Researchers to get a bill of rights from P&G

February 24, 2006

Revelations that academics had published findings on a drug without full access to trial data have led Procter & Gamble to make a commitment to transparency and integrity. Phil Baty reports

Pharmaceutical giant Procter & Gamble has published a "bill of rights" for researchers that guarantees the independence of the academic research it sponsors. The move follows widespread concern over the company's handling of a drug study in collaboration with Sheffield University.

The Times Higher reported exclusively in November last year that researchers at Sheffield's Bone Metabolism Research Unit had published findings on the company's billion-dollar osteoporosis drug Actonel without having conducted independent analyses of the drug trial data.

It was revealed that the head of the unit, Richard Eastell, had published research findings on the drug, which is used to reduce the risk of fractures in those suffering from the bone-thinning disease, despite relying solely on P&G's in-house statisticians to interpret the results of laboratory tests.

Professor Eastell later asked that his university colleagues be allowed to carry out independent analyses to ensure that they could verify P&G's conclusions, but he was refused. And when P&G finally granted limited access to some of its data, Aubrey Blumsohn, a senior lecturer at the Bone Metabolism Research Unit, expressed doubts about the conclusions being drawn and raised his concerns with The Times Higher .

After criticism from MPs and international scientists, P&G this week confirmed it had established a "bill of rights" governing its relationships with independent academics to improve transparency and to ensure that academics funded by the company could fully vouch for conclusions published in their names. The document also guarantees academics' right to publish findings.

A P&G spokeswoman acknowledged for the first time that the company had mishandled its work with Dr Blumsohn, who was named as lead author on published research abstracts but was unable to verify the conclusions made in his name.

"This issue is about a relationship fraught with misunderstanding, and we sincerely regret that," she says in a statement. "In hindsight, we should have dedicated more time to communicate directly with Dr Blumsohn so we could have avoided these issues around how the study conclusions were reached."

She continues: "Our research collaborations at P&G are very important to us. A true partnership in science is built on trust, which is why we have reaffirmed our commitment to our researchers, underscoring our desire for transparency through our researcher bill of rights, which we know only strengthens our already strong relationships with the world's leading researchers."

The company's "bill" says: "Our commitment is to maintain the highest standards of research integrity, sound science and open communication during the research process."

It says that when its collaborations with academics involve publishing data - including abstracts, manuscripts and meeting presentations - "researchers will have access to all data relevant to their work with P&G. Research collaborators have our commitment to their independent analysis of data.

They will have full access to all relevant data to confirm the accuracy of statements and conclusions published with them as co-authors, or when they are cited by P&G as a co-author."

This goes further than P&G's previous stated position, which was that it is "standard industry practice" to limit external access to raw data.

P&G has always argued that it gave the Sheffield team sufficient access to the Actonel data to "be confident and comfortable with the conclusions"

published in their names.

The bill of rights also states that "research authors will define and control the content and direction of any publications resulting from their work" and will have "final authority" over all publication content.

Company-sponsored "ghostwriters" will provide help with writing papers "only if requested".

The company has also pledged that although P&G will retain ownership of its data, researchers will "own the analysis and conclusions" of their studies and will be "in no way" restricted from publishing their findings.

Dr Blumsohn, the whistleblower in this case, said: "It does seem to be a useful statement of intent."

Sir David Weatherall, emeritus professor of medicine at Oxford University, said: "It is very encouraging that a large company has honestly identified that there is a problem and has come out with what looks like a simple and sensible way of dealing with it. I'm really pleased to see this."

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said the bill was "absolutely excellent".

phil.baty@thes.co.uk

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