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House of Commons Health Committee Inquiry on Procedures related
to Adverse Clinical Incidents and Outcomes in Medical Care
UK, June 1999
Memorandum by Dr Reg Peart, Select Committee on Health, June 1999.
Transcript of Verbal Submission to the Select Committee on Health Inquiry on June 30th 1999.
Transcript of Verbal Submission to the Select Committee
on Health Inquiry on June 30th 1999
Dr R F Peart
I am aware that, because of the long term and wide ranging nature of the Benzodiazepine problems, some of my written submission was outside the remit of this inquiry.
In this statement I have attempted to distil it to be consistent with the terms of reference and the definitions in the Oxford English Dictionary.
Because of time restriction and my residual drug induced cognitive impairment I would like to, with the Committees permission, read from my notes. This should ensure a more precise statement with greater content, but perhaps some loss of impact.
The adverse clinical incident I wish to talk about, is 40 years of mis-prescribing, mis-diagnosis and mis-treatment. In the late 1970s Professor Lader of the Institute of Psychiatry, warned that the biggest medical epidemic of the 1980s was in the making - it happened. A better way of describing it, is chemical rape of the body mind and soul. Investigation of this incident has been very limited. Although there are many medical publications on a worldwide basis, these have been restricted in scope, with few relevant epidemiological studies. The CRM issued guidelines for drug data sheets, in 1980, the CSM published guidelines for prescribing in 1988 and the Institute of Psychiatry, also published a similar set, the same year.
The outcome of these, was at best to have a marginal impact on the problem. Questions like, what happened? why did it happen? why is it ongoing? have largely been unanswered.
Another important question, is, why have there been so few investigations - the answer must be associated with vested interests.
From the 1960s onwards, patients bombarded their doctors with complaints about these drugs. By the late 1970s, independent authorities estimated that about 1,000,000 were addicted to them. This figure has remained about the same to this day.
It is of interest to note, that for Valium, the most widely used drug, only 16 reports of addiction were received by the MCA, via the Yellow Card System, from 1963-1996. The usefulness and effectiveness of this system must be in grave doubt, when massive under reporting of drug adverse reactions has been going on for so long. One point is clear - the system does not work for the patient, but works hand in hand with vested interests.
Decades of little or no reference to patients complaints was finally picked up by the media and no doubt forced the hand of the CSM into issuing guidelines in 1988. Patients tired of the stonewalling by their prescribers, were reluctant to take action against them - like any addict they wanted to safeguard the access to and supply of their drugs. Instead, thousands of letters of complaint were written to the drugs companies, CSM, MCA, Dept of Health, BMA, GMC, MPs and Ministers. Most patients, simply wanted recognition, acceptance and treatment, and, as this was not forthcoming, many finally resorted to legal action. Others, like myself tried to get access to their medical records. I was refused access by the doctors who (mis)treated me, one indicating that all communication should be via the Medical Defence Union. I therefore started legal action and joined the group action against the drug companies.
This was a disaster from beginning to end, confirming that the English Legal System is incompetent and incapable of running group actions for medical negligence. £50 million was spent without a penny going to the claimants - 'money making machine for members of the legal and medical professions'. Briefly the reasons for its failure include:-
Defence Tactics - Refused to allow test cases - each individual case, to be tested in court, Kennedy very aware of tactics, but did nothing to prevent them. Geared to pushing up claimants' costs
Bias of Justice Kennedy - Against claimants, case experts, imposing impractical deadlines and other restrictions
Conflict of Interest - Case expert Psychiatrists for claimants, were also prescribers - hostile to claimants and to generic experts
Many sufferers have tried to obtain state benefit, including DLA, because of the long term debilitating adverse reactions to these drugs. Few have succeeded, due to the refusal by prescribers to recognise and diagnose problems caused by the Benzodiazepines. A sick note quoting Benzodiazepine addiction is a rarity. The few who get benefits, like DLA, are granted them for reasons other than the cause. e.g. symptoms like depression, agoraphobia are quoted.
It is interesting to note, that the DLA handbook 1998, contains no reference to prescription drug addiction and the phraseology used for other addictions, rules out the inclusion of iatrogenic addiction.
The biggest barrier to patients obtaining recognition, acceptance and treatment for this problem, is the prescribers themselves - those whose clinical judgment created the problem in the first place.
Voluntary support groups get little or no co-operation from doctors. They refuse to display information to patients (see submission by Una Corbett of BAT - Battle Against Tranquillisers). Most surgeries, if not all, have lists of Benzodiazepine users in data base form. It would be easy and helpful, if doctors sent details of help available, in the voluntary sector to these patients. By definition, relatives and carers, are similarly uninformed, unable to be supportive and in some cases, their actions are destructive - often aided and abetted by misinformation from prescribers.
There appears to be a lack of will, to open up and do something about this problem, by the statutory services sector. Often Health Authorities are keen to work within Government guidelines and directions from the Dept of Health, with the voluntary sector. Their inward looking stance, is covered by cries of 'clinical judgment' - a mantra taken up by the prescribers, the NHS, MCA, and other authorities. The old precept 'First do no harm', has been turned on it's head, and now applies to the prescribers and the medical profession, under the cover of 'clinical judgment'.
As a result of this minimum level of investigation, the overall problem has shown little improvement over the last 10 years. The Benzodiazepine prescribing rate, is still about 16 million (UK); 70% are repeat prescriptions. Suicides, traffic accidents, damaged babies, destruction of lives and families, are still happening. There are, in addition, signs that the problem is increasing. Prescribing of all sedative / hypnotic drugs, has increased over the past few years. In particular, Valium has increased by 15% and in addition the prescribing of Benzodiazepine-like drugs: Zopiclone and Zolpidem is rising dramatically. I think a significant factor in this and other drug prescribing, is the redefining, packaging and selling of illness, as practiced by some factions of the medical profession and the drug companies.
An additional outcome, is the growing number of people with a primary problem of benzodiazepine addiction, who are turning to, and becoming addicted to alcohol and illicit drugs - as reported by support groups, for a variety of drug addictions. Also, many, who are addicted to other drugs, are given Benzodiazepines, for treatment nominally and initially to aid withdrawals, but often resulting in full blown addiction to the Benzodiazepines. Correspondence between BAT - Battle Against Tranquillisers and Keith Helliwell, shows that, he is very aware of this problem.
Another outcome, is the paucity of treatment and treatment facilities. There are many residential facilities for those with alcohol and illicit drug problems, but these are largely unsuitable for the unique problems of Benzodiazepine addiction. e.g., most are treated for 4-6 weeks in primary care. Last year 14,000 alcoholics were given residential treatment - how many Benzodiazepine addicts? The 'best' these can obtain, is a few weeks in a psychiatric unit - often resulting in a fast withdrawal, followed by a relapse.
Many Benzodiazepine addicts suffer from panic attacks and agoraphobia and are unable to get to support groups, if available. For these, there is no organised system or support for a 'home detox'. There is a desperate need for such a system under the supervision of Benzodiazepine agency experts - with little or no participation by the prescribers.
With regards to support groups and agencies - there are relatively few scattered over the UK. Allocated resources are nominal, e.g., financial input amounts to pennies per year per Benzo addict. There is very little information re the physical and mental problems caused by the benzos and the opportunities for training staff for agencies is non existent.
On the subject of information, in spite of a huge number of medical papers and great interest shown by the media, there is no significant improvement in the nature, or extent of knowledge reaching the patients, or the lower echelons of the medical profession. There still exists a filtering process at every stage in the transfer of information from the drug companies to the patients. The system works in such a way as to maximise the benefits and minimise the risks of drugs.
The belated introduction of PILs (Patient Information Leaflets), should be of significant value, if it operates for all drugs - there appears to be some doubt of their issue with generic drugs. Many of these are stocked in large numbers and are being dispensed, without any leaflets.
The information given in the BNF, is at best patchy. It needs to be upgraded, perhaps along the lines of the PDR of the USA.
Measures to Improve Situations:-
Freedom of information Act - with teeth - current proposals are a sham
Independence of Committees - MCA, CSM
Ring Fenced Funding and Resources for Support Groups, training of staff
Professional Training - at all levels - Emphasis on drug side effects
Residential Treatment Facilities / Home Detox System
Addiction Warnings on pill bottles and packets
Drug Compensation Scheme, in lieu of legal actions
Re-examination of Clinical Judgment - Accountability and Responsibility of Doctors
Research on Long Term Benzodiazepine problems / Epidemiological Research
Changes under the Misuse of drugs Act - Rescheduling the Benzodiazepines, from 4 to 3, and from Class C to Class B
Prescription Drug History of Criminals - Computerised on Police records - re senseless acts of violence
As requested by many - a separate and full inquiry, into the Benzodiazepines - this will reduce prescribing far more than guidelines to prescribers.
Comments on Issues Raised at the Health
Committee Inquiry on 24th June 1999
30th June 1999
There was complete unanimity of the witnesses on the following issues:-
The need for a non negligence harm (no fault) medical drug compensation scheme as previously recommended by a Royal Commission and other bodies.
It was agreed, that the Yellow Card System for referring drug adverse reactions should be scrapped. The MCA estimates of 10-15% of reactions reported may be relevant to the number of different reactions, but not to the number of cases / reaction e.g., for the benzodiazepines. 1 in 10,000 - 100,000 is appropriate.
Establishment of complaints system, patients advocacy system, independent of the NHS and the medical profession.
That the GMC, CSM / MCA be replaced by independent bodies with both lay and professional members.
Re-examination of the concept of 'clinical judgment' in terms of responsibility and accountability.
At a previous meeting of the committee (June 17th 1999), there was a 'discussion' of an appeal court hearing judgment that the NHS does not have a duty of care to patients or a duty to inform patients or does not have to tell the truth. We believe this decision should be challenged and reversed by legislation if necessary. It is a denial of accountability and responsibility similar to the use of clinical judgment.
The above issues and other proposed changes, although highly desirable to improve the health of the nation, long term, do relatively little for ongoing health problems, like benzodiazepine addiction. Unless changes to the level of recognition and acceptance of the dangers of the benzodiazepines are made, then lessons will not be learnt. The problems of driving accidents, damaged babies, use as street drugs and senseless acts of violence will continue to be 'swept under the carpet'. Similar problems with other drugs will continue to occur, as is already happening with Zopiclone and Zolpidem.
There are two areas where action is required. Firstly the setting up of organisations with appropriate financial support, to enable benzodiazepine addicts and ex-addicts to help themselves and others. There exists a wealth of talent and experience that could be harnessed and trained for counselling, advocacy, home detoxification and other support group work.
The second area is similar to that proposed for the tobacco industry. Representatives of the drugs industry Roche and Wyeth should be summoned before the Health Committee to establish who knows what and when about the addictive nature and other adverse reactions of the benzodiazepines. VOT has sufficient evidence from the public domain in the UK and overseas and from other sources that the drug companies knew, pre 1973, most of the information admitted and accepted today.
Additional answers to questions on 24th June 1999
30th June 1999
Question (Mr Ivan Lewis) - On the role of benzodiazepines in the treatment of mental health problems.
Answer (Dr R F Peart) - The benzodiazepines are prescribed for a range of physical and mental problems. For the latter they have a very limited and restricted role for short-term use (4 weeks) and for severe problems of anxiety and insomnia in accordance with the CSM guidelines (1988). The problem is that most prescribing is contrary to these guidelines. e.g., two thirds of patients have been on them for more than 4 weeks. Many people prescribed post 1988 have been on them for years and 70% are repeat prescriptions. Support groups are frequently contacted by people who have been on these drugs for up to 30 years.
Question (Mr Ivan Lewis) - Can GPs diagnose whether individual sensitivity will lead to addiction?
Answer (Dr R F Peart) - The simple answer is no, unless the patient has a history of drug or alcoholic problems. There is no other connection between premorbid health and the probability of becoming addicted. In general there is a wide variability in the patterns of response to drugs among individuals, in both therapeutic effects and adverse reactions. This individual variability is determined largely by genetic programming of drug metabolism and responsiveness. The key to early diagnosis is identifying side effects, because chronic addiction is the repeated use of a drug to alleviate side effects caused by that drug. The problem of individual variability is well recognised but very little attention has been directed to understanding it. The WHO has stressed the need for it to become an integral part of clinical trials and post marketing studies. The only certainty is that if patients are on these drugs long enough, even low doses, they will become addicted. (90% become addicted in 1-2 years).
Question (Mr John Austin) - Did I notify the GMC of my case?
Answer (Dr R F Peart) - No. I was aware of the outcome of others who had tried this route. The answers were in effect that the problem was one for the prescribers to exercise their clinical judgement and it was not appropriate for the GMC to be involved. I do not know of any benzodiazepine addiction case that has been seriously considered by the GMC.
Question (Mr D Hinchliffe) - On the nature of vested interests.
Answer (Dr R F Peart) - Any discussion of vested interests automatically centres on the activities of the drug manufacturers. These activities are geared to maximising the benefits and minimising the risks of their product. The end result is the control of and distortion of information. They thrive on producing conflict of interest.
Examples of such activities include:-
Design of protocols for clinical trials to conform only with drug licensing regulations as apposed to being informative about drug properties.
Double standards. The use of extremely high scientific standards to criticise research unfavourable to their drugs. If the same standards were used on their own research, their drugs would not be marketed.
Financial and other support to 'independent' researchers leading to control of publications with selection of content and control of terminology to favour their drugs. They have 'semantic prestidigitation' off to a fine art and make most spin-doctors look like amateurs.
Extensive financial links with Government bodies e.g., CSM / MCA. Individual members have financial links and the MCA is heavily dependent on drug licensing fees.
Control of and restriction of information for drug data sheets. Either by non-disclosure or aided and abetted by the CSM, or both.
Financial and other inducements for doctors to use their drugs. These range from payment of conference costs, to those for surgery contents and stationery. Another aspect of vested interests is placing the interests of the doctor and the medical profession above those of the patient, contrary to the Hippocratic Oath. Complaints are met with a defensive posture, cover up, absence of transparency, denial and delay - a culture evolved by decades of self regulation. Preserving the reputation of individuals and their profession is paramount. From the public perspective, there is a great need for independent regulatory authorities for the pharmaceutical industry, the medical profession and government committees such as the CSM and MCA. In addition, an independent organisation responsible for the collection, collation, correlation and dissemination of medical / drug information is urgently required. In this context a Freedom of Information Act with teeth is essential. Unless and until these changes are made, drug licenses issued by the Government, will remain licenses to kill and destroy the lives of many thousands of people, with no adequate means of redress for the victims.
Question (Mr D Hinchliffe) - Should the GMC be reorganised?
Answer (Dr R F Peart) - Yes!! The GMC shows all the defects of years of inbreeding and self-interest. Self-regulation by definition (Ref. The Science of Systems), is intrinsically prejudiced and biased. A new and independent body (with a new name) consisting of both professional and lay members should be formed. It is a myth propagated by the medical profession that lay people cannot understand medical problems and issues. In my experience the only problem is understanding the terminology. Once this is achieved, then those with common sense and above average intelligence from many walks of life are able to act in this capacity. Those with political careers often do it.
Question (Mr D Hinchliffe) - On my qualifications for commenting on medical issues.
Answer (Dr R F Peart) - My doctorate is in Nuclear Physics. I have found little difficulty in transferring my experience and knowledge in academic and industrial research (including many publications) to the study and research of several areas of medicine and pharmacy. This has ranged from critiquing clinical trials to an in depth understanding of the pharmacodynamics and the pharmacokinetics of drugs. In addition I have visited drug treatment centres, attended many support group meetings for a range of addiction problems, including alcohol, illicit drugs as well as prescribed drugs. I have met, spoken with and listened to thousands of addicts of all persuasions. These experiences, plus my own 16 years of iatrogenic Valium addiction, I believe, have given me a highly relevant insight in to the field of chemical substance addiction and allied medical problems.
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