As Italy’s parliament votes in draconian new laws to expand and enforce vaccine mandates over its children it may be helpful to look at some of the origins of the deal which led to the takeover over the Novartis vaccine division by GSK (Glaxo SmithKline). The takeover move began in April 2014 shortly after the United Kingdom’s Joint Committee on Vaccination and Immunisation (JCVI) made a controversial decision to recommend Novartis’s Bexsero Meningitis B vaccine for infant use – one of the items on Italy’s compulsory schedule. The decision was presided over by the JCVI’s recently appointed chairman, Andrew Pollard, who also happened to be the product’s lead developer . Less than a year earlier the JCVI had been put under pressure to recommend Bexsero by the UK’s Secretary of State for Health, Jeremy Hunt (see picture), but failed to agree. The decision was taken at the second meeting presided over by Prof Pollard, without anybody recusing themselves and without a vote being taken. This greatly enhanced the commercial prospect of the vaccine which hitherto had been having difficulty establishing itself in the market.
As Secretary of State for Culture, Media and Sport during the early years of the Cameron coalition government Hunt was shown to have colluded with the interests of the Murdoch media empire and made inappropriate communications with James Murdoch, despite which he was promoted to the role of Secretary of State for Health in 2012 and is the only British cabinet minister to remain in position since that time (despite great unpopularity and mistrust). The Murdoch news empire has notably been at root of relentless fraudulent claims against Andrew Wakefield who questioned the safety of MMR vaccine in 1998 and subsequently, while in February 2009 James Murdoch was appointed to the board of GSK with a brief to help defend the group’s reputation. Within days a further string of attacks on Wakefield followed. Murdoch retired from the board of GSK in January 2012 with his own name surrounded in controversy. GSK or its precursor SKB, was the manufacturer of an MMR type vaccine which had to be withdrawn in Canada in 1987/8 and the United Kingdom in 1992, and was subject of a legal suit in which Wakefield was a witness.
However the appointment of Prof Pollard came about it is apparent that it furthered the policy request of the Health Secretary Hunt (and the new Men B vaccine was also used as political window dressing in the in 2015 British General Election). While the Secretariat of the JCVI has continued to defend the appointment of Prof Pollard, hiding behind a maze of complex rules, it is hard to see on the basis of any normal public standards a scientist can sit in judgment on the future of a product of which he was lead developer, any more than an architect could head a planning committee considering his own design. Blatantly, Pollard later addressed a GSK sponsored meeting in September 2015 at the Royal College of Paediatrics and Child Health under the title:
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
Another departure in standards took place when in February 2016 the Joint Committee on Vaccines and Immunisation enjoyed the hospitality of Prof Pollard’s institutions in Oxford. As well as having limited efficacy the Bexsero vaccine which is now being mandated and made compulsory for infants in Italy was recorded as having serious side effects in above 1 in 50 cases in a group of 10 to 25 year-olds, according to the FDA package insert.
According to a report on an Italian pharmaceutical website the CEO of GSK Italy, Daniele Finocchiaro, talked of the terms of the deal struck more than two years ago years ago with the Italian government:
... I also met with Minister Lorenzin and other members of the government who reiterated the sensibility of the government towards those who invest, create jobs and opportunities for young people. In short, we started on the right foot.
Such sensibility in the Roman palaces is not to be dismissed. As for us, Andrew Witty has asked for a few things: clear rules and stability in return for strong investment in advanced research and production equipment. We were of one intent.
But while a weak and no doubt corrupt Italian government had its eyes on GSK money – and were all too ready to offer the nation’s children up to the modern Moloch - GSK, was perhaps even more focussed on the exploitation of Novartis’s Bexsero vaccine, which it was acquiring through the deal, the prospects of which have been transformed by the arrival of Prof Pollard at the JCVI. FiercePharma reported earlier this year:
In making the massive Novartis asset swap, Witty navigated GSK away from costly cancer drugs and toward low price, high volume vaccines and consumer healthcare products…Meningococcal group B vaccine Bexsero, picked up from Novartis, continued its ascent as it more than doubled sales from 2015 to reel in £390 million, or $486 million, on the year. The company will continue spending to boost its manufacturing capacity for the shot, CFO Simon Dingemans said on the Q4 conference call.
Until the end of 2013 Andrew Witty was also 'lead non-executive director' (a title equivalent to chairman) at the UK Department of Business, and thus a senior member of the British government infrastructure.
As director of Oxford Vaccine Group which developed Bexsero Prof Pollard sits on its funding body, the Jenner Vaccine Foundation with the Vice-President and Chief Medical Officer of GSK Biologicals, Dr Norman Begg, while the chairman of the committee is Dr David Salisbury, who back in 2013 as the Department of Health Head of Immunisation chaired the panel which invited Prof Pollard to chair the JCVI .
Prof Pollard is also under investigation by the European Ombudsman over conflicts in European Medicines Agency after complaints by Nordic Cochrane. Last December it was reported in Le Monde:
The complainants also questioned why the agency dismissed some experts from deliberations due to conflicts of interest, while the chairman of one of the EMA panels, Andrew Pollard from Oxford, has been maintained. The latter has, in particular, conducted four studies financed by GlaxoSmithKline (GSK) or Sanofi, between 2010 and 2014. Moreover, according to our information, its declaration of interests at the EMA omits to mention certain financial support from manufacturers of some welknown vaccines at his institution. There was no response to the enquiries of Le Monde over these interests.
The Nordic Cochrane Foundation complaint addressed the EMA’s failure to investigate harms from HPV vaccines including Cervarix manufactured by GSK. Issues encompassed flawed handling of data, failure to acknowledge or report professionally dissenting opinions, and the absence of evidence surrounding the safety of aluminium adjuvants (used in many vaccines including Cervarix and Gardasil).
With so much uncertain science these many tangles are more than usually undesirable in public life.
With thanks to Pietro Monari.
John Stone is UK Editor for Age of Autism.
These are some additional observations.
While the media and the politicians remain on-side over vaccines in the UK it is widely recognised or at least suspected that Jeremy Hunt has a commercial agenda to demolish the National Health Service from the inside (and of course it is always on the point of financial collapse). One feature of this seems to the creation of the agency Public Health England to run it: bodies like the JCVI and Oxford Vaccine Group, both headed by Prof Pollard and both of which have close connections with industry come under PHE, and if you enquire at Department of Health they say PHE has nothing to do with them, and presumably nothing to do Secretary of State - it may also remove it from aegis of Parliament, which is perhaps a "de facto" situation rather than "de jure".
Another feature of the present situation in 2017 is that the hate campaign remains in place at Times Newspapers against Andrew Wakefield: vitriolic, harassing, gratuitous and completely mendacious. In my opinion they know exactly what they are doing. This is so, even though James Murdoch left the board of GSK more than five years ago.
From a report on FiercePharma 20 June 2017:
A key pickup from its massive Novartis asset swap, GlaxoSmithKline’s meningitis B shot Bexsero has been a standout performer in recent quarters. That’s not set to change, according to an analyst group, which predicted this week that the shot and pipeline vaccine Shingrix will each haul in more than $1 billion by 2022.
In its just-released World Preview report, life science commercial intelligence firm Evaluate projected that GSK’s Bexsero will more than double sales to $1.17 billion in 2022. Last year, the vaccine brought in $528 million.....
To give Bexsero a boost after the Novartis asset swap, GlaxoSmithKline quickly agreed on a price with the U.K. government for a national immunization program. Afterward, demand was so strong that the company ran into a brief shortage for private clinics.
Since then, supply has rebounded and Glaxo is moving to make the most of the vaccine. The company started construction in March on a $175 million plant in Germany, where it plans to move production of three of Bexsero’s four active components currently made at a Sandoz plant in Austria...
A new paper by Prof Pollard indicates that he would like to increase number of shots of Bexsero that a child receives (the present UK schedule is for three shots 2-12 months) which will obviously drive up sales but argues against effectiveness.