Thanks to Ken Kramer for the following, I urge you ALL to read and sign.
Fid
As kids head to class again, pharmaceutical companies are ramping up their drug marketing
We need to ramp up informing parents across the country about the mental screening trap.
Please, send this message to everyone you know and urge them to do the same:
I am writing to you on an important matter. There is a psychiatric / pharmaceutical plan to "suicide screen" every child in the United States before they graduate from high school.
Evidence exists that shows massive pharmaceutical backing that will result in even more overdrugging of kids with psychiatric drugs .
Can you take a moment to view this very short video? Click here: http://www.youtube.com/watch?v=RfU9puZQKBY
And then sign and forward this petition http://www.petitiononline.com/TScreen/petition.html to your associates and everyone you know? It already has over 22,500 signatures.
It's simply a race to inform enough parents so something can be done about this.
Related link - HERE
"It's not about what they tell you, it's about what they don't."
~ Bob Fiddaman, Author, Blogger, Researcher, Recipient of two Human Rights awards
Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Friday, August 31, 2007
Thursday, August 30, 2007
Paxil/Driving & Health Insurance
Michael Moore's new movie, Sicko, pretty much showed up the United States health care system and health insurance companies as being uncaring bastards... word of warning though, it could soon be the same here in the UK. The FDA have a file on their website that I happened to stumble across, a file that I or others have never seen or heard of before.
It's always been a great wonder to me whether or not it is safe to drive whilst on Seroxat medication. I would strongly urge anyone suffering withdrawal NOT to drive - I would also recommend to anyone to let their partners or friends drive them anywhere - we all know how easy it is to turn into road rage when something happens you don't agree with. I'd guess that the slightest 'mistake' by the driver in front would be enough to tip the driver following over the edge if he/she were on Seroxat.
The AA and RAC don't recognise that it is dangerous for motorists driving whilst under the influence of Seroxat, not just a danger to themselves but to other motorists free from the poison too. Insurance companies here in the UK don't mention it either.
Maybe after this surfaces they will.
GlaxoSmithKline would have us all believe that it is perfectly safe to drive whilst taking Seroxat, I mean there is absolutely nothing wrong with Seroxat now is there?
So where does that leave the drivers? Be warned - If you have an accident whilst out driving and you have been taking Seroxat then you may be liable - it only takes a lawyer for an insurance company to find this particular loophole - I'm just surprised it hasn't been used already!
Maybe an email to some of the top insurance companies out there will (forgive the pun) set the wheels in motion.
Here is the file - DOWNLOAD
Pay particular attention to page 9
"...patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Paxil CR therapy does not affect their ability to engage in such activities."
It's always been a great wonder to me whether or not it is safe to drive whilst on Seroxat medication. I would strongly urge anyone suffering withdrawal NOT to drive - I would also recommend to anyone to let their partners or friends drive them anywhere - we all know how easy it is to turn into road rage when something happens you don't agree with. I'd guess that the slightest 'mistake' by the driver in front would be enough to tip the driver following over the edge if he/she were on Seroxat.
The AA and RAC don't recognise that it is dangerous for motorists driving whilst under the influence of Seroxat, not just a danger to themselves but to other motorists free from the poison too. Insurance companies here in the UK don't mention it either.
Maybe after this surfaces they will.
GlaxoSmithKline would have us all believe that it is perfectly safe to drive whilst taking Seroxat, I mean there is absolutely nothing wrong with Seroxat now is there?
So where does that leave the drivers? Be warned - If you have an accident whilst out driving and you have been taking Seroxat then you may be liable - it only takes a lawyer for an insurance company to find this particular loophole - I'm just surprised it hasn't been used already!
Maybe an email to some of the top insurance companies out there will (forgive the pun) set the wheels in motion.
Here is the file - DOWNLOAD
Pay particular attention to page 9
"...patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Paxil CR therapy does not affect their ability to engage in such activities."
Aropax (Seroxat) - The Bitterest Pill?
Source: Brisbane Times
Below is an edited version - for full story click HERE
Bitter pills
IT BRINGS a wry smile to people's faces to hear that two drug companies made it into the top 10 most ethical companies in the world. Most of us benefit from medications developed by these multinationals, but we deeply distrust their methods. Old drugs are repackaged for new conditions, generic medicines are opposed, negative research results are withheld and developing countries are forced to pay crippling fees as part of deeply unfair medication pricing structures.
In September 2004 the blockbuster anti-inflammatory Vioxx was suddenly withdrawn from the market by its manufacturer, Merck & Co, after it emerged that the drug increased the risk of heart attack and stroke. At the time 250,000 to 300,000 Australians were taking the drug to treat the symptoms of arthritis. The company is facing more than 14,000 lawsuits in the US and a class action in Australia.
It soon emerged that Merck had either misrepresented or failed to disclose the health risks associated with the drug and that its highly effective public relations machine had capitalised on a generally uncritical medical profession
Merck was not one of the companies that made it into the world's top 10 ethical companies on the Geneva-based Covalence reputation index. Set up to provide a "barometer of how multinationals are perceived in the ethical field", the index classifies companies according to 45 criteria of business contribution to human development, including labour standards, waste management, the social utility of products and human rights policy.
Under those measurements, the drug companies GlaxoSmithKline and Bristol-Myer Squibb came in at No. 8 and No. 9 respectively.
Jon Jureidini is the head of psychological medicine at Adelaide's Women's and Children's Hospital, and the chairman of Healthy Skepticism, a website that exposes pharmaceutical company marketing techniques. He is deeply critical of Glaxo's failure to warn doctors and consumers about the potentially negative side effects of its anti-depressant Aropax/Paxil on children - a charge the drug company strenuously denies.
Jureidini says. "GSK has made mileage out of the fact that they have published two negative studies on the effects on children, but what they don't say is that they had to do that as part of another settlement."
"GSK is being hailed as an ethical company and I am sitting here working on a draft of a paper about their behaviour in relation to the study they publicised saying that Aropax/Paxil was safe and effective for children, whereas in fact the study showed just the opposite," Jureidini says.
"Donations by drug companies to patient self-help and advocacy groups are almost certain to score brownie points on an ethical measure. But many activists see such donations as covert marketing, making these groups advocates for a disease that suits their product," Jureidini says.
Medicines Australia, the pharmaceutical industry self-regulator with drug companies as its members, was quick to congratulate GlaxoSmithKline and Bristol-Myers Squibb on gaining "significant international recognition" for their work. "This is indicative of the pharmaceutical industry as a whole and reflects the value and contribution of the industry to society," Medicines Australia's chief executive, Ian Chalmers, said.
Yet only 18 months ago, the Medical Journal of Australia published a study that found the publication of incomplete or biased pharmaceutical trials is common. Interference was most blatant when the research showed potentially negative effects of a drug or treatment, it found.
Results like this confirm that despite their contribution to the health of people in the world, drug companies have a way to go before they achieve an "A" for ethics.
Below is an edited version - for full story click HERE
Bitter pills
IT BRINGS a wry smile to people's faces to hear that two drug companies made it into the top 10 most ethical companies in the world. Most of us benefit from medications developed by these multinationals, but we deeply distrust their methods. Old drugs are repackaged for new conditions, generic medicines are opposed, negative research results are withheld and developing countries are forced to pay crippling fees as part of deeply unfair medication pricing structures.
In September 2004 the blockbuster anti-inflammatory Vioxx was suddenly withdrawn from the market by its manufacturer, Merck & Co, after it emerged that the drug increased the risk of heart attack and stroke. At the time 250,000 to 300,000 Australians were taking the drug to treat the symptoms of arthritis. The company is facing more than 14,000 lawsuits in the US and a class action in Australia.
It soon emerged that Merck had either misrepresented or failed to disclose the health risks associated with the drug and that its highly effective public relations machine had capitalised on a generally uncritical medical profession
Merck was not one of the companies that made it into the world's top 10 ethical companies on the Geneva-based Covalence reputation index. Set up to provide a "barometer of how multinationals are perceived in the ethical field", the index classifies companies according to 45 criteria of business contribution to human development, including labour standards, waste management, the social utility of products and human rights policy.
Under those measurements, the drug companies GlaxoSmithKline and Bristol-Myer Squibb came in at No. 8 and No. 9 respectively.
Jon Jureidini is the head of psychological medicine at Adelaide's Women's and Children's Hospital, and the chairman of Healthy Skepticism, a website that exposes pharmaceutical company marketing techniques. He is deeply critical of Glaxo's failure to warn doctors and consumers about the potentially negative side effects of its anti-depressant Aropax/Paxil on children - a charge the drug company strenuously denies.
Jureidini says. "GSK has made mileage out of the fact that they have published two negative studies on the effects on children, but what they don't say is that they had to do that as part of another settlement."
"GSK is being hailed as an ethical company and I am sitting here working on a draft of a paper about their behaviour in relation to the study they publicised saying that Aropax/Paxil was safe and effective for children, whereas in fact the study showed just the opposite," Jureidini says.
"Donations by drug companies to patient self-help and advocacy groups are almost certain to score brownie points on an ethical measure. But many activists see such donations as covert marketing, making these groups advocates for a disease that suits their product," Jureidini says.
Medicines Australia, the pharmaceutical industry self-regulator with drug companies as its members, was quick to congratulate GlaxoSmithKline and Bristol-Myers Squibb on gaining "significant international recognition" for their work. "This is indicative of the pharmaceutical industry as a whole and reflects the value and contribution of the industry to society," Medicines Australia's chief executive, Ian Chalmers, said.
Yet only 18 months ago, the Medical Journal of Australia published a study that found the publication of incomplete or biased pharmaceutical trials is common. Interference was most blatant when the research showed potentially negative effects of a drug or treatment, it found.
Results like this confirm that despite their contribution to the health of people in the world, drug companies have a way to go before they achieve an "A" for ethics.
Wednesday, August 29, 2007
New Benbow quotes... well old but unseen on Seroxat Sufferers
My personality changed so drastically I started to shop lift. I had violent thoughts towards other people - homicidal thoughts, suicidal thoughts.. All of this culminated in me robbing a local garage
"We saw here a case of potential violence and aggression "All the data suggests that actually Seroxat does not cause violence, whereas depression does.
Ally Benbow
Commenting on Mark Hamilton, who claims that the drug turned him into a violent robber.
----
"Depression is the most important cause of suicide, suicidal ideation and suicide attempts. There is no compelling evidence that Seroxat causes suicide and indeed, the adult clinical trial database does not demonstrate that Seroxat causes suicide, suicidal thinking or suicide attempts."
Ally Benbow
Commenting on the warning issued to children about the safety of children
----
"The clear message is we are doing something that we think is in the best interests of patients and physicians. We believe this is a major step forward,"
Ally Benbow
Commenting on why Glaxo changes tack after Spitzer assault
----
"Unless I am misreading something here it sounds like they [the WHO] will accept funding from you but not from the industry. Worse than this, they will accept funding from you even if they know it originally came from us in order to bypass their own rules. This is hypocritical in the extreme. It makes a complete mockery of attempts at transparency, which should be welcome and which the WHO have called for."
Ally Benbow
Commenting about The World Health Organisation, the drugs company and the $10,000 funding offer
----
We are confident that we have acted responsibly not only in conducting the trials but in bringing the information to the attention of the regulator
Ally Benbow
Commenting on GSK being accused of witholding damning data
----
...the decision by the MHRA was concerned only with children and teenagers. "It is not related to the use of Seroxat by adults where this treatment has proven effective and has helped millions of people
Ally Benbow
Commenting about the findings that Seroxat can be a danger to under 18s
----
"We saw here a case of potential violence and aggression "All the data suggests that actually Seroxat does not cause violence, whereas depression does.
Ally Benbow
Commenting on Mark Hamilton, who claims that the drug turned him into a violent robber.
----
"Depression is the most important cause of suicide, suicidal ideation and suicide attempts. There is no compelling evidence that Seroxat causes suicide and indeed, the adult clinical trial database does not demonstrate that Seroxat causes suicide, suicidal thinking or suicide attempts."
Ally Benbow
Commenting on the warning issued to children about the safety of children
----
"The clear message is we are doing something that we think is in the best interests of patients and physicians. We believe this is a major step forward,"
Ally Benbow
Commenting on why Glaxo changes tack after Spitzer assault
----
"Unless I am misreading something here it sounds like they [the WHO] will accept funding from you but not from the industry. Worse than this, they will accept funding from you even if they know it originally came from us in order to bypass their own rules. This is hypocritical in the extreme. It makes a complete mockery of attempts at transparency, which should be welcome and which the WHO have called for."
Ally Benbow
Commenting about The World Health Organisation, the drugs company and the $10,000 funding offer
----
We are confident that we have acted responsibly not only in conducting the trials but in bringing the information to the attention of the regulator
Ally Benbow
Commenting on GSK being accused of witholding damning data
----
...the decision by the MHRA was concerned only with children and teenagers. "It is not related to the use of Seroxat by adults where this treatment has proven effective and has helped millions of people
Ally Benbow
Commenting about the findings that Seroxat can be a danger to under 18s
----
Martin B. Keller - Good or Evil?
Sources - Black (1) Red (2)
Dr.Keller is the Mary E. Zucker Professor and Chairman of the Department of Psychiatry and Human Behavior at the Brown University School of Medicine.
Brown University professor who was forced last year to forfeit hundreds of thousands of dollars in state grant money was paid more than $500,000 in consulting fees in 1998, most of it from pharmaceutical companies whose drugs he touted in medical journals and at conferences.
He is also Executive Psychiatrist-in-Chief at the seven Brown University affiliated hospitals.
Dr. Martin Keller of Newton earned more than $842,000 in 1998 while serving as chief of the psychiatry department at Brown, according to financial records. More than half of his compensation came from the pharmaceutical industry, including companies such as Pfizer Inc., Bristol-Myers Squibb, Wyeth-Ayerst, and Eli Lilly, all of which market antidepressants that Keller lauded in a series of medical research reports.
Dr. Keller received his medical training at Cornell University, and completed a medical internship at Bellevue Medical Center in New York City and a psychiatric residency at Massachusetts General Hospital in Boston.
In addition, Keller did not disclose the extent of his financial ties with the companies to the medical journals that published his research in 1998, or to the American Psychiatric Association, which sponsored the meetings at which Keller presented his findings.
His research interests include investigation of nosology and long-term course of psychiatric illnesses, including mood disorders, anxiety disorders and eating disorders, and the effect of treatment of neuropsychopharmacologic compounds and psychotherapy on the short-and long-term clinical course of these illnesses in children, adolescents and adults.
Several ethicists contacted by the Globe say Keller's unusually large consulting fees - he pulled in a total of $556,000 in 1998 and $444,000 in 1997 - constitute the most serious potential conflict they've heard of yet.
Dr. Keller has received over 20 research grants from the National Institute of Health and numerous grants from research foundations and pharmaceutical industry. He serves on numerous professional committees and editorial boards, published over 240 articles for peer-reviewed journals, and has been the recipient of several prestigious awards in recognition of making major contributions to the understanding and treatment of mood disorders.
Keller, meanwhile, is a valuable resource for Brown University, attracting millions in research grants and donations. According to the psychiatry department's annual report and other documents, Keller has brought in about $14.4 million in research funding from pharmaceutical companies and federal agencies since 1993. Approximately $8.4 million has come from the National Institute for Mental Health for research on mental illness.
The most recent honor he received is the 2001 American College of Psychiatrists (ACP) Mood Disorders Lifetime Research Award which he received in February, 2001.
In 1998, Brown was forced to return $300,170 Keller's psychiatry department had collected from Massachusetts for research that state officials say the department never performed. Brown returned the money shortly after the Massachusetts attorney general's office filed a civil lawsuit in Suffolk Superior Court, accusing Brown of breaching research contracts with the Massachusetts Department of Mental Health.
Keller and Study 329:
(3) GlaxoSmithKline conducted a study, numbered 329, in which it examined the efficacy and safety of paroxetine versus placebo in the treatment of adolescent depression. Keller was the lead author on the article (J American Academy of Child and Adolescent Psychiatry, 2001, 762-772) which appeared regarding the results of this study.
(1)
(2)
Dr.Keller is the Mary E. Zucker Professor and Chairman of the Department of Psychiatry and Human Behavior at the Brown University School of Medicine.
Brown University professor who was forced last year to forfeit hundreds of thousands of dollars in state grant money was paid more than $500,000 in consulting fees in 1998, most of it from pharmaceutical companies whose drugs he touted in medical journals and at conferences.
He is also Executive Psychiatrist-in-Chief at the seven Brown University affiliated hospitals.
Dr. Martin Keller of Newton earned more than $842,000 in 1998 while serving as chief of the psychiatry department at Brown, according to financial records. More than half of his compensation came from the pharmaceutical industry, including companies such as Pfizer Inc., Bristol-Myers Squibb, Wyeth-Ayerst, and Eli Lilly, all of which market antidepressants that Keller lauded in a series of medical research reports.
Dr. Keller received his medical training at Cornell University, and completed a medical internship at Bellevue Medical Center in New York City and a psychiatric residency at Massachusetts General Hospital in Boston.
In addition, Keller did not disclose the extent of his financial ties with the companies to the medical journals that published his research in 1998, or to the American Psychiatric Association, which sponsored the meetings at which Keller presented his findings.
His research interests include investigation of nosology and long-term course of psychiatric illnesses, including mood disorders, anxiety disorders and eating disorders, and the effect of treatment of neuropsychopharmacologic compounds and psychotherapy on the short-and long-term clinical course of these illnesses in children, adolescents and adults.
Several ethicists contacted by the Globe say Keller's unusually large consulting fees - he pulled in a total of $556,000 in 1998 and $444,000 in 1997 - constitute the most serious potential conflict they've heard of yet.
Dr. Keller has received over 20 research grants from the National Institute of Health and numerous grants from research foundations and pharmaceutical industry. He serves on numerous professional committees and editorial boards, published over 240 articles for peer-reviewed journals, and has been the recipient of several prestigious awards in recognition of making major contributions to the understanding and treatment of mood disorders.
Keller, meanwhile, is a valuable resource for Brown University, attracting millions in research grants and donations. According to the psychiatry department's annual report and other documents, Keller has brought in about $14.4 million in research funding from pharmaceutical companies and federal agencies since 1993. Approximately $8.4 million has come from the National Institute for Mental Health for research on mental illness.
The most recent honor he received is the 2001 American College of Psychiatrists (ACP) Mood Disorders Lifetime Research Award which he received in February, 2001.
In 1998, Brown was forced to return $300,170 Keller's psychiatry department had collected from Massachusetts for research that state officials say the department never performed. Brown returned the money shortly after the Massachusetts attorney general's office filed a civil lawsuit in Suffolk Superior Court, accusing Brown of breaching research contracts with the Massachusetts Department of Mental Health.
Keller and Study 329:
(3) GlaxoSmithKline conducted a study, numbered 329, in which it examined the efficacy and safety of paroxetine versus placebo in the treatment of adolescent depression. Keller was the lead author on the article (J American Academy of Child and Adolescent Psychiatry, 2001, 762-772) which appeared regarding the results of this study.
(1)
(2)
Seroxat Archives: FDA Will Probe SmithKline On Pitch for Unlicensed Drugs
Thanks to the Truthman for digging this up.
Source: Washington Post 1991
FDA Will Probe SmithKline On Pitch for Unlicensed Drugs
SmithKline last month held three sessions in Baltimore in which a "marketing consultant" met with doctors to discuss nabumetone, a pain-killer and anti-inflammation drug the company is developing. Three more meetings are planned for this month to discuss paroxetine, an antidepressant. Neither has been approved by the FDA.
"Priming prescribing doctors to be poised to write prescriptions for a drug whose safety and effectiveness have not been established to FDA's satisfaction is a practice which FDA has clearly stated to be illegal," Sidney M. Wolfe, a physician and director of the Health Research Group, wrote to FDA Commissioner David A. Kessler. Wolfe asked Kessler to "promptly initiate criminal prosecution" of SmithKline.
"If we find that the invitation was sent out to a large number of physicians," an FDA spokesman said, "it would be considered a promotional activity and not legitimate marketing research. In that case, it would probably violate FDA rules regarding promotion of unapproved drugs."
GSK - committed to improving the quality of human life
Source: Washington Post 1991
FDA Will Probe SmithKline On Pitch for Unlicensed Drugs
SmithKline last month held three sessions in Baltimore in which a "marketing consultant" met with doctors to discuss nabumetone, a pain-killer and anti-inflammation drug the company is developing. Three more meetings are planned for this month to discuss paroxetine, an antidepressant. Neither has been approved by the FDA.
"Priming prescribing doctors to be poised to write prescriptions for a drug whose safety and effectiveness have not been established to FDA's satisfaction is a practice which FDA has clearly stated to be illegal," Sidney M. Wolfe, a physician and director of the Health Research Group, wrote to FDA Commissioner David A. Kessler. Wolfe asked Kessler to "promptly initiate criminal prosecution" of SmithKline.
"If we find that the invitation was sent out to a large number of physicians," an FDA spokesman said, "it would be considered a promotional activity and not legitimate marketing research. In that case, it would probably violate FDA rules regarding promotion of unapproved drugs."
GSK - committed to improving the quality of human life
MHRA Freedom of Information request
I have not wrote to the MHRA for a while, so I thought I'd give it a shot regarding its members having close ties with GlaxoSmithKline.
I have requested the following information under the Freedom of Information Act:
----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Sent: Wednesday, August 29, 2007 7:19 AM
Subject: FOI Request: MHRA Current GSK Investigation
Dear MHRA,
Under the FOI Act I would like you to answer the following question.
Under the MHRA's current investigation of GlaxoSmithKline, are, or have any of the following members of the MHRA, been involved? If so, whom?
Regards
Robert Fiddaman.
Professor A Blenkinsopp
Professor H Dargie
Dr M Donaghy
Dr J C Forfar
Dr R Leonard
Prof D J Nutt
Professor J F Smyth
Professor Christopher Bucke
Prof Nicholas Mitchison
Dr Brian J Clark
Professor Robert Booy
Professor S M Cobbe
Professor J E Compston
Dr A Glasier
Dr Andrew A Grace
Dr P Hindmarsh
Professor P D Home
Dr R F A Logan
Professor R MacSween
Professor J O’D McGee
Professor David R Matthews
Dr A Smyth
Professor A D Struthers
Professor J C E Underwood
Dr A Gerard Wilson
Dr Rosemary Leonard
Mr David P S Dickinson
Dr Charlotte C D Williamson
Professor Anthony H Barnett
Professor V Krishna K Chatterjee
Professor Albert
Sir Alistair Breckenridge
Dr Ian Hudson
I have requested the following information under the Freedom of Information Act:
----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Sent: Wednesday, August 29, 2007 7:19 AM
Subject: FOI Request: MHRA Current GSK Investigation
Dear MHRA,
Under the FOI Act I would like you to answer the following question.
Under the MHRA's current investigation of GlaxoSmithKline, are, or have any of the following members of the MHRA, been involved? If so, whom?
Regards
Robert Fiddaman.
Professor A Blenkinsopp
Professor H Dargie
Dr M Donaghy
Dr J C Forfar
Dr R Leonard
Prof D J Nutt
Professor J F Smyth
Professor Christopher Bucke
Prof Nicholas Mitchison
Dr Brian J Clark
Professor Robert Booy
Professor S M Cobbe
Professor J E Compston
Dr A Glasier
Dr Andrew A Grace
Dr P Hindmarsh
Professor P D Home
Dr R F A Logan
Professor R MacSween
Professor J O’D McGee
Professor David R Matthews
Dr A Smyth
Professor A D Struthers
Professor J C E Underwood
Dr A Gerard Wilson
Dr Rosemary Leonard
Mr David P S Dickinson
Dr Charlotte C D Williamson
Professor Anthony H Barnett
Professor V Krishna K Chatterjee
Professor Albert
Sir Alistair Breckenridge
Dr Ian Hudson
Monday, August 27, 2007
Fund us and we will support your drugs
Just to recap some members of the MHRA and their 'interests in GlaxoSmithKline
Click on the names highlighted and read more about them or why not leave them a message of your outrage
PERSONAL INTERESTS
MEMBER
Professor A Blenkinsopp - GSK Specific – Fees
Professor H Dargie - GlaxoSmithKline Consultancy
Dr M Donaghy - GSK Shares
Dr J C Forfar - GSK Shares
Dr R Leonard - GSK Fees/ Publicity work
Prof D J Nutt - GSK Consultancy Psychotropics and 300 shares (1)
Professor J F Smyth - GSK Consultancy
Professor Christopher Bucke - SKB Shares
Prof Nicholas Mitchison - GSK Shares
Dr Brian J Clark - GSK PHD student funding
Professor Robert Booy - GSK Consultancy
Professor S M Cobbe - GSK Research grant
Professor J E Compston - GSK Consultancy
Dr A Glasier - GSK Shares (£10,000)
Dr Andrew A Grace - GSK Consultancy
Dr P Hindmarsh - GSK Consultancy on growth, probably lapsed by now
Professor P D Home - GSK Consultancy - Another ex-employee of GSK
Dr R F A Logan - GSK Shares
Professor R MacSween - SmithKline Beecham Shares
Professor J O’D McGee - SmithKline Beecham Shares
Professor David R Matthews - GSK Honorarium for advice - Wonder what he has to say about Avandia?
Dr A Smyth - GSK Conference expenses
Professor A D Struthers - GSK Shares
Professor J C E Underwood - GSK Shares
Dr A Gerard Wilson - GSK Consultancy
Dr Rosemary Leonard - GSK Fees/ Publicity work
Mr David P S Dickinson - GSK Fee paid work
Dr Charlotte C D Williamson - GSK Shares
Professor Anthony H Barnett - GSK Advisory work and lectures diabetes related products
Professor V Krishna K Chatterjee - GSK Consultancy on preclinical research with a Vanillord Receptor antagonist (Consultancy end of 2004)
Professor Albert - GSK Shares
Not to mention Alistair Breckenridge (2) (3) (4) (5) and Ian Hudson (6) (7) (8) , both former employees at GlaxoSmithKline, both worked closely with Seroxat, both now work for the MHRA
An 'independent' advisory committee huh?
(1) This is the email of the Departmental Library Representative of which Prof DJ Nutt is the Head of Department
Fid
Click on the names highlighted and read more about them or why not leave them a message of your outrage
PERSONAL INTERESTS
MEMBER
Professor A Blenkinsopp - GSK Specific – Fees
Professor H Dargie - GlaxoSmithKline Consultancy
Dr M Donaghy - GSK Shares
Dr J C Forfar - GSK Shares
Dr R Leonard - GSK Fees/ Publicity work
Prof D J Nutt - GSK Consultancy Psychotropics and 300 shares (1)
Professor J F Smyth - GSK Consultancy
Professor Christopher Bucke - SKB Shares
Prof Nicholas Mitchison - GSK Shares
Dr Brian J Clark - GSK PHD student funding
Professor Robert Booy - GSK Consultancy
Professor S M Cobbe - GSK Research grant
Professor J E Compston - GSK Consultancy
Dr A Glasier - GSK Shares (£10,000)
Dr Andrew A Grace - GSK Consultancy
Dr P Hindmarsh - GSK Consultancy on growth, probably lapsed by now
Professor P D Home - GSK Consultancy - Another ex-employee of GSK
Dr R F A Logan - GSK Shares
Professor R MacSween - SmithKline Beecham Shares
Professor J O’D McGee - SmithKline Beecham Shares
Professor David R Matthews - GSK Honorarium for advice - Wonder what he has to say about Avandia?
Dr A Smyth - GSK Conference expenses
Professor A D Struthers - GSK Shares
Professor J C E Underwood - GSK Shares
Dr A Gerard Wilson - GSK Consultancy
Dr Rosemary Leonard - GSK Fees/ Publicity work
Mr David P S Dickinson - GSK Fee paid work
Dr Charlotte C D Williamson - GSK Shares
Professor Anthony H Barnett - GSK Advisory work and lectures diabetes related products
Professor V Krishna K Chatterjee - GSK Consultancy on preclinical research with a Vanillord Receptor antagonist (Consultancy end of 2004)
Professor Albert - GSK Shares
Not to mention Alistair Breckenridge (2) (3) (4) (5) and Ian Hudson (6) (7) (8) , both former employees at GlaxoSmithKline, both worked closely with Seroxat, both now work for the MHRA
An 'independent' advisory committee huh?
(1) This is the email of the Departmental Library Representative of which Prof DJ Nutt is the Head of Department
Fid
MHRA - "shite is so often characterized as excellence"
Matthew Holford not happy with the MHRA it seems... join the queue Matt. I wrote on and off to them over a two year period. They are about as transparent as tinted windows!
Matthew's complaint can be read on his blog 'It's Quite an Experience'. I've reproduced it in its entirety here but please do hop over to his blog - he likes a good old rant - as many of you already know with his own section within this blog - See Matthew Holford Rant
Here's his latest offering:
Yellow card report - complaint
I have a keen desire to understand why it is that shite is so often characterized as excellence, so I sent this to the MHRA, copied to Breckenridge, Woods, Vara, Johnson and a whole bunch of daily newspapers:
Dear Sir or Madam,
I would like to complain formally about the fact that my Yellow Card report has not been followed up.
I experienced suicidal ideations coincidental to fluoxetine use, which I take to be about as serious as it can possibly be, short of incapacity or death, and yet I have heard nothing following the receipt of a hard copy of my submission. I would like an explanation for the MHRA's failure to follow up. I wish to be advised of the manufacturer's details (it being a generic drug that I was prescribed). I wish to understand why the system that I was subjected to was so monumentally incompetent, and I imagine the MHRA's contribution will be definitive, in this regard.I would like the explanation to be full, and detailed, with all considerations properly (as assessed by me) discussed. And I would like an apology, please, even though it's a bit late for that.
Best regards
Matthew Holford
Matthew's complaint can be read on his blog 'It's Quite an Experience'. I've reproduced it in its entirety here but please do hop over to his blog - he likes a good old rant - as many of you already know with his own section within this blog - See Matthew Holford Rant
Here's his latest offering:
Yellow card report - complaint
I have a keen desire to understand why it is that shite is so often characterized as excellence, so I sent this to the MHRA, copied to Breckenridge, Woods, Vara, Johnson and a whole bunch of daily newspapers:
Dear Sir or Madam,
I would like to complain formally about the fact that my Yellow Card report has not been followed up.
I experienced suicidal ideations coincidental to fluoxetine use, which I take to be about as serious as it can possibly be, short of incapacity or death, and yet I have heard nothing following the receipt of a hard copy of my submission. I would like an explanation for the MHRA's failure to follow up. I wish to be advised of the manufacturer's details (it being a generic drug that I was prescribed). I wish to understand why the system that I was subjected to was so monumentally incompetent, and I imagine the MHRA's contribution will be definitive, in this regard.I would like the explanation to be full, and detailed, with all considerations properly (as assessed by me) discussed. And I would like an apology, please, even though it's a bit late for that.
Best regards
Matthew Holford
Sunday, August 26, 2007
Protect Your Family from Bad Drugs
Am loving Jeffrey Dach, MD's website at the moment. He's just published a newsletter that is well worth the read. You can view it HERE
Here's a few extracts
Over the last 30 years, 20 per cent of drugs approved by the FDA were classified as “BAD Drugs”, meaning that they were later withdrawn from the market or given a black box warning. (1) (2). Why does the FDA approve risky drugs which end up being banned? This question is explored in these two articles (3) (4). “The FDA is incapable of protecting the American Public against another Vioxx”. This is a quote from David Graham MD, director of drug safety at the FDA, during congressional testimony. (5) (6) (7) (8)
How can you tell if you are dealing with a BAD DRUG?
Here are the early warning signs:
1) The drug has been recalled or given a black box warning.
2) The drug is in litigation with numerous lawsuits against the drug company.
3) The drug has been banned in other countries.
Listing of Drugs which have black box warnings: Click Here (9)
Consumer Reports listing of risky drugs: Click Here (12).
Computer Search Engine Listing of Drugs in Litigation. Click Here for Unsafe drugs in litigation (380,000 listings) (14)
SSRI Antidepressants, Prozac, Zoloft, and Paxil Antidepressant Users v. Eli Lilly, Pfizer, and GlaxoSmithKline (39)
Some 200 legal actions have been filed against Eli Lilly, Pfizer, and GlaxoSmithKline, the manufacturers of Prozac (fluoxetine), Zoloft (sertraline), and Paxil (paroxetine) to recover for suicides or homicides by patients. The lawsuits claim that the companies knew about, but hid the documents which showed increased risk of akathisia, a form of agitation causing suicide and violence.
Paxil
Paxil causes serious side effects, agitation, violent or suicidal behavior, painful withdrawal and addiction problems. It may cause birth defects in pregnant women. Paxil has been recklessly prescribed to children when it was proven no more effective than a placebo. Both children and adults taking Paxil have demonstrated suicidal tendencies during treatment, while trying to quit and during withdrawal.
Credit where it's due, we have an MD here who isn't afraid to speak out. This world needs more people like Jeffrey Dach MD, Dr Aubrey Blumsohn, Prof David Healy et al
Fid
Here's a few extracts
Over the last 30 years, 20 per cent of drugs approved by the FDA were classified as “BAD Drugs”, meaning that they were later withdrawn from the market or given a black box warning. (1) (2). Why does the FDA approve risky drugs which end up being banned? This question is explored in these two articles (3) (4). “The FDA is incapable of protecting the American Public against another Vioxx”. This is a quote from David Graham MD, director of drug safety at the FDA, during congressional testimony. (5) (6) (7) (8)
How can you tell if you are dealing with a BAD DRUG?
Here are the early warning signs:
1) The drug has been recalled or given a black box warning.
2) The drug is in litigation with numerous lawsuits against the drug company.
3) The drug has been banned in other countries.
Listing of Drugs which have black box warnings: Click Here (9)
Consumer Reports listing of risky drugs: Click Here (12).
Computer Search Engine Listing of Drugs in Litigation. Click Here for Unsafe drugs in litigation (380,000 listings) (14)
SSRI Antidepressants, Prozac, Zoloft, and Paxil Antidepressant Users v. Eli Lilly, Pfizer, and GlaxoSmithKline (39)
Some 200 legal actions have been filed against Eli Lilly, Pfizer, and GlaxoSmithKline, the manufacturers of Prozac (fluoxetine), Zoloft (sertraline), and Paxil (paroxetine) to recover for suicides or homicides by patients. The lawsuits claim that the companies knew about, but hid the documents which showed increased risk of akathisia, a form of agitation causing suicide and violence.
Paxil
Paxil causes serious side effects, agitation, violent or suicidal behavior, painful withdrawal and addiction problems. It may cause birth defects in pregnant women. Paxil has been recklessly prescribed to children when it was proven no more effective than a placebo. Both children and adults taking Paxil have demonstrated suicidal tendencies during treatment, while trying to quit and during withdrawal.
Credit where it's due, we have an MD here who isn't afraid to speak out. This world needs more people like Jeffrey Dach MD, Dr Aubrey Blumsohn, Prof David Healy et al
Fid
Labels:
bobfiddaman,
Deaths,
Devious Sales,
Litigation,
Other Sites,
Paxil,
Seroxat,
Seroxat Sufferers,
SSRis
Profit numbers for the top five pharmaceutical companies
1. Johnson & Johnson 11,053,000,000
2. Pfizer 19,337,000,000
3. GlaxoSmithKline 9,915,000,000
4. Novartis 7,175,000,000
5. Sanofi-Aventis 5,026,100,000
That's JUST the profits….after all the big salaries and big advertising and all the rest have been paid. Quite a bit of money even using 2007 standards.
Source: Ohio.com
2. Pfizer 19,337,000,000
3. GlaxoSmithKline 9,915,000,000
4. Novartis 7,175,000,000
5. Sanofi-Aventis 5,026,100,000
That's JUST the profits….after all the big salaries and big advertising and all the rest have been paid. Quite a bit of money even using 2007 standards.
Source: Ohio.com
Labels:
bobfiddaman,
Deaths,
Devious Sales,
Moneytalks,
Paxil,
Seroxat,
Seroxat Sufferers,
SSRis
Friday, August 24, 2007
Paroxetine-Induced Hyponatremia in Older Adults
Ever heard of the file drawer effect?
Did GlaxoSmithKline keep this hidden from us all during the Paroxetine clinical trials?
For those of you who don't know hyponatremia is explained here:
Severe hyponatremia may cause osmotic shift of water from the plasma into the brain cells. Typical symptoms include nausea, vomiting, headache and malaise. As the hyponatremia worsens, confusion, diminished reflexes, convulsions, stupor or coma may occur. Since nausea is, itself, a stimulus for the release of ADH, which promotes the retention of water, a positive feedback loop may be created and the potential for a vicious circle of hyponatremia and its symptoms exists.
Basically ladies and gentlemen hyponatremia is the zaps. We all know what the zaps are don't we? It seems GlaxoSmithKline must have known to. Such a valuable tool is the file drawer effect. I'm sure GlaxoSmithKline lawyers know what it is too.
Now I'd like to ask GlaxoSmithKline, the FDA or the MHRA what constitutes an 'older adult'?
Are we to assume that it is someone over the age of 30,40,50,60?
Surprising that the young and the old seem to be being safeguarded by the various studies out there - what about those that don't fall into these catagories? To be honest I'm unsure as to what catagory I would fall into - I'm 43 now, was 33 (I think) when I first took Seroxat.
Now did GlaxoSmithKline throw hyponatremia into the file drawer effect vault as they did with study 329?
You tell me.
Fid
A 12-Week Prospective Study
Tanya J. Fabian, PharmD; Janet A. Amico, MD; Patricia D. Kroboth, PhD; Benoit H. Mulsant, MD; Sharon E. Corey, PhD; Amy E. Begley, MA; Salem G. Bensasi, BS; Elizabeth Weber, RN, CNP; Mary Amanda Dew, PhD; Charles F. Reynolds III, MD; Bruce G. Pollock, MD, PhD
Arch Intern Med. 2004;164:327-332.
Background Older depressed patients are at high risk for development of hyponatremia after initiation of the selective serotonin reuptake inhibitor paroxetine, despite clinical monitoring and preventive management. The purposes of this study were to determine the incidence and etiology of paroxetine-induced hyponatremia in older patients and to identify patient characteristics that may account for variability in susceptibility to this adverse event.
Methods This prospective, longitudinal study was conducted in a university-based ambulatory psychiatric research clinic from August 1999 through September 2001. Patients included 75 men and women aged 63 through 90 years (mean ± SD age, 75.3 ± 6.0 years) who received a diagnosis of a current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, major depressive episode and were prescribed paroxetine. We monitored plasma sodium levels before initiating paroxetine therapy and after 1, 2, 4, 6, and 12 weeks of treatment. In a subset of individuals, we measured levels of antidiuretic hormone, glucose, serum urea nitrogen, and creatinine. Hyponatremia was defined as a plasma sodium level of less than 135 mEq/L after initiation of paroxetine therapy.
Results Hyponatremia developed in 9 (12%) of the 75 patients after initiation of paroxetine treatment. Mean ± SD time to development of hyponatremia was 9.3 ± 4.7 days (median, 9 days; range, 1-14 days; n = 8). In the multivariate regression, lower body mass index and lower baseline plasma sodium level (<138 mEq/L) were significant risk factors for the development of hyponatremia in these patients.
Conclusions Hyponatremia is an underrecognized and potentially serious complication of paroxetine treatment in older patients. Our results provide a foundation for understanding the etiology and risk factors associated with paroxetine-induced hyponatremia.
Did GlaxoSmithKline keep this hidden from us all during the Paroxetine clinical trials?
For those of you who don't know hyponatremia is explained here:
Severe hyponatremia may cause osmotic shift of water from the plasma into the brain cells. Typical symptoms include nausea, vomiting, headache and malaise. As the hyponatremia worsens, confusion, diminished reflexes, convulsions, stupor or coma may occur. Since nausea is, itself, a stimulus for the release of ADH, which promotes the retention of water, a positive feedback loop may be created and the potential for a vicious circle of hyponatremia and its symptoms exists.
Basically ladies and gentlemen hyponatremia is the zaps. We all know what the zaps are don't we? It seems GlaxoSmithKline must have known to. Such a valuable tool is the file drawer effect. I'm sure GlaxoSmithKline lawyers know what it is too.
Now I'd like to ask GlaxoSmithKline, the FDA or the MHRA what constitutes an 'older adult'?
Are we to assume that it is someone over the age of 30,40,50,60?
Surprising that the young and the old seem to be being safeguarded by the various studies out there - what about those that don't fall into these catagories? To be honest I'm unsure as to what catagory I would fall into - I'm 43 now, was 33 (I think) when I first took Seroxat.
Now did GlaxoSmithKline throw hyponatremia into the file drawer effect vault as they did with study 329?
You tell me.
Fid
A 12-Week Prospective Study
Tanya J. Fabian, PharmD; Janet A. Amico, MD; Patricia D. Kroboth, PhD; Benoit H. Mulsant, MD; Sharon E. Corey, PhD; Amy E. Begley, MA; Salem G. Bensasi, BS; Elizabeth Weber, RN, CNP; Mary Amanda Dew, PhD; Charles F. Reynolds III, MD; Bruce G. Pollock, MD, PhD
Arch Intern Med. 2004;164:327-332.
Background Older depressed patients are at high risk for development of hyponatremia after initiation of the selective serotonin reuptake inhibitor paroxetine, despite clinical monitoring and preventive management. The purposes of this study were to determine the incidence and etiology of paroxetine-induced hyponatremia in older patients and to identify patient characteristics that may account for variability in susceptibility to this adverse event.
Methods This prospective, longitudinal study was conducted in a university-based ambulatory psychiatric research clinic from August 1999 through September 2001. Patients included 75 men and women aged 63 through 90 years (mean ± SD age, 75.3 ± 6.0 years) who received a diagnosis of a current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, major depressive episode and were prescribed paroxetine. We monitored plasma sodium levels before initiating paroxetine therapy and after 1, 2, 4, 6, and 12 weeks of treatment. In a subset of individuals, we measured levels of antidiuretic hormone, glucose, serum urea nitrogen, and creatinine. Hyponatremia was defined as a plasma sodium level of less than 135 mEq/L after initiation of paroxetine therapy.
Results Hyponatremia developed in 9 (12%) of the 75 patients after initiation of paroxetine treatment. Mean ± SD time to development of hyponatremia was 9.3 ± 4.7 days (median, 9 days; range, 1-14 days; n = 8). In the multivariate regression, lower body mass index and lower baseline plasma sodium level (<138 mEq/L) were significant risk factors for the development of hyponatremia in these patients.
Conclusions Hyponatremia is an underrecognized and potentially serious complication of paroxetine treatment in older patients. Our results provide a foundation for understanding the etiology and risk factors associated with paroxetine-induced hyponatremia.
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