Miracle pills or pharmaceutical hype?
When atypical drugs for schizophrenia were in the dock, it didn't take long for passions to stir - and awkward questions to emerge.
The question was simple: 'Should typicals be an option for first-line treatment?'
Since the speakers' answers at the debate hosted by HSJ and sponsored by the Pharmaceutical Schizophrenia Initiative (PSI) ranged from 'yes'to 'yes, but. . .', one might have expected a short debate. Not so.
Anecdotal evidence on the merits of the new atypicals was compelling. Timothy Newery, a 28-year-old diagnosed with schizophrenia eight years ago, described atypical drugs as 'like the sun itself '.
Dr Martin Deahl, consultant and senior lecturer in psychological medicine at East London and the City Mental Health trust and Barts and the London trust, suggested that if traditional treatments for schizophrenia such as chlorpromazine and haloperidol went to the Committee on Safety of Medicines today 'they would never be given a licence - no doubt about it'.
No speaker denied that the old-style drugs - described by David Taylor, chief pharmacist at South London and Maudsley trust, as 'barbaric anachronisms'- are associated with devastating side-effects. These include tremors, shuffling, impotence, sedative effects and hyperprolactinaemia, leading to breast milk production.
Cliff Prior, chief executive of the National Schizophrenia Fellowship, suggested that failures to prescribe new drugs as a first-line treatment risked 'poisoning' the relationship between patients and medics from the outset. 'If you are put on a medication that leaves you impotent, with your eyes rolling [and] unable to rest. . . are you ever going to trust your doctor again?' he asked.
Many advocates of increased use of the new drugs such as olanzapine and risperidone argue that current rates of prescribing have been limited by their cost. Psychiatrists have argued that the cost can amount to£215 a month, compared to£5 a month for traditional treatments.
But Mr Prior said: 'The main cost of schizophrenia is not to the NHS but [in] lost employment and amount spent on benefits.' He suggested the Human Rights Act might have something to say about denying care on financial grounds to mental health service users receiving care under a section.
Even the most enthusiastic fans of the new drugs agreed that the vital point was to offer choice, and to tailor treatments to the needs of the individual.
It was down to Dr Clive Adams, co-ordinating editor at the Cochrane schizophrenia group, which reviews research data on treatments, to pour cold water on the rising passion for atypicals. He defended his controversial review, published last year, which queried the quality of research on atypicals (see box).Insisting it was not 'an excuse for rationing', he listed the study's findings. His account dealt some punishing blows.
The study recorded that half of trials for atypicals lasted six weeks or less. And even the short trials suffered enormous drop-out rates. Dr Adams quoted a six-week trial of risperidone which lost 30 per cent of patients before it was over, and trials of olanzapine where 42 per cent of patients dropped out. 'The most chaotic ward would not lose 30 per cent of its patients within six weeks, 'he said.
Fellow editor Dr Simon Gilbody took a similar line.He also suggested that the use of atypicals as first-line treatment would cost between£200m and£400m, wiping out much of the£700m recently allocated to the national service framework for mental health.
Martin Brown, co-director of the Northern Centre for Mental Health and former Department of Health head of health, asked what the Royal College of Psychiatrists had done to promulgate good practice regarding the availability of such data.
Dr Deahl could only confess that 'as a professional group we have been pretty lamentable'.
Perhaps that was what gave John Steel, a member of Leeds community health council, the courage to demand 'some form of rigour. . .
regarding the competence of your profession, retraining for those not competent. . . and effective monitoring of the motives of the pharmaceutical industry'.
Dr Deahl had to agree.
But it took Dr Adams to bite the hand that sponsored the debate. He questioned the benevolence of the companies that joined PSI, an 'association of UK pharmaceutical companies committed to sharing best practice in the treatment of schizophrenia'.
Dr Adams flagged the failures of most pharmaceutical companies to make available unpublished data relating to research on new drugs. He compared the approach of Glaxo Wellcome and Shearing, which register trials at inception, with those of other pharmaceutical companies, which choose which data is available for publication. Dr Adams singled out Janssen-Cilag, one of the six companies within PSI, for special attention.
When he first asked the company when it would make data available for trials, the question was avoided. But when Sue Mason, head of mental health liaison for Janssen Cilag, was put on the spot a second time, she promised to 'look into it'.
Dr Adams was not convinced, later telling HSJ: 'I can't be naive about it. Those boys have no compulsion to publish.'
Of about 200 HSJ readers, just one voted against the motion: 'Should atypicals be an option for first line treatment?'
The story so far The National Institute for Clinical Excellence is considering the question asked by the debate. The drugs' proponents hope NICE will cast aside draft guidelines commissioned by the Department of Health, and leaked to HSJ a year ago, that said the drugs should only be prescribed if traditional treatments had failed.
The guidelines suggested patients should not be given atypical drugs, which are cost more, unless they had failed to respond to old-style drugs or suffered 'unacceptable'side-effects.
The recommendations, from the Royal College of Psychiatrists and the British Psychological Society, aroused strong emotions.
The National Schizophrenia Fellowship urged the DoH to allow doctors to prescribe 'the best and not just the cheapest option', describing traditional treatments as 'dirty old drugs with nasty side-effects'.
Two months later, the Effective Health Care Bulletin from York University's NHS Centre for Reviews and Dissemination published a review headed by Dr Clive Adams. It criticised the poor quality of the research evidence backing atypical drugs, which, while deemed to have fewer side-effects, are associated with impotence and weight gain.
As well as attacking the short length of trials and high drop-out rates, Dr Adams' study questioned the relevance of the symptom scales used to measure the effects of the drugs. It suggested publication bias meant less favourable reports about atypicals were difficult or impossible to trace.
NICE has collected stakeholder submissions for a set of guidelines on schizophrenia management and a technology assessment on the atypical agent, which are currently being commissioned and will be published next year.