Where did Seroxat Come from ?..
Who created it?..
What can we learn from its origins?…
Find out HERE
Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Thursday, May 31, 2007
Wednesday, May 30, 2007
GlaxoSmithKline - A History of 'dodgy' drugs
Please click on the following link that will take you to a fascinating read: HERE
GSK hit as Avandia market share slides after health scare
It seems the writing is on the wall for GlaxoSmithKline
Source: The Independent 30th May 2007
Doctors have virtually stopped prescribing the GlaxoSmithKline diabetes pill Avandia in the wake of a health scare, and frightened patients are abandoning a long-term trial of the drug that is aimed at proving its safety.
GSK has become so alarmed at the threat to the 4,400-patient safety study that it is examining ways to persuade volunteers to stick with the drug.
The company has found itself at the middle of a political and public relations firestorm after an academic study found that Avandia dramatically increased the risk of heart attacks among users. While the company insists the study is flawed, and US regulators have told patients not to panic, there is growing evidence that sales are being significantly hit.
Analysts were yesterday poring over prescription data from the days after the study was published in the New England Journal of Medicine last Monday. Avandia's weekly market share of prescriptions for new diabetes patients fell from 10 per cent before publication to 6 per cent for the week to 23 May.
Pharmaceuticals analysts at Deutsche Bank said that meant that Avandia's market share has fallen to "approximately zero". However, ImpactRx, which collected the data, said it disagreed with that conclusion, and said prescriptions were still being written for Avandia.
GSK shares fell a further 2.1 per cent to 1,306p, and are now down almost 11 per cent since the NEJM study came out. In all, more than £9bn has been wiped off the value of the company.
Two days of prescription data is not enough to reach sensible conclusions on the trend for Avandia new prescriptions, GSK said, adding that the safety of the drug would be vindicated when the Food & Drug Administration, the US drug regulator, convenes an expert panel to examine the issue.
The NEJM study calculated heart attack risk by adding together data from lots of small trials, but both GSK and the FDA say that early data from a 4,400-patient trial specifically designed to measure such risks is "quite reassuring". This so-called "Record" study began four years ago and is scheduled to run until 2009.
Other stories:
Drug Maker Facing Investor Headache (From Sky News)
GlaxoSmithKline has staged a fresh defence of its diabetic drug Avandia amid reports linking the treatment to heart attacks.
The pharmaceutical giant told shareholders at its AGM that research suggesting Avandia increased the risk of heart attacks by 43% was flawed.
The group added it was "confident" the treatment would be vindicated.
GSK's share price fell 5% on Monday after news broke of the research findings and the stock has continued to slide despite assurances from the drug firm
"We remain confident that the significant benefits of the medicine continue to outweigh any treatment risks," GSK chairman Christopher Gent said.
Europe's drug watchdog, the European Medicines Agency, also issued a statement urging patients not to stop treatment with rosiglitazone (Avandia).
It confirmed the drug was kept under "close surveillance" over any possible links to heart risks.
But analyst and investor fears failed to subside, with GSK's share price closing down a further 2%.
Shareholders voiced their anger at the meeting in London over the poor performance of GSK's share price, which has dropped by almost 15% over the past year.
GSK investor John Farmer blasted the group for its "colossal under-performance" and demanded the resignation of chairman Sir Christopher and a more speedy exit for CEO Jean-Pierre Garnier
Mr Garnier is due to step down in May 2008
Source: The Independent 30th May 2007
Doctors have virtually stopped prescribing the GlaxoSmithKline diabetes pill Avandia in the wake of a health scare, and frightened patients are abandoning a long-term trial of the drug that is aimed at proving its safety.
GSK has become so alarmed at the threat to the 4,400-patient safety study that it is examining ways to persuade volunteers to stick with the drug.
The company has found itself at the middle of a political and public relations firestorm after an academic study found that Avandia dramatically increased the risk of heart attacks among users. While the company insists the study is flawed, and US regulators have told patients not to panic, there is growing evidence that sales are being significantly hit.
Analysts were yesterday poring over prescription data from the days after the study was published in the New England Journal of Medicine last Monday. Avandia's weekly market share of prescriptions for new diabetes patients fell from 10 per cent before publication to 6 per cent for the week to 23 May.
Pharmaceuticals analysts at Deutsche Bank said that meant that Avandia's market share has fallen to "approximately zero". However, ImpactRx, which collected the data, said it disagreed with that conclusion, and said prescriptions were still being written for Avandia.
GSK shares fell a further 2.1 per cent to 1,306p, and are now down almost 11 per cent since the NEJM study came out. In all, more than £9bn has been wiped off the value of the company.
Two days of prescription data is not enough to reach sensible conclusions on the trend for Avandia new prescriptions, GSK said, adding that the safety of the drug would be vindicated when the Food & Drug Administration, the US drug regulator, convenes an expert panel to examine the issue.
The NEJM study calculated heart attack risk by adding together data from lots of small trials, but both GSK and the FDA say that early data from a 4,400-patient trial specifically designed to measure such risks is "quite reassuring". This so-called "Record" study began four years ago and is scheduled to run until 2009.
Other stories:
Drug Maker Facing Investor Headache (From Sky News)
GlaxoSmithKline has staged a fresh defence of its diabetic drug Avandia amid reports linking the treatment to heart attacks.
The pharmaceutical giant told shareholders at its AGM that research suggesting Avandia increased the risk of heart attacks by 43% was flawed.
The group added it was "confident" the treatment would be vindicated.
GSK's share price fell 5% on Monday after news broke of the research findings and the stock has continued to slide despite assurances from the drug firm
"We remain confident that the significant benefits of the medicine continue to outweigh any treatment risks," GSK chairman Christopher Gent said.
Europe's drug watchdog, the European Medicines Agency, also issued a statement urging patients not to stop treatment with rosiglitazone (Avandia).
It confirmed the drug was kept under "close surveillance" over any possible links to heart risks.
But analyst and investor fears failed to subside, with GSK's share price closing down a further 2%.
Shareholders voiced their anger at the meeting in London over the poor performance of GSK's share price, which has dropped by almost 15% over the past year.
GSK investor John Farmer blasted the group for its "colossal under-performance" and demanded the resignation of chairman Sir Christopher and a more speedy exit for CEO Jean-Pierre Garnier
Mr Garnier is due to step down in May 2008
Tuesday, May 29, 2007
Drug Manufacturers to "Spy" on Blogs and Other Internet Postings
Source: Drug Injury.com
Internet Spying by Drug Companies Said to be "for the good of the patient"
On May 30, 2005 the Financial Times (London, UK) newspaper reported that drug manufacturers GlaxoSmithKline, Pfizer, and Johnson & Johnson are considering the use of proprietary computer software to monitor web logs, commonly known as blogs, news groups, and patient online forums for mention of the companies' pharmaceutical products in internet postings.
To implement their internet monitoring -- or, some might say, internet spying -- operation, these drug companies have conferred with Netrank, a UK company. Netrank's "i-reputation" service apparently uses "software robots" to constantly monitor the content of new postings made to blogs, news groups, and other types of web sites. John Straw, head of Netrank, claims that the drug companies' motives for monitoring efforts are essentially good:
You could say we are spying, but actually this information is in the public domain. We are doing it for the good of the patient, allowing companies to react more quickly to concerns.
Use of Netrank's "i-reputation" service would enable GlaxoSmithKline, Pfizer, and Johnson & Johnson to seek out and identify thousands of internet postings per day that make certain types of references to their prescription drugs.
There are several reasons that these drug companies might want to engage in such an internet monitoring, or internet spying, operation. As suggested by Netrank's Mr. Straw, one reason could be to warn drug companies of emerging potential side effects associated with one of their prescription drugs. Another motivation is that the "i-reputation" service would allow the drug companies to learn about internet postings which might positively or negatively affect one of their pharmaceutical products or, more generally, their corporate reputation.
Potentially, by use of the "i-reputation" service, these drug companies could ultimately choose to contact directly some or all patients who made an internet posting. The Financial Times article pointed out that this latter practice would likely be prohibited in European countries, because there is a ban on direct advertising of prescription drugs to patients, there. The odds for some type of marketing use for this internet-posting "intelligence" seem better in the U.S., given that some forms of direct-to-consumer (DTC) advertising are permitted by the FDA, here.
This news of drug companies monitoring blogs and other internet postings met with a mixed review from Katherine Murphy, who commented on behalf of the Patients' Association, a patients' rights group in the UK:
If this information is used constructively it could be a good thing. But I would be slightly concerned about how the drug companies would use the information. I don't think it would be right for them to have direct access to patients.
No doubt, the possible use of Netrank's "i-reputation" internet monitoring service by drug companies like GlaxoSmithKline, Pfizer, and Johnson & Johnson will be the source of considerable controversy as more consumers and patients become aware of this rather unsettling news.
Internet Spying by Drug Companies Said to be "for the good of the patient"
On May 30, 2005 the Financial Times (London, UK) newspaper reported that drug manufacturers GlaxoSmithKline, Pfizer, and Johnson & Johnson are considering the use of proprietary computer software to monitor web logs, commonly known as blogs, news groups, and patient online forums for mention of the companies' pharmaceutical products in internet postings.
To implement their internet monitoring -- or, some might say, internet spying -- operation, these drug companies have conferred with Netrank, a UK company. Netrank's "i-reputation" service apparently uses "software robots" to constantly monitor the content of new postings made to blogs, news groups, and other types of web sites. John Straw, head of Netrank, claims that the drug companies' motives for monitoring efforts are essentially good:
You could say we are spying, but actually this information is in the public domain. We are doing it for the good of the patient, allowing companies to react more quickly to concerns.
Use of Netrank's "i-reputation" service would enable GlaxoSmithKline, Pfizer, and Johnson & Johnson to seek out and identify thousands of internet postings per day that make certain types of references to their prescription drugs.
There are several reasons that these drug companies might want to engage in such an internet monitoring, or internet spying, operation. As suggested by Netrank's Mr. Straw, one reason could be to warn drug companies of emerging potential side effects associated with one of their prescription drugs. Another motivation is that the "i-reputation" service would allow the drug companies to learn about internet postings which might positively or negatively affect one of their pharmaceutical products or, more generally, their corporate reputation.
Potentially, by use of the "i-reputation" service, these drug companies could ultimately choose to contact directly some or all patients who made an internet posting. The Financial Times article pointed out that this latter practice would likely be prohibited in European countries, because there is a ban on direct advertising of prescription drugs to patients, there. The odds for some type of marketing use for this internet-posting "intelligence" seem better in the U.S., given that some forms of direct-to-consumer (DTC) advertising are permitted by the FDA, here.
This news of drug companies monitoring blogs and other internet postings met with a mixed review from Katherine Murphy, who commented on behalf of the Patients' Association, a patients' rights group in the UK:
If this information is used constructively it could be a good thing. But I would be slightly concerned about how the drug companies would use the information. I don't think it would be right for them to have direct access to patients.
No doubt, the possible use of Netrank's "i-reputation" internet monitoring service by drug companies like GlaxoSmithKline, Pfizer, and Johnson & Johnson will be the source of considerable controversy as more consumers and patients become aware of this rather unsettling news.
What we have here is... a failure to communicate 3
My third and final post about my recent correspondence with three leading figures who, in one way or another, represent mental health charities here in the UK.
This will be my last say on the matter - Seroxat Secrets is still digging and unearthing a plethora of information regarding this issue and as I have said previously, does a much better job than I.
My previous two posts should be read before continuing - (1) & (2)
To recap:
Amelia Mustapha, Dr Chris Manning and Jim Thomson were at some point working for the mental health charity Depression Alliance who, in the past have been chastised for accepting up to 80% of Pharmaceutical funding (see the Select Committee on Health Minutes of Evidence)
Depression Alliance have never spoke out against Seroxat despite the thousands of adverse reactions reported by patients.
It was Amelia who first brought my attention to the way Depression Alliance thinks with a post on her blog entitled ' Seroxat Turned Me Green' and then later another post entitled 'Taking the Devil's Money, Doing the Lord's Work'. Although she does not advocate the use of Seroxat, she dismisses those who speak out against it. Amelia and I entered into email correspondence but she called it a day when her name was mentioned on Seroxat Secrets. She never told me she was going to cease communication with me, that was left to her friend, Jim Thomson. Mr Thomson was later to inform me that Dr Chris Manning had also decided to stop communicating with me.
This leads me to believe that Jim Thomson was copied in on my correspondence with Amelia Mustapha and Chris Manning although this cannot be proven (it is just a belief) - Jim was, after all, the CEO of Depression Alliance.
I entered into email correspondence with Jim Thomson after I saw he had commented on an article written by Seroxat Secrets ' What a tangled web we weave…'. Personally, I thought it was a brave thing to go public on a site that has a growing number of daily visitors. His comments came across as someone who was angry, some might say he had every right to be angry considering what had been wrote but as a former CEO I would have thought he would have at least learned decorum and people skills. His lack of tact became more apparent during our email correspondence as you will see when reading this.
At the end of this post I will leave Jim to have the final say - He wrongfully assumed that I would not let him - I always allow people to have their say on this blog, unless they advertise or use foul language.
Before reading on, please remember that Amelia Mustapha, Dr Chris Manning and now Jim Thomson all decided to cease communication with me. Read into that what you will.
I contacted Jim Thomson after I read his comments on Seroxat Secrets. His opening paragraph to the author of Seroxat Secrets was straight on the defence:
...I have been alerted to your comments about me and have just spent a most diverting half hour reading them. You are extremely lucky that I am not the litigious type. What you have “uncovered” is a tissue of conjecture and you are, clearly, a master at putting two next to two and seeing several dozen. For the record (and this will be the only message you receive from me as I have far better things to do with my days) I’ll try to sort out your maths. Just this once. (see here for full response)
Mr Thomson added further comments despite stating in the opening paragraph that he wouldn't. ( '...and this will be the only message you receive from me as I have far better things to do with my days'). In fact Mr Thomson added a further 4 comments!
In response to my first email I sent him he told me that he had spoken with Dr Manning and had learned that Dr Manning had decided not to sue for libel, although Mr Thomson was unsure whether he was referring to me or the author of Seroxat Secrets. I pointed out that I had never even mentioned Dr Manning on this blog, the only correspondence I had ever had with him was via email. Mr Thomson went on to tell me that Dr Manning was hurt by the comments/articles written on him and suggested that I find out more about him before any further implications about his integrity or that of Primhe. He went on to tell me that Dr Manning had once opened a blister pack of tablets live on air, he informed listeners that the medicine 'kept him alive'
I took tablets for nigh on 6 years but didn't feel the need to make a show of it. I really can't see why a doctor would do such a thing other than to prove to the listener that the product he was consuming was safe... this begs the question, why would he do such a thing? Was it to play down the talk that these particular drugs were dangerous?
Once again I pointed out that I had never spoken out against Manning - Jim replied with ' And he has chosen – rightly in my view – to cease communicating with you.'
Once again I had learned third party that an ongoing communication had been stopped, you may remember Amelia Mustapha had decided to cease communication with me too. Neither Dr Manning nor Amelia Mustapha had the decency to tell me, instead I was informed by the former CEO of Depression Alliance, Jim Thomson!
Jim later moved the goalposts when I brought him to task regarding my apparent 'dissing' of Manning. ' When you criticise Primhe, you criticise Chris Manning, because he IS Primhe'
So Primhe are not an organisation then, they are merely one person?
Jim asked me to provide him with evidence where he had endorsed any Pharmaceutical drug, he went on to say that he had previously asked Richard Brook (formerly of MIND), Paul Flynn MP, Charles Medawar, and Andrew Herxheimer to supply evidence. Incidently, the aforementioned have all spoken out against Seroxat and suppressed data. Coincidence that Jim Thomson should mention these names?
He claimed that there was a raging silence from us all because there is no evidence that he has ever endorsed any pharmaceutical product. I found this statement rather odd as I had never once said that he had? I will however go on record to say that although he does not 'endorse' pharmaceutical products, he does not speak out against them either - despite the overwhelming evidence that people are suffering at the hands of them, despite the fact that the MHRA are currently investigating GlaxoSmithKline, despite the fact that there have been four Panorama programmes on the subject and countless internal documents released on the internet.
I felt, as with Amelia Mustapha, that Jim and I were making headway when he informed me that he would contact the MHRA to verify the status of any investigation. We were on the same page when it came to the MHRA so that was enlightning.
I mentioned my correspondence with Amelia to Jim Thomson who informed me the reasons for her ceasing communication with me had nothing to do with the Seroxat Secrets website, later in the paragraph he told me ' You (or your chum – again, it’s hard to tell) chose not to remove the offending comments about her, so she broke off communication.'
Hmmm, so she did cease communication with me because of something that was written about her on another website?
Jim seemed to be hellbent on finding out whether or not I was party to a class action lawsuit. I pointed out to him that I wasn't aware that any such application had been made to the courts and if indeed I was part it would be improper to discuss it on a public forum that was visited regularly by GSK and it's lawyers.
His response?
'...Oh for God’s sake grow up man.'
'...you should declare whether you stand to gain financially from your stance on Seroxat.'
'...if you are pursuing GSK, then I think you should say so.'
'...if you are, you might also be getting very rich quite soon and I think your readers (or at least those who are not also part of the action) deserve to know.'
I am aware of the parallel Mr Thomson is trying to make here and if such a case is applied to the courts then he will be made aware if I am part of that case. Until then, I cannot make assumptions as to whether or not I am part of such a case.
I had previously asked Jim whether he had ever publically criticised any of the Pharmaceutical Companies that you receive funding from? He informed me that he had done so three times, two that featured the same company. He also stated that he had criticised the industry as a whole in front of the OECD, the WHO and the US Senate.
Strangely Jim asked me whether or not I had embarked on any previous compensation cases against large corporations, adding, ...' I know the answer anyway'
The only time I have ever had to use a solicitor was when I went through a divorce. I used the services of an Employment Law Advisor once when the company I worked for couldn't find me alternative employment when I developed bi-lateral osteoarthritis. If this is what he means by ' I know the answer anyway' then I really cannot see the parallel he is trying to make?
Then we have the issue of charity law. I've never disputed that charity have guidelines. I know charities have to accept funding from Pharma - my gripe is that some of these charities refuse to speak out against any of the drugs their funders manufacture. For me that is a conflict of interest. Jim mentioned that I would probably quote MIND to him (I had no intention of) then added ' ...in my view they are acting contrary to Charity Law. Incidentally, I broke off contact with them when they wrote threatening to sue me for having the audacity to criticise them'
Don't you just love the last line?
Audacity to criticise, threatening to sue - Exactly what Dr Manning had 'threatened' to do because someone had the 'audacity to criticise' - Pot, Kettle and black spring to mind.
Jim believes that Pharma set out to make profit by improving life, he wrongfully assumed I believe they set out to kill people. I just highlight the facts where they have killed people, something Depression Alliance, Primhe and Healthwell have never done. Why bite the hand that feeds you eh?
Jim eventually got around to talking about Paroxetine (Seroxat), telling me he knows how many prescriptions have been written for Paroxetine since it was launched and adding '...if the medicine is “a killer”, the numbers just don’t stack up. The suicide statistics alone do not support the argument'
Maybe he could be given access to the records David Healy was when called as an expert witness in June 2001, with the judgement in a Cheyenne, Wyoming court that paroxetine (Paxil/Seroxat) had contributed to the wrongful and violent deaths of Don and Rita Schell and Deborah and Alyssa Tobin and that SmithKline Beecham (now part of Glaxo SmithKline) had been responsible for failures to test and warn. In the course of this case, David Healy (as an expert witness for the Plaintiffs) discovered key company documents, detailing the results of very early studies in which paroxetine had been taken by healthy volunteers.
There were a further number of emails between myself and Jim Thomson, basically which went over old ground about whether or not he or his organisation were right. He had wrote a 'scathing' reply to me (his own words) but apparently could not send it due to a malfunction in his email client... he, once again wrongfully assumed it had something to do with me, '...but I assume it is something you have done to your outgoing messages'
His last email was to let me know he no longer wished to correspond with me and, as promised, I shall leave the last words with Jim Thomson. I will not add any further comment other than to offer Amelia Mustapha, Dr Manning and Jim Thomson the further right to reply via the comments section of this blog.
I would like to take this opportunity to thank all three concerned for communicating with me.
Here are Jim Thomson's final words.
I decline to play your game and you intend to publish my declination anyway. You do not have my permission to publish any of our exchange. If you decide to do so anyway, which I am fairly convinced you will, then so be it. I trust if you have a shred of decency, that you will also publish the following comment, without commentary from you, and that you will let your readers judge….
“I went to great lengths to illustrate to Mr Fiddaman that he and others are totally mistaken when they imply that I and my colleagues, are in some way a mouthpiece for big pharma. At no point in our exchanges, did I conceal any information from Mr Fiddaman. I was at all times honest. I have never, in over a quarter of a century in the charity sector, received any funding based on any endorsement of any product – pharmaceutical or otherwise. None of those questioning my integrity have, or ever will, provide evidence to the contrary. On the other hand, I have been targeted and criticised by people who do stand to gain financially and reputationally (and in some cases have already gained) from their position regarding pharmaceutical products. I will no longer play on such a sloping playing field. Eventually, it became clear to me that Mr Fiddaman had no intention of listening to anything I had to say. There was no point in continuing, particularly as the final response that I wrote was, on reflection, extremely scathing. I decided not to send it. I wish the readers of this blog nothing but the best – and in particular I wish you all good health. Above all, I ask you all to do this one thing. When you see or hear anything in this context, ask yourself one question….”What does this person, or this organisation, have to gain from taking this position?” All may become marginally clearer. Jim”.
This will be my last say on the matter - Seroxat Secrets is still digging and unearthing a plethora of information regarding this issue and as I have said previously, does a much better job than I.
My previous two posts should be read before continuing - (1) & (2)
To recap:
Amelia Mustapha, Dr Chris Manning and Jim Thomson were at some point working for the mental health charity Depression Alliance who, in the past have been chastised for accepting up to 80% of Pharmaceutical funding (see the Select Committee on Health Minutes of Evidence)
Depression Alliance have never spoke out against Seroxat despite the thousands of adverse reactions reported by patients.
It was Amelia who first brought my attention to the way Depression Alliance thinks with a post on her blog entitled ' Seroxat Turned Me Green' and then later another post entitled 'Taking the Devil's Money, Doing the Lord's Work'. Although she does not advocate the use of Seroxat, she dismisses those who speak out against it. Amelia and I entered into email correspondence but she called it a day when her name was mentioned on Seroxat Secrets. She never told me she was going to cease communication with me, that was left to her friend, Jim Thomson. Mr Thomson was later to inform me that Dr Chris Manning had also decided to stop communicating with me.
This leads me to believe that Jim Thomson was copied in on my correspondence with Amelia Mustapha and Chris Manning although this cannot be proven (it is just a belief) - Jim was, after all, the CEO of Depression Alliance.
I entered into email correspondence with Jim Thomson after I saw he had commented on an article written by Seroxat Secrets ' What a tangled web we weave…'. Personally, I thought it was a brave thing to go public on a site that has a growing number of daily visitors. His comments came across as someone who was angry, some might say he had every right to be angry considering what had been wrote but as a former CEO I would have thought he would have at least learned decorum and people skills. His lack of tact became more apparent during our email correspondence as you will see when reading this.
At the end of this post I will leave Jim to have the final say - He wrongfully assumed that I would not let him - I always allow people to have their say on this blog, unless they advertise or use foul language.
Before reading on, please remember that Amelia Mustapha, Dr Chris Manning and now Jim Thomson all decided to cease communication with me. Read into that what you will.
I contacted Jim Thomson after I read his comments on Seroxat Secrets. His opening paragraph to the author of Seroxat Secrets was straight on the defence:
...I have been alerted to your comments about me and have just spent a most diverting half hour reading them. You are extremely lucky that I am not the litigious type. What you have “uncovered” is a tissue of conjecture and you are, clearly, a master at putting two next to two and seeing several dozen. For the record (and this will be the only message you receive from me as I have far better things to do with my days) I’ll try to sort out your maths. Just this once. (see here for full response)
Mr Thomson added further comments despite stating in the opening paragraph that he wouldn't. ( '...and this will be the only message you receive from me as I have far better things to do with my days'). In fact Mr Thomson added a further 4 comments!
In response to my first email I sent him he told me that he had spoken with Dr Manning and had learned that Dr Manning had decided not to sue for libel, although Mr Thomson was unsure whether he was referring to me or the author of Seroxat Secrets. I pointed out that I had never even mentioned Dr Manning on this blog, the only correspondence I had ever had with him was via email. Mr Thomson went on to tell me that Dr Manning was hurt by the comments/articles written on him and suggested that I find out more about him before any further implications about his integrity or that of Primhe. He went on to tell me that Dr Manning had once opened a blister pack of tablets live on air, he informed listeners that the medicine 'kept him alive'
I took tablets for nigh on 6 years but didn't feel the need to make a show of it. I really can't see why a doctor would do such a thing other than to prove to the listener that the product he was consuming was safe... this begs the question, why would he do such a thing? Was it to play down the talk that these particular drugs were dangerous?
Once again I pointed out that I had never spoken out against Manning - Jim replied with ' And he has chosen – rightly in my view – to cease communicating with you.'
Once again I had learned third party that an ongoing communication had been stopped, you may remember Amelia Mustapha had decided to cease communication with me too. Neither Dr Manning nor Amelia Mustapha had the decency to tell me, instead I was informed by the former CEO of Depression Alliance, Jim Thomson!
Jim later moved the goalposts when I brought him to task regarding my apparent 'dissing' of Manning. ' When you criticise Primhe, you criticise Chris Manning, because he IS Primhe'
So Primhe are not an organisation then, they are merely one person?
Jim asked me to provide him with evidence where he had endorsed any Pharmaceutical drug, he went on to say that he had previously asked Richard Brook (formerly of MIND), Paul Flynn MP, Charles Medawar, and Andrew Herxheimer to supply evidence. Incidently, the aforementioned have all spoken out against Seroxat and suppressed data. Coincidence that Jim Thomson should mention these names?
He claimed that there was a raging silence from us all because there is no evidence that he has ever endorsed any pharmaceutical product. I found this statement rather odd as I had never once said that he had? I will however go on record to say that although he does not 'endorse' pharmaceutical products, he does not speak out against them either - despite the overwhelming evidence that people are suffering at the hands of them, despite the fact that the MHRA are currently investigating GlaxoSmithKline, despite the fact that there have been four Panorama programmes on the subject and countless internal documents released on the internet.
I felt, as with Amelia Mustapha, that Jim and I were making headway when he informed me that he would contact the MHRA to verify the status of any investigation. We were on the same page when it came to the MHRA so that was enlightning.
I mentioned my correspondence with Amelia to Jim Thomson who informed me the reasons for her ceasing communication with me had nothing to do with the Seroxat Secrets website, later in the paragraph he told me ' You (or your chum – again, it’s hard to tell) chose not to remove the offending comments about her, so she broke off communication.'
Hmmm, so she did cease communication with me because of something that was written about her on another website?
Jim seemed to be hellbent on finding out whether or not I was party to a class action lawsuit. I pointed out to him that I wasn't aware that any such application had been made to the courts and if indeed I was part it would be improper to discuss it on a public forum that was visited regularly by GSK and it's lawyers.
His response?
'...Oh for God’s sake grow up man.'
'...you should declare whether you stand to gain financially from your stance on Seroxat.'
'...if you are pursuing GSK, then I think you should say so.'
'...if you are, you might also be getting very rich quite soon and I think your readers (or at least those who are not also part of the action) deserve to know.'
I am aware of the parallel Mr Thomson is trying to make here and if such a case is applied to the courts then he will be made aware if I am part of that case. Until then, I cannot make assumptions as to whether or not I am part of such a case.
I had previously asked Jim whether he had ever publically criticised any of the Pharmaceutical Companies that you receive funding from? He informed me that he had done so three times, two that featured the same company. He also stated that he had criticised the industry as a whole in front of the OECD, the WHO and the US Senate.
Strangely Jim asked me whether or not I had embarked on any previous compensation cases against large corporations, adding, ...' I know the answer anyway'
The only time I have ever had to use a solicitor was when I went through a divorce. I used the services of an Employment Law Advisor once when the company I worked for couldn't find me alternative employment when I developed bi-lateral osteoarthritis. If this is what he means by ' I know the answer anyway' then I really cannot see the parallel he is trying to make?
Then we have the issue of charity law. I've never disputed that charity have guidelines. I know charities have to accept funding from Pharma - my gripe is that some of these charities refuse to speak out against any of the drugs their funders manufacture. For me that is a conflict of interest. Jim mentioned that I would probably quote MIND to him (I had no intention of) then added ' ...in my view they are acting contrary to Charity Law. Incidentally, I broke off contact with them when they wrote threatening to sue me for having the audacity to criticise them'
Don't you just love the last line?
Audacity to criticise, threatening to sue - Exactly what Dr Manning had 'threatened' to do because someone had the 'audacity to criticise' - Pot, Kettle and black spring to mind.
Jim believes that Pharma set out to make profit by improving life, he wrongfully assumed I believe they set out to kill people. I just highlight the facts where they have killed people, something Depression Alliance, Primhe and Healthwell have never done. Why bite the hand that feeds you eh?
Jim eventually got around to talking about Paroxetine (Seroxat), telling me he knows how many prescriptions have been written for Paroxetine since it was launched and adding '...if the medicine is “a killer”, the numbers just don’t stack up. The suicide statistics alone do not support the argument'
Maybe he could be given access to the records David Healy was when called as an expert witness in June 2001, with the judgement in a Cheyenne, Wyoming court that paroxetine (Paxil/Seroxat) had contributed to the wrongful and violent deaths of Don and Rita Schell and Deborah and Alyssa Tobin and that SmithKline Beecham (now part of Glaxo SmithKline) had been responsible for failures to test and warn. In the course of this case, David Healy (as an expert witness for the Plaintiffs) discovered key company documents, detailing the results of very early studies in which paroxetine had been taken by healthy volunteers.
There were a further number of emails between myself and Jim Thomson, basically which went over old ground about whether or not he or his organisation were right. He had wrote a 'scathing' reply to me (his own words) but apparently could not send it due to a malfunction in his email client... he, once again wrongfully assumed it had something to do with me, '...but I assume it is something you have done to your outgoing messages'
His last email was to let me know he no longer wished to correspond with me and, as promised, I shall leave the last words with Jim Thomson. I will not add any further comment other than to offer Amelia Mustapha, Dr Manning and Jim Thomson the further right to reply via the comments section of this blog.
I would like to take this opportunity to thank all three concerned for communicating with me.
Here are Jim Thomson's final words.
I decline to play your game and you intend to publish my declination anyway. You do not have my permission to publish any of our exchange. If you decide to do so anyway, which I am fairly convinced you will, then so be it. I trust if you have a shred of decency, that you will also publish the following comment, without commentary from you, and that you will let your readers judge….
“I went to great lengths to illustrate to Mr Fiddaman that he and others are totally mistaken when they imply that I and my colleagues, are in some way a mouthpiece for big pharma. At no point in our exchanges, did I conceal any information from Mr Fiddaman. I was at all times honest. I have never, in over a quarter of a century in the charity sector, received any funding based on any endorsement of any product – pharmaceutical or otherwise. None of those questioning my integrity have, or ever will, provide evidence to the contrary. On the other hand, I have been targeted and criticised by people who do stand to gain financially and reputationally (and in some cases have already gained) from their position regarding pharmaceutical products. I will no longer play on such a sloping playing field. Eventually, it became clear to me that Mr Fiddaman had no intention of listening to anything I had to say. There was no point in continuing, particularly as the final response that I wrote was, on reflection, extremely scathing. I decided not to send it. I wish the readers of this blog nothing but the best – and in particular I wish you all good health. Above all, I ask you all to do this one thing. When you see or hear anything in this context, ask yourself one question….”What does this person, or this organisation, have to gain from taking this position?” All may become marginally clearer. Jim”.
Monday, May 28, 2007
Coming Soon...
... My correspondence with Jim Thomson, former CEO of Depression Alliance - the third and final health charity advocate who decided to cut off communications with me. I don't think any of the regular readers on here will be surprised by his attitude and use of words.
Keep em peeled
Bob
Keep em peeled
Bob
What we have here is... a failure to communicate 2
Following on from my correspondence with three leading figures for mental health patient support groups HERE I now will turn my attention to Dr Chris Manning with whom I had brief correspondence with via email. If you read my first post on this subject you will have learned that the author of Seroxat Secrets had unearthed what seemed like very close ties between Depression Alliance, Primhe, Healthwell and pharmaceutical marketing.
On closer inspection I learned that Primhe were funded by pharma and on their site they boast “Primhe is the UK primary care professional charity dedicated to mental health and the care of those with mental illness in primary care settings. Our mantra is “bringing ‘mental’ into the mainstream”.
I wrote to Primhe because I was unhappy to say the least that the Pharmaceutical funding Primhe were receiving was from Lundbeck who have a bad history of manufacturing bad pills.
I wrote the following:
Dear Primhe
Why is it that you are associated (funded) by Lundbeck when the three antidepressants they manufacture are all known to cause serious side effects?
I thought Primhe was set up to HELP patients with mental illness?
CIPRALEX
Total reports: 75
Reported deaths: 9
Reported hospitalizations: 30
Learn about CIPRALEX serious adverse events reported to Food and Drug Administration
LEXAPRO
Total reports: 413
Reported deaths: 71
Reported hospitalizations: 136
Learn about LEXAPRO serious adverse events reported to Food and Drug Administration
SEROPLEX
Total reports: 74
Reported deaths: 15
Reported hospitalizations: 39
Learn about SEROPLEX serious adverse events reported to Food and Drug Administration
Dr Manning wrote back thanking me for raising the issue and adding that Primhe have excellent working relationships with funders (including pharma). At the end of his email he asked what it is I do? I replied sometime later telling him I was a campaigner speaking out against GlaxoSmithKline, The MHRA and Seroxat... his response? "Well, you can continue to do that. Primhe has other fish to fry".
I asked him if he thought the public were confident in the light that Primhe were funded by pharma to which he replied, "I have no idea; you clearly are not".
I told him I would applaud Primhe if they were to carry warnings on their web page regarding the drugs their funders manufactured - His reply came as a bit of a shock:
"Then we can agree to disagree and there is no way that the charity can, or will, do as you suggest"
Make of that what you will folks.
He also went on to tell me that Suicide rates have fallen in every country where SSRIs have been prescribed (and there are now rises in US states in children and adolescents where SSRI prescribing rates have fallen. This, as we know, is a myth and more than likely Pharma spin (SEE HERE). He also added "The charity does not promote any single medicine or inform professionals or patients as to what specific medicines or interventions they should prescribe or take".
I replied to Dr Manning and he responded with which was to be his last email to me.
I asked: Do you not feel, as a doctor, you should warn patients that the Patient Information leaflet in certain drugs does not tell the whole story of side effects?
He replied, Whilst in practice, I was meticulous in this regard. Primhe cannot do everything and I am confident that there are more than enough people (including yourself) and other organisations tackling this issue.
I guess that's a fair comment - Set up a charity to help people with mental health problems yet leave it to the layman to warn those same patients of the serious adverse effects certain antidepressants can cause. Do you wish Dr Manning was your GP folks?
It seems those that DO NOT speak out against SSRi's constantly bang the same drum, always asking 'What other alternative is there'? Dr Manning was no exception.
Just because there is one remedy, that for all intents and purposes is causing great distress amongst thousands of patients, DOES NOT mean that it is ok to continue taking it because no other remedy seems to have been scientifically proven to help depressives. I find this attitude ignorant and it smacks of burying ones head in the sand regarding the problems patients are having to endure at the hands of these drugs.
Dr Manning continued with his 'pro ssri stance' by informing me that he had personally witnessed people, who as a direct result of various programmes and articles had stopped taking vital medications causing them serious adverse effects and in two cases suicide.
I assume that he is referring to Panorama here. I cannot recall Panorama ever telling anyone to suddenly stop taking their medication. I have not come across any article that suggests that either.
Dr Manning further wrote, "I have learned that everyone on this plant has agendas of one sort or another and I make it my general habit to be very sceptical of any single lobbying voice, however well motivated".
I pointed out that he only needed to type the word 'Seroxat' into Google to see there were many lobbying voices speaking out against this drug - his reply? "It's ok, I know you are not alone. Perhaps I'll start a website for those who feel they are helped by their SSRI...or would you just call them deluded? (I met two yesterday)".
Whilst Amelia Mustafa, Dr Chris Manning and Jim Thomson robustly deny they promote any pharmaceutical product, it seems they do a great job in defending them, which pretty much amounts to the same thing don't you think?
Dr Manning is what his titles says, he is a doctor, one that is in a position to offer advice to patients suffering from withdrawal from Seroxat. With comments like 'Perhaps I'll start a website for those who feel they are helped by their SSRi', it seems Dr Manning has made his mind up that SSRi's are beneficial. Hardly surprising seeing as Primhe receive funding from Pharma who manufacture antidepressants.
Or am I just being cynical?
As always, I offer Dr Manning the chance to reply via the comments section on this blog.
He hasn't replied via email
You can read more about Dr Manning, Amelia Mustafa and Jim Thomson HERE, HERE. Or just pop over to Seroxat Secrets where the research into mental health charities and funding has proved to be very popular with Seroxat Secrets readers... including Jim Thomson
Bob
On closer inspection I learned that Primhe were funded by pharma and on their site they boast “Primhe is the UK primary care professional charity dedicated to mental health and the care of those with mental illness in primary care settings. Our mantra is “bringing ‘mental’ into the mainstream”.
I wrote to Primhe because I was unhappy to say the least that the Pharmaceutical funding Primhe were receiving was from Lundbeck who have a bad history of manufacturing bad pills.
I wrote the following:
Dear Primhe
Why is it that you are associated (funded) by Lundbeck when the three antidepressants they manufacture are all known to cause serious side effects?
I thought Primhe was set up to HELP patients with mental illness?
CIPRALEX
Total reports: 75
Reported deaths: 9
Reported hospitalizations: 30
Learn about CIPRALEX serious adverse events reported to Food and Drug Administration
LEXAPRO
Total reports: 413
Reported deaths: 71
Reported hospitalizations: 136
Learn about LEXAPRO serious adverse events reported to Food and Drug Administration
SEROPLEX
Total reports: 74
Reported deaths: 15
Reported hospitalizations: 39
Learn about SEROPLEX serious adverse events reported to Food and Drug Administration
Dr Manning wrote back thanking me for raising the issue and adding that Primhe have excellent working relationships with funders (including pharma). At the end of his email he asked what it is I do? I replied sometime later telling him I was a campaigner speaking out against GlaxoSmithKline, The MHRA and Seroxat... his response? "Well, you can continue to do that. Primhe has other fish to fry".
I asked him if he thought the public were confident in the light that Primhe were funded by pharma to which he replied, "I have no idea; you clearly are not".
I told him I would applaud Primhe if they were to carry warnings on their web page regarding the drugs their funders manufactured - His reply came as a bit of a shock:
"Then we can agree to disagree and there is no way that the charity can, or will, do as you suggest"
Make of that what you will folks.
He also went on to tell me that Suicide rates have fallen in every country where SSRIs have been prescribed (and there are now rises in US states in children and adolescents where SSRI prescribing rates have fallen. This, as we know, is a myth and more than likely Pharma spin (SEE HERE). He also added "The charity does not promote any single medicine or inform professionals or patients as to what specific medicines or interventions they should prescribe or take".
I replied to Dr Manning and he responded with which was to be his last email to me.
I asked: Do you not feel, as a doctor, you should warn patients that the Patient Information leaflet in certain drugs does not tell the whole story of side effects?
He replied, Whilst in practice, I was meticulous in this regard. Primhe cannot do everything and I am confident that there are more than enough people (including yourself) and other organisations tackling this issue.
I guess that's a fair comment - Set up a charity to help people with mental health problems yet leave it to the layman to warn those same patients of the serious adverse effects certain antidepressants can cause. Do you wish Dr Manning was your GP folks?
It seems those that DO NOT speak out against SSRi's constantly bang the same drum, always asking 'What other alternative is there'? Dr Manning was no exception.
Just because there is one remedy, that for all intents and purposes is causing great distress amongst thousands of patients, DOES NOT mean that it is ok to continue taking it because no other remedy seems to have been scientifically proven to help depressives. I find this attitude ignorant and it smacks of burying ones head in the sand regarding the problems patients are having to endure at the hands of these drugs.
Dr Manning continued with his 'pro ssri stance' by informing me that he had personally witnessed people, who as a direct result of various programmes and articles had stopped taking vital medications causing them serious adverse effects and in two cases suicide.
I assume that he is referring to Panorama here. I cannot recall Panorama ever telling anyone to suddenly stop taking their medication. I have not come across any article that suggests that either.
Dr Manning further wrote, "I have learned that everyone on this plant has agendas of one sort or another and I make it my general habit to be very sceptical of any single lobbying voice, however well motivated".
I pointed out that he only needed to type the word 'Seroxat' into Google to see there were many lobbying voices speaking out against this drug - his reply? "It's ok, I know you are not alone. Perhaps I'll start a website for those who feel they are helped by their SSRI...or would you just call them deluded? (I met two yesterday)".
Whilst Amelia Mustafa, Dr Chris Manning and Jim Thomson robustly deny they promote any pharmaceutical product, it seems they do a great job in defending them, which pretty much amounts to the same thing don't you think?
Dr Manning is what his titles says, he is a doctor, one that is in a position to offer advice to patients suffering from withdrawal from Seroxat. With comments like 'Perhaps I'll start a website for those who feel they are helped by their SSRi', it seems Dr Manning has made his mind up that SSRi's are beneficial. Hardly surprising seeing as Primhe receive funding from Pharma who manufacture antidepressants.
Or am I just being cynical?
As always, I offer Dr Manning the chance to reply via the comments section on this blog.
He hasn't replied via email
You can read more about Dr Manning, Amelia Mustafa and Jim Thomson HERE, HERE. Or just pop over to Seroxat Secrets where the research into mental health charities and funding has proved to be very popular with Seroxat Secrets readers... including Jim Thomson
Bob
Sunday, May 27, 2007
Cocaine v Seroxat/Paxil - Addiction
Cocaine addiction withdrawal symptoms include but are not limited to:
agitation
depression
intense craving for the drug
extreme fatigue
anxiety
angry outbursts
lack of motivation
nausea/vomiting
shaking
irritability
muscle pain
disturbed sleep
depression
intense craving for the drug
extreme fatigue
anxiety
angry outbursts
lack of motivation
nausea/vomiting
shaking
irritability
muscle pain
disturbed sleep
Reported Paxil/Seroxat addiction withdrawal symptoms
anxiety
dizziness
fatigue
headache
migraine-like feelings
nerves jangling when moving eyes
continuous indigestion
continuous indigestion
neck and back pain
psychotic features such as visual and/or audial hallucinations/illusions
insomnia
nausea
restlessness
"electrical shock" like phenomena/electrical surges or shocks through the head and/or body hyper-sensitivity of the nervous system to light, sound, colours & stressors
tremors
tinnitus and a vertiginous-like experience
depressive thoughts
suicidal thoughts
homicidal thoughts
extreme anger
severe agitation
extreme irritability
"over-reacting"
ringing in ears and throbbing in head
vomiting
paranoia
aggressive behaviour
rollercoaster emotions rapidly following up on each other
out of character behaviour
severe malaise
general dysphoria
derealization
panic attacks
The Head of European Clinical Psychiatry at the pharmaceutical company GlaxoSmithKline, Dr Alistair Benbow, has denied that the drug Seroxat can lead to addiction.
Dr Benbow also says there is no reliable evidence that the drug can cause addiction or dependence.
"Addiction is characterised by a number of different criteria which includes craving, which includes increasing the dose of drug to get the same effect, and a number of other features, and these are not exhibited by Seroxat."
He added that if you used the dictionary definition of addiction, then they could be applied to most prescription medicines.
Here's a word to look up in your dictionary Ali.
'LIAR'
'LIAR'
n. One that tells lies.
O.E. leogere; agent noun from Anglian legan, W.Saxon leogan "be untruthful, lie" (see lie (v.1)).
noun
a person who has lied or who lies repeatedly
a person who has lied or who lies repeatedly
noun
a person who tells lies, especially as a habitExample: You can't trust what she says — he's such a liar.
a person who tells lies, especially as a habitExample: You can't trust what she says — he's such a liar.
Whatever language you use Ali:
Arabic:
كَذّاب
Chinese (Simplified):
说谎的人
说谎的人
Chinese (Traditional):
愛說謊的人
愛說謊的人
Czech:
lhář, -ka
lhář, -ka
Danish:
løgner; løgnhals
løgner; løgnhals
Dutch:
leugenaar
leugenaar
Estonian:
valetaja
valetaja
Finnish:
valehtelija
valehtelija
French:
menteur, *-euse
menteur, *-euse
German:
der Lügner
der Lügner
Greek:
ψεύτης
ψεύτης
Hungarian:
hazug
hazug
Icelandic:
lygari
lygari
Indonesian:
pembohong
pembohong
Italian:
bugiardo
bugiardo
Japanese:
嘘つき
嘘つき
Korean:
거짓말쟁이
거짓말쟁이
Latvian:
melis
melis
Lithuanian:
melagis
melagis
Norwegian:
løgner
løgner
Polish:
kłamca
kłamca
Portuguese (Brazil):
mentiroso
mentiroso
Portuguese (Portugal):
mentiroso
mentiroso
Romanian:
mincinos
mincinos
Russian:
врун
врун
Slovak:
klamár, -ka
klamár, -ka
Slovenian:
lažnivec
lažnivec
Spanish:
mentiroso
mentiroso
Swedish:
lögnare
lögnare
Turkish:
yalancı
yalancı
L
I
A
R
Saturday, May 26, 2007
GlaxoSmithKline's, Alistair Benbow's infamous quote
I think patients have nothing to fear from taking Seroxat.
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director6/13/2002
Notice the year he made that rather brash statement folks? 2002.
Lets just have a look through some archives here to highlight one of two things.
1. Benbow is a liar or
2. Benbow has been kept in the dark and his employer (GSK) have been lying to him.
Archive 1 is from Green Left Online. It is an article that was published in 1993, some 9 years before Benbow declared that patients had nothing to fear taking Seroxat. Surely this is a misprint on the page - 1993?
Archive 2 In 2001 Benbow's employers GSK actually acknowledged that patients may be at increased risk of suicide soon after starting the medicine SOURCE
Yet one year later Benbow appears in front of millions of viewers on BBC's Panorama claiming ' I think patients have nothing to fear taking Seroxat'
Now, why would he make that statement when 12 months or so previously his own employers had acknowledged there was an increased risk of suicide? Maybe Benbow sees suicide as nothing to fear? Maybe, he is kept hidden away in a dark room in Brentwood, only to surface to defend Seroxat when bad publicity arises.
Don't you think GSK should have hauled him into their office after he made that statement on Panorama?
"What the fuck were you doing saying that you bufoon?'
There has been no retraction from Benbow which suggests to me that the man has severe psychological problems - either that or he has a complete disregard for human life.
What is it GSK?
Bob
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director6/13/2002
Notice the year he made that rather brash statement folks? 2002.
Lets just have a look through some archives here to highlight one of two things.
1. Benbow is a liar or
2. Benbow has been kept in the dark and his employer (GSK) have been lying to him.
Archive 1 is from Green Left Online. It is an article that was published in 1993, some 9 years before Benbow declared that patients had nothing to fear taking Seroxat. Surely this is a misprint on the page - 1993?
Archive 2 In 2001 Benbow's employers GSK actually acknowledged that patients may be at increased risk of suicide soon after starting the medicine SOURCE
Yet one year later Benbow appears in front of millions of viewers on BBC's Panorama claiming ' I think patients have nothing to fear taking Seroxat'
Now, why would he make that statement when 12 months or so previously his own employers had acknowledged there was an increased risk of suicide? Maybe Benbow sees suicide as nothing to fear? Maybe, he is kept hidden away in a dark room in Brentwood, only to surface to defend Seroxat when bad publicity arises.
Don't you think GSK should have hauled him into their office after he made that statement on Panorama?
"What the fuck were you doing saying that you bufoon?'
There has been no retraction from Benbow which suggests to me that the man has severe psychological problems - either that or he has a complete disregard for human life.
What is it GSK?
Bob
The need for strict controls on anti-depressant drugs in Ireland
Thanks to the Truthman for alerting me to this article written by Ciaragh O’Neill. The article can be found HERE you will have to scroll down to locate it. I have republished it here for your convenience.
Ciaragh O’Neill writes about the need for strict controls on anti-depressant drugs in Ireland
The chances are that you or someone you know is taking Seroxat. Prescribed for everything from anxiety to depression it has fast become one of the most popular SSRI’s (Selective Serotonin Reuptake Inhibitors) on the market.
Seroxat is Ireland’s most popular anti-depressant, but its popularity here is nothing compared to its popularity in the U.S. In the States Seroxat is known as Paxil and due to loopholes in licensing laws it can be advertised directly to the public. In 2000 GlaxoSmithKline (Seroxat’s
manufacturer) spent approximately $90 million on advertising for the drug, Glaxo reported $2bn in profit from Paxil.
The reason behind Seroxat’s success is licensing. Seroxat has been licensed to treat more conditions than any other drug; it’s even licensed to treat some conditions that haven’t been internationally recognised yet like Generalised Anxiety Disorder.
However these ‘wonder drugs’ have a darker side that revealed itself as prescriptions increased in the ‘90’s. The most common reported symptoms dealing with Seroxat withdrawal include heightened anxiety, dizziness, and loss of balance, electric shock sensations, violent mood swings and vivid nightmares. Dr. Alistair Benbow, head of European Clinical Psychiatry for GlaxoSmithKline says that Seroxat is a “well tolerated medicine that has been used extensively around the world over the last ten years”.
However, this assertion is proved weak when you consider the mounting evidence against Seroxat. In 1998 Toby Tobin decided to sue GlaxoSmithKline after his father-in-law Donald Schell killed himself, his wife, his daughter and his granddaughter in Gillette, Wyoming. Schell
had previously shown no indications of a violent personality; he had been mildly depressed but not suicidal for the previous ten years. Schell had taken just two Seroxat (Paxil) tablets before these tragic events occurred. GlaxoSmithKline were found to be negligent in failing to provide information to Doctors about the possible side affects of Seroxat (Paxil), and were ordered to pay $6 million in compensation. It was revealed during the course of the trial that GlaxoSmithKline had hidden clinical trials, which showed that around one in four healthy volunteers suffered the sort of mental turmoil that Schell suffered.
Since 1991 Seroxat has been licensed to treat depressive illness. In 2003 the Irish Medicines
Board issued a warning that the drug Seroxat should not be used to treat anyone under the age of 18 as it appeared to raise the incidence of suicide and self harm in children and adolescents, and had no benefit in the treatment of depressive illness. A clinical trial was also carried out in which children with depressive illness were prescribed either Seroxat or a placebo. The results of the survey were remarkable; it was found that Seroxat had no greater effect in the treatment of depressive illness than the placebo. The survey also revealed that the risk of suicidal thoughts and behaviour was greater with Seroxat than the placebo. Yet due to loopholes in the drug
licensing laws Seroxat can still be prescribed by Doctors to people under the age of 18 if the Doctors deem it appropriate. The European Agency for the Evaluation of Medicinal Products (EMEA) has also reviewed the drug and determined that patients with a history of suicidal behaviour or thoughts are at a greater risk of suicidal attempts during treatment with Seroxat. Yet still approximately 350 children and adolescents under the age of 18, in Ireland are currently being treated with Seroxat.
Another research group in Sweden ran a similar trial and found that among 916 on the drug
seven-attempted suicide compared to just one in a placebo group.
Why do so many Doctors continue to prescribe the drug in vast quantities, especially to children and adolescents?
GlaxoSmithKline has never had the best reputation for marketing ethics. Glaxo was investigated in 1995 for allegedly bribing health ministry officials. Dr. Reccha, the spokesman for GlaxoSmithKline in Italy responded with the comment “Glaxo is a leader in the world pharmaceutical market. We do not need to do anything here that we do not do in other European countries” Similar investigations are underway in the America where GlaxoSmithKline are charged with bribery and corruption. Allegations include gifts ranging from free holidays abroad to cash payments up to $26,873. Although no formal charges have been
brought officials believe that as many as 3000 Doctors and Sales Rep’s are involved. In Germany 3,500 Doctors are being investigated for alleged undue financial advantages and corruption. The District Attorney’s Office in Munich started to investigate GlaxoSmithKline after a reported increase in their marketing activities. GlaxoSmithKline had invited hospital doctors and their spouses to conferences abroad with 5800 payments of EUR 25, 000 were paid to doctors to cover ‘travel costs’. Other gifts including books, computers and donations were given to Doctors. In one case at the launch of GlaxoSmithKline’s ACE inhibitor drug doctors were invited to travel to the World Cup and to a nearby Formula One race.
One wonders whether GlaxoSmithKline’s aggressive marketing tactics can be linked to the ongoing prescription of their drug Seroxat despite repeated health warnings.
For Alistair Benbow GlaxoSmithKline
I think patients have nothing to fear from taking Seroxat.
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director6/13/2002
You think so?
Friday, May 25, 2007
What we have here is... a failure to communicate
The saying goes that there are two sides to every story. I am a firm believer in that saying, hence the comment sections within this blog - yes, they are moderated but I have only on one occasion refused to let a comment go through due to the bad language that was used.
The Seroxat debate also has two sides. There are some that say it is a great drug and has helped them whilst there are others who say the complete opposite.
As some of you know, I have touched on patient support groups on this blog, in the main my gripe was with the Australian patient support groups as you can see HERE, HERE, and more importantly, HERE.
It was the author of Seroxat Secrets that uncovered a 'tangled web' with his posts about Depression Alliance, a patient support group here in the UK. To be honest I try to steer away from subjects covered by Seroxat Secrets because the author writes so well and I feel I could not do justice to his investigations.
I became involved when a friend of mine informed me of a post on a blog on the popular myspace.com website. Reading it I felt the person was misinformed . I posted comments questioning the author's stance but unfortunately these were deleted as were comments by fellow campaigner Roger Cleghorn. The reason, say's the author, was that we were rude.
The blog post was created by Amelia Mustapha who is Vice President of the European Depression Association and Communications Director of the UK’s Centre for Mental Health. Amelia was previously Fundraising, Marketing and Communications Director of the Depression Alliance, the leading UK Charity for people affected by depression.
What caught my immediate attention was her particular stance on anyone who dared speak out against Seroxat - you can read the blog that first gained my interest here and you will see exactly what I mean. Terms such as ' Panorama witch-hunt programmes about Seroxat' and 'There have been 5 or 6 programmes in all and each has been an exemplar in bad science and shock tactics' . Not content with speaking out against the Seroxat (Panorama) programmes, Amelia later has a dig at Scientology and Prof David Healy, using inverted comma's to describe Healy as an expert. She also accuses certain patient support groups jumping on the 'profitable' anti-Seroxat bandwagon. One can see why this invoked a response from me.
It became apparent that adding comments to the blog post were really getting us nowhere so I contacted her and we emailed one another with opinions, admittedly both her and my emails were childishly filled with tints of sarcasm at first but after a while we seemed to be making headway although we both still strongly held our own views. We were pretty much in agreement over the MHRA and the chemical imbalance theory, so much so that she wrote to GSK to ask why they state on their Australian site that ' AROPAX corrects the chemical imbalance and so helps relieve the symptoms of depression.'
I asked Amelia if she would be prepared to talk to a group of us about Seroxat but seeing as we were just in the early stages of correspondence she declined. I also asked Amelia if she would accept a challenge to come up with more than 10,000 patients who support the use of Seroxat opposed to the 10,000 + that I could give her.
Unfortunately Amelia ceased contact with me after She learned that Seroxat Secrets had mentioned her name - I don't know why as I am not affiliated with Seroxat Secrets and cannot control what one wants to write about on their personal blogs. To be honest if anyone should be annoyed for being lambasted then it should be David Healy after what Amelia wrote on her blog about him.
Amelia never told me she was not going to communicate with me anymore, that was left to her friend, Jim Thomson (More on Jim Thomson another time). It's a great pity that two adults with opposing views cannot debate without one throwing the 'dummy out of the pram' and doing a runner because of something negative that was written about them on a site that has nothing to do with Seroxat Sufferers apart from sharing the same passion for justice.
Everyone is entitled to their own views but it is my belief that someone who works with mental health patients should talk to sufferers and collect their stories before writing off Panorama's Seroxat programmes and labelling them a 'witch hunt.'
I'm sure deep down Amelia is a nice person with a genuine belief that she is right and others including SSRi experts are wrong. The evidence she provided me to back up her claims were all funded by Pharma. Breggin's evidence, which I sent to her, was merely glossed over and added with Amelia disputing his credentials.
In truth, we could have gone on for years arguing over who was right and who was wrong. Any evidence I may have put forward to her will have been written off with a whim. The difference between my opinion and Amelia's is that I have experienced the perils of Seroxat first hand - she hasn't. Yes she has spoke to sufferers but I have spoke to women that have had babies and I and any other man could not possibly know the pain a woman goes through when giving birth.
As always, this post is open for comments.
Later this week I shall write about my brief correspondence with Dr Chris Manning of Primhe (formerly of Depression Alliance) and also the rather animated Jim Thomson who used to be the CEO of Depression Alliance.
Keep em peeled
Bob
The Seroxat debate also has two sides. There are some that say it is a great drug and has helped them whilst there are others who say the complete opposite.
As some of you know, I have touched on patient support groups on this blog, in the main my gripe was with the Australian patient support groups as you can see HERE, HERE, and more importantly, HERE.
It was the author of Seroxat Secrets that uncovered a 'tangled web' with his posts about Depression Alliance, a patient support group here in the UK. To be honest I try to steer away from subjects covered by Seroxat Secrets because the author writes so well and I feel I could not do justice to his investigations.
I became involved when a friend of mine informed me of a post on a blog on the popular myspace.com website. Reading it I felt the person was misinformed . I posted comments questioning the author's stance but unfortunately these were deleted as were comments by fellow campaigner Roger Cleghorn. The reason, say's the author, was that we were rude.
The blog post was created by Amelia Mustapha who is Vice President of the European Depression Association and Communications Director of the UK’s Centre for Mental Health. Amelia was previously Fundraising, Marketing and Communications Director of the Depression Alliance, the leading UK Charity for people affected by depression.
What caught my immediate attention was her particular stance on anyone who dared speak out against Seroxat - you can read the blog that first gained my interest here and you will see exactly what I mean. Terms such as ' Panorama witch-hunt programmes about Seroxat' and 'There have been 5 or 6 programmes in all and each has been an exemplar in bad science and shock tactics' . Not content with speaking out against the Seroxat (Panorama) programmes, Amelia later has a dig at Scientology and Prof David Healy, using inverted comma's to describe Healy as an expert. She also accuses certain patient support groups jumping on the 'profitable' anti-Seroxat bandwagon. One can see why this invoked a response from me.
It became apparent that adding comments to the blog post were really getting us nowhere so I contacted her and we emailed one another with opinions, admittedly both her and my emails were childishly filled with tints of sarcasm at first but after a while we seemed to be making headway although we both still strongly held our own views. We were pretty much in agreement over the MHRA and the chemical imbalance theory, so much so that she wrote to GSK to ask why they state on their Australian site that ' AROPAX corrects the chemical imbalance and so helps relieve the symptoms of depression.'
I asked Amelia if she would be prepared to talk to a group of us about Seroxat but seeing as we were just in the early stages of correspondence she declined. I also asked Amelia if she would accept a challenge to come up with more than 10,000 patients who support the use of Seroxat opposed to the 10,000 + that I could give her.
Unfortunately Amelia ceased contact with me after She learned that Seroxat Secrets had mentioned her name - I don't know why as I am not affiliated with Seroxat Secrets and cannot control what one wants to write about on their personal blogs. To be honest if anyone should be annoyed for being lambasted then it should be David Healy after what Amelia wrote on her blog about him.
Amelia never told me she was not going to communicate with me anymore, that was left to her friend, Jim Thomson (More on Jim Thomson another time). It's a great pity that two adults with opposing views cannot debate without one throwing the 'dummy out of the pram' and doing a runner because of something negative that was written about them on a site that has nothing to do with Seroxat Sufferers apart from sharing the same passion for justice.
Everyone is entitled to their own views but it is my belief that someone who works with mental health patients should talk to sufferers and collect their stories before writing off Panorama's Seroxat programmes and labelling them a 'witch hunt.'
I'm sure deep down Amelia is a nice person with a genuine belief that she is right and others including SSRi experts are wrong. The evidence she provided me to back up her claims were all funded by Pharma. Breggin's evidence, which I sent to her, was merely glossed over and added with Amelia disputing his credentials.
In truth, we could have gone on for years arguing over who was right and who was wrong. Any evidence I may have put forward to her will have been written off with a whim. The difference between my opinion and Amelia's is that I have experienced the perils of Seroxat first hand - she hasn't. Yes she has spoke to sufferers but I have spoke to women that have had babies and I and any other man could not possibly know the pain a woman goes through when giving birth.
As always, this post is open for comments.
Later this week I shall write about my brief correspondence with Dr Chris Manning of Primhe (formerly of Depression Alliance) and also the rather animated Jim Thomson who used to be the CEO of Depression Alliance.
Keep em peeled
Bob
Please remember Sharise Gatchell
Sharise committed suicide on the 25th May 2003...age 18... Sharise had been prescribed the anti-depressant Seroxat, also known as Paxil in the U.S.
Take a minute out today and send some positive thoughts to her family and friends.
http://www.sharisegatchell.com/
Rest in Peace
Bob
Take a minute out today and send some positive thoughts to her family and friends.
http://www.sharisegatchell.com/
Rest in Peace
Bob
Thursday, May 24, 2007
When the going gets tough...
I have been in correspondence with three leading spokespersons from a range of mental health charities over the past couple of months. Unfortunately, all three have now broken communication with me. I shall be writing about this soon on my blog and, as always, offer these three individuals a chance to have their say via the comments section.
I would like to take this opportunity in thanking all three of them for their insight but not for their attitude.
All three have decided to end correspondence with me, two of them never had the decency to tell me this was so. It was the third person who informed me that his colleagues no longer wished to communicate.
All will become apparent soon.
Meantime, may I suggest the following reading from Seroxat Secrets. This will put you all in the picture regarding the three individuals.
Please go:
HERE
HERE
HERE
HERE
It is a great shame that communications broke down because I genuinely wanted to give these people/charities a chance to voice their opinion regarding patient support groups and the Pharma funding which they recieve. Anyway, I'll be posting about it soon so keep em peeled.
You may want to see why I took a particular interest in this. It was an article written on myspace.com. One that clearly shows the thoughts of a person who works closely with mental health. Go HERE. A hard copy has been kept of this particular page.
Bob
I would like to take this opportunity in thanking all three of them for their insight but not for their attitude.
All three have decided to end correspondence with me, two of them never had the decency to tell me this was so. It was the third person who informed me that his colleagues no longer wished to communicate.
All will become apparent soon.
Meantime, may I suggest the following reading from Seroxat Secrets. This will put you all in the picture regarding the three individuals.
Please go:
HERE
HERE
HERE
HERE
It is a great shame that communications broke down because I genuinely wanted to give these people/charities a chance to voice their opinion regarding patient support groups and the Pharma funding which they recieve. Anyway, I'll be posting about it soon so keep em peeled.
You may want to see why I took a particular interest in this. It was an article written on myspace.com. One that clearly shows the thoughts of a person who works closely with mental health. Go HERE. A hard copy has been kept of this particular page.
Bob
Wednesday, May 23, 2007
For GlaxoSmithKline
A Letter from Michael Moore: 'Sicko' is Socko in Cannes!
May 23rd, 2007
Friends,
Well, as you may have read by now, our premiere of "Sicko" at the Cannes Film Festival has been an overwhelming success. The 2,000 people inside the Lumiere Theater were alternately in tears and laughing during the two-hour film -- and when it was over, they gave it a standing ovation that seemed to go on for nearly 15 minutes! Many came up to me and said (and critics seem to agree) that this is my best film yet. I don't know about that, and it seems weird to compare any of these movies in the first place. But I do feel safe in saying that I am very, very happy with this film and I can't wait to show it to you when it opens on June 29th.
Cannes is a crazy place. There are film lovers here from nearly every country in the world. And then there are the people in "show business." These dark forces have virtually ruined this art form (invented by the French and nurtured to brilliance by the country I call home). There are so many bad, awful films now and less and less people are going to the movies. Many who run Hollywood believe that the American people are too stupid to enjoy a film that respects their intelligence.
At the press screening for "Sicko," the Wall Street Journal reported that hardened reporters and critics wept. Even those who have been harsh to me in the past, or who have not agreed with my politics, were moved. Aside from my stated desire that "Sicko" ignite a fire for free, universal health care (and a larger wish that we, as Americans, do a better job of treating each other with a true sense of solidarity and respect), I continue to hope that I can make a contribution to the art of cinema and give people a good reason to get out of the house for a few hours.
At my festival press conference, the only negative word came from the Canadians. Two critics didn't like all the nice things I said about their health care system. Yes, Canadian health care has its flaws, but when I asked the two critics if they would exchange their health care cards for mine, they said "No!" Of course they wouldn't. Canadians live longer than we do and their infant mortality is not as high as ours. Their system is underfunded because their leaders have been trying to push for more American-style health care.
The rest of the week has been good and I am now on my way back to the U.S. The New York Post reported Sunday that the Bush administration, in addition to going after me for filming scenes in or near Cuba, may now go after the 9/11 rescue workers I took with me to get the medical care they were denied by our own government. I couldn't make up irony like this if I wanted to, and I will do whatever is necessary to defend the human right of these true American heroes to receive the medical attention they deserve.
We've also received word that the HMO and pharmaceutical industries are gearing up to fight "Sicko." We received so many great whistleblower letters while we were making the movie from employees of these companies. We'd like to hear from you again! Send us the internal memos and any other plans you run across at the company copying machine or internet server. It will help to stay ahead of whatever they are up to, and it will also give us a chance for a bit of fun at the industry's expense.
I will soon have a special section of my website devoted to "Sicko." Until then, we'll move forward toward our June 29th release date. Hope to see you all there that weekend!
Yours,
Michael Moore
michael@michaelmoore.com
May 23rd, 2007
Friends,
Well, as you may have read by now, our premiere of "Sicko" at the Cannes Film Festival has been an overwhelming success. The 2,000 people inside the Lumiere Theater were alternately in tears and laughing during the two-hour film -- and when it was over, they gave it a standing ovation that seemed to go on for nearly 15 minutes! Many came up to me and said (and critics seem to agree) that this is my best film yet. I don't know about that, and it seems weird to compare any of these movies in the first place. But I do feel safe in saying that I am very, very happy with this film and I can't wait to show it to you when it opens on June 29th.
Cannes is a crazy place. There are film lovers here from nearly every country in the world. And then there are the people in "show business." These dark forces have virtually ruined this art form (invented by the French and nurtured to brilliance by the country I call home). There are so many bad, awful films now and less and less people are going to the movies. Many who run Hollywood believe that the American people are too stupid to enjoy a film that respects their intelligence.
At the press screening for "Sicko," the Wall Street Journal reported that hardened reporters and critics wept. Even those who have been harsh to me in the past, or who have not agreed with my politics, were moved. Aside from my stated desire that "Sicko" ignite a fire for free, universal health care (and a larger wish that we, as Americans, do a better job of treating each other with a true sense of solidarity and respect), I continue to hope that I can make a contribution to the art of cinema and give people a good reason to get out of the house for a few hours.
At my festival press conference, the only negative word came from the Canadians. Two critics didn't like all the nice things I said about their health care system. Yes, Canadian health care has its flaws, but when I asked the two critics if they would exchange their health care cards for mine, they said "No!" Of course they wouldn't. Canadians live longer than we do and their infant mortality is not as high as ours. Their system is underfunded because their leaders have been trying to push for more American-style health care.
The rest of the week has been good and I am now on my way back to the U.S. The New York Post reported Sunday that the Bush administration, in addition to going after me for filming scenes in or near Cuba, may now go after the 9/11 rescue workers I took with me to get the medical care they were denied by our own government. I couldn't make up irony like this if I wanted to, and I will do whatever is necessary to defend the human right of these true American heroes to receive the medical attention they deserve.
We've also received word that the HMO and pharmaceutical industries are gearing up to fight "Sicko." We received so many great whistleblower letters while we were making the movie from employees of these companies. We'd like to hear from you again! Send us the internal memos and any other plans you run across at the company copying machine or internet server. It will help to stay ahead of whatever they are up to, and it will also give us a chance for a bit of fun at the industry's expense.
I will soon have a special section of my website devoted to "Sicko." Until then, we'll move forward toward our June 29th release date. Hope to see you all there that weekend!
Yours,
Michael Moore
michael@michaelmoore.com
For Drug Makers, a Downside to Full Disclosure
For Drug Makers, a Downside to Full Disclosure
Source: The New York Times - Wed 23rd May 2007
When GlaxoSmithKline settled a lawsuit three years ago with the State of New York over the antidepressant medication Paxil, the company agreed to take an unusual step: publicly disclosing the results of its clinical trials for Paxil and other drugs.
The company, which was criticized at the time for failing to publicize all pediatric trials of Paxil, not just the positive ones, made good on its promise. The first posting on a new Web site was about 65 studies involving its popular diabetes drug, Avandia.
This week, GlaxoSmithKline learned what that greater disclosure could mean.
A cardiologist at the Cleveland Clinic, Dr. Steven Nissen, stumbled onto the Glaxo Web site while researching Avandia last April. He and a colleague quickly analyzed the data, and on Monday, The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.
“It was a treasure trove,” Dr. Nissen said about the Web site.
GlaxoSmithKline has disputed the journal’s interpretation. Officials with the Food and Drug Administration said they were reviewing whether to take any action on Avandia.
Whatever the drug’s fate, the episode is likely to fuel efforts by some medical experts, including Dr. Nissen, to persuade lawmakers to require makers of drugs and medical devices to disclose study results publicly. Currently, producers are not required to do so, but Congress is considering legislating a requirement.
Many companies besides GlaxoSmithKline already post results from some studies or trials on their Web sites, or one operated by the Pharmaceutical Research and Manufacturers Association, a trade group in Washington.
Dr. Bruce M. Psaty, a cardiologist at the University of Washington, said that having such information can play a critical role, as the case of Avandia suggests, in spotting signals of a drug’s possible dangers.
Other experts have argued that the relative efficacy or cost of competing drugs can be compared only when all study results, rather simply those that a company chooses to publicize, are available.
Studies have found that the vast majority of drug and medical device studies are never published in medical journals.
“The more information, the better,” Dr. Psaty said.
Dr. Ronald L. Krall, chief medical officer for Glaxo, said his company sharply disputed the methodology of Dr. Nissen’s study, and a top F.D.A. official said that the agency had previously informed doctors about Avandia’s heart risks.
Dr. Krall said his company was aware when it created its database of study results a few years ago that it might lead to controversy. Other scientists might look at its data or choose to analyze it differently than company officials did, he said.
“We are committed to the principle of transparency,” Dr. Krall added. “But we knew that when starting this, by putting the data in the public, many things could happen, some of which could be trouble.”
Some experts also believe that releasing the results of hundreds of studies involving drugs or medical devices might create confusion and anxiety for patients who are typically not well prepared to understand the studies or to put them in context.
“I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion,” said Dr. Steven Galson, the director for the Center for Drug Evaluation and Research at the F.D.A.
Roughly a decade ago, some experts raised concerns that doctors were not getting the full picture about a drug’s risks and benefits because they tended to hear or read about only those trials in which the medication showed a benefit.
Companies and researchers typically did not seek publication of studies that showed that a drug had little benefit or might even cause harm. In some cases, trials that were started and stopped before completion were not disclosed.
As a result, outside researchers could not learn what trials of a drug had been performed so they could put findings in context or compare studies of competing drugs.
That issue caught the public’s attention after it was disclosed that Glaxo had not publicized trials of Paxil in children in which the drug showed little, if any, benefit. The company was subsequently sued by Eliot Spitzer, who was then the attorney general and who is now the governor of New York. The drug maker, as part of the lawsuit’s settlement, created a public Web site for trial results. Glaxo was by no means the only drug company that came under scrutiny. In late 2004, a group of leading medical journals, including The New England Journal of Medicine, said that they would no longer publish articles about study results unless producers publicly registered the tests on Web sites like ClinicalTrials.gov, which is run by the National Library of Medicine.
As a result, the number of drug trials registered on that site has sharply increased, said Dr. Deborah Zarin, its director. (Currently, drug manufacturers are required to register trials of new drugs for serious or life-threatening conditions).
But even before the recent Avandia episode, advocates for greater study transparency like Dr. Nissen were pushing lawmakers to take the next step by requiring that producers of drugs and makers of devices not only register trials but also publicly disclose study findings.
“It is critical, but this raises the question of how many other drug safety issues are out there,” Dr. Nissen said. Recently, the Senate passed an F.D.A.-related bill that would set up a process for developing a mechanism that experts expect would result in a government-run database where companies and others would post the results of clinical trials. The House is currently considering a bill that has somewhat different provisions.
Dr. Alan Goldhammer, a senior executive at the Pharmaceutical Research and Manufacturers Association, said the organization supported the disclosure provision in the Senate bill that had passed.
He said the group, however, was concerned that some states may be trying to get ahead of the federal government on the issue; for instance, Maine recently passed a bill that mandates the release of study findings.
“We want to make sure it is done in a reasonable way,” Dr. Goldhammer said.
Recently, a report issued by the Institute of Medicine, a part of the National Academy of Sciences, recommended that the F.D.A. release all summaries of study data it had collected in the process of approving new drugs as well as all post-marketing studies of those products.
The F.D.A. rejected the first recommendation as overly burdensome and Dr. Galson, the director of the F.D.A.’s drug evaluation and research, said that the agency already released much of this information. “It is not that we are philosophically opposed to it, but the work would be enormous,” he said.
Even those supporting mandatory results disclosure acknowledge that finding uniform ways to disclose complex scientific information would prove difficult and time-consuming. For example, Dr. Zarin of ClinicalTrials.gov said that reviewing a study’s results to make sure that it was free of any biases interjected by researchers involved in a study or by its sponsor was a major undertaking.
Then, there is also the question of who the audience for such information should be — scientists, consumers or both?
Dr. Zarin said that there had been significant discussion among experts over the last year about that issue. Most have agreed that data is best understood by experts, a view that might not prove popular with patients.
Dr. Krall of Glaxo agreed, saying the drug maker had considered providing summaries of its studies for patients, but then dropped the efforts after deciding it would require making subjective decisions about trial results.
“There is not a uniform view about how to interpret results,” he said. “It is quite problematic to go that next step.”
Stephanie Saul contributed reporting.
Source: The New York Times - Wed 23rd May 2007
When GlaxoSmithKline settled a lawsuit three years ago with the State of New York over the antidepressant medication Paxil, the company agreed to take an unusual step: publicly disclosing the results of its clinical trials for Paxil and other drugs.
The company, which was criticized at the time for failing to publicize all pediatric trials of Paxil, not just the positive ones, made good on its promise. The first posting on a new Web site was about 65 studies involving its popular diabetes drug, Avandia.
This week, GlaxoSmithKline learned what that greater disclosure could mean.
A cardiologist at the Cleveland Clinic, Dr. Steven Nissen, stumbled onto the Glaxo Web site while researching Avandia last April. He and a colleague quickly analyzed the data, and on Monday, The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.
“It was a treasure trove,” Dr. Nissen said about the Web site.
GlaxoSmithKline has disputed the journal’s interpretation. Officials with the Food and Drug Administration said they were reviewing whether to take any action on Avandia.
Whatever the drug’s fate, the episode is likely to fuel efforts by some medical experts, including Dr. Nissen, to persuade lawmakers to require makers of drugs and medical devices to disclose study results publicly. Currently, producers are not required to do so, but Congress is considering legislating a requirement.
Many companies besides GlaxoSmithKline already post results from some studies or trials on their Web sites, or one operated by the Pharmaceutical Research and Manufacturers Association, a trade group in Washington.
Dr. Bruce M. Psaty, a cardiologist at the University of Washington, said that having such information can play a critical role, as the case of Avandia suggests, in spotting signals of a drug’s possible dangers.
Other experts have argued that the relative efficacy or cost of competing drugs can be compared only when all study results, rather simply those that a company chooses to publicize, are available.
Studies have found that the vast majority of drug and medical device studies are never published in medical journals.
“The more information, the better,” Dr. Psaty said.
Dr. Ronald L. Krall, chief medical officer for Glaxo, said his company sharply disputed the methodology of Dr. Nissen’s study, and a top F.D.A. official said that the agency had previously informed doctors about Avandia’s heart risks.
Dr. Krall said his company was aware when it created its database of study results a few years ago that it might lead to controversy. Other scientists might look at its data or choose to analyze it differently than company officials did, he said.
“We are committed to the principle of transparency,” Dr. Krall added. “But we knew that when starting this, by putting the data in the public, many things could happen, some of which could be trouble.”
Some experts also believe that releasing the results of hundreds of studies involving drugs or medical devices might create confusion and anxiety for patients who are typically not well prepared to understand the studies or to put them in context.
“I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion,” said Dr. Steven Galson, the director for the Center for Drug Evaluation and Research at the F.D.A.
Roughly a decade ago, some experts raised concerns that doctors were not getting the full picture about a drug’s risks and benefits because they tended to hear or read about only those trials in which the medication showed a benefit.
Companies and researchers typically did not seek publication of studies that showed that a drug had little benefit or might even cause harm. In some cases, trials that were started and stopped before completion were not disclosed.
As a result, outside researchers could not learn what trials of a drug had been performed so they could put findings in context or compare studies of competing drugs.
That issue caught the public’s attention after it was disclosed that Glaxo had not publicized trials of Paxil in children in which the drug showed little, if any, benefit. The company was subsequently sued by Eliot Spitzer, who was then the attorney general and who is now the governor of New York. The drug maker, as part of the lawsuit’s settlement, created a public Web site for trial results. Glaxo was by no means the only drug company that came under scrutiny. In late 2004, a group of leading medical journals, including The New England Journal of Medicine, said that they would no longer publish articles about study results unless producers publicly registered the tests on Web sites like ClinicalTrials.gov, which is run by the National Library of Medicine.
As a result, the number of drug trials registered on that site has sharply increased, said Dr. Deborah Zarin, its director. (Currently, drug manufacturers are required to register trials of new drugs for serious or life-threatening conditions).
But even before the recent Avandia episode, advocates for greater study transparency like Dr. Nissen were pushing lawmakers to take the next step by requiring that producers of drugs and makers of devices not only register trials but also publicly disclose study findings.
“It is critical, but this raises the question of how many other drug safety issues are out there,” Dr. Nissen said. Recently, the Senate passed an F.D.A.-related bill that would set up a process for developing a mechanism that experts expect would result in a government-run database where companies and others would post the results of clinical trials. The House is currently considering a bill that has somewhat different provisions.
Dr. Alan Goldhammer, a senior executive at the Pharmaceutical Research and Manufacturers Association, said the organization supported the disclosure provision in the Senate bill that had passed.
He said the group, however, was concerned that some states may be trying to get ahead of the federal government on the issue; for instance, Maine recently passed a bill that mandates the release of study findings.
“We want to make sure it is done in a reasonable way,” Dr. Goldhammer said.
Recently, a report issued by the Institute of Medicine, a part of the National Academy of Sciences, recommended that the F.D.A. release all summaries of study data it had collected in the process of approving new drugs as well as all post-marketing studies of those products.
The F.D.A. rejected the first recommendation as overly burdensome and Dr. Galson, the director of the F.D.A.’s drug evaluation and research, said that the agency already released much of this information. “It is not that we are philosophically opposed to it, but the work would be enormous,” he said.
Even those supporting mandatory results disclosure acknowledge that finding uniform ways to disclose complex scientific information would prove difficult and time-consuming. For example, Dr. Zarin of ClinicalTrials.gov said that reviewing a study’s results to make sure that it was free of any biases interjected by researchers involved in a study or by its sponsor was a major undertaking.
Then, there is also the question of who the audience for such information should be — scientists, consumers or both?
Dr. Zarin said that there had been significant discussion among experts over the last year about that issue. Most have agreed that data is best understood by experts, a view that might not prove popular with patients.
Dr. Krall of Glaxo agreed, saying the drug maker had considered providing summaries of its studies for patients, but then dropped the efforts after deciding it would require making subjective decisions about trial results.
“There is not a uniform view about how to interpret results,” he said. “It is quite problematic to go that next step.”
Stephanie Saul contributed reporting.
Tuesday, May 22, 2007
Watching you... watching me
10. 22 May 20:23 Glaxo., King Of Prussia, Pennsylvania, United States
Hi guys. Glad you are enjoying the free publicity
Yours
Bob
Hi guys. Glad you are enjoying the free publicity
Yours
Bob
GlaxoSmithKline Shares: SELL! SELL! SELL!
FTSE 100 movers: GlaxoSmithKline slumps on Avandia concerns
LONDON (ShareCast) - GlaxoSmithKline slumped to the bottom of the FTSE 100 movers on concern that problems with diabetes treatment Avandia might be serious.
ABN Amro chopped the drug major to 'hold' from 'buy' in reaction to reports Monday that its popular type 2 diabetes drug Avandia increases the risk of heart attack.
FULL STORY HERE
LONDON (ShareCast) - GlaxoSmithKline slumped to the bottom of the FTSE 100 movers on concern that problems with diabetes treatment Avandia might be serious.
ABN Amro chopped the drug major to 'hold' from 'buy' in reaction to reports Monday that its popular type 2 diabetes drug Avandia increases the risk of heart attack.
FULL STORY HERE
GlaxoSmithKline stock down
GlaxoSmithKline stock down on fears over diabetes drug
Source: Philadelphia Business Journal
Shares of GlaxoSmithKline dropped 8 percent Monday after The New England Journal of Medicine published a study that says the company's anti-diabetes drug Avandia increases the risk of heart attack in patients.
GlaxoSmithKline sells $3 billion worth of Avandia worldwide every year. The journal's article analyzed results from dozens of studies on the drug, comparing thousands of patients who took Avandia to patients who took another anti-diabetes drug or a placebo. The article concluded that Avandia increases heart-attack risk in patients by 43 percent.
Glaxo (NYSE:GSK) responded sharply to the article in both a conference call and a written statement. The company said that the study's methodology was flawed, that the best way to examine the safety of a drug is in long-term clinical trials, and that the company's own data show that the drug is as safe as competing treatments.
Shares of GSK closed down 8 percent at $53.18 Monday after closing last Friday at $57.71.
GlaxoSmithKline is based in London and has a U.S. headquarters in Philadelphia.
----
The company said that the study's methodology was flawed, that the best way to examine the safety of a drug is in long-term clinical trials, and that the company's own data show that the drug is as safe as competing treatments.
Now where have we haeard that before?
Source: Philadelphia Business Journal
Shares of GlaxoSmithKline dropped 8 percent Monday after The New England Journal of Medicine published a study that says the company's anti-diabetes drug Avandia increases the risk of heart attack in patients.
GlaxoSmithKline sells $3 billion worth of Avandia worldwide every year. The journal's article analyzed results from dozens of studies on the drug, comparing thousands of patients who took Avandia to patients who took another anti-diabetes drug or a placebo. The article concluded that Avandia increases heart-attack risk in patients by 43 percent.
Glaxo (NYSE:GSK) responded sharply to the article in both a conference call and a written statement. The company said that the study's methodology was flawed, that the best way to examine the safety of a drug is in long-term clinical trials, and that the company's own data show that the drug is as safe as competing treatments.
Shares of GSK closed down 8 percent at $53.18 Monday after closing last Friday at $57.71.
GlaxoSmithKline is based in London and has a U.S. headquarters in Philadelphia.
----
The company said that the study's methodology was flawed, that the best way to examine the safety of a drug is in long-term clinical trials, and that the company's own data show that the drug is as safe as competing treatments.
Now where have we haeard that before?
Monday, May 21, 2007
Another GlaxoSmithKline Drug linked to DEATH!!!
Diabetes drug Avandia linked higher death risk
CHICAGO, May 21 (Reuters) - Avandia, a popular drug to treat type 2 diabetes made by GlaxoSmithKline Plc.(GSK.L: Quote, Profile, Research , increased the risk of death from heart problems by 64 percent and the risk of heart attack by 43 percent, U.S. researchers said on Monday.
Researchers at The Cleveland Clinic said more than 65 percent of the deaths among diabetic patients are attributed to heart disease. The study will be published in the New England Journal of Medicine.
European Patients’ Forum
European Patients’ Forum
What is it?
On their homepage they boast 'EPF believes that ALL patients, no matter their condition, background or nationality, have a fundamental and legitimate human right of access to information about their health, medical conditions and the availability of treatments including knowledge of the best available management of their disease. It is a question of solidarity, equity and patients' rights.'
Whom do they recieve their funding from?
PhRMA
PFIZER
European Federation of Pharmaceutical Industry Associations
and our good friends, GlaxoSmithKline - see HERE how Glaxo brag about how they fund The European Patients’ Forum:
From GlaxoSmithKline's website
During 2006:
We provided €35,000 as an unrestricted grant to help support their activities.
We gave an additional unrestricted grant of €36,250 to support EPF’s spring conference planned for 2007.
We also gave EPF an honorarium of €500 to support the attendance of the Director General at GSK’s European Health Advisory Board meeting.
No ulterior motive hey?
Bob
What is it?
On their homepage they boast 'EPF believes that ALL patients, no matter their condition, background or nationality, have a fundamental and legitimate human right of access to information about their health, medical conditions and the availability of treatments including knowledge of the best available management of their disease. It is a question of solidarity, equity and patients' rights.'
Whom do they recieve their funding from?
PhRMA
PFIZER
European Federation of Pharmaceutical Industry Associations
and our good friends, GlaxoSmithKline - see HERE how Glaxo brag about how they fund The European Patients’ Forum:
From GlaxoSmithKline's website
During 2006:
We provided €35,000 as an unrestricted grant to help support their activities.
We gave an additional unrestricted grant of €36,250 to support EPF’s spring conference planned for 2007.
We also gave EPF an honorarium of €500 to support the attendance of the Director General at GSK’s European Health Advisory Board meeting.
No ulterior motive hey?
Bob
Pfizer - the truth will out
Fascinating read on Dr Aubrey Blumsohn's blog, Scientific Misconduct.
Shows you just how Pharmaceutical companies, in this case Pfizer, hide the truth just to help their profits.
Harrowing reading indeed.
Read it here
Shows you just how Pharmaceutical companies, in this case Pfizer, hide the truth just to help their profits.
Harrowing reading indeed.
Read it here
New Section - The Matthew Holford Rant
Matthew has been active behind the scenes as it were for some considerable time now. He has copied me and others in with his correspondence to the MHRA et al.
My recent post on here about Pharma TV prompted this response from Matt (Below)
He writes with fluency and a level head and he deserves to be heard. Therefore, I am giving him a regular slot on Seroxat Sufferers.
Here is Matthew's Rant on my post 'Coming soon, the shopping channel run by Pharma'
It wouldn't be so bad if there was some sort of counterbalance. When somebody's trying to sell something, it's absolutely natural that they're going to big up the positives, and ignore or play down any less attractive features. That's fine, although irritating, if we're talking about a cheap CD player, which gives up the ghost 13 months after purchase. It's not OK in a drug.
We know all about the concerns surrounding the efficacy and safety of Seroxat, but we're still being told it's a wonderdrug, and that everything's under control, when the very people who are saying this have a vested interest in our believing every word we're told, just so that we'll go on buying the product. That is, we have 17 years of new information in the public domain, which undermines the original claims made of the drug. We've moved on in our understanding, but GSK, and others, are still trying to sell us that CD player, when there's a history of design faults.
"We're keeping an eye on it" just doesn't wash, when it's fairly evident that even that isn't true. My own experience advises me that NICE's guidelines are not being followed, in any real sense. I wasn't being monitored in a "close and continual" manner, or whatever the language is. I was completely isolated. So, the drug's crap, and the back-up's crap. The rules/guidance/whatever are utterly meaningless, if they're too much trouble for everybody to comply with. Or there's a perceived benefit in not complying.
Is this the prevailing pattern, then? We've got any amount of legislation, guidance, and so on, which ought to ensure that things are very closely monitored, before, during and after licensing. And every party under scrutiny argues that they have the highest standards, just by dint of these rules. Well, I don't believe that follows. Does it really need stating that the existence of a rule doesn't necessarily guarantee compliance? Moreover, if there's a benefit to be accrued by not complying, a more immediate benefit than knowing that one has done all one could to ensure that the general public are safe from shite drugs, then what is the individual likely to do?
I already know that the MHRA doesn't have a Procedures Manual, although the presence of one wouldn't necessarily improve matters, unless there were compliance spot-checks, regularly. How on earth does it know that it's people are complying with the legislation and guidance, as set down, in the circumstances? It doesn't. And it doesn't because it has never thought about how that compliance should be achieved. If it had, it would have written it down, so that everybody knew what was required of them, because otherwise they'd be working in the dark, making up their own stuff, as they went along.
The question is, why hasn't it thought about how compliance should be achieved? Because those at the top already know how to do it, and take it for granted that those lower down know? Or because those at the top don't really care if those lower down know, because they think that provided the underlings are controlled sufficiently closely, there won't be any fuck-ups? Or because they genuinely don't want the underlings to know how to regulate, because then they'd understand that no such thing was actually happening, and regulation was not the interest of the people at the top? Or something else, that I haven't thought of?
So many possibilities; so few answers from those in a position to provide them.
Matt
Copyright Matthew Holford, 2007
My recent post on here about Pharma TV prompted this response from Matt (Below)
He writes with fluency and a level head and he deserves to be heard. Therefore, I am giving him a regular slot on Seroxat Sufferers.
Here is Matthew's Rant on my post 'Coming soon, the shopping channel run by Pharma'
It wouldn't be so bad if there was some sort of counterbalance. When somebody's trying to sell something, it's absolutely natural that they're going to big up the positives, and ignore or play down any less attractive features. That's fine, although irritating, if we're talking about a cheap CD player, which gives up the ghost 13 months after purchase. It's not OK in a drug.
We know all about the concerns surrounding the efficacy and safety of Seroxat, but we're still being told it's a wonderdrug, and that everything's under control, when the very people who are saying this have a vested interest in our believing every word we're told, just so that we'll go on buying the product. That is, we have 17 years of new information in the public domain, which undermines the original claims made of the drug. We've moved on in our understanding, but GSK, and others, are still trying to sell us that CD player, when there's a history of design faults.
"We're keeping an eye on it" just doesn't wash, when it's fairly evident that even that isn't true. My own experience advises me that NICE's guidelines are not being followed, in any real sense. I wasn't being monitored in a "close and continual" manner, or whatever the language is. I was completely isolated. So, the drug's crap, and the back-up's crap. The rules/guidance/whatever are utterly meaningless, if they're too much trouble for everybody to comply with. Or there's a perceived benefit in not complying.
Is this the prevailing pattern, then? We've got any amount of legislation, guidance, and so on, which ought to ensure that things are very closely monitored, before, during and after licensing. And every party under scrutiny argues that they have the highest standards, just by dint of these rules. Well, I don't believe that follows. Does it really need stating that the existence of a rule doesn't necessarily guarantee compliance? Moreover, if there's a benefit to be accrued by not complying, a more immediate benefit than knowing that one has done all one could to ensure that the general public are safe from shite drugs, then what is the individual likely to do?
I already know that the MHRA doesn't have a Procedures Manual, although the presence of one wouldn't necessarily improve matters, unless there were compliance spot-checks, regularly. How on earth does it know that it's people are complying with the legislation and guidance, as set down, in the circumstances? It doesn't. And it doesn't because it has never thought about how that compliance should be achieved. If it had, it would have written it down, so that everybody knew what was required of them, because otherwise they'd be working in the dark, making up their own stuff, as they went along.
The question is, why hasn't it thought about how compliance should be achieved? Because those at the top already know how to do it, and take it for granted that those lower down know? Or because those at the top don't really care if those lower down know, because they think that provided the underlings are controlled sufficiently closely, there won't be any fuck-ups? Or because they genuinely don't want the underlings to know how to regulate, because then they'd understand that no such thing was actually happening, and regulation was not the interest of the people at the top? Or something else, that I haven't thought of?
So many possibilities; so few answers from those in a position to provide them.
Matt
Copyright Matthew Holford, 2007
Coming soon: the shopping channel run by drug firms
Four of the world's biggest pharmaceutical companies are proposing to launch a television station to tell the public about their drugs, amid strenuous lobbying across Europe by the industry for an end to restrictions aimed at protecting patients. Pharma TV would be a dedicated interactive digital channel funded by the industry with health news and features but, at its heart, would be detailed information from drug companies about their medicines.
Read full article by Sarah Bosely in todays Guardian HERE
Read full article by Sarah Bosely in todays Guardian HERE
Another GSK victim... another blog
A mother speaks out against Paxil after her son, Manie, was born with a congenital heart defect.
Here's a snippet from her blog:
The reason why Manie was born with a congenital heart defect was because of my ingestion of an antidepressant while I was pregnant. I took Paxil within the first three months that I was pregnant with Manie. At the time that I was pregnant with Manie Paxil was a class C drug. Now Paxil is a class D drug.
I will be adding to this blog about Manie and his connection to birth defects caused by Paxil
Kudos to Julie, Manies mother, for speaking out
Bob
Her blog can be found here - http://bigpharmavictim.blogspot.com/
Here's a snippet from her blog:
The reason why Manie was born with a congenital heart defect was because of my ingestion of an antidepressant while I was pregnant. I took Paxil within the first three months that I was pregnant with Manie. At the time that I was pregnant with Manie Paxil was a class C drug. Now Paxil is a class D drug.
I will be adding to this blog about Manie and his connection to birth defects caused by Paxil
Kudos to Julie, Manies mother, for speaking out
Bob
Her blog can be found here - http://bigpharmavictim.blogspot.com/
Sunday, May 20, 2007
NEW GUESTBOOK FEATURE
Guestbook now removed - Too much spam.
In the meantime, read one of the more popular posts on Seroxat Sufferers HERE
In the meantime, read one of the more popular posts on Seroxat Sufferers HERE
GlaxoSmithKline's Whore?
Visitors to this blog from the United States and possibly Canada will know exactly who Terry Bradshaw is, however us Europeans maybe unfamiliar seeing as American Football is rarely shown on our screens.
Bradshaw, 58, has been travelling around the USA for the past three years discussing his personal struggles with depression and drawing attention to mental health issues.
What a guy huh? How many Premiership footballers would do that?
You have to dig a little deeper though to find that Terry Bradshaw isn't as white as what he would like us all to believe.
Bradshaw, has for some time now, had a very close relationship with drug giants, GlaxoSmithKline. In fact GlaxoSmithKline have even gone to the great lengths of giving Terry Bradshaw his very own page on their website - SEE HERE
GSK proudly state ' Terry's tour is sponsored by GlaxoSmithKline as part of a nationwide educational campaign. ' Bradshaw is quoted on GSK's page with the following comment "With depression, I have always had problems focusing. I suffered from terrible panic attacks and was unable to concentrate," said Terry. "With the help of therapists, counselors and the medication they prescribed for me, Paxil CR, my panic attacks are gone and I can pay attention to the elements of my life that are important."
It seems that GlaxoSmithKline are using Terry Bradshaw to market Paxil, I'm surprised they never approached David Beckham in this country - would be ironic if they tried to approach Robbie Williams now wouldn't it?
So his trips across the USA are getting paid for - does this include the hotel expenses, dinners, functions he attends? You can bet your life it does. Think of all the free publicity GlaxoSmithKline will get when Terry Bradshaw is interviewed on TV for his 'sterling' work for the less fortunate.
I've said it before... and I'll say it again, I have to take my hat off to GlaxoSmithKline's marketing team. Personally, I think they could market dog turds. I hope your boss, Mr Garnier, pays you all handsomely.
Meantime, people such as myself and a host of others try desperately hard day in day out to dispel the facts that GlaxoSmithKline are a caring company with the patients health at heart - we do this with no funding whatsover - we do it with a passion to seek the truth.
Bradshaw is nothing more than a whore. As far as I am concerned he has sold his soul to the devil for financial gain. This is my opinion and if Bradshaw wants to take me up on it then I am open for debate... my guess is he already knows he has sold his soul but the vast amounts of money he is earning from this 'tour' quite clearly mask the feeling of guilt any other normal human being would feel.
Mr Bradshaw - you are an utter disgrace
Bob
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