Disputes over medical research growing

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Wed, Feb. 22, 2006

Disputes over medical research growing

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 hadn't written or reviewed the

report, he wasn't sure it was accurate.

The incident turned into a public feud when Blumsohn charged that the

U.S. drug company paying for the study rebuffed his attempts to

personally analyze the data.

It's 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 Blumsohn now questions, are grappling anew with how to assure

that they print complete results.

" This is a major problem, for both researchers and scientific

journals, " said Dr. ph 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's an important question, considering that the pharmaceutical

industry provides about 70 percent 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 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 downplayed 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 hadn't been listed in a public

registry. And Sen. Grassley, R-Iowa, is pushing for

legislation to mandate full disclosure of such research results.

But 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. Blumsohn

finally got a brief look in July 2003 - only to conclude that about 40

percent of the data was missing, skewing the results, he said.

" This issue is about a relationship fraught with misunderstanding, and

we sincerely regret that, " P & G spokesman Tom Millikin said Tuesday.

" 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.

Millikin added that Blumsohn willingly presented the research at two

medical meetings.

Blumsohn counters 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, "

charges Blumsohn, who is meeting this week with 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 percent 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 last month published

principles for industry-funded research that affirm the importance of

access to full data.

--

Regards,

" Life is not an exact

science, it is an art. "

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