Healthy Skepticism Library item: 16333

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Publication type: news

Bowie C
NEJM & BMJ editors to challenge pharma conducting its own clinical trials
Pharma Times 2009 Aug 27
http://www.pharmatimes.com/WorldNews/article.aspx?id=16490

Full text:

The pharmaceutical industry faces an ethical dilemma when it conducts trials on its own drugs, Dr Jeffrey Drazen Editor in Chief of the New England Journal of Medicine and Dr Fiona Godlee, Editor in Chief of British Journal of Medicine, will argue in the world famous debating chamber at Oxford Union next month alongside Guardian Bad Science columnist Ben Goldacre.

Clinical trials are central to the success of the industry, providing the bedrock of evidence for a medicine’s use. Typically, these studies are conducted and paid for by pharma: in other words, the medicines developed by industry are tested by the industry.

But is this a conflict of interest? Is it acceptable for industry to pay for and run clinical trials of its own medicines – either for the purposes of registration or subsequent use?

Arguing in industry’s favour at the PharmaTimes’ Great Oxford Debate will be Robert Ruffolo, former R&D President of Research at Wyeth, Scott Gottlieb, former FDA senior official and a frequentWall Street Journal columnist, and Vincent Lawton, ex-Managing Director of MSD and President of the Association of the British Pharmaceutical Industry.

“The motion – There is an unacceptable conflict of interest when pharma conducts trials on its own drugs – hits at the heart of the way new medicines are evaluated and how the pharmaceutical industry interacts with researchers, regulators, journals and clinicians,” comments Dr Godlee.

Prof Trevor Jones CBE, who will introduce the debate, calls it a very timely and especially relevant topic to debate in the current climate of expansion of international clinical trial size and requirements. “It will be of particular interest to hear from the expert speakers how the needs of the pharmaceutical industry, regulators, academic researchers, publishers of learned journals and not least, the public, can accommodated”, he notes.

Can any scientific endeavour be run without experimental bias? Have your say by joining us on September 23 at the Oxford Union. For more details and to register your attendance go to www.pharmatimes.com/god