The Benzodiazepines: House of Commons Health Committee Inquiry

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The Benzodiazepines:

 

House of Commons Health Committee Inquiry on Procedures related

to Adverse Clinical Incidents and Outcomes in Medical Care

 

UK, June 1999

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Memorandum by Dr Reg Peart, Select Committee on Health, June 1999.

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Transcript of Verbal Submission to the Select Committee on Health

Inquiry on June 30th 1999.

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Comments on Issues Raised at the Health Committee Inquiry on 24th June

1999.

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Additional answers to questions on 24th June 1999.

 

Transcript of Verbal Submission to the Select Committee

on Health Inquiry on June 30th 1999

 

The Benzodiazepines

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:-

 

1.

 

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

2.

 

Bias of Justice Kennedy - Against claimants, case experts,

imposing impractical deadlines and other restrictions

3.

 

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). 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 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:-

 

1.

 

Freedom of information Act - with teeth - current proposals are

a sham

2.

 

Independence of Committees - MCA, CSM

3.

 

Ring Fenced Funding and Resources for Support Groups, training

of staff

4.

 

Professional Training - at all levels - Emphasis on drug side

effects

5.

 

Residential Treatment Facilities / Home Detox System

6.

 

Upgraded BNF

7.

 

Addiction Warnings on pill bottles and packets

8.

 

Drug Compensation Scheme, in lieu of legal actions

9.

 

Re-examination of Clinical Judgment - Accountability and

Responsibility of Doctors

10.

 

Research on Long Term Benzodiazepine problems / Epidemiological

Research

11.

 

Changes under the Misuse of drugs Act - Rescheduling the

Benzodiazepines, from 4 to 3, and from Class C to Class B

12.

 

Prescription Drug History of Criminals - Computerised on Police

records - re senseless acts of violence

13.

 

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

 

The Benzodiazepines

30th June 1999

 

There was complete unanimity of the witnesses on the following issues:-

 

1.

 

The need for a non negligence harm (no fault) medical drug

compensation scheme as previously recommended by a Royal Commission

and other bodies.

2.

 

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.

3.

 

Establishment of complaints system, patients advocacy system,

independent of the NHS and the medical profession.

4.

 

That the GMC, CSM / MCA be replaced by independent bodies with

both lay and professional members.

5.

 

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

 

The Benzodiazepines

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:-

 

1.

 

Design of protocols for clinical trials to conform only with

drug licensing regulations as apposed to being informative about drug

properties.

2.

 

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.

3.

 

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.

4.

 

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.

5.

 

Control of and restriction of information for drug data sheets.

Either by non-disclosure or aided and abetted by the CSM, or both.

6.

 

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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