ADDICTION TO MEDICINES HANSARD EDITION - JUNE 16, 2009
(Please click on the above link and scroll down to bottom of page to view report.)
(Please click on the above link and scroll down to bottom of page to view report.)
Tuesday, June 30, 2009
Message from Jim Dobbin, Chair of APPGITA
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:
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.
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
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
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
SUBMISSION TO HEALTH SELECT COMMITTEE
ENQUIRY INTO THE INFLUENCE OF THE
PHARMACEUTICAL INDUSTRY
2004
Michael Behan
August 30, 2004
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:
clinical trials;
worldwide Wyeth Benzo Data Sheets;
Wyeth benzo adverts in USA medical journals;
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:
the number of benzo related deaths;
the number of people affected 1.5m+;
the magnitude of addiction;
the duration of addiction;
the social cost of benzo addiction;
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:
CSM advice and addiction warning.
Data sheet addiction warning.
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:
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".
To provide no research into and no treatment for benzodiazepine injuries.
To ignore the problem - there is no quantification, no figures, no statistics.
To claim withdrawal facilities are available when they are not.
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.
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:
The Department of Health has been compromised by years of denial and cover-up.
Tackling the benzo problem involves confronting the pharmaceutical industry which they will not do.
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.
Melanie Johnson MP, Minister of Health has registered a financial contribution of £20,000 from Hoffman La-Roche. (15).
Recommendations for Action
Establishment of benzo withdrawal facilities nationwide including clinics, self-help groups and a help line.
Prescribing guidelines to be enforced.
Compensation for benzodiazepine injuries with no-fault compensation scheme.
Prosecution of negligent manufacturers by a government agency.
Medical research into benzo injuries and after-care for victims - alternative, non-drug treatment.
An independent and open licensing procedure.
Education of the medical profession on psychotropic drugs.
New government experts, adviser and regulations.
References
'Central Nervous System and Cardiovascular Effects of Lorazepam in Man'. HW Elliot, Clinical Pharmacology and Therapeutics 1971
UK Ativan Data Sheet, 1974
'Clinical Experience with Lorazepam…', R De Buck, Current Med Res and Opinion 1973
Serax Advert Psychosomatic, Sept 1965
Ativan Advert Journal of the American Medical Association, 1978 v 240
Ativan Data Sheet, USA 1978; Australia 1978
Whistleblower Testimony: Thomas Harry
Letter: Graham Ross to Neil Fearn
Amnesty Disclosure on Corrupt Payments by AHP to SEC
SCRIP World Pharmaceutical News, 1990
Fen-Phen Litigation from Internet
ACMD Submission, 2003
Home Office Refusal, 2004
The Psychopharmacology of Anxiety, Professor Nutt
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.
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?
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?
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.
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.
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:
Highly addictive
Poisonous
Kills people
Has efficacy approaching zero
Yet the MHRA has:
Issued a Product Licence for Ativan
Conducted a review and found Ativan safe
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
The MHRA is a non-stop party for corrupt professors and should be shut down.
Withdraw Ativan.
An independent review of the safety and efficacy of all other Benzodiazepines.
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.
A public enquiry into the Benzodiazepine scandal.
Behan
29th October 2004
THE BENZODIAZEPINES
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
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