Category: Clinical Trial

The Irish Nuns, The Babies For Sale, And The Scandal Of The GSK (Wellcome Foundation) Vaccine Trials In Ireland…


“Dr Saunders, happy with the trials wrote “the results confirm the results obtained by Wellcome with guinea pigs”.

“According to a 1932 medical journal, Wellcome lab workers who prepared the vaccine for diphtheria had a “complete lack of experience of its use with human beings”

“The initial trials were carried out on 436 kids from the general child population in cork”

“Some of the original batches of the alum-toxoid vaccine, which comprised of 9 per cent aluminium, caused severe reaction like fatal abscesses and hard lumps at the injection site.”

“As over one third of children vaccinated didn’t return for subsequent treatments, the severity of many of the side-effects were not known.  “

(Sunday World 6th June 2014)

“A spokesman for GSK – formerly Wellcome – said: ‘The activities that have been described to us date back over 70 years and, if true, are clearly very distressing.”

…The trial was published in the ‘British Medical Journal’ in 1962. The final paragraph of it read:

“We are indebted to the medical officers in charge of the children’s homes. . . for permission to carry out this investigation on infants under their care.”


“The trials involved incredibly poor judgment on the part of all involved. We were basically used as human guinea pigs,” Ms Steed told the Irish Independent.”

“It was time the truth came out about the drugs trials.”

“The call came after it emerged a woman adopted from Ireland in 1961, who was involved in a vaccine trial as a baby without the permission of her mother, is to take legal action against the drugs company involved.”

“Mari Steed (50), who lives in the US, is to take action along with three others against GlaxoSmithKline, which as “The Wellcome Foundation” at the time the trials were conducted.”

(Irish Times 2010

and Belfast Telegraph)

nuns

A few years ago, I drew attention to GSK’s vaccine trials on Irish orphans in the 60’s and 70’s and I thought that the story had disappeared. However with the current spate of scandals in Ireland regarding buried orphaned babies and mass graves (under the care of corrupt nuns) hitting the headlines- it seems that it has been revived. Above is tomorrow’s headline from the Irish Daily Mail. The next story is a link to the current scandal, and underneath are previous links from similar news headlines in previous years, and also the original article I wrote on this blog. I am sure more will come out about this travesty in the coming days, weeks and months ahead.


http://www.broadsheet.ie/2014/06/05/the-septic-tank-was-in-this-location/

‘The Septic Tank Was In This Location’

 at 5:12 pm June 5, 2014

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[Historian Catherine Corless (pic 4) and Tuam author JP Rodgers (above) who was a resident at the Bon Secours mother-and-baby home until he was fostered at the age of six]

Tuam Co Galway this afternoon.

Laura writes:

“The grounds where the unmarked mass grave apparently containing the remains of nearly 800 infants who died at the Bon Secours mother-and-baby home in Tuam Co Galway from 1925-1961 rests.

The site is now part of the Dublin Road housing estate and records show that the former mother and baby home’s septic tank was in this location. The names of the children buried here have been confirmed by  Catherine’s’ research and she hopes to raise funds to erect a plaque as a memorial to them. JP has written two books on the subject detailing his mother’s life and his own.”

Earlier: What About Dublin

(Laura Hutton/Photocall Ireland)


 

https://truthman30.wordpress.com/2013/03/23/remembering-glaxos-controversial-vaccine-trials-on-irish-orphans/

A Scandal Emerging: Glaxo’s Irish Vaccine Trials

Bob Fiddaman over at the ‘Seroxat Sufferers’ blog is hot on the pulse today with his post about GSK’s vaccine trials in Ireland. Although this blog is primarily about the Seroxat Scandal, it seems that the controversial vaccine trials on Irish orphans could become yet another big scandal for GSK. The reason why I’m bringing attention to this is not because it is more bad news for GSK but because I believe that those who were prescribed Seroxat were guinea pigs too. Seroxat was inadequately tested before GSK obtained a license for it. Those who were prescribed Seroxat over the past 20 years were the public clinical trial.

This from the Irish Times:

http://www.irishtimes.com/newspaper/ireland/2010/0821/1224277318309.html

Call for inquiry into vaccine trials in institutions

FIONA GARTLAND

AN INDEPENDENT inquiry should be set up to examine vaccine trials carried out on babies and children in orphanages and mother-and-baby homes in the 1960s and 1970s, a former resident has said.

Victor Boyhan, former chairman of Past Residents of Smyly Homes and Cottage Homes, said that after almost 20 years of seeking answers from the State, it was time the truth came out about the drugs trials.

The call came after it emerged a woman adopted from Ireland in 1961, who was involved in a vaccine trial as a baby without the permission of her mother, is to take legal action against the drugs company involved.

Mari Steed (50), who lives in the US, is to take action along with three others against GlaxoSmithKline, which as “The Wellcome Foundation” at the time the trials were conducted.

Ms Steed was administered the experimental vaccine while at the Sacred Heart Convent, Bessborough, Co Cork, between December 1960 and October 1961 when aged between nine and 18 months old. She also hopes to bring legal action against the Sacred Heart order in the Irish courts.

In the 1960s, clinical trials compared a 3-in-1 vaccine for Diphtheria, Tetanus and Pertussis and separate polio immunisation to a 4-in-1 vaccine for the illnesses. The studies in the 1970s looked at two different types of 3-in-1 vaccines.

The trials took place in institutions including the Bessboro home, St Patrick’s Home, Navan Road, Dublin, Cottage Home for Little Children, Dun Laoghaire and the Bird’s Nest Home, Dun Laoghaire.

In 1993, then minister for health Labour Party deputy Brendan Howlin, through his private secretary, wrote to a past resident of one of the homes about the trials. He said his department had inquired into them and he was satisfied there was “no added risk whatsoever” to the children who received the vaccines.

A report published by the Department of Health in 2000, showed that at least 211 children in homes and orphanages were given test vaccines during three separate drug trials in 1960/1961, 1970 and in 1973.

The Laffoy commission on Child Abuse was then asked by the Government to investigate those trials and any others carried out in institutions between January 1940 and December 1987. But the commission’s investigation was dropped following court action taken by the medical practitioners involved.

There has been no further progress in establishing the details of the trials or if the drugs had any long-term effects on the individuals involved.

Mr Boyhan, who is also a councillor in Dún Laoghaire Rathdown County Council, called for an independent inquiry to be set up to establish the facts. He said a lot of information had been received by the Laffoy Commission before its investigation was closed down and the records of many of the institutions involved were still “surprisingly intact”.

“Bodily integrity is a fundamental right of every citizen, it is not unreasonable to want to know what happened,” he said.

And from the Belfast Telegraph :

http://www.belfasttelegraph.co.uk/news/local-national/republic-of-ireland/irelands-hidden-scandal-child-vaccine-trials-14918544.htm

Ireland’s hidden scandal: child vaccine trials

By Patricia McDonagh
Friday, 20 August 2010

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Suspicions that vaccine trials had taken place on vulnerable Irish children — many of whom were in state care — first surfaced in the early 1990s.

As the current decade dawned, former residents of children’s homes began to publicly raise concerns that they had been the subject of experimental trials.

However, it was not until 1997 that the State gave an assurance that it would formally inquire into the issue.

Brian Cowen, who was then Health Minister, directed the chief medical officer at the Department of Health, Dr James Kiely, to investigate the allegations.

In 2000, a report — entitled the “Report On Three Clinical Trials Involving Babies And Children In Institutional Settings, 1960/61, 1970 and 1973″ — was finally drawn up.

The document found that 211 children had been administered vaccines during three separate vaccine trials conducted on behalf of a drugs company, The Wellcome Foundation.

More than 123 of these infants and toddlers were residents in children’s homes in Dublin, Cork and the midlands when the trials took place in the 1960s and 1970s.

Trial one involved 58 children in five children’s homes in Dublin, Cork, Westmeath and Meath. The trial investigated what would happen if four vaccines — diphtheria, pertussis (also known as whooping cough), tetanus and polio — were combined in one overall four-in-one shot.

The trial was published in the ‘British Medical Journal’ in 1962. The final paragraph of it read: “We are indebted to the medical officers in charge of the children’s homes. . . for permission to carry out this investigation on infants under their care.”

Trial two, which was conducted during the summer of 1970, saw 35 children administered with the intra-nasal rubella vaccine.

It involved children from St Anne’s Industrial School in Booterstown, Co Dublin, and children living in the Killucan area of Westmeath.

Published in the ‘Cambridge Journal of Hygiene’ in 1971, the trial attempted to find out if German measles vaccine, administered intranasally, could spread to susceptible contacts.

Both trials were carried out by Professor Irene Hillery and Professor Patrick Meenan, from the department of Medical Microbiology in University College Dublin, and other doctors.

The final trial involved 53 children from institutional homes. The homes were: St Patrick’s Home, Madonna House, Cottage Home, Bird’s Nest and Boheennaburna. A further 65 children living at home in Dublin also took part.

The purpose of the trial was to compare commercially available batches of the three-in-one vaccine, Trivax and Trivax AD, with that of a modified vaccine prepared for the trial.

Dr Kiely’s report said the decision to conduct such clinical trials was acceptable, given the diseases that the vaccines sought to counter.

But, crucially, he insisted the lack of documentation available meant it had not been possible to confirm if consent had been given by the parents or guardians of the children involved or what arrangements were arrived at with managers of the homes.

He added that this lack of information also meant he could not confirm if the Therapeutic Substances Act 1932 had been complied with in relation to the licensing of the trials.

The damning document was laid before the Houses of the Oireachtas on November 7, 2000.

On November 9, the then Health Minister Micheal Martin told the Dail an important part of the probe was to establish if the State had fulfilled its obligations to children in its care.

But he admitted that the report was incomplete.

“It raises as many questions as it answers. Some of those questions go to the heart of our attitudes to children and their rights,” he said at the time

“The report is incomplete because in some areas, the most rigorous interrogation of the system failed to produce documentary records of the trials.”

Mr Martin said the Government had no evidence that any child had contracted a serious illness as a result of the trials.

But he branded the lack of documentation “puzzling” and insisted that the report had to be the “beginning and not the end” of the matter.

The minister referred the report of the investigation to the Commission to Inquire into Child Abuse — known then as the Laffoy Commission.

A government order was subsequently made on June 19, 2001 to provide the commission with the powers to create a separate module to formally investigate the issues involved.

The ‘Vaccines Module’ initially convened a public sitting on January 23, 2002, to outline its terms of reference. It then began investigating the trials.

It obtained documents from GlaxoSmithKline, the successor of Wellcome, which allowed it to definitively identify the homes and people involved in the trials.

Investigators received so much information relating to trial one that they were able to identify the children given the ‘four-in-one’ vaccine.

It also conducted private interviews with witnesses to get a more accurate picture.

But just before the start of public hearings into the first trials, which were due to begin on June 17, 2003, the work of the commission was dealt a severe blow when the Supreme Court ruled that Prof Meenan did not have to give evidence.

Prof Meenan had appealed a High Court order requiring him to comply with the commission’s direction to give evidence about his involvement in the trial.

The inquiry received a further setback when the Government’s order directing the Laffoy Commission probe was held to be invalid by the High Court in November 2003.

Mr Justice Aindrias O Caoimh gave his decision in a challenge brought by Prof Hillery. However, he ruled that other machinery could exist for an appropriate inquiry.

On November 25, 2003, an undertaking was given to the High Court by the commission that it would not conduct any hearings in relation to matters within the ambit of the order.

It had been hoped that the Government would appeal this decision. But on November 2006, Health Minister Mary Harney ordered the vaccine module to be closed down.

Now, some of the victims have been left with no alternative but to seek redress in a US court after Ms Harney again firmly ruled out any further inquiries into existing or new allegations.

The victims’ basic requests appear to be far from unreasonable; an apology for what was done to them; full medical screening to see if they have suffered any damaging long-term effects from the trials; and psychiatric counselling to help them get over their ordeal.

But even this, it appears, is beyond the capacity or willingness of the State to deliver.

Read more: http://www.belfasttelegraph.co.uk/news/local-national/republic-of-ireland/irelands-hidden-scandal-child-vaccine-trials-14918544.html#ixzz0xLdiCaXt

https://truthman30.wordpress.com/2010/08/22/a-scandal-emerging-glaxos-irish-vaccine-trials/

http://www.belfasttelegraph.co.uk/news/local-national/republic-of-ireland/i-was-used-as-a-guinea-pig-in-child-vaccine-scandal-28553906.html

‘I was used as a guinea pig in child vaccine scandal’

A woman subjected to a controversial vaccine trial as a baby without her mother’s consent broke her silence last night to reveal her traumatic decades-long fight for justice.

http://www.belfasttelegraph.co.uk/news/local-national/republic-of-ireland/i-was-used-as-a-guinea-pig-in-child-vaccine-scandal-28553906.html

Mari Steed (50) was effectively used as a guinea pig during the ‘four-in-one’ vaccine trials carried out on her between December 1960 and October 1961 when she was between nine and 18 months old.

She was given up for adoption to a couple in the US shortly afterwards and is now preparing a class action in the US courts against the multinational drugs giant responsible for the medical tests, an Irish Independent investigation reveals.

Ms Steed and three others who were also subjected to the trials are looking to separately sue the Catholic religious order that they claim facilitated the experiments in the early 1960s.

She was administered the vaccine on at least four occasions at the Sacred Heart Convent, Bessborough, in Cork, also known as the Bessborough Mother and Baby Home.

Ms Steed became aware she had been subjected to the vaccine trials after she retrieved her medical documents while trying to track down her mother, Josephine, in the late 1990s.

Josephine, who is now in a nursing home in the UK, last night said the tests were carried out on her baby daughter without her consent or knowledge of her medical history.

“They didn’t ask me for my permission to give her that shot,” she said.

Ms Steed, who now lives in Philadelphia, and a number of other victims in the US are taking the landmark case because repeated attempts to seek justice in the Republic of Ireland have failed.

She and the three others are planning to file a class action against the GlaxoSmithKline drug company in the US courts. GlaxoSmithKline was called ‘The Wellcome Foundation’ when the trials were conducted.

They are also hoping to separately take a case against the Sacred Heart Order — either individually or as a group — in the Irish courts.

Victims have queried if the religious order received any financial payment in return for the children being used in the trials. However, it has never been established if any payment was received.

“The trials involved incredibly poor judgment on the part of all involved. We were basically used as human guinea pigs,” Ms Steed told the Irish Independent.

“There are at least four of us who are aware we were part of the trials, but there are probably more out there who don’t know what happened to them.”

At least 211 children were given the test vaccines during three separate drug trials, says a report commissioned by then-Health Minister Brian Cowen and drawn up by the Republic’s Department of Health in 2000.

Ms Steed was involved in the first trial, which took place between December 1960 and November 1961 on 58 children in five children’s homes. These included St Patrick’s Mother and Baby Home, Dublin; the Bessborough Mother and Baby home in Cork; and St Peter’s Mother and Baby Home, Castlepollard, Co Westmeath. Children from St Clare’s Baby Home in Stamullen, Co Meath, and the Good Shepherd Mother and Baby Home in Dunboyne, Co Meath, also participated.The trial examined what would happen if four vaccines for diphtheria (a life-threatening disorder caused by a highly contagious bacterial infection), pertussis (whooping cough), tetanus and polio were combined in one overall jab, known as the four-in-one shot.

However, the four-in-one jab never went into production after it failed to improve the previous standard vaccine.
Ms Steed’s mother, Josephine, who was forced to give her daughter up for adoption to a US couple just months after the trials took place, insisted she never gave her consent for Mari to be used in the trial.

She added: “What happened to mothers, like myself, and the babies at that home was cruel. I am still angry and would like an apology for what happened.”

However, the report concluded that it had not been possible to find documentation to confirm whether or not trials were licensed or received consent.

After its publication, the report was referred to the investigation of the Commission to Inquire into Child Abuse, then known as the Laffoy Commission. But court challenges from doctors involved in the trials prompted Health Minister Mary Harney to shut down the module without conclusion.

Ms Steed and other victims called on Ms Harney to publicly apologise on behalf of the State for what happened.

However, Ms Harney last night insisted there would be no further inquiries into the allegations already made. The minister also declined to say if she would apologise to the victims, or if the Government would provide life-screening or counselling.Susan Lohan of the Adoption Rights Alliance said Ms Steed and other victims had been treated like “second-class” citizens.

A spokesman for the Sacred Heart Order said they would not make any comment until the case was taken. He said he was not aware of any other live actions against the order and insisted the issue surrounding the trials had been dealt with. A GlaxoSmithKline spokeswoman also refused to comment.


http://banishedbabies-ireland.blogspot.ie/2010/11/human-guinea-pig-vaccine-trials-on.html

Banished Babies:The Secret History of Ireland’s Baby Export Business

Since this story broke in 1996, the Irish media have been chasing down details of the “export” –primarily to the U.S.–of 2,000-plus infants and toddlers born to unmarried Irish mothers between the late ’40s and the mid-’70s. Reporter Milotte did a TV documentary on the subject; his book incorporates new archival material released by the Irish government and the Catholic Church, as well as three involving case studies of efforts by adoptees or the mothers who reluctantly gave them up to get back together.
At mid-century, both church and state in Ireland stressed shame, secrecy, and the religion of adoptive parents over all other considerations; only in the mid-’50s did Eire require confirmation that proposed parents could provide a healthy (as well as a Catholic) home for Irish kids, and several money-based schemes slipped through the Republic’s lax rules. An enlightening international sidebar to studies of the consequences of open versus closed adoption.

Human Guinea Pig: Vaccine trials on children under the care of nuns

http://banishedbabies-ireland.blogspot.ie/2010/11/human-guinea-pig-vaccine-trials-on.html

TUESDAY, NOVEMBER 16, 2010

 

Mari Steed doesn’t get angry very easily. Her presence has a very calming influence, but when you bring her back 50 years to a harrowing time in a mother-daughter home in Co. Cork she tenses up.

Steed, 50, spoke to the Irish Voice from her home in Levittown, Pennsylvania about intrusive, illegal medical trials that were conducted on her young body as a baby.

Steed says she was used as a human guinea pig for a large medical firm to test and improve vaccines for tetanus, diphtheria and whooping cough.

Steed presented her medical files to the Irish Voice as proof. They reveal she received her first injection on December 9, 1960 and another on January 6, 1961. Despite being ill after the third injection on January 7, 1961, she was given her fourth and final shot on February 10, 1961, and a booster shot of polio on October 3, 1961.

Steed was born Mary Fitzgerald to a young Co. Wexford woman by the name of Josephine Fitzgerald in 1960. Because Josephine became pregnant with her daughter out of wedlock she was sent to a mother-daughter orphanage style home to have the baby.

Josephine, now in her sixties and also born out of wedlock, was familiar with such homes. She grew up in them and quickly realized she didn’t want her daughter to have the same sort of upbringing. Instead she nursed, played with and loved young Mary until she was 18-months-old.

Josephine then painstakingly handed over her daughter to an Irish American couple in Pennsylvania who promised to take good care of her.

Steed, now director of technology and new media at the World Affairs Council of Philadelphia, has no memories of her time in Bessborough Mother and Baby Home in Cork, but she does have the doll her mother made for her and other memorabilia she brought with her on the plane journey from Ireland.

Forty years later, during a search for her birth mother, Steed horrifyingly discovered she was used as a guinea pig on a drug trial.

A young Steed was one of 211 children in the care of the Catholic Church that the Wellcome Foundation (now GlaxoSmithKline) frequented to test a four-in-one drug in the sixties and seventies in Ireland.In Steed’s case it was between December 1960 and October 1961, when she was between nine and 18-months-old.

The Commission to Inquire into Child Abuse, also known as the Laffoy Commission in Ireland, investigated the drug testing in 2001, but a court order by two doctors involved in the trials put a halt to the probe by 2003.

Steed and her birth mother Josephine both presented evidence to the Laffoy Commission before it was disbanded.

However, Steed is hopeful that the case will be reopened in Ireland as calls for the government to deal with the scandal intensifies.

“We were very upset that the investigation was called to a halt. So many mothers and children came forward but nothing more could be done,” said Steed bitterly.

Although putting it on the back burner, Steed said the injustice she suffered as a baby was always in the back of her mind.

She recently teamed up with three other victims living in the U.S. who were also adopted from Ireland to take legal action against GlaxoSmithKline and the Sacred Heart Order, which allowed the tests at the Bessborough Mother and Baby Home and other homes throughout Ireland.

“I feel it’s the right thing to do,” she said.

Steed, a mother of three, isn’t interested in financial gain. She seeks the truth behind her ordeal. Why, she wonders, were such experiments allowed to be carried out, and who gave the permission?

“A formal apology for one would be nice, and everyone used during these trials should be given some sort of medical follow-up to make sure there are no side effects,” said Steed, admitting that as far as she knows her health is good.Her birth mother Josephine told the Laffoy Commission her permission was never sought or given, from either the multinational drug company responsible for the vaccine trials or the Sacred Heart order.

“My mother never gave permission to anyone to test these drugs on me, so why did they do it?” she asks emotionally.

Steed’s own story is remarkable. Seemingly following in her mother’s footsteps Steed, after falling pregnant as a teenager, gave up her eldest daughter, Kerry, for adoption at the request of her adoptive mother.

Steed too was sent to a mother and baby home in Philadelphia and cut off from her family at the time.

“It was when Kerry was born in 1978 that I began getting curious about my own mother. After all, I was walking in her same shoes,” said Steed, who is now back in Kerry’s life.

Her curiosity sparked a journey that turned out to be a blessing. While working at a college in Florida, Steed was introduced to the powers of the Internet and its search engines.

“The very first word I typed into the search engine was adoption. From there I found a few U.S.-based support groups, but no one had any idea how I would go about finding out information from Ireland,” Steed said.

Determined to stay focused, Steed proceeded with her quest and was finally introduced to a heritage researcher in Dublin who pointed her in the right direction.

“This guy was amazing. He was able to fax me my actual birth certificate within 24 hours,” said Steed, adding how emotional it was to see it.

From there Steed become involved with the Adopted People’s Association in Dublin (now Adoption Ireland), which lead her on a journey of self-discovery.

Finally through an Irish contact living in England, Steed was able to locate her mother through her marriage certificate to Swindon in England.

Within a matter of days Steed was reunited, via telephone, with her birth mother after 41 years.

Steed recalls the phone conversation so well.

“It was right after 9/11 and I was due to go up to New York that morning when the phone rang. It was Judy, my friend in England, who called to say she had found my mother,” recalls Steed.

“I was a wreck. I didn’t know what to think or do. Finally I called my mother and it was the oddest thing,” she said with a broad smile on her face.

“The minute I heard her voice the nerves melted away. It was like we just spoke last week and we hadn’t in 41 years.

“I told her I still had the doll she made for me. She couldn’t believe it. It was extremely emotional as you would expect.”

A year later Steed went to visit her mother in England, and since then they have maintained a great relationship.

“I couldn’t believe how alike we were both in personality and physically. It really was unbelievable,” she said.

“We talk at least once a week now,” she said.

Josephine has promised to help Steed right the wrong that was done to her as a child in Cork.


 

 http://www.irishexaminer.com/ireland/education/400-babies-were-dissected-at-universities-169948.html


400 babies were dissected at universities

HUNDREDS of dead babies from mother-and-baby homes across the country were dissected in Irish universities — without the knowledge or permission of their mothers.

An RTÉ Prime Time investigation into the vaccine trials carried out in the homes, where unmarried women were sent to have their children, revealed that more than 400 babies were dissected by medical students around the country. The practice continued into the 1960s.

The Adoption Rights Alliance last night called for a state inquiry into how these dissections were sanctioned and into the vaccine trials that were regularly held on infants born in these homes.

“There are many more questions that need to be answered about this time and we are once again asking the Government to open up all adoption records to adopted people,” said spokeswoman Claire McGettrick.

Up to 400 dead babies from St Patrick’s Mother and Baby Home on the Navan Road and the nearby St Kevin’s Hospital were sent for dissection.

In 1942 alone, 57 babies were sent to UCD, 34 to the Royal College of Surgeons and 27 to Trinity College Dublin. Between 1940 and 1965, 35 were sent to UCG.

Mari Steed was born at Bessborough Mother and Baby Home in Cork, but sent to the US to be adopted as a toddler. She has campaigned endlessly for adopted people to be given information on the vaccine trials they were subjected to.

“These latest revelations serve to further hit home how little we were though of. We were little more than a number. We weren’t worthy of a name or a decent burial plot,” she said.

It has previously been revealed how hundreds of children born into these homes were subjected to vaccine trials by established international medical companies. The trials in Ireland were headed up by some of the country’s most eminent medical professionals.

The victims have spent years trying to access data on these trials but the religious orders will not release the files.

The Anatomical Committee of Irish Medical Schools issued a statement last night saying that “today such practices would be unacceptable”.

A joint statement from the Departments of Health and Children said they “deeply regretted” these “outdated practices”.

Earlier this month, the Irish Examiner revealed how adoption files held by the Sacred Heart Convent at Bessborough have yet to be transferred to the HSE — two months after the initial deadline for the transfer.

The files include those involving controversial vaccine trials carried out on children at the then mother-and-baby home.


 Watch RTE PrimeTime’s Documentary (Below) On The Hundreds (And Perhaps Thousands) Of Dead Babies Buried, Experimented On,  And Incinerated In Ireland… 

 

http://www.rte.ie/player/ie/show/10290343/

 

 

140605-ireland-infant-grave_1_3d6b5b7384a047db52f35a7a07427dff

http://www.dailymail.co.uk/news/article-2650475/More-mass-baby-graves-Ireland-Prime-Minister-Enda-Kenny-orders-investigation-memorial-800-dead-babies-planned.html 

Thousands of children in Irish care homes at centre of ‘baby graves scandal’ were used in secret vaccine trials in the 1930s

  • Scientists secretly gave 2,051 children and babies diphtheria vaccine
  • They were used as guinea pigs for drugs giant Burroughs Wellcome in 1930s
  • Academic Michael Dwyer uncovered shock truth in old medical records
  • He found no evidence of consent, nor of how many died or were affected
  • Comes as Irish PM intervenes from U.S. over scandal of mass baby grave
  • Hundreds of babies are believed to have been buried at former baby home
  • Enda Kenny says he’s ordered his officials to examine ‘if there are others’

By HARRIET ARKELL and NEIL MICHAEL

Old medical records show that 2,051 children and babies in Irish care homes were given a one-shot diphtheria vaccine for international drugs giant Burroughs Wellcome between 1930 and 1936.

There is no evidence that consent was ever sought, nor any records of how many may have died or suffered debilitating side-effects as a result.

The scandal was revealed as Irish premier, Enda Kenny, ordered ministers to see whether there are more mass baby graves after the discovery that 800 infants may be buried in a septic tank outside a former mother and baby home in Tuam, Co. Galway.

Children at Sean Ross Abbey in Tipperary are thought to have been used in secret drug trials in the 1930s

Children at Sean Ross Abbey in Tipperary are thought to have been used in secret drug trials in the 1930s

Children's homes are under the spotlight since it emerged that 796 babies may be buried at the former mother and baby home at Tuam, Co. Galway - Enda Kenny has ordered officials to see if other mass graves exist

Children’s homes are under the spotlight since it emerged that 796 babies may be buried at the former mother and baby home at Tuam, Co. Galway – Enda Kenny has ordered officials to see if other mass graves exist

The Irish premier has ordered his officials to examine the possibility that there may be other mass graves, too

The Irish premier has ordered his officials to examine the possibility that there may be other mass graves, too

The Taioseach intervened from the United States yesterday to say that he had ordered his officials to ‘see what the scale is, what’s involved here, and whether this is isolated or if there are others around the country that need to be looked at.’

Michael Dwyer, of Cork University’s School of History, found the child vaccination data by trawling through tens of thousands of medical journal articles and archive files.

He discovered that the trials were carried out before the vaccine was made available for commercial use in the UK.

Homes where children were secretly tested included Bessborough, in Co. Cork and Sean Ross Abbey in Roscrea, Co. Tipperary, both of which are at the centre of the mass baby graves scandal.

Other institutions where children may also have been vaccinated include Cork orphanages St Joseph’s Industrial School for Boys, run by the Presentation Brothers, and St Finbarr’s Industrial School for Girls, run by the Sisters of the Good Shepherd.

In Dublin, it is believed that children for the trials came from St Vincent’s Industrial School, Goldenbridge, St Joseph’s School for Deaf Boys, Cabra, and St Saviours’s Dominican Orphanage.

But Mr Dwyer said: ‘What I have found is just the tip of a very large and submerged iceberg.

‘The fact that no record of these trials can be found in the files relating to the Department of Local Government and Public Health, the Municipal Health Reports relating to Cork and Dublin, or the Wellcome Archives in London, suggests that vaccine trials would not have been acceptable to government, municipal authorities, or the general public.

‘However, the fact that reports of these trials were published in the most prestigious medical journals suggests that this type of human experimentation was largely accepted by medical practitioners and facilitated by authorities in charge of children’s residential institutions.’

Horror: The scandal of the babies in the mass grave was discovered by local historian, Catherine Corless

Horror: The scandal of the babies in the mass grave was discovered by local historian, Catherine Corless

Innocence: Academic Michael Dwyer found out about the secret drugs trials by going through old medical records - children from the Sean Ross Abbey home in Tipperary, pictured, are thought to have been involved

Innocence: Academic Michael Dwyer found out about the secret drugs trials by going through old medical records – children from the Sean Ross Abbey home in Tipperary, pictured, are thought to have been involved

 

A spokesman for GSK – formerly Wellcome – said: ‘The activities that have been described to us date back over 70 years and, if true, are clearly very distressing.

‘We would need further details to investigate what actually took place, but the practices outlined certainly don’t reflect how modern clinical trials are carried out. We conduct our trials to the same high scientific and ethical standards, no matter where in the world they are run.’

A spokeswoman for the Sisters of Sacred Hearts of Jesus and Mary, the order that ran Bessborough and Sean Ross Abbey, said that like GSK, they would also welcome an independent inquiry.

Fianna Fáil leader Micheál Martin called on the Irish government to add vaccine trials into the investigative remit of any inquiry into the mother and baby homes.

He said: ‘We need to start with an independent investigation into the mother and baby homes which would be followed by a wider separate investigation into the vaccine testing.’

Historian Catherine Corless, whose discovery of the suspected mass baby grave at Tuam was revealed by the Mail earlier this week, said her study of death records for the St Mary’s home run by Catholic Bon Secours nuns from 1925-1961 pointed to the existence of the mass grave.

Children's homes in Ireland were often the only place where a woman pregnant out of wedlock could go

Children’s homes in Ireland were often the only place where a woman pregnant out of wedlock could go

Children were looked after by nuns and often adopted abroad - now it seems they were used in drugs trials, too

Children were looked after by nuns and often adopted abroad – now it seems they were used in drugs trials, too

The Irish PM interrupted a trade visit to San Francisco to order an inquiry in the Tuam home and others, saying that Dublin must decide what is the ‘best thing to do in the interest of dealing with yet another element of our country’s past.’

St Mary’s was one of several such ‘mother and baby’ homes for ‘fallen women’ who had become pregnant outside marriage in early 20th century Ireland.

Another such institution was the Sean Ross Abbey in Tipperary, was where Philomena Lee gave up her son for adoption in the 1950s. Her story was made into the Oscar-nominated film ‘Philomena’ last year.

The ‘mother and baby’ homes accommodated women who were ostracised from their own families and had nowhere else to turn.

Under conservative Catholic teaching of the time, children born outside of marriage were not baptised and were therefore denied a Catholic burial on consecrated ground.

Read more: http://www.dailymail.co.uk/news/article-2650475/More-mass-baby-graves-Ireland-Prime-Minister-Enda-Kenny-orders-investigation-memorial-800-dead-babies-planned.html#ixzz33sfN7Ltx 
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Participant In Original GSK Seroxat (Paxil) Trial Speaks Out


From David Healy’s Blog: 

http://davidhealy.org/lives-touched-by-gsk/

Lives Touched by GSK

November 25, 2013 3 Comments

Anonymous

Notes of a Paxil Guinea Pig

What does GSK owe to the youngsters in its infamous Study 329 who became suicidal while taking the company’s paroxetine (Paxil/Seroxat)?

As someone who was briefly a GSK Guinea Pig, I’d say the most important thing they’re owed is the truth. It’s a highly delinquent debt – but it’s not too late for GSK to pay up.

I took part in a study of Paxil back in 1994. Like many U.S. subjects, I signed up mainly for the free medical care: I was tired of battling my employer’s HMO which doled out mental health treatment with an eyedropper. However, having already taken Prozac with little or no effect, I was also as curious as anyone to find out if these drugs “worked” or not, according to Big Science. I was willing to be a guinea pig if it would lead to some answers.

The protocol was that everyone was put on Paxil for a number of weeks, after which half of us would be switched cold-turkey to placebos, the other half would continue on Paxil.

Supposedly, this would determine whether people with “recurrent depression” should stay on long-term Paxil maintenance therapy. Looking back, however, what the study really did was to produce drug-withdrawal distress, then interpret that as the original depression coming back.

And most likely, by 1994, GSK knew that.

Treatment Related Injury?

After the switch to either placebo or Paxil I fell asleep at the wheel of my car and had an auto accident with minor injuries. I didn’t want to drop out – I was pretty sure the cause of my accident wasn’t Paxil, but working a sixteen-hour shift. But I was told the study protocol demanded my removal. Not knowing the research design, I never found out whether they were being conscientious, or just the opposite – dropping my results to cover up problems.

The Paxil hadn’t helped me much. But after the switch, I quickly felt the ground under my feet get rockier, at least for awhile.

Well, I thought, it didn’t feel like the Paxil was doing me any good – but here I was feeling worse without it. It didn’t occur to me that this could be down to Paxil withdrawal, because I had never heard of it.

Once the blind was broken, the researchers confirmed I had indeed been switched to placebo.

I never found out if my study was published. When I finally saw a psychiatrist, his reaction was that this had been a “pretty stupid study,” because “everyone already knew” that people like me who’d had several depressive spells should be on medication for life. That makes me think there were already multiple published studies of this type – and possibly dozens more that the drug companies never bothered to publish.

GSK & Responsibility

I’m angry with GSK, not only for putting me through Paxil withdrawal, which, thank god, was not severe in my case, but also for what they later did to me and other patients by hiding the results. They and the other drug manufacturers led millions of us to believe we needed these drugs for life, “just like diabetics need insulin.”

At a minimum this deprived millions of people of a normal sex life, and may have numbed their ability to respond to life in other ways. Untold numbers of children have been exposed in utero. And I and millions of others became part of a twenty-year uncontrolled experiment on the long-term use of these drugs to control a “deficiency” that we may never have had.

Study 329

For the kids in Study 329 who became suicidal on Paxil, GSK’s deception may have done much worse. To this day, I’d bet some of them don’t know the role of the drug in their suicide attempt. Being “the kid who tried to hang himself at fourteen” affected how they saw themselves, to say nothing of how their families, schools and juvenile courts may have seen them. It’s long overdue – but not too late – to tell them that “what you did was not necessarily your own doing.”

Knowing the facts about the limited effectiveness of these drugs could also open doors for those who have not responded to them. For two decades we’ve been told we were a small minority whose condition, being Treatment Resistant, must be very grave indeed. That verdict led many to accept punishing multidrug treatments, ECT, or simply becoming resigned to a life of disability.

Like the kids in Study 329, we deserve the opportunity to rewrite the life story handed to us by well-meaning professionals acting under the influence of GSK.

GSK owes…

It’s not too late to learn something useful from the changes GSK put us all through. It might help us learn more about SSRI withdrawal and SSRI-induced agitation, including who suffers what effects and why. I have no idea what consent forms I signed 20 years ago, but I sure as hell never intended to give GSK the right to hide the results of the experiment they ran on me.

GSK owes me the truth. It owes at least as much to many others, like the kids in Study 329, who suffered far more than I did. To say nothing of the patients who never took part in research, but whose lives were altered by it nonetheless. It would have been infinitely better if they had owned up twenty years ago. But that’s no reason to write off the debt now.

– See more at: http://davidhealy.org/lives-touched-by-gsk/#comments

Peter Gøtzsche (Cochrane Foundation) Discusses The Organized Crime of Big Pharma


Essential viewing…

Peter Gøtzsche says that psychiatric drugs are the worst killers of patients world-wide.

“what I have seen in psychiatry is the worst I have seen anywhere”…

Greetings Ben Goldacre


Three days ago I wrote a blog post titled: “Would The Real Ben Goldacre Please Stand Up?”. The gist of the blog post was a general illustration of how people (particularly doctors, psychiatrists and academics) can be seduced and manipulated by the pharmaceutical industry. I used Ben Goldacre as an example because quite frankly- his stance on the pharmaceutical industry confused me. On the one hand- he writes about drug company corruption and advocates for better access to clinical trail data- but on the other- he accepts awards from GSK (one that I am aware of anyhow) and gushes undue praise on the management of the company (GSK ) that he criticizes in his books.

I find this  attitude baffling. I really do.

   I understand that there are obvious overlaps within the pharmaceutical world between the industry, regulation, academia, universities, marketing and science etc. It is common for scientists and academics to receive bursaries and funding for research (particularly early on in their careers) and this doesn’t always mean that a conflict of interest, a bias, or corruption comes along with that -but what really frustrates me is how the industry (and those attached to it) doesn’t seem to see anything wrong with this generally. It’s as if there is an attitude of- “it’s so rampant and ingrained” that they wonder why anyone would question it? The attitude seems to be- “everyone has either done it- is doing it- or will do it” so what’s the problem?

   And herein lies exactly the problem…

Because it is so widespread: this forms the crux of the problem! Industry has too much power and influence. That’s the problem!

   Companies like GSK have their monetary tentacles in literally every facet of UK society. Globally they are powerful too- but it is on their home-turf where they are virtually untouchable. They basically operate above the law.

   Why is this?

It’s simply because they are the UK’s biggest drug company (and second biggest globally)- they are massively important for the UK economy- not just in terms of jobs in research, development, factories etc- but also in terms of what they donate to, support, and sponsor in regards to universities, science, scholarship etc. They are massively influential. Too influential.

Often it is difficult to entangle who is indirectly being funded by pharmaceutical companies because they can sometimes donate to organizations  (patient groups, astro-turfing) who then funnel funding through to different people and on to individuals. And then we have the problem of who owns stocks and shares in companies like GSK? How does that influence policy? How much influence and power do GSK have over politicians, the government, regulation, academia, etc etc etc.

  From what I have researched- GSK have immense power in the UK. Too much power.

   This wouldn’t be a problem if GSK were an ethical and moral drug company who cared about patients before profits. But, alas they are not. They are just simply not ethical and they have never given any reason for us to believe that they ever will be.

   I could rattle off dozens of instances of GSK’s unethical behavior but I won’t as I have almost 500 blog posts documenting that.. and I think anyone who knows the industry would have to be aware that GSK are amongst the worst offenders of corporate crime of recent times…but anyhow all that has been documented on this blog and all over the web so I won’t talk about that now…

But what I would like to talk about is Ben Goldacre’s comments on my blog-post.

   I did not expect Ben Goldacre to comment on the blog-post and I was surprised when I noticed views coming from the Guardian. I did not expect the comments after the post to turn into something of a debate either. Furthermore, I honestly have had little interest in Ben Goldacre until recently. I was aware that he was involved in Alltrials and wrote Bad Pharma, but it wasn’t until I began to think to myself that he was possibly being manipulated by GSK that I started to research stuff online.

  I don’t think that Ben Goldacre is corrupt at all. Not in the slightest bit. I think his heart is sincerely in the right place. I honestly think he is one of the good guys and I think he genuinely wants to do the right thing, but I do think he could be being misled by GSK and I think it could be precisely because of his trusting nature that GSK have endorsed him and his Alltrials organization. I also think GSK are cynically using his celebrity and popularity for PR purposes – and I hope Ben begins to see that too, or at least becomes a little aware of it…

That’s just what I think and that’s my opinion- and that was the purpose of the blog post. I hope I am proved wrong and that GSK will give access to all their trials- particularly the raw data- nobody would like that more than me- it’s what I have been calling for – for several years on this blog! I was prescribed Seroxat and I would love to know what GSK have hidden about that!

   However, I have been scrutinizing GSK for a long time now- and I just do not trust them- nor will I ever -and I think it’s foolish to approach them with anything but mistrust and caution. They have broken every promise in relation to trial data so far so it is likely that they will not change their policy now, or they will find a way around all this… they always do. If they do give data it will be on their terms- they will not do anything that goes against their interest- they never do.

I could go on and on about how corrupt, fraudulent and criminal GSK are but everyone knows that- or at least they should!

But I would like to sincerely say to Ben..

Be careful..

and if you would like to contact Bob Fiddaman – he has information that he would like to pass on to you- it might help..

E-mail him here:

fiddaman@zoho.com

Good luck 🙂

Are Ben Goldacre and AllTrials Being Manipulated By GSK?


And are they perhaps being too trusting?

It seems some people aren’t afraid to ask these awkward questions…

Reposted from 1boringoldman’s blog (who is far from boring by the way- and possibly one of the best writers around on these issues ).


 

 

“I notice GSK is a member of both organizations. Is this GSK’s policy on data sharing as well? If so, I think it poses a real question for the AllTrials group and particularly those who have expressed enthusiasm for GSK’s data sharing initiative. (I like a number of things Ben Goldacre has done but I am really puzzled as to why he wants to “do cartwheels” over GSK’s offerings in this field so far. And I fear he and AllTrials could get manipulated into total irrelevancy, or worse, if they get too trusting.)” 

http://1boringoldman.com/index.php/2013/07/28/a-closing-argument/

a closing argument…

Posted on Sunday 28 July 2013

I’ll have to admit that my iPhone® skills are mostly limited to receiving. Typing with thumbs is a recently evolved skill that passed me by, so I’m reduced to using an inaccurate index finger. That post from on the road a week ago was from a motel lobby computer on a very rainy day [an irreducible conflict…]. But these days, WiFi is everywhere, even on coastal Maine, so I could keep up with things of interest. Pharmagossip is a favorite site of mine, and Jack Friday has kept me riveted to the GSK China·Gate story [great reading with a harbor restaurant lobster roll]. In writing about it, I mentioned this Guardian piece from last week:
Leaked memo from industry bodies reveals strategy to combat calls by regulators to force companies to publish results
The Guardian
by Ian Sample
21 July 2013

The pharmaceutical industry has “mobilised” an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials. Drugs companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice. If companies published all of their clinical trials data, independent scientists could reanalyse their results and check companies’ claims about the safety and efficacy of drugs. Under proposals being thrashed out in Europe, drugs companies would be compelled to release all of their data, including results that show drugs do not work or cause dangerous side-effects.

While some companies have agreed to share data more freely, the industry has broadly resisted the moves. The latest strategy shows how patient groups – many of which receive some or all of their funding from drugs companies – have been brought into the battle. The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian.

The memo, from Richard Bergström, director general of EFPIA, went to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies. It was leaked by a drugs company employee. The email describes a four-pronged campaign that starts with “mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data”. Translated, that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare. The lobbying is targeted at Europe where the European Medicines Agency (EMA) wants to publish all of the clinical study reports that companies have filed, and where negotiations around the clinical trials directive could force drug companies to publish all clinical trial results in a public database…
I wasn’t surprised. We can hardly expect the Pharmaceutical Industry to embrace Data Transparency given their past behavior and the Billions they’ve made from their over-rated “blockbusters.” Then I got home yesterday and read this [also linked by Pharmagossip]:
Exclusive: The Devil is in the Details
eye·for·pharma

Market Access

by Craig Sharp
Jul 26, 2013

The ongoing battle for clinical trial transparency took an unexpected turn this past Sunday, 21st July, when the Guardian ran a story featuring details of a leaked memo, apparently containing a plan to conceal “secret documents on drugs trials” from the public and concerned medical practitioners.

On Wednesday, 24thJuly, EFPIA and PhRMA responded to the ongoing argument with a joint set of new principles aimed at addressing these transparency concerns. Speaking exclusively to eyeforpharma, Richard Bergström, EFPIA Director General, explains the intentions of the joint position document and the real story behind that leaked memo…
The “real story” comes from an interview with the memo’s author, Richard Bergström, director general of EFPIA,:
Following the Sunday scandal and the resulting press coverage, eyeforpharma reached out to Richard Bergström to get the full story behind the memo and find out what the intention really was, and as it turns out the Guardian story wasn’t only incomplete, it was grossly biased in its assumptions…
I’ll not paraphrase it. It’s there for the reading and not that long. In essence, the memo’s author explains that the intent of the memo was not to mount a fight, but simply to find the best way to cooperate while protecting the clinical trial subject’s privacy and PHARMA’s legitimate interests. There’s a bit of confusing parsing of word meanings. It even has a response from the Guardian’s article author, Ian Sample. Their two accounts of the interaction between the author and Richard Bergström prior to the article’s publication were widely divergent. And who iseye·for·pharma anyway [the link takes you to their about·us page]?
eye·for·pharma is a hub for senior-level pharma executives, patient advocacy groups and other health experts to exchange ideas and stay up to date with shifting trends and practices within the pharmaceutical industry.
It’s The Guardian [home to Ben Goldacre’s long-runningBad Science column] versus eye·for·pharma [“a hub for senior-level pharma executives, patient advocacy groups…”] each accusing the other of misbehavior. If this were an episode on Masterpiece Mystery, it would be titled “Who’s Black? The Pot or The Kettle?” [speaking of conflict of interests].

In case you haven’t noticed, both The Guardian and eye·for·pharma talk about the Memo they’ve seen without showing it to us! Which is the whole point of this post and Data Transparency in the first place.

Without the Memo, we’re left to our own biases and the biases of these two articles’ authors and their media venues. Apparently, I’m not the only person who noticed that the Memo itself was missing in action. Mercifully, in an Update,eye·for·pharma later appended it to the end of their article with this comment:

UPDATE: I’ve had a few requests now for the memo to be printed [we didn’t run it originally as it’s around 600 words long], for privacy reasons all names and contact details have been redacted. That aside, you can [read] the memo in it’s entirety below:
Dear members and colleagues,

please find below a message from Richard Bergstroem, EFPIA DG with respect to the various elements of the Clinical Data sharing debate, the assignment of responsibilities (including work with US PhRMA colleagues) and next steps

A. Forthcoming industry commitment, incl advocacy:
The EFPIA Board has approved the draft position paper developed jointly by PhRMA and EFPIA. The final version is attached, and is now subject to confirmation by the PhRMA Board two weeks from now. PhRMA and EFPIA plan concomitant press releases in the week of July 22. The advocacy plan, previously approved by the two Boards is underway, and follows four strands:
      1. Mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data.
      2. Engaging with scientific associations to shape the industry commitment for data sharing, and to discuss concerns about re-use of data.
      3. Work with other business sectors that are also concerned about release of trade secrets and commercially confidential data.
      4. For the long-term, build a network of academics across Europe that has the capacity to counteract mis-use of data (that is deemed to be happen in any case).
There will be a series of meetings in Brussels, organised jointly by PhRMA and EFPIA, in the week of August 26 to advance these strands. This work (commitment and advocacy) is coordinated by [Redacted], in close cooperation with PhRMA ([Redacted] and [Redacted]), with oversight by Richard Bergstroem and [Redacted], PhRMA.
B. EMA consultation on draft :
On June 24th , the EMA published its revised policy on the publication and access to clinical trial data for consultation. Comments are invited and should be provided to the EMA by 30 September 2013. Whereas the press release was quite balanced, the detailed proposal raises concerns:
      1. No process outlined to discuss CCI in CSRs prior to release.
      2. Raw data: unenforceable controls to ensure robust and scientifically credible secondary analyses.
      3. Requirement for anonymised raw data to be supplied at submission negates EMA’s responsibility for release of PP information.
      4. Publication of CSRs from withdrawn or unsuccessful submissions could undermine future commercial viability of product.
      5. Identification of study personnel.
The EMA document takes into consideration the outcome of the process run by the 5 CT advisory groups earlier in the year to which EFPIA contributed through the input prepared by the 5 Temporary Working groups (TWG) set up under the SRM PC auspices.
A detailed response will be prepared by a joint EFPIA-PhRMA team. The work will be led by [Redacted], Lilly, [Redacted]. From the EFPIA side the EFPIA TWG chairs (Rules of engagement, Patient confidentiality, good analysis practice, CT data format, legal aspects) will be part of the drafting group: [Names of four individuals within the drafting group redacted] PhRMA will assign a small group of people from the bigger EMA data disclosure WG. The drafting group will tentatively have a TC July 9. The final draft will be shared for consultation with the broader membership later this month.
C: EFPIA-PhRMA intervention in the AbbVie case:
[Name], Pfizer, leads this work, in close cooperation with PhRMA and external legal counsel.
D: Clinical Trial Regulation:
Advocacy directed at Council (and EC and EP) will focus on:
      • avoiding definitions of CCI in the CTR itself,
      • seek to delete preamble text that CSRs do not “in general” include CCI (even if current text is acceptable as fall-back position).
The EFPIA PACT(Public Affairs on Clinical Trials) is responsible and will work closely with national associations and Brussels staff.
Regards,
[Redacted]

I have rarely been afforded the luxury of writing such a satisfying post. Whether you agree with The Guardian or eye·for·pharma, or even land in some completely different place, the point remains the same. With the Memo there in front of you, you’re able to reach your own conclusions – deal with your own biases and conflicts of interest unimpeded. Your opinion is worth a whole lot more than it was before you read it. Very satisfying.

I rest my case for Data Transparency…
  1.  
    July 28, 2013 | 8:11 PM
     

    Let’s hear it for enactments.

  2.  
    July 29, 2013 | 4:52 AM
     

    Great job Mickey. :)

  3.  
    berit bj
    July 29, 2013 | 7:05 AM
     

    Excellent exposure! As expected by this biased mom, as foretold by George Orwell.

    “Advocacy” they call it, lobbying the European Council and scores of big-business-friendly politicians, media, bureaucrats, big-pharma-sponsored consumer groups NAMI with sister EUFAMI..

  4.  
    Johanna
    July 29, 2013 | 7:11 PM
     

    I ran across this joint statement on “responsible” data-sharing practices from PhRMA and its European cousin EFPIA. It is a real piece of poop, of course … we will share data only with “responsible” parties in a “responsible” format. In other words, we are committed to telling you everything we think you need to know. Trust us.

    I notice GSK is a member of both organizations. Is this GSK’s policy on data sharing as well? If so, I think it poses a real question for the AllTrials group and particularly those who have expressed enthusiasm for GSK’s data sharing initiative. (I like a number of things Ben Goldacre has done but I am really puzzled as to why he wants to “do cartwheels” over GSK’s offerings in this field so far. And I fear he and AllTrials could get manipulated into total irrelevancy, or worse, if they get too trusting.)

    So I hope they ask GSK: Are you standing behind this Orwellian piece of poop issued by your trade associations? If not, please stand up and say so. And if so, what the heck does it mean that you also “endorse” AllTrials?

  5.  
    a-non
    July 30, 2013 | 3:27 PM
     

    Is COI limited to pharma only?

    “OPINION: Health service researchers – are we blind to our own conflicts of interest?” Healthy Debate July 3, 2013 by

    Andreas Laupacis

    “It might be worthwhile articulating different degrees of conflict of interest. One scheme might go as follows, in order of increasing conflict of interest: 1) receipt of only operating funds to conduct the research from the payor, 2) receipt of personal salary or consulting fees, 3) receipt of funds for a research group or institute, so many individuals are dependent upon those funds for all or part of their salary and/or projects, and 4) potential to derive entrepreneurial profits in partnership with the payor. An important point here is that, except for the fourth conflict, the others pertain to both industry and the public sector.”

    http://healthydebate.ca/opinions/health-service-researchers-are-we-blind-to-our-own-conflicts-of-interest

 

 

The Great Glaxo Transparency Swindle


For those who believe in the fairy-tale that Glaxo will ever manifest any real sense of transparency -or  give uncensored/uncontrolled access to their private trove of clinical trial data..    

..get real.

329 2

GSK 329

 

http://www.pharmalive.com/glaxo-falls-short-of-open-data-disclosure-jureidini-explains

Glaxo ‘Falls Short Of Open Data Disclosure:’ Jureidini Explains

Over the past few months, a group of researchers has been haggling with GlaxoSmithKline over access to detailed data for an infamous 2001 study of its Paxil antidepressant called 329 that tested the pill for treating depression in adolescents. The researchers, who are led by Jon Jureidini, a clinical professor of psychiatry at the University of Adelaide in Australia, want a 1998 clinical study report that they hope to reanalyze and republish. The original results reported that Paxil was effective, but the trial actually missed its endpoints and figured in a ghostwriting controversy (here is the study). As a result, Glaxo signed a consent order with the New York State Attorney General to publicly disclose trial data and has since vowed to do so. But the drugmaker says that Jureidini, who also led an unsuccessful quest to have the study retracted (see this), must follow its new system for submitting proposals (back story and more here). We spoke with Jureidini about his efforts. This is an excerpt of our conversation…

Pharmalot: Why did you make this request?

Jureidni: I’ve been occupied with trying to get some truth about that study for a long time. And just because it had such an impact in child psychiatry in Australia at the time it came out. It was used to try to shift the approach to (treating) childhood depression and (Paxil) became first line (therapy). I looked at it the first time I read it and thought perhaps medication is the answer. But then, I reread it and spotted some problems. I then had others look at it, and it seemed flaw and then deliberately so. This was in 2002 and 2003.

Pharmalot: Why does this matter now, though?

Jureidini: We have an editorial failure by a major medical journal. We have a failure of the peer review process. We have misconduct by a major pharmaceutical company. Most worrying for me is that we have a careless, at least, and probably more than careless, work by senior academics. And we have the whole issue of ghostwriting. Most of all, we have harm potentially done to children. Those sound like pretty significant issues to me.

Pharmalot: So what exactly are you seeking?

Jureidini: The primary goal is to get the data… We want to use the data to check what they published… Our guess is that the representation of the efficacy data in the clinical study report is accurate, but we have real concerns about the accuracy with which the adverse event data that has been transferred from individual patient records to the clinical study report, which is why we wanted individual patient records. The fact that it serves as a test of GSK resolve (to disclose trial data) is welcome to us, but not our primary interest.

Pharmalot: Glaxo has said publicly, though, that it has procedures for releasing data now and will review researcher requests.

Jureidini: The procedure doesn’t meet our requirements. That’s the problem. One of the positive things about us testing their process is that we’ve already illustrated we’re carrying out a project with GSK data, but the system doesn’t meet the needs of the research group.

Pharmalot: Which is….?

Jureidini: They won’t provide individual patient records. They’ve defined what they will make available and make it sound that’s all anybody what would want in order to behave ethically. We’re concerned that this (approach) gives them a level of control over the data, which might facilitate them withholding inconvenient truths. We haven’t been given any data yet, but you’ll see from the letters from Shannon (James Shannon, Glaxo’s chief medical officer) that the process doesn’t allow them to provide the kind of data we’re requesting.

Pharmalot: And what does he say?

Juredini: In the last letter, he says he’d like to have a phone call about that process and how it might change. I said I‘d like to do this by email, but haven’t heard back. But they have made clear it’s not the kind of information they’ll make available, even though they’re advertising it as open disclosure. It falls short of that.

I’ve done what they’ve requested, which is to put the application on the (new) web site (for data disclosure)…  And we’ll do what they request, which is to apply their analytical plan to the data, but we want to go a step further and ensure what’s in the data taggles collected by GSK reflects what was reported by patients to the (Paxil) researchers.

Pharmalot: When did this last exchange occur?

Jureidini: On November 5, he suggested a phone call. On November 8, I wrote back saying thanking him and didn’t think a phone conversation was best way to proceed.

Pharmalot: Why insist on e-mail and not a phone call?

Jureidini: Well, for one thing, I’m representing a team.  I’m not an individual functioning alone here. And it’s also partly because part of this process is to document interaction with GSK. Another reason is that I expect that it’s likely Shannon is a more skilled communicator than I am, so it’s more neutral, I think, to communicate in writing.

Unless they can come up with some plausible reason why there are genuine ethical concerns about providing the data, which may satisfy an independent appraisal, then you’d have to suggest there are other reasons why they don’t want us to see it. But we should be clear that GSK hasn’t said no to this request and I don’t want them backed into a corner of being acused of not providing information. I‘m not accusing them of that at all.

But the ability is there. It’s really easy. It’s a small expense to render documents confidential. It’s a question of whether there are more bad things happening that needn’t be hidden. It would be they had something to hide.

Pharmalot: Beyond this one study, what do you expect to accomplish?

Jureidini: There’s some good that can be done here. We can bring to account different parties that failed the community in the process of the publication of the (original) article – the company, the key opinion leaders… And we’re hoping that other people will be interested to make (the same sort of request). It’s an onerous task, but if you form a group, it can be done in the margins of your ordinary working life.

STORY ENDS HERE

Would The Real Ben Goldacre Please Stand Up?


Ben Goldacre is a doctor, journalist, blogger and writer whose media profile has risen exponentially over the past few years, particularly with the release of his last book on the pharmaceutical industry, Bad Pharma.  But who is the real Ben Goldacre- and what does he really stand for?

   Whilst Bad Pharma catapulted Ben Goldacre’s career firmly into the mainstream (and his trendy hip-doctor/guardian-journo persona seemed to capture the interest of the public imagination)- the content of Bad Pharma had more or less been covered already by other writers such as David Healy , Marcia Angell and others- over the years.

   Actually, most of the topics and issues in Goldacre’s book had also already been covered on this blog alone – predating the content of his book by five years ( I set up this blog in 2007- Bad Pharma was published in 2012).

   In other words- for a seasoned pharmaceutical industry critic, patient advocate, ex-Seroxat addict and blogger like me – what he had to ‘reveal’ about the badness and misdeeds of pharmaceutical companies was hardly revelatory at all. I could  have written it myself as I was certainly familiar with most of the information.

All that aside- what interests me most about Goldacre is his association with GlaxoSmithKline.

   Back in 2003- Goldacre received the GSK/ABSW award for his Guardian article ‘never mind the facts’. The article itself was basically a rebuttal piece in defense of MMR Vaccines and thus in turn- a defense of the pharmaceutical companies who make them and somewhat of an attack on those who claim that they can cause harm.

   I am no expert on vaccines or their link to Autism, nor would I ever claim to be- but I am well versed in pharmaceutical misdeeds- in particular those of GSK (I have been researching and blogging about GSK related issues for over 7 years now). I am aware that one of GSK’s vaccines, Pluserix was banned in 1992 and like other GSK medicines-  such as Seroxat and Avandia- not only was it causing immense harm- but GSK were allegedly aware of it.

  From my own experience of Seroxat- I would like to categorically state that I believe GSK were aware that Seroxat might harm me but like many instances with many other GSK products, they failed to warn- because all that matters to GSK is the health of GSK. Profit is the bottom line. Patients- like me- are merely collateral damage. However, considering that Goldacre is a psychiatrist (a fact he seems resistant to overtly publicize) maybe he just doesn’t care much for those who claim to be harmed by psychiatric drugs like Seroxat? Nonetheless- there is surely enough quackery and pseudo-science in Seroxat marketing which could keep a self-proclaimed quack-buster like Goldacre steeped in column inches for months.

   GSK have a murky history of malpractice and deception- their corporate history is littered with headline after headline of disturbing unscrupulous behavior. They are quite simply- pathologically sociopathic when it comes to harming the public. As a physician- I am surprised that Ben Goldacre would be so quick to jump to their defense- surely fraudulent clinical trials, intimidation of critics and widespread corruption resulting in damage to patients- would go entirely against the physician’s hippocratic oath?

Not so- it seems… in Ben Goldacre’s world.

Below is a picture of Goldacre receiving his BSW/GSK ‘science writers’ award from (none other than) GSK’s infamous Seroxat apologist Alastair Benbow (pictured right) in 2003. Apparently the award includes a 2000 pound bursary. (see link) http://www.badscience.net/2006/07/test-2/

6a00d8357f3f2969e2013485f7e002970c

Benbow was interviewed by BBC Panorama for their Seroxat documentaries and in (a diabolically delivered) defense of Seroxat he basically eventually admitted that Seroxat caused some children to commit suicide (after previously denying this in the Panorama documentary before it). Chillingly, Benbow seemed to think that this fatal side effect was almost inconsequential in the grand scheme of pharmaceutical depression treatment.

   The year Mr Goldacre was receiving awards from GSK for writing articles in favor of the pharmaceutical industry, was also the year that coroners in the UK were calling for a withdrawal of GSK’s Seroxat from the market (see here).

   2003 was also the year that (due to overwhelming evidence from the public) GSK were forced to abandon their no addiction claim about Seroxat. (see here)

   The year that Ben was posing with an award from a GSK funded initiative is also the year that the UK regulator banned Seroxat for under-18’s due to it’s propensity to make them suicidal- a sinister fact that GSK failed to inform the public of- for years. (see here)

 (Thankfully, for users of Seroxat, it was Ben Goldacre’s colleague- Sarah Boseley of the Guardian -who covered most of these stories)

   According to a tweet (screen-grab below) sent in 2010 in response to Seroxat Secrets, Goldacre, knows the’ Seroxat story well‘ and apparently he thinks it’s ‘vile‘. If this is the case then perhaps he would relay his opinion on Seroxat to his chum Andrew Witty because Mr Witty doesn’t seem to give a damn about Seroxat at all. If Goldacre really thinks that the Seroxat story is so vile- then why be so chummy with GSK?

gold

   Goldacre’s stance on pharmaceutical companies seemed to take a sharp turn with the release of Bad Pharma, which on the surface paints them in a very negative light. However, since most of the content of Bad Pharma had already been covered either online,  by blogs, in news-articles or in print form already- one would have to question whether it really had any negative impact at all on the reputation of the industry? Did it enlighten us to anything we did not know already?

   An insightful (albeit also complex) review of Bad Pharma from David Healy (not so bad pharma) seems to conclude that the problem with Bad Pharma rests not upon the repetition of content already covered, or the many flawed arguments raised which seem to rally against the pharmaceutical  industry but actually often work in their favor, “but on the premium Ben puts on controlled trials not found in other books”.

  You would have to read Healy’s review a few times to understand just how flawed and  -dare I say it- impotent –Bad Pharma is- particularly from a patient’s (or patient advocate’s) perspective. Perhaps it’s justified to ask- if a book highlighting the badness of Pharma actually serves to work in their favor in the long term- what use is it for the benefit of the public? Are we any safer? Possibly not.

   In a video of a parliamentary discussion of clinical trial transparency in the UK parliament from April 2013- Goldacre sits alongside GSK exec- James Shannon, and William Burns from Roche (19:06:00). In this inquiry, Goldacre refers to GSK as being ‘rather badly behaved‘ in the past- he then goes on to congratulate them on their current progress towards atonement (a fairy-tale like ‘atonement agenda’ which Goldacre seems to be swallowing hook-line-and sinker). The irony of this is- GSK have no intention of giving any access to clinical trials which predate 2000- therefore trials on drugs like Seroxat will not be released for inspection (Seroxat Trials pre-date the 90’s).

   I find Goldacre’s choice of words also quite astounding- ‘rather badly behaved‘ really doesn’t describe the destruction of life from a defective drug like Avandia or Seroxat.  “Rather badly behaved‘ doesn’t illustrate the magnitude of a 3 Billion dollar fine for fraud and corruption does it? “Rather badly behaved‘ is the kind of phrase we might use in regards to naughty children who won’t do their homework- not the UK’s biggest drug company (with the responsibility and power to enhance or extinguish human life on any given day depending on which way their ethical compass intends to sway). Goldacre then proceeds to  heavily criticize Roche and their Tamiflu debacle -conveniently leaving GSK looking much more ethical by comparison.

In an interview from March 2013– Goldacre says that he met Andrew Witty, CEO of GSK, before the announcement that GSK will release all trial data relating to its current products, with older data being released over several years. “He’d obviously thought very carefully about the practicalities of it, and that reassures me – he’d thought about how to do it, what the costs would be, and I think it’s to his enormous credit.”  Following the announcement Among one of many celebratory tweets, Goldacre said the news was: “Amazing. Fantastic. Historic.

   Thanking GSK for its decision, he added: “This is the beginning of the end for a dark era in medical history.” This ‘end of an era‘- and ‘the beginning of a new ethical GSK’ concept– has long been the mantra of Andrew Witty and GSK- particularly in regards to crimes that were committed prior to Andrew Witty’s tenture as CEO. I’m sure that GSK is delighted to have people like Goldacre championing (and echoing) its PR agenda- tweets from Ben Goldacre (with 250,000 followers) go far and wide.   Furthermore, these are just the perfect type of glowing PR sound-bytes that- pharmaceutical reputation management consultants- can’t even buy for GSK. Goldacre’s support must therefore be -utterly invaluable to them…

   And here we come back  again to Ben Goldacre and his association with GSK. At every given opening in the clinical trial transparency debate- it seems Ben Goldacre  just can’t resist an opportunity to lavish praise upon GSK CEO Andrew Witty. In an article from October last year (2012) he says:

“I think Andrew Witty, the current head of GSK, is a good guy, and I discuss this at length in the afterword of Bad Pharma: because I don’t realistically think that we can rely on one person in one company being nice, as a strategy to address ongoing regulatory failure in a global $600bn industry where lives are at stake.” (see here

   Perhaps Goldacre is incredibly naive, easily manipulated, under a spell, or utterly gullible? or maybe he genuinely does believe that GSK have changed their spots? I really have no idea

  However, considering that Andrew Witty has worked for GSK in various high level positions for most of his adult life I think it would be safe to assume that as CEO now he would have knowledge of most things that have – and do occur -within the company- including those things which would often undoubtedly come under the banner of big bad pharma

   And Ben… “good guys don’t become CEO’s of Billion-dollar Global Pharmaceutical companies”…

“You cannot hope to bribe or twist,
Thank God, the British Journalist,
For seeing what the man will do
Unbribed, there’s no occasion to.1

What is true cannot be minted

into a falsehood, even by

the most distinguished professor. 4

1 Anon.
4 Samuel Hahnemann.”

(Quotes Kindly Taken From http://www.whale.to/b/dwarfs01.pdf)

Hey Hey GSK: The Seroxat Hidden Data Debate Won’t Go Away


http://pharmagossip.blogspot.ie/2013/11/bmj-hidden-data-putting-glaxosmithkline.html

FRIDAY, NOVEMBER 15, 2013

BMJ – Hidden Data Putting GlaxoSmithKline to the test over paroxetine

Cite this as: BMJ 2013;347:f6754
  1. Peter Doshi, associate editor

Author Affiliations

  1. pdoshi@bmj.com

Blockbuster antidepressant paroxetine is no stranger to headlines. The drug is now back centre stage as requests for clinical data from one of its trials are testing manufacturer GlaxoSmithKline’s commitment to full transparency, Peter Doshi reports

When the Journal of the American Academy of Child and Adolescent Psychiatry(JAACAP) published study 329 in 2001,1 its editors could have had no idea that the paper would spark a controversy, not only about the use of the antidepressant paroxetine in children but also about secrecy in clinical trials. It is a controversy that rages to this day and that goes to the heart of recent campaigns to gain access to drug companies’ trial data.

By most accounts, GlaxoSmithKline is leading the pack in its efforts to liberate access to its clinical trial data. It was the first major pharmaceutical company to sign up to the international AllTrials petition calling for all trials to be registered with the full methods and the results reported.2 Whereas companies like AbbVie and InterMune have lodged lawsuits aiming to block access to clinical trial data,3 GSK has forged ahead with a new website enabling third party access to deidentified participant level data “because it is the right thing to do, both scientifically and for society.”4 GSK’s website states that five requests have been approved up to 20 September. None have been rejected. One is under review.

But one group’s request for data is testing the limits of GSK’s commitment to full transparency. Jon Jureidini, clinical professor of psychiatry at the University of Adelaide, is leading a team to reanalyse and republish the results of GSK’s study 329—a randomised, double blind, placebo controlled trial of paroxetine for the treatment of depression in adolescents. For over a decade, Jureidini has been critical of how the study was reported in JAACAP in 2001. In 2003, Jureidini and Tonkin wrote toJAACAP: “We believe that the Keller et al study shows evidence of distorted and unbalanced reporting that seems to have evaded the scrutiny of your editorial process.”5 They noted that “on neither of [the study’s two primary outcome] measures did paroxetine differ significantly from placebo”—yet the Keller et al paper concluded that “paroxetine is generally well tolerated and effective for major depression in adolescents.”1

Jureidini was subsequently contracted to provide expert advice as part of a class action lawsuit against GSK in 2004. Through this legal action, some internal company documents were released into the public domain, and Jureidini and colleagues reported that study 329 had an additional six secondary outcomes specified in the protocol.6 Paroxetine was not more effective than placebo on any of these outcomes either.

TROUBLED HISTORY

Paroxetine was a blockbuster antidepressant, known by its trade names Paxil in the United States and Seroxat in the United Kingdom, and was widely prescribed “off label” for use in children and adolescents. The drug came under heightened attention in the early 2000s, after a decade of rising antidepressant use among youths,7 over concerns about a link between paroxetine and suicidality in children.

In 2003, the UK Committee on Safety of Medicines recommended that paroxetine not be used in children and adolescents for the treatment of depressive illness because of concerns about an increased risk of self harm and potentially suicidal behaviour.  And in 2004, the US Food and Drug placed a boxed warning, its most serious type of warning, on all antidepressants, stating that they increase the risk of suicidal thinking and suicidal behaviour in these age groups.8

In 2012, GSK agreed to pay $3bn (£2bn; €2.4bn) in a fraud settlement with the United States government. In a statement connected with the lawsuit, the Department of Justice declared that “the centerpiece of GSK’s efforts to market Paxil for childhood depression was the GSK funded Study 329,” about which the published JAACAP“article distorted the study results and gave the false impression that the study’s findings were primarily positive, when they were, in fact, primarily negative.”9

Jureidini and colleagues have led a long campaign to compel the journal to correct or retract the article, which was authored by both academics and GSK employees.10Earlier this year, Jureidini presented GSK’s chief executive, Andrew Witty, with a final plea to help correct the scientific record. “Your corporation has so far failed to take responsibility for a published report that has harmed young patients who were prescribed paroxetine on the basis of this misleading article. As the CEO of GSK, you have the opportunity to correct the scientific record. I respectfully urge you to do so,” Jureidini wrote (see data supplement on bmj.com ).

But GSK defended the integrity of the 2001 publication. “GSK does not agree that the article is false, fraudulent or misleading,” John E Kraus, head of medical governance, wrote to Jureidini.

Jureidini has responded by assembling a team to reanalyse and republish study 329. In July they publicly declared their intention to produce a new journal report of study 329, written in accordance with the BMJ endorsed restoring invisible and abandoned trials (RIAT) initiative, which calls for third party authors to publish or republish unpublished and misreported clinical trials.11 The team’s starting place is a trove of over 6000 pages from a previously internal clinical study report written by SmithKline Beecham in 1998 that was forced into the public domain as a condition of a consent order GlaxoSmithKline agreed to in the settlement of a 2004 lawsuit with the New York State Attorney General.12 (SmithKline Beecham and Glaxo Wellcome merged in 2000 forming GSK.) The pages include a report of the trial, the study protocol, statistical analysis plan, blank case report forms, and numerous data tables, which Jureidini’s team will use for its analysis.

But GSK’s public posting of its internal report on study 329 is incomplete, lacking an unknown number of pages containing original case report forms from Appendix H. Jureidini and colleagues have therefore asked GSK for access to the deidentified case report forms and the corresponding deidentified electronic participant level data, “so that we can restore the publication of trial 329 in a fair, complete and publicly transparent way.”

“With regard to the electronic database,” James Shannon, GSK’s chief medical officer, wrote to Jureidini on 11 October, “I would ask that you do indeed submit an analysis plan via the website and sign a data sharing agreement.” Jureidini had initially rejected submitting an analysis plan arguing that “such a plan is irrelevant when restoring a publication where our primary focus is the original analysis plan drawn up and implemented by your own statisticians.” Nonetheless, Jureidini complied, and submitted an analysis plan—mostly a direct copy and paste from the protocol contained in the company’s 1998 clinical study report—placing GSK’s independent review panel in the unusual position of refereeing the appropriateness of the manufacturer’s own analysis plan.

As for the case report forms, GSK initially rejected Jureidini’s request, explaining, “We do not publicly disclose Case Report Forms (CRFs) and we do not provide them to other researchers. Complete CRFs are available to regulatory authorities for audit and for them to assure the integrity of the data sets and CSRs.” However, last week the company suggested a phone call with Jureidini, “to explore with you how we can help with this.”

COMMITMENT TO TRANSPARENCY

GSK’s wavering responses contrast with the many upbeat public proclamations by its executives about the company’s commitment to transparency. “Increasing transparency about our research is a critical area we’ve been pursuing at GlaxoSmithKline for almost a decade,” Shannon wrote in a September editorial in theHuffington Post.13 “We’ve also launched a new website allowing scientists to request access to the very detailed, anonymised patient-level data sitting behind the results of our clinical trials. This will mean independent researchers, with a fresh perspective, can conduct further research which could advance medical science and improve patient care.”

Transparency is “at the core of how we work,” Shannon explains. “People have asked me, ‘what if a new side effect comes to light for one of your medicines? Or what if a scientist discovers that you made a mistake in your research?’ My answer back is ‘why wouldn’t we want that to happen? Isn’t it better that we know? There is always the potential for us to find a better way to do things.’”13

Last month, Witty took it one step further in a television interview with the US Fox News. “We’re not simply going to publish data on trials still to come, but we’re going to go back, and we’re going to publish all the data for all the trials that have been done since the company was formed.”14

Witty’s phrase “all the data” sounds straightforward, but the company’s 11 October response to Jureidini implied that “all the data” would not include case report forms from study 329—or, it would seem, any other study. Nor, it seems, is GSK going to “publish” any of the deidentified patient level data on its new website, if “publish” means to make something public and freely accessible.

CAVEATS

A more careful reading of GSK’s stance is that it believes in what it calls a “closed-access system,”4 in which only approved researchers are permitted to query (but not download) data in preapproved ways. To gain access to GSK’s participant level data, requestors must first submit and have their analysis plan approved by an “independent review panel” and sign a data sharing agreement. A sample agreement posted on GSK’s website indicates that researchers are expected to run only preapproved analyses: “GSK and Researcher agree that GSK will provide the Researcher with access to patient level data from the GSK-sponsored clinical studies listed in Exhibit A for the sole purpose of analysis according to Researcher’s approved research plan (the “Analysis”) attached as Exhibit B and for no other purpose.”15

GSK suggests that such a system is necessary to protect the privacy of research participants. It is not enough to simply remove personally identifiable information from the participant level dataset. “It may be possible to combine deidentified data with other information to identify individuals. To minimize any such risk, our approach will be to provide access to anonymous patient-level data on a password-protected website that has controls in place to prevent data from being downloaded or transferred.”4

This concern is underscored in an editorial, published in the Lancet, coauthored by Patrick Vallance, GSK president of pharmaceuticals research and development, and Iain Chalmers, one of the founders of the Cochrane Collaboration and now coordinator of the James Lind Initiative.16 They write that “the protection of privacy is vital in IPD [individual participant data] analyses,” but point out that the process of deidentification can be carried out so thoroughly as to render the scientific value of the data useless. Deidentify the data insufficiently, and trial participants may be re-identified, violating their privacy. Vallance and Chalmers posit that a “controlled system” of restricted access offers a possible solution to the reidentification problem.16

It is therefore unsurprising that GSK initially refused Jureidini and colleagues access to the case report forms on grounds of protecting the privacy of trial participants. “The content of Appendix H is not posted on our website because it contains information (such as names) that can be used to readily identify the patients concerned.”

But Jureidini and company are challenging GSK. “As a group we do not accept your argument about patient confidentiality . . . The blank case report forms (CRFs) in the Clinical Study Reports (CSRs) make it clear that the only patient identifiers in any CRF not contained in the CSRs were initials. Redacting initials is the work of minutes.” Jureidini adds that reidentification of patients “is not our intention. We think anyone in our group attempting to do this would do significant damage to the data access cause. We are happy to sign agreements that there will be no effort to identify anyone and that the de-identified CRFs will not be shared with anyone outside the 329 group, with access limited to two to three designated individuals within our group.”

Jureidini also questioned GSK’s commitment to its patients: “noting the concern you expressed in your letter for the wellbeing of patients who participate in clinical trials, can we enquire as to GSK’s follow-up of patients who were in Study 329? For instance, were those who became suicidal or violent on Paxil subsequently advised of the possible role of the drug in their dangerous and distressing feelings/actions and counselled that it may be better for them to avoid SSRIs [selective serotonin reuptake inhibitors] in future?”

Perhaps most concerning, Jureidini explained to GSK that his team has concerns about how some of the adverse event data were reported in the 1998 clinical study report and therefore needs the additional requested data.

Recently, GSK has softened its position and seems willing to discuss the possibility of rethinking its previous position. “I recognize, however, that you believe you need to see the CRFs and I would like to explore with you how we can help with this,” Shannon wrote. “Please could we arrange a telephone call to discuss this more fully and agree a way forward?”

Jureidini has declined the telephone call, and requested keeping the interactions by email. “I would be grateful if you could indicate what in your opinion is the safest way of getting all CRFs from study to me, suitably de-identified, but otherwise complete with narrative elements intact.”

“RESPONSIBLE” DATA SHARING

Jureidini’s quest to access the complete participant level data for study 329 highlights some of the anxieties surrounding disclosure of clinical trial data.

Looming large are concerns about misuse of data. “We believe that there are public health risks if the proposed analyses are not scientifically robust and give rise to erroneous concerns about safety or false hopes of a potential benefit for patients,” GSK has declared.4 This fear of misleading analyses is embodied in an adjective gaining popularity among discussions over data sharing: “responsible.” The Institute of Medicine has named its ongoing consensus study on the topic “Strategies for Responsible Sharing of Clinical Trial Data” and a recent essay in the New England Journal of Medicine entitled Preparing for Responsible Sharing of Clinical Trial Data, warns that “poor-quality analyses can harm rather than advance public health, it must ensure responsible use of data.”17

IRONY OF STUDY 329

There is a certain irony in the story of study 329 and its 2001 publication in JAACAP. In a letter to Jureidini, GSK explained that the JAACAP publication “was subjected to peer review on three occasions” and “accurately reflects the honestly-held views of the clinical investigator authors.” But a more pertinent question is whether the published article accurately reflects the trial.

In their most recent letter to GSK, Jureidini and his colleagues reiterate their need for the study 329 case report forms and their intention to analyse study 329 “following the original analytic plan.” As such, Jureidini’s team’s efforts to independently analyse and publish the results of study 329 can be viewed as perhaps the most “responsible” of all analyses—and one that it seems may yet overturn the JAACAP publication that GSK continues to defend.

Story of study 329

  • 1994-98: SmithKline Beecham conducts study 329, a study of 275 adolescents with depression

  • 24 November 1998: Date of SmithKline Beecham’s internal clinical study report for study 329, which was made public by the 2004 consent order

  • July 2001: Keller et al publish study 329 in the Journal of the American Academy of Child and Adolescent Psychiatry1

  • 26 August 2004: GSK signs consent order with the New York State Attorney General, agreeing to pay $2.5m and publicly post clinical study reports for GSK sponsored trials of paroxetine in children and adolescents

  • 2 July 2012: US Department of Justice announced that GSK “agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices”18

  • 26 April 2013: Jureidini writes to GSK chief executive requesting his help in retracting the Keller et al JAACAP article

  • 3 May 2013: GSK responds that “GSK does not agree that the article is false, fraudulent or misleading”

  • 13 June 2013: BMJ publishes the restoring abandoned and invisible trials (RIAT) declaration11

  • 25 June 2013: GSK expresses support for RIAT, stating that “by making the Clinical Study Reports available we are very happy for others to publish on the records if they wish to and if journals consider the work to be of scientific merit”

  • 15 July 2013: Jureidini publicly announces his team’s intent to republish study 329 in accordance with the RIAT initiative

  • 28 October 2013: Jureidini and colleagues formally submit a request for deidentified electronic participant level data through GSK’s website. The result of their request is pending review by GSK’s independent review panel

NOTES

Cite this as: BMJ 2013;347:f6754

FOOTNOTES

  • Competing interests: I have read and understood the BMJ policy on declaration of interests and declare the following interests: I am the first author of the RIAT declaration, which was co-authored by David Healy, who is part of Jureidini’s team. I am providing the Jureidini team with unpaid advice on the RIAT process. I am also a member of a Cochrane review of neuraminidase inhibitors that is based in part on clinical study reports provided by GSK for zanamivir. I initiated an inquiry in 2012 that resulted in an additional 38 781 pages from the clinical study reports of study 329 and eight other studies to be publicly posted on GSK’s website.

  • Provenance and peer review: Commissioned; not externally peer reviewed.

REFERENCES

  1. Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry2001;40:762-72.
  2. Kmietowicz Z. GSK backs campaign for disclosure of trial data. BMJ2013;346:f819.
  3. Hawkes N. Industry and drug regulators disagree on which data should remain confidential. BMJ2013;347f5390.
  4. Nisen P, Rockhold F. Access to patient-level data from GlaxoSmithKline clinical trials. N Engl J Med2013;369:475-8.
  5. Jureidini J, Tonkin A. Paroxetine in major depression. J Am Acad Child Adolesc Psychiatry2003;42:514, author reply 514-5.
  6. Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Saf Med2008;20:73-81.
  7. Zito JM, Safer DJ, dosReis S, Gardner JF, Soeken K, Boles M, et al. Rising prevalence of antidepressants among US youths. Pediatrics2002;109:721-7.
  8. Olfson M, Marcus SC, Druss BG. Effects of food and drug administration warnings on antidepressant use in a national sample. Arch Gen Psychiatry2008;65:94–101.
  9. United States ex rel. Greg Thorpe, et al v. GlaxoSmithKline plc, and GlaxoSmithKline llc. United States’ complaint. C.A. No. 11-10398-RWZ. 2011 www.justice.gov/opa/documents/gsk/us-complaint.pdf.
  10. Newman M. The rules of retraction. BMJ2010;341:c6985.
  11. Doshi P, Dickersin K, Healy D, Vedula SS, Jefferson T. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ2013;346:f2865.
  12. Civil Action No 04-V-5304 MGC. People of the State of New York against GlaxoSmithKline, plc and SmithKline Beecham Corporation. Consent order & judgment. 2004. www.ag.ny.gov/sites/default/files/press-releases/archived/aug26a_04_attach1.pdf.
  13. Shannon J. Unlocking access to clinical trial data— what are we afraid of? Huffington Post2013 Sep 9. www.huffingtonpost.co.uk/james-shannon/clinical-trial-data_b_3859734.html.
  14. GlaxoSmithKline CEO on increasing transparency of clinical trials. Fox Business2013 Oct 10, http://video.foxbusiness.com/v/2735629915001/glaxosmithkline-ceo-on-increasing-transparency-of-clinical-trials/.
  15. Vallance P, Chalmers I. Secure use of individual patient data from clinical trials. Lancet2013;382:1073-4.
  16. Mello MM, Francer JK, Wilenzick M, Teden P, Bierer BE, Barnes M. Preparing for responsible sharing of clinical trial data. N Engl J Med 2013;369:1651-8.
  17. US Department of Justice. GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety data. 2012. www.justice.gov/opa/pr/2012/July/12-civ-842.html.

Dr David Healy: The Church of GSKology


David Healy continues his brilliant blog posts on GSK…

http://davidhealy.org/the-church-of-gskology/

Editorial Note: This post is about midway through a series of posts that are broadly part of the AbbVie series. The series began with GSK’s Ttransparency and Access Journey, moved on to The House of GSK and will have at least two more posts after this. 

Reading the Minneapolis StarTribune, it was the reference to privacy that clinched it.

Facing a sexual abuse lawsuit, the archdiocese of St Paul and Minneapolis made a big deal of putting an independent panel in place to investigate.  They put the Reverend Reginald Whitt in charge of appointing the panel and receiving its reports on behalf of the archdiocese.

An Independent Panel that Sticks to the Rules

Rev. Whitt told priests and deacons that the task force may review specific files to determine whether the policies of the archdiocese concerning clergy sexual misconduct were properly followed. But, he wrote, “Access to these files will be within my control, and limited only to what is necessary for the task force.”

He also wrote that he recognized that many priests and deacons “may be anxious about your right to privacy and a good reputation.” He assured them that the archdiocese will proceed according to the principles of due process and uniform application of canon policy.

This sounds terribly like the approach Sir Andrew Witty is attempting to put in place for GSK, AbbVie and the rest of the branded pharmaceutical industry vis-a-vis abuses, including child abuse committed in their name.

Investigating Abuse

Is Abuse too strong a word? In Study 329, a controlled trial of Paxil given to children, there was a statistically significant increase in suicidality on Paxil compared to placebo. These children were unquestionably injured but it seems about as likely that GSK have contacted the children involved to tell them what happened as the Catholic Church have voluntarily got in touch with anyone who has been affected by their priests or nuns to inquire about their wellbeing.

In Study 329, the consent form tells parents and children that the child will not be exposed to any danger or risks beyond what would be found in normal clinical practice – but the protocol for the study involved an attempt to force titrate children up to a dose of 300 mg of imipramine. This is double the standard dose used for adults – at least in Europe. One reasonable hypothesis as to why this might have been done was that it was an effort to make Paxil look good. Pretty grim if it was.

Privacy Rights 

Just as the Church is insisting on the Privacy Rights of its priests, GSK, AbbVie and others have taken a legal action against the European Medicines Agency in an effort to claim Corporate Privacy Rights (See Let’s Do the AbbVie Again,  Avoiding Adverse Events).

Just as we respect an individual’s right to believe what they want – to be a Muslim, Hindu, Christian or Jew – and defend a pregnant woman’s right to control what happens to her body, GSK and AbbVie are claiming a comparable right to decide what the clinical trial data they hold means.

They are asserting their right to spin their version of what it is you put in your body even though this clashes fundamentally with your right to know what you are putting in your body.

Canon Law

Companies operate their own version of Canon Law. Canon law is the Church’s own internal legal system that the Church insists has primacy over national judicial systems. The Bishops and Cardinals adhere to this rather than the laws of the US or other countries. Whether intended or not, this is a system that favors the clerical abusers over abused children. It is this that has fueled the anger of those who have been abused. There would be little problem if the Church’s legal system were harder on the Clerics than on Children. But using a system that defies natural justice to safeguard Clerics not unsurprisingly causes anger.

GSK and other companies run something similar. They actively attempt to over-ride the legal systems of the United States and other countries with claims that unless findings are demonstrated in controlled trials to a statistically significant extent that they simply aren’t happening.

The US Federal Judicial Manual states that convincing evidence of challenge, dechallenge and rechallenge is the way to demonstrate that a drug has caused an adverse event. No place here for statistical significance.

With a flourish worthy of the best Jesuits, internally GSK and other companies apply exactly the approach advocated by the Federal Judicial Manual when assessing whether Paxil has caused a birth defect or suicide, but even after deciding in private their drug is guilty, in public they insist there is no absolutely no evidence that their drug has caused a problem.

This can even leave GSK personnel stating in public that they are not aware of a single side effect that is caused by Paxil or likely any of their drugs. See Burn in Hell.

The US Supreme Court has weighed in on this question and decided that GSK’s model is wrong. People have a right to make up their own minds as to what an adverse event profile means. The only people who have this right at the moment though are investors. Patients and doctors have no rights – at least not established.

Church of GSKology

GSK have applied to be treated as engaged in Science. They say that what they do has all the features of Science – clinical trials, peer reviewed publications.

Ideally the Courts would decide that rather than being a Science they are a Church – they operate a system that requires belief without evidence. There is less doubt that their publications are ghost-written than the Bible is.

While they have people with great public relations skills like James Shannon who say all the right things in public, like the Catholic Church GSK appear to operate an Opus Dei like arm which enables them to place their people close to heart of Britain’s regulator the MHRA and other bodies. They are close to being the Established Church in England.

In the face of abuse, GSK make a big deal about apparent reform but the Rev Whitt described the mechanism GSK have put in place perfectly: “Access to these files will be within my control, and limited only to what is necessary for a Responsible research proposal.”

Waiting for a Frances?

When it comes to reform it seems Andrew is a Ben not a Frankie.

We need some Martin Sixsmith or Dan Brown to write a book and make a movie on the lines of The Lost Child of Philomena Lee.

Don’t hold your breath. GSK are a lot scarier than the Catholic Church.

– See more at: http://davidhealy.org/the-church-of-gskology/#sthash.d1qIlFwJ.dpuf

GSK And The Spectre Of Seroxat Study 329


From Dr David Healy’s blog (for full article see link)

http://davidhealy.org/gsks-transparency-and-access-journey/

The Moral High Ground?

GSK are claiming the moral high ground of concern for patient welfare. Have they in the process managed to co-opt groups from the House of Commons to AllTrials who might otherwise hold them to account?

Study 329 is GSK’s most famous clinical trial.  In this a large number of children became suicidal on paroxetine. Antidepressants like paroxetine – thanks to Study 329 but not thanks to GSK – now come with a Black Box Warning that they may cause suicide.

Study 329 was worth roughly $1 Billion to GSK.  It enabled the company to get six months patent extension on Paxil-Seroxat.

The children who became suicidal on Paxil in Study 329 are more likely than others to become suicidal again if exposed to another SSRI.

Against this background:

  • What should a company genuinely concerned about the welfare of patients who have done so much for the welfare of the company (participating in this trial without payment) do at this point?
  • Should GSK’s concern about patient welfare extend to informing the subjects in Study 329 of the link between their treatment and their problems and future risks they may run?
  • Andrew – have you contemplated the possibility that if you don’t inform those affected you are in fact still to this day making suicide more likely for some of those affected?
  • Has GSK – or any pharmaceutical company – ever gone back to any of the subjects enrolled in any of its trials to explain to them what might have happened to them and the role their drug might have played in what happened? Please send known examples.
  • Would explaining to people how their injury arose not be a more telling indicator of concern for patients than an effort to keep identifiers out of the public domain?
  • What would the patients who have participated in clinical trials think was the more important indicator of genuine company concern?
  • What do Flaminia Macchia and Eurordis think would be the most appropriate indicator of genuine company concern?

Confidentiality

Following a legal action taken by New York State in 2004, GSK agreed to post Clinical Study Reports (CSRs) for their pediatric Paxil trials and other trials on the company website along with further details of  their Avandia and other trials on the company website.

Any good investigative journalist could likely identify each of the children who became suicidal on paroxetine from the CSRs available on GSK’s website. Pretty well the only additional details that the patient level data that the company refuses to release contains are the patients’ initials. These could easily be redacted.  This raises the question as to why GSK are so resistant to making the original case report forms (CRFs) available?

The only obvious other details that the CRFs contain not found in the CSRs are adverse effects. Its clear from looking at the CSRs, there are a very large number of mismatches (several hundred) between what the CSRs show and the CRFs are likely to contain.

Testing GSK

There is a team attempting to rewrite Study 329 according to the RIAT process.  See Reading the Riat Act .  The difficulties they are having in getting data out of GSK have been covered by Ed Silverman of Pharmalot.

1boringoldman has also covered this ground and the apparent growing links between GSK and AllTrials, and how GSK are using their model of transparency to block access to the data.

Because there is a mismatch between the CSRs and CRFs, the Study 329 RIATers are at a point where they require the raw data – the CRFs. GSK refuses to hand over the CRFs.

What would the now 35-year-old or so children who participated in Study 329 think should happen at this point?

Coalition Politics

If you are a small player in the scheme of things, you may know just how the world should work but will never get a chance to implement any of your ideas.  If you go into coalition with a bigger power you may get to implement policies you have always supported but have no chance to see brought into being.  Or perhaps you can temper policies your partners might want to put in place that you disagree with.

What do AllTrials think should happen at this point?

– See more at: http://davidhealy.org/gsks-transparency-and-access-journey/#sthash.uC61cabA.dpuf