Payout in P&G drug data row

April 7, 2006

The researcher who raised the alarm over restricted access to trial results has settled with Sheffield University. Phil Baty reports

Sheffield University has reached a settlement with the whistleblower it threatened to sack after he raised concerns about scientific misconduct at the university, and it has dropped all disciplinary charges against him.

It is believed that Aubrey Blumsohn, who has parted company with the university, has received a six-figure payment to settle his differences with Sheffield. Both parties refused to provide details about the terms of the deal. Dr Blumsohn, who declined to comment, had earlier rejected an offer from Sheffield of £145,000, including £25,000 compensation for injury to feelings, because it included an extensive gagging clause.

Dr Blumsohn's concerns surrounded the conduct of a drug study that university researchers were working on in collaboration with pharmaceutical giant Procter & Gamble. Sheffield this week confirmed that it would conduct a review of the allegations "to enable an independent panel to look into these issues", two years after concerns were raised internally.

This week, the university issued a brief statement to staff, which says:

"Dr Blumsohn... left the university on 31 March 2006. Dr Blumsohn and the university are pleased to announce that they have compromised their differences upon mutually satisfactory terms, which they have agreed will remain confidential."

Sheffield later released the statement to The Times Higher .

Dr Blumsohn, senior lecturer at the university's Bone Metabolism Research Unit, was suspended in September after openly co-operating with a Times Higher investigation.

He informed the university that he was talking to the media after losing faith in its internal systems for dealing with such allegations. He was subsequently told that he could lose his job over alleged "conduct incompatible with the duties of office".

The charges included raising concerns outside agreed university procedures, "briefing journalists" and "distributing information, including a Times Higher article, to third parties with apparent intent to cause embarrassment".

After working with Dr Blumsohn, The Times Higher reported in November that researchers from his unit had published findings on P&G's billion-dollar osteoporosis drug Actonel without conducting independent analyses of the drug-trial data.

Richard Eastell, head of the unit, had published research findings on the drug despite relying solely on P&G's in-house statisticians to interpret the results of laboratory tests.

Dr Blumsohn, who joined the study in 2001, said he was repeatedly refused access to drug-trial data, preventing him from verifying findings that were published by P&G in his name. When he eventually gained limited access to data, he expressed doubts about the conclusions being drawn.

The case, which was raised in Parliament and in the US Senate, led P&G to issue a "bill of rights" guaranteeing academics access to its data and ensuring independence of academic research it sponsors.

There were never any questions about the drug's safety, and P&G always maintained that the Sheffield researchers had sufficient access to the data to satisfy themselves about any conclusions being published.


'Malign' effect

An MP is concerned about the limited progress of a government-backed investigation into the conduct of Sheffield University's study of Actonel, Procter & Gamble's billion-dollar osteoporosis drug.

After The Times Higher reported concerns last November that Sheffield researchers had put their names to the findings of a study on Actonel without carrying out their own independent analysis of the firm's drug-trial data, the Government's Chief Medical Officer asked the Medicines and Healthcare products Regulatory Agency to investigate.

But correspondence between the whistleblower, Aubrey Blumsohn, and the MHRA shows that little progress has been made.

On February 15, he wrote to Ian Oulsnam, the MHRA's senior investigator: "I have not been asked to provide any documentary evidence or data, no party at the MHRA has arranged to meet with me." In early March, he wrote: "I have no idea what you are supposedly 'investigating' since, as you know, you have had no relevant evidence or information from me and seem not to understand the ethical or scientific problem."

In the correspondence, Mr Oulsnam calls the case "low priority" and explains that the MHRA does not have a proper remit to investigate the issue because its "priority" is to inspect clinical trials where the risk to patients is "more apparent and immediate".

Paul Flynn, a Labour MP, said: "I trust entirely in Aubrey Blumsohn's integrity, but if the MHRA told me it is Monday I'd check the calendar. I have long campaigned against the malign selfish, greedy influence of the pharmaceutical industry in academic life and in subverting science. Their tentacles spread everywhere including deeply into the MHRA, which is the pharmaceutical industry regulating the pharmaceutical industry."

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