Memorandum submitted by Barry Haslam (PI
76)
PERSONAL HISTORY
I am an ex-Senior Accounting Technician, now
aged 61 years. From 1976 to 1986 I was G P prescribed benzodiazepine
drugs eg Librium, Valium, Ativan. At the peak of my iatrogenic
addiction in 1985, I was ingesting 30 mgs of Ativan daily (the
equivalent of 300mg of Valium) (Para 1)
As a direct result of the above "medical
treatment", the period from 1976 to 1986 is a complete blank.
I have no memory of family life (1 have two daughters), no memory
whatsoever of my 10 year coma. (Para 2)
I am now permanently brain damaged (Ref 1) and
suffer from brain atrophy, cognitive defects, hypothyroidism,
neuro pathway pain—right side of body, semi-deaf in both
ears, mood swings, violent headaches, narrow airways disease,
chronic fatigue syndrome and aggression. (Para 3).
Despite the above, I love life. I love my wife,
family and grandchildren. I have been re-born. (Para 4)
For the past 14 years I have been Chairman of
a drug support group— Oldham (Tranx). I have counselled
thousands of people both in this country and abroad over the past
18 years, all done voluntarily. I have written articles for the
local and national press via interviews, (Ref 2) and on TV. I
have written a report on benzodiazepine drugs for the European
Commission (Ref 3), and presented the report in February 2004
to Mr David Byrne, The Health Commissioner in Brussels at the
request of Euro MP Mr Chris Davies. (Para 5.)
In addition I have worked closely with Mr Phil
Woolas MP Deputy Leader of The House of Commons, and Oldham PCT
. . . (Ref 4.A,B,C.) The result being that from August 2004, Oldham
will have a benzodiazepine drug withdrawal service for legal drug
addiction. We have 5,200 long term benzodiazepine drug addicts
in Oldham and need a large increase in funding from Government
to fully address the problem. (Para 6)
1. Patient use and Past Consumer of Benzodiazepine
Drugs
See Paragraphs 1-3.
2. Drug Innovation
Barbiturate drugs were replaced partly by the
Benzodiazepines. The World Health Organisation (WHO) in 1964 said
"that barbiturates and Benzodiazepines could have been expected
to produce dependence of substantially the same kind". (Para
8)
The medical profession welcomed the benzodiazepines
as an alternative drug of treatment due to easy overdosing with
barbiturates and alcohol resulting in death, (Para 9)
However, benzodiazepines cause suicidal ideation
(Ref 5) and many deaths by suicidal poisoning as illustrated clearly
by Home Office statistics (Ref 6) of 761 deaths between 1990-96
(Excluding 1994). (Para 10)
3. The Conduct of Medical Research
Medical research by the drug companies eg, Roche
and Wyeth were in the main short term trials of a few weeks only.
Yet both these drug companies actively promoted their products
of Valium and Ativan for long- term treatment of patients. In
essence, the patients became human guinea pigs (Ref 7 A,/B) both
in terms of length of enforced addiction and in excessive recommended
dosage. (Para 11)
DUTY OF CARE! Was the producer (Wyeth) in possession
of evidence about the performance of their drug which if it had
been passed to the prescriber would have caused the prescriber
to modify his prescribing behaviour? The dosage recommendations
are clearly excessive for Ativan eg the equivalent of up to 40
mg of Valium daily dosage for mild anxiety. (Para 12)
In Canada and the USA 0.5 mg Tablets of Ativan
were available unlike in the UK where only l mg and 2.5 mg tablets
were available. Indeed such is the strength and short half life
(Leading to addiction) that Professor C Heather Ashton of Newcastle
University advocated that 0.25 mg and 0.125 mg tablets be made
available for Ativan tablets. (Para 13)
4. The Provision of Drug Information and Promotion
In April 1967, the ABPI published the 3rd edition
of its Code of Practice for Member Firms. Both Roche and Wyeth
were members. (Para 14)
They include:
"Methods of marketing must never be such
as to bring discredit upon the pharmaceutical industry" (Para
15)
"Information furnished to the medical profession
about a medical speciality product must be accurate and balance
and must not be misleading either directly or by implication"
(Para 16)
"Claims for the usefulness of a product
must be based on an up to date evaluation of all the evidence
and must reflect this evidence accurately and clearly" (Para
17)
"Communications on medical specialities
must reflect an attitude of caution". (Para 18)
"Observance of the Code is a requirement
of membership" (Para 19)
Clearly Roche and Wyeth broke the Code of Practice
and clearly did not give a damn for the recipients of their drugs.
They rode roughshod over principles all the way to their bank.
(Para 20)
On 5 March 1980, (Ref 8) Roche (Producers of
Librium and Valium) wrote to all GP's and consultant psychiatrists
a "Dear Doctor" letter. Clearly, they were concerned
about their market share and a fall in profits and went on the
offensive. Dr John Marks (a former Roche employee), whose thinking
was in line with the 1980 CRM (Ref 9) systematic review of the
benzodiazepines decision, to fudge the report on benzodiazepines.
"The number dependent on the benzodiazepines in the UK from
1960 to 1977 has been estimated to be 28 persons". This lie
was printed despite approximately 350 million prescriptions being
issued during this period. Dr Marks, a few years later, revised
his opinion on the true addictiveness of benzodiazepines. This
came too late. The pattern was set and the damage done, all due
to the criminally inept yellow card ADR System. (Para 21)
Watts 1972 cited in Parish 1973 pp 30-31 "The
patient must be warned that tablets are only to help him over
the crisis. Longer courses are very hazardous and likely to provide
drug dependent patients. When their use was accepted in our area
as a reasonable form of treatment, so many people were on tranquillisers
that a partner suggested we might as well put Chlordiazepoxide
(Librium) into the tap water" (Para 22)
Wyeth issued deliberately misleading advice
re data sheets from 1974—1981-82. "it is advisable
to avoid abrupt discontinuation of Ativan as some sleep disturbance
MAY result. This applies especially when high doses have been
given for prolonged periods." (Para 23)
"The dependence potential of the benzodiazepines
is low but this increases when high doses are used, especially
when given over long periods." (Para 24)
The date of the first warning in UK data sheets
was 1984-85 yet the USA data sheet warned of possible physical
and psychological dependence to Diazepam in 1971 and Canada 1973.
(Para 25)
"Little is known regarding the efficacy
of safety of benzodiazepines in long term use". The date
of the first warning in the UK Valium data sheets was 1984-85.
(Para 26)
Roche admitted to the US Senate hearings in
1979 that it had NOT itself undertaken or sponsored any research
into dependence. Roche has deliberately or otherwise altogether
omitted any reference to the development of "tolerance in
data sheets for Valium. This could be expected to cause prescribers
to seriously underestimate the risks of dependence involved with
this drug. (Para 27)
5. Regulatory Review of Drug Safety and Efficacy
The 1980 CRM's (Committee on the Review of Medicines)
"Systematic Review of the Benzodiazepines" states: "This
report further observed that sleep laboratory studies show most
hypnotics tend to lose their sleep-promoting properties within
three to 14 days of continuous treatment. There was little convincing
evidence that benzodiazepines were efficacious in the treatment
of anxiety after four months continuous treatment" (Para
28)
I could take members of the Committee to Oldham
people who have been benzo addicts for 20-40 years so much for
efficacy! The only reason they are still taking their drugs is
to keep withdrawal symptoms to a minimum (Para 29)
The UK Regulatory Authority MHPRA (Ref 10),
just like its predecessor (MCA) is far too closely linked, almost
incestuously so, to the drug industry. A completely new organisation,
independent and with new Parliamentary powers and chaired by Mr
Charles Medawar, needs to be set up as a matter of urgency. (Para
30)
6. Product Evaluation Including Assessments
of Value for Money.
How do you start to put a monetary value on
human suffering, loss of freedom, loss of employment. loss of
memory, loss of family and loss of your soul to these mind altering
drugs called benzodiazepines? (Para 31)
Home Office statistics from 1990-96 (Ref IOA)
(excluding 1994) show that benzodiazepine drug deaths by poisoning
equal 1,810 compared with 291 heroin deaths, and 43 deaths from
cocaine. Surely Class "A" drugs are more dangerous—or
so the Home Office Minister Mr David Blunkett (Ref 11 A/B) tells
us! (Para 32)
If people taking tranquillisers did not drive
(Ref 12), there would be an estimated 110 fewer road deaths and
1,600 fewer accidents each year. (Para 33)
The Economic and Social Costs of Mental illness,
Policy Paper 3 produced by 13 the Sainsbury Centre for Mental
Health (Ref 13), in June 2003 estimated that the economic and
social costs of mental illness for England 2002-03 totals £77.4
billion. When you consider that benzodiazepine drugs mimic mental
health symptoms in addiction and withdrawal modes, and these drugs
produce paradoxical symptoms, eg insomnia, depression, rage, anxiety
and aggression, just what part of that £77.4 billion cost
is directly and indirectly caused by benzodiazepine drugs? (Para
34)
The BMJ, June 2004 stated that 10,000 deaths
per year were from bad reactions to medication side effects at
a cost of £466 million per year (Para 35)
Trust me I'm a Doctor, but at what cost to the
nation! "The health of my 14 patient will be my first consideration"—(Ref
14) The Declaration of Geneva Hippocratic Oath, 1948. (Para 36)
I estimate that total deaths caused by benzodiazepine
drugs from 1959 to 2004 are 18,450. (Para 37)
7. Recommendations for Action by the Government
or Others
(a) An independent full Public Inquiry to
be ordered by Government as a matter of urgency into mind altering
benzodiazepine, SSRI and "Z" Drugs. (Para 38)
(b) To completely change the UK Regulatory
Authority under its present set up (as per para 30) (Para 39)
(c) To sack the Health Minister Ms Rosie
Winterton MP, and her special 15 advisers forthwith. Appoint Mr
Phil Woolas MP (Ref 15) (Presently Deputy Leader of the House
of Commons) in her place and ex-addicts of benzodiazepine drugs,
who are the real experts, as special advisers. Mr Woolas would
be a master of his brief on benzodiazepine drugs, unlike Ms Winterton
who has not got a clue, and has relied far too heavily on her
special advisers on benzodiazepine drug matters of importance.
(Para 40)
(d) for government to adopt in its entirety
the recommendations for European Best Practice Guidelines of Beat
The Benzos Report (Ref 16) "A call for EU guidelines on the
prescribing of benzodiazepines, Europe's most harmful drugs"
by Barry Haslam, 7 October, 2003 as a matter of urgency to the
victims of these drugs. (Para 41)
(e) The Government to explain to the nation
just why benzodiazepine drugs have been so freely and criminally
prescribed in Britain when, under the 1991 Chemical Weapons Convention,
drugs such as Valium or other calmatives would be outlawed. This
protocol prohibits any chemical which can cause death, temporary
incapacitation, or permanent harm. (Ref 17) (Para 42) So it's
in order for Valium to be considered by the MOD as a chemical
weapon and banned under the Chemical Weapon Convention, BUT—GIVE
IT TO UK PATIENTS—THAT'S ACCEPTABLE? (Para 43). Go tell
Mr. Blair I have found his weapons of mass destruction, they are
in Britain NOT Iraq, they have been hidden since 1959 and are
called benzodiazepines. (Para 44)
(f) For Paul Boateng MP (Ref 18) (now Chief
Secretary to the Treasury) to honour his pledge of 25 April, 1994
to Barry Haslam and loosen the treasury purse strings for services
and compensation when he said "Clearly the aim of all involved
in this sorry affair is the provision of justice to the victims
of these drugs (Ativan)" (Para 45)
(g) Drug companies, Roche and Wyeth, producers
of Valium and Ativan respectively, should be urgently investigated
by the DTI and Serious Fraud Squad, into corporate fraud and corruption.
(Para 46) Roche and Wyeth should also be the subject of Police
Authority investigations into charges of Corporate Manslaughter
and other criminal acts. (Para 47)
(h) With regard to legal benzodiazepine drug
addiction (1.2 million UK addicts long term), the Department of
Health's record for services is a disgrace, abysmal and heads
should roll. There is not one UK designated benzodiazepine drug
withdrawal clinic at the present time. This despite 45 years of
producing these neuro-poisoning chemicals and 45 years of super
profits for the drug companies. (Para 48)
Professor C Heather Ashton of the University
of Newcastle states (Ref 19)
"Facilities for benzodiazepine dependent
people need to be developed. Detoxification units dealing with
dependence on alcohol and illicit drugs, are not appropriate for
prescribed benzodiazepine users who have unwittingly become dependent
through no fault of their own. Such places usually withdraw the
drugs too rapidly and apply rigid contract rules which are quite
unsuitable for benzodiazepine patients struggling with withdrawal
symptoms.
Much needed are clinics specialising in benzodiazepine
withdrawal where clients can receive individualised, flexible,
understanding and supportive counselling. At present only too
few voluntary support groups (Ref 20) valiantly strive to fill
this gap with minimal finances. Proper financing would also allow
provision of residential accommodation where clients in need could
go for short breaks in a supportive non-hospital atmosphere at
crucial times during their withdrawal process". (Para 49)
Psychiatric units are completely the wrong environment and setting
to withdraw legal drug addicts (iatrogenic). This procedure adds
insult to injury. Benzodiazepine drug addiction is a chemical
addiction problem, not a mental health issue. In my opinion, this
has been deliberate Department of Health Policy to cover up the
short-comings of the Medical Profession and Government. (Para
50)
Legal benzodiazepine addicts get their "Fix"
from their doctors. If this was not the case and they had to rob
to feed their habit! Then the resulting chaos would make illegal
heroin/cocaine addiction look like a "tea party". (Para
51.)
A no fault compensation scheme for benzodiazepine
drug injured victims should be funded by the manufacturers. Such
a scheme exists in New Zealand for all drug injuries. Failing
this, Government could slap a "windfall tax" on the
manufacturers themselves, thereby obtaining optimum funding for
compensation and finally putting in the required withdrawal and
support services the benzodiazepine legal drug addicts so desperately
need and deserve. (Para 52).
REFERENCES
| 1 | Manchester DSS Tribunal Report, January 1997.
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| 2 | Oldham Chronicle, 16 June, 2004.
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| 3 | A report on Benzodiazepine drug dependence submission to the European Commission—Barry Haslam. 7 October, 2003.
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| 4A | Oldham Chronicle, 9111 August, 2002.
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| 4B | Oldham Chronicle 30 January, 2004.
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| 4C | Oldham Chronicle, 15 April, 2004.
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| 5 | Increase in Suicidal Thoughts and Tendencies, Association with Diazepam Therapy JAMA, 25 March, 1968, Vol 203, No 13.
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| 6 | Statistics of the Misuse of Drugs.
Addicts notified to the Home Office—J M Corkery.
Deaths from Poisoning by Solid or Liquid Substances—compiled by Barry Haslam, 26 July, 2002.
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| 7A | Barry Haslam letter dated 9 October, 2002, to Ben Holgate, Legal Director Wyeth.
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| 7B | MCA Letter Mrs. Leigh Henderson to Barry Haslam, 7 December, 2000.
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| 8 | "Dear Doctor" letter from Roche, 5 March 1980.
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| 9 | Systematic Review of the Benzodiazepines, Guideline for Data Sheets. Committee on the Review of Medicines (CRM)—BMJ 29111 March, 1980.
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| 10 | Statement on the position of Professor Sir Alasdair Breckenridge, Chairman, Medicines and Healthcare Products Regulatory Agency—Charles Medawar, 16 March, 2004.
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| 11A | Letter from David Blunkett MI' to Barry Haslam, 24 February, 1994.
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| 11B | Home Office Deaths Statistics—Barry Haslam, 12 May, 1998.
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| 12 | The Guardian, 23 October 1998.
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| 13 | The Economic and Social Costs of Mental Illness Policy, Paper 3. The Sainsbury Centre, June 2003.
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| 14 | The Declaration of Geneva Hippocratic Oath, 1948.
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| 15 | Parliamentary debates (Hansard) Westminster Hall, 7 December, 1999.
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| 16 | "Beat the Benzos" Campaign—Barry Haslam A Call for EU Guidelines on the Prescribing of Benzodiazepines. Europe's Most Harmful Drugs.
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| 17 | The Observer 26 May, 2002.
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| 18 | Paul Boateng MI's letter to Barry Haslam, 25 April, 1994.
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| 19 | Benzodiazepines—How They Work and How to Withdraw.
Medical Research Information from a benzodiazepine withdrawal clinic—Professor Heather Ashton, Revised Edition August. 2002.
Tranquilliser problems?—Tranx (Oldham)
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