It is easier to decipher the following than it is to decipher communications from the MHRA!
Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Saturday, January 06, 2007
Friday, January 05, 2007
Paxil’s Ghost - More GSK corruption!
Paxil’s Ghost
BY CARL ELLIOTT
When the FDA’s Psychopharmacologic Drugs Advisory Committee holds its public hearing on December 13 to consider yet again the possible links between suicidality and the SSRI/SNRI antidepressants, one distinguished member of the advisory committee will be Dr. Bruce Pollock. Pollock used to be on the faculty at the University of Pittsburgh, but last year he was appointed to the Sandra A. Rotman Chair in Neuropsychiatry and Head of the Division of Geriatric Psychiatry at the University of Toronto. Pollock is also one of three committee members with extensive financial ties to antidepressant manufacturers. Pollock will not be allowed to vote, but his expertise was deemed so important by the FDA that his conflicts of interests were waived so that he could be included on the committee.
Pollock’s name may be familiar to scandal watchers. Two years ago, Congress was holding hearings on the question of whether GlaxoSmithKline had suppressed studies unfavorable to Paxil, and the New York attorney general had charged GlaxoSmithKline with consumer fraud. (GlaxoSmithKline settled the lawsuit without admitting wrongdoing, but paid a $2.5 million fine.) In December 2004, ABC News aired an investigative report on GlaxoSmithKline titled “Drug Maker Withheld Paxil Study Data: ABC News Uncovers Documents Unknown to Regulators and Many Study Doctors.” One of those documents concerned Pollock’s work for GlaxoSmithKline.
In the late 1990s, worries had emerged that patients might become dependent on the SSRIs. To combat the perception that people who stopped using Paxil might experience withdrawal symptoms – or “discontinuation” symptoms, as they were often called – GlaxoSmithKline (then still known as SmithKline Beecham) hired a public relations agency called Ruder Finn. Ruder Finn drafted letters that they planned to submit to scientific journals and that downplayed the idea that Paxil was associated with discontinuation symptoms. According to internal memos, Pollock was one of four psychiatrists whom they planned to invite to “author” the letters.
A letter from Pollock eventually appeared in the Journal of Clinical Psychiatry. Although the wording of Pollock’s letter was somewhat different from the draft written by Ruder Finn, it made all the same points. It even made them in the same order. But there was no disclosure, no mention of industry funding, no mention of “editorial assistance,” and no mention of Ruder Finn. Pollock concluded his letter by saying, “Rather than directing our efforts towards the relatively infrequent, minor and transient discontinuation symptoms associated with SSRI therapy, clinicians may be well advised to focus their energies on the greater issues of efficacy, safety, and patient outcome.” The bottom line: concerns about discontinuation symptoms were overblown
Pollock was on the GlaxoSmithKline advisory board at the time, but he told ABC News that he had written the letter to the Journal of Clinical Psychiatry himself and had no knowledge of the draft letter prepared by the PR firm with his name on it. He did admit, however, that "could imagine a scenario where a representative from the makers of Paxil said, 'Could you make this point?'" According to ABC News, Pollock’s letter later appeared in an internal business plan guide prepared for GlaxoSmithKline sales reps. It cited Pollock's letter as "an effective tool for addressing discontinuation."
Writing about the Paxil fraud case last year in the Hastings Center Report, Leemon McHenry described today’s pharmaceutical company marketing strategy as “defending the molecule.” Rather than drawing conclusions from the evidence, wrote McHenry, the strategy is to select the data that promote the drugs, ignore the unfavorable data, pay a prominent academic to sign onto ghostwritten articles about the positive data, and publish the ghostwritten article in the best journals. Then you complete the circle by citing the ghostwritten articles in your marketing literature.
Actually, McHenry left out one crucial part of the circle. If you are the person who signs the ghosted article, you just may get a seat on an FDA advisory committee and a named chair at the University of Toronto.
Copies of Ruder Finn's letters can be found here:
PDF RUDER FINN (right click and save as)
PDF DR POLLOCK'S WAIVER BY THE FDA (right click and save as)
PDF DR POLLOCK'S CONFLICT OF INTERESTS (right click and save as)
BY CARL ELLIOTT
When the FDA’s Psychopharmacologic Drugs Advisory Committee holds its public hearing on December 13 to consider yet again the possible links between suicidality and the SSRI/SNRI antidepressants, one distinguished member of the advisory committee will be Dr. Bruce Pollock. Pollock used to be on the faculty at the University of Pittsburgh, but last year he was appointed to the Sandra A. Rotman Chair in Neuropsychiatry and Head of the Division of Geriatric Psychiatry at the University of Toronto. Pollock is also one of three committee members with extensive financial ties to antidepressant manufacturers. Pollock will not be allowed to vote, but his expertise was deemed so important by the FDA that his conflicts of interests were waived so that he could be included on the committee.
Pollock’s name may be familiar to scandal watchers. Two years ago, Congress was holding hearings on the question of whether GlaxoSmithKline had suppressed studies unfavorable to Paxil, and the New York attorney general had charged GlaxoSmithKline with consumer fraud. (GlaxoSmithKline settled the lawsuit without admitting wrongdoing, but paid a $2.5 million fine.) In December 2004, ABC News aired an investigative report on GlaxoSmithKline titled “Drug Maker Withheld Paxil Study Data: ABC News Uncovers Documents Unknown to Regulators and Many Study Doctors.” One of those documents concerned Pollock’s work for GlaxoSmithKline.
In the late 1990s, worries had emerged that patients might become dependent on the SSRIs. To combat the perception that people who stopped using Paxil might experience withdrawal symptoms – or “discontinuation” symptoms, as they were often called – GlaxoSmithKline (then still known as SmithKline Beecham) hired a public relations agency called Ruder Finn. Ruder Finn drafted letters that they planned to submit to scientific journals and that downplayed the idea that Paxil was associated with discontinuation symptoms. According to internal memos, Pollock was one of four psychiatrists whom they planned to invite to “author” the letters.
A letter from Pollock eventually appeared in the Journal of Clinical Psychiatry. Although the wording of Pollock’s letter was somewhat different from the draft written by Ruder Finn, it made all the same points. It even made them in the same order. But there was no disclosure, no mention of industry funding, no mention of “editorial assistance,” and no mention of Ruder Finn. Pollock concluded his letter by saying, “Rather than directing our efforts towards the relatively infrequent, minor and transient discontinuation symptoms associated with SSRI therapy, clinicians may be well advised to focus their energies on the greater issues of efficacy, safety, and patient outcome.” The bottom line: concerns about discontinuation symptoms were overblown
Pollock was on the GlaxoSmithKline advisory board at the time, but he told ABC News that he had written the letter to the Journal of Clinical Psychiatry himself and had no knowledge of the draft letter prepared by the PR firm with his name on it. He did admit, however, that "could imagine a scenario where a representative from the makers of Paxil said, 'Could you make this point?'" According to ABC News, Pollock’s letter later appeared in an internal business plan guide prepared for GlaxoSmithKline sales reps. It cited Pollock's letter as "an effective tool for addressing discontinuation."
Writing about the Paxil fraud case last year in the Hastings Center Report, Leemon McHenry described today’s pharmaceutical company marketing strategy as “defending the molecule.” Rather than drawing conclusions from the evidence, wrote McHenry, the strategy is to select the data that promote the drugs, ignore the unfavorable data, pay a prominent academic to sign onto ghostwritten articles about the positive data, and publish the ghostwritten article in the best journals. Then you complete the circle by citing the ghostwritten articles in your marketing literature.
Actually, McHenry left out one crucial part of the circle. If you are the person who signs the ghosted article, you just may get a seat on an FDA advisory committee and a named chair at the University of Toronto.
Copies of Ruder Finn's letters can be found here:
PDF RUDER FINN (right click and save as)
PDF DR POLLOCK'S WAIVER BY THE FDA (right click and save as)
PDF DR POLLOCK'S CONFLICT OF INTERESTS (right click and save as)
Serotonin cannot be measured... says Dr
Dear Robert,
Your question about the proper chemical balance of Serotonin in the brain is difficult to answer. Serotonin levels, like the levels of other neurotransmitters in the brain, are in a constant state of change, depending upon our thoughts, feelings, and actions. Serotonin is released when needed (if available) and reabsorbed when not actively needed. Serotonin is released and absorbed in the brain on a minute-to-minute basis. It's similar to trying to estimate the "normal" level of muscle tension when muscle tension is a factor of what we are doing at the time such as relaxing, lifting weights, etc
The biggest problem in measuring brain Serotonin is the nature of the brain. It's a closed system and highly resistive to invasive procedures. Any attempt to sample brain fluid or tissue not only creates a high risk of infection but possible brain injury as well. While we can draw blood, spinal fluid, urine, etc for chemical analysis - we can't draw substances from inside the brain tissue. The closest we can come is a Positron-Emission Tomography (PET Scan - non-invasive) which can color-code and display levels of glucose metabolism and other chemicals in the brain. That fluid snapshot is still of the levels at the time - depending on the activity, feeling, and thoughts of the individual.
Over the years, attempts have been made to estimate Serotonin levels based on the byproducts of Serotonin as evidenced in blood or urine. Several "natural" or herbal labs on the internet have reported they can measure Serotonin levels, suggesting brain Serotonin. This is a false claim and they draw samples from urine and the gastrointestinal tract. Serotonin is located in the brain and gastrointestinal tract (that's why antidepressants give you an upset stomach). Levels of Serotonin in the GI tract are unrelated to levels in the brain.
In clinical practice, we must estimate the "level" of Serotonin in the brain by it's impact and influence on recognized and connected systems. Like muscle tension - the ability to use our muscles within a certain range of relaxation and lifting suggests normal levels. The inability to pick up a small object would suggest low muscle tension while spasms of the muscles would suggest abnormally high muscle tension. Changes in sleep, appetite, energy level, body temperature, etc. are recognized to reflect low levels of brain Serotonin - something confirmed by PET scans. Flu-like symptoms and dehydration are associated with too much brain Serotonin. During clinical examinations, we ask about physical and emotional symptoms related to neurotransmitter levels in the brain. Patient responses then dictate what medications might be appropriate to stabilize those levels.
In short, we can't accurately measure something we can't easily access, especially when the levels change on a minute to minute basis. All treatments associated with brain neurotransmitters are based on well-recognized clinical symptoms directly associated with specific neurotransmitters and supported by PET scan research. On-going research is focusing on better ways to estimate brain neurotransmitter levels but obviously, any accurate measure that can be used by a clinician in the community is still probably decades away.
While this response may not provide a number, percentage, or other accurate "normal" level for Serotonin, it may shed some light on the difficult task of working with neurotransmitters without using an invasive procedure.
Dr. Carver
Joseph M Carver, Ph.D.
www.drjoecarver.com
jmcarver@roadrunner.com
Your question about the proper chemical balance of Serotonin in the brain is difficult to answer. Serotonin levels, like the levels of other neurotransmitters in the brain, are in a constant state of change, depending upon our thoughts, feelings, and actions. Serotonin is released when needed (if available) and reabsorbed when not actively needed. Serotonin is released and absorbed in the brain on a minute-to-minute basis. It's similar to trying to estimate the "normal" level of muscle tension when muscle tension is a factor of what we are doing at the time such as relaxing, lifting weights, etc
The biggest problem in measuring brain Serotonin is the nature of the brain. It's a closed system and highly resistive to invasive procedures. Any attempt to sample brain fluid or tissue not only creates a high risk of infection but possible brain injury as well. While we can draw blood, spinal fluid, urine, etc for chemical analysis - we can't draw substances from inside the brain tissue. The closest we can come is a Positron-Emission Tomography (PET Scan - non-invasive) which can color-code and display levels of glucose metabolism and other chemicals in the brain. That fluid snapshot is still of the levels at the time - depending on the activity, feeling, and thoughts of the individual.
Over the years, attempts have been made to estimate Serotonin levels based on the byproducts of Serotonin as evidenced in blood or urine. Several "natural" or herbal labs on the internet have reported they can measure Serotonin levels, suggesting brain Serotonin. This is a false claim and they draw samples from urine and the gastrointestinal tract. Serotonin is located in the brain and gastrointestinal tract (that's why antidepressants give you an upset stomach). Levels of Serotonin in the GI tract are unrelated to levels in the brain.
In clinical practice, we must estimate the "level" of Serotonin in the brain by it's impact and influence on recognized and connected systems. Like muscle tension - the ability to use our muscles within a certain range of relaxation and lifting suggests normal levels. The inability to pick up a small object would suggest low muscle tension while spasms of the muscles would suggest abnormally high muscle tension. Changes in sleep, appetite, energy level, body temperature, etc. are recognized to reflect low levels of brain Serotonin - something confirmed by PET scans. Flu-like symptoms and dehydration are associated with too much brain Serotonin. During clinical examinations, we ask about physical and emotional symptoms related to neurotransmitter levels in the brain. Patient responses then dictate what medications might be appropriate to stabilize those levels.
In short, we can't accurately measure something we can't easily access, especially when the levels change on a minute to minute basis. All treatments associated with brain neurotransmitters are based on well-recognized clinical symptoms directly associated with specific neurotransmitters and supported by PET scan research. On-going research is focusing on better ways to estimate brain neurotransmitter levels but obviously, any accurate measure that can be used by a clinician in the community is still probably decades away.
While this response may not provide a number, percentage, or other accurate "normal" level for Serotonin, it may shed some light on the difficult task of working with neurotransmitters without using an invasive procedure.
Dr. Carver
Joseph M Carver, Ph.D.
www.drjoecarver.com
jmcarver@roadrunner.com
Wednesday, January 03, 2007
Serotonin - GSK & The MHRA
Here is my latest FOI request to the MHRA:
Tuesday 2nd Jan 2007
FOI Request
Dear Sir/Madam,
Could you please provide me with answers to the following:
On the Seroxat Patient Information Leaflet (PIL) it states;
'Seroxat is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain'
I would like to bring to your attention the statement in blue, 'People who are depressed or anxious have lower levels of serotonin than others.'
In a recent communication with your MHRA Vigilance and Risk Management of Medicines (VRMM) Division, I was told,
"...we are not aware of an internationally agreed "proper chemical balance of serotonin in the brain"
Therefore, this begs the question how Glaxo SmithKline can issue such a statement on their PIL for Seroxat?
1. Did GSK provide the MHRA background documents giving details about the imbalance of serotonin in the brain?
Please answer Yes or No
2. Did GSK provide the MHRA documents with figures for the effect the drug had in changing the imbalanced state?
Please answer Yes or No
3. Please forward me documents that GSK supplied the MHRA during the application procedure for Seroxat that relate to the 'correcting effect' regarding people with lower levels of serotonin.
Meantime, I look forward to your reply.
Mr Robert Fiddaman
------
I will, of course, upload answers from the MHRA to this blog when I recieve them
Bob
Tuesday 2nd Jan 2007
FOI Request
Dear Sir/Madam,
Could you please provide me with answers to the following:
On the Seroxat Patient Information Leaflet (PIL) it states;
'Seroxat is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain'
I would like to bring to your attention the statement in blue, 'People who are depressed or anxious have lower levels of serotonin than others.'
In a recent communication with your MHRA Vigilance and Risk Management of Medicines (VRMM) Division, I was told,
"...we are not aware of an internationally agreed "proper chemical balance of serotonin in the brain"
Therefore, this begs the question how Glaxo SmithKline can issue such a statement on their PIL for Seroxat?
1. Did GSK provide the MHRA background documents giving details about the imbalance of serotonin in the brain?
Please answer Yes or No
2. Did GSK provide the MHRA documents with figures for the effect the drug had in changing the imbalanced state?
Please answer Yes or No
3. Please forward me documents that GSK supplied the MHRA during the application procedure for Seroxat that relate to the 'correcting effect' regarding people with lower levels of serotonin.
Meantime, I look forward to your reply.
Mr Robert Fiddaman
------
I will, of course, upload answers from the MHRA to this blog when I recieve them
Bob
Tuesday, January 02, 2007
Do the MHRA know 'What constitutes a proper chemical balance of serotonin in the brain?
...It seems not
----- Original Message -----
From: MHRA Information Centre
To: fiddaman64@blueyonder.co.uk
Sent: Tuesday, January 02, 2007 1:58 PM
Subject: FW: Serotonin
Dear Mr Fiddaman
In reply to your question of 4th December, please see the response below from our Vigilance and Risk Management of Medicines (VRMM) Division:
A variety of factors can contribute to an individual's predisposition to depression. Although it is believed that depression may be caused by a biochemical imbalance and it is recognised that serotonin plays a role in the development of depression it is considered that there is more than one final common pathway in the aetiology of depression, and we are not aware of an internationally agreed "proper chemical balance of serotonin in the brain" that would prevent or reduce the likelihood of experiencing depression.
As you are aware the role of the MHRA is to license medicinal products and ensure that medicines and medical devices on the UK market work, and are acceptably safe. As the precise role that serotonin plays in depression is still subject to ongoing research we really are not best placed to provide you with a response on this particular issue. You may wish to contact professional organisations such as the Royal College of Psychiatrists to seek their view on this matter.
I hope this is helpful to you.
Ben
Central Enquiry Point Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000
----- Original Message -----
From: MHRA Information Centre
To: fiddaman64@blueyonder.co.uk
Sent: Tuesday, January 02, 2007 1:58 PM
Subject: FW: Serotonin
Dear Mr Fiddaman
In reply to your question of 4th December, please see the response below from our Vigilance and Risk Management of Medicines (VRMM) Division:
A variety of factors can contribute to an individual's predisposition to depression. Although it is believed that depression may be caused by a biochemical imbalance and it is recognised that serotonin plays a role in the development of depression it is considered that there is more than one final common pathway in the aetiology of depression, and we are not aware of an internationally agreed "proper chemical balance of serotonin in the brain" that would prevent or reduce the likelihood of experiencing depression.
As you are aware the role of the MHRA is to license medicinal products and ensure that medicines and medical devices on the UK market work, and are acceptably safe. As the precise role that serotonin plays in depression is still subject to ongoing research we really are not best placed to provide you with a response on this particular issue. You may wish to contact professional organisations such as the Royal College of Psychiatrists to seek their view on this matter.
I hope this is helpful to you.
Ben
Central Enquiry Point Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000
MHRA DEFINITIONS
It seems that the MHRA are using their own definitions of the English language in their communications. One instance is their definition of the term 'Young Adult'.
Let's examine the following MHRA statement shall we?
"Young adults (18-29 years of age) are at a higher
background risk of suicidal behaviour than older adults and
therefore should be monitored particularly closely."
Firstly, a seach on Wikipedia for the term 'Young Adult' provides us with the following:
From Wikipedia, the free encyclopedia
Young adult refers to:
a person in the early years of adulthood
an adolescent
in human development, the stage between adolescence and adulthood, roughly ages 16 to 30.
Young adult (psychology), persons aged 20 to 40
in the Catholic Church, persons aged 18 to 34
in Unitarian Universalist circles, persons aged 18 to 35
Young adult literature, works targeted to ages 12 to 18.
in the computer game The Sims 2, "young adult" is the life stage associated with The Sims 2: University.
Basically, the MHRA are saying that the risk of suicidal behaviour is higher in 'young' adults up to the age of 29. In effect they think that if you are over the age of 29 then you DO NOT fall into the background risk of suicidal behaviour.
Now I find this quite absurd as each human being... or 'Young Adult' are made up of individual components. It seems the MHRA only think people between the ages of 18-29 should be monitored 'particularly closely' Bad news if you are 30+ then eh?
The MHRA need to change the wording from 'Young Adult' to 'Adult', there should be no age restrictions. Quite why they use this terminology is baffling - particularly as many of the adverse withdrawal reactions reported to them regarding Seroxat come from people over the age of 29.
Try this link on Wikipedia for the word 'Transparency'
http://en.wikipedia.org/wiki/Transparency_%28linguistic%29
Bob
Let's examine the following MHRA statement shall we?
"Young adults (18-29 years of age) are at a higher
background risk of suicidal behaviour than older adults and
therefore should be monitored particularly closely."
Firstly, a seach on Wikipedia for the term 'Young Adult' provides us with the following:
From Wikipedia, the free encyclopedia
Young adult refers to:
a person in the early years of adulthood
an adolescent
in human development, the stage between adolescence and adulthood, roughly ages 16 to 30.
Young adult (psychology), persons aged 20 to 40
in the Catholic Church, persons aged 18 to 34
in Unitarian Universalist circles, persons aged 18 to 35
Young adult literature, works targeted to ages 12 to 18.
in the computer game The Sims 2, "young adult" is the life stage associated with The Sims 2: University.
Basically, the MHRA are saying that the risk of suicidal behaviour is higher in 'young' adults up to the age of 29. In effect they think that if you are over the age of 29 then you DO NOT fall into the background risk of suicidal behaviour.
Now I find this quite absurd as each human being... or 'Young Adult' are made up of individual components. It seems the MHRA only think people between the ages of 18-29 should be monitored 'particularly closely' Bad news if you are 30+ then eh?
The MHRA need to change the wording from 'Young Adult' to 'Adult', there should be no age restrictions. Quite why they use this terminology is baffling - particularly as many of the adverse withdrawal reactions reported to them regarding Seroxat come from people over the age of 29.
Try this link on Wikipedia for the word 'Transparency'
http://en.wikipedia.org/wiki/Transparency_%28linguistic%29
Bob
Monday, December 25, 2006
GlaxoSmithKline staff told not to publicise ineffectiveness of its drug
ANGRY YET?
Maybe these two will fuel that anger?
Email to Prof Kent Woods CEO of the MHRA
Dear Mr Woods,
As you are probably aware a recent previously sealed court document was opened in the United States which is damning for Glaxo SmithKline.
It clearly shows that they witheld vital information during the clinical trials for Seroxat.With the evidence attached to this email I would like to know if you still stand by your original letter to me.
Mr R. Fiddaman Dip.Couns MOC & MSFTR
Group Moderator of the Online Seroxat Support Group
Dear Mr Fiddaman
I have already given you a full account of the Agency's position in this matter and there is nothing to add to it.
Prof. Kent Woods Chief Executive MHRA
Sunday, December 24, 2006
SOMEONE GET ME A LANGUAGE LINGUIST!
A recent FOI request to the MHRA was finally 'answered' by Andrew French, Group Manager, Licensing Division of the MHRA. I would be grateful if anyone out there could determine the definition of the cleverly constructed language he uses?
Mr Robert Fiddaman
Quinton
Birmingham
19th December 2006
Dear Mr Fiddaman
REF: FOI 06/384
Thank you for your letter dated 21st November 2006 regarding a request under the Freedom of Information Act (FOIA), and which has been passed to me for reply. You raised several questions which I have reproduced below and which I will address in turn.
I also note from Sir Alasdair’s reply which you quote, that UK Public Assessment Reports (UKPARs) are mentioned. I should point out that UKPARs only came into being for medicinal products authorised in the UK on or after the 30th October 2005, and as such there was no UKPAR for Paroxetine / Seroxat. However,
Returning to your questions;
1) Please explain what is meant by "data". Does it mean
a) the mere existence of trials
b) company interpretation of data
c) the part of the company interpretation of data actually passed to the MHRA
d) the actual raw and complete data.
"Data" generally means the complete data package generated in support of the application submitted to the competent authority. This includes all data seen as both favourable and unfavourable to the support of the licence application as is required by the current European legislation. This data is normally provided in summary format and does not comprise the "raw data", although the regulatory authority can demand this if it is thought necessary. In the UKPAR, "data" are usually summarised rather than reported in full.
2) Will such "data" also include a listing of the data known to exist, but which the MHRA did not use to make its decision. (please answer only yes or no)
As stated above, all data, favourable and unfavourable, must be submitted.
3) Have the MHRA placed such "data" relating to Paroxetine/Seroxat on the MHRA website (answer yes or no). If yes, please refer me to such data
The report of the Committee on Safety of Medicines Expert Working Group on SSRIs was published on the website. This provided summaries of all the data, including clinical trial data, which underpinned the decisions of the group. In the case of paroxetine, clinical trial study reports were examined by the Agency in parallel with MAH analyses of their clinical trials. Link to data below. http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=242
4) The word "transparency" was used. Please supply a definition of this word as used in MHRA communications
The release of a national public assessment report for a medicinal product has two aims (i) to give transparency to the regulatory process, and (ii) to provide information on the product and the data supporting its authorisation or refusal. Transparency, as used, means providing all of the data on which the licensing decision was reached, together with the reasons for the opinion of the licensing authority, after deletion of any information of a commercially confidential nature.
I hope this information satisfies your queries
Yours Sincerely
Andrew French
Group Manager, Licensing Division
....and they call themselves transparent!
Bob
Mr Robert Fiddaman
Quinton
Birmingham
19th December 2006
Dear Mr Fiddaman
REF: FOI 06/384
Thank you for your letter dated 21st November 2006 regarding a request under the Freedom of Information Act (FOIA), and which has been passed to me for reply. You raised several questions which I have reproduced below and which I will address in turn.
I also note from Sir Alasdair’s reply which you quote, that UK Public Assessment Reports (UKPARs) are mentioned. I should point out that UKPARs only came into being for medicinal products authorised in the UK on or after the 30th October 2005, and as such there was no UKPAR for Paroxetine / Seroxat. However,
Returning to your questions;
1) Please explain what is meant by "data". Does it mean
a) the mere existence of trials
b) company interpretation of data
c) the part of the company interpretation of data actually passed to the MHRA
d) the actual raw and complete data.
"Data" generally means the complete data package generated in support of the application submitted to the competent authority. This includes all data seen as both favourable and unfavourable to the support of the licence application as is required by the current European legislation. This data is normally provided in summary format and does not comprise the "raw data", although the regulatory authority can demand this if it is thought necessary. In the UKPAR, "data" are usually summarised rather than reported in full.
2) Will such "data" also include a listing of the data known to exist, but which the MHRA did not use to make its decision. (please answer only yes or no)
As stated above, all data, favourable and unfavourable, must be submitted.
3) Have the MHRA placed such "data" relating to Paroxetine/Seroxat on the MHRA website (answer yes or no). If yes, please refer me to such data
The report of the Committee on Safety of Medicines Expert Working Group on SSRIs was published on the website. This provided summaries of all the data, including clinical trial data, which underpinned the decisions of the group. In the case of paroxetine, clinical trial study reports were examined by the Agency in parallel with MAH analyses of their clinical trials. Link to data below. http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=242
4) The word "transparency" was used. Please supply a definition of this word as used in MHRA communications
The release of a national public assessment report for a medicinal product has two aims (i) to give transparency to the regulatory process, and (ii) to provide information on the product and the data supporting its authorisation or refusal. Transparency, as used, means providing all of the data on which the licensing decision was reached, together with the reasons for the opinion of the licensing authority, after deletion of any information of a commercially confidential nature.
I hope this information satisfies your queries
Yours Sincerely
Andrew French
Group Manager, Licensing Division
....and they call themselves transparent!
Bob
Friday, December 22, 2006
Health Select Commitee wash their hands of Seroxat!
I recieved a letter from my MP, Gisela Stuart who wrote to The Health Select Commitee on my behalf. As you can see they have now totally washed their hands of Seroxat, this, despite overwhelming evidence that the drug is unsafe.
The strange thing is that on the day the House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing.
MPs had expected to be able to question Ian Hudson as well… unfortunately Dr Hudson could not attend as he had a prior engagement.
Dr Ian Hudson is the MHRA’s Director of Licensing - but the job he had before he joined the agency was at GlaxoSmithKline - he was their Worldwide Director of Safety, and we know that one of the drugs he had “significant involvement with” was, in fact, Seroxat. (Also, the Chairman of the MHRA, Professor Alasdair Breckenridge, sat on Glaxo’s scientific advisory committee for many years.)
GlaxoSmithKline Secrets & Lies Part 2
Stuart Dollow, medical director of GlaxoSmithKline UK, "We published the results of all its studies on all drugs "whether negative or positive".
Stuart Dollow, medical director of GlaxoSmithKline UK
Product liability cases against drug companies like GlaxoSmithKline are often settled with an agreement that the potentially incriminating data found in the drug company files will be sealed or kept secret. In the case of Lacuzong v. GlaxoSmithKline, my report disclosed extensive manipulation of data concerning Paxil's adverse effects, including rates of suicidality, psychomotor agitation (akathisia), and over-stimulation. In a subsequent lawsuit against the company, my report was unsealed and is now available to the public. I placed the entire report on my website and published three scientific articles based on it.
Peter R. Breggin, MD
----------------------------------------------------------------
Panorama: Did GlaxoSmithKline act promptly in getting this information to you?
Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Health and products Regulatory Agency
This is a matter which we are investigating at the present time. There is an investigation going on, being conducted by the.. one of this.. the inspection and enforcement sector of the agency and with lawyers to decide whether or not they did.
I enquired about this to the MHRA under the Freedom of Information Act. It has been over two years since this initial statement from Prof Sir Alasdair Breckenridge.
Here is the reply I recieved:
Thank you for your enquiry of 4th December 2006. I am writing to let you know that we are unable to supply the information you have requested. Under the Freedom of Information Act (FOIA) certain exemptions apply to the information we can make available. The information you have requested concerns a criminal investigation and is subject to the exemption contained in the FOIA, namely exemption 30. We have concluded that disclosing this information would not be appropriate because it would prejudice an ongoing criminal investigation. I am satisfied that both categories in exemption 30 are applicable;
a) where information has at any time been held for the purpose of specified criminal and other investigations or proceedings; and
b) where information relates to the obtaining of information from confidential sources and was obtained or recorded for a number of specified investigations or proceedings
Therefore it would not be in the public interest to disclose the outcome of the criminal investigation in advance of any potential court proceedings
---------------------------------------------------------------
...if you imagine a school of more than a thousand children all of whom are deeply troubled by depression, less than a small class size would have these suicidal thoughts or attempts, so it's a small but important signal…
Dr ALASTAIR BENBOW Head of European Psychiatry, GlaxoSmithKline
Thanks for that scenario Dr Benbow. You clearly show that you are a man full of compassion
---------------------------------------------------------------
There is very good clinical trial evidence that these drugs do not cause suicide, they do not cause suicidal thoughts in adults. There is a very large database.
Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare and products Regulatory Agency
What Prof Sir ALASDAIR BRECKENRIDGE fails to tell you is the MHRA have NOT examined the raw data, basically they examine the data that GSK give them, in other words they examine the positive data and NOT the negative data
----------------------------------------------------------
More Coming Soon
Fiddy
Stuart Dollow, medical director of GlaxoSmithKline UK
Product liability cases against drug companies like GlaxoSmithKline are often settled with an agreement that the potentially incriminating data found in the drug company files will be sealed or kept secret. In the case of Lacuzong v. GlaxoSmithKline, my report disclosed extensive manipulation of data concerning Paxil's adverse effects, including rates of suicidality, psychomotor agitation (akathisia), and over-stimulation. In a subsequent lawsuit against the company, my report was unsealed and is now available to the public. I placed the entire report on my website and published three scientific articles based on it.
Peter R. Breggin, MD
----------------------------------------------------------------
Panorama: Did GlaxoSmithKline act promptly in getting this information to you?
Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Health and products Regulatory Agency
This is a matter which we are investigating at the present time. There is an investigation going on, being conducted by the.. one of this.. the inspection and enforcement sector of the agency and with lawyers to decide whether or not they did.
I enquired about this to the MHRA under the Freedom of Information Act. It has been over two years since this initial statement from Prof Sir Alasdair Breckenridge.
Here is the reply I recieved:
Thank you for your enquiry of 4th December 2006. I am writing to let you know that we are unable to supply the information you have requested. Under the Freedom of Information Act (FOIA) certain exemptions apply to the information we can make available. The information you have requested concerns a criminal investigation and is subject to the exemption contained in the FOIA, namely exemption 30. We have concluded that disclosing this information would not be appropriate because it would prejudice an ongoing criminal investigation. I am satisfied that both categories in exemption 30 are applicable;
a) where information has at any time been held for the purpose of specified criminal and other investigations or proceedings; and
b) where information relates to the obtaining of information from confidential sources and was obtained or recorded for a number of specified investigations or proceedings
Therefore it would not be in the public interest to disclose the outcome of the criminal investigation in advance of any potential court proceedings
---------------------------------------------------------------
...if you imagine a school of more than a thousand children all of whom are deeply troubled by depression, less than a small class size would have these suicidal thoughts or attempts, so it's a small but important signal…
Dr ALASTAIR BENBOW Head of European Psychiatry, GlaxoSmithKline
Thanks for that scenario Dr Benbow. You clearly show that you are a man full of compassion
---------------------------------------------------------------
There is very good clinical trial evidence that these drugs do not cause suicide, they do not cause suicidal thoughts in adults. There is a very large database.
Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare and products Regulatory Agency
What Prof Sir ALASDAIR BRECKENRIDGE fails to tell you is the MHRA have NOT examined the raw data, basically they examine the data that GSK give them, in other words they examine the positive data and NOT the negative data
----------------------------------------------------------
More Coming Soon
Fiddy
Thursday, December 21, 2006
GlaxoSmithKline - Truth & Lies
Truth & Lies
"There is no reliable evidence that Seroxat can cause addiction"
Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline
Despite thousands of yellow card reports, emails, letters and phone calls to both GlaxoSmithKline and the MHRA from patients suffering with addiction to Seroxat, does Dr ALASTAIR BENBOW still stand by this comment?
------------------------------------------------------------------------------------
"Addiction is characterised by a number of different criteria which includes craving, which includes increasing the dose of drug to get the same effect and a number of other features, and these are not exhibited by Seroxat."
Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline
addiction - Dictionary.com
well-defined physiological symptoms upon withdrawal; broadly : persistent compulsive use of a substance known by the user to be harmful.
the state of being enslaved to a habit or practice or to something that is psychologically or physically habit-forming, as narcotics, to such an extent that its cessation causes severe trauma.
----
addictive - Cambridge International Dictionary of English
An addictive drug is one which you cannot stop taking once you have started
----
dependence - The Wordsmyth English Dictionary
that which is relied upon
-------------------------------------------------------------------------------------
A spokesperson for GlaxoSmithKline commented: “Depression affects a huge number of people here in the UK - one in seven of the population at any one time.“It is a potentially deadly condition and Seroxat is an effective treatment that since launch, has helped tens of millions of patients worldwide lead fuller and more productive lives."
An all too familiar response that really diverts from the facts.
What happened in the UK when cattle were infected?
What happend when traces of salmonela were found in eggs in the UK?
Seems to be one rule for the farmers and one for the pharma's!
---------------------------------------------------------------------------------------
MORE COMING SOON
Fiddy
"There is no reliable evidence that Seroxat can cause addiction"
Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline
Despite thousands of yellow card reports, emails, letters and phone calls to both GlaxoSmithKline and the MHRA from patients suffering with addiction to Seroxat, does Dr ALASTAIR BENBOW still stand by this comment?
------------------------------------------------------------------------------------
"Addiction is characterised by a number of different criteria which includes craving, which includes increasing the dose of drug to get the same effect and a number of other features, and these are not exhibited by Seroxat."
Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline
addiction - Dictionary.com
well-defined physiological symptoms upon withdrawal; broadly : persistent compulsive use of a substance known by the user to be harmful.
the state of being enslaved to a habit or practice or to something that is psychologically or physically habit-forming, as narcotics, to such an extent that its cessation causes severe trauma.
----
addictive - Cambridge International Dictionary of English
An addictive drug is one which you cannot stop taking once you have started
----
dependence - The Wordsmyth English Dictionary
that which is relied upon
-------------------------------------------------------------------------------------
A spokesperson for GlaxoSmithKline commented: “Depression affects a huge number of people here in the UK - one in seven of the population at any one time.“It is a potentially deadly condition and Seroxat is an effective treatment that since launch, has helped tens of millions of patients worldwide lead fuller and more productive lives."
An all too familiar response that really diverts from the facts.
What happened in the UK when cattle were infected?
What happend when traces of salmonela were found in eggs in the UK?
Seems to be one rule for the farmers and one for the pharma's!
---------------------------------------------------------------------------------------
MORE COMING SOON
Fiddy
GSK's dirty tricks in competing class actions
Wednesday, December 20, 2006
By Steve Gonzalez - Edwardsville Bureau
It was a busy day for lawyers in the Paxil litigation in Madison County on Tuesday as a routine hearing to enforce an injunction branched into three separate, contentious hearings with two judges.
GlaxoSmithKline (GSK) filed a motion asking Madison County Associate Circuit Judge Ralph Mendelsohn to enforce an injunction which would prohibit plaintiffs in a similar St. Clair County Paxil class action suit from holding a certification hearing on Dec. 28.
But before Mendelsohn would issue a ruling he referred the case to Circuit Judge Barbara Crowder to hear a motion that sought to have him removed for cause.
In October the pharmaceutical agreed to allocate $63,833,148 and any obligations it may otherwise have to settle a class action case brought by attorney Stephen Tillery.
Tillery stands to reel in a whopping $16.8 million award in attorneys' fees.
The plaintiffs, Teri Hoormann, Mary Kopsie, and Bonita and Mark Helfer, alleged they suffered actual economic damages because GlaxoSmithKline promoted Paxil and Paxil CR for prescription to patients under the age of 18, while concealing negative information.
The preliminary settlement was approved Oct. 6 by Mendelsohn, the first day he was assigned to the case. The order was originally filed under seal, but was unsealed Oct. 27.
When issuing his order, Mendelsohn concluded that competing class actions would jeopardize his ability to rule on the settlement and would substantially increase the cost of litigation.
He further concluded competing class actions would also create risk of conflicting results, would waste court resources, and could prevent plaintiffs and the class members from benefiting from any negotiated settlement.
After Mendelsohn issued his preliminary settlement order, GSK entered motions to stay four other class actions pending throughout the country, including the St. Clair County case.
That's when the problems started.
Attorneys Chris Cueto of Belleville and John Driscoll of St. Louis, who represent Donita Baldwin -- a plaintiff in St. Clair County -- sent out a notice on Nov. 28 that they intended to hold the class certification hearing before St. Clair County Circuit Judge Michael O'Malley on Dec. 28.
According to GSK that violated Mendelsohn's injunction.
Cueto and Driscoll opposed GSK's motion and called Mendelsohn's injunction 'grandiose and absurd."
They argued to O'Malley that GSK's attempt to stay is among its latest attempt to further a course of action to deceive O'Malley, the public, and the putative class members so GSK can "enshroud their secret maneuverings and collusion with select claimants."
Cueto also argued that GSK failed to inform O'Malley that former Madison County Circuit Judge Phillip Kardis, who originally heard the case, placed it under seal on May 26, 2005, and removed it from the public view.
"In fact, beyond GSK there are only three people in the world that would have been granted access to the contents of the case file," Cueto argued.
"Yes, believe it or not, GSK had every single page of every single court filing in Madison County sealed and removed from the public," Cueto wrote.
Cueto said if O'Malley stayed the case, he would be complicit in secret maneuvering that GSK and Tillery are crafting.
He also said that Mendelsohn's claim in the preliminary settlement that he has "exclusive jurisdiction" is absurd.
"That is a powerful Circuit Court," Cueto wrote.
Cueto said there is no instance in which an Illinois Circuit Court ever had exclusive jurisdiction over anything.
Cueto also argued that GSK entered orders on two occasions that continued class cetification hearings.
He said that while it was by the agreement of both parties, it was only achieved due to GSK's deception.
"In discussing their desire to continue, GSK represented that they needed more time to conduct discovery on class issues," Cueto wrote. "It is now apparent that GSK was simply stalling my client and delaying this court while crafting a secret deal in Madison County."
O'Malley denied GSK's motion to stay on Nov. 20, but acknowledged that the plaintiffs and their counsel are subject to Mendelsohn's injunction and need to go to Madison County to take care of it before he can proceed.
Cueto and Driscoll then filed a motion to intervene, and followed that with a motion to remove Mendelsohn for cause and a motion to remove Mendelsohn as a matter of right.
They wanted to intervene claiming:
The settlement amount was inadequate;
There was apparent existence of a reverse action conducted by Tillery and counsel for GSK;
There was an attempt by the attorneys for the parties to enjoin and parallel proceeding while simultaneously representing the Hoormann case as an "opt-out" class action;
There is strong evidence of collusion by the parties to the detriment of the class;
The nature of the fees sought by Tillery should be questioned;
There is an insufficient and inadequate notice plan as mentioned in the preliminary order approving the settlement; and
There was inappropriate wholesale sealing of the Hoorman case from public view.
Mendelsohn would not hear any arguments on any motion until the substitution for cause was resolved.
Crowder held an emergency hearing and after hearing arguments ruled that Cueto and Driscoll did not meet the requirements to have Mendelsohn removed for cause.
Cueto argued Mendelsohn's injunction order was ex-parte and therefore was already biased against his client since he already ruled against her.
Crowder disagreed and said that an attorney cannot seek to remove a judge for cause just because he disagrees with the judge's ruling.
She then referred the case back to Mendelsohn for the hearing on motion to enforce the injunction and the motion for a substitution as a matter of right.
Mendelsohn ruled that he has already made a major ruling in the case and quickly denied the motion for substitution.
Dwight Davis of Georgia, who represents GSK, told Mendelsohn that he cannot allow Cueto and Driscoll to simply ignore his valid injunction.
"Rather than comply with this court's injunction, the plaintiffs are blatantly flouting it," Davis said.
Davis said Cueto's clients are members of the Hoormann settlement class, as are the absent class members they purport to represent. He said they cannot be prejudiced by the injunction since they can gain relief from the Hoormann class and pointed out the attempt to move forward in the St. Clair County case presents the very difficulties Mendelsohn intended to prevent.
"They are trying to undermine the settlement judge," Davis said. "I ask that everyday they continue to do so they be assessed a fine of $10,000 per day that would go to members of the class."
Mendelsohn ruled that Cueto did in fact violate the injunction but would not issue any fines. He indicated he would revisit any violations of the injunction should it be necessary.
By Steve Gonzalez - Edwardsville Bureau
It was a busy day for lawyers in the Paxil litigation in Madison County on Tuesday as a routine hearing to enforce an injunction branched into three separate, contentious hearings with two judges.
GlaxoSmithKline (GSK) filed a motion asking Madison County Associate Circuit Judge Ralph Mendelsohn to enforce an injunction which would prohibit plaintiffs in a similar St. Clair County Paxil class action suit from holding a certification hearing on Dec. 28.
But before Mendelsohn would issue a ruling he referred the case to Circuit Judge Barbara Crowder to hear a motion that sought to have him removed for cause.
In October the pharmaceutical agreed to allocate $63,833,148 and any obligations it may otherwise have to settle a class action case brought by attorney Stephen Tillery.
Tillery stands to reel in a whopping $16.8 million award in attorneys' fees.
The plaintiffs, Teri Hoormann, Mary Kopsie, and Bonita and Mark Helfer, alleged they suffered actual economic damages because GlaxoSmithKline promoted Paxil and Paxil CR for prescription to patients under the age of 18, while concealing negative information.
The preliminary settlement was approved Oct. 6 by Mendelsohn, the first day he was assigned to the case. The order was originally filed under seal, but was unsealed Oct. 27.
When issuing his order, Mendelsohn concluded that competing class actions would jeopardize his ability to rule on the settlement and would substantially increase the cost of litigation.
He further concluded competing class actions would also create risk of conflicting results, would waste court resources, and could prevent plaintiffs and the class members from benefiting from any negotiated settlement.
After Mendelsohn issued his preliminary settlement order, GSK entered motions to stay four other class actions pending throughout the country, including the St. Clair County case.
That's when the problems started.
Attorneys Chris Cueto of Belleville and John Driscoll of St. Louis, who represent Donita Baldwin -- a plaintiff in St. Clair County -- sent out a notice on Nov. 28 that they intended to hold the class certification hearing before St. Clair County Circuit Judge Michael O'Malley on Dec. 28.
According to GSK that violated Mendelsohn's injunction.
Cueto and Driscoll opposed GSK's motion and called Mendelsohn's injunction 'grandiose and absurd."
They argued to O'Malley that GSK's attempt to stay is among its latest attempt to further a course of action to deceive O'Malley, the public, and the putative class members so GSK can "enshroud their secret maneuverings and collusion with select claimants."
Cueto also argued that GSK failed to inform O'Malley that former Madison County Circuit Judge Phillip Kardis, who originally heard the case, placed it under seal on May 26, 2005, and removed it from the public view.
"In fact, beyond GSK there are only three people in the world that would have been granted access to the contents of the case file," Cueto argued.
"Yes, believe it or not, GSK had every single page of every single court filing in Madison County sealed and removed from the public," Cueto wrote.
Cueto said if O'Malley stayed the case, he would be complicit in secret maneuvering that GSK and Tillery are crafting.
He also said that Mendelsohn's claim in the preliminary settlement that he has "exclusive jurisdiction" is absurd.
"That is a powerful Circuit Court," Cueto wrote.
Cueto said there is no instance in which an Illinois Circuit Court ever had exclusive jurisdiction over anything.
Cueto also argued that GSK entered orders on two occasions that continued class cetification hearings.
He said that while it was by the agreement of both parties, it was only achieved due to GSK's deception.
"In discussing their desire to continue, GSK represented that they needed more time to conduct discovery on class issues," Cueto wrote. "It is now apparent that GSK was simply stalling my client and delaying this court while crafting a secret deal in Madison County."
O'Malley denied GSK's motion to stay on Nov. 20, but acknowledged that the plaintiffs and their counsel are subject to Mendelsohn's injunction and need to go to Madison County to take care of it before he can proceed.
Cueto and Driscoll then filed a motion to intervene, and followed that with a motion to remove Mendelsohn for cause and a motion to remove Mendelsohn as a matter of right.
They wanted to intervene claiming:
The settlement amount was inadequate;
There was apparent existence of a reverse action conducted by Tillery and counsel for GSK;
There was an attempt by the attorneys for the parties to enjoin and parallel proceeding while simultaneously representing the Hoormann case as an "opt-out" class action;
There is strong evidence of collusion by the parties to the detriment of the class;
The nature of the fees sought by Tillery should be questioned;
There is an insufficient and inadequate notice plan as mentioned in the preliminary order approving the settlement; and
There was inappropriate wholesale sealing of the Hoorman case from public view.
Mendelsohn would not hear any arguments on any motion until the substitution for cause was resolved.
Crowder held an emergency hearing and after hearing arguments ruled that Cueto and Driscoll did not meet the requirements to have Mendelsohn removed for cause.
Cueto argued Mendelsohn's injunction order was ex-parte and therefore was already biased against his client since he already ruled against her.
Crowder disagreed and said that an attorney cannot seek to remove a judge for cause just because he disagrees with the judge's ruling.
She then referred the case back to Mendelsohn for the hearing on motion to enforce the injunction and the motion for a substitution as a matter of right.
Mendelsohn ruled that he has already made a major ruling in the case and quickly denied the motion for substitution.
Dwight Davis of Georgia, who represents GSK, told Mendelsohn that he cannot allow Cueto and Driscoll to simply ignore his valid injunction.
"Rather than comply with this court's injunction, the plaintiffs are blatantly flouting it," Davis said.
Davis said Cueto's clients are members of the Hoormann settlement class, as are the absent class members they purport to represent. He said they cannot be prejudiced by the injunction since they can gain relief from the Hoormann class and pointed out the attempt to move forward in the St. Clair County case presents the very difficulties Mendelsohn intended to prevent.
"They are trying to undermine the settlement judge," Davis said. "I ask that everyday they continue to do so they be assessed a fine of $10,000 per day that would go to members of the class."
Mendelsohn ruled that Cueto did in fact violate the injunction but would not issue any fines. He indicated he would revisit any violations of the injunction should it be necessary.
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