drugtrails

The pharmaceutical industry has spoken out against introducing transparency when conducting clinical trials.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) have argued that the process must remain secretive in order to boost competition and increase their bottom line.

Director of the EFPIA, Richard Bergstrom made the arguments after the organisation was pressured into publishing new ethical commitments relating to clinical research, following accusations of a lack of clarity about how drugs were tested.

But he complained that being too honest about the way drugs were tested, would limit the European pharmaceutical industry’s ability to protect trade secrets and compete with other drug companies from across the world.

He said: “We don’t want our competitors to learn too quickly about how we go about the clinical trials. We believe that a framework which is run by the industry itself is much more likely to take care of these balances. Maybe we have come slowly to this debate – both the regulators and the industry – but we’re doing this now. Maybe we could have done this a year ago or two years ago, but nevertheless, it’s not too late.”

The pharmaceutical industry has sparked fierce criticism over recent years over the lack of transparency on clinical trials. Those accusations were highlighted by Ben Goldacre, in a book called Bad Pharma. Goldacre is a research fellow of epidemiology at the London School of Hygiene and Tropical Medicine, and a co-founder of the transparency campaign All Trials.

In his book, Goldacre revealed how many of the medicines currently on the market are usually tested using techniques that exaggerate the benefits of treatment, therefore producing inaccurate results that systematically favour the manufacturer.

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It was also found that when unfavourable results were discovered, pharmaceutical companies were able to hide those results from doctors and patients, so that the public only ever sees a distorted picture of any drug’s true effects.

Speaking at a conference organised by the EFPIA, Goldacre said that only around half of the clinical trials that are being done today are being registered, and positive results are twice as likely to be registered.

He added: “It’s important that we do get hold of clinical study reports because there can often be methodological shortcomings in the design of the trial which means that it’s no longer quite such a fair test, as one might think, which are glossed over in the brief reports in academic journals or a regulator website.”

In May, the European Parliament’s environment and public health committee gave unanimous backing to proposed new EU guidance on clinical trials aimed at simplifying and harmonising rules that will encourage research while keeping patients safe.

But Goldacre said the EFPIA’s new commitments didn’t go far enough as they would only cover new clinical trials.

“The one thing that would fix all of this is retrospective access. So we need access, I would say going back two decades to look at the error of approval for current prescribed medications.

“We need to go back two decades for all clinical trials for all prescribed treatments. We need them registered, we need summary results and we need an appropriately reacted clinical study report,” he said: “And I don’t think there’s any ethical argument against that. Patients are harmed if we fail to do this.”

The European Medicines Agency is currently conducting a consultation to formulate new transparency rules and will publish its final policy in November.

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