WASHINGTON - June 16 - Under pressure from Government Accountability Project (GAP) client Dr. Audrey Blumsohn, Proctor & Gamble finally (P&G) released the full research data set for its osteoporosis drug Actonel. Blumsohn had sought these data for four years. As Blumsohn anticipated, the data fail to support P&G’s claim that Actonel is as effective as industry leaders in treating osteoporosis.

Blumsohn is currently on a North American speaking tour, presenting a series of lectures on scientific research integrity and spreading the word about his eventually successful, but overlong uphill battle against P&G. Earlier this week, Blumsohn spoke at the Harvard School of Public Health. Lectures to take place next week will be held at:

• University of Toronto, Toronto, Canada. June 19, 2006.
• Maine Medical Center, Portland, Maine. June 21, 2006.

In Maine, Blumsohn’s lecture is entitled, “Where Are My Data? Learning from Ethical Crises at the University-Pharmaceutical Interface.”

Blumsohn’s story began in 2002, when he was contracted by P&G to study the effectiveness of Actonel by determining how the drug prevented bone fractures and its relation to change in bone resorption, the rate at which bone is removed. P&G hoped to prove that Actonel was more effective than its leading competitor, Merck’s Fosamax, in strengthening bones and preventing fractures in post-menopausal women. As a senior faculty member at the University of Sheffield in the United Kingdom with research experience in skeletal disease, Blumsohn was fully qualified to evaluate Actonel’s effectiveness.

From the onset of the study, Blumsohn was consistently denied access to P&G’s “randomization codes” which are crucial in interpreting the data accrued in Blumsohn’s study of Actonel. In order to avoid data manipulation by corporate drug companies, researchers are supposed to be granted access to full data sets in order to reach informed conclusions. Despite Blumsohn’s refusal to draw conclusions from incomplete data sets, P&G began publishing articles and market reports under Blumsohn’s name without his consent or approval, declaring the effectiveness of Actonel, and going as far to claim the drug’s equivalence to Fosamax. From that point forward, Blumsohn has fought P&G for the release of the full data set, repeatedly demanding the removal of his name in the studies.

In February 2006, GAP’s Food and Drug Safety Program stepped in to aid Blumsohn’s cause, setting up meetings between Blumsohn and multiple congressional officials concerned with consumer safety and scientific integrity in order to raise awareness of this crucial issue. Due to mounting pressure and negative publicity, P&G launched a public relations campaign intended to salvage their reputation. The company first issued the researcher’s “Bill of Rights,” which stated researchers would have access to all information about which they are writing. Finally, in recent months, P&G released Actonel’s full data sets to Blumsohn, a tremendous victory for Blumsohn and GAP. The full data sets verified Blumsohn’s suspicions and provided evidence against P&G for scientific fraud.

“Blumsohn’s tale illustrates the great need for accountability in the pharmaceutical industry, which puts a higher priority on profits than quality and safety,” stated GAP Food and Drug Safety Director Mark Cohen. GAP continues to advocate the need for transparency in the pharmaceutical community in order to eliminate the practice of generating self-serving data to ensure the financial success of products.

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