Trounced by Trivax
UK babies given toxic vaccines, admits Glaxo

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The following article by Antony Barnett and Tracy McVeigh originally appeared in the Sunday June 30, 2002 edition of The Observer.

British drug giant GlaxoSmithKline has finally admitted that thousands of babies in this country were inoculated with a batch of toxic whooping cough vaccines in the 1970s.

Some experts believe that these Trivax vaccines — which had not passed critical company safety tests — may have caused permanent brain damage and even fatalities in young children.

In 1992, the family of an Irish boy, Kenneth Best, who suffered brain damage from one of these toxic vaccines, was awarded £2.7 million in compensation by the Irish Supreme Court.

Despite a long and fierce battle with the drug giant, the boy's family finally won this historic case after his mother Margaret made a startling find when sifting through tens of thousands of company documents.

She discovered that the Trivax vaccine used on her son, from a batch numbered 3,741, had been released by the company despite it having failed to pass a critical safety test. Documents revealed that the 60,000 individual doses within this batch were known to be 14 times more potent than normal.

At the time the Irish judge accused GlaxoSmithKline — then known as Glaxo Wellcome — of negligence and attacked the company's poor quality control at its Kent laboratory. Immunology experts condemned Glaxo in court for what one US scientist described as an 'extraordinary event'.

Last year an investigation by The Observer found evidence to suggest that vaccines from this faulty batch, which may have wrecked Kenneth Best's life, had also been used in Britain.

Liberal Democrat MP Norman Baker raised questions in the House of Commons, asking whether vaccines from this batch had been given to British babies. Then Health Minister Yvette Cooper wrote to the company asking for information.

Now, almost a year later, GlaxoSmithKline has replied that it is 'highly probable' the toxic batches had been used in Britain.

The Department of Health is under pressure to make efforts to trace the children who received the suspect vaccines.

Last week in the House of Commons, Health Minister Hazel Blears said: 'Unfortunately they no longer have details of the quantitites of vaccine or the places where the vaccine was supplied.

'Since vaccines were not centrally purchased and distributed at that time there are no central records either. Information on individuals who received these vaccines will only exist if the general practioner at the time of the immunisation recorded the batch number and the patient's notes are still available.'

Baker will now write to the Minister to demand that she asks health authorities to check the records to find out who received the vaccine. It is believed that at least one boy from Wales died after receiving a jab from toxic batch 3,741, although the parents have never been informed.

A spokesman for GlaxoSmithKline told The Observer: 'We do not accept that these batches were harmful.'

But as we found out, in our own investigation, the "Trivax story" doesn't stop here. Far from it.

Earlier, in our Breaking News column, we reported on GlaxoSmithKline's involvement in the testing of its experimental AIDS drug, Epivir, as used in captive populations of orphans and babies — some as young as three months old — at New York's Incarnation Children's Center. See Glaxo Guinea Pigs.

Delving deeper into the history of the Trivax vaccine we discovered — in a document entitled "Report on Three Clinical Trials Involving Babies and Children in Institutional Settings in 1960/61, 1970 and 1973" (authored by the Chief Medical Officer of the (Irish) Department of Health and Children, Dr. James Kiely) that in a Trivax drug trial — one carried out on behalf of the multinational drug company Wellcome (now GSK), in Dublin in 1973 that:

"In this trial 53 children, in "Mother and Baby" homes and children's homes in Dublin and 65 children living at home in Dublin were administered vaccine to compare the reactogenicity of the commercially available batches of Trivax vaccine (that is a proprietary name for Diptheria Tetanus and Pertussis vaccine) and Trivax AD vaccine with a vaccine of equivalent efficacy but in relation to the pertussis or whooping cough component of lesser potency. This trial was apparently conducted in 1973. The outcome of this trial was not published."

This trial (and others like it) were the subject of intense scrutiny by the (Irish) Commission to Inquire into Child Abuse Act (2000) because:

"....the fact that some of the children who participated in the trials were resident in children's homes or orphanages at the time of such participation and questions have been raised as to the ethical propriety of the trials."

Sound familiar? It gets even worse.

Some of those very same children "taking part" in the 1973 Trivax drug trial were "inadvertently" given a veterinary vaccine with a similar brand name, Tribovax T. The animal vaccine is solely for use on farm stock. Wellcome's register of its manufactured products shows clearly that the vaccine was part of a consignment of Tribovax T which was produced at the company's manufacturing plant in the UK in early September, 1972.

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In a PR Newswire press release issued on August 31st, 2005 by GlaxoSmithKline announced that the company is expanding its ability to increase vaccines supplies for Americans by acquiring a vaccine research and production facility in Marietta, Pennsylvania. This acquisition adds to the company's growing vaccines presence in the United States, following GSK's recent purchase of Corixa Corporation.

"GlaxoSmithKline can help boost the availability of vaccines for Americans in the future by growing our research and manufacturing capacity in Pennsylvania and the United States today," said Jean-Pierre Garnier, Chief Executive Officer of GlaxoSmithKline. "We are working hand-in-hand with government officials to help meet public health needs by expanding our capabilities as a reliable supplier of vaccines for the US."

Reliable as in: the Trivax vaccine?

Reliable as in: GSK's production facilities being shut down in 2005 by federal marshals — with millions of doses of two GSK drugs seized — because Glaxo repeatedly refused to comply with minimum manufacturing standards mandated by the Food and Drug Administration? (Here is the first in a series of warning letters sent to GlaxoSmithKline by the FDA regarding substandard manufacturing practices at its Cidra, Puerto Rico facility where Paxil is made.)