Friday, March 16, 2007

Actonel, Procter and Gamble, and Things That Go Bump in the Night

We had posted a while back and again here and here about the story of Dr Aubrey Blumsohn's dispute with Procter and Gamble (P&G) and the University of Sheffield in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.

This story, like those of other cases of research suppression and health care whistle-blowers, has not received a lot of press coverage, given their broad implications about the creation, as Wally Smith would call it, of pseudoevidence. To counter this version of the anechoic effect, Dr Blumsohn has his own blog, the Scientific Misconduct Blog, where he has posted updates on his ongoing efforts to get the word out about his dispute with Procter and Gamble and the University of Sheffield.

He just posted a fascinating new story. It seems that Dr Blumsohn submitted an abstract to The International Bone and Mineral Society (IBMS) Meeting (to be held in Montreal) which featured a re-analysis of some of the data of his original study of risedronate. This work failed to show a "plateau effect" in measures of bone resorbtion and fracture. The presence of such an effect was a point of contention between Dr Blumsohn and Procter and Gamble, and the failure to find such an effect did not help arguments the company was making in favor of risedronate.

At the bottom of the abstract, Dr Blumsohn noted that the study was funded by Procter and Gamble, as indeed was the original study from which this data which was re-analyzed had been derived. Blumsohn later received a message that one Dr Christopher Purple, of Medical & Technical Affairs, Procter & Gamble Pharmaceuticals had sent to the IBMS. Dr Purple, who has no known relationship to Blumsohn's study of risedronate, requested that the statement that disclosed support from Procter and Gamble be removed from the abstract. When the IBMS meeting staff learned they had been misled, they restored the funding disclosure statement.

This appears to be a new variant on ghost authorship, in which a ghost author managed temporarily to alter a manuscript without the knowledge of the manuscript's true authors. I have not previously heard of a case in which a disclosure statement was altered with the effect of erasing the support of a commercial sponsor for a project that did not turn out to provide data that fit that sponsor's vested interests.

Add this to the catalog of how pseudo-evidence is created. Add this also as a reminder that those who truly want to practice evidence-based health care need to heed this old Scottish poem:
From ghoulies and ghosties,
And long-leggedy beasties,
And things that go bump in the night,
Good Lord, deliver us!

See also this post on the Clinical Psychology and Psychiatry blog.

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