GSK Bribery In China: Was (GSK’s ‘Alleged’ Corruption King Pin) Mark Reilly’s Sex Tape Sent To Andrew Witty?


Strange story from the Daily Mail UK:

http://www.dailymail.co.uk/news/article-2673963/How-secret-sex-tape-plunged-British-drugs-giant-Glaxo-90million-bribery-probe.html


How a secret sex tape plunged British drugs giant Glaxo into a £90million bribery probe

  • Executives at GlaxoSmithKline were sent a sex tape featuring China boss Mark Reilly and his girlfriend 
  • They hired a private investigator to work out who had sent the video 
  • But after he probed a powerful businesswoman, the Chinese authorities cracked down on Glaxo amid allegations of fraud and bribery 
  • Mr Reilly has been charged with illegally selling £90million worth of drugs

By HUGO GYE

Probe: Glaxo's China boss Mark Reilly was caught on camera having sex with his Chinese girlfriend

Probe: Glaxo’s China boss Mark Reilly was caught on camera having sex with his Chinese girlfriend

The bribery probe which has rocked British drugs giant GlaxoSmithKline was sparked by a secretly filmed video showing one of the firm’s managers having sex with his girlfriend, it was claimed today.

The £76billion pharmaceutical company is under investigation in China for allegedly bribing doctors and other officials in order to increase the price of Glaxo’s drugs.

Now it has been reported that the scandal started after a sex tape featuring the firm’s China chief was emailed to senior staff including chief executive Andrew Witty in March 2013.

The footage showed Mark Reilly and his Chinese girlfriend, and was filmed inside his flat in Shanghai, according to the Sunday Times.

After it was sent to Mr Witty and others, Glaxo hired private investigator Peter Humphrey to determine how the video had come to light.

It was thought that the sex tape must have been filmed by someone who had access to Mr Reilly’s apartment building.

Glaxo agreed to pay Mr Humphrey £20,000 for his investigation, which focussed on the company’s former employee Vivian Shi.

However, monitoring the prominent businesswoman appears to have brought him to the attention of the Chinese authorities, and Mr Humphrey was arrested in July last year.

This was around the time that China began a police probe into Glaxo’s alleged bribery – the biggest investigation into a foreign company for more than a decade.

It emerged that, as well as the sex tape featuring Mr Reilly, senior executives had been sent two emails detailing allegations of corruption in the firm’s Chinese division.

Mr Reilly, 52, who is separated from his wife, stepped down as Glaxo’s China boss last July, but after he agreed to return to the country to be interviewed by police he was banned from leaving again.

Email: The footage was apparently sent to executives including chief executive Andrew Witty

Six weeks ago, he was officially charged with bribery and fraud, accused of being involved in £90million of illegal sales.

Soon afterwards, Britain’s Serious Fraud Office announced that it would investigate Glaxo’s ‘commercial practices’ in a probe thought to be linked to the Chinese allegations.

Glaxo told the Sunday Times: ‘The Chinese authorities are continuing their investigation into GSK’s China business.

‘We respect their process and investigation and are co-operating fully.’

The drugs firm has previously admitted that some of its Chinese executives had apparently broken the law in marketing its products to doctors.

Read more: http://www.dailymail.co.uk/news/article-2673963/How-secret-sex-tape-plunged-British-drugs-giant-Glaxo-90million-bribery-probe.html#ixzz3640ToUiF
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GSK Whistleblower Blair Hamrick- ” I have suffered nothing compared to the parent of a child who committed suicide on Paxil”


He continued …

 

“Imagine how horrifying that is” .. “It’s so repulsive”… “You’re just talking about a bad company run by bad people in my opinion”… 

Damn right Blair.

What kind of company encourages the prescription of drugs which they know will harm kids? Many people lost loved ones to Paxil (Seroxat) and many more were damaged from this defective Glaxo pill.

.

http://fiddaman.blogspot.ie/2014/06/hey-glaxo-guess-whos-been-talking.html

Thursday, June 26, 2014

Hey Glaxo, Guess Who’s Been Talking?

GSK Whistleblower Blair Hamrick & Bob Fiddaman
I started writing this blog back in 2006. I had some issues with the antidepressant drug manufactured and marketed by British pharmaceutical giant GlaxoSmithKline. I also had some issues with the way drugs were regulated in this country by the British drug regulator, the MHRA.

GSK’s Weak Defense Over Corruption Charges


At the beginning of the April, Glaxo was accused of hiring government-employed doctors and pharmacists in Iraq to act as paid sales representatives. GSK employs about 60 people in Iraq and hence claimed that the incident of bribery involved just a few individuals. However, the Wall Street Journal had reported that GSK was warned about the misconduct by a whistleblower familiar with the company’s operation in the Middle East. GSK issued a statement claiming, “We have zero tolerance for unethical or illegal behavior”. 

Earlier, in 2007, GSK had been accused of shady business dealings with Saddam Hussein’s regime including payment of bribes to bag contracts for the supply of medicines. GSK denied any wrongdoing saying that all its dealings under the Iraqi oil-for-food programme were transparent and in accordance with the regulations.

Last year in June, GSK executives in China were accused of using travel agencies as a conduit to transfer $490 million to government officials, medical associations and foundations, hospitals and doctors to persuade them to prescribe GSK’s medicines. The payments allegedly began in 2007. The money was channelled through 700 conference organizers/ travel agencies, said China’s ministry of public security. The crackdown by the Chinese government saw GSK, which claimed initially that it had investigated and found no evidence to support the charges of bribery, back down and accept that senior executives of the company working in China appeared to have broken the law. Following the scandal, GSK’s sales in China fell by 61%. China accounts for 3% of the corporation’s global revenue. GSK Chief Executive Andrew Witty said the situation was “shameful” and “deeply disappointing”.

In 2012, GSK set a new record by shelling out $3 billion, the largest health care fraud settlement ever in the US. This covered many frauds from April 1998 to August 2003, which included promoting several drugs for unapproved uses by paying kickbacks to healthcare professionals to induce them to promote and prescribe these drugs. GSK was accused of promoting Paxil for treating depression in patients under 18 years of age, even though the FDA has never approved it for paediatric use. Similarly, Wellbutrin, approved only for major depressive disorders, was promoted by GSK for weight loss, the treatment of sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder, all conditions for which it was not approved. The US Department of Justice alleged that GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote these drugs and several others including Advair, Lamictal and Zofran, for unapproved uses. 

Despite such a large number of bribery cases surfacing, GSK has continued to insist that its investigations into allegations of bribery have shown wrongdoing by just a handful of staff outside the GSK’s control systems. GSK insists that it does not have a systemic issue with unethical behavior though bribery cases have been surfacing for more than two decades.

“To be clear: we have zero tolerance for unethical or illegal behaviour. Anyone who conducts such behaviour has no place in our company. We believe the vast majority of our employees uphold our values,” a company spokesperson said in response to a questionnaire. In all there were 3,128 instances of employee discipline for policy violations, mainly related to attendance and payroll issues, and 375 employees were dismissed.

According to Sidney M Wolfe of the health research group Public Citizen, GSK topped the list of repeat offenders with total criminal and civil penalties of $7.56 billion since 1991 paid at different points of time. After penalties, GSK often signed Corporate Integrity Agreements (CIAs) with the US government, which were meant to stop the company from committing fraud. In an article he wrote for the British Medical Journal on escalating civil and criminal violations by the pharma industry in the US, Wolfe pointed out that GSK had been under a series of CIAs from 2003 to 2018, with the exception of the 2010 to 2012 interval. Wolfe showed how all the penalties GSK paid over a decade did not amount to much as its profits for 2012 alone were $7.7 billion.

“These escalating patterns of repeated criminal violations and civil settlements to resolve serious allegations of civil lawlessness hardly bespeak corporate integrity for GSK, Pfizer, or the many other companies who are also repeat offenders. We are forced to conclude that neither the current level of penalties nor corporate integrity agreements are effective and that there is a pathological lack of corporate integrity in many drug companies,” concluded Wolfe. 

Across the world, countries like the US, the UK and others in Western Europe, Latin America and Central Asia are cracking down on the culture of bribery and corruption in the pharmaceutical industry. The silence from India on the issue is deafening.

Bob Fiddaman Meets GSK Whistleblower Blair Hamrick


http://fiddaman.blogspot.ie/2014/06/hey-glaxo-guess-whos-been-talking.html

Thursday, June 26, 2014

Hey Glaxo, Guess Who’s Been Talking?

GSK Whistleblower Blair Hamrick & Bob Fiddaman
I started writing this blog back in 2006. I had some issues with the antidepressant drug manufactured and marketed by British pharmaceutical giant GlaxoSmithKline. I also had some issues with the way drugs were regulated in this country by the British drug regulator, the MHRA.
Eight years on and I have learned so much about GlaxoSmithKline… I learned more about them yesterday evening as I sat down to dinner with Blair Hamrick, one of the whistleblowers who blew the lid on Glaxo’s fraud in the US, a blow which, after 11 years of legal wrangle, Glaxo settled for a record breaking $3 billion.
Blair is a very brave soul for going up against the company that he once worked for. His life is now back on track after Glaxo sacked him then muddied the waters so he couldn’t get a job elsewhere in the pharmaceutical field. Yes, he was paid handsomely for his bravery and is now living a life that most could only dream of.
Despite the publicity, fame and riches Blair is one of the most down to earth people you could ever wish to meet, a trait that became evident when he just couldn’t bring himself to promote the antidepressant Wellbutrin off-label to doctor’s.Wellbutrin is an antidepressant and indicated to treat adults that are depressed. Blair, whilst working for GSK, was prompted by senior management to promote it off-label to doctors for treating children. He just couldn’t bring himself to do that. One of the side effects of Wellbutrin is seizures and Blair envisaged kids going into seizure. “It was wrong, it wasn’t indicated for kids and I just couldn’t bring myself to tell doctor’s it was okay for kids to take,” Blair told me over a glass of wine in the plush settings of one of Westminster’s finest hotels in London. “They also tried to market it as the happy-horny-skinny pill because they had learned through post marketing that patients taking it for depression were losing weight and reporting high sex drives.” [increased libido] Wellbutrin was not indicated for this but the Glaxo marketing team came up with the “happy-horny-skinny pill” line so reps could convince doctors to prescribe it to patients who were overweight and also those who were experiencing a low sex drive [decreased libido]
Blair also spoke about the doctors who were paid by GlaxoSmithKline, a staggering 48,000 doctors were paid speaker fees, attendance fees and given lavish gifts, all in an attempt to get them to prescribe more of Glaxo’s drugs.

“We’d pay doctor’s between $2-4000 to give a talk to other doctor’s.

“6 or 7 doctors would be invited out for dinner, sometimes with their spouses in tow, they’d be wined and dined and then the speaker would talk about the wonders of drug a or b, of course these were off-label “wonders” – that’s how Glaxo rolled.

“Our marketing team would send them a slide-show and a carefully scripted narrative so they could convince other doctor’s that it was okay to prescribe a number of drugs off-label.

“Some doctor’s, whose basic annual salary was around $150,000, could give 2 or 3 talks in a week, giving them a potential to earn up to an extra $12,000 per week.

“I was also given luxury private box tickets for sporting events, these would be given to doctors as a ‘thank-you’ or incentive to prescribe more and more of Glaxo’s drugs.”

Glaxo, at some point during these wanton violations, caught wind that their off-label promotion had been leaked and reps were told to be careful what they added to their call-notes.Call-notes are what pharmaceutical reps use to familiarize themselves with a doctor.

“The way it worked was that a doctor would be visited by a rep who would  then add notes to a hand-held device.

“It was useful because we knew what these doctor’s liked, be it a particular football, baseball team or if he had a sweet tooth – on the next visit we would bring in a small token of gesture, be it tickets to the game or sweet tasting delicacies – it was just a way to keep them prescribing more drugs.”

Blair recalled a meeting where reps were told to be careful what they wrote in the call-notes, the crux of the meeting was basically to tell reps to “write right”, in other words write down the legal stuff and not the violations.

I asked Blair about Glaxo’s recent announcement that they are going to be more transparent.

“The whole transparency thing wasn’t a conscious decision by Glaxo, their hand was forced, it was all part of the settlement – it makes me laugh when I now read how they are claiming to offer up the results of their clinical trials, they were told that’s what they had to do as part of the agreement they entered into with the Department of Justice.”

Regular readers of this blog will note the tagline I use, “It’s perverse when GSK claim that they are going to be more transparent when they do not offer transparency when writing about their transparency.”
I could have listened and talked to Blair all night, alas I had a train to catch back home, a train that I almost missed due to losing track of the time.Blair Hamrick, along with the other whistleblowers in this particular case, should be applauded for their efforts. It’s no coincidence that Glaxo are now being investigated for the same type of violations in other countries. 
Blair blew the whistle and it almost took the roof off GSK, for that he deserves a future of happiness. His conscience not to promote a drug that could cause kids to have seizures was frowned upon by senior management at GSK – what kind of human being could promote a drug that could be potentially harmful to children, moreover, what type of human being could sanction such a promotion?On a side note, I wasn’t just in London yesterday to meet Blair. Earlier on I met with a film-maker who is in the process of making a documentary about antidepressants. The film-maker also dined with myself, Blair and his partner. More about the documentary in a future post.I now have something to tell my grandchildren.

I once had dinner with Blair.

Bob Fiddaman

FDA orders GlaxoSmithKline to review manufacturing worldwide


Britain’s biggest drugmaker warned by US watchdog over flu vaccine production at Canadian subsidiary
GlaxoSmithKline sold 26m doses of flu vaccines in the US last year, generating £150m in sales. Photograph: Photofusion/Rex Features

The US Food and Drug Administration has ordered GlaxoSmithKline to review its manufacturing operations globally after finding that its Canadian subsidiary violated quality requirements during the manufacture of its flu vaccine FluLaval.

It is another serious blow to Britain’s biggest drugmaker, already reeling from corruption allegations in Poland, Iraq, Jordan, Lebanon and China, and facing a criminal investigation by the UK’s Serious Fraud Office into its sales practices. It also recently paid out £63m to settle US marketing allegations. Earlier this week GSK had to apologise for the pitch adopted by a marketing firm working for the FTSE 100 company to recruit unpaid interns for clinical trials in the UK.

In a warning letter to the British company, the FDA cited “deviations from current good manufacturing practice” in the manufacture of FluLaval at GSK’s Quebec-based subsidiary ID Biomedical, which makes the vaccine for Canada and the US.

The US watchdog said when it inspected the site in Sainte-Foy, Quebec, in April it found that the plant had failed to take appropriate steps to prevent microbiological contamination of drug products purporting to be sterile. It also found that controls for the purified water system at the site, which employs 600 people, were inadequate to prevent contamination.

The FDA said it “expects ID Biomedical and GSK to undertake a comprehensive and global assessment of all of its manufacturing operations to ensure that all products conform to FDA requirements”.

The letter piles further pressure on GSK’s boss, Sir Andrew Witty, whopledged a major overhaul of the company two years ago after a £1.9bn US fine for mis-selling drugs. At the same time, he has been behind industry leading measures on data transparency, clinical trials and access to medicines. The company also claims that Witty has transformed sales and manufacturing practices. GSK said on Tuesday that it was working with the FDA and making progress addressing the concerns. “We are committed to working with the agency to fully resolve all outstanding issues,” the drugmaker added.

“Patient safety is our first priority and we are confident in the safety of the influenza vaccines we have provided to patients. Every batch of GSK vaccines is subject to extensive review before it is released. Vaccines that do not pass this rigorous review are discarded.”

Pending FDA approvals, GSK now expects to provide between 28m and 33m doses of flu vaccine to the US health authorities for next winter. It had planned to supply 36m doses, 23m of which would be made in the Sainte-Foy site in Quebec. GSK is also working with the Canadian health authorities to meet its supply commitments for 2014-15.

GSK sold 26m doses of flu vaccines (Fluarix and FluLaval) in the US last year, which generated £150m in sales. While it is still working to determine the impact the FDA concerns will have on supply, it expects to increase output this year. Its sites in Dresden in Germany and Rixensart in Belgium, which make Fluarix, are not affected by the warning letter.

Vaccines is one of GSK’s key growth areas. The company won plaudits within the industry when it unveiled a complex asset swap with Switzerland’s Novartis in April. GSK beefed up its vaccines business with the acquisition of Novartis’s vaccines divisions for up to $7.1bn and offloaded its portfolio of cancer drugs.

GSK points out that it had six new medicines approved by the FDA last year, nearly a fifth of all approvals and the highest number of any drugmaker.

In early June, GSK settled allegations by 44 US states and the District of Columbia going back 14 years that it promoted its big-selling medicines Advair, Paxil and Wellbutrin for unapproved uses. The £1.9bn Federal fine from the FDA for mis-selling drugs also related to anti-depressents Paxil and Wellbutrin as well as Avandia, once the world’s most popular type-2 diabetes drug, until it was found to have potential serious side effects, including heart attacks.

Another Contaminated GSK plant: This Time In Canada


(Reuters) – A GlaxoSmithKline Plc plant in Canada that makes the flu vaccine Flulaval has been cited by the U.S. Food and Drug Administration for failing to meet quality control standards.

GSK said it is working to rectify the problems and does not expect a delay in distributing the vaccine for the 2014-2015 flu season. The company typically starts shipping the product at the end of July.

In a warning letter dated June 12 to GSK’s flu vaccine manufacturing facility in Ste-Foy, Quebec, the FDA said the company failed to take appropriate steps to prevent microbiological contamination of products, among other violations.

GSK said on Tuesday no contaminated products had been released to the public.

“Every batch of GSK vaccines is subject to extensive review before it is released,” the company said. “Vaccines that do not pass this rigorous review are discarded.”

The FDA said controls for the purified water system at the plant were inadequate and that some Gram-negative bacteria identified in water used for equipment washing had been implicated in product contamination issues at the facility as far back as 2011.

In 2011, 24 vaccine lots were rejected due to the excessive presence of endotoxins. These are found in the cell walls of Gram-negative pathogens such as salmonella. When bacteria die the endotoxins are released, possibly contaminating laboratory equipment and causing health problems in people and animals.

Other lots were rejected in March and July 2012, and certain test lots were contaminated last year. These were manufactured on the same equipment as commercial lots for release to the United States, the FDA said in its warning letter.

This year, 20 of the lots manufactured, or 21 percent, showed bacterial growth and endotoxin levels. These lots were also rejected. GSK said the lots were rejected as part of the company’s quality review process.

The FDA said there was no set schedule for disinfection of the water system and that manufacturing controls in place were inadequate to control bacteria on unsterilized surfaces. The agency said the company’s investigation into the repeated accumulations of bacteria had been inadequate.

The deficiencies, the FDA said in its letter, “are an indication of your quality control unit not fulfilling its responsibility to assure the identity, strength, quality, and purity of your licensed biological drug product and intermediates.”

GSK said it anticipates providing between 28 and 33 million doses of flu vaccine to the United States for the upcoming season and said it is working with health agencies in Canada and the United States to “support their efforts in managing supply of influenza vaccines for the 2014-15 flu season.”

(Reporting by Toni Clarke in Washington and Esha Dey in Bangalore; Editing by Sriraj Kalluvila, Marguerita Choy and Paul Simao)

 

Ben Goldacre Is Not Arrogant, Smug, Immature And Egotistical ..


There…

That got your attention didn’t it…

Of course, the title of this post is merely a parody and satire on the current Alltrials debate which is currently raging across the social media- blog and -twitter universe (so no need to be running to the lawyers Ben and Andrew – it’s merely black humor).

Ben is not an arrogant,.. Of course he is not…

He’s not a Pharma shill either (as some people claim)… he is NOT those things OK!..

I repeat.. Ben Goldacre is NOT those things

He’s merely a misguided geek with patient interests at heart… isn’t he?…  yes..


The following quotes from David Healy’s latest post are an illustration of why I trust that he has patient’s interests at heart and the photo after it, of Ben Goldacre , is … well… that kind of speaks for itself.. (as does Ben’s recent belittling and sarcastic comments to me, Bob Fiddaman, David Healy and others in this debate).

I don’t see Ben Goldacre or Sense About Science engaging with people like me, or Bob Fiddaman- both damaged by GSK’s Seroxat. I don’t see them highlighting the plight and the horror stories of the hundreds of thousands of people who are damaged by pharmaceutical drugs either.

In fact, the attitude from doctors like Ben seems to me to be- ‘avoid pharmaceutical drug casualties like the plague- call us conspiracy theorists if we ask questions -and deem our criticisms as mere smears- our drug horror stories as anecdotal…’…

…the game seems to be to ‘silence us with ridicule and disparagement’ or ‘ignore us and we’ll go away’…

I can guarantee Ben, that if he was prescribed a damaging drug like Seroxat, and treated the way those injured and harmed by pharmaceutical drugs are treated and if he had to endure the lies of drug companies-  he would be a little angry about it too.. and quite rightly so…

When doctors, the regulators, the medical system, and even the government abandons you, often all you have left is the ability to shout..

We stand up for ourselves, because the people we entrusted with our health and our lives refuse to…


From David Healy’s latest: 

See more at: http://davidhealy.org/sense-about-science-follow-the-patient/#sthash.5nNxDICt.dpuf

“The simple act of defining doctors or patients concerned about adverse events as “critics” is a rhetorical stroke that marginalizes concerns – makes you  a one percenter rather than one of the ninety-nine”

“Despite doctors being trained to be ever more civil, patients who have a Drug Traffic Accident become nearly invisible to their doctors.  They are just healthcare kill.”

“When something does go wrong, the patient becomes a loser and is ostracised.  The herd moves on leaving the wounded animal to the hyenas”

“In essence, doctors have a choice.  They are either the steamroller that rolls over their patient or the steamroller rolls over them. The moment needs its John Le Carre to write The Doctor who came in from the Cold.  Just as I write this, news is coming in that some senior doctors have had the temerity to go public with claims – that despite Ben Goldacre’s paper on statins – these drugs cause significant problems.  Will they be shot as they attempt to get over the Wall?”

– See more at: http://davidhealy.org/sense-about-science-follow-the-patient/#sthash.5nNxDICt.dpuf

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ImageGen

GlaxoSmithKline sorry for drugs trial pitch to unpaid interns


http://www.theguardian.com/money/2014/jun/22/glaxosmithkline-gsk-interns-drug-trial-pitch

GlaxoSmithKline sorry for drugs trial pitch to unpaid interns

Pharmaceuticals company says tone of blog offered by marketer to graduate website ‘trivialises role of clinical trials’
The GlaxoSmithKline HQ in Brentford, Middlesex

The GlaxoSmithKline HQ in Brentford, Middlesex: the pharmaceutical company says a pitch to interns trivialised clincial trials. Photograph: Photofusion/REX

GlaxoSmithKline, the pharmaceuticals multinational, has apologised after being accused of playing on the hardship of unpaid interns to recruit them to take part in clinical trials.

A marketing firm working for the FTSE 100 company sought to place a blog on careers advice websites boasting that involvement in drug trials could help graduates to finance their way through unpaid work placements.

In a proposed “guest blog” for the website Graduate Fog, an employee at TouchPoint Digital, working on behalf of GSK, wrote: “Clinical trials could be your solution.”

A spokesman for GSK told the Observer the behaviour of the marketing company had been “unacceptable” and that it was no longer working with the firm. TouchPoint, of Cambridge, had contacted Graduate Fog with the suggestion of an “informative article about ways to earn money while job hunting, ie temporary solutions when struggling financially”, targeted at those who could not afford to take an unpaid internship.

The proposed article read: “Having a degree is fantastic, but that doesn’t mean much to start with if you don’t have work experience. Internships can be very valuable by giving you a step on that career ladder, but today most are unpaid. I did an unpaid internship for 3 months, and had a part-time job as well in order to support myself.

“However, perhaps you won’t have time for both jobs and would prefer an immediate income to tide you over for the coming months. Clinical trials could be your solution. Depending on the length of the study, you could earn up to £2,000 per trial for up to 4 trials a year, plus reasonable travel expenses.”

Touchpoint provided examples of similar articles previously published on websites targeted at students. In an email to the founder of Graduate Fog, Tanya de Grunwald, it added: “Your readers would also benefit if there is a small link at the end of the article to the GSK website, which is the biggest pharmaceutical company in the UK, so that if they want to find out more or get answers to more specific questions they can do so.”

De Grunwald said she rejected the article as “not just crass [but] downright irresponsible”.

GSK said it did not usually “specifically target young people in ads for clinical trial participants or approve of the use of inducements to recruit subjects of any age”. It added: “In this specific case, the agency was asked to create a general advertisement for clinical trial enrolment. We’re no longer working with the agency.

“The tone used here is wrong. It trivialises the role of clinical trials in developing new medicines and the part our volunteers play in that process. This isn’t acceptable and we’re looking into what happened.”

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.


‘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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GSK And Catch 22 (Wendy Dolan Sues For Husband Stewart’s Generic Paroxetine Induced Suicide)


This Present Madness

GSK and Catch 22

June 5, 2014 • Leave a comment

Editorial: This post by Johanna Ryan notes a significant legal development for anyone taking a generic drug.  Its also a testament to the ability of  motivated women to make a difference to the landscape.

We’re posting this interview with Wendy Dolin to draw attention to a victory – a possible break in the terrible legal Catch-22 faced by people in the United States who suffer harm after taking a generic drug.

Wendy will now be able to sue GSK for the suicide of her husband, Stewart Dolin, after six days on generic paroxetine or Paxil (Seroxat in the UK).   Under a theory endorsed by the Supreme Court in 2011, she could not sue Mylan, the generic drugmaker.   That’s because the law requires them to use the same information label, and the same chemical formula, as GSK developed for Paxil.   Yet she also couldn’t sue GSK, which developed the drug and wrote the label, because the six pills her husband swallowed were not made by GSK.   In February, however, a federal judge ruled that Wendy Dolin could indeed sue GSK for negligence.

Wendy Dolin has founded MISSD (The Medication-Induced Suicide Education Foundation in Memory of Stewart Dolin) to start a conversation in her community and beyond about the problem that took her husband’s life.   The takes on the issue full and squarely of the link between antidepressants and suicide in adults.  The risk of suicidal acts in 45-65 year olds from FDA data is the same as that in 18-25 year olds.  The mystery is trying to work out what was done to the data to try and hide and the risk to adults.  The data Pfizer sent to FDA for adults was totally different to the data they sent regulators in Europe and to the data the company itself published some years later.  See Where were the adults?

This interview, first aired May 27th on Chicago’s Channel 5 evening news, is part of that effort.  The video is here

And yesterday, June 4th, the 7th Circuit denied GSK’s writ questioning Judge Zagel’s ruling in this case.  GSK had argued that Judge Zagel’s decision was “patently wrong” and he – Judge Zagel – should be ordered to enter judgment in favor of GSK.

Watch this spot.  This could be legal history in the making.

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