Andrew Pollard  Medicines Control Agency (MCA)

Rearranging the Deck Chairs on the Deck of the MHRA (UK FDA)

Managing Editor's Note: We are pleased to welcome back Martin Walker, whose prolific coverage of the Wakefield GMC hearings was a mainstay of our site.  Please visit his website Slingshot Publications  which features his many books.

By Martin Walker MA

Throughout the years the major UK committee overseeing licensing and safety of new drugs, the Joint Committee on Vaccination and Immunisation (JCVI) one of the committees under the central Medicine and Health Care Regulations Agency (MHRA) has been subjected to criticism over members’ conflict of interests and strong links with the pharmaceutical industry.

The JCVI is charged with making recommendations to the Government on matters of vaccine schedules and vaccine safety and as such it is thought by critics that it should be comprised of individuals who can at all times be said to be impartial and neutral especially in respect of receipt of funding through their employment.

While attention has been frequently drawn to conflict of interest, the fact that the whole governing regulatory sector, the MHRA, commonly accepted by the public as an independent part of government and always described as a ‘government agency’, is actually funded in its entirety by the pharmaceutical industry. Not only this, but members of all regulatory and advisory committees charged with addressing the safety of pharmaceutical products for the UK, are forbidden to discuss such matters in the public arena, apparently for reasons of commercial competition, under the rules of section 118 of the 1968 Medicines Act and Britain’s notorious Official Secrets Act.

A relatively recent row over vested interest and conflict of interest, with respect to vaccination, occurred in 2004 when the JCVI Chairman Professor Michael Langman, made it public that he had advised the Government to introduce a vaccine manufactured by Merck Sharpe and Dome whilst his Birmingham University department carried out medical research funded by that company. Langman claimed in his defence that he was allowed to chair the JVCI’s discussions on the vaccine because he was not personally paid by the drugs company.

The false distinction between personal financial payment or other benefits and liaison with and payments to University Departments by pharmaceutical companies, is a common screen erected to protect committee members from serious criticism.

However, it now appears that a partial message at least, has been accepted by the JCVI acknowledging that both specific and non specific ‘personal pecuniary interests involving vaccine manufacturers’ might be perceived as conflicts and should be avoided. At their meeting of the 11th and 12th February 2014 the JCVI agreed that:

The code of practice should be revised to indicate that members should avoid bothspecific and non-specific personal pecuniary interests involving vaccine manufacturers, since such interests might be perceived as conflicts, even if the interest is related to a non-vaccine product or a vaccine not under consideration by the Committee.

Of course, this falls significantly short of an all-out ban on members having such links. The agreed revision to the Code of Practice is confined to the instruction that members should ‘avoid’ these conflicts. This may be explained by the admission in the Code of Practice at item 3 where it is says that, ‘The JCVI Code of Practice does not have legal force’.

Paper Promises

Unless followed up by strict enforcement these changes in the rules could all be interpreted as an empty gesture to pacify the growing tide of protest about the inappropriate nature of the UK’s advisory committee to the Government on issues of vaccination and immunisation having such strong links to the pharmaceutical industry.

It is difficult to envisage what the high thinking executives inside the MHRA, or even the civil servants privy to these suggested changes, were thinking at the time they introduced them. Were they about to overturn 40 years of committee tilting in favour of fair rules? This would be a bit too much to expect from the pharmaceutical industry and we should look for more subtle movements below this apparently tectonic shift.

After all, what is being asked for are declarations and retirement from discussion not the complete exclusion of members. If the new changes had suggested that members of the public, parents of vaccine damaged children or even epidemiologists and social scientists to check safety data might attend open public meetings of the JCVI, we might of course have been shocked, even stupefied.

An insight into what might have contributed to this apparent change of heart might lie in the minutes from the meeting in October 2013. At this meeting Professor Pollard the Committee Chair introduced his own particular situation to the meeting, attempting to draw a distinction between direct pecuniary reward received for specific pharmaceutical work and a more general association with, for instance, a funded department at work. At item 3, the minutes read:

The Chair (Professor Pollard) explained to the committee that he directs a research group at the University of Oxford which undertakes collaborative research with vaccine manufacturers and that the University receives research grants for some of these activities. However, Professor Pollard does not obtain any personal financial benefit from these interactions, he does not accept any gifts or expenses from industry nor does his Department receive any travel expenses on his behalf. Professor Pollard does not advise industry or work as a consultant for any vaccine manufacturer. The Committee noted this and agreed that any conflict of interest present would not impinge on Professor Pollard’s ability to act as Chair to the committee in an independent manner. It was agreed a more detailed statement would be prepared in order to clarify this matter.

At the next meeting of the 11th and 12 February 2014 with the agreement to revise the Code of Practice, Professor Pollard having previously made the committee aware of his situation is quoted in the minutes as saying the following:

(That it was important) for the Committee to be independent and to be seen to be independent when providing advice to the Government. This meant 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, particularly following recent institutional structural changes in the relationship between JCVI Secretariat, Public Health England (PHE) and the Department of Health following the formation of Public Health England.

Basic definitions are clearly needed here, for instance, what should members be independent of – the pharmaceutical industry, the vaccine industry, the academic mainstream, the MHRA, the Department of Health? When you think about it, it’s all very fuzzy, rather like asking General Practitioner doctors to be independent of medical orthodoxy and have a fair and balanced view of alternative treatments.

In the past, all the declared interests of members were produced in a table but in more modern times the Minutes of each meeting have contained tables of members declared interests only in relation to the items discussed on the agenda and the resultant action taken as part of the proceedings.

But that too has been absent from the Minutes since the meeting of June 2013, on October 2013 and February 2014. This is despite the advice of Professor Saul Faust that there should be a record of any declared conflict of interest in the meetings minutes. ‘Relevant interests must be declared at the start of each item on meeting agenda and recorded in meeting minutes.’

Professor Pollard and conflictless vaccine propaganda

To a great extent, the public continue to be bamboozled by the dark and dishonest ways of the pharmaceutical cartels, offer carefully crafted plastic confectionary to placate the peoples hunger for democracy. Funding is only one singularly recognisable part of the ‘conflict of interest’ equation.

It is ironic that Professor Pollard should have been the messenger apparently carrying the torch for the new rules to the JCVI. Although it appears that Professor Pollard is not in receipt of any personal financial remuneration from his work activities, it doesn’t follow that his place of employment at which he has a ‘senior’ role also does not.

Of course, Pollard’s hand on heart assertions could all be seen as the idle chatter of the corporate academic class, which doesn’t add up to much at the end of the day. Everyone with a brain knows that industry keeps university departments and their staff going by funding which is quietly laundered into disguised direct funding as wages, equipment and buildings. We have to ask ourselves whether any of the committees under the MHRA, but most especially the JCVI would ever entertain a vaccine skeptic academic or member of the public.

According to the new June 2013 code of practice, non personal pecuniary interest of a non personal nature received, for instance, by a University department - financial payments or benefits relating to a product or service which is being considered, by the committee must be declared to the committee by the member involved. However, the only proviso enacted against this member, will be:

If the payment or benefit is connected with a product under consideration, the member will still be able to participate in the discussion, unless the chair rules otherwise, but not any subsequent vote.

And even this optimistic and progressive sounding proviso is somewhat spoiled by the let out in the same paragraph:

 If the payment or benefit relates wholly to other products (even if produced by the same company. added by the author), the Member will be able to participate in the discussion and any subsequent vote.

What is apparent here is the same clever semantic circus act indulged in by the pharmaceutical cartels with respect to every public subject they touch. The wording actually nullifies the faux principled approach of the new rule. If payment from GlaxoSmithKline to the members department is for advanced laboratory equipment for GSK research into a new vaccine to cure academic stupidity, but the JCVI meeting discussion and vote is for a GSK vaccine for medicine induced arthritis, then the member can be involved in both the discussion and the vote.

Where this new ruling not to be so dodgy, it would look possible that Professor Pollard could find himself repeatedly in a position whereby he had to abstain from voting - thank God the issue in the new ruling addresses only specific products! The newly revised Code of Practice also contains one other recommendation which, had it been written up honestly, might have seen Professor Pollard making other announcements to the committee in the near future.

Involvement with charities was considered as a potential conflict and should be declared;personal pecuniary interests with charities should be avoided.

However, again, we can see how slightly slanting the ruling leaves it ambiguous. The problem with many charities is that they have been taken over by pharmaceutical companies and pursue the ‘treatment line’ of that company. Clearly the first part of this ruling is sensible but weak, involvement with a charity could be ‘a potential conflict and should be declared. However, as in all these matters, the defining of bias or conflict beyond any declaration is decided upon by whom?

If a member is on a scientific advisory panel to a heart disease charity whose members are mined by GSK for trial subjects, or to whose members the new ‘most effective’ pharmaceutical treatment from GSK is promoted, and this committee member also runs a University Department funded by GSK conducting or overseeing trials for other GSK products, who will decide that his advisory panel position with the heart disease charity represents a conflict of interest? Again, the ruling that personal pecuniary interests with charities is stated, as if this is a norm that defines a conflict. Most scientists who are embedded in charities are not paid by the charities, even in small amounts.  

In Professor Pollard’s case, an important issue in relation to charities comes to the fore which isn’t even addressed in the new rules. Is there a conflict of interest if someone sitting on a committee that discusses the safety of vaccines is a member of a charity which is heavily committed to proselytizing the message that vaccines are completely safe?

Professor Pollard is a Trustee of the Jenner Vaccine Foundation, which is chaired by Professor Salisbury, until his recent retirement Director of Immunisation at the Department of Health and Medical Advisor to the JCVI, now heading up his own vaccine consultancy business linked to the Jenner Vaccine Foundation. For two years between 2011 and 2013 Salisbury had been serving two masters, the DOH and the largest vaccine development organisation in the western world, the Jenner Vaccine Foundation.

The Foundation has a bogus charitable status and is a massively rich organisation, part funded by the Department of Health, the Bill & Melinda Gates Foundation, together with major US vaccine research organisations. The Foundation funds the Jenner Institute, which is partnered by the University of Oxford and the The Pirbright Institute. Apart from proselytizing vaccines and many other science based roles, the Jenner Vaccine Foundation runs vaccine trials.

According to its internet blurb, the Foundation seeks to ‘enhance philanthropic support of vaccinology and currently supports vaccine research and development through the Jenner Institute’. The Foundation Board appoints the Director of the Institute, elects Jenner Investigators (currently numbering 24) and has funded space and facilities for vaccine research and development.

The Pirbright Institute, the third party to the vaccine research conglomerate, is funded by the BBSRC, one of seven Research Councils funded by the Government's Department for Business, Innovation and Skills (BIS), to the tune of millions of pounds. The Pirbright’s total annual coffers recently of £467M, also retain funding from various corporate sources, it supports 1600 scientists and 2000 research students in universities and institutes across the UK.

It is difficult to see how this information, tangled like a ball of wool, could easily identified as a clear conflict of interest, with a declaration of membership of the Jenner Institute, by anyone looking in on JCVI meetings. Pollard appears quite well insulated sitting with the ex head of the DoH Department of Vaccine and Immunisation, on a body carrying out vaccine trials which is funded indirectly by the government itself, the biotech industry and other corporate interests.

The newly revised Code of Practice still allows invited guests/experts to the JCVI meetings to have pecuniary interests, although they require to be declared and noted. So, no doubt the minutes of the new independent JCVI meetings will record the continuing attendance by the expert Professor David Salisbury, the man who presided over the Urabe fiasco, from 1987 through to 1992 and then some. 

One thing is clear about the new rules introduced most probably at the behest of the MHRA, and behind them the pharmaceutical and vaccine industry: nothing much has really changed, and until the matter of regulatory sector funding is addressed seriously by an independent body and the system is opened up to public scrutiny and attendance, shuffling around and rearranging the deck chair is not going to save the JCVI or its governing body the MHRA, from future exposure as a cat’s paw for the pharmaceutical industry.

 Martin Walker has written essays and edited and published two books by parents about the adverse reactions caused to children given the MMR vaccination. I followed and wrote about the case of Dr Andrew Wakefield attending every day of the bogus three year trial organised by the General Medical Council.  Read his full bio at his website.