Wednesday, February 27, 2013

Alltrials contd. - UCB warns of data ‘voyeurism’ | Pharmafile

Published on 27/02/13 at 03:28pm
UCB image

UCB chief executive Roch Doliveux has attacked the idea of making all clinical trial data publicly available, saying it could be ‘dangerous and misleading’.

“I support the notion of transparency,” said Doliveux. “I don’t support the notion of voyeurism. You have to put any data in context.”

UCB data is open to ‘credible’ researchers to look at, he went on, but warned against a free-for-all. “That’s the guiding principle: somebody who has the skills to make a decision,” he explained.

Speaking to journalists at the announcement of the Belgian manufacturer’s full-year results for 2012, he said the ‘worst thing’ would be to mislead patients.

“There has to be complete transparency with regulatory authorities and every expert authority in the field,” he went on. “But the idea of posting on the net every patient-level data - that is overload of information.”

It would lead to “misinformation and is really, really bad for patients”, he went on.

Doliveux is a board member of European pharma trade body EFPIA, which has warned against the ‘indiscriminate’ release of data.

Speaking about the groundswell in favour of greater disclosure, he suggested: “It is a very UK topic. I have difficulty even understanding the passion of the debate.”

Given the amount of health-related data online generally, there are more fruitful areas to concentrate on, he believes.

“A big topic in Europe is the whole internet quality of information: how do you give the right information to patients,” said Doliveux. “That’s a real topic, we should really spend our energy on that.”

UCB is already sharing data on failed compounds, he says. “We are starting to do that so we can learn from each other. Everybody’s interested in success.”

But he said: “Transparency in the competitive phase of trials would be destructive for research.”

Doliveux also issued a thinly-veiled warning about the future of R&D in the UK if the upcoming value-based pricing (VBP) negotiations arrive at a formula which pharma companies dislike.

Asked if he understood what VBP might mean, he said: “No. The way it is articulated will be key to the future of a company like UCB investing in the UK, to be blunt.”

UCB’s revenue in 2012 rose 7% year-on-year €3.5 billion.

Sales of flagship arthritis drug Cimzia were up 50%, with Vimpat for epilepsy up 53% and Parkinson’s disease drug Neupro up 40 per cent.

Emerging markets such as China, India and Brazil would be key areas of investment in future, although Doliveux also praised the relative stability of the UK’s business environment.

“I like about the UK that you’re agnostic about where the investment is coming from,” he said. “The openness of the UK is a strength. You have thriving universities, excellence in science and a positive view on intellectual property and the benefits that can flow from that,” he suggested.

Adam Hill

Posted via email from Jack's posterous

No comments: