Colin's Blog

One in six patients 'wrongly diagnosed by NHS doctors'

http://www.dailymail.co.uk/health/article-1215243/One-patients-wrongly-diagnosed-NHS-doctors.html

22nd September 2009

Up to one in six patient consultations in hospitals and primary care could be wrong.
 
Hundreds of thousands of people could be misdiagnosed by NHS doctors every year, an investigation has revealed.

Medics could be getting it wrong in as many as one in six of patient consultations in hospitals and primary care, according to Misdiagnosis, a BBC radio programme broadcast yesterday.

While most cases do not result in the patient suffering serious harm, a sizeable number are likely to experience significant health problems as a result.

But cases of misdiagnosis are not recorded anywhere in the NHS and this has led to growing demands for better reporting systems to help doctors prevent it.
 
The National Patient Safety Agency (NPSA) runs a database that records medical errors, patient incidents, mistakes in medical notes and near-misses on a voluntary basis. Between April 2008 and March 2009 there were 39,500 reports of incidents involving clinical assessment.
 
Dr Kevin Cleary, the medical director of the NPSA, said reasons for misdiagnosis included lack of training, test results that were misinterpreted, poor communication and diseases that had similar symptoms.
 
Patient charity Action Against Medical Accidents (AAMA) has called for a change in the law to make reporting of misdiagnoses a mandatory requirement of doctors.
 
AAMA chief executive Peter Walsh said: 'We have 4,000 inquiries a year and of those in primary care a large proportion, perhaps about 50 per cent of cases, involve misdiagnosis of some sort.
 
 'We see no reason why it shouldn't be a legal requirement on healthcare organisations, including general practices, to report incidents that go wrong in healthcare, including incidents of misdiagnosis.
  
'It's ridiculous that we get so few reports when we know there are significant numbers of this going on already.

‘This is just the tip of the iceberg.’

A review published recently in the American Journal of Medicine, about misdiagnosis in developed countries, suggested that up to 15 per cent of all cases could be misdiagnosed.  Professor Graham Neale, of the Centre for Patient Safety and Service Quality at Imperial College London, has been researching misdiagnosis for the past four years and wants to see improvements to medical training.
 
He said: 'I think it's a very big problem, and a problem that we should address. But I think we're going to have to tackle it from both ends, try to get the colleges more involved in this and get senior staff to take this seriously, and then on the educational side bring it up from below.'
 
Earlier this year a Westminster parliament health committee report identified that:

 'Delayed or missed diagnosis in general practice is a significant problem, generating many complaints and claims.'
 
Separate research suggested that one in 10 patients in hospital was harmed because of the care they received.
 
Comment.

One in six - and that figure is only the ones that are known about - it doesn't include unrecorded ones. If you added to that the number of patients mis-prescribed (e.g. around 1.5 million addicted benzo patients) you might feel inclined to wonder how much harm the NHS system actually inflicts to set against the good it does. Apparently August (July in the US) is a good time to die because that is when newly trained doctors arrive in hospitals.

 

Prescription addiction
10 Sep 2009

http://www.gm.tv/lifestyle/health/38271-prescription-addiction.html

When you think of drug addiction you may think of the 400,000 heroin addicts in the UK, but seven times that number are thought to be addicted to legal drugs such as tranquillisers and painkillers, either bought over the counter or prescribed by GPs.
 
Dependency

Britain has a new drug problem: two million of us are addicted to tranquillisers, while countless thousands abuse over-the-counter painkillers.The most common addicts are women aged 18-36.

The main culprits

Although all drugs can cause side effects, two types of legal drug are habit-forming:
 
• Benzodiazepines (tranquillisers)
• Opiate-based painkillers (such as morphine and codeine)

Both can have serious, even fatal, consequences for users.

Experts say that addiction to prescription drugs is a real problem and one that GPs need to be made more aware of.

Dr Hilary's advice

All prescription medication must be used appropriately. It is recommended to take the minimum dosage for the shortest duration in order to achieve the best possible effect.

Just like other drugs, prescription medication has the potential for side-effects.

1. Tolerance – prolonged use means eventually taking more in order to achieve the same result.

2. Dependency – after prolonged use, withdrawal symptoms may occur, as the body craves the chemical within the medication.

Doctors and pharmacists should adhere to guidelines and strict protocols about the best use of medicines.

And where are the consequences if they don't?

Morality? What’s that?

http://www.dailymail.co.uk/news/article-1213448/Campaigning-solicitor-saved-80-care-homes-closure-faces-struck-off.html

http://www.dailymail.co.uk/news/article-1213691/Alan-Johnson-forced-deny-conspiracy-shut-care-homes.html

Oh Colin, I'm so pleased I went to the hearing- Yvonne was brilliant, she was not defending but was fighting her case like a prosecutor. Now I know why government offered her the job as prosecutor for 'their' side (if she would stop doing the Care home closures, which she refused) her skills are as such she had everyone in awe. She even lengthened the time of the tribunal on insisting that she would continue asking her questions on the line that 'she' had chosen, because the chair and the prosecutor could not see where she was going and they wanted her to stop, saying, her questions were not pertinent to the case, and, why not just ask the witness 'the'  question. Yvonne replied, if I were to ask that question the witness would simply reply no. Boy, did the court go quiet, you could feel the tension. Several times  the three judges went out to consider whether they would let her do what she had demanded, to question as she felt fit to do so..  Each time they returned to say 'continue'. The first two days were electric!

On every day, the main judge said, 'we are independent etc, when he said this on the third day there were many titters, as we all know it is a stitch up, and he asked for silence in court. One man at the back of me shouted, I'm sorry, it was me!. It was so funny.

Everyday the reporters and film crews were there to meet us including the BBC, before we went in. They were also there at lunchtime and in the evening as we left. And I was on the news Lookeast after speaking my mind to the BBC reporter, but thankfully I did not see it, although someone said it was good. We all wore our tea shirts and the film crews loved it, and we kept them on in court. We also wore white, brimmed hats, with dangling corks, like they do in Australia, to signify it was a kangaroo court, these we placed on the tables in court. .We also had small, brown blow up kangaroos to wave- kangaroo court.

The receptionist and staff at the court were lovely, they plied us with coffee and were very helpful, I used their kitchen, one saying, 'we will miss you'- I don't think they had ever had such a happy bunch because we were all laughing and joking and eating. We only had a half hour lunch, no time at all.  And I kept losing my way to the ladies and had problems remembering on what floor are they? I met so many different staff on different floors, we all new each other after three days!

Even the prosecutor said, every day, there is no doubting that Mrs Hossack is a very caring lady, however....the allegations etc. I believe he said this because the court was full of reporters, and ditto, the judges had to be seen to be impartial as well, so they acquiesced to several of Yvonne demands, you could actually see it happening. She was just brilliant in explaining every single detail of her case. Time went by and the main Judge would look at the clock, then lower his head, as if to say. ah well, there is nothing I can do about this, too many reporters,  and so Yvonne continued, as if she had all the time in the world. The case went way over time for the first two days, but of course, reporters were there and as the judge said, this is a high profile case. They had to be 'seen' to be doing the right thing. I laughed because I could see what was happening, it was so obvious. Yvonne had them all in the palm of her hand.

She also broke one prosecution witness with her relentless questioning, summing up straight afterwards by saying tersely to the witness, so you 'assumed', .laying sarcastic emphasis on the word 'assumed'. .She had made her point.

Alan Johnson, the home Secretary, witness for Yvonne, (she had issued a summons warrant for him to attend) arrived on Tuesday with two women minders, so the court was packed with reporters, they would not let anyone else in. You could feel the tension of excitement tingling.

We all expect her to be disbarred or fined. heavily. We shall see.

You should know Colin that the attitude of the judges and the prosecution, in fact all of us- and the atmosphere in court changed dramatically to that of being humbled and deeply ashamed, when one of Yvonne's disabled witnesses, who is wheelchair bound came to give his verbal evidence.

His special wheelchair was high, both legs were thickly bound, his clean brown hair was long and loose with a bun on top as well. In his thirties, he was tall and an imposing figure of a man. He explained his dire situation of how he was left with no carers to attend to his personal needs, of how he was left to sit in his own faeces for more than a week, over Christmas, and of how he tried to take his own life because he did not have a life, and how when he made contact with Yvonne he just new she would help him, which she did, because I was there at her office when he made the first call to her.. And how when they took him to Hospital to clean him up of all this faeces, which had impacted deeply into his skin, which was very difficult to remove, and the smell being so terrible, the nurses had to wear face masks.

People hung their heads in shame, to know that this is actually happening in the UK. I have never seen so many people hang their heads in shame. It was as though you could hear them all thinking, there but for the grace of God go I. Yes, reality had hit them in the eye. MB

Comments

Isn't this now typical of our viper infested society??! This women has tried to help those who are most vulnerable and her own profession has turned against her! It's sickening.

It will be a travesty of justice if she is struck off. Those who have maliciously complained about her should be thoroughly ashamed of themselves.

The law is important but people are more so; Mrs Hossack I take my hat off to you

More power to your elbow Yvonne! We need a lot more like you. WHY DON'T THE AUTHORITIIES LISTEN, LISTEN, LISTEN! What she's telling them is the truth.

We should all be supporting her .... don't forget - it's your turn next and it's not a pretty prospect, believe me.

I am 100% behind her as a care home manager.

Camouflage for Medical Practice or Real Assistance?


Stopping Long-Term Benzodiazepines and Z Drugs
A sample letter

     This is a sample letter from the web that has been widely used to write to patients who are on long-term tranquillisers and sleeping pills. A variation of this letter sent to me can be found below.

Dear
I am writing to you because I note from our records that you have been taking a medicine called ........................ for some time now. Recently, family doctors have become concerned about this kind of medication when it is taken over long periods. Our concern is that the body can get used to these tablets so that they no longer work properly. If the tablets are stopped suddenly, a few people experience withdrawal effects. Research shows that repeated use of the tablets over a long time may actually cause anxiety and sleeplessness and that the tablets can be addictive.

I am writing to ask you to consider cutting down on your dose of these tablets and perhaps stopping them at some time in the future. The best way to do this is to cut down very gradually on your tablets (for example, if you take three tablets, reduce to two and a half tablets; or if you take one tablet divide it in half). You should make these changes slowly over a period of two to four weeks. In this way, you might be able to make a prescription last longer.

Once you have cut down, you might be able to think about stopping them altogether. Most people even feel better when they are off their tablets.

If you would like to talk to me personally about this, I would be glad to see you in the surgery.
Yours sincerely


     My main objection to these letters is that what they say was not particularly true - there was no recent concern because of recent research on the part of family doctors - it was a camouflage for licensed drugs which turned out to be dangerous and negative for many. It was a way to not involve doctors (who still continued to over-prescribe) in their own responsibilities. When I received one I had almost completed withdrawal myself and had taken the first steps towards understanding what was going and had been going on. 

     There is a blank space in the suggested letter for the insertion of a drug name - a Z drug  (zaleplon, zopiclone or zimovane) or less usually of a benzodiazepine such as Valium (Diazepam). In my case I never received one about benzodiazepines which I had been taking for nearly thirty years so presumably there was no concern on the part of family doctors about them in the area where I lived!

     There is no real advice in these letters about how to stop and the letters are therefore dangerous, though in the eyes of local NHS administration they can be pointed to as an attempt to get people off – positive action. The letter (including the one sent to me and reproduced below) shows no understanding of the seriousness of withdrawal – maintaining ignorance really should be the motto of the Department of Health.

     Mary Baker who has attempted to help many people over the years produces some salient points below and they are well worth reading. Those who have personal experience of benzos will understand what she is saying though others may not.

These sample letters. I agree, it is the back-door approach of reducing benzo prescriptions only and abdicating their responsibility for patient care with incorrect information. For instance, when does the patient reduce their dose - every day, or once per week? Or do they reduce it every other day or once per month?

Most patients would be very frightened and not want to see their doctor but would have no clear idea of how to reduce or when, or what to expect in the way of withdrawal symptoms. Some being too drugged to know they would have withdrawal symptoms.(my experience)

I believe that many patients would try to reduce on their own for fear of being taken off the drugs, make a hash of it, become very ill, reinstate the drug, to feel better, but would remain ill. Then it's too late, the damage has been done. And ill patients are far too ill to start reducing all over again. That is why patients should be prepared well in advance on how to manage their drug withdrawal with all relevant information to hand and constant support.

And to state 'most people even feel better when they are off their tablets' we know is totally incorrect. Most patients cannot even imagine in their wildest dreams what it is like to live without benzos because it doesn't bear thinking about. Plus, for many patients it is long forgotten what life was like prior to taking drugs!

They also stating 'if the tablets are stopped suddenly, a few people experience withdrawal effects'. Some patients may even think, in ignorance, okay, I can handle that because I'm fed up with taking these drugs for years anyway, and stop taking them. (my experience) We know the outcome of stopping benzos suddenly, cold turkey and the possibility of fits and death. And are these letters targeted and discriminatory? Are they being sent to elderly patients or anyone living on their own?

People need to know about this treatment, by letter. Not forgetting that most GP's have not had proper training in benzo drug addiction, benzo illness, benzo drug tolerance, benzo adverse effects, side effects or benzo withdrawal symptoms, and post withdrawal symptoms, plus the permanent damage coursed by taking prescribed medication for far to long.

Tell me, is this how doctors are treating their patients who have dementia? Do they just send them a letter and say, just pop in to talk about treatment for your dementia? Would these doctors really think that anyone with dementia would actually remember what was said during the appointment? No. They would not. Yet these benzo patients are known to be suffering from a drug induced dementia. They are seen to be forgetting all the time - see Prof. Lader's research, which is very telling on how these benzo patient are thought to have dementia by doctors, especially the elderly, whereas, their short-term memory impairment and confusion is due to taking benzos.

And so these patients, in particular, need to have 'written' information, preferably Prof. Ashton's manual, given to them 'prior' to reducing from their drugs, so that they can read and re-read it again, how to safely withdraw. And even then, many/most patients will not remember what they have read! That is why patients who do have the manual, call it their bible, for they have to refer to it on a regular basis.  Every doctor should be giving this manual out to all their addicted patients as part of and for their information on treatment for coming off benzos. It should be supplied free on prescription-.free information to all benzo patients, just as other patients are also entitled to have and are supplied with- free information on their health conditions.

These disgraceful cop-out letters that replace proper treatment and consultation with patients, make me so very angry!
Mary Baker

P.S. Not forgetting that these patients have drugged induced short-term memory problems, so even if they do consult with their doctors, they will forget most of what has been discussed!  (my experience also)

Important Advice
Dear Colin Downes-Grainger,

I am writing to you because I note from our records that you have been taking Zopiclone for some time now. Recently, family doctors have become concerned about this kind of tranquilizing (sic) medication when it is taken over long periods. The concern is that the body can get used to these tablets so that they no longer work properly. If you stop taking the tablets suddenly, you may experience unpleasant withdrawal effects. Research work done in this field shows that repeated use of the tablets over a long period of time is no longer recommended. More importantly, these tablets may actually cause anxiety and sleeplessness and they can become addictive.

I am writing to ask you to consider cutting down on your dose of these tablets and perhaps stopping them at some time in the future!

The best way to do this is to take the tablets only when you feel they are absolutely necessary. Try to take them only when you know you have something to do which might be difficult for you. In this way you will be able to make your prescription last longer and longer.

Once you have begun to cut down, you might be able to think about stopping them altogether! It is best to cut down gradually and then you will be less likely to have withdrawal symptoms.

In the future we will be running clinics to help patients manage their reduction of the drug. If you would like to know more about these clinics please contact the Practice Manager.

We believe this advice is a positive and forward step to a healthier future for you, so please give it your most careful consideration.

Yours sincerely

E. Walker

Prescribing support pharmacist on behalf of Dr John, O’Flanagan, Smith and Ingledew


My Reply

7 November 2002

Dear Elizabeth Walker,

I am writing with reference to the letter and ‘advice’ you sent me on Dr John’s headed notepaper at the end of September concerning my prescription for Zopiclone.

So sleep problems 'are not as damaging as you might think'

Well there are no problems as regards the NHS drugs bill, it goes down.
There is no problem for doctors, out of sight is out of mind, and past damage is water under the bridge.
There is a problem for patients innocently caught up in hypnotic addiction and withdrawal:

•    Disturbed sleep pattems/no sleep, which often made it impossible to go out to work.
•    Disturbed sleep patterns/no sleep, which may well have made it dangerous to work with machinery.
•    Disturbed sleep patterns/no sleep, which places the individual who drives in a potentially criminal position in the event of an accident.
•    Disturbed sleep caused by benzodiazepines and ineffectually managed by Z drugs.

There is no treatment or antidote for the physical withdrawal pains, going on for months and even years in some cases, which follow long-term addiction to sleeping pills - benzodiazepines or otherwise.

It has long been common knowledge among experts with open minds and those who wish to become aware, that hypnotics are not effective after a surprisingly short time, and that use after that is merely feeding a dependence and staving off  withdrawal symptoms. But you do not address this issue.

Informing people about Zopiclone, whatever the motive, is of course an excellent policy, but you should be informing doctors, not addicts retrospectively. Normal everyday insomnia may not be a great problem, the real problem is the uninformed over-prescribing by GPs. Addressing your centrally provided letter to addicted patients who may have been taking sleeping pills for years or decades, is not only inappropriate but downright misleading and dangerous, not least because it is being sent out in isolation, -divorced from patient circumstances.

Family doctors have NOT recently become concerned by RECENT evidence - the evidence goes way back and many of them ignored it. Frankly, I doubt if they are much involved in this medical message', particularly since local pharmacists say that new prescriptions have not reduced particularly.

You ought really to consider whether it is advisable to omit details of withdrawal symptoms. If Pharmacy Advisers are going to be the main source of advice on benzodiazepines and similar drugs such as Zopiclone, then you might consider it a positive step for patients to make an attempt at filling in the blanks that family doctors have left open for forty years.

The most effective and efficient way of saving the NHS money on its drugs bill, is to advise doctors to read back numbers of the British Medical Journal (Br Med J, 1980:280,910-912 is a good place to start) and also to read the various PILS leaflets, the relevant BNP advice and the CSM Guidelines, basic though they are.

I had already started to withdraw from Zopiclone some time before your letter came, and I had been withdrawing from Diazepam for more than 18 months (after I discovered by chance the harm it and subsequent drugs were causing). I have to tell you that I have not experienced 'limited side-effects' in spite of a much more gradual and. scientific reduction than you recommended. In the first six months after beginning a withdrawal and achieving a cessation of use, I lost the equivalent of three months’ sleep.

Some nine months after the last portion of tablet, going to steep at night is still very problematical, and exhaustion is a daily feature. This experience and worse is widely reported, but of course is totally unaddressed where it matters.

One final point -  recommend to those with the power to make decisions, that the Area Health Authority buys copies of the Ashton Manual (Professor Heather Ashton, DM, FRCP, Newcastle University) in bulk, and sends them to all doctors in its area - it really is very informative. You will be able to read it online at the website benzo.org.uk should you wish to check it out first.

Yours sincerely,
Colin Downes-Grainger

What fascinates me about the war on drugs is the fact that there are many legal drugs in doctors' surgeries which are far worse and which are sold as medicine. Largely, any damage done by such drugs didn't happen because they are legal and used by the new established religion of medicine. When you've read this article, read the one below it from the Sunday Times last year - it offers a new perspective.


The war on drugs is immoral idiocy. We need the courage of Argentina
While Latin American countries decriminalise narcotics, Britain persists in prohibition that causes vast human suffering

Simon Jenkins
guardian.co.uk, Thursday 3 September 2009

http://www.guardian.co.uk/commentisfree/2009/sep/03/drugs-prohibition-latin-america

I guess it had to happen this way. The greatest social menace of the new century is not terrorism but drugs, and it is the poor who will have to lead the revolution. The global trade in illicit narcotics ranks with that in oil and arms. Its prohibition wrecks the lives of wealthy and wretched, east and west alike. It fills jails, corrupts politicians and plagues nations. It finances wars from Afghanistan to Colombia. It is utterly mad.

There is no sign of reform emanating from the self-satisfied liberal democracies of west Europe or north America. Reform is not mentioned by Barack Obama, Gordon Brown, Nicolas Sarkozy or Angela Merkel. Their countries can sustain prohibition, just, by extravagant penal repression and by sweeping the consequences underground. Politicians will smirk and say, as they did in their youth, that they can "handle" drugs.

No such luxury is available to the political economies of Latin America. They have been wrecked by Washington's demand that they stop exporting drugs to fuel America's unregulated cocaine market. It is like trying to stop traffic jams by imposing an oil ban in the Gulf.

Push has finally come to shove. Last week the Argentine supreme court declared in a landmark ruling that it was "unconstitutional" to prosecute citizens for having drugs for their personal use. It asserted in ringing terms that "adults should be free to make lifestyle decisions without the intervention of the state". This classic statement of civil liberty comes not from some liberal British home secretary or Tory ideologue. They would not dare. The doctrine is adumbrated by a regime only 25 years from dictatorship.

Nor is that all. The Mexican government has been brought to its knees by a drug-trafficking industry employing some 500,000 workers and policed by 5,600 killings a year, all to supply America's gargantuan appetite and Mexico's lesser one. Three years ago, Mexico concluded that prison for drug possession merely criminalised a large slice of its population. Drug users should be regarded as "patients, not criminals".

Next to the plate step Brazil and Ecuador. Both are quietly proposing to follow suit, fearful only of offending America's drug enforcement bureaucracy, now a dominant presence in every South American capital. Ecuador has pardoned 1,500 "mules" – women used by the gangs to transport cocaine over international borders. Britain, still in the dark ages, locks these pathetic women up in Holloway for years on end.

Brazil's former president, Fernando Henrique Cardoso, co-authored the recent Latin American Commission on Drugs and Democracy. He declares the emperor naked. "The tide is turning," he says. "The war-on-drugs strategy has failed." A Brazilian judge, Maria Lucia Karam, of the lobby group Law Enforcement Against Prohibition, tells the Guardian: "The only way to reduce violence in Mexico, Brazil or anywhere else is to legalise the production, supply and consumption of all drugs."

America spends a reported $70bn a year on suppressing drug imports, and untold billions on prosecuting its own citizens for drugs offences. Yet the huge profits available to Latin American traffickers have financed a quarter-century of civil war in Colombia and devastating social disruption in Mexico, Peru and Bolivia. Similar profits are aiding the war in Afghanistan and killing British soldiers.

The underlying concept of the war on drugs, initiated by Richard Nixon in the 1970s, is that demand can be curbed by eliminating supply. It has been enunciated by every US president and every British prime minister. Tony Blair thought that by occupying Afghanistan he could rid the streets of Britain of heroin. He told Clare Short to do it. Gordon Brown believes it to this day.

This concept marries intellectual idiocy – that supply leads demand – with practical impossibility. But it is golden politics. For 30 years it has allowed western politicians to shift blame for not regulating drug abuse at home on to the shoulders of poor countries abroad. It is gloriously, crashingly immoral.
The Latin American breakthrough is directed at domestic drug users, but this is only half the battle. There is no rational justification for making consumption legal but not the supply of what is consumed. We do not cure nicotine addiction by banning the Zimbabwean tobacco crop.

The absurdity of this position was illustrated by this week's "good news" that the 2009 Afghan poppy harvest had fallen back to its 2005 level. This was taken as a sign both that poppy eradication was "working" and that depriving Afghan peasants of their most lucrative cash crop somehow wins their hearts and minds and impoverishes the Taliban.

The Afghan poppy crop is largely a function of the price of poppies compared with that of wheat. The only time policy has disrupted this potent market was in 2001, when the old Taliban responded to American pressure by ruthlessly suppressing supply. Since the Nato occupation it has boomed, inevitably polluting Kabul politics and plunging western diplomats and commentators into hypocrisy over Hamid Karzai's corrupt regime. What did they think would happen?
The crop has shrunk because the wheat price has risen and the recession has dampened European demand. It will rise again. The policy of Nato and the UN's economically illiterate drug tsar, Antonio Maria Costa, of treating Afghan opium as the cause of heroin addiction, not a response to it, means trying to break supply routes and stamp out criminal gangs. It has failed, merely increasing heroin's risk premium. As long as there is demand, there will be supply. Water does not flow uphill, however much global bureaucrats pay each other to pretend otherwise.

The trade in drugs is a direct result of their unregulated availability on the streets of Europe and America. Making supply illegal is worse than pointless. It oils a black market, drives trade underground, cross-subsidises other crime and leaves consumers at the mercy of poisons. It is the politics of stupid. The incarceration of thousands of poor people (11,000 in England and Wales alone) also deprives economies of a large labour pool.

As the Brazilian judge pointed out, the tide of violence associated with any illegal trade will not abate by only licensing consumption. The mountain that must be climbed is licensing, regulating and taxing supply, thus ending a prohibition now outstripping in absurdity and damage America's alcohol prohibition between the wars.

From the the deaths of British troops in Helmand to the narco-terrorism of Mexico and the mules cramming London's jails, the war on drugs can be seen only as a total failure, a vast self-imposed cost on western society. It is the greatest sweeping-under-the-carpet of our age.

The desperate politicians of Latin America have at last found the courage to grasp the nettle. Will Britain? According to the UN, it has the highest number of problem drug users in Europe. I imagine Gordon Brown and David Cameron agree with the Argentine supreme court, but they are too frightened to say so, let alone promise reform. In all they do they are guided by fear.

I sometimes realise that, if Britain still had the death penalty, no current political leader would have the guts to abolish it.



Prescription drugs: legal and lethal

Forget heroin and cocaine. The dangerous drugs claiming the lives and minds of the stars are prescription painkillers and a new class of happy pills that doctors are handing out by the million

The Sunday Times

Robert Sandall

What finally killed Heath Ledger wasn’t heroin or cocaine. Despite his well-publicised problems with illegal hard drugs in the past, the potentially lethal compounds found in the Manhattan apartment of the 28-year-old Hollywood actor after his death in January had all been legally prescribed. Just another victim of the American private-health system, you might think, the prescription-on-demand culture that wiped out Elvis Presley and Marilyn Monroe. Not our problem.

Think again. Of the six sedatives, painkillers and anti-anxiety drugs Ledger was taking, three had been prescribed here during his recent spell filming in London. In common with a growing number of young serial drug abusers – including his fellow film star Owen Wilson, whose attempted suicide last year was attributed to a three-day binge on the legal painkiller OxyContin – Ledger had moved on from street drugs. Having been caught on film two years ago at the Chateau Marmont in LA snorting a white powder, he had discovered a less troublesome, if no less dangerous, route to oblivion.

That most of us haven’t yet registered this shift reflects the fact that when it comes to thinking about drugs, we’re like a broken record. We think about the drugs governments are prone to declare “war” on. So it is that the argument about the dangers of cannabis drags on, while the tabloids feast on pictures of Pete Doherty and Amy Winehouse with their crack pipes, or speculate that Britney Spears might be a victim of the new “drug scourge” methamphetamine, better known as “crystal meth”. But beneath the media headlines and moral panics, the ground is shifting. The problem with drugs is moving insidiously closer to home. All of our homes.

In one of its less sensational aspects, our escalating fondness for taking drugs that won’t get you arrested can be measured in the 10% annual rise over the past three years in the use of antidepressants, notably our old friend Prozac. The NHS issued 31m scripts for Prozac in 2006, a blanket figure that, however it breaks down in terms of the numbers of users referred to, suggests that a lot of people are regularly taking a powerful antidepressant. Then there are the Valium guzzlers. The Council for Involuntary Tranquilliser Addiction (Cita), run by Liverpool University, guesstimates that there are as many as 1.5m nervous types in this country who have become accidentally addicted to benzodiazepines, the family of tranquillisers to which Valium belongs. Others take them knowingly, for fun. According to Professor Heather Ashton of Newcastle University, author of a pamphlet on addiction to benzodiazepines, these “are now taken illicitly in high doses by 90% of drug abusers worldwide. They are part of the drug scene”. So well integrated are they that abusers will crush the pills and snort or inject them, the same way they might cocaine or heroin.

More worrying in a way, because they attract less attention, are those habit-forming drugs that can be bought without prescription at high-street pharmacies. Concern about these has given rise to a new coinage in the world of drug dependency, “OTCs”, an abbreviation for painkillers bought “over the counter”. This usually refers to the more powerful varieties of OTCs, such as codeine, which contains synthetic opiates. At a conference of the General Medical Association in 2004 it was suggested that there might be 50,000 OTC addicts in Britain today. The authorities are also concerned about OTC drugs causing suicidal tendencies: the European Medicines Agency is calling for OTC drugs to come with a “suicide rating”.

A few words of reassurance at this point for those concerned that they might be developing a dependency on analgesics, anti-inflammatories, hay-fever tablets or other popular remedies. Drugs that carry a risk of addiction do so because they alter the binding of neurotransmitters to receptors in the brain. In short, they are, in different ways, mood-enhancers. A couple of aspirin cannot affect your Monday-morning feeling nor induce a sense of numbness the way synthetic opiates do.

We could, though, get hooked on other readily available painkillers. The comedian Mel Smith publicly confessed to having developed a dependency on Nurofen Plus – the enhanced version that adds an opioid to ibuprofen, the active ingredient – while treating himself for gout. Smith suffered a seven-year addiction he referred to as his “dark secret”. “They didn’t make me feel high. They helped me to relax.” His 50-tablet-a-day habit landed him in hospital with two burst stomach ulcers. The pharmacists’ trade body, the Royal Pharmaceutical Society, has become increasingly insistent that its members check the symptoms of anybody asking for OTCs; the move was prompted by a survey of its members in Scotland that revealed that nearly half suspected they had sold painkillers to customers with something other than pain relief in mind.

But would this help a user such as Mark, an IT manager from the Midlands in his forties? His OTC drug problem began after he contracted MRSA while in hospital with severe pneumonia. The excruciating pain he felt eventually passed, and he was discharged; but then a chest infection set in, reawakening memories of his MRSA agony. As he didn’t have a good relationship with his GP, he asked a chemist for the strongest pain relief available. He came away with co-codamols, which contain codeine. For years Mark carried on taking these tablets – primarily for migraine symptoms – until in 2004 he was diagnosed with high blood pressure. Signed off from work, he soon realised it wasn’t the anxieties of his job that were causing his blood pressure to soar: it was the stress he felt without his painkillers. “I managed to get them down to eight a day, but I couldn’t cut them out totally. I went on like this for about four months.” Luckily, the doctor he eventually confided in worked part-time with the South Derbyshire Substance Misuse team.

Clean for four years, Mark now helps to run Codeine Free, one of the websites that have sprung up recently to offer advice and discussion forums on OTC drug addiction. The best-known of these, Over Count, was set up in Dumfries by David Grieve, a former policeman who spent £18,000 over a two-year period getting hooked on a popular proprietary cough medicine with a synthetic opiate base.

The prescription drugs causing most concern are antidepressants. Prozac, which has been around for 20-odd years, is old news. The two newcomers currently causing medical debate are the branded drugs Efexor and Cymbalta. These are classed as “selective seratonin and noradrenaline reuptake inhibitors”, or SSNRIs. The added “N” is what makes them special. Unlike Prozac and other SSRIs, these drugs do not simply increase levels of seratonin, the brain chemical that makes us feel more sociable and relaxed. They also boost adrenaline, making us more energetic and sometimes slightly manic.

Cymbalta was developed by Eli Lilly after its patent on Prozac ran out in 2001, which meant that the latter could now be manufactured as a “generic” drug and sold more cheaply. During the clinical trials of Cymbalta in 2003, one of the paid guinea pigs, a female student, committed suicide; but it was approved for medical use in the US in 2004, and a year later was generating $1 billion worth of sales. In the UK, Cymbalta has only just started to be prescribed. In America it’s a phenomenon, one of the pharmaceutical industry’s greatest hits. The financial analysts at Merrill Lynch, which part-owns Eli Lilly, have estimated that the market for Cymbalta will be worth over $3 billion in 2009, overtaking the original SSNRI drug it was modelled on, Efexor.

Currently prescribed in the UK for conditions that range from chronic depression to hormonally related hot flushes, Efexor is less common but more controversial than Prozac. One of its most prominent former users is Robbie Williams. Hooked on cocaine and alcohol for most of the 1990s, Williams was back in rehab in February 2007 for what he described as “prescription-drug addiction”, the chief of these being his favourite antidepressant, Efexor. Whether Williams realised what was happening when he began taking pills prescribed by his LA psychiatrist is not clear. But he must have had an inkling that keeping depression at bay was not the only role Efexor played in his ostensibly sober life. He compared the feeling of taking it to “coming up on an E” (ecstasy tablet), and spoke glowingly to George Michael about its energising effect on his live performances – both of which endorsements were reported in Chris Heath’s biography of the star, Feel.

Efexor, which has been around for a decade, has become a cause for concern since an online petition was started in America in 2001. It now contains over 15,000 aggrieved signatories. There are complaints that doctors gave no indication, or flatly denied, that the drug carried any significant side effects or risk of dependency. For its part, the drug’s manufacturer, Wyeth, acknowledges that Efexor may cause unpleasant side effects such as nausea, insomnia and raised blood pressure in a small number of cases – its data suggest around 10%. The online complaints about the withdrawal symptoms go further, listing raging headaches, panic attacks, night sweats and vomiting. One petitioner writes: “I have lived my life saying ‘no’ to drugs. Now I’m having withdrawals from something my doctor gave me. This is a crime.”

It does at least suggest how hazy the line is that separates the gear you buy from a dealer on the street and the stuff prescribed by the guy in a white coat. Plenty of British doctors, however, disagree. One Harley Street GP with several highly stressed celebrity patients says Efexor is “a formidable agent that can change people’s lives in ways that are wonderful. To demonise it is wrong”. Efexor dependency is manageable, and ultimately avoidable, he says. The key lies in careful administration and monitoring to minimise the problems. “It’s like having a brilliant chainsaw. You don’t try to have a shave with it.”
When predicting the future for prescription-drug abuse in this country, all eyes are on America, where the situation has been barrelling out of control for decades. It was reported last year that prescription drugs in the States are responsible for more deaths than either cancer or road accidents. Tranquillisers abused by recreational users enjoy a high profile there thanks to Xanax. Designed to combat anxiety, but widely taken in excess with alcohol – whose effects it mimics and intensifies – Xanax is as common as Prozac, and far more socially troublesome. It has become synonymous, in law-enforcement circles, with wildly uninhibited behaviour and late-night call-outs to suburban addresses. It was one of the six prescription drugs found, along with empty bottles of booze, in Heath Ledger’s apartment.

The real worries, though, surround painkillers. Dihydrocodeine, or DF118, as it is referred to in the UK, is the preferred American alternative to diamorphine, the pharmaceutical name for heroin. In the US, which outlawed heroin in the 1920s, dihydrocodeine is the active ingredient in the popular branded painkiller Vicodin. Recently identified by the US Drug Enforcement Administration as the fourth most widely abused drug in the country – after cocaine, heroin and marijuana – Vicodin has seeped into American popular culture. The rapper Eminem wears a Vicodin tattoo on his arm. Celebrity abusers have ranged from Ozzy Osbourne to the ultra-conservative chat-show host Rush Limbaugh, who began taking it for back pain and went on to spend $300,000 on it in three years. Or at least that’s what his former housekeeper told the National Enquirer.

An English film producer who works in LA, and does not consider himself a druggie, was prescribed Vicodin for a back problem. “There was no warning that it was addictive,” he says. “But I knew it was dangerous the first time I took it. It gives you this warm feeling which is rather delicious, and I am very careful not to take it now unless the pain is serious.” His view is that in LA today the misuse of prescription drugs is “not about getting out of it. They keep you going.

They encourage a hyper work ethic”. The epidemic of prescribed antidepressants he holds in similar regard. “There’s an incredible stigma against depression in California, where it’s regarded as worse than bad breath.”

The actor Owen Wilson had his own prescription for a bout of severe depression last year: OxyContin (oxycodone). Manufactured in the UK, but only sparingly prescribed here while its effects are monitored by our Medicines and Healthcare products Regulatory Agency (MHRA), this powerful opiate offers a dystopian glimpse of future drug abuse. Its rocketing popularity with the recreational crowd derives in no small part from its superior design. Like many of the new prescribed substances, OxyContin is, by comparison with the powders that are traded on mean streets, a smart drug. Whereas a shot of heroin will deliver its entire opiate charge at once, with possibly fatal results, OxyContin is released in stages over six to eight hours. For the cancer sufferers for whom the drug was developed, this means longer and more effective pain relief. For an abuser, it means a longer, more consistent high, with a reduced risk of an overdose.

In the US, OxyContin is now regarded as the most dangerous substance in the recreational arsenal, widely tipped to take over from heroin as America’s favourite opiate. In its first year on the market, sales of OxyContin were worth $40m. Four years later the manufacturers were shipping $1 billion worth of a drug that had acquired the nickname “hillbilly heroin” because of its popularity among poor rural communities in the Appalachians. Sales of OxyContin have roughly doubled in America in this century. Since the cost of it is often covered in the first instance by health-insurance plans, it offers a double whammy for the potential abuser: a long, strong high that is both highly addictive and cheap.

This new pharmaceutical order has been vigorously embraced in the US, particularly by the young. Several studies have shown an alarming hike in prescription-drug abuse in the under-25s. A National Household Survey in 2001 discovered a doubling of the numbers of 12- to 17-year-olds reporting an interest in Xanax and Vicodin between 1996 and 2000.

Wherever youth pitches its tent, a new slang takes root. “Pharming” is consuming a cocktail of prescription drugs. “Doctor shopping” is visiting several physicians to fulfil a medicines wish list. And if that doesn’t pan out, there are always “pill ladies”, elderly prescription-holders who take advantage of the difficulties experienced by the young in obtaining heavy-duty drugs created to ease chronic back pain or the suffering of cancer patients. And for the truly desperate, the practice of robbery has acquired a new subdivision: “prescription theft”.

The most vivid insight into the transmission of the new drug culture has been provided by the stars of the real-life soap The Osbournes. The head of the family, metal guru Ozzy, was for years addicted to Vicodin, a subject he explored on his latest album, Black Rain. His children have long since overtaken him. His daughter Kelly entered a rehab clinic at the end of the TV series claiming: “They found 500 pills in my room when they cleaned it.” His son Jack started popping Vicodin aged 14. At 17 he was a multiple prescription-drug addict. Street drugs he never bothered with. After he cleaned up, Jack Osbourne spilt his guts on MTV, naming nine medications that he used on a regular basis. His favourite was OxyContin.

Evidence of just how deeply entrenched over-medication currently is in the US unfolded in the LA courtroom where Phil Spector stood trial last year for the murder of Lana Clarkson.

In one of the pre-trial hearings, his lawyers argued that the police, who kept their client locked in a cell for most of the day after the fatal incident, had acted unlawfully. Their reason was that Spector, at the time, was a prescription junkie, suffering withdrawal symptoms from seven named medicines. Two of these were powerful benzodiazepines. One, Klonopin, is a tranquilliser much more potent than Valium.

It is notoriously dangerous when taken with alcohol: users become quite unhinged. Which was why Spector’s lawyers were so insistent that although the accused spent a lot of time in bars on the night of Clarkson’s death, and ordered a number of alcoholic cocktails, he didn’t actually drink them. That Clarkson was, at the time, buzzing lightly on Vicodin, the painkiller she was still taking two years after breaking both of her wrists, was another twist in the tale. Spector and Clarkson were a very modern American couple: plain-clothes druggies whose habits were known only to their doctors.

The situation in the UK is nowhere near as bad, but it does seem to be getting worse. In the same week last year that Robbie Williams went public with his prescription-drug habit, a private GP was banned for nine months for prescribing addictive or dangerous drugs from his website, e-med. The General Medical Council ruled that Julian Eden had adopted a “cavalier” approach to patients who contacted him online. In particular, the GMC was appalled by the case of a 16-year-old boy, with a history of self-harming and mental instability, who tried to kill himself after Eden issued him with a prescription for the beta-blocker propranonol. Another woman, a mother of three, obtained a year’s supply of dihydrocodeine and Valium. A third “patient” received 51 repeat prescriptions for two so-called “hypnotic” sedatives similar to the date-rape drug Rohypnol.

Eden’s activities came to light after he was exposed by two undercover reporters, both of whom were prescribed drugs that usually require a full medical consultation within minutes of logging on to e-med. Making matters worse, the GMC said, was the fact that Eden made no attempt to contact the GPs of his online clients.
 
Eden is, or was, a real doctor. As anybody with a broadband connection on their computer knows, prescription drugs of the more popular kind are now being sold from thousands of websites by anonymous peddlers. Every day I receive spam e-mails offering unlimited quantities of, say, the tranquilliser Xanax, or the highly addictive and widely abused sleeping pill Ambien. The asking price is usually $2 a tab. This dodgy online pharmacy is invariably just a click and a credit-card payment away.

According to a report published in 2006 by the United Nations’ International Narcotics Control Board, the misuse of pharmaceutical drugs now outstrips the trade in illicit substances globally.

As many as a tenth of these “medicines” the UN estimates to be counterfeits – crude, even dangerous, chemical copies of generic drugs manufactured by criminals in the Third World. The UN report explains this growth as a guerrilla response to the “war on drugs” fuelled by improved electronic communications.

Parliament is at last waking up to the problem. Dr Brian Iddon MP, chair of the House of Commons all-party group on drugs misuse, is carrying out the first proper assessment of prescription and OTC drug abuse in this country. A scientist by training, with degrees in chemistry, Iddon understands the problem better than most MPs. He reports a surge in intravenous Valium and Prozac abuse by crack addicts in his Bolton constituency who use tranquillisers and antidepressants to soften their comedown. Iddon’s group hopes to publish its report in the spring.

Iddon, whose committee is considering the findings carefully and has already received evidence from many users and their families, says: “Whatever happens in the USA comes to the UK, usually about 5-10 years later. So my guess is that we’re heading for the rates of misuse of legal substances that the USA is seeing now. The internet supplies the drugs if doctors will not, or if patients do not want their doctors to know what they are up to. Anything is available on the internet, and there is little control of internet pharmacies or wholesale suppliers.

“The DoH has produced guidance for doctors which is still being ignored. For those who become addicted there should be more access to treatment. The NTA [National Treatment Agency] should treat all those with problems caused by ‘misuse’ of any substance – legal or illegal, including prescription medicines and OTCs, as well as alcohol.”

But the pharmaceutical companies have a responsibility too. The MHRA yellow-card scheme is slow to pick up problems and, even when adverse reactions to a new medicine start to come in to the MHRA, it has little power to take action against the drugs companies.

Not that a parliamentary report will do a lot to tackle the root of the matter: our proclivity as a species to seek chemical solutions to our chronic discontents. Harry Shapiro, who heads DrugScope, a British charity that offers advice on addiction issues, blames the rise in prescription and OTC drug abuse on our increasing tendency “to medicalise feelings which can’t simply be wished away by swallowing a pill”. Then again, depriving the desperately unhappy of what may turn out to be bad solutions won’t work either, Iddon believes. “What on earth do we prop these people up with, then?” This is not a purely rhetorical question. Iddon has seen blue-sky policy documents, so-called “foresight programmes”, drawn up by the old Department of Trade and Industry, that call on drugs companies to invent a “safe” recreational drug: a happy high with no side effects and no risk of dependency. It could signal the beginning of the end of the war on drugs. It could also take us one step nearer to the zonked anaesthesia of Aldous Huxley’s Brave New World. More soma, anyone? 

This is something of an incoherent article and I'm not sure what its real point is. While I have no doubt that the NHS does take benzodiazepines more seriously than the US system it does not take the addiction question anywhere near as seriously as it should do. If you include drugs such as zopiclone, zaleplon and zimovane (broadly similar in their effects), prescription levels in the UK are rising not falling, creating new addicts continuously in spite of the victims of historic prescribing being left to fend for themselves. Nasty things do migrate from the US to the UK but there is no justification for an American continuing love affair with tranquillisers to assist in the resurrection and rehabilitation of a truly devastating class of drugs here.


From The Sunday Times
September 6, 2009
The growth of prescription drug addiction

I discovered that the relaxing haze Xanax induced was rather essential on all flights, anxiety or no anxiety
Laurel Ives

http://women.timesonline.co.uk/tol/life_and_style/women/the_way_we_live/article6816905.ece

The revelation about the mass of prescription drugs that were pumped around Michael Jackson’s body by his enabling doctor reminded me of a brief flirtation with the world of tranquillisers when I was living in New York. It was soon after 9/11, and having witnessed the terrorist attacks, I was jittery about a flight to LA. A friend suggested Xanax, one of the family of so-called benzodiazepine drugs that includes Valium, so off I went to my dishy doctor. Xanax was duly prescribed with a bedside manner (“Any questions or concerns?”). I discovered that the relaxing haze it induced was rather essential on all flights, anxiety or no anxiety. Fortunately, I was on a repeat prescription. No questions asked. As long as I had the $80 or thereabouts (insurance paid some, but by no means all, of the bill), the pills were mine.

Back in the UK, it was a different story. Contemplating the jet lag of an upcoming trip to Malaysia, I went to my GP to get sleeping pills. Once I’d convinced him I wasn’t an addict (he barely looked up from his pad during this “conversation”), I left with a prescription for four pills. Four! I felt as I imagine my toddler feels when I won’t allow her a second helping of ice cream.
 
Yet, in a way, the old-fashioned stuffiness that takes drugs like these seriously was reassuring. Prescription pill-popping has become fashionable in America — after all, why risk a brush with the law when you can get a legal high that is reliably pure without any dodgy dealing? The Wire may dramatise the story of the poor skulking on corners to score heroin for a few dollars, but for celebs and the aspirant middle-class mainstream with the financial means, the man in the white coat has become the pusher in chief.

One expat friend in New York got so hooked on Ambien (the sleeping pill of choice in the States), it wasn’t until she returned to Blighty that she was able to go to bed without it. Most trends wend their way across the Atlantic, however bastardised they become on the way (just look at what we did to nail bars). The number of prescription drugs dispensed in the UK rose by 5.8% last year, that 1970s staple Valium is back in fashion and, in recent weeks, we have heard about the death of a talented young student who took a drug — GBL, used in nail-polish remover — that we didn’t even know people were abusing. Yet experts at the Priory say it can take six months to get an addict off Valium, whereas heroin can take a measly 10 days. Yes, the NHS may be crusty and stuffy, but in this case (and there aren’t many), substance is definitely better than style.

Comments

jay herron wrote:

I was prescribed Xanax in the generic name of Alprazolam. I was also needing comfort while flying to Hawaii-I suffer from anxiety related to PTSD. (BTW-I am a US citizen-our Veterans Administration medical system gave me the drugs)
The effects were good in the beginning-I was given a prescription and refill that lasted me almost 200 days. I became strange-strange enough it bothered me and I dumped them.

Being a former 'coke' addict-I can say honestly,cocaine was easier and faster to shed my body clean.
I read-Alprazolam is also used to treat dogs that have behavior problems.
I learned that NO ONE is to have more than a 14 day supply/treatment. I learned the chemical builds up in our brain and 'time releases' over months.
It took months-MONTHS to be be clean, and the sickness and withdrawals were misery.
Never again.

And-the States call marijuana dangerous?

Michelle Wiley wrote:

I'm currently going through a hell of a withdrawal from Ativan. It has taken me a month just to cut 1/8 of the dose, and I have health issues now from it. If anyone out there is thinking about taking these drugs, please think again. Try exercise, a change in diet, meditation...all of these can help anxiety. These drugs can actually make it worse if you take them on a regular basis.

I'm an educated person, but I wasn't educated enough. I never thought I'd be an addict.


ros levine wrote:

Six months to taper safely off tranguilisers is a very optimistic evaluation. Depending on how long they hae been taken can take years. Cold turkey can be extremely unpleasant and even in some cases cause death. Some people can become chemically adicted after just 2 weeks. The recent advice that you can become chemically addicted to painkillers after just 3 days should also be applied to these drugs. Some people can get away with it but many are left with long-term withdrawal that is devastating. doctors need to become more educated about the Ashton manual.
 

From The Times
August 31, 2009

UK’s Vioxx users call for justice
US claimants won billions so why can't British victims have their day in court?

http://www.timesonline.co.uk/tol/life_and_style/health/features/article6813991.ece
Mark Pigott

When my father Michael was prescribed a new painkiller called Vioxx in 1999 he found it highly effective at reducing pain in his arthritic neck. Then, in 2004, aged 60, he suffered a near-fatal heart attack. During a life-saving angioplasty at a Dublin hospital a stent was inserted and now he’ll be on medication for the rest of his life. My father is convinced that Merck’s drug, Vioxx, is responsible — and he’s not alone.

For Gary Cummings, a former police officer, the heart attack also came out of the blue: “I’d served in the Police and Army for 30 years; I was in the Household Cavalry, worked in traffic patrol for 15 years and then worked with horses. I was fit and active — only 48.”

Years of horse-riding took its toll and Gary’s hip became painful; a hospital consultant recommended Vioxx in June 2002. That November he had a heart attack that almost killed him. He had angioplasties and a stent was inserted. Although still in his fifties, the attack changed him physically and psychologically. “I was shocked. I’ve never smoked, never taken tablets, always played rugby; my cholesterol levels have always been low and there’s no history of heart problems in the family. I’ve had health checks regularly all my life, you have to in my line of work, and no concerns had ever arisen.”

Cummings was forced to retire early on medical grounds. Two years later, in 2004, his daughter read in a newspaper that Vioxx was being withdrawn due to safety concerns — in particular the increased rates of cardiovascular problems among users. Gary took legal advice and joined a group action of UK victims who were set to go to the US to provide evidence to a lawsuit against Merck at the Superior Court of New Jersey. “The judge [Carol Higbee] ruled that people based outside the States couldn’t bring claims against Merck. I was absolutely gutted. It just seemed totally discriminatory.”

The multinational corporation Merck launched Vioxx in 1999 and the drug was soon being heralded as one of the most effective treatments for arthritis, the debilitating condition that affects nine million people in the UK. Vioxx became one of the most-prescribed drugs in history — 80 million people around the world used the drug regularly, 400,000 of them in the UK. Merck’s headquarters are in New Jersey but it employs 55,200 people across the world and its revenue for 2008 was $23.9 billion.

It claims that the drug was taken off the market when health risks became apparent, as a spokesperson explains: “Merck believes that it behaved responsibly with Vioxx, from testing the medicine in studies involving approximately 10,000 patients before it was approved by regulatory authorities around the world to consistently disclosing the results of its studies to the medical community, to voluntarily withdrawing the medicine within a week of learning the results in 2004. The company’s decision to voluntarily withdraw Vioxx from the market was based on new data in 2004, and it was a prompt decision based on what Merck then believed was in the best interests of patients.”

However, the medical journal The Lancet claimed that serious health risks were apparent in Vioxx users as early as 2000; in 2001 a Federal Drug Administration (FDA) investigation in the US reported that Vioxx increased the risk of heart disease, and Merck’s own study uncovered similar data. Labelling on the medication was changed to reflect cardiovascular risk in 2002 but the drug wasn’t withdrawn from sale worldwide until 2004 — by which time the damage had apparently been done. It’s now estimated that up to 2,000 people in the UK may have died after taking the drug.

As a result of the US lawsuit, in 2007 Merck was ordered to pay $4.85 billion to 44,000 US-based claimants who could prove that they had received at least 30 doses prior to their attack. That amount was much lower than some in the industry had expected and was generally seen as a “victory” for the company — particularly as Merck made no admission of guilt.

Of approximately 10,000 people in the UK believed to have been negatively affected, only a tiny number have successfully sued Merck in court. Having been refused the right to sue in the US, Gary Cummings went to the Houses of Parliament last year to demand legal aid and justice for UK victims, backed by several MPs including Jenny Willott and Norman Lamb, both LibDems, who signed an early day motion in support of “victims of Vioxx”.

Lamb, a qualified lawyer, expresses his exasperation at the legal situation in Britain: “A constituent brought the matter to my attention and I subsequently met with other MPs, victims and legal experts. Here in the UK most actions have petered out because legal aid isn’t available. UK law is pernicious in this respect — if you take on a drug company you can be bankrupted. In countries such as the US there is no rule of costs so it’s easier to challenge corporations.”

Ivan Lewis, the former Health Minister, gave his support to the campaign in Parliament on June 17, 2008, but after a meeting with representatives from Merck on July 10, 2008 the Government backtracked. A Department of Health spokesman said: “While the Government has every sympathy with those UK patients who believe that they have been adversely affected by Vioxx, this is a complex issue and it would be inappropriate for ministers or government officials to intervene in or comment on current or potential claims for compensation.”

Background note from Colin Downes-Grainger

At the end of 2005, Martyn Day, a solicitor involved with Vioxx claimants confirmed that legal aid for group actions against drug companies had been massively cut back in recent years. The No-win, No-fee arrangements—known as conditional fee agreements—had been ostensibly meant to take up the slack. But insurance against losing and having to pay the drug company's costs is hard to get and prohibitively expensive. In the Vioxx case, the costs of losing were estimated at £5m.

Lord Brennan QC, a Deputy High Court judge expressed the opinion that people injured by prescribed drugs would no longer be able to mount claims for compensation in UK courts. The five hundred people who had had strokes or heart attacks following treatment with the withdrawn painkiller Vioxx had lost their appeal against the LSC refusal to grant legal aid. Almost 500,000 people in the UK were taking Vioxx when its US producers Merck removed it from sale in 2004. The case against Merck was a strong one and quite possibly might have been potentially much more successful than the benzodiazepine group action.

Although Merck had tried to make it seem as though as its withdrawal of Vioxx was motivated by concern for public health, the evidence does not point in that direction. Analysts believe the decision had more to do with the health of Merck’s finances and the fact that the lawsuits in the US were building up. The evidence showed that Merck actually wanted to broaden the market for COX-2 inhibitors. This was a re-run of GSK’s attempt to broaden the use of Seroxat as an antidepressant for children. As in that case, Merck’s attempt backfired.

In November 2004, FDA Safety Officer Dr David Graham appeared before the US Senate Finance Committee. In Dr. Graham’s opinion, even using Merck’s own trials data, some 88,000 to 139,000 had suffered heart attacks as a result of taking Vioxx in America alone and of that number, 30% to 40% had probably died. He likened the situation to 500 to 900 aircraft dropping from the sky:

“This translates to two to four aircraft every week, week in and week out, for the past 5 years. If you were confronted by this situation, what would be your reaction?”

In a press release Merck had stated that the drug was being withdrawn despite its belief that:

“It would have been possible to continue to market Vioxx with labelling that would incorporate these new data…”

The APPROVe trial which Merck carried out may have had less to do with safety and more to do with gaining FDA approval for using Vioxx as a prevention treatment against colon polyps. Had the three year study not been halted by the Data Safety Monitoring Board for safety reasons, Vioxx might well still be on the market and the heart attack toll still rising.

On February 13 1992, the consumer charity Social Audit said that more than 10,000 hospital beds are constantly occupied by people suffering from the side-effects of prescribed drugs. The claim was based on four studies between 1981 and 1988 suggesting that adverse reactions to drugs were to blame for between three and five per cent of admissions. The cost to the National Health Service of the side-effects of cardiovascular, arthritis and ulcer medicines and antibiotics was up to £1 billion a year. Charles Medawar, described how the receivers of drugs were kept in ignorance of risks associated with them, doctors were influenced by drug salesmen and the Committee on Safety of Medicines worked in secret and was staffed by people who had financial links to drug companies. As an example of official complacency, he pointed to the statement made in 1980 by the drugs watchdog of the time, the Committee on the Review of Medicines. The statement said that nationally there were only twenty-eight cases of dependence associated with benzodiazepines between 1960 and 1977. As Medawar said:

“Anyone taking the drugs would have known that was balderdash.”

The legal reality for the many thousands of patients who suffered hypnotic and tranquilliser damage due to over-prescription and the activities of the manufacturers goes something like this:

Many were first prescribed these drugs in the 1960s and 70s and many were, in ignorance, prescribed other drugs, to deal with symptoms produced by the benzodiazepines. This fact of course was a boon to the manufacturers, and as the law stands, it is very difficult to prove cause and effect, when a variety of drugs are involved. The law does not recognize common themes—ten thousand people can take a drug and report similar experiences as a result, but that has no currency in UK law, particularly with drugs marketed as psychotropic medication.

Those who became aware of what the drugs were doing to their lives often withdrew without medical encouragement or help, a process which can extend over several years.

Benzodiazepines frequently produce severe and debilitating physical and psychiatric symptoms while they are being taken. They are not only drugs which are notoriously hard to withdraw from but they also produce a new range of symptoms during the withdrawal process. Many people never recover their health, and many find they have been cast adrift in society, without jobs and security. There are those who lost their jobs through the effects of the drugs while they were taking them, but ironically there are also those who first became unable to work because of the severity of the withdrawal symptoms. Some people have been unable to work for decades with an obvious impact on family life and economic well-being. But the government does not recognize this situation and the law provides no redress for this state-induced situation.

Since the group action against the manufacturers, various guidelines were issued by them as to prescription. For example, it was recommended in the late 1980s by Roche, the manufacturer of Valium that it should only be prescribed for a maximum of 4 weeks. Having issued these guidelines, the manufacturers were able to produce benzodiazepines with legal impunity, effectively passing the responsibility wholly to those who did the prescribing. There, patients hit another snag—legal aid to sue a doctor was now unlikely to be forthcoming because of false assessments of damage caused and therefore inadequate figures of damages likely to be awarded. Finding a solicitor to take a case on a contingency basis was extremely difficult and the wholly unknown number who have managed to extract some degree of damages, have not done so in court, but have been given them by doctors’ insurance companies based on a perceived threat of success.

A handy legal fiction has been maintained that before the second part of the 1980s, GPs and psychiatrists were quite justified in not being aware of the extent of the addictiveness of benzodiazepines, in spite of a mountain of independent research from around the world and patient reporting that clearly demonstrated how addictive they were. Professor Heather Ashton, Charles Medawar and others have condemned the gullibility of drug regulators and doctors for thinking benzodiazepines were non-addictive tranquillisers. As Medawar has said:

“First it was alcohol and opium; then morphine, cocaine and heroin; then chloral, bromides and barbiturates—until it was the turn of the benzodiazepines.”

NHS compensation costs rise to £807m
Legal costs soar from £613m to £807m over three years as complaints of medical negligence against the service rise sharply

Owen Bowcott
The Guardian, Wednesday 19 August 2009

http://www.guardian.co.uk/society/2009/aug/19/nhs-legal-costs-compensation

The NHS spent more than £800m settling legal claims last year as complaints of medical negligence against the service rose sharply.
The surge in payouts is revealed in the NHS Litigation Authority's annual accounts which show that maternity services attract the highest legal costs. Clinical errors in delivering babies can result in lifelong damage and payments accordingly reflect the intensive medical care often needed for decades to come.

Among the contested claims highlighted in the report are the case of six male cancer patients who had banked semen samples with the North Bristol NHS Trust for possible future use. The samples thawed and became unviable.

Five claimants allegedly sustained psychiatric trauma as a result, believing that possibly their last chance to become a father had been lost. The sixth suffered mental distress. "In fact, the fertility of three claimants subsequently returned," the report notes.

The case, which has already been to the court of appeal, will return to the county court to assess damages payable. "This is a very novel ruling and has arguably increased NHS liabilities," the authority comments.

In one case a child born with congenital rubella syndrome, "due to admitted NHS negligence", is receiving care costing £130,000 a year. Legal costs for the NHS have risen significantly over the past three years, from £613 million three years ago, to £807 million in the last financial year. The latest figure alone represents a 22% increase over the previous year.

The liabilities show no sign of easing off. After five years of relatively consistent levels of claims for compensation due to errors by NHS staff, numbers leap last year by 11%. "We have not been able to identify any single factor that might have precipitated the rise," the authority commented in its report.
Most cases are settled out of court. Of the 8,885 clinical and non-clinical claims made in 2008/09, fewer than 4% are expected to end in a court hearing. There were almost 6,000 claims received last year under the clinical negligence scheme for NHS trusts. The sums include both damages paid to claimants (including patients, staff and members of the public) and the legal costs incurred on both sides where they are paid for by the NHS.

The popularity of Conditional Fee Agreements (CFAs) - where lawyers take on cases for a proportion of the final settlement rather than for up front fees – is one factor in the growth in litigation. Claimants' costs are often significantly disproportionate to the amount of damages paid, particularly in low-value claims," the report observes."This was not a vintage year for corporate defendants generally, nor for the NHS in particular, in most areas of litigation managed by the authority," the report says.

The NHSLA fears that several landmark judgments will stimulate future claims. It has warned that "no win, no fee" solicitors are damaging NHS patient care and that compensation payouts and lawyer fees can only come from the NHS's budget.

The Conservatives seized on the figures. The shadow health minister, Mark Simmonds, said: "We need a robust and fair way for patients who have received negligent treatment in an NHS hospital to get the compensation they deserve.

"Instead, we have an inefficient system which incurs vast legal costs for NHS Trusts involved in legal battles.The government could have saved a lot of money if they had listened to our proposals during the passage of the NHS Redress Bill three years ago.

"Our proposals would have required an initial 'fact-finding' phase, which would then allow more cases to be resolved without costly litigation.But the government missed this opportunity and as a result hospitals will now have less money to spend on patient care."

Stephen Walker, the NHSLA's chief executive, explained that there had been an increase in the number of claims settling in the £100-£500,000 range and delayed resolution of more than 100 catastrophic injury cases that had been awaiting the outcome of a test case.

A Department of Health spokesperson said: "Patients deserve high quality healthcare from their NHS. The vast majority of the millions of people treated by the NHS every year experience good quality, safe and effective care and we are one of the world leaders in the international drive to improve the safety of healthcare.

"However, on the rare occasions that patients do not receive the treatment they should, and mistakes are made, it is right that they receive an apology and explanation and, if appropriate, receive financial compensation.

"The amount spent on clinical negligence in 2008/09 does not necessarily reflect the number of new claims being made in that year, but could indicate that more claims were settled and compensation paid. However, disproportionate litigation costs are a concern across government and beyond, not just in the NHS. This is why Lord Justice Jackson is currently reviewing civil litigation costs to ensure that fees are proportionate and the results of this review are due to be published later this year."

Patients in England are being forced to fight lengthy and costly legal battles to receive an apology and an explanation of what went wrong

By Nina Lakhani
Sunday, 30 August 2009

http://www.independent.co.uk/life-style/health-and-families/health-news/plan-to-help-victims-of-nhs-negligence-is-left-to-languish-on-statute-book-1779386.html

Ministers have been condemned for failing to implement a law designed to help victims of NHS negligence and improve patient safety.
The 2006 NHS Redress Act was intended to offer patients a quicker and fairer alternative to expensive and lengthy legal battles, which have caused the cost of NHS negligence to spiral dramatically in recent years. But the Department of Health has failed to produce the necessary secondary legislation to make it operational, leaving the Act totally unworkable in England.

In contrast, the Welsh and Scottish governments are accelerating their own plans to set up similar schemes.
Lawyers, medical professionals and patient safety campaigners have severely criticised the failure. The Parliamentary Health Select Committee described it as "appalling", while Peter Walsh, chief executive of the patient safety charity Action Against Medical Accidents, said his organisation was "dismayed" by the Government's failure to act.

Mr Walsh said England was now lagging behind the rest of the world. The Welsh Assembly government had "shown a refreshing willingness" to act and its scheme will be up and running by next year, while the Scottish governmen is considering the more radical step of introducing a "no-fault compensation" scheme. A similar system is well established in New Zealand but has been rejected for England.

He added: "Given that Andy Burnham was a key supporter of the legislation at the time and has now returned to health as the Secretary of State, we hope there may be a renewed enthusiasm to move forward. It is completely unacceptable for the Government to sit on its hands and do nothing."

The NHS Litigation Authority this month revealed a 22 per cent year-on-year rise in compensation payouts in England. Nearly half of the £807m paid out by the authority in 2008-09 was spent on lawyers. There has been a four-fold increase in clinical negligence costs incurred by the NHS over the past decade. Official figures from 2002 show that legal fees exceed the sums paid out to patients in two thirds of cases where compensation is under £50,000. Though the time taken to settle a claim has been reduced, it still takes on average 1.4 years.

The proposed NHS Redress Scheme was intended to offer a swift resolution for patients when things go wrong by providing investigation, remedial treatment, rehabilitation and care where needed, as well as explanations and apologies, and financial compensation in certain circumstances. It would largely eradicate the need for lawyers for claims under £20,000, saving an estimated £7.6m in legal costs in the first year. Its contents are based largely on recommendations made by the Chief Medical Officer in his 2003 report Making Amends, which criticised the current system as "slow, complex, unfair and expensive".

The Government claims it will consider implementing the new scheme after recent reforms to the complaints system have been fully assessed. But critics say this is disingenuous.

Peter Gooderham, lecturer in law and bioethics at Manchester University Law School, said: "While the Act did not offer the radical reforms some people hoped for, the Redress Scheme it provided for did offer an alternative to the clinical negligence system for lower-value cases.
"I suspect it has not been implemented because the Government thinks it can better keep the lid on the costs by sticking with the current system, however unsatisfactory."

The scheme was also intended to build trust between NHS staff and patients by discouraging blame and encouraging openness. According to the British Medical Association, the current clinical negligence system is focused on finger-pointing rather than improving services.
The select committee said: "By dragging its heels over implementing the scheme, the Department of Health is... obliging the NHS to spend considerable sums on legal costs and... hindering the development of a safety culture in the NHS."

When two-year-old Chloe Coyle became unwell in September 2002, her parents, Kate and Chris, took her to an accident and emergency department, but were sent home. It took three more visits for Chloe to be admitted to hospital, by which time she was suffering from an excruciating headache. Blood tests were taken, but the results were not seen; antibiotics were prescribed, but not given. By the time meningitis was finally diagnosed, it was too late.

Kate Coyle said: "We just wanted to know why things had gone so wrong and have some reassurance that it would never happen again. We had no choice but to see a lawyer because the [NHS] trust kept fobbing us off. It took three years of battling to get a three-line apology from the trust and just over £20,000 compensation.

"We had absolutely no interest in the money but it was the only way they would accept responsibility – take it or leave it. We spent so much energy writing letters, while trying to grieve, just to get an apology.
"I cannot understand why the new scheme has not started – we would never have gone to lawyers if there had been another option."

Doped and duped
Adverse effects of widely-prescribed drugs are often overlooked because there is so little truly independent academic evidence
David Healy
guardian.co.uk, Saturday 8 August 2009 09.30 BST

http://www.guardian.co.uk/commentisfree/2009/aug/08/seroxat-pharmaceutical-birth-defect

Since 2005, the SSRI paroxetine, first marketed by GlaxoSmithKline as Seroxat, has carried warnings of risk of birth defects. In the US litigation in which I have been asked to give evidence, the plaintives will argue that, even before they were launched, there was good laboratory evidence that the SSRIs might cause problems, and, following their initial marketing, evidence emerged over a decade ago from clinical use that the drugs actually do cause problems. Yet these drugs have been actively promoted, de facto primarily to women of child-bearing years. How could this happen?

Part of the problem is that having gone to their GP with a nervous problem, many women become dependent on a prescribed SSRI and find it impossible to stop using it whether they wish to get pregnant or if they find they are pregnant while on treatment. But few, if any, of these women will have been informed of either the risk of birth defects or the risk of becoming addicted. Why not?

What we are seeing here is the astonishing marketing power of pharmaceutical companies, which can now effect huge changes in medical culture within months. In this case, a great part of the scientific literature (the primary marketing tool of companies) on the use of antidepressants in pregnancy and on dependence on antidepressants is ghostwritten – just as virtually all literature on giving antidepressants to children was, at one point, company-written. Firms of medical writers are contracted to pharmaceutical companies to place in academic journals articles attributed to, but not actually authored by, university researchers.

Because of this, guideline makers like Nice, which can only go by the published literature, are trapped. Regulators, like the FDA and MHRA, which reflect a professional consensus rather than lead on issues like this, are likewise stuck. Doctors who believe their role is to follow Nice, the MHRA and the scientific evidence are in the same bind.

The process of manufacturing clinical consensus has become so slick that it is now almost impossible to find independent articles from academic physicians with no links to industry that will sound a note of caution about prescribing antidepressants to women of child-bearing years. This is a problem that increasingly applies across all of medicine – from the use of HRT, to drugs for osteoporosis, respiratory or gut problems, pain-relief, as well as all psychotropic drugs.

Where once drugs were seen as poisons to be used judiciously and with caution, they are now treated as fertilisers whose more or less indiscriminate use can only do good. Where once farmers knew to keep their cattle out of fields growing the serotonin reuptake inhibiting weed, St John's Wort, as it caused miscarriages, under industry influence women have been herded by doctors in exactly the opposite direction.

Comments

• Getting off Seroxat can take years and cause a much greater problems that the unhappiness it was prescribed to solve.

• We now have this new (and fatal) disease called "evidence-based medicine" . Only Big Pharma has the means to perform randomised controlled trials (the "best" evidence).

• There is a solution - this is to abolish copyright for medicines. Pharmacutical companies then become manufacturing companies only. The cost of research and testing would be carried out by an international body, complemented with national and NGO bodies, all using standard accepted protocols, and financing would depend on human need, not future profit. Private innovation could be encouraged through major cash prizes for companies or individuals who make major breakthroughs.

• What a slick and successful business model these pharmaceutical companies have adopted! They've managed to manufacture their lucrative products yet quash all criticism of them.

• This is a huge issue, with almost all drugs. If there are severe and catastrophic side effects, like death, the medical profession reacts quite quickly, usually. However, for heavily prescribed drugs, the only side effects the doctors act on are those on the patient information leaflets that come with the drugs. Any thing not on the list can't be a side effect, must be another cause. Even if half the patients report the same adverse effect. A good example is that of statins, the cholestorol wonder drug. A US survey found that half of all patients had side effects such as confusion, loss of memory, reduced intellectual abilities, excessive sensitivity to touch, muscle pains, joint pains, sexual dysfunction, and a whole host of other effects which diminished the quality of life of those people. Half of those reported the symptoms to their doctors, all of them were told it was their age, some other factor, or imaginary, because these were not listed adverse effects.

• It takes years for non-catastrophic side effects to get accepted by the medical profession, even where the evidence is overwhelming. And to expect patients to understand the risks when qualified medical personnel don't is absurd, especially for depressed people. One of the key symptoms of depression is inability to focus on anything, or to make decisions at all.

• Let's face it, the big pharmaceutical companies have behaved like your stereotypical drug pushers when it came to marketing all of the new re-uptake inhibiting drugs like Seroxat and Prozac.

Antidepressants once seen as miracle drugs: now risks are becoming evident
US courts to hear claims that insufficient attention was paid to dangers to foetus
•    Sarah Boseley
•    guardian.co.uk, Friday 7 August 2009 22.10 BST

http://www.guardian.co.uk/society/2009/aug/07/antidepressants-drugs-health-risk

Since the horror of the Thalidomide scandal in the 1960s, pharmaceutical companies and medicines regulators have been acutely aware of the dangers drugs may pose to the unborn child.

Establishing what the effect of a drug may be on a foetus, however, is no simple task. Companies must rely on animal studies in the early stages of research and hope that the drug will behave in humans in the same way. Trials on pregnant women are rarely carried out, for obvious reasons.

Depression and anxiety became big business for the pharmaceutical industry in the 1990s as doctors became better at diagnosing the problems, exposing a population of over-achieving, highly-stressed, worried-well.

Women, always more willing to see a doctor than men, were a large proportion of those diagnosed and put on SSRIs (selective serotonin reuptake inhibitors) such as Prozac and the British drug Seroxat, known as Paxil in the US. For a while, these seemed to be the new miracle drugs. They were safer than older antidepressants because the severely depressed could not overdose on them.

But in court cases about to begin in the US, it will be argued that insufficient attention was paid to the possible dangers for young women who were pregnant or might become pregnant and more particularly, for their babies.

Twenty years ago, when serotonin, a chemical which sends messages to the brain, was under investigation, it was recognised that it was likely to have an effect on the developing foetus, according to David Healy, professor of psychiatry in Bangor, Wales, and an expert witness in the legal action against GlaxoSmithKline. It was not just a neurotransmitter, but played a role in organ development in the embryo.

Animal tests appear not to have been reassuring, he says. By 1991, a study by Shuey and Lauder had shown that all SSRIs were potentially teratogenic – could cause birth defects – in animals, albeit in small numbers. GSK denies this. "The animal and human studies did not show teratogenicity, and were made available to regulatory agencies as part of the approvals," said a spokesman. But based on Lauder's work, Pfizer which made a rival drug, Zoloft, recommended that women on their drug "should employ an adequate method of contraception".

Datasheets

GSK launched Seroxat in 1992. It was recognised that insufficient work had been done to establish the safety of any of the SSRIs during pregnancy, and as a result, throughout the 1990s, the standard statement on the drug datasheets which go to doctors was that they "should not be used during pregnancy or by nursing mothers unless the potential benefit outweighs the potential risk".

But pregnant women become depressed too. "I think depression is generally underestimated in pregnancy," said Dr Tim Kendall, joint director of the National Collaborating Centre for Mental Health in the UK. "It is much more common than people think. It used to be thought you gave birth and you are suddenly depressed – the withdrawal of all those oestrogens. But in fact people who have postnatal depression are quite commonly depressed before the birth."

GSK began to market Seroxat as the SSRI of choice for women who were depressed and pregnant, or might become pregnant, says Healy. GSK says marketing to women of childbearing age was valid, as women make up a high proportion of those diagnosed with depression and anxiety and most would be of childbearing age.

Seroxat was positioned as the best SSRI in cases where the benefits of treating depression outweighed any risk. It was found in only low concentrations in breast milk, the company said, which meant that breastfeeding would not be a problem. It pointed to studies which showed children born to mothers on Seroxat had no mental or behavioural problems.

GSK also argued that depression itself could harm the baby because an untreated mother is more likely to smoke, drink and take drugs and maybe even to harm herself. Healy says there is no evidence relating to women with depression during pregnancy – only to those who were diagnosed with postnatal depression.

From 2000, GSK in the US was running a targeted promotional campaign to increase sales of Paxil to pregnant women and women of reproductive age. The Mother Knows Best Campaign had three main objectives: to raise awareness of its greater claims for safety than other antidepressants, such as the low Paxil levels in breastmilk, to educate doctors and consumers generally on the benefits of the drug for women of childbearing age and to encourage women with depression to ask specifically for Paxil.

Influential psychiatrists, called in the business "key opinion leaders" were recruited to give talks and author articles on Paxil's safety for mothers to be.

But in February 2005, the Lancet published an analysis of almost 100 cases from the World Health Organisation's adverse drug effects monitoring centre in Sweden of babies who suffered from convulsions and other withdrawal symptoms after birth because their mother had been taking an SSRI for depression during her pregnancy.

The effects were most marked on Seroxat, it said, and recommended that all SSRIs "should be cautiously managed in the treatment of pregnant women with a psychiatric disorder".

Malformations

In 2003, the Food and Drug Administration (FDA) which regulates medicines in the United States had asked GSK to look at the incidence of birth defects on Seroxat, or Paxil. In 2005, the company handed over a retrospective epidemiological study which found an increased risk of major congenital malformations in the babies of women who took it in the first three months of pregnancy.

GSK pointed out that data from other places did not show up a problem. Nonetheless, the FDA changed the pregnancy warning from category C, meaning not enough research has been done to be sure of safety, to category D, meaning there are signs it may not be safe.

"FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the foetus," it said.

A later advisory notice from the FDA drew attention to a raised risk of a life-threatening lung condition called persistent pulmonary hypertension in babies whose mothers took Paxil later in pregnancy – up sixfold from the usual level of one or two per 1,000 babies born in the US. But at the same time it pointed to a study in the Journal of the American Medical Association showing women who stopped taking antidepressants while pregnant were five times more likely to relapse.

GSK insists that their drug has only ever been promoted for those who need it – in the case of pregnant women, those in whom the dangers of depression are greater than any possible risk from the drug. "GSK appropriately marketed paroxetine for use by the patients for whom it was indicated and who could benefit from it," said the company in a statement.


Women given antidepressant that can cause birth defects
Revealed: GPs still prescribing pill, despite evidence of risk in pregnancy

•    Sarah Boseley, health editor
•    guardian.co.uk, Friday 7 August 2009 22.22 BST


http://www.guardian.co.uk/society/2009/aug/07/women-antidepressant-birth-defects

Seroxat has been marketed to women to relieve depression but GPs have now been given stricter guidelines.

Thousands of women in the UK may be taking antidepressants prescribed by their GPs without knowing that the pills, which are hard to stop taking, could cause birth defects in unborn children.

The problems relate to a class of drug known as SSRIs (selective serotonin reuptake inhibitors), which includes Prozac and, in particular, the British-made Seroxat. Several studies have shown a link to birth defects, particularly malformed hearts, in a small proportion of the babies born to women who were taking the drug in the early weeks of pregnancy.

Most GPs in the UK believe that these drugs are safer than older antidepressants. Seroxat has been marketed to women as a drug to relieve anxiety and depression.

In the US, the Food and Drug Administration, which licences medicines, issued a warning in 2005 and changed the status of Seroxat, which is sold there under the brand name Paxil. The FDA warns doctors "not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate".

The UK regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) wrote to doctors telling them to prescribe Seroxat for pregnant women only when the benefits outweigh the risks. The National Institute for Health and Clinical Excellence (Nice) also urged caution.

But experts including Dr Tim Kendall, joint director of the National Collaborating Centre for Mental Health which wrote the Nice guidelines on depression, say GPs are still giving SSRIs to pregnant women and other women of childbearing age without warning of the potential dangers.

Most psychiatrists he knew would no longer prescribe Seroxat, said Dr Kendall. "But in primary care it is still quite widely prescribed. GPs are quite flooded with advice. It is unlikely they will have picked up a specialist piece of advice from Nice about mental health."

In the US, a series of legal actions is about to begin. Lawyers representing women suing the manufacturer of Seroxat, GlaxoSmithKline, say the British company knew or should have known about the birth defects more than 10 years ago. GSK denies it, saying it told the authorities as soon as it was aware of the issue.

All the SSRIs are implicated. According to David Healy, professor of psychiatry in Bangor, Wales, who has been asked to give evidence in the US cases, the rate of birth defects is doubled from 2% in the general population to 4% of those on the drugs. The rate of major defects rises from 1% to 2%. The general rate of miscarriages is 8%, but 16% of women on Seroxat miscarry.

Concern about depression in pregnancy has grown in recent years. Midwives at antenatal clinics are increasingly encouraged to ask pregnant women about their mood and feelings, to pick up any signs of depression which could cause them to harm themselves or fail to bond with the baby when it is born. Talking therapies should be an option but are often in short supply.

Kendall believes the issue of the SSRIs in pregnancy needs to be addressed. "They are addictive," he said. "The question is should we warn young people before they take them that if they think they might be wanting to get pregnant, these drugs are quite hard to get off?"

"From the late 1980s there was work which very clearly showed that the SSRI group of drugs ought to be regarded as posing a high risk of birth defects to women in the early stages of pregnancy or when they didn't even know they were pregnant," said Healy.

One of the SSRI manufacturers, Pfizer which made Zoloft, indicated in the prescribers' bible, the British National Formulary, that their drug was not recommended for women who might become pregnant. This warning, said Healy, "probably did very little to deter women from taking the drug or doctors from prescribing it, but GSK went further and actually promoted the drug to women of childbearing age".

All SSRIs pose a risk, said Healy. The danger with recent warnings from the FDA and MHRA about Seroxat is that GPs will switch women to another drug of the same class. Emily Jackson, professor of law at the London School of Economics, believes there may be a case for legal action in the UK. Cases could potentially be brought against either the GP or the manufacturer for a failure to warn of potential risks.

"The group of patients who often receive an inadequate warning are women who are not currently pregnant or trying to become so, but who are not warned that there is a danger that they will become addicted to paroxetine [Seroxat] while they are not pregnant, and will find themselves unable to stop taking it once they become pregnant, perhaps many years later," she said.

She raises the possibility of an action under the Congenital Disabilities Act of 1976 on behalf of a child injured by antidepressants prescribed for the mother.

She compares the "no alcohol" message put out by the department of health to pregnant women to the "more equivocal advice" on Seroxat and pregnancy. In both cases, she says, "it seems that women are not to be trusted with making choices for themselves".

GlaxoSmithKline argues there is still insufficient scientific evidence to prove that the drugs directly cause defects. A spokesman said: "Tragically, birth defects can occur whether or not the mother was taking medication during pregnancy. We have monitored reports of foetal exposure to paroxetine since the first studies of the drug and there was no indication of increased risk from studies, adverse event reports or any other source until the summer of 2005.
 
"As soon as we became aware of a potential increased risk, we promptly notified regulatory authorities and physicians.  We strongly believe that doctors should be advised of the potential risk of medicines before prescribing them, and the potential risk of paroxetine use during pregnancy is detailed in the information provided with the medicine."

Comments

1. The tragedy is that the majority of the doctors instead of questioning the results of the clinical trials simply behave as they are part of the medical industry and use their own patients as customers "selling" them a product which is nothing more but a fake.

2. For me this is probably the story that made me decide not to take the rushed out flu vaccine that we're all supposed to take.

3. It is interesting that American psychiatrists now classify shyness as a mental illness although everyone knows that there are millions of people who live and work normally and probably never think about shyness as a problem. And suddenly pharmaceutical companies come up with new drugs telling people that these drugs cure their "illness." If a person feels depressed it is not because of chemical substances in his brain as the pharmaceutical companies like to show but there must be much deeper causes.

 4. Nowadays many scientists believe they are more intelligent than nature. And of course they like to experiment without knowing the consequences. And we all know that even the greatest scientists have suffered from vanity...

Dear Colin
 
I agree with your many points.  The Benzo issue is political.  It needs a political solution.
The injustice is immense, and was summed up perfectly by Phil Woolas's Westminster Speech.  We have no choice but to fight on, for those who cannot.
 
Have you received a reply from Nina L?
 
Best wishes,
Barry Haslam


Dear Colin
Thanks for your email.
I'm sorry that you are so angry and disappointed at the article. I however would like to say this: I never promised to include large chunks about you or the excellent political work you have done around benzos. Nor did I say that i would be writing the piece as you wanted it - I'm sorry but I am a journalist and therefore make my own decisions about what the story should include. Whilst I valued talking to you and reading (some, but you're right not all) of the material you sent me, at no point was I ever going to only include your findings.
I disagree with you on the point about personal stories, and more to the point, the article would never have got in the magazine without them because it is an issue many people would otherwise find difficult to engage with. I also think I made several points throughout the piece which refer readers to the political inaction, or worse, and the role of doctors.
If I have included any inaccuracies about your personal story then I unreservedly apologise. And I am also truly sorry if I have put you off journalists, but I do think you have to understand that my job isn't to represent one side, no matter how strong the evidence or what I personally believe.
Very best wishes

Nina Lakhani
Independent on Sunday
News Desk
020 7005 2498
 

Tranquillisers - what the DoH is avoiding answers to and the meaning of

The drugs are addictive. What does this addiction mean? Drug withdrawal experts including Professor Malcolm Lader have said in the past that withdrawal is far worse than withdrawal from heroin but there are no dedicated government- provided withdrawal centres for those addicted to tranquilliser prescriptions in the UK. There are roughly 400,000 self-addicted heroin addicts in the UK and government action and help is focused on them. Yet there are certainly a million and perhaps two million who are addicted to prescribed benzodiazepines and Z drugs who receive little help and who government certainly does not focus on.

Mike Shooter, the former President of the Royal College of Psychiatrists acknowledged over 200 side-effects related to benzodiazepine use (and Z drugs are similar) – far more than heroin provides. You will not find this reality acknowledged by the Department of Health, by Pharmaceutical companies or in your local doctor’s surgery. Ask yourself the question that the DoH does not – why is this? Some of these side-effects are extremely serious (including death) and for an unfortunate 15% (Professor Heather Ashton’s estimate) could be permanent. In other words coming off the drugs may not save you from the benzo legacy.
 
The addiction happens as has always been the case because prescribers do not appreciate the potential impact on an officially unquantified number of patients and because they have traditionally ignored attempts to get them to prescribe safely. Even those doctors who do now prescribe benzodiazepines safely have little idea of withdrawal protocols for those already addicted and, it seems, little idea of the full range of symptoms long-term prescribing can produce. The main reason why prescribing doctors have little idea of the seriousness of benzodiazepine addiction is because the information available to them is limited due to a system of regulation that does not protect patients, the role of pharmaceutical companies, the ignorance of politicians, the partiality of advisers and an almost complete absence of any research into patient experiences. As an Independent Article on 2 August 2009 (A pill for every ill: Two million Brits have become addicted to prescription drugs) said:

“Curiously, she [Professor Heather Ashton] has repeatedly been denied funding to study these effects [long term health problems cause by benzodiazepines] more rigorously by The Wellcome Foundation, the Medical Research Council and the other main supporters of medical research.”

The victims of the last 50 years of benzodiazepine over-prescribing are yesterday’s men and women – the show has moved on. Today the DoH prefers to call all tranquilliser addicts drug abusers, whether they addicted themselves by ordering drugs from the internet, bought them on the street, or were given the drugs by doctors – without warnings. Internet use is a recent phenomenon but it has given medicine providers an excellent cover for their past profligate activities as it impacted on the forgotten men and women of the 60s through to the 80s when the bulk of the over-prescribing took place. What happened to many of these forgotten people – health destroyed, relationships harmed and economic life blasted, is not an issue today, they were all drug abusers/misusers. Any present day commentator in articles or programmes which appear in the media on benzodiazepines has no understanding of what happened to the historical victims. Their ignorance provides acceptance and misunderstanding of a practice that ruined health for many and made them un-persons thereafter.

To summarise, politicians have avoided engaging with the results of the addiction and they have avoided this for so long that we have now moved into the era of ‘choice’ where people do choose to use benzodiazepines and Z drugs illegally (and other drugs). The world has moved on, and although there have been many deaths in the past 50 years, there are still many alive today who have been addicted for decades or who are no longer addicted but whose lives, choices and opportunities have been taken completely away from them. These people did not use the internet because it did not exist, trusted doctors, received no warnings and have never received help or recognition. We all have dreams when we are young and the future seems full of possibilities but for many of the addicts created by doctors, the end of a positive and meaningful life came early and for a significant percentage there was no rising from the ashes even when the drugs were stopped.

But surely there is some cure for the health problems created by tranquillisers? I can say categorically that no agonist for benzodiazepine damage exists. There are other drugs but they are inadequate sticking plasters for an unrecognised cause and as all defenders of prescription  drug use are fond of telling us – all drugs have side-effects. Why after the experience of benzodiazepines would you want to run the risk of further side-effects from further drugs? The answer to that is most of those affected. Most people are completely unaware of the reality of benzodiazepines – who would tell them unless they feel able to investigate for themselves?

Not all people suffer a serious health impact from the drugs by any means but a sufficiently large number do (though the DoH is uninterested in finding out how many). Withdrawal symptoms whether permanent or not are usually not recognised or called something else – atypical pain or Fibromyalgia are favourite diagnoses. Symptoms can mimic early multiple sclerosis, ME, arthritis or thyroid problems and the cost of false investigations must be enormous.

In The Independent newspaper article, Professor Heather Ashton, emeritus professor of clinical psychopharmacology at the University of Newcastle upon Tyne said this:

“The inaction from government is incomprehensible. I have spoken to so many ministers and committees and each time you think you've made your point, then nothing happens. The right of doctors to prescribe as they see fit always takes preference – but it hasn't worked."

In the same article, Suzanne Atreides of the charity Addiction Dependency Solutions, who tries to help people dependent on painkillers as well as tranquillisers. As she says, "People dread coming in to me... They think I'm going to stop it straight away and can't imagine life without their tablets...There are so many people addicted out there; left on the drugs, as it's easier."

It becomes easier to do that in a culture which has allowed itself to avoid the impact of the addiction and where a few people such as Professor David Nutt, the Home Office chief adviser on drug misuse still maintain that the drugs have no serious downside. The Department of Health says it is reviewing its policy on legal drug addiction but significantly and completely foreseeable it does not intend to analyse the ‘problem’, preferring to maintain the age old message of referring all responsibility to prescribers and local health authorities. Remember it is the state that licences drugs such as benzodiazepines which go on to wreak havoc, it is the state that is in charge of drug regulation, it is the state which employs doctors (even if most are for historical reasons private contractors in the UK) and it is the state which receives the bulk of the evidence from patients and campaigners. Why would the state not want to gauge how bad the ‘problem’ is and why it happened? Why would the state refer the problem to the class of people who addicted patients in the first place? There is nothing ‘minor’ about benzodiazepine tranquillisers - they are as Phil Woolas (now a government minister) said in 2004, “responsible for more pain, damage and unhappiness than anything else in our society.” Even those who believe in medicine as it now is and in its institutions, must wonder why government has refused to control the prescribing of tranquillisers, has not instituted some form of recognition and help for those affected (beyond the lottery of DWP benefits) and still maintains that it has no responsibility for what happens and has happened in the past.
 

Dear Nina,

I have no idea if you have ever realised who I am, but to summarise, as far as I am aware I am the only person in this country who has analysed the history of benzodiazepines and Z drugs and the politics surrounding their use, and then written extensively about it. It is all there in my book and various other writings, backed up by authoratative evidence you presumably would accept if you had read it. But you seem not to have read it (including the pieces I sent you), presumably telling yourself that you did not have the time or perhaps the newspaper would not print it.

The article, whilst good on OTC drugs, made some promising points about benzodiazepines but they were almost completely unfocused and without conclusions. Incidentally, you might have mentioned that many people end up on painkillers because of the physical effects of benzodiazepines but perhaps you were not aware of that. As you know very well, I do not believe in the real effectiveness of personal stories (or government would have been forced into action by now) and I told you that I would only agree to talk to you if you stressed the political points. I said this to you in my email:

"I must stress that the important point in this is the political background and not my personal story...."

What do I find in the article? What I found was a somewhat inaccurate personal story (very shortened) and a cobbled together quote. What of this that I sent you is reflected in the piece?

Head of Department in a Primary school at 25.  ‘Mentioned in despatches’ by Her Majesty’s Inspectorate of Schools (which I was told was a rare thing). Overworked and went to doctor. Addicted after a few months. Ran out of pills one day which had dire mental effects. I was coming out of it after a couple of days but a new doctor I had seen at the surgery ‘kindly’ brought another bottle of Valium from the pharmacist when he came to see me at home and so the addiction continued. He obviously had no idea that what he had seen was withdrawal.

Things went from bad to worse and eventually I resigned. I was given antidepressants and applied to return to teaching after a few weeks. This was successful but I had lost my previous role and was sent to a new school as an ordinary teacher. I managed to carry on until 38 when I resigned on grounds of ill health and have not been able to work since.

During the whole of this time (25-38) I was given 17 mind altering drugs and a variety of other drugs for physical symptoms caused by tranquillisers. For roughly ten years afterwards I virtually existed in a bedroom and never went out.

I found out what the problem with my life and health was quite by accident. Somewhere around age 52 we changed our car insurance policy and I was asked the question of whether I was taking any medication. I gave chapter and verse and my driving licence was taken away by a drug misuse committee which appalled me. I went to the doctor’s and said I wanted to get my licence back. The only role the doctor had in this was to provide prescriptions for reducing amounts of Valium (diazepam) and Zopiclone. At the same time I stopped taking antidepressants. Getting off took about two years. Shortly afterwards withdrawal symptoms began to appear, most of which the medical profession as a whole does not recognise because Pharma hasn’t owned to them and they have never been researched. Many of these symptoms have remained with me including exhaustion, permanent insomnia, joint and muscle pain making walking difficult and a variety of sensory problems. The symptoms I now have are quite different to the ones I had when taking prescriptions but they remain unrecognised in spite of an absence of research that demonstrates no link. These symptoms are commonly reported by patients as are the common symptoms experienced when taking tranquilliser/hypnotics but make no waves in medicine.

I did not find any reference to what I have done since coming off the drugs nor to the fact that I have had no normal life since the age of 25 (and neither has my wife). There was no mention of benzo.org.uk where my writing is found alongside the biggest benzodiazepine library on the internet.

I have campaigned against a background of ill health and lack of money for seven long years and I have demonstrated beyond any doubt the cover-up that government, pharmaceutical companies and medicine has organised. Benzodiazepines are not ' a new drug problem' - this scandal has been taking place for 50 years. Use of the internet to buy drugs and OTC addiction may be a relatively new problem but iatrogenic addiction is not.

To give just one example of where you failed the victims of benzodiazepines by not making the political point, you referred to the CMO's 2004 reminder to doctors. You did not mention that Ray Nimmo, Heather Ashton (whom you quote elsewhere) and others, regard this reminder as disastrous for patients. Heather Ashton, who knows far more about benzodiazepines than the CMO offered to help with the wording of the reminder but was ignored. The reaction of many doctors was to abruptly stop patient's prescriptions leaving them to either source the drugs elsewhere if they could (including the internet) or failing that to be precipitated into abrupt and dangerous withdrawal. Note The reminder was only sent because of campaigner representation at the Department of Health.

Associating benzodiazepine prescribing with OTC medicines was never a good idea as I told Brian Iddon - the two problems are completely separate - one is a scandal and the other somewhat less than that involving personal responsibility. I imagined that having told you of that and my desire that you should examine the politics and failures behind the 50 years of benzodiazepines, that I was steering the article in the right direction. But I was wrong. What you have done in the end is ensure that I will never speak to a journalist again. This of course matters little in a country which seems not to want to face up to reality. Government Minister Phil Woolas once said:

"The scale of the [benzodiazepine] problem is so large...that it is beyond the grasp of many politicians and people in power to solve it...you have this huge problem with a huge number of people involved and yet we seem as a society to be incapable of acting on it. We can only cope with problems that are so big...we can't cope with this one."

It seems he was perfectly right.

All the Best

Colin Downes-Grainger

A pill for every ill: Two million Brits have become addicted to prescription drugs
http://www.independent.co.uk/life-style/health-and-families/features/a-pill-for-every-ill-two-million-brits-have-become-addicted-to-prescription-drugs-1764497.html

Britain has a new drug problem: two million of us are addicted to tranquillisers, while countless thousands abuse over-the-counter painkillers. How has this unchecked culture of legal drug addiction been allowed to flourish, asks Nina Lakhani?

Sunday, 2 August 2009

What do Michael Jackson, Heath Ledger, Marilyn Monroe and Elvis Presley have in common? They were all taking tranquillisers – prescription drugs for insomnia, depression, anxiety – at the time of their deaths. The results of toxicology tests undertaken after Jackson's death in June are expected to reveal the presence of drugs to alleviate pain, depression and anxiety, and will inevitably reignite the debate about the benefits and human costs of drugs that are prescribed by doctors or bought over the counter in vast quantities the world over.

All drugs can cause side effects, but two types of legal drug are habit-forming: benzodiazepines (tranquillisers) and opiate-based painkillers (such as morphine and codeine); both can have serious, even fatal, consequences for users. Yet addiction to legal drugs is a controversial and complicated issue. It typically involves an accidental or involuntary dependence to medication first taken, and given, in good faith for a genuine ailment or condition. Jackson, for instance, is believed to have become addicted to Demerol (known as Pethidine in Britain) after suffering from a serious burn during the filming of a Pepsi commercial in 1984.

But critics, including many former addicts, argue that these drugs are too readily available, and are taken for too long, with little regard for, or understanding of, the long-term physical and psychological consequences. The addictive qualities of the drugs in question are all too apparent: tranquillisers, as the name suggests, relax and calm the subject; by contrast, opiate-based painkillers induce a state of euphoria (though they can have a sedative effect in high dosages). Worse, the chemistry of both types of medication means taking them every day for just a few weeks can lead to dependence and, if stopped abruptly, nasty physical and psychological withdrawal symptoms – occasionally, fatal seizures. The rising numbers of people thought to be addicted to legal drugs in the UK is shocking: there are in this country around 400,000 heroin addicts, yet there are believed to be up to seven times as many in thrall to tranquillisers and opiates.

Benzodiazepines ("benzos") were touted as the world's first wonder drugs. Introduced in the 1960s to treat anxiety and insomnia, within a decade they became the UK's most commonly used medication, with more than 30 million prescriptions annually at their peak. Last year, more than 22 million prescriptions for these drugs, including diazepam (Valium), lorazepam and temazepam and the newer "Z" tranquillisers, such as zopiclone, were dispensed by chemists in Britain (this does not include drugs used in hospital). The figures confirm what support groups and helplines have long said: millions in Britain are still in the grip of "Mother's little helpers", which continue to be inappropriately prescribed to men and women, young and old, for everyday and normal pressures such as wedding-day nerves, bereavement, domestic violence and financial woes – and lead many to addiction.

The Government can claim some success in its war on illegal drugs: its strategy between 1998 and 2008 was primarily focused on heroin users, and it succeeded in getting record numbers of the country's estimated 400,000 addicts into contact with drug-treatment services and on to the legal substitute, methadone. In stark contrast, the policy of successive governments for prescription drugs has been simply to warn doctors about the potential of dependence on benzodiazepines to try to prevent addiction occurring. This has led to informed estimates that between 1.5 and two million people are addicted to tranquillisers in the UK; we have little idea of how many are addicted to prescription and over-the-counter (OTC) painkillers, but it is thought, conservatively, to be tens of thousands. And many of these "legal addicts" are fighting their drug battles alone. They are generally not welcome in government-funded drug services, nor do many want to seek help in centres frequented by street-drug users, as they do not perceive themselves as addicts and have quite different needs. Nor do most GPs understand enough about the drugs, their long-term effects or how to wean people off them. So, apart from a handful of services set up by pioneering individuals, charities and NHS organisations, the majority of these addicts have nowhere to turn.

The problem with these drugs (though they are very useful medications when used correctly) is not only their addictive nature, but also the manner in which, for decades, they have been prescribed. In 1988, the Committee on Safety of Medicines told doctors that tranquillising drugs should be prescribed only for severe anxiety or insomnia, and for a maximum of two to four weeks. A reminder of these guidelines was issued by the Government's chief medical officer, Sir Liam Donaldson, in 2004, but apart from that, there has been scant interest from a succession of governments. The figures suggest this "hands-off" strategy has failed. The Department of Health has finally agreed to review its policy, but has rejected calls to study the problem in greater depth, deflecting responsibility back on individual doctors and "abusers" – a label that angers many of those who lost years to these widely prescribed drugs, which are mistakenly viewed as benign.

Colin Downes-Grainger, 62, a former primary-school teacher, was given 17 different tranquillisers, sleeping tablets and anti-depressants from the age of 25 for work-induced stress. "To be labelled as a drug abuser feels dark, surreal and wrong," he says. "All I did was go to my GP with a problem and follow his advice. I spent the next 10 years in my bedroom, missed my children growing up in large parts, and had my life taken away needlessly. I can live with the fact that when these drugs were first introduced, no one really knew about all of the problems. But the fact that, decades later, people are still being made into addicts is indefensible."

Heather Ashton, emeritus professor of clinical psychopharmacology at the University of Newcastle upon Tyne, set up the first NHS withdrawal clinic in 1984; it was oversubscribed for 12 years, but none of her colleagues wanted to take over from her when she retired in 1996. "It just wasn't fashionable in the medical world – not enough people believed it was a problem, and although many have now come round, it still isn't widely understood. The inaction from government is incomprehensible. I have spoken to so many ministers and committees and each time you think you've made your point, then nothing happens. The right of doctors to prescribe as they see fit always takes preference – but it hasn't worked."
 
Ten years after coming off all the medication, Downes-Grainger still suffers from various sensory problems, joint and muscle pain, permanent insomnia and exhaustion. According to Professor Ashton, around 15 per cent of long-term benzo-diazepine users will have long-term, possibly permanent, physical problems (which can mimic symptoms of early multiple sclerosis) even after they stop. Curiously, she has repeatedly been denied funding to study these effects more rigorously by The Wellcome Foundation, the Medical Research Council and the other main supporters of medical research.

Since reporting of such incidents began, there have been 12,247 adverse reactions related to benzodiazepines (including 198 deaths) and opiate painkillers (403 deaths) reported to the Medicines and Healthcare products Regulatory Agency (MHRA). But reporting is itself problematic: research shows that only five to 10 per cent of adverse drug reactions are ever reported by health professionals, which means thousands of people may have suffered harm or died as a result of medications meant to help them – far more, it may be surmised, than have ever died from taking illegal drugs such as heroin or ecstasy. Yet the current head of the Government's Advisory Council on the Misuse of Drugs, Professor David Nutt, is on the record denying that there are any risks associated with long-term use of benzodiazepines.

The over-use of opiates as painkillers is equally alarming. Despite being the most common reason why any of us ' visits the doctor, pain is poorly understood and frequently treated with pills rather than investigated. Sir Liam has called for urgent action to address a gaping hole in medical training, which currently fails to teach students anything about chronic pain, saying: "Although we now have effective means of tackling both pain and the consequences of pain, services have not kept up with demand and too many people struggle to cope with their symptoms."
 
There were 15.96 million community prescriptions for opiates such as morphine and dihydrocodeine in England and Wales in 2008 – a rise of 55 per cent in five years. In the same year, 290 million packets of OTC painkillers such as paracetemaol, aspirin and Nurofen Plus were sold in Britain's chemists and supermarkets. Of these, 27.5 million packs were products containing codeine – similar to, but much milder than, morphine. As with all opiates, the most serious potential side effect is death due to respiratory depression – something linked to, but not yet confirmed in Michael Jackson's death. Withdrawal symptoms are similar to those experienced by a heroin user: stomach cramps, diarrhoea, vomiting, the sweats and hallucinations.

Brian Iddon, a chemist and Labour MP, chaired the All-Party Parliamentary Group on Drug Misuse for ten years. Under his watch (he stepped down in June), the group conducted an inquiry into OTC and prescription-medication addictions in 2008 and found too many doctors were still not following prescribing guidelines, and handing out repeat prescriptions for habit-forming drugs. The committee also criticised the MHRA for failing to reduce the pack size of OTC codeine painkillers from 32 to 18, and urged it, and the drugs firms, to do more to monitor the risks posed by these drugs.

Martin Johnson, a Barnsley GP and chairman of the Royal College of GPs' pain-management committee, first became interested in pain as a medical student after his grandfather's very sore sciatic shingles was badly treated. A quarter of all the patients in his surgery are on painkillers but he, like other GPs, has no idea how many are taking OTC medications as well, as there is no joined-up system for counting or monitoring patients who take habit-forming painkillers. "The problem is that pain has never been accepted as a true area of medicine and most doctors are still not that interested. So, for too many doctors, a prescription is a quick fix and quick consultation," says Dr Johnson. "This means that you, I, or anyone who has an acute problem can end up with a long-term untreated condition. For example, there are 650,000 whiplash injuries a year in UK and a high proportion are given a prescription and told to go away and rest, which is totally inappropriate advice and will lead to unnecessarily pain and more painkillers. Even fewer doctors can recognise a dependency or would know how to help someone withdraw safely. Medically speaking, addiction and pain are in different worlds."

Dr Beverly Collett, a consultant in pain management in Leicester, set up a monthly clinic for patients addicted to painkillers 10 years ago. She sees patients jointly with a psychiatrist – one of only a handful of such services in the UK. Together, they try to deal with the physical and psychological aspects of pain, drug dependence, withdrawal and the mental-health problems many of their patients have. "The people we see have different chronic-pain problems and have often been put on multiple medications and mixtures of drugs," she says. "The relationship with their GP has often broken down. These aren't people who set about trying to get high; these are people who are desperate to get their pain under control and the addiction creeps up on them. Back pain is common among these patients and we have one man who smashed his ankle during a suicide attempt. But at the heart of all these problems is that doctors do not understand how to treat chronic pain."

A recent survey of callers to the telephone helpline Over-Count (set up to help those addicted to OTC drugs) found the most common age range of those addicted is 18 to 36; two-thirds are women; users generally stick to one product, and 100 per cent say they have no inclination to progress to harder or illegal drugs. The vast majority ended up accidentally hooked, because the cause of their headache or backache had never been treated. Allowing people easier access to medication is something the Government is keen to promote in order to reduce the NHS medication bill – which hit £10bn in 2007 – and relieve some of the burden on GPs. But this could lead to more addiction – and expense.
 
Barry Haslam, 65, a former accountant from Oldham, persuaded his local NHS Trust to pay for a specialist withdrawal clinic – one of only a handful in the country – after he lost 10 years of his life to a cocktail of antidepressants and benzodiazepines. He was the first person to be awarded Disability Living Allowance because of the long-term damage caused by the medication. The Benzo Project, run by Suzanne Atreides for the charity Addiction Dependency Solutions, has started to see people dependent on painkillers as well. "People dread coming in to me," says Atreides. "They think I'm going to stop it straight away and can't imagine life without their tablets. But I work as slowly as they need me to, at their own pace – 92 weeks in one case. Many people feel embarrassed and keep it secret from their families for years, but the fear of getting caught just adds to their stress. There are so many people addicted out there; left on the drugs, as it's easier."

There is no doubt that drugs which alleviate pain, crippling anxiety and insomnia help millions of people across the world every year, but are they given out too easily when other options could be considered? The most effective pain clinics advocate the use of psychology and psychiatry alongside pharmacology, but patients can wait years for an appointment.

Michael Jackson's blood results are expected any day now. But for the millions of people living the nightmare of legal drug addiction – ashamed, unacknowledged and with nowhere to turn for help – pointing the finger of blame at Jackson's doctor or scrutinising the troubled star's addictive personality will change nothing. Instead, the millions who are believed to be caught up in legal addiction, the pharmaceutical industry, the medical profession, the Government, and all of us who are happy to take a pill for every ill, have a duty to acknowledge the truth – and do something about it.
 
Mark Lawton: addicted to morphine

"It was an ordinary Sunday night in 2002: we were getting the kids ready for school the next day – the eldest was in the bath – when the door bell rang. My partner Julie answered it and then, bang, everything changed. A man ran into the house and shot me twice in my right leg, in a case of mistaken identity.

The next thing I knew, I had woken up in hospital with doctors telling me they'd have to cut my leg off."
Mark Lawton, now 40, refused to accept this fate and, against medical advice, signed himself out. He spent the next few months at home in agony, taking just paracetamol while searching for a surgeon who would try to save his leg.

Finally, in August 2002, he was admitted to the nearby Hope Hospital, for the first of 15 operations.
His shin was removed and his foot was attached just below his knee with 19 pins. He was told in hospital to take as much morphine as he needed to stay on top of the pain, so he did.

"I was in agonising pain and I started eating the Sevredol tablets like toffees; I would clock-watch until it was time for the next one. I went home after 23 days with a spanner, so I could break the bone everyday to let the shin re-grow, and as many tablets as I needed. Looking back now I was already hooked – I was a junkie."

Around a year later, still in a wheelchair, still on regular morphine from his GP, he missed a dose.

"I was lying on the bed, curled up in a ball, sweating and shaking. The doctor came around, gave me an injection and I felt better. That was the first time I realised what I'd become: I was as bad as a heroin addict who needed his fix."

But over the next few years, try as he did to cut down, he couldn't do without the tablets completely. His weight dropped, his appetite got smaller, and he rarely left the house, having lost his job as a butcher.

"You know how a man should be able to eat a proper plate of meat pie and chips; well, I couldn't do it any more. All I could think about was making sure I didn't run out of medication. It was the first thing I thought about when I woke up and the last thing before I went to bed. It's wrecked my life; I hate it."

After begging his GP for help again, he was recently referred to see Suzanne Atreides, a counsellor with the charity Addiction Dependency Solutions, who runs a unique project in Oldham, where he lives. Lawton is now down to 15mg of morphine a day (from 40mg), his appetite is improving and for the first time in years, he has some hope.

"The doctors never once told me I could get hooked," he says. "It was always like, 'Take as many as you need, the nerve damage is really painful, so don't try to do without them.'

"I would just pick up the prescriptions, no questions asked, no advice. Now I've found someone to help me, I'm determined to get off them by Christmas. I have to get my life back."
 
Jane Hadi: addicted to Valium

Jane Hadi, 52, from Bristol, can't remember a life without pills. "I was going through a personal crisis, I was ill and stressed, so my mum took me to the doctor. He gave me Ativan [a form of lorazepam]; I was 12."

In 1969, Hadi wanted to be a lawyer. She loved school, liked playing outside with her friends and she remembers herself now as a happy child. The day she started taking lorazepam, all that changed."I can't really remember how I felt before. I was emotional and used to cry sometimes, and the tablet made me feel nice. My mum never questioned it – why would she? But if she knew then what we know now, she would never have let me take them."
 
Life went on. Hadi met her husband, Basem, a car mechanic, when she was 18. They got married and had four children. It was when she was pregnant with her eldest child, in 1977, that she first stopped taking the medication. "I remember feeling really emotional, having mood swings; I was a nightmare to live with. I thought it was the pregnancy but looking back now it was withdrawal symptoms." She stopped during each pregnancy, but after each birth, the doctor put her straight back on Valium.

"I would take them every time something went wrong with the kids; maybe one of them fell over, and I would take one to cope. This is how I'd been brought up: 'Take a pill if you're not coping.'"

Ten years ago, Hadi was admitted to a psychiatric hospital where she was diagnosed with bipolar affective disorder (manic depression), taken off the Valium

and instead prescribed a major tranquilliser. The next four years at home were hell. "I couldn't cope with the kids, the housework, with cooking; I couldn't do anything. My legs hurt, my back ached, I felt terrible. So I started to drink, heavily, from 10am to 11pm, just so I could cope with life." In 2005, as her son's wedding day approached, Hadi looked into the mirror and hated the overweight, puffy face in front of her. "I'd seen a programme on TV about people buying Valium online. I couldn't go to my GP – she's been so happy that I'd come off them and I didn't want to disappoint her – so I started buying them on the internet.

"It was easy, it only cost me £80 for 100 tablets and soon I was taking 30mg a day, more than ever before."

Three months ago, Hadi went back to her GP for help after she realised she couldn't pay the £2,000 credit-card bill for the pills. She now gets help from Battle Against Tranquillisers (www.bataid.org) and is reducing her dose by 1mg every three weeks. "I don't want to ever stop completely, I couldn't cope, but I'd like to get down to 10mg a day. It's like a love-hate relationship: I can't live without them but they rule my life. I do feel angry because I should never have been put on them, but it's all I know."

David Grieve: addicted to cough syrup

It was 1975; David Grieve (now 59 and living in Dumfriesshire) was working as a psychiatric nurse in Portsmouth, when he developed a bad cough, so he went to the chemist, and got some cough linctus. It contained codeine (a mild, but addictive opiate like morphine) and ephedrine (a stimulant and decongestant, also addictive). He took it for four days, then stopped. But his cough came back, so bought another bottle.

"I was taking it as directed on the bottle and I felt great; full of energy and alert. After the second bottle, my cough was gone, so I stopped. But a few weeks later I was having a bad weekend, so I bought a bottle to make the downer go away. Over the next year I did it a few times, but soon two teaspoons weren't enough, so I kept upping the dose, to get the same effect."

Over the next few years, Grieves moved to Merseyside, trained as a policeman and progressed on to a bottle a day, still trying to kid himself that he could stop at any time. By the time he moved his family to Scotland, he was close to taking 90 bottles – nine litres – every week.

"I would go 'trawling' three times a week: Monday I'd travel north to Edinburgh or Glasgow, Wednesday as far south as Stafford, and Friday I'd go east to Newcastle. Each time I'd buy 30 bottles from different pharmacies. My wife had found out by this point, but I loved the cough mixture more than my family." By 1990, it had become a huge burden. Grieve had given up work so he could trawl, and spent £20,000 in the last two years of his addiction. His doctors were at a loss as to how to treat such a serious addiction. It wasn't until 1992, 17 years after he had begun, when he became critically ill, having damaged his liver, kidneys and gall bladder, that he pleaded with his doctor and a chemist to help him withdraw. "If I had carried on, I'd have been dead in a year, so over the next nine-and-a-half months, I cut down from 10 bottles a day to none. It was 10.25am on 13 September 1992 that I drank my last 50ml; I haven't touched a drop since."

The following year he started up the Over-Count helpline to help those addicted to OTC drugs, after a magazine article about his life attracted interest. In the first year, the line took 1,000 calls; it has taken nearly 20,000 since. The addictions have moved on – very few people are dependent on OTC cough mixtures now that the ingredients have been changed. Instead, most people use codeine-based tablets such as Nurofen Plus, which the majority – 92.9 per cent – started taking for minor, but painful, physical ailments. "The Government's move towards more self-health means this is a 21st-century problem which is not going away. More and more people come to us each year and all are struggling to get help, yet stopping these medications abruptly can be fatal. "Joe Public has to take more responsibility, but he can only do that if the information is available in a form he understands. Most people still don't think something which is so easy to buy can be addictive, and many don't read the information leaflet after the first time; it's too small, too technical and people find it boring."

To contact Over-Count, call 01387 770 404 or visit myweb. tiscali.co.uk/overcount/index.htm. For Addiction Dependency Solutions, call 0161 834 9777 or visit www.adsolutions.org.uk