Amidst the latest attempts by the UK Department of Health to convince a skeptical population that MMR is completely safe, Professor David Salisbury urges people to look carefully at decisions made 15 years ago. Around 1993 in fact, and well before the notorious Wakefield et al Lancet paper brought deep rooted concerns to public attention in 1998.
But why choose 15 years ago? Could it be that in referring to events around this time Professor Salisbury is asking the UK population to forgive past mistakes? Is he, possibly, asking for a second chance? Whatever the reason, perhaps whilst asking others to revisit their decisions made at that time, Professor Salisbury might also consider examining some of his own.
I have access to documented evidence from various sources, many gathered under FOIA, that appear to implicate David Salisbury in the introduction into the UK, of a brand of MMR known, by him, to have caused damage to children in other countries. On the positive side it was cheaper than the safer versions. Here is some of the history. Much more, about this and other similar issues, will be made available in the next few months. I have no reason to doubt the evidence, and I believe it is in the public interest to make it known.
In 1986 Trivirix (MMR containing the Mumps Urabe strain AM-9), was introduced in Canada to replace MMR I. Concerns regarding the introduction of MMR in the UK are recorded in the minutes of the Joint Working Party of the British Paediatric Association and the Joint Committee on Vaccination and Immunization (JCVI) Liaison Group on June 26th of that year. Such concerns were soon to prove well grounded, as reports began to come in of an increased incidence of aseptic meningitis in vaccinated individuals. Ultimately, all MMR vaccines containing the Urabe strain of mumps were withdrawn in Canada in early 1988. This was before Urabe containing vaccines were licenced by the Department of Health (DoH) for use in the UK, followed in June of that year.
Smith-Kline--French (the pharmaceutical company who became Smith-Kline-Beecham and were involved in UK manufacture at that time) were concerned about these safety issues and were reluctant to obtain a UK license for their Urabe-containing vaccines. As a result of their ‘concern’ that children might be seriously damaged by one of their products, they requested that the UK government indemnify them against possible legal action that might be taken as a result of ‘losses’ associated with the vaccine, which by then was known to carry significant risk to health. The UK government, advised by Professor Salisbury and representatives from the Department of Health, in it’s enthusiasm to get a cheap MMR onto the market, agreed to this request. Clearly, the DoH and UK government were well aware of the problems occurring with the Urabe strain of mumps vaccine not only before the vaccine was given to millions of children in this country, but even before the vaccine was approved for licence. Concerns were clearly referred to in the Minutes of the Joint Sub-Committee on Adverse Reactions to Vaccination and Immunisation, (ARVI) March 8th, 1988.
In fact, introduction of MMR was planned for the UK in 1987, ironically, in the same year that Canada reported its first cases of MMR induced mumps encephalitis (see Champagne et al. Can Dis Weekly Rep. 1987;13:155-157). In 1988 distribution of the Urabe containing MMR was ceased in Canada and the product recalled. In July of the same year a UK license was granted and a UK deal struck to indemnify the manufacturers. In other words, despite the fact that a possibly safer but more expensive MMR vaccine was available Professor Salisbury opted for a cheaper and potentially more dangerous version without ever having performed the recommended comparison trials advocated by the JCVI. Professor Salisbury apparently states on his CV, presumably with some pride, that he was responsible for the introduction of this vaccine into the UK.
Soon after the introduction of Urabe-strain MMR, by then recalled in Canada because it was damaging children, a UK MMR vaccination campaign, similar to the one being launched today, was supported by Professor Salisbury. Immediate reports of meningitis followed (see Gray JA. Lancet 1989;2:98). An additional report (see Murray MW., Lancet 1989;2:677) confirmed that the emergent meningitis in UK children was identical to that which was the basis for withdrawal of the vaccine in Canada.
In March 1989, MMR (Urabe AM-9) was introduced in Japan. In September 1989 the first Japanese case of aseptic meningitis, post MMR vaccine, was reported to the Japanese Public Health Council (see http://www.nih.go.jp/JJID/55/101.pdf.
On May 4th 1990, the minutes of the JCVI, headed by Professor Salisbury, contain reference to some concerns. One might expect these concerns to relate to the vaccine’s safety. Not so. The JCVI expressed concern that details of the vaccines dangers are to be published in the UK, thereby exposing the problem and causing a scare (JCVI Minutes 4 May 1990 Article 9.2g.) So, just to run through that one again, the JCVI members were concerned about the Japanese data being published and the public being warned, but apparently unconcerned about the fact they had licensed a vaccine that is associated with meningitis.
On 17th September 1990, the ARVI minutes refer to reports of emerging cases of meningitis in Crawley, Cambridge, Kidderminster and Nottingham, with clusters of cases in the latter three locations. 25 cases were reported spontaneously between February and September 1990.
The draft of a later to be published paper (see Sugira et al. Ped Infect Dis J. 119;10 (3):204-209, 1991 ‘A prefecture-wide survey of mumps meningitis associated with measles, mumps and rubella vaccine’, was discussed at the ARVI meeting on 17th September 1991, again with no apparent concern for the fact that the same pattern of damage observed in Japan was now occurring in the UK. According to ARVI minutes these data had apparently been disclosed previously to the JCVI.
Later in 1990 the license for Urabe-containing MMR was revoked in Canada, followed by Malaysia, the Phillipines and Singapore. In May 1991 it was secretly withdrawn in Australia, then in September 1991 there was a worldwide withdrawal (but no product recall) of Pluserix, a Urabe containing vaccine manufactured by Smith-Kline-Beecham. Whilst vaccine manufacturers had therefore clearly acknowledged the dangers of Urabe strain vaccines, the JCVI failed to warn the public.
In 1992 a UK company knowingly sold the UK-licensed defective vaccine to 3rd world countries. Mass immunisation with GSK’s Urabe-strain MMR was introduced in Brazil at around the time MMR vaccination was halted elsewhere. A mass epidemic of encephalitis followed its introduction
In the UK, in October 1998, the first two writs issued in the class action MMR litigation were for Urabe containing products and many more were to follow.
With respect to the indemnity offered by the DoH to UK manufacturers, Professor Salisbury has both denied and acknowledged its existence. A series of emails from Professor Salisbury have been brought to our attention:
On Sept 13th 2006, Professor Salisbury states:
“as has been stated on innumerable occasions, there was no immunity/indemnity given to MMR manufacturers"
Later on the 23rd of March 2007 he states:
“We have found that North East Thames District Health Authority (that no longer exists) agreed with at least one MMR vaccine manufacturer to indemnify them against outcomes that were consequences of failure by
And then in an email sent on 3rd April 2007 he states:
“In the contract between NHS Procurement Directorate, acting by its agent NETRHA, and Smith Kline & French (SKF), there is a paragraph on indemnity
"NHS shall indemnify SK&F against any proven loss which SK&F shall suffer as a result of any act or omission of the Nominated Distributor in connection with the performance or non performance of this Agreement where such act or omission appears to be within the scope of the Nominated Distributor's authority as agent of NHS provided that SK&F shall immediately notify NHS of any claim under the provisions of this clause"
The indemnity is an “all cause” indemnity. Clearly the JCVI and the UK government understood at least one of the MMR manufacturers to be indemnified when marketing their MMR product. This is confirmed in the unambiguous JCVI minutes of May 7th 1993:
‘SKB continued to sell the Urabe strain vaccine without liability.’
Today David Salisbury is appealing to the nation to trust in his judgment. He is asking parents to revisit decisions made 15 years ago, at around the time when he appears to have been responsible for the introduction into the UK of a vaccine known, to him, to have already damaged substantial numbers of children around the world. David Salisbury seems also to have denied knowledge of a deal with the UK government, indemnifying the manufacturers of this vaccine against any potential claims from damaged children in the UK. Ultimately he appears to have ignored consistent evidence to suggest that the effects observed in countries where the vaccine had been withdrawn were beginning to appear, identically, in UK children soon after the vaccine had been introduced. These devastating adverse effects were acknowledged long before the public were made aware, and even longer before the vaccine was withdrawn and distributed to the 3rd World.
Would you trust this man with your child’s health?
A C Golding, August 2008