INVESTIGATION: FORTY YEARS OF VALIUM
Sunday Tribune, Ireland
March 2, 2003
The Background
by Harry McGee
The benzodiazepine guidelines announced in Britain and Ireland in 1988 led to a huge number of lawsuits in Britain. In all, 17,000 cases were taken alleging that manufacturers such as Roche, Wyeth and Upjohn had long been aware of the dangers of addiction and other side-effects but had not made this information available to prescribers and patients.
In particular, it was claimed that much higher levels of warning were issued in Scandinavia, the US and Australia than in Britain and Ireland. The claims were initially backed by legal aid in Britain (eventually running up a bill of £40m), but legal aid was withdrawn in 1994 after being challenged by the manufacturers. In the end, the number of cases was reduced from 17,000 to one, which was struck out two years ago. The litigant in that last case was Michael Behan, who was hooked on Ativan for seven years. "It destroyed my life," he told The Sunday Tribune. I quickly became addicted, after four weeks. I did not get proper warnings."
Behan is now acting as an expert advisor for a claim still being pursued by a Dublin solicitor, one of a number of such cases here. These tend to be David and Goliath-type struggles between a small solicitor's firm and a pharmaceutical giant. In the case that Behan is advising on, there are over one million documents pertaining to the case and the company involved, Wyeth, is attempting to strike out the claim "for want of prosecution".
When asked to comment on the case, Wyeth told The Sunday Tribune that "we are aware of three claims currently proceeding against us, all of which were originally filed in the early 1990s. Wyeth has always vigorously denied these claims."
When the cure becomes more dangerous that the disease
by Harry McGee and Kate O'Flaherty
Forty years ago, when Valium was first introduced as a 'wonder drug' it was hailed as a potential side-effects free cure for a whole range of psychological ailments. Four decades on, it is now clear that such enthusiasm was dangerously misguided.
Picture the typical Irish drug addict and you will probably be wrong. The immediate image that comes to most people's minds is the sad visible one, the skeletal heroin addict with pinhole eyes who floats through city streets. But there is a far larger and much less visible group made up of people who are chronic users of potent, addictive drugs, many, for decades rather than years or months. To try and characterise them is more tricky. You are, after all, describing your own community; neighbours, grandparents, parents, relatives - all leading normal lives bar the fact that they are hooked on a type of drug that a doctor has prescribed for them and that they have 'scored' legally across the counter of a pharmacy. The class of drug, to give it its pharmacological name, is benzodiazepines.
Widely prescribed in the 1960s and 1970s, benzodiazepines- such as Valium, Xanax, Rohypnol and Mogadon - were at first considered 'wonder drugs'. But something was amiss with this panacea which promised domestic bliss. During the '70s, articles began appearing in medical journals seriously questioning the assertion that benzodiazepines had few side effects. In particular, studies began to suggest that they were addictive.
In 1988, the UK Committee on Safety of Medicines (CSM) issued a warning that these drugs should only be used for short periods of time as there was a high risk of addiction, and a serious withdrawal syndrome after long-term use.
In 2000, our own Department of Health and Children established a Benzodiazepine Committee to examine the current use and prescribing of these drugs in Ireland, and it reported late last year.
The report observes that these drugs have a problem of "dependence when taken on a long-term basis, even in prescribed therapeutic doses", but that "in many cases, the prescribing of these drugs is excessive and perhaps has become a matter of routine". It further adds that "it would appear that these patients receive little support from their doctors, and generally it would appear that some medical practitioners are not well-informed about benzodiazepine withdrawal symptoms or methods of withdrawal.
But this problem is not confined to a small group of patients. Arriving at the number of long-term users of these drugs is notoriously difficult, but the committee's own findings reveal some startling statistics.
For one, the evidence suggests a continuing increase in the prescribing rate for these drugs to medical card-holders between 1995 and 2000, with one in 10 people with a medical card being prescribed benzodiazepines at any one time. More than two-thirds of these people are taking them for longer than four weeks, and when the figures are extrapolated, they suggest that as many 100,000 Irish people are taking these drugs, many of them for many years.
Campaigners say that the majority of these are addicts, whose reasons for taking the drug have nothing to do with their original symptoms. GPs renew their prescriptions almost as a matter of routine - sometimes on the basis that an elderly patient on a therapeutic dose for many years is better off left on the drug than being coerced to undergo the trauma of withdrawal.
Disturbingly, the report also highlights a small number of doctors who are "prescribing inappropriately - thereby putting their patients and others at risk". It also draws attention to the fact that benzodiazepines are often a second drug of abuse for heroin addicts - the most common type of drug involved in the 86 heroin-related deaths recorded by the Dublin City Coroner in 1999 was, in fact, benzodiazepines.
Limerick-based GP and author Dr Terry Lynch is well known for his concerns about the over-reliance of his profession on medications to treat the problem of mental distress.
"It's now 15 years since the Committee on Safety of Medicines gave its advice about prescribing benzodiazepines, and unfortunately the truth seems to be that they weren't followed," he says. "The problem was created by prescribing, and a considerable part of the problem was created by not paying sufficient attention to what patients were telling us. Historically, we have a problem recognising the addiction potential of medications and acting swiftly on the information - I mean, we had similar problems in the past with barbiturates and amphetamines, more recently with benzodiazepines, and I personally believe that in the future we will have a similar problem with the anti-depressants which are so enthusiastically prescribed at the moment.
"Twenty years ago, benzodiazepines were held as 'wonder drugs', so there is an eerie repetitiveness about this. Each drug that comes along gives doctors a new 'hope' to believe in and to prescribe, and prescribing is second nature to doctors, that is how they are trained. But many of them have a very basic understanding of anxiety and distress and what patients are going through, what is causing their pain."
Matthew Daly's story would be typical of tens of thousands of others who became addicted to these drugs. Daly (48) now counsels long-term users of the drugs.
"I started off on Valium in 1973 when I was 18." he says. "I had gone to the GP because I felt a bit shy and introverted. I was not a very outgoing fellow and there was some personal stuff in my childhood. I had anxiety, tension and stress. The doctor gave me Valium. I took it and felt that it was great. I felt very attached to it."
So attached that it was to dominate the next 14 years of his life. "For all that time, I was living in a haze. I lost my job and did not care. Once I had it I could float around. I stopped for a very short time and felt that the world was a frightening place."
Daly alternated in the early years between alcohol and benzodiazepines but by his late 20s, the pills had taken over completely. But giving them up became a prospect too horrible to contemplate. "I did not realise that this was worse than a heroin addiction. It's very secretive as well. It's like putting on a mask. Behind it all you are a shell, dying inside."
Daly finally stopped taking benzodiazepines at the age of 32 but, not until after he had taken two overdoses. The withdrawal process was a nightmare, he says, that took many months. He looks back on that 14-year period as a time when "my life was on hold and I was emotionally frozen".
Benzodiazepines are, of course, valuable drugs in the short-term treatment of extreme distress, anxiety and insomnia, and often the decision to prescribe or consume these drugs is not a simple one.
Dr John Fleetwood, a GP based in Dun Laoghaire feels that there are a number of reasons why these drugs are still over-prescribed. "Many people do not want to or are afraid to come off these drugs, and may become hostile when a doctor suggests that they need to wean themselves off them," he says. "And the increasing levels of stress and anxiety in our society affecting everyone from teenagers to the elderly, places enormous pressures of time and resources on our health services. And sometimes there is a certain blasé attitude towards drugs by too many people in society, who may want a 'quick fix' for their ills, rather than looking at these drugs as a last resort."
Dr Kieran Harkin, a Dublin-based GP who was a member of the Benzodiazepines Committee, argues that in some cases long-term prescribing may be necessary. "While it is good practice to limit therapy to two to four weeks, it doesn't necessarily mean that everybody being prescribed for more than four weeks is inappropriately prescribed," he says. "There are people who may have become addicted who started off buying tablets on the street or people who were initially prescribed while waiting for services such as methadone treatment. There are also a number of people with chronic anxiety who may benefit from long-term treatment, assuming that they appreciate issues such as dependence but are prepared to tolerate it because their life is so miserable. Sometimes there may be conflict between what a patient thinks and what the doctor thinks. A doctor may prefer not to prescribe, but if you are faced with an 80-year-old patient who cannot sleep, it's a very difficult situation. A doctor can't tell a patient 'I don't care what you think', there is a grey area there and a good caring doctor is going to respect a patient's opinion."
However, there is not full agreement with this approach within the medical profession.
"There is, of course, some truth in the argument that patients also have a responsibility here and doctors often come under pressure to prescribe," says Dr Lynch. "But I think this is often exaggerated as it tends to absolve doctors and merely passes the blame onto me patients. I do think more of the pressure comes from the doctor's side. As regards the somewhat plaintive comments from our profession about lack of time and resources, that's not the full story at all. I feel that if we don't have enough time, we should make more time or refer people to services such as counselling where they will get the time they need. But we don't hear many doctors out there really pushing for more counselling services. And it's important to realise that GPs are not the sole prescribers of these drugs, they are also prescribed by psychiatrists. I frequently encounter people who have been put on tranquillisers in psychiatric hospitals, and then released without any advice about addiction or any plan to come off their medication over time. Another factor in this debacle relates to the lack of external, independent monitoring and surveillance of the medical profession."
Ireland's problem with benzodiazepines, however, is not unique - it is a Europe-wide phenomenon - and the report's recommendations mirror those of European efforts, such as better collection of data relating to the use of these drugs, better training for doctors, manufacture of smaller pack sizes of these drugs, and a need for greater public awareness of the problems associated with the use of these drugs.
"Much of the current problem with benzodiazepines is an inherited problem," says Harkin, "and I believe that prescribing practice in general is becoming more consistent. The number of new long-term prescriptions is decreasing but there will be no great immediate effects. Very often, people start using benzodiazepines for psychological reasons and those reasons are still there to be dealt with, but the resources for psychological support are not there in the community I do believe there are serious moves afoot to deal with this issue and the report is an important first step, but unfortunately you do get people in every profession who don't practice to the highest standards."
100,000 Irish addicted to tranquilliser drugs
by Harry McGee and Kate O'Flaherty
As many as 100,000 Irish people may be unwittingly addicted to medications they have been prescribed for several months or even years, despite warnings issued 15 years ago that the drugs should not be used for longer than four weeks.
The drugs, known as benzodiazepines, include many common tranquillisers and sleeping tablets, such as Valium, Ativan, Mogadon and Rohypnol.
Benzodiazepines carry a high risk of addiction and other side effects, including a severe withdrawal syndrome that can last for several months after a person comes off the drugs.
A recent report by a government-appointed Benzodiazepine Committee concluded that "the prescribing of these drugs is excessive" and adds that "some medical practitioners are not well-informed about benzodiazepine withdrawal symptoms or methods of withdrawal".
In addition, the report expresses concern about a small number of rogue doctors who may be prescribing these drugs inappropriately, some even for financial gain, stating they are "putting their patients and others at risk".
As many as one in ten medical card holders are being prescribed these drugs at any one time, the majority of them for longer than the four weeks advised by the UK Committee on Safety of Medicines as far back as 1988. In fact, the prescribing rates of these drugs continued to rise in Ireland during the 1990s, despite increasing concerns worldwide about their safety.
During the 1990s, up to 17,000 claims were made in the UK against the manufacturers of these drugs, and there are currently a small number of claims still being pursued by Irish people, although none to date has been successful.
Later this month, the pharmaceutical company Wyeth, which vigorously denies such claims, will attempt to strike out one of these claims in the Irish courts for "want of prosecution".
'Mother's Little Helper' - a global phenomenon
by Harry McGee
Forty years ago this month, the first and most famous of the benzodiazepine group was launched. In March 1963, Valium (diazepam) was introduced amid claims that it was the new 'wonder drug'. The drug's precursor had been shown to have a significant calming effect on lions and tigers that were part of a circus act.
When developed for humans by the Swiss pharmaceutical company Hoffmann-La Roche, it was marketed as a revolution in the treatment of a variety of ailments including stress, anxiety, insomnia and other sleep disorders, safer and more effective than barbiturates, and with few serious side-effects and no addictive properties.
Valium and its sister-drug Librium catapulted Roche into the stratosphere, making it the biggest pharmaceutical company in the world.
The other major drug companies quickly followed suit, and began to produce and market their own benzodiazepines, including Wyeth's Ativan, and Upjohn's Xanax, while Roche developed others such as Rohypnol, Dalmane, Lexotan and Mogadon. Soon these names were as familiar to the ears of many families as Daz and Persil.
The impact of benzodiazepines was indeed massive. They were prescribed in their billions in the 1960s and 1970s - some three billion prescriptions were written worldwide in 1979 alone.
Valium achieved an iconic status as the drug of the suburban housewife - 'Mother's Little Helper' was how the Rolling Stones wryly described it in 1966.
Withdrawal can be worse than original symptoms
by Kate O'Flaherty
Most tranquillisers and sleeping tablets belong to a group of drugs known as benzodiazepines, which is the name of their general chemical structure.
They are used to treat severe anxiety and insomnia, and are valuable in the short-term treatment of these conditions. As these are sedative drugs, they can impair a person's judgement and memory and their ability to drive safely However, some people can have what is known as a paradoxical reaction to these drugs, and instead become hostile, aggressive or talkative.
In 1988, the UK Committee on Safety of Medicines (CSM) issued the advice that these drugs should be used only for the "short-term relief (two to four weeks only) of anxiety... and insomnia.., that is severe, disabling or subjecting the individual to unacceptable distress", that the use of benzodiazepines to treat short-term, "mild" anxiety is inappropriate and unsuitable".
As far back as 1980, doctors were advised that the effectiveness of these drugs after four months' use was not guaranteed.
Dependence or addiction is a major risk with benzodiazepines and this is why their use should be limited to a few weeks.
Anyone coming off these drugs is advised to gradually withdraw the drugs, as coming off them suddenly can cause confusion, convulsions or psychosis.
The benzodiazepine withdrawal syndrome can last for several weeks or months after a person comes off the drug.
The symptoms may be similar to the original complaint for which the drugs were prescribed, such as insomnia, anxiety and tremors. Often people may continue to take the drugs in the mistaken belief that they are treating these symptoms, when in fact they are relieving their physical withdrawal symptoms.
Detoxing from these drugs should be done slowly and under medical supervision as the withdrawal syndrome can be difficult to cope with, mentally and physically.
"All I was doing was blocking out my life"
by Kate O'Flaherty
Rosaleen Masterson found a way out of her cycle of dependency
The word that springs to mind when you meet Rosaleen Masterson is 'survivor'. One of 21 children, she was born and reared in Rialto, Dublin, and at the age of 21, married and moved to St Teresa's Gardens.
"I brought problems into my marriage that I wasn't even aware of, I never had the education," says Masterson.
"And that was because of where I came from. Like most people from those areas, I was put down, stigmatised, never offered chances. After I got married, I felt stuck, I felt I didn't really fit into the role I was in, but I couldn't explain what was wrong. I was empty inside, no self-confidence. I started drinking and labelling myself as an 'alcoholic'." After a few years, Masterson sought medical help for her problems.
"I went to the doctor and was prescribed Valium and Librium. That was about 1976, and I was treated for alcoholism and depression. I didn't take the tablets all the time because deep down somehow, I realised they weren't what I needed. And I heard other people talking about the problems they had with them. But when I did take them I was in a haze and a daze. You'd feel 'good' but all you were doing was blocking out your life. They blocked you from feeling and thinking, and I felt they made me even more depressed. But anytime I went to the doctor, he'd write a prescription and you felt that you had to take them because the doctor told you to. You didn't think you had any other options."
Despite having to cope with depression, alcohol abuse, and other problems, Masterson always felt there was a light at the end of the tunnel.
"I always had a strong faith, I used to go to Lourdes every year and my nickname was 'follow the novena' because I went to anything going. So I was always searching for help, but I was given the wrong directions. I knew my life wasn't good for me, and that it was damaging my children, but it was all I knew."
The combination of a diagnosis of breast cancer and the birth of her first grandchild was the unlikely catalyst that led to the start of her recovery.
"When my grandchild was born, I was in a treatment centre and I just thought, 'no more'. And then when I got the breast cancer it was actually a turning point for the better, because I came to believe more strongly in a higher power and I was determined to beat the cancer, that I was going to live. Since then, I have gone from strength to strength."
Masterson first approached Elah, a counselling and community training service in Hamilton Street, Dublin, for counselling, recalling that one psychiatrist had told her that what she needed was therapy, not medication. Named Elah after the place where David slew Goliath, its mission is to help people defeat their own particular giants or monsters.
'I knew my life wasn't good for me, and that it was damaging my children, but it was all I knew'
"I eventually ended up getting a job at Elah, and now I work on reception there. The first day, I couldn't even answer the phone because I hadn't a clue what I would say to anyone who called, that's how low my self-confidence was. Now I am a trained facilitator in parenting programmes and this summer, I will get my qualification in Reality Therapy. My goal then is to become a professional counsellor, and maybe even write a book about my Journey. I want to give something back, to give hope to other people who are stuck. What people need is someone to listen to them and believe them, and education is the key to help you reach your potential. I feel that I am one of the lucky ones that I've found these things myself."
Elah is at 48 Hamilton Street, Dublin 8, (01-4541278)
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