Fraud in Science: Rent-a-Researcher_SLATE

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[sSRI-Research] Fraud in Science: Rent-a-Researcher_SLATE

 

 

 

Fraud in Science: Rent-a-Researcher_SLATE

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

An article in SLATE by Jennifer Washburn (author of University.Inc:

The Corporate Corruption of American Higher Education ) provides not

only the details of major research misconduct involving Proctor &

Gamble Pharmaceuticals and its osteoporosis drug, Actonel, and the

unseemly conduct of University of Sheffield officials, but SLATE has

posted an array of secret documents backing up the accusations of

misconduct. Such documents are not usually available for public scrutiny.

 

These documents provide a roadmap of (as SLATE aptly calls it) " fraud

in science " - in particular, they demonstrate that when academic

research institutions enter into partnerships with pharmaceutical

companies, thy compromise their integrity and the integrity of

academic scientists who can no longer trust either their academic

colleagues or the institution to act in good faith to protect the

integrity of Science.

 

The documents confirm the company's refusal to provide Dr. Blumsohn

access to key data, and efforts to ghostwrite his analysis for him.

And they reveal that 40% of the clinical trial data was " missing " from

P & G's data analysis of the Actonel trial-which a P & G official

explains as follows: " Because that is contradicting our original

manuscript. " he said. " I just know what Merck are like. I think they

are going to use it. "

 

The documents include:

The research contract between P & G and Sheffield; Sheffield

University's proposed settlement offering Dr. Aubrey Blumsohn

--$252,000 (L.145,000); a taped conversation between a P & G

official, Sheffield's dean of research, and Dr. Blumsohn; finally, a

cache of e-mail correspondence between the three.

 

Academia bears the greatest moral and professional responsibility for

having voluntarily traded its ivory towers for Golden Calfs--selling

out to the highest pharmaceutical company bidders. Academia's sell

out to the pharmaceutical industry has resulted in a credibility

crisis in medicine: the integrity of medical research and also the

integrity of researchers has suffered irreparable damage.

 

" 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. "

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

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

SLATE

Rent-a-Researcher

Did a British university sell out to Procter & Gamble?

By Jennifer Washburn

Posted Thursday, Dec. 22, 2005

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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