Did a British university sell out to Procter & Gamble?

[Guest guest]

http://www.slate.com/id/2133061/

go to webpage for links embedded in article

Rent-a-Researcher

Did a British university sell out to Procter & Gamble?

By Washburn

Posted Thursday, Dec. 22, 2005, at 2:38 PM ET

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.

Continue Article

In the summer of 2002, Blumsohn, a senior lecturer and bone metabolism

specialist, and Dr. 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

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.

Washburn is a fellow at the New America Foundation and author of

University, Inc.: The Corporate Corruption of Higher Education.

--------------------------------------------------------

Sheri Nakken, R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

$$ Donations to help in the work - accepted by Paypal account

vaccineinfo@... voicemail US 530-740-0561

(go to http://www.paypal.com) or by mail

Vaccines - http://www.nccn.net/~wwithin/vaccine.htm

Vaccine Dangers On-Line course - http://www.nccn.net/~wwithin/vaccineclass.htm

Homeopathy On-Line course - http://www.nccn.net/~wwithin/homeo.htm

ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL

OR LEGAL ADVICE. THE DECISION TO VACCINATE IS YOURS AND YOURS ALONE.

******

" Just look at us. Everything is backwards; everything is upside down.

Doctors destroy health, lawyers destroy justice, universities destroy

knowledge, governments destroy freedom, the major media destroy information

and religions destroy spirituality " .... Ellner