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H O U S E OF C O M M O N S
APPGITA - All Party Parliamentary Group for
Involuntary Tranquilliser Addiction
House of Commons, London SW1A 0AA
Letter from Jim Dobbin MP to
The Rt Hon Gillian Merron MP
February 2, 2010
February 2, 2010
Gillian Merron MP
Minister of State
Department of Health
London SW1A 2NS
Thank you for your letter dated 19.01.2010 in which you reply to my letter to Mike O'Brien dated 26.11.2010 on the subject of involuntary tranquilliser addiction. I would like to thank you for reading and acknowledging the APPGITA report and the personal attention you have given to this issue.
With regard to the update you have provided on the progress of the Department of Health's review of policy on addiction to prescription drugs I have to say that I am not happy with the arrangements that have been made. You have commissioned an expert review of evidence by the National Addiction Centre at Kings College London. It appears that much of the work of the review has now been delegated to the National Addiction Centre. In my view this has introduced a significant bias into the review.
A main cause of the continuation of the involuntary tranquilliser addiction problem is poor prescribing by psychiatrists, together with GPs. As a profession psychiatrists continue to mis-prescribe tranquillisers outside the guidelines. Psychiatrists are trained and experienced in looking for disorders in people's minds, not for problems with drugs. Professor Strang and Doctor Reed of the National Addiction Centre are both Psychiatrists. Our point of view is that this is a drug toxicity problem, not a mental health problem and that a more objective review of the properties of tranquillisers could be carried out by a pharmacist or a pharmacologist.
As far as tranquillisers are concerned this cannot be classified as an expert review because the National Addiction Centre does not have expertise in this field. The experts on tranquilliser dependence, tranquilliser withdrawal and the effects of long term tranquilliser use are Professor Heather Ashton, Professor Peter Tyrer and Professor Malcolm Lader. The NAC has specialized in treatment for those dependent, through misuse, upon illegal drugs and provides this group with maintenance treatment. The subject of the review is involuntary dependence upon prescribed drugs and the solution which we recommend is the provision of withdrawal services designed to achieve complete abstinence.
Also I am unhappy with the structure and composition of the Department's review. My information is that groups such as the Department of Health Mental Health Team, the National Treatment Agency and the MHRA have been designated as internal stakeholders to the review. Yet these groups have all been part of the problem. The Mental Health team, in particular the Senior Policy Adviser Dr Anna Higgitt, opposed our campaign for many years. The NTA systematically refuses to treat involuntary tranquilliser addiction.
The MHRA had a leading part in the creation of the problem of involuntary tranquilliser addiction through weak regulation. The MHRA's predecessor organization, the Committee of Safety on Medicines issued the benzodiazepines with Licences of Right without an assessment of their safety or efficacy. Information on the addictiveness and toxicity of these drugs was available to them in the manufacturers clinical trials from the 1950 s onwards. The World Health Organization Expert Committee on Drug Dependence warned in 1964 that the first benzodiazepine, Librium, was a drug of dependence. In the United States a Senate sub-committee inquiry was conducted in 1979 by Senator Edward Kennedy into the benzodiazepines. Even the Rolling Stones wrote a song about Valium in 1966 entitled "Mother's Little Helper".
Yet the MHRA ignored the warnings and did not accept that there was a problem until the 1980s. Even today the product information provided by the MHRA on tranquillisers is far below that provided in other jurisdictions. Warnings on teratogenicity, death by respiratory depression, suicide and addiction are below those provided in the USA, Canada, Australia and Scandinavia. The MHRA has conducted a long and determined defence of benzodiazepines and Z- drugs and opposed our campaign.
These criticisms of the MHRA are confirmed by the report of the Health Select Committee inquiry "The Influence of the Pharmaceutical Industry" in 2004-05. The HSC found that:
- (362) "Our inquiry revealed major failing in the regulatory system"
- (365) "The MHRA does not routinely examine raw data submitted with the licence application but is dependent on summaries provided by the applicant."
- (13) "Post-marketing surveillance in the UK is inadequate."
- (36) "We recommend that there be an independent review of the MHRA."
Therefore in my opinion the MHRA should be a subject of the present inquiry and not an internal stakeholder to it.
Meanwhile the world class scientific experts on tranquillisers listed above have been designated as "external stakeholders". The withdrawal charities Battle Against Tranquillisers and Council for Information on Tranquillisers and Anti-depressants, who have a 20 year track record of successfully withdrawing tranquilliser addicts, are also designated external stakeholders. Patient campaign groups are external stakeholders and the APPGITA is no stakeholder at all. I also understand that there has been no public consultation, meaning that individual victims have no opportunity to make their voice heard. In my view the bias and structure of the review is a recipe for a very limited and conservative report.
As you may know we consider involuntary tranquilliser addiction to fall within the definition of disability given by Paragraph 3 (2) of Statutory Instrument 1996 No.1455 "The Disability Discrimination (Meaning of Disability) Regulations 1996". We have an ongoing complaint with the Equality and Human Rights Commission and our understanding is that the above mentioned Department of Health review arrangements do not comply with the Disability Discrimination Act 1995 in that victims of these drugs have a right to be involved in the policy making process.
In our view presumptions have already been made and false parameters have been set for the review. For example in your recent letter (19.01.2010) in your section about prescribing figures you separate Clonazepam and Clobazam off from the other benzodiazepines on the grounds that they are licensed for epilepsy and not for insomnia or anxiety. However the problem is that, as for all benzodiazepines, doctors do not observe the licensed indications. Clonazepam and Clobazam are prescribed for anxiety and insomnia and for other inappropriate reasons as well. Therefore my question here is will the review make the same presumptions as your letter, that Clonazepam and Clobazam are seperate, used as indicated and not problematic?
A second set of presumptions are contained in the paragraph dealing with Z-drugs "Over the same period, the number of Z-drug prescription items has risen but, according to the March 2009 edition of the BNF, these drugs are indicated for short- term use only for insomnia. According to the BNF, dependence has been reported in a small number of patients. As the table shows, there has been a large fall benzodiazepine prescription items dispensed for both anxiolytic and hypnotic purposes over the last two decades."
The first presumption here is that BNF information is always accurate, we believe that BNF information on tranquillisers should be improved and the process of producing BNF information should be looked at. The second presumption is that doctors always follow the prescribing guidelines and prescribe Z-drugs for short term use only, we believe doctors often ignore this guideline. A third presumption, or proposition, is that dependence is occurring in only a small number of Z-drug patients.
These three presumptions are then joined together to underwrite the Department of Health's contention that the statistical transfer of large numbers of patients from benzodiazepines to Z-drugs is an improvement . We believe Z-drugs to be at least as addictive and toxic as benzodiazepines and the transfer is not an improvement. The question arises, will the Department of Health's review of addiction to prescription medicines pre-judge issues in the same way that the letter has?
A weakness of the prescribing information provided on tranquillisers by the BNF and SPC is that there is no indication of the incidence of Adverse Drug Reactions (ADRs). With other medication the warnings listed often refer to 1/10,000 chances or 1/20,000 chances, which are remote or theoretical risks. With tranquilliser warnings the odds are much shorter, many tranquilliser ADRs are 1/3 or 1/1 chances. Cognitive impairment from tranquillisers, for example, is a certainty and bound to happen from the ingestion of the first tablet. This may be one reason why doctors ignore the prescribing guidelines- they may assume that normal ADR odds apply to the ADRs listed for tranquillisers.
In summary I have complained that the commissioning of the National Addiction Centre has introduced bias into the review and that the structure of the review is unfair in that groups responsible for the problem are part of the review and have been given priority over experts on and victims of tranquillisers. Also several presumptions contained in your last letter may be carried over into the review thereby pre-judging contentious issues. In connection with this I would like to request from you copies of the terms of reference for each of the three parts of the review; the terms of reference the Department of Health has set for itself; the terms of reference set for the review manager Anne Grosskurth; the terms of reference that have now been set for the National Addiction Centre.
Despite all this we still welcome and support the review and would like to thank you for the inclusion of important and previously overlooked issues in the review such as the extent to which doctors are not warning patients, the prevalence of dependence, support services and the effects of long-term use of addictive medicines. In connection with the last issue I have enclosed two lists of scientific articles, both compiled by Reg Peart.
"Extracts from Articles in Medical Publications on the Physical, Psychological and Social Decline of Long Term Benzodiazepine Users"
"The Benzodiazepines: Toxicity, Cognitive Impairment, Long Term Damage and the Post-Withdrawal Syndrome."
Finally, I would like to inform you that I have written to Alan Johnson at the Home Office asking for tranquillisers to be considered for reclassification and/or rescheduling according to the provisions of the Misuse of Drugs Act 1971.
Jim Dobbin MP
cc. Professor Heather Ashton, Sarah Teather MP, Phil Woolas MP, Greg Mullholland MP, Lord Sandwich, Dai Davies MP, Barry Haslam, Paul Flynn MP, Anne Grosskurth, Brian Iddon MP, Pam Armstrong, Claire Curtis-Thomas MP, Una Corbett, John Grogan MP, Lord Mancroft, Rt Hon Sean Woodward MP, Baroness Masham, Equality and Human Rights Commission, Kelvin Hopkins MP, Rt Hon Alan Johnson MP, Kerry McCarthy MP
Email Jim Dobbin MP
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