The following 'specialists', doctors, call them what you will, have all had ties with GlaxoSmithKline be it through sitting on panels or receiving funding. Maybe it's time they were asked to explain what the word 'Morals' means?
Hagop S. Akiskal, M.D., Professor of Psychiatry, Director of the International Mood Center, University of California at San Diego, La Jolla. Received grant or research support from Eli Lilly. Served as a consultant to Abbott, Janssen Pharmaceutica, and Eli Lilly. Served on the speakers’ bureaus of Abbott, GlaxoSmithKline, Janssen Pharmaceutica, and Eli Lilly. (http://www.wpic.pitt.edu/STANLEY/5thbipconf/introduction.htm; accessed 5/27/05)
EMAIL
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David B. Badesch, M.D., F.C.C.P., Professor of Medicine and Clinical Director, Pulmonary Hypertension Center, University of Colorado Health Sciences Center, Denver. Served as a consultant or on a speakers bureau for Glaxo Wellcome/GlaxoSmithKline, Actelion, InterMune, Encysive, Myogen, Astra-Merck, AstraZeneca, Exhale Therapeutics/CoTherix, Forrest Labs, INO Therapeutics, and Berlex. Received research support from Glaxo Wellcome/GlaxoSmithKline, United Therapeutics, Boehringer Ingelheim, Actelion, Encysive, ICOS/Texas Biotechnologies/Encysive, Myogen, INO Therapeutics, Scleroderma Foundation, United Therapeutics, and Pfizer. (Chest 2004;126:1)
EMAIL
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David A. Baker, M.D., Professor, Obstetrics, Gynecology, and Reproductive Medicine, and Director, Division of Infectious Diseases, Health Sciences Center, Stony Brook University, Stony Brook, NY. Speaker and researcher for GlaxoSmithKline. (Am J Obstet Gynecol. 2005; 193:1887-8.)
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George L. Bakris, M.D., Professor of Internal Medicine and Preventive Medicine, Department of Preventive Medicine, Rush-Presbyterian-St. Luke Medical Center, Chicago. Advisor to Abbott Laboratories, Alteon Inc., AstraZeneca Pharmaceuticals LP, AusAm Biotechnologies, Inc., Biovail Corporation, BMS-Sanofi, Boehringer Ingelheim Pharmaceuticals Inc., Eli Lilly & Company, Forest Laboratories, GlaxoSmithKline, Merck & Co., Novartis Pharmaceuticals, Inc., Takeda Pharmaceuticals North America, Inc., and Wyeth Pharmaceuticals; received research support from Abbott Laboratories, Alteon Inc., AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc., Eli Lilly & Company, Forest Laboratories, GlaxoSmithKline, Merck & Company, Inc., and Novartis Pharmaceuticals, Inc.; member of the speakers' bureaus of Abbott Laboratories, Alteon Inc., AstraZeneca Pharmaceuticals LP, AusAm Biotechnologies, Inc., Biovail Corporation, BMS-Sanofi, Boehringer Ingelheim Pharmaceuticals Inc., Eli Lilly & Company, Forest Laboratories, GlaxoSmithKline, Merck & Company, Inc., Novartis Pharmaceuticals, Inc., Takeda Pharmaceuticals North America, Inc., and Wyeth Pharmaceuticals. (http://www.medscape.com/viewprogram/3599_authors; accessed 7/28/05) Received grants, served as a consultant to, and received honoraria for serving as a speaker from AstraZeneca, Abbott, Alteon, Biovail, Boehringer-Ingelheim, Bristol-Myers Squibb, Forest, GlaxoSmithKline, Merck, Novartis, Sankyo, Sanofi and Solvay. (JAMA. 2003;289:2560-72.)
EMAIL
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Robyn J. Barst, M.D., Director, New York Presbyterian Pulmonary Hypertension Center, New York, NY. Served as a consultant and received research support from Actelion, Encysive, Exhale Therapeutics, INO, Myogen, United Therapeutics, Pfizer and GlaxoSmithKline. Received unrestricted education grants from GlaxoSmithKline, Encysive, and Actelion. (Chest 2004;126:1)
EMAIL
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Robert B. Belshe, M.D., Professor, Director, Division of Infectious Disease and Immunology, Saint Louis University, St. Louis, MO. Receives research support from Merck and MedImmune; receives consulting fees and/or lecture fees from MedImmune, Merck, Novartis, GlaxoSmithKline, and Sanofi. (N Engl J Med. 2007 Feb 15;356(7):685-96.)
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Constance A. Benson, M.D., Professor of Medicine, Division of Infectious Diseases, University of California San Diego, and Member, Board of Directors, International AIDS Society–USA. Served as a scientific advisor to Boehringer Ingelheim, GlaxoSmithKline, Johnson & Johnson, Merck, and Tibotec. (http://www.iasusa.org/people/disclosure.html; accessed 11/7/06)
EMAIL
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Karl R. Beutner, M.D., Ph.D., Chief Medical Officer, Solano Clinical Research, Dow Pharmaceutical Sciences. Also, Associate Clinical Professor, Department of Dermatology, University of California, San Francisco. Research on the use of Valtrex (valacyclovir) to reduce the risk of transmission of genital herpes partially funded by GlaxoSmithKline Research and Development. Received consultation and lecture fees from GlaxoSmithKline, Eli Lilly, and 3M. (N. Engl. J. Med. 2003;350:11-22)
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Alison Blenkinsopp, Ph.D., Professor of Medicines Management, Keele University, Newcastle, England. Received research funding from Servier, Pfizer, GlaxoSmithKline, and Merck Sharp & Dohme Ltd. (http://www.mca.gov.uk/aboutagency/regframework/csm/csmdoi01.pdf; accessed 7/18/03)
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Charles L. Bowden, M.D., Professor and Chairman, Department of Psychiatry, University of Texas Health Science Center, San Antonio. Received grant or research support from Abbott, Bristol-Myers Squibb, Glaxo Wellcome, Janssen Pharmaceutica, Lilly Research, Parke-Davis, and SmithKline Beecham. Served as a consultant for Abbott, Glaxo Wellcome, Janssen Pharmaceutica, Lilly Research, Sanofi Synthelabo, and UCB Pharma. Served on the speakers’ bureau of Abbott Laboratories, Astra Zeneca, Glaxo Wellcome, Janssen Pharmaceutica, Lilly Research, and Pfizer. (http://www.wpic.pitt.edu/STANLEY/5thbipconf/introduction.htm; accessed 5/27/05) “Olanzapine in the Treatment of Recently Unresponsive Manic Illness” funded by Eli Lilly. (http://psychiatry.uthscsa.edu/Searches/SearchProfileData.asp?ID=24; accessed 3/4/05) Consultant for Abbott Laboratories, GlaxoSmithKline, Janssen, Ortho-McNeil, Eli Lilly, Sanofi-Synthelabo and UCB Pharma. Receives grant support from Abbott Laboratories, Bristol-Myers Squibb, Elan Pharmaceuticals, SmithKline Beecham (now GlaxoSmithKline), Janssen, Parke-Davis, and Eli Lilly and is a member of the speakers bureau for AstraZeneca, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Ortho-McNeil and Sanofi Synthelabo. (Neuropsychopharmacology 2003;28:1374-82.; Conference disclosure notes; 41st Annual Meeting of the American College of Neuropsychopharmacology, December 2002, San Juan, Puerto Rico; on file with CSPI)
EMAIL
More coming soon.
Source: Integrity in Science
Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Wednesday, January 02, 2008
Tuesday, January 01, 2008
Coronation Street - 'Liz McDonald' memory loss when on Seroxat
Despite her collapse and diagnosis, Beverley returned to work the next day, hoping the drug would make her feel better, although she had been warned it could be six weeks before it took effect.
'Actually, I felt worse as the weeks went on. I never forgot my lines, but an hour after a conversation, I wouldn't remember what had been said.'
FULL STORY
Thursday, December 27, 2007
MHRA - What more do you want?
I've banged the drum enough times about the utter incompetence of Kent Woods and the MHRA - Why?
Well they are into there fourth year investigating GlaxoSmithKline despite overwhelming evidence that clearly shows how GlaxoSmithKline secretly planned to push Seroxat onto an unsuspecting public despite the myriad of side effects known to them.
Once again this post goes out to the CEO of the MHRA - Just in case he missed it first time around.
Lets go back to November 7th 2004 and show you an article from The Observer - The MHRA would have only been a year into their investigation when this was published and probably at that time thought they could push it under the carpet - little did they know that advocates such as myself, Seroxat Secrets, Charles Medawar et al would be on their case pushing them... no, demanding them for answers.
FOR YOU MR KENT WOODS:
(I have highlighted (in red) points you may wish to discuss/investigate with your colleagues)
Britain's largest drug company drew up a secret plan to double sales of the controversial anti-depressant Seroxat by marketing it as a cure for a raft of less serious mental conditions, The Observer can reveal today.
The contents of the 250-page document have alarmed health campaigners who accuse the firm, GlaxoSmithKline (GSK), of putting profit before the therapeutic needs of patients by attempting to broaden the market for the drug which has been linked to a spate of suicides.
The revelation is likely to prompt further concerns about the role and influence of the pharmaceutical industry, which has come under severe scrutiny in recent months. The document is now being investigated by a parliamentary inquiry into the drugs industry.
The internal report carries a section which outlines how GSK planned to double sales of 'selective serotonin reuptake inhibitors (SSRI)' - the industry term for anti-depressants - by winning the marketing war against Seroxat's chief rival, Prozac, manufactured by Eli Lilly.
Written in 1998 and subsequently updated in following years, the section is entitled: 'Towards the second billion - all SSRIs are not the same' and discusses strategies to see off the threat posed by Prozac.
The document outlined how GSK intended to market Seroxat for a range of conditions other than clinical depression. Chief among these was a condition the company identified as social anxiety disorder, although other forms of anxiety were also discussed internally.
'What this document makes clear is that a number of different forms of anxiety were being targeted in a systematic way. The thrust was to move sales beyond the $1 billion to $2 billion mark by pushing it to people who were not clinically depressed,' said Professor David Healy, a psycho-pharmacologist at Cardiff University, who has given evidence to the House of Commons Health Select Committee.
Richard Brook, chief executive of Mind, the mental health charity which submitted the document to the committee, told the MPs it was 'all about developing new conditions for that drug and demolishing the arguments of other competitors about why their drug was not any good'.
In addition the document shows GSK made a great virtue of the fact that Seroxat had a relatively short 'half-life' compared with Prozac, an argument which has subsequently proven deeply controversial.
A half-life is the scientific term for how long it takes for the concentration of a drug to drop by 50 per cent in a patient's bloodstream. The company suggested Seroxat's short half-life meant patients could come on and off the drug easily, compared with those on Prozac, even to the extent that they could take 'treatment holidays'. 'There was an argument that a short half life was really good news,' Brook said.
'But five years later, Seroxat has withdrawal issues. It's the short half life that causes the problems. The substances get into the body so quickly it causes some sort of dependency reaction. So one of the things the company was saying was a benefit was actually a problem.'
In its submission to the parliamentary committee Mind said the original trial data submitted to the UK regulators by GSK showed the claim was at best 'naive and at worst seriously misleading'. It added that 'the Seroxat file is highly illustrative of using marketing information as facts'.
Concerns about the addictive properties of Seroxat saw the government ban its prescription to people under the age of 18 last year. This followed a review which found children taking it were more likely to self-harm or commit suicide.
A spokesman for GSK said Seroxat could be marketed at new conditions only after stringent testing. 'Medical authorities around the world have required that GSK study each condition separately in order to prove benefit in each condition specifically.'
Hope this helps you Kent
Happy New Year
Fid
Well they are into there fourth year investigating GlaxoSmithKline despite overwhelming evidence that clearly shows how GlaxoSmithKline secretly planned to push Seroxat onto an unsuspecting public despite the myriad of side effects known to them.
Once again this post goes out to the CEO of the MHRA - Just in case he missed it first time around.
Lets go back to November 7th 2004 and show you an article from The Observer - The MHRA would have only been a year into their investigation when this was published and probably at that time thought they could push it under the carpet - little did they know that advocates such as myself, Seroxat Secrets, Charles Medawar et al would be on their case pushing them... no, demanding them for answers.
FOR YOU MR KENT WOODS:
(I have highlighted (in red) points you may wish to discuss/investigate with your colleagues)
Britain's largest drug company drew up a secret plan to double sales of the controversial anti-depressant Seroxat by marketing it as a cure for a raft of less serious mental conditions, The Observer can reveal today.
The contents of the 250-page document have alarmed health campaigners who accuse the firm, GlaxoSmithKline (GSK), of putting profit before the therapeutic needs of patients by attempting to broaden the market for the drug which has been linked to a spate of suicides.
The revelation is likely to prompt further concerns about the role and influence of the pharmaceutical industry, which has come under severe scrutiny in recent months. The document is now being investigated by a parliamentary inquiry into the drugs industry.
The internal report carries a section which outlines how GSK planned to double sales of 'selective serotonin reuptake inhibitors (SSRI)' - the industry term for anti-depressants - by winning the marketing war against Seroxat's chief rival, Prozac, manufactured by Eli Lilly.
Written in 1998 and subsequently updated in following years, the section is entitled: 'Towards the second billion - all SSRIs are not the same' and discusses strategies to see off the threat posed by Prozac.
The document outlined how GSK intended to market Seroxat for a range of conditions other than clinical depression. Chief among these was a condition the company identified as social anxiety disorder, although other forms of anxiety were also discussed internally.
'What this document makes clear is that a number of different forms of anxiety were being targeted in a systematic way. The thrust was to move sales beyond the $1 billion to $2 billion mark by pushing it to people who were not clinically depressed,' said Professor David Healy, a psycho-pharmacologist at Cardiff University, who has given evidence to the House of Commons Health Select Committee.
Richard Brook, chief executive of Mind, the mental health charity which submitted the document to the committee, told the MPs it was 'all about developing new conditions for that drug and demolishing the arguments of other competitors about why their drug was not any good'.
In addition the document shows GSK made a great virtue of the fact that Seroxat had a relatively short 'half-life' compared with Prozac, an argument which has subsequently proven deeply controversial.
A half-life is the scientific term for how long it takes for the concentration of a drug to drop by 50 per cent in a patient's bloodstream. The company suggested Seroxat's short half-life meant patients could come on and off the drug easily, compared with those on Prozac, even to the extent that they could take 'treatment holidays'. 'There was an argument that a short half life was really good news,' Brook said.
'But five years later, Seroxat has withdrawal issues. It's the short half life that causes the problems. The substances get into the body so quickly it causes some sort of dependency reaction. So one of the things the company was saying was a benefit was actually a problem.'
In its submission to the parliamentary committee Mind said the original trial data submitted to the UK regulators by GSK showed the claim was at best 'naive and at worst seriously misleading'. It added that 'the Seroxat file is highly illustrative of using marketing information as facts'.
Concerns about the addictive properties of Seroxat saw the government ban its prescription to people under the age of 18 last year. This followed a review which found children taking it were more likely to self-harm or commit suicide.
A spokesman for GSK said Seroxat could be marketed at new conditions only after stringent testing. 'Medical authorities around the world have required that GSK study each condition separately in order to prove benefit in each condition specifically.'
Hope this helps you Kent
Happy New Year
Fid
MHRA Just not good enough
Source: BBC News
Drug reactions 'kill thousands'
Almost 3,000 people have died in the past three years after suffering serious side-effects or allergies to their medicines, say official figures.
More than 13,000 others in the same period had an "adverse drug reaction", but survived with hospital treatment.
The statistics, obtained by the Liberal Democrats, include damage caused by "over the counter" drugs such as aspirin and ibuprofen.
Experts said that medicines could not be blamed for all the reported cases.
The figures are drawn from "yellow card" scheme, run by the Medicines and Healthcare products Regulatory Authority (MHRA) to gather reports of all adverse reactions from both clinicians and patients.
Last year, there were reports of 964 patients in the UK who died as a result of an adverse reaction, compared with more than 1,000 the previous year, and 861 in 2004.
However, there is evidence that the vast majority of adverse drug reactions are never reported to the MHRA.
Bigger problem
A study published last year suggested that 6.5% of all patients admitted to hospital had experienced a reaction, and that in four out of five cases, the medicines they were taking were to blame.
This adds up to as much as 250,000 cases a year - and an annual cost of £466 million to the NHS.
The MHRA has urged patients to join doctors in reporting drug reactions to them via the NHS Direct phone line.
While in some cases a deadly side-effect or allergy could not have been predicted, Chief Medical Officer Sir Liam Donaldson has conceded that some cases should have been avoided.
"We have to become better at learning from these mistakes," he told a conference last month.
However, the Liberal Democrats are calling for a "full investigation" into the issue.
MP Norman Lamb said: "This is a dangerously escalating problem, which is putting lives at risk and placing a big cost burden on the NHS."
While many of the cases involve drugs commonly prescribed by GPs and in hospitals, such as the blood-thinning drug warfarin and diuretics, a list of common culprits includes some which can be bought without prescription in any high street chemist.
These include aspirin, and the anti-inflammatory drug ibuprofen, both of which can cause gastric bleeding if taken in high doses over longer periods.
Dr June Raine, the Director of Vigilance and Risk Management of Medicines at the MHRA said that every medicine carried some risk of side-effects.
"Our role is to ensure that the benefits of medication outweigh the risks. "It is important to note that a report of an adverse drug reaction does not necessarily prove that it was caused by the drug.
"Other factors such as underlying disease or other medicines may contribute to suspected adverse reactions."
Dr June Raine eh? Sounds like a stuck record!
Drug reactions 'kill thousands'
Almost 3,000 people have died in the past three years after suffering serious side-effects or allergies to their medicines, say official figures.
More than 13,000 others in the same period had an "adverse drug reaction", but survived with hospital treatment.
The statistics, obtained by the Liberal Democrats, include damage caused by "over the counter" drugs such as aspirin and ibuprofen.
Experts said that medicines could not be blamed for all the reported cases.
The figures are drawn from "yellow card" scheme, run by the Medicines and Healthcare products Regulatory Authority (MHRA) to gather reports of all adverse reactions from both clinicians and patients.
Last year, there were reports of 964 patients in the UK who died as a result of an adverse reaction, compared with more than 1,000 the previous year, and 861 in 2004.
However, there is evidence that the vast majority of adverse drug reactions are never reported to the MHRA.
Bigger problem
A study published last year suggested that 6.5% of all patients admitted to hospital had experienced a reaction, and that in four out of five cases, the medicines they were taking were to blame.
This adds up to as much as 250,000 cases a year - and an annual cost of £466 million to the NHS.
The MHRA has urged patients to join doctors in reporting drug reactions to them via the NHS Direct phone line.
While in some cases a deadly side-effect or allergy could not have been predicted, Chief Medical Officer Sir Liam Donaldson has conceded that some cases should have been avoided.
"We have to become better at learning from these mistakes," he told a conference last month.
However, the Liberal Democrats are calling for a "full investigation" into the issue.
MP Norman Lamb said: "This is a dangerously escalating problem, which is putting lives at risk and placing a big cost burden on the NHS."
While many of the cases involve drugs commonly prescribed by GPs and in hospitals, such as the blood-thinning drug warfarin and diuretics, a list of common culprits includes some which can be bought without prescription in any high street chemist.
These include aspirin, and the anti-inflammatory drug ibuprofen, both of which can cause gastric bleeding if taken in high doses over longer periods.
Dr June Raine, the Director of Vigilance and Risk Management of Medicines at the MHRA said that every medicine carried some risk of side-effects.
"Our role is to ensure that the benefits of medication outweigh the risks. "It is important to note that a report of an adverse drug reaction does not necessarily prove that it was caused by the drug.
"Other factors such as underlying disease or other medicines may contribute to suspected adverse reactions."
Dr June Raine eh? Sounds like a stuck record!
Wednesday, December 26, 2007
A threat... it seems?
Dunno who the smart arse is. I do wish people would be more open with whom they are and not post anonymously. Time of posting ties in with a poster from Australia according to my webstats.
Lemme know who you are... if you have the bollocks
The link in the message takes you to a picture/painting of some sort.
Tuesday, December 25, 2007
I want to help the MHRA...
...Investigate GlaxoSmithKline. Call it a Christmas present if you will. They (MHRA) have been investigating GlaxoSmithKline now for 4 years so I think they need a little help.
This post goes out to Kent Woods, I shall be emailing him and others to point him in the direction of the documents that should help them come to a decision.
Firstly, we have a document that shows what GSK really think about Seroxat for children.
FOR YOU MR WOODS - HERE
Next up an article that shows GSK Sales Reps whom were told NOT to Divulge Seroxat Data
FOR YOU MR WOODS - HERE
If this hasn't whet your appetite Mr Woods then perhaps the following may help?
Here we have an article that shows how GlaxoSmithKline staff were told not to publicise ineffectiveness of its drug.
Or maybe GlaxoSmithKline's release studies showing suicide and hostility may help speed up the MHRA investigation?
FOR YOU MR WOODS - HERE
Your counterparts in the USA, the FDA, have warned about the dangers of withdrawal on Seroxat - maybe YOU should warn members of the British public Mr Woods? You are after all supposed to safeguard the public from these types of things aren't you?
Maybe, you didn't see the Panorama specials on GlaxoSmithKline concealing data Mr Woods, or maybe you did but just plain refused to accept that one of the MHRA's funders could do such a thing? Maybe the fact that you have two ex GlaxoSmithKline employees sitting on the MHRA is enough to make you believe that YOU are right and the public outcry is nothing more than scaremongering by investigative journalist Shelly Jofre? Here's a brief summary for you to read Mr Woods.
You getting all this Kent?
Am I being helpful Kent?
Maybe you would like to take some of Charles Medawars comments on board Mr Woods? I particularly liked his 'What they have done is just despicable' comment - Do you have anything to add Mr Woods?
Maybe you would like to see how GSK paid a Dr to promote Seroxat Mr Woods? You come down pretty hard of fake drugs being sold don't you Kent? Why don't you come down on GlaxoSmithKline for selling this drug - it clearly does not mention the host of side-effects one can get whilst on it now does it Kent? Do you believe Martin Keller was right? Take a look HERE and let me know Kent.
I hope these documents and articles may help you progress your investigation into GlaxoSmithKline Kent. If I can be of more assistance please do not hesitate to ask. I have no affiliations with GlaxoSmithKline and will not hide anything from you.
Meantime, I wish all at the MHRA a very merry Christmas... especially you Mr Woods
Finally Kent, I'd like you to take a good, long hard look at the following video - it's only 4 minutes long (approx) - I'm sure you can find time, it has after all taken you four years to get where you are in the current GlaxoSmithKline investigation. Take a look Kent.
This post goes out to Kent Woods, I shall be emailing him and others to point him in the direction of the documents that should help them come to a decision.
Firstly, we have a document that shows what GSK really think about Seroxat for children.
FOR YOU MR WOODS - HERE
Next up an article that shows GSK Sales Reps whom were told NOT to Divulge Seroxat Data
FOR YOU MR WOODS - HERE
If this hasn't whet your appetite Mr Woods then perhaps the following may help?
Here we have an article that shows how GlaxoSmithKline staff were told not to publicise ineffectiveness of its drug.
Or maybe GlaxoSmithKline's release studies showing suicide and hostility may help speed up the MHRA investigation?
FOR YOU MR WOODS - HERE
Your counterparts in the USA, the FDA, have warned about the dangers of withdrawal on Seroxat - maybe YOU should warn members of the British public Mr Woods? You are after all supposed to safeguard the public from these types of things aren't you?
Maybe, you didn't see the Panorama specials on GlaxoSmithKline concealing data Mr Woods, or maybe you did but just plain refused to accept that one of the MHRA's funders could do such a thing? Maybe the fact that you have two ex GlaxoSmithKline employees sitting on the MHRA is enough to make you believe that YOU are right and the public outcry is nothing more than scaremongering by investigative journalist Shelly Jofre? Here's a brief summary for you to read Mr Woods.
You getting all this Kent?
Am I being helpful Kent?
Maybe you would like to take some of Charles Medawars comments on board Mr Woods? I particularly liked his 'What they have done is just despicable' comment - Do you have anything to add Mr Woods?
Maybe you would like to see how GSK paid a Dr to promote Seroxat Mr Woods? You come down pretty hard of fake drugs being sold don't you Kent? Why don't you come down on GlaxoSmithKline for selling this drug - it clearly does not mention the host of side-effects one can get whilst on it now does it Kent? Do you believe Martin Keller was right? Take a look HERE and let me know Kent.
I hope these documents and articles may help you progress your investigation into GlaxoSmithKline Kent. If I can be of more assistance please do not hesitate to ask. I have no affiliations with GlaxoSmithKline and will not hide anything from you.
Meantime, I wish all at the MHRA a very merry Christmas... especially you Mr Woods
Finally Kent, I'd like you to take a good, long hard look at the following video - it's only 4 minutes long (approx) - I'm sure you can find time, it has after all taken you four years to get where you are in the current GlaxoSmithKline investigation. Take a look Kent.
Saturday, December 22, 2007
Aropax Hell Part II
It seems the word is spreading throughout Australia.
This is an account taken from the firesnake website, I urge yo to visit, the guy has obviously done his homework when it comes to Paxil 329 study.
I've republished it here in its entirety, hope the author does not mind.
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Yes, Aropax kills. In this second part of 'Aropax Hell' we touch on the behind the scenes documentation and "The" memo - "it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine" - that exposed GSK's intention to place the money before the box - as it were. A concerted plan to educate sales rep's from wavering under the strain of humane thoughts was launched. We know it's the fourth most addictive drug on the planet. And we pay good money, for a drug that makes well subjects anxious and depressed to the point of suicide, and has no effect upon depression at all.
Justifiably, criminal charges followed. It is plain Paroxetine must be considered carefully. European Paroxetine Q&A here.
Why was it reviewed? What are concerns? What's the evidence?
We touch on Study 329 which produced the very data GSK decided to hide. Self harm, highly addictive and non-efficacy: things look bad for paroxetine. Problems continue to unfold and GSK released studies "showing suicide, hostility, etc". It's clear that the jury verdict [original document] holding GSK 80% liable for the murder-suicide case of Donald Schell was reported widely and led to the BBC Panorama investigation - which actually continues in court today [timeline]. The argument over addiction or discontinuation semantics proceeds splendidly with the courts eventually catching on to the shortfalls of addiction definitions.
For those involved on the inside, it's a bizarre ride. Aside from the raft of personality fragmentation even modest struggles with paroxetine induce, it is clear this induces suicide and self sabotage in previously stable or asymptomatic persons. We can see a gradual "chronology of admission" as GSK confirms dangers effect all ages and quietly reveal it's a major risk during pregnancy. At last after more time - and possibly energy - than earning a PhD, GSK admit what we wanted: paroxetine is an absolute tragedy regardless of age, and kills without compunction. Thankfully, the FDA agree.
Annoying the FDA is kinda silly and when Eliot Spitzer was given the run around by GSK over paroxetines inefficacy, one imagines his blood boiled. Ultimately, Spitzer lodged a class action [original PDF] on behalf of New York residents deceived by GSK. The FDA succeeded in agitating for close reviews of paroxetines trials: the famous and detailed Article 31. This episode includes more out-takes of Dr. Alistair Benbow lying heroically as authours drag his name through mud [2]. GSK itself continually releases token "warnings" and basks in the credit-for-responsibility spotlight.
Firesnake also looks closely at SSRI induced aggression, depression per se, what we know of Donald Schell, his mood swings, prior medication, SSRI blood levels and time needed to observe any effect of any SSRI - no matter how inefficacious. Paroxetine may be a useless SSRI, but an SSRI it is. Did Schell kill and suicide as a direct result of paroxetine? Or, did justice really catch up with GSK due to illegal business practices and appalling ethics, revealed in so much damning documentation? If the latter, legal purists may find this challenging, but none can deny paroxetine was going to kill, did kill thousands of others, destroyed lives, families, careers and if not for dedicated advocates, we may never know. Firesnake considers the only conclusion possible, and reflects upon "justice" - no matter how it comes.
Australians must be proactive. Ethnocentric, we are blind to global dynamics and receive a filtered trickle of data. I myself have brilliant colleagues, who still, in blind error and with no small amount of defensive, guilt-in-hindsight-arrogance, insist paroxetine's safe. Why? They are busy, prone to follow "best practice" over evidence based practices, meet the needs of pestering patients, staff, colleagues, employers, registrars, ethics committees and of course, the drug companies that paid for their beach front property with decades of obscene perks. And let's not forget because the company blurb says so - and to ever admit the reality is to invite litigation.
If your GP, psychiatrist or gym instructor prescribes or recommends Aropax, take your business - and life quality - elsewhere; that person is genuinely mistaken.
Our TGA is silent, yet vocal on Straterra - the type of medication one leap up from SSRI's targeting norepinephrine also. Read the documentation, find your own answers. Never use paroxetine - but it is your choice.
This is an account taken from the firesnake website, I urge yo to visit, the guy has obviously done his homework when it comes to Paxil 329 study.
I've republished it here in its entirety, hope the author does not mind.
----
Yes, Aropax kills. In this second part of 'Aropax Hell' we touch on the behind the scenes documentation and "The" memo - "it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine" - that exposed GSK's intention to place the money before the box - as it were. A concerted plan to educate sales rep's from wavering under the strain of humane thoughts was launched. We know it's the fourth most addictive drug on the planet. And we pay good money, for a drug that makes well subjects anxious and depressed to the point of suicide, and has no effect upon depression at all.
Justifiably, criminal charges followed. It is plain Paroxetine must be considered carefully. European Paroxetine Q&A here.
Why was it reviewed? What are concerns? What's the evidence?
We touch on Study 329 which produced the very data GSK decided to hide. Self harm, highly addictive and non-efficacy: things look bad for paroxetine. Problems continue to unfold and GSK released studies "showing suicide, hostility, etc". It's clear that the jury verdict [original document] holding GSK 80% liable for the murder-suicide case of Donald Schell was reported widely and led to the BBC Panorama investigation - which actually continues in court today [timeline]. The argument over addiction or discontinuation semantics proceeds splendidly with the courts eventually catching on to the shortfalls of addiction definitions.
For those involved on the inside, it's a bizarre ride. Aside from the raft of personality fragmentation even modest struggles with paroxetine induce, it is clear this induces suicide and self sabotage in previously stable or asymptomatic persons. We can see a gradual "chronology of admission" as GSK confirms dangers effect all ages and quietly reveal it's a major risk during pregnancy. At last after more time - and possibly energy - than earning a PhD, GSK admit what we wanted: paroxetine is an absolute tragedy regardless of age, and kills without compunction. Thankfully, the FDA agree.
Annoying the FDA is kinda silly and when Eliot Spitzer was given the run around by GSK over paroxetines inefficacy, one imagines his blood boiled. Ultimately, Spitzer lodged a class action [original PDF] on behalf of New York residents deceived by GSK. The FDA succeeded in agitating for close reviews of paroxetines trials: the famous and detailed Article 31. This episode includes more out-takes of Dr. Alistair Benbow lying heroically as authours drag his name through mud [2]. GSK itself continually releases token "warnings" and basks in the credit-for-responsibility spotlight.
Firesnake also looks closely at SSRI induced aggression, depression per se, what we know of Donald Schell, his mood swings, prior medication, SSRI blood levels and time needed to observe any effect of any SSRI - no matter how inefficacious. Paroxetine may be a useless SSRI, but an SSRI it is. Did Schell kill and suicide as a direct result of paroxetine? Or, did justice really catch up with GSK due to illegal business practices and appalling ethics, revealed in so much damning documentation? If the latter, legal purists may find this challenging, but none can deny paroxetine was going to kill, did kill thousands of others, destroyed lives, families, careers and if not for dedicated advocates, we may never know. Firesnake considers the only conclusion possible, and reflects upon "justice" - no matter how it comes.
Australians must be proactive. Ethnocentric, we are blind to global dynamics and receive a filtered trickle of data. I myself have brilliant colleagues, who still, in blind error and with no small amount of defensive, guilt-in-hindsight-arrogance, insist paroxetine's safe. Why? They are busy, prone to follow "best practice" over evidence based practices, meet the needs of pestering patients, staff, colleagues, employers, registrars, ethics committees and of course, the drug companies that paid for their beach front property with decades of obscene perks. And let's not forget because the company blurb says so - and to ever admit the reality is to invite litigation.
If your GP, psychiatrist or gym instructor prescribes or recommends Aropax, take your business - and life quality - elsewhere; that person is genuinely mistaken.
Our TGA is silent, yet vocal on Straterra - the type of medication one leap up from SSRI's targeting norepinephrine also. Read the documentation, find your own answers. Never use paroxetine - but it is your choice.
Wednesday, December 19, 2007
Tuesday, December 18, 2007
GlaxoSmithKline – Big pharma, big risks
Source: Ethical Corporation
Some fantastic bullshit quotes from GSK here. I've added my own comments in blue after each paragraph.
Fid
GlaxoSmithKline – Big pharma, big risks
Drug firms are opening up to address public distrust, says GlaxoSmithKline’s head of corporate communications (1)
Excuse me! Did I read that correctly? Drug firms are opening up? Opening up surely means they've been shut doesn't it? What's this, GlaxoSmithKline admitting that they have been less than transparent? Surely not!
For drug maker GlaxoSmithKline, 2007 has been a year of severe ill health followed by mild recovery. The firm’s share price crashed to a two-year low in May after its second biggest selling drug, diabetes treatment Avandia, was linked to increased risks of heart attacks. Since the scare, sales of the drug have slumped 50 per cent in the US and 40 per cent worldwide. Avandia last year racked up sales of £1.6 billion. (2)
2007 a year of severe health because more and more resources are available. JP Garnier must rue the day the internet was invented. All praise Bill Gates.
Nice to see GSK hit where it hurts (in the pocket) - £1.6 billion for Avandia sales. GSK Accounts Dept must have had such a wonderful time counting the pennies, hope they washed the blood off their hands after!
There was better news for GSK last month when the US Food and Drug Administration ruled, as expected, that the company must slap a “black box” warning on the drug, but did not ban it. The decision backed up GSK’s claim that the original study linking Avandia to a 43 per cent increase in risk of heart attacks was misleading. But another study, published in September, supported these findings. GSK maintains that “meta-analysis”, looking at a large body of historical clinical data, has found no clear evidence of a link. (3)
The FDA should be utterly ashamed of themselves. Even with a 50% drop in sales Avandia could still earn GSK £800M - Who fund the FDA ladies & gentlemen? Pharma that's who! No conflict of interest with the FDA's descision then huh?
Look at paragraph (1) again then the bottom of paragraph (3) - You see people - GSK are already shutting its doors after stating in the opening paragraph that they would be opening them! Avandia causes heart attacks, it's been proven but GSK want to have the last say on the matter, probably to protect the 50% of sales that haven't yet been affected by Avandiagate.
Let me spell it out for GSK - THERE IS A HIGH RISK OF HEART ATTACKS IF YOU TAKE AVANDIA
GSK’s losses over Avandia show the high stakes that research-based pharmaceutical firms take on when developing drugs. Vice-president for corporate communications Duncan Learmouth admits this is hard to explain to the public, saying: “We feel like we are shouting in a storm.” His concern is that big pharma is too often associated with big risks, such as health scares. “There’s a danger in the media overplaying the risk side without balancing it with the benefit, and oversimplifying what is a very complicated situation of giving a drug to someone,” he says. (4)
Oh look at Duncan Learmouth patronising the public. 'Hard to explain to the public'? What is hard about it? Are GSK some form of extra terrestrial intelligence that us mere mortals (public) are not yet ready for? Mr Learmouth, you are a pious pillock. You don't give the public the credit they richly deserve. Isn't it members of the public that are giving your employers such a hard time right now?
Learmouth doesn't stop at the public, he even has a go at the press for overplaying the risk side without balancing the benefit. Tell you what Mr Learmouth, lets say we get together, just the two of us, we can play russian roulette - one bullet, six chambers - you up for it - hey the benefits far outweigh the risks doncha think? Failing that we could always find a member of your family or a close friend who has diabetes. Maybe you would like to offer them Avandia? Hey, the benefits far outweigh the risks wouldn't you say?
Despite concerns about how product risks will be interpreted by the public, Learmouth expects pharma to become ever more transparent. Two years ago GSK decided to publish data on clinical trials online, although he admits the register could be more user-friendly. The decision came after damaging claims that it had concealed clinical trial results from the general public in the case of anti-depressant Seroxat. (5)
Is Learmouth taking the piss here? Ever more transparent? When have GSK EVER been transparent? They even lied about the Vitamin C content in their Ribena for fucksake! And what about the Paxil 329 study - how was that being transparent? They might argue that they have learned from their mistakes - thing is... they have NEVER admitted to their mistakes. Maybe then the 'public' may take them seriously when they tell us that they are going to be transparent. Do they even know the meaning of the fucking word? Maybe they have the same guidelines as the MHRA when it comes to transparency because they are about as transparent as a scene from a Hammer Horror film featuring Jack the Ripper on the streets of London!
The firm denies that it “improperly” withheld data from Seroxat clinical trials of the 1990s and says that it filed all information with regulators. Learmouth says it is wrong to judge the case by today’s standards of corporate transparency: “Before it was not that there was some conspiracy to hide this information, it was just never done.” (6)
Oh puhlease, you are beginning to sound like that other GSK mouthpiece, Ali Benbow. YOU DID NOT.... I REPEAT... YOU DID NOT file ALL information with the regulators. PAXIL STUDY 329 Mr Learmouth. Your company has settled out of court on numerous occasions regarding your defective product, admittedly, your team of lawyers have persuaded the prosecution to accept gagging orders. Clever... so clever. There will come a day where GSK stumble across some stubborn individual who will not bow down to the money you wave at them. There is no conspiracy - there is only fact!
Similarly, GSK has “recognised the need for much stronger policies” on using ghostwriters in preparing end of trial papers, says Learmouth. He admits that the old practice of using PR agencies to write papers today “does not really pass the smell test”. These days a report’s lead author, a physician, must have written the most significant part of a paper. GSK employees and other outsiders involved must also be named in the paper, and their affiliation noted. (7)
The smell test? HAHAHA now there's a new one from GSK. What is a smell test? The smell test failed when you hired Martin Keller to write his bollocks about the safety of Paxil - did he write it? The only smell coming from that particular test was bullshit Mr Learmouth. Would you be making such comments if Keller had been allowed to get away with it? I doubt it.
An area where GSK is improving its reputation is expanding access to medicines for patients in developing countries. The firm has a malaria vaccine that is about to go into the final phase of clinical trial, which has been part funded by the Gates Foundation. If all goes to plan, the vaccine could hit the market by 2010, says Learmouth. (8)
Developing countries huh? Would these be the same developing countries GSK charged excessive prices for Aids drugs to the detriment of South Africans with HIV/Aids and in violation of the Competition Act? Didn't GSK drop their legal effort to prevent South Africa from importing cheaper anti-AIDS drugs and other medicines?
Don't throw the developing countries line at us Mr Learmouth. We know from your history how you treat developing countries. This IS NOT about helping the ill, it's about making money so please cut the crap!
Next year should see GSK launch a combination vaccine, Globorix, for illnesses that mainly kill children in Africa such as diphtheria, tetanus and whooping cough. The company has spent $400 million developing the drug, despite expecting little return on this investment. Globorix will be a tiered-priced product, meaning its price will vary depending on governments’ ability to pay. (9)
And how big is GSK's gun going to be when they ask each indivdual government? They remind me of Spielberg's character Indianna Jones, you all know the scene, he takes a sip of his cocktail only to find out that it is poison - he is however given hope, the villain has the antedote and is prepared to give it to Indianna Jones.... for a rather huge diamond. How big does the diamond have to be for GSK before they give this new combination vaccine to some poor African child?
The company’s efforts to improve access to medicines have won two cheers of support from Oxfam. Policy adviser Helena Vines Fiestas says of the company’s work on access: “GSK is probably the leading company within the sector. But it still falls far short of a desirable position.” She welcomes GSK’s current work on developing 11 new drugs predominantly aimed at patients in poor countries, saying: “This number is high for the industry.” (10)
Oxfam are a charity - who on earth are they to pass comment on how 'wonderful' GSK are? Wait am minute... Do they recieve funding from GSK? I wonder if Helena Vines from Oxfam knows about the following GSK misdameanours? HERE
Critics have sounded the death knell for big pharma because of the lack of new drugs in their research pipelines. Learmouth disagrees. “Because the risk is high and probability is low, chance plays a big part in whether a company can discover a new class of drugs,” he says. “You have to be a certain size to play the odds of that.” (11)
'Risk is high and probabilty low' - maybe you should stick that on Seroxat patient information leaflets!
Despite its recent travails, GSK has the resources to keep playing those odds – for the potential benefit of patients in developed and developing markets alike. (12)
Hmmm, I beg to differ. People have had enough of the lies. The stench eminating from within GSK is overpowering so much so that it can even be smelled outside the offices of the FDA in America and the MHRA in England!
Rant over
Fid
Some fantastic bullshit quotes from GSK here. I've added my own comments in blue after each paragraph.
Fid
GlaxoSmithKline – Big pharma, big risks
Drug firms are opening up to address public distrust, says GlaxoSmithKline’s head of corporate communications (1)
Excuse me! Did I read that correctly? Drug firms are opening up? Opening up surely means they've been shut doesn't it? What's this, GlaxoSmithKline admitting that they have been less than transparent? Surely not!
For drug maker GlaxoSmithKline, 2007 has been a year of severe ill health followed by mild recovery. The firm’s share price crashed to a two-year low in May after its second biggest selling drug, diabetes treatment Avandia, was linked to increased risks of heart attacks. Since the scare, sales of the drug have slumped 50 per cent in the US and 40 per cent worldwide. Avandia last year racked up sales of £1.6 billion. (2)
2007 a year of severe health because more and more resources are available. JP Garnier must rue the day the internet was invented. All praise Bill Gates.
Nice to see GSK hit where it hurts (in the pocket) - £1.6 billion for Avandia sales. GSK Accounts Dept must have had such a wonderful time counting the pennies, hope they washed the blood off their hands after!
There was better news for GSK last month when the US Food and Drug Administration ruled, as expected, that the company must slap a “black box” warning on the drug, but did not ban it. The decision backed up GSK’s claim that the original study linking Avandia to a 43 per cent increase in risk of heart attacks was misleading. But another study, published in September, supported these findings. GSK maintains that “meta-analysis”, looking at a large body of historical clinical data, has found no clear evidence of a link. (3)
The FDA should be utterly ashamed of themselves. Even with a 50% drop in sales Avandia could still earn GSK £800M - Who fund the FDA ladies & gentlemen? Pharma that's who! No conflict of interest with the FDA's descision then huh?
Look at paragraph (1) again then the bottom of paragraph (3) - You see people - GSK are already shutting its doors after stating in the opening paragraph that they would be opening them! Avandia causes heart attacks, it's been proven but GSK want to have the last say on the matter, probably to protect the 50% of sales that haven't yet been affected by Avandiagate.
Let me spell it out for GSK - THERE IS A HIGH RISK OF HEART ATTACKS IF YOU TAKE AVANDIA
GSK’s losses over Avandia show the high stakes that research-based pharmaceutical firms take on when developing drugs. Vice-president for corporate communications Duncan Learmouth admits this is hard to explain to the public, saying: “We feel like we are shouting in a storm.” His concern is that big pharma is too often associated with big risks, such as health scares. “There’s a danger in the media overplaying the risk side without balancing it with the benefit, and oversimplifying what is a very complicated situation of giving a drug to someone,” he says. (4)
Oh look at Duncan Learmouth patronising the public. 'Hard to explain to the public'? What is hard about it? Are GSK some form of extra terrestrial intelligence that us mere mortals (public) are not yet ready for? Mr Learmouth, you are a pious pillock. You don't give the public the credit they richly deserve. Isn't it members of the public that are giving your employers such a hard time right now?
Learmouth doesn't stop at the public, he even has a go at the press for overplaying the risk side without balancing the benefit. Tell you what Mr Learmouth, lets say we get together, just the two of us, we can play russian roulette - one bullet, six chambers - you up for it - hey the benefits far outweigh the risks doncha think? Failing that we could always find a member of your family or a close friend who has diabetes. Maybe you would like to offer them Avandia? Hey, the benefits far outweigh the risks wouldn't you say?
Despite concerns about how product risks will be interpreted by the public, Learmouth expects pharma to become ever more transparent. Two years ago GSK decided to publish data on clinical trials online, although he admits the register could be more user-friendly. The decision came after damaging claims that it had concealed clinical trial results from the general public in the case of anti-depressant Seroxat. (5)
Is Learmouth taking the piss here? Ever more transparent? When have GSK EVER been transparent? They even lied about the Vitamin C content in their Ribena for fucksake! And what about the Paxil 329 study - how was that being transparent? They might argue that they have learned from their mistakes - thing is... they have NEVER admitted to their mistakes. Maybe then the 'public' may take them seriously when they tell us that they are going to be transparent. Do they even know the meaning of the fucking word? Maybe they have the same guidelines as the MHRA when it comes to transparency because they are about as transparent as a scene from a Hammer Horror film featuring Jack the Ripper on the streets of London!
The firm denies that it “improperly” withheld data from Seroxat clinical trials of the 1990s and says that it filed all information with regulators. Learmouth says it is wrong to judge the case by today’s standards of corporate transparency: “Before it was not that there was some conspiracy to hide this information, it was just never done.” (6)
Oh puhlease, you are beginning to sound like that other GSK mouthpiece, Ali Benbow. YOU DID NOT.... I REPEAT... YOU DID NOT file ALL information with the regulators. PAXIL STUDY 329 Mr Learmouth. Your company has settled out of court on numerous occasions regarding your defective product, admittedly, your team of lawyers have persuaded the prosecution to accept gagging orders. Clever... so clever. There will come a day where GSK stumble across some stubborn individual who will not bow down to the money you wave at them. There is no conspiracy - there is only fact!
Similarly, GSK has “recognised the need for much stronger policies” on using ghostwriters in preparing end of trial papers, says Learmouth. He admits that the old practice of using PR agencies to write papers today “does not really pass the smell test”. These days a report’s lead author, a physician, must have written the most significant part of a paper. GSK employees and other outsiders involved must also be named in the paper, and their affiliation noted. (7)
The smell test? HAHAHA now there's a new one from GSK. What is a smell test? The smell test failed when you hired Martin Keller to write his bollocks about the safety of Paxil - did he write it? The only smell coming from that particular test was bullshit Mr Learmouth. Would you be making such comments if Keller had been allowed to get away with it? I doubt it.
An area where GSK is improving its reputation is expanding access to medicines for patients in developing countries. The firm has a malaria vaccine that is about to go into the final phase of clinical trial, which has been part funded by the Gates Foundation. If all goes to plan, the vaccine could hit the market by 2010, says Learmouth. (8)
Developing countries huh? Would these be the same developing countries GSK charged excessive prices for Aids drugs to the detriment of South Africans with HIV/Aids and in violation of the Competition Act? Didn't GSK drop their legal effort to prevent South Africa from importing cheaper anti-AIDS drugs and other medicines?
Don't throw the developing countries line at us Mr Learmouth. We know from your history how you treat developing countries. This IS NOT about helping the ill, it's about making money so please cut the crap!
Next year should see GSK launch a combination vaccine, Globorix, for illnesses that mainly kill children in Africa such as diphtheria, tetanus and whooping cough. The company has spent $400 million developing the drug, despite expecting little return on this investment. Globorix will be a tiered-priced product, meaning its price will vary depending on governments’ ability to pay. (9)
And how big is GSK's gun going to be when they ask each indivdual government? They remind me of Spielberg's character Indianna Jones, you all know the scene, he takes a sip of his cocktail only to find out that it is poison - he is however given hope, the villain has the antedote and is prepared to give it to Indianna Jones.... for a rather huge diamond. How big does the diamond have to be for GSK before they give this new combination vaccine to some poor African child?
The company’s efforts to improve access to medicines have won two cheers of support from Oxfam. Policy adviser Helena Vines Fiestas says of the company’s work on access: “GSK is probably the leading company within the sector. But it still falls far short of a desirable position.” She welcomes GSK’s current work on developing 11 new drugs predominantly aimed at patients in poor countries, saying: “This number is high for the industry.” (10)
Oxfam are a charity - who on earth are they to pass comment on how 'wonderful' GSK are? Wait am minute... Do they recieve funding from GSK? I wonder if Helena Vines from Oxfam knows about the following GSK misdameanours? HERE
Critics have sounded the death knell for big pharma because of the lack of new drugs in their research pipelines. Learmouth disagrees. “Because the risk is high and probability is low, chance plays a big part in whether a company can discover a new class of drugs,” he says. “You have to be a certain size to play the odds of that.” (11)
'Risk is high and probabilty low' - maybe you should stick that on Seroxat patient information leaflets!
Despite its recent travails, GSK has the resources to keep playing those odds – for the potential benefit of patients in developed and developing markets alike. (12)
Hmmm, I beg to differ. People have had enough of the lies. The stench eminating from within GSK is overpowering so much so that it can even be smelled outside the offices of the FDA in America and the MHRA in England!
Rant over
Fid
Monday, December 17, 2007
Oakes and McCafferty Smith Kline Beecham
I was copied in on Matthew Holford's latest email to the 'usual suspects'.
It deserves a wider audience.
Fid
From: Matthew Holford
To: johnsona@parliament.uk ; alasdair.breckenridge@mhra.gsi.gov.uk ; kent.woods@mhra.gsi.gov.uk
Cc: Shailesh Vara
Sent: Monday, December 17, 2007 5:00 AM
Subject: Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trials
Gentlemen,
There's that word, again: efficacy! Could you explain to me how it is that two SKB employees have their names on this (toilet) paper? That's Oakes and McCafferty, to save you looking. http://www.jaacap.com/pt/re/jaacap/abstract.00004583-200107000-00010.htm;jsessionid=Hl8WfvyFqqHnXGPWJHX1mFJfl4mCnQQL8TYQg5LLc7vxfrRD2fh2!1219373867!181195629!8091!-1
Is this a joke? I've got the MHRA telling me that it relies on peer-reviewed papers, (when making marketing authorization assessments), which appear to be written by the very same fucking people who make the snake oil remedies.
The MHRA also tells me that this is a satisfactory alternative to troubling themselves to establish what "efficacy" means, in the context of any given drug (there's that "taken on trust" nonsense, again). We already know that this paper was written by Sally Laden, a ghostwriter, in collusion (I don't think that's too strong a word) with McCafferty. That the other charlatans and snake oil salesmen had the audacity to enter it on their CVs is still a mystery to me.
Arse:elbow. Do you note the difference? "Elbow" is the primary criteria, which has to outweigh "arse". OK? These are your rules, not mine.
Best regards
Matthew Holford
Read more of Matt's correspondence with the MHRA here
It deserves a wider audience.
Fid
From: Matthew Holford
To: johnsona@parliament.uk ; alasdair.breckenridge@mhra.gsi.gov.uk ; kent.woods@mhra.gsi.gov.uk
Cc: Shailesh Vara
Sent: Monday, December 17, 2007 5:00 AM
Subject: Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trials
Gentlemen,
There's that word, again: efficacy! Could you explain to me how it is that two SKB employees have their names on this (toilet) paper? That's Oakes and McCafferty, to save you looking. http://www.jaacap.com/pt/re/jaacap/abstract.00004583-200107000-00010.htm;jsessionid=Hl8WfvyFqqHnXGPWJHX1mFJfl4mCnQQL8TYQg5LLc7vxfrRD2fh2!1219373867!181195629!8091!-1
Is this a joke? I've got the MHRA telling me that it relies on peer-reviewed papers, (when making marketing authorization assessments), which appear to be written by the very same fucking people who make the snake oil remedies.
The MHRA also tells me that this is a satisfactory alternative to troubling themselves to establish what "efficacy" means, in the context of any given drug (there's that "taken on trust" nonsense, again). We already know that this paper was written by Sally Laden, a ghostwriter, in collusion (I don't think that's too strong a word) with McCafferty. That the other charlatans and snake oil salesmen had the audacity to enter it on their CVs is still a mystery to me.
Arse:elbow. Do you note the difference? "Elbow" is the primary criteria, which has to outweigh "arse". OK? These are your rules, not mine.
Best regards
Matthew Holford
Read more of Matt's correspondence with the MHRA here
Friday, December 14, 2007
LIAR LIAR YOUR PANTS ARE ON FIRE! ALI BENBOW GSK
Dr Benbow defended the use of the drug, (Seroxat) saying: "Anybody who suffers side effects of any sort I feel every sympathy for, but that does have to be balanced by the enormous benefit that is seen by many millions of patients around the world. He said that the company took every single safety report seriously but that based on the data available to him, he was "absolutely certain" that Seroxat was not addictive.
GSK European Promotion of Medicines Code of Practice 2nd Edition 2007.
Page 6: (Clause 4 - 4.10) "It must not be stated that a product has no side-effects, toxic hazards or risks of addiction or dependency."
So IS Benbow a liar after all?
Make your own minds up
GSK European Promotion of Medicines Code of Practice 2nd Edition 2007.
Page 6: (Clause 4 - 4.10) "It must not be stated that a product has no side-effects, toxic hazards or risks of addiction or dependency."
So IS Benbow a liar after all?
Make your own minds up
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