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Submission to Phil Woolas MP with regard
to a Health Select Committee inquiring
into the Benzodiazepines
Dr R F Peart BSc PhD
National Co-ordinator for Victims of Tranquillisers
25 March, 1998
The benzodiazepines are a class of drug with sedative (anxiolytic)/hypnotic properties. Valium, Librium, Ativan, Mogadon and Temazepam are amongst the most commonly prescribed. They are depressants of the central nervous system with marked disinhibitory effects and, as such, have similar therapeutic effects, side-effects and addiction potential to the barbiturates, meprobamate (Equinol), alcohol and many other sedative/hypnotic drugs used by the medical profession since at least the middle of the 19th Century.
These drugs were marketed and promoted as non-addictive, low-toxicity and safe in overdose drugs but, like the pattern of events for all sedative/hypnotics, these claims have turned out to be predictably untrue. Exhibit 1 contains lists of UK benzodiazepines with details of marketing, equivalences, elimination half lives and active metabolites.
The benzodiazepines act on receptors of two types:
central receptors in the brain, eyes and spinal chord; and
peripheral receptors over most of the body in the skin, membranes, muscles and fatty tissues. Because they are lipophilic, they segregate and accumulate in many organs and parts of the body, producing a wide range of side-effects. Exhibit 9 gives the MCA list of adverse reactions for diazepam (Valium) and shows hundreds of examples for over 20 organ systems and over 100 sub-organ systems.
Prescribing Misprescribing, Misdiagnosis and Mistreatment
Since 1960 there have been over 700 million prescriptions for benzodiazepines. At its peak in the late 1970s, there were about 31 million per year in the UK. This level has reduced at an average rate of 2.5% per year to just over 18 million per year in 1996. This rate has decreased in recent years overall in the UK and there is an increase in the number of prescriptions in both Wales and Northern Ireland. For England and Scotland the data for Valium shows an increase of up to 15% from 1993-1996.
Surveys in the 1980s suggest that about 3 million patients were on benzodiazepines for six months or more and over 1 million for more than 12 months. In view of the 1988 CSM guidelines stating that these drugs lose their efficacy in up to four weeks at the longest, the only viable reason for patients to take these drugs longer than 12 months is that they are dependent on them. Recent surveys suggest that the overall decrease in prescribing is largely due to a reduction in short-term users, with the core of long-term users, about a million, remaining roughly the same. We believe that most of this reduction is largely due to media publicity causing patient resistance to these drugs, plus the following mandatory measures:
the reduced NHS prescription list, 1985;
the banning of Halcion (Triazolam), 1991;
making Temazepam a schedule 3 drug in 1997.
We also believe that the approximately constant core figures reflects the minimal efforts of prescribers to provide appropriate treatment for benzodiazepine addicts. The non-mandatory 1988 CSM guidelines (Exhibit 12) appears to be largely ignored by prescribers. Comments from VOT members and other support groups re the prescribers include:
they are the biggest barrier to obtaining appropriate treatment;
they deny the problem;
they have little knowledge about addiction, the benzodiazepines or the NHS Guidelines for Drug Dependency, 1984 and 1991;
they often blame the patient;
they are unable to differentiate between normal clinical pathology and that induced by drugs.
In view of the limited information in data sheets and the British Medical Formulary (BNF) and because few GPs or psychiatrists are trained in addiction, these comments are not surprising. Many GPs appear to believe in the l9th Century myth that addiction is a mental disorder and is the result of an "addictive personality." This myth is exposed by a recent report of the Royal College of Psychiatrists - "Drug Scenes" (see p.43 of the extract given in Exhibit 3). The simple truth, that dependence is the repeated use of a drug to alleviate side-effects/withdrawal symptoms produced by that drug, appears to be unpalatable to prescribers. Another myth is that those who become dependent are anxiety-ridden patients who need these drugs in order to cope with the normal stresses and situations in life. Only a very small percentage of these drugs are prescribed for anxiety neuroses; they are, in fact, prescribed for a wide range of indications and reasons, as illustrated in the lists given in Exhibit 3.
These myths, coupled with the lack of appropriate knowledge, have resulted in many cases of misdiagnosis, e.g. psychotic disorders like schizophrenia or manic depression, as well as dementia, multiple sclerosis, liver and kidney problems. The resultant maltreatment includes polypharmacy and ECT to treat drug induced side-effects.
Very few patients are offered residential drug treatment for benzodiazepine addiction and, where it is given in psychiatric units or occasionally in treatment centres, knowledge of particular problems of dependence on these drugs is very limited and often results in patients being withdrawn in a short period of time with sometimes disastrous and long-term consequences.
The need for treatment centres specialising in prescribed drug addiction is great because many will never overcome this problem in a home environment or without the help of support groups, which are too few and far between. The European Association of Treatment of Addiction (EATA) with over 50 centres in the UK has only one which professes to specialise in prescribed drug problems (and that is in Scotland). Some centres state that they would provide appropriate treatment but they cannot get the funding from the NHS. Although the detox and withdrawal period is very much larger than for alcoholics or hard drug addicts, this factor, in principle, should not be a problem because the latter groups receive treatment for up to a year, including primary and secondary care. Why not benzodiazepine addicts? It is just not happening.
A few support groups receive grants from local Health Authorities, and MIND receives money to help run their support groups. We believe the total from these sources is likely to be less than £200,000 (official figures are not forthcoming). This sum represents about 20p per benzo addict.
Recently the Liberal Democrat spokesman for Health stated that one in seven medical remedies are ineffective and one in six places in hospitals are due to medical error. Also, Charles Medawar in a report by Social Audit Ltd (see Exhibit 14) stated, "The true cost of adverse drug effects would thus exceed the £5 billion the NHS spends on the drugs themselves." He strongly recommends a thorough review of the whole of the medicines control system and a rethinking of the 1968 Medicines Act.
State of Knowledge
Since the first benzodiazepine (Librium) was marketed in 1960, there have been thousands of publications in the medical literature on this subject. About 1,500 of these are specifically on the risks, side-effects and dependence. Of this number, about 300 were published, mainly independent research, prior to 1973, and, in essence, they revealed all the problems that are generally accepted and admitted today. Few of these problems were included in the first data sheets (1973/4) and only some in the mid-1980s data sheets and onwards.
Exhibit 4 gives extracts from Roche clinical trials; Exhibit 5 is data sheets from the USA, Canada and Sweden; Exhibit 5 also gives adverts by Roche and Wyeth in the USA. These exhibits from the period 1960-1970 reveal extensive knowledge of side-effects and the dependence potential of benzodiazepines. The WHO in several reports in the 1950s and 1960s warned of the addiction potential of all sedative/hypnotic drugs and by 1983 declared 33 of the benzodiazepines as drugs of addiction.
It was not until 1980 and 1988 that the CRM and CSM respectively (see Exhibit 12) belatedly issued guidelines in the prescribing and use of benzodiazepines, up to 25 years after the appropriate knowledge existed and was available. Exhibit 12 also gives a letter from the CSM to Upjohn withdrawing its licence for Halcion (Triazolam) on the grounds that Upjohn did not disclose known information about side-effects produced by this drug. The paucity of information in the data sheets suggests a similar situation for Roche and Wyeth. The alternative, that the CSM knew and allowed and agreed with the data sheets should also be investigated.
Recent data sheets in the UK still do not contain information that was included in data sheets and adverts in North America/Scandinavia. This paucity of information feeds through into the British National Formulary (BNF), which does not contain crucial data on the pharmacological and pharmacokinetic properties of these drugs.
Such data, known for over 20 years, would have prevented much of the misprescribing, misdiagnoses, and mistreatment of patients, and the deaths of many others. Examples include data on the wide range (thirty fold) of individual sensitivity to these drugs and the elimination half lives - e.g. for Valium (Diazepam) the elimination half life is up to 10 days. This leads to accumulation in the brain and body at levels of up to 10 times the daily dose. This results in chronic intoxication and the many adverse reactions given in Exhibit 9.
The consumer, of course, receives very little information even if he/she asks for it. According to European law, all drugs sold by pharmacists should have patient information leaflets (PILs) by 1993. This is blatantly not happening with the benzodiazepines. In this connection there is no requirement in the BNF for pharmacists to give warnings re addiction or pregnancy.
In the 1970s, Professor Malcolm Lader (Institute of Psychiatry) called benzodiazepines "the Opium of the Masses". In 1981 he warned of an epidemic in the making, and in 1988 he stated that benzodiazepine dependence was the largest iatrogenic (medically induced) epidemic of the 1980s. Exhibit 7 contains three review papers by Professor Heather Ashton on this subject on the adverse socioeconomic problems and cost to the nation. Many would agree that it is the biggest medical scandal of the 20th century.
Finally, I will highlight a few of these adverse problems listed by Professor Ashton.
There are about 150 papers in the medical literature on pregnancy and lactation problems. In addition there have been newspaper and magazine articles and two TV programmes in the past year. It is evident that there have been thousands of babies born either addicted to these drugs and/or suffering from long term physical and/or psychological damage. Exhibit 8 gives further details.
Deaths Suicides and Accidents
The Home Office Bulletin of Statistics records that from 1989 to 1993 about 1,500 deaths were due to benzodiazepines causing suicides and accidents, or being involved in deaths of undetermined cause. This figure gives an average of 15 deaths per million prescriptions, which translates into about 10,000 deaths in the period 1960 to 1996.
Examples of these statistics are given in Exhibit 10, along with a paper on "Fatal Poisonings (only) due to benzodiazepines." Nearly 1,600 deaths through this cause occurred between 1980 and 1989 at a rate of over 5 deaths per million prescriptions. This translates into about 4,000 deaths in the period 1960 -1996 due to this single cause.
The whole area of deaths and accidents including those on the road, in the home and at work is covered by at least 70 references in the medical literature, many exposing the myth that these drugs are safe in overdose.
This subject would fill many volumes. It will suffice to indicate that between the Legal Aid Board and the drug manufacturers the total cost was over £50 million. In addition the UK government is being taken to the European Court of Human Rights. Once again, the English legal system and the Legal Aid Board have proven their inability and incompetence in dealing with class actions for medical negligence. Some of the reasons for the failure of this litigation are given in detail in Exhibit 11*, not least is the publicity ban imposed by Justice Ian Kennedy as highlighted in my affidavit.
* The article by Roche accepting and admitting problems was distributed when they were denying these problems in court.
Other areas highlighted by Professor Ashton include the non-medicinal (illegal) use of these drugs. It is generally accepted that this is a very large problem. The Narcotics Control Board in a report (1994) stated that the benzodiazepines are among the most frequently diverted from illicit manufacturers and trade into illicit traffic. In addition diazepam is the most widely used benzodiazepine in the world and the most widely "abused" by drug addicts.
SUMMARY OF AREAS OF CONCERN
The large number of benzodiazepine addicts (approx 1m).
Misprescribing, misdiagnosis and mistreatment.
Lack of appropriate medical treatment.
Deaths by suicide and accident.
Need for scrapping and replacing 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.
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/lack of state benefits.
LIST OF EXHIBITS* FROM V.O.T. ARCHIVES
List of U.K. Benzodiazepines and properties.
Benzodiazepine prescribing data.
Lists of reasons and indications for prescribing benzodiazepines.
Extracts from Roche clinical trials.
Data sheets from the USA, Canada, Sweden, and the U.K.
Roche and Wyeth adverts for launch of drugs in the USA.
Review paper on benzodiazepines by Professor Heather Ashton.
Information on benzodiazepine baby problems.
MCA List of Adverse Reactions for diazepam.
Medical papers and Home Office Statistics on benzodiazepine deaths.
Documents on the benzodiazepine litigation.
CSM, CRM documents on benzodiazepine problems.
Roche documents on benzodiazepine dependency.
Social Audit Ltd - Press Release, C Medawar December 1997.
*Not to be used for any other purpose but a select committee investigation without permission of VOT.
"Institutions, like some individuals, are constitutionally incapable of being honest with themselves." Anon
"There is a bar against all information, which is proof against all arguments, and which cannot fail to keep a man in everlasting ignorance - that principle is contempt prior to investigation." Herbert Spencer.
Victims of Tranquillisers
Flat 9, Vale Lodge, Vale Road,
Bournemouth, BH1 3SY,
England, United Kingdom
Telephone / Fax : 01202-311689
Dr RF Peart, BSc, PhD
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