SHARING RESULTS OF CLINICAL TRIALS

Under new European laws, pharmaceutical companies could be forced to publish secret research into how drugs are created. This could potentially lead to drug companies having to disclose information about dangerous and unknown side-effects of many drugs.

The rules would mean that some of the world’s most powerful pharmaceutical companies would have to share the results of clinical trials which could then be analysed by independent scientists.

Analysts say that the move will also reveal if patients have been fooled by the use of placebos or drugs that have not been scientifically proven to work.

Drug companies have only ever released small amounts of their research data from clinical trials, with critics claiming that spurious and negative results are only half as likely to be published.

The disclosure rules being drawn up by the European Medicines Agency, an EU body, have been met with stiff resistance from pharmaceutical companies. They claim that some of their information might be misinterpreted, which might spark significant health scare’ around the use of particular drugs.

In just the last three years, 26 drug companies have racked up financial fines amounting to more than £7 billion for acting dishonestly.

GlaxoSmithKline (GSK), Britain’s largest pharmaceutical company, announced earlier this year that it would support a move for such laws by publishing the results and data of all its clinical trials.

The move and announcement by GSK followed fierce criticism of the company after it was given a £1.9 billion fine in the United States last year, in part for withholding safety data about Avandria, its best-selling and highly profitable diabetes drug.

A leaked e-mail message from the head of a leading pharmaceutical industry body to company executives revealed that ‘patient groups’ would be used in an attempt to block legislative amendments to the clinical trials directive.

The e-mail, first seen by the Guardian, a London based broadsheet newspaper, was sent by the director-general of the European Federation of Pharmaceutical Industries and Associations, Richard Bergström, to the directors and legal departments at companies including Pfizer and GlaxoSmithKline.

In his message, Mr Bergström says that patient groups will be ‘mobilised’ to express concerns about…

… the risk to public health by non-scientific re-use of data.

Campaigners have hit back and have said that the groups – which are often funded by the companies themselves – are a ‘front for the pharmaceutical industry’.

Health Action International, a campaign group, said it was ironic that such a transparency initiative being promoted by the pharmaceutical industry was now ready to use patient organisations to fight their corner. The health lobby group says that patient groups in the pay of the pharmaceutical industry will now go into battle for them, and has suggested there is a clear ‘hidden agenda’. In a statement the group said:

… Patient groups get traction because they are assumed to represent the voice of the suffering. But industry uses them to say we’re not going to get innovative medicines if the industry is deterred from investing by having to be transparent about their clinical trials.