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Not as it seems

The public may find it hard to reconcile approval with seeming ineffectiveness

A painter painting a wall red from a paint pot with 'blue' on the sideThere's a joke doing the rounds: What's the difference between Prozac and the management? Answer: We know the management doesn't work; we're just not sure about the Prozac.

The whole Prozac, antidepressant saga is not a joke; it strikes at the heart of the regulatory process, the evaluations process and the prescribing process.

An incredulous public will find it hard to believe it is possible for a drug to be approved for prescription by doctors, and paid for by the taxpayer, when not all the information about that drug is in the public domain. They may take the view that it is little short of fraud. Are we buying things that are not what they say on the tin? Are we buying a pig-in-a-poke?

The fact is insiders know medicines are approved and assessed by the National Institute for Health and Clinical Excellence (NICE) and that neither the regulatory authorities nor NICE have the full picture. They do not get to see unpublished trial data. We are in chocolate teapot territory.

We are marrying a bride not knowing what she looks like without make-up. She may have a glass eye, wooden leg, a blonde wig and a padded bra. By the time we get her between the sheets there may be more of her on the dressing table than there is in the bed.

Do antidepressants work? We don't seem to know. For people who feel better, they do. For people who don't feel better, they don't. In either case it might be dangerous to assume that the treatments play any part in their recovery.

There is a cunning complication: placebo versus nocebo. It is very nicely explained courtesy of Wikipedia: 'A woman goes to her doctor with an issue. The doctor diagnoses with certainty, then explains clearly the diagnosis and the expected route towards recovery. If he does this convincingly, calming her, removing fear and instilling hope, she will likely, through (something called) positive expectancy, experience the placebo effect, aiding her recovery.

'On the other hand, if her doctor has little time for her, is uncertain about the diagnosis, gives her a prescription combined with a message along the lines of 'this may help sometimes' and adds a message about the horrible side effects (combine this with talking to a neighbour who says more along the same lines about the horrible side effects), the chance of negative subject-expectancy, or nocebo, becomes quite large.'

POOR STATISTICS
If it walks like a mess, talks like a mess and looks like a mess - it's chaos.

Mental health statistics are mind-blowing: in 2002/03, mental health spending by the NHS and local social services in England was estimated at £7.9bn, or 11.8 per cent of health services spending.

MIND, the mental health charity, reports that 55 per cent of GPs believe psychological or 'talking treatments' are the most effective way to treat mild or moderate depression, yet 78 per cent have prescribed an antidepressant despite believing an alternative would have been preferable. Some eight out of 10 GPs admit that they are over-prescribing antidepressants and three-quarters say they are handing out more of the drugs than they did five years ago, even though they may not work.

In 2005, 27.7 million antidepressant prescriptions were written in England, at a cost of £338m.

There seems to be increased recognition among mental health professionals that 'talking therapies' are a better bet than anti-depressants. However, the NHS appears to have failed to act on recommendations from NICE to offer psychological (or talking) therapies to people with depression, anxiety and schizophrenia. Apparently, there is a lack of investment in these therapies. There's a surprise.

In a joint report called We Need to Talk (www.mind.org.uk) the Mental Health Foundation, Mind, Rethink, The Sainsbury Centre for Mental Health and Young Mind all claim waiting times for talking therapies can be as long as six to 18 months. As a result, many GPs admit prescribing antidepressant medications because they can't access talking therapies for their patients.

According to the report, inexplicably, black people are less likely to be offered talking treatments and more likely to be given medication and coercive treatments. Refugees and asylum seekers often find it difficult to access therapies, especially in languages other than English.

IN RESPONSE
What was pharma's response to all this? When the news broke that antidepressants might be no better than snake-oil, there was a loud banging sound as the hatches were battened down. When breakfast time news audiences heard that drug trial data was hidden from regulators' inspection, there was a screeching noise as the wagons were circled.

The Association of the British Pharmaceutical Industry (ABPI) mumbled and fumbled its way through media interviews. In fairness to it, it is indefensible that drugs are licensed on the basis of only favourable data being available. The ABPI can do little else. All the dodgy stuff is locked away in a drawer.

There may be an alternative group we can look to for a more balanced view. The Drugs Information Association (DIA) (www.diahome.org) is a professional outfit with more than 18,000 members worldwide who are involved in the discovery, development, regulation, surveillance and marketing of pharma or related products.

They are going through something of a renaissance and have recently appointed Linda McGoldrick as CEO. McGoldrick comes with an international reputation and, if she were not an American, might be better known as the Duchess of Consultancy. She travels the world fixing healthcare systems and the firms that work with them. She is tough, independent and unlikely to approve of locking anything away in a drawer.

The DIA website says it works 'in a neutral, global environment that operates independent of the influence of any one organisation or authority and operates as a financially independent, non-profit organisation that funds itself from meetings and membership fees'.

It is time we put them to the test. Let's hope they are more effective than some antidepressants seem to be.

The Author
Roy Lilley is a (sometimes controversial) healthcare author and broadcaster

10th April 2008

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