[Ip-health] [From: Spring Gombe] Drug firms pressed on secret pill data

[Guardian Unlimited]

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Drug firms pressed on secret pill data
Jo Revill, Whitehall editor
Sunday March 2 2008
The Observer


The big pharmaceutical companies are to be 'shamed' into handing over their=
 secret data on the effects of antidepressant medications, amid growing con=
cern that the 'sunshine pills' may not work as well as originally promised.

A government minister has taken the unprecedented step of calling on the dr=
ugs companies to give the data to the body that will review the current dep=
ression guidelines, the National Institute for Health and Clinical Excellen=
ce (Nice). Ivan Lewis, the minister with responsibility for mental health, =
 said that 'a failure to do so would leave the inevitable impression they h=
ad something to hide'.

Nice, the body that looks at the effectiveness of all treatments and recomm=
ends to the NHS how they should be used, is embarking on a fresh look at th=
e antidepressants known as selective serotonin reuptake inhibitors, or SSRI=
s. Its most recent guidance was published four years ago. However, the orga=
nisation has no legal right to see unpublished data and can only request it=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 negativ=
e.

Backed by the government, Nice is now set publicly to ask for all the data,=
 which would leave the companies facing huge criticism if they did not hand=
 it over. The toughening stance towards the companies follows the publicati=
on last week of a major review that examined all available data on the drug=
s, including trials that had not been published.

It showed that antidepressants taken by millions of people worldwide did no=
t appear to work well - unless they were being given to the most severely d=
epressed patients. They found that when patients on the drugs were compared=
 with those who were taking a placebo they showed similar rates of improvem=
ent.

The number of prescriptions for antidepressants hit a record high of more t=
han 31 million in England in 2006, with more than four million people thoug=
ht to be on them. Even though official guidance stresses they should not be=
 a first-line treatment for mild depression, they are still being routinely=
 prescribed.

Lewis said: 'I have no doubt that medication can and does help some people =
with mental health problems. Equally a major expansion of psychological the=
rapies that Alan Johnson [the Health Secretary] announced last week reinfor=
ces the need for an end to the "prescription not therapy" culture which has=
 characterised our mental health system.

'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 impr=
ession that they have something to hide.'

Dr Tim Kendall, head of the National Collaborating Centre for Mental Health=
, said it had proved impossible to get access to unpublished trials in the =
past. 'We know that there have been thousands of trials since the drugs wer=
e licensed. We would like to use the data and recrunch it using our own met=
hods and do a proper analysis.'

In 2005, the Labour manifesto included a promise to make it mandatory for c=
ompanies to hand over published data, but under EU law Britain is unable to=
 force foreign companies to do so.

Copyright Guardian Newspapers Limited 2008

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