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P&G Drug Data Verified as False; North American Speaking Trip Underway
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helen delaney
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PostPosted: Mon Jun 26, 2006 12:03 pm    Post subject: P&G Drug Data Verified as False; North American Speaking Trip Underway Reply with quote

http://www.commondreams.org/news2006/0616-11.htm
Common Dreams Newswire

Procter & Gamble Surrenders Data to GAP Client
Drug Data Verified as False; North American Speaking Trip Underway


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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