[spam] Research integrity in osteoporosis

sawyerc@erinet.com · medicine forum beginner Joined: 01 Mar 2006 Posts: 1

FOR IMMEDIATE RELEASE
FEBRUARY 22, 2006
10:35 AM
CONTACT: Government Accountability Project
Dylan Blaylock, Communications Director
Phone: 202.408.0034 ext. 137, cell 202.236.3733
Email: dylanb@whistleblower.org

GAP Client Exposes Flawed Procedure in Procter & Gamble Drug Study
Osteoporosis Drug “Actonel” Data Being Misrepresented; GAP Client to
Meet with Congressional Representatives this Week

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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