WASHINGTON - February 22 - Government Accountability Project (GAP) client and Sheffield University senior faculty member Dr. Aubrey Blumsohn is in Washington, D.C. today, beginning a week-long effort to inform Congressional officials and interested parties about data concealment and manipulation performed on behalf of Proctor & Gamble (P&G) regarding that company’s osteoporosis drug, Actonel. The drug is primarily used by post-menopausal women to strengthen bones and help prevent fractures. Blumsohn, the intended lead author on the P&G commissioned study, believes the data actually disprove P&G’s therapeutic claims for Actonel, and says the company used his name in medical reports regarding the drug despite his not having full access to data sets – information that he repeatedly asked for.

Blumsohn works for Sheffield University in England, where he is a senior medical faculty member specializing in bone health. In 2002, Sheffield entered into a contract with P&G to collect Actonel data – the purpose of which was to determine how the drug prevented bone fractures, and how this related to change in bone resorption (the rate at which bone is removed) and bone mineral density. Consistent with research protocols in collecting data, Blumsohn was blind to which research subjects received Actonel and who got placebos. To later analyze the data, he needed its key, P&G’s “randomization codes.” Despite his repeated requests over 18 months, P&G denied him access to the data, even as it published ghost-written abstracts in his name falsely implying the therapeutic equivalence of Actonel to Merck’s Fosamax, the industry leader.

Researchers are supposed to be granted access to full data sets to reach informed conclusions. In 2001, an international coalition of the world’s leading medical journal editors called for all journal article authors to pledge that they had “full access” to drug study data. This was recommended in order to avoid data manipulation by corporate sponsors of product information. That editorial appears in the September 18, 2001 edition of the Annals of Internal Medicine.

In 2004, P&G allowed Blumsohn to review, at one of its British facilities, what the company purported to be the actual data set. In reviewing the data, Blumsohn realized that numerous graphs (illustrating Actonel’s effectiveness in preventing bone fractures) omitted 40 percent of a data set, apparently manipulating results to suit P&G’s marketing objectives. P&G officials told Blumsohn that if these additional data were included in the results, the study would have favored a competitor’s drug – Merck’s Fosamax.

Since that time, Blumsohn has kept raising his concerns regarding P&G with Sheffield University, which subsequently offered him a large sum of money to leave his post. He refused because the settlement agreement required his silence; he was suspended by the university for speaking out about the issue to the BBC. GAP accepted him as a client earlier this year.

“This is all about the way in which science is conducted,” states Blumsohn. “Pharmaceutical companies have succeeded in overturning the usual safeguards and procedures of science for corporate purposes. These drug companies use universities to give research a veneer of respectability and credibility.”

Blumsohn will be in Washington, D.C. from February 21 – 27, meeting with Congressional officials, along with GAP Food and Drug Safety Director Mark Cohen. Cohen is Blumsohn’s lawyer.

“Clearly, this is an example of an American drug company running roughshod over good science to gain product credibility,” stated Cohen. “If drug companies and universities can’t be trusted to conduct honest research, the government needs to step in to protect physicians and consumers from this sort of fraudulent ghost science.”

Both Blumsohn and Cohen will be available to the media throughout the week.

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