Fwd: Unhappy Anniversary of Valium

[Guest guest]

Sunday February 2, 2003

The Observer

 

Unhappy Anniversary

http://www.observer.co.uk/Print/0,3858,4596569,00.html

 

Forty years ago, Valium was the new wonder pill. Now, with up to a

million

Britons addicted to tranquillisers, GPs and drug companies are under

fire.

But as the long battle for compensation is fought out, the suffering

continues

 

Simon Garfield

 

 

Much has changed in Pat Edwards's life in the past 40 years. She has

divorced, she has moved from London to the South Coast, she has

become a

grandmother. But one thing has stayed the same: she is still taking

the

Valium.

 

Pat Edwards was 25 when she was first prescribed the drug at the end

of

1962, a few months before its official launch the following year. She

had

become unaccountably weepy after the birth of her second child, a

condition

we may now recognise as post-natal depression. Her local GP in

Hackney gave

her four days' supply of Valium, a suitably cautious amount for a new

treatment, and four days later, after some improvement, Edwards was

given

another small supply. The drugs seemed to have an immediate effect,

and she

made plans to return to her job as a hairdresser. But then something

else

happened.

 

'One morning I was on my mum's doorstep crying my eyes out. My mother

called

the doctor, and he didn't come round to see me but upped the dosage

of my

tablets. They went up from one tablet of five milligrams to two, so I

was on

10 milligrams a day. This went on for another month, until one day I

simply

couldn't leave my mother's house. My mother thought I was being

silly, but I

would have terrible panic attacks and start sweating if I couldn't

see the

front door.'

 

Agoraphobia was not a well-recognised medical condition in the early

Sixties. The doctor was called again, but Edwards says he failed to

visit.

Instead, the dosage was increased again, to 15 milligrams. He also

prescribed Marplan, an anti-depressant. Edwards's condition failed to

improve. 'In those days you believed in what your doctor gave you

without

question. I used to send him a stamped addressed envelope every month

and he

sent me back a month's supply of tablets.'

 

Edwards is 65 now, and housebound. She is a heavy-set woman, and

looked to

me like the actress Kathy Burke plus 30 years. She lives alone in a

bungalow

in Durrington, a short distance from Worthing in Sussex. Her mother

died

nine years ago, and her principal support comes from her daughter and

her

neighbour. She has received disability allowance only for the past

eight

years, since her osteoarthritis necessitated use of a wheelchair.

 

'In the past 40 years I haven't had a life,' she says. 'No one can say

they've seen me go up the street on my own, or take my children out

on my

own, or go on a bus. When my daughter was at primary school her

teacher told

her she couldn't understand why I never came to the parents'

evenings. If my

mum hadn't been there to look after them they probably would have

been taken

into care.'

 

She is still taking the tablets, now prescribed under the generic name

diazepam. Her dosage has been greatly reduced in the past few months,

but

she had a traumatic experience at Christmas after cutting down below

five

milligrams a day. When she first visited the local surgery in

Durrington

last summer her new GP greeted her with disbelief. He didn't think

the drugs

were doing any good. She told him she'd been on them for 40 years. He

said:

 

'You shouldn't have been on them for more than four weeks.'

Valium and similar drugs in the benzodiazepine group are widely

considered

to belong to a previous generation, replaced in the treatment of

insomnia,

panic attacks and all manner of modern anxieties by more

sophisticated drugs

with side-effects of their own. The reality is somewhat different. In

the

year to March 2002, 12 and a half million prescriptions to

benzodiazepines

were written in England alone. In the previous year there were 13.028

million. The Department of Health has no indication as to how many

patients

are receiving repeat prescriptions, or for how long. But Professor

Heather

Ashton, a specialist in psycho-pharmacology at Royal Victoria

Infirmary in

Newcastle who ran a withdrawal clinic for more than a decade,

believes there

are half a million people in the UK who have been taking

benzodiazepines for

several years. The official guidelines issued to prescribing doctors

15

years ago advises continued use for no more than 28 days. The Home

Office

has other figures, for the amount of deaths in England and Wales in

which

drug poisoning is included in coroners' reports. Between 1997 and

2000,

cocaine was included in 273 reports, while diazepam and tamazepam -

only two

generic types out of 17 available for prescription - were included in

795.

 

Campaigners claim that more than one million people in the UK may be

addicted to benzodiazepines, a family which includes anti-anxiety

tranquilisers such as Ativan (lorazepam) and Xanax (alprazolam),

sleeping

pills such as Mogadon (nitrazepam) and anti-convulsive muscle-

relaxants such

as Klonopin (clonazepam). This is a disturbing statistic for many

reasons,

not least because it is a problem inflicted by our own health service.

 

Addiction may occur after only two weeks' use, and it is so common

that it

is often ignored in the big debates about drug policies and the

funding of

withdrawal treatment. It is an addiction whose victims largely suffer

in

silence, impeded by the symptoms that first drove them to seek

medical help

and worsened by long-term use of what should have been a short-term

solution.

 

Most patients in receipt of tranquillisers or sleeping pills do not

consider

themselves to be addicts until they attempt to reduce their dosage

and, like

Pat Edwards, find complete withdrawal impossible. It is not hard to

find

people who have suffered from benzodiazepine use, or people who are

happy to

talk of their experiences as a warning to others. The several men and

women

I spoke to tell stories unique only in their early details; their

tales of

involuntary dependence on their medication all end with a common

catalogue

of suffering and distress. They all find it hard to understand why

this

state of affairs has been allowed to exist for so long, and why we

ever

thought that these drugs would be the answer to our ills.

 

Part of the explanation lies among the trial papers of an experiment

conducted in Sheffield in the late Fifties. Alec Jenner and his

colleagues

at the United Sheffield Hospital were at the beginning of their

careers in

psychiatric medicine when they read in a newspaper of a Swiss circus

trainer

who had found something that would calm his lions and tigers. 'I was

intrigued whether this would have any human applications,' Jenner

remembers.

 

'So I phoned up Roche, who produced this series of drugs in

Switzerland, and

they were already thinking about marketing it for people. They wanted

people

to do studies which would add to the conviction that it was worth

giving to

humans. So they jumped on us, really.'

 

Jenner believes he conducted the first double-blind controlled trial

of both

Librium and Valium (a trial in which neither the patient nor the

doctor

knows who's taking what until after the results are

compiled). 'Before us,

people had published their impressions of it,' he says 'but it was

less

scientific than ours. The way we did this - and now it looks naive,

but then

I didn't see it - we gave people two bottles marked A and B, and we

told

them what was in them without saying which was which. The bottles

contained

two of three things - either a barbiturate, or a benzodiazepine, or

nothing

- just chalk pills. They had to say which helped them most.'

 

Jenner is 73 now, and still lives in Sheffield. He speaks without the

benefit of his notes from the trials, and he admits he cannot

remember the

exact number of patients he studied - he thinks it was about 200. But

he is

sure of his findings. 'The benzodiazepines came out heavily on top.

The

improvement of patients on the drugs was the only thing that came out

strikingly - the side-effects were unconvincing. They were infinitely

safer

than barbiturates, which was what people had used to treat anxiety

before,

and which carried a great risk of fatal overdose. So we were

enthusiastic. I

myself took enormous quantities to see if there was any toxic

effects, but

my wife said I was just the same.' But Jenner did not test his drugs,

or

those of his patients, over time. 'In those days drug addiction didn't

appear to be a problem in Britain at all - I'd never seen a heroin

addict,

for example. It now seems rather mad that we didn't consider this.

One of

the most interesting things was that the side-effects experienced by

those

on the chalk was about the same as those on the drugs.'

 

Jenner's work came as a delight to Hoffmann-La Roche. Parallel

studies,

which also failed to consider the possibility of addiction, did find

great

uses for Librium and Valium (both drugs have a similar chemical

formula, but

Valium is five times as potent). In 1961 Roche's researchers in its

laboratories in New Jersey published a report stating that Valium had

only

mild side-effects, including fatigue, dizziness and rash, but these

were

results based on only seven patients. The results from two other

patients

were not included because they considered their side-effects too

severe to

continue on the trial. On average, patients took Valium for only

12-and-a-half weeks.

The drug was launched globally in 1963, and it became, along with

LSD, the

smallest icon of its generation (taken together, the two drugs

signalled a

paradoxical age of peace, love and anxiety). By the time the Rolling

Stones

sang about 'Mother's Little Helper' in 1966, Librium and Valium and

the

sleeping pill Mogadon had helped Roche to become the biggest

pharmaceuticals

company in the world. Valium's triumph inspired every large

pharmaceutical

company to market a benzodiazepine of its own. Upjohn was soon

competing

with Xanax; Wyeth would grow wealthy on Ativan.

 

In Sheffield, Alec Jenner remembers feeling glad that his work was

having

some beneficial effects. 'I had no idea that it was going to be so

enormously successful. We were quite excited that we'd backed a

winner.'

Financially his rewards were scant. 'We weren't offered anything for

doing

it. They did pay for us to have a camping holiday in Vienna and they

gave me

money to buy a flame photometer for measuring lithium in blood which

must

have cost about £50.'

 

In 1979, about 30 million prescriptions for benzodiazepines were

issued in

the UK, while the worldwide figure was put at three billion. But by

then

problems with the drugs had been a regular feature of medical

literature for

more than a decade. As early as 1968 the Journal of the American

Medical

Association had noted how a number of psychiatric patients had become

suicidal after only a few days' use, and noted how the condition of

others

worsened when they came off the treatment.

 

'The problems of addiction took me some time to believe,' Jenner

says. 'But

after a while it became obvious that that scepticism was not

justified.' In

the Seventies, Jenner subjected Valium to another trial, though not

with

Roche. He told 50 or 60 local people to come off the drug without a

gradual

reduction in dosage. About 30 per cent complained of problems. 'It was

becoming obvious that we had been naive about the addiction

potential. I was

on the Committee on Safety of Medicines for a while, so I was getting

more

and more information through. One chap made a suicide attempt and we

got a

long letter from his wife saying, " Put him back on and use this

letter as

our permission that we feel it's the only way he can go on living. "

So we

went on prescribing it.'

 

Jenner is now retired, but says he likes to keep in touch with

developments

in psychiatric care. He is interested in the mental healthcare drugs

that

followed his work on Librium and Valium, but notes that they too are

beset

with damaging consequences. (Upjohn's Halcion was banned in Britain

in 1991

after many reports of amnesia, depression, and violent behaviour,

while

Rohypnol still receives adverse coverage for its illicit use as a

'date-rape' drug. The newer drugs such as Prozac and Seroxat target a

different receptor in the brain, and despite the fact that one of

their

chief selling points at launch was that they were non-addictive, many

users

suffer severe symptoms when they withdraw.)

 

Jenner regards his researches with a combination of pride and

embarrassment.

 

'I feel naive but not guilty,' he says. 'What seemed so good about the

benzodiazepines when I was playing with them was that it seemed like

we

really did have a drug that didn't have many problems. But in

retrospect

it's difficult to put a spanner into a wristwatch and expect that it

won't

do any harm.'

 

Ten weeks ago in the Terrace Marquee at the House of Commons, Phil

Woolas, a

Labour government whip and MP for Oldham East and Saddleworth, spoke

at a

meeting to mark the tabling of an Early Day motion seeking redress

for some

of the damage of benzodiazepine addiction. 'So what's the scale of the

problem,' he asked his audience of MPs, solicitors and current users.

 

'Statistics show that something in the order of 1.2 million people in

this

country are still in receipt of repeat prescriptions of

benzodiazepines,

some 20 or 30 years after the danger of that repeat prescription

became well

known.'

 

The motion, which has now been signed by more than 100 MPs, called

for a

review of the disability guidelines to ensure recognition of

benzodiazepine

addiction, and for greater support services for addicts. 'We are not

just

telling people to come off the drugs instantly,' Woolas

said. 'Sometimes I

have the nightmare that if we do have the breakthrough that we are all

campaigning for, whereby the Department of Health were to stop

prescriptions, the problems that would cause would be horrendous. The

key is

phased withdrawal, and treatment and help for people coming off the

drugs.'

 

That was not the first time the issue had been raised at Westminster.

Woolas

addressed the problem in a debate in 1999, and five years earlier,

when he

was Shadow Secretary of State for Health, David Blunkett wrote a

supportive

letter to a patient suffering withdrawal symptoms in which he called

the

issue of benzodiazepines 'a national scandal'. Since Labour came to

power,

however, progress has been slow at best, and there is still no

specific

funding for benzodiazepine withdrawal treatment. 'We shall not give

up,'

Phil Woolas maintains. 'In my view there's a conspiracy of

silence ... I

believe the problem exists because at a fundamental level, it is too

huge

and too horrific for people to cope with and grasp the enormity of.'

As well as political lobbying, redress has been sought through the

courts.

 

By the late Eighties 1,700 people had received legal aid to bring a

class

action against Roche Products Ltd and John Wyeth and Brothers Ltd, the

makers of Ativan. Their principal claim was that the companies were

aware of

the dangers of addiction and other side-effects before making this

information available to prescribers and patients. Roche and Wyeth

denied

this, and the action was discontinued in 1994 after the Legal Aid

Board

withdrew funding. The majority of the claimants' cases were

complicated by

the difficulty in proving the harm caused by the drugs as opposed to

the

psychological problems they may have had before they were prescribed

them.

 

Seventy-five people subsequently tried to pursue their own cases

against the

companies, but were also hampered by lack of funds and their claims

were

struck out by the Court of Appeal in 1996. One case, begun in 1993

against

Roche by a formerly successful Scottish businessman who claims his

life was

ruined by Mogadon, is under consideration for trial in the Court of

Session

in Edinburgh and may be heard in full next year. Another, brought by

a woman

against Wyeth, is under consideration in Dublin.

 

Last summer, benzodiazepine addicts did receive news of a legal

success,

albeit against a new target: overprescribing GPs. Ray Nimmo, the

patient

involved in the case, and his solicitor Caroline Moore of Keeble

Hawson in

Sheffield, were also present for the launch of the parliamentary

motion in

November, and Moore outlined the case. Nimmo was 32 when he was first

prescribed benzodiazepines in the mid-Eighties, after an allergic

reaction

to another drug and stress brought on by illness to his father. He

was given

90 milligrams of Valium a day, a prescription that continued at a

reduced

dosage for 14 years.

 

'The effects were shocking,' Caroline Moore recalled. 'Ray's

personality

changed, he became agoraphobic, and he became unable to cope with

life. In

1986 he gave up his co-directorship [of a scaffolding company]. Ray

and his

wife planned to extend their family, but Ray became convinced he was

not fit

to be a father.'

 

When another doctor advised withdrawal in 1998, Nimmo underwent the

usual

problems, from which he believes he is still suffering. His legal

action

against his GPs, a husband and wife team, was settled out of court in

June

2002 for £40,000 plus costs. Success was made possible by reference

to a key

report issued in January 1988 by the UK Committee on Safety of

Medicines.

This noted that 'withdrawal symptoms can occur with benzodiazepines

following therapeutic doses given for SHORT periods of time' (the

report's

own emphasis). New guidelines were issued to all GPs. This document,

only

two pages long, advised clearly that benzo diazepines should not be

prescribed for more than four weeks, including a tapering-off period.

 

Similar guidelines were adopted by the Royal College of

Psychiatrists, and

were swiftly included in the new literature from Roche. Caroline

Moore says

that anyone who has been prescribed benzodiazepines for a prolonged

period

since 1988 who wasn't part of the group actions may be able to bring

a claim

against their prescriber, although their chances of success may

depend on

what advice they received regarding addiction and whether they have

been

offered help with withdrawal.

 

Moore doubts whether Ray Nimmo's case was the first to reach a

successful

conclusion, but merely the first not to include a gagging clause.

Since his

case was made public, she has received many phone calls from people

who have

similar claims. 'More stories about ruined lives,' she

says, 'including one

case of a girl who was given benzodiazepines at 13.'

 

After her address at the House of Commons, Moore was congratulated by

Barry

Haslam, who also has a case against a former GP. Haslam, a qualified

accountant from Oldham, spent 10 years on various benzodiazepines and

is the

driving force behind a charity called Beat the Benzos. His

organisation has

many aims, including the reclassification of the drugs from Class C

to Class

A, which would put them on a par with heroin. He is hopeful that the

lead on

this may come from the European Parliament. He shows me a report from

the

Hong Kong Medical Journal which notes a 50 per cent reduction in

average

yearly prescription of benzodiazepines since they were classified as

dangerous drugs in 1992.

 

When Haslam came off Valium, Ativan and others he says some remarkable

things happened. 'I couldn't believe the colour of the sky and the

flowers,

and the noise was so loud.' But his wonder has now been replaced by

anger.

 

'For me, the Government Ministers are cowards,' he says. 'If they had

gone

through one-hundredth of what I've gone through then they would have

done

something about this long ago.

 

'Why have GPs and psychiatrists been allowed to ride roughshod over

the

advice of people more qualified to judge the drugs than they are? And

why

have the Government looked the other way? Why have they allowed so

many

people to get addicted to a legal drug and not put any money into

services

to help people?'

 

These are valid questions, and they are as valid now as they were 15

years

ago. Used correctly, for very short periods, benzodiazepines may still

provide a respite from common symptoms. But their overprescription

has left

a trail of misery for which no one will take responsibility and only

a few

seem prepared to confront.

 

Roche still makes three brands of benzodiazepine for the UK, but it

discontinued its production of Valium last year. In its press

release, the

company explained how effective the treatment had been, how widely it

was

available in generic form, and of its pleasure that it was designated

'essential drug status' by the World Health Organisation. In what

some may

regard as a paradoxical statement, the Swiss firm also claimed it

continued

to be the second largest foreign investor in healthcare in the UK.

 

www.benzo.org.uk Beat the Benzos: (01457) 876 355

 

Guardian Unlimited © Guardian Newspapers Limited 2003

--- End forwarded message ---