Sunday, December 04, 2005

More on the Blumsohn - Procter & Gamble - Sheffield University Case

We had previously posted on the case of Sheffield University (UK) faculty member Aubrey Blumsohn. The original reports of the case in the Times Higher Education Supplement were not accessible on the web without a subscription. Now the Guardian has also published about it. (See its two articles here and here.)
The Guardian reports much the same story as we had narrated earlier. In short, Blumsohn was the lead scientist (principle investigator) for a clinical study of a Procter & Gamble (P&G) drug, Actonel (risedronate). After Blumsohn lead data collection efforts for this randomized controlled trial, P&G refused to give him the raw data from the trial, or to allow an independent analysis of this data. P&G arranged for three abstracts to be written about study results, which designated Blumsohn first author, even though he did not draft the abstracts, nor, again, have access to the data to which they alluded. Blumsohn eventually made his concerns known about his inability to access the data to several officials at his university. Because, however, the University charged that he did not go through proper channels, and eventually talked to the news media, it has suspended him.
The Guardian reports add something to those by the Times. Particularly revealing was a conversation Blumsohn had with Professor Richard Eastell, head of the university's bone and metabolism unit, about his attempts to get the data from P&G. Eastell said,

The only thing that we have to watch all the time is our relationship with P&G. Because we are... we have the big Sheffield Centre Grant which is a good source of income, we have got to really watch it. So, the reason why I worry is the network within P&G is like lightning. So if Ian [Barton] is unhappy it goes to Arkadi [Chines, global medical director of P&G Pharmaceuticals] and before we know it, there is an issue, there is a problem.
The Guardian also reported that the case may be investigated by the UK Medicines and Healthcare Regulatory Authority. It may also come up in a House of Commons debate this week.
Finally, the Guardian quoted Stephen Evans, Professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, "If a research partnership is a genuine one then there has to be complete openness."

Worse, as we have said before, allowing commercial sponsors to keep data from clinical research done in academic settings secret may
  • cause patients to suffer
  • violate promises made by subjects who volunteered to participate in the research, and
  • conflict with the core mission of the university.
Unfortunately, we have heard of too many university leaders who seem to be more concerned about their industrial funding streams than the interests of their patients, students, and faculty.

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