Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Saturday, June 30, 2007
Trials Data - Part V: Answer
Matthew writes exclusively for Seroxat Sufferers
Read part IV before you do anything else.
Advanced Bromide Consumption plc do not exist... this is merely an exercise (in the essay sense)
Trials Data - Part V: Answer
Advanced Bromide Consumption plc is a large pharmaceutical company with a product portfolio covering a wide range of medicines, amongst other things...
...Discuss the criminal liability, if any, of Advanced Bromide Consumption, Dave, Edwina, Fatima, Good Healthy Information and Jake and his colleagues.
We are not provided detail of the trials' authorization process, including the location of said trials, which would impact on any liability under Regulations 33 and 34. Nor are we told when the trials were carried out. As such, the writer humbly proceeds on the assumption that the Regulations were in force when the trials were authorized; that applications have been properly submitted and authorized, under Regulation 12; that the trials were properly terminated, under Regulation 27; conducted in accordance with the protocol, under Regulation 29; conducted in accordance with good clinical practice, under Regulation 28; that any breaches have been properly notified under Regulation 29A; that qualified person(s) were in place to carry out the duties specified by Art 13(3) and (4) of the Clinical Trials Directive, under Regulation 43; and that proper labelling of the product was carried out under Regulation 49.
The first question, then, that presents itself, concerns that of whether Advanced Bromide, as sponsor, has made proper notification and report of any SAEs that came to its attention, during the course of the trials that it conducted. Under the Regulations, the investigators would be obliged to report the Serious Adverse Events ("SAEs") to the sponsor promptly. Again, this detail is not provided, but the writer assumes that this has been done. If it has not been done, then the investigators may be liable, under Regulation 32, and they may also be liable for not submitting a written report to the sponsor.
If the investigators have reported the serious adverse events properly, then we have to speculate as to whether or not the sponsor has advised the regulator (which may be done by entering the incidents on the European database) under Regulation 33. However, the Regulations state that a SAE has to be fatal or life-threatening for Regulation 33 to apply. And unless one conceives that suicidal ideations will lead eventually to suicide, then merely thinking about suicide will not qualify, under this Regulation. In the absence of guiding precedent, the writer would err on the side of caution, and suggest that any form of suicidality should be regarded as a SAE, and should be reported, as such.
On this basis, the sponsor should have informed the regulator of those SAEs, and would be liable, had it failed to do so. Assuming that the trials have been conducted outside the EU, liability would accrue to the sponsor, where it had failed to enter SAEs on the European database, under Regulation 34. It would also be liable under Regulation 35, in the event that it had failed to submit an annual SAE report, and/or a safety report for all trialists affected.
Next, there appears to be an issue over the application of Regulation 50, which concerns the provision of false, or misleading information, where such provision impacts upon the assessment of safety and efficacy. It is unclear from the facts, as presented, to establish whether or not the sponsor, or any of its agents, provided the UK regulator with false information. There appears to be a question as to how the information that was given was interpreted, at least publicly, with Advanced Bromide initially accepting the unsatisfactory nature of the trials and deciding against a licence application, although it then appears to change its mind, and by some mechanism, which is unclear from the facts, Dave, Edwina, Fatima and Jake arrive at a conclusion that appears to be very nearly diametrically opposed to that that Advanced Bromide reached.
Nevertheless, it is not clear from this that Advanced Bromide did other than interpret the statistics at its disposal in its favour, whereas an alternative reading would permit a disinterested party to reach the same conclusion that the Company did, originally. As such, unless the Company not only provided Jake's publication to the regulator, but also provided raw data (or statistical summary) that had been edited to exclude or diminish evidence of SAEs, then it is difficult to establish liability under Regulation 50, on the basis of the publication, alone.
However, the writer respectfully observes that he believes there to be a grey area, here. And this is that the Regulations do not provide for data withheld, which might impact on the assessment of safety and/or efficacy in a drug. According to the facts of the case, Advanced Bromide carried out more than one trial, and yet it seems that the results of only one trial were published. We are not advised as to whether the data from these other trial(s) were provided to the regulator, and it is not clear that it is an offence even if they were not.
In the absence of caselaw, the writer is obliged to argue that a failure to communicate adverse data from a "failed" trial amounts to providing false or misleading information, although it is by no means the natural meaning of those words. It is evidently the intention of Parliament to establish a system of legislation, which permits the regulator with the best possible opportunity to properly assess a drug for licensing. Any conduct that undermines that effort is going against the spirit of the legislation, I would argue. Moreover, given that withholding trials data is viewed as both unscientific and potentially detrimental to the public, it cannot have been Parliament's intention to permit this loophole to remain, even for the purpose of protecting information proprietary to pharmaceutical companies. Viewed from a wider perspective, then, the provision to the regulator of no more than half of the available data amounts to an attempt to mislead, in the writer's opinion. The trial that was published, then, should not be viewed in isolation, and should be seen merely as part of the information, which Regulation 50 requires to be made available. As such, if Advanced Bromide has withheld the (even) less favourable data from its other trial(s) it is suggested that this amounts to an offence under Regulation 50.
Furthermore, given that there seems to be a suggestion that the Company chose to represent the data other than in accordance with its belief that the trial had not been successful, there may be liability for fraud, here. Given that the mechanism is missing from the facts set down, which led to the Company deciding to press ahead with a licence for minors in the face of its initial judgement, it is difficult to come to a definitive conclusion on this, particularly if Dave, Edwina, Fatima and Jake are determined that their interpretation of the data was good, despite the side effects. The facts, as presented, do not indicate either way whether there was an instruction to Dave from a superior. As such, one might deduce that he was acting on his own volition, but even this is unclear.
Without the benefit of the raw data, it is not possible to establish whether Edwina misrepresented this, when rendering those data into the "manageable format" that it is assumed was presented to Fatima. Nor, from the facts, is it clear that Fatima has done other than write up a report in accordance with the data that was presented to her, although there remains a question over the instructions that Dave gave to Fatima, as to the form that those instructions took. If Dave was deliberately attempting to mislead, then it is not clear what his motive was for doing this: there is certainly no mention of any financial advantage accruing to him, which would be a requirement of any liability for fraud.
If Fatima has acted in bone fide, then Good Healthy will presumably avoid vicarious liability for any civil action. There is no evidence presented in the facts to suggest that Good Healthy was involved in any attempt to mislead the regulator, and as such it appears not to have any liability under Regulation 50. Finally, Jake and his colleagues, one step further removed from the process, may not have acted with complete propriety, given that they put their names to a piece of work that was not theirs, solely for the purpose of increasing the profile of the report, when it was published. However, there is no evidence that Jake's actions misled the regulator.
Matthew Holford (c) 2007
Read part IV before you do anything else.
Advanced Bromide Consumption plc do not exist... this is merely an exercise (in the essay sense)
Trials Data - Part V: Answer
Advanced Bromide Consumption plc is a large pharmaceutical company with a product portfolio covering a wide range of medicines, amongst other things...
...Discuss the criminal liability, if any, of Advanced Bromide Consumption, Dave, Edwina, Fatima, Good Healthy Information and Jake and his colleagues.
We are not provided detail of the trials' authorization process, including the location of said trials, which would impact on any liability under Regulations 33 and 34. Nor are we told when the trials were carried out. As such, the writer humbly proceeds on the assumption that the Regulations were in force when the trials were authorized; that applications have been properly submitted and authorized, under Regulation 12; that the trials were properly terminated, under Regulation 27; conducted in accordance with the protocol, under Regulation 29; conducted in accordance with good clinical practice, under Regulation 28; that any breaches have been properly notified under Regulation 29A; that qualified person(s) were in place to carry out the duties specified by Art 13(3) and (4) of the Clinical Trials Directive, under Regulation 43; and that proper labelling of the product was carried out under Regulation 49.
The first question, then, that presents itself, concerns that of whether Advanced Bromide, as sponsor, has made proper notification and report of any SAEs that came to its attention, during the course of the trials that it conducted. Under the Regulations, the investigators would be obliged to report the Serious Adverse Events ("SAEs") to the sponsor promptly. Again, this detail is not provided, but the writer assumes that this has been done. If it has not been done, then the investigators may be liable, under Regulation 32, and they may also be liable for not submitting a written report to the sponsor.
If the investigators have reported the serious adverse events properly, then we have to speculate as to whether or not the sponsor has advised the regulator (which may be done by entering the incidents on the European database) under Regulation 33. However, the Regulations state that a SAE has to be fatal or life-threatening for Regulation 33 to apply. And unless one conceives that suicidal ideations will lead eventually to suicide, then merely thinking about suicide will not qualify, under this Regulation. In the absence of guiding precedent, the writer would err on the side of caution, and suggest that any form of suicidality should be regarded as a SAE, and should be reported, as such.
On this basis, the sponsor should have informed the regulator of those SAEs, and would be liable, had it failed to do so. Assuming that the trials have been conducted outside the EU, liability would accrue to the sponsor, where it had failed to enter SAEs on the European database, under Regulation 34. It would also be liable under Regulation 35, in the event that it had failed to submit an annual SAE report, and/or a safety report for all trialists affected.
Next, there appears to be an issue over the application of Regulation 50, which concerns the provision of false, or misleading information, where such provision impacts upon the assessment of safety and efficacy. It is unclear from the facts, as presented, to establish whether or not the sponsor, or any of its agents, provided the UK regulator with false information. There appears to be a question as to how the information that was given was interpreted, at least publicly, with Advanced Bromide initially accepting the unsatisfactory nature of the trials and deciding against a licence application, although it then appears to change its mind, and by some mechanism, which is unclear from the facts, Dave, Edwina, Fatima and Jake arrive at a conclusion that appears to be very nearly diametrically opposed to that that Advanced Bromide reached.
Nevertheless, it is not clear from this that Advanced Bromide did other than interpret the statistics at its disposal in its favour, whereas an alternative reading would permit a disinterested party to reach the same conclusion that the Company did, originally. As such, unless the Company not only provided Jake's publication to the regulator, but also provided raw data (or statistical summary) that had been edited to exclude or diminish evidence of SAEs, then it is difficult to establish liability under Regulation 50, on the basis of the publication, alone.
However, the writer respectfully observes that he believes there to be a grey area, here. And this is that the Regulations do not provide for data withheld, which might impact on the assessment of safety and/or efficacy in a drug. According to the facts of the case, Advanced Bromide carried out more than one trial, and yet it seems that the results of only one trial were published. We are not advised as to whether the data from these other trial(s) were provided to the regulator, and it is not clear that it is an offence even if they were not.
In the absence of caselaw, the writer is obliged to argue that a failure to communicate adverse data from a "failed" trial amounts to providing false or misleading information, although it is by no means the natural meaning of those words. It is evidently the intention of Parliament to establish a system of legislation, which permits the regulator with the best possible opportunity to properly assess a drug for licensing. Any conduct that undermines that effort is going against the spirit of the legislation, I would argue. Moreover, given that withholding trials data is viewed as both unscientific and potentially detrimental to the public, it cannot have been Parliament's intention to permit this loophole to remain, even for the purpose of protecting information proprietary to pharmaceutical companies. Viewed from a wider perspective, then, the provision to the regulator of no more than half of the available data amounts to an attempt to mislead, in the writer's opinion. The trial that was published, then, should not be viewed in isolation, and should be seen merely as part of the information, which Regulation 50 requires to be made available. As such, if Advanced Bromide has withheld the (even) less favourable data from its other trial(s) it is suggested that this amounts to an offence under Regulation 50.
Furthermore, given that there seems to be a suggestion that the Company chose to represent the data other than in accordance with its belief that the trial had not been successful, there may be liability for fraud, here. Given that the mechanism is missing from the facts set down, which led to the Company deciding to press ahead with a licence for minors in the face of its initial judgement, it is difficult to come to a definitive conclusion on this, particularly if Dave, Edwina, Fatima and Jake are determined that their interpretation of the data was good, despite the side effects. The facts, as presented, do not indicate either way whether there was an instruction to Dave from a superior. As such, one might deduce that he was acting on his own volition, but even this is unclear.
Without the benefit of the raw data, it is not possible to establish whether Edwina misrepresented this, when rendering those data into the "manageable format" that it is assumed was presented to Fatima. Nor, from the facts, is it clear that Fatima has done other than write up a report in accordance with the data that was presented to her, although there remains a question over the instructions that Dave gave to Fatima, as to the form that those instructions took. If Dave was deliberately attempting to mislead, then it is not clear what his motive was for doing this: there is certainly no mention of any financial advantage accruing to him, which would be a requirement of any liability for fraud.
If Fatima has acted in bone fide, then Good Healthy will presumably avoid vicarious liability for any civil action. There is no evidence presented in the facts to suggest that Good Healthy was involved in any attempt to mislead the regulator, and as such it appears not to have any liability under Regulation 50. Finally, Jake and his colleagues, one step further removed from the process, may not have acted with complete propriety, given that they put their names to a piece of work that was not theirs, solely for the purpose of increasing the profile of the report, when it was published. However, there is no evidence that Jake's actions misled the regulator.
Matthew Holford (c) 2007
Friday, June 29, 2007
It never rains but it pours for GlaxoSmithKline
Source: age.com.au
Biota to beef up flu drug lawsuit
Biota plans to hike up its damages claim against Europe's biggest drugmaker for failing to promote flu drug Relenza properly.
Peter Cook, chief executive of Biota Holdings Ltd, said the Melbourne-based biotech firm would file its revised claim against GlaxoSmithKline next month.
Biota started its litigation in May 2004 and is currently seeking up to $A430 million in damages.
Cook said this original claim would be increased because it failed to take into account the recent explosion in demand for flu drugs, which are being stockpiled by governments around the world in case of a pandemic that may be triggered by bird flu.
Biota claims Glaxo failed to back it properly and so lost out when demand for flu drugs soared after the H5N1 bird flu virus re-emerged in Asia in 2003.
FULL STORY
D'oh! Another lawsuit for poor old GSK
Biota to beef up flu drug lawsuit
Biota plans to hike up its damages claim against Europe's biggest drugmaker for failing to promote flu drug Relenza properly.
Peter Cook, chief executive of Biota Holdings Ltd, said the Melbourne-based biotech firm would file its revised claim against GlaxoSmithKline next month.
Biota started its litigation in May 2004 and is currently seeking up to $A430 million in damages.
Cook said this original claim would be increased because it failed to take into account the recent explosion in demand for flu drugs, which are being stockpiled by governments around the world in case of a pandemic that may be triggered by bird flu.
Biota claims Glaxo failed to back it properly and so lost out when demand for flu drugs soared after the H5N1 bird flu virus re-emerged in Asia in 2003.
FULL STORY
D'oh! Another lawsuit for poor old GSK
Trials Data - Part IV: Essay Panic
By Matthew Holford
Matthew writes exclusively for Seroxat Sufferers.
Yes, students: it's essay time. Essays must be submitted on or before the deadline, or will not be awarded a mark! Let me know if I've missed anything. I'll have a go at writing an answer over the next week, or so (unless you want to have a go yourself, of course!).
Advanced Bromide Consumption plc is a large pharmaceutical company with a product portfolio covering a wide range of medicines, amongst other things. Advanced Bromide has had a particular product, called The Drug, on the market for some time, and it has been very successful, in terms of sales. However, The Drug has only been licensed by regulators for prescription to adults, and as such may not be marketed for use in the treatment of minors. The Company is keen to have the product licensed for children and adolescents, because it perceives that it would be a valuable medicine, and should be available to doctors to prescribe more widely. The Company carries out several licensed trials with the medicine, but finds that the results are less than had been hoped for, with The Drug failing to demonstrate efficacy satisfactorily, and, moreover, the safety of The Drug is also called into question. Within the Company, it is accepted that these trials will not support an application for licensing of The Drug to minors.
Dave is a project director for Advanced Bromide, and his job description includes responsibility for overseeing and directing to completion clinical trials for his employer. Edwina is a senior statistician at Advanced Bromide. Amongst her duties, she is required to take raw data generated by trials investigators, analyse it and render it into a meaningful format, in order to establish the success of the trial. Fatima is a medical writer, employed by Good Healthy Information, Inc., which is a company specializing in writing up trials data with a view to submission for publication. Advanced Bromide is a client of Good Healthy. Jake is a key opinion leader in one of the areas that Advanced Bromide has significant interests in, and Jake is approached by Advanced Bromide with a view to authoring a piece reporting on one of the trials of The Drug for publication, with a view to licensing The Drug. Jake agrees, along with several of his professional colleagues, who have been similarly invited.
Dave and Edwina collaborate with Fatima, who then writes the piece, although key information concerning safety is deliberately underplayed, on Dave's instructions. In fact, the summary of adverse reactions indicates that six times as many triallists taking The Drug experienced suicidality as did placebo triallists, and with significantly more of The Drug's triallists being hospitalized due to this and other serious adverse reactions. The piece is published in the name of Jake and his colleagues, wherein it is claimed that The Drug was well tolerated and efficacious.
Discuss the criminal liability, if any, of Advanced Bromide Consumption, Dave, Edwina, Fatima, Good Healthy Information and Jake and his colleagues.
Answers must be no more than 2000 words, typed in 12-point and double line spaced.
Related links:
None, it's a completely fictitious exercise.
Matthew writes exclusively for Seroxat Sufferers.
Yes, students: it's essay time. Essays must be submitted on or before the deadline, or will not be awarded a mark! Let me know if I've missed anything. I'll have a go at writing an answer over the next week, or so (unless you want to have a go yourself, of course!).
Advanced Bromide Consumption plc is a large pharmaceutical company with a product portfolio covering a wide range of medicines, amongst other things. Advanced Bromide has had a particular product, called The Drug, on the market for some time, and it has been very successful, in terms of sales. However, The Drug has only been licensed by regulators for prescription to adults, and as such may not be marketed for use in the treatment of minors. The Company is keen to have the product licensed for children and adolescents, because it perceives that it would be a valuable medicine, and should be available to doctors to prescribe more widely. The Company carries out several licensed trials with the medicine, but finds that the results are less than had been hoped for, with The Drug failing to demonstrate efficacy satisfactorily, and, moreover, the safety of The Drug is also called into question. Within the Company, it is accepted that these trials will not support an application for licensing of The Drug to minors.
Dave is a project director for Advanced Bromide, and his job description includes responsibility for overseeing and directing to completion clinical trials for his employer. Edwina is a senior statistician at Advanced Bromide. Amongst her duties, she is required to take raw data generated by trials investigators, analyse it and render it into a meaningful format, in order to establish the success of the trial. Fatima is a medical writer, employed by Good Healthy Information, Inc., which is a company specializing in writing up trials data with a view to submission for publication. Advanced Bromide is a client of Good Healthy. Jake is a key opinion leader in one of the areas that Advanced Bromide has significant interests in, and Jake is approached by Advanced Bromide with a view to authoring a piece reporting on one of the trials of The Drug for publication, with a view to licensing The Drug. Jake agrees, along with several of his professional colleagues, who have been similarly invited.
Dave and Edwina collaborate with Fatima, who then writes the piece, although key information concerning safety is deliberately underplayed, on Dave's instructions. In fact, the summary of adverse reactions indicates that six times as many triallists taking The Drug experienced suicidality as did placebo triallists, and with significantly more of The Drug's triallists being hospitalized due to this and other serious adverse reactions. The piece is published in the name of Jake and his colleagues, wherein it is claimed that The Drug was well tolerated and efficacious.
Discuss the criminal liability, if any, of Advanced Bromide Consumption, Dave, Edwina, Fatima, Good Healthy Information and Jake and his colleagues.
Answers must be no more than 2000 words, typed in 12-point and double line spaced.
Related links:
None, it's a completely fictitious exercise.
Thursday, June 28, 2007
Dear GSK...... From Manies Mom, Julie
The following comment was left by Julie, the mother of Manie who is featured in my rant 'Question for GSK and it's Lawyers'
This is for GSK and the people it employs. It is also a poignant message for those who refuse to acknowledge that Seroxat/Paxil is a drug that is toxic. It is also for Martin Keller, Alistair Benbow. And also for three particular members of the MHRA, namely, Ian Hudson, Alisdair Breckenridge & Kent Woods.
This is for GSK and the people it employs. It is also a poignant message for those who refuse to acknowledge that Seroxat/Paxil is a drug that is toxic. It is also for Martin Keller, Alistair Benbow. And also for three particular members of the MHRA, namely, Ian Hudson, Alisdair Breckenridge & Kent Woods.
Julie was prescribed Paxil/Seroxat during her pregnancy
Let me paint a picture for you so to speak.
I sit with Manie in my lap. Doctors and nurses everywhere. I am told "Now hold the mask over his mouth and his nose".
I struggle with Manie to keep the mask on his face as I tell him over and over "you are so brave I love you I love you".
Soon the gas starts to take over.
Manie stops fighting because his body starts going into convulsions.
I hold him as tight as I can and try to hold back the tears.
I can feel his little body twitching in my arms.
Even though I know this is the way it is suppose to happen I am scared.
I can feel his tiny heart beating faster and faster.
Then his eyes roll in the back of his head and his body goes limp.
Manie is asleep.
The nurses take him from me and place his small body on the table.
I say I love you one last time and force myself to leave the room.
My arms now feel empty as I wait for what seems to be a lifetime.
This is just a small bit of a 14 hr. day at the hospital during one of Manie's cardiac caths.
How about someone from GSK stand there while my son loses control of his body and explain how they could let this happen.
Manie's Mom
Julie
Question for GSK and it's Lawyers
Knowing what you do about the dangers of taking Seroxat/Paxil whilst pregnant - will you be issuing a statement over the following research currently being posted around the net?
Study: antidepressants pose little risk to unborn babies
According to two new studies, antidepressants, including Prozac, Paxil and Zoloft pose little risk of causing birth defects in unborn babies.
Story here
Now, a descision has to be made by GSK. Do they come out and slam this research or do they sit back in the hope that this research gathers pace and allows them to once again poison a human life as it grows inside a mother's womb?
Do you (GSK) know what Transposition of the Great Arteries is?
Do you (GSK) know what congenital heart defect is?
Do you (GSK) know what an arterial switch is?
Do you (GSK) know what a cardiac cath is?
Let me help you
Tell this child, when he is old enough to understand, how you (GSK) stood by and allowed his mother to take Paxil - not only that, you stood by when researchers claimed that it was indeed safe for pregnant women to take Paxil.
Whaddya say GSK?
How big are your balls GSK?
Read more about Manie here
Study: antidepressants pose little risk to unborn babies
According to two new studies, antidepressants, including Prozac, Paxil and Zoloft pose little risk of causing birth defects in unborn babies.
Story here
Now, a descision has to be made by GSK. Do they come out and slam this research or do they sit back in the hope that this research gathers pace and allows them to once again poison a human life as it grows inside a mother's womb?
Do you (GSK) know what Transposition of the Great Arteries is?
Do you (GSK) know what congenital heart defect is?
Do you (GSK) know what an arterial switch is?
Do you (GSK) know what a cardiac cath is?
Let me help you
Tell this child, when he is old enough to understand, how you (GSK) stood by and allowed his mother to take Paxil - not only that, you stood by when researchers claimed that it was indeed safe for pregnant women to take Paxil.
Whaddya say GSK?
How big are your balls GSK?
Read more about Manie here
Trials Data - Part III: Penalties and Miscellaneous under the MHU 2004
Part III of the Trials Data by Matthew Holford. Parts 1 & 2 can be seen here and here.
Matthew writes exclusively for Seroxat Sufferers.
Welcome back, gentle reader! Today, I will be tying up a few loose ends, in terms of our whistlestop tour of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended by the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006). This will involve a brief outline of the penalties for transgression of the Regulations, and a quick look at the role of the Ethics Committee, in the process.
Penalties
Regulation 52(a) and (b) - A prosecution may be brought summarily (before a Magistrates' Court), or on indictment (before a jury in a Crown Court). Magistrates' Courts tend to deal with less serious offences, which explains the lower penalties in para (a). On summary conviction, then, a defendant will be liable to a fine not exceeding the statutory maximum, which if my memory serves me is currently £50,000 and/or a prison sentence of 3 months. Before a Crown Court, the fine will be unlimited, and the defendant may also be liable to a two year prison sentence.
This is, then, not regarded as the most serious of offences. However, it should be borne in mind that presumably the punishment will be multiplied according to the number of offences for which the defendant is found guilty.
The Ethics Committee
What a mysterious thing "the" Ethics Committee is! Given the prominence given it in the MHU, the uninitiated might be given to think that this was a permanent body established to oversee the probity of such activities as it was assigned, from time to time. But one would be wrong.
The Ethics Committee is any committee that is recognized as such by the United Kingdom Ethics Committee Authority, (the "UKEA"), any member of which may act jointly or severally, by agreement. You didn't know that we had such a thing as the UKEA? Well, we do, and it is a body consisting of the Secretary of State for Health, the National Assembly of Wales, the Scottish Ministers and the Department of Health, etc for Northern Ireland. So says Regulation 5, anyway.
Now, aside from acting jointly and severally, the UKEA may appoint such person(s) as it sees fit to discharge its functions, in accordance with Regulation 5(4). Furthermore, in accordance with Regulation 5(5), the UKEA may make arrangements with any government department, local or public authority or holder of public office to discharge its duties for it. In theory, then, I imagine the UKEA could instruct the MHRA to act for it. Under Regulation 5(6) it says that the UKEA retains responsibility for any fuck-ups, though, which is just as well, because the words "piss-up" and "brewery" spring to mind in relation to anything that the MHRA has dealings with.
Under Regulation 6, the UKEA may appoint and abolish (under Regulation 8) ethics committees as it sees fit, as far as I can make out. It can broaden the remit, or the geographical jurisdiction of a committee, and so on. It can establish ethics committees to act with respect to certain classes and descriptions of clinical trials. Now, I find this interesting. I would quite like to know who was on the current version of the SSRI clinical trials Ethics Committee (if there is such a thing), wouldn't you? Do you imagine the DoH or the MHRA would tell us, at all?
Regulation 7 deals with recognition of Ethics Committees, and provides for the procedure by which an application to be recognized as an Ethics Committee operates. Schedule 2 of the Regulations deals with a bunch of administrative stuff, which impacts on the selection of members of the Committee, appointment of Chair and Vice Chair, reimbursement of expenses, creation of sub-committees, meetings, annual reports, I've lost interest. Finally, under Regulation 10, the UKEA is required to monitor ethics committees, in order to ensure that they are doing their job adequately, and may give such advice and assistance as is necessary to assist the ethics committees in their operation.
Any clearer? No, me neither. However, what I understand this to amount to is that there may be any number of ethics committees, across the UK, governing any number of different geographic locales, and any number of industries. Within the pharmaceutical industry, there may be any number of ethics committees, overseeing the conduct of trials of different types of drugs, for example. Nice work, if you can get it, I imagine.
Now, very briefly, you will remember from Part I that the Ethics Committee is responsible for providing opinion on a range of matters, including the granting of trials licences and any amendment to such licence. Unless a favourable opinion has been granted, a trial may not proceed.
To be honest, I'm losing interest in this subject, simply because the operation of the relevant ethics committee is of greater interest to me than the broad brushstrokes of the Regulations. However, Regulation 14 deals with the procedural niceities of an application for an opinion and Regulation 15 covers a whole bunch of issues that the ethics committee should consider, when forming its opinion, which I'm not going to go into, other than suggest that the gentle reader takes a look for him/herself. Finally, Regulation 16 deals with appeals against an ethics committee's opinion.
Please stay tuned and alert, gentle readers: in Part IV, I may be asking questions!
Matthew Holford (c) 2007
Related links:
MHRA
UK Department of Health
Matthew writes exclusively for Seroxat Sufferers.
Welcome back, gentle reader! Today, I will be tying up a few loose ends, in terms of our whistlestop tour of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended by the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006). This will involve a brief outline of the penalties for transgression of the Regulations, and a quick look at the role of the Ethics Committee, in the process.
Penalties
Regulation 52(a) and (b) - A prosecution may be brought summarily (before a Magistrates' Court), or on indictment (before a jury in a Crown Court). Magistrates' Courts tend to deal with less serious offences, which explains the lower penalties in para (a). On summary conviction, then, a defendant will be liable to a fine not exceeding the statutory maximum, which if my memory serves me is currently £50,000 and/or a prison sentence of 3 months. Before a Crown Court, the fine will be unlimited, and the defendant may also be liable to a two year prison sentence.
This is, then, not regarded as the most serious of offences. However, it should be borne in mind that presumably the punishment will be multiplied according to the number of offences for which the defendant is found guilty.
The Ethics Committee
What a mysterious thing "the" Ethics Committee is! Given the prominence given it in the MHU, the uninitiated might be given to think that this was a permanent body established to oversee the probity of such activities as it was assigned, from time to time. But one would be wrong.
The Ethics Committee is any committee that is recognized as such by the United Kingdom Ethics Committee Authority, (the "UKEA"), any member of which may act jointly or severally, by agreement. You didn't know that we had such a thing as the UKEA? Well, we do, and it is a body consisting of the Secretary of State for Health, the National Assembly of Wales, the Scottish Ministers and the Department of Health, etc for Northern Ireland. So says Regulation 5, anyway.
Now, aside from acting jointly and severally, the UKEA may appoint such person(s) as it sees fit to discharge its functions, in accordance with Regulation 5(4). Furthermore, in accordance with Regulation 5(5), the UKEA may make arrangements with any government department, local or public authority or holder of public office to discharge its duties for it. In theory, then, I imagine the UKEA could instruct the MHRA to act for it. Under Regulation 5(6) it says that the UKEA retains responsibility for any fuck-ups, though, which is just as well, because the words "piss-up" and "brewery" spring to mind in relation to anything that the MHRA has dealings with.
Under Regulation 6, the UKEA may appoint and abolish (under Regulation 8) ethics committees as it sees fit, as far as I can make out. It can broaden the remit, or the geographical jurisdiction of a committee, and so on. It can establish ethics committees to act with respect to certain classes and descriptions of clinical trials. Now, I find this interesting. I would quite like to know who was on the current version of the SSRI clinical trials Ethics Committee (if there is such a thing), wouldn't you? Do you imagine the DoH or the MHRA would tell us, at all?
Regulation 7 deals with recognition of Ethics Committees, and provides for the procedure by which an application to be recognized as an Ethics Committee operates. Schedule 2 of the Regulations deals with a bunch of administrative stuff, which impacts on the selection of members of the Committee, appointment of Chair and Vice Chair, reimbursement of expenses, creation of sub-committees, meetings, annual reports, I've lost interest. Finally, under Regulation 10, the UKEA is required to monitor ethics committees, in order to ensure that they are doing their job adequately, and may give such advice and assistance as is necessary to assist the ethics committees in their operation.
Any clearer? No, me neither. However, what I understand this to amount to is that there may be any number of ethics committees, across the UK, governing any number of different geographic locales, and any number of industries. Within the pharmaceutical industry, there may be any number of ethics committees, overseeing the conduct of trials of different types of drugs, for example. Nice work, if you can get it, I imagine.
Now, very briefly, you will remember from Part I that the Ethics Committee is responsible for providing opinion on a range of matters, including the granting of trials licences and any amendment to such licence. Unless a favourable opinion has been granted, a trial may not proceed.
To be honest, I'm losing interest in this subject, simply because the operation of the relevant ethics committee is of greater interest to me than the broad brushstrokes of the Regulations. However, Regulation 14 deals with the procedural niceities of an application for an opinion and Regulation 15 covers a whole bunch of issues that the ethics committee should consider, when forming its opinion, which I'm not going to go into, other than suggest that the gentle reader takes a look for him/herself. Finally, Regulation 16 deals with appeals against an ethics committee's opinion.
Please stay tuned and alert, gentle readers: in Part IV, I may be asking questions!
Matthew Holford (c) 2007
Related links:
MHRA
UK Department of Health
Wednesday, June 27, 2007
Latest news from blogs
Seroxat Secrets ploughs deeper into patient support groups, in particular Jim Thomson who is mentioned numerous times within the pages of Seroxat Sufferers.
A new forum has been set up over at the Seroxat Weblog. It's a UK based forum to enable British users of 5 or more years on Seroxat (Paroxetine/Paxil) to share their story of withdrawal symptoms, organ damage (with particular emphasis on liver problems), neurological difficulties or side effects of any kind.
Over at Clinical Psychology there is a post about Pharmaceutical Companies, money and Psychiatrists.
Furious Seasons has an interesting post on the Treatment Advocacy Center (TAC). Furious Seasons kindly offers you the email addresses of the TAC. Read the article then email them
Health Care Renewal is banging the drum loudly about conflicts of interests regarding research on occupational hearing loss carried out by Prof William W Clark of the Department of Otolaryngology of the Washington University School of Medicine.
Dr Aubrey Blumsohn links the whole Martin Keller affair to two cases he is investigating over at the Scientific Misconduct Blog. The case of David Kern will be of particular interest to students at Brown University and residents of Rhode Island who regularly visit this site.
If you get the chance please visit these sites. These are people who are pissed off and are doing something about it.
Fid
A new forum has been set up over at the Seroxat Weblog. It's a UK based forum to enable British users of 5 or more years on Seroxat (Paroxetine/Paxil) to share their story of withdrawal symptoms, organ damage (with particular emphasis on liver problems), neurological difficulties or side effects of any kind.
Over at Clinical Psychology there is a post about Pharmaceutical Companies, money and Psychiatrists.
Furious Seasons has an interesting post on the Treatment Advocacy Center (TAC). Furious Seasons kindly offers you the email addresses of the TAC. Read the article then email them
Health Care Renewal is banging the drum loudly about conflicts of interests regarding research on occupational hearing loss carried out by Prof William W Clark of the Department of Otolaryngology of the Washington University School of Medicine.
Dr Aubrey Blumsohn links the whole Martin Keller affair to two cases he is investigating over at the Scientific Misconduct Blog. The case of David Kern will be of particular interest to students at Brown University and residents of Rhode Island who regularly visit this site.
If you get the chance please visit these sites. These are people who are pissed off and are doing something about it.
Fid
Conflict Alleged in Drug Firms' Education Role
Source: Washington Post
By Elizabeth Williamson and Christopher Lee
June 27, 2007
Drug companies have become the biggest sponsors of continuing medical education courses in recent years, even at the nation's top medical schools, a development that critics say raises health-care costs, skews doctors' treatment decisions and allows the industry to skirt laws against advertising "off-label" uses for its products.
The trend accelerated after the government backed off a plan to limit commercial sponsorships in 2002 at the urging of the industry, Senate investigators said.
Now, nearly two-thirds of the cost of continuing education courses sponsored by medical schools, popular for their prestige, are paid for by drug and medical device companies and other commercial interests, figures show. Overall, commercial sponsors pick up about half of the $2.25 billion annual cost of the courses doctors must attend to keep their licenses.
"Most of what doctors know about drugs comes from the industry, and that's not healthy," said Jerry Avorn, a Harvard Medical School professor and critic of the sponsorships. "Academic organizations lend their names to courses that are nothing more than infomercials."
But Scott Lassman, senior assistant general counsel at Pharmaceutical Research and Manufacturers of America, said industry funding of continuing medical education is a great way to educate physicians about the latest medical and scientific research.
The courses "are viewed as running independently of the pharmaceutical company," Lassman said. "The company may be providing the funding for it, but they are not directing the content."
He also defended the practice of discussing off-label uses for drugs -- uses not approved by the Food and Drug Administration -- in the courses. "A lot of times, the regulatory process lags behind the science," he said. "I think it's a benefit for physicians, as long as it's independent and as long as the scientific information is solid."
For doctors, though, drug company funding "makes it very difficult to know what research to believe," said J. Gregory Rosenthal, an Ohio retinal surgeon and a founder of Physicians for Clinical Responsibility, a group pushing for tighter controls on conflicts of interest in medicine. "Even at the [specialty] academy level, you can't go onto a Web site without being confronted by sponsorship logos."
Rosenthal will testify today in a hearing before the Senate Special Committee on Aging, which is looking into physician links with the drug industry. Sen. Herb Kohl (D-Wis.), the chairman, said the commercial sponsorship of courses creates a conflict of interest.
"It appears that everyone profits from this pervasive system of gifts and payments, except the consumer," Kohl said.
The hearing marks the second time this year that the Senate has examined the independence of industry-sponsored continuing education. In April, a Senate Finance Committee study found that the Accreditation Council for Continuing Medical Education, the main accrediting body for education providers, does not scrutinize course materials for accuracy or evidence of bias toward sponsors' products. At times, sponsors have been able to select topics, and presenters have discussed off-label uses for drugs, the report found.
"There has to be a bright line between drug company spending on medical education and spending on marketing," Sen. Max Baucus (D-Mont.), the committee's chairman, said in remarks echoed by Charles E. Grassley of Iowa, the panel's top Republican.
Murray Kopelow, chief executive of the accrediting council, acknowledged that concerns over the drug industry's influence persist despite the advent of stricter oversight and ethical guidelines. "We've done a lot, but we believe we could do more in putting into place detection systems and monitoring systems in order to provide data to address those concerns," Kopelow said.
He said the drug industry does hold some sway over which topics are covered in the courses.
"Commercial interests fund educational activities that are consistent with their business," he said. "To that extent, the industry has some control over the topics that are taught. The title of the activity would not be in the hands of the commercial interest but would be in the hands of the accredited provider."
Last year's meeting of the American Psychiatric Association in Toronto, the field's biggest educational conference, reflects the extent of corporate sponsorships. In the meeting program, a voluntary listing of the financial ties to drug firms of the physicians who served as instructors covered 14 pages. Some instructors were sponsored by at least a dozen companies.
"Between a third and a half of medical providers have a relationship with industry," said Jerome P. Kassirer, a professor at Tufts University's School of Medicine and the author of a book about the financial links between doctors and drug companies. "These are promotional activities disguised as education."
In 2002, after identifying prescription drugs as the biggest factor in soaring federal health-care costs, the inspector general's office at the Department of Health and Human Services drafted tighter rules governing industry sponsorship of the courses, according to the Senate aging committee. Soon after, however, lawyers for the industry hand-delivered a 56-page memo objecting to the draft, and the guidelines the government eventually adopted closely matched the industry's voluntary code of ethics.
Some states have begun looking into the issue. In Pennsylvania, for example, Avorn, the Harvard professor, helped create RxFacts ( http://www.rxfacts.org), a two-year-old program that provides physicians with evidence-based, noncommercial prescription information.
"I don't think we ever can or should prevent companies from making honest statements about their approved products," Avorn said. "But we need to give doctors a chance to hear from people who don't have products to sell."
Thanks to Ken Kramer for sending me this article
See also - Psychiatrists Top List in Drug Maker Gifts
By Elizabeth Williamson and Christopher Lee
June 27, 2007
Drug companies have become the biggest sponsors of continuing medical education courses in recent years, even at the nation's top medical schools, a development that critics say raises health-care costs, skews doctors' treatment decisions and allows the industry to skirt laws against advertising "off-label" uses for its products.
The trend accelerated after the government backed off a plan to limit commercial sponsorships in 2002 at the urging of the industry, Senate investigators said.
Now, nearly two-thirds of the cost of continuing education courses sponsored by medical schools, popular for their prestige, are paid for by drug and medical device companies and other commercial interests, figures show. Overall, commercial sponsors pick up about half of the $2.25 billion annual cost of the courses doctors must attend to keep their licenses.
"Most of what doctors know about drugs comes from the industry, and that's not healthy," said Jerry Avorn, a Harvard Medical School professor and critic of the sponsorships. "Academic organizations lend their names to courses that are nothing more than infomercials."
But Scott Lassman, senior assistant general counsel at Pharmaceutical Research and Manufacturers of America, said industry funding of continuing medical education is a great way to educate physicians about the latest medical and scientific research.
The courses "are viewed as running independently of the pharmaceutical company," Lassman said. "The company may be providing the funding for it, but they are not directing the content."
He also defended the practice of discussing off-label uses for drugs -- uses not approved by the Food and Drug Administration -- in the courses. "A lot of times, the regulatory process lags behind the science," he said. "I think it's a benefit for physicians, as long as it's independent and as long as the scientific information is solid."
For doctors, though, drug company funding "makes it very difficult to know what research to believe," said J. Gregory Rosenthal, an Ohio retinal surgeon and a founder of Physicians for Clinical Responsibility, a group pushing for tighter controls on conflicts of interest in medicine. "Even at the [specialty] academy level, you can't go onto a Web site without being confronted by sponsorship logos."
Rosenthal will testify today in a hearing before the Senate Special Committee on Aging, which is looking into physician links with the drug industry. Sen. Herb Kohl (D-Wis.), the chairman, said the commercial sponsorship of courses creates a conflict of interest.
"It appears that everyone profits from this pervasive system of gifts and payments, except the consumer," Kohl said.
The hearing marks the second time this year that the Senate has examined the independence of industry-sponsored continuing education. In April, a Senate Finance Committee study found that the Accreditation Council for Continuing Medical Education, the main accrediting body for education providers, does not scrutinize course materials for accuracy or evidence of bias toward sponsors' products. At times, sponsors have been able to select topics, and presenters have discussed off-label uses for drugs, the report found.
"There has to be a bright line between drug company spending on medical education and spending on marketing," Sen. Max Baucus (D-Mont.), the committee's chairman, said in remarks echoed by Charles E. Grassley of Iowa, the panel's top Republican.
Murray Kopelow, chief executive of the accrediting council, acknowledged that concerns over the drug industry's influence persist despite the advent of stricter oversight and ethical guidelines. "We've done a lot, but we believe we could do more in putting into place detection systems and monitoring systems in order to provide data to address those concerns," Kopelow said.
He said the drug industry does hold some sway over which topics are covered in the courses.
"Commercial interests fund educational activities that are consistent with their business," he said. "To that extent, the industry has some control over the topics that are taught. The title of the activity would not be in the hands of the commercial interest but would be in the hands of the accredited provider."
Last year's meeting of the American Psychiatric Association in Toronto, the field's biggest educational conference, reflects the extent of corporate sponsorships. In the meeting program, a voluntary listing of the financial ties to drug firms of the physicians who served as instructors covered 14 pages. Some instructors were sponsored by at least a dozen companies.
"Between a third and a half of medical providers have a relationship with industry," said Jerome P. Kassirer, a professor at Tufts University's School of Medicine and the author of a book about the financial links between doctors and drug companies. "These are promotional activities disguised as education."
In 2002, after identifying prescription drugs as the biggest factor in soaring federal health-care costs, the inspector general's office at the Department of Health and Human Services drafted tighter rules governing industry sponsorship of the courses, according to the Senate aging committee. Soon after, however, lawyers for the industry hand-delivered a 56-page memo objecting to the draft, and the guidelines the government eventually adopted closely matched the industry's voluntary code of ethics.
Some states have begun looking into the issue. In Pennsylvania, for example, Avorn, the Harvard professor, helped create RxFacts ( http://www.rxfacts.org), a two-year-old program that provides physicians with evidence-based, noncommercial prescription information.
"I don't think we ever can or should prevent companies from making honest statements about their approved products," Avorn said. "But we need to give doctors a chance to hear from people who don't have products to sell."
Thanks to Ken Kramer for sending me this article
See also - Psychiatrists Top List in Drug Maker Gifts
Trials Data - Part II: Defences, etc under the MHU Regulations 2004
Trials Data - Part II: Defences, etc under the MHU Regulations 2004
Part I can be read here
By Matthew Holford
Matthew writes exclusively for Seroxat Sufferers
Now, if I may remind the gentle reader, Part I involved a brief analysis of the offences created by the the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended by the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006). In this piece, I will be discussing the concept of "reasonability", as it applies to the wider law. The reason for this will become clear, once one takes a look at the list of defences available to a defendant charged with an offence under the Regulations.
Defences
Regulation 51(1) and (2) - The essence of this Regulation is that a defendant will avoid liability for any conduct, which would otherwise amount to an offence under the Regulations, if he/she/it is able to demonstrate that he/she/it took all reasonable precautions and exercized due diligence in order to avoid committing that offence. The court (or jury) is required to assume that the requirements for the defence is met, unless the prosecution is able to demonstrate that it is not. Presumably, this requires evidence of an intention to commit the offence.
This is a concept that is in operation in the financial services industry, in essence. The Financial Services Authority (the "FSA") has a bunch of overarching principles, which inform the rules that it creates and enforces. However, given the multiplicity of forms that its members take, a rule governing any aspect of Financial Services Law/regulation will not apply equally to all. Or will not apply in the same way. So, for example, a consultancy will not have to concern itself unduly with issues raised with respect to the holding client funds, because it doesn't hold any - the only cash it receives would be for services rendered, against invoices properly raised. As such, the provisions that it puts in place, in order to comply with the rules concerning client funds will not be the same as that of a bank, for example, which clearly does hold client funds. In point of fact, a consultancy might only need to evidence that fact that it had considered the issue, and had regarded it as irrelevant to its business.
The upshot of this is that the FSA's (note: it shouldn't really be called this, because the FSA is the Food Standards Agency!) guidance to members is that rules should be applied proportionately. That is, if something goes down, did the member do what would normally be considered appropriate, in terms of its business model, to avoid what happened, such that what happened was anomalous, or extraordinary? Now, the FSA is streets ahead of the MHRA, in my view, as to its understanding of the issues surrounding compliance. The FSA understands (and acknowledges) that any commerical enterprise is driven by profit. As such, most decisions are taken in accordance with whether they will cost the firm money, and whether there will be a reward for that outlay. This is not necessarily a good thing, if one is trying to encourage a compliance culture, because firms may have a tendency to turn a blind eye to the activities of clients, simply because they do not wish to lose the custom (largely because most firms think that there is another firm, much like themselves, perfectly happy to take on any client that they reject - and they're probably right). This is particularly true where a company is run at a senior level by a dominant few who are marketing oriented.
Now, in the context of this analysis, it becomes quite difficult for me to provide any insight into the specifics of pharmaceutical companies' operations, because I've never worked in that industry. That issue becomes further muddied by the fact that what might be regarded as reasonable, (eg, the withholding of raw data, tacitly approved as it is by the MHRA), actually undermines the efficient operation of the system, as a whole. The MHRA, then, apparently regards this type of behaviour as "reasonable", and I imagine that the greater part of the industry would agree. Indeed, the standard test of reasonability in operation within the law of negligence is such that what is reasonable is that which the reasonable pharmaceutical company would regard as reasonable (perhaps it might be worth establishing definitively what the reasonable pharmaceutical company thinks, in this regard), and not what the reasonable person (patient?) believes to be reasonable. In any event, we've seen the issues that this gives rise to, and so I would argue that it is not reasonable to withhold raw data.
And there, my friends, in a nutshell, we have the issue that would face any court considering a case brought under the Regulations, in my view. Now, if I were to argue this point further, I would point out, as is my wont, that sailing with the bow doors open was standard industry practice, at the time that the Herald of Free Enterprise sank in Zeebrugge harbour. That is, the very fact that something is standard practice does not point to the reasonability of that activity, necessarily. The difference is, that the car ferry industry learnt from the error: bow doors have to be closed, prior to sailing, nowadays.
And yet, despite the issues that have been noted with respect to regulatory assessments made pursuant to the issue of marketing authorizations on the basis of a summary of data provided by the applicant, there appears to be no great determination to avoid similar issues, in the future, by changing that facet of the system. "Why is that?" I hear you ask. I don't know: why is that?
The MHRA is four years old.
Matthew Holford (c) 2007
Related links:
Glaxo SmithKline
MHRA
Part I can be read here
By Matthew Holford
Matthew writes exclusively for Seroxat Sufferers
Now, if I may remind the gentle reader, Part I involved a brief analysis of the offences created by the the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended by the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006). In this piece, I will be discussing the concept of "reasonability", as it applies to the wider law. The reason for this will become clear, once one takes a look at the list of defences available to a defendant charged with an offence under the Regulations.
Defences
Regulation 51(1) and (2) - The essence of this Regulation is that a defendant will avoid liability for any conduct, which would otherwise amount to an offence under the Regulations, if he/she/it is able to demonstrate that he/she/it took all reasonable precautions and exercized due diligence in order to avoid committing that offence. The court (or jury) is required to assume that the requirements for the defence is met, unless the prosecution is able to demonstrate that it is not. Presumably, this requires evidence of an intention to commit the offence.
This is a concept that is in operation in the financial services industry, in essence. The Financial Services Authority (the "FSA") has a bunch of overarching principles, which inform the rules that it creates and enforces. However, given the multiplicity of forms that its members take, a rule governing any aspect of Financial Services Law/regulation will not apply equally to all. Or will not apply in the same way. So, for example, a consultancy will not have to concern itself unduly with issues raised with respect to the holding client funds, because it doesn't hold any - the only cash it receives would be for services rendered, against invoices properly raised. As such, the provisions that it puts in place, in order to comply with the rules concerning client funds will not be the same as that of a bank, for example, which clearly does hold client funds. In point of fact, a consultancy might only need to evidence that fact that it had considered the issue, and had regarded it as irrelevant to its business.
The upshot of this is that the FSA's (note: it shouldn't really be called this, because the FSA is the Food Standards Agency!) guidance to members is that rules should be applied proportionately. That is, if something goes down, did the member do what would normally be considered appropriate, in terms of its business model, to avoid what happened, such that what happened was anomalous, or extraordinary? Now, the FSA is streets ahead of the MHRA, in my view, as to its understanding of the issues surrounding compliance. The FSA understands (and acknowledges) that any commerical enterprise is driven by profit. As such, most decisions are taken in accordance with whether they will cost the firm money, and whether there will be a reward for that outlay. This is not necessarily a good thing, if one is trying to encourage a compliance culture, because firms may have a tendency to turn a blind eye to the activities of clients, simply because they do not wish to lose the custom (largely because most firms think that there is another firm, much like themselves, perfectly happy to take on any client that they reject - and they're probably right). This is particularly true where a company is run at a senior level by a dominant few who are marketing oriented.
Now, in the context of this analysis, it becomes quite difficult for me to provide any insight into the specifics of pharmaceutical companies' operations, because I've never worked in that industry. That issue becomes further muddied by the fact that what might be regarded as reasonable, (eg, the withholding of raw data, tacitly approved as it is by the MHRA), actually undermines the efficient operation of the system, as a whole. The MHRA, then, apparently regards this type of behaviour as "reasonable", and I imagine that the greater part of the industry would agree. Indeed, the standard test of reasonability in operation within the law of negligence is such that what is reasonable is that which the reasonable pharmaceutical company would regard as reasonable (perhaps it might be worth establishing definitively what the reasonable pharmaceutical company thinks, in this regard), and not what the reasonable person (patient?) believes to be reasonable. In any event, we've seen the issues that this gives rise to, and so I would argue that it is not reasonable to withhold raw data.
And there, my friends, in a nutshell, we have the issue that would face any court considering a case brought under the Regulations, in my view. Now, if I were to argue this point further, I would point out, as is my wont, that sailing with the bow doors open was standard industry practice, at the time that the Herald of Free Enterprise sank in Zeebrugge harbour. That is, the very fact that something is standard practice does not point to the reasonability of that activity, necessarily. The difference is, that the car ferry industry learnt from the error: bow doors have to be closed, prior to sailing, nowadays.
And yet, despite the issues that have been noted with respect to regulatory assessments made pursuant to the issue of marketing authorizations on the basis of a summary of data provided by the applicant, there appears to be no great determination to avoid similar issues, in the future, by changing that facet of the system. "Why is that?" I hear you ask. I don't know: why is that?
The MHRA is four years old.
Matthew Holford (c) 2007
Related links:
Glaxo SmithKline
MHRA
Tuesday, June 26, 2007
Seroxat/Paxil and Birth Defects
Source: Houston Personal Injury Lawyer
Cynics would suggest that a lawyer is in it just for the money - however, it is usually those same cynics that have something to hide and to a certain extent should be helping those suffering at the hands of a drug they (the cynics) refuse to acknowledge causes problems
Shae Conlin took Paxil for two months before she knew she was pregnant. Her daughter only lived for one hour before passing away.
She had been taking Paxil for anxiety as well as the birth control pill at the time, so her pregnancy seemed to surprise her. She stopped taking the drug as soon as she found out. She was supposed to have twins and was told that only one baby had a heartbeat. After that, she was told that the baby was perfectly fine and everything was okay.
An in depth ultrasound proved otherwise. Tests showed that the baby would probably die at birth. The baby was born totally deformed with no muscles or bones. She was born paralyzed and couldn't swallow anything. Imagine your baby being born like this...very scary to think about. Doctors weren't 100% sure why this happened, but they told Mrs. Conlin that it could possibly happen again. She was so scared to have a third child. She ended up having a tubal ligation after her third child was born. She will never have kids again.
It turns out that Mrs. Conlin wasn't mad at her doctor because he didn't know that Paxil could have such side effects, but she was very upset with the drugmaker, rightfully so.
Cynics would suggest that a lawyer is in it just for the money - however, it is usually those same cynics that have something to hide and to a certain extent should be helping those suffering at the hands of a drug they (the cynics) refuse to acknowledge causes problems
Shae Conlin took Paxil for two months before she knew she was pregnant. Her daughter only lived for one hour before passing away.
She had been taking Paxil for anxiety as well as the birth control pill at the time, so her pregnancy seemed to surprise her. She stopped taking the drug as soon as she found out. She was supposed to have twins and was told that only one baby had a heartbeat. After that, she was told that the baby was perfectly fine and everything was okay.
An in depth ultrasound proved otherwise. Tests showed that the baby would probably die at birth. The baby was born totally deformed with no muscles or bones. She was born paralyzed and couldn't swallow anything. Imagine your baby being born like this...very scary to think about. Doctors weren't 100% sure why this happened, but they told Mrs. Conlin that it could possibly happen again. She was so scared to have a third child. She ended up having a tubal ligation after her third child was born. She will never have kids again.
It turns out that Mrs. Conlin wasn't mad at her doctor because he didn't know that Paxil could have such side effects, but she was very upset with the drugmaker, rightfully so.
Say it with flowers to GSK
Source: PR Newswire
MIAMI, June 25 /PRNewswire/ -- For 40 million anxiety sufferers in the United States who do not respond well to traditional drugs such as Prozac and Paxil, there is now help to alleviate their distress without worrying about potentially dangerous side effects. This is especially welcome news for young children and teenagers who have had a higher incidence of suicide from taking anti-anxiety medication.
In a newly published study by the University of Miami School of Nursing in conjunction with The Sirkin Creative Living Center (SCLC), researchers found that using a natural remedy that is created from wildflowers has a comparable effect to the more traditional pharmaceutical drugs without any of the known adverse side effects including addiction.
FULL STORY
MIAMI, June 25 /PRNewswire/ -- For 40 million anxiety sufferers in the United States who do not respond well to traditional drugs such as Prozac and Paxil, there is now help to alleviate their distress without worrying about potentially dangerous side effects. This is especially welcome news for young children and teenagers who have had a higher incidence of suicide from taking anti-anxiety medication.
In a newly published study by the University of Miami School of Nursing in conjunction with The Sirkin Creative Living Center (SCLC), researchers found that using a natural remedy that is created from wildflowers has a comparable effect to the more traditional pharmaceutical drugs without any of the known adverse side effects including addiction.
FULL STORY
Seroxat Sufferers hits 20,000
At 12.07 today Seroxat Sufferers hit the 20,000 mark.
I'd like to take this opportunity to thank all of those who visit this site.
The fight is not over yet... I has only just begun
Fid
I'd like to take this opportunity to thank all of those who visit this site.
The fight is not over yet... I has only just begun
Fid
Trials Data - Part I: Offences under the MHU Regulations 2004
By Matthew Holford
Ed: Here Matthew continues his rants with an in-depth look into the transparency of the Medicines Healthcare and products Regulatory Agency (MHRA)
Matthew writes exclusively for Seroxat Sufferers.
I was moved to ask the MHRA a month or two back about the investigation that its Intelligence Unit (note: not the police) is conducting into allegations that GSK withheld trials data concerning its Seroxat paediatric trials. If my memory serves me, the investigation began some 3-4 years ago, and I must say that I'm impressed that the MHRA should be so diligent in its efforts, given that, whilst it is a criminal offence to withhold trials data, the penalty is a maximum term of imprisonment, upon conviction, of only two years and/or a maximum fine of £50,000, if I remember aright (but more of that, later). Presumably it wants to ensure that it has an absolutely watertight case to present to the CPS (or is that the Department of Health?) for a decision on whether or not to prosecute, should it come to that.
Anyway, I thought it would be a valuable exercize to understand the legislation that the MHRA is implementing in its investigation. It wouldn't disclose any details to me, on the ground that it might prejudice any subsequent prosecution, and rightly so. As such, I'm limited to deconstructing The Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended by the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006) which governs this area of healthcare regulation.
To be honest, I wasn't really sure how I should approach this, and I decided to fall back on the format presented to me by my alma mater, Birkbeck College School of Law. To this end, I'm going to present you with the offences, first, then the defences, and finally the sanctions. Any extraneous bits and bobs, like a discussion of the role of the relevant Ethics Committee, I'll tack on at the end.
Offences
Regulation 12(1) - It is an offence to start, cause to be started, or conduct a clinical trial, without the requisite approval of the Ethics Committee and the licensing of said trial by the regulatory authority (ie, the MHRA).
Regulation 12(2) - It is an offence to recruit patients or to advertise for patients to take part in a trial, without the requisite approval of the Ethics Committee and the licensing of the trial by the MHRA.
Regulation 13(1) - It is an offence to sell an investigational medical product for the purpose of administering said product in a clinical trial unless the trial has been authorized by the MHRA or, where the product has been manufactured within the EU, but outside the UK, the product is compliant with the Clinical Trials Directive (2001/20/EC)
Regulation 27 - It is an offence to not inform the MHRA in writing of the termination of a trial within 90 days of said termination. However, if the trial is terminated early (ie, before the date or event specified in the protocol has occurred), then the sponsor must inform the MHRA within 15 days of said termination.
Regulation 28(1) to (3) - It is an offence to not conduct a trial in accordance with good clinical practice, whatever that might be. It is an offence to not put in place arrangements to ensure that good clinical practice is adhered to. It is also an offence to charge participants in a trial for the products being trialled, subject to certain restrictions under the National Health Service Act 1977 (and the corresponding legislation pertaining to Scotland and Northern Ireland).
Regulation 29 - It is an offence to conduct a trial other than as specified in the particulars of the documentation requesting authorization of that trial, other than where urgent safety measures need to be taken.
Regulation 29A - This Regulation was introduced under the 2006 Amendment Regulations and provides that where there is a serious breach (ie, a breach which impacts upon the safety of the trialists, or undermines the scientific value of the trial) of the protocol governing the trial, or where the principles and conditions of good clinical practice have been breached, then there is a duty to inform the MHRA within 7 days of such breach coming to light. It is a criminal offence to fail to do so.
Regulation 30 (2) - Where urgent safety measures have been implemented, it is an offence to fail to report immediately (within 3 days) in writing this deviation from the conduct of the trial, as originally communicated in the documentation, to the MHRA and the Ethics Committee.
Regulation 32(1),(3) and (5) to (9) - It is an offence for an investigator to fail to report a serious adverse event (SAE) to the sponsor immediately (presumably within 3 days, but it doesn't state a timescale). It is an offence for the investigator to fail to make a detailed written report of the event, following the immediate report to the sponsor. I'm not sure what sub para (5) adds, aside from the fact that it indicates that reporting requirements for adverse events should be set down in the protocol, particularly those that impact upon the very safety of the trial, as I read it. Sub paras (6) to (8) identify particulars of the information which must be kept and supplied, failure to do so being an offence. Finally, under (9), it is an offence for the sponsor to keep detailed records of all adverse events reported to it by investigators.
Regulation 33(1) to (5) - It is an offence for the sponsor of a trial to fail to record and report as soon as possible (ie, within 7 days) to the MHRA (or relevant authorities, if the trial is being conducted outside the UK) and to the Ethics Committee concerning a suspected unexpected(?) SAE, which is fatal or life-threatening (the time limit is 15 days, if the SAE is non-fata/life threatening). If any additional evidence is available, then it is an offence to fail to make this available to the MHRA within 8 days of the initial report having been submitted. The duties outlined above may be discharged by entering the report on the European database (established under Art 11 of the Directive) - let's just assume that that's being monitored, for the time being, shall we? Finally, under (5) it is an offence to fail to disclose to investigators in a trial a SAE that occurs in a different trial, but which uses the same products.
As an aside, I see that under 33(6) there is a duty on the regulator to ensure that any reports made under Regulation 33 are included on the European database. However, if a sponsor has reported direct to the database, then unless the MHRA is monitoring the database, it won't know if new information has been entered, unless there is a duty on the sponsor to advise the MHRA of any new entries, (I saw no mention of such a duty, in the Regulations). Indeed, the duty to enter details of SAEs on the database, as it pertains to the MHRA, is limited to those brought to its attention. I spy with my little eye a loophole.
Regulation 34 - Where a trial is being held in several sites, presumably including sites outside the EU, in addition to a site(s) in the UK, then reports of SAEs must still be made to the European database. It will be an offence for the sponsor to fail to do so.
Regulation 35(1) - It is an offence for a sponsor to fail to report, at the end of each reporting year (whenever that may be), a list of all SAEs identified during trials conducted, including SAEs experienced by placebo trialists. This list should include trials in the UK and elsewhere, and a safety report should also be submitted for any triallists affected.
Regulation 36(1) - It is an offence to assemble, manufacture or import an investigational medicinal product other than in accordance with the manufacturing authorization that has been granted. However, under Regulation 37 where a trial, etc, is being carried out in a hospital or health centre, this restriction does not apply.
Regulation 42 - It is an offence to not comply with certain specified manufacturing standards.
Regulation 43(1) and (6) - It is an offence for a manufacturing authorization holder to fail to have a "qualified person" at its disposal to carry out the duties specified under Arts 13(3) and (4) of the Directive.
Regulation 49 - There's a bunch of offences relating to the above, and to labelling, including possession of medicinal products with an intention to sell, in contravention of 13(1), labelling of products other than in accordance with Regulation 46, and so on.
Regulation 50 - There is a range of offences under Regulation 50, pertaining to the provision of false or misleading information. I quite like the look of Regulation 50(2), which provides that anybody who provides the MHRA or the Ethics Committee with "relevant information," which is false or misleading in any material particular, will have committed an offence. Relevant information will be information relating to the evaluation of safety, efficacy and quality of a product; or the safety or scientific validity of a trial; or whether the principles of good clinical practice are being adhered to.
Comment
This is a technical and quite wide-ranging piece of legislation. It should be remembered at all times that this legislation came into force on 1 May, 2004, and that no legislation will be retrospective. That is to say, if a person does something that one does not like, one should not formulate a rule forbidding that conduct, and then punish the person for having done what they did - the rule with only have effect with respect to similar conduct, in the future.
So, back in 1998, when SKB was dicking around with the 329 data, there was presumably no specific offence relating to the failure to submit information concerning SAEs, as there is now. However, if one were to withhold data completely legitimately, perhaps on the ground that it was proprietary information (this is customary in the pharmaceutical industry, I understand), and then a piece of legislation came into effect that provided that one had to give up that information, then if one continued to withhold it, that would constitute an offence. That withholding data in 1998 may have amounted to an offence in force at that time is another matter.
It would appear that there is a duty, under Regulation 34, for SAEs to be notified on the European database, even though they occurred in, say, the US. Assuming that Seroxat was also trialled in the UK, which appears to be a pre-requisite, it might be amusing to trawl the database, in an idle moment!
It seems that raw data is still regarded as propietary information. As such, even though the MHRA would be well within its remit to demand sight of raw data, during the course of its assessment process, there is no obligation upon the sponsor to submit this sort of information of its own accord (although there is an obligation to not supply false or misleading information). Indeed, given the Select Committee's comments, it seems that the MHRA tends not to bother with this kind of thing, and I'm not even sure that, in practice, individual assessors may demand that sort of information - they can ask the MHRA to ask the sponsor, but that's all, I think.
If the MHRA did require a copy of all raw data to be made available as a standard feature of the marketing authorization portfolio, it would be able to scrutinize these up front, and any discrepancies in interpretation could be ironed out, right then and there. God forbid that such a massive grey area should be removed from discussion, though. As such, even with the 2004 Regulations (as amended) in place, it is not beyond the bounds of the imagination to conceive a scenario where a sponsor withholds certain information, or summarizes it in its own favour, and then pleads that a particular SAE only became apparent, once the drug had been on the market, for a while. Only an investigation and subsequent prosecution would demonstrate whether or not this has been done, because any evidence of prior knowledge of a risk will be held by the marketing authorization holder.
Anyway, I think I've reached saturation point with this not-very-interesting piece of legislation for the time being, so I'll leave the gentle reader to digest that, and I will address the question of defences, in due course. To be honest, I doubt that there's very much precedent in this area, not least because the legislation has not been around for very long. Because of this, I think it boils down to a matter of expert opinion as to whether one were successful in obtaining a prosecution, but I'll explain why I think that, next time!
Matthew Holford (c) 2007
Related links:
FDA
GSK
MHRA
Ed: Here Matthew continues his rants with an in-depth look into the transparency of the Medicines Healthcare and products Regulatory Agency (MHRA)
Matthew writes exclusively for Seroxat Sufferers.
I was moved to ask the MHRA a month or two back about the investigation that its Intelligence Unit (note: not the police) is conducting into allegations that GSK withheld trials data concerning its Seroxat paediatric trials. If my memory serves me, the investigation began some 3-4 years ago, and I must say that I'm impressed that the MHRA should be so diligent in its efforts, given that, whilst it is a criminal offence to withhold trials data, the penalty is a maximum term of imprisonment, upon conviction, of only two years and/or a maximum fine of £50,000, if I remember aright (but more of that, later). Presumably it wants to ensure that it has an absolutely watertight case to present to the CPS (or is that the Department of Health?) for a decision on whether or not to prosecute, should it come to that.
Anyway, I thought it would be a valuable exercize to understand the legislation that the MHRA is implementing in its investigation. It wouldn't disclose any details to me, on the ground that it might prejudice any subsequent prosecution, and rightly so. As such, I'm limited to deconstructing The Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended by the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006) which governs this area of healthcare regulation.
To be honest, I wasn't really sure how I should approach this, and I decided to fall back on the format presented to me by my alma mater, Birkbeck College School of Law. To this end, I'm going to present you with the offences, first, then the defences, and finally the sanctions. Any extraneous bits and bobs, like a discussion of the role of the relevant Ethics Committee, I'll tack on at the end.
Offences
Regulation 12(1) - It is an offence to start, cause to be started, or conduct a clinical trial, without the requisite approval of the Ethics Committee and the licensing of said trial by the regulatory authority (ie, the MHRA).
Regulation 12(2) - It is an offence to recruit patients or to advertise for patients to take part in a trial, without the requisite approval of the Ethics Committee and the licensing of the trial by the MHRA.
Regulation 13(1) - It is an offence to sell an investigational medical product for the purpose of administering said product in a clinical trial unless the trial has been authorized by the MHRA or, where the product has been manufactured within the EU, but outside the UK, the product is compliant with the Clinical Trials Directive (2001/20/EC)
Regulation 27 - It is an offence to not inform the MHRA in writing of the termination of a trial within 90 days of said termination. However, if the trial is terminated early (ie, before the date or event specified in the protocol has occurred), then the sponsor must inform the MHRA within 15 days of said termination.
Regulation 28(1) to (3) - It is an offence to not conduct a trial in accordance with good clinical practice, whatever that might be. It is an offence to not put in place arrangements to ensure that good clinical practice is adhered to. It is also an offence to charge participants in a trial for the products being trialled, subject to certain restrictions under the National Health Service Act 1977 (and the corresponding legislation pertaining to Scotland and Northern Ireland).
Regulation 29 - It is an offence to conduct a trial other than as specified in the particulars of the documentation requesting authorization of that trial, other than where urgent safety measures need to be taken.
Regulation 29A - This Regulation was introduced under the 2006 Amendment Regulations and provides that where there is a serious breach (ie, a breach which impacts upon the safety of the trialists, or undermines the scientific value of the trial) of the protocol governing the trial, or where the principles and conditions of good clinical practice have been breached, then there is a duty to inform the MHRA within 7 days of such breach coming to light. It is a criminal offence to fail to do so.
Regulation 30 (2) - Where urgent safety measures have been implemented, it is an offence to fail to report immediately (within 3 days) in writing this deviation from the conduct of the trial, as originally communicated in the documentation, to the MHRA and the Ethics Committee.
Regulation 32(1),(3) and (5) to (9) - It is an offence for an investigator to fail to report a serious adverse event (SAE) to the sponsor immediately (presumably within 3 days, but it doesn't state a timescale). It is an offence for the investigator to fail to make a detailed written report of the event, following the immediate report to the sponsor. I'm not sure what sub para (5) adds, aside from the fact that it indicates that reporting requirements for adverse events should be set down in the protocol, particularly those that impact upon the very safety of the trial, as I read it. Sub paras (6) to (8) identify particulars of the information which must be kept and supplied, failure to do so being an offence. Finally, under (9), it is an offence for the sponsor to keep detailed records of all adverse events reported to it by investigators.
Regulation 33(1) to (5) - It is an offence for the sponsor of a trial to fail to record and report as soon as possible (ie, within 7 days) to the MHRA (or relevant authorities, if the trial is being conducted outside the UK) and to the Ethics Committee concerning a suspected unexpected(?) SAE, which is fatal or life-threatening (the time limit is 15 days, if the SAE is non-fata/life threatening). If any additional evidence is available, then it is an offence to fail to make this available to the MHRA within 8 days of the initial report having been submitted. The duties outlined above may be discharged by entering the report on the European database (established under Art 11 of the Directive) - let's just assume that that's being monitored, for the time being, shall we? Finally, under (5) it is an offence to fail to disclose to investigators in a trial a SAE that occurs in a different trial, but which uses the same products.
As an aside, I see that under 33(6) there is a duty on the regulator to ensure that any reports made under Regulation 33 are included on the European database. However, if a sponsor has reported direct to the database, then unless the MHRA is monitoring the database, it won't know if new information has been entered, unless there is a duty on the sponsor to advise the MHRA of any new entries, (I saw no mention of such a duty, in the Regulations). Indeed, the duty to enter details of SAEs on the database, as it pertains to the MHRA, is limited to those brought to its attention. I spy with my little eye a loophole.
Regulation 34 - Where a trial is being held in several sites, presumably including sites outside the EU, in addition to a site(s) in the UK, then reports of SAEs must still be made to the European database. It will be an offence for the sponsor to fail to do so.
Regulation 35(1) - It is an offence for a sponsor to fail to report, at the end of each reporting year (whenever that may be), a list of all SAEs identified during trials conducted, including SAEs experienced by placebo trialists. This list should include trials in the UK and elsewhere, and a safety report should also be submitted for any triallists affected.
Regulation 36(1) - It is an offence to assemble, manufacture or import an investigational medicinal product other than in accordance with the manufacturing authorization that has been granted. However, under Regulation 37 where a trial, etc, is being carried out in a hospital or health centre, this restriction does not apply.
Regulation 42 - It is an offence to not comply with certain specified manufacturing standards.
Regulation 43(1) and (6) - It is an offence for a manufacturing authorization holder to fail to have a "qualified person" at its disposal to carry out the duties specified under Arts 13(3) and (4) of the Directive.
Regulation 49 - There's a bunch of offences relating to the above, and to labelling, including possession of medicinal products with an intention to sell, in contravention of 13(1), labelling of products other than in accordance with Regulation 46, and so on.
Regulation 50 - There is a range of offences under Regulation 50, pertaining to the provision of false or misleading information. I quite like the look of Regulation 50(2), which provides that anybody who provides the MHRA or the Ethics Committee with "relevant information," which is false or misleading in any material particular, will have committed an offence. Relevant information will be information relating to the evaluation of safety, efficacy and quality of a product; or the safety or scientific validity of a trial; or whether the principles of good clinical practice are being adhered to.
Comment
This is a technical and quite wide-ranging piece of legislation. It should be remembered at all times that this legislation came into force on 1 May, 2004, and that no legislation will be retrospective. That is to say, if a person does something that one does not like, one should not formulate a rule forbidding that conduct, and then punish the person for having done what they did - the rule with only have effect with respect to similar conduct, in the future.
So, back in 1998, when SKB was dicking around with the 329 data, there was presumably no specific offence relating to the failure to submit information concerning SAEs, as there is now. However, if one were to withhold data completely legitimately, perhaps on the ground that it was proprietary information (this is customary in the pharmaceutical industry, I understand), and then a piece of legislation came into effect that provided that one had to give up that information, then if one continued to withhold it, that would constitute an offence. That withholding data in 1998 may have amounted to an offence in force at that time is another matter.
It would appear that there is a duty, under Regulation 34, for SAEs to be notified on the European database, even though they occurred in, say, the US. Assuming that Seroxat was also trialled in the UK, which appears to be a pre-requisite, it might be amusing to trawl the database, in an idle moment!
It seems that raw data is still regarded as propietary information. As such, even though the MHRA would be well within its remit to demand sight of raw data, during the course of its assessment process, there is no obligation upon the sponsor to submit this sort of information of its own accord (although there is an obligation to not supply false or misleading information). Indeed, given the Select Committee's comments, it seems that the MHRA tends not to bother with this kind of thing, and I'm not even sure that, in practice, individual assessors may demand that sort of information - they can ask the MHRA to ask the sponsor, but that's all, I think.
If the MHRA did require a copy of all raw data to be made available as a standard feature of the marketing authorization portfolio, it would be able to scrutinize these up front, and any discrepancies in interpretation could be ironed out, right then and there. God forbid that such a massive grey area should be removed from discussion, though. As such, even with the 2004 Regulations (as amended) in place, it is not beyond the bounds of the imagination to conceive a scenario where a sponsor withholds certain information, or summarizes it in its own favour, and then pleads that a particular SAE only became apparent, once the drug had been on the market, for a while. Only an investigation and subsequent prosecution would demonstrate whether or not this has been done, because any evidence of prior knowledge of a risk will be held by the marketing authorization holder.
Anyway, I think I've reached saturation point with this not-very-interesting piece of legislation for the time being, so I'll leave the gentle reader to digest that, and I will address the question of defences, in due course. To be honest, I doubt that there's very much precedent in this area, not least because the legislation has not been around for very long. Because of this, I think it boils down to a matter of expert opinion as to whether one were successful in obtaining a prosecution, but I'll explain why I think that, next time!
Matthew Holford (c) 2007
Related links:
FDA
GSK
MHRA
Monday, June 25, 2007
Alisdair Breckenridge of the MHRA
If you go back - and I read this out to the Health Select Committee - to the data sheet on Seroxat when it was licensed in 1991, we spelt out word for word the problems of withdrawal from Seroxat, in words that we could not improve now. This idea that the regulators have been hiding the data is just not true. The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish.
Alasdair Breckenridge - Chair of the Medicines and Healthcare products Regulatory Agency
Taken from The Lancet - 2005
Alasdair Breckenridge is a former employee of GlaxoSmithKline and has had numerous opportunities to 'nail' the subject of Seroxat. A classic example can be seen when the bumbling buffoon was seen on BBC's Panorama stuttering and red faced when interviewed by investigative journalist, Shelly Jofre.
An edited version of his 'performance' can be seen here
I just love to look of complete disbelief on Shelley Jofre's face... it kinda says 'This man actually believes in the the bullshit that is coming out of his own mouth'
Step down Breckenridge. You have failed to protect the public
Fid
Sunday, June 24, 2007
Corporate America's Deadliest Secret
Source: Information Liberation
A number of major pharmaceutical corporations and biotech firms are concealing the nature of the biological warfare research work they are doing for the U.S. government.
Since their funding comes from the National Institutes of Health, the recipients are obligated under NIH guidelines to make their activities public. Not disclosing their ops raises the suspicion they may be engaged in forbidden kinds of germ warfare research.
According to the Sunshine Project, a nonprofit arms control watchdog operating out of Austin, Texas, among corporations holding back information about their activities are:
Abbott Laboratories, BASF Plant Science, Bristol-Myers Squibb, DuPont Central Research and Development, Eli Lilly Corp., Embrex, GlaxoSmithKline, Hoffman-LaRoche, Merck & Co., Monsanto, Pfizer Inc., Schering-Plough Research Institute, and Syngenta Corp. of Switzerland.
FULL STORY
Any of you surprised?
A number of major pharmaceutical corporations and biotech firms are concealing the nature of the biological warfare research work they are doing for the U.S. government.
Since their funding comes from the National Institutes of Health, the recipients are obligated under NIH guidelines to make their activities public. Not disclosing their ops raises the suspicion they may be engaged in forbidden kinds of germ warfare research.
According to the Sunshine Project, a nonprofit arms control watchdog operating out of Austin, Texas, among corporations holding back information about their activities are:
Abbott Laboratories, BASF Plant Science, Bristol-Myers Squibb, DuPont Central Research and Development, Eli Lilly Corp., Embrex, GlaxoSmithKline, Hoffman-LaRoche, Merck & Co., Monsanto, Pfizer Inc., Schering-Plough Research Institute, and Syngenta Corp. of Switzerland.
FULL STORY
Any of you surprised?
New Seroxat Forum
The Seroxat Forum conjunction with SeroxatUserGroup is a UK based forum to enable British users, both past and present, of Seroxat (Paroxetine/Paxil) to share their story of withdrawal symptoms, organ damage (with particular emphasis on liver problems), neurological difficulties or side effects of any kind. The aim of this particular forum is to enable us to show the world the bigger picture regarding the effects, both past, present and long term, of taking Seroxat.
If you are a user of Seroxat, or know someone who is or was taking Seroxat; or if you or someone you know has stopped taking Seroxat, please feel free to share your story on the Seroxat Forum. Withdrawal symptoms, organ damage or side effects of any kind can be shared here.
Please visit this new forum and share your stories
Fid
seroxat
If you are a user of Seroxat, or know someone who is or was taking Seroxat; or if you or someone you know has stopped taking Seroxat, please feel free to share your story on the Seroxat Forum. Withdrawal symptoms, organ damage or side effects of any kind can be shared here.
Please visit this new forum and share your stories
Fid
seroxat
Huge weight gains reported by patients on prescription drugs
Source: The Independent
Thousands of people who take prescription medicines for everyday conditions are gaining large amounts of weight as an unexpected side effect, scientists have warned.
Researchers, who found that some patients were putting on up to 22lbs in a year, say that the drugs may even be contributing to the nation's rocketing obesity epidemic.
Full Story
Good news for Glaxo's 'Shit yourself thin pill' hey?
Every cloud... as they say
Bob
Thousands of people who take prescription medicines for everyday conditions are gaining large amounts of weight as an unexpected side effect, scientists have warned.
Researchers, who found that some patients were putting on up to 22lbs in a year, say that the drugs may even be contributing to the nation's rocketing obesity epidemic.
Full Story
Good news for Glaxo's 'Shit yourself thin pill' hey?
Every cloud... as they say
Bob
Saturday, June 23, 2007
The Life and Times of Martin B Keller, MD - Part V: Ghost in the Machine
More rantings from Matthew Holford regarding the works (or not as it appears) of Martin B Keller.
Parts 1-4 can be seen here - One, Two, Three and Four
Matthew writes exclusively for Seroxat Sufferers
The Life and Times of Martin B Keller, MD - Part V: Ghost in the Machine
By Matthew Holford
It is from Gilbert Ryles' critique of Descartes' view of dualism that I have taken the title of Part V. It is a play on words, though, because this little offering is about ghostwriters within the medical establishment. One particular ghostwriter, in fact, and one particular ghostwriting incident. Having said that, whilst conducting the research on this piece, my colleagues and I have, perhaps, clarified something that is potentially more valuable.
However, as an opening gambit, I would like to observe that mind/body dualism is not an original theory, by any means, and I would like to do this, because I can't conceive that I can make the subject matter of this piece any more bizarre than it already is by doing so. Once again, Classical Antiquity appears to witness the first recorded instance of this idea being discussed. Consider Plato's Concept of Forms, whereby universal concepts (ideas) permit us to understand the world. The intellect, then, may not be attributed to any particular organ of the body. Presumably this holds true of corporate persons, as well as natural persons. More recently, Descartes believed that the immaterial mind causally interacted with the material body, and vice versa.
Presumably, this means that body language is capable of being read: the mind will cause the body to behave in a particular way (I'm a fan of the practical benefits of theoretical discourse, as you may have gathered). If the understanding of a person was sufficiently subtle, this might even be done with precision, given that the eye takes in more information than any other organ of the senses, I'm told. This is fine, as long as mind, body and verbal communication are fully congruent. That doesn't happen very often, though, in my experience: people tend to modify their verbal language, in accordance with what is socially acceptable, for example, or to gain an advantage (lie, in other words).
This issue becomes significant, when the "incongruent person" insists that the verbal communication represents a truth. Consider the stiff body language of politicians, for example, when judging the value of this suggestion. Are people subconsciously aware that their body language communicates more than they would like it to, and attempt to suppress it?
I will leave the gentle reader to ponder that particular question as I return to the issue at hand. Now, we should, perhaps, recall that Study 329 was a cluster fuck, as far as SmithKline Beecham ("SKB") was concerned (my succinct appraisal of its position). The data suggested that the drug was dangerous and inefficacious in the target demographic (minors), by the Company's own admission. We should recall that the Company engaged a PR Company, Scientific Therapeutics Information, Inc. ("STI"), to prepare a piece for publication in a peer-reviewed journal, JAACAP, and that Dr Martin Keller seemingly was chosen to endorse this piece, because he was perceived to be a key opinion leader, whatever that might be. Although, in the words of Drs Keller and Ryan, it seems that anybody who wanted to put their name to it, should feel free to do so, according to their draft letter to the Editor of JAACAP, Dr Mina Dulcan. I suppose that's one way to bulk out one's CV. Next, the piece, written by one Sally Laden, I am reliably informed, who no longer works for STI, received some stiff criticism from reviewers, if I may understate it like that, before having marketing authorizations refused in both the UK and US, although, as far as I am aware, none of the criticism was ever acted upon. Amusingly, in the draft letter to Dulcan, Keller and Ryan argue that if a trial fails to demonstrate efficacy, then the regulator will refuse to license. I was similarly amused by the additional detail that Keller and Ryan read into Drs Jureidini and Tonkin's critique. By extension, anybody who agrees with Drs Keller and Ryan will be as intellectually and morally superior, as they are, in their view.
Anyway, I don't like to dish dirt, so you can Google Laden's name, for yourself. Actually, no. Here's one perspective on the Cyberonics business, in the Write Stuff. And here's another, from the Alliance for Human Research. Make of that what you will, although I would note that Cyberonics is not directly concerned with ghostwriting, and so doesn't fit my theme as well as I would have liked, because, per Laden's own words, as quoted by Bloomberg News, she was just a facilitator (ie, she made things easier, presumably). A ghostwriter, as in the 329 case, will always be anonymous.
Now, I've tried to restrict myself to the bare facts, without engaging in histrionics, supposition or hyperbole, but I have to say, in my opinion as a compliance professional, the whole 329/JAACAP thing doesn't look good. And yet, because I have access to some very talented people, aside from my own skills and experience, I understand that this is by no means a complete picture of the process that was followed in order to transform Seroxat/Paxil from a dubious-looking piece of chemistry into a product that was "generally well tolerated and effective for major depression in adolescents."
So, who is the ghost in the machine, today? Is it Sally Laden? Was she given SKB's "disappointing" data, and then took to spinning it for the benefit of Dr Keller and his co-authors? Well, one of my good friends and colleagues (a pathologist) has rejected that possibility, and I'm inclined to agree with him. It seems that the likely scenario was that a SKB statistician was given the data, and, how shall I put this most delicately, was led or led him/herself to understand what was required? This re-jigged data would then have been presented, most likely in the form of a statistical report, to Sally Laden, who would have proceeded to base her view on that, possibly in complete ignorance of the true position. So taken were we by this theory that we decided to test it, and the upshot is that somebody else, aside from the statistician, is the ghost, so we're still looking, but it's only a matter of time.
Now, at the time that 329's numbers were being crunched, Rosemary Oakes was a senior statistician at SKB, or is that "Senior Statistician"? The person who managed and directed the US-based phase four (whatever that means) Paxil clinical trials was a chap by the name of James McCafferty, per his deposition made pursuant to several actions brought against SKB in various states, in 2006. This deposition is concerned with a discussion of primary endpoints and covariant analyses, which a dumbass like me isn't going to pretend to understand, although I found it quite amusing, because McCafferty doesn't appear to understand it, either. Now, Oakes and McCafferty were concerned with the generation of data from 329, as evidenced by this exchange, taken from Oakes' deposition, and, presumably, with the generation of the statistical report that most likely would have been presented to Laden.
"So what?", I hear you ask, and quite rightly. Well, we know that in October, 1998, SKB believed that it had a turkey on its hands. And quite rightly. And yet, in March, 1999, we have Oakes and McCafferty's 'mail to Laden, which is appended, here, which is of greater interest to me, just now. McCafferty, then, was apparently Laden's primary contact at SKB. Given the juxtaposition between these various communications, one might also lead oneself to understand that the document that Oakes and McCafferty are working on is an early draft of Laden's finest work. It is also in this exchange that we see the first appearance of Dr Marty Keller (remember him?), and it is clear that McCafferty is in direct contact with both him and Ryan, which may or may not be an issue.
Moving on to July, 1999, and McCafferty is now in contact with Laden, here. He has noticed the incongruence between the claims made as to the drug's safety in Laden's latest draft, as against the admission in the same draft of significant reports of adverse events. He also expresses his concern that the editors (of JAACAP, or just generally?) will rumble this inconsistency, which I find quite amusing, given that Dulcan's failure to do so was, by exension, what Drs Jureidini and Tonkin were complaining of, so Keller tells us. In the words of Michael Stipe the "shit's so thick, you could stir it with a stick." Even SKB had noticed the stench. Two days later, McCafferty again contacts Laden, apparently this time to suggest a solution to the issue raised in his mail of 19 July, here.
Now, being the nitpicker that I am, I am not satisfied that this demonstrates that Laden had seen the original 329 trial data, particularly given that Oakes was still crunching 329 data eight months after the trial ended, according to that deposition. I am not even sure that this crunching of data means that Oakes was arranging for a "biased" statistical report to be made available to Laden. However, given McCafferty's comments with respect to suggested amendments to Laden's draft, she might have come to the conclusion that a rigorous appraisal of the data that was made available to her was not what was required, although I say this as a compliance professional, and not a medical writer. As to Dr Keller, being an honourable man, I don't doubt that he would be appalled to have a piece of work such as this on his CV.
Matthew Holford (c) 2007
Related Links:
Bad Day Lyrics (REM)
BBC Panorama
Brown University
Glaxo SmithKline
"Seroxat Sufferers ("SS") is fully committed to open discourse and transparency. The right to reply is a fundamental tenet of this belief. The facility provided on this site is limited only by language including but not limited to that which is foul, abusive, defamatory, vexatious, boring, provocative, inconsequential or intemperate, or language that in SS's judgement transgresses any criminal statutory provisions (for example, inciting terrorism, etc). The parties mentioned in this piece have been given advance notice of publication, and have been invited to submit their comments as to the accuracy of "facts" stated and opinion expressed. The MHRA is four years old.
Bob
glaxosmithkline
Parts 1-4 can be seen here - One, Two, Three and Four
Matthew writes exclusively for Seroxat Sufferers
The Life and Times of Martin B Keller, MD - Part V: Ghost in the Machine
By Matthew Holford
It is from Gilbert Ryles' critique of Descartes' view of dualism that I have taken the title of Part V. It is a play on words, though, because this little offering is about ghostwriters within the medical establishment. One particular ghostwriter, in fact, and one particular ghostwriting incident. Having said that, whilst conducting the research on this piece, my colleagues and I have, perhaps, clarified something that is potentially more valuable.
However, as an opening gambit, I would like to observe that mind/body dualism is not an original theory, by any means, and I would like to do this, because I can't conceive that I can make the subject matter of this piece any more bizarre than it already is by doing so. Once again, Classical Antiquity appears to witness the first recorded instance of this idea being discussed. Consider Plato's Concept of Forms, whereby universal concepts (ideas) permit us to understand the world. The intellect, then, may not be attributed to any particular organ of the body. Presumably this holds true of corporate persons, as well as natural persons. More recently, Descartes believed that the immaterial mind causally interacted with the material body, and vice versa.
Presumably, this means that body language is capable of being read: the mind will cause the body to behave in a particular way (I'm a fan of the practical benefits of theoretical discourse, as you may have gathered). If the understanding of a person was sufficiently subtle, this might even be done with precision, given that the eye takes in more information than any other organ of the senses, I'm told. This is fine, as long as mind, body and verbal communication are fully congruent. That doesn't happen very often, though, in my experience: people tend to modify their verbal language, in accordance with what is socially acceptable, for example, or to gain an advantage (lie, in other words).
This issue becomes significant, when the "incongruent person" insists that the verbal communication represents a truth. Consider the stiff body language of politicians, for example, when judging the value of this suggestion. Are people subconsciously aware that their body language communicates more than they would like it to, and attempt to suppress it?
I will leave the gentle reader to ponder that particular question as I return to the issue at hand. Now, we should, perhaps, recall that Study 329 was a cluster fuck, as far as SmithKline Beecham ("SKB") was concerned (my succinct appraisal of its position). The data suggested that the drug was dangerous and inefficacious in the target demographic (minors), by the Company's own admission. We should recall that the Company engaged a PR Company, Scientific Therapeutics Information, Inc. ("STI"), to prepare a piece for publication in a peer-reviewed journal, JAACAP, and that Dr Martin Keller seemingly was chosen to endorse this piece, because he was perceived to be a key opinion leader, whatever that might be. Although, in the words of Drs Keller and Ryan, it seems that anybody who wanted to put their name to it, should feel free to do so, according to their draft letter to the Editor of JAACAP, Dr Mina Dulcan. I suppose that's one way to bulk out one's CV. Next, the piece, written by one Sally Laden, I am reliably informed, who no longer works for STI, received some stiff criticism from reviewers, if I may understate it like that, before having marketing authorizations refused in both the UK and US, although, as far as I am aware, none of the criticism was ever acted upon. Amusingly, in the draft letter to Dulcan, Keller and Ryan argue that if a trial fails to demonstrate efficacy, then the regulator will refuse to license. I was similarly amused by the additional detail that Keller and Ryan read into Drs Jureidini and Tonkin's critique. By extension, anybody who agrees with Drs Keller and Ryan will be as intellectually and morally superior, as they are, in their view.
Anyway, I don't like to dish dirt, so you can Google Laden's name, for yourself. Actually, no. Here's one perspective on the Cyberonics business, in the Write Stuff. And here's another, from the Alliance for Human Research. Make of that what you will, although I would note that Cyberonics is not directly concerned with ghostwriting, and so doesn't fit my theme as well as I would have liked, because, per Laden's own words, as quoted by Bloomberg News, she was just a facilitator (ie, she made things easier, presumably). A ghostwriter, as in the 329 case, will always be anonymous.
Now, I've tried to restrict myself to the bare facts, without engaging in histrionics, supposition or hyperbole, but I have to say, in my opinion as a compliance professional, the whole 329/JAACAP thing doesn't look good. And yet, because I have access to some very talented people, aside from my own skills and experience, I understand that this is by no means a complete picture of the process that was followed in order to transform Seroxat/Paxil from a dubious-looking piece of chemistry into a product that was "generally well tolerated and effective for major depression in adolescents."
So, who is the ghost in the machine, today? Is it Sally Laden? Was she given SKB's "disappointing" data, and then took to spinning it for the benefit of Dr Keller and his co-authors? Well, one of my good friends and colleagues (a pathologist) has rejected that possibility, and I'm inclined to agree with him. It seems that the likely scenario was that a SKB statistician was given the data, and, how shall I put this most delicately, was led or led him/herself to understand what was required? This re-jigged data would then have been presented, most likely in the form of a statistical report, to Sally Laden, who would have proceeded to base her view on that, possibly in complete ignorance of the true position. So taken were we by this theory that we decided to test it, and the upshot is that somebody else, aside from the statistician, is the ghost, so we're still looking, but it's only a matter of time.
Now, at the time that 329's numbers were being crunched, Rosemary Oakes was a senior statistician at SKB, or is that "Senior Statistician"? The person who managed and directed the US-based phase four (whatever that means) Paxil clinical trials was a chap by the name of James McCafferty, per his deposition made pursuant to several actions brought against SKB in various states, in 2006. This deposition is concerned with a discussion of primary endpoints and covariant analyses, which a dumbass like me isn't going to pretend to understand, although I found it quite amusing, because McCafferty doesn't appear to understand it, either. Now, Oakes and McCafferty were concerned with the generation of data from 329, as evidenced by this exchange, taken from Oakes' deposition, and, presumably, with the generation of the statistical report that most likely would have been presented to Laden.
"So what?", I hear you ask, and quite rightly. Well, we know that in October, 1998, SKB believed that it had a turkey on its hands. And quite rightly. And yet, in March, 1999, we have Oakes and McCafferty's 'mail to Laden, which is appended, here, which is of greater interest to me, just now. McCafferty, then, was apparently Laden's primary contact at SKB. Given the juxtaposition between these various communications, one might also lead oneself to understand that the document that Oakes and McCafferty are working on is an early draft of Laden's finest work. It is also in this exchange that we see the first appearance of Dr Marty Keller (remember him?), and it is clear that McCafferty is in direct contact with both him and Ryan, which may or may not be an issue.
Moving on to July, 1999, and McCafferty is now in contact with Laden, here. He has noticed the incongruence between the claims made as to the drug's safety in Laden's latest draft, as against the admission in the same draft of significant reports of adverse events. He also expresses his concern that the editors (of JAACAP, or just generally?) will rumble this inconsistency, which I find quite amusing, given that Dulcan's failure to do so was, by exension, what Drs Jureidini and Tonkin were complaining of, so Keller tells us. In the words of Michael Stipe the "shit's so thick, you could stir it with a stick." Even SKB had noticed the stench. Two days later, McCafferty again contacts Laden, apparently this time to suggest a solution to the issue raised in his mail of 19 July, here.
Now, being the nitpicker that I am, I am not satisfied that this demonstrates that Laden had seen the original 329 trial data, particularly given that Oakes was still crunching 329 data eight months after the trial ended, according to that deposition. I am not even sure that this crunching of data means that Oakes was arranging for a "biased" statistical report to be made available to Laden. However, given McCafferty's comments with respect to suggested amendments to Laden's draft, she might have come to the conclusion that a rigorous appraisal of the data that was made available to her was not what was required, although I say this as a compliance professional, and not a medical writer. As to Dr Keller, being an honourable man, I don't doubt that he would be appalled to have a piece of work such as this on his CV.
Matthew Holford (c) 2007
Related Links:
Bad Day Lyrics (REM)
BBC Panorama
Brown University
Glaxo SmithKline
"Seroxat Sufferers ("SS") is fully committed to open discourse and transparency. The right to reply is a fundamental tenet of this belief. The facility provided on this site is limited only by language including but not limited to that which is foul, abusive, defamatory, vexatious, boring, provocative, inconsequential or intemperate, or language that in SS's judgement transgresses any criminal statutory provisions (for example, inciting terrorism, etc). The parties mentioned in this piece have been given advance notice of publication, and have been invited to submit their comments as to the accuracy of "facts" stated and opinion expressed. The MHRA is four years old.
Bob
glaxosmithkline
Friday, June 22, 2007
Angry Aussie slams Alli
Miracle diet pill! (with a teenty-tiny side effect)
You can read more of the Angry Aussie's rants here
alli
Avandia lawsuit filed in federal court
Here's another lawsuit for GSK's lawyers to settle out of court
Source: The South Texas Record
6/21/2007
A Type 2 diabetic, Lany Stanford died of a heart attack on May 21, 2007, the very same day that an article published in the New England Journal of Medicine claimed his prescribed medication Avandia increased one's chances of a heart attack.
Stanford was taking the popular diabetes drug to help regulate his insulin. Type-2 diabetes increases a patient's risk for heart disease and other complications. However, Stanford's family doesn't believe it was a coincidence that he died the same day the study was published.
Peggie Stanford, a Dallas County resident, and her son Ryan filed their wrongful death suit against GlaxoSmithKline with the U.S. District Court for the Eastern District of Texas, Marshall Division, on June 19.
According to the GSK Web site, in 1999 Avandia (rosiglitazone maleate) was approved by the Food and Drug Administration. It is an oral anti-diabetic agent that acts primarily by increasing insulin sensitivity.
The Stanfords, along with their lawyer Stephen Drimion, allege the global pharmaceutical manufacture "unfairly" convinced the FDA to approve its drug, and then went on a "marketing assault" with a drug GSK officials knew was harmful.
"On May 21, 2007, Dr. Steven Nissen, a prominent cardiologist associated with the Cleveland Clinic, published a study in the New England Journal of Medicine with (evidence that Avandia could increase a patient's risk of a heart attack)," the suit said.
"GSK (was aware of Nissen's findings) since September of 2005."The suit alleges GSK concealed the evidence because such findings would diminish sales. "Apparently, the phenomenal profits that GSK accumulated between May of 1999 through the summer of 2005 were not enough."
"By September of 2005, GSK was in possession of evidence that could reasonably be expected to diminish the sales of its second largest selling drug, rosiglitazone," the suit said. "The evidence in its possession at the time was an overview analysis of approximately 42 different studies of patients using its drug, rosiglitazone. However, GSK provided only preliminary results of the analysis to the FDA in September 2005. The complete results of the study were not provided to the FDA for another year."
The suit goes on to say that during the following year of alleged concealment, GSK pressed its sales of Avandia to a distribution of approximately 13 million prescriptions in the U.S. "With a month's supply of rosiglitazone costing between $90 and $200, GSK was able to rack up sales of $2.2 billion in 2006 even though it was finally compelled to disclose the complete study results to the FDA in August 2006."
"GSK continued onward and upward with its sale of rosiglitazone after August 2006," the suit said. "Knowing that its drug was unreasonably dangerous and that the diabetic patient population was uninformed of the dangers, (the company) continued to expand sales of rosiglitazone to existing and new patients."
The suit faults GSK with negligently and recklessly failing to warn the general public of the risks associated with taking Avandia, product liability, marketing a defective drug,failing to provide adequate warnings, fraud, negligence, misrepresentation, expressed warranty for goods, warranty of merchant ability, warranty of fitness, unjust enrichment and wrongful death.
The plaintiffs are suing for damages to punish GSK for Stanford's death, funeral expenses, mental anguish, medical and counseling expenses, loss of companionship and suffering of plaintiffs' decedent.
Source: The South Texas Record
6/21/2007
A Type 2 diabetic, Lany Stanford died of a heart attack on May 21, 2007, the very same day that an article published in the New England Journal of Medicine claimed his prescribed medication Avandia increased one's chances of a heart attack.
Stanford was taking the popular diabetes drug to help regulate his insulin. Type-2 diabetes increases a patient's risk for heart disease and other complications. However, Stanford's family doesn't believe it was a coincidence that he died the same day the study was published.
Peggie Stanford, a Dallas County resident, and her son Ryan filed their wrongful death suit against GlaxoSmithKline with the U.S. District Court for the Eastern District of Texas, Marshall Division, on June 19.
According to the GSK Web site, in 1999 Avandia (rosiglitazone maleate) was approved by the Food and Drug Administration. It is an oral anti-diabetic agent that acts primarily by increasing insulin sensitivity.
The Stanfords, along with their lawyer Stephen Drimion, allege the global pharmaceutical manufacture "unfairly" convinced the FDA to approve its drug, and then went on a "marketing assault" with a drug GSK officials knew was harmful.
"On May 21, 2007, Dr. Steven Nissen, a prominent cardiologist associated with the Cleveland Clinic, published a study in the New England Journal of Medicine with (evidence that Avandia could increase a patient's risk of a heart attack)," the suit said.
"GSK (was aware of Nissen's findings) since September of 2005."The suit alleges GSK concealed the evidence because such findings would diminish sales. "Apparently, the phenomenal profits that GSK accumulated between May of 1999 through the summer of 2005 were not enough."
"By September of 2005, GSK was in possession of evidence that could reasonably be expected to diminish the sales of its second largest selling drug, rosiglitazone," the suit said. "The evidence in its possession at the time was an overview analysis of approximately 42 different studies of patients using its drug, rosiglitazone. However, GSK provided only preliminary results of the analysis to the FDA in September 2005. The complete results of the study were not provided to the FDA for another year."
The suit goes on to say that during the following year of alleged concealment, GSK pressed its sales of Avandia to a distribution of approximately 13 million prescriptions in the U.S. "With a month's supply of rosiglitazone costing between $90 and $200, GSK was able to rack up sales of $2.2 billion in 2006 even though it was finally compelled to disclose the complete study results to the FDA in August 2006."
"GSK continued onward and upward with its sale of rosiglitazone after August 2006," the suit said. "Knowing that its drug was unreasonably dangerous and that the diabetic patient population was uninformed of the dangers, (the company) continued to expand sales of rosiglitazone to existing and new patients."
The suit faults GSK with negligently and recklessly failing to warn the general public of the risks associated with taking Avandia, product liability, marketing a defective drug,failing to provide adequate warnings, fraud, negligence, misrepresentation, expressed warranty for goods, warranty of merchant ability, warranty of fitness, unjust enrichment and wrongful death.
The plaintiffs are suing for damages to punish GSK for Stanford's death, funeral expenses, mental anguish, medical and counseling expenses, loss of companionship and suffering of plaintiffs' decedent.
Thursday, June 21, 2007
Who will be Seroxat Sufferers 20,000th visitor?
As you can see the counter is approaching 20,000. I just thought who may get the honour of being the 20,000th visitor.
The following have all paid visits to this site the past month so it could be them who receive the honour.
Glaxo., King Of Prussia, Pennsylvania
Glaxo, Raleigh, North Carolina
GlaxoSmithkline, Mississauga, Ontario
SmithKline Beecham, Ickenham, Slough, United Kingdom
SmithKline Beecham, North Weald, Havering, United Kingdom
Come on - the race is on - Which branch of Glaxo will it be?
FREE YEARS SUPPLY OF ALLI AND TOILET PAPER FOR THE WINNERS
The following have all paid visits to this site the past month so it could be them who receive the honour.
Glaxo., King Of Prussia, Pennsylvania
Glaxo, Raleigh, North Carolina
GlaxoSmithkline, Mississauga, Ontario
SmithKline Beecham, Ickenham, Slough, United Kingdom
SmithKline Beecham, North Weald, Havering, United Kingdom
Come on - the race is on - Which branch of Glaxo will it be?
FREE YEARS SUPPLY OF ALLI AND TOILET PAPER FOR THE WINNERS
GlaxoSmithKline Gets Social
GSK has launched a blog authored by their very own Steve Burton, VP of weight control for GSK consumer healthcare. (He of 'We have gone out of our way to be honest fame').
The blog is entitled 'Alliconnect' not to be confused with the amusing http://alliconnect.wordpress.com/
It seems GSK are now jumping aboard the blog bandwagon to publicise their products so I would like to take this opportunity to welcome them and thank them for highlighting just how low they will stoop to launch a product.
Alliconnect even has a forum... now why haven't GSK created a Seroxat forum for worried patients? I mean they have had many years to do so!
Alas, it is left to the sufferers to bang the drum warning over the dangers.
Bob
The blog is entitled 'Alliconnect' not to be confused with the amusing http://alliconnect.wordpress.com/
It seems GSK are now jumping aboard the blog bandwagon to publicise their products so I would like to take this opportunity to welcome them and thank them for highlighting just how low they will stoop to launch a product.
Alliconnect even has a forum... now why haven't GSK created a Seroxat forum for worried patients? I mean they have had many years to do so!
Alas, it is left to the sufferers to bang the drum warning over the dangers.
Bob
MHRA's role in Alli?
So what was the role of the MHRA in passing GlaxoSmithKline's new shit pill Alli?
Surely they saw the clinical trial data this time or did GlaxoSmithKline just show them the positive results... as they always do when trying to launch a new product.
I'm fascinated by the name 'Alli' - Ironically it is pronounced 'A LIE' and not Ali, as in Muhammed Ali.
Personally, I think the GlaxoSmithKline marketing team dropped a huge bollock on this one. Maybe, Alli is a subliminal message or a piss-take to the general public, meaning 'We can produce shit drugs and still get away with it?
This table intrigues me:
Surely they saw the clinical trial data this time or did GlaxoSmithKline just show them the positive results... as they always do when trying to launch a new product.
I'm fascinated by the name 'Alli' - Ironically it is pronounced 'A LIE' and not Ali, as in Muhammed Ali.
Personally, I think the GlaxoSmithKline marketing team dropped a huge bollock on this one. Maybe, Alli is a subliminal message or a piss-take to the general public, meaning 'We can produce shit drugs and still get away with it?
This table intrigues me:
Take a look at the adverse event section, Fecal Urgency.
22.1% of patients felt the need to take a dump whilst being 'under the influence' of Alli
6.7% of patients who NEVER took Alli (Placebo) also felt the need to take a rather large plop into the porcelain bowl.
What is the significance?
Are GlaxoSmithKline trying to weigh up the statistics with a natural urge here?
So some guy takes a sugar pill and thinks 'Hmmm, I know I may have took Alli and I know that it may cause me to poo... strangely, I feel like a poo now'
What are GlaxoSmithKline trying to say here?
Look, it clearly shows that people who took the sugar pill suffered with psychosomatic problems because they knew Alli caused the sensation of wanting a crap!
What utter bollocks!
Yet again, one of GlaxoSmithKline's drugs has slipped through those great minds at the MHRA.
Youtube and blogs are full of bad publicity for this drug - even rival pharmaceutical companies are making mock videos and posting them on youtube.
It's been a bad couple of months for GlaxoSmithKline what with the Avandia scandal and now this little shit popper called Alli...
...and I'm loving every minute of it
'TAKE MORE...SHIT LONGER'
GlaxoSmithKline Complaints Dept
"We've done everything to go out of our way to be honest,"
Steven Burton, vice-president weight control division of GlaxoSmithKline
alli
Wednesday, June 20, 2007
Alli - The Poem
ALLI - The Poem
So Glaxo launched its Alli
a pill to make us thin.
It's full of hidden side-effects
so where do I begin?
First it causes bum juice
of the smelly kind.
Be careful not to break wind
in spaces so confined.
Your stomach will be churning
and bubbling all day long.
I recommend dark trousers
a diaper or sarong.
Glaxo's big blockbuster
is sure to be a hit.
A pill to help us lose weight,
and one to help us shit!
Consider exercising
to keep that weight gain down.
Forget the pill that turns your pants
into the colour chocolate brown.
© Bob Fiddaman 2007
alli
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