The title of a recent paper submitted to the Public Library of Science Medicine journal – "Initial severity and antidepressant benefits: a meta-analysis of data submitted to the FDA" – does not sound like the sort of document likely to inspire a revolution. But a revolution is precisely what this paper by researchers from the University of Hull promises to effect in the world of clinical depression.
Since they emerged two decades ago as a new, safe, chemical remedy for depression and anxiety, Selective Serotonin Reuptake Inhibitors (SSRIs) have been a staggering commercial success story. These drugs are now taken by some 40 million depression sufferers worldwide. Their names – Prozac and Seroxat – have become emblems of 21st century popular culture.
But the so-called "Prozac Nation" is now under unprecedented threat. The Hull study, which analyses 47 separate clinical trials, concludes that SSRIs provide little clinical benefit for most people with mild and moderate depression and actively help only a small group of the most severely depressed.
The manufacturers of Prozac and Seroxat are questioning the study's conclusions. But the drug companies have a strong commercial incentive in protecting a market that generates considerable revenue. And their history of keeping secret the results of their own drug trials into the effectiveness of SSRIs does not support their position. The Hull researchers had to use the US freedom of information laws to gain access to this unpublished data.
The implications of this study should be clear to policymakers here in Britain, where some 30m prescriptions for antidepressants are being written every year: we need to prescribe vastly fewer of these drugs. Thankfully, the NHS has already been moving in this direction in recent years. The National Institute for Health and Clinical Excellence guidelines state that "talking therapies", rather than drugs, should be offered by GPs as a first response to cases of depression. And Alan Johnson, the Health Secretary, has announced that 3,600 therapists are to be trained during the next three years in England to this end.
This is the right road. Cognitive behavioural therapy has been shown to deliver genuine clinical benefits to depression sufferers. No overall cost savings should be expected from this treatment shift. Fewer Seroxat prescriptions will bring down the NHS drugs bill, but it will cost considerably more to train therapists. Yet, we will end up with a more efficient NHS in the end.
The other major implication of this report is that we need more transparency from the pharmaceutical industry over its drug trials to prevent a similar situation occurring again. Can they be prevailed upon to be more open? The record is not encouraging. Up until now the drug companies have only been willing to publish research that shows their products in a good light.
Is legislation necessary? This is a problematic area. Badly-drafted legislation could jeopardise research. It is not in our interests for drug companies to be prevented from developing and profiting from new products. There is also a question over when exactly to demand the disclosure of trial results from a public safety perspective. A single successful trial for a drug could lead to a spike in demand. But later trials might highlight dangerous side effects. Decisions over disclosure would have to be taken sensitively and on a case by case basis.
Yet some form of compulsion clearly needs to be brought to bear on the drug companies. The overwhelming lesson of the Prozac years is that secrecy is no good for our health.Reuse content