APPGITA

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2010-07-18T17:40:00.008+01:00

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Letter to G Merron MP from Lord Sandwich

2009-12-20T18:12:00.006Z

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

2009-12-20T17:57:00.014Z

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

2009-12-12T11:58:00.003Z

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

2009-11-16T10:38:00.006Z

Please click on images for larger view.

Debate on Health: Side Effects of Medication

2009-11-11T12:05:00.012Z

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

2009-10-29T15:04:00.003Z

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

2009-10-29T09:53:00.003Z

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

2009-10-28T14:38:00.009Z

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

Letter to Gillian Merron

2009-10-28T14:19:00.001Z

APPG for Involuntary Tranquilliser Addiction

Gillian Merron MP
Department of Health

20 October 2009

Dear Gillian,

I would like to thank you on behalf of the APPGITA for your visit to the Oldham tranquilliser clinic and for the encouragement you gave to the patients and staff. I would like to meet with you to discuss the current review of Department of Health policy on addiction to prescription drugs. Involuntary tranquilliser addiction is a large part of the subject matter under review. This APPG was set up to deal specifically with the problem of ITA and we have access to experience and expertise on this subject.

Our campaign has been for specialist withdrawal clinics and services to be provided to deal with this problem and provide people with the opportunity to become drug free. I would like to be consulted at the political level on this subject and to be included in all consultations.

Kind Regards,
Jim Dobbin MP.

c.c.Phil Woolas MP.

Health Minister's Visit to Oldham

2009-09-22T15:05:00.004+01:00

The following is a news article from the Oldham Evening Chronicle:

‘Rebuilding lives’

Reporter: JANICE BARKER
Date online: 22/09/2009

Drugs help service is leading the way

A model of good practice — that’s the verdict of health minister Gillian Merron after visiting Oldham’s specialist service for prescription drug addicts . . . and it could be copied in other parts of the country.

The public health minister talked to addicts who are getting their lives back after being helped to come off benzodiazepines and other prescribed drugs at the Addiction Dependency Solutions centre in Greaves Street.

Ms Merron has already set up a review of the problems of addiction to legal drugs. And a health specialist has visited Oldham campaigner Barry Haslam, who fought his own addiction to Ativan, for his views.

After meeting health professionals, ADS staff and clients yesterday, the minister said: “This is a model of good practice which is why I was very keen to look at it as part of the review.” Asked if the Oldham model could be repeated, Ms Merron added: “I am very interested in seeing if we can.

“It is the kind of thing we can look at. Clearly, they do an excellent job in Oldham and the whole team is to be congratulated.

“Individuals have been generous in their honesty in telling me their experiences. They are very positive about rebuilding their lives with the help of this service.”

Care is given by Suzanne Atreides and Angela Rankin, benzodiazepine withdrawal support workers.

They are invited by GPs to help patients to reduce their addiction.

One client, a 34-year-old single Oldham woman, said: “Without Suzanne and the support of the group, I would never have known that when I was angry or crying, it was not me it was the drugs.” Wendy Kay, area director of ADS, said the service — paid for by NHS Oldham, the primary care trust — is putting a business case to the trust to double the service from one full-time and one part-time worker to three full-time workers.

She added: “If we had three workers we could go into every GP surgery in Oldham — we only do a third at the moment.”

After talking to the minister, Barry Haslam said: “I have been waiting at least 20 years for this — I am delighted.”

(PHOTO . . . (from left) Suzanne Atreides, Gillian Merron, Barry Haslam and Immigration Minister and local MP Phil Woolas)

DIRECT LINK TO ARTICLE

Public Health Minister to visit Oldham Tranq. Clinic

2009-09-12T11:08:00.002+01:00

Gillian Merron MP, the Public Health Minister, is to visit the Oldham Tranquilliser Clinic on 21 September. Also visiting will be Phil Woolas MP and Jim Dobbin MP.

Michael Jackson

2009-08-25T16:39:00.004+01:00

Press Release
25 August 2009
from Jim Dobbin M.P., Chair of the All Party Parliamentary Group on Involuntary Tranquilliser Addiction.

Sky News and the Times are reporting today that Michael Jackson's death has been ruled to be a homicide and that the drugs found in his body included the anaesthetic Propofol but also the benzodiazepine tranquillisers Ativan (Lorazepam),Valium and Midazolam.

I would like to comment on the dangers of the benzodiazepine tranquillisers involved. In 2004 the Canadian Ativan data sheet contained the warning that "Use of benzodiazepines,including lorazepam may lead to potentially fatal respiratory depression." It also contained a seven day addiction warning and suicide warning ,for lorazepam.

Phil Woolas M.P. wrote to Sir Alastair Breckenbridge, Chair of the U.K. drug licensing authority the MHRA,in 2004 asking for similar warnings to be introduced into the U.K. product information.The warnings were never introduced and in fact no product information sheet for lorazepam tablets was published at all in the U.K. in 2009, despite the increased number of licenses issued.

Tranquilliser related deaths in the U.K. are running at some 300 per year, in some years they have exceeded the total number of deaths for all class A drugs added together, according to Home Office figures. In answer to a Parliamentary question the Department of Health reported that in 2008 over 17 million tranquilliser prescriptions were issued in the U.K., an increase on 2007. My question is how many people have died a Michael Jackson type death in the U.K. and elsewhere, but with no homicide investigation or any other kind of investigation.

Tranquillisers are highly addictive yet the Department of Health provides no withdrawal treatment at all except for one worker in Belfast and two in Oldham. The All Party Parliamentary Group on Involuntary Tranquilliser Addiction (APPGITA) is campaigning for the introduction of specialized tranquilliser withdrawal services by the Department of Health.We are also campaigning for medical research into the damage caused by tranquillisers, a review of the benzodiazepine product licenses which were issued with no assessment of safety or efficacy and a no-fault drug compensation scheme for patients who suffer drug injuries.

Jim Dobbin M.P.

DoH Review

2009-08-20T13:42:00.001+01:00

The Department of Health has undertaken a review of policy on addiction to prescribed and over-the-counter medication with the intention of producing a report in December 2009.

The review manager is Anne Grosskurth and her address is:

Department of Health
133-135 Waterloo Road, 616
LONDON
SE1 8UG

Letter from Home Office re ACMD

2009-08-20T13:38:00.007+01:00

Please click on image for larger view.

Withdrawal Services Campaign Support

2009-07-28T18:00:00.006+01:00

"Gillian Merron MP is the new Minister of State for Public Health (appointed 8th June 2009). In two recent answers to Parliamentary questions she indicated that the Department of Health is about to undertake a review of its policy on addiction to prescription drugs and over the counter medicines, including tranquillisers.

This is an important point in our campaign for tranquilliser withdrawal services. The APPGITA has requested to be directly involved in the review process, and I have asked the Department of Health to listen to the advice of Professor Heather Ashton, Pam Armstrong of CITA and Una Corbett of BAT.

I would like to ask people to write directly to Gillian Merron MP at the Department of Health in support of our campaign, and also to lobby their own MP to write to Gillian Merron.

Jim Dobbin MP"

Parliamentary Question - 20 July 2009

2009-07-24T20:27:00.012+01:00

Column 1006W

Tranquillisers

Jim Dobbin: To ask the Secretary of State for Health which (a) policy advisers, (b) special advisers, (c) other individuals and (d) other groups have provided advice to his Department on the subject of tranquillisers in the last two years; and what expertise each has to advise on that subject. [264896]

Gillian Merron: The Department is not aware of any advice given by policy advisers, special advisers, other individuals or advisory groups specifically in relation to tranquilisers. The Commission on Human Medicines, the UK Health Ministers’ independent safety experts and advisers, provides scientific advice on all medicines for human use before a product is given a marketing authorisation or if any post marketing safety issue arise.

Over the coming months the Department will be reviewing its policy on addiction to prescriptions and over the counter (OTC) drugs, including tranquilisers.

20 July 2009 : Column 1009W
This review will identify where and how policy should be advanced, so that those addicted to prescription or OTC drugs receive high quality, effective services.

Parliamentary Question - 16 July 2009

2009-07-21T14:16:00.006+01:00

Column 673W

Tranquillisers

Jim Dobbin: To ask the Secretary of State for Health if he will assess the efficacy of his policy on the prescription of tranquillisers in limiting the number of medicines prescribed. [276005]

Gillian Merron: The addiction to prescription drugs, such as benzodiazepines, is a very important issue and a number of steps have been taken to tackle this problem with the main focus on advice to prevent such dependence occurring in the first place, by warning general practitioners of the potential side-effects of prescribed medicines and the dangers of involuntary addiction to benzodiazepines.

Over the coming months the Department will be reviewing its policy on addiction to prescription and over the (OTC) drugs, including tranquillisers. This review will identify where and how policy should advanced, so that those addicted to prescription or OTC drugs receive high quality, effective services.

EHRC Submission

2009-07-21T13:49:00.013+01:00

SUBMISSION TO

EQUALITIES AND HUMAN RIGHTS COMMISSION

By Michael Behan, Parliamentary Researcher to

Jim Dobbin MP, Chair of the APPG on ITA

Monday 20^th July 2009

Introduction

Thank you for your letter of 19^th June in which you invited the APPG to submit information. This is a submission from the All Party Parliamentary Group on Involuntary Tranquilliser Addiction (APPG on ITA) to the EHRC providing information on aspects of tranquilliser addiction, with regard to discrimination by the Department of Health and Department of Work and Pensions against involuntary tranquilliser addicts, on the basis of their illness and disability.

Tranquillisers

Benzodiazepine tranquillisers such as Diazepam (Valium), Lorazepam (Ativan) and Nitrazepam (Mogadon) were introduced by the pharmaceutical companies in the 1960s with exaggerated claims for their indications, efficacy and safety. Benzodiazepines are highly addictive and toxic. At any given time in the UK there are an estimated 1.5 million benzodiazepine addicts.

‘Z’ tranquillisers such as Zopiclone were introduced in the 1990s as a safer option but have proved to be as bad or worse. An estimated 0.5 million people are addicted to Z drugs.

Tranquilliser side-effects occur during addiction as a result of the build up of toxic chemicals within the body. These side-effects are physical, psychological and neurological. They are painful, intense, bizarre and progressive; an addict may suffer 20-30 different side-effects contemporaneously.

If tranquilliser withdrawal is undertaken, additional withdrawal symptoms will occur. When the addict has reduced their dosage to zero, they may be left with numerous symptoms of long-term or permanent damage. This is known as the Protracted Withdrawal Syndrome.

Tranquilliser addiction is a treatable illness - it is possible to withdraw from tranquillisers. Withdrawal has been scientifically studied by Professor H. Ashton, Emeritus Professor of Clinical Psychopharmacology at the University of Newcastle, who ran a benzodiazepine withdrawal clinic from 1982-94 and designed a tapered tranquilliser withdrawal system. That withdrawal system has been produced in a booklet form, “Protocol for the Treatment of Benzodiazepine Withdrawal” and is used successfully and worldwide.

Safe and successful tranquilliser withdrawal can take from 6 months to 2 years. Patients need large amounts of support and reassurance during withdrawal, sometimes on a daily basis.

The benzodiazepine clinical trials show that the problems were well known to the manufacturers from the 1960s. For commercial reasons the negative information was withheld and benzodiazepines were marketed, particularly in the U.K., as a wonder drug, non-addictive, very safe, with few side-effects, and appropriate for almost any medical condition.

Benzodiazepines were granted full product licences in the U.K. without any assessment of safety or efficacy. Licences were issued by the Committee on Safety of Medicines (CSM), which was then a part of the Department of Health. Benzodiazepines were wildly over-prescribed as a result of a promotional campaign by the manufacturers and became firmly entrenched in prescribing practice. The highly addictive properties of benzodiazepine mean that even a short initial prescription can result in a patient becoming an unknowing and involuntary addict for many years or decades.

During the 1990s the pharmaceutical manufacturers gradually conceded, in their prescribing information, many of the previously denied problems with their drugs. Prescribing guidelines limit use to 2-4 weeks. However doctors have continued to prescribe at very high levels. According to a recent answer by the Department of Health to a Parliamentary Question by Jim Dobbin M.P., there were over 17 million tranquilliser prescriptions in 2008, a 2% increase on 2007. Prescribers are ignoring the manufacturers’ warning, such as the 2-4 week limit, and have perpetuated the tranquilliser problem.

The manufacturers have taken no corrective action; they are happy to sit back and continue to sell benzodiazepines and ‘Z’ tranquillisers at whatever demand level occurs.

By Involuntary Tranquilliser Addicts, we mean normal people who have become addicted to prescription tranquillisers through no fault of their own. They have been introduced to these drugs by their doctor without proper warnings of the danger involved, of addiction and side-effects, and have not made an informed choice.

Tranquilliser withdrawal is a complex and painful process and many addicts are unable to withdraw without expert information and support. No treatment is provided by the Department of Health for Involuntary Tranquilliser Addiction, with the exception of two workers in Oldham and three in Belfast. Small tranquilliser withdrawal charities also exist, such as CITA (Council for Information on Tranquillisers and Anti-Depressants) in Liverpool, and BAT (Battle Against Tranquillisers) in Bristol.

Discrimination by the Department of Health

This is the first part of the complaint - that the Department of Health systematically discriminates against Involuntary Tranquilliser Addicts by refusing them medical treatment for their illness. It is an illness that the Heath Service has created, through over prescribing by doctors, by not enforcing guidelines and by poor regulation.

The effect of the discrimination of refusing treatment is to abandon patients to continued addiction. Like all drug addictions, tranquilliser addiction is misery for the addicts and they suffer loss of health, jobs, marriage and homes. Tranquilliser addiction is a progressive illness, the longer it continues the worse it becomes. Over time, tolerance and dose escalation can occur, side effects can increase, withdrawal becomes more difficult for each year of addiction, the post-withdrawal period will become longer and the rate of permanent damage will increase.

The Department of Health has resisted the call for tranquilliser withdrawal services for over 20 years and this is well documented. From 1997 the “Beat the Benzos” campaign lobbied for services, led by Phil Woolas M.P., now a Home Office Minister. This is recorded in a long correspondence, in Parliamentary Questions, Early Day Motions, a Parliamentary Debate in 1999, and a BBC Panorama programme.

In the last 18 months Jim Dobbin MP formed the All Party Parliamentary Group (APPG) on Involuntary Tranquilliser Addiction (ITA). The APPG has particularly focussed on requesting treatment services and again this is recorded in Parliamentary Questions, EDMs, correspondence with Ministers and unsuccessful requests for meetings.

The Department of Health response is to say that the 152 PCTs are responsible for providing tranquilliser withdrawal services. The Department of Health does not provide a budget to the PCT for tranquilliser services, and no targets are set, thereby ensuring that, in practice, no services can be established.

Also the Department of Health does not recognise or treat the tranquilliser protracted withdrawal syndrome suffered by many former tranquilliser addicts who have withdrawn by themselves, or with the aid of the charities. This is another form of discrimination, which results in former addicts having to try to treat themselves for a condition that can last many years and can be extremely debilitating, and can be permanent in nature.

Discrimination by the Department for Work and Pensions

The second major discrimination against involuntary tranquilliser addicts comes from the DWP, who discriminate in two areas; benefit payment and back to work assistance.

Involuntary tranquilliser addicts often become unable to work as a result of the effects of their addiction. However, they have great difficulty obtaining appropriate benefits from local DWP offices and at tribunals or appeals. For benefit purposes the DWP does not accept that there is such an illness.

Involuntary tranquilliser addicts often have to try and argue their case from first principles. They are required to prove, to a high standard, that there is such a condition, that they suffer from it and certain symptoms have resulted. They often suffer from debilitating symptoms as a result of the drugs. Cognitive impairment and agoraphobia, for example, are very common in tranquilliser addiction, withdrawal, and post-withdrawal. DWP tribunals often rely for medical advice on retired G.P.s who may have spent their own careers over-prescribing tranquillisers and therefore not accept that they are addictive or toxic.

Regarding back to work assistance there is no special programme, rehabilitation or help for withdrawn involuntary tranquilliser addicts who want to return to work. The recent implementation by the DWP of the Welfare Reform Bill has increased discrimination by explicitly excluding ITA from the regime introduced. Pilot projects for only heroin and crack addicts have been set up. In correspondence the DWP ministers have said that programmes may be extended to ITA if the heroin and crack pilots are successful.

Discrimination by statistics

A third form of discrimination against ITA is a virtual prohibition across government on the collection of any information or data on the subject. For example, no government department has ever counted the number of involuntary tranquilliser addicts, the number of ex-addicts, the numbers permanently disabled, the numbers on both tranquillisers and Disability Benefit, the numbers of tranquilliser damaged babies or the number of babies born addicted to tranquillisers.

In comparison there are mountains of official statistics on illegal drug addicts. For example a 200 page statistical report on drug use has just been produced by the Association of Public Health Observatories (APHO), commissioned by the Chief Medical Officer, Sir Liam Donaldson.

Human Rights Issues

We also believe there are Human Rights aspects to involuntary tranquilliser addiction. Tranquillisers have very limited medical use, and they do not cure any illnesses. The maximum claim now made is that they can alleviate the physical symptoms of anxiety for a number of weeks.

The overwhelming reason that doctors prescribe tranquillisers is to feed the addictions that they have created. In effect tranquilliser addiction can be a form of torture as patients are slowly and painfully poisoned without their knowledge or consent.

Between 1990 and 1996 the Home Office collected statistics for benzodiazepine related deaths as part of a statistical summary of controlled drug deaths. The statistics show Benzo related deaths to be 300 per annum, during this period they exceed the deaths for all class A drugs added together. Professor Heather Ashton of Newcastle University has calculated that these deaths when added to benzo-related Road Traffic Accidents give a total of 17,000 benzo-related deaths.

The tranquilliser problem has existed for nearly fifty years. Governments from both parties have failed to take action and have allowed the problem to continue.

Legislation

I believe that an involuntary tranquilliser addict falls clearly within the definition of a Disabled Person as defined by Statutory Instrument 1996 No 1455, The Disability Discrimination (Meaning of Disability) Regulations 1996 Para. 3.

“Addictions

3. – (1). Subject to paragraph (2) below, addiction to alcohol, nicotine or any other substance is to be treated as not amounting to an impairment for the purposes of the Act.

(2) Paragraph (1) above does not apply to addiction which was originally the result of administration of medically prescribed drugs or other medical treatment.”

Conclusion

This submission has identified five different areas of discrimination by government against involuntary tranquilliser addicts.

Exclusion from appropriate medical treatment by the Department of Health.
Failure to treat or recognise the tranquilliser post-withdrawal syndrome by the Department of Health.
Non-recognition of the illness of Involuntary Tranquilliser Addiction or Post Withdrawal Syndrome in processing benefit claims. (DWP)
Failure to provide back to work support or rehabilitation for tranquilliser addicts and ex-addicts, particularly in the arrangements introduced under the Welfare Reform Bill. (DWP)
Failure to collect statistics on ITA, by all departments.

Additionally, we believe that there are human rights issues.

The discrimination is large scale, long-standing and deliberate. Government Departments are aware that they are discriminating but reject the available solutions. The discrimination has disastrous effects on the lives of those affected. There is also a social cost to this discrimination in that those affected often become unable to work and have to live on benefit with no productive output.

Statutory Instrument 1996 No. 1455

The Disability Discrimination (Meaning of Disability) Regulations 1996

1996 No. 1455

DISABLED PERSONS

The Disability Discrimination (Meaning of Disability) Regulations 1996

Made

4th June 1996

Laid before Parliament

6th June 1996

Coming into force

30th July 1996

In exercise of the powers conferred on the Secretary of State by paragraphs 1(2), 2(4), 3(2) and (3), 4(2)(a) and 5(a) of Schedule 1 to the Disability Discrimination Act 1995^[1], the Secretary of State for Social Security hereby makes the following Regulations:

Citation and commencement
1. These Regulations may be cited as the Disability Discrimination (Meaning of Disability) Regulations 1996 and shall come into force on 30th July 1996.

Interpretation
2. In these Regulations—

"the Act" means the Disability Discrimination Act 1995; and

"addiction" includes a dependency.

Addictions
3.—(1) Subject to paragraph (2) below, addiction to alcohol, nicotine or any other substance is to be treated as not amounting to an impairment for the purposes of the Act.

(2) Paragraph (1) above does not apply to addiction which was originally the result of administration of medically prescribed drugs or other medical treatment.

Other conditions not to be treated as impairments
4.—(1) For the purposes of the Act the following conditions are to be treated as not amounting to impairments:—

(a) a tendency to set fires,

(b) a tendency to steal,

(d) exhibitionism, and

(e) voyeurism.

(2) Subject to paragraph (3) below for the purposes of the Act the condition known as seasonal allergic rhinitis shall be treated as not amounting to an impairment.

(3) Paragraph (2) above shall not prevent that condition from being taken into account for the purposes of the Act where it aggravates the effect of another condition.

Tattoos and piercings
5. For the purposes of paragraph 3 of Schedule 1 to the Act a severe disfigurement is not to be treated as having a substantial adverse effect on the ability of the person concerned to carry out normal day-to-day activities if it consists of—

(a) a tattoo (which has not been removed), or

(b) a piercing of the body for decorative or other non-medical purposes, including any object attached through the piercing for such purposes.

Babies and Young Children
6. For the purposes of the Act where a child under six years of age has an impairment which does not have an effect falling within paragraph 4(1) of Schedule 1 to the Act that impairment is to be taken to have a substantial and long-term adverse effect on the ability of that child to carry out normal day-to-day activities where it would normally have a substantial and long-term adverse effect on the ability of a person aged 6 years or over to carry out normal day-to-day activities.

Alistair Burt

Minister of State, Department of Social Security

4th June 1996

Letter re Welfare Reform Bill

2009-07-13T10:21:00.010+01:00

Thursday 9^th July 2009

The Right Honourable Jim Knight M.P.

Department for Work and Pensions

Dear Jim,

Thank you for your letter of 30 June 2009. My question was: in what circumstances would the provisions of the Welfare Reform Bill be extended to Involuntary Tranquilliser Addicts. Your answer is that you will gauge from your pilots with heroin and crack addicts whether the new regime is likely to have a positive impact on other groups of drug users.

Involuntary Tranquilliser Addicts are normal people who have become addicted to prescription tranquillisers through no fault of their own. They have been introduced to these drugs by doctors without proper warnings of the dangers involved, of addiction and side effects. These people have had no opportunity to make an informed choice. They are often left on these drugs for many years and decades and as a result are often unable to work. Withdrawal is a complex and painful process and many tranquilliser addicts are unable to withdraw without expert information and support. This help is not provided by the NHS. I am therefore suggesting tranquilliser withdrawal services should be provided to ITA under the provisions of the Welfare Reform Bill.

Involuntary Tranquilliser Addicts are a completely different group of people from heroin and crack addicts. ITA are involuntary addicts of prescribed drugs, heroin and crack addicts are voluntary addicts of illegal drugs.

Therefore I believe that your approach is misconceived in that you will not be able to draw valid conclusions of the impact of the new Welfare Reform Bill regime upon Involuntary Tranquilliser Addicts from the pilots conducted with voluntary drug addicts. You are not comparing like with like.

In any case we already know the impact of withdrawal treatment upon ITA. Success rates are high for withdrawal treatment. David McKeown for example, the NHS’s only prescribed medication nurse, recorded his work in the Falls Family Doctors practice in Belfast from December 2006 to March 2008. Complete cessation was achieved by 57% of patients who were on long term tranquilliser prescriptions. The coercion and sanctions component of the Welfare Reform Bill is not necessary for ITA as they are normal people and are highly motivated to be rehabilitated back to work. Treatment of ITA is cost-effective. We have already provided the DWP with estimates of costs from the tranquilliser withdrawal charity CITA (Council for Information on Tranquillisers) of £2,000 per client for withdrawal treatment.

The numbers involved in ITA are large, an estimated 2 million people are on long-term prescriptions for benzodiazepine tranquillisers (1.5m) and Z tranquillisers (0.5m.) This is a larger target group, and the potential number of people who could be rehabilitated back to work, if the scheme were successfully applied to ITA, would be much larger than for illegal drugs.

Involuntary Tranquilliser Addicts are suffering from an illness created by the NHS. They then suffer discrimination on the basis of that illness in that the NHS will treat people addicted to illegal drugs but not those addicted to these prescribed drugs. The implementation of the Welfare Reform Bill is extending discrimination by including voluntary drug addicts but excluding involuntary tranquilliser addicts from the scheme.

Furthermore the provision of future assistance from the Welfare Reform Bill for Involuntary Tranquilliser Addicts has been made dependent upon the performance in the pilot projects of voluntary drug addicts, a notoriously unreliable group of people.

I would like to suggest that the way forward is to set up a Welfare Reform Bill pilot project designed to assist ITA by providing withdrawal services followed by rehabilitation back to work. This could be based on the Belfast prescribed medication clinic and the existing tranquilliser withdrawal charities in Bristol (Battle Against Tranquillisers) and Liverpool (CITA).

This would enable large groups of people to receive the treatment they need and would enable many to return to work. It would save patients from many years of addiction and its effects, the loss of health, jobs, homes, and marriages. It would also achieve the large saving to the taxpayer that the Welfare Reform Bill is designed to achieve.

Yours sincerely,

Jim Dobbin MP

Reply to Ministerial Response to "Addiction to Medicines" Debate

2009-07-02T19:33:00.007+01:00

1^st July 2009

The Rt. Hon Phil Hope MP

Minister of State for Care Services

Dear Phil,

I am chair of the All-Party Parliamentary Group on Involuntary Tranquilliser Addiction (ITA). In reply to your ministerial response in the Adjournment debate in Westminster Hall, Tuesday 16^th June 2009, on “Addiction to Medicines”, I would like to make the following points.

Involuntary Tranquilliser Addiction

In the debate both Brian Iddon M.P. and Greg Mullholland M.P. specifically referred to Involuntary Tranquilliser Addiction as a substantial part of the overall problem of addiction to medicines.

In your response you do not acknowledge the existence of the ITA group. Instead you refer to “constituents… with experience of misuse.” Involuntary Tranquilliser Addicts strongly object to being called drug misusers. “Misuse” suggests blame on the part of the patient. It categorises them with people who misuse illegal drugs, such as heroin and cocaine. This issue arose before in 2006/7 when the then Health Minister, Rosie Winterton M.P., used this word in correspondence with Barry Haslam of Oldham. Michael Meacher M.P. complained on behalf of Mr Haslam, with the outcome that Rosie Winterton M.P. wrote a letter of apology and agreed it was unhelpful to apply such terminology (Your ref. P.O.00000175712 17/3/07).

Involuntary Tranquilliser Addition refers to patients who have become addicted to tranquillisers through no fault of their own. They have been introduced to the drugs by their doctors without proper warnings and have been unable to make an informed choice. In your response you discuss the amount of money the government spends on drug misuse as if part of that money is spent on ITA. The reality is that none of the drug misuse treatment budget is spent on ITA. Tranquilliser addicts are excluded from treatment and none of your remarks on the effectiveness of treatment apply to ITA.

Brian Iddon informed the debate that 1.5 million people are addicted to benzodiazepine drugs, if ‘Z’ tranquillisers are included the total is around 2m.

The MHRA

Your description of the role of the MHRA is incomplete. Historically the MHRA, and its predecessor organisations, have a large responsibility for the involuntary tranquilliser problem. The Committee on Safety of Medicines (CSM) issued Product Licences in the 60’s and 70’s for benzodiazepines with no assessment of safety or efficacy. Data sheets were issued with inadequate warnings on toxicity and addiction. Patient complaints were dismissed as anecdotal. UK benzodiazepine data sheets have been, and still are, 10-15 years behind those issued in the USA, Canada, Australia and Scandinavia.

Post-marketing surveillance by the MHRA regulators has been poor and relies on a discredited Yellow Card System. It is not a matter of strategies. The Chairman of the MHRA, Professor Sir Alastair Breckenbridge, told the Health Select Committee:

“One cannot say what the incidence of an adverse reaction is. You cannot tell that from Yellow Card reports.”

(Q802, Health Committee Enquiry, 2004/5 “The Influence of the Pharmaceutical Industry”)

“In view of the failings of the MHRA, we recommend a fundamental review of the organisation in order to ensure that safe and effective medicines with necessary prescribing constraints are licensed.” (HSC Report V.1. P5)

Regarding the regulatory powers of the MHRA which you mention, these have not been used in the case of tranquillisers, and the manufacturers Roche Products and John Wyeth.

Internet Pharmacies

As far as involuntary tranquilliser addiction is concerned, internet pharmacies are a secondary issue. ITA is created within the Health Service. Later that addiction may be fed by the internet but the original addiction is created by Health Service doctors. Large scale tranquilliser addiction existed before the internet.

Controlling Prescribing

You listed various mechanisms and publications used to “promote and support high quality clinically effective prescribing… to ensure patient safety.”

A similar list of mechanisms was read out in 1999 by the then Health Minister, John Hutton M.P., in a debate on “Benzodiazepines” also held in Westminster Hall. John Hutton assured “that we are acting to reduce high levels of prescribing.” (Hansard 7.12.99).

In the period 1998-2009 tranquilliser prescriptions have increased from some 13 million p.a. to 17 million p.a. (Answer by Dawn Primarolo to P.Q. 274692. 18/5/09). Clearly the mechanisms did not work for John Hutton and are unlikely to begin to work now.

The Department of Health abdicates responsibility for controlling the large scale mis-prescribing of tranquillisers:

“We expect individual prescribers to be aware of the potential for addiction and to ensure that medicines are prescribed appropriately, depending on a patients individual needs.”

(Phil Hope M.P., Westminster Hall, 16/6/09)

The Department of Health tries to nominate the General Medical Council (G.M.C.) to take on the responsibility of controlling prescribing. The GMC has never accepted that responsibility. The GMC may look at individual cases. In individual cases a doctor prescribing outside the guidelines is not considered negligent if other doctors are prescribing in the same way (the “Bolitho” defence). Mis-prescribing of tranquillisers is so common that the individual mis-prescriber becomes legitimised. This defence applies both before the GMC and is successfully used by doctors in civil litigation cases where patients have alleged negligent prescribing by their doctors.

The GMC does not look at the large-scale systemic mis-prescribing that underpins ITA. The GMC is not responsible for enforcing prescribing guidelines and does not claim to do so. The Department of Health has not asked the GMC to enforce prescribing guidelines. This is an imaginary responsibility that the Department of Health invokes when avoiding its own responsibility for controlling prescribing.

Research

The two areas of research you mention are understanding addiction and treatment. As far as involuntary tranquilliser addiction, these two areas have been researched by Professor Heather Ashton of Newcastle University. Professor Ashton has developed a system of tapered withdrawal and produced a handbook “Protocol for the treatment of Benzodiazepine Withdrawal.” This has been used successfully worldwide, and has been developed by the U.K. tranquilliser withdrawal charities CITA (Council for Information on Tranquilliser and Anti-Depressants)and BAT (Battle Against Tranquillisers).

We do not know the mechanisms whereby patients are damaged physically and mentally by these drugs. Research is needed into the long-term and permanent damage caused by tranquilliser use.

Treatment of Involuntary Tranquilliser Addiction

No treatment is provided by the National Health Service for Involuntary Tranquilliser Addiction. Patients who become addicted are excluded from treatment and left to fend for themselves.

The Department of Health policy is to make repeated declarations that treatment for ITA is the responsibility of the Primary Care Trusts. However the Department of Health provides the PCT’s with no budget and no targets for this service, thereby ensuring that there can be no treatment provided.

There is no reason why ITA should be the responsibility of PCT’s. For illicit drugs there is a National Treatment Agency, National Drug Strategy and National Budget. It should be the same for ITA.

Our recommendations for treatment are:

A national network of local specialised tranquilliser withdrawal clinics
NHS funded local support groups
NHS funded 24 hour national tranquilliser helpline
Regional residential clinics for severe addiction
Training for specialised tranquilliser withdrawal counsellors.

Statistics

On 18 May 2009, Health Minister Dawn Primarolo M.P. answered Parliamentary Question 274692 and gave the total 2008 tranquilliser prescriptions for the UK as:

Benzodiazepines 11,439,000

Z Drugs 5,665,000

Giving a total of 17,104,000 tranquilliser prescriptions for 2008. This is an increase of 2% on 2007. This is about the prescribing level of 1992.

The Department of Health have created a smokescreen of imaginary responsibilities for various groups regarding tranquilliser prescription controls and for tranquilliser withdrawal. None of these responsibilities exist in the real world. The various groups, the MHRA/GMC/PCT, do not accept these responsibilities and do not take any appropriate action. Phil Woolas MP said in 1999 in the first Westminster Hall debate;

“The story of benzodiazepines is of awesome proportions and has been described as a national scandal. The impact is so large that it is too big for Governments, regulatory authorities and the pharmaceutical industry to address head on, so the scandal has been swept under the carpet…

We need joined-up policy. We need recognition of harm done to thousands of people, robust guidelines that are forcefully promoted and a review of the classification of Benzodiazepines. We need stringent support for addicts in the NHS, social services and the voluntary sector, to ensure that the withdrawal from such drugs is beneficial and does not increase the pain and suffering of many addicts.”

(Hansard 7.12.1999).

Yours sincerely,

Jim Dobbin MP

Addiction to Medicines Parliamentary Debate - June 16, 2009

2009-06-30T13:10:00.007+01:00

ADDICTION TO MEDICINES HANSARD EDITION - JUNE 16, 2009

(Please click on the above link and scroll down to bottom of page to view report.)

Letter from DoH re Ministerial Visit

2009-06-30T13:04:00.002+01:00

Message from Jim Dobbin, Chair of APPGITA

2009-06-30T13:03:00.002+01:00

The APPG was set up to raise awareness of Involuntary Tranquilliser Addiction and lobby for support from health service providers, local authorities and government.

In order to pursue our objectives we need more MPs to become involved with the APPG. I myself became involved in this issue by listening to the story of only one constituent, Rob Wilson from Rochdale who was withdrawing from Ativan lorazepam). MPs can become involved in an issue if they are lobbied by a constituent. You can lobby your MP in two ways:

1. Write to your MP at the House of Commons, Westminster, London, SWIA OAA.

2. Attend your MP's constituency surgery. Find out when and where the surgery is from your Town Hall's Information service and attend the surgery.

Involuntary Tranquilliser Addiction is an appropriate subject to bring to the attention of your MP. Your MP should support you in that there is no justification for the present situation. Tell your MP your own personal tranquilliser story and how you want things to change. If necessary make notes for your visit. You can refer your MP to the Early Day Motion and Parliamentary Questions that I have submitted to Parliament and which are available here on this website (see below).

The focus of our campaign at the moment is to lobby the Department of Health for specialised withdrawal services for Involuntary Tranquilliser Addiction to be provided throughout the country. As current or ex-tranquilliser addicts you may be disillusioned with politics and the way the system operates. However it is only through political action by MPs that we will be able to change things for the better. An MP will normally respond on an issue if lobbied by a constituent.

Jim Dobbin MP
Chair APPG
October 22, 2008

"Addiction Today" Article

2009-06-30T13:00:00.001+01:00

INVOLUNTARY TRANQUILLISER ADDICTION

Michael Behan
May 12, 2009

An All-Party Parliamentary Group recently drew the nation's attention to the damage caused by prescription and over-the-counter drugs – harms to a greater volume of people than from all illicit drugs. Michael Behan reports a worsening situation.

The March 2009 edition of Addiction Today contained an article from the All Party Parliamentary Drug Misuse Group – APPDMG – summarising its recent report on the group's inquiry into physical dependence and addiction to legal drugs. The All Party Parliamentary Group on Involuntary Tranquilliser Addiction – APPGITA – originally assisted in this inquiry. After reading a draft copy of the inquiry's report we disassociated ourselves and decided to produce an alternative report on involuntary tranquilliser addiction, and to make alternative recommendations.

We had provided expert witnesses to the inquiry on the tranquilliser problem: Professor Heather Ashton of Newcastle University, Una Corbett of the withdrawal charity Battle Against Tranquillisers and Pam Armstrong of the Council for Information on Tranquillisers and Antidepressants. However, the authors discounted that oral and written evidence put to the enquiry in reporting their own conclusions and ideas on tranquillisers. Those ideas correspond closely to existing Department of Health misconceptions on the subject.

It is DoH misconceptions which have led to the present situation: described by a witness to the enquiry, Milly Kieve, as a "public health emergency".

BACKGROUND

By "involuntary tranquilliser addicts" we mean patients introduced to tranquillisers by their doctors without appropriate warning of the dangers involved. Guidelines for tranquilliser use recommend prescribing for short periods only, two-four weeks. But doctors are prescribing tranquillisers to patients for months, years – and to some patients for 30-40 years.

Tranquillisers are highly addictive and toxic drugs. They consist of benzodiazepines such as Valium (diazepam), Ativan (lorazepam), temazepam and Mogadon (nitrazepam) and the "Zed" drugs such as zopiclone. Tranquillisers cannot cure any illness but they can alleviate symptoms of anxiety for a short time.

In chronic use, tranquillisers produce physical and psychological side effects which can be intense and bizarre. 200 side effects are listed and addicts often experience 20-30 at one time.

Tranquilliser addiction is a physical addiction which alters the chemistry of the brain, which is slow to recover after chronic use. So tranquilliser withdrawal is complex and can be traumatic and painful. To be safe and successful, withdrawal from a therapeutic dose can take from six months to two years.

Good-practice withdrawal involves slow tapering of dosage. A withdrawal protocol has been designed and published by Ashton. This has been used successfully worldwide and is available in 9 languages at www.benzo.org.uk. When addicts have reduced to a zero dose, they might experience a post-withdrawal syndrome lasting months or years and which could be permanent.

Benzodiazepine tranquillisers were introduced into the UK in the 1960s by Roche Products with exaggerated and proven-to-be-untrue claims for their indications and safety. Benzodiazepines were issued with "licences of right" by the Department of Health licensing agency with no assessment of safety or efficacy. A population of involuntary addicts was created which has existed continuously ever since – and is currently estimated at over 1million people.

Throughout this time, the DoH has refused to provide withdrawal services to involuntary tranquilliser addicts, with the current exceptions of one worker in Oldham and one prescribed medication nurse in Belfast.

The APPGITA was set up to raise awareness of this problem, and in particular to lobby for specialised withdrawal services to be provided by the DoH.

HARMFUL EFFECTS OF INVOLUNTARY TRANQUILLISER ADDICTION

Deaths. From 1990-1996, during which time the Home Office collected this statistic, benzodiazepine tranquillisers were responsible for more deaths – 1,810 – than all class A drugs added together, which totalled 1,660. Ashton has extrapolated those figures to cover the 45 years of tranquilliser prescribing, and added tranquilliser-related road traffic accident deaths, to produce a total of 17,000 tranquilliser deaths in the UK.
Benzo-babies. Babies born to mothers who have ingested tranquillisers during pregnancy can be born addicted and with damage such as floppy infant syndrome, neurological hyper-excitability and poor feeding.
Accidents. Tranquilliser impairment causes accidents in the home, such as falls and fractures in the elderly, at work and on the road.
Tranquillisers are routinely overused in care homes and homes for the elderly.
Social Cost. The social cost of involuntary tranquilliser addiction remains uncalculated but must be enormous. Like all drug addictions, involuntary tranquilliser addiction leads to the loss of employment, homes and marriages.

I believe that the APPDMG report ignores or under-reports all aspects of the tranquilliser problem. As mentioned, its recommendations resemble existing DoH policy on tranquillisers.

The only explanation offered for the tranquilliser problem is that, in the 1960s, "benzodiazepines were very favourably received by most patients" (p7).This is akin to the “blame the patient” explanation used by the DoH under this and previous administrations.

We believe that the tranquilliser problem does not come from the minds of patients but from within the DoH, where the pharmaceutical lobby dominates control of policy.

THREE WAVES OF DISASTER

The DoH failure to tackle the tranquilliser scandal paved the way for a second drug disaster, the SSRI – selective serotonin re-uptake inhibitor – antidepressants. The third psychoactive disaster is also on the way.

As with tranquillisers, the drug manufacturers were able to obtain a product licence for SSRIs as safe and efficacious – but SSRIs have been found to be toxic with low efficacy and cause a withdrawal reaction which can be severe. An estimated 7.5million people in the UK are long-term users of SSRIs.

Meanwhile, pro-drug campaigners are at work in and around government to introduce a third wave of psychoactive drugs. The new products include so-called "cognitive enhancers", "safe recreational drugs" and "psychedelic treatments for mental illness".

These plans can be seen on the website of Foresight, a government think-tank, in its Drugs Futures 2025 literature and on the website of The Beckley Foundation. Many of the new products will contain the ingredients of drugs that are currently illegal.

The pharmaceutical companies can convert those ingredients into supposedly safe products, obtain product licences and then manufacture drugs designed to take control of the huge illegal market. The outcome could be that increasingly large segments of the population will be drugged – using drugs endorsed by the DoH. Sound familiar?

We believe that the DoH should break free from the pharmaceutical lobby and start work against all prescribed-drug addiction.

Furthermore, we believe that the DoH policy on tranquillisers is immoral because thousands of patients are introduced to addictive drugs by the NHS and reduced to the misery of drug dependence and addiction. Addicts are then been stigmatized as drug abusers and denied NHS treatment for their addiction. We have prepared a list of alternative recommendations which reflects the evidence of witnesses to the inquiry and are designed to seriously tackle involuntary tranquilliser addiction.

RECOMMENDATIONS

There should be... a national network of NHS-funded specialised tranquilliser withdrawal clinics with regional residential clinics for difficult cases... NHS-funded local support groups... a NHS-funded 24-hour national tranquilliser helpline... and training courses for specialised tranquilliser withdrawal counsellors.
There should be medical research sponsored by the DoH into the mechanisms of damage from long-term use tranquilliser damage, which are so far unknown.
Statistics should be compiled by the DoH to measure, for example, the number of addicts, the duration of addiction, the number of ex-addicts and the proportion of addicts permanently damaged, and the correlation between tranquilliser addiction and the uptake of Disability Benefit.
Rehabilitation and back-to-work schemes should be available to those whose lives have been ruined by tranquilliser addiction.
A review of all tranquilliser product licences should be conducted.
A no-fault drug compensation scheme funded by a levy on the pharmaceutical industry should be created.

Newsletter 4 - February 24, 2009

2009-06-30T12:54:00.005+01:00

A P P G I T A
House of Commons, London SW1A 0AA

The All Party Parliamentary Group on Involuntary Tranquilliser Addiction held an AGM in November and re-elected the officials.
We held a week-long exhibition in the Upper Waiting Hall in the Houses of Parliament. We provided a display of slides from Professor Heather Ashton, copies of Heather's Withdrawal Protocol; Colin Downes-Grainger's 'Blaming the Patient' and Charles Medawar's 'Power and Dependence'.
Ray Nimmo has kindly provided us with a page on his website benzo.org.uk.
Jim Dobbin made an intervention in the Debate on the Welfare Reform Bill. This resulted in a meeting with a Department of Work and Pensions Minister, Tony McNulty MP, on the status of Tranquilliser Addicts within the provisions of the Welfare Reform Bill. Mr McNulty has asked for further information which we have provided him with.
The APPGITA participated in the All Party Parliamentary Drug Misuse Group enquiry; Professor Ashton, Pam Armstrong, Una Corbett, Milly Kieve, Barry Haslam and Michael Behan gave evidence. We were disappointed with the enquiry's report. The APPGITA produced an alternative report which is available on the benzo.org.uk website.
We have recently tabled an EDM, number 787, on Professor Nutt. This is available on the website, please ask your MP to sign.
Phil Woolas MP wrote to the Health Minister Alan Johnson on January 26, 2009 inviting him to visit the Oldham clinic and asking him for a comprehensive government policy on addiction to prescription drugs (see Oldham Chronicle). The APPGITA will also be writing to Alan Johnson asking for a government response to the enquiry and the two reports, and also for a meeting with the Department of Health on this issue.

Yours sincerely,

Jim Dobbin MP, Chair

JOHN WYETH AND ATIVAN

2009-06-30T12:47:00.002+01:00

SUBMISSION TO HEALTH SELECT COMMITTEE
ENQUIRY INTO THE INFLUENCE OF THE
PHARMACEUTICAL INDUSTRY
2004

Michael Behan
August 30, 2004

INTRODUCTION

Ativan is a highly addictive and dangerous benzodiazepine drug. The more inaccurate and defective are the warnings issued with such a drug then the more dangerous that drug becomes.

The purpose of this submission is to draw the attention of the Health Select Committee to the benzodiazepine scandal and to its architects the pharmaceutical manufacturers John Wyeth and Hoffman La-Roche (Roche Products). These manufacturers introduced a successful mass benzo addiction trap into this country. The trap was based on the provision of inadequate and defective drug safety warnings to the public and prescribers.

Those defective warnings remained in place until 1988 by which time a benzodiazepine addict population had been created.

The benzodiazepine addiction problem and the commercial success of the drugs has continued ever since. A stream of unwary patients is initiated into drug addiction by trusted doctors. Meanwhile, the Government has tinkered in the face of an enormous problem, and is misled by a flawed system of advisers, experts and regulators.

My perception is that of a sufferer of a benzodiazepine drug injury. My experience and the theme of this submission is that the pharmaceutical manufacturers have introduced and openly operated a psychotropic drug scandal with impunity.

They are confident that their influence is so strong that they possess a complete defensive shield - in the legal system, in the regulatory system and the Government Departments and can never be held accountable for their actions.

Application of the Terms of Reference

The first section of the submission, parts 1 and 2, address 'the provision of drug information and promotion'.

The second section, parts 3 and 4, address 'regulatory review of drug safety and efficacy'.

I am willing to give oral evidence.

My name is Michael Behan and I took the benzodiazepine Ativan from 1981-87 on prescription from my GP in the belief that it was a medicine.

Upon discovering that Ativan was a drug, I withdrew to a zero dose over six months. I suffered side-effects whilst ingesting Ativan and severe withdrawal symptoms during the tapering period. Many of these symptoms have persisted ever since, particularly neurological and musculo-skeletal symptoms, and I now believe that they represent permanent damage.

I was a litigant in the benzodiazepine litigation against the benzodiazepine manufacturers John Wyeth (Ativan) and Roche Products (Valium, Librium, Mogadon). I became a litigant-in-person in the High Court and the Court of Appeal. I subsequently petitioned the House of Lords and the ECHR. In connection with this I privately researched all aspects of the benzodiazepine for three years in The British Library, the Royal Pharmaceutical Library and the WHO and UN Libraries. I contributed to the Panorama special 'The Tranquilliser Trap'. I am assisting solicitors in Ireland in their Ativan litigation and acted as a researcher for the continuing Scottish Mogadon case against Roche Products. I was a founder and a Director of the charity "Beat the Benzos".

In these phases, as involuntary benzodiazepine addict, litigant, researcher and campaigner, I have encountered the pharmaceutical industry in several different ways. I have divided these experiences into four parts and draw my own conclusions.

LITIGATION: The domination of the legal process by the pharmaceutical companies.
RESEARCH: The drug companies own documents show the UK benzodiazepine scandal to be the intended outcome of the manufacturers - mass addiction.
REGULATION: The processing and issuing of the Benzodiazepine Drug Licence by the CSM/MCA is suspect.
GOVERNMENT: Control of psychotropic drugs has been infiltrated by regulators, advisers and self-styled experts who promote the agenda, the ideas and the products of drug manufacture to the detriment of public health.

SECTION ONE: THE PROVISION OF DRUG INFORMATION AND PROMOTION

Benzodiazepines: The Problem

Benzodiazepines are highly addictive. Ativan is one of the most addictive drugs known to man, a three year withdrawal (tapering of dose to zero) from the prescribed dose may be necessary, 12 months withdrawal is common. Benzodiazepine addiction is a physical addiction. The nervous system becomes reliant on the benzodiazepine chemicals, which replace natural chemicals in the nervous system. If the benzo chemicals are removed or reduced the nervous system cannot operate properly. The natural chemicals may regenerate slowly or not at all. Furthermore, benzodiazepines are poisonous. They insidiously poison the body and its organs.

While the dangers of benzodiazepines are enormous, their efficacy is limited. They do not cure anything. Benzodiazepines can only suppress the symptoms of anxiety and only for a short period. The Data Sheet recommendation is for a prescribing period of 2-4 weeks in total.

As the efficacy of benzodiazepines decrease, addiction can already be setting in. Also, paradoxical reactions can start to appear, the drug produces the conditions it attempts to treat such as anxiety, insomnia and anger. These are the first stages of the Tranquilliser Trap.

The current number of benzo addicts in the UK is estimated at one and a half million although no official figures exist. Many more people are ingesting benzos and are on their way to addiction. Many other ex-addicts have withdrawn but remain damaged. There is no treatment for benzo damage. Post-benzo sufferers are often left to struggle alone, stigmatised and excluded by the Health Service that made them ill.

Benzo Litigation

Benzo victims are often told by Government letter writers at the Home Office, Department of Health, MHRA, etc to seek compensation through the courts for any injury they have suffered. In fact, this is an impossibility. The pharmaceutical companies dominate the courts and the legal process with their power and money.

I was a litigant in the benzo litigation against the manufacturers John Wyeth and Brother and Roche Products. The litigation ran from 1986 to 1996 with a peak of 17,000 complaints. The plaintiffs alleged that the manufacturers were negligent in failing to give adequate warnings of the dangers associated with their products. The manufacturer delayed and complicated the proceedings to the point that the Legal Aid Board could no longer meet the expense of the litigation. Each side spent more than £35m yet not one minute of court time was spent on the merits of the case; the time and the money was spent on technical motions and procedural wranglings. Under pressure from the defendants the LAB withdrew funding from the litigation.

The defendants then successfully applied to the court for a strike out on the basis that the Plaintiffs would be unable to continue without funding and legal representation. The Legal Aid Board was disbanded in the wake of the benzo litigation and re-constituted as the Legal Services Commission with a new set of regulations designed to exclude the possibility of any similar litigation occurring again.

The failure of the benzo litigation gave the pharmaceutical companies the green light. They had demonstrated they could not be brought to trial and that the evidence against them would not see the light of day. In reality, the consumer has no protection in law against pharmaceutical companies or rogue drugs.

Powerful commercial corporations should not be immune to liability. Such potential liability acts as an incitement to developers of new products to ensure that their product is safe, this is a valuable counterbalance to the temptation to make fast profits.

Recommendation

My recommendation here is a no fault drug compensation scheme for sufferers of drug injuries.

Secondly, the Government should set up an independent prosecuting authority to take on the pharmaceutical companies when necessary. It is unrealistic to expect a firm of solicitors to be able to take on the might of a multi-national. When convicted the pharmaceutical companies should pay proportionate fines in order to provide a deterrent.
Documents

The benzodiazepine manufacturers have pretended that the litigation collapsed because the drugs were safe and the case was weak.

In fact, the evidence of negligence against the manufacturers was overwhelming and their defence was a fraud that never had to be tested. The benzodiazepine scandal is the outcome of a deliberate strategy by the manufacturers. Mass benzodiazepine addiction is not something that just happened, it was the intended result of a world-wide benzo strategy devised by Wyeth and Roche.

Wyeth and Roche released co-ordinated information on benzos in each country according to the strength and vigilance of the regulatory authorities in that country. Ativan first appeared in the UK in 1972 with warnings well below the level of information in the possession of Wyeth. The minimal warnings and the exaggerated indications for Ativan increased prescribing and therefore sales and profits for Ativan. The addictiveness of Ativan works a ratchet effect. Any unwary patient who is prescribed Ativan for a month or more can become an addict for decades and thus a steady customer for Wyeth drugs.

Wyeth deliberately issued defective information on Ativan in their UK Data Sheets. This defectiveness can be shown by collating and cross-referencing Wyeth's own documents:
1. clinical trials;
2. worldwide Wyeth Benzo Data Sheets;
3. Wyeth benzo adverts in USA medical journals;
4. information provided by Thomas Harry, Wyeth Medical Director and Whistleblower.
(i) Ativan Clinical Trials

The Wyeth Ativan Clinical Trials were poor quality and short term; none provide reliable evidence that Ativan is safe, several of the Ativan trials report what were to become the classic Ativan problems.

The earliest Ativan trial sponsored by Wyeth was conducted in a US prison in 1970 and is by HW Elliot (1). This was a one-tablet only, one day trial. Subjects are reported with:

EEG modification to alpha rhythms; 'minimal' changes in cardiovascular reflexes; being unable to repond to their spoken names; unable to walk; instantly falling asleep; amnesia; post treatment depression of CO2 response; unable to complete a test because of fear; EEG - loss of alpha rhythm, burst of spindles; cardiovascular problems.

Cross-referencing this trial with the 1974 UK Ativan Data Sheet (2) shows Wyeth withheld vital safety information from the Data Sheet. Omissions from a Data Sheet are a simple but effective way of sabotaging the mechanism for drug safety put in place by the 1968 Medicine Act.

De Buck 1972 trial 'Clinical Experience with Lorazepam' (3) is also Wyeth sponsored. This trial reported epileptic seizures in two patients (of 30) when withdrawing from Ativan after three weeks ingestion. Epileptic seizures are an extreme withdrawal symptom and were clear warnings of the highly addictive nature of Ativan.

The appropriate warning for a specific Adverse Drug Reaction (epileptic seizure) that the De Buck trial should generate does not appear in the UK Ativan Data Sheet. Neither does an appropriate high level addiction warning.

The deeper question consequently arises - did Wyeth provide the CMS/MCA with all available safety information when they applied for an Ativan Product Licence? My answer is most definitely not but, as long as Wyeth's Ativan Drug Licence Application remains secret, Wyeth will deny any wrongdoing. A DLA application is the country's most secret document, and it remains secret in perpetuity.

These discrepancies - between the trial results and the Data Sheets - are not administrative details or secretarial problems. The withheld trial results correspond closely to the injuries suffered ever since by unwary ingesters of Ativan.

The discrepancies are at the heart of a multi-million pound drug swindle perpetrated in the UK by Wyeth. It is a swindle that has condemned 1000s in the UK to the misery of Ativan addiction and the slow incurable poisoning of their bodies organs and nervous systems.

Up until now Wyeth have escaped responsibility by hiding behind the shield of a supposedly all powerful 'right' to commercial confidentiality.

Recommendation (during enquiry)

I strongly recommend that the Health Select Committee root out the truth by subpoena of the DLA for Ativan, in particular the Summary Basis of Approval (SBA) which is the section dealing with safety as opposed to commercial information.

ii) Wyeth's Benzodiazepine Advertisements

Oxazepam (Serax), Wyeth's first benzo, was launched in the USA in 1965. All benzodiazepines are analogues of one another. This means they are not just similar to one another but closely similar. Any warning or information provided for Oxazepam (Serax) is applicable to Ativan. Particularly when Ativan is twenty times the strength of Oxazepam (Serax).

Oxazepam (Serax) prescribing information (FDA approved) is provided in a Wyeth advertisement in Psychosomatics, September 1965 (4), one of a series of advertisements that appeared in USA Medical Journals. The nightmare list of side-effects associated with this low-strength earlier product can be compared with the innocuous warnings (CSM/MCA approved!) provided by the UK Ativan Data Sheet nine years later in 1974.

Similarly, when Ativan itself was launched in the USA in 1978 it was done so under a different higher-level set of warnings (JAMA 1978) (5).

Ativan is described in the USA as a potent and dangerous compound. Ativan is described in the UK as clean, mild and efficient. US consumers and prescribers have proper addiction warnings, pregnancy and lactation warnings, liver function warnings, etc. Generally, it can take ten or fifteen years for safety warnings to travel from the USA to the UK Data Sheet.

iii) Wyeth's Ativan Data Sheets

The origin of drug information in the UK is the Data Sheet. It is a legal document required by the Medicine Act 1968. Wyeth consistently issue a lower level of information on Ativan in the UK Data Sheet, lower than the information provided in the equivalent year Data Sheet for Ativan in the USA, Canada or Australia. I have provided copies of 1978 Ativan Data Sheets (6) for the Committee to examine - and I have complete Ativan Data Sheets collection for those countries.

Recommendation (during enquiry)

Senior Directors of John Wyeth should be summoned before the HSC to explain these safety information discrepancies and to take responsibility for the results of these discrepancies.

Recommendation (during enquiry)

Unpublished clinical trials for Oxazepam (Serax) and Ativan should be subpoenaed from John Wyeth.

iv) Whistleblower Statements

During the benzodiazepine litigation, two ex-Wyeth Medical Directors made detailed and incriminating statements against their former employers. They are Dipak Malhotra and Thomas Harry (7) who was responsible for the development of Ativan. Thomas Harry states clearly and consistently that Wyeth were fully aware of the problems with Ativan and that for commercial reasons they did not warn doctors or patients.

These statements were taken by my former solicitor Graham Ross. So far this document has been swept under the carpet and ignored by Government and regulators.

Recommendation (during enquiry)

That Graham Ross (8) and the original Thomas Harry statements and authentication be subpoenaed by the HSC.
The Ativan Licence

My submission is that Wyeth did not tell the truth when they made their Ativan Licence Application.

Furthermore, the licensing procedure that was applied to the benzodiazepines, and in particular to Ativan, was not the vigorous assessment procedure that has been claimed by the CSM/MCA. Far from it.

Most of the benzodiazepines - Valium, Librium, Mogadon - were on the market before the Medicine Act of 1968. These drugs were issued "Licences of Right". The Licences of Right were a registration procedure and involved no assessment of safety or efficacy. Assessment was deferred to a future review by the CRM. Significantly, those reviews did not occur until 1983/84. By then the damage was done, the huge benzo addict population had been created and still exists to this day.

The first application for a full Benzo Product Licence was for Ativan in 1972. The relevant safety requirement was that the drug should be no less safe than other drugs indicated for the same condition (ie, the existing benzos). This was not an objective standard, it was a comparative standard and it was a comparison to Roche's benzodiazepine products that had not yet been assessed for safety themselves. As Ativan had secured a full Product Licence it was not even subject to the future CRM review. Can it be said that Ativan was ever fully assessed for safety by the licensing authority?

The senior members of the licensing authority have what has been quaintly described as a conflict of interest - they receive large amounts of money from the drug companies they regulate. In 1996/97, for example, ten members of the CSM/MCA declared financial links with John Wyeth and Brother.

Wyeth is a subsidiary of American Home Products. In the 1970s the USA Securities Exchange Commission offered US corporations an amnesty from prosecution in return for disclosure of corrupt payments. American Home products (9) declared from 1971-75 corrupt payments of $3.4m in 41 different countries by their subsidiaries and divisions.

AHP's auditors, Arthur Andersen, submitted form 8K in 1975:

"These payments were intended to further business with government agencies or to obtain action on necessary government clearances". (Item 13).

"Non-commission type payments were made in a number of countries to foreign government employees primarily in connection with the granting of required government approvals". (P4).

Recommendation (during enquiry)

That Wyeth and the MHRA should be questioned on all aspects of the Ativan Licence application, its truthfulness and the process applied. That Wyeth be questioned on involvement in corrupt payments in the UK.

Recommendations (for actions)

That the MHRA be disbanded. That it should be replaced with an independent body. That clinical trials should be supervised by an independent body. That there should be no retainers from the pharmaceutical industry to regulators. There should be significant lay membership and an end to secrecy.

Wyeth have plenty of form when it comes to avoiding regulatory control and manipulating information on safety and efficacy. Dr Rheinstein of the FDA in the United States wrote a regulatory letter to Wyeth-Ayerst in 1989 telling them they had an "intolerable record of compliance with the law" (on drug promotion). (10).

Wyeth-Ayerst had "in case after case…disseminated promotional materials that are clearly false and misleading" indicating a "general and wilful disregard for legal and regulatory limitations upon drug promotion".

Dr Rheinstein told Wyeth-Ayerst that a 1989 advertisement for the heart drug Cordarone was "clearly intended to minimise the hazards of the drug and emphasise the drugs efficacy".

Dr Rheinstein's Office of Drug Standards issued 18 notices of violation to Wyeth-Ayerst concerning drug advertising and labelling in 1988/89.

In 1999, AHP had to pay $4.85 billion compensation in the 'Fen-Phen' litigation to 5.8 million ex-users who suffered heart-valve damage. The drug was marketed through Wyeth-Ayerst, it was linked to serious lung disease and leaky heart valves. Wyeth-Ayerst were found to have concealed this information. Settlements included medical care and monitoring for the victims, paid for by the manufacturers. (11)

Also in 1999, Wyeth Laboratories were convicted by the Supreme Court of New Jersey of failing to warn adequately of side-effects associated with the contraceptive device Norplant.
Government Control of Psychotropic Drugs

In 1997, the campaign group 'Beat the Benzos' was formed by Barry Haslam, Phil Woolas MP, myself and others. We hoped that if we brought the benzo problem to the attention of the Government that appropriate action would be taken across the various government departments. There has been no action. In my opinion the strength and influence of pharmaceutical companies extends into Government.

Ministers come to the complex subject matter of psychotropic drugs as lay people and move on regularly, this produces an over-reliance on advisers who are presumed by Government to be unbiased. There is no balance or brake on these advisers. The Government takes advice on the psychotropic drug problem from people who help to sustain the problem, namely the psychiatric profession, specialised prescribers of drugs. The psychiatric profession has both feet firmly in the camp of the manufacturer with whom they share the common desire to extend the use of psychotropic drugs.

The advisers on psychotropic drugs claim possession of "The Science" and that thereby Ministers can believe that their policies are underwritten by science. "The Science" they possess is actually information emerging from the pharmaceutical companies and the clinical trial system - also known as "The Evidence". The psychiatrists claim the exclusive ability to understand and interpret this information and they insist that it is true. What anyone else says, for example the patient or ex-patient, is excluded as 'anecdotal evidence' as opposed to their 'scientific evidence'. The government experts define their own expertise. They create a monopoly for their own extreme viewpoint. The policy outcome is a non-policy of minimum regulation and inaction, the ideal environment for drug addiction to take root and spread.

In our case the 'Beat the Benzos' group attended a meeting in April 2003 with the Home Office Minister Bob Ainsworth MP. We asked Bob Ainsworth to consider re-scheduling and re-classifying benzodiazepines and he invited us to prepare a submission (12) to the Home Office Advisory Council on the Misuse of Drugs (ACMD), which we did. The submission was referred to the Technical Committee of the ACMD which is chaired by Professor David Nutt, a key Government adviser and regulator. The ACMD was set up by and derives its power from the Misuse of Drugs Act 1971. The Act states (Section 2) that class and schedule are to be determined by the drugs level of misuse and the harmful effects to the public thereby caused.

We submitted that on any relevant criteria benzodiazepines are one of the most harmful of drugs and are wrongly classified and scheduled. Example of criteria that are used in the submission are:
1. the number of benzo related deaths;
2. the number of people affected 1.5m+;
3. the magnitude of addiction;
4. the duration of addiction;
5. the social cost of benzo addiction;
6. the suffering of addicts and its immorality.
It emerged that in fact the original scheduling (1986) and classifying of the benzos was not based on a risk assessment. The concern in 1986 was to conform with international legal obligations created by a UN Convention.

The ACMD has not so far carried out, in fact, a risk or safety assessment of the benzos. We received a refusal letter from the Home Office in April 2004.(13). The ACMD do not respond to any of the evidence, arguments or suggestions put forward in the submission. The ACMD make an assertion that re-classifying and/or re-scheduling benzodiazepines would be likely to be ineffective in curtailing their misuse but gave no reason.

Professor Nutt has financial links with John Wyeth. In the 2001 CSM Declaration of Interest, Nutt declares an 'Honorarium' and a non-personal grant from benzo manufacturers John Wyeth. He did not declare that interest in his dealings with us.

Professor Nutt chaired a recent CSM/MCA/MHRA review on SSRIs which found them to be safe. He was later revealed by the Guardian to have financial links to GlaxoSmithKline, as had two out of three of the other members of the review committee.

Professor Nutt sets out his own position on benzodiazepines in his paper "The Psychopharmacology of Anxiety". (14). Professor Nutt recommends prescribing practices that directly contradict:
1. CSM advice and addiction warning.
2. Data sheet addiction warning.
3. The Department of Health stated position.
Professor Nutt advocates treatment for 6-10 weeks, 6 months, 1-2 years and life-long use - "some patients appear to require maintenance benzodiazepines".

In this medical paper, Nutt also takes the trouble to present the manufacturers' account of the litigation. Nutt wrongly claims that "it was decided by the presiding judge that the case for benzodiazepine dependence causing real damage has not been made".

At the original meeting with Bob Ainsworth and in a letter dated 11 July 2003 from the ACMD, it was indicated to us that our submission would be assessed by a point scoring system that would measure levels of harm. Professor Nutt did not apply that system. I have requested the minutes of the ACMD Technical Committee meeting of 2 October 2003 but have been refused for "reasons of confidentiality".

The processing of our ACMD submission on benzos followed the pattern of benzo drug regulation set by the CSM/MCA. The case against drugging is not addressed, it is ignored and avoided by bureaucratic manoeuvering. There is extreme secrecy and no engagement between the regulator and consumer. The complete absence of a safety assessment is revealed. Power and control is concentrated in the hands of Professor Nutt, an all powerful benzo-enthusiast who claims expertise and is in the pay of the manufacturers.

Recommendation for enquiry

To examine Professor Nutt. That the scheduling and classification of benzos be properly assessed by an independent and open process.

Beat the Benzos final attempt to change the benzodiazepine status quo was a meeting with Health Minister Rosie Winterton in 2003. We outlined our concerns and suggested solutions. Rosie Winterton asked for more information and told her advisers she had not been kept informed or had been wrongly informed of the situation. However, the arrangement was unexpectedly ended in January 2004 when we received a letter that shut the door in our face and re-affirmed Department of Health policy. That policy is:
1. To exclude any consideration of benzo damaged people for aftercare by setting the parameter "the main focus is to prevent addiction in the first place".
2. To provide no research into and no treatment for benzodiazepine injuries.
3. To ignore the problem - there is no quantification, no figures, no statistics.
4. To claim withdrawal facilities are available when they are not.
5. To blame over-prescribing on GPs and psychiatrists as if these employees are nothing to do with the Department of Health. The Department of Health makes no effort to enforce benzo prescribing guidelines. As long as guidelines are not enforced prescribers will continue to over-prescribe in dosage, in time and by polypharmacy.
6. To pretend the benzo problem is a mental health problem - it is not, it is a problem of physical drug addiction and drug toxicology.
Chief spokesperson and letter writer for the Department of Health, and this policy, for the last several years has been Dr Anna Higgitt who styles herself as Senior Policy Adviser on benzodiazepines. It is a policy of denial and inaction which provides the perfect environment for psychotropic drug addiction to flourish.

The pharmaceutical industry have created the benzodiazepine problem and have left it in the lap of the Department of Health. The Department of Health will not tackle the problem because:
1. The Department of Health has been compromised by years of denial and cover-up.
2. Tackling the benzo problem involves confronting the pharmaceutical industry which they will not do.
3. The apparent cost of tackling the benzo problem appears massive - benzo withdrawal facilities, medical treatment and compensation payments - but is not massive when calculated against the social cost of benzo-addiction.
4. Melanie Johnson MP, Minister of Health has registered a financial contribution of £20,000 from Hoffman La-Roche. (15).
Recommendations for Action
1. Establishment of benzo withdrawal facilities nationwide including clinics, self-help groups and a help line.
2. Prescribing guidelines to be enforced.
3. Compensation for benzodiazepine injuries with no-fault compensation scheme.
4. Prosecution of negligent manufacturers by a government agency.
5. Medical research into benzo injuries and after-care for victims - alternative, non-drug treatment.
6. An independent and open licensing procedure.
7. Education of the medical profession on psychotropic drugs.
8. New government experts, adviser and regulations.
References
1. 'Central Nervous System and Cardiovascular Effects of Lorazepam in Man'. HW Elliot, Clinical Pharmacology and Therapeutics 1971
2. UK Ativan Data Sheet, 1974
3. 'Clinical Experience with Lorazepam…', R De Buck, Current Med Res and Opinion 1973
4. Serax Advert Psychosomatic, Sept 1965
5. Ativan Advert Journal of the American Medical Association, 1978 v 240
6. Ativan Data Sheet, USA 1978; Australia 1978
7. Whistleblower Testimony: Thomas Harry
8. Letter: Graham Ross to Neil Fearn
9. Amnesty Disclosure on Corrupt Payments by AHP to SEC
10. SCRIP World Pharmaceutical News, 1990
11. Fen-Phen Litigation from Internet
12. ACMD Submission, 2003
13. Home Office Refusal, 2004
14. The Psychopharmacology of Anxiety, Professor Nutt
15. Private Eye
Declaration

Name: Michael Behan, Beat the Benzos
Date: 30 August 2004

ADDENDUM

October 29, 2004

This is an addendum to my earlier submission: "THE BENZODIAZEPINES, JOHN WYETH AND ATIVAN". This further submission is necessary for two reasons. Firstly, in response to clarification made by the HSC of its terms of reference. Secondly, to incorporate into the submission information on an ATIVAN data sheet warnings introduced by Wyeth in Canada in 2004.

TERMS OF REFERENCE

The HSC members have indicated their interest in recent and current problems. Richard Brook of Mind has in his evidence referred to the Benzodiazepine problem in the past tense.

"Nine years ago I was involved in the same issue around drugs like Valium and That’s Life, which most people recall, so there is a long history here." - Richard Brook 14/10/04 p23 of HSC TRANSCRIPT

Unfortunately this remark gave an incorrect impression that the Benzodiazepine problem is old or has been resolved. There is also a general misconception that the Benzodiazepine problem is now a prescriber problem rather than a problem with the pharmaceutical companies. In my view, the Benzodiazepine scandal is very much a current problem and is the result of the excessive and continuing influence of the Pharmas over the UK regulatory process and specifically the compilation of Data Sheet Information.

The Benzodiazepine and SSRI scandals have followed similar patterns.

Stage one of both of these scandals involves the development and marketing of the drug, the clinical trials, the Licence Application, the targeting of an appropriate illness, the hype, the launch and the broadening of indications.

Stage Two is the Backlash stage: patient complaints, litigation, questions in the media and the manufacturers defensive response - denial, delay, blaming the patient, the solicitors, the media and the stigmatisation of the victims.

The SSRI scandal has faltered at this point. Secret information has been uncovered by Professor Healey and Richard Brook and the safety review process been discredited. However, in the case of the Benzodiazepine the manufacturers, Wyeth and Roche Products were able to overcome the safety review procedure and defeat mass litigation.

By negotiating these two obstacles the manufacturers were able to achieve a third stage of success where their product is now firmly established and secure on the market. Injured patients can be stonewalled by reference to the licensing authority decisions.

Several factors help the Benzodiazepine scandal to continue: bad prescribing habits and addiction- 1.5 million Benzodiazepine addicts are driven each day to make sure they have their drugs. However, the main strength of the Benzodiazepine manufacturers is their ability to control, through subservient and weak regulators, the product information in the Benzodiazepine Data Sheets.
THE ATIVAN DATA SHEET: Perverse and Defective

The UK Ativan Data Sheet, and all the Benzodiazepine Data Sheets are an abuse of the Data Sheet system. Data Sheets are intended, and believed by prescribers to list unusual but theoretically possible ADRs - 1/100 or 1/1 000 chances.

There are many hundreds of Ativan ADRs covered by the generic terminologies used in the Ativan Data Sheet. Some of the ADRs are unlikely possibilities but many are probabilities and others are certainties. The inevitable outcome of the ingestion of Ativan is a bizarre and crippling collection of these physical and psychological illnesses. The patient is locked into the Ativan ADRs by his physical addiction to the drug. Mike Burkinshaw, a constituent of John Grogan, M.P for Selby, is in this very predicament - physically addicted, unable to withdraw and suffering 73 ADRs.

The perversity of the Data Sheet is no accident; the manufacturers and the MHRA have colluded to turn the Data Sheet system on its head. The Ativan Data Sheet is not a warning but a prognosis of the patient’s future Ativan induced illness.

Furthermore the Ativan UK Data Sheet is not only perverse but also defective. The manufacturers deliberately withhold vital safety information from the UK Ativan Data Sheet.
1. Death Warning
  
  The 2004 Wyeth Canadian Ativan Data Sheet contains an ADR Death warning: "Use of benzodiazepine, including lorazepam, may lead to potentially fatal respiratory depression".
  
  This warning is not included in the 2004 Wyeth Ativan Data Sheet. This Canadian warning is a prescribed dose warning not an overdose warning, and can only be based on scientific evidence that is within the knowledge and control of Wyeth. What is that evidence? how long have Wyeth had that evidence and why has it not been reported to the MHRA as required by the Medicines Act 1968?
2. Seven Day Addiction Warning
  
  The 2004 Wyeth Canadian Data Sheet also contains a seven-day addiction warning. The dosage information warns:
  
  "Withdrawal symptoms can appear following cessation of recommended doses after a little as one week of therapy."
  
  Wyeth have also provided the warning in Australia since 1999 yet no such warning appears in the UK. Again the Canadian and Australian warnings must be based on scientific evidence. What is that evidence, how long have Wyeth possessed that evidence and why have they not informed the MHRA?
3. Ativan Withdrawal Information
  
  Ativan is so addictive that, in order to successfully and safely withdraw, a long tapering to zero period is required (6-18 months in my experience) from the prescribed dose. The Australian Data Sheet goes someway to provide relevant information and has suggested since 2001 a tapering period of up to four months. Again this information must be based on scientific evidence but this has not been provided to the MHRA.
4. Damage
  
  No Ativan Data Sheet warns in any jurisdiction that ADRs - side effects and withdrawal symptoms - do not necessarily disappear after patients stop ingesting Ativan. ADRs Ativan may reverse but can also persist as long term and permanent (physical, neurological and psychological) damage.
5. No Cure
  
  No Ativan Data sheet in any jurisdiction warns that there is no known cure or treatment for Benzodiazepine damage.
CORRUPTION

"Willing to act dishonestly in return for money or gain." - Oxford English Dictionary

Ativan is:
1. Highly addictive
2. Poisonous
3. Kills people
4. Has efficacy approaching zero
Yet the MHRA has:
1. Issued a Product Licence for Ativan
2. Conducted a review and found Ativan safe
3. Continued to issue perverse and defective Ativan Data Sheets for thirty years
How can this happen?

The MHRA employs thousands of people - highly qualified and experienced academics, scientists and experts.

The regulators take multiple retainers from the pharmaceutical manufacturer, share options, grants and retainers. This is not a conflict of interest this is corruption, large scale and systematic of the MHRA, its personnel and its function.
SUMMARY

The Benzodiazepine scandal is not old or nothing to do with the Pharmas, it has simply rumbled on to a more advanced and successful third stage. The perverse and defective Ativan Data Sheet is not an accident or a mistake - it is the product of collusion between the Pharma and the Regulators.

The final outcome is a huge and unnecessary danger to public health. In this way the Benzodiazepine problem is a current problem of pharmaceutical industry influence over the MHRA.
RECOMMENDATION
1. The MHRA is a non-stop party for corrupt professors and should be shut down.
2. Withdraw Ativan.
3. An independent review of the safety and efficacy of all other Benzodiazepines.
4. That UK regulators be compelled to cross reference with Canadian, Australian and other Data Sheets and thereby provide at least the same standard of information in the UK.
5. A public enquiry into the Benzodiazepine scandal.

Behan
29^th October 2004

THE BENZODIAZEPINES

2009-06-30T11:44:00.002+01:00

SUBMISSION TO THE HOME OFFICE - ADVISORY COUNCIL ON THE MISUSE OF DRUGS

Michael Behan
July 26, 2003

"The story of Benzodiazepines is of awesome proportions and has been described as a national scandal. The impact is so large that it is too big for governments, regulatory authorities and the pharmaceutical industry to address head on, so the scandal has been swept under the carpet." - Phil Woolas MP, Parliamentary Debate, December 7, 1999.

1. INTRODUCTION

Michael Behan makes this submission in association with Barry Haslam. We are the Directors of Beat the Benzos a registered charity formed by ex-involuntary Benzodiazepine addicts.

We have support from three MPs who are the Trustees of the charity; Sir Sydney Chapman, John Grogan, and Phil Woolas, Deputy Leader of the House of Commons.

We are qualified to write this submission through long experience of Benzodiazepines. We have both suffered addiction and withdrawal from "Ativan" and also permanent damage. We were both litigants in person against the Benzodiazepine manufacturers in the High Court, the Court of Appeal, and the European Court of Human Rights.

We have researched Benzodiazepines in the British Library, the Pharmaceutical Library, the WHO and UN Libraries. We have provided research material for numerous newspaper articles and television programmes including "The Tranquilliser Trap" - a Panorama special. We have provided free information and counselling to hundreds of withdrawing addicts.

Our objective is to stimulate the Government into producing a co-ordinated Benzodiazepine policy. Responsibility for the continuing Benzodiazepine disaster is spread across several Government departments but principally the Department of Health and the Home Office. For this reason we hope to gain the support of the ACMD with its power under the Misuse of Drugs Act to advise all the relevant Ministers of the harmful effects and social problems arising from the Benzodiazepines.

Our central submission is that Benzodiazepines are incorrectly classified and scheduled and should be reclassified to Class A and rescheduled to Schedule 2.

2. THE ORIGIN OF THE BENZODIAZEPINE PROBLEM

Benzodiazepines are potent tranquillisers introduced by John Wyeth and Brother Ltd. and Hoffman La Roche into the UK in the 1960s and 1970s. Benzodiazepines are highly addictive and toxic and will quite naturally cause enormous harm to the patient if not controlled correctly. Before describing the Benzodiazepine problem, we explain our view of the origins and history of Benzodiazepine addiction. The problem did not "just happen". There are reasons for the Benzodiazepine problem and these reasons have to be understood in order to formulate solutions.

Benzodiazepines have never been properly tested for safety or efficacy. The manufacturers carried out poor quality short-term trials. Nevertheless the classic Benzodiazepine problems appeared immediately from the first Librium trials conducted by Hoffman La Roche in Texas in 1959.

Hoffman La Roche and John Wyeth withheld clinical trial information on Adverse Drug Reactions. They aggressively and successfully promoted Benzodiazepines with a combination of inadequate warnings and exaggerated and false claims as to their therapeutic value. The drug companies have disseminated information on Benzodiazepines on a differential basis according to the strength and the vigilance of the regulatory authorities in each country.

In the United Kingdom, the manufacturers have had an easy run, all Benzodiazepines on the market pre Medicines Act (1968) were awarded "Licences of Right"(1), which was an automatic registration procedure. There was no assessment of safety or efficacy, this was deferred until a later date and did not occur until the mid 1980s.

Meanwhile, after 1972, further Benzodiazepine Licences were issued as Full Product Licences, by a peculiar procedure. A Product Licence was granted providing that a drug was more effective than a placebo and apparently no less safe than other drugs indicated for the same condition(2). Safety was therefore gauged against the standard of products that did not have their safety assessed in the first place.

In the UK Drug information for prescribers is provided in the Data Sheets. Having obtained licences for their products as safe and non-addictive the drug companies were able to provide a correspondingly low level of safety information in the UK Data Sheets.

Much lower levels of warnings for Benzodiazepines were provided in the UK in any given year than in the US, Canada, Scandinavia, or Australia. The UK Benzodiazepines Data Sheets contained ambiguous warnings, diluted warnings, qualified warnings, silent warnings and omissions. The UK Data Sheets were seriously defective; the manufacturers withheld safety information.

There is an inverse correlation between the level of Data Sheet warnings and the level of prescribing. Benzodiazepines became the biggest drug blockbuster of all time. Valium is the top selling prescription drug ever.

3. WITHHOLDING OF SAFETY INFORMATION IN THE UK

The withholding of information in the UK is demonstrated firstly, by the comparative analysis, between countries of Benzodiazepine Data Sheets, for example by comparing the 1979 Ativan Data Sheet in the US with an Ativan Data sheet produced in the UK(3,4).

There is no suicide warning in the UK.
There is no lactation warning in the UK.
The UK pregnancy warning is weaker.
Fewer side effects are disclosed in the UK.
No proper warning is given in the UK about the likelihood of addiction.
In the UK Wyeth dangerously recommend doses twice those recommended in the US.

It has taken 18 years for information to transfer from the US Data Sheets to the UK Data Sheets.

Secondly, the withholding of Benzodiazepine safety information is evident from Benzodiazepine advertising in the US and Canada(5). These adverts are vetted by the FDA and contain high level warnings not repeated in the UK Benzodiazepine Data Sheets of the equivalent year.

Thirdly, the manufacturers own clinical trials record problems that did not appear in the UK Data Sheets for many years. Most notoriously the "De Buck Trial"(6) of 1972 recorded two patients out of 30 experiencing eleptiform seizures upon withdrawing from Ativan after short term use (30 days) at a dose within the therapeutic range recommended in the UK Data Sheets. This finding was a danger sign and an indicator of the high addiction potential of the drug: John Wyeth withheld this information from the MCA/CSM.

Other trials by H.W. Elliot and A.N. Singh told a similar story and Wyeth's negligence is confirmed by the "Whistleblower" statements of Thomas Harry and Dipak Malhotra, former Medical Directors of John Wyeth(7).

The Data Sheets are cornerstones of Drug Regulation in the UK. If the warnings are wrong or if the Data Sheet is defective, the system of drug regulation breaks down. Consequently, by the 1980s, a huge population of Benzodiazepine addicts had been created.

The MCA/CSM carried out its long overdue Benzodiazepine reviews in 1983 and 1984. Improved Benzodiazepine warnings were introduced in 1985 and 1988. These warnings have been routinely ignored by prescribers ever since.

4. HARMFUL EFFECTS OF BENZODIAZEPINES ON SOCIETY

Addiction

1.1. Numbers affected

The current long-term Benzodiazepine user population in the UK is estimated at between 1.2 and 1.9 million(8,9,10). Additionally there are an estimated 0.5 million medium term users and up to 3 million short term users. Added to that there are two steadily accumulating supplementary groups; 1) individuals who were addicted and damaged in the womb (Benzo Babies who have grown up) and 2) ex-addicts who have withdrawn but are permanently damaged.

1.2. Duration of Addiction

Involuntary Addicts are supervised and serviced by a prescriber who maintains the supply of the drug for years or even decades. Often the patient is not informed of his situation and may remain on Benzodiazepines for 20 to 30 years.

1.3. Suffering of Addiction

The individual Benzodiazepine victim/patient is typically initiated into the drug by a trusted General Practitioner or Psychiatrist, as a supposed treatment for a minor medical complaint or life problem. The onset of addiction varies according to the individual but can occur very quickly, often within two or three weeks and is usually unrecognised. The addiction locks the addict into a gradual toxic build up and poisoning by Benzodiazepines.

Benzodiazepine poisoning is insidious and invisible and leads to the inexorable and progressive deterioration in the life of the individual. The victim/patient experiences bizarre and inexplicable side effects and often becomes isolated. He quickly loses higher functions such as his awareness; self-awareness and the ability to self-assess himself or his own health. He is unable to comprehend the inexplicable deterioration of his life. He suffers confusion in an extreme and total form of the senses, the organs, the body, mind and spirit. Benzodiazepines destroy the chemistry of the brain. Benzodiazepines inflict progressive, neurochemical brain damage(11). This process begins with the ingestion of the first tablet and the damage remains after ingestion ceases. There is no treatment for Benzodiazepine damage.

Addicts who are informed of or who somehow realise their addiction are offered no support from the Health Service and no facilities for withdrawal. At this point they are in imminent danger of being consigned to the mental health dustbin. Here withdrawal problems are commonly misdiagnosed as mental illness. These addicts are offered convoluted and impenetrable psychological explanations of their withdrawal problems and wrongly treated with more drugs.

Alternatively, addicts withdraw in dangerous isolation. If they are lucky they come into contact with the skeleton helpline and counselling services that do exist, CITA in Liverpool(12), BAT in Bristol and Professor Heather Ashton at the University of Newcastle upon Tyne(13).

1.4 Magnitude of Addiction and Duration of Withdrawal

Benzodiazepines are among the most addictive drugs ever created and are more addictive than Heroin or Cocaine. The manufacturers who once claimed in the UK that the drugs were not addictive are now advising many weeks of supervised withdrawal. Wyeth in Australia recommend up to 4 months of supervised withdrawal from therapeutic doses of Ativan.

UK counsellors such as CITA regularly make 6 month withdrawal plans for addicts on "therapeutic" doses. Longer schedules are drawn up for addicts prescribed or misusing over the guidelines. More difficult cases may need 2 to 3 years to reduce to a zero dose. Withdrawal does not finish at that point. The body then has to detox itself and readjust and repair itself, if it can over further months and years.

Deaths

In the period from 1990 to 1996 Benzodiazepines caused more deaths than all Class A drugs put together(14).

According to Home Offices statistics for this period Class A drugs, including Heroin and Cocaine were responsible for 1663 deaths: Benzodiazepines were responsible for 1810 deaths. Additionally Benzodiazepines have long been known to cause suicidal ideation(15). Benzodiazepines can be the cause or motivation of a suicide but because another method of suicide is used the death will not appear as Benzodiazepine related in statistics.

Benzo Babies

In the FDA pregnancy system, (A,B,C,D and X) Benzodiazepines are category D and X, the most dangerous. Opiates are at B and C. Babies exposed prenatally to Benzodiazepines are at risk of the following:

Low birth weight
Breathing difficulties
Floppy muscles
Unstable body temperature
Alteration in heart rate and function
Altered EEG measurement
Withdrawal syndrome
Cot death.
Malformation
Developmental difficulties
Estimates of pregnant women taking Benzodiazepines vary from between 1 and 40%, i.e. the incidence of Benzo Babies is unclear(16)

Date Rape

Benzodiazepines are known to be used as date rape drugs. Rohypnol is misused in this way(17). The amnestiac effect of Benzodiazepines makes prosecution more difficult.

Illegal Combination Use(18,19,20)

Benzodiazepines are used in combination with illegal drugs such as Heroin or Cocaine as a "booster" to cheaply enhance their effect. The problem was partly recognised and Temazepam Gel and liquid were withdrawn.

However, evidence suggests that illegal users quickly switched to other Benzodiazepines for the same effect(21,22), notably Valium. The differences between Benzodiazepines have always been invented or exaggerated by manufacturers, originally for marketing reasons. Supposed differences are now used by manufacturers as part of a tactic to concede ground on one Benzo in order that the others may continue with minimum regulation. In particular Hoffman La Roche have used the tactic before the FDA hearings in 1997 and the recently formed Irish Department of Health and Children Benzodiazepines Committee. Benzodiazepines are analogues of one another; they are closely similar. For the practical purposes of abuse, any one of many available will qualify for the same effect. Differential regulation of Benzodiazepines is a red herring.

Illegal Sources

There are three main sources for illegal use.

Pilfering and stealing from warehouses and pharmacies

Smuggling. There is large scale smuggling of Benzodiazepines. Panorama uncovered large scale, organised smuggling of Benzodiazepines into the UK. Interpol estimated 8 million Temazepam capsules a year are being smuggled into the UK. A capsule costs the smuggler 2p, and is sold for £1.00 or more.

According to Professor Heather Ashton, "The primary source of illicit Benzodiazepines is from Doctors prescriptions."(23)

Abuse of the elderly

Benzodiazepines are routinely overused in Care Homes and Homes for the Elderly for the convenience of staff.

Cause of Accidents

Benzodiazepines impair co-ordination and judgement. They are a source of Road Traffic Accidents, accidents at work and in the home. There are more Benzo-drivers than drunk-drivers. There are no mechanisms in place for controlling this.

Paradoxical Reaction

Benzodiazepines can lose their efficacy in a matter of weeks. The 'therapeutic benefits' can then reverse and an opposite effect can occur. The Manufacturer Data Sheets refer to this as a 'paradoxical reaction'. The effect of the drugs can be the opposite of that intended. One variety of paradoxical reactions is mood disorders, the patient does not become calm or tranquil, and he becomes tense and aggressive and may experience violent and uncontrollable rages. 'Paradoxical reactions' cause family and marriage break-ups and violent crime(24).

Social Cost

The social cost of the Benzodiazepine problem must be enormous, almost incalculable. The Sainsbury Centre have recently produced a policy paper entitled the "The Economic and Social Costs of Mental Illness"(25). The social cost of that problem is estimated at £77bn in 2003. They use 3 headings to describe and evaluate the problem which could also be used for the Benzodiazepine problem.

These are:

The cost of Health and Social care.
The human cost of mental illness.
The costs of output loss in the economy.

We believe a similar calculation is needed for the Benzodiazepine problem.

The hidden cost to the NHS alone from Benzodiazepines related problems must be huge. Benzodiazepine addicts experience numerous bizarre and intense side effects whilst on the drug and a further range of withdrawal symptoms afterwards. Benzodiazepine side effects and withdrawal are still not properly listed in the UK Manufacturer Data Sheets. Benzodiazepine addicts are suspected of showing symptoms of other unidentified illnesses. They are put on a merry-go-round of tests and investigations for each individual symptom. They can spend years on futile cycle of referrals, appointments, misdiagnoses, and inappropriate treatments.

Benzodiazepine patients who suffer psychological symptoms can fall under the control of Psychiatrists who are prone to misdiagnose a psychological illness for which more psychotropic drugs will be prescribed. The patient may be prescribed a chemical cocktail of drugs. Benzodiazepine symptoms are toxicology problems, which can mimic psychiatric conditions and should not be treated with more drugs.

The relevant point for the NHS is that this cost and waste is self-inflicted. Essentially these are Government Issue drugs.

5. ABUSE LEGAL AND ILLEGAL

The harm and social problems arising from Benzodiazepines are out of all proportion to any therapeutic value that they might have. The maximum therapeutic claim made by the manufacturers is that Benzodiazepines can alleviate the symptoms of anxiety during ingestion - there is no claim that Benzodiazepines can actually cure anything. Furthermore Benzodiazepines can lose their efficacy in a matter of weeks.

The risk and harm the public is subjected to is excessive and disproportionate to the therapeutic value of the drug. Unusually it is not a member of the public who is abusing these drugs; it is the prescribers who are abusing their patients. We suggest four reasons for this abuse and its continuation.

A misconception on the part of the prescriber that it is cheaper to continue to feed the patient drugs than it is to confront addiction.
There are no controls or sanctions on the prescribers, only a set of unenforceable guidelines.
Prescribers are uninformed about the drugs they are using and about the nature of addiction.
Withdrawing Benzodiazepine addicts require a lot of time and support to be successful and to be safe. Each prescriber services an average of 180 to 200 addicts (according to Professor Ashton) and does not have the resources or time to support them in withdrawal - if indeed he knows how to do that.

6. PROPOSED SOLUTIONS

The rescheduling and reclassification of addictive drugs as an isolated measure would be irresponsible and dangerous. This would push thousands of addicts into abrupt and unexpected withdrawal as their supply becomes restricted. Restriction of supply and the withdrawal of addicts are our objectives but these should be achieved in a controlled way(26).

We propose that

Long-term and medium-term regular Benzodiazepine users must be identified from G.P. records according to agreed objective definitions and criteria.
The risks of addiction must be explained to regular users who must be supplied with standard information packs on Benzodiazepines.
An individually written withdrawal schedule must be drawn up at the request of the user. This schedule to be implemented through the following alternatives:

Benzodiazepine withdrawal advice and support to Benzodiazepine dependent patients be given within the GP's surgery. NHS financial support to provide trained community pharmacists, community nurses, counsellors and the GPs.
Outside the surgery situation a network of dedicated Benzodiazepine withdrawal clinics must be established providing tapered withdrawal. A prototype CITA clinic already exists(27). Similarly CITA can provide staff training facilities for the schemes. Clinics must provide outpatient and inpatient facilities access to clinics to be outside the control of the prescribers, i.e. users are independently entitled to enrol themselves.

These measures must be recorded and supervised by a central body responsible directly to the Minister of Health.
There must be an additional national safety-net of 24 hour telephone helplines. The existing helpline services CITA, BAT, NECA must be properly funded.
Local self-help groups must be established and funded. These groups, the clinics and the helplines must follow the existing protocols of the experts, Professor Ashton and Pam Armstrong, until and if better protocols develop through practice and research.
Education Education Education for prescribers about drugs and addiction. In practice education is in the hands of the drug companies at the moment. Courses on Benzodiazepines and addiction to be made available to prescribers.
Prescribing guidelines must become mandatory. It must become an offence to create a new addict. Limits must be placed on the system of absolute discretion and self-regulation for prescribers that operates at the moment under the guise of clinical judgement. Prescribers have had since 1988 to introduce the new guidelines and have not done so. The existing MCA and Data Sheet Guidelines are continually ignored; no penalties for infringement operate at the moment.

There must be a transitional period during which addicted Benzodiazepine users are withdrawn and provided with maintenance doses outside of the guidelines. Exceptions will exist e.g. for terminally ill patients and for those who choose not to withdraw.
The Data Sheet 'guidelines' themselves must be updated and revised in line with current knowledge of Benzodiazepines and the more advanced warnings available in foreign Data Sheets in the USA, Australia, Scandinavia etc.
Research must be commissioned into the long-term effects of the Benzodiazepines. Further investigation of long-term cognitive defects and structural effects (brain imaging studies) should be undertaken in accordance with the research proposals of Professor Ashton submitted to MRC(28) in 1995/6 (subject to updating). Further research to be undertaken into other aspects of damage; physical, psychological, Benzo Babies and the statistical occurrence of addiction and of permanent damage.
Preventative measures to be introduced against benzo-driving and dangers at work (train driving, crane driving, airline pilots) by information, testing techniques, and penalties.
Any treatments identified by the research results must be made available, particularly alternative therapies. Benzodiazepine addiction and brain damage to become recognised illnesses and disabilities. Denial and stigmatisation of benzo victims must be ended.
A "no fault" compensation scheme for Benzodiazepine addiction injuries should be introduced, funded by the manufacturers. Such a scheme exists in NZ for all drug injuries(29). A vaccine damage scheme already operates in the UK.

7. CONCLUSION

It is a huge event in any person's life to become a drug addict. The existing situation is that a large number of people are introduced to and maintained on Benzodiazepines with no information, no good reason and no choice.

The original scheduling and classifying of Benzodiazepines in 1986 was not based on a risk assessment. The ACMD have not so far carried out a risk or safety assessment(30). The ACMD's primary concern in 1988 was the changes required at that time, by the UN convention and a recommendation by the WHO.

In any case the information and evidence on the risks and dangers of Benzodiazepines has transformed since 1986. The risks associated are current and real and large scale risks. They are not theoretical or potential risks.

We would like to draw attention to the establishment in 2000, of a Benzodiazepines Committee to report(31) on the misuse of Benzodiazepines in Ireland. The Committee made twenty-four recommendations of measures to tackle illegal use.

The start-up costs of the measures suggested above will be significant. However as Benzodiazepine addiction and harm are reduced the social cost of the problem will reduce and the cost of the proposals would also decrease proportionately.

The current Home Office message on Benzodiazepines is that the associated risk is low. Furthermore there is a belief that the scheduling and classification of Benzodiazepines reflects an objective and official scientific assessment of the associated risk. Both the message and belief are wrong and should be corrected.

The ACMD Secretariat has indicated that the ACMD will receive this submission to assist the Technical Committee in considering whether reclassification and rescheduling should be recommended. Additionally we have suggested various other measures, which are in accordance with Section 1 Para 2(a) (b) (c) (d) (e) of the Misuse of Drugs Act 1971.

Michael Behan · 34 Greenside Road · Shepherds Bush · London W12 9JG · Fax: +44 (0)208 740 7340

8. REFERENCES

Medicines Act, 1968, Sec 25
Medicines Act, 1968, Sec 19
USA Ativan Data Sheet, 1979
USA Ativan Data Sheet, 1979
USA Ativan Advert, JAMA, 1979
R. De Buck (1973), Clinical experience with Ativan, Curr. Med. Res. Opinion
Statement of Thomas Harry, John Wyeth Medical Director
Panorama Special: "The Tranquilliser Trap"
David Taylor & Paul Williams in "Benzodiazepines in current clinical practice, 1987
Professor C.H. Ashton in "Evidence submitted to the House of Commons", 2002
List of references and extracts from academic articles on benzodiazepines
CITA Protocol
Professor C.H. Ashton in "Benzodiazepines: How They Work & How to Withdraw"
Home Office Figures on Benzodiazepine Deaths 1990-96 from Martin Corkery
Ryan et al. JAMA, 1968 203,13,1137
Professor C.H. Ashton in "Drink, Drugs and Dependence" Ed. Caan & Belleroche
Professor C.H. Ashton in "Drink, Drugs and Dependence" Ed. Caan & Belleroche
Professor C.H. Ashton in "Drink, Drugs and Dependence" Ed. Caan & Belleroche
Alan Stears "Report on Temazepam in the UK"
Jane Fountain in "The Use of Temazepam in the UK"
Alan Stears "Report on Temazepam in the UK"
Jane Fountain in "The Use of Temazepam in the UK"
Professor C.H. Ashton in "Drink, Drugs and Dependence" Ed. Caan & Belleroche
Pam Armstrong in "Benzodiazepines and Clinical Behaviour"
"The Economic and Social Cost of Mental Illness", Sainsbury Centre, 2003
"Benzodiazepine Prescribing in Hong Kong", K.F. Chung, HKMJ, 1997 (PDF File)
Pam Armstrong BJ of GP, April 2002
Professor C.H. Ashton "Research Proposals to MRC", 1995/6
Advocate wins compensation for patient, Waikato Times, 2002
Home Office Letter to Michael Behan, July 11, 2003
"Report of Irish Benzodiazepine Committee, Irish Department of health and Children, August 2002 (PDF File)