Journal warned about P&G data

December 9, 2005

The whistleblower who raised the alarm about the probity of his research unit's conduct of a study carried out with the pharmaceutical company Procter & Gamble warned the editor of a prestigious medical journal more than a year ago that he had "serious concerns" about the validity of research it had published.

But the journal confirmed only this week that it had begun an inquiry into the scientist's concerns, first raised in 2004, about research it had published.

The Times Higher revealed last month how findings on P&G's osteoporosis drug Actonel had been released under the name of Sheffield University researchers despite the fact that the academics had not carried out their own independent analysis of the firm's drug-trial data.

Academics from Sheffield's Bone Metabolism Research Unit published an article on the effectiveness of Actonel in the Journal of Bone and Mineral Research ( JBMR ) with the incorrect declaration that "all authors had full access to the data and analyses".

And two research abstracts with further findings on the drug were published by the journal under the name of Aubrey Blumsohn, a senior lecturer at Sheffield, although his access to the drug-trial data had been limited and he had doubts about the conclusions being drawn.

Other material obtained by The Times Higher this week shows that Dr Blumsohn wrote to the JBMR in November 2004. He said that he had concerns about "the probity of data analysis" in the published article, which he had not authored, and about the two abstracts published in his name.

"I am first author on both abstracts and have serious concerns about the analysis which has been presented in my name, as first author. Is there a mechanism for comment of dissociation? (sic)," he wrote.

Amber Williams, the managing editor of the journal, replied with the suggestion that he write a letter to the editor about the published paper and asked for more detail about the abstracts.

Dr Blumsohn asked to have "a quiet and very confidential chat with one of the senior clinical members" of editorial staff. In late December, Ms Williams said she would get back to him.

But almost five months later, Dr Blumsohn had to repeat his concerns. He wrote in May 2005 with details of the abstracts, adding: "Since I am the first author of these abstracts it might be assumed that I vouch for this work and was able to verify the findings. Sadly this is not the case."

In early June, Dr Blumsohn was invited to have a conference telephone call with John Eisman, the editor-in-chief, and Joe Lorenzo, the chair of the American Society of Bone and Mineral Research publications committee. But despite several reminders, no conversation had been set up by September. Dr Blumsohn wrote to complain on September 11.

The Times Higher presented the JBMR with detailed concerns about the journal article on October 14, but received no reply. A further inquiry to Professor Eisman was made on November 5.

He replied that the journal "takes the issues you raise very seriously" but said he could not comment on "unsubstantiated statements".

He said that the journal had had "some communications that may relate to this issue but, despite several attempts to have these detailed, we have been unable to obtain more than the hearsay comments to which you refer".

This week he made a further statement, adding: "We have attempted previously - and would be pleased now - to meet with and receive any further information from Dr Blumsohn. "With the additional information received from other sources recently, we are able to continue our procedures and pursue an internal inquiry into what, if anything, was misrepresented or inadequately represented to JBMR in the process of publication."

P&G has repeatedly insisted that it is "standard industry practice" to limit outside researchers' access to its multimillion-pound drug-trial database, and said that all Sheffield researchers had had sufficient access to satisfy themselves about conclusions being reached.

MPs debate 'excessive influence' of pharmaceutical industry

MPs were due to debate concerns about the pharmaceutical industry's negative influence on medical research as The Times Higher went to press.

A debate on the Commons' Health Select Committee's April 2005 report, The Influence of the Pharmaceutical Industry , was scheduled for the floor of the House of Commons on Thursday.

The report found evidence that "company influence is excessive and contrary to the public good" in some areas. "As it does most of the research, inevitably the industry not only has a major effect on what gets researched, but also how it is researched and how results are interpreted and reported," it says.

The report highlights cases where drug trials were designed to show new drugs in the best light, where pharmaceutical companies had suppressed any research findings that damaged their commercial interests.

It also highlights the practice where professional medical writers working for the drug firms were "ghostwriting" journal articles under the name of independent academics, to give the research more credibility.

"The key question is whether and to what extent these (named) authors designed and conducted the studies, then independently analysed the original data and critically reviewed the article," the report says.

The report concludes: "The regulator, the Medicines and Healthcare Products Regulatory Agency, has failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate. The regulatory authority, which is responsible for controlling much of the behaviour of the industry, has significant failings."

phil.baty@thes.co.uk  

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