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.
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.
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.
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
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)
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