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Tranquilliser Addiction -
A Medically-Induced Epidemic
Dr R F Peart
Victims of Tranquillisers (VOT)
Presented at the Conference:
"Stress - A Change of Direction"
London, 15th June 1998
On 11th June, 1998 a BBC Radio 4 programme posed the question "who are the biggest drug pushers in the country?" and gave the answer - "the NHS and the medical profession." During the last 15 to 20 years there has been a lot of similar publicity in the press and other media on the subject of tranquilliser problems, especially addiction to the benzodiazepine group of drugs. This has largely been dismissed by the authorities as "sensationalist." The reality is that the most sensational reports have appeared in the medical literature. Professor Malcolm Lader of the Institute of Psychiatry has published many papers on this subject. In the 1970s he called these drugs "the opium of the masses" because of the very high prescribing rates. In 1981 he warned that in the context of tranquilliser addiction "there is an epidemic in the making" and in 1988 he stated that this was "the biggest medically-induced problem of the late 20th Century."
Recent estimates suggest that there are from 1/2 to 1 million people addicted to these drugs. Many have asked the following questions:
How did this happen?
Why was it allowed to happen?
What are the authorities doing about it?
Why is it continuing?
I will try to answer these questions, but first I will briefly describe some properties of the benzodiazepines - these include many household names, Valium (diazepam), temazepam (a sleeping pill, now injected by street addicts), Rohypnol (the so-called date-rape drug) and Halcion (which caused a mass murder in the USA in the 1980s and which was banned in the UK in 1991 because of the failure of Upjohn (the manufacturers) to disclose information to the Committee on Safety of Medicines about its psychotic and other side-effects).
The benzodiazepines are a class of drugs with sedative, anxiolytic and hypnotic properties. There is relatively little difference between the drugs in this group, the most significant being the rate at which they are eliminated from the body. The elimination half-life varies from 2 hours to 10 days and has no effect on the pharmacological action but determines the duration of action. These drugs were marketed and promoted as non-addictive, of low toxicity and safe in overdose but these claims have turned out to be predictably untrue. They are depressants of the central nervous system with marked disinhibitory effects and as such have very similar properties, side-effects and addiction potential as the barbiturates, meprobamate (Equanol), alcohol and other sedative-hypnotic drugs used by the medical profession since the middle of the last century. These drugs are in principle prescribed for a wide range of clinical indications (see Table 1). In practice they have been prescribed as "social medication" - a pill for all ills as listed in Table 2 - this dispels the myth propagated by prescribers and the drug companies that the withdrawal symptoms are a return of the original problem.
The benzodiazepines act on at least two types of receptors:
Central receptors in the brain, eyes, and spinal cord.
Peripheral receptors over most of the body, in the skin, membranes, muscles and tissues.
Also, because they are fat-soluble, they segregate in many parts of the body and because of the long elimination time they can accumulate at levels up to 10 times the daily dose, causing a wide range of side effects. The list of adverse reactions for diazepam reported by doctors to the MCA (Medicines Control Agency) from 1962-1997, shows over 200 adverse drug reactions were reported for about 20 organ classes and over 100 sub-organ systems. It mirrors and enlarges upon the side-effects given in the medical literature, the WHO and advertisements by the drug companies. In the 1960s Apley gave a wide range of known physical, psychological and social consequences of benzodiazepine ingestion. The title of his paper illustrates a root cause of this epidemic, i.e. "Doctors who treat the symptoms tend to give a prescription; doctors who treat the patient are more likely to offer guidance." See Table 3 for a list of consequences.
A list of "socio-economic costs of long term benzodiazepine use" was recently published by Professor Heather Ashton, Professor of Psychopharmacology at Newcastle University. (See Table 4).
On the problem of accidents a "World in Action" TV programme (1995) concluded that deaths and accidents on the road caused by prescribed drugs are on a par with those for alcohol, and that drug tests were available and had been in use in other countries for some years. Why are there no tests in the UK?
Home Office statistics for 1989-1996 show about 2,000 deaths by suicide, accidents or other causes due to benzodiazepine ingestion, more than any other illegal or prescribed drug. Using the number of prescriptions to extrapolate this data suggests a possible 8,000-10,000 deaths from 1960-1997 due to these drugs.
Recently Charles Medawar of Social Audit Ltd quoted the cost of drug side-effects as being about 5 billion - more than the entire NHS drugs bill - and this does not include the cost of problems due to illicit use.
The first benzodiazepine marketed was Librium in 1960 on the basis of one set of clinical trials presented at a symposium at the University of Texas. This was quickly followed by Valium (1963) and Mogadon (1965), both with very limited trials prior to marketing. Within months of these drugs coming on to the market papers were published warning of the addictive nature and side-effects of these drugs. During the first decade or so after their introduction virtually all of the problems now accepted with benzodiazepines were reported in over 300 medical papers and in many adverts in American medical journals.
It is therefore quite astonishing that in the first data sheets in the UK issued by Roche through the CSM that there was essentially no mention of the known problems, and especially surprising when many of these were given in data sheets in the USA, Canada and Scandinavia.
By 1980 there were there were over 700 medical papers on these problems and the CRM (Committee on the Review on Medicines) belatedly issued guidelines for data sheets on the benzodiazepines but it took years for some of these to filter into the data sheets and then in a muted form, after protracted dispute with the drug companies.
Strong warnings about addiction, loss of efficacy and side-effects were not given until 1988 by the CSM, about 25 years after these problems were recognised and reported in other parts of the world.
As stated in the Medicines Act 1968, the CSM was established to "give advice with respect to safety, quality or efficacy" of medicines and to promote "the collection and investigation of information relating to adverse reactions for the purpose of enabling such advice to be given." Both UK and European law state that the principal task of the licensing authority is to protect public health.
There are two points which require answers:
Did Roche declare all appropriate information to the CSM, and if so why did it not appear in the data sheets?
If Roche failed to disclose all appropriate information, then as the CSM members should have been aware of most of it, why was it not included in the data sheets?
Unless the UK gets a very open Freedom of Information Act we will probably never know the answers. What we do know is that as published by the National Consumers' Council in recent years about two thirds of the CSM and the CRM members have direct financial links, such as consultancies, with the drug manufacturers, and that vested interests overshadow the rights of the consumer. Not surprisingly, as a result of the paucity of information, in the UK the prescribing rates have been two and a half times higher than in America. Over the years at least one million people have become dependent on these drugs in the UK.
Since 1960 there have been over 700 million prescriptions for benzodiazepines in this country. At its peak there were about 31 million per year in the late 70s and this has reduced currently to about 18 million per year. The attitude of the government to the overall situation has been to introduce measures to reduce prescribing such as restricting the number of these drugs on the NHS list. These have been to some extent successful, along with highly increased public awareness and the fear of litigation by the prescribers.
Both the government and the prescribers have paid very little attention to those who are chronically addicted. The number of these has reduced very little in the last ten years. The current level of prescribing is totally inconsistent with the 1988 CSM guidelines that these drugs be prescribed for short periods only (2-4 weeks maximum) because of the loss of efficacy and the occurrence of withdrawal symptoms for therapeutic doses given for short periods of time. The total of 18 million prescriptions per year translates to about 700,000 people on these drugs continuously: in other words, they are dependent.
There are many myths and, quite frankly, a lot of nonsense talked about addiction - e.g. stress causes addiction. Addiction to drugs is a physical problem, with psychological and social consequences. Chronic addiction is the repeated use of a drug to alleviate the side effects/withdrawal symptoms produced by that drug. In 1983 a panel of international experts in a WHO report rejected the concept of psychological addiction unless it was used in the context of physiological changes produced by a drug: in other words all aspects of drug addiction can be explained in biological terms. Use of the term "psychological addiction" in isolation is like "a desire to scratch without an itch." Unfortunately many prescribers use this outmoded concept to blame the patient and avoid taking responsibility for their own actions.
The attitude of prescribers is largely one of silence or denial. To obtain a sick note with benzodiazepine addiction on it is a rarity and to receive disability benefits for long-term damage caused by these drugs is even more unusual. The chances of getting residential treatment and rehabilitation is one-fiftieth of that for an alcoholic or an illegal drug addict. One of the reasons for this is the cost: the length of time for detoxification and withdrawal is much longer than for alcoholics and hard drug addicts and the withdrawal syndrome is very much worse. There are many who have been addicted to these drugs who have to come to terms with huge losses that have occurred because of addiction e.g. loss of career, marriage, family, possessions and sometimes their sanity. So it is not surprising that some suffer from PTSD (post-traumatic stress disorder) problems in recovery. This often requires long and sensitive therapy which is unlikely to be obtained on the NHS. The correlation between high cortisol levels and stress is well established, but for PTSD sufferers, low levels have been reported and those with base line levels are said to be more likely to have PTSD. Many benzodiazepine addicts in early recovery and withdrawal have a compromised endocrine system with low cortisol and ACTH levels and will therefore be predisposed to PTSD. Many believe they have suffered PTSD in recovery and that the symptoms have been incorporated into the protracted withdrawal syndrome that can last for many years.
A measure of the interest, or lack of it, by prescribers is the very few reports that they have submitted using the yellow card system for benzodiazepine dependence, e.g. for diazepam from 1963-1997 there were only 16, compared with at least a quarter of a million people addicted to this drug.
A final aspect of this overall problem is the fact that these drugs are still being dispensed with few or no warnings from doctors or pharmacists. They are dispensed under their generic names which most people do not relate to their commercial names, e.g. diazepam for Valium and lorazepam for Ativan.
I recently submitted a briefing for the chairman of the Health Select Committee in the House of Commons. In this I highlighted areas of ongoing concern (as per Table 5).
It appears that the dream of the perfect sedative/hypnotic has not come true: the lessons from the past have not been learnt. For many it has been a recurrent nightmare. Chloral hydrate, the bromides, heroin, the barbiturates and the benzodiazepines have all been touted by vested interests as the ideal non-addictive, anti-anxiolytic drug. Until and unless this country obtains independent committees to control medicines and a Freedom of Information Act with teeth the nightmare will continue. The next line of "non-addictive" drugs is already on the market and these act upon the same receptors as the benzodiazepines. Needless to say reports on their addictive properties are already proliferating.
Some Clinical indications claimed for benzodiazepine prescribing
Anxiety. Tardive dyskinesias, dystonias.
Alcohol/drug withdrawal reactions.
Night terrors and somnambulism.
Neurological: Epilepsy, febrile seizures.
Gastrointestinal: Irritable bowel syndrome.
Obstetric: Eclampsia, pre-eclampsia.
Anaesthetic/surgical: Operative premedication,
general and local anaesthetic.
Dermatology: Oral lichen planus.
General: Potentiation of analgesics.
Reasons for prescribing benzodiazepines to people who became addicted
Nursing sick wife
Scared of dying.
Lack of confidence.
Mother committed suicide.
Loss of hearing.
Cooker blew up.
Post natal depression.
Floater in the eye.
Physical, mental & social consequences and problem areas caused by benzodiazepine ingestion
low Apgar scores
protracted withdrawal syndrome
Some Socioeconomic Costs of Long-Term Benzodiazepine Use
Increased of accidents - traffic, home, work. Increased risks from overdose if combined with other drugs. Increases risk of attempted suicide, especially in depression. Increased risk of aggressive behaviour and assault. Increased risk of shoplifting and other antisocial acts. Contributions to marital/domestic disharmony
(due to emotional and cognitive impairment).
Contributions to job loss, unemployment, loss of work through illness. Cost of hospital investigations / consultations / admissions. Dependence and abuse potential (therapeutic and recreational). Costs of drug prescriptions. Costs of litigation.
Ongoing Areas of Concern relating to Benzodiazepine Use
The large number of benzodiazepine addicts (approximately 1 million). Misprescribing, misdiagnosis and mistreatment. Lack of appropriate medical treatment. Deaths by suicide and accident. Need for scrapping the Medicines Control system. Need for a Freedom of Information Act free from
commercial secrecy to protect consumers.
Rescheduling of benzodiazepines to Schedule 3 at least. Need for establishment of no-fault compensation scheme
to replace litigation in medical negligence.
Need for epidemiological surveys of benzodiazepine-related problems. Need to upgrade Data Sheets and the BNF. Lack of recognition of long-term / permanent damage
and consequent lack of state benefits.
"The Benzodiazepines in Current Clinical Practice", Eds. H. Freeman, Y. Rue, Royal Society of Medicine Services, Jan.1987 p 48.
"The Lost Years", Joan Jerome, Virgin Books,1991 p 24.
Apley J, Journal of Royal College of Gen. Pract. 1978, 28, pp 515-522.
"Toxicity and Adverse Consequences of Benzodiazepine Use", Ashton H, Psychiatric Annals. 25, 3, 1995, pp158-165.
Medawar C, press release from Social Audit Ltd, "The Antidepressant Web", Dec 1997, p3.
National Consumer Council, 1993 - "Balancing Acts - Conflicts of Interests in the Regulation of Medicines".
National Consumer Council, 1994 - "Secrecy and Medicines in Europe."
"Current Problems", Committee on Safety of Medicines, No 21, Jan 1988.
"Psychobiology of Post Traumatic Stress Disorder", Annals of the New York Academy of Sciences 821, June 1997, pp 57-75.
"Systematic Review of the Benzodiazepines", British Medical Journal, March 1980, pp 910 - 912.
Dr Reg Peart
Victims of Tranquillisers (VOT)
Flat 9, Vale Lodge, Vale Road,
Bournemouth, BH1 3SY,
England, United Kingdom
Telephone/Fax : 01202-311689
Definition of Denial = I don't even know I am lying.
At the end of this presentation one of the doctors approached the organiser and said, "Of course it is not like this any more."
"Physicians pour drugs of which they know little, to cure diseases of which they know less, into humans of whom they know nothing." - Voltaire 1694-1778.
LITTLE HAS CHANGED.
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