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Monday, April 14, 2008

The Parallels of Scientific Misconduct

Dr Aubrey Blumsohn over at Scientific Misconduct has a rather interesting set of posts recently added to his blog.

Although not Seroxat related there are some parallels to the recent investigation of GlaxoSmithKline by the MHRA.

They key to Aubreys posts is basically 'accountability' where he focuses on an individual named Professor Eastell.

Eastell is the Head of the Academic Unit of Bone Metabolism at the University of Sheffield and Honorary Consultant in the Metabolic Bone Centre at Sheffield Teaching Hospital´s NHS Trust.

This from Jennifer Washburn at (Dec. 22, 2005)

Did a British university sell out to Procter & Gamble?

Earlier this month, Sheffield University in Britain offered $252,000 to one of its senior medical professors, Aubrey Blumsohn. According to a copy of a proposed settlement released by Blumsohn, the university promised to pay him if he would agree to leave his post and not make "any detrimental or derogatory statements" about Sheffield or its employees.

...In the summer of 2002, Blumsohn, a senior lecturer and bone metabolism specialist, and Dr. Richard Eastell, Sheffield's research dean, signed a $250,000 research contract with Procter & Gamble. Blumsohn and Eastell were to evaluate the effectiveness of P&G's osteoporosis drug, Actonel. The goal was not to win FDA approval; Actonel was already being widely prescribed. Instead, the Sheffield study would shed further light on how Actonel affects women's bones and their susceptibility to fractures. According to Blumsohn, Eastell had already reviewed blood and urine samples from two previous P&G clinical trials of Actonel. Now Blumsohn was supposed to evaluate a third trial, with the aim of providing a final analysis of all three.

But in the past, it seemed, P&G had not allowed Eastell to perform his own data analysis. In an e-mail that Eastell wrote to P&G and copied Blumsohn on, he confessed that while presenting a paper at the International Osteoporosis Foundation, he had been unable to respond to questions about his own research posed by a fellow academic. "I think that to avoid criticism in the future it would be good if we could say that we had done the analyses independently," Eastell wrote in the e-mail. He suggested that Blumsohn be entrusted with the independent analysis, so he could vouch for results that would be published under both their names.

Blumsohn and his staff reviewed thousands of blood and urine samples from women with osteoporosis. At this stage, they were "blinded" from knowing which patients had taken Actonel and which had taken a placebo. This helped to ensure objectivity. But when he finished examining the samples in December 2002, Blumsohn says he asked P&G to release the codes for the raw data so he could independently interpret the results.

Blumsohn requested the data access codes for 18 months, as numerous e-mails and other records document (here's one). P&G officials wrote back refusing to permit independent access to the data. However, in a written statement, the company denied that it withheld necessary data. "We have appropriately shared our clinical data with both investigators and regulatory authorities, and have conducted our business with the highest of standards."

...the company denied that it withheld necessary data. "We have appropriately shared our clinical data with both investigators and regulatory authorities, and have conducted our business with the highest of standards."

Ring any bells?

The MHRA involvement seems like a state of Déjà vu considering recent events regarding the hidden data of the Seroxat by GSK.

Dr Blumsohn, like myself, has been banging the drum loudly about a prescribed drug, in this case Actonel. Like me, Blumsohn has merely been trying to raise awareness. Actonel Media Case Reports can be read here and the MHRA's 'investigation' can be downloaded in pdf form here.

It reads:

The Sheffield dispute was discussed inthe UK Parliament in December 2005, and was transmitted by the Health Minister to the UK drugs regulator (the Medicine and Healthcare Products Regulatory Agency, MHRA) for “investigation.” The MHRAis itself accused of failing to examine or to secure raw data in drug licensing applications, simply accepting the word of industry with blind faith (6, 14). Since this was precisely the problem in Sheffield, its disinclination to investigate was hardly surprising.

No investigation (or at least anythingfitting that definition) took place. TheMHRA failed to produce any report, declined to accept any documentary evidence (17, MHRA response to FOIrequest #06/115), stated that the matter was of “low priority” (17), and that the agency does not have any procedure for investigating research misconduct (17,MHRA response to FOI #06/188). Further, it claimed that the drug regulator has no remit, nor any necessary obligation to be interested in the integrity of the scientific literature about drugs (17, MHRA FOI#06/188) unless related to licensing (and collected using documentation appropriate for licensing). It even argued that it is“illegal” for a scientist to have data pertaining to information written in his name without the consent of the company“owning” that data (17, MHRA FOI#06/115).

It refused to compare data itwas sent from Sheffield with the original data it should have received and examined as part of the licensing process forActonel. Initially, this refusal was on the basis that it would be “too much work”(17, MHRA FOI #06/059). Later, it admitted that it had not in fact seen or retained raw data prior to approving the drug (17, MHRA FOI #05/404). With governments setting the standard for scientific conduct, it is hardly surprising that independent science has encountered such difficulties.

For some time now Aubrey has voiced his opinion regarding pharma giants Procter and Gamble and the drug Actonel including, and here I quote, "... the serious implications of the failed but rather sad attempts at coverup and delay by "regulators".

That line in itself prompted me to post about this matter on here. Its parallels are plainly obvious.


Related Links

Actonel Case Media Reports
Did a British university sell out to Procter & Gamble?
Money and accountability (Procter and Gamble)
The Scientific Misconduct Wiki (Procter and Gamble)

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7



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