Forcing drug companies to publish negative trial results ‘is against law’
An election pledge to require drugs companies to publish full details of clinical trials for medicines cannot be fulfilled because it is illegal under EU law, the Government has admitted.
Psychiatrists and health campaigners renewed a call yesterday for all data on the effectiveness of medicines to be published after a review of clinical trials concluded that antidepressant drugs were no more effective than a placebo for patients suffering from depression.
The pharmaceutical industry is encouraged to publish findings of all clinical trials online but is still, to a large extent, allowed to regulate itself. Critics argue that this system is not enough to ensure that patients, doctors and watchdogs, such as the the National Institute for Health and Clinical Excellence (NICE), get the information that they need to assess the effectiveness of drugs properly.
The review referred to trials submitted in the 1980s and 1990s when four antidepressant medications were being licensed by the US Food and Drug Administration.
* Anti-depression drugs 'no better than a placebo'
* Pressures of consumerism make children depressed
The team, led by Irving Kirsch at the University of Hull, examined published and unpublished data from clinical trials obtained under Freedom of Information rules in the United States.
NICE said that it will consider the findings when it reviews its guidance on treatments for depression in December.
It is a criminal offence to withold information about safety issues or adverse drug reactions to the European Medicines Agency or the Medicines and Healthcare Regulatory
Authority, which licence medicines. But companies can still choose to not publish negative studies or supply full details to NICE, which rates the clinical effectiveness and value-for-money of treatments.
The 2005 election manifesto of Labour promised to “require registration of all clinical trials and publication of their findings for all trials of medicinal products with a marketing authorisation in the UK”. But the Department of Health said that it would be illegal, under European regulations, to make companies do this.
Tim Kendall, deputy director of the Royal College of Psychiatrists, who helped to create NICE’s guidance on treating depression, said: “We have called on the Government to change this and it is extraordinary that we did not know about this legal barrier before.”
A spokesman for the Department of Health said: “We planned to support the principle of mandatory registration of clinical trials but legal advice stated this would be illegal under EU law. For that reason we have adopted a voluntary approach in the UK.”
The spokesman said that the department had created a register of trials, which was available publicly, and that it was encouraging the EU to make public its medicines agency register.
The Association of the British Pharmaceutical Industry said that since 2005 all its members have been required to publish findings online within a year of clinical trials taking place.
In the review Professor Kirsch and his team found that even trials suggesting benefit for the depressed did not provide evidence of clear clinical benefit when compared with a placebo.
Louis Appleby, the National Clinical director for Mental Health, said: “New guidance on the treatment of depression will be issued later in the year. Until then the message to patients and doctors remains that antidepressants are an appropriate treatment.”
Thursday, February 28, 2008
Corrupt legislation designed to benefit corrupt corporations against the public interest
Along the same lines of protecting telecommunications for their illicit role in spying on citizens.