Letter to G Merron MP from Lord Sandwich

Gillian Merron MP,

Under-Secretary of State,

Department of Health 17 December 2009

I am writing to you as the Minister responsible for drugs and drugs policy. You may remember that I asked you a question at the recent meeting of the All-Party Group on the Misuse of Drugs, and I wanted to give you a little more background.

A member of my family has been withdrawing from the prescribed drug clonazepam since last January, and has recently benefited from a cross-over to citalopram followed the advice of Pam Armstrong of CITA in Liverpool. You can imagine the pain and distress that this has caused him, and all my family, over the last few months. During this time he has received no help from the health services, since there are none.

Following exchanges with Baroness Thornton in this House during my question on November 3rd (1) I am well aware that the Department is conducting a review of policy concerning prescribed drugs, with a report to be published ‘later in the spring’. However, with the election coming on and the wide range of issues to be examined, I am very concerned that this review may not be given the priority and resources it deserves.

Accordingly I have put further questions down this week, and I have applied for a short debate in January or early February. I am copying this letter to colleagues in this House, including Lord Williamson, Lord Crisp, Lord Ashley and others who I hope may be able to speak in this debate, and to members of Parliament who have taken an interest in the issue.

Yours sincerely,

Earl of Sandwich

(1) http://www.publications.parliament.uk/pa/ld200809/ldhansrd/text/91103-0001.htm

Letter to the Department of Health

Thursday 26 November 2009

RT. Hon. Mike O’Brien MP

Minister for Health Services

Department of Health

All Party Parliamentary Group on Involuntary Tranquilliser Addiction

Dear Mike,

I have received a letter from you dated 30 October 2009 in response to my letter to Gillian Merron on the subject of Involuntary Tranquilliser Addiction. Unfortunately your reply does not answer the content of my letter. The reply is a summary of a Department of Health policy position and is a standard information letter which has been sent out for several years in response to enquiries and complaints from MPs and members of the public on this subject. The correspondence clerk seems to be unaware that the policy changed some months ago. The DoH has accepted that change is necessary on this subject and is conducting a review of policy on addiction to prescription drugs. The review was announced by Gillian Merron in response to PQ264896 and was explained and debated in Westminster Hall on 16 June 2009 and in the House of Lords on 3 November 2009.

Your correspondence clerk also provided me with benzodiazepine prescription totals for the years up to 2005, with a comment for me to note that benzodiazepine prescription numbers had fallen, if 1995 is taken as a base year. However these are not the latest figures. On 18 May 2009 in answer to Parliamentary Question 274692 Dawn Primarolo MP provided a benzodiazepine prescription total of 11,439,000 for 2008 which is an increase on 2005 (11,252,113) and shows a recent upward trend. Also, I have written as chair of the All Party Parliamentary Group on Involuntary Tranquilliser Addiction which means all prescribed tranquillisers and so the relevant figure should be the total benzodiazepine prescriptions plus the number of Z tranquilliser prescriptions. In the same answer to PQ 274692 Dawn Primarolo gave the Z drug prescription total for 2008 as 5,665,000. This gives a grand total of 17,104,000 tranquilliser prescriptions for 2008, the highest total figure since 1992.

An article in the Independent newspaper of 31 October 2009 entitled “Action on Britain’s pill addiction” reports a DoH spokesperson making a similar claim, that prescribing of benzodiazepines had declined substantially in the last ten years. The spokesperson is also reported by the Independent to have referred to the “misuse” of prescription medication, thereby characterising involuntary tranquilliser addicts as drug misusers, with an inference that they are responsible for their own addiction. The overwhelming majority of tranquilliser addicts are involuntary addicts and not drug misusers at all. They have been introduced to these highly addictive drugs by trusted GPs and psychiatrists with no proper warning of the dangers involved. Patients are led to believe that the drugs are a medicine, they have no opportunity to make an informed choice and become addicted through no fault of their own. Therefore use of the term misuse is regarded by involuntary tranquilliser addicts as an insult and a stigmatization.

This issue has arisen before, in 2007 the same terminology was used by Rosie Winterton MP whilst Health Minister in correspondence with campaigner Barry Haslam of Oldham. In response to a complaint by Michael Meacher MP Rosie Winterton apologised, in a letter dated 17 March 2007.

The use of this word is significant and is connected to the old policy on addiction to prescription drugs. Applying the term drug misusers to involuntary tranquilliser addicts includes them within a particular psychological model in which drug misuse is seen as a chronic relapsing condition. Misusers are considered resistant to treatment and in need of an indefinite maintenance dose.

However, addiction to tranquillisers is not caused by flaws or weaknesses in the people addicted, it is caused by negligent prescribing and by the extreme addictiveness of the drugs. Organisations such as the Council for Involuntary Tranquilliser Addiction (CITA), Battle Against Tranquillisers (BAT), the Oldham Tranquilliser project and the benzodiazepine cessation project in Belfast demonstrate continuously that the misuser label is wrong. These specialized tranquilliser withdrawal services have consistently withdrawn tranquilliser addicts safely and successfully for many years.

The withdrawal methods used by all these organisations are based on the slow tapering method developed by Professor Heather Ashton in her benzodiazepine withdrawal clinic at Newcastle University in the 1980s. The withdrawal is based upon scientific understanding of the pharmacokinetic properties of each drug and recognition of their high potential to cause addiction. Each patient is provided with proper information on their drug or drugs. Withdrawal may take from six months to two years. An individualized and flexible withdrawal schedule is designed for each patient and the patient is given regular face to face support and reassurance.

Addiction to prescription drugs is a serious illness and has become a worldwide medical problem. Professor Ashton’s tapering method has been adapted for withdrawal from other addictive prescribed drugs such as SSRI anti depressants. It is used worldwide and her withdrawal manual has been translated into several languages. It is a valid and important medical treatment which originated right here in the U.K. yet it has been repeatedly overlooked by the Department of Health.

In my opinion this method should be adopted by the Department of Health as best practice. This treatment should be provided in special clinics throughout the National Health Service using the existing clinics and their staff as a foundation. I welcome the current review by the Department of Health on their policy on addiction to prescription drugs as an opportunity to introduce this treatment.

Unfortunately there are groups which oppose the introduction of tranquilliser clinics. The enquiry and report by Brian Iddon MP and the All Party Parliamentary Drug Misuse Group was useful in that it helped to bring this issue to the attention of the Department of Health. However the reports section on tranquillisers is misleading and the recommendations do not include a network of withdrawal clinics. Consequently it was necessary for the APPGITA, of which I am chair, to produce an alternative report. This APPG was set up specifically to deal with the tranquilliser problem. We have access to a great deal of experience and expertise from clinics, campaigners, ex-addicts and Professor Ashton. Brian Iddon’s group have no such experience, qualification or knowledge on this subject. Their report dilutes the evidence of the enquiry witnesses, under reports the tranquilliser problem and makes inadequate recommendations.

The purpose of this letter is to try and clarify some of the complex issues around tranquilliser addiction, to urge ministers to take heed of the advice made available by the APPGITA and to ask them to use the current review as the opportunity to introduce specialized tranquilliser withdrawal clinics as a successful, cost effective treatment for addiction to a prescription drug. As chair of the APPG I would value a discussion on the content of this letter in order to arrive at a clear and transparent view on the real problems faced by victims of this iatrogenic illness.

I have enclosed a copy of the APPGITA alternative report. This letter is for the personal attention of the Minister.

Kind regards

Jim Dobbin MP

OMAND REVIEW OF THE ACMD

SUBMISSION BY

JIM DOBBIN MP

I am chair of the All Party Parliamentary Group on Involuntary Tranquilliser Addiction (APPGITA) which was set up to raise awareness of the problems associated with involuntary tranquilliser addiction. Tranquillisers are highly addictive and toxic prescribed drugs. The tranquilliser drug group consists of the older benzodiazepines such as Diazepam/ Valium and Lorazepam/ Ativan and the newer “Z” drugs such as Zopiclone. Tranquillisers are heavily over prescribed by the medical profession, with over 17 million prescriptions in 2008 and an estimated 1.5 million patients dependent at any one time. Those dependent may suffer side effects whilst on the drug, a severe withdrawal syndrome which can last from 6 months to two years. Withdrawn patients may realise that they have suffered long term or permanent damage. The Department of Health is currently conducting a review of its policy on addiction to prescribed tranquillisers as part of a review on policy on addiction to prescription drugs in general.

Tranquillisers have been successfully over promoted by their manufacturers. In reality they have limited medical use and rapidly lose their efficacy. Prescribing guidelines restrict their use to 2-4 weeks but patients are often left on them for decades. There are numerous harms associated with their prescribed use but tranquillisers also have a high potential for misuse and have increasingly become a drug of misuse.

On the 7 April 2003 the tranquilliser campaign group then known as “Beat the Benzos”, led by Phil Woolas MP, John Grogan MP and Jim Dobbin MP attended a meeting with the then Home Office Minister Bob Ainsworth MP. The outcome of the meeting was that the group was invited by the Minister to make a submission to the ACMD on the harms associated with tranquillisers, with the intention of stimulating the ACMD to investigate the problem. In response to a written Parliamentary Question by John Grogan MP Bob Ainsworth MP repeated this invitation. This was the correct procedure according to the Misuse of Drugs Act and prescription drug harm falls within the remit of the ACMD. Consequently we expected the ACMD to give serious and proper consideration to the submission.

On the advice of the ACMD Technical Committee chaired by Professor Nutt the ACMD concluded that the reclassifying and/or rescheduling of benzodiazepines would be likely to be ineffective. At the time we were concerned that the Technical Committee had not given the submission proper consideration. The ACMD minutes later confirmed that the submission and attached evidence had been dealt with by a brief discussion, the issues raised were not addressed and no evidence scientific or otherwise was produced to validate the decision of the Technical Committee. The ACMD full Committee and the Technical Committee did not discuss benzodiazepine related deaths, benzo-babies, benzodiazepine date rape, the social cost of benzodiazepine dependence or the proposition that benzodiazepines had become a fully fledged drug of abuse.

We subsequently discovered that Professor Nutt had a serious conflict of interest in that he had a financial arrangement with the benzodiazepine manufacturer John Wyeth and Brother Ltd. Professor Nutt was in receipt of an honorarium and a research grant from Wyeth. Furthermore Professor Nutt did not disclose that conflict of interest in his dealings with us. This gives rise to a strong suspicion of bias on the part of Professor Nutt. Wyeth are the inventors and manufacturers of Ativan a controversial and notoriously addictive benzodiazepine. Ativan has been the subject of litigation in various jurisdictions including Australia, Ireland and Scotland. There were over 4,000 cases in the U.K. claiming manufacturer negligence and drug injury, although they were struck out on procedural grounds. Ativan has been implicated in celebrity deaths most recently that of Michael Jackson.

It is the purpose of this submission to argue that conflicts of interest are unacceptable for members of regulatory bodies such as the ACMD. It is not my purpose here to revisit the merits of the original 2003 submission although I have included a copy of it with the attachments (A) However I do intend to ask the Home Secretary for permission to return the 2003 submission to the ACMD on the grounds that he can have no confidence in the previous decision and advice.

The conflict of interest I have outlined above is only a small part of Professor Nutt’s financial arrangements with the pharmaceutical industry. In my view this is most important issue and the underlying cause of the Nutt affair. I believe the debates over scientific independence and freedom of speech are red herrings which have diverted attention away from the real issue.

A brief search gives the following results. The Medical Research Council website register of members interests (attachment B) shows Professor Nutt has consultancies with Sanofi, Aventis and Lundbeck; speakers fees from Eli Lilly, Glaxo Smith Kline and Bristol Myers Squibb and share options with Pivotal. According to a disclosure in a recent article in the Journal of Psychopharmacology “Prescribing antidepressants post Cipriani et al.”(attachment C) Professor Nutt also has grants, speakers honoraria or fees from Pfizer, Solvay Pharmaceuticals, Cypress Bioscience , Forest Labs., Organon and Wyeth. My information from academics is that these will all be substantial amounts in the region of £10,000 - £20,000 each. I would like to suggest that it would be beneficial if your review could obtain exact figures for each of the above interests and. also figures for the other members of the ACMD who have or had financial links with the pharmaceutical industry, particularly those who resigned in support of Professor Nutt.

Professor Nutt has repeatedly claimed in the media that he is an independent scientist working for the ACMD for no pay. It is my contention that Professor Nutt is in reality a campaigner and lobbyist for the pharmaceutical industry and he is well paid by them for the work he does. Professor Nutt is involved in numerous campaigns across the spectrum of prescribed and illegal drugs. He is involved in the development of “safe” recreational drugs, cognitive enhancers for healthy people, vaccinations against drugs, mood altering drugs and psychedelic treatments (LSD) for mental illness. Evidence for this is contained firstly in the “Drugs Futures 2025” literature of the Foresight think tank I have included their “Executive Summary and Overview” booklet in the attachments(D). Professor Nutt is the “Project key science expert” for Foresight. Secondly Professor Nutt is a Scientific Advisor to the Beckley Foundation who campaign for the legalisation of cannabis ,LSD and magic mushrooms.(Attachment E).

Professor Nutt has made no secret of his intention to replace the existing system of drug regulation at the ACMD with a new system designed by himself. The new system would end the distinction between legal and illegal drugs and would be the vehicle for the drug legalisation and normalisation which Professor Nutt advocates. The strategy set out in the above literature is to replace existing illegal drugs with Pharmacological Alternatives (PA) which would be licensed and certified as safe by the new regulatory system. This would capture huge markets and huge profits for the pharmaceutical industry. In my opinion this is the objective behind Professor Nutt’s agitation and the real cause of the current controversy.

My main recommendation is that ACMD members should no longer be allowed to have financial links with the pharmaceutical industry. The recently introduced ACMD Register of Members’ Interests should be improved so that members be required to make complete declarations, non-specific entries such as “independent consultant” should not be acceptable. For clarity an appropriate Code of Ethics should be designed for the ACMD Register to inform members of when conflicts exist and how they should be avoided. This is in addition to the existing Code of Conduct. I have attached information on Conflicts of Interest and Codes of Ethics (4).

There is also a possibility that conflicts of interest for pharmaceutical regulators are illegal under European law. In a Parliamentary Debate on the MHRA in November 2004 the then Health Minister Melanie Johnson MP informed the House of Commons that “we will bring UK policy into line with the new EU legislation on these matters, which requires experts should have no financial or other interest in the pharmaceutical industry which could affect their impartiality.” I have included a copy of the Hansard for this as attachment (G). I intend to request more information on this legal point by tabling a Parliamentary Question. I have also attached (HI) a copy of Early Day Motion 787 which I tabled 11.02.2009 calling for the resignation of Professor Nutt and a copy (JK) of correspondence with the ACMD, the Home Office and Professor Nutt on this issue.

Jim Dobbin MP 09.11.2009.