New Jennifer Aniston Movie “Cake” Inpired By Real Life Paxil (Seroxat) Murder/Suicide Case..


http://www.dailymail.co.uk/news/article-2962358/The-true-story-Jennifer-Aniston-s-Cake-movie-s-scriptwriter-inspired-brutal-murder-brother-s-wife-baby-daughter-mother-law.html

EXCLUSIVE: The true story behind Jennifer Aniston’s Cake – how movie’s scriptwriter was inspired by the brutal murder of his brother’s wife, baby daughter and mother-in-law

  • Cake has been acclaimed for Aniston’s portrayal of suicidal mom hooked on prescription drugs in aftermath of car crash that killed her child
  • Daily Mail Online can reveal movie was written by Patrick Tobin after his brother’s young family was slaughtered by a relative
  • Deb Tobin and her nine-month-old daughter Alyssa were shot dead by her father, along with her mom Rita Schell, by Don Schell, her father
  • Tim Tobin, Patrick’s brother, found the horrific scene at father-in-law’s home in Gillette, Wyoming on Valentine’s Day, 1998
  • Schell was taking anti-depressant Paxil and Tim Tobin sued maker, winning $6.4m compensation after it was named ‘proximate cause’ of killings 
  • Patrick Tobin then quit Hollywood to look after his suicidal brother and eventually wrote Cake as a result of experience

Jennifer Aniston’s career-defining performance in hit movie Cake has earned her a flurry of plaudits and award nominations.

The Friends star gives a gritty portrayal of suicidal mom Claire Bennett who is hooked on prescription drugs while struggling to live with debilitating injuries she endured in a car crash that killed her child.

When it was missed from the Oscars shortlist, many critics said it was a miss and should have been included.

But few watching the heart-wrenching Hollywood film will be aware that the screen drama is in fact inspired by a tragic and brutal real life story.

Daily Mail Online has learned that screenwriter Patrick Tobin penned the powerful movie following a devastating family tragedy that saw four of his brother’s family slaughtered.

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Acclaim: Critics have hailed Jennifer Aniston's performance in Cake and questioned why it did not at least get her shortlisted for an Oscar 

Acclaim: Critics have hailed Jennifer Aniston’s performance in Cake and questioned why it did not at least get her shortlisted for an Oscar

Happiness: Tim and Deb Tobin with their daughter Alyssa. Tim's father-in-law murdered both mother and baby as well as his own wife before killing himself

Happiness: Tim and Deb Tobin with their daughter Alyssa. Tim’s father-in-law murdered both mother and baby as well as his own wife before killing himself

So much promise: Deb and Alyssa Tobin. Not long after these pictures were taken Deb's father murdered his daughter, granddaughter and wife

So much promise: Alyssa Tobin. Not long after these pictures were taken she and her mother were murdered by her grandfather

So much promise: Deb Tobin with Alyssa. Not long after these pictures were taken both were dead

And in an exclusive interview Tobin, 50, opens up about the life-changing event, reveals how it inspired the story behind Cake and explains how his brother Tim gave him his blessing to speak about it for the first time.

‘My brother gave me permission to speak about it, and I think it honors his wife and daughter to talk about how they inspired this movie. Because they definitely did,’ explains Tobin.

On February 14, 1998, Patrick’s brother Tim Tobin made a grisly discovery while picking up his family from his father-in-law’s home in the small town of Gillette, Montana – he found four members of his family dead.

His wife Deb’s father Don Schell took a .22 calibre pistol and a 357 magnum in the middle of the night and shot dead the three people in the world dearest to him – his wife Rita, his daughter Deb and baby granddaughter Alyssa. Then he killed himself.

The following afternoon Tim found the scene of carnage that will stay with him for as long as he lives.

And seeing his wife Deb and nine-month-old daughter Alyssa lying in a pool of blood still haunts him today.

But what shocked the family most was that Schell, 60, had been a non-violent man all his life and had been a doting grandfather to Tim’s young daughter.

Wedding day: Tim Tobin and his groomsmen with his new bride Deb 

Wedding day: Tim Tobin and his groomsmen with his new bride Deb

Family love: Tim Tobin with his wife Deb and baby daughter Alyssa before they were murdered by his father-in-law

Family love: Tim Tobin with his wife Deb and baby daughter Alyssa before they were murdered by his father-in-law

The events that took place were drastically out of character and forced Tim to sue GlaxoSmithKline, the British drug giant that makes Paxil, the anti-depressant that Schell had been prescribed to treat a bout of depression.

In 2001 Tobin’s family won the case and were awarded $6.4million in compensation.

A U.S. District Court jury decided that taking Paxil was the proximate cause of the deaths of Schell and his wife, daughter and granddaughter.

The jury also found that evidence showed Paxil can cause some people to kill themselves and/or others.

After the slaughter Tim felt he truly had nothing else to live for and he sank into a deep, suicidal depression.

Realizing his brother was in pain, Patrick Tobin packed up his life in Los Angeles and moved back to Montana to be with his sibling and steer him as far away from suicide as possible.

‘I moved twelve hundred miles to keep an eye on him – mainly to make sure he didn’t kill himself,’ says Patrick in an exclusive interview.

‘I’d come home and often find Tim in the basement, nursing a bottle of scotch while watching videos of his daughter. Videos of her eating solid food for the first time or crawling.

‘When the tapes were done playing I’d help Tim stagger to his bedroom.’

Tobin said his brother replayed the horror of that day over and over in his mind.

‘Nothing I could say could take away the horror of Tim discovering the bodies when he went to Deb’s father’s house to pick up his family,’ said Tobin.

‘Each night he would take a handful of Tylenol PMs just so he could get an hour or two of dreamless sleep.’

Tobin said he drew on the pain of the tragedy to write the film Cake, which highlights how prescription medication can destroy people’s lives.

‘A personal inspiration was my brother’s experience,’ he said. ‘The year I spent with him was very hard and it was so painful and horrible to watch.

Writer: Patrick Tobin (right) at the Toronto film festival with, from left director Daniel Barnz, and cast members Sam Worthington, Adriana Barraza, Jennifer Aniston, and Anna Kendrick

Writer: Patrick Tobin (right) at the Toronto film festival with, from left director Daniel Barnz, and cast members Sam Worthington, Adriana Barraza, Jennifer Aniston, and Anna Kendrick

‘It was never my intention to write about that, but it quickly came out in Jen’s character Claire.

‘Claire lost her child and her character was tapping into a lot of my brother’s pain and our family’s pain.

‘My brother was self-destructive for a couple of years and didn’t care about life and I think he was really looking for a reason to be alive.’

Tobin’s powerful movie script caught the attention of some of Hollywood’s most celebrated actors including Sam Worthington, Felicity Hoffman, Anna Kendrick and William H. Macy, who star alongside Aniston in the movie.

Yet Tobin said his greatest hope for the movie was that it made people rethink about how we are using medicine to treat pain.

‘I could go and see a doctor tomorrow and tell the doctor I’m experiencing extreme pain and I can guarantee you I would get 30 Vicodin pills easily,’ says Patrick.

‘If I couldn’t then I’d go somewhere else instead because there’s no system of tracking what I’m taking or who gave it to me.

‘Jen’s character, Claire, even goes to Tijuana to get hers, and that really happens.

‘Cake asks the question, what is pain management? Is it something to make pain go away or is it just dulling it, but keeping it alive at the same time?

‘The problem is, in America we say, “We’re Americans and we want pain to go away immediately.” That’s the goal. Make the pain go away.’

But Tobin believes the trick to living with chronic pain is ‘coming to terms with it and finding peace with it and learning to deal with it, in spite of it’.

Official trailer for Cake, starring Jennifer Aniston

Personal: Tobin was inspired to write a character battling chronic pain - played by Jennifer Aniston - after his brother's tragic experience.  She stars alongside Anna Kendrick, whose character commits suicide

Personal: Tobin was inspired to write a character battling chronic pain – played by Jennifer Aniston – after his brother’s tragic experience.  She stars alongside Anna Kendrick, whose character commits suicide

He added: ‘Advances in pain management are actually narcotics and are addictive and can ruin people’s lives.’

Tobin has shocking first-hand experiences of the devastation prescription medication can cause.

But he said the issue is also one that is close to the heart of the movie’s leading lady Aniston.

He said: ‘Initially I knew nothing about dealing with a lot of pain. I contacted the American Pain Society and talked to doctors.

‘There are a wealth of people, especially in Los Angeles, who all they do is manage pain and treat pain.

‘One interesting thing I found out was that methadone, the medication they use to treat heroine addiction, is also used in pain medication.

‘Jennifer has been very willing to talk about these issues too. Her stuntwoman, Stacy Courtney, is a good friend of Jen’s and was in a bad boating accident that saw her become addicted to pain pills.

‘Stacy went through a whole ordeal and Jen really relied on Stacy as a source for how to portray the role. They went on the Dr. Oz show together and talked about chronic pain and pain management.

‘Jen knows people who have addictions and has worked with people with addictions. For that reason, this was a very tough role for her to play.

‘For me, I thought it was an interesting choice not to tell the audience why Jen’s character is the way she is until later in the movie. I didn’t want people to hate her, so that’s where we were able to use humor.’

Tobin says Aniston’s character Claire was based on one of his mother’s friends, called Wilma.

‘She was the only one of my mom’s friends who would really speak her mind,’ he said.

‘She was really honest and blunt and didn’t care what anyone thought.’

Pain-filled: Jennifer Aniston's character, Claire, is addicted to prescription pain medication. Tobin says: 'Cake asks the question, what is pain management? Is it something to make pain go away or is it just dulling it, but keeping it alive at the same time?

Pain-filled: Jennifer Aniston’s character, Claire, is addicted to prescription pain medication. Tobin says: ‘Cake asks the question, what is pain management? Is it something to make pain go away or is it just dulling it, but keeping it alive at the same time?

Jennifer Aniston talks skipping the gym for movie Cake on Dr Oz

Patrick is full of praise for the former Friends star – who was so dedicated to the role she stopped exercising for several months and gained weight.

‘Jen was so terrific from the beginning,’ he said. ‘She’s so hardworking and she knew it was going to be a tough role because she was playing a person with chronic pain and she had to convey that every second of every scene.

‘Jen didn’t exercise for several months, and when you’re a fit person and you don’t exercise, that changes you mentally and that happened for her and she really embraced that.

‘When Jen was cast as Claire, it became apparent very quickly she was the perfect choice because she’s such a great comedian and it comes so naturally to her.

‘The humor in the movie was crucial because it helps to take you along through the story, and Jen managed that perfectly.’

He added: ‘The first day I met Jennifer she said, ‘Thank you so much for writing such a beautiful script’.

‘She was always so lovely to everyone and if we had to work late she would always apologize and thank us all for staying.

‘I saw her at the wrap party two weeks later and I barely recognized her. I knew she’d stopped exercising and had put on a little bit of weight for the part, but two weeks after shooting her transformation was incredible, she just looked fantastic.’

The whole experience has been quite surreal for Tobin, who never imagined his family’s experience would one day become a box office hit.

‘It happened so quickly. As a writer, I wish I’d spent less time worrying and a little more time enjoying it,’ he explained.

‘It was such an exciting time for me. I kept thinking, ‘Oh my God, Jennifer Aniston and Sam Worthington are going to be in this, and Felicity Hoffman and Anna Kendrick and William H. Macy.’

‘Friends told me, ‘Just enjoy it, this doesn’t happen often, just make the most of it.’

‘But I felt like I was holding my breath sometimes and should have relaxed more.’

Positive: Despite the tragic background to the story starring Jennifer Aniston, Tobin says: ‘The message in this movie is that as bad as life gets there is always, always hope.’

Positive: Despite the tragic background to the story starring Jennifer Aniston, Tobin says: ‘The message in this movie is that as bad as life gets there is always, always hope.’

Importantly for Tobin, Cake has been able to honor the devastating family tragedy that almost saw his brother take his own life.

‘He and my mom came to the movie premiere in Toronto and were just in tears when they watched it,’ Tobin revealed.

‘The scene with the wind chimes is actually something that we did for my sister-in-law and my niece. I hadn’t told my brother and mom about that. They thought it was so beautiful that they were in the movie.

‘Sam Worthington’s character, Roy, has also lost his wife and in many ways, Roy is also my brother as well as Claire. I think it is fair to say he inspired both of those characters.

‘The year I spent with my brother was the most experience I have had with suicide. Every once in a while, people go through a hard time, but actually being around someone who really doesn’t have anything left to live for is just horrible.’

Tobin said his brother Tim, now 46, has since dedicated his life to helping people and he re-trained to become a nurse.

‘He stayed strong, he stuck it out and now his life is great,’ Tobin said.

‘He’s remarried, he has two kids now and, as a nurse, he now helps people everyday, which is great.

‘A lot of people have empathized with the character of Claire, and so that makes me feel quite strongly that the real message truly is that there is always hope and to just never give up.

‘I get a lot of emails now from chronic pain sufferers. I got a lovely letter just yesterday from a woman in Kansas saying thank you for translating my experience and dealing with it in the way you did.

‘The message in this movie is that as bad as life gets there is always, always hope.

Sunday, June 28, 2015

The Seroxat/Paxil Cake.

Cake stars Jennifer Aniston as Claire, a member of a support group for people who are affected by chronic pain. As she learns that one of her fellow group members attempted suicide, Claire becomes obsessed with the woman’s story, gets to know the woman’s husband, and faces her own inner demons.

I’ve not seen the movie yet and, to be honest, I had no intentions of seeing it, until, that is, I recently learned that the screenplay for the movie was written by Patrick Tobin.

So, who is Patrick Tobin?

Patrick Tobin
Feb. 13, 1998
Before killing himself, Donald Schell, 60, killed his wife, Rita Schell, 55. their daughter, Deborah Tobin, 31; and Alyssa Tobin, 9 months. Tobin’s widower, Tim Tobin, and Donald Schell’s sister, Neva Hardy, filed a wrongful-death lawsuit against GlaxoSmithKline (then known as SmithKline Beecham) because they believed that Don Schell acted out of character due to the antidepressant he had been prescribed, Paxil (known as Seroxat in the UK and Europe). Schell had taken just two Paxil pills prior to shooting family members and then himself.
On June 7, 2001, a jury in Cheyenne, Wyoming, found SmithKline Beecham liable for the deaths caused by a Schell. Furthermore, the jury concluded that Paxil could cause someone to commit suicide or homicide and that the drug was in fact a proximate cause of the deaths in this case.

The jury attributed 80 percent of the fault in the case to the drug maker and 20 percent to Donald Schell. Verdict here.

SmithKline, being SmithKline, appealed the decision which saw Tim Tobin et al awarded $6.4 million.

The Tobin family were represented by Andy Vickery and James Fitzgerald.
SmithKline Beecham were represented by Thomas Gorman, Charles Preuss and Tamar Halparin.

During the trial SmithKline internal documents surfaced and showed how they was aware that a small number of people could become agitated or violent from Paxil. Despite this knowledge, Paxil packaging did not include a warning about suicide, violence or aggression.

Before the trial date attorneys representing SmithKline Beecham filed a motion which, if granted by the presiding judge, would have excluded expert testimony from Andy Vickery’s two expert witnesses, British psychiatrist Dr. David Healy and Dr. John T. Maltsburger, an associate clinical professor of psychiatry at Harvard Medical School. Their motion was not granted.

Why did SmithKline try to file this motion? Well, they knew that, in the instance of Healy, that he had had access to SmithKline documents that showed results of a Paxil test involving more than 2,000 healthy volunteers taking either the drug or a placebo.

The test showed results of volunteers who had adverse reactions – ranging from insomnia or anxiety to attempted suicide – that Beecham doctors said were either “possibly,” “probably” or “definitely” caused by Paxil. Plaintiff attorney, Andy Vickery, pointed out that volunteers in the Paxil test experienced anxiety, nightmares, hallucinations and other side effects definitely caused by the drug – within two days of taking it. As early as four days, one volunteer experienced akathisia, a form of agitation that increases the risk of violence and suicide. Two volunteers attempted suicide after 11 and 18 days, respectively.

SmithKline’s attorneys argument was basically that two pills didn’t cause this crime but evidence produced during the trial proved otherwise. Vickery showed  results of SmithKline’s own Paxil test that showed a whole range of adverse reactions that had, in the main, all occurred within a day or two of the healthy volunteers taking Paxil.

What is striking about the depositions in this trial is the lengths that SmithKline Beecham would go to keep this evidence away from the public, healthcare professionals and medicine regulators.

Ironically, at the time, Dr Ian Hudson, was head of World Safety at SmithKline Beecham. Today, Dr Ian Hudson is the Chief Executive of the British medicine regulator, the MHRA. Parts of his deposition can be seen in the video (The Secrets of Seroxat) below. The documentary was aired on British TV a year after the Tobin verdict.

I’m a bit of a geek when it comes to reading court documents, particularly depositions, none more so than the deposition, in this case, of Dr. Tadataka Yamada who, at the time of his deposition, was Chairman GSK Research and Development at SmithKline Beecham.

During his deposition Yamada was asked the following. I include this because I wish to highlight how SmithKline employees, including Ian Hudson, specialised in answering questions about the Paxil suicide link – One can only assume that their evasiveness was engineered by the attorneys representing SmithKline during this particular trial. I’m also including it because it’s a fascinating exchange.

Q.    Suicide is a risk of depression, correct?

A.    That’s correct.

Q.    Now, if a patient is on an antidepressant such as Paxil and they become suicidal or more suicidal or actually kill themselves or attempt to do so, then the question that confronts us as we examine that situation is well what caused it or contribute to it.  Was it the depression, was it the drug, was it a combination of both, were there other factors. Would you agree with me that that’s the case?

A.    Uh huh.  Yes.

Q.    But if the patient was not depressed and had no other physical condition that we know about that would cause them to become suicidal and yet they became suicidal on the drug, that’s the kind of thing that would sort of make us, make our antenna go up, make red flags go off or bells go off?  In other words, concern us; wouldn’t it? If people from a healthy study which means that they didn’t, did not have any underlying disease process that put them at risk for suicide became suicidal on taking Paxil or any other SSRI drug, would that be a cause for concern that the drug may be causing or contributing to this suicidality?

A.    We would look at all of the data obtained in our healthy volunteers and examine in the proper context.  I can give you an example, examples of drugs that caused people to faint in Phase I studies that we took forward in the clinical studies, because viewed in the proper context the fainting episode was not relevant to the effect of the drug. We have had other circumstances when people would have altered rhythms of the heart during the course of a Phase I study.  That would not necessarily prevent us nor would it the FDA prevent us from continuing on those clinical studies, because bad things happen to people all the time and the temporal relationship does not necessarily imply causation.

Q.    We can certainly agree on that. Can we also agree that if the bad thing happens to a person on a drug and that person is a healthy volunteer that at east we can take some underlying disease process out of the equation in trying to figure out what caused Mr. Jones to have this bad result?

A.    No.  I think the reason why I answered your question originally the way that I did was because nobody’s healthy.  See, healthy. I mean you’re not healthy and I’m not healthy. We all tomorrow could have some event that we didn’t know about, and that event might be temporally associated with drinking a cup of coffee or signing your name.  You know, one can develop a lot of superstitions about what may or may not be associated between an illness and supposed causation that was association, associated in the events starting that illness. So, you know, some people may feel a cold coming on.  They’ll do certain things because they think it makes them, it will prevent the cold.  It doesn’t mean that whatever they’re doing will either prevent the cold or one fact have any bearing on the evolution of that cold.  This is the reason why the FDA and also pharmaceutical companies always take any event that occurs in healthy volunteers in the context of the overall phase of our program to make a decision about whether a Phase, further patients should be exposed to the medication.

In essence here, Yamada cannot give a straight answer regarding healthy volunteers who became suicidal whilst taking Paxil. Instead he deflects it all by claiming that nobody is healthy. It baffles me, then, why SmithKline would label such studies as ‘healthy volunteer studies’. Surely, given Yamada’s deposition, these studies should be called, ‘The we don’t know if they are healthy volunteer studies’?

I mean, what is the point of putting healthy volunteer studies into place when you can’t even agree if the volunteers are healthy?

What is also striking about the deposition of Yamada is that he testified that a GlaxoSmithKline decision to put proper warning label on Paxil is “never a business decision.”

Yet an internal  1997 GlaxoSmithKline document showed otherwise (Fig 1)

Fig 1

Cake.

I’ve yet to see the  movie, Cake, but look forward to it, if only to see if Patrick Tobin’s screenplay relates to the shocking incident of his extended family.

The link between the movie and the Tobin case was brought to my attention by members of The International Coalition For Drug Awareness Facebook group, which is run by Dr Ann Blake-Tracy. Members had posted and commented on a recent Daily Mail article who had wrote “The true story behind Jennifer Aniston’s Cake – how movie’s scriptwriter was inspired by the brutal murder of his brother’s wife, baby daughter and mother-in-law.”

The video below highlights the Tobin case and also shows the difficulty people have had when taking or trying to stop Seroxat. It was the first Seroxat documentary screened in the UK in a series of Panorama specials. The BBC commissioned a further three documentaries after this. To date, there has not been any other drug that has been covered regarding its side effects more times than GlaxoSmithKline’s Seroxat.

The video will show you yet more evasiveness from the current CEO of the MHRA, Dr Ian Hudson, who remember, at the time, was the World Safety Officer for SmithKline Beecham.

Pay special attention also to GSK’s Alistair Benbow. His answers to Shelley Jofre’s questions are, at best, staggering!

Bob Fiddaman.
 
 

Tobin v SmithKline Beecham Pharmaceuticals Depositions can be found here.

Tobin v SmithKline Beecham Pharmaceuticals Transcripts can be found here.

GSK.. misleading or false claims…


Bob Fiddaman has been rattling the cages again, check out his new posts about GSK’s product placement on Channel 5’s Big Brother…

http://fiddaman.blogspot.ie/2015/06/gsks-product-placement-channel-5-respond.html?spref=tw

Thursday, June 25, 2015

GSK’s Product Placement – Channel 5 Respond!

Last week I wrote about how I had learned that, in 2013, GlaxoSmithKline and bosses at Channel 5, a UK terrestrial TV channel, had struck a deal to have GSK’s product, Maximuscle, placed into the popular TV show Big Brother (Back story)

Here’s the email I wrote…

Dear Sir/Madam,

I’d be grateful if you could pass this along to the relevant department at CH 5.

It recently came to my attention that GlaxoSmithKline’s product, Maximuscle, was used as a  product placement deal for a Celebrity Big Brother task in 2013.

Whilst I understand, to a small degree, business and advertising revenue, I cannot understand why Channel 5 would agree to placing a product marketed and manufactured by GlaxoSmithKline given that the British pharmaceutical giant, one year previous to collaboration with Ch 5, were fined a record $3 billion in a fraud settlement in the United States.

The criminal charges involved the illegal marketing of the antidepressants Paxil and Wellbutrin and the withholding of data on the health risks of the diabetes medication Avandia.

Paxil (Known as Seroxat in the UK)

Although the antidepressant Paxil is not approved for patients under 18, Glaxo illegally marketed the drug for use in children and teens, offering kickbacks to doctors and sales representatives to push the drug. Many children and teens who took the drug went on to self harm and/or carry out acts of violence on other and/or kill themselves.

Wellbutrin

Glaxo used the help of PR firms and the appeal of lavish vacations to convince medical professionals to prescribe the antidepressant Wellbutrin for weight loss, sexual dysfunction, drug addiction and ADHD, even though the drug is FDA approved only to treat depression. 

Avandia

For seven years, Glaxo failed to report data to the FDA showing that its blockbuster diabetes drug, Avandia, approved in 1999, increased heart risks in patients.

In 2007, the drug was banned in Europe. The European Medicines Agency concluded that the heart risks of Avandia did not justify its blood sugar benefits.

I’d be grateful if a representative of CH 5 could explain why they endorsed a GlaxoSmithKline product on one of its most popular TV programmes given that they (GSK) had one year previously plead guilty and paid $3 billion to resolve fraud allegations and failure to report safety data.

I look forward to you reply.

Sincerely,
— 

I also sent a copy to Viacom, the owners of Channel 5.

Earlier today I received a response. It’s priceless.

Date:  25th June 2015

Dear Bob

Thank you for your recent enquiry regarding Celebrity Big Brother. 

We were sorry to read your concerns regarding a GlaxoSmithKine product being featured in the 2013 series of this programme. Irrespective of any past legal action involving this company in the United States, they are a legitimate company and although some people may have concerns about their business practices, we do not believe that this should preclude them from placing products in a television programme in accordance with the relevant guidelines.

As a commercial television channel we fund our programming and engineering costs through advertisements and programme sponsorship opportunities. However, this does not mean that we will accept advertising or sponsorship from companies or products making misleading or false claims.

Nevertheless, we do appreciate your concerns and we would like to thank you for taking the time to contact us. Your comments on this issue have been logged in our Viewer Enquiries Report for the attention of all relevant personnel.

Thank you for your interest in Channel 5. 

Yours sincerely

Ian
VIEWER ADVISOR

I’ve wrote back the following. You will note where I have highlighted what Channel 5 appear to have missed when doing their homework on the British multi-million pharmaceutical company.

Thank you for your reply.

However, I am somewhat baffled by the line, “this does not mean that we will accept advertising or sponsorship from companies or products making misleading or false claims.”

Did you read the Department of Justice Department’s verdict?

Here’s what GlaxoSmithKline agreed to plead guilty to.

  • GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.

Civil Settlement Agreement

As part of this global resolution, GSK has agreed to resolve its civil liability for the following alleged conduct: (1) promoting the drugs Paxil, Wellbutrin, Advair, Lamictal and Zofran for off-label, non-covered uses and paying kickbacks to physicians to prescribe those drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex; (2) making false and misleading statements concerning the safety of Avandia; and (3) reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.

Off-Label Promotion and Kickbacks: The civil settlement resolves claims set forth in a complaint filed by the United States alleging that, in addition to promoting the drugs Paxil and Wellbutrin for unapproved, non-covered uses, GSK also promoted its asthma drug, Advair, for first-line therapy for mild asthma patients even though it was not approved or medically appropriate under these circumstances. GSK also promoted Advair for chronic obstructive pulmonary disease with misleading claims as to the relevant treatment guidelines. The civil settlement also resolves allegations that GSK promoted Lamictal, an anti-epileptic medication, for off-label, non-covered psychiatric uses, neuropathic pain and pain management. It further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women. It also includes allegations that GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex. The United States alleges that this conduct caused false claims to be submitted to federal health care programs.

GSK has agreed to pay $1.043 billion relating to false claims arising from this alleged conduct. The federal share of this settlement is $832 million and the state share is $210 million.

This off-label civil settlement resolves four lawsuits pending in federal court in the District of Massachusetts under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery.

Avandia: In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleadingrepresentations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs. Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia. The federal share of this settlement is $508 million and the state share is $149 million.

Not to mention the fact that GSK are also the subject of UK litigation regarding the antidepressant Seroxat. How do you think the plaintiffs in the case against them feel when they see GSK products advertised on your programme?

Is it possible to make a request under the terms of the FOIA to Viacom or Channel 5? The answer you gave me, to be honest, is quite shocking and someone at Viacom or Channel 5 obviously did not do their homework on GlaxoSmithKline.

Sincerely

Bob Fiddaman.

For me, the above correspondence is of public interest, hence the publication of it on this blog.
I will endeavor to keep readers updated should Channel 5, or indeed Viacom, wish to further answer my query.
Bob Fiddaman.

GSK Wikileaks Cables..


https://search.wikileaks.org/plusd/?qproject[]=ps&qproject[]=cc&qproject[]=fp&qproject[]=cg&q=GlaxoSmithKline#result

https://www.wikileaks.org/plusd/cables/09DAMASCUS254_a.html

5. (C) Nahas characterized U.S. economic sanctions against Syria as a “PR disaster” that strengthens hardliners’ arguments to Bashar against improving relations with the U.S. He claimed he had very little personal stake in the lifting of U.S. sanctions, as his only U.S. business affiliation is with Oshkosh to provide rescue vehicles at Syria’s airports. (Note: Post understood that the interagency had taken a decision on a pending export license application for Oshkosh in mid-March 2009, but Oshkosh had not contacted Nahas Enterprises with the result of that decision as of this writing. End note.)

6. (C) Nahas lamented, however, that U.S. sanctions are deterring the UK pharmaceutical giant GlaxoSmithKline (GSK) from purchasing Avenzor, Nahas’ financially-troubled pharmaceutical factory in Syria. GSK, he said, is afraid that U.S. sanctions would prevent them from importing the necessary automation hardware and software required to manufacture GSK products in Syria.

(Note: An executive with Unipharma, the largest pharmaceutical manufacturer in Syria, recently told us that GSK had found Avenzor in violation of its contract to make Panadol a few years ago. According to our contact, Avenzor technicians were discovered using cheap, imported acetaminophen from India instead of a more expensive required ingredient. Following the discovery, Nahas reluctantly signed away his right as the exclusive Syrian manufacturer of Panadol to Unipharma. End note.)

https://search.wikileaks.org/plusd/cables/08BUCHAREST983_a.html

Sensitive but Unclassified, not for Internet distribution.

1. (SBU) Summary. An effort by the Romanian Ministry of Health (MOH) to address the inordinately high levels of cervical cancer deaths in Romania through a Human Papillomavirus (HPV) vaccination campaign has largely failed. With parental refusal rates of up to 90 percent two thirds of the way through the campaign, the Government of Romania (GOR) has lost control of the public message, with misinformation regarding the safety and efficacy of HPV vaccines prevalent in the media.

What began as a sincere effort to improve the health of Romanian women instead turned into a handy pre-election target for parties looking to undermine the credibility of the current government, which itself invited the fiasco with its own failure to properly educate and prepare the populace. The hope is that, post-election, the new government can be persuaded to develop a better education and outreach campaign and then revisit vaccinating the same age groups of girls in the spring. End Summary.

2. (SBU) Romania has the highest incidence of cervical cancer in Europe and was targeted by Merck Sharpe and Dohme (MSD) and GlaxoSmithKline (GSK) as a good location to develop a broader European market for their respective HPV vaccines. With an average of six Romanian women dying every day from cervical cancer, the companies had hoped that the GOR’s agreement to provide an anti-HPV vaccine at no cost to targeted recipients could be used as a precedent in encouraging other EU countries to follow suit. MSD, maker of market-leading HPV vaccine Gardasil, has been actively pushing this project since May of 2008, when the company invited former Secretary of State Madeleine Albright to Romania to make the pitch for a vaccination campaign (reftel). Albright’s meetings with the GOR were successful, and MOH announced in July it would initiate a campaign in the fall covering all 10- to 11-year-old girls in the country. 3. (SBU) Post has been engaged at various steps in the process, helping to organize the Albright visit, reinforcing her message with officials at MOH, and encouraging the MOH to complete the vaccine procurement procedures in a fair and transparent manner. In the end, MOH decided to split the procurement evenly between GSK and MSD, with the price negotiated directly with each company. While MSD country director Agata Jakoncic says the company did receive a small premium for having a quadrivalent vaccine (GSK’s version only targets two HPV strains), she commended the GOR for bargaining hard with MSD to offer the vaccine at a more than 15 percent discount from the prevailing Romanian market price. 3. (SBU) According to Jakoncic, the political calendar was a major factor in timing of the campaign, with the sitting government determined to begin vaccinating girls prior to the November 30th parliamentary elections as a demonstration of political commitment to health care. MOH completed procurement on a compressed schedule and began offering the vaccine to fourth-grade girls just ten days before elections. Anticipating a positive public reaction, the GOR was blindsided when the press quickly turned negative in what appeared to be a well-orchestrated misinformation campaign. Without clear and coherent information from the central government, local public health officials were clearly unprepared for the sudden push to start offering an HPV vaccine and provided only minimal information to parents in hastily convened school meetings.

4. (SBU) Lacking credible and consistent information from official sources, parents turned to the media, which played up stories of adverse vaccine reactions, claims that Gardasil had led to 20 deaths in the U.S., and even charges (in the face of solid scientific evidence) that there is no demonstrable link between HPV and cervical cancer. The GOR strategy to defuse potential controversy by giving parents a first-ever “opt out” clause for what was billed as a mandatory vaccination quickly backfired; the TV news was filled with images of school meetings across the country where parent after parent raised their hands to refuse the vaccine. To date, 70 percent of girls in the target group have been offered vaccination but the parental refusal rate for them is almost 90 percent, rendering the campaign a failure. The intensity of the negative media was in sharp contrast to the notable silence of top government officials as the campaign came under increasing criticism. 5. (SBU) MOH has suspended the campaign with the school Christmas break looming. MSD’s plan, after the Holidays, is to focus education efforts on the remaining 30 percent of the target group to try to change the tenor of the debate and thus open the door for all girls to be offered the vaccination again later in the spring. Jakoncic expressed great frustration that, early on, the GOR had rebuffed MSD’s offers to help prepare a public relations campaign; officials told her that MSD’s job was solely to supply the vaccine and that MOH would do the rest. After the PR debacle, and now sitting on a large stockpile of unused vaccines with limited shelf life, the GOR is proving more willing to work with MSD to craft an improved message for the girls remaining to be vaccinated. With the elections over, the issue has already faded from the press, and MSD hopes that parents will be more receptive to well-prepared, accurate information in the months ahead. 6. (SBU) Comment.

This appears to be a textbook case of how not to conduct a public vaccination campaign, particularly one involving vaccines that have already met with some controversy in the U.S. and elsewhere. By rushing the campaign to try to score political points, the GOR failed to prepare the ground adequately. This was especially apparent in the school meetings, where poorly trained school nurses and regular classroom teachers were often left on their own to explain the link between HPV and cervical cancer to bewildered parents. Deluged by Internet rumors as well as poorly researched and sensationalistic press reports, it is no mystery that most parents — asked for the first time ever to sign a vaccination consent form — proved unwilling to trust public health authorities. Complicating matters was the decision to focus on 10- and 11-year-old girls, with few parents perceiving an urgent need to vaccinate their prepubescent daughters against a sexually transmitted disease which is only linked to cancer in adulthood. Romanian health authorities may have had good intentions in launching this campaign, but the disastrous execution has been a real setback for public health in this country. Much hard work lies ahead to repair the damage. End Comment. GUTHRIE-CORN

https://search.wikileaks.org/plusd/cables/09BERLIN1007_a.html

1. (U) SUMMARY: The number of confirmed H1N1 infections in Germany increased by 627 new cases, bringing the total as of August 17 to 12,120. The majority of new infections occurred abroad. The German government plans to order enough vaccine for 80 percent of its population. END SUMMARY 2. (U) At its August 17 press briefing, the National Reference Center for Influenza at the Robert Koch Institute (RKI) confirmed a total of 627 new (laboratory and non-laboratory) H1N1 cases in Germany over the week end. This increases the total number of H1N1 cases to 12,120. New cases were distributed among fifteen federal states: Baden-Wuerttemberg (196), North Rhine-Westphalia (162), Rhineland-Palatinate (71), Bavaria (46), Lower-Saxony (45), Hesse (29), Berlin (11), Mecklenburg-Vorpommern (9), Saarland (8), Brandenburg (24), Saxony (7), Thuringia (7), Hamburg (5), Saxony-Anhalt (4) and Bremen (3).

3. (U) According to RKI, 482 of the 627 new cases are attributed to people returning from travel abroad. New cases include also non-laboratory H1N1 cases from people who exhibited symptoms after being in contact with a laboratory confirmed infected person. So far, all new cases are reportedly mild. 4. (U) North Rhine-Westphalia remains the German state with the highest number of confirmed virus cases with a total of 4,246, followed by Lower-Saxony (2,065) and Baden-Wuerttemberg (1,379 cases). About 23 percent (2,746) of all confirmed infections in Germany have resulted from domestic transmission. H1N1 Vaccine for Eighty Percent of the Population ———————————- 5.

(U) The German Government announced plans to increase the stockpile of antiviral medication and now plans to obtain enough vaccine to immunize 80 percent of the population, up from its prior plan to immunize approximately one-third of the German population. According to the media, an inoculation rate of over 80 percent is necessary to stop the spread of the virus. Germans, however, tend to be vaccine-adverse.

Media reports indicate that fewer than 80 percent are likely to get immunized against the new virus. (Note: Only 22 percent of the population in Germany follow the annual recommendation and gets vaccinated against seasonal influenza.) However, if the inoculation rate is less than 80 percent, the Government could sell excess serum abroad, according to media reports. 6. (U) In order to produce enough “Pandenrix”, the new H1N1 antiviral medication, Dresden-based pharmaceutical company GlaxoSmithKline (GSK) plans to hire an additional 150 workers. GSK currently employs 700 workers. The production of Pandenrix began in July. GSK will produce over 300 million vaccine doses by fall and will be sent to Europe and parts of Asia. BRADTKE

Al-Saleh said that the GCC is considering a Glaxo Smith-Kline (GSK) proposal presented in October for the pre-purchase of a possible new H5N1 vaccine. The Government of Oman is currently representing the GCC in these discussions with GSK. A recent GCC recommendation called for the stockpiling of 10,000 Tamiflu doses for the first GCC country affected by a pandemic.
Al-Saleh said that this stock would likely target Yemen, given that country’s limited resources for pandemic preparedness planning. 7.
U) Note: Embassy Kuwait recently convened a meeting of the pandemic flu working group, comprising relevant Post personnel and four medical officers from U.S. military elements in Kuwait. Participants reviewed the Department’s updated guidance on pandemic preparedness (reftel) and agreed to meet quarterly. Post is in the process of reviewing the actions items outlined in reftel.

Great Post: Bob Fiddaman Investgates GSK’s (SKB’s) Lethal Selacryn Drug…


http://fiddaman.blogspot.ie/2015/06/glaxosmithkline-two-lawsuits-one.html

Wednesday, June 24, 2015

GlaxoSmithKline – Two Lawsuits – One Withdrawal.

 





What is/was Selacryn?

Selacryn – a drug to combat high blood pressure.

Marketed an manufactured by SmithKline Beckman. **(SKB)

Selacryn was introduced in May 1979 and withdrawn by SmithKline the following January. It lasted just 8 months on the American market.

Why was it withdrawn from the market?

In the United States it was reported that there were 36 deaths and at least 500 severe cases of liver and kidney damage linked to Selacryn.

Should we praise GlaxoSmithKline for withdrawing the drug?

One would think, reading the above, that GlaxoSmithKline (then SKB) acted promptly and swiftly.

Think again.

In June 1984, some 4 years after SKB withdrew Selacryn from the market, they were charged with failing to warn consumers and the Federal Government about the dangerous side effects of Selacryn.

In December 1984 SKB pleaded guilty and three of its medical officials pleaded no contest to charges of failing to report to the Food and Drug Administration the lethal side effects of the blood-pressure drug.

In total there were 34 Federal misdemeanor charges against SKB. They pleaded guilty to all of them.

Three officials of SmithKline’s medical affairs department, Dr. Ralph M. Myerson of Merion, Pa., and Dr. Philip J. Tannenbaum of Broomall, and Dr. Theodore Selby of Haverford, a former official, pleaded no contest to 14 counts of failing to file reports.

FDA Fast Tracking

Selacryn was developed by Anphar Laboratories, a subsidiary of Albert Rolland S. A., a French pharmaceutical company. In 1973, SmithKline obtained a license to develop and sell the drug in the United States.

Selacryn was introduced on May 2, 1979, after an unusually speedy review by the F.D.A. Typically the agency’s approval of new drugs follows clinical tests on up to 1,500 patients. But, bizarrely,  in April 1979, after Selacryn had been tested on 533 patients, officials of the agency concluded that no further tests were required.

Also, in April 1979, SmithKline and the three company physicians received reports from Anphar Laboratories that Selacryn had damaged patients’ livers. The information was translated from French to English at SmithKline headquarters in Philadelphia in May 1979.

SKB never reported this. Instead they continued to market the drug for a further 8 months, reaping in the rewards of sales to an estimated 200,000 patients.

The Punishment

In February 1985 Federal District Judge Edward Cahn placed Glaxo on two years’ probation and ordered them to give $100,000 to a child abuse program for failing to promptly report the side effects of a Selacryn. He also ordered them to provide 500 hours of community service.

The three company doctors were sentenced to five years’ probation and ordered to perform 200 hours of community service.

The company and doctors were charged with failing to promptly file reports of the drug’s harmful effects on kidneys and livers with the Food and Drug Administration. They also were charged with falsely labeling the drug with a statement saying no cause-and- effect relationship existed between the drug and liver damage.

Here’s what surfaced during the trial.

In August, 1979, Mervyn Lakin of Phoenix, Ariz., fell ill with an inflamed liver, jaundice, chills, a high fever, the classic symptoms of hepatitis. The 45-year-old internist suspected that a prescription drug he was taking was harming him so he contacted SKB by placing an urgent call on Aug. 9, 1979, to Dr. Ralph M. Myerson, a group director for medical affairs at SmithKline.

Instead of informing the FDA, SmithKline sent a form letter to Lakin in Phoenix requesting additional information. On Sept. 7, 1979, after receiving a brief report from Lakin describing his original symptoms, Selby classified Lakin`s hepatitis as “unrelated“ to Selacryn .

On receiving this assessment from SKB, Lakin carried out a ‘positive rechallenge’ on himself: He stopped taking the drug, and the symptoms of hepatitis disappeared; he resumed taking Selacryn, and they reappeared.

With this finding he, once again, contacted SKB. One day later, according to court records, Selby classified the side-effect as “indeterminate,” recommended that no unusual or unexpected reaction be reported to the FDA, and sent his report to Myerson and Tannenbaum.

Lakin’s adverse reaction report, along with 11 other cases of Selacryn-related liver damage was buried deep in the third volume of a routine, seven-volume, 2,500-page report.

By late December, 1979, or early January, 1980, FDA regulators read the report and realized that a dozen Selacryn users had developed hepatitis symptoms. They called an emergency meeting for Jan. 15, 1980, convening 17 SmithKline corporate officers and medical personnel and 15 FDA officials.

On that day, SmithKline officials revealed to the federal regulators that 40 more Selacryn users had suffered hepatitis reactions. Five of them were dead.

SmithKline’s Drug Application, filed with the FDA in 1977 and 1978, showed that the company never tested the clinical trial data by performing positive rechallenges.

On June 22, 1979, seven weeks after the drug went on the U.S. market, representatives of the French company, Anphar Laboratories, met with SmithKline officials in Philadelphia and told them that they had six cases of positive rechallenges that linked Selacryn to liver damage. SmithKline did nothing.

It’s unknown whatever happened to Messrs. Myerson, Tannenbaum and Selby. Did SmithKline keep them on their books or did they take a nice little early retirement package? It wouldn’t surprise me, in the least, if they went on to higher paid jobs within the company.

Paxil/Seroxat – No Withdrawal

As far as I am aware GlaxoSmithKline or any of their previous names they were known by, never did any positive rechallenges during the Paxil clinical trials. Begs the question, why?

I find it remarkable that one phone call to SKB kicked off a lawsuit against them, particularly when over 9,000 consumers who had experienced Paxil withdrawal signed an online petition where reports of Paxil addiction were summarized by those who signed the petition (Links at bottom)

Here’s just a handful of some of those 9,000+ concerns. (Paxil is the brand name of Seroxat in the US and Canada)

I have tried twice to stop taking Paxil. Each time I tried I got severely sick with shakes, vomiting, severe headache and flu like symptoms where I missed several days of work. I was completely incapacitated, I could not even get out of bed as everything seemed to be spinning around. My doctor finally put me back on Paxil but lowered the dosage. I have been taking Paxil now for three years with no hope of withdrawing any time soon. Before I was put on Paxil, I specifically asked my doctor if this medication is habit forming and I was assured that it is not, however, my experience has been one of desperation and extreme fear that I am now dependent on this medication. I need help. – HH – USA

I thought I was the only one feeling the zaps, extreme dizziness, lumps, and emotional detachments. I’m 28 and have been on 60 mg of Paxil for a year. I am terrified to come off of it – PP – Canada

I tried suicide on Paxil and my 17 year marriage ended. This drug is dangerous. I am not the same person anymore. I am trying to get off Paxil after four and a half years and the symptoms of withdrawal are so severe that I have chosen to stay on it at this time. – MC – USA

I called the company because my symptoms were so severe. The representative told me I was the exception and to go to my doctor. I specifically asked for instructions on what I could be doing to lessen the side effects and they refused to offer me any assistance. I even asked if I could have my doctor contact them directly so that he could assist me and they refused! – DC – USA

Remember, there were over 9,000 of these reports. Are we expected to believe that none of these 9,000 ever contacted GlaxoSmithKline?

We know, through various litigation in the US that GlaxoSmithKline monitor the internet and should act on what they see. Or are these 9,000 reports just anecdotal, ergo meaningless because they wasn’t reported through the ‘official channels’? Why would anyone want to report an adverse reaction to Glaxo anyway, given that adverse reactions to Selacryn were reported then subsequently ignored?

GlaxoSmithKline are due to defend their corner in the UK where consumers allege that they were not warned that Paxil (known as Seroxat in the UK and Europe) had a propensity to cause severe withdrawal reactions. Not warned that they would have to endure months, sometimes years, injecting a syringe of Seroxat liquid into their mouths because breaking the pill in half just wasn’t an option due to the severity of cutting down the dosage by too much. Not warned either about those electric zaps jolting through the head due to the brain trying to readjust to the lack of Seroxat it had come accustomed to over the years. Hey, thanks for that Glaxo!

Despite settling over 3,000 similar Paxil withdrawal/addiction cases in America, GSK believes that there is no merit in the UK litigation. The reason for settling those American lawsuits, claim Glaxo, was to avoid costs for both parties. All 3,000 plaintiffs agreed to sign a confidentiality agreement that a, laid no blame on Paxil for their addiction and b, laid no blame on GlaxoSmithKline. It is unknown how much Glaxo paid to settle this case (All documents were sealed as part of the agreement.)

It takes just one phone call to SKB to spark a lawsuit and investigation into Selacryn.

It takes over 9,000 consumers to report severe withdrawal side effects regarding its best selling antidepressant for GlaxoSmithKline to do… well, um, nothing, at least not for its UK consumers.

How utterly perverse.

Plus ça change, plus c’est la même chose.

Bob Fiddaman.

**Smith, Kline, French, became the SmithKline Corporation in 1976, and then SmithKline Beckman in 1982, after merging with diagnostics company, Beckman Instruments. Glaxo later merged with Wellcome, a company established in the nineteenth century and built up since, to become Glaxo Wellcome. In 2000, the year of the millennium, Glaxo Wellcome and SmithKline Beecham merged to form the name we know today, GlaxoSmithKline.**

Online Seroxat/Paxil Petition.

Seroxat Withdrawal Reports Part I

Seroxat Withdrawal Reports Part II

Seroxat Withdrawal Reports Part III

Selacryn back story here.

Google Selacryn here.

RIP Gavin Clark


http://judecalverttoulmin.blogspot.ie/2007/05/gavin-clark-singer-songwriter-guitarist.html

“Gavin Clark: I’m not sure how to answer this without sounding like a nut. I’ve had bouts of depression and panic attacks since my early 20s and had the usual addictions to booze and drugs that go hand in hand with mental illness. I can’t escape it and have almost learnt to accept it, it’s part of me. My songs are a reflection of the world as i see it, and the world as I see it is often dark but not hell. I’m filled with hope sometimes I think but mostly it’s dark with the odd shaft of light.”

I’ve just watched a documentary called ‘The Living Room‘ by director Shane Meadows about his friend, and collaborator, the recently deceased musician Gavin Clark. Shane Meadows is an English director whose groundbreaking film (and subsequent series), This Is England,  is one of the finest works of British film making of recent times, for those of you that haven’t seen it, check it out.

Gavin’s music features in much of Shane Meadows works, and some of it can be seen in the recent documentary by Meadows about Gavin’s struggle to perform live.

Gavin’s long struggle with depression and anxiety can be clearly seen half-way through the documentary when he attempts for the first time to play his music to an audience in his living room. As with all of Meadows work, this documentary is both poignant and moving. Anyone who has ever struggled with depression and anxiety would be able to identify with Gavin’s struggles and inner demons- themes which he also explored in his music.

Sadly, Gavin passed away at the age of 46 in February of this year. It is unknown whether Gavin took his own life or what the exact cause of death was, but it seems (considering Gavin’s long battle with anxiety and depression) that it may have been a suicide. It’s also unknown whether Gavin was treated by a psychiatrist at the time, or whether he was on SSRI’s or other psychiatric drugs…

RIP Gavin..

(2012) GlaxoSmithKline Bribes..


http://www.theguardian.com/commentisfree/2012/jul/04/glaxosmithkline-big-pharma-not-working?CMP=share_btn_tw

GlaxoSmithKline’s bribes are evidence that Big Pharma isn’t working

Philip Ball The inadequacies of relying solely on market forces for our drugs are clearer than ever. This scandal should prompt a rethink

Wednesday 4 July 2012 14.45 BST Last modified on Wednesday 21 May 2014 05.11 BST

Comments 132

Perhaps the most shocking thing about the latest GlaxoSmithKline drug scandal is that malpractice among our overlords still has the ability to shock at all. Yet despite popular cynicism about doctors being in the pockets of the drug companies, there remains a sense that the people responsible for our healthcare are more principled and less corruptible than expenses-fiddling politicians, predatory bankers, amoral media magnates and venal police.

If this were a junk food company lying about its noxious products, or a tobacco company pushing ciggies on schoolkids, we’d be outraged but hardly surprised. When a major pharmaceutical company is found to have been up to comparable misdemeanours – bad enough to warrant an astonishing $3bn fine – it seems more of a betrayal of trust.

This is absurd, of course, but it shows how the healthcare industry benefits from its proximity to the Hippocratic oath. “Do more, feel better, live longer” GSK purrs. How can we doubt a company that announces as its priorities as “improving the health and wellbeing of people around the world” and “being open and honest in everything we do”?

Now GSK admits that, in effect, it risked damaging the health of people around the world, and was secretive and fraudulent in some of what it did. Among other things, it promoted antidepressant drug Paxil, approved only for adults, to people under 18. It marketed other drugs for non-approved uses; it suppressed scientific studies that didn’t suit (for example over the heart attack risks of its diabetes drug Avandia), and over-hyped others that did. It also hosted outings for doctors in exotic locations and showered them with perks, knowing that this would boost prescriptions of its drugs.

 

Conor Cusack on depression: ‘I was fuelled with medication to the point that I didn’t know day from night and reality from unreality’


http://www.independent.ie/life/health-wellbeing/mental-health/conor-cusack-on-depression-i-was-fuelled-with-medication-to-the-point-that-i-didnt-know-day-from-night-and-reality-from-unreality-31027481.html

Conor Cusack on depression: ‘I was fuelled with medication to the point that I didn’t know day from night and reality from unreality’

As a teenager with mental health issues, Conor Cusack found the Irish psychiatric system dehumanising and ineffective, but in psychotherapy he found a safe space to express the emotions he had suppressed for years

Conor Cusack

Published 02/03/2015 | 02:30

Conor Cusack - found space to express his emotions in psychotherapy Open Gallery 3
Conor Cusack – found space to express his emotions in psychotherapy


For some, it’s the first time they have felt the safety that coheres with their need to be able to share a part of their previously silent, inner worlds – worlds they are the sole inhabitants of.

American poet Maya Angelou, said, ‘There is no greater agony than the bearing of an untold story within you’. To witness these people embracing their vulnerability and seeing the relief they feel after expressing their story and hidden pain, which is invisible to the naked eye, is always a humbling and sacred thing to share with another human being.

Recently, after one of these talks in a community hall, Derek, a man of 72 years, approached me when the place was almost empty. He had waited until all the others had left. I can understand why he waited until the others had departed: Derek carries within him the fears of a previous generation, where people that exhibited any form of emotional distress could be locked in an institution and fuelled with medication, never again to be seen in public life.

There is a lot of support and awareness being created nowadays for young and middle-aged people, but the older generation seems to be forgotten about amidst the fresh conversation around the emotional wellbeing of our people.

Conor Cusack pictured in Cork Open Gallery 3
Conor Cusack pictured in Cork

Derek told me how he had began to experience depression about six months ago. Like most people, he suffered in silence. His days were slowly becoming ones of quiet desperation. To add to his difficulties, his true love, his wife of 45 years, passed away only recently.

This all led Derek to the point where he felt the only way out of his suffering was to end his life. A week before, he took his shotgun from his shed and walked down to the river bank near his home. To use his words, “As I wrapped my lips around the barrel of the shotgun and placed my finger on the trigger, my pet dog came rushing into view and the thought flashed through my mind ‘Who will look after the dog when I’m gone’.” It was enough to snap Derek out of his suicidal frame of mind and give him a reason to live.

Derek’s story reminded me of going through the Irish public psychiatric system as a teenager. It was a system that was cold, impersonal, dehumanising and ineffective for me. I was spoken to and not with; little or no authentic listening occurred. Psychiatrists put an intellectually sounding label on me, but that did little to reflect the immense depth, complexity and vastness that existed within me. It offered little validity to my story or to the wisdom of my symptoms.

I was fuelled with medication to the point that I didn’t know day from night and reality from unreality. A psychiatrist wanted to pump electricity through me in the ‘crazy’ idea that it would help me to deal with the issues I had in my life. I still wonder as to how a vulnerable 19-year-old, whose life was in chaos and who felt so isolated, still had the dignity to tell this guy to go ‘f**k’ himself and his electro shock therapy.

I am not against medication. Everybody finds their own solutions, and whatever works for them and whatever they are comfortable with, is all that matters. Medication can help in certain situations to alleviate some of the physical symptoms that arise from a person’s emotional challenges, but it’s my belief that medication on its own is not the most effective solution in the long-term.

I got to know another patient of these services at that time, an elderly man named John. We shared a common bond, like soldiers that have fought in a battlefield. But our war was internal, both of us fighting our own individual war – inwardly suffering but united in our grief and sense of hopelessness about our lives and our future.

John was a warm man. He lived alone, having been abandoned by his family many years before due to his emotional difficulties and the immense stigma that existed in his youth around these issues.

I remember clearly when I called to John’s house for the first time. I had left the psychiatric system and was working with a psychotherapist (a word that could never do justice to the man) who, through unconditional love, was creating a safe space where my vulnerability could find expression and I was finally able to express what had been de-pressed within for years.

It was a summer’s evening with a blue, cloudless sky, the type you love as a hurler. As I drove along the secluded road home after another therapy session, a wonderful, profound feeling flooded through my body. It was the first time that I touched on that place that exists in us all, that place that houses our real selves, a place of pure joy, love, hope and peace that encourages you to go into the world and live your life from the inside out; to see yourself through the authentic lens of yourself, as opposed to the false eyes of others.

It was the first time in many years that I felt I was going to regain my wellbeing. I was so ecstatic that I drove to John’s house to hug him and tell him that there was a way out of his darkness. The vibrant peace I was now feeling could be his peace, the hope I now had could be his hope. I knocked on his door but there was no answer. A neighbour came out and my heart sank when she told me he had ended his life a few days before. I sobbed uncontrollably.

John had nobody, only a ‘hope’-less psychiatric label that left him feeling disempowered and fatalistic about his life. John never got to experience the wonderful things I have discovered about myself and this world we inhabit over the last 13 years; the powerful freedom that flourishes when you pull back the veils of illusion and see the world anew from the solidity and sanctuary of your own real self; where new possibilities come alive that were previously only full of dead landscapes; where you dissolve the old cages that confined you in an unlived life.

The journey home to your real self is full of rewarding but difficult learning. It’s the road less travelled, but in the words of Robert Frost, ‘The one that has made all the difference’. We have neglected the sacredness of our inner worlds with tragic outer consequences. Never before has it been so easy to connect with others through technology, but the greatest challenge for us is to connect more deeply with our real selves and the inner worlds we so often flee from.

No matter how technologically advanced our world becomes, the cravings of the human soul, spirit and heart will never change: the inward yearning of each human being to be valued and appreciated for their own unique and sacred presence; the desire to love whom we want to love and to be loved, the deep longing for unconditional belonging; the craving to remove our masks and be who we really are and not the false image we portray to the outer world.

The aspiration to be free to live our own lives and not those of our parents, teachers, religions or communities, will always dwell in the heart of each of us. There is no pill or psychiatric label that will ever satisfy those human needs.

We will look back in a few years time with horror at the current solutions we use for people experiencing emotional difficulty. This includes over medicalisation; the shamefully inadequate training for our GPs, who are often the first port of call for a person in distress. It includes the lack of emphasis in our educational systems that affects students’ awareness of valuing themselves – this will far more determine their effectiveness in their personal and professional lives than their knowledge of geography, maths, physics and so on.

Within the GAA and the Gaelic Players Assocation (GPA), a new breed of warrior has emerged among inter-county hurlers and footballers. These ‘Warriors of the Light’ are bringing visibility to issues in our communities. By sharing their stories, and with immense support from the GPA, they have shattered the cultural caricature of pity that people with wellbeing difficulties have been characterised with.

They are empowering fellow players and their influence is rippling out beyond the GAA field to the wider communities. The days of the strong, silent man are over: the real strength now is in embracing your vulnerabilities. These players are illuminating the path so others can emerge from the darkness of depression, anxiety and addiction, through projects like the award-winning #wewearmore campaign.

Niall Breslin is one of those. Niall and I have worked together, and one of the most interesting events was when we spoke at the Mindfield arena at Electric Picnic last August.

I have never had any difficulty with public speaking so I was quite relaxed, but Niall was not. I could see the anxiety build in him as the time to go on stage neared. By the end of our talk, the arena was bulging with people outside unable to get in. It reinforced our belief that there is an urgency in our country for more open discussion of these core issues of the human experience, and to see real change.

After witnessing Niall’s anxiety, and considering how often he puts himself through it with all the events he partakes in, my love for him has soared. My1000Hours has come about through his incessant pursuit of developing ways for people to empower themselves to manage the challenges they are experiencing.

I look forward to journeying the challenging road ahead, the road less travelled but the one that will make a difference for all of us.

To GSK’s Mark Antrobus: How Can You Work For A Company Which Harms Kids (By Suppressing/Hiding Data)?


MARK

“’Big Brother’ is one of the most successful shows on TV in recent times and the partnership will allow us to highlight the importance of protein in your diet to a nationwide audience,” explained Mark Antrobus, a marketing executive is GlaxoSmithKline UK.

Hi Mark,

I find is astounding how people can work for companies like GlaxoSmithKline and ignore how they behave, how they make their profits and how they conduct their business.

Personally I couldn’t work for a company which thinks its perfectly fine to suppress drug studies that result in children being harmed, and by being harmed I’m talking about GSK hiding (and withholding) negative data about Seroxat which led to many kids self harming and committing suicide. Do you think this is acceptable behavior Mark? Do you think it’s ok that GSK made money off the backs of a drug like Seroxat? Have you watched the 4 Panorama documentaries on Seroxat? Have you read about Paxil study 329?

Do you think it’s ok that GSK were recently caught red-handed in China’s biggest bribery scandal of recent times? And this in light of the fact that in 2012 GSK signed a corporate integrity agreement with the US department of Justice because they had settled a 3 Billion fraud charge with the DOJ in 2012- the biggest fine in US health care history. Do you think this kind of thing is acceptable?

Maybe you do, maybe you don’t or maybe you think it’s just simply nothing to do with you? Well, personally I believe anyone who works for GSK and is aware of their abhorrent corporate history, should re-think their employment ethics and morals, because GSK’s track record proves that they don’t have any… from animal rights abuses, to tax evasion, environmental damage, to dodgy trials on orphans and babies, to suppressing data on defective drugs like Seroxat and Avandia, not to mention mass fraud charges and allegations of bribery. From these countless examples of ethical breeches- GSK have proven time and time again that they simply have no morals whatsoever… and the worst of it is people die because of GSK’s greed.

Most people are unaware that every-time they brush their teeth with products like Sensodyne, or use Nicorette gum, or drink a Maximuscle protein shake for example- that they are effectively funding a criminal cartel which thought nothing of marketing a product with known harmful effects to both children and pregnant women…

Most of the public are blissfully unaware when they use these products, and I’m sure that a lot of basic level GSK staff are unaware of the vast extent of unethical behavior behind these products too, however I doubt very much if their marketing department or lawyers are unaware of these grave misdeeds yet they keep collecting the salaries regardless don’t they?

GSK recently did a deal with the makers of Big Brother for a product placement of their protein drink Maximuscle..

Now I wonder if Channel 5, or maybe even some GSK marketing staff, would have either the muscle or the balls, to challenge GSK on why they sold dangerous drugs which killed, harmed, and maimed – kids, unborn babies, and adults too?

Yes.. I’m talking about Seroxat..

As for Maximuscle and Big Brother..

Bob Fiddaman is on the case..

Read on:

http://fiddaman.blogspot.co.uk/2015/06/big-brother-gsk-and-product-placement.html

Sunday, June 21, 2015

Big Brother, GSK and Product Placement.

Stumbling on stories usually, for me at least, kicks off a series of events. None more so than the story I stumbled across today.

In 2013 GlaxoSmithKline’s Maximuscle protein shakes and Maximuscle-branded gym equipment featured in a fitness task in the ‘Celebrity Big Brother’ house. The product placement deal placed Maximuscle protein shakes, Maximuscle-branded gym equipment and accessories and bathroom products in the house. The housemates also wore branded sweat suits.

The partnership was negotiated for GSK by MediaCom with Channel 5’s partnerships team and Endemol, the ‘Big Brother’ creator and production company. (Source) It’s important to look at the timing of this deal. 2013. With this in mind I have wrote to Channel 5. If they respond I will publish on this blog. Here’s the email.

Dear Sir/Madam,

I’d be grateful if you could pass this along to the relevant department at CH 5.

It recently came to my attention that GlaxoSmithKline’s product, Maximuscle, was used as a  product placement deal for a Celebrity Big Brother task in 2013.

Whilst I understand, to a small degree, business and advertising revenue, I cannot understand why Channel 5 would agree to placing a product marketed and manufactured by GlaxoSmithKline given that the British pharmaceutical giant, one year previous to collaboration with Ch 5, were fined a record $3 billion in a fraud settlement in the United States.

The criminal charges involved the illegal marketing of the antidepressants Paxil and Wellbutrin and the withholding of data on the health risks of the diabetes medication Avandia.

Paxil (Known as Seroxat in the UK)

Although the antidepressant Paxil is not approved for patients under 18, Glaxo illegally marketed the drug for use in children and teens, offering kickbacks to doctors and sales representatives to push the drug. Many children and teens who took the drug went on to self harm and/or carry out acts of violence on other and/or kill themselves.

Wellbutrin

Glaxo used the help of PR firms and the appeal of lavish vacations to convince medical professionals to prescribe the antidepressant Wellbutrin for weight loss, sexual dysfunction, drug addiction and ADHD, even though the drug is FDA approved only to treat depression. 

Avandia

For seven years, Glaxo failed to report data to the FDA showing that its blockbuster diabetes drug, Avandia, approved in 1999, increased heart risks in patients.

In 2007, the drug was banned in Europe. The European Medicines Agency concluded that the heart risks of Avandia did not justify its blood sugar benefits.

I’d be grateful if a representative of CH 5 could explain why they endorsed a GlaxoSmithKline product on one of its most popular TV programmes given that they (GSK) had one year previously plead guilty and paid $3 billion to resolve fraud allegations and failure to report safety data.

I look forward to you reply.

Sincerely, — 

This should prove interesting if, indeed, they respond. Bob Fiddaman. 

TG4 Documentary: “Dark Side Of A Pill 2014”


Good all-round documentary about the dangers of SSRI medications, how drug companies harm the pubic by suppressing studies and deceiving doctors and patients, and last but not least – the lethal consequences of these greed-driven actions upon individual people’s lives..

UK Seroxat Claimants.. Please Read..


http://fiddaman.blogspot.ie/2015/06/uk-seroxat-litigation-update-june-2015.html

http://fiddaman.blogspot.ie/2015/06/uk-seroxat-litigation-update-june-2015.html

Saturday, June 20, 2015

UK Seroxat Litigation Update – June 2015

Many of the Seroxat Claimants have received notice this week that unless the Group Action secures funding soon the case against GlaxoSmithKline will be struck out of Court. For those of you who have received the Court Order through the post, don’t panic, there is no need to do anything.

Solicitors, funders and insurers are putting together a funding package with no risk of exposure to costs to you and will be filing this in Court.

There really is nothing more to add publicly but if you want further information please contact me here(No media)

Let battle commence.


Bob Fiddaman