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GSK and vaccine trials

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GSK and vaccine trials

    Seven vaccine trials and two trials on infant milk formula were carried out on more than 600 babies                                                                     and children;SOPA

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Two months ago, we learned about 

children used as Guinea Pigs in Ireland.

In 1965, Hillary tested a measles vaccine called Glaxo Quintuple V CT21 on up to 25 infants at Bessborough and St Patrick’s. One child died of cardiac and respiratory failure two weeks after receiving the first injection. “The available medical records do not suggest this child’s death was in any way linked to the vaccine,” the report said.

The trial of another measles vaccine in 1969 was run by Victoria Coffey, a doctor who taught at Trinity College Dublin, and involved 250 children at St Patrick’s home, where she was the medical officer. She received a personal cheque for IR£230, about €5,000 in today’s money, from Glaxo “to assist with the purchase of laboratory equipment”. It was followed by a second cheque, also made payable to Coffey, for IR£250. To put the value of the payments into further context, a redbrick artisan house sold in Ringsend, Dublin 4 that year for IR£2,000.


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In November 1969, William Burland, a doctor at Glaxo’s head office in England, wrote to the company’s official in Ireland about plans for testing an experimental baby milk formula. The letter was marked “highly confidential”. “I am looking for establishments such as homes for illegitimate babies, etc where these investigations could be set up and where there are sufficient numbers to enable us to have two groups of babies, one fed with experimental milk, and one to act as controls,” it said. “Do you think it would be possible to set up a trial of this nature in Eire?”

Following a meeting between Burland and nuns at Bessborough, the trial went ahead in March 1968. The babies lined up for it had to be more than 7lb in weight. It was conducted simultaneously with trials of the same experimental milk in Malaya and Argentina.

In the Cork home, 14 children were recruited as subjects. Eithne Conlon, a GP to whom Glaxo offered a free airline flight in return for her participation, reported that the infants “experienced moderate to severe vomiting, moderate to severe wind, loose stools and green stools”. Severe vomiting, regurgitation and irritableness were noted in nine other children used for the trial at St Patrick’s. Glaxo’s L14 milk was discontinued “due to the severity of the side effects”.

 

 

Also that Doctors were paid thousands for mother and baby home trials.

Two doctors who blocked a state inquiry into vaccine trials they conducted on hundreds of children in mother and baby homes received personal cheques from the British pharmaceutical companies involved, last week’s report on the institutions shows.

Two other doctors who ran vaccine and baby-milk trials in homes in Dublin and Cork were offered money and a free flight for a holiday in England.

Patrick Meenan, a former president of the Medical Council of Ireland, and Irene Hillary, who led the National Virus Reference Laboratory in University College Dublin (UCD), made successful court challenges after being called as witnesses to the Laffoy Commission on child abuse in residential institutions. As a result, its investigation of vaccine trials for Glaxo Laboratories and the Wellcome Foundation between 1960 and 1973 was shut down by the High Court in 2004.

It has now emerged in the 3,000-page report of the commission of investigation into mother and baby homes, published last Tuesday, that Meenan and Hillary received combined payments of IR£3,950 in the early 1970s, the equivalent of about €60,000 in today’s money. This was in return for conducting trials of unapproved vaccines for measles, polio, diphtheria and whooping cough. Meenan and Hillary, who were both professors of microbiology, are now dead.

The 600 children from the homes who were used in seven vaccine and two infant milk trials were mostly unaccompanied, “illegitimate” by law, had congenital conditions, or were of mixed race. Many of their mothers had psychiatric disorders, mental illness, low IQ or were under the age of consent. One mother was just 15.

The commission found the trials were conducted illegally, without medical or import licences, and without seeking the consent of the children’s mothers.

The report says the trials contravened ethical standards of the time, including the Nuremberg code, the Helsinki declaration, and British Medical Research Council guidelines.

According to the report, Meenan, who was also the head of UCD’s faculty of medicine, “appealed” to Wellcome in 1972 for a grant to employ a laboratory technician and suggested that the company give him a non-renewable grant of IR£1,650 by way of a personal cheque, which he would then endorse and make payable to the university bursar.

“He also recommended that a ‘personal grant’ of £650 be put in place [for Hillary]”, the report states. At that time, she was about to commence a trial of Wellcome’s modified three-in-one vaccine. Both payments were made by personal cheques. Meenan received a second cheque the following year for a further IR£1,650, bringing his payments to IR£3,300.

Glaxo also promised a IR£250 grant to buy laboratory equipment in return for the co-operation of Victoria Coffey, who was the medical officer for St Patrick’s mother and baby home on Dublin’s Navan Road. She asked that the payment be sent to the Medical Research Council of Ireland but it was issued directly to Coffey and made payable in her name.

Coffey wrote to Glaxo saying earlier “complications” in sourcing children for a measles trial had been surmounted. Noting the company’s “offer for financial assistance in the follow-up trial”, she said she “could easily trial at least 250 children”. Eithne Conlon, a GP and deputy medical officer for the Bessborough mother and baby home in Cork, was offered a free air fare for a holiday in England “as reimbursement” when she agreed to test baby milk in the home. The report does not state if she accepted it.

The commission found no evidence that any child was harmed by the trials, but its report chronicles episodes of vomiting and “green diarrhoea” in some children after being vaccinated.

Both Wellcome and Glaxo were subsumed into the pharmaceutical multinational GlaxoSmithKline (GSK) in 2000. The company has refused to say whether it will contribute to any redress scheme for survivors of the institutions.

It said last week: “GSK understand that practices described in the report make for difficult reading and our thoughts are with the families involved. The report does not reflect how clinical studies are conducted today. In today’s clinical studies, participants or their parents/guardians must give their informed consent to participate after being told about the study, its potential benefits and its potential risks. Withdrawal from a clinical study remains the right of all participants.

“Given the lapse of time, GSK is unable to provide any further comment on the historic events outlined in the report and its conclusions.”

About 9,000 of the 57,000 babies born in the 18 homes investigated died. In the 1930s and 1940s, 40% of babies in the institutions died before their first birthdays.

Some 56,000 women were incarcerated, 5,616 of them under 18.

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Today, on the Sunday Times, we can read that

Children's minister urges GSK to compensate vaccine trial victims

Roderic O’Gorman, the minister for children, has asked GlaxoSmithKline (GSK), the pharmaceutical firm, to consider making “reparations” to the former residents of mother and baby homes where vaccine trials were conducted in the Sixties and Seventies.

Last week O’Gorman wrote to Dame Emma Walmsley, GSK’s chief executive in Britain, seeking “appropriate action” to meet the company’s moral and ethical responsibility, after further detail about the trials emerged in the final report of the commission of investigation into mother and baby homes in January.

The commission, chaired by Judge Yvonne Murphy, said seven vaccine trials and two trials on infant milk formula were carried out on more than 600 babies and children in the homes, between 1960 and 1973, on behalf of Glaxo Laboratories and the Wellcome Foundation. These companies later became part of the GSK group.

 

 



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