Paxil (Seroxat) And The Dangers Of Suppressing Medical Research..


https://www.vox.com/the-big-idea/2017/8/1/16012946/clinical-trial-research-public-transparency

 

 

A surprising amount of medical research isn’t made public. That’s dangerous.

Dan Kitwood / Staff

When the results of clinical trials aren’t made public, the consequences can be dangerous — and potentially deadly.

Consider the case of the anti-depressant Paxil, produced by the drug company SmithKline Beecham (now part of GlaxoSmithKline). GSK got approval from the FDA in 1999 for treatment of depression in adults, but not in teenagers. That meant that while doctors could prescribe the drug to adolescents — a so-called “off label” prescription — GSK could not promote the drug to doctors for that purpose.

But the company did just that, according to criminal and civil complaints filed by the Justice Department and a suit by then-New York Attorney General Eliot Spitzer. What’s more, the Justice Department claimed, GSK selectively and misleadingly released information about three studies it had conducted of the drug: It hired a consulting company to write a journal article that played up evidence from one study that the drug worked better as a treatment for pediatric depression than a placebo, played down (better) evidence from the same study that it hadn’t, and soft-pedaled the side effects.

These side effects included suicidal thoughts and actions.

It buried two other studies, the Justice Department noted, in which Paxil had failed to show efficacy in treating depression.

In the end, GSK paid the US government $3 billion in fines for illegal and misleading promotion Paxil and other drugs, and, in 2004, the FDA required manufacturers to put a “black box” warning label on Paxil and other antidepressants about the potential risks of increased suicidal thoughts and actions when used in children and teenagers.

In 2015, researchers published a second look at the data and clinical study reports underlying the study GSK had relied on for promoting Paxil’s use in adolescents. They affirmed the drug “was ineffective and unsafe in this study.” This was part of a much bigger problem afflicting drug research, they said: “There is a lack of access to data from most clinical randomised controlled trials, making it difficult to detect biased reporting.”

You might think a crisis of that scope, involving teenage suicide and billions of dollars, would rouse the scientific establishment to make sure that the results of all clinical trials be made public. But it didn’t happen. Despite public campaigns, and even legal requirements, many clinical trials still report results publicly late or not at all. What, if anything, will prod researchers — and universities and drug companies — to act?

The issue at stake here isn’t the FDA’s approval process. The FDA makes drugmakers go through an intensive application process before it deems new drugs or medical devices safe and effective. When drug companies seek FDA approval for a drug or device, they aren’t allowed to cherry-pick which results they report. The agency requires that companies submit plans outlining all trials they’ll submit for approval, and scrutinizes the trial results (even conducting its own statistical review). But the FDA does not ensure that all of those trial results also enter the public view.

That means doctors and researchers trying to get a full picture of a drug’s effects are out of luck.

During the Paxil legal battles, there was not yet a law in the United States requiring that clinical trials publicly share their results. What is remarkable is that today there is such a law — yet researchers and companies often ignore it.

Some researchers do share their trial results through journal publications. However, one synthesis of studies on the topic found that from one quarter to one half of clinical trials are never published — or are published only years after trials end. In that same report, from 2012, new research found that roughly half of all trials funded by the National Institutes of Health remained unpublished 30 months after the end of a trial (though 68 percent were ultimately published at some point). The reasons for delays and non-publication vary, from researchers’ lack of interest in reporting negative results — the infamous “file drawer problem” — to constraints on the time of researchers.

Progress on transparency legislation

The research transparency movement has been gaining steam, but still can’t declare victory. A 1997 federal requirement mandated that researchers register some trials in a public database (those pertaining to serious or life-threatening diseases). Then in 2005, an association of medical journals started requiring that any study published in one of their publications be registered in an online database before the time of first patient enrollment. That didn’t guarantee results would be made public, but it at least provided an incentive to researchers to make some information about the trial available.

A few years later, an even bigger shift occurred. Congress passed the FDA Amendments Act of 2007, which required that “applicable clinical trials” register and publicly report results within one year of trial completion. (The requirement excluded some trials, such as Phase 1 trials of drug safety as opposed to efficacy.) The site ClinicalTrials.gov, run by the National Library of Medicine, had started posting general information about trials in 2000 — so sick people could sign up, for example — but now became the place where those results were posted. And the law included a penalty: Those who failed to report on time could face fines of up to $10,000 per day.

Yet nearly a decade later, it’s clear that many researchers and institutions basically ignore the law. They report trials late or not at all, but the FDA has yet to levy a fine. An investigation by the health journalism organization STAT, published in December 2015, looked at about 9,000 trials across 98 institutions, from 2008 to 2015. Of trials that were required by the FDA to report their results, 74 percent of industry trials were either not reported or reported late. The figure, maybe surprisingly, was even worse for academic institutions: 90 percent late or unreported.

By STAT’s calculation, if the FDA had enforced the law using the $10,000-per-day day fine, it could have collected over $25 billion since 2008, funding the agency several times over.

And the thrust of STAT’s conclusions has been echoed by other investigations. (After the Paxil episode, GSK, for its part, has been posting trial results to the company website; it also fares better than many other companies and institutions in several recent transparency scorecards.)

A medical culture too comfortable with non-publication and non-reporting

Why hasn’t the FDA enforced the 2007 law on publicizing results, and why hasn’t it levied financial penalties?

One reason, according to several of those that I spoke with, including Deborah Zarin, director of ClinicalTrials.gov, is that the 2007 law contained ambiguity about some of the requirements, including which trials were subject to the law.

Jennifer Miller, founder of Bioethics International, agrees that some researchers have been, at least till very recently, uncertain about whether the 2007 law applied to their trial. The language used in the law to describe applicable studies included the phrase “controlled clinical trials,” and there was some uncertainty about which trials would count as “controlled.” “How can you impose fines on an ambiguous law?” Miller said.

Researchers I spoke to emphasized, however, that clinical trial results are not just a legal issue: It’s an ethical matter, too. Regardless of the law, shouldn’t reporting results be part of the culture of doing clinical trials?

If so, there’s a problem with the current culture. Researchers are rewarded primarily for publishing as much as possible in the highest-ranked journals that they can, says Joseph Ross, an associate professor of medicine at Yale and an associate editor at JAMA Internal Medicine. “There’s no clear incentive for investigators to have a member of their staff do everything required by ClinicalTrials.gov. It gets deprioritized because it is a substantial amount of work, and investigators don’t put it at the top of their list.”

Competition may play a role. Someone who is running a trial might think: “My competitor has similar molecules in the pipeline, why should I tell them why it failed so that they don’t pump money into it?” says Tomasz Sablinski, co-founder of the drug development firm Transparency Life Sciences, who was previously with the pharmaceutical company Novartis.

How to change the norms, so that there’s an internal commitment to reporting results from researchers and institutions? Steven Goodman, an associate dean and professor of medicine at Stanford, notes that it will be important for institutions to provide education to researchers on how to report results, and pay for staff support.

AllTrials, a nonprofit organization founded by medical doctor and public intellectual Ben Goldacre, took on the mission of pushing for clinical trial transparency. AllTrials, which started in the UK and also has a campaign in the US, thinks the laws don’t go far enough: None of the regulations governing clinical trial reporting require sharing results retroactively (that is, before the laws are passed), which leaves many results for already-approved drugs unreported.

Goldacre also collaborated with a web developer and scientist, Anna Powell-Smith, to create the automatically updated Trials Tracker. The tracker scans ClinicalTrials.gov and PubMed to identify how many clinical trials have been reported by companies and institutions with 30 clinical trials or more. After working on transparency for many years, Goldacre believes “naming and shaming” is the main thing that will really grab the attention of those who haven’t reported their trials.

Momentum seems to be gathering, although the Trump administration’s commitment to the cause remains uncertain. In September 2016, Health and Human Services, which oversees the FDA, issued a “final rule” clarifying and expanding the requirements of the 2007 law: It specifies what was meant by “controlled clinical trials,” among other things. (“All interventional studies with prespecified outcome measures.”) The rule also expands the scope of the requirement to include results from certain trials of new drugs and devices which haven’t yet been approved by the FDA.

The National Institutes of Health (NIH) also announced a policy in September 2016 requiring that all its grant recipients publicly report their clinical trial results. The NIH policy and HHS final rule took effect on January 18. Will the organizations ramp up pressure to comply with the law, and will researchers take this obligation seriously? It’s too soon to say.

The obligation to research participants

One reason to care about whether clinical trial results are shared is that hundreds of thousands of patients have put themselves on the line as research subjects. We owe it to them not to let the information their participation enabled get stuck in a file drawer.

“If we made a pact with a person to enter into this experiment, then we have an ethical and scientific obligation to have the results out there, no matter what happened,” said Stanford’s Goodman.

Everyone who conducts a clinical trial should report their results, whatever the outcome. It’s the law, and it’s past time that it was followed. When researchers fail to do so, we should point that out early and often — for the sake of public health.

Stephanie Wykstra is a freelance writer and consultant with a focus on research transparency. She has recently worked with nonprofits including AllTrials USA and Robert Wood Johnson Foundation. Twitter: @Swykstr.

Donation Option..


Click on the paypal Link Below if you’d like to donate.

PayPal-Donate-Button-PNG-File-180x100

 

 

I’ve recently set up a PayPal account and readers have the option of making a donation towards the upkeep of this blog– should they wish to (if not- that’s totally fine too). I got the idea from reading the Guardian website (which also offers a donation option). In the digital age, broadsheet newspapers are finding it difficult to survive, and most now offer a donation option or have a paywall. I don’t expect much in the way of donations to be honest, as my blog isn’t a commercial or mainstream site, however I do believe that the research, writing, blog posts and activism, I have done over a decade here, attest to the work and dedication I have put in.

Writing and blogging, takes time and effort, and I’m proud of the work I have done for over 10 years now. I like to write anyhow, and the stuff I write about needs to be expressed. I get regular hits from the BBC and the Guardian (among many others), and I have certainly covered a wide range of controversial topics in the best journalistic manner I could over the years. I try my best to blog well, and I try to blog about interesting topics not often covered in the mainstream.

The option is there now to donate. Either way, I will continue to blog for as long as my health allows me to. I’ve recently had some health set backs, so I will be taking intermittent breaks to rest and nurture myself. There is usually always something interesting to cover on the blog, and I feel compelled to write most of the time, as it has become a passion of mine. Even if people don’t choose to donate, I will still always very much appreciate people reading, and any kind of support is always humbly appreciated.

Thanks

Even if you don’t donate, I hope you enjoy this beautiful song anyhow!…

 

 

Reed Smith Widow Fires Back At GSK Bid For New Trial


https://www.law360.com/articles/945046/reed-smith-widow-fires-back-at-gsk-bid-for-new-trial

Law360, New York (July 17, 2017, 8:40 PM EDT) — The widow of a Reed Smith LLP attorney who died after taking a generic form of one of GlaxoSmithKline’s antidepressant drugs has blasted the company’s bid for a new trial, saying the company’s arguments for a do-over ignore evidence that does not fit its narrative.
A jury this spring awarded Wendy Dolin $3 million in her suit claiming her husband Stewart committed suicide after taking the generic version of GSK’s antidepressant Paxil and that the company failed to disclose the risk, and the company is now seeking a new trial, arguing Dolin didn’t prove her husband’s physician had been improperly warned about the drug’s side effects.

But Dolin on July 12 shot back at the pharmaceutical giant’s request for a new trial, saying that its claims are “patently untrue.”

For instance, GSK said that Stewart Dolin’s doctor testified he knew that suicidality was a common side effect of drugs like Paxil before he prescribed the drug and that he informed his patients, including Dolin, of the risks.

“These bold pronouncements of the record are, at best, misplaced and, at worst, outright false,” his widow said.

But the doctor testified that he relied on the 2010 Paxil label when he made his decision to prescribe the drug, which didn’t warn that Paxil could lead to suicidal behavior in adults over the age of 24. And he also testified that if GSK had warned of that risk, he wouldn’t have prescribed the drug to Dolin in 2010, Wendy Dolin said.

GSK argues the doctor knew that Paxil could induce suicidality in adults over age 24, since there was was language about suicide risks for all ages, according to Dolin.

But that’s a conflation of his testimony — the doctor knew that suicide was a risk associated with depression and anxiety, but not that Paxil could up that risk in adults over age 24, Dolin said.

GSK also argues that the U.S. Food and Drug Administration considered the label change Dolin said was necessary to fully warn doctors and rejected it, Dolin said.

But Dolin says GSK never proposed the warning that should have been included on the label, a short statement that taking Paxil is associated with suicidality in adults older than 24.

“Since GSK never attempted to insert that simple warning anywhere into the Paxil label, GSK cannot meet its burden of providing ‘clear evidence’ that the FDA would have rejected such a labeling change, especially when the only FDA expert to testify at trial rejected that notion,” Dolin said.

Dolin sued GSK in 2012, two years after her husband stepped in front of a train in downtown Chicago. Stewart Dolin had struggled with anxiety and depression off and on, and had begun taking generic Paxil just a few days earlier.

After the judge ruled that GSK is liable for the labeling on the generic versions of its drugs, Dolin argued the company had failed to alert the U.S. Food and Drug Administration to data that showed an increased risk of suicide in adults who take Paxil. With a short exception, the potential for suicide in adults was left off the drug’s label, the suit said, leaving doctors uninformed.

A jury agreed with Dolin, awarding her $2 million for Stewart’s wrongful death and $1 million for the pain he suffered in the days before he took his own life.

The FDA also invited GSK to discuss the inclusion of adult Paxil-specific language about suicidality in the label at a formal meeting in 2007, but the company didn’t take the agency up on its offer, Dolin said.

Representatives for the parties didn’t immediately respond to requests for comment on Monday.

Wendy Dolin is represented by R. Brent Wisner, Michael L. Baum, Bijan Esfandiari and Frances M. Phares of Baum Hedlund Aristei & Goldman PC, and David Rapoport, Joshua L. Weisberg and Melanie VanOverloop of Rapoport Law Offices PC.

GSK is represented by Andrew T. Bayman, Todd P. Davis, Ursula Henninger and Heather M. Howard of King & Spalding LLP and Alan S. Gilbert and Anders C. Wick of Dentons LLP.

The case is Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403, in the U.S. District Court for the Northern District of Illinois.

What Did They Prescribe Chester Bennington?


Petrusich-Chester-Bennington-1

 

http://www.eonline.com/news/868229/the-dark-side-of-linkin-park-s-chester-bennington-alcoholism-and-depression-inspired-and-plagued-singer-shadowing-his-massive-success

 

“…Meeting his second wife helped pull him out of a period of “absolute self-destruction,” he told Bullz-Eye.com in 2009 while promoting Out of Ashes. “I don’t know when to stop when I’m in that mode. I’ll go through a gallon of Jack Daniels and down some antidepressants in one night and keep on going. I just hated my life at one point. I loved my band, career and friends, but when I got home from tour, I couldn’t deal with stuff. I would just begin drinking.”

 

RIP Chester..

 

https://www.theguardian.com/music/2017/jul/21/chester-bennington-obituary

Chester Bennington obituary

Vocalist with the band Linkin Park whose sound was emblematic of the nu-metal genre

Current Time 0:00
/
Duration Time 0:52
Loaded: 0%
Progress: 0%
Mute

Linkin Park’s Chester Bennington dies aged 41

The death of Chester Bennington, vocalist with the rap and nu-metal band Linkin Park, at the age of 41, curtails a brilliantly successful career that brought a string of awards and multimillion-selling albums and singles. Linkin Park enjoyed enormous and immediate acclaim with their debut album Hybrid Theory (2000), released on Warner Bros after the band had been rejected by several labels. The combination of Mike Shinoda’s rapping and Bennington’s soaring, impassioned singing became the band’s instant focal point, with the group’s metallic thunder enhanced by edgy electronic treatments. Their sound became emblematic of the nu-metal genre, alongside like-minded artists such as Korn and Limp Bizkit.

Hybrid Theory sold nearly 5m copies in its first year and to date has sold more than 20m, and reached No 2 on the US chart and No 4 in the UK. The singles Crawling, One Step Closer and In the End became radio favourites, receiving heavy airplay on MTV, and in 2002 Crawling won a Grammy for best hard rock performance. The album Reanimation (2002) comprised remixes of Hybrid Theory songs plus additional material, and was another international multimillion-seller.

When the band released Meteora in 2003, following intensive touring in the US, including dates with their own multi-artist Projekt Revolution tour, it shot to the top of the US and UK album charts and spawned a fresh batch of hit singles, including Somewhere I Belong, Breaking the Habit and Numb, the last of these an anthem of Bennington’s disconnection from the world. The album went on to sell more than 10m copies. In 2004, Linkin Park teamed up with Jay-Z on the EP Collision Course, mixing rap with metal; the track Numb/Encore, splicing together the band’s Numb with Jay-Z’s Encore, went to 20 on the US singles chart and 14 in the UK. In 2005 it won a Grammy for best rap/sung collaboration.

But while his music provided a cathartic outlet, Bennington had experienced an assortment of emotional and drug-related issues since childhood. He was a close friend of Chris Cornell, the lead singer of Soundgarden, who killed himself in May, and wrote a heartfelt posthumous letter to Cornell. Bennington was found dead at his home in California on what would have been Cornell’s 53rd birthday.

Bennington was born in Phoenix, Arizona. His mother, Susan Elaine Johnson, was a nurse, and his father, Lee Russell Bennington, a police detective who often worked on child abuse cases. They divorced when he was 11, after which his father gained custody of Chester. He had two older sisters and an older half-brother, Brian. Since his father often worked double shifts, Chester frequently found himself at home alone. He fell into a pattern of drug and alcohol abuse, and, he once told Metal Hammer magazine, “dropped so much acid I’m surprised I can still speak. I’d smoke a bunch of crack, do a bit of meth and just sit there and freak out. Then I’d smoke opium to come down.”

His emotional state was further affected by the fact that he suffered sexual abuse by an older friend between the ages of seven and 13. “It destroyed my self-confidence,” he told Kerrang! in 2008. “Like most people, I was too afraid to say anything. I didn’t want people to think that I was gay or that I was lying.” He was also bullied at school.

He found some respite in drawing and songwriting, and was a fan of Depeche Mode and Stone Temple Pilots. At 17 he moved in with his mother, and worked at Burger King while attempting to become a musician. His first group, Sean Dowdell and His Friends?, made a three-track cassette in 1993, after which Bennington and Dowdell formed the alternative-rock band Grey Daze, who released three albums during the 1990s.

Bennington married Samantha Olit in 1996, quit Grey Daze in 1998 and moved to Los Angeles to further his musical career. He auditioned for a band called Xero, and when he was hired as vocalist he completed the original line-up of what then became Linkin Park (a pun on Lincoln Park in Santa Monica), alongside Shinoda, Brad Delson, Dave Farrell, Rob Bourdon and Joe Hahn.

In 2005 Bennington put together a side project, Dead By Sunrise, featuring musicians from Orgy and the Street Drum Corps and comprising songs he considered “darker and moodier than anything I’d come up with for the band”. In 2009 they released their only album, Out of Ashes, which scraped into the US Top 30.

Linkin Park returned in 2007 with the album Minutes to Midnight, co-produced with Rick Rubin and marking a deliberate step towards a more mainstream rock sound. This delivered the big hit singles What I’ve Done, Bleed It Out and Shadow of the Day, which all scored heavily in the American alt and rock charts. New Divide, from the soundtrack compilation album Transformers – Revenge of the Fallen (2009), gave them another major hit. Their subsequent albums, A Thousand Suns (2010) and Living Things (2012), saw sales falling way below their earlier peaks, but they still delivered big hit singles including The Catalyst, Waiting for the End and the anthemic Burn It Down.

In 2013 Bennington joined Stone Temple Pilots after they fired the vocalist Scott Weiland, and, after recording the EP High Rise, stayed with them until 2015. “I got to create and perform with one of the greatest rock bands of our generation, that had so much influence on me growing up,” he said afterwards. He was back with Linkin Park for The Hunting Party (2014), on which they tacked back towards a heavier rock sound. One More Light (2017) was, by comparison with the group’s original sound, virtually a pop record. “It’s a great record, we love it,” insisted Bennington to hostile critics, and the album shot to the top of the US Billboard chart.

Bennington had tackled his addiction issues with some success, admitting falling off the wagon in 2005 when he divorced, but getting clean again in 2006 when he married Talinda Bentley, a schoolteacher and former model. In the run-up to the release of One More Light, he seemed optimistic and positive, saying that he had shaken off the depression he had felt two years earlier. “I know exactly who I am, I know exactly what I’m made of and I’m totally happy with it,” he said.

He is survived by Talinda and their children, Tyler Lee, Lily and Lila; by a son, Draven Sebastian, from his first marriage; and by two sons, Jaime and Isaiah, from a relationship with Elka Brand.

Chester Charles Bennington, singer and songwriter, born 20 March 1976; died 20 July 2017

 

Watch The Full Panorama Documentary ‘A Prescription For Murder’ Here…


Is it possible that a pill prescribed by your doctor can turn you into a killer? Over 40 million prescriptions for SSRI anti-depressants were handed out by doctors last year in the UK. Panorama reveals the devastating side effects on a tiny minority that can lead to psychosis, violence, possibly even murder. With exclusive access to psychiatric reports, court footage and drug company data, reporter Shelley Jofre investigates the mass killings at the 2012 midnight premiere of a Batman movie in Aurora, Colorado. Twenty-four-year-old PhD student James Holmes, who had no record of violence or gun ownership, murdered 12 and injured 70. Did the SSRI anti-depressant he had been prescribed play a part in the killings? Panorama has uncovered other cases of murder and extreme violence which could be linked to psychosis developed after the taking of SSRIs – including a father who strangled his 11-year-old son. Panorama asks if enough is known about this rare side effect, and if doctors are unwittingly prescribing what could be a prescription for murder.

Dr David Healy Explains, In Detail, Why He Thinks James Holmes Had A Severe Reaction To The SSRI Sertraline (Zoloft/Lustral)


Anybody taking SSRI’s can end up in the same predicament as James Holmes, particularly if the SSRI is making you agitated, aggressive, or act ‘out of character’. The only difference between those who act out aggressive SSRI reactions, and those that don’t, is a hair’s breath and bad luck…

I know, because I have been there…

See Dr David Healy’s compelling new post on RXisk.org

https://rxisk.org/prescription-for-murder/

Prescription for Murder

Print Friendly
July 26, 2017 | 4 Comments

The BBC’s Explosive Documentary On SSRI (Antidepressant) Induced Violence Airs Tonight…


 

So BBC panorama are airing a Panorama investigation tonight into anti-depressant induced violence, and of course, even before the documentary has aired, we have all the pro-SSRI mouthpieces (most notably from the Royal college of Psychiatry UK) coming out en masse to condemn it before it has even been broadcast.

This is no surprise considering the Royal college of psychiatry and most of its members (not just UK psychiatrists but global psychiatrists) have long been in the pocket of the pharmaceutical industry. Of course, most of the mainstream media outlets, fail to mention that very significant fact.

However, despite the melodrama, it was interesting to note the position of Mind (the UK’s biggest and most respected mental health charity) who said:

….”Stephen Buckley, head of information at Mind, said: “Millions of people take SSRIs and other antidepressants and many find them useful in managing their mental health problems. “Side effects from medication can be serious but it’s important to recognise that severe side effects such as those explored in this programme are incredibly rare. “Anyone prescribed medication for a mental health problem should be fully informed about the drug and its side effects so they can make an informed choice about whether it’s the right treatment for them.”…


Stephen Buckley, from Mind, is wise to err on the side of caution, and that is part of what his job entails, however isn’t it interesting that he does not disagree with the findings of the documentary? He says that “severe side effects such as those explored in this programme are incredibly rare“. I agree with him, somewhat, antidepressant induced violent acts are relatively rare, however, anti-depressant induced violent thoughts are perhaps more common than most people realize.

Many people have antidepressant induced violent thoughts and impulses, it’s just Russian Roulette that decides who will act on them, and who won’t..

Seroxat (GSK’s notorious SSRI) causes aggression, akathisia (a feeling of unbearable anxiety), and violent thoughts/dreams/impulses; the whole class of SSRI drugs can cause these reactions. Many tens of thousands of people have been saying this about them for decades. I have experienced these side effects myself, from Seroxat.

There is no disputing this.

Of course, the (owned by the Pharmaceutical industry) Royal College of Psychiatry, and the other organizations with vested interests, will dismiss my experiences, and those of others who were harmed by SSRI’s, as merely anecdotal, but in the same breath they will quote (anecdotally) that that ‘these medicines save lives’. They will then quote the vague and mysterious ‘evidence based medicine’ to back up their stance, but what they won’t tell you is that the ‘evidence base’ is entirely unreliable, and in most cases -utterly corrupted, and in the worse cases- outright lies. They won’t tell you that the pharmaceutical industry is among the most corrupt industries on the planet (see Whisleblower Greg Thorpe’s GSK felony complaint here), and that death from psychiatric drugs in particular is a staggeringly high outcome for many.

See SSRI Stories for many thousands of documented cases

Or QuitPaxil.org for more.

 


https://www.thesun.co.uk/tvandshowbiz/4061091/a-prescription-for-murder-on-bbc-one-shelley-jofre-time-documentary/
CAN A PILL MAKE YOU KILL?

When is A Prescription For Murder? on BBC One, who is Shelley Jofre and what’s the documentary about?

Find out about this new show that looks at whether a pill can cause you to kill

A PRESCRIPTION For Murder? is a BBC documentary focusing on the potential effects of prescription antidepressants.

But what is it about? And when can you watch it? Here’s what we know…

A Prescription For Murder is a new BBC documentary fronted by Shelley Jofre

NOT KNOWN REFER TO COPYRIGHT HOLDER
2
A Prescription For Murder is a new BBC documentary fronted by Shelley Jofre

What is A Prescription For Murder?

This new Panorama documentary looks into whether prescription antidepressants can turn you into a killer.

Over 40 million prescriptions for SSRI antidepressants were handed out by doctors last year in the UK.

Panorama reveals the devastating side effects on a tiny minority that can lead to psychosis, violence, possibly even murder.

With exclusive access to psychiatric reports, court footage and drug company data, reporter Shelley Jofre investigates the mass killings at the 2012 midnight premiere of a Batman movie in Aurora, Colorado. Twenty-four-year-old PhD student James Holmes, who had no record of violence or gun ownership, murdered 12 and injured 70.

Did the SSRI antidepressant he had been prescribed play a part in the killings?

Panorama has uncovered other cases of murder and extreme violence which could be linked to psychosis developed after the taking of SSRIs – including a father who strangled his 11-year-old son.

Panorama asks if enough is known about this rare side effect, and if doctors are unwittingly prescribing what could be a prescription for murder.

When is A Prescription for Murder? on?

You can catch the show at 9pm on Wednesday July 26, 2017.

If you miss it, you can catch it again on the BBC iPlayer.

Who is Shelley Jofre?

Shelley is a journalist who was born in Irvine, Ayrshire.

She began her career back in 1995 and is now one of the top investigators for Panorama.

Shelley is married and has a daughter.

James Holmes was responsible for the Batman shootings

GETTY IMAGES
2
James Holmes was responsible for the Batman shootings

Who is James Homes and what was the Aurora massacre?

James Eagan Holmes was born December 13, 1987 and is an American convicted mass murder.

He was responsible for the Aurora cinema shooting that killed 12 people and injured 70 others at a Century movie theatre in Aurora, Colorado, on July 20, 2012.

He walked into a midnight screening of Batman movie The Dark Knight Rises and threw two gas canisters into the audience.

Many in the audience thought it was a publicity stunt until he began spraying the crown with the shotgun, then the assault rifle and finally the pistol.

A witness said he went outside and and shot people as they ran.

Cops apprehended Holmes in his car behind the cinema within minutes of the shooting. He told them that he was “The Joker”.

On August 7 2015 Holmes was sentenced to life in prison without parole, avoiding the death penalty because the jury could not come to a unanimous decision.


http://www.bbc.co.uk/news/resources/idt-sh/aurora_shooting

 

The Batman Killer –
a prescription for murder?

James Holmes, a young man with no record of violence, murdered 12 people watching Batman in a Colorado cinema in 2012.

Did an SSRI antidepressant, prescribed by a doctor, play a part in the killings?

He slumps wild-eyed across the desk from detectives, with a mess of badly dyed red hair, his clothes hanging off him.

James Holmes looks every inch the monster who coldly executed 12 innocent people and injured dozens more at a midnight screening of the Batman film, The Dark Knight Rises.

Holmes had carried out the killings with an arsenal of weaponry he had accumulated in the preceding weeks. He had planned the shootings down to the tiniest detail, even booby-trapping his own apartment with home-made bombs to divert police resources while he launched the attack.

Watching a recording of his interview at the police station, conducted just hours after he carried out one of the worst mass shootings in recent US history, who could feel anything but loathing for this callous 24-year-old graduate student? When asked how to spell his surname, Holmes cockily replies, “Like Sherlock”.

When left alone with paper bags on his hands to secure forensic evidence, he’s caught on camera using them to talk to one another, like sock puppets.

The only hint he may have some inkling of what he’s just done is when he asks a detective, “There wasn’t any children hurt?” In fact, six-year-old Veronica Moser-Sullivan was the youngest of Holmes’s victims that night in July 2012 – killed as she watched the movie premiere with her mother at the packed cinema in Aurora, Colorado.

Americans have become wearily accustomed to mass shootings. Usually, in the days and weeks that follow, some kind of warped explanation emerges – be it terrorism, revenge or a predisposition to violence. It’s highly unusual for the perpetrator to be taken alive. Usually they are killed or kill themselves at the scene.

Holmes survived, and as the evidence stacked up it looked like another tragic collision of mental breakdown with America’s lax gun laws.

Holmes's Glock 22 Pistol photographed on the bonnet of his car

Holmes’s Glock 22 Pistol photographed on the bonnet of his car

Why else would a clever, shy guy with no history of violence, from a loving home, carry out such a heinous attack? Holmes had no enemies, no terrorist ideology to drive him on.

But the student had been seeing a psychiatrist at the University of Colorado Denver and this was no barrier to him buying a handgun, tear gas, full body armour and a semi-automatic rifle.

 .223 M&P Assault Rifle photographed outside the cinema

 .223 M&P Assault Rifle photographed outside the cinema

Before he faced a court of law, Holmes was evaluated by a number of psychiatrists. No two doctors reached exactly the same conclusion. There were diagnoses of schizophrenia, schizoid personality disorder, schizotypal disorder – or no diagnosable disorder at all. Some thought Holmes couldn’t legally be held responsible for his crime, on grounds of insanity. Others disagreed, arguing he still knew right from wrong when he carried out the shootings.

When these questions came before a jury two years ago, the verdict was unanimous. Holmes was found guilty on all counts of murder and multiple counts of attempted murder.

Judge Carlos Samour Jr said:

It is the court’s intention that the defendant never set foot in free society again. Get the defendant out of my courtroom please.”

He was led from the dock to jeers of “loser”, as his bewildered parents Bob and Arlene looked on, to begin one of the longest prison terms in US history – 12 life sentences plus 3,318 years in prison. He only narrowly escaped the death penalty.

Holmes is being held in solitary confinement at a maximum security prison in an undisclosed state, because the nature of his crimes make him a target for other prisoners. That’s how he will spend the rest of his days.

Like any other casual observer skimming over the court reporting online, I thought justice had been done, and that this was where Holmes’s story ended. Then I spoke to psycho-pharmacologist and long-time campaigner on the potential dangerous side effects of antidepressants, Prof David Healy.

Healy had been hired as an expert witness in the James Holmes case and had visited him in jail before the trial. The public defender appointed to represent Holmes wanted Healy to evaluate whether the antidepressant sertraline (also known as Lustral in the UK and Zoloft in the US), which Holmes had been prescribed, could have played a role in the mass murder.

Prof David Healy

Prof David Healy

I have worked with David Healy in the past on a number of investigative films for the BBC’s current affairs programme, Panorama.

These films revealed cases where people with no previous history of suicidal thoughts or violence went on to seriously harm themselves or others after being thrown into a state of mental turmoil by the newer generation of SSRI antidepressants, such as paroxetine and fluoxetine.

Before meeting Holmes, Healy doubted the pills had played a part. But by the end of his prison visit he had reached a controversial conclusion.

He was never called to give evidence at the trial of James Holmes, but he told me in August 2016 that he would have told the court:

These killings would never have happened had it not been for the medication James Holmes had been prescribed.”

David Healy

SSRIs are thought to work by boosting serotonin levels to the brain.

Stephen Buckley, from mental health charity Mind, says:

Millions of people take SSRIs and other antidepressants and many find them useful in managing their mental health problems. Side effects from medication can be serious but it’s important to recognise that severe side effects are incredibly rare.”

He adds that no-one should stop taking medication suddenly, without advice from a health professional.

“If anyone is concerned that they may be experiencing harmful side effects they should speak to their doctor or pharmacist about alternatives.”

Prof Wendy Burn, president of the Royal College of Psychiatrists, says: “In all treatments – from cancer to heart disease – medicines which do good can also do harm. This applies in psychiatry. Current evidence from large-scale studies continues to show that for antidepressants the benefits outweigh the risks.”

David Healy maintains that while antidepressants can be a lifesaver for some, for others they can cause more harm than the original problems they were prescribed to treat.

But what makes a young man plan over months a mass shooting, then carry it out with cold precision? Could antidepressants possibly do that?

‘He was too good’

Arlene and Bob Holmes sat through every day of their son’s trial but rejected all approaches to talk in public about their son out of respect for the victims and their families.

However, a book that Arlene wrote, When the Focus Shifts: The Prayer Book of Arlene Holmes 2013-2014, gives an insight into her thoughts in the run-up to the trial in April 2015.

Arlene and Bob Holmes arrive at the court building

Arlene and Bob Holmes arrive at the court building

In one section, she describes the effects of taking the lowest dose of an SSRI antidepressant in March 2014:

I have become fatter, ‘flatter’, dumber, number. Less tearful, yes. Unfortunately, less of everything. The sunset and the beach no longer lift my spirits.”

She continues: “I sit through church service and sift through the Bible, uninspired. I’m fuzzy. Weird dreams. Crying used to be a release. Now I cannot cry, or laugh. I hate this feeling.”

Arlene Holmes, a nurse, wrote that she stopped taking the pills before the trial, telling her doctor she wanted to be able to feel things and to cry if she wanted to.

If she had a bad experience with an SSRI antidepressant, what would she make of David Healy’s view of her son’s case?

I contacted the couple’s lawyer explaining my own background in investigating antidepressants and suggesting that Arlene and Bob Holmes might hold information that could, ultimately, help prevent future tragedies.

A few weeks later an email from Arlene dropped into my inbox. Short and to the point, it requested more information and asked me not to share her contact details with anyone.

“Some people bear my family ill will,” she wrote.

When we finally spoke on the phone, it became clear Arlene and Bob had never seriously considered the effect antidepressants might have had on their son’s behaviour. In fact, they hadn’t even known of David Healy’s involvement as a pre-trial expert witness.

Persuaded that exploring their son’s case in depth may ultimately help others, they reluctantly agreed to a filmed interview. It wouldn’t help their son – they know he will spend the rest of his life in prison.

Approaching their low-rise detached home in a neat suburb of San Diego, what struck me was the sheer ordinariness – a man out washing his car, another mowing his lawn, kids playing baseball in the park. Inside, the Holmes’ house is modest, understated – just like Arlene and Bob.

“We are an introverted family,” says Arlene. “We are not showy but we like having people around. We care about the larger picture in society and we are Christians, we go to church.”

If you had told me this would happen to us I just wouldn’t have believed it.”

Arlene Holmes

The couple have struggled to understand how their boy could cause so much hurt and pain to others.

“Not in your wildest dreams would you think your son would shoot strangers,” says Arlene. “For someone who loved kids and dogs and always did his homework and his chores. You can’t believe it is possible for anyone to cause that much harm, let alone the man you raised.”

She says they never saw any signs of violence, and that her son had not shown any interest in drink or drugs.

“In retrospect, I think he was too good. Maybe I should have worried about the fact he was so good, but as a mother you can worry about just about anything.”

Bob Holmes, a retired statistician, is a man of few words.

“He was never interested in guns or really even a violent kid, that’s why it was surprising. It came out of nowhere. He seemed happy enough, just pretty much a normal everyday kid growing up, so…” Bob’s voice trails off as though he can’t bear to finish the thought.

They say there had been ups and downs along the way but little to mark them out from any other family.

They moved home when James was 13 and he found the transition hard. He was quiet but he had friends and took part in sports. He cruised through his academic work at school and, later, as an undergraduate.

Bob and Arlene speak about taking James to a counsellor:

The first real hump in the road was when Holmes applied to six top universities to study for a doctorate in neuroscience. Academically bright, his shyness in interviews appeared to work against him. He was rejected by all of them.

“He came home and he just kind of didn’t do much of anything for a while, and he just kind of hung out,” says Bob.

Arlene says her son was sleeping a lot and not going out much.

“So I got mad and I said, ‘You are done with college, you need to do something.’”

Holmes took his mother’s advice and found a job working night shifts in a pill factory while he applied to more universities.

In 2011, he accepted an offer to study neuroscience at University of Colorado Denver and started in the autumn. Not his first choice, says his mother, but it all seemed to be working out fine.

“He still was happy to be at Colorado, talked to us about eventually settling and he eventually borrowed money to buy a town house on the outskirts of Denver,” she says.

So when you hear something like that, the last thing in the world that you would ever think is that something as bad as a shooting could possibly happen. He was planning a future there.”

Very few of Holmes’s former friends are willing to talk, but one – a young man who knew him well as an undergraduate – spoke to me on condition of anonymity. The Holmes he knew and liked was just as Bob and Arlene described – shy, polite, frugal and smart.

They used to play video games together – strategy games, not the violent kind, he says. There was the occasional beer, but no drugs, parties or girls.

“We were pretty nerdy,” he says.

Discovering someone he was close to could commit mass murder had been “a profound experience”. When he heard what his friend had done, he knew something must have happened to him.

“I still don’t know how to make sense of it,” he says.

Hillary Allen

Hillary Allen

Someone who spent time with Holmes in the crucial months before the shootings was Hillary Allen, a fellow graduate student on the neuroscience programme at CU Denver.

In class he didn’t really take notes, so that was something that made me jealous because I was vigorously writing notes down… it seemed like he got a lot of work done in his lab and he seemed very successful. I remember thinking like, ‘Wow, James is very smart, he’s very intelligent’”

Sometimes the friendship was hard work.

“He was kind of quiet and kept to himself. He did have a kind of a quirky sense of humour,” says Allen.

“We were part of a group of scientists so I think everyone’s a bit odd. Maybe he was a little bit more odd than the rest of us, maybe more socially awkward.”

Socially awkward. It’s a phrase that comes up time and again to describe Holmes. It’s what led him to make contact with the university counselling department in the spring of 2012, just months before the shootings.

Cracks had started to appear in Holmes’s apparently effortless success. Over the Christmas break he was diagnosed with glandular fever. Tired and ill for the first couple of months of 2012, he kept going to classes, but his work was going downhill.

The shy and anxious Holmes found giving presentations in front of his classmates particularly hard.

His first proper relationship with fellow graduate student Gargi Datta had also come to an end. Datta didn’t want to speak to me, but according to Arlene Holmes the break-up hit her son hard.

I think he loved her. He did say that she wanted to still see him again, which he found difficult to understand since they were broken up

“It was a cordial break-up. That’s the word he used, ‘cordial’. They both parted as friends.”

It was Datta who suggested Holmes seek help at the campus student wellness centre. On 21 March 2012, James Holmes had his first appointment there with psychiatrist Dr Lynne Fenton.

Sifting through the mountain of court testimony and evidence, this date sticks out.

Does it – as the prosecution would argue – mark the point at which Holmes first acknowledges he’s struggling mentally in the perfect storm of his relationship breakdown, academic problems and long-standing social anxiety? A storm that explains why he decided he had nothing to lose and everything to gain from killing as many people as he could?

Or was that date significant – as David Healy would say – because it was the day Lynne Fenton prescribed to James Holmes the antidepressant, sertraline?

Mania

First page of Holmes’s notebook

In his first meeting with Lynne Fenton, Holmes was hard to engage but described his anxiety around people. And during that 45-minute session worrying details emerged that he’d never talked about with his family.

Holmes said he was having thoughts of killing people three or four times a day.

Although it sounds alarming, Fenton didn’t regard him as dangerous at that point. The thoughts were abstract, there was no plan or, it seemed, any real intent. She prescribed the antidepressant sertraline to ease his anxiety and obsessive thoughts.

Holmes in custody

Holmes in custody

In later prison interviews with court-appointed forensic psychiatrist Dr William Reid, Holmes said he’d had intrusive thoughts like this since his teens. Not of actually killing people, rather of wishing them dead to escape from awkward social situations.

According to Reid, these kinds of intrusive thoughts are not uncommon.

“He wasn’t talking about a vengeful hatred,” he says. “He was talking about an aversion to mankind. Being around much of mankind was uncomfortable to him and it wasn’t very rewarding to him so he wanted to avoid it.”

With hindsight, it provides a clear motive, according to Colorado District Attorney, George Brauchler, who successfully prosecuted the case. He says Holmes had a long-standing hatred of mankind – that’s why he killed so many people.

As he puts it, Holmes was “evil”.

District Attorney, George Brauchler

District Attorney, George Brauchler

Brauchler says Holmes kept his evil desires at bay until it became clear he wasn’t going to get what he wanted to be happy.

He’s not going to get that PhD, he’s not going to find that woman to love and have that house with those two kids and the dog. And that’s when he turns his sights on this lifelong passion that he’s had to kill other people and that’s when we see him start to set these things in motion.”

It’s a persuasive argument, and one some experts, and ultimately the jurors, had no trouble in accepting. But the timeline of what happened between Holmes’s first prescription of sertraline and the shootings wasn’t explored at trial.

When you scrutinise that timeline, it raises serious questions about the role of the widely prescribed antidepressant.

Page from Holme’s notebook

Just before he carried out the shootings, Holmes posted to Fenton a notebook he had written in. At times rambling, it gives some contemporaneous insight into his troubled mind. Both William Reid and David Healy agree it’s a valuable piece of evidence.

Holmes wrote about the initial effects of going on sertraline.

No effect when needed. First appearance of mania occurs, not good mania. Anxiety and fear disappears. No more fear, no more fear of failure. Fear of failure drove determination to improve, better and succeed in life. No fear of consequences.”

The first evidence that his thoughts of killing were turning real came in an online conversation with Gargi Datta on 25 March, four days after starting on sertraline.

At Holmes’s trial, Datta testified that at first she thought he was joking.

But as she challenged him, the details of his delusional theory spilled out.

This theory about increasing his so-called “human capital” by actually killing people was quite different to the abstract thoughts he’d had up until then about wishing people dead to get out of uncomfortable social situations.

Psychiatrists I’ve spoken to agree it was delusional, a sign of psychosis.

Datta was asked in court if he’d ever said anything delusional before this chat. She confirmed he hadn’t.

Forensic psychiatrist Dr Philip Resnick, from Ohio, was engaged as a prosecution expert. He was not called to give evidence at trial.

Dr Philip Resnick

Dr Philip Resnick

In his first interview on the subject, he told me the “human capital” conversation with Datta was a key moment.

“I don’t think we have evidence of a plan to do it [kill] with an intention to do it before the human capital theory,” he says.

Holmes went back to see psychiatrist Lynne Fenton two days after telling Datta about human capital but he didn’t mention it to her. He did tell Fenton the medication hadn’t helped his obsessive thoughts. She doubled the dose of sertraline from 50mg to 100mg.

David Healy believes this made Holmes’s mental state worse:

There’s every evidence that if the drugs are suiting a person that an increase in the dose might be helpful – and I use these drugs even though they can cause a problem.”

He adds: “But when they are causing a problem, increasing the dose is a recipe for disaster.”

Nearly a fortnight after the dose increase on 9 April, the previously shy and awkward Holmes made a move on his classmate, Hillary Allen. His texts to her became uncharacteristically bold. One hot day he messaged her about the clothes she was wearing in class.

“Oh Hillary, Why yuh gotta distract me with those short shorts…?”

“I remember receiving that and just like kind of blushing and being like, I don’t remember what I said, but kind of trying to laugh it off and just trying not to create an awkward situation,” she says.

For David Healy, this was further evidence of the effect sertraline was having on Holmes.

Aside from the fact that you have a guy who is now actively beginning to think and plan about harming others in a way that he just hadn’t been doing before, you have a change of personality. This is a totally different person.”

At his fourth appointment with Lynne Fenton on 17 April, Holmes told her his homicidal thoughts had increased, though he still didn’t tell her about his human capital delusion. Fenton’s notes of that meeting documented a decline in his mental state.

“Psychotic level thinking… Guarded, paranoid, hostile thoughts he won’t elaborate on,” she wrote.

Whatever effect the sertraline was having, it certainly wasn’t helping. Healy firmly believes the psychotic-level thinking Fenton noted was a consequence of the medication.

At this appointment, Fenton upped the dose to 150mg. At Holmes’s trial she told the court this was the dose she had always been aiming for.

“It isn’t on her radar that this drug could be causing the kinds of problems that he’s having,” Healy says.

Fenton declined to be interviewed, but a statement from the University of Colorado Denver says patient-doctor confidentiality laws forbid her from talking about Holmes’s care without his consent, which he has not given.

The ‘mission’

By May, Holmes’s “mission”, as he later described it, got real. He began spending large amounts of money accumulating
weapons. In the notebook he wrote:

Starts small. Buy stungun and folding knife. Research gun laws and mental illness. Buy handgun. Committed. Shotgun, AR-15, 2nd handgun…”

By this time, Holmes’s coursework had badly deteriorated. He gave a disastrous final presentation and then failed his exams. He was offered the chance to re-sit but on 11 June dropped out of university. Just before that, he had one last meeting with psychiatrist Lynne Fenton and her colleague.

Holmes's final presentation

Holmes’s final presentation

They were so concerned by his state of mind at this appointment they offered to keep treating him free of charge, but Holmes refused. Fenton had the power to detain Holmes under a mental health hold, but she told his trial she felt there were insufficient grounds.

She did contact the campus security team to ask for criminal-record and weapon-permit checks. Holmes was given the all clear. He never told Fenton about the weapons he’d bought or the plans he was making.

Fenton also called Holmes’s mother.

“She said, ‘Do you know that he is not going to continue in school?’” Arlene tells me. “I thought that was the purpose of her phone call, and I said, ‘Did he ask you to call me?’ And she said, ‘No he didn’t want me to call you and he didn’t want you to worry.’

I was reassured by her phone call, rather than alarmed. I said, ‘My husband and I both work, we can pay you out of pocket to keep seeing him, I’m glad he’s getting some help for social anxiety.’ I didn’t know that she would never see him again, which is what happened.”

Arlene Holmes

How Doctors And Pharma Manipulate Drug Trials


The classic standardized clinical trial used to be a simple trial of one endpoint, like death. But to find a way to reduce cost or improve the chance for a positive outcome cunning doctors along with Pharma are producing trials where there are composite endpoints or even trials that have “run-in periods” that toss out anyone with an adverse effect before officially starting the trial. Many may not be aware of this so I discuss two major trials, one with a positive composite endpoint even though the drug killed more people than placebo and another, run-in trial, where the investigators tossed out 15% of the participants because of adverse effects before the official trial began.

Glaxo’s Dark And Disturbing Medical Trials On Irish Orphans Still Making Headlines…


http://www.irishexaminer.com/viewpoints/analysis/new-bessborough-revelations-show-wider-range-of-products-tested-on-children-453349.html

 

Previously unseen details of a medical trial by Glaxo in 1974 at a Cork mother and baby home have generated a whole new series of questions for the nuns and the companies involved, writes Conall Ó Fátharta.

For almost two decades, the public has been drip-fed revelations about medical testing by British pharmaceutical companies on children in care in Ireland.

These tests involved the trialling of various vaccine combinations by predecessor companies of pharmaceutical giant GlaxoSmithKline (GSK) — Glaxo Laboratories and Burroughs Wellcome. These revelations generated more questions than answers — answers it is hoped the Mother and Baby Homes Commission can provide.

However, it has now emerged thashoot Glaxo Laboratories was also trialling other products on children here — namely lactose and baby formulas.

This occurred in 1974 in the Bessborough Mother and Baby Home in Cork and had never been made public. Once again, the revelation has generated lots of questions but few answers.

A trial sheet obtained by the Irish Examiner reveals that Glaxo Laboratories carried out a “clinical acceptability and safety trial” of “Golden Ostermilk and Lactose”, while a separate trial sheet reveals a trial of “overseas milk powders (by 0111)”.

The “clinician responsible” for the tests was Eithne Conlon — a local Cork GP who worked with the institution for many years.

The trial sheets recorded a range of reactions to the products. These included vomiting (slight, moderate, severe, or none), excessive regurgitation, wind (slight, moderate, severe, or none), stools (locae, normal, or constipated) and stool colour (yellow, grass green, olive green, yellow green, no stools, meconium, changing).

Other “abnormal conditions” were also noted. These included excessive crying, irritability, napkin rash, thrush, and others.

The latter trial sheet was contained in the records of Breda Bonass, who had sought information on her medical history from Tusla under Freedom of Information.

The former only came to light when Ms Bonass sought further information from Tusla.

However, this only confused matters further as the trial sheet for “Golden Ostermilk and Lactose” was found in the antenatal records of other women — and all contain identical details including patient numbers — something which the FOI officer told Ms Bonass was “perplexing”.

“In the majority of cases where this record was present the record was glued to another copy of the same record [front to front] and details about the respective baby’s feeding schedules, types of formula given, reactions to feeds, etc, were hand written on this paper,” said the FOI officer.

“When I pried the two sheets apart I noticed that these trial sheets all contained the exact same patient and trial numbers and identifying details as the trial sheet located in your file.”

Ms Bonass went to the religious order which ran Bessborough — the Sisters of the Sacred Hearts of Jesus and Mary — and GSK looking answers.

The nuns responded via their solicitors, telling her they no longer held the records nor had any access to them and that she should go to Tusla.

GSK’s UK data protection section informed her that the data had been “destroyed” as the “retention period has already expired some years ago”.

The Irish Examiner contacted GSK in an effort to get answers as to why this trial was carried out in Ireland, how many children it involved and if consent was sought.

It responded by saying it was “unable to locate any records relating to a 1974 study” but that it had located records relating to a trial from 1967.

“The assumption therefore would be that the 1974 study’s purpose was to compare current milk powder with a newer formulation. The records contain no names or information about the children involved,” said GSK in a statement.

The scene at the Littles Angles Plot, in Bessborough, Blackrock, Cork.Picture: Jim Coughlan

It had no documentation to explain why Ireland was chosen as a location, but that the 1967 trial was also carried out in the UK, Kenya, Argentina, Malaysia, “and probably more”.

With regard to the consent of mothers, GSK said that, due to the fact that it had no records, it could not confirm who gave consent but that its assumption was that it would have been “those Sisters running the homes as the legal guardians”.

Obtaining consent would been left to the doctor conducting the trial.

The company said that, to the best of its knowledge, no financial remuneration would have been provided to the Order for allowing children in its care to be used for the trial.

GSK said the identical sheets were probably blank forms or templates and that the information entered “appear to be codes, possibly relating to a spreadsheet collating all responses”.

It also confirmed that this was the first time it was made aware of this study and that it had not been asked to disclose it in any official capacity, “as this is clearly outside of the current Commission’s [Into Mother and Baby Homes] vaccines inquiry”.

That, of course, is technically correct. The Commission is only tasked with examining vaccine trials carried out by GSK legacy companies. This latest revelation confirms that it wasn’t just vaccines that were being tested on children in care here.

The involvement of Burroughs Wellcome and Glaxo Laboratories in trials on children in Mother and Baby Homes and other institutions is worth repeating.

It’s been a long tale which saw a previous State inquiry —the Commission to Inquire into Child Abuse (CICA) in 2000 — try and fail to fully investigate the matter.

Before that inquiry was halted following a Supreme Court ruling in 2002, GSK had confirmed just three vaccine trials in the 1960s and 1970s involving more than 250 children.

In 2011, in a response to an RTÉ investigation, it acknowledged a fourth trial but stated that this was the only other clinical trial sponsored by Wellcome using children in institutions in Ireland.

However, in 2014, documents uncovered by Michael Dwyer of UCC’s School of History revealed a fifth trial of a measles vaccine on 34 children took place in 1965.

It was carried out by Irene Hillary and Patrick Meenan of UCD’s microbiology department and AJ Beale of Glaxo Laboratories. The UCD academics (both now deceased) were also involved in the first two vaccine trials also.

Earlier that year, Dr Dwyer also discovered evidence that Wellcome had carried out vaccine trials on more than 2,000 Irish children in 24 residential institutions between 1930 and 1935.

Despite this, the Inter-Departmental Group on Mother and Baby Homes published in 2014 only referred to three vaccine trials. It also failed to mention a 1965 trial of a 5-in-1 vaccine carried out on Philip Delaney at Bessborough Mother and Baby Home in Cork.

Questions around the involvement of British pharmaceutical companies in vaccine trials in Ireland have been popping up in the media for almost three decades now.

They first hit the headlines in the 1990s, but it wasn’t until 1997 that then health minister Brian Lenihan gave an undertaking that the matter would be examined.

This resulted in the Kiely Report in 2000, by Jim Kiely, chief medical officer of the Department of Health, which confirmed three trials had been conducted on behalf of the pharmaceutical company the Wellcome Foundation.

The i nstitutions involved were Wellcome Laboratories in Britain, the Department of Medical Microbiology in UCD, and the Eastern Health Board.

The first trial took place between December 1960 and November 1961 in four Mother and Baby Homes — St Patrick’s on the Navan Road in Dublin (14 children), Bessborough in Cork (25 children), Castlepollard in Westmeath (six children), and Dunboyne (nine children).

Four children from Stamullen baby home in Meath were also used for this trial.

The purpose of the trial was to look at the response the children would have to a 4-in-1 vaccine — diphtheria, whooping cough, tetanus, and polio.

The second trial involved 69 children from St Anne’s Industrial School in Booterstown in Dublin being administered an intranasal rubella vaccine. A further 53 children from the wider community in Kilcullen in Westmeath were also used in this trial.

The first two trials were carried out by Prof Hillary and Prof Meenan from the department of Microbiology in UCD, as well as other doctors.

The third trial involved 53 children in a number of residential institutions in Dublin including St Patrick’s Home, Madonna House, Bird’s Nest, and Boheenaburna.

A total of 65 children living at home in Dublin also received the vaccine.

The Bessborough Centre and Convent, Cork. Picture Denis Minihane.

The aim of the third trial was to compare commercially available batches of the 3-in-1 vaccine — Trivax and Trivax D — with that of equivalent vaccines prepared for the trial. There is no published paper or report of this trial, but the Eastern Health Board was aware it was being conducted.

Dr Kiely’s report in 2000 concluded that, given the conditions which the vaccines sought to counter, the decision to conduct the trials was “acceptable and reasonable”.

However, Dr Kiely said there was a lack of documentation available to clarify whether consent was either obtained or sought from the parents of the children or the managers of the institutions.

However, an entry in the 1962 British Medical Journal concerning the first trial seems to confirm that parental consent was not sought.

“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,” it wrote.

Responding to the Kiely Report in 2000, Prof Hillary said it was her “invariable practice at the time to obtain consent of the competent authority”, be it the mother, the manager, or the medical officer.

However, no record of written consent has been acknowledged. The religious orders who ran the homes involved in the trials have also denied that they authorised any clinical trials.

Of the victims of the vaccine trials who have located their natural mothers, all mothers have said they were not asked for their permission.

In 2000, then minister for children Micheál Martin admitted the Kiely report was “incomplete” and raised “as many questions as it answered”.

However, despite this, Mr Martin reassured the Dáil that the trials appeared to have had no medically negative consequences for any of the children involved.

In an effort to deal with the matter, the Government decided to extend the terms of reference of CICA.

This was done despite objections that the trials could not adequately be dealt with by an inquiry looking primarily into physical and sexual abuse.

The ‘Vaccines Module’ of CICA began investigating in early 2002.

It obtained documentation from GSK — the successor of Wellcome — and identified the names and addresses of some of those involved in the trials.

It also sought records from a range of religious orders who were caring for the children used in the trials.

In November of last year, the Irish Examiner revealed that the files of vaccine trial victims from Bessborough involved in the 1960/61 4-in-1 vaccine were altered just weeks after the CICA sought discovery of records from the Sisters of the Sacred Hearts of Jesus and Mary.

The document listing the changes opens with: “8.8.02 Checked the 20 files.” This is immediately followed by: “9.8.02 Made the changes.”

The changes made to files Nos 5, 8, 11, 12, and 15-20 are then detailed.

The changes include:

  • The alteration of discharge dates of mothers (by a period of one year and two years):
  • The changing of discharge dates of children;
  • The changing of admission dates of mothers;
  • The alteration of the age of a mother (by two years);
  • The alteration of dates of adoption;
  • The changing of baptism dates and location of baptism;
  • The insertion of certain named locations and information into admission books.

In a series of statements, the order said it wished to “categorically state that no documents were altered”.

“In your recent correspondence, you are suggesting that something illegal or inappropriate had occurred in regard to the documents to which you refer. This is entirely untrue; and we will continue to deal directly with the official commission on all such matters,” said a statement.

This document listing the changes was discovered in the Bessborough archive handed over to the HSE by the nuns in 2011.

It wasn’t discovered until 2016 — some 13 years after CICA’s investigation into the vaccine trials was suspended.

This occurred after the probe was hit with a Supreme Court ruling which upheld Prof Meenan’s challenge against a High Court order directing him to give evidence before the inquiry.

The court also criticised the decision to ask the commission to examine the vaccine trials in the first place, stating they had “only the most tenuous connection, if any, with the appalling social evil of the sexual and physical abuse of children in institutions, which was the specific area into which the commission was established to inquire”.

View of Douglas estuary including Bessborough with Douglas village in background in 1980. Picture: Richard Mills

Mr Justice Hardiman stated that Prof Meenan’s involvement in vaccine trials related only to one trial in 1960/61 and that the issue of the “reputational damage” associated with being involved with a commission primarily looking at sexual abuse had to be considered.

Following this, Prof Hillary challenged the Government’s order directing an investigation into the vaccine trials and when the the Government declined to appeal this decision, the work of the Vaccines Module ceased in November 2003.

However, at the time, many people believed there were far more than three trials carried out by Wellcome here.

The Third Interim Report from CICA in December 2003 confirmed as much when it stated that the documentation it received from GSK “disclosed a considerable amount of information in relation to other vaccine trials conducted in the State”.

When RTÉ’s Prime Time asked the pharmaceutical giant about this statement in 2011, it confirmed a fourth trial had taken place in 1965. This trial involved giving differing doses of the measles vaccine to 12 babies aged between nine and 19 months in the Sean Ross Abbey mother-and-baby home in Tipperary.

GSK stated that this fourth trial was the only other clinical trial sponsored by Burroughs Wellcome using children in institutions in Ireland.

Then, in 2014, the Irish Examiner revealed a fifth trial also occurred during this period.

An article in The Lancet medical journal in August 1965, discovered by Dr Dwyer confirms that Glaxo Laboratories Ltd carried out another measles vaccine trial on 34 children aged between eight months and just over two years.

The trial was carried out by Prof Hillary and Prof Meenan and AJ Beale of Glaxo Laboratories. It is also the first trial which confirms Glaxo Laboratories involvement in a vaccine trial.

The report does not mention an institution. However, it makes reference to the fact that the reaction to the vaccine were monitored by “the adults looking after the children”.

It also says examinations were done on the children from day six to 14 at the same time — 6pm — indicating the children were in a group setting.

However, in response, GSK disagreed that these references amounted to evidence that the trial was carried out on children in care.

The pharmaceutical giant pointed out that, in other papers by the same investigator, it was stated explicitly that the study was carried out on children in care. GSK said if it had any evidence that this trial was carried out on children in care, it would have handed it over to the CICA at the time.

So, three years on, we now know that it wasn’t just vaccines that were being tested on children in Ireland’s Mother and Baby Homes.

Now, we know that clinical acceptability and safety trials of lactose, Golden Ostermilk and “overseas baby powders” were being trialled in at least one Mother and Baby Home.

Can and will the commission examine this latest development? Why was a British company testing such products in Ireland?

Were religious orders benefiting financially by allowing children in their care to be involved in such trials? Was the consent of mothers obtained, or was it even sought?

The Mother and Baby Homes Commission said it will investigate all aspects of living conditions and care arrangements at Bessboro.