RENT-A-RESEARCHER

Forwarded message from http://groups.yahoo.com/group/SoFlaVegans 

[ Subject: Rent-a-Researcher
[ From: "Fidyl" <fidyl@yahoo.com>
[ Date: Sat, 31 Dec 2005
   
Rent-a-Researcher

Did a British university sell out to Procter & Gamble?

By Jennifer Washburn
Thursday, Dec. 22, 2005, at 2:38 PM ET

http://www.slate.com/id/2133061/?nav=fo

Earlier this month, Sheffield University in Britain offered $252,000
to one of its senior medical professors, Aubrey Blumsohn. According
to a copy of a proposed settlement released by Blumsohn, the
university promised to pay him if he would agree to leave his post
and not make "any detrimental or derogatory statements" about
Sheffield or its employees. For several years, Blumsohn had been
complaining of scientific misconduct. His concerns primarily revolved
around a $250,000 research contract between Sheffield and the
Ohio-based Procter & Gamble Pharmaceuticals. Blumsohn claimed that
the company had denied him access to key data and then tried to
ghostwrite his analysis of it. He further alleged that P&G had
engaged in such practices before.

Why did Sheffield, a top-flight research university, try to silence
and get rid of Blumsohn? The answer appears to lie in the complex and
increasingly compromised relationships that have grown up between
some research universities and the pharmaceutical industry. In 2001,
the editors of nearly a dozen prominent medical journals warned that
growing industry interference with academic research (from study
design to data analysis and publication) was threatening the
objectivity and trustworthiness of medical research. The editors
issued new guidelines requiring all authors publishing in the
journals to verify that they "had full access to all of the data"
related to their studies and that they took "complete responsibility"
for "the accuracy of the data analysis."

But in the years since, universities with medical schools have become
dependent on drug companies for an ever-larger share of their
research budgets - roughly 80 percent of clinical research is now
privately funded. And drug companies, in turn, have pressed for
greater control over the research process, making it easier for them
to obscure or delete negative results from published academic papers.
Earlier this month, the New England Journal of Medicine accused Merck
of failing to report three patient deaths in the trial that led to
FDA approval of the painkiller Vioxx, which was pulled from the
market last year because of its association with heart attacks and
strokes. The careful record Blumsohn kept of his dealings with
Procter & Gamble and Sheffield suggests that P&G didn't control
academic research on its own. It needed Sheffield University to
permit incursions on scholarly independence.

In the summer of 2002, Blumsohn, a senior lecturer and bone
metabolism specialist, and Dr. Richard Eastell, Sheffield's research
dean, signed a $250,000 research contract with Procter & Gamble.
Blumsohn and Eastell were to evaluate the effectiveness of P&G's
osteoporosis drug, Actonel. The goal was not to win FDA approval;
Actonel was already being widely prescribed. Instead, the Sheffield
study would shed further light on how Actonel affects women's bones
and their susceptibility to fractures. According to Blumsohn, Eastell
had already reviewed blood and urine samples from two previous P&G
clinical trials of Actonel. Now Blumsohn was supposed to evaluate a
third trial, with the aim of providing a final analysis of all three.

But in the past, it seemed, P&G had not allowed Eastell to perform
his own data analysis. In an e-mail that Eastell wrote to P&G and
copied Blumsohn on, he confessed that while presenting a paper at the
International Osteoporosis Foundation, he had been unable to respond
to questions about his own research posed by a fellow academic. "I
think that to avoid criticism in the future it would be good if we
could say that we had done the analyses independently," Eastell wrote
in the e-mail. He suggested that Blumsohn be entrusted with the
independent analysis, so he could vouch for results that would be
published under both their names.

Blumsohn and his staff reviewed thousands of blood and urine samples
from women with osteoporosis. At this stage, they were "blinded" from
knowing which patients had taken Actonel and which had taken a
placebo. This helped to ensure objectivity. But when he finished
examining the samples in December 2002, Blumsohn says he asked P&G to
release the codes for the raw data so he could independently
interpret the results.

Blumsohn requested the data access codes for 18 months, as numerous
e-mails and other records document (here's one). P&G officials wrote
back refusing to permit independent access to the data. However, in a
written statement, the company denied that it withheld necessary
data. "We have appropriately shared our clinical data with both
investigators and regulatory authorities, and have conducted our
business with the highest of standards."

Meanwhile, Blumsohn says P&G began to analyze his Actonel data and
write up the final results for him to present at the American Society
of Bone and Mineral Research in Minneapolis in fall 2003. The
previous April, P&G statistician Ian Barton informed Blumsohn and
Eastell by e-mail that Mary Royer, the company's medical ghostwriter,
would help write up the Actonel manuscripts for publication. Blumsohn
and Eastell would both be listed as authors. Barton emphasized that
the ghostwriter was "familiar with ... our key messages."

By now, Blumsohn thought he knew what those "key messages" were. In
2004, P&G's main rival, Merck, was due to publish a head-to-head
study comparing its osteoporosis drug, Fosamax, with Actonel. Many
doctors considered Fosamax more effective at increasing bone density
and decreasing the rate at which bones degenerate - and thus probably
also more effective in preventing fractures, the biggest concern for
women with osteoporosis. Fosamax's global sales were $3 billion a
year, compared to about $1 billion for Actonel. In the summer of
2003, Blumsohn received a copy of P&G's proposed "statistical plan"
for analyzing his data. It stated that the purpose of his research
was to bring about an "Osteoporosis Paradigm Shift."

Eastell's earlier research asserting P&G's claims about the
effectiveness of Actonel appeared in June in the prestigious Journal
of Bone and Mineral Research. Eastell and his co-investigators stated
that "all authors had full access to the data and analyses." Based on
Eastell's earlier e-mail, Blumsohn knew that wasn't true and that
Eastell had most likely violated the new safeguards that medical
journal editors had put in place in 2001. Blumsohn says he warned
Eastell they could both be accused of scientific fraud if they kept
authoring papers without seeing the underlying data. A few days
later, P&G's Barton sent an e-mail reiterating that Blumsohn could
not perform his own independent analysis of his data but could come
to P&G's offices to look at it.

When Blumsohn sat down with Barton at the company's Surrey
headquarters in late July, he says he spotted something peculiar. In
one critical graph showing how Actonel affects fracture rates,
Blumsohn noticed that 40 percent of the patient data was missing.
Inclusion of the data, he thought, would have disproved P&G's "key
message" about Actonel's effectiveness in reducing bone fractures.
Several months later, Blumsohn recorded a meeting in which Barton
expressed concern that if P&G included the missing 40 percent of the
data, Merck would exploit the results. "Because that is contradicting
our original manuscript," he said. "I just know what Merck are like.
I think they are going to use it."

P&G denies that it skewed data to achieve desired results, saying
that Blumsohn "was given access to all of the data related to his
research." But the company's previous written statements seem to
contradict this assertion. When Blumsohn's lawyer filed a formal data
request on his behalf, P&G responded: "It is not the standard
practice of P&G to allow unlimited access to raw data from clinical
trials to individual investigators, as these data are proprietary."

In November, Blumsohn won a few concessions. He says P&G agreed to
remove the graph he'd objected to from an oral presentation and to
delete some text from a paper appearing in his name. But P&G's
educational materials and other writings continued to make assertions
about Actonel's effectiveness, which Blumsohn believed the data he'd
seen did not support.

Increasingly, Blumsohn felt he was doing battle not only with P&G but
with his university. Shortly after Blumsohn complained about the
apparent manipulation of his Actonel data, he recorded a conversation
in which Eastell warned, "The only thing we have to watch all the
time is our relationship with P&G." The P&G money "is a good source
of income, we have got to really watch it."

Over the next 22 months, Blumsohn wrote formal complaint letters to
various Sheffield officials. The university didn't investigate his
claims, according to an article in the British Times Higher Education
Supplement. In July, Blumsohn announced that he would go public with
his concerns. Sheffield suspended him in September, citing, among
other things, his "refusal to comply with a reasonable management
instruction by briefing journalists." Sheffield then offered him the
$300,000. Sheffield states that it repeatedly asked Blumsohn to
provide evidence supporting his allegations and urged him to bring
that evidence "through the proper channels." The university says
legal negotiations were initiated "at Blumsohn's request" and
"undertaken in good faith by the University."

Universities have long accepted funding from pharmaceutical companies
to conduct clinical drug trials. But in the past, their professors
insisted on running those trials independently of the sponsor. As the
Blumsohn case makes clear, this arm's-length relationship appears to
be breaking down. Earlier this month, the Wall Street Journal
reported on the growing willingness of some academics to sign their
names - and lend their prestige - to articles and editorials penned by
drug-company ghostwriters. In addition to the Vioxx episode, recent
reports indicate that published academic studies related to the drugs
Celebrex, Paxil, and Zoloft appear to have been skewed when their
authors permitted the suppression of negative results.

The British Parliament has promised to investigate Blumsohn's
allegations. And in January, medical journal editors will be
gathering once again to discuss what can be done to restore the
integrity of the research they publish. One idea that's been floated
in the United States is a new arm of the National Institutes of
Health that could serve as a repository for complete clinical trial
data while also monitoring trials and verifying the accuracy of
published results. Whatever the solution, something needs to be done
soon. Scholarly independence has already taken too many hits.

Jennifer Washburn is a fellow at the New America Foundation and
author of University, Inc.: The Corporate Corruption of Higher
Education.

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