Wednesday, October 13, 2010

Love 'is a drug which eases pain'

Love hurts, at least according to many a romantic songwriter, but it may also help ease pain, US scientists suggest.

Brain scans suggest many of the areas normally involved in pain response are also activated by amorous thoughts.

Stanford University researchers gave 15 students mild doses of pain, while checking if they were distracted by gazing at photos of their beloved.

The study focused on people early in a romance, journal PLoS One reported, so the "drug of love" may wear off.

The scientists who carried out the experiment used "functional magnetic resonance imaging" (fMRI) to measure activity in real-time in different parts of the brain.

It has been known for some time that strong feelings of love are linked to intense activity in several different brain regions.

These include areas linked to the brain chemical dopamine, which produces the brain's feel-good state following certain stimulants - from eating sweets to taking cocaine.

"Light up"

The Stanford University researchers had noticed that when we feel pain, some of the same areas "light up" on the scans - and wondered whether one might affect the other.

They recruited a dozen students who were all in the first nine months of a relationship, defined as "the first phase of intense love".

Each was asked to bring in a picture of the object of their affection and photos of what they deemed an equally attractive acquaintance.

"Start Quote

It's important to recognise that people who feel alone and depressed may have very low pain thresholds, whereas the reverse can be true for people who feel secure and cared for"

End Quote Professor Paul Gilbert University of Derby

While their brains were scanned, they were shown these pictures, while a computer controlled heat pad placed in the palm of their hand was set up to cause them mild pain.

They found that viewing the picture of their beloved reduced perceptions of pain much more than looking at the image of the acquaintance.

Dr Jarred Younger, one of the researchers involved, said that the "love-induced analgesia" appeared to involve more primitive functions of the brain, working in a similar way to opioid painkillers.

"One of the key sites is the nucleus accumbens, a key reward addiction centre for opioids, cocaine and other drugs of abuse.

"The region tells the brain that you really need to keep doing this."

Professor Paul Gilbert, a neuropsychologist from the University of Derby, said that the relationship between emotional states and the perception of pain was clear.

He said: "One example is a footballer who has suffered quite a painful injury, but who is able to continue playing because of his emotionally charged state."

He added that while the effect noticed by the Stanford researchers might only be short-lived in the early stages of a love affair, it may well be replaced by something similar later in a relationship, with a sense of comfort and wellbeing generating the release of endorphins.

"It's important to recognise that people who feel alone and depressed may have very low pain thresholds, whereas the reverse can be true for people who feel secure and cared for.

"This may well be an issue for the health service, as patients are sometimes rushed through the system, and perhaps there isn't this focus on caring that might have existed once."



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Public 'misled' over drug trials

Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned.

Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings.

The German team give the example of the antidepressant reboxetine, saying publications have failed to show the drug in a true light.

Pfizer maintains its drug is effective.

Reboxetine (Edronax), made by Pfizer, is used in many European countries, including the UK.

But its rejection by US drug regulators raised doubts about its effectiveness, and led some to hunt for missing data.

This is not the first time a large drug company has come under fire about its published drug trial data.

Trial information

Pharmaceutical giant GlaxoSmithKline (GSK) was criticised for failing to raise the alarm on the risk of suicidal behaviour associated with its antidepressant Seroxat.

GSK rejected claims that it improperly withheld drug trial information.

"Start Quote

Our findings underline the urgent need for mandatory publication of trial data"

End Quote The research authors

But GSK has also been forced to defend itself over allegations about hiding negative data regarding another of its drugs, Avandia, which is used to treat diabetes.

Now researchers from The German Institute for Quality and Efficiency in Health Care say there is unpublished trial data for Pfizer's antidepressant reboxetine that should be made public because it could change views about the drug.

Dr Beate Wieseler and colleagues carried out their own assessment of reboxetine, looking at the results of 13 trials, including eight previously unpublished trials from the manufacturer Pfizer.

They found the drug was no better than a placebo in terms of remission and response rates. And its benefit was inferior when compared with other similar antidepressants.

Furthermore, a higher rate of patients had side effects with reboxetine than with placebo. And more stopped taking the drug because of side effects compared with those taking a placebo or a different antidepressant.

Biased picture

The researchers said there has been a publication bias and this had overestimated the benefit of reboxetine and underestimated potential harm. And, they said, it was a widespread problem that applied to many of the drugs in use today.

"Our findings underline the urgent need for mandatory publication of trial data," they say in the BMJ.

They warn that the lack of all information means policy makers are unable to make informed decisions.

In the US, it is already a requirement that all data - both positive and negative - is published. The UK is also striving to achieve this.

The UK's regulator, the MHRA, said: "There is a European initiative to provide public access to the results of clinical trials. The currently planned timeline is that this information could become available in late 2011/early 2012."

A spokeswoman for Pfizer said: "In the UK, Pfizer's reboxetine is licensed for the acute treatment of depressive illness/major depression and for maintaining the clinical improvement in patients initially responding to treatment.

"This medicine presents an effective treatment option to clinicians for the use in patients suffering from these conditions.

"Pfizer discloses the results of its clinical trials to regulatory authorities all around the world. These regulatory authorities carefully balance the risks and benefits of each medication, and reflect all important safety and efficacy information in the approved product labelling.

"Pfizer will review the meta-analysis relating to reboxetine published in the British Medical Journal on 13th October 2010 in detail and will provide further comment after completing the review."

Others lay at least some of the blame with the medical journals that publish drug trial data.

In response, the BMJ has promised to devote an entire issue to the topic next year.

BMJ Editors Dr Fiona Godlee and Dr Elizabeth Loder said: "It is time to demonstrate a shared commitment to set the record straight."



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Tuesday, October 12, 2010

NHS 'bonuses for life' attacked

Large pay bonuses cannot be taken away from doctors, even if their performance deteriorates, because of a loophole in the system, the BBC has found.

It means that more than half of the 36,000 consultants in England now get what are effectively "lifetime" awards on top of their �89,400 basic pay.

The scheme, which is under review, is worth more than �75,000-a-year to the best-performing consultants.

But doctors defended the system, saying it ensured excellence was rewarded.

The bonus scheme dates back to 1948 when the NHS was created. In England, there are 16 different levels, ranging from �2,957 to �75,889 a year.

Similar schemes operate elsewhere in the UK, although only a small number of doctors receive the awards.

During the summer, all four governments agreed to a review of the bonuses amid concerns about the costs.

In England, the cost of the awards topped �200m last year.

But news of the pay protection clause has added weight to calls for the scheme to be scrapped.

According to latest figures, 19,892 consultants in England are paid the bonuses.

Pay protection

To apply for an award, consultants nominate themselves and are asked to provide details of excellent performance and innovation in terms of clinical care, research and training.

The awards are reassessed every five years, but critics said the loophole had created a culture where that checking process was effectively obsolete.

In fact, in evidence to a government review by the Advisory Committee on Clinical Excellence Awards - the body which oversees the top payouts - even acknowledges that reassessments have not always taken place.

During the four years between 2006 to 2009, just seven of the top awards worth over �35,484 were withdrawn.

In 2010, the committee chased up those doctors who had not been taking part in the reassessment process.

However, because of the pay protection clause all these doctors have continued to get the payouts even though the 'bonuses' have been formally withdrawn from them.

Those who have had their awards withdrawn do not receive annual pay rises so the NHS can start to claw back some of the money, but as pay is currently frozen, that is having little impact.

It is not known how many of the local awards have been withdrawn, but according to those who have helped administer the scheme the bonuses come with a virtual "lifetime" guarantee.

Professor Alan Maynard, an expert in health policy at York University, was chairman of a local NHS trust for 12 years during which time he sat on the committee that handed out the awards.

He said: "They never get stopped, once they have them they have them for their lifetime. The system needs completely changing.

"The applicants provide very little information, but you can't spend the money on anything else as it is earmarked for these awards. I would have preferred to spend it on providing more care."

He said the evidence for performance-related pay was questionable anyway, but if there was to be an incentives scheme it should be much tougher.

Professor John Appleby, chief economist at the King's Fund, agreed.

"I think they are out of step with how the NHS should be paying staff. They should be abolished."

But Dr Paul Flynn, of the British Medical Association consultants' committee, defended the scheme.

"It is an integral part of the pay structure for consultants. It is only right that those who go over and above what is expected and do the best job get their performance rewarded."

He said the BMA would be willing to engage with the government to make sure the system was "transparent, fair and responsive".

But he said pay protection was important as doctors needed "security of income" and so that the bonuses "engaged and motivated, but not distracted" them.

A Department of Health spokeswoman said there were "anomalies" in the system and that was why it was being reviewed.

She added: "In future we want to see a much tougher approach, including withdrawing them from people who no longer display the quality of work that would merit an award now."

The review is being carried out by independent Doctors' and Dentists' Review Body and is due to report next summer.



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NHS campaigner Claire Rayner dies

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A look back at the life of Claire Rayner

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Tributes have been paid to agony aunt Claire Rayner, who has died at the age of 79.

She told her relatives she wanted her last words to be: "Tell David Cameron that if he screws up my beloved NHS I'll come back and bloody haunt him."

She worked for the Sun, Sunday Mirror and Woman's Own and was named medical journalist of the year in 1987. She also wrote a string of novels.

In May she had intestinal surgery but had remained poorly.

She died in hospital near her home in Harrow, north-west London.

Mrs Rayner, who had three children - Amanda, Adam and restaurant critic Jay - will have a humanist funeral for family and close friends.

A former nurse and midwife, for many years she was also president of the Patients Association.

She was diagnosed with breast cancer at 70, but beat the illness. In 2006 she wrote about her experience on the BBC News website.

Her husband of 53 years, Des Rayner, said: "I have lost my best friend and my soulmate. I am immensely proud of her."

Mr Rayner, who was also her agent and manager, said: "Through her work she helped hundreds of thousands of people and doubtless, by talking frankly about the importance of safe sex in the 80s when almost nobody else would discuss it, helped to save thousands of lives.

"Right up until her death she was being consulted by both politicians and the medical profession about the best way to provide the health services the nation deserved and nothing mattered to her more than that. Her death leaves a vacancy which will not be filled."

In 1996 she was awarded the OBE for "services to women's issues and health issues".

She was involved with 50 charities, and was a member of the Prime Minister's Commission on Nursing and the last government's Royal Commission on the Care of the Elderly.

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Her no-nonsense manner led to the BBC employing her to demonstrate how to put on a condom and she was one of the first people used by advertisers to promote sanitary towels.

The chief executive of the Patients' Assocation, Katherine Murphy, expressed her "deep sadness" at the news and added: "For almost 30 years Claire has devoted so much of her time and energy to championing patients' issues. She was a figurehead and inspiration to us all."

Her close friend, Baroness Helena Kennedy, said: "She was an extraordinary woman - passionate, committed, warm and exuberant. The key thing about Claire was that she was a campaigner to her toes - her mission was to improve the lot of others and she did it with great humility and common sense."

Your comments

I got to know Claire very well during the 80s when I worked with a health insurance company. At that time Claire was working with Woman's Own magazine and we organised health weeks when women could call to talk about their medical problems. Later Claire became a patron of the Medical Advisory Service. Claire talked about wearing three hats: "Agony aunt, journalist but above all a nurse."

George Maskell, London

I read Claire's autobiography a few years ago and was particularly moved by her account of her episode of depression. It was a fabulous story of someone with real backbone, gumption and determination. Having read the book I e-mailed her publisher who, to my surprise, passed my comments on and she typed me the most wonderful letter of thanks which I have kept and treasured.

Jane Shand, Welwyn Garden City, Hertfordshire

I had my first child in 1979 and remember Claire Rayner's books about childcare being very practical with common sense. She gave down to earth encouraging advice in language everyone could understand. As far as I can remember the alternatives were Dr Spock or medical encyclopaedias.

Pauline Davis, Bristol

It must be 35-40 years ago and I must admit that it was with some trepidation I attended a meeting organised by Croydon Campaign for Homosexual Equality. The hall was packed with local lesbians and gay men. She said loud and clear: "There's nothing wrong with you, but there's lots wrong with the way society and the politicians treat you. Just by being here tonight, proves that you've had enough and intend to organise, be visible, win friends and change the world you're living in." Well, Claire, we listened and took your words to heart. There's still much to do, but we've come along way.

RMJ Harvey-Amer, Croydon

How very sad. I worked closely with Claire for seven years when I was CEO of the Patients Association. She was a great boss and also a really good friend. She gave me the chance to advance my career and the confidence to give media interviews both to the press and to television. She was quite simply a wonderful, caring person who did so much for the NHS and patients. She will be a great miss to so many people.

Mike Stone, Reading

I met Claire and her husband Des on a cruise going to the Canaries a few years ago. Claire gave a talk on the ship which was very well attended. I bumped into them in the town of Vigo where they were shopping. By then she was walking with the aid of a stick. Des was a tower of strength, always in attendance. Their love shone out even to a casual observer.

Martin Holland, Horley

Anyone who can part this world still trying to influence those in control of systems that affect populations as Claire has done with David Cameron, is a truly special and giving person. I never met Claire but being a nurse, I was aware of Claire's influence. Claire did what nurses do in their day-to-day work and provided a voice for their patients. A remarkable person indeed.

Kerri Shaw, New Zealand

I only have a handful of heroes but Claire Rayner is one of them. Few people have both the ability of insight into someone's true problems whilst also providing the solution. We've lost a unique British icon.

Oliver Davis, London

Claire Rayner made an important contribution as president and vice-president of the British Humanist Association, and her atheistic humanistic beliefs were an important part of her make-up and personality. She will be greatly missed.

George Shilling, Shipston on Stour

I met Claire Rayner on one memorable occasion some years ago, and it was perfectly obvious that she was what everybody said about her - a hugely generous spirit, vivacious and fun, but above all genuine in her interest in and concern for others. She was a big personality with an even bigger heart, and in today's world there aren't many of her calibre. She will be missed.

Christopher Warwick, Ascot, Berkshire

Claire inspired me to train as a nurse and gave me sensible honest advice about all manner of problems. She is totally irreplaceable.

Maria Garner, Grantham

What are your memories of Claire Rayner? Did you meet her? Send us your comments.

At no time should you endanger yourself or others, take any unnecessary risks or infringe any laws. In most cases a selection of your comments will be published, displaying your name as you provide it and location unless you state otherwise. But your contact details will never be published.



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First human trial of stem cells

US doctors have begun the first official trial of using human embryonic stem cells in patients after getting the green light from regulators.

The Food and Drug Administration has given a license to Geron to use the controversial cells to treat people with spinal injuries.

The cells have the potential to become many of the different cell types found in the body, including nerve cells.

The trials at a hospital in Atlanta will check if the treatment is safe.

Pivotal research

Geron, a biotech company based in "silicon valley" south of San Francisco, has spent $170m on developing a stem cell treatment for spinal cord injury.

The research will use cells coaxed to become nerve cells which are injected into the spinal cord.

In animal trials of the treatment, paralysed rats regained some movement.

But it is not yet known if it will offer any benefit to people with spinal cord injuries.

"Start Quote

This is very exciting news, however, it is very important to appreciate that the objective of trials at this stage is to confirm first of all that no harm is done to patients, rather than to look for benefits"

End Quote Professor Sir Ian Wilmut MRC Centre for Regenerative Medicine

Every year around 12,000 people in the US sustain spinal cord injuries. The most common causes are automobile accidents, falls, gunshot wounds and sports injuries.

In the trial, patients who have sustained such an injury within the last 14 days will be given the experimental stem cell treatment.

Geron president Dr Thomas Okarma said: "When we started working with human embryonic stem cells in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials.

"This accomplishment results from extensive research and development and a succession of inventive steps."

But it will take some time to get the results.

And there are many years of rigorous testing ahead before it can be known if the therapy is safe and effective.

Professor Sir Ian Wilmut, director of the Medical Research Council Centre for Regenerative Medicine at the University of Edinburgh, said: "This is very exciting news, however, it is very important to appreciate that the objective of trials at this stage is to confirm first of all that no harm is done to patients, rather than to look for benefits.

"Once that has been confirmed then the focus moves on to development and assessment of the new treatment."

Ben Sykes, executive director of the UK National Stem Cell Network, said: "This is indeed a significant milestone in our journey towards the promise of stem cell-based medicines.

"The global stem cell and regenerative medicine community will be awaiting the results of this safety trial with much anticipation."

Professor Chris Mason, an expert in regenerative medicine at University College London, said UK researchers hope to follow suit and begin trials next year with a stem cell treatment for age-related macular degeneration - a leading cause of blindness.



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Trial shows prostate drug promise

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Richard Pflaum: the drug is like 'magic'

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A drug discovered in the UK could help thousands of men with advanced prostate cancer, experts say.

Trials involving men who had exhausted all other treatment options found abiraterone acetate extended life by an average of four months.

Researchers hope that in less advanced cases, the benefits could be greater.

The drug's makers, the pharmaceutical firm Janssen, are now seeking a licence which would allow it to be used on the NHS.

Significant benefit

More than 36,000 men are diagnosed with prostate cancer each year in the UK - more than 10,000 die from the disease.

If the disease spreads beyond the prostate, a small gland found near the bladder, then it becomes far more difficult to treat.

Abiraterone acetate interferes with the production of the hormone testosterone, which can fuel the growth of prostate cancer.

The trials involved more than 1,000 men with very advanced, aggressive cancers, whose prognosis was poor, with only months left to live.

"Start Quote

It's certainly a significant improvement in what might be expected for men with such advanced prostate cancer"

End Quote Harpal Kumar Cancer Research UK

The 797 patients given abiraterone plus a steroid lived for an average of 14.8 months, compared to 10.9 months for the remainder who simply got the steroid.

Scans showed that tumour growth halted for longer in the group given the drug.

Another advantage of the drug was the relative lack of side effects compared with chemotherapy or radiotherapy, making it a far more attractive prospect for patients.

The drug was first discovered at the Institute of Cancer Research in London, and its chief executive Professor Peter Rigby said he was "very proud" that men with advanced prostate cancer had this new treatment option.

Other cancer charities, who helped fund research into the drug, also welcomed the study results, presented at the European cancer drug conference ESMO.

John Neate, from the Prostate Cancer Charity, said that the drug represented a "significant move forward".

He said: "These initial findings are particularly important as they offer new hope to men diagnosed with an advanced form of prostate cancer who can quickly run out of treatment options once their tumour stops responding to the existing methods of controlling its progression."

He said that while the full results of the study had yet to be published in medical journals, he hoped that they would provide the evidence needed to allow the drug to be licensed for use in the NHS.

Harpal Kumar from Cancer Research UK, added: "It's certainly a significant improvement in what might be expected for men with such advanced prostate cancer."

Pharmaceutical firm Janssen will now apply for a European licence, which would allow UK doctors to prescribe it, although there is no decision yet on how much it should cost.

Further trials will look at whether men with slightly less advanced prostate cancer could also benefit from the drug, perhaps even more than those taking part in this study.

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Richard Pflaum: the drug is like 'magic'

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Richard Pflaum: the drug is like 'magic'

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