Irish Athlete Conor Cusack Gives Insight Into His Experiences Of Depression, ECT and Psychiatric Drugs


This is a great interview which highlights the disgraceful approach of psychiatry when it comes to the treatment of depression. (more on this later).

Here is an excerpt from Conor’s blog-post which has gone viral in Ireland.

The full post is below.

______________________________

“…In here in my room was a living hell. I was now on about 18 tablets a day and not getting better but worse. I was eating very little but the medication was ballooning my weight to nearly twenty stone. I was sent to see another psychiatrist and another doctor who suggested electric shock therapy which I flatly refused. It was obvious to me I was never going to get better. My desire for death was now much stronger than my desire for living so I made a decision…”

http://www.independent.ie/blog/conor-cusack-depression-is-a-friend-not-my-enemy-29707558.html

CONOR CUSACK – 29 OCTOBER 2013

I still remember the moment well. It was a wet, cold, grey Friday morning. I rose out of bed having had no sleep the night before. Panic attacks are horrific experiences by day, by night they are even worse.

As I drove to work on my trusted Honda 50, a group of my friends passed in their car heading to college. They all smiled and waved and looked so happy. I smiled and waved and acted happy.

I had loved and excelled in school but it was the same with my hurling, it was the same with my friends, it was the same with my family, it was the same with the people of Cloyne, it was the same with life, I had lost interest in all of them. Losing interest in people was the worst.


SEE ALSO

Nationwide praise for Conor Cusack for his ‘bravery and honesty’ on battle with depression


Where once I would have felt sadness at seeing my friends heading to where I had always wanted to go, I now didn’t. Something much larger, deeper, darker had taken hold of my mind and sadness, despair, hopelessness were not strong enough to survive alongside what I was feeling.

They say something has  to crack to allow the light in. At about 11am that morning, I finally cracked. I couldn’t do it anymore, all my strength at keeping up my pretence had gone. I curled up in the corner of the building and began to cry. One of the lads working with me came over and he didn’t know what to do. I asked him to take me home.

The GP called to my house and prescribed some sleeping pills and arranged for me to be sent to the hospital for some tests.

I spent a week there and they done every test imaginable. Physically, I was in perfect health. I was diagnosed with suffering from ‘Depression’ or in laymans terms, that awful phrase ‘of suffering with his nerves’. I had never heard of the word before.

I was sent to see a psychiatrist in my local day care hospital. I was 19 years of age in a waiting room surrounded by people much older than I was. Surely I am not the only young person suffering from depression, I thought to myself. There was a vacant look in all of their eyes, a hollowness, an emptiness, the feeling of darkness pervaded the room.

The psychiatrist explained that there might be a chemical imbalance in my brain,  asked me my symptoms and prescribed a mixture of anti depressants, anxiety and sleeping pills based on what I told him. He explained that it would take time to get the right cocktail of tablets for my type of depression.

I had an uneasy feeling about the whole thing. Something deep inside in me told me this wasn’t the way forward and this wasn’t what I needed. As I walked out a group of people in another room with intellectual disabilities were doing various things. One man had a teaching device in front of him and he was trying to put a square piece into a round hole. It summed up perfectly what I felt had just happened to me.

I now stayed in my room all day, only leaving it to go to the bathroom. I locked the door and it was only opened to allow my mother bring me some food. I didn’t want to speak to anybody. The only time I left the house was on a Thursday morning to visit the psychiatrist. When everbody had left  to go to work and school, my Mother would bring me my breakfast.

I cried nearly all the time. Sometimes she would sit there and cry with me, other times talk with me and hold my hand, tell me that she would do anything to help me get better, other times just sit there quietly whilst I ate the food.

Depression is difficult to explain to people. If you have experienced it there is no need, if you haven’t, I don’t think there are words adequate to describe its horror. I have had a lot of injuries playing hurling, snapped cruciates, broken bones in my hands 11 times, had my lips sliced in half and all my upper teeth blown out with a dirty pull but none of them come anywhere near the physical pain and mental torture of depression.

It permeates every part of your being, from your head to your toes. It is never ending, waves and waves of utter despair and hopelessness and fear and darkness flood throughout your whole body.  You crave for peace but even sleep doesn’t afford that. It wrecks your dreams and turns your days into a living nightmare. It destroys your personality, your relationship with your family and friends, your work, your sporting life, it affects them all. Your ability to give and receive affection is gone. You tear at your skin and your hair with frustration. You cut yourself to give some form of physical expression to the incredible pain you feel.

You want to grab it and smash it, but you can’t get a hold of it.  You go to sleep hoping, praying not to wake up. You rack your brain seeing is there something you done in your life that justifies this suffering. You wonder why God is not answering your pleas for relief and you wonder is he there at all or has he forgotten about you. And through it all remains the darkness. It’s as if someone placed a veil over your soul and never returned to remove it. This endless, black, never ending tunnel of darkness.

I had been five months in my room now. I had watched the summer turn into the autumn and then to Winter through my bedroom window. One of the most difficult things was watching my teammates parade through the town after winning the U21 championship through it. That was the real world out there.

In here in my room was a living hell. I was now on about 18 tablets a day and not getting better but worse. I was eating very little but the medication was ballooning my weight to nearly twenty stone. I was sent to see another psychiatrist and another doctor who suggested electric shock therapy which I flatly refused. It was obvious to me I was never going to get better. My desire for death was now much stronger than my desire for living so I made a decision.

I had been contemplating suicide for a while now and when I finally decided and planned it out, a strange thing happened. A peace that I hadn’t experienced for a long time entered my mind and body. For the first time in years, I could get a good night’s sleep. It was as if my body realized that this pain it was going through was about to end and it went into relax mode. I had the rope hidden in my room. I knew there was a game on a Saturday evening and that my father and the lads would be gone to that.

After my Mother and sister would be gone to Mass, I would drive to the location and hang myself. I didn’t feel any anxiety about it.  It would solve everything, I thought. No more pain, both for me and my family. They were suffering as well as I was and I felt with me gone, it would make life easier for them. How wrong I would have been. I have seen the effects and damage suicide has on families. It is far,far greater than anything endured while living and helping a person with depression.

For some reason  my Mother never went to Mass. I don’t know why but she didn’t go. It was a decision on her part that saved my life.

The following week, a family that I had worked for when I was younger heard about me being unwell. They rang my Mother and told them that they knew a clinical psychologist working in a private practice that they felt could help me.

I had built up my hopes too many times over the last number of months that a new doctor, a new tablet, a new treatment was going to help and had them dashed when he or it failed to help me. I wasn’t going through it again. My mother pleaded to give him a try and eventually I agreed. It was a decision on my part that would save my life.

After meeting Tony, I instantly knew this was what I had been searching for. It was the complete opposite of what I felt when I was being prescribed tablets and electric shock therapy. We sat opposite each other in a converted cottage at the side of his house with a fire lighting in the corner. He looked at me with his warm eyes and said ‘I hear you haven’t been too well. How are you feeling’. It wasn’t even the question, it was the way he asked it.

I looked at him for about a minute or so and I began to cry. When the tears stopped, I talked and he listened intently. Driving home with my mother that night, I cried again but it wasn’t tears of sadness, it was tears of joy. I knew that evening I was going to better. There was finally a chink of light in the darkness.

 Therapy is a challenging experience. It’s not easy baring your soul. When you sit in front of another human being and discuss things you have never discussed with anyone, it can be quite scary. Paulo Coelho says in one of his books that ‘A man is at his strongest when he is willing to be vulnerable’.

Sadly, society conditions men to be the opposite and views vulnerability as a weakness. For therapy to work, a person has to be willing to be vulnerable.  Within a week, I was off all medication. For me, medication was never the answer.  My path back to health was one of making progress, then slipping and making progress again. It was far from straightforward.

 I had to face up to memories I had buried from being bullied quite a lot when I was a young kid. Some of it occurred in primary school, others in secondary. It was raw and emotional re-visiting those times but it had to be done.

A lot of my identity was tied up with hurling and it was an un-healthy relationship. The ironic thing is that as I began to live my life more from the inside out and appreciate and value myself for being me and not needing hurling for my self esteem, I loved the game more than ever. I got myself super fit and my weight down to 13 and a half stone.

I made the Cloyne Senior team and went on to play with the Cork Senior hurling team, making a cameo appearance in the final of 2006. It is still one of the biggest joys of my life playing hurling with Cloyne, despite losing three County finals and an All-Ireland with Cork. Being involved with the Cloyne team was a huge aid in my recovery and my teammates gave me great support during that time.

 I went back to serve my time as an electrician. I went to college by night and re-discovered my joy of learning. I work for a great company and have a good life now. I finished therapy in 2004. I have not had a panic attack in that time and have not missed a day’s work because of depression since then.

I came to realise that depression was not my enemy but my friend.  I don’t say this lightly. I know the damage it does to people and the lives it has wrecked and is wrecking so I am only talking for myself. How can you say something that nearly killed you was your friend? The best coaches I have ever dealt with are those that tell you what you need to hear, not what you want to hear. You mightn’t like it at the time but after or maybe years later, you know they were right.

I believe depression is a message from a part of your being to tell you something in your life isn’t right and you need to look at it.  It forced me to stop and seek within for answers and that is where they are. It encouraged me to look at my inner life and free myself from the things that were preventing me from expressing my full being. The poet David Whyte says ‘the soul would much rather fail at its own life than succeed at someone else’s’.

 This is an ongoing process. I am still far from living a fully, authentic life but I am very comfortable now in my own skin. Once or twice a year, especially when I fall into old habits, my ‘friend’ pays me a visit. I don’t push him away or ignore him. I sit with him in a chair in a quiet room and allow him to come. I sit with the feeling. Sometimes I cry, other times I smile at how accurate his message is. He might stay for an hour, he might stay for a day. He gives his message and moves on.

He reminds me to stay true to myself and keep in touch with my real self. A popular quote from the Chinese philosopher Lao Tzu is ‘a journey of 1000 miles begins with a single step’. A correct translation of the original Chinese though is ‘a journey of a thousand miles begins beneath one’s feet’. Lao Tzu believed that action was something that arose naturally from stillness. When you can sit and be with yourself, it is a wonderful gift and real and authentic action flows from it.

 Many, many people are living lives of quiet misery. I get calls from people on the phone and to my house because people in my area will know my story. Sometimes it is for themselves, other times it is asking if I would talk to another person. I’m not a doctor or a therapist and anyone I talk to in distress, I always encourage them to go to both but people find it easier at first to talk to someone who has been in their shoes. It is incredible the amount of people it affects. Depression affects all types of people, young and old, working and not working, wealthy and poor.

For those people who are currently gripped by depression, either experiencing it or are supporting or living with someone with it, I hope my story helps.  There is no situation that is without hope, there is no person that can’t overcome their present difficulties. For those that are suffering silently, there is help out there and you are definitely not alone.

Everything you need to succeed is already within you and you have all the answers to your own issues. A good therapist will facilitate that process. My mother always says ‘a man’s courage is his greatest asset’. It is an act of courage and strength, not weakness, to admit you are struggling. It is an act of courage to seek help. It is an act of courage to face up to your problems.

 An old saying goes ‘there is a safety in being hidden, but a tragedy never to be found’. You are too precious and important to your family, your friends, your community, to yourself, to stay hidden. In the history of the world and for the rest of time, there will never again be another you. You are a once off, completely unique.

The real you awaits within to be found but to get there requires a journey inwards . A boat is at its safest when it is in the harbour but that’s not what it was built to do. We are the same.

Your journey in will unearth buried truths and unspoken fears.  A new strength will emerge to help you to head into the choppy waters of your painful past. Eventually you will discover a place of peace within yourself, a place that encourages you to head out into the world and live your life fully.  The world will no longer be a frightening place to live in for you.

The most important thing is to take the first step. Please take it.

Former Cork hurler Conor Cusack, from Cloyne, spoke to Miriam O’Callaghan last night on RTÉ One’s Prime Time. His appearance came after he wrote an article detailing his battle with depression and how he almost tried to take his own life. He posted the article, entitled ‘Depression is a friend, not my enemy‘, on his blog on Monday.

Miriam O’Callaghan: “Conor, you’re very welcome.”

Conor Cusack: “Miriam, thanks very much for having me here. It’s great to be up here. I suppose, look, I’m not here to paint a picture of myself as being an angel. I’ve a lot of friends down in Cloyne and Cork and they’ll tell you, I’m the furthest thing from being an angel that you can find. I’m not here to bash medication, or bash psychiatry. They have their place within the treatment of depression and there’s a lot of people who get a lot of benefit out of it. But I suppose I’m here to tell my story and I think it’s a story that resonates with an awful lot of people in the country. If it can be a bit of help, a bit of comfort, a bit of hope to some few people and if it can perhaps break the taboo and maybe lessen the stigma that’s attached with it? Well then I’m very glad to tell this story.”

O’Callaghan: “Let’s go back, Conor. When did you first experience depression? When did you know you were suffering from depression?”

Cusack: “Well, look, I suppose I was probably around 15 or 16 when I first started experiencing panic attacks and for anyone who’s experienced panic attacks, it’s an horrific experience. You’re convinced your world is ending, pains in your chest, can’t catch your breadth, you’re convinced you’re going to die. And that was the start of my problems, really, you know. Now, it just progressed along, bit by bit. It wasn’t something that was sudden. Gradually, I started to lose interest in my friends, started to lose interest in school that I loved, started to lose interest in hurling and the worst of all, I started to lose interest in people. I always loved people and loved being in their company but it was a gradual, bit-by-bit thing. And I suppose, I was in work one morning, in [inaudible] down in Midleton, and finally, the image that I had been keeping up along, I didn’t have the strength any more, to keep up that image. And finally I cracked. And, you know sometimes they say that something has to crack for the light to allow in, well that morning I cracked. And I lay down in the corner inside in the building, started balling my eyes out. One of my fellow workers came over, poor man didn’t know what to do, he was looking foolish with me and I said ‘look will you just take me home’. GP came and prescribed a few relaxing tablets and stuff. Went to hospital the following week, had a battery of tests done, had every test imaginable and at the end of it all, a doctor came to my bed at the end of it, and said ‘look, we think you’re suffering from depression’. It was the first time that I’d heard the word and that was the first time that I would have realised that I had something like that wrong with me.”

O’Callaghan: “And, for anyone who hasn’t read the blog, I mean you basically retreated to your bedroom, didn’t you? I mean it was so bad, you almost stayed in your bedroom a lot and hardly ever came out?”

Cusack: “Lived in my bedroom, Miriam, lived in my bedroom. For five months, the metre-by-metre window in front of me, that was my link to the outside world, you know? And there was probably 10mm of glass separating me from there but I was a million miles away from that. That was the real world out there. This was a living hell in here for me. I saw the summer pass, I saw the autumn pass, I saw the winter pass through that window. There was only one person, well two people, my mother and my aunt Marie that I’d allow in to that room, just to bring me food. And, on the Thursday morning, when I’d used to go to see the psychiatrist, that was the only time I’d leave the house. I didn’t want to speak to anyone, I didn’t want to talk to anyone. That room was my sanctuary away from the world. But, in reality, it was a living hell.”

O’Callaghan: “You came to your lowest moment, didn’t you? Tell the story about the day your mother didn’t go to mass.”

Cusack: “Well, I suppose, previous to that, I’d been to a lot of different doctors and psychiatrists and I was on 18 tablets a day at this stage, you know, and I wasn’t getting better. I was sent to another psychiatrist in a place in Cork City, it’s called St. Anne’s and St. Anne’s would probably have, it would be a place that would be associated with a lot of people with mental difficulties. And I went in to see the doctor and the first thing he said to me was ‘oh, your brother is the famous Cork goalkeeper’. And he proceeded to talk for the next ten minutes about hurling. I had zero interest in hurling at that time and my esteem and whatever was on the floor at that stage and here was this guy and he talking to me about hurling and not talking to me about me. And at the end of it all, he suggested this electric shock therapy to me. And intrinsically I don’t know why but something inside of me always told me that medication and something like that was not the path that I needed to follow. And I remember coming out of the hospital and I was utterly distraught. Because this was like my final hope, that I thought that this was the guy that was going to finally help me. And, instead, he was suggesting something that was alien to me. And I…”

O’Callaghan: “Though it could work for other people..”

Cusack: “It could work, exactly, yeah, absolutely..”

O’Callaghan: “But keep going.”

Cusack: “Absolutely, as I say, this is my story, you know, and everyone has their own. But..So I came home and I remember I was utterly distraught and, you know, I decided one night I couldn’t…the desire for death outweighed my desire for living. And I decided I was going to kill myself. And an incredible thing happened. A peace that I hadn’t experienced in years came over my body. It was like as if my body realised no longer is it going to have to suffer this horrific physical and mental pain that I had been going through for the last number of years, no longer was I going to have to suffer these panic attacks, waking up, soaked in sweat every night. And I got a night’s sleep that I hadn’t had in years. And I was very calm about it. There was no anxiety. I knew my dad and my brothers, Victor and Dónal Óg, would be going to a match that Saturday evening and I knew my mam and my sister would be going to mass. And so I had the rope in my room, I was quite calm about it, very matter of fact, I was going to get into my car, drive to my location that I had arranged and hang myself. And for some reason, I don’t know why, but my mother never went to mass. And, ultimately, it was the decision on her part that saved my life.”

O’Callaghan: “It’s amazing, actually.”

Cusack: “Yeah.”

O’Callaghan: “But after that, you transformed yourself. You got better. Your story is a happy story at the end, Conor. Explain that path to recovery for you. How that came about?”

Cusack: “Well, look, I worked for Darina Allen since I was eight years of age, I worked there for eight or nine years in her gardens and in her kitchen and, you know, Darina is an incredible woman, she never forgets anybody who’s ever worked for her. Still to this day she’ll send in if there’s something happened to the family, a death or something, a table full of food would come into the house. And my aunt Marie has worked with Darina for years. And Darina asked one day ‘How’s Conor doing? Is he in school or what is he doing?’ And my aunt told her, you know, that I was in a bad way. So Darina suggested a person that she knew, that she felt could have been of benefit to me. And, now I’d been to loads of, loads of doctors at this stage. I’d given up all hope. But my mother pleaded with me, just to go one more time. And, that was the decision on my part, that ultimately saved my life. I went to see this clinical psychologist and from the moment I met him, I don’t know what it was but from the moment I met him I knew ‘This was it. I’m going to get better with this person. He is the man that I’ve been seeking all along’. And it was an incredible thing. I remember coming home with my mother,  driving home, with my mother in the car that evening, and I was crying but it was tears of joy, it was absolute tears of joy because I knew this was the thing that I’d been waiting for all along. And it was an incredible moment in my life. And it was the moment that transformed the whole lot for me, you know?”

O’Callaghan: “And you’re well now. And I know the reason, you said to me earlier, you wrote the blog and what you want mostly to say tonight is to give hope to other people, don’t you Conor?”

Cusack: “Absolutely, Miriam. Look there’s people at the moment out there that are going through depression or anxiety and they’re getting treatment and I just want to say to them, I want to encourage them to stay on the path. It’s not an easy, it’s not an easy journey, it’s very difficult and I salute their courage for doing that. And the rewards at the end of it are great. There’s another group of people out there that are living with and helping, supporting friends and loved-ones that are ill with depression or anxiety, or whatever, I know the powerlessness that they feel, looking at their loved-ones and that it’s not like a cut in your leg that you can fix or anything. It’s a difficult place for them. But the person themselves might not say it but, inside in them, they very much appreciate your support and your comfort. I remember mother saying to me one time: ‘I will patiently wait til eternity and beyond for my son to get better’, so keep giving your love and support.

To those people out there that are living a life of silent misery, and are afraid to take that step, you’re not alone, there’s a load of people in your same situation. You know, there’s a certain comfort and safety in remaining hidden but it’s a terrible tragedy if you can’t be found. And, you know, there’s an incredible amount of help and support out there for those people. It’s an act of courage and strength, not weakness, to admit that you’re struggling. It’s an act of courage to say that I need help but you need to take the first step, you need to take the first step, and I plead with those people to please take that first step. And, finally, to those people out there tonight, Miriam, that are perhaps contemplating suicide. I know the terrible torture and pain that you’re going through, I know the horrific thing that your day-to-day living and existence is, I know that you think that this world and your family and friends and community will be a better place without you in it. But I guarantee you it won’t, it’s not. The destruction and the pain that’s left in families with someone that’s committed suicide is incredible and the distress they’re going through now is nothing compared to what it would be, without you in the world. As human beings, you know, we’re a once-off phenomenon in this universe. Of all the billions of people that have ever lived or all the billions of people that are going to come after us, there’ll never again be another Miriam O’Callaghan, there’ll never again be another Conor Cusack. We’re totally unique and the world needs us, the world needs all the people that we have in our communities. So, you know, I promise those people that are in that terrible place, there’s a place within them, it’s a place of peace, it’s a place of joy, it’s a place of love, it’s a place of hope and it’s waiting for them to rediscover it. It’s waiting for them to rediscover it. And it’s within their grasp, it’s within their grasp. They’ve all the skills and all the abilities to be able to get there. And the thing about it Miriam is these people, they’ll emerge stronger people. They’ll emerge people that are living their life from the inside out, independent of other people’s opinions, they’re living their life fully and freely. They’re gonna not be frightened of this world any more, they’re going to be embraced by it. They’re going to look at challenges and difficulties and take them all on. And somewhere along the way, I’ll get to meet those souls, souls on the road less travelled, and I’ll look forward to that. Embrace the journey, start the journey.”

O’Callaghan: “Conor, thank you so much for coming in tonight.”

http://www.broadsheet.ie/2013/10/30/embrace-the-journey-start-the-journey/

Cut The Bullshit GSK…


d56d9999977b6b65bc2d2cffbd18faee

http://www.pinterest.com/pin/22025485650742329/

http://pharmamkting.blogspot.ie/

just that simple…

Posted on Sunday 13 October 2013


[SmithKlineFrench in former days]

The corporate history of GlaxoSmithKline [GSK] starts with a Drug Store in Philadelphia [1830] and a Trading Company in New Zealand [1873], a history sketched through the many mergers on their website. But the parts that are of current interest were the acquisition of SmithKlineBeecham by GlaxoWelcome in 2000 and the coming of Andrew Witty as CEO in 2008. Witty has been with Glaxo since 1985, straight from university at age 21 – rising through the ranks.

Eliot Spitzer and Andrew WittyThe story would be incomplete without yet another character, Eliot Spitzer, then Attorney General of New York who settled a lawsuit against GSK in 2004 over false claims about using their antidepressant Paxil in children and adolescents [Study 329]. The financial part of the settlement was insignificant, but this part wasn’t at all trivial:
In addition to the monetary portion of the settlement, GSK has also agreed to publicly disclose all of its clinical drug trials about the safety of an antidepressant for children. The company will put summaries of all of its studies since December 2000 in a clinical trial registry on its Web site…
Witty took over in 2008 and set about to restore GSK’s tarnished image. In 2008, he announced that GSK would publish their payments to physicians [after they were revealed in Senator Grassley’s investigations of academic psychiatrists]. But the sins of the past continued to haunt GSK, culminating in a record breaking $3 B settlement in July 2012 for improprieties involving multiple drugs. Then, a year ago, we heard this:
Forbes
by Matthew Herper
10/12/2012

In an unprecedented move that could signal dramatic changes in the drug industry, GlaxoSmithKline is promising to make detailed data from its clinical trials available to independent researchers so that scientists can draw their own conclusions about the safety and effectiveness of its new drugs. The change, which has yet to be implemented, is being announced at a speech in London at the Wellcome Trust, where Glaxo chief executive Andrew Witty is also detailing how the British drug giant has made its chemical libraries available to researchers working on drugs against tuberculosis and malaria. It could be a dramatic change for a company that has been dogged by scandal over lack of disclosure.

“Because of our unique role, we recognize that society holds us to higher standards than for other industries,” Witty says in his prepared remarks, which may change. “This is how it should be. Over the last four or so years we at GSK have been working hard to be more open and transparent. As I have shown these new approaches are helping to provide new solutions for serious global health issues. They will also help build society’s trust.”

Right now, Glaxo publishes results from its clinical trials on its own Web site and on another site run by the National Institutes of Health, and it says it tries to publish scientific papers on every study in research journals. But doctors outside the company don’t have access to vast databases of how each patient in a clinical trial did. What Glaxo is promising to do is to create a process through which researchers can request this raw data and use it to do new analyses…

Witty, who became Glaxo’s chief executive in 2008, has tried to distance the company from the Avandia controversy, focusing attention on the company’s efforts in the developing world, including research to create the first vaccine for malaria and now, announced today, new initiatives against tuberculosis and other emerging diseases. In Glaxo’s press release announcing the settlement with the feds, he said that the Avandia and Paxil controversies “originate in a different era for the company” and expressed his “regret” and said that his company had learned from its mistakes.

What Witty is saying he will do now goes way beyond anything even Eliot Spitzer asked for. Glaxo would put in place a system by which independent researchers could request the data about what happened to individual patients in its clinical trials, and would be granted access if an independent group of experts thought the idea had scientific merit.

“We think that it’s the right thing to do for patients, we think it’s the right thing to do for understanding our medicines,” says Patrick Vallance, the senior vice president in charge of drug research at Glaxo. “I think if you volunteered to be in a clinical trial, your legitimate expectation is that your data will be used to insure that future generations of patients get the maximal advantage.” Vallance denied that the initiative was a response to past scandals. “It’s absolutely what I’ve believed for a long time. It’s what Andrew believed. It’s what many people in the company believed”…
This story has as many individual ripples as a mountain stream, and it’s easy to get lost in the blather that surrounds every twist and turn. I’m going to skip over all the rhetoric, like GSK’s very public signing up for AllTrials and the media blitz in places like the Huffington Post and elsewhere. I don’t mind their public sainthood so long as it’s matched by pious actions – but I’m not so sure the good works yet live up to the spoken gospel. The details of GSK’s offer were announced in August in the New England Journal of Medicine [article behind a paywall]. :
Access to Patient-Level Data from GlaxoSmithKline Clinical Trials
by Perry Nisen, M.D., Ph.D., and Frank Rockhold, Ph.D.
New England Journal of Medicine. 2013 369:475-78.
What information will be made available?
GlaxoSmithKline will provide the raw data set [the data collected for each patient in the clinical study] and the analysis-ready data set [the data set analyzed by GlaxoSmithKline and provided to regulatory authorities]…
What information will investigators be required to submit?
It is important that the analyses proposed by investigators petitioning to access a data set have scientific credibility. We believe that there are public health risks if the proposed analyses are not scientifically robust and give rise to erroneous concerns about safety or false hopes of a potential benefit for patients. Therefore, in accordance with the expectations of usual good scientific practice,investigators will be required to submit a brief research proposal with the use of an online form [Section 2 in the Supplementary Appendix], describing their analysis and publication plans, their management of potential conflicts of interest, and the qualifications and experience of their search team [which should include a statistician]
How will research proposals be reviewed?
After they have been processed to ensure that the submitted information is complete, proposals will be reviewed by an independent review panel. The panel will initially comprise external experts appointed by GlaxoSmithKline. The independent review panel will accept or reject proposals on the basis of their scientific rationale and relevance to medical science or patient care.The panel will also consider the qualifications of the investigators and the management of potential conflicts of interest. To make the decision-making process fully transparent, we provide a list of the members of the independent review panel and their charter on the website…
What are the conditions on which access will be provided?
Investigators will be responsible for obtaining any other approval that may be required for their research [e.g., from ethics committees, institutional review boards, relevant research institutions, or funding bodies]. They will also be required to sign a data-sharing agreement that commits them to use the data only for the research purpose described in the accepted research proposal
My complaint, recurrently voiced ad nauseum, has to do with the conditions for access to this data. To quote Andrew Witty from a few days ago [see trojan horse or real reform? the jury’s still out… ]:
[beginning at 1:37] “Well what we’ve done – well sequentially we’ve been increasing the level of data transparency around the data we generate on clinical trials. So we’ve been publishing clinical trials summaries for a while. We’ve now committed the publish all of our clinical trial reports that are detailed reports of those trials, and also the patient level data. Now nobody else in the world is committed to doing that…
[beginning at 2:02] “And we’re not simply going to publish data on trials still to come, but we’re going to go back and we’re going to publish all the data for all the trials that have been done since the company was formed… since 2000.”
[beginning at 2:33] “We’re doing it because we think it’s in the interest of patient safety, first of all, so that it gives as many people as want to look at the data a chance to make sure that absolutely the right conclusions have been drawn. If we’ve missed something, we want to hear about it…”
Sir Andrew and I are on the exact same page in this latter comment [in red]. And it highlights that complaint of mine. I consider myself a solid member of the domain of as many people as want to look at the data. And it’s because I want to make sure that absolutely the right conclusions have been drawn. That’s me in a nutshell – a practicing physician who is considering prescribing Andrew Witty’s medication to a patient. So I want to see if they proved the efficacy of the drug and if the adverse effects have been reported accurately. You’d think I should be able to tell that from the published article, but that hasn’t been the case for a pretty good while, at least in psychiatry. So I want to look for myself.

Do I have the credentials they might find suitable? Would my primitive statistical expertise stand their test? Am I capable of tallying up the adverse events appropriately? And what’s my research proposal? All I want is to make sure that absolutely the right conclusions have been drawn. In fact, I did that with their Study 329 data when it finally showed up on their website last year [some eleven years after they published the article, some seven years after they were court ordered to post the data publicly – see the lesson of Study 329: an unfinished symphony…]. The data was in a text format so I had to copy the values by hand to a spread sheet. And as you know, that study was negative every which way but Sunday, unlike the published article’s conclusions.

So when I read this as a condition of access to the data …
It is important that the analyses proposed by investigators petitioning to access a data set have scientific credibility. We believe that there are public health risks if the proposed analyses are not scientifically robust and give rise to erroneous concerns about safety or false hopes of a potential benefit for patients. Therefore, in accordance with the expectations of usual good scientific practice, investigators will be required to submit a brief research proposal with the use of an online form, describing their analysis and publication plans, their management of potential conflicts of interest, and the qualifications and experience of their search team [which should include a statistician].
… it pisses me off. The authors of that paper gave false hopes of a potential benefit for patients and didn’t give enough rise to concerns about safety, not only with GSKs safe passage but with their help, including their paying the real author, Sally Laden. And management of potential conflicts of interest? Out the window. So that’s why I’m not ready to make nice [see the wisdom of the Dixie Chicks…]. They want to check my credentials? Well I want to check theirs.

This blog and many others are full of similar examples – unpublished studies, studies with biased design, statistical manipulations, omissions, creative graphs, etc. There’s even a growing field in medicine of people who spend their time using creative but indirect methods to find all the games being played to distort the Clinical Trial results. The record speaks for itself, and GlaxoSmithKline is prominently represented. I really like and respect the work Iain Chalmers and Ben Goldacre have done. I fully support AllTrials. I own Bad Science and two versions of Bad Pharma. I even think I might like Andrew Witty if he lived on my street. But, if he’s going to say he has a policy that gives as many people as want to look at the data a chance to make sure that absolutely the right conclusions have been drawn, he’s going to have to make his company’s actual policy match the words.

My point is easy. If the journal article is in the public domain, it’s only a proxy for the data – a wrapper. The data needs to be there too. It’s just that simple…

3 Comments for ‘just that simple…’

  1. October 13, 2013 | 6:20 PM

    A 50-something psychiatrist told me that the people running SmithKlineBeecham had been psychopaths and Glaxo bought their messes.

    But since then, GSK has hardly distinguished itself as a beacon of trustworthiness.

  2. Annonymous
    October 14, 2013 | 12:18 AM
  3. October 14, 2013 | 5:07 AM

    Here’s a little twist. The descendent of the family who owned the Trading Company in New Zealand is now our Prime Minister’s Chief Science Advisor and an avid supporter of drug treatment for suicidal kids.

GSK In China : Cash, Bribes and Prostitutes: Can They Sink Any Lower?


http://www.theguardian.com/business/2013/oct/23/gsk-china-corruption-scandal-glaxosmithkline

GSK boss says firm won’t pull out of China despite corruption scandal

GlaxoSmithKline’s sales fall 61% since July after allegations it bribed doctors and hospital officials with cash and prostitutes

GlaxoSmithKline chief executive Sir Andrew Witty

GlaxoSmithKline’s chief executive, Sir Andrew Witty, said there “is absolutely no question about our commitment to China” despite the corruption scandal. Photograph: Stephen Morrison/EPA

The boss of GlaxoSmithKline insists the pharmaceutical giant will not pull out of China despite a lurid corruption scandal that has wiped out two-thirds of its business in the world’s second-largest economy.

GSK, one of the UK’s largest blue-chip companies, reported that sales in the fast-growing Chinese market had dropped by 61% since July as buyers ditched its medicines and vaccines.

GSK is accused of using a £320m fund to bribe doctors and hospital officials with cash and prostitutes in order to sell its products.

Sir Andrew Witty, GSK’s chief executive, said the company had no intention of scaling back in China. “There is absolutely no question about our commitment to China,” he said. “Even with this decline in sales this is still a multi-hundred million pound business. This would still be at these levels of reduction a very significant European-sized country business.”

Witty was speaking as the pharmaceutical company unveiled its results for the third quarter, which revealed that global sales grew modestly at 1%.

He said media comments had led to sales dropping across GSK’s portfolio of products. “The bottom line is that just simply the media in China, the commentary in China has created an anxiety, which has led to some disruption in the business.”

The Chinese state news agency Xinhua went on the attack last month, saying that the corruption scandal had been orchestrated by senior executives at GSK China, at odds with the defence of “bad apples” in the sales department that GSK had suggested.

Witty declined to comment on the allegations in detail until the investigation is concluded. “The activities described by the authorities are very serious and totally unacceptable. They are contrary to our values and to everything I believe in. We very clearly recognise there is a profound need to earn the trust of Chinese people again. We will take every action to do so.

“We continue to fully co-operate with the authorities and respect the progress of the investigation. As such there is very little further I can say.”

He said it was too early for the company to make decisions on setting aside money for fines or to assess the long-term damage to its China business

The GSK China Bribery Scandal Rages On…


http://www.fiercepharma.com/story/telegraph-glaxosmithklines-ex-china-chief-barred-leaving-country/2013-10-16

Telegraph: GlaxoSmithKline’s ex-China chief barred from leaving country

GSK says Mark Reilly staying in China voluntarily to cooperate with bribery probe
October 16, 2013 | By 

GlaxoSmithKline’s former China chief, absent from the country when bribery allegations surfaced this summer, returned in late July to cooperate with investigators. Now, The Telegraph reports that Mark Reilly is no longer on the scene voluntarily. Chinese authorities have barred him from leaving the country, the U.K. newspaper reports.

Glaxo ($GSK) confirms that Reilly met with authorities in Changsha recently “to provide them with information and assistance.” But he hasn’t been confined to the country, much less held in a hotel room as the Telegraph‘s sources suggest. “At no point was he detained,” a spokesman told the newspaper. “Mark remains in China to help further with the investigation should it be required.”

The story the Telegraph‘s sources tell is more dramatic: Reilly was initially barred from international travel before he flew home to London in July. “The police were really angry that Reilly left in the first place,” one of the sources said. “They had put a travel ban on him.”

GSK maintains that Reilly is not and was not subject to an official travel ban. If he had been–or is–he would have had company; Glaxo’s local finance chief, Steve Nechelput, was barred from leaving in July. And with dozens of GSK employees detained–and still in custody months later–confinement to China’s borders seems mild by comparison. GSK has acknowledged that some employees may have breached Chinese law, offering apologies and price cuts in recompense.

As the investigation wears on, The Telegraph notes, families of detained GSK workers have banded together to argue for leniency. Meanwhile, top officials of both countries are on the case: U.K. Chancellor George Osborne is in China now on a mission to improve economic relations, and took the chance to discuss the GSK case with his Chinese counterparts, while Chinese Prime Minister Li Keqiang is personally overseeing the case, the Telegraph says.

A cadre of Chinese higher-ups has been spearheading the investigation, which is just part of a government crackdown on alleged corruption and monopolistic pricing. Multinational drugmakers have borne the brunt of it, with whistleblowers fingering a Big Pharma who’s who, including Eli Lilly ($LLY), Novartis ($NVS), Bayer and Sanofi ($SNY). The probes have spooked doctors and sales reps alike, so the industry’s promotional activities have all but ground to a halt, and companies expect a hit to China sales. We’ll find out just how much as drugmakers unveil their third-quarter results.

– see the story from the Telegraph
– get more from Reuters

Read more: Telegraph: GlaxoSmithKline’s ex-China chief barred from leaving country – FiercePharma http://www.fiercepharma.com/story/telegraph-glaxosmithklines-ex-china-chief-barred-leaving-country/2013-10-16#ixzz2iJecGZuM
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http://www.scmp.com/news/china/article/1333239/former-gsk-china-head-mark-reilly-remains-china-help-graft-probe

Former GSK China head Mark Reilly remains in China to help graft probe

PUBLISHED : Thursday, 17 October, 2013, 12:00am
UPDATED : Friday, 18 October, 2013, 5:03am

Reuters in London

  • gsk_shanghai.jpg
GlaxoSmithKline’s office in Shanghai. Photo: Reuters

Mark Reilly, GlaxoSmithKline’s former head of operations in China, is helping anti-corruption officials in the country investigating allegations of bribery by the drug maker.

One person familiar with the situation said Reilly had been asked to remain in China while the investigations proceeded and was happy to do so.

Both GSK and the British embassy in Beijing said yesterday Reilly had not been detained.

An embassy spokesman said it was in regular contact with him and was providing consular assistance.

Reilly was replaced as GSK’s China head on July 25 after police accused the drug maker of funnelling up to 3 billion yuan (HK$3.8 billion) to travel agencies to facilitate bribes to doctors and officials.

GSK said at the time that Reilly would continue to help lead its response to the investigation.

“Mark is working closely with the Chinese authorities to conduct a thorough investigation and voluntarily returned to China to help them,” a GSK spokesman said.

“Several weeks ago he met with the Chinese authorities in Changsha to provide them with information and assistance. At no point was he detained. Mark remains in China to help further with the probe should it be required.”

A number of Chinese employees of GSK have been detained, including four senior members of the local management team. But the authorities have not detained any foreign nationals working for the drug maker.

The police allegations against GSK, laid out in detail on July 15, sent shockwaves through the industry and cast doubt over GSK’s ability to ensure compliance standards in fast-growing markets like China.

The crackdown reflects a growing determination by Chinese authorities to stamp out corporate bribery and corruption, which can drive up prices for consumers.

GSK has admitted that some of its Chinese executives appeared to have broken the law and has said it planned to change its business model to lower the cost of medicines in the country.

Several other international drug makers – including Sanofi, Novartis, AstraZeneca, Eli Lilly and Bayer – have also been visited by Chinese officials and the episode has undoubtedly hit sales in the mainland pharmaceutical market.

Analysts at Deutsche Bank said this week that the anti-bribery campaign was likely to last for some time, affecting both multinational and domestic drug companies.

GSK will report third-quarter results on October 23, when the scale of the impact of the affair on its business in China is expected to be revealed.

This article appeared in the South China Morning Post print edition as Former GSK China head helps inquiry

Glaxo’s China chief Mark Reilly faces bribes quiz as he secretly returns to the country


Glaxo’s China chief Mark Reilly faces bribes quiz as he secretly returns to the country

 Read more: http://www.thisismoney.co.uk/money/news/article-2463620/GlaxoSmithKlines-China-chief-Mark-Reilly-faces-bribes-quiz.html#ixzz2hz9cH3da

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The British former head of GlaxoSmithKline’s Chinese operations has secretly returned to the country and is assisting authorities with their bribery investigation.

Mark Reilly left China in July just before police arrested four senior GSK executives amid allegations the firm used more than 700 travel agents to funnel bribes to doctors and medical professionals to boost sales of its drugs.

The 47-year-old Briton continued to work for the firm from its London offices. It yesterday emerged that he has been stuck in China for several weeks, having volunteered to return.

Bribery investigation: Chinese police have blamed the company for orchestrating the alleged paymentsBribery investigation: Chinese police have blamed the company for orchestrating the alleged payments

A GSK spokesman said: ‘Mark is working closely with the Chinese authorities to conduct a thorough investigation, and voluntarily returned to China to help them.

‘Several weeks ago he met with the authorities in Changsha to provide them with information and assistance. At no point was he detained.

‘Mark remains in China to help further with the investigation should it be required.’

Chinese police have blamed the company itself for orchestrating the alleged payments – said to total £321million – and not individual employees.

GSK denies this claim. Chief executive Sir Andrew Witty has, however, admitted that some of his staff may have broken Chinese bribery and corruption laws. 

Among the claims are that GSK used ‘sexual bribery’ – offering prostitutes to doctors to persuade them to prescribe its medicines. Witty described this ‘inappropriate and illegal behaviour’ as ‘shameful’.

The allegations have rocked the pharmaceuticals industry and reflect a new determination by China to crack down on corporate corruption, which can drive up prices for consumers.

Several other international drugmakers, including Sanofi, Novartis, AstraZeneca, Eli Lilly and Bayer, have also been visited by Chinese officials, and the episode has hit sales in the Chinese pharmaceutical market.

GSK is due to report third-quarter earnings next week. Its shares closed flat at 1575p last night.

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Read more: http://www.thisismoney.co.uk/money/news/article-2463620/GlaxoSmithKlines-China-chief-Mark-Reilly-faces-bribes-quiz.html#ixzz2hz9mOd66
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Seroxat : MPs Alerted To ‘Unfavorable Medical Trials Being Withheld’


http://www.gulf-times.com/uk-europe/183/details/366031/unfavourable-medical-trial-results-being-withheld%3A-mps

Guardian News and Media/London

Drug companies and medical researchers are putting patients’ lives in danger by failing to publish unfavourable results from clinical trials, MPs have warned.

The lack of transparency means many trials are not registered before they are done, while results are held as private documents that cannot be scrutinised by patients or independent experts.

The practice skews the information that is available to doctors because trials that show new experimental drugs in the best light are more likely to be published, and results that could prevent harm or save patients’ lives may never see the light of day.

Often, trials that indicate a new treatment is not effective are never published.

In a report delivered to ministers, MPs express dismay at the government’s efforts to tackle the problem and set out concrete proposals to make data from clinical trials more openly available.

“Many of the trials taking place today are unregistered and unpublished, meaning the information that they generate remains invisible to both the scientific community and the public. This is unacceptable, undermining public trust, slowing the pace of medical advancement and potentially putting patients at risk,” said Andrew Miller, chair of the Commons science and technology committee.

The MPs’ report broadens the traditional battleground over clinical trials data to include academic researchers who fail to publish studies of companies’ drugs or other medical interventions. The pharmaceutical industry is under intense pressure to release more clinical trial data, and some companies, such as GSK, are already committed to greater openness.

But the MPs call for government action to speed the process, by requiring all future trials to be registered, and summaries of trial results to be made public. More detailed “clinical study reports” should also be released, with redactions to protect patient privacy, when they have already been prepared for regulators.

In another recommendation, the MPs urge the government to demand the registration of past trials too, with summary results released for all publicly funded trials since 2000. Failure to release clinical trials data has led to hefty fines for some pharmaceutical companies.

In 2004, GSK paid $2.5mn to settle a consumer fraud case during which it emerged that the company had lied about the safety and effectiveness of its antidepressant Paxil, also known as Seroxat.

But academics are also guilty of suppressing data that could have helped patients. In 2006, six volunteers suffered severe reactions to an experimental drug called TGN1412 in a trial at Northwick Park hospital in London. An inquiry into the incident found that a single patient had suffered the same catastrophic reaction after taking a similar drug, but the scientists had never reported the findings.

Scientists estimate that half of all clinical trials that have been completed have never been published in academic journals, and trials with favourable results are twice as likely to be published as others.

“There have been these examples of publication bias which have resulted in lots of people suffering and dying unnecessarily, which somehow people haven’t taken seriously,” said Iain Chalmers, co-ordinator of the James Lind Initiative at Oxford University, which lobbies for better trials.

GSK’s Seroxat Files: What are they hiding?…


Birth Defects, Suicide, Aggression, Withdrawal? …What other Seroxat side effects have GSK concealed in their clinical trial cupboards? 

http://davidhealy.org/gsks-manifesto-voyeurs-of-the-world-unite/

GSK’s Manifesto: Voyeurs of the World Unite!

October 9, 2013 3 Comments

Editorial Note: There is a widespread impression that the pharmaceutical industry are split on the issue of access to clinical trial data with the bad guys like AbbVie taking legal actions to block access and the good guys like GSK in favor of transparency. An editorial like this one from GSK’s James Shannon in the Huffington Post on September 3rd might support such impressions. See Neal Parker Avoiding Adverse Events.

Nothing could be further from the truth. A recent House of Commons report on Clinical Trials in the UK, which entols the supreme virtues of GSK at every possible turn, contains the following summary recommendation:

“We are not in favor of placing anonymized individual patient-level data (IPD) in the public domain in an unrestricted manner…  specific individuals should be provided with controlled access to IPD through carefully managed and secure “safe havens”. Access should be facilitated by an independent gatekeeper responsible for ensuring that the data … makes a useful contribution to scientific understanding”.

This is GSK’s preferred way to deny access to the data written into a House of Commons recommendation. In practice, as outlined in April Fool in HarlowGSK are offering an opportunity for voyeurism rather than the full-bodied engagement with the data that is science.

Several researchers are at present attempting to write up GSK’s most famous ever clinical trial – Study 329, a study of Paxil given to children, that led to charges of fraud from New York State and contributed to GSK’s recent $3Billion dollar fine. Despite an undertaking given to the Courts to make the data from this study available, GSK are currently refusing to do so – requiring investigators instead to apply through their “safe haven” which seems exquisitely designed to make it impossible to establish what the data actually shows. See Reading the RIAT Act. This is a space to watch.

You’d never guess at GSK’s stonewalling tactics from James Shannon’s editorial below. This editorial suggests the company is supremely confident it has successfully pulled the wool over the eyes of academics and politicians – as suggested last April Fool’s Day – See April Fool in Harlow.

___________________________________________________________________________________________

Unlocking Access to Clinical Trial Data – what are we afraid of?  James Shannon, GlaxoSmithKline’s Chief Medical Officer. Huffington Post 03/09/2013 Today thousands of people all over the world will take part in clinical trials. Why do they volunteer, willingly sacrifice their time and in some cases experience discomfort and inconvenience? Of course there is the hope that perhaps they can benefit from the medicine under the microscope. But they also do it to contribute something to the wider population – the hope that they can play their part in developing new medicines for diseases like cancer or Alzheimer’s disease that we are still trying to tackle. And I think they expect something else – when that trial is over, regardless of whether it results in a new medicine on the pharmacy shelves, they expect that the data gathered – their contribution – will be used to help others, to drive forward discovery through the scientific community learning from research already undertaken. In recent months the words ‘data transparency’ have found their way into our vernacular, with calls for pharmaceutical companies to be more transparent about their research and to publish results from all their clinical trials. The pharmaceutical industry has been the source of a great many advances and there are many people in the world today living longer, healthier lives because of the medicines researched and developed by the industry. But despite this, it is an industry which still draws criticism and concern. Historically, being open and transparent aren’t traits the industry has been famed for. We haven’t always done a good enough job to be transparent so that people trust and feel proud of how we operate and what we achieve. Increasing transparency about our research is a critical area we’ve been pursuing at GlaxoSmithKline for almost a decade. In 2004 we launched an online study register which means visitors to our website can see any trial that we are running or are about to start. We also post every set of results here, regardless of whether they are positive or negative. Since then we’ve taken more action to increase the information we share, culminating this year with our commitment to disclose detailed reports of our studies and support for the AllTrials campaign, led by Sense about Science and British doctor, Ben Goldacre. We’ve also launched a new website allowing scientists to request access to the very detailed, anonymised patient-level data sitting behind the results of our clinical trials. This will mean independent researchers, with a fresh perspective, can conduct further research which could advance medical science and improve patient care. It’s inevitable that some will still worry that we are hiding something. Honestly, we’re not. GSK is not alone in its drive to increase transparency, as we have seen from the growing support for the likes of the AllTrials campaign. It is obviously for others to decide the approach they take in this space but it is certainly an issue that has captured the attention of not just pharmaceutical companies but academic and public institutions carrying out research. So what could we possibly be afraid of? Concerns have been raised about greater transparency introducing a competitive disadvantage. We don’t see it. People have asked me, “what if a new side effect comes to light for one of your medicines? Or what if a scientist discovers that you made a mistake in your research?” My answer back is “why wouldn’t we want that to happen? Isn’t it better that we know? There is always the potential for us to find a better way to do things.” We still need new treatments to tackle diseases and there are still many scientific unknowns that stand in the way of us developing those treatments. Who knows? Perhaps increased transparency in clinical research and the sharing of knowledge and data will help solve some of our trickiest scientific questions. We hear from scientists that making more information available will be incredibly helpful – it will enable them to study the science behind today’s medicines more closely, combine data from different studies and look at how medicines can best be used. Ultimately this has the potential to improve patient care, which can only be a good thing. There is more to be done. All those carrying out clinical research, whether they are companies like GSK, academic institutions or other research organisations, have a role to play in ensuring information from their clinical trials is made publicly available. There is also a clear need for a broad, independent system to be created where researchers can access data from any trial from multiple companies and organisations. We want a truly independent organisation from the public or charity sector to take on the oversight of this and make it a reality as soon as possible. There is a lot to be gained by having that transparency at the core of how we work. I think science, society and, most importantly, patients, will be better for it. [As for scientists we figure they’ll get by looking]. –

See more at: http://davidhealy.org/gsks-manifesto-voyeurs-of-the-world-unite/#sthash.XBXbvrGb.dpuf

– See more at: http://davidhealy.org/gsks-manifesto-voyeurs-of-the-world-unite/#sthash.XBXbvrGb.dpuf

GSK Transparency… my arse….


http://fiddaman.blogspot.ie/2013/10/glaxosmithkline-era-of-transparency.html

Thursday, October 10, 2013

GlaxoSmithKline: The Era of Transparency

Transparent

: able to be seen through

: easy to notice or understand

: honest and open : not secretive

: characterized by visibility or accessibility of information especially concerning business practices

So, yesterday I, along with others, was invited along to the House of Commons in Westminster to hear a talk given by David Healy. If you are reading this blog then chances are you already know who Healy is, if not, check out his website and list of published books he has written on the subject of antidepressant medication and/or the corruption that exists in the world of the pharmaceutical industry.

I’ve watched David Healy’s presentations many times through the medium of Vimeo and YouTube. Yesterday’s was pretty easy to follow for the attending crowd as analogies were often used to hammer home the point that we, as consumers, are being totally misled about the safety and efficacy of antidepressant type medication. Flawed clinical trial results, ghostwritten papers and promised transparency that is, in itself, so murky that it’s less clear than the Cumbrian skies that GlaxoSmithKline polluted after being accused of  releasing 773 tonnes of waste chemicals back in 2001. [1]

GlaxoSmithKline were used by Healy as an example yesterday, hey, they are, after all, a British company.

You see, Glaxo have promised to be more transparent with their clinical trial results. Yay, big pat on the back for Sir Andrew. After listening to Healy one would suggest a cow pat on the back for GSK’s knight.

It transpired that Glaxo’s announcement that they are going to be more transparent is nothing more than a good will gesture in the shape of a chastity belt.

Glaxo are opening their doors to the world, they claim…but only if you have Willy Wonka’s golden ticket, only if you are prepared to jump through the loopholes put in place for the sole reason of deterring you from getting to the truth.

What’s worse is that the UK government have accepted a proposal put forward by GlaxoSmithKline, a proposal which includes the following:

“We are not in favour of placing anonymised individual patient-level data (IPD) in the public domain in an unrestricted manner…  specific individuals should be provided with controlled access to IPD through carefully managed and secure “safe havens”. Access should be facilitated by an independent gatekeeper responsible for ensuring that the data … makes a useful contribution to scientific understanding”. [2]

In other words, we [GSK] have the information you need but we [GSK] have found a way in which you can’t have access to it unless you can prove that the data we provide you would make a useful contribution to scientific understanding… even then, we [GSK] would argue that the only people allowed access would be those who would show favoritism toward our company.

The UK government, which incidentally has a Business Council where GSK’s Andrew Witty sits [3] will now have to decide whether Glaxo’s proposal is the way forward.

Forgive my flippancy. We are talking about a government who fought tooth and nail not to have MP’s expenses in the public domain.

GSK – Ball Squeezing the UK Government

Here’s the real deal folks.

Glaxo have cupped the testicles of the British government. They are slowly twisting those testicles, with each twist they are threatening/bribing the UK government – let’s face it, Glaxo are the past-masters at bribing, right?

The message is clear from Glaxo, either you do business our way or we will leave these shores and conduct our business elsewhere.

Case in point, the UK Seroxat litigation. Glaxo have settled over 3,000 addiction cases in the US. They won’t settle similar claims in the UK because, it’s my belief, they have the backing of the UK government, a new chief at the helm of all drug-making decisions, Ian Hudson [4] and a UK legal system that has failed on more than one occasion to bring pharmaceutical companies to justice, not because of incompetent lawyers but because the way the system is designed to offer legal aid, or not as the case may be, to victims harmed by pharmaceutical products.

Invites to the meeting yesterday were sent out to both the MHRA and GSK. Neither of them showed.

Bob Fiddaman

[1] North’s top polluters named
[2] “Antidepressants and the Politics of Health”
[3] Cameron’s Business Council: the official line-up
[4] Former Glaxo Safety Officer Becomes Head of MHRA

Remembering GSK’s 3 Billion Fine: The Biggest Healthcare Fraud in US History!


It is just unbelievable how this pharmaceutical company is permitted to continue to operate…

Remembering GSK’s Cidra Disaster, Ian Mc Cubbin and Courageous Whistleblower Cheryl Eckard


http://pharmagossip.blogspot.ie/2011/01/gsk-whistleblower-cheryl-eckard-vs-gsks.html

MONDAY, JANUARY 03, 2011

GSK whistleblower Cheryl Eckard vs GSK’s Ian McCubbin on 60 Minutes

Back story here and here.

So. How does one defend the indefensible?

Here’s GSK’s Ian McCubbin’s (pic) attempt:

Ian McCubbin is a senior vice president from Glaxo headquarters in London.

“We regret what happened in Cidra. But we’ve worked really, really hard to resolve those issues. We spend $600 million every year on make sure that our plant and equipment is state of the art,” McCubbin said.

“Would you say that the company was chastened by all of this?” Pelley asked.

“No, I’d say the company was very disappointed that this occurred and that we regret that this occurred. But we’ve learned from it. And what you learn from, you become stronger,” McCubbin replied.

McCubbin told Pelley the company has about 80 plants around the world. When asked if any of them operate the way Cidra did, he said, “Absolutely not.”

“So how did Cidra go wrong?” Pelley asked.

“They all operated to the same standard, to the same quality system that we had in place. The difference between Cidra and all the rest of the plants is the effectiveness with which that quality system was implemented it was much weaker and that resulted in the compliance issues that occurred,” McCubbin said.

“Cheryl Eckard says that she was issuing warnings and no one was listening,” Pelley remarked.

“I don’t know Cheryl Eckard. And I don’t know all the details of her accusations. What I do know is that we were working with the FDA before Cheryl went to that plant,” McCubbin said.

http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247_page2.shtml?tag=contentMain;contentBody

Nice try Ian!

But who is Ian McCubbin? And why did GSK have him speak on their behalf if he didn’t know Cheryl Eckard or all of the details of her accusations?

Ian is currently responsible for strategy development and execution within GSK’s Global Manufacturing & Supply organisation. In addition he holds responsibility for the Global Logistics organisation which delivers supply chain processes connecting the Manufacturing and Commercial organisation. Prior to rejoining GSK in July 2006 Ian undertook significant Global Operations roles in the generic Pharmaceutical sector with two of the top 10 Global generic companies. Ian is a pharmacy graduate with additional management qualifications.

http://criticaleye.net/community-profile.cfm?id=198

Glaxo pleaded guilty to a felony. It admitted it distributed “adulterated drugs Paxil CR, Avandamet (a diabetes drug), Kytril (a drug given to cancer patients), and Bactroban.” All together, the company paid $750 million to settle the criminal conviction and Eckard’s suit.

“Can anything like this happen at Glaxo again?” Pelley asked Glaxo’s Ian McCubbin.

“I absolutely hope not. We will work really hard to resolve these issues and make sure that our quality management system is in place and robust,” he replied.

http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247_page4.shtml?tag=contentMain;contentBody

Well done Ian!

Now – how many senior execs who ignored Cheryl Eckard’s pleas and tears still have jobs at GSK?

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Posted by at 12:54 pm

3 comments:

Anonymous said…

According to The Guardian, there were still quite a few such execs there as late as Oct 2010: http://www.guardian.co.uk/business/2010/oct/28/glaxosmithkline-executives-allegedly-ignored-eckardSurprised? Not me!

4:25 pm

AJ said…

…Now – how many senior execs who ignored Cheryl Eckard’s pleas and tears still have jobs at GSK?…I detect a trick question.

9:42 pm

Bernard Carroll said…

Dr. Jerry Avorn also delivered a body blow to GSK’s obfuscations. In the piece that ran on 60 Minutes, he dismissed talk like “… We will work really hard to resolve these issues and make sure that our quality management system is in place and robust…” Dr. Avorn reminded viewers that in medicine the standard is we get it right, as in brain surgery. Glaxo’s lame excuse that drug manufacturing is a complicated process does not hold water.And then, as so often, the subsequent coverup deepened the ethical failure.

12:43 pm