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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_ (http://www.fraudinscience.org/PG/gag.doc) 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_ (http://www.icmje.org/spon.pdf) 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_

(http://www.icmje.org/#conflicts) 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_ (http://content.nejm.org/cgi/reprint/NEJMe058314v1.pdf) 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. Eastell, Sheffield's research dean, signed a

$250,000

_research contract_ (http://www.fraudinscience.org/PG/contract.pdf) 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_

(http://www.fraudinscience.org/PG/20020527email.htm) 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_

(http://www.fraudinscience.org/PG/20050525mckay.pdf) ). P & G officials _wrote

back_

(http://www.fraudinscience.org/PG/20020708email.htm) _refusing_

(http://www.fraudinscience.org/PG/20020614email.htm) 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_

(http://www.fraudinscience.org/PG/20030424email.htm) 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_ (http://www.slate.com/id/2133061/sidebar/2133098/) 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_ (http://www.fraudinscience.org/PG/statplan02.pdf) 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_

(http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstr\

act & list_uids=12817758 & query_hl=1) 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_

(http://www.fraudinscience.org/PG/20020527email.htm) , 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_

(http://www.fraudinscience.org/PG/20030619email.htm) 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_ (http://www.slate.com/id/2133061/sidebar/2133099/) P & G's " key

message "

about Actonel's effectiveness in reducing bone fractures. Several months

later, Blumsohn _recorded a meeting_

(http://www.fraudinscience.org/PG/20030909audio.htm) 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_

(http://www.fraudinscience.org/PG/attorneyreq.pdf) : " 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_

(http://www.medicalcrossfire.com/online_learning/cme/04_osteo.pdf) 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_

(http://www.fraudinscience.org/PG/20030910audio.htm) 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_ (http://www.slate.com/id/2133061/sidebar/2133100/) . The

university didn't investigate his claims, according to _an article_

(http://www.thes.co.uk/search/story.aspx?story_id=2026780) 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_

(http://www.amazon.com/gp/product/0465090516/qid=1135198879/sr=2-1/ref=pd_bbs_b_\

2_1/103-15128

17-2852621?s=books & v=glance & n=283155) .