So did the MHRA
But now...
The proof is out.
This graph taken from the recently released court documents
The left hand column shows the ages of patients taking the drug during the trial (over 15 years ago)
What more evidence is needed?
Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Sunday, February 10, 2008
GSK Have 9 'Lives'... or pages they are STILL witholding
So the recently opened court documents that were previously sealed are not all what they seem to be?
Apparently there are nine (count them) pages missing. A clerical error? Lost in transit? Or merely GlaxoSmithKline keeping hold of the damning evidence that showed an 8-fold increase in suicide amongst patients taking Seroxat during the clinical trials?
When one reads through the papers it becomes clear that this is NOT just about people under the age of 25 - Do these missing 9 pages throw more light on the suicidal reactions in adults?
Why are they being held back? More importantly, How can they be held back?
Well, a Senator in the United States (one with balls) is asking questions about the missing 9 pages and the recently opened documents. Unlike our Ministers of Parliament here in the UK, we have here a man with compassion, one who actually cares about life.
Senator Grassley has wrote to Mr. Christopher Viehbacher, President of GlaxoSmithKline (United States) asking for the missing nine pages.
February 6, 2008
Mr. Christopher Viehbacher President
U.S. Pharmaceuticals
GlaxoSmithKline
5 Moore Drive
P.O. Box 13398
Research Triangle Park,
NC 27709
Dear Mr. Viehbacher:
As the Ranking Member of the United States Senate Committee on Finance (Committee), I have an obligation to the more than 80 million Americans who receive health care coverage under Medicare and Medicaid to ensure that taxpayer and beneficiary dollars are appropriately spent on safe and effective drugs and devices. This includes the responsibility to conduct oversight of the medical and pharmaceutical industries that provide products and services to Medicare and Medicaid beneficiaries.
As reported today in New Scientist, several documents were unsealed on January 18, 2008, in the case of O'Neal v. SmithKline Beecham d/b/a GlaxoSmithKline. Several of these documents and transcripts suggest that GSK knew as far back as 1989 that Paxil is associated with an increased risk of suicide. However, the American public was never adequately informed of this risk until May 2006 in a "Dear Healthcare Professional" letter that reported a "higher frequency of suicidal behavior" associated with Paxil as compared to placebo.
Specifically, Dr. Joseph Glenmullen, a Clinical Instructor in Psychiatry at Harvard Medical School, prepared an expert report based on a review of internal GSK documents. Dr. Glenmullen's report suggests that GSK ensured that suicides and suicidal attempts were systematically included in the placebo arm of GSK's study, which had the effect of making it more difficult to detect suicide risks associated with Paxil. This information was then submitted to the FDA.
Dr. Glenmullen concluded in his report: Analyses of GlaxoSmithKline's data demonstrate a causal link between the antidepressant and suicidal behavior. This has been true since 1989 although the "bad" Paxil numbers obscured the risk for a decade-and-a-half.
It is my understanding that 9 pages of Dr. Glenmullen's report are not available publicly. Accordingly, please respond to the following questions and request for information. Please repeat each enumerated question and follow it with your response.
1. When did GSK first learn that Paxil was associated with an increased suicide risk?
2. When did GSK first report to FDA that Paxil was associated with an increased suicide risk?
3. When did GSK first notify patients and doctors that Paxil was associated with an increased suicide risk? Please provide all pertinent documents and communications.
4. Please provide the Committee with the complete, unredacted version of Dr. Glenmullen's report. Along with that report, please provide the appendix and all documents that are referred to in the report, in the order that they are referenced.
5. Please provide the Committee with the accompanying children and adolescents report.
Along with this report, please provide the appendix and all documents that are noted in the report, in the order that they are referenced.
Thank you again for your continued assistance in this matter. Because I understand that these documents are already available in electronic format, I would appreciate receiving the documents and information requested by no later than February 14, 2008.
Sincerely,
Charles E. Grassley Ranking Member Committee on Finance
Apparently there are nine (count them) pages missing. A clerical error? Lost in transit? Or merely GlaxoSmithKline keeping hold of the damning evidence that showed an 8-fold increase in suicide amongst patients taking Seroxat during the clinical trials?
When one reads through the papers it becomes clear that this is NOT just about people under the age of 25 - Do these missing 9 pages throw more light on the suicidal reactions in adults?
Why are they being held back? More importantly, How can they be held back?
Well, a Senator in the United States (one with balls) is asking questions about the missing 9 pages and the recently opened documents. Unlike our Ministers of Parliament here in the UK, we have here a man with compassion, one who actually cares about life.
Senator Grassley has wrote to Mr. Christopher Viehbacher, President of GlaxoSmithKline (United States) asking for the missing nine pages.
February 6, 2008
Mr. Christopher Viehbacher President
U.S. Pharmaceuticals
GlaxoSmithKline
5 Moore Drive
P.O. Box 13398
Research Triangle Park,
NC 27709
Dear Mr. Viehbacher:
As the Ranking Member of the United States Senate Committee on Finance (Committee), I have an obligation to the more than 80 million Americans who receive health care coverage under Medicare and Medicaid to ensure that taxpayer and beneficiary dollars are appropriately spent on safe and effective drugs and devices. This includes the responsibility to conduct oversight of the medical and pharmaceutical industries that provide products and services to Medicare and Medicaid beneficiaries.
As reported today in New Scientist, several documents were unsealed on January 18, 2008, in the case of O'Neal v. SmithKline Beecham d/b/a GlaxoSmithKline. Several of these documents and transcripts suggest that GSK knew as far back as 1989 that Paxil is associated with an increased risk of suicide. However, the American public was never adequately informed of this risk until May 2006 in a "Dear Healthcare Professional" letter that reported a "higher frequency of suicidal behavior" associated with Paxil as compared to placebo.
Specifically, Dr. Joseph Glenmullen, a Clinical Instructor in Psychiatry at Harvard Medical School, prepared an expert report based on a review of internal GSK documents. Dr. Glenmullen's report suggests that GSK ensured that suicides and suicidal attempts were systematically included in the placebo arm of GSK's study, which had the effect of making it more difficult to detect suicide risks associated with Paxil. This information was then submitted to the FDA.
Dr. Glenmullen concluded in his report: Analyses of GlaxoSmithKline's data demonstrate a causal link between the antidepressant and suicidal behavior. This has been true since 1989 although the "bad" Paxil numbers obscured the risk for a decade-and-a-half.
It is my understanding that 9 pages of Dr. Glenmullen's report are not available publicly. Accordingly, please respond to the following questions and request for information. Please repeat each enumerated question and follow it with your response.
1. When did GSK first learn that Paxil was associated with an increased suicide risk?
2. When did GSK first report to FDA that Paxil was associated with an increased suicide risk?
3. When did GSK first notify patients and doctors that Paxil was associated with an increased suicide risk? Please provide all pertinent documents and communications.
4. Please provide the Committee with the complete, unredacted version of Dr. Glenmullen's report. Along with that report, please provide the appendix and all documents that are referred to in the report, in the order that they are referenced.
5. Please provide the Committee with the accompanying children and adolescents report.
Along with this report, please provide the appendix and all documents that are noted in the report, in the order that they are referenced.
Thank you again for your continued assistance in this matter. Because I understand that these documents are already available in electronic format, I would appreciate receiving the documents and information requested by no later than February 14, 2008.
Sincerely,
Charles E. Grassley Ranking Member Committee on Finance
Friday, February 08, 2008
It just gets worse for GSK - GlaxoSmithKline still can’t get its tax right!
Source: Tax Research UK
GlaxoSmithKline can’t get its tax right, and is Sir Christopher Hogg covering for them?
By Richard Murphy
GlaxoSmithKline still can’t get its tax right. The IRS is now challenging it concerning the period from 2001 to 2003. The dispute is over inter-company financing arrangements. Call that transfer pricing by any other name.
GSK, of course disputes the claim. But let’s recall, this is the company that has already settled $3.4 billion over transfer pricing issues with the IRS in 2006 (the biggest tax settlement ever), and remains in conflict with HM Revenue & Customs on the same issue for all periods since 1994.
Now I could look on this with just technical interest but for one thing. Sir Christopher Hogg, chair of the Financial Reporting Council, was at GSK and predecessor companies throughout these periods of dispute. He has been engaged in discussion and correspondence with me concerning country-by-country reporting since December 2007, for which he can see no justification.
Are you sure you’re not just covering your own backside Sir Christopher? Country-by-country reporting would, of course, highlight potential transfer pricing abuses. Now you wouldn’t want that, would you Sir Christopher? That would never do, would it?
GlaxoSmithKline can’t get its tax right, and is Sir Christopher Hogg covering for them?
By Richard Murphy
GlaxoSmithKline still can’t get its tax right. The IRS is now challenging it concerning the period from 2001 to 2003. The dispute is over inter-company financing arrangements. Call that transfer pricing by any other name.
GSK, of course disputes the claim. But let’s recall, this is the company that has already settled $3.4 billion over transfer pricing issues with the IRS in 2006 (the biggest tax settlement ever), and remains in conflict with HM Revenue & Customs on the same issue for all periods since 1994.
Now I could look on this with just technical interest but for one thing. Sir Christopher Hogg, chair of the Financial Reporting Council, was at GSK and predecessor companies throughout these periods of dispute. He has been engaged in discussion and correspondence with me concerning country-by-country reporting since December 2007, for which he can see no justification.
Are you sure you’re not just covering your own backside Sir Christopher? Country-by-country reporting would, of course, highlight potential transfer pricing abuses. Now you wouldn’t want that, would you Sir Christopher? That would never do, would it?
Grassley Requests GSK Documents
Source: Furious Seasons
Sen. Chuck Grassley (R-Iowa) yesterday sent a letter to GSK asking for copies of documents recently unsealed in a court in California that point to the company knowing of elevated suicide risks around its anti-depressant Paxil as far back as 1989. In particular, the senator wants nine pages of documents that were left out of the public release.
Download the letter and read his questions/requests to GlaxoSmithKline.
Maybe these are questions the MHRA should be asking?
Fid
Sen. Chuck Grassley (R-Iowa) yesterday sent a letter to GSK asking for copies of documents recently unsealed in a court in California that point to the company knowing of elevated suicide risks around its anti-depressant Paxil as far back as 1989. In particular, the senator wants nine pages of documents that were left out of the public release.
Download the letter and read his questions/requests to GlaxoSmithKline.
Maybe these are questions the MHRA should be asking?
Fid
Thursday, February 07, 2008
GSK Seroxat trial data - The outcome?
I think we can all now accept that GlaxoSmithKline DID hold back negative results for 15 years regarding Seroxat safety in children. One only has to read the recently released court documents to see that GSK are guilty as sin.
As promised, I sent the documents to the MHRA in the hope of speeding up their sham of an investigation into GlaxoSmithKline. The MHRA replied to me with:
----- Original Message -----
From: MHRA Information Centre
To: fiddaman64
Sent: Thursday, February 07, 2008 3:04 PM
Subject: RE: GSK Investigation
Dear Bob Fiddaman,
Thank you for your recent enquiry to the MHRA. Thank you for sending us these documents, which we have passed on to those who are dealing with these matters
Please contact us again if you need further assistance with this, or any other queries.
Kind Regards,
Central Enquiry Point Information Centre Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000
Personally I am in no doubt that GlaxoSmithKline and the MHRA are intertwined - one only has to look at my post from 10.33am today to see that staff at GSK looked in at my blog then a minute later staff from the MHRA looked in. Coincidence? I think not.
So what of the outcome?
It would be highly unlikely that the MHRA find GSK not guilty, particularly faced with the new evidence they have, though then again I have very little faith in the medicines regulator so it wouldn't surprise me if they actually did find GSK not guilty.
Let's say that they do find GSK guilty - what then?
Criminal proceeedings? Well if MHRA Chairman Alisdair Breckenridge is to be beleived then yes that is a possibilty, at least that is what he said when interviewed by Shelley Jofre on BBC TV's Panorama (See video 2.42) Breckenridge also said in the same Panorama programme:
"Remember Seroxat has never been licensed in children, it has never been licensed in children at all... but nevertheless practitioners have, on their own behest, have used it extensively. Our best evidence is that some 7,000 children a year were ... or children and adolescents were recieving Seroxat"(See video 1.00)
7,000 children a year? It just rolled off the tongue - meant nothing to Breckenridge. If the MHRA had done their job properly that 7,000 figure could have turned into a zero. But no, the MHRA stubbornly refused to accept that they had been duped by GlaxoSmithKline. Why would GSK dupe them?, they do after all have two ex-employees sitting on the board at the MHRA, of which Breckenridge is one, the other being Ian Hudson.
The MHRA have to ask themselves why 7,000 children a year were recieving Seroxat, they must hold up their hands and take some of the blame. If they decide to push for criminal proceedings against GlaxoSmithKline then they themselves must be impartially investigated and have criminal proceedings issued against them. They have failed to protect the very essence of life - Our children.
And what of GlaxoSmithKline mouthpiece Alistair Benbow?
When asked in 2003 if he thought the drug (Seroxat) could be still safe for children - he replied:
"Absolutely, it could be, we haven't got a license in children yet" (See video 0.24)
This suggests to me that GlaxoSmithKline were pushing for a license - I mean why say '...we haven't got a licence in children yet'?
So even as late as 2003 GlaxoSmithKline were still denying there was a problem with Seroxat in children. Yet in 1989 the company had trial data demonstrating an eightfold increase in suicide risk. Can Benbow say that he didn't know? Who hid this evidence from him? Or was Benbow lying on national television?
So what will become of Alistair Benbow? Will he be criminally prosecuted? Will his defence be 'I never knew'?
You have to admit that this is the kind of stuff that makes Hollywood blockbusters.
With so many people knowing a drug can cause suicide in children why were so many kept in the dark?
There are many questions that need answering, many paths that need 'impartial' investigation. Heads should roll for this huge corporate cover-up - not only at GlaxoSmithKline but at the MHRA too.
As promised, I sent the documents to the MHRA in the hope of speeding up their sham of an investigation into GlaxoSmithKline. The MHRA replied to me with:
----- Original Message -----
From: MHRA Information Centre
To: fiddaman64
Sent: Thursday, February 07, 2008 3:04 PM
Subject: RE: GSK Investigation
Dear Bob Fiddaman,
Thank you for your recent enquiry to the MHRA. Thank you for sending us these documents, which we have passed on to those who are dealing with these matters
Please contact us again if you need further assistance with this, or any other queries.
Kind Regards,
Central Enquiry Point Information Centre Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000
Personally I am in no doubt that GlaxoSmithKline and the MHRA are intertwined - one only has to look at my post from 10.33am today to see that staff at GSK looked in at my blog then a minute later staff from the MHRA looked in. Coincidence? I think not.
So what of the outcome?
It would be highly unlikely that the MHRA find GSK not guilty, particularly faced with the new evidence they have, though then again I have very little faith in the medicines regulator so it wouldn't surprise me if they actually did find GSK not guilty.
Let's say that they do find GSK guilty - what then?
Criminal proceeedings? Well if MHRA Chairman Alisdair Breckenridge is to be beleived then yes that is a possibilty, at least that is what he said when interviewed by Shelley Jofre on BBC TV's Panorama (See video 2.42) Breckenridge also said in the same Panorama programme:
"Remember Seroxat has never been licensed in children, it has never been licensed in children at all... but nevertheless practitioners have, on their own behest, have used it extensively. Our best evidence is that some 7,000 children a year were ... or children and adolescents were recieving Seroxat"(See video 1.00)
7,000 children a year? It just rolled off the tongue - meant nothing to Breckenridge. If the MHRA had done their job properly that 7,000 figure could have turned into a zero. But no, the MHRA stubbornly refused to accept that they had been duped by GlaxoSmithKline. Why would GSK dupe them?, they do after all have two ex-employees sitting on the board at the MHRA, of which Breckenridge is one, the other being Ian Hudson.
The MHRA have to ask themselves why 7,000 children a year were recieving Seroxat, they must hold up their hands and take some of the blame. If they decide to push for criminal proceedings against GlaxoSmithKline then they themselves must be impartially investigated and have criminal proceedings issued against them. They have failed to protect the very essence of life - Our children.
And what of GlaxoSmithKline mouthpiece Alistair Benbow?
When asked in 2003 if he thought the drug (Seroxat) could be still safe for children - he replied:
"Absolutely, it could be, we haven't got a license in children yet" (See video 0.24)
This suggests to me that GlaxoSmithKline were pushing for a license - I mean why say '...we haven't got a licence in children yet'?
So even as late as 2003 GlaxoSmithKline were still denying there was a problem with Seroxat in children. Yet in 1989 the company had trial data demonstrating an eightfold increase in suicide risk. Can Benbow say that he didn't know? Who hid this evidence from him? Or was Benbow lying on national television?
So what will become of Alistair Benbow? Will he be criminally prosecuted? Will his defence be 'I never knew'?
You have to admit that this is the kind of stuff that makes Hollywood blockbusters.
With so many people knowing a drug can cause suicide in children why were so many kept in the dark?
There are many questions that need answering, many paths that need 'impartial' investigation. Heads should roll for this huge corporate cover-up - not only at GlaxoSmithKline but at the MHRA too.
Glaxo’s Garnier: ‘There Are More Unknowns’
Source: Pharmalot
Hat Tip - The Truthman
The drugmaker is having a rough time. The earnings report released today shows a steeper decline in fourth-quarter profit than analysts estimated and, to top it off, Glaxo ceo JP Garnier says earnings will drop this year, mostly due to docs abandoning the Avandia diabetes pill over safety concerns.
In response, Glaxo shares plunged as much as 9.5 percent earlier, the most in almost nine years, Bloomberg News points out. Net income fell 10 percent to $2.1 billion, missing analyst estimates. Revenue was little changed, with drug sales dropping 2 percent. Avandia sales, in particular, fell 55 percent, continuing a slide after a study last May linked the pill to an increased risk of heart attacks and strokes. Several other best-sellers, such as Coreg for high blood pressure and antidepressant Wellbutrin, faced greater competition from generic drugs. (Here is the Glaxo report).
FULL ACCOUNT OVER AT PHARMALOT
Hat Tip - The Truthman
The drugmaker is having a rough time. The earnings report released today shows a steeper decline in fourth-quarter profit than analysts estimated and, to top it off, Glaxo ceo JP Garnier says earnings will drop this year, mostly due to docs abandoning the Avandia diabetes pill over safety concerns.
In response, Glaxo shares plunged as much as 9.5 percent earlier, the most in almost nine years, Bloomberg News points out. Net income fell 10 percent to $2.1 billion, missing analyst estimates. Revenue was little changed, with drug sales dropping 2 percent. Avandia sales, in particular, fell 55 percent, continuing a slide after a study last May linked the pill to an increased risk of heart attacks and strokes. Several other best-sellers, such as Coreg for high blood pressure and antidepressant Wellbutrin, faced greater competition from generic drugs. (Here is the Glaxo report).
FULL ACCOUNT OVER AT PHARMALOT
Look Kent - That Fiddaman bloke is on to us.
Amazing isn't it?
I post a link to recently opened court documents - an hour or so later GSK pay this blog a visit... a minute after they visit, the MHRA also make an appearence. And there is no conflict of interest at the MHRA huh?
So who is emailing who.
One can only imagine.
Kent,
That bastard Fiddaman has just posted a link to a court document that shows we hid information. You do realise that you will have to hurry up the investigation into us now don't you Kent? Try and drag it out a little longer Kent, we can ride this storm together. The dust will settle and they will forget about it.
Yours JP
4. 7 February 09:25 GlaxoSmithKline, London, London, City of, United Kingdom
5. 7 February 09:25 GlaxoSmithKline, London, London, City of, United Kingdom
6. 7 February 09:26 Exponential-e Customer Allocation, London, London, City of, United Kingdom
7. 7 February 09:27 GlaxoSmithKline, London, London, City of, United Kingdom
Exponential-e Customer Allocation is the server used by the MHRA
I post a link to recently opened court documents - an hour or so later GSK pay this blog a visit... a minute after they visit, the MHRA also make an appearence. And there is no conflict of interest at the MHRA huh?
So who is emailing who.
One can only imagine.
Kent,
That bastard Fiddaman has just posted a link to a court document that shows we hid information. You do realise that you will have to hurry up the investigation into us now don't you Kent? Try and drag it out a little longer Kent, we can ride this storm together. The dust will settle and they will forget about it.
Yours JP
4. 7 February 09:25 GlaxoSmithKline, London, London, City of, United Kingdom
5. 7 February 09:25 GlaxoSmithKline, London, London, City of, United Kingdom
6. 7 February 09:26 Exponential-e Customer Allocation, London, London, City of, United Kingdom
7. 7 February 09:27 GlaxoSmithKline, London, London, City of, United Kingdom
Exponential-e Customer Allocation is the server used by the MHRA
Did GSK trial data mask Seroxat suicide risk?
There are some court documents to download in this story. I have sent them to the MHRA - It should speed up their current investigation into GlaxoSmithKline.
Source: New Scientist
Jim Giles
AN INAPPROPRIATE analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years, suggest court documents (897kb, requires Acrobat Reader) released last month. Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.
An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it's "virtually impossible" that GSK simply misunderstood the data - a claim the company describes as "absolutely false".
Glenmullen's report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public.
The analysis focuses on the "washout" phase preceding a trial, when subjects stop taking most or all medications to avoid confusion with results from the trial itself. Because the washout occurs before patients randomly receive either the drug or the placebo control, adverse events during this time can't be attributable to the trial and so are seldom if ever included in final results.
However, GSK researchers submitting data on Paxil to the US Food and Drug Administration in the late 1980s and early 1990s included suicides and suicide attempts from the washout period in the results for the placebo arms of trials, but not from the Paxil arms. Glenmullen alleges that these extra "placebo" suicides negated suicides attributed to Paxil in the trials, making the drug appear safer than it really was. He says that if the washout results had been excluded, the data would have showed that Paxil increased eightfold the risk of suicidal behaviour in adults.
GSK spokeswoman Mary Anne Rhyne says inclusion of the washout data "was intended to present the full picture of events that occurred in all phases of the clinical trials - starting from the time patients were enrolled, before they were randomised". She says that even without the washout data, Paxil still came out as safe as the placebo in this trial. She accused Glenmullen of incorrectly analysing the data to reach the opposite conclusion, but didn't respond to a request for numerical proof that Glenmullen's verdict was wrong.
Glenmullen suggests that the FDA would have acted differently had the use of the washout data been made more explicit. Rhyne says that material still under seal shows the FDA to be fully aware of how the washout data was being used. But Glenmullen quotes Martin Brecher, the FDA official who reviewed Paxil's safety, as agreeing during a pre-trial hearing that the use of the washout data was "scientifically illegitimate".
Independent researchers say it was wrong to use washout data as GSK did. "I can't imagine circumstances in which it would be appropriate," says Bruce Psaty of the University of Washington in Seattle.
Weblinks
GSK's 2006 letter to doctors
http://www.fda.gov/MedWatch/SAFETY/2006/paroxetineDHCPMay06.pdf
FDA page on Paxil
http://www.fda.gov/Cder/drug/infopage/paroxetine/default.htm
Source: New Scientist
Jim Giles
AN INAPPROPRIATE analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years, suggest court documents (897kb, requires Acrobat Reader) released last month. Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.
An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it's "virtually impossible" that GSK simply misunderstood the data - a claim the company describes as "absolutely false".
Glenmullen's report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public.
The analysis focuses on the "washout" phase preceding a trial, when subjects stop taking most or all medications to avoid confusion with results from the trial itself. Because the washout occurs before patients randomly receive either the drug or the placebo control, adverse events during this time can't be attributable to the trial and so are seldom if ever included in final results.
However, GSK researchers submitting data on Paxil to the US Food and Drug Administration in the late 1980s and early 1990s included suicides and suicide attempts from the washout period in the results for the placebo arms of trials, but not from the Paxil arms. Glenmullen alleges that these extra "placebo" suicides negated suicides attributed to Paxil in the trials, making the drug appear safer than it really was. He says that if the washout results had been excluded, the data would have showed that Paxil increased eightfold the risk of suicidal behaviour in adults.
GSK spokeswoman Mary Anne Rhyne says inclusion of the washout data "was intended to present the full picture of events that occurred in all phases of the clinical trials - starting from the time patients were enrolled, before they were randomised". She says that even without the washout data, Paxil still came out as safe as the placebo in this trial. She accused Glenmullen of incorrectly analysing the data to reach the opposite conclusion, but didn't respond to a request for numerical proof that Glenmullen's verdict was wrong.
Glenmullen suggests that the FDA would have acted differently had the use of the washout data been made more explicit. Rhyne says that material still under seal shows the FDA to be fully aware of how the washout data was being used. But Glenmullen quotes Martin Brecher, the FDA official who reviewed Paxil's safety, as agreeing during a pre-trial hearing that the use of the washout data was "scientifically illegitimate".
Independent researchers say it was wrong to use washout data as GSK did. "I can't imagine circumstances in which it would be appropriate," says Bruce Psaty of the University of Washington in Seattle.
Weblinks
GSK's 2006 letter to doctors
http://www.fda.gov/MedWatch/SAFETY/2006/paroxetineDHCPMay06.pdf
FDA page on Paxil
http://www.fda.gov/Cder/drug/infopage/paroxetine/default.htm
Wednesday, February 06, 2008
MHRA - Merely fanning the coals
There are drinking laws in the UK whereby a person under the age of 18 cannot buy alcohol. I think we can take it as a given that alcohol is a drug and that no matter your age it has the same desired effect on a person who is under 18 to one who is over 18. Admittedly, one can be expected to consume much more according to their age... but the end result is the same isn't it?
So why are people 25 or under the only ones at risk to suicidal behaviour/thoughts when taking antidepressants?
To make a statement like this the MHRA surely must have read through the raw data, if they haven't then why make such a statement?
You have to sit back and take stock of the new wording on patient information leaflets for ALL antidepressants here in the UK. It smacks of a huge corporate cover-up and is a slap in the face to anyone over the age of 25 who has ever felt suicidal or had suicidal thoughts whilst on prescribed antidepressants... but more importantly it is basically telling new patients over the age of 25 that they will not have suicidal thoughts when taking these drugs - and that people is scandalous.
Let me take alcohol as an example. It has side effects in people PERIOD!
Any mind altering drug (of which Seroxat clearly is) has side effects - whether you be 6 or 76 it works in the same way.
The MHRA are merely fanning the coals and are leaving the door open for pharmaceutical companies to make yet more money by promoting these drugs to psychiatrists and family practitioners.
Dr Smith will be reading through his 'Dear Doctor' letter this morning and think to himself... Hey, it's perfectly safe to prescribe Seroxat to Jack Jones because he is 27. The MHRA say he won't have suicidal thoughts because of the drug - if he does then it will be purely down to the depression he is suffering from.
Yeh right.
When will the MHRA learn that the yellow card system (they set up) is real people reporting side effects. They only have to take a trip over to the Paxil Progress forum to see countless stories of folk having such a torrid time on this drug - the majority of which are well over the age of 25.
And then there is the question of withdrawal - why has this not been addressed?
Seroxat in particular should come with a warning regarding the withdrawal - something along the lines of:
It may take you some considerable time to withdraw from Seroxat. We highly suggest you taper using the Seroxat liquid. This may take from 6 months to 3 years... or even longer.
The MHRA have failed yet again to protect the public. Take it from me - Seroxat can cause people over the age of 25 to have suicidal/homicidal thoughts, to suggest otherwise is patronising.
Fid
So why are people 25 or under the only ones at risk to suicidal behaviour/thoughts when taking antidepressants?
To make a statement like this the MHRA surely must have read through the raw data, if they haven't then why make such a statement?
You have to sit back and take stock of the new wording on patient information leaflets for ALL antidepressants here in the UK. It smacks of a huge corporate cover-up and is a slap in the face to anyone over the age of 25 who has ever felt suicidal or had suicidal thoughts whilst on prescribed antidepressants... but more importantly it is basically telling new patients over the age of 25 that they will not have suicidal thoughts when taking these drugs - and that people is scandalous.
Let me take alcohol as an example. It has side effects in people PERIOD!
Any mind altering drug (of which Seroxat clearly is) has side effects - whether you be 6 or 76 it works in the same way.
The MHRA are merely fanning the coals and are leaving the door open for pharmaceutical companies to make yet more money by promoting these drugs to psychiatrists and family practitioners.
Dr Smith will be reading through his 'Dear Doctor' letter this morning and think to himself... Hey, it's perfectly safe to prescribe Seroxat to Jack Jones because he is 27. The MHRA say he won't have suicidal thoughts because of the drug - if he does then it will be purely down to the depression he is suffering from.
Yeh right.
When will the MHRA learn that the yellow card system (they set up) is real people reporting side effects. They only have to take a trip over to the Paxil Progress forum to see countless stories of folk having such a torrid time on this drug - the majority of which are well over the age of 25.
And then there is the question of withdrawal - why has this not been addressed?
Seroxat in particular should come with a warning regarding the withdrawal - something along the lines of:
It may take you some considerable time to withdraw from Seroxat. We highly suggest you taper using the Seroxat liquid. This may take from 6 months to 3 years... or even longer.
The MHRA have failed yet again to protect the public. Take it from me - Seroxat can cause people over the age of 25 to have suicidal/homicidal thoughts, to suggest otherwise is patronising.
Fid
Tuesday, February 05, 2008
Implementation of warnings on suicidal thoughts and behaviour with antidepressants by MHRA
...but this does not apply to anyone over the age of 25
The MHRA has notified companies that hold authorisations for antidepressant products that they will shortly be receiving letters requesting Type II variations to update the warnings on suicidal thoughts and behaviour in line with European agreements. The Pharmacovigilance Working Party (PhVWP) had considered the results of a meta-analysis of adult clinical trial data for SSRIs and other antidepressants recently completed by the FDA. It agreed that the ‘EU core SPC for SSRIs and related substances’ of October 2005 should be modified with regard to suicidality and should now be extended to cover all antidepressants. In particular, the wording should be updated with respect to the increased risk to young adults and the need for close monitoring of patients, and it will be applicable to all antidepressants, not only SSRIs. The timetable for implementation has also been agreed at European level to ensure that healthcare professionals, patients and their carers receive this important safety information as soon as possible.
Wording on ALL antidepressants PDF
So if you take antidepressants and are over the age of 25 the MHRA think you are not at risk!
I wonder if this release has anything to do with the current MHRA investigation into GlaxoSmithKline regarding them witholding clinical trial data?
More than likely will be their statement if they find GSK guilty.
I can just hear the MHRA now
'We have agreed to change the wording on the patient information leaflets on ALL antidepressants'
This is JUST NOT GOOD ENOUGH!
Forgive me if I don't break open the Champagne. A step in the right direction it is but there is much more work to be done - this is merely papering over the cracks and is over one year behind what the FDA already did in America regarding black box warnings.
Don't take the plaudits too serious yet Mr Woods - there are still many of us over the age of 25 who disagree with this pathetic 'age ruling'
The MHRA has notified companies that hold authorisations for antidepressant products that they will shortly be receiving letters requesting Type II variations to update the warnings on suicidal thoughts and behaviour in line with European agreements. The Pharmacovigilance Working Party (PhVWP) had considered the results of a meta-analysis of adult clinical trial data for SSRIs and other antidepressants recently completed by the FDA. It agreed that the ‘EU core SPC for SSRIs and related substances’ of October 2005 should be modified with regard to suicidality and should now be extended to cover all antidepressants. In particular, the wording should be updated with respect to the increased risk to young adults and the need for close monitoring of patients, and it will be applicable to all antidepressants, not only SSRIs. The timetable for implementation has also been agreed at European level to ensure that healthcare professionals, patients and their carers receive this important safety information as soon as possible.
Wording on ALL antidepressants PDF
So if you take antidepressants and are over the age of 25 the MHRA think you are not at risk!
I wonder if this release has anything to do with the current MHRA investigation into GlaxoSmithKline regarding them witholding clinical trial data?
More than likely will be their statement if they find GSK guilty.
I can just hear the MHRA now
'We have agreed to change the wording on the patient information leaflets on ALL antidepressants'
This is JUST NOT GOOD ENOUGH!
Forgive me if I don't break open the Champagne. A step in the right direction it is but there is much more work to be done - this is merely papering over the cracks and is over one year behind what the FDA already did in America regarding black box warnings.
Don't take the plaudits too serious yet Mr Woods - there are still many of us over the age of 25 who disagree with this pathetic 'age ruling'
MHRA - Good Clinical Practice duped by GSK?
MHRA - Good Clinical Practice (GCP) Inspectorate is part of the Inspections & Standards Division of the MHRA. It assesses the compliance of organisations conducting clinical trials using investigational medicinal products with UK and EU legislation.
...or so it says
Why then did it fail regarding the Paxil 329 study?
Here is the EU Directive definition of 'Good Clinical practice' taken from the MHRA website
“Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.”
Hmmm - really?
And what would those 'requirements' be then?
Next paragraph on the MHRA webpage tells us.
Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate.
It seems the MHRA's 'Good Clinical Practice' has been duped by GlaxoSmithKline... or maybe just 'overlooked'?
Surely they have provisions that such an event couldn't happen?
Enter the MHRA Good Clinical Practice Inspectorate:
What is the MHRA GCP Inspectorate?
In the UK, the GCP inspectorate is responsible for inspecting clinical trials for compliance with Good Clinical Practice.
The GCP inspectorate consists of a team of GCP inspectors. By conducting inspections at the sites of organisations conducting or involved in clinical trials, the GCP Inspectors assess compliance with the requirements of legislation and guidelines relating to conduct of clinical trials involving investigational medicinal product. Each Inspector has a statutory duty to assess compliance with medicines legislation and holds a warrant accordingly.
I'll ask again... What about Paxil Study 329?
For further inforomation ask the MHRA*
*Be prepared - a thesaurus is always a good tool when reading responses from the MHRA - Be warned though because the meaning of a word in your thesaurus may differ from the one the MHRA uses. The word 'Transparent' for example.
Read more about Paxil Study 329 HERE
Watch a two and a half minute video about Paxil Study 329 HERE
Alternatively you could always read the MHRA's take on Good Clinical Practice HERE and if you have questions to ask them then please do not hesitate to contact them
here -> info@mhra.gsi.gov.uk
For more recent failings by the MHRA and their 'Good Clinical Practice' read about the TGN1412 drug trials HERE
Also click on the following links:
"Six seriously ill in London hospital as drug trial goes wrong." Breaitbart.com. March 15, 2006
TeGenero AG. Press Releases. March 15, 2006
"They say he needs a miracle." BBC News. March 15, 2006
"London Drug Trial Victims May Be Ill for Life, Lawyers Say." Bloomberg.com. April 21, 2006.
"Drug trial victim may lose fingers and toes." Reuters. April 18, 2006.
...or so it says
Why then did it fail regarding the Paxil 329 study?
Here is the EU Directive definition of 'Good Clinical practice' taken from the MHRA website
“Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.”
Hmmm - really?
And what would those 'requirements' be then?
Next paragraph on the MHRA webpage tells us.
Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate.
It seems the MHRA's 'Good Clinical Practice' has been duped by GlaxoSmithKline... or maybe just 'overlooked'?
Surely they have provisions that such an event couldn't happen?
Enter the MHRA Good Clinical Practice Inspectorate:
What is the MHRA GCP Inspectorate?
In the UK, the GCP inspectorate is responsible for inspecting clinical trials for compliance with Good Clinical Practice.
The GCP inspectorate consists of a team of GCP inspectors. By conducting inspections at the sites of organisations conducting or involved in clinical trials, the GCP Inspectors assess compliance with the requirements of legislation and guidelines relating to conduct of clinical trials involving investigational medicinal product. Each Inspector has a statutory duty to assess compliance with medicines legislation and holds a warrant accordingly.
I'll ask again... What about Paxil Study 329?
For further inforomation ask the MHRA*
*Be prepared - a thesaurus is always a good tool when reading responses from the MHRA - Be warned though because the meaning of a word in your thesaurus may differ from the one the MHRA uses. The word 'Transparent' for example.
Read more about Paxil Study 329 HERE
Watch a two and a half minute video about Paxil Study 329 HERE
Alternatively you could always read the MHRA's take on Good Clinical Practice HERE and if you have questions to ask them then please do not hesitate to contact them
here -> info@mhra.gsi.gov.uk
For more recent failings by the MHRA and their 'Good Clinical Practice' read about the TGN1412 drug trials HERE
Also click on the following links:
"Six seriously ill in London hospital as drug trial goes wrong." Breaitbart.com. March 15, 2006
TeGenero AG. Press Releases. March 15, 2006
"They say he needs a miracle." BBC News. March 15, 2006
"London Drug Trial Victims May Be Ill for Life, Lawyers Say." Bloomberg.com. April 21, 2006.
"Drug trial victim may lose fingers and toes." Reuters. April 18, 2006.
Saturday, February 02, 2008
Eli Lilly - We Pay Up... You Shut Up
Seroxat Secrets has a great story regarding Eli Lilly's latest out of court settlement with another 900 personal-injury claims against its antipscyhotic drug Zyprexa.
Basically, an out of court settlement pays compensation to the claimants with a 'catch', that 'catch' being, the claimants cannot discuss the settlement with anyone thus leaving the blame at the door.
GlaxoSmithKline have done it in the past, no doubt they will do it again in the future.
Thank God murderers, rapists and child molesters don't have this 'luxury' that Pharma giants seem to have.
Full Zyprexa story here
Basically, an out of court settlement pays compensation to the claimants with a 'catch', that 'catch' being, the claimants cannot discuss the settlement with anyone thus leaving the blame at the door.
GlaxoSmithKline have done it in the past, no doubt they will do it again in the future.
Thank God murderers, rapists and child molesters don't have this 'luxury' that Pharma giants seem to have.
Full Zyprexa story here
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