On 22 Feb 2006 at 9:25, LucyC wrote:
GLOBE AND MAIL
POSTED AT 11:42 AM EST ON 22/02/06
http://www.theglobeandmail.com/servlet/story/RTGAM.20060222.wrese0222/BNStory/Science/home
Medical research: Who publishes what?
LAURAN NEERGAARD
Associated Press
Washington - Dr. Aubrey Blumsohn was stunned: Research results were
submitted to a scientific meeting under his name - yet the British
bone specialist insists he not only had not written or reviewed the
report, he wasn't sure it was accurate.
The incident turned into a public feud when Dr. Blumsohn charged that
the U.S. drug company paying for the study rebuffed his attempts to
personally analyze the data.
It is the latest in a string of controversies about pharmaceutical
industry control of medical research, from hidden antidepressant risks
to the undercounting of heart attacks in a critical study of the
painkiller Vioxx.
Whoever pays for medical research - not necessarily the scientists
who do the work - controls what doctors, and the public, learn about
its outcome. Scientific journals, including one that published some of
the reports that Dr. Blumsohn now questions, are grappling again with
how to assure that they print complete results.
"This is a major problem, for both researchers and scientific
journals," said Dr. Joseph Lorenzo of the American Society for Bone
and Mineral Research, which has convened a task force to consider
whether extra steps are needed to protect against "hidden biases"
in industry-funded research.
It is an important question, considering that the pharmaceutical
industry provides about 70 per cent of the financing for studies of
medications in the United States.
Questions about that research started making headlines in 2004, when a
Food and Drug Administration reanalysis of industry antidepressant
studies concluded that those drugs sometimes increase the risk of
suicide in children.
Then Merck & Co. pulled its arthritis drug Vioxx off the market, after
research found long-term use doubled the risk of heart attacks. Critics
say the risk was played down until then - and last December, the New
England Journal of Medicine revealed that it had published a 2000 Merck
study that failed to disclose some heart attacks, making the drug
appear less risky than later determined.
Reeling from bad publicity, the industry pledged to do better at
revealing results of clinical trials. Editors of leading medical
journals attempted to force them to, by declaring they would no longer
publish results of any studies that had not been listed in a public
registry. Republican Senator Charles Grassley of Iowa is pushing for
legislation to mandate full disclosure of such research results.
But Dr. Blumsohn, in a Capitol Hill visit arranged by the watchdog
Government Accountability Project, is raising questions of more subtle
influence - which Procter & Gamble, the company that funded his work,
disputes.
His lab at Sheffield University was hired by P&G to study data from
thousands of women who used its osteoporosis drug Actonel. The goal: to
determine what rate of bone renewal gives the most protection against
fractures.
He said P&G denied him full access to the data until months after
results had been submitted in his name to the bone society. Dr.
Blumsohn finally got a brief look in July, 2003 - only to conclude
that about 40 per cent of the data were missing, which skewed the
results, he said.
"This issue is about a relationship fraught with misunderstanding,
and we sincerely regret that," P&G spokesman Tom Millikin said.
"Dr. Blumsohn was provided full and unfiltered access to all of the
data that was relevant to the work he performed."
That appears to be in line with industry standards, as outlined by the
Pharmaceutical Research and Manufacturers of America, the trade group.
Mr. Millikin added that Dr, Blumsohn willingly presented the research
at two medical meetings.
Dr. Blumsohn countered that he presented only the data he could
confirm.
"Access to data means you've got the numbers. They redefined access
to data meaning a company statistician would give you some tables,"
charged Dr. Blumsohn, who is meeting this week with Mr. Grassley's
staff and drug regulators in Washington.
"These companies are using scientists, university scientists, to give
their research a veneer of university respectability and
credibility," he added.
The researcher made headlines in Britain, and his case was raised in
Parliament, last December after the university suspended him. He said
it was for speaking to the press. The university said it had encouraged
him to raise his concerns using proper channels, according to reports
at the time.
Many leading scientific journals require researchers to affirm that
they analyzed all the raw data, not averages or compilations from
someone else. Yet a recent survey, published in the New England Journal
of Medicine, of 122 universities' standards for drug-company research
found 17 per cent reported disputes over control of or access to data.
Also, they reported widespread disagreement over whether the companies
that pay for the research should be allowed to help write the results
for publication, or insert their own interpretation of those results.
The American Association of Medical Colleges published principles for
industry-funded research last month that affirm the importance of
access to full data.
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