Here is the very sad position of the Scottish Government in respect of baclofen use for alcoholism and my response (I promised Mr. Clark I would post his response on a public forum):
...I?m sorry if my letter was unclear. You have referred to the remit in your email. I should clarify that this is the remit of the SMC, not the Scottish Government Health Directorates as you have suggested. Also, in your email to Maureen Stark at the SMC, you state that I advised that ?the SMC has no remit to advise the profession about new indications for drugs licensed after 2002?. In fact, my letter explained that the remit of the SMC is to provide advice to NHS Boards and their Area Drug and Therapeutic Committees across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products (licensed from January 2002). The remit does not include the provision of advice to doctors on the use of off-licence medication.
I have been copied into the email Maureen Stark sent to you earlier today which accurately explains the position and I have nothing to usefully add to the information contained in Maureen?s email.
I hope this is helpful.
Regards.
Gordon Clark
Scottish Government Health Directorates
Pharmacy and Medicines Division
St Andrew?s House
Regent Road
Edinburgh
EH1 3DG
Tel: 0131 244 2523
Dear Mr. Clark
I apologize if I am misconceiving your department's remit. I don't understand your response. I wrote to the SMC on the advice of my GP, Dr N... ... who has been prescribing baclofen under the direction of both Drs. Jonathan Chick, the former head of NHS Lothian Psyciatry and editor of the Oxford Journal on Alcohol and Alcoholism, and Dr. Mathes Heydtmann Ph.D. who, along with Dr.Chick and other doctors, is using baclofen to treat chronic liver disease at the Royal Alexandra Hospital in Paisley. I had taken it upon myself to arrange for the translation into English of the results of a 1500 patient study into the use of baclofen to treat alcoholism in France. The doctors involved in that study, headed by Renaud de Beaurepaire have approved the translation as the official English version of their report and prescribing guide. That study lead to the French alcohol agency changing its position and advising doctors to begin prescribing baclofen off licence for alcoholism. It also precipitated the trials which are now underway in France to have baclofen licenced for alcoholism, in that country. After I alerted NICE to this, they referred baclofen to a newly set up committee to consider whether advice should be given on the best evidence for prescribing off licence medications. The approved version of the prescribing guide is now being circulated on an ad hoc basis, having been posted on various forums and internet sites relating to alcoholism treatment.
You have now written to me advising that the SMC has no role in this "new indication" for baclofen. I don't know whether this is because the drug was licensed before 2002 or because, in your words, it is "off licence". I would suggest that all "new indications" are initially "off licence" so that makes little sense to me. If the remit is limited by date then this appears to me to be an arbitrary fettering of the discretion of the SMC. If you are unaware of this concept I would commend this article to you which describes the "illegality" of such action by government agencies: http://www.publiclawproject.org.uk/d...eGroundsJR.pdf
I will quote from the article which shows that you are indicating the SMC are, in fact, acting illegally:
"Here, illegality can occur where the action, failure to act or decision in question violates the
public law principles set down by the courts for processes of this kind. These principles require
public bodies to:
... ensure that they have not fettered their discretion by for example applying a very rigid
policy as if it were legislation."
I would also point out that the failure to act in relation to this issue is more than likely to result in deaths. Indeed, it is certain to. Your position in respect of the remit of the SMC appears indefensible and you seem to gloss very lightly over the issue of the failure of this body to investigate a new indication when the most senior addictions researchers in this country use this medication and have published numerous paper on the drug.
Your email is also remarkable because you point out that the Scottish Government Health Directorates has no similar limitation on its remit. You fail, however, to respond to the substance of my enquiry, which is why, when this medication is being used in Scotland by senior, respected doctors to treat alcoholism, the Scottish Government is doing nothing at all either to assist in its use, advise doctors of its potential in this area or even make enquiries about the medication.
Your department is now on notice of this development, and the use of the drug in other countries. The drug is being used by doctors in Scotland and is being self prescribed by patients obtaining the drug over the internet. This is an extraordinary situation. My own GP advised that the prescribing guide should be made known to the medical profession but you seem to feel there is no need. Is that the case? This seems like an incredibly negligent position for a civil servant charged with a duty of care in public health matters to take.
Could you please advise me whether your immediate superior/line manager is aware of this position as I consider your position to be a gross dereliction of your and your department's duties.
I am sending a copy of this letter, as advised, to my MSP.
I look forward to hearing from you.
Yours sincerely
...I?m sorry if my letter was unclear. You have referred to the remit in your email. I should clarify that this is the remit of the SMC, not the Scottish Government Health Directorates as you have suggested. Also, in your email to Maureen Stark at the SMC, you state that I advised that ?the SMC has no remit to advise the profession about new indications for drugs licensed after 2002?. In fact, my letter explained that the remit of the SMC is to provide advice to NHS Boards and their Area Drug and Therapeutic Committees across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products (licensed from January 2002). The remit does not include the provision of advice to doctors on the use of off-licence medication.
I have been copied into the email Maureen Stark sent to you earlier today which accurately explains the position and I have nothing to usefully add to the information contained in Maureen?s email.
I hope this is helpful.
Regards.
Gordon Clark
Scottish Government Health Directorates
Pharmacy and Medicines Division
St Andrew?s House
Regent Road
Edinburgh
EH1 3DG
Tel: 0131 244 2523
Dear Mr. Clark
I apologize if I am misconceiving your department's remit. I don't understand your response. I wrote to the SMC on the advice of my GP, Dr N... ... who has been prescribing baclofen under the direction of both Drs. Jonathan Chick, the former head of NHS Lothian Psyciatry and editor of the Oxford Journal on Alcohol and Alcoholism, and Dr. Mathes Heydtmann Ph.D. who, along with Dr.Chick and other doctors, is using baclofen to treat chronic liver disease at the Royal Alexandra Hospital in Paisley. I had taken it upon myself to arrange for the translation into English of the results of a 1500 patient study into the use of baclofen to treat alcoholism in France. The doctors involved in that study, headed by Renaud de Beaurepaire have approved the translation as the official English version of their report and prescribing guide. That study lead to the French alcohol agency changing its position and advising doctors to begin prescribing baclofen off licence for alcoholism. It also precipitated the trials which are now underway in France to have baclofen licenced for alcoholism, in that country. After I alerted NICE to this, they referred baclofen to a newly set up committee to consider whether advice should be given on the best evidence for prescribing off licence medications. The approved version of the prescribing guide is now being circulated on an ad hoc basis, having been posted on various forums and internet sites relating to alcoholism treatment.
You have now written to me advising that the SMC has no role in this "new indication" for baclofen. I don't know whether this is because the drug was licensed before 2002 or because, in your words, it is "off licence". I would suggest that all "new indications" are initially "off licence" so that makes little sense to me. If the remit is limited by date then this appears to me to be an arbitrary fettering of the discretion of the SMC. If you are unaware of this concept I would commend this article to you which describes the "illegality" of such action by government agencies: http://www.publiclawproject.org.uk/d...eGroundsJR.pdf
I will quote from the article which shows that you are indicating the SMC are, in fact, acting illegally:
"Here, illegality can occur where the action, failure to act or decision in question violates the
public law principles set down by the courts for processes of this kind. These principles require
public bodies to:
... ensure that they have not fettered their discretion by for example applying a very rigid
policy as if it were legislation."
I would also point out that the failure to act in relation to this issue is more than likely to result in deaths. Indeed, it is certain to. Your position in respect of the remit of the SMC appears indefensible and you seem to gloss very lightly over the issue of the failure of this body to investigate a new indication when the most senior addictions researchers in this country use this medication and have published numerous paper on the drug.
Your email is also remarkable because you point out that the Scottish Government Health Directorates has no similar limitation on its remit. You fail, however, to respond to the substance of my enquiry, which is why, when this medication is being used in Scotland by senior, respected doctors to treat alcoholism, the Scottish Government is doing nothing at all either to assist in its use, advise doctors of its potential in this area or even make enquiries about the medication.
Your department is now on notice of this development, and the use of the drug in other countries. The drug is being used by doctors in Scotland and is being self prescribed by patients obtaining the drug over the internet. This is an extraordinary situation. My own GP advised that the prescribing guide should be made known to the medical profession but you seem to feel there is no need. Is that the case? This seems like an incredibly negligent position for a civil servant charged with a duty of care in public health matters to take.
Could you please advise me whether your immediate superior/line manager is aware of this position as I consider your position to be a gross dereliction of your and your department's duties.
I am sending a copy of this letter, as advised, to my MSP.
I look forward to hearing from you.
Yours sincerely
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