Immunisation Advisory Committee

Note by the Clerk
PE1584

– Lodged 7 October 2015
Petition by Angus Files calling on the Scottish Parliament to urge the Scottish Government to set up an advisory committee within NHS Scotland to provide advice
on immunisation and vaccination policy.


Purpose

1. This is a new petition that was not opened for collecting signatures. The petitioner has been invited to speak to the petition and a SPICe briefing has been provided. The Committee is invited to consider what action it wishes to take on the petition.
Background

2. Members are provided a SPICe briefing with their papers from which much of the following information is taken.

3. The Joint Committee on Vaccination and Immunisation (JCVI) issues guidance to the four UK health departments on the use of vaccines. The JCVI has a statutory basis as a Standing Advisory Committee in England and Wales. However the JCVI has no statutory basis within Scotland and, although the
matter falls within devolved competence, the Scottish Government and previous administrations have chosen to receive its advice. Nevertheless, it is entirely up
to the Scottish Government whether or not it accepts the JCVI’s advice and chooses to implement it within Scotland.

4. Scotland does not have membership of the JCVI but it does have observer status. There are two Scottish observers (from Health Protection Scotland and
the office of the Chief Medical Officer) who attend committee meetings and receive papers. Observers do not have voting rights but can contribute to meetings in order to, for example, clarify points of fact, provide additional
information or offer an interpretation of data.

5.Once the JCVI issues a recommendation, the Scottish Government and Health Protection Scotland consider it within a Scottish context and decide whether or
not the recommendation should be adopted in Scotland. Decisions are usually issued via a letter from the Chief Medical Officer.

PPC/S4/15/21/1

Membership of the JCVI
6. Membership of the Committee normally consists of academics, practicing clinicians and lay members. Members are usually appointed for a period of three years but, subject to satisfactory annual appraisals and attendance, may be reappointed for a second or third term. Members cannot serve on the Committee for more than 10 years.

Conflicts of Interest

7.The petitioner is concerned that the JCVI is not sufficiently transparent.

8.The JCVI Code of Practice sets out that appointments are made on merit and in accordance with principles of the
Code of Practice for Scientific Advisory Committees
and the Code of Practice issued by the Commissioner for Public Appointments. In exercising their duties, JCVI members must observe the seven principles of public life set out by the Committee on Standards in Public Life.
These are:

1.Selflessness
2.Integrity
3.Objectivity
4.Accountability
5.Openness
6.Honesty
7.Leadership
8. Under the principle of ‘Honesty’ the JCVI’s Code of Practice says that 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”. The JCVI’s Code of Practice also states that members of the
JCVI must declare any conflicts of interest at the time of their appointment and promptly notify the Committee secretariat of any changes.
9.The Code of Practice describes declarable interests as pecuniary and non-pecuniary interests of the Committee member or a family member that have been received in the last 12 months. All registered interests are appended to the minutes of the Committee meetings (see minutes from the meeting of June 2015
for the most recent register of interests).

Action
9.The Committee is invited to consider what action it wishes to take. Options include –
(i) To write to the JCVI to ask how potential conflicts of interest are dealt with during considerations by the JCVI and whether it would consider publishing the register more prominently;
PPC/S4/15/21/1
(ii) To write to the Scottish Government seeking its opinion on what the petition seeks;
(iii) To write to, Sir David Normington GCB, the Commissioner for Public Appointments (England and Wales) to ask whether he is content that the practices of the JCVI comply with the Code for which he has
responsibility and offer a suitable degree of transparency..
(iv) To take any other action it considers appropriate.

Jenny Allan

@ Angus Files
"This is a matter for the UK Department of Health rather than the Scottish Government, as the JCVI is the Department of Health’s Expert Advisory Committee."

What a cop out!! The UK Department of Health, is a UK Government department and 'the buck stops' with the Government.
Health in Scotland has been devolved for years. I'm afraid, telling you to "take up your concerns with the UK Department of Health", will just send you round in ever decreasing circles. Don't buy it. It's the Scottish Government's responsibility NOT Westminster's.

angus files

Thanks Elizabeth Hart for the posts

This Men B Math calculation is great by RFK..as always it only benefits PHARMA.

"According to their package inserts, Menactra and Menveo produce "serious adverse events" in 1 percent of recipients. Menomune, with its hefty mercury load, sickens 1.3 percent of those receiving it. According to the CDC Pink Book, 0.3 percent of those with "serious adverse events" from meningitis vaccines will die. So here is the math calculation that thoughtful student governments in Colorado must consider: If you inoculate Colorado's 400,000 college students with the older vaccines, you can expect 4,000 serious adverse events and 12 dead. We do not yet know the effects of widespread vaccination of the hastily-expedited B vaccines, but according to their package inserts, about 2 percent of students who receive the B vaccine will be sickened or hospitalized with a serious adverse event. This could translate into an additional 8,000 sick students and 24 deaths, for a total of 12,000 sick and 36 dead in the attempt to possibly avert three meningitis cases."

MMR RIP

Elizabeth Hart

Re the Bexsero Meningococcal B vaccine also see (including rapid responses):

- Introducing a new group B meningococcus vaccine: http://www.bmj.com/content/348/bmj.g2415

- Do we need a new approach to making vaccine recommendations? Controversy about the evidence, economics, ethics, lobbying, and decision making surrounding a new vaccine for serogroup B meningococcal disease should trigger change in the way we develop recommendations for new vaccines say Natasha Crowcroft and colleagues: http://www.bmj.com/content/350/bmj.h308


angus files

Thanks Jenny .that's a head scratcher for me as well..but the official line is as supplied to the panel which they will have to read...

"Scottish Ministers are confident in the independence of the JCVI and as previously indicated, we will continue to develop policy on vaccination on the basis of their advice. You raise a number of points about the operation and management of the JCVI, including publication of historic papers. This is a matter for the UK Department of Health rather than the Scottish Government, as the JCVI is the Department of Health’s Expert Advisory Committee. Therefore, you may wish to take up your concerns with the UK Department of Health."

MMR RIP


Elizabeth Hart

In regards to the implementation of the Bexsero Meningococcal B vaccine in the UK…

Meningococcal B disease is a rare disease.(1)

The questionable implementation of the Bexsero Meningococcal B vaccine in the UK raises important questions about what level of disease risk justifies mass vaccination, particularly when there are many uncertainties about the effectiveness of the vaccine product.

In Australia the Bexsero Meningococcal B vaccine has been rejected three times by the Pharmaceutical Benefits Advisory Committee (PBAC).

In relation to GlaxoSmithKline’s resubmission for the Multicomponent Meningococcal Group B Vaccine (4CMENB) (Bexsero) to be added to the Australian national vaccination schedule, the PBAC made the following statements in July 2015(2):

QUOTE:

- The PBAC rejected the re-submission requesting listing of the 4CMenB vaccine on the NIP Schedule for the prevention of meningococcal B disease in infants and adolescents. The basis of the rejection was that the re-submission did not address multiple uncertainties in relation to the clinical effectiveness of the vaccine against the disease when delivered in a vaccination program, that the use of optimistic assumptions about the extent and duration of effect and herd immunity as raised by the PBAC in previous consideration of this vaccine were not addressed, and the unacceptably high and uncertain ICER, presented in the re-submission.

- The PBAC reaffirmed its November 2013 and July 2014 conclusions that the vaccine is effective in inducing antibodies against the component antigens of 4CMenB. However, in the context of a population-based intervention against invasive meningococcal B disease, the Committee considered the clinical claim was highly uncertain because of the likely short persistence of the antibody response in children, uncertainty about the correlation between antibody responses and protection, the unknown effect on carriage of the bacteria, the overall uncertain long-term protective efficacy against infection and disease, and the unknown influence of projected herd immunity effects on overall disease burden. These issues were not addressed in the re-submission, although the PBAC acknowledged the limitations of the evidence base.

- The PBAC noted that the submission had not addressed the previous concerns of the PBAC in regards to the model, namely uncertain and optimistic assumptions about the extent and duration of effect and herd immunity. The PBAC was also concerned with the discounting rate applied in the model that considerably favoured the 4CMenB vaccine. The PBAC considered that none of the proposed program options were cost effective as presented in the submission.

END OF QUOTE

References:

1. “Invasive meningococcal B disease (IMD) is a rare disease caused by the bacterium Neisseria meningitidis.” PBS Public Summary Document – Multicomponent Meningococcal Group B Vaccine, 0.5mL, injection, prefilled syringe, Bexsero® - November 2013: http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2013-11/meningococcal-vaccine
2. Recommendations made by the PBAC July 2015 – Subsequent decisions not to recommend. http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2015-07/web-outcomes-july-2015-subsequent-decision-not-to-recommend.pdf

angus files

Thanks for the comments everyone and if you can share all the better.A very approachable Parliament and 1st class questions from the panel although never easy to come up with the answers of such awkward questions in a short space of time.

MMR RIP.

Jenny Allan

Well done Angus and John. It amazes me the way Scottish MSPs, most of whom want a measure of devolution, if not complete independence from Westminster, seem quite happy to allow important health decisions, including child vaccination policies, to be dictated by so called 'experts' based in London. You certainly gave the petitions committee members 'food for thought' and your presentations were impeccable. Grateful thanks.

Michelle B

Well done! Nice to see the faces that provide us with such important content on AofA.

Reader

Great job! Love to you both!!!!

Laura Hayes

Thank you, Angus and John, for speaking publicly and exposing the vast corruption, unending greed, egregious lies, and immoral willful ignorance that are the 4 cornerstones of every nation's vaccine program!

Adriana

Thank you Angus and John. The discussion is about deaths and maiming of children, corruption and conflicts and you're forced down these various tunnels of technicalities. Considering this, your equilibrium is quite amazing to witness.

angus files

Thanks Bob Moffitt,
Its a "larf" as one of our old friends on here used to say,the only problem is, the subject matter isn't larfable.

I was wondering whether the present chair was put in to make a deliberate shambles offit,and at the same time, make the previous chair look, even better than he did on leaving.

Possibly it might cause a petition to have the old chair back..such are these in-bread-institutions, doomed by make up to fail.

MMR RIP

angus files

Thanks Grace Green so sad,but not surprised, that you see clever people, thinking people, sitting on panels that have obviously been brainwashed into thinking, that there is no other option available and we would be dead if it weren't for pharma.

I am sure on here we could put up an alternative to the JCVI,the MRHA, and the VDPU within 24 hrs completely made up of independent people....

come to think offit no vaccines problem solved

MMR RIP

Bob Moffitt

Professor Andrew J Pollard JCVI minutes ,12th February 2014, item 6:

"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"

Obviously .. with the exposed .. extensive .. record of the "Chair's" close personal as well as professional relationship with the vaccine industry .. now on the public record .. thanks to Angus Files .. the "Chair" can no longer pretend to be providing "independent advice to government".

Unfortunately .. these people are shameless .. incapable of pushing themselves away from the pharma "public trough" which funds their own vested interests .. rather than the vested interests of the PEOPLE.

It is no wonder they claim being unable to find ANYONE who does not have some connections to big pharma .. because .. ANYONE who proved themselves un-corruptible have long since been "purged" from consideration.

After reading Angus' scathing expose of the "Chair" .. his stated goal of being "seen as being independent" is no longer possible.


Grace Green

Very well done, Angus and John! The Chairman's contention that it would not be possible to find suitably qualified scientists without connections to the industry to sit on the JCVI ignores the fact that this only arrises because the Pharmaceutical companies have deliberately extended their financial influence into the universities as well as other spheres. My father was Senior Lecturer in Pharmacology at Dundee University from 1955 to the late '70s and had no connections with the industry. Indeed, listening to this debate, I wonder if the explanation for my family's persecution for many decades could be that Big Pharma doesn't like people who have knowledge but are not bribable! Angus's point about such scientists being ostracised fits very much with my memories of how my father was treated after there was a change of head of his department.

angus files

Thanks John and lets hope a great day will be made greater.

MMR RIP

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