[e-drug] UK: all Clinical Trials to be published before registration

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: UK: all Clinical Trials to be published before registration
-------------------------------------------------------------------
[Labour wants UK to move from self-regulatory promisis to a legal requirement to publish clinical trials results in the public domain before registration of the drug can take place. A good step forward for transparency and against secrecy in drug regulation! Thanks to Andy for spotting. Copied as fair use. WB]

http://society.guardian.co.uk/health/news/0,8363,1457583,00.html 

Tighter controls promised on drug claims 

Pharmaceutical companies to be forced to publish details of side-effects 

Michael White, political editor
Tuesday April 12, 2005
The Guardian 

Pharmaceutical companies will be forced to publish the findings of all their
clinical trials, including potentially adverse side effects, as a condition for
obtaining a UK marketing licence for new drugs, Labour's election manifesto will
promise tomorrow. 

It would mean that both doctors and patients would be able to check the downside of
"wonder drugs" being promoted by the big global firms simply by logging on to an
agreed website which meets internationally endorsed standards of openness. 

The proposed change, which would require legislation in the next parliament, would
help to restore public trust on both sides of the Atlantic, after confidence in the
industry was undermined by a series of scares. 

The move, proposed by the health secretary, John Reid, follows years of controversy
and concern about such drug groups as anti-depressants, which are widely suspected
of making children or young people suicidal or aggressive. 

An 18-month inquiry by the Medicines and Healthcare Products Regulatory Authority
(MHRA) concluded last December that there was no firm evidence of drugs such as
Prozac and Seroxat causing self-harm or suicide in adults, unlike its conclusion a
year earlier that young people were at risk. It recommended monitoring of the
under-30s and steps to ensure depressed patients do not exceed the stated dose. But
the royal colleges of medicine and mental health charities still complain that the
regulator had seen only the firms' own summaries of the clinical trials. 

"People sometimes wonder if early warning signs of the downside haven't been missed
or concealed," a Labour official said. 

The side effects of anti-stroke drugs such as Vioxx and other inhibitor medicines
have also been the subject of concern. 

Some drug companies have been caught out not publishing data which did not support
their own claims about the benefits from potentially profitable discoveries. 

As a result of disappointing results from health minister Lord Warner's efforts to
encourage more voluntary openness - encouraged by the industry's own association -
the wording of tomorrow's manifesto will state: "We will require registration of all
clinical trials and publication of their findings for all trials of medical products
with a marketing authorisation in the UK." 

In practice it will mean that new drugs would be licensed only if their trial data
was published in a "peer review" journal - the top medical magazines - or on a
recognisable database, such as the MHRA's website or others approved by the World
Health Organisation, within three months of getting the licence.