Pharmacies caught illegally selling addictive drugs

Nine pharmacists accepted cash for prescription-only medicines

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Pharmacies caught illegally selling addictive drugs to undercover reporters face three separate investigations - including a criminal probe.

Nine west London pharmacies sold drugs including Valium, Viagra, temazepam and morphine to BBC1's Inside Out.

Now both the Metropolitan Police and regulator the General Pharmaceutical Council (GPhC) have requested evidence gathered by the programme.

Selling drugs without prescription has a maximum penalty of two years in jail.

An inspector at the Met's Drugs Directorate told the BBC: "It looks like you have evidence of criminality and obviously we need to look at that very closely.

"We would want to look at that as a matter of urgency."

Council contract suspended

The GPhC also requested the evidence. The organisation has the power to remove pharmacists' right to practise in Great Britain.

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WHAT THE BBC BOUGHT AND WHERE

• Al Farabi, Paddington: Oramorph, Diazepam, Viagra, amoxicillin
• Curie Pharmacy, Maida Vale: Temazepam, Diazepam, Viagra, amoxicillin
• Bin Seena, Paddington: Valium, Tramadol (offered), amoxicillin
• R and C Pharmacy, Willesden: Amoxicillin
• Safeer, Paddington: Valium, Viagra, amoxicillin
• Craig Thomson, Willesden: Amoxicillin
• Al Razi, Paddington: Viagra, amoxicillin

It admitted that prior to the BBC investigation it had only taken one pharmacist in England to a fitness to practise hearing for selling drugs without a prescription in 2012.

Meanwhile a third investigation is being launched jointly by Westminster Council and Inner North West London Primary Care Trust.

Westminster Council has said it is suspending its contract with one of the pharmacies involved.

The council had used Curie Pharmacy in Maida Vale to provide supervised methadone doses to drug addicts.

Undercover reporters were sold temazepam, Diazepam, Viagra and amoxicillin at the business - all without a prescription.

'Extremely disturbing'

Councillor Rachael Robathan, Westminster City Council's Cabinet Member for Adults, said: "The council has suspended its contract with Curie for services, such as controlled consumption by people on recovery programmes.

"We have launched an immediate investigation with Inner North West London Primary Care Trust of these extremely disturbing revelations."

This chemist advised the researcher to take whatever dose of morphine he wanted

Councillor Robathan continued: "The council expect that all pharmacies operate at all times within the law and the regulations governing them.

"The fitness to practise of this pharmacist and others identified will be a matter for our Primary Care Contracts Team."

A Westminster Council spokesman said its officers were also checking training standards were being met at the dozen pharmacies in its area which deliver local authority services.

He added: "This is in direct response to the revelations made by your report."

A spokeswoman for the trust said: "Clearly the accusations are very serious. We will follow our normal procedures and respond to any formal evidence or complaint that is forwarded to us."

Continue reading the main story

“Start Quote

This is the antithesis of what we'd like pharmacists to be doing”

Neal PatelRoyal Pharmaceutical Society

Contacted on Tuesday about the latest developments, all the pharmacies involved declined to comment.

Several London pharmacies sold the reporters from the BBC's Inside Out programme diazepam or its trade name drug Valium - a strong and addictive sedative in the benzodiazepine family - for up to £85.

The BBC was acting on specific intelligence about the pharmacies.

Latest figures show 293 people died in the UK in 2011 from misuse of benzodiazepines, more than double the 125 killed by cocaine and ecstasy combined.

And for £200, Al Farabi Pharmacy in Paddington dispensed a bottle of Oramorph - containing morphine.

A standard NHS prescription would cost about £7.65.

'Shocked and appalled'

Over a few weeks, researchers bought 288 Valium tablets, 21 temazepam tablets, 294 amoxicillin tablets, 24 Viagra tablets and one bottle of Oramorph without prescriptions.

Neal Patel, spokesman for the Royal Pharmaceutical Society, said: "I have been speaking to pharmacists and colleagues are absolutely shocked and appalled at the behaviour we've seen.

"The allegations are the most serious ones I can imagine - pharmacists I know pride themselves on patient safety and this is the antithesis of what we'd like pharmacists to be doing.

"I'm a pharmacist myself and watching this is very difficult for me."

The Labour Party continues to call for a fourth inquiry - into whether the pharmaceutical regulatory system is robust enough.

Shadow Health secretary Andy Burnham said: "The government should review again how pharmacy is regulated. For instance, there is a clear case for unannounced spot-checks to change the regulatory culture."

The Department of Health insists it takes abuse of prescription drugs seriously

Diabetes: 1-in-3 inpatients suffer NHS error, report to claim

Diabetes: 1-in-3 inpatients suffer NHS error, report to claim

The care of David Joseph was criticised by the ombudsman

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• Diabetes death failures meeting
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Almost one-in-three diabetic inpatients in Wales has experienced at least one NHS medication error, a new report by Diabetes UK Cymru is to reveal.

The charity is concerned because the number of people with diabetes in Wales rose more than a quarter in five years.

Meanwhile figures obtained by BBC Wales show only one of the seven Welsh health boards has taken on more specialist diabetic nurses in the last four years.

One board has cut staffing while the other five have kept the same total.

The Diabetes UK Cymru report to be published on Wednesday reveals diabetes is growing rapidly with an increase of 35,000 people with the condition in Wales over the past five years to 160,000 - a rise of 28%.

By 2025, the number of people with diabetes is forecast to top 250,000 with 66,000 people currently undiagnosed.

Despite the concern, the charity says 70% of adults with type 1 diabetes and 43% with type 2 are not getting simple checks, such as blood glucose tests.

Diabetes UK Cymru director Dai Williams told the BBC Wales Week In Week Out programme: "The cost of diabetes is massive - the bottom line is - it's a ticking time bomb.

"We've got people wandering around with high blood sugars, not even realising it's going to cause a problem."

The report, called State of the Nation 2012, will also claim that 29.8% of inpatients with diabetes experienced at least one medication error while on a ward.

The programme features the family of David Joseph, from Aberaeron, Ceredigion, whose care before his death in 2009 was criticised in April this year by the Public Services Ombudsman for Wales, Peter Tyndall.

Madie Joseph said she 'foolishly' thought her husband would be safe in hospital

Mr Tyndall raised concerns over clinical record keeping by the Hywel Dda health board and made recommendations.

Mr Joseph's widow, Madie, a former nurse, tells the programme: "We thought, foolishly, that patients with diabetes in hospital would be safe and clearly he was not.

"I still don't understand how they [nurses] could have been so mistaken - so ignorant - and it mustn't happen again to another patient."

The family received an apology following the release of the ombudsman's report.

Week In Week Out has also learned about three more complaints about the treatment of diabetic inpatients at Hywel Dda health board hospitals.

Councillor Elizabeth Evans, a senior case worker for Mark Williams MP, tells the programme the complaints received over the past 18 months include concerns over fluid intake and patients not eating properly.

She says: "Every single case would go into hospital for a very different reason. So it was issues about fluid intake, about food, not eating, and obviously any diabetic specialist will tell you that a diabetic needs to eat."

In a statement Hywel Dda health board said it takes any allegation of a breach of professional standards seriously and an investigation was ongoing.

Hywel Dda was the only health board in Wales which has increased the number of specialist diabetes nurses, from seven in 2008/9 to the equivalent of 12.34 full-time staff in 2012/13.

Cwm Taf in the south Wales valleys was the only board to cut staffing, from the equivalent of 14.89 full-time nurses in 2008/9 to 12 in 2012/13.

Cwm Taf Health Board is pioneering a new scheme to cut diabetes-related medication errors in their hospitals.

It is a highly visible branding campaign called Think Glucose and involves raising awareness of diabetes with all staff throughout every ward.

Hypo Boxes on every medication trolley means treatment can be given to patients suffering a hypoglycemic attack quickly; pre-printed medication charts cut the risk of mis-reading doseage; and colour-coded blood sugar monitoring charts mean that dangerously low blood sugar levels go into a red zone - alerting staff of the need to treat the patient quickly.

The campaign has seen medication errors at one hospital, the Royal Glamorgan, decrease from 50% to 6%.

At the moment, Cwm Taf is the only health board running Think Glucose, but other health boards are showing interest - and Hywel Dda says it will be rolling out the programme in the New Year.

Week In Week Out is on BBC One Wales on Tuesday 20 November at 22:35 GMT.

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• Diabetes death failures meeting
  08 JUNE 2012, MID WALES
• Falsified patient record concern
  18 APRIL 2012, WALES

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• Diabetes UK
• Welsh Government

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'Antipsychotic drugs

'Antipsychotic drugs made me want to kill myself'

By Melissa HogenboomBBC News

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While antipsychotic drugs are seen as the most effective treatment of psychotic episodes, they are also recognised to have devastating side effects.

Doctors say many patients don't like taking medication long term, but a study published in the Lancet suggests that taking antipsychotic medication more than halves the risk of relapse in schizophrenic patients.

"I used to see nasty, dirty rat-like things running around when I went outside, I could see people in the streets screaming abuse at me and making obscene and threatening gestures.

"I was hearing a voice that was saying all kinds of nasty things about me. I was terrified, I tried to kill myself."

David Strange was diagnosed with paranoid schizophrenia when he was 25. He was sectioned and given antipsychotic drugs, which he says made him feel "a bit better for a while," but gave him a succession of unpleasant side effects.

Continue reading the main story

“Start Quote

When I first became ill, I was warned there are certain drugs that weaken the lower lip, even now I still dribble”

Daniel Levy

But without medication, the voice he hears is a constant stream of abuse that "comments on what other people are thinking and the horrible things they want to do to me".

'Unliveable hell'

Professor of psychiatry Stefan Leucht, from the Technische Universitat in Munich, led the latest research. He also found that fewer patients on antipsychotic drugs were readmitted to hospital - one of the highest costs associated with mental illnesses.

David says taking antipsychotic drugs for 14 years has helped him deal with his hallucinations and the voices he hears. They are still present but they no longer dominate his life.

Continue reading the main story

Antipsychotic drugs explained

• Antipsychotic medication helps weaken delusions and hallucinations. It can control (but not cure) symptoms in about four out of five people
• Older antipsychotics work by reducing the action of a chemical in the brain called dopamine. They can cause side effects such as stiffness, shakiness, restlessness, sexual problems and unwanted movements, mainly of the mouth and tongue
• Newer antipsychotics work on different chemicals in the brain. These are less likely to produce unwanted movements but can cause weight gain, diabetes, tiredness and sexual problems

Source: Royal College of Psychiatrists

• More about mental health
• Schizophrenia explained

One of the many drugs he was given was thioridazine, which gave him an irregular heartbeat, something which can be potentially fatal. David remembers lying down with his heart beating really fast, thinking he did not have long left to live.

"Some drugs made me so anxious I tried to kill myself and ended up getting locked up in hospital."

Even what he refers to as the "good ones" give him muscle and joint pain, jerkiness similar to the symptoms of Parkinson's Disease and severe sexual dysfunction.

But he says he would still rather take the drugs than try and function without them.

"Being unmedicated is an unliveable hell. I'm happy to put up with all of this just to be more functional and less scared."

'Price to pay'

The longer antipsychotic drugs are taken, the more chronic the side effects become. The nature of mental illness means patients are often prescribed medication for the rest of their lives.

Daniel Levy, aged 54, has bipolar disorder and has been taking antipsychotic drugs for nearly 30 years. During that time he has been sectioned and has also attempted suicide.

David has been taking antipsychotics for many years

"The drug chlorpromazine made me tremble, it also made me dribble. When I first became ill I was warned there are certain drugs that weaken the lower lip, even now I still dribble.

"I don't know I'm doing it until I notice it on my clothes. It looks absolutely terrible."

But the drug did help him to stay out of hospital and was effective in controlling his symptoms.

"The side effects are the price I pay for keeping out of hospital," says Daniel.

"It's a balancing act - doctors never know in advance how you will react to a particular drug."

Newer "atypical" antipsychotic drugs show fewer of the physical tremor-inducing side effects and are commonly prescribed to patients starting treatment for the first time, says Dr Oliver Howes from the Institute of Psychiatry.

These still often lead to severe weight gain, increasing the risk of diabetes, blood clots and cardiovascular diseases. The risk is especially high for patients who stay on medication for many decades.

"We have no way of knowing in advance if a given drug is going to suit a patient - so sometimes patients have to try several before they find one that both helps them and is tolerable," says Dr Howes.

Unfortunately the drugs with the most side effects are also the ones which have been shown to be the most effective and are supported by many years of research, says Prof Leucht.

He says that if a patient experiences unpleasant side effects, their clinician should always try another drug, but acknowledges that this is not always possible in practice as some doctors are afraid to change their patient's medication if it appears to be working well.

Dr Howes says the side effects of antipsychotics need to be put into perspective.

"Mental health illnesses are devastating. There is a substantial loss of life associated with illnesses such as schizophrenia, predominantly from suicide. We want to prevent that."

laser treatment

Doctor trials laser treatment to change eye colour

After the brief laser procedure, the colour change is said to take a few weeks to take effect

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A US doctor is trying to pioneer a laser treatment that changes patients' eye colour.

Dr Gregg Homer claims 20 seconds of laser light can remove pigment in brown eyes so they gradually turn blue.
He is now seeking up to $750,000 (£468,000) of investment to continue clinical trials.
However, other eye experts urge caution because destroying eye pigment can cause sight problems if too much light is allowed to enter the pupil.
Stroma Medical, the company set up to commercialise the process, estimates it will take at least 18 months to finish the safety tests.
'Irreversible' The process involves a computerised scanning system that takes a picture of the iris and works out which areas to treat.
The laser is then fired, using a proprietary pattern, hitting one spot of the iris at a time.
When it has hit every spot it then starts again, repeating the process several times.

“Start Quote

The pigment is there for a reason. If it is lost you can get problems such as glare or double vision”

End Quote Larry Benjamin Stoke Mandeville Hospital, UK

However the treatment only takes 20 seconds.

"The laser agitates the pigment on the surface of the iris," Dr Homer - the firm's chairman and chief scientific officer - told the BBC.
"We use two frequencies that are absorbed by dark pigment, and it is fully absorbed so there is no danger of damage to the rest of the eye.
"It heats it up and changes the structure of the pigment cells. The body recognises they are damaged tissue and sends out a protein. This recruits another feature that is like little pac-men that digest the tissue at a molecular level."
After the first week of treatment, the eye colour turns darker as the tissue changes its characteristics.
Then the digestion process starts, and after a further one to three weeks the blueness appears.
Since the pigment - called melanin - does not regenerate the treatment is irreversible.
Lasers are already used to remove the substance in skin to help treat brown spots and freckles.

Dr Gregg Homer said he first had the eye laser idea in the mid-1990s

Safety concerns Other eye experts have expressed reservations.
"The pigment is there for a reason. If the pigment is lost you can get problems such as glare or double vision," said Larry Benjamin, a consultant eye surgeon at Stoke Mandeville Hospital, in the UK.
"Having no eye pigment would be like having a camera aperture with a transparent blade. You wouldn't be able to control the light getting in."
Dr Homer said that he only removes the pigment from the eye's surface.
"This is only around one third to one half as thick as the pigment at the back of the iris and has no medical significance," he said.
He also claimed patients would be less sensitive to light than those born with blue eyes. He reasoned that brown-eyed people have more pigment in the other areas of their eyeballs, and most of it will be left untouched.
"We run tests for 15 different safety examination procedures. We run the tests before and after the treatment, and the following day, and the following weeks, and the following months and the following three months.
"Thus far we have no evidence of any injury."
Testing in Mexico
Dr Homer originally worked as an entertainment lawyer in Los Angeles, but gave up full-time practice in the mid-1990s to study biology at Stanford University in California.
He said he filed his first patent for the laser treatment in 2001. But it was not until 2004 that he began carrying out experiments on animals at a hospital facility.
To fund his research he used his own savings, attracted investments from venture capital funds and secured a government grant. Dr Homer said he has raised $2.5m to date.

Dr Homer said his treatment only removes pigment from the eyeball's surface

Tests on humans initially involved cadavers, and then moved on to live patients in Mexico in August 2010.
"From a regulatory perspective it is easier," Dr Homer said, "and I can speak Spanish fluently so I can closely monitor how everyone is doing."
Seventeen people have been treated so far. All are very short-sighted. They have been offered lens transplants in return for taking part.
Dr Homer said the work is checked by a board of ophthalmology experts to ensure it is up to standard.
The new funds will be used to complete safety trials with a further three people.
Stroma Medical then intends to raise a further $15m to manufacture hundreds of lasers and launch overseas - ideally within 18 months.
A US launch is planned in three years' time, because it takes longer to get regulatory approval there.
Stroma Medical believes the treatment will be popular; its survey of 2,500 people suggested 17% of Americans would want it if they knew it was completely safe. A further 35% would seriously consider it.
There is also evidence of a growing desire to alter eye colour overseas - a recent study in Singapore reported growing demand for cosmetic contact lenses.

 That ageing Thalidomide generation now faces rising care bills - but some hope a possible Nazi link to the drug could bring more compensation.

Fifty years ago, the sedative Thalidomide was withdrawn after thousands of mothers gave birth to disabled babies. That ageing Thalidomide generation now faces rising care bills - but some hope a possible Nazi link to the drug could bring more compensation.

In November 1961, I was five months old. My family had no idea why their otherwise healthy baby boy had been born with short arms, twisted hands and no thumbs.
But by the end of that month, the truth was finally out in the open.
After a German newspaper reported that Thalidomide was the likely cause for the mysterious spate of disabled babies born in Germany since 1958, the drug's producer, Chemie Gruenenthal, caved in to growing pressure, and on 26 November withdrew all products containing Thalidomide from what had been very lucrative, over-the-counter sales.
A few days later, Thalidomide's British licensee, Distillers, followed suit in the UK. But by then, the damage was done.
Thalidomide has strong sedative properties and many women in the early weeks of pregnancy had taken it to ease their morning sickness, utterly unaware its effect on the unborn child can be teratogenic, or "monster-forming".

Frederick Dove

• Born in Hamburg, West Germany, in June 1961
• Thalidomide-affected hands and hips
• Five hip operations as a child
• Grew up in Germany, Nigeria, Netherlands, UK
• Taught in Sudan 1985-89
• Joined the BBC World Service in 1989
• Presented Outlook from 1998-2008 and now occasionally hosts World Briefing
• Former captain of England's Disability Cricket XI

Limbs can fail to develop properly, in some cases also eyes, ears and internal organs. No-one knows how many miscarriages the drug caused, but it's estimated that, in Germany alone, 10,000 babies were born affected by Thalidomide. Many were too damaged to survive for long.

Today, fewer than 3,000 are still alive. In Britain, it's about 470. Among the nearly 50 countries affected are Japan (approximately 300 survivors), Canada and Sweden (both more than 100), and Australia (45). Spain's government only recently acknowledged the drug was ever distributed there. No-one knows how many Spanish survivors there are. It could be hundreds.
After 1961, the drug didn't disappear - medical researchers discovered it can be extremely effective in certain treatments. Stringent precautions should be taken, particularly with women patients of child-bearing age. But sadly, in Brazil, where the drug has been widely used in treating certain leprosy symptoms, there is now another, younger generation of about 800 disabled Thalidomide survivors.
Just as the drug's effect in the womb seems totally random, so too was the compensation received. In recent years, UK survivors have won concessions from the government, the tax authorities and Distillers' successor company, which has boosted current average compensation pay-outs in the UK to around $63,000 (£40,000) a year.

“Start Quote

There is overwhelming circumstantial evidence that it was tested as part of their [Nazis'] search for an antidote to nerve gas”

End Quote Martin Johnson UK Thalidomide Trust

But elsewhere, survivors still get nothing, or very little. Of today's 6,000 estimated survivors around the world, nearly half fall under the compensation deal in Germany. That currently provides a yearly maximum of about 13,500 euros (£11,840), which does not cover the needs of those with multiple limb deficiencies. Many have no independent income and require constant care.

Campaigns for higher compensation are gaining support - in Germany and elsewhere. Progress has been slow, but that could change dramatically, if proof is found that it was not Chemie Gruenenthal which discovered Thalidomide, as has always been claimed, but scientists working for the Nazi regime.
Gruenenthal patented Thalidomide in the mid-1950s. But investigations in the past two years have confirmed that the German brand-name - Contergan - was owned by the French pharma-company, Rhone-Poulenc, during the early 1940s, when it was effectively under Nazi control.
It's also now becoming clear that Gruenenthal was part of a post-war network of German scientists and businessmen who had played leading roles during the Nazi era. Immediately after the war, for example, Gruenenthal employed Dr Heinrich Mueckter as chief scientist, who was sought in Poland on charges of war crimes after conducting medical experiments in prison camps, during which hundreds of prisoners may have died.

The severity of the condition varies

"Gruenenthal taking on someone like Dr Mueckter is one of the key factors we must highlight in the Thalidomide scandal," says Gernot Stracke, a leading spokesman for survivors in Germany.
He adds: "To my knowledge, no representative for the German government has yet made any public comments about Thalidomide's possible roots in the Nazi-era, or whether the government would accept greater liability and offer more help to survivors if proof of such a link were found."
Martin Johnson, director of the UK Thalidomide Trust, and Professor Ray Stokes, of the University of Glasgow, are preparing to publish a book after investigating Thalidomide's possible Nazi origins.
Mr Johnson says: "Although, at this stage, we cannot prove that Thalidomide was definitely developed and tested in prison camps by the Nazis, there is overwhelming circumstantial evidence that it was tested as part of their search for an antidote to nerve gas."
For the survivors, decades of coping with stunted, twisted or missing limbs has meant greater wear and tear on remaining joints and muscles, and virtually guaranteed the premature onset of arthritis and chronic pain.
Many who managed to go out and work have already been forced into early retirement, while others who used to rely on their parents for everyday care, can no longer do so. Every year, more and more are becoming totally dependent on other family members, on social benefits or health insurance payouts - or on charity.
Which is why, on 26 November - 50 years on - we, the German survivors, will march, waddle, limp or roll in wheelchairs from the Brandenburg Gate to the Federal Chancellery in Berlin.
To celebrate that we are still alive, and to remember those who never lived

IVF linked to ovarian tumours

Fertility drugs are used to force the ovaries to produce eggs

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IVF has been linked to an increased risk of ovarian tumours in later life, according to a preliminary study.

Women given fertility drugs to produce eggs had more than triple the risk of an ovarian tumour that may turn cancerous, say Dutch researchers.

But the absolute risks are very low, they add.

A cancer charity said numbers involved in the study, published in the journal Human Reproduction, were too small to draw firm conclusions.

The study tracked more than 25,000 women attending IVF clinics in The Netherlands in the 80s and 90s.

Follow-up investigations revealed more cases than expected of ovarian tumours in women who had gone through IVF, which involves stimulating the ovaries to make eggs.

The biggest increase was in a type of growth, known as a borderline ovarian tumour, which can sometimes turn into cancer. It is less aggressive than other types of ovarian tumour, but requires surgery.

“Start Quote

Women should be informed about this but the risk should not be overstated”

End Quote Prof Flora van Leeuwen Netherlands Cancer Institute, Amsterdam

It normally affects around one in 1,000 women in the general population, but was found in about 3.5 in 1,000 women who had gone through IVF, say the researchers.

A smaller increase in other types of ovarian tumour was also found. Overall, ovarian cancer rates were twice as high among women who had gone through fertility treatment, the experts said.

Prof Flora van Leeuwen, a co-author of the study, told the BBC: "The absolute risk of these tumours is very low. But there is an increased risk of a borderline malignant tumour that needs surgery.

"Women should be informed about this but the risk should not be overstated."

Another co-author, Prof Curt Burger added: "The main message is that women who have had IVF shouldn't be alarmed. The incidence of ovarian cancer was extremely low."

'Reassuring'

Further research is planned to confirm the finding in a larger number of patients, and to look at whether some women are more at risk.

At present, the numbers involved are small. There were 61 women with ovarian tumours in the IVF treatment group; 31 had borderline ovarian tumours and 30 had ovarian cancer.

Continue reading the main story

Ovarian cancer

• Ovarian cancer is the 5th most common cancer in women in the UK
• Most cases are in women who are past the menopause
• Risk factors include a family history of cancer, being infertile or having fertility treatment, and smoking
• The symptoms of ovarian cancer can be very vague, particularly when the disease is in its early stages.
• Early symptoms can include pain in the lower abdomen or side, and/or a bloated, full feeling in the abdomen
• Source: Cancer Research UK

Commenting on the study, Prof Hani Gabra, of the Ovarian Cancer Action Research Centre at Imperial College London, said:

"Reassuringly, and in keeping with lots of previous research in this area, this study shows that the risks of invasive ovarian cancer are small in populations of patients receiving ovarian stimulation for IVF.

"Although this study shows that ovarian stimulation may increase the risk of much less aggressive borderline ovarian tumours, it underlines the fact that ovarian stimulation for IVF is not a major risk factor for invasive ovarian cancer."

Dr Claire Knight, senior health information officer at Cancer Research UK, said: "This interesting study suggests a possible link between ovarian stimulation for IVF and borderline ovarian tumours, but it certainly doesn't show that IVF causes invasive ovarian cancer.

"There were only a relatively small number of cases in this study, and the researchers didn't find that risk increased with the number of cycles a woman had, making conclusions hard to reach.

"Women can reduce their risk of ovarian cancer by being a non-smoker and keeping a healthy weight, and women who have taken the Pill or been pregnant are also at lower risk." Pill 'lowers ovarian cancer risk' Ovarian Cancer Action humrep.oxfordjournals.org

• Ovarian cancer risks and causes Cancer Research UK

A painkiller taken by millions can increase the risk of heart attack and stroke

A painkiller taken by millions can increase the risk of heart attack and stroke by 40%, the Daily Mail has today reported. The newspaper says that researchers are calling for the drug, called diclofenac, to be available on prescription only.

The news is based on a large review that looked at the cardiovascular risks associated with a class of widely used painkillers called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs in high-dose formulations are usually only available on prescription, but some low-dose NSAIDs, including ibuprofen, naproxen and diclofenac, can be bought over the counter.

The review found that diclofenac raised the risk of heart problems by 22% when taken at over-the-counter doses and by 40% at prescription strength. Naproxen and low-dose ibuprofen were least likely to increase the risk of heart attacks and strokes.

While previous research has highlighted the cardiovascular risks of some NSAIDs, this review of observational studies provides some important new information about the risks associated with all currently available NSAIDs at different doses. As such, its findings will no doubt be important to future decisions about how these drugs should be used and regulated.

However, it is important to note that for a healthy individual who takes diclofenac, the increased risk to the heart is still very small. The nature of this research means it is not possible to estimate accurately how small this risk is. Anyone who is concerned about taking NSAIDs should not stop taking these drugs but should consult their doctor.

Where did the story come from?

The study was carried out by researchers affiliated with Hull York Medical School, the Institute for Clinical Evaluative Sciences, the University of Toronto in Canada and the University of Newcastle in Australia. It received no external funding. The study was published in the peer-reviewed journal PLoS Medicine.

The research was covered fairly in most newspapers. In its print version of the story the Daily Mail featured a large front-page headline warning of a “Painkiller heart alert”, which may have been alarming. However, within the article itself the Daily Mail did feature prominent messages that patients should not panic and should not stop taking their medication. Both the Daily Mail and The Daily Telegraph reported that, for most healthy people, the increased risk of heart and other problems from diclofenac was small, and the reports featured in the Daily Mail, The Daily Telegraph and the Daily Express all included comments and advice from independent experts.

What kind of research was this?

This was a systematic review comparing the risks of individual NSAIDs taken at typical doses by people at home, rather than in hospital. The researchers say that there are concerns about the risk associated with non-prescription NSAIDs available in low-dose forms, such as ibuprofen, naproxen and diclofenac.

The researchers point out that while some randomised trials have highlighted the cardiovascular risk of some NSAIDs, little is known about how the risks of individual drugs compare when used at different doses, for different lengths of time and in different populations. For this reason the researchers set out to examine the outcomes seen in controlled observational studies, which would better reflect the risks associated with the typical domestic use of NSAIDs rather than the risks associated with their use in the idealised setting of a clinical trial. To date, randomised trials of NSAIDs have reported only small numbers of heart and stroke problems.

What did the research involve?

The researchers searched a wide range of electronic databases for relevant studies published between 1985 and 2010 that had reported on the cardiovascular risks associated with the use of individual NSAIDs in population settings. They included only non-randomised, controlled observational studies in their literature search. These observational studies included case control, cohorts and case-crossover studies. They then assessed the methodological quality of the selected studies. From a total 459 potentially relevant papers, 51 studies met their criteria.

From the studies gathered, the researchers extracted and pooled information about the risk of major cardiovascular events associated with individual NSAIDs. They also assessed subsets of studies that provided relevant information to examine the risk of NSAIDs in different doses and in people with low and high existing risk of heart problems. To compare different drugs they carried out a further type of analysis, called a pair-wise comparison, where they indirectly compared each drug against another in turn, taking the results from separate trials.

The overall analyses included data from 30 case-control studies and 21 cohort studies involving more than 2.7 million individuals and featuring a total of 184,946 cardiovascular events.

What were the basic results?

The researchers looked at the drugs where there were 10 or more studies. Of drugs where there were 10 or more studies, researchers found that the highest overall risks were seen with rofecoxib and diclofenac, and the lowest with ibuprofen and naproxen. Compared with not using any NSAIDs, the researchers found:

• rofecoxib increased the risk of heart problems by 45% (95% CI 1.33 to 1.59)
• diclofenac increased the risk by 40% (95% CI 1.27 to 1.55)
• ibuprofen increased the risk by 18% (95% CI 1.11 to 1.25)

In a subset of studies that looked at risk associated with lower doses they found:

• low doses of rofecoxib increased the risk by 37% (95% CI 1.20 to 1.57)
• low doses of celecoxib increased the risk by 26% (95% CI 1.09 to 1.47)
• low doses of diclofenac increased the risk by 22% (95% CI 1.12 to 1.33)

It is important to note that the drug rofecoxib has already been withdrawn from the market because of its association with a raised risk of cardiovascular events. Including it in the study allows the risk associated with other drugs to be compared with the risks of rofecoxib.

Ibuprofen only posed a risk when taken at a higher dose and naproxen had no significant risk at any dose.

The researchers say the increase in risk was proportional for both high- and low-risk groups. This means that, relative to their risk if not using NSAIDS, the risks for both groups increased to the same extent. The risk of cardiovascular problems also rose early in the course of treatment. For some NSAIDs, risk was found to increase within the first month of taking the drug.

How did the researchers interpret the results?

The researchers say the results of their review “are robust enough to inform clinical and regulatory decisions”.

• They call for “regulatory action” on diclofenac, as it is currently available without prescription.
• They say the limited data on etoricoxib “raises serious concerns” about safety, particularly as similar drugs such as rofecoxib have been withdrawn.
• They say that, in the case of ibuprofen, labelling warnings should be strengthened to stop patients who are already at high risk of cardiovascular problems from exceeding the maximum recommended dose.
• They question the continued use of indomethacin.

Conclusion

This large review has published some important information on the cardiovascular risks associated with NSAIDs, including the risk associated with different doses and in populations at both high and low risk of cardiovascular events. It raises concerns about some of these risks, in particular the risk associated with the widely used non-prescription drug diclofenac.

As its authors point out, it had some limitations.

• It had to rely on observational studies (rather than randomised controlled trials), which are subject to bias, especially in terms of other factors (confounders) that might influence results. However, the researchers did take steps to minimise this risk.
• The data in the studies mainly came from large administrative databases and electronic health records, and may not have been comprehensive, especially concerning key information such as use of non-prescription NSAIDs and aspirin, or information about people’s risk of heart problems.
• The review suffered from ‘heterogeneity’. This means that many of the studies varied in their design, their methods and how they analysed results. Heterogeneity makes it harder to combine the results of different studies accurately and can, therefore, throw doubt on the findings of systematic reviews.

Patients using NSAIDs who are worried about side effects should not stop taking them, but instead consult their doctor.

Links To The Headlines

Painkiller heart alert: Don't stop taking pills, but do talk to your GP, British scientists urge. Daily Mail, September 28 2011

Common painkillers can raise heart risk. The Daily Telegraph, September 28 2011

Health alert over common painkiller. Daily Express, September 28 2011

Links To Science

McGettigan P, Henry D. Cardiovascular Risk with Non-Steroidal Anti-Inflammatory Drugs: Systematic Review of Population-Based Controlled Observational Studies. PLoS Medicine 8(9)