Select Committee on Health Minutes of Evidence

Memorandum by Dr Reg Peart


  This submission concerns the nature and causes of 40 years of Benzodiazepine dependency and is a skeletal outline of chronological events, circumstances and consequences, plus suggestions to improve the current situation and prevent such a problem in the future with other drugs. The objective is to present an overview, and to provide a framework for more detailed submissions on specific areas by other organisations and individuals. It is requested that a separate inquiry be set up for the Benzodiazepine health problem.



  1.  This submission is by Dr R F Peart, National Co-ordinator of Victims of Tranquillisers (VOT) and concerns the nature, causes and consequences of 40 years of Benzodiazepine dependency, arguably the biggest medically induced health problem of the 20th Century.

  2.  My purpose is to present an overview of this problem, to provide a framework for the more detailed submissions on specific areas made by other organisations and individuals. In the absence of a national organisation, strategy or funding for this problem, VOT has attempted to fill this gap by liaising, co-ordinating with and providing information to various support groups and individuals in the UK and overseas (a list of some of these is given in Appendix 1).[3] For convenience, I have enclosed two previous submissions by myself, "Tranquillizer Addiction—A Medically Induced Epidemic", and "A Submission to Phil Woolas MP with regard to a Health Select Committee inquiry into the Benzodiazepines".

  3.  The VOT archives contain many thousands of documents from the UK and overseas, including over 150 lever arch files of medico/legal information. It also has over 2,000 papers on Benzodiazepine problems, cross filed in chronological order, author, alphabetical order and subject matter, along with pharmaceutical data sheets from about 30 countries, and documentation from the WHO, the FDA and other organisations from countries which have Freedom Information Acts (USA, Canada, Sweden, Australia). VOT activities also include supporting and supplying information to claimants pursuing legal cases at the European Court of Human Rights, against prescribers, drug manufacturers, for DLA Tribunals and complaints to the Parliamentary Ombudsman.

  4.  Assessment of the medical literature and other documents clearly shows that there are three root causes of the Benzodiazepine epidemic—a catalogue of misprescribing, misdiagnosis and mistreatment which has cost this nation billions of pounds.

    (1)  Drug Secrecy.

    (2)  Absence of an effective system for dissemination of information to prescribers and patients.

    (3)  The education, training, attitudes and beliefs of prescribers.

  5.  I believe that the nature, magnitude and consequences of this health problem warrants a separate inquiry and request that it not be subsumed into the above enquiry.

  6.  The following is a skeletal outline of the events, circumstances and consequences of Benzodiazepine dependency and suggestions to ameliorate the current situation and prevent such a problem in the future.


  7.  VOT has made an assessment of the state of knowledge and consensus of medical opinion on prescribed drug dependence in general, and on Benzodiazepine dependency per-se. The first UK data sheets were published in 1973-74. Sources of information used were:

    (1)  Drug company clinical trials and studies;

    (2)  Commercial information;

    (3)  Independent medical research and opinions;

    (4)  Pharmaceutical data sheets from overseas;

    (5)  Physicians Desk Reference (USA) and the British National Formularly (UK);

    (6)  World Health Organization (WHO) and the Food and Drug Administration (FDA, USA).

  8.  It is clear that there was a general acceptance that all sedative/hypnotic drugs could produce dependence. There was a high awareness of the problems with the barbiturates and meprobamates and very specific recognition that Librium and Valium were dependence producing drugs (WHO). In 1970, the WHO declared that 10 other Benzodiazepines should be considered as having the same potential as Librium and Valium. All the key indicators for dependence were well documented eg high cross-tolerance with other sedative/hypnotic drugs, tolerance with use, withdrawal symptoms of the barbiturate alcohol type and the reinforcing nature of these drugs.


  9.  The first data sheets in the UK (1973-74) were extremely limited in scope. Much information given in those of other countries was omitted, and the main thrust appeared to avoid litigation, with pre-emptive strikes against the users and prescribers rather than information for the benefit of the patients.

  10.  This position remained relatively unchanged until the mid 1980s when a few minor additions were made after years of discussions between the drug companies and the Committee of Safety of Medicines(CSM)/Committee of Review of Medicines(CRM).

  11.  During this period there was a very active campaign by the pharmaceutical industry and sections of the medical profession extolling the virtues of the Benzodiazepines over Barbiturates. This campaign, led by Roche Products Ltd included 1,000 visits per week by medical representatives to doctors, letters to all GPs and consultant psychiatrists and over 10,000 copies of a book on Benzodiazepines by J Marks the ex Director of Clinical Research for Roche. The nature, methodology and conclusions of this "research" were severely criticised in the medical literature and the author recanted in 1983. The prescribers were not notified of this.

  12.  There has been very little comparative research assessing the merits of the Benzodiazepines over the Barbiturates. The few studies made suggest that the benefit/risk ratio is very similar and some are in favour of the Benzodiazepines.

  The risk of toxicity in overdose appears to be the only significant difference between these drugs. Home Office Statistics give about 300 deaths per year caused by the Benzodiazepines over the last decade. The 760 million prescriptions for Benzodiazepines since 1960 suggest over 10,000 deaths were caused by these drugs. Over the last two decades the Benzodiazepines have become the "drug of choice" for those attempting suicide by overdose. This is probably a reflection of the higher suicidal ideation caused by the Benzodiazepines. Some observers believe that the changes in personality and brain chemistry produced by the Benzodiazepines are responsible for some of the increase in senseless violence in recent years. In this context, all of the students involved with the schools shootings and killings in the USA were on prescribed drugs. Estimates of the number of patients per million prescriptions dependent on the Barbiturates are about one third of those for the Benzodiazepines.

  13.  The combination of little information in data sheets plus the campaign resulted in a rapid increase in prescribing levels which reached just over 30 million in 1979. The rate of prescribing in the USA was about half of this and supports the observation of an inverse correlation between the amount of information in data sheets and prescribing rates.


  14.  The prescribing rates in the UK have steadily decreased from 1979 to about 18 million in 1997, about 2 per cent per year. The factors responsible for this include public protests, reports in the press and media and mandatory measures such as the restricted prescribing list imposed by the NHS in 1985, the banning of Halcion (Triazolam) in 1991 and the prescribers fear of prosecution. Awareness by the prescribers appears to be a minor factor.

  15.  In 1988, the CSM issued guidelines severely restricting the indications and length of time for prescribing of Benzodiazepines. The prescribing, several years before and after these guidelines were issued, shows a similar rate of decrease suggesting no significant reduction due to this action alone. It is more likely that the continual decrease was due to extensive publicity given to the litigation against the CSM, Health Authorities, prescribers and the drug companies which began in 1988.

  16.  In 1993-94 the Benzodiazepine Litigation ended owing to the withdrawal of Legal Aid Board funding. Over £50 million pounds was spent on legal aid and by the drug companies. Since this event the number of prescriptions for all Sedative/Hypnotic drugs has increased by several per cent overall, and that for Valium has increased by 15 per cent (1994-97). The prescribing of the new Sedative/Hypnotic drugs Zolpidem and Zopiclone, which act on the Benzodiazepine receptors has risen dramatically and is now about two million per year. It is very significant that the number of adverse reactions (No/yr/106 pres.) reported for these drugs is very much greater (x100) than for any of the Benzodiazepines. This coincides with many reports to support groups of dependency on these drugs. It appears that the lessons of history have not been learnt and there is an additional dependency epidemic in the making.


  17.  The Benzodiazepines like all Sedative/Hypnotic drugs are depressants of the central nervous system with marked dis-inhibitory properties. They are fat soluble, accumulate and are stored in the body and brain. These properties produce extensive toxic effects causing a multi-symptom illness with a wide range of physical, mental and sociological problems. VOT files contain thousands of papers on these eg 420 on Addiction/Dependency/Withdrawals, 158 on Illegal Use, 130 on paradoxical Reactions, 112 on Pregnancy/Neonates and Children, 96 on Deaths/Toxicity and Poisoning, 90 on Accidents and Injuries, 58 on Geriatric/Elderly, 42 on Muscular Skeletal and 36 on Heart/Respiratory problems. A complete list of about 70 topics is given in Appendix 2. The number of papers probably represents less than 50 per cent of the total in the medical literature.

  18.  Dependence on the Benzodiazepines occurs quickly and frequently ie in a few days or weeks. The Institute of Psychiatry recognises that it can occur within four weeks—hence the time limit on prescribing in the 1988 CSM Guidelines. Various estimates of the percentage of patients dependent on these drugs are 20-45 per cent after 6 months and 50-90+ per cent for 1-2 years. All longer term users including some who have been on these drugs for over 30 years are dependent (addicted) on them. It is now generally accepted that Benzodiazepine withdrawals are far worse and last much longer than those for alcohol, heroin or the barbiturates. Estimates for long term users of alcohol suggest only about 5 per cent become dependent. Hence it is arguable that the Benzodiazepines are as addictive as any other legal or illegal drug.

  19.  Estimates on the number of people using prescribed Benzodiazepines vary from 10-17 per cent of the adult population with from 1-3 per cent on these drugs for over 12 months. The current 18 million prescriptions for Benzodiazepines (UK) equates to about 2.5 million people using them for periods greater than one month as specified in the guidelines. Consideration of all sedative/hypnotic drugs give significantly higher figures eg over 1 million of the elderly take sleeping pills regularly at night (MIND 1995). These figures suggest that there has been only a small improvement in the long term problem over the last decade with the possibility that it is getting worse again.

  20.  The very wide range of physical and mental problems caused by these drugs is very well documented but the sociological problems and denial of basic human rights is less so. These are summarised in the following extract from an affidavit to the Benzodiazepine Litigation 1995 by R F Peart "includes loss of family, colleagues, work, reputation, respect, personality and character. We have also lost rights such as freedom to think, talk, act, or react normally and to experience the normal range of human emotions" "Many have lost the rights to choose friends or have normal relationships, to marry and to have children. Some have had babies terminated or borne addicted to these drugs suffering from physical and other mental problems. Many have lost the right to work and to support themselves and their families financially". Many have been stripped of their dignity, lost meaning of life and most aspects of what it means to be a human being.


  21.  The pharmaceutical industry has a long history of convictions for illegal activities on a world wide basis. In 1950, Hoffman La Roche were convicted in the USA of failure to warn of the hazards of a drug. As a result of a Department of Health initiative a Monopolies Commission in 1973 into un-competitive practices and profiteering by Roche Products Ltd resulted in the payments of several million pounds to the UK Government. Very recently (May 1999) Roche has been fined $500 million in the USA for a global price fixing conspiracy.

  22.  The root cause of the Benzodiazepine problem is the suppression of information by the drug manufacturers. They knew of the probability that these drugs would cause dependence by 1960 and all the information currently given in the UK data sheets and Patient Information leaflets was known prior to the first data sheets in 1973-74. VOT archives contain extensive material demonstrating these propositions. It has all been supplied to Mr Ian Caldwell who is a litigant against Roche Products Ltd in the Scottish Courts. He has written to the Health Committee under separate cover.

  23.  n 1968, Wyeth Lab Inc were convicted in the USA with failing in its duty to warn of the dangers of a drug and in more recent times the FDA in a letter to Wyeth in 1989 stated that "Wyeth has an intolerable record of compliance with the law on drug promotion". Wyeth were issued with 18 motions of violation of drug advertising and labelling laws over a two year period. One violation was that Wyeth had disseminated promotional material clearly false and misleading indicating a general and wilful disregard for legal and regulatory limitations on drug promotions. The information in VOT files shows that Wyeths' activities in the UK follows the same pattern as those for Roche. VOT is using this information to support a complaint to the Parliamentary Ombudsmen about the refusal of the MCA to release details of Wyeths licence application for Ativan (lorazepam).

  24.  In 1992, Halcion (Triazolan) manufactured by Upjohn was banned from sale in the UK. The reasons for this included the failure of Upjohn to disclose, in the licence application, information concerning frequent and disabling psychiatric adverse reactions as given in the clinical trials.


  25.  The CSM/CRM/MCA along with the Medicines Act and the 1972 Medicines (Datasheets) Act have been severely and extensively criticised over the years. The primary purpose and responsibility of these committees is the health and safety of the public. In practise, their primary function has been as a protective shield for the pharmaceutical industry with their action and activities shrouded by "official" secrecy. It would be an insult to the intelligence of committee members to assume that they were/are not aware of the consequence of their actions.

  26.  With regard to the first data sheets in the UK, there are two scenarios that require investigation:

    (1)  Did Roche and Wyeth declare all appropriate information to the CSM and if so why did it not appear in the data sheets?

    (2)  If Roche and Wyeth failed to disclose this information, then why did the CSM members not query the submission and ensure that the data sheets contained all information that existed in the medical literature?

  27.  The Department of Health under successive governments could have and should have intervened to diminish the Benzodiazepine problem from the early 1970s onwards. When they finally did in 1985 with the selected list of generic Benzodiazepine they were, as with their previous initiatives, motivated by financial considerations. Ironically it was this action that prevented thousands of sufferers from suing the drug companies.

  28.  A major criticism of the CSM/MCA is the overwhelming conflict of interest produced by financial links, including consultancies with the drug companies. Recent changes introduced in 1993 ensure that the MCA is financed by licence application fees and other remuneration from drug companies. Such financial links inevitably produce a strong bias and loss of independence in the system. The establishment of truly independent committees and the passing of a Freedom of Information Act (with teeth) are both required to ensure that further health scandals do not occur.

  29.  The prescribing of drugs to the population at large acting as a giant human laboratory with no adequate controls on long term use or pharmacovigilance is both unethical and immoral. The principle that the minority must suffer, with no practical means of redress, for often dubious benefits to the majority, can only be justified with blatant casuistry and sophistry. Redress via legal action is a non-starter for group medical negligence actions. No case in the UK against a pharmaceutical company has reached the stage of a legal ruling. The failure of the Benzodiazepine litigation is one more example of the inability and incompetence of the English legal system, and those who operate it, to deal with Group Medical Negligence claims. The strong conflict of interest in the roles of consultant psychiatrists as case experts and prescribers was a key reason for its failure. The basic problem of "inequality of arms" can only get worse with the recent changes in the law concerning legal aid.

  30.  After the Thalidomide tragedy (another sedative/hypnotic drug), a number of official bodies looked at compensation schemes for drug damage, eg a Royal Commission, the Law Commissions for England, Wales and for Scotland. They recommended that the law should change and that companies should be responsible for compensating those injured without the victims having to prove negligence in court. The EEC agreed but UK governments have failed to implement the findings. There should be a mandatory requirement that drug manufacturers finance and support ongoing research into the causes of a treatment of long-term and permanent adverse reactions caused by ingestion of prescribed drugs. Many victims have been made unemployed and unemployable because of the long term effects of Benzodiazepines. Because of the relatively few studies in this area, lack of knowledge and denial by doctors, many are not receiving Disability Living Allowance and other benefits they should be getting.


  31.  There are two factors which have heavily influenced the attitudes and activities of prescribers and caused the misprescribing, misdiagnosis and mistreatment over the last 40 years. Firstly the pressure of extensive promotion by the drug industry in the 1960's and 1970's has produced a mindset in many of the older doctors. A recent survey showed that over 70 per cent of GPs and over 30 per cent of Psychiatrists had little or no knowledge of the effects of Benzodiazepines on brain chemistry. Secondly tradition and training makes it difficult for doctors to appreciate adverse consequences of drug use. Most are not trained to diagnose and to recognise the syndrome of addiction and its adverse consequences and are unable to differentiate between normal clinical pathology and that produced by drugs.

  32.  Many doctors propagate myths and fallacies concerning addiction and drug side effects as a part of their denial of the problem, eg the side effects are a resurgence of a pre-existing or underlying problem, or its all in the mind, or it shows the patient needs to be on these drugs for the rest of their life and the patient has an addictive personality. The reality is that most who become addicted to these drugs were put on them for somatic symptoms, sleep problems or sociological reasons. Only a very small minority had any diagnosed pre-existing mental disorder. In a recent report by the Royal College of Psychiatrists two important statements were made in this connection:

    (1)  No single underlying trait or unique constellation of personality features can be identified as predisposing to drug misuse.

    (2)  It is improbable that gross mental illness is ever likely to make more than a marginal contribution to drug misuse.

  In addition the WHO (1993) categorically states that all aspects of dependence can be explained by biochemical factors.

  33.  The lack of recognition and acceptance by prescribers of Benzodiazepine induced problems have many consequences and impacts heavily upon the patient's endeavours to obtain appropriate treatment. The non-recognition of depression and anxiety as major side effects and part of the withdrawal syndrome has led to many being given ECT inappropriately. Others have been misdiagnosed as neurotic, psychotic, alcoholic, depressive, schizophrenic or having senile dementia, multiple sclerosis or Parkinson's disease and subjected to years of inappropriate multi-drug prescribing. Both the counsellors and clients attending tranquillizer support groups bitterly complain of the absence of interest or support from the doctors, in their attempts to recover. Many would like, and some really need, residential treatment to come off these drugs but unlike the alcoholic or hard drug addict such treatment is rarely available because of the high cost of the length and severity of the withdrawal process. A system of help and recovery that is independent of prescribing doctors is urgently needed.


  34.  There are a number of recent reputable reports that are highly relevant to the Benzodiazepine problem in the UK, those include:

    (1)  The International Narcotics Central Board 1998

  "The Board requests to Governments of countries with high levels of consumption of Benzodiazepine and their increasing abuse to conduct, in co-operation with non governmental organisations involved with treatment and rehabilitation, comprehensive surveys to determine the size of the population abusing/and using these substances. There are indications that some doctors prescribe Benzodiazepine for unnecessarily long periods and for symptoms that may not require such treatment. The Board invites the Governments of countries in Europe to raise the awareness of medical practitioners of the need to use those substances in a more rational manner."

    (2)  The International Society of Drug Bulletins (ISDB, 1997). This report severely criticises the role and activities, especially the lack of transparency, of drug regulatory authorities.

    (3)  A study by the Kings Fund health charity, 1998 "Informing Patients" concludes that information materials contained out of date, inaccurate and sometimes misleading information.

    (4)  The Erice Declaration resulting from an international WHO sponsored conference on "Effective Communications in Pharmocovigilance". This contains five key recommendations all of which are pertinent to this submission (see Appendix 3).

    (5)  Medication for Older People (Royal College of Physicians, 1997) "Adverse drug reactions remain an important cause of morbidity even mortality in older people" . . . "older people suffer much drug related iatrogenic disease caused by inappropriate treatment which may be incorrect medication, inappropriate polypharmacy and/or inadequate monitoring of therapy".

  35.  This submission is supported by further information and factual evidence, in my previous report (attached) to Phil Woolas MP, albeit that contains only token samples of the total evidence available in VOT archives and other sources.


    —  The only difference between a drug addict and the rest of society is the drug—Krivanek, 1988.

    —  The level of science in psychiatry lies between astrology and witchcraft—Anon.

June 1999

3   Appendices not printed. Back

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