Yes. Thank you very much for inviting us to the committee. It is a great showcase for Scottish democracy.
I want to speak about Scotland’s reliance for vaccine policy on the advice of the United Kingdom Joint Committee on Vaccination and Immunisation. In the brief space that has been allocated, I want to focus on the initial statement in Rachel Smith’s letter to me of 29 October, that
“Scottish Ministers are confident in the independence of the JCVI”.
The chairman of the Joint Committee on Vaccination and Immunisation, Andrew J Pollard, said on 12 February 2014:
“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 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”.
That was said in item 6 in the minute of the meeting.
If the prime reason for trusting the JCVI’s advice is that it is an independent body, ministers must, sadly, have failed to do their research. A number of its members, including the chairman, have a concerning catalogue of links to the pharmaceutical industry. Among his other appointments, its current chair, Professor Pollard, is 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 that try to promote vaccine products. Although he stated in his declaration of interests that he does not receive personal remuneration from the industry, he is the director of an enterprise that acknowledges participation in a significant number of drug trials. Following those trials, he has co-authored numerous papers on the outcomes. Very recently, he co-authored a paper on trials associated with an Ebola vaccine. He acknowledged a
“research grant and research support”
from Janssen Pharmaceutica, which is a pharmaceutical division of Johnson & Johnson. However, his European Medicines Agency declaration for 2015 said that he had “no interest declared” where he was asked for details of “grant/funding to an institution”.
When Professor Pollard was appointed chairperson of the JCVI in October 2013, 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 was not planning to take on any new grants for clinical trials and research. In June this year, his JCVI statement noted:
“Since taking up his role with JCVI he no longer takes on research grants from industry sources.”
That is confusing, as his 2015 EMA declaration includes a clinical trial funded by Pfizer that commenced in November 2013, which was a month after he took up office.
With that background, Professor Pollard has chaired the JCVI for two years now. His June 2013 EMA declaration of interests indicates that he was working as principal investigator from October 2012 for the Novartis rMenB+OMV NZ, or Bexsero, vaccine trial, which was at the time described as “current”, and he had previously done so in a number of trials involving the Bexsero meningitis B vaccine between 2008 and 2012. Under his chairmanship, the JCVI recommended the inclusion of the Bexsero vaccine into the UK immunisation scheme in March 2014, having previously decided against it in July 2013 before he took office. However, in a paper that was published in Clinical and Vaccine Immunology dated February 2014 that he co-authored, he declared that he was
“named on patents in the field of group B meningicoccal vaccines”.
The JCVI revised code of practice demands that the chair
“cannot have any interests that may conflict with his or her responsibilities to JCVI”
“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 minute of the meeting on 12 February 2014, in which Bexsero was discussed, does not include a declaration of members’ interests, so it is impossible to know what conflicts of interest were declared. However, it is clear from the minute 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.
Five days after that meeting, a clinical trial was lodged involving Bexsero with Professor Pollard as principal investigator. That was partially funded by Novartis vaccines. It is currently described as “ongoing” and is not expected to terminate until December 2015.
In June 2014, while 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 who were approaching routine vaccinations to participate in the Bexsero trial.
The professor’s JCVI declaration of interests from June this year acknowledges that “other investigators” in his department were undertaking trials in respect of a meningitis B vaccine, which were funded by Novartis and which are said to have ended. There is no indication that that vaccine is Bexsero but, if it is not, one wonders where Professor Pollard noted his involvement in the on-going Novartis Bexsero trial, which was not expected to conclude until December this year. If it is the Bexsero trial that is being referred to, then, according to the clinical trial register, it is still “ongoing” and not “ended”, as stated in the professor’s declaration.
In February 2014 the JCVI agreed:
“any conflict of interest should continue to remain for one year after it ceased”.
It follows that Professor Pollard’s association with Novartis will not be expunged until December 2016.
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 dependent on pharmaceutical companies continuing to invest money in clinical trials and so on for their products, to be carried out by the members’ institutions.
JCVI members have additionally benefited by advancing their careers as co-authors of numerous publications that are published following trials. It is critical that the chair should be free of conflict, as it is 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 past two years and seven meetings have any declarations been published. That was on 3 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 GlaxoSmithKline and Novartis for the transfer of Novartis’s vaccine division began the month after the JCVI recommended the vaccine. The Government’s agreement of a price for the Bexsero vaccine was also part of the Conservative Party window-dressing for the recent general election.
Ministers must surely have concerns that the recommendations that are circulated by the JCVI promoting the inclusion of vaccines in the immunisation schedule is not done by a committee that is entirely devoid of influence from the manufacturers. It is hard to understand how officials in the Department of Health and Public Health England, for instance, could have been completely unaware of any of Professor Pollard’s entanglements.
In recent years, a number of serious adverse reactions have been uncovered following receipt of JCVI-advocated vaccines, including Pandemrix and Fluenz, both of which have caused narcolepsy or cataplexy in some recipient children. Cervarix and Gardasil, the human papillomavirus vaccines that are now the subject of thousands of yellow-card adverse drug reaction—ADR—reports of serious lasting conditions in our young women, and Rotarix, with its unacceptable risk of intussusception of the bowel, have already been removed from the schedule in France. Fluenz places immune-compromised people and people with asthma at unnecessary risk by continuing to shed for weeks.
The JCVI has an established history of permitting its members not only to hold consultancies and shares in pharmaceutical companies but to accept remuneration for lecturing and carrying out clinical trials spanning decades. The members of the committee are appointed by the Secretary of State for Health via the Department of Health senior responsible officer, in consultation with PHE, the public health directorate. Sub-committees invite industry representatives to their meetings.
It looks as if, according to 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 that. 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.
I am sorry if I overran there.