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H O U S E   OF   C O M M O N S

APPG for Involuntary Tranquilliser Addiction

ALTERNATIVE REPORT ON AN INQUIRY CARRIED OUT BY THE
ALL-PARTY PARLIAMENTARY DRUG MISUSE GROUP

by Michael Behan, Parliamentary Researcher to
Jim Dobbin MP, Chair of the APPG on ITA

January 22, 2009

Introduction

The All Party Parliamentary Group on Involuntary Tranquilliser Addiction (APPGITA) was asked to assist in the All Party Parliamentary Group on Drug Misuse (APPDMG) inquiry into "physical dependence and addiction to prescription and over the counter medicine." As a result seven people attended an evidence session to give oral evidence on Tranquilliser addition and 40 people submitted written evidence.

The oral evidence session was very successful. Professor Heather Ashton (Emeritus Professor of Clinical Psychopharmacology at the University of Newcastle upon Tyne), an expert on Benzodiazepine addiction gave evidence; Pam Armstrong of the Council for Information on Tranquillisers and Antidepressants (CITA) and Una Corbett of Battle against Tranquillisers (BAT) who both run charitable organisations providing Tranquilliser withdrawal services gave evidence; and also ex-Involuntary Tranquilliser Addicts Barry Haslam and Michael Behan.

However, upon reading a draft of the report we decided to disassociate ourselves from it and prepare this alternative version on Involuntary Tranquilliser Addiction, in order to provide a critique of the APPDMG report and make alternative recommendations. We were disappointed to see that those writing the report had misunderstood the Tranquilliser issue. They had ignored much of the evidence put before them and substituted their own ideas. These ideas correspond very closely to the Department of Health misconceptions on Tranquillisers which have led to the present situation described by one witness to the enquiry, Milly Kieve of the Charity APRIL as a "Public Health Emergency."

We felt that the official report did not reflect the contributions on Involuntary Tranquilliser Addiction and that more detail of the evidence presented was required together with more specific recommendations. The aim of the All Party Group on Involuntary Tranquilliser Addiction is to focus the Department of Health on the 1.5 million people who have had their lives and careers ruined by addiction to prescribed medication.

We are also concerned with the effect Involuntary Tranquilliser Addiction is having upon the workforce. Tranquilliser side effects, withdrawal symptoms and post withdrawal syndrome can render a person unfit for work and as a result they are on long term incapacity benefits. This is an unnecessary cost to the economy which we have asked the Department of Works and Pensions to consider.

Involuntary Tranquilliser Addiction

The APPDMG report's definition of involuntary addiction is wrong as far as Tranquilliser addiction is concerned:

"The term involuntary addiction has been coined by some experts and patient groups to describe the type of drug dependence which has occurred through medication taken initially to treat a medical condition (and often under medical supervision) but to which the patient has subsequently become dependent." (p.9) (1)

Firstly, for involuntary Tranquilliser addiction in the U.K., addiction is always under the supervision of the doctors who prescribe the medication. Secondly, doctors do not always give Tranquillisers to treat a medical condition. They also give them for a variety of other inappropriate reasons, e.g. bereavement; toothache; divorce. Thirdly, and most importantly, the Tranquilliser is given without the patient's informed consent as the dangers associated with the Tranquilliser have not been explained by the prescriber to the patient.

Context

The report claims to be "setting the context" and "defining the problem" but fails to do either.

Defining the problem properly and accurately is essential if correct solutions are ever to be introduced by government.

  1. The report does not mention the bizarre, intense and painful side effects that people experience whilst on Tranquillisers. Over 200 have been listed, and addicts often suffer 30 or 40 of them.(4)

  2. The report does not mention the Tranquilliser post-withdrawal syndrome(3) in which painful symptoms persist for many years and are sometimes permanent. Side-effects and post-withdrawal syndrome are common amongst Tranquilliser addicts and extremely debilitating to the extent that ex-addicts are unable to work. Both Barry Haslam and Michael Behan gave verbal evidence to the enquiry on this point and many others have produced written evidence e.g. Colin Downes-Grainger(4). The two Tranquilliser case studies paraphrased by the report contain no mention of side-effects or post-withdrawal; the Department of Health also refuses to acknowledge post withdrawal or permanent damage.

  3. The report makes no mention of Tranquilliser deaths. Professor Ashton has calculated, from Home Office yearly figures(2) that 17,000 Tranquilliser deaths have occurred during the last 50 years, including road traffic accidents and overdoses. The Department of Health have refused to acknowledge this figure.

  4. The report acknowledges the withdrawal syndrome but does not mention the prolonged withdrawal period. The addiction created by Tranquillisers is so strong that safe and successful withdrawal can take from six months to two years. Again the Department of Health does not acknowledge safe withdrawal time frames.

  5. The impression given by the report is that the first warning of a problem with Tranquillisers was on the Esther Rantzen Show, in 1985 but in fact there were danger signals with Benzodiazepines from when Librium was first introduced in the United States in 1961, only the Department of Health and their licensing authority did not see them.

  6. The original clinical trials(5) for Benzodiazepines conducted by Roche show the addictiveness and toxicity of these drugs. Valium, Librium and Serax adverts in United States' medical journals carried serious warnings throughout the 60s and 70s. Data sheets for Benzodiazepines in Canada, the United States, Australia, and Scandinavia also contained high level warnings. In 1964 the W.H.O. Expert Committee on Dependence Producing Drugs6 identified the first Benzodiazepine (Librium) as capable of producing 'dependence of the barbiturate type.'

    Nevertheless when the drug licensing system was introduced in the U.K. in 1972 the Benzodiazepines were awarded "Licences of Right" with no assessment of safety or efficacy.

    In 1972 the U.K. Monopolies Commission(7) investigated Roche Products for profiteering on the sale of Benzodiazepines to the NHS. This resulted in the repayment of several million pounds. In 1979 the USA Senate Sub-Committee on Health(8) conducted an enquiry into Benzodiazepine use and misuse.

    From 1986-1995 the Benzodiazepine litigation was the largest class action ever in the English legal system with. Over 17,000 litigants claimed damages against the manufacturers, only to be defeated by 10 years of procedural motions and delaying tactics by the defendants. This is the context of the Tranquilliser problem, not the Esther Rantzen Show in 1985.

  7. The report claims to be in agreement with the report by the Parliament of the State of Victoria in Australia but the Australian report enquired into voluntary addiction only and made no investigation or recommendations on Involuntary Tranquilliser Addiction.

  8. The report claims on Page 19 that "prescription rates of benzodiazepines are beginning to fall gradually", but fails to mention that total Tranquilliser prescriptions have increased due to the introduction of the 'Z' drugs such as Zopiclone, which have a similar action to the Benzodiazepines, and are even more toxic and addictive. The latest Diazepam figures from the Department of Health show an increase in prescriptions.(11)

  9. The report casts doubt upon Professor Ashton's tapering withdrawal method from Benzodiazepines.(9) This has been used successfully worldwide for many years and is based on an understanding of the highly addictive properties of Tranquillisers. Abrupt withdrawal (cold turkey) from Tranquillisers is a common mistake made by badly informed doctors. It is a result of Doctors thinking the Tranquillisers are not particularly addictive and that the patient's supposed "addictive personality" must be the problem. Abrupt withdrawal is likely to be unsuccessful, is extremely painful for the patient, can cause fits, convulsions, and psychosis, and can result in permanent damage.

    The report does not give any evidence to support its opinion on tapered withdrawal.

  10. The report discusses what it calls the issue of 'prenatal exposure' to Benzodiazepines and toxicity or withdrawal effects in the baby. The authors cast doubt upon this without providing any evidence to support their opinions. They refrain from even using the term "Benzo Baby" or discussing the real issue which is damage to the unborn child caused by Tranquillisers. The authors provide as a reference for their opinions (No. 32) the BENZACT website of Susan Tuke. Susan Tuke is an experienced and well-known Tranquilliser campaigner and has compiled the overwhelming scientific evidence of Tranquilliser damage to the unborn and placed it on her BENZACT website. It is inappropriate for the report to use her website as a reference for their opposite point of view.

    Damaged babies were common knowledge in the early 1990s, with an entry in the second edition (1981) of Davies's Textbook of Adverse Drug Reactions.(14)

    The report is well in step with the Department of Health on this issue. The Department of Health have consistently refused to accept the damage to the unborn caused by Tranquillisers. Most famously John Hutton MP, then Minister for Health, told a debate in 1999 in Westminster Hall on "The Benzodiazepines" that: "I understand and am currently advised that there is no proven link between Benzodiazepine use and damage to developing foetuses"(10) but did not provide any evidence.

    According to Professor Ashton in her withdrawal manual, Benzodiazepines "cross the placenta, and if taken regularly by the mother in late pregnancy, even in therapeutic doses, can cause neonatal complications. The foetus and neonate metabolise benzodiazepines very slowly, and appreciable concentrations may persist in the infant up to two weeks after birth, resulting in the 'floppy infant syndrome' of lax muscles, oversedation, and failure to suckle. Withdrawal symptoms may develop after about two weeks with hyperexcitability, high pitched crying and feeding difficulties.

    "Benzodiazepines in therapeutic doses appear to carry little risk of causing major congenital malformations. However, chronic maternal use may impair foetal intrauterine growth and retard brain development. There is increasing concern that such children in later life may be prone to attention deficit disorder, hyperactivity, learning difficulties, and a spectrum of autistic disorders."(9)

  11. Professor Ashton is an expert on Tranquillisers and Tranquilliser withdrawal. She appeared before the enquiry and gave oral evidence. The authors of the report made reference to three different aspects (24, 29, 36) of her work diversion of Benzodiazepines to illegal users; withdrawal protocol; and a number of illicit Benzodiazepine users mixing alcohol and Benzodiazepines. However, they completely ignore the substance of her work and evidence on involuntary Tranquilliser addiction.

    Professor Ashton's work explains that Benzodiazepines are highly addictive and powerful drugs which are misunderstood by the Department of Health and the medical profession. They have numerous (200+) severe side effects and are extensively misused by the medical profession in the UK and elsewhere. A population of involuntary addicts has existed since the 1960s which has never been treated by the NHS; Tranquilliser Withdrawal is a complex and difficult process which requires expert help and support.

    The report claims, without citing any evidence, that many Benzodiazepine patients have "co-existing mental health problems" (p.21), although this is the opposite of Professor Ashton's view. Her work shows that Benzodiazepines interfere with the chemistry of the mind and produce mental health problems, such as depression, anxiety, agoraphobia and aggression, as side effects and withdrawal symptoms. The report gives no other reference for their mental health claim. Again the report follows the Department of Health on this point. The Department of Health regularly stigmatises Tranquilliser addicts in this way.

    Professor Ashton has read our alternative report and endorses our version.

  12. The report makes no mention of the planned and deliberate causes of the Tranquilliser problem. The origin of the Benzodiazepine Tranquilliser problem was the unprecedented marketing campaign by manufacturers Roche Products throughout the 60s and 70s. Roche organised on one hand a disease mongering campaign which redefined the emotion of anxiety as a medical condition and on the other hand presented their Benzodiazepine as the new wonder drug, safe and effective, for anxiety and almost any other medical condition. Valium became the highest value drug blockbuster in history. The original Benzodiazepine clinical trials conducted by Roche in the 1950s show they knew from the beginning of the problems associated with the use of these drugs.

    The explanation of the overuse offered by the APPDMG report is: "because benzodiazepines were very favourably received by most patients."(1) (p. 7) This claim is unreferenced and it is a stigmatisation of involuntary Tranquilliser addicts. The Department of Health also regularly blames Tranquilliser patients for their own addiction by referring to them as drug misusers.

    Benzodiazepines became almost overnight the "most widely prescribed of all prescription medicines", not because they were favourably received by most patients as the report states, but because they were so highly addictive that patients needed to maintain their addictions.

50 Years of Tranquillisers

With the number of deaths, the limited efficacy, the ruined lives and the cost of these to the economy, why does the government and the Department of Health in particular refuse to accept the magnitude of the problem and refuse to provide treatment and rehabilitation to those who have been made drug addicts? We believe the relevant question to ask and which should have been asked by the enquiry is: Why has the Tranquilliser scandal been allowed to continue for nearly 50 years?

We believe that the explanations lie within government, not within faults and weaknesses attributed to patients. The Tranquilliser problem is not just a medical problem it is a political problem as well. We believe that large-scale Involuntary Tranquilliser Addiction continues. because of the influence on Department of Health policy by the Pharmaceutical Companies and fear of the financial cost of possible compensation for those damaged.

Compensation

Many victims believe they are entitled to compensation, so too did the Health Minister Dawn Primarolo MP when she asked for the introduction of a compensation scheme in 1989.(13)

Only one person has managed to obtain compensation from the Pharmaceutical Companies for Tranquilliser addiction. Iain Caldwell in Scotland received a no liability settlement of over 100,000 for alleged addiction to Roche Product's Mogadon (Nitrazepam) after a 13 year legal battle.

We would like to suggest a solution to the compensation issue; a no-fault compensation scheme such as the one in New Zealand in which many Tranquilliser victims have been compensated. This should be funded by the pharmaceutical companies. The gambling industry pays a levy into a fund to help people damaged by gambling, the alcohol industry pays a similar levy. The same levy system should also apply to the pharmaceutical industry, to fund a compensation scheme.

We believe the APPDMG report was a wasted opportunity. The Tranquilliser problem has to be properly described in order to produce a solution. People had their expectations raised by the enquiry, spent time and effort writing submissions and travelling to London to give evidence. The APPDMG report has ignored this evidence and instead provided us with a mixture of the authors' personal opinions and the Department of Health's existing policy.

We have compiled a list of alternative recommendations based on the evidence to the enquiry.

Alternative Recommendations arising from the APPDMG Inquiry

Treatment:

  1. In the treatment section of Recommendations the report suggests "Help from GPs" (5.1) and "appropriate treatment by PCT. (5.2) The Department of Health claims these services are already provided, so the report is really recommending the status quo as far as tranquilliser withdrawal is concerned.

  2. The recommendation for "specialist advice clinics" (5.2) is new but is not specific enough. Firstly, any services should be on an outreach basis. Doctors should examine their records to identify all patients prescribed outside the guidelines. These patients should be sent full information on their tranquilliser medication, offered an appointment to discuss the issue and the option to be referred for withdrawal.

    The term "appropriate treatment" (5.2.) used in the recommendations is not helpful and could be taken to mean "maintenance treatment" or transfer to other drugs rather than withdrawal.

    Secondly, the Department of Health needs to develop a best practice on withdrawal and shall draw on the experience and expertise of the successful charitable organisations, CITA, BAT and others. Also the Department of Health needs advice from them on staff training, rehabilitation, and other aspects of providing these services.

    Thirdly, local clinics are needed in each area, because of the large number of people involved. Introducing tranquilliser withdrawal services would be an enormous logistical exercises involving the processing and detoxification of large groups of people. Regional residential clinics are needed for more difficult cases.

  3. NHS funded local support groups. Experience has shown that these are extremely useful to support withdrawal from Involuntary Tranquilliser Addiction.

  4. NHS funded 24-hour national Tranquilliser helpline. CITA has experience in this field.

  5. Regional residential clinics for severe addiction. Withdrawal from Tranquillisers can be extremely difficult with severe and multiple physical and mental withdrawal symptoms.

  6. Training courses for specialised Tranquilliser withdrawal counsellors. Ex-addicts are good candidates as counsellors. The voluntary groups have experience of providing training.

Medical Research:

Medical Research sponsored by the Department of Health into the mechanism of how the drugs cause damage. There is no known treatment for the damage to addicts from Tranquillisers.

Quantification of the Tranquilliser Problem:

The Department of Health should compile official statistics on aspects of the problem, such as:

  1. The number of addicts

  2. The duration of addiction and withdrawal
  3. The number of ex-addicts
  4. The proportion of ex-addicts permanently damaged
  5. The correlation of involuntary Tranquilliser addiction with incapacity benefit
  6. The social cost of involuntary tranquilliser addiction

Rehabilitation Programs:

These should be available through the withdrawal clinics for people whose lives have been ruined by Involuntary Tranquilliser Addiction. Heroin and other voluntary drug addicts are already given this opportunity.

Review of the Benzodiazepine Product Licence:

The Manufacturers were granted Licences of Right in 1972 for the Benzodiazepine products. These drugs have never been properly scrutinised for safety and efficacy. The manufacturers' trials were of poor quality and short term.

Compensation

A no-fault compensation scheme funded by a levy on pharmaceutical companies.

References

  1. "Physical Dependence and Addiction to Prescription and over-the-counter Medicines". Report on an inquiry carried out by the All-Party Parliamentary Drug Misuse Group in the 2007-8 Parliamentary Session.

  2. Home Office Drug Statistics, 1992-96.

  3. Protracted Withdrawal Syndromes from Benzodiazepines. Heather Ashton, Journal of Substance Abuse Treatment, V.8. 1991.

  4. "Prescription for Injury", Colin Downes-Grainger.

  5. "Pharmacological And Clinical Studies of Valium", L.O. Randall. Hoffman La Roche. Current Therapeutic Research September 1961.

  6. Report of WHO Scientific Group. Geneva WHO 1964.

  7. Monopolies Commission, "Chlordiazepoxide and Diazepam" HMSO 1973.

  8. Use and Misuse of Benzodiazepines, US Government Printing Offices 1980.

  9. Benzodiazepines: How They Work and How to Withdraw. Heather Ashton (2002).

  10. Hansard 7/12/1999 (163 WH).

  11. NHS Prescription Services, Pharmaceutical Policy & Services, Newcastle Upon Tyne.

  12. Psychosomatics Sept. 1965, Serax Advert by Wyeth.

  13. Hansard 11.4.89. Vol. 150 c496w.

  14. Disorders of the Foetus and Infant in Davies's Textbook of Adverse Drug Reactions, Oxford University Press.


Jim Dobbin MP, Chair

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Email Mick Behan

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