Good morning and thank you for inviting me to address the committee.
I make it clear that the brand of measles, mumps and rubella vaccine that is the subject of my petition is not in use today and has not been used in the United Kingdom since 1992. The issues that I have raised are historical in nature, but are nevertheless of huge significance to the young people in Scotland who received Pluserix MMR and as a consequence still suffer lasting neurological disabilities.
In October 1988, despite the fact that the Urabe-containing Trivirix vaccine had been introduced and almost immediately removed from use in Canada in 1986 following concerns that it was causing mumps meningitis in recipient children, the Scottish home and health department supported and implemented the marketing of a Urabe-containing brand of MMR—Pluserix—in Scotland. After the Canadian authorities had stopped using the vaccine to await laboratory-confirmed test results to conclusively determine whether it was the cause of the meningitis and the manufacturer had voluntarily ceased marketing it, Pluserix was introduced in Scotland.
Despite a number of early indications that a similar problem to that encountered in Canada was occurring here, the Scottish home and health department continued to support the use of Pluserix for four years, two of which were after the Canadian licence was cancelled in 1990, when it was conclusively proven that the Urabe mumps strain had been isolated from the cerebrospinal fluid of the Canadian children. At that time, the Canadians concluded that the vaccine
“was not considered safe for immunization of Canadian children.”
One has to wonder how anyone could have thought that the vaccine was safe for Scottish children.
Eleven months after the introduction of the vaccine here, in September 1989, the Committee on Safety of Medicines reported 10 cases of mumps meningitis. Dr Alistair Thores was the senior medical officer and named point of contact in the Scottish home and health department circulars that advised that Pluserix was to be one of the MMR brands to be introduced into Scotland. He also represented the department on the joint committee on vaccination and immunisation and the sub-committee of the JCVI on adverse reactions to vaccination and immunisation, and he was present when committee members reported on the high incidence of mumps meningitis.
In April 1990, despite the fact that the Scottish home and health department wrote to the JCVI to outline its concerns about the incidence of mumps meningitis and to question whether an alternative brand of vaccine should be used, it still continued to support the use of Pluserix on Scottish children. Dr Thores was also present when, in May 1990, the JCVI heard that three districts had switched from Urabe-containing MMR to the alternative brand. One has to wonder why Scotland, with the very obvious heightened concerns, did not do likewise.
The JCVI’s statutory functions do not extend to Scotland and the authorities were not bound to comply, either in part or in total, with any advice given to them by the JCVI. It was, at all times, open to the Scottish home and health department to cease using Pluserix and to switch to an alternative brand.
In September 1992, the Department of Health removed Pluserix from use, and it became the subject of an import ban in 2002, at which time the CSM chairman spoke of the risk of “potentially serious neurological complication” to children.
Pluserix was insufficiently attenuated and considered to be a defective product within the meaning of the Consumer Protection Act 1987. It was originally estimated to cause mumps meningitis at a rate of one case per 100,000 doses, but scientists in Nottingham provided a laboratory confirmed rate of one case per 3,800 doses, a significant difference.
The Department of Health commissioned a study, conducted by the British paediatric surveillance unit, of all reported cases of mumps meningitis, which included a follow-up study a year later to determine any lasting sequelae in the children. Nine cases of sensorineural deafness, a condition which is included in the manufacturer’s list of possible adverse reactions to Pluserix, were detected in the cohort and reported on in a paper by Stewart and Prabhu.
The vaccine damage payment scheme only provides financial assistance to applicants who can satisfy the assessors that they have experienced a 60 per cent disability. Some applicants seeking compensation for sensorineural deafness following the administration of Pluserix have been acknowledged as vaccine damaged, but not damaged enough to qualify for a payment.
Despite the fact that the Scottish home and health department was aware of both the historical background to Pluserix from Canada and the fact that identical problems had been and were occurring here, parents bringing their children for the measles, mumps and rubella vaccine vaccination were entirely unaware. It is difficult to see how informed consent could have arguably been obtained in those circumstances.
Unfortunately, in 2008, Miss Nicola Sturgeon, the then health minister, acknowledged:
“Senior medical officer files were not held centrally within the Scottish Home and Health Department but retained by individual doctors during their period of employment and destroyed thereafter.”
It follows that relevant files on Pluserix MMR have been destroyed and are not available to the committee.
I respectfully request that the committee consider how this highly problematic dangerous vaccine was able, first, to enter the Scottish market, and secondly, to remain there for four years despite the obvious concerns and problems identified by the Scottish home and health department.
To date, the children who have suffered lasting neurological disability following the administration of the Pluserix vaccine in Scotland have received neither acknowledgement nor compensation. In 1982, Lord Campbell of Alloway in the House of Lords advocated that where a child has been damaged through vaccination, in the interests of the community there should also be
“absolute liability and fair compensation.”—[Official Report, House of Lords, 1 December 1982; Vol 436, c 1241.]
Today, on behalf of those who have suffered lasting neurological disability following use of the Pluserix vaccine, I seek both.