Drugmakers are going to be 'shamed' into handing over their clinical-trial data on the effects of antidepressants, amid growing concern that the pills may not work as well as originally promised,The Guardian reports.
A government minister has taken the unprecedented step of calling on pharma to give the data to the body that will review the current depression guidelines, the National Institute for Health and Clinical Excellence, or NICE. Ivan Lewis, the minister with responsibility for mental health, says that 'a failure to do so would leave the inevitable impression they had something to hide,' the paper writes.
You may recall that NICE, which looks at the effectiveness of all treatments and recommends to the UK's National Health Service how meds should be used, is embarking on a new look at the SSRI antidepressants. Its most recent guidance was published four years ago. However, NICE has no legal right to see unpublished data and can only request it from a company, which might refuse to give it if the findings were negative, the Guardian writes.
Backed by the government, NICE is now set publicly to ask for all the data, which would leave pharma facing huge criticism if they don't hand it over. The toughening stance follows the publication last week of a study that found antidepressants don't appear to work well - unless they were being given to the most severely depressed patients. The study showed that when patients on the drugs were compared with those who were taking a placebo they showed similar rates of improvement.
The number of prescriptions for antidepressants hit a record high of more than 31 million in England in 2006, with more than four million people thought to be on them, the Guardian writes, adding that, even though official guidance stresses they should not be a first-line treatment for mild depression, they are still being routinely prescribed.
"I have no doubt that medication can and does help some people with mental health problems. Equally a major expansion of psychological therapies that Alan Johnson (the Health Secretary) announced last week reinforces the need for an end to the "prescription not therapy" culture which has characterised our mental health system," Lewis tells the paper. "I would call on any company in possession of any relevant evidence to make it available to Nice. The failure to do so would leave the inevitable impression that they have something to hide.'"
Tim Kendall, head of the National Collaborating Centre for Mental Health, says it has been impossible to get access to unpublished trials in the past. "We know that there have been thousands of trials since the drugs were licensed. We would like to use the data and recrunch it using our own methods and do a proper analysis," he tells the Guardian.
In 2005, the Labour manifesto included a promise to make it mandatory for companies to hand over published data, but under EU law Britain is unable to force foreign companies to do so.