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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.

Letter to Dr Iddon MP re Evidence Session 06/2008

Please click on images for larger view.

Debate on Health: Side Effects of Medication

Parliamentary Debate

The Earl of Sandwich, House of Lords, Tuesday November 3rd, 2009

Health: Side Effects of Medication

Question

2.41 pm

Asked By The Earl of Sandwich

To ask Her Majesty’s Government how they will ensure that doctors and pharmaceutical companies fully recognise the long-term side effects of prescribed tranquillisers and antidepressants, and the nature of withdrawal symptoms.

Baroness Thornton: My Lords, the Government are aware of concerns around prescribing these medicines, particularly after the report of the All-PartyParliamentary Group on Drugs Misuse. The Department of Health is undertaking a review of addiction to medicines which is due to report next year, and of course the Medicines and Healthcare Products Regulatory Agency continuously monitors the safety of medicines on the UK market and issues advice to raise awareness of the potential for side effects.

The Earl of Sandwich: MyLords, I thank the Minister for her reply and I welcome the review. Can she confirm that there are approximately 1.5 million people in the UK who are addicted to prescribed drugs such as benzodiazepines? I declare an interest. A member of my family is confined to his room; he is trying to withdraw from one of these drugs. He cannot work or take the children to school. There is no government benefit or assistance for people in his situation. Can the Government confirm that they are getting on with a proper NHS network of support for these patients?

Baroness Thornton: The noble Earl is, I fear, not alone in direct experience of what can happen to people who suffer from withdrawal reactions to these drugs. There are support services available in some areas of the country which have a good success rate in helping people to withdraw from medicines to which they have become inadvertently addicted, but we recognise that the availability of these services is variable and patchy. Our review will seek to identify what needs to be done to better support people experiencing these problems. We will also review the services that are currently provided in order to gauge the level of support available, and draw on best practice to ensure that we get full cover and support for people in these situations.

Lord Ashley of Stoke: My Lords, have the Government made their own special study of the effects of these tranquillisers? Are they able to impose their views on doctors and pharmaceutical companies? Does the Minister agree that pharmaceutical companies can be far more resistant to pressure from the Government than doctors and that it will require much stronger pressure on the companies than on the medical professions?

Baroness Thornton: My noble friend asks a very pertinent question. Product warnings are kept under close review. One example of this relates to products containing codeine, where new, hard-hitting warnings such as “can cause addiction” and “for three-day use only” on the front of the pack will be introduced next year. Guidance to the healthcare professions will be considered as part of the review that is taking place.

Lord Williamson of Horton: My Lords, I declare an interest as a patron of Rethink, the mental health charity, which does excellent work. There is also the medication helpline of the Maudsley Hospital. Will the Minister consider whether there could be improvements in the information available to those who suffer from mental health problems as the result of withdrawal from prescription drugs? There may be a gap there that we could help to fill.

Baroness Thornton: The noble Lord makes an important point, and the review will be looking at that. There are examples in Liverpool and Bristol of counselling information, education and advice being made available to people, but the noble Lord points to the importance of telling people who are being prescribed these drugs what the side effects might be.

Lord Elton: My Lords, will the inquiry bear in mind the advisability of advising doctors not merely on the dangers of addiction but on the method of keeping in view the condition of people for whom they prescribe these drugs long-term, and who will become addicted without their own knowledge unless they are carefully monitored?

Baroness Thornton: There is a great deal of information available to prescribers of these drugs: the British National Formulary; product information; the National Prescribing Centre, which has an excellent record;

and—for the treatment of depression, for example—NICE 113 Introduction [3 NOVEMBER 2009] Health: Side Effects of Medication 114 [BARONESS THORNTON] guidance talks not only about the effect of prescribing but about the need to provide other therapies to people who are suffering from depression.

Baroness Barker: Does the Minister agree that it would be beneficial if all pharmaceutical companies were required to print information about the half-life of tranquillisers and anti-depressant drugs, so that individuals trying to manage the process of coming off them could do so knowing what the effects were likely to be over a short period?

Baroness Thornton: In answer to a Question put by my honourable friend Jim Dobbin, the Minister said that:

“The half-life of a drug intended for use as a sleeping tablet is only one of many factors that influences the safe use of a medicine. Information to aid … safe use … is provided in the product information which consists of the Summary of Product Characteristics…and the Patient Information Leaflet”.—[Official

Report, Commons, 20/5/09; col. 1435W.]

The key point is that those resources are used at the right time.

Lord Crisp: My Lords, in setting up the review, will the Minister ensure that it takes full account of implementation? She will know as well as I do that there is a difference between policy and implementation. Does she have any thoughts about how to ensure that this policy, which needs to be a very personal one to every member of the primary care team, is disseminated so that people are not only aware of it but follow it in practice in all the individual cases that we are talking about?

Baroness Thornton: The review will be completed next year, with a report published later in the spring. We are doing a counting exercise, reviewing evidence of the prevalence of addiction, effective treatment and the long-term effects of the use of a range of antidepressants, sleeping pills and codeine-based painkillers. That will influence future policy. The noble Lord is right, though, that the policy leadership within the department has to address how to ensure that this is rolled out and how to use the machinery and levers that we have to ensure that it is implemented.

Baroness Gardner of Parkes: My Lords, does the Minister agree that these drugs are obviously very complicated and must be of benefit to a number of patients or they would not be in such common use? Does she have any figures on the percentage of people who become addicted?

Baroness Thornton: I do not have any figures on the percentage of people who become addicted. That is part of the exercise that we are undergoing. The noble Baroness is right that we must not forget the impact of depression, for example, on sufferers, and that depressive illness is a debilitating condition. One in four women and one in 10 men in the UK is likely to suffer from depression at some point in their lives, and these drugs will help to transform their lives and enable them to cope and recover.

Lord Acton: My Lords, does my noble friend agree that “next year” is a rather long and elastic time? Could the review not be tightened up a bit?

Baroness Thornton: We are moving with all speed because we know that this is important, but I promise my noble friend that I will take his views back to the department and see if there is any way that we can hurry up.

Parliamentary Copyright House of Lords 2009

Announcement

There will be a short debate on tranquillisers in the House of Lords on Tuesday 3 November at 2.30 pm. It may be televised on the parliament channel or parliament website.

Early Day Motion

EDM 2164

WITHDRAWAL FROM PRESCRIPTION DRUGS
27.10.2009


Dobbin, Jim

That this House congratulates Pam Armstrong of the Council for Information on Tranquilliser and Anti-depressants and Doctor Ghosh Arun and the nursing staff at the Sefton Suite of the Aintree Hospital in Liverpool for setting up the first in-patient withdrawal facility for patients involuntarily addicted to prescription medication; congratulates Sandwell Primary Care Trust, Birmingham for partly funding this facility; further congratulates the Department of Health for undertaking a review of its policy on addiction to prescription medication; and urges the Department of Health to establish a national network of specialist out-patient clinics to treat those addicted to tranquillisers and other prescription medications, and regional in-patient clinics like the Sefton Suite for those too addicted to withdraw at home.

Letter to A Grosskurth, Dept. of Health

All Party Political Group on Involuntary Tranquilliser Addiction

21 October 2009

Dear Ms. Grosskurth,

I understand that you are conducting a Department of Health policy review on addiction to prescription drugs. A large part of this problem is Involuntary tranquilliser addiction. I am chair of the APPG on Involuntary Tranquiliser Addiction, which was set up specifically to deal with this problem. We are campaigning, amongst other things ,for specialized tranquilliser withdrawal clinics and services designed to give involuntary tranquilliser addicts the opportunity to become drug free.

I would be very grateful if you would meet with me to discuss this issue. My diary secretary will be able to offer you some dates so that we can arrange a mutually convenient appointment. The telephone number is 0207 219 4530. I look forward to hearing from you.

Yours sincerely

Jim Dobbin MP