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UK doctor questions P&G over Actonel study

Academic alleges that company denied him full access to data for research written in his name

The thorny issue of ghost writing in drug research has been raised again after a senior doctor in the UK said US firm Procter and Gamble (P&G) had published a study in his name even though he had not been given full access to the data it was based on.

The claims were made by Dr Aubrey Blumsohn, senior lecturer and bone metabolism specialist at Sheffield University in the Observer after he became concerned about the analysis of data he had collected as part of a study on drugs manufactured by Procter and Gamble, including blockbuster osteoporosis treatment Actonel.

Dr Blumsohn said the eventual report was written by an `external medical writer' at P&G's expense before being given to him to agree. He claims that he was prevented from seeing the full data for nearly a year, despite being named as the lead author on the study, and having two reports published in his name.

He also claims that for nine months between 2002-03, he struggled to see the data and sent evidence in the form of taped telephone conversations and emails to the Observer to prove it. One email from P&G tells Dr Blumsohn that Mary Royer, the external medical writer, was familiar with ìthe risedronate data and our key messagesî.

Two years after he first raised the issue, Dr Blumsohn said he was suspended from his university post after he threatened to speak to the medical press.

P&G has strongly denied the claims, saying that it is ìstandard industry practiceî not to hand over all data to academics. The company said that it had given Dr Blumsohn as much access as possible to the information that formed the basis for papers and conference posters about the effects of Actonel.

ìThe study being discussed by Dr Blumsohn was a post hoc analysis of existing data, carried out several years after the pivotal trials, to explore the role of a surrogate marker, and was not in any way related to the efficacy or safety of Actonel,î said P&G in a statement. ìDr Blunsohn was not an investigator in the clinical trials that generated these data, and was not engaged in the pre-specified analyses of the data to support approval of the drug.î

UK regulator the Medicines and Healthcare products Regulatory Agency (MHRA) said it would hold an initial inquiry into the allegations. ìAn allegation has been made and the MHRA is investigating,î said a spokesman.

Despite the allegations, Dr Blumsohn said that the concerns he raised did not question the safety and efficacy of Actonel, which has a good record of reducing the risk of broken, hips, spines and wrists.

Actonel (bisphosphonate risedronate) is used to treat osteoporosis in postmenopausal women and Paget's disease (a deformed bone disorder) and made annual sales of $1.35bn in 2004. It competes with the best-selling drug in the osteoporosis class, Fosamax (made by Merck & Co).

30th September 2008

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