Industry-Funded Research Disputes Grow

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Wed, 22 Feb 2006 21:21:56 -0500

[sSRI-Research] Industry-Funded Research Disputes Grow

 

 

 

 

 

Industry-Funded Research Disputes Grow

 

By LAURAN NEERGAARD, AP Medical Writer

 

http://www.latimes.com/news/nationworld/politics/wire/sns-ap-research-conflicts,\

1,4397125.story?coll=sns-ap-politics-headlines & ctrack=1 & cset=true

 

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

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

ensure that they print complete results.

 

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

journals, " said Dr. Joseph 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 do so, by declaring they would no

longer publish results of any studies that hadn't been listed in a

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

legislation to mandate full disclosure.

 

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.

 

P & G hired his lab at Sheffield University to analyze samples 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.

 

E-mails that Blumsohn provided to The Associated Press suggest P & G

denied him access to the patient 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.

 

" We've allowed the basic rules of science to be flouted without a

murmur from anyone, " contends Blumsohn, who is meeting this week with

Grassley's staff and drug regulators in Washington.

 

P & G spokesman Tom Millikin said 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 standards outlined by the industry's

Pharmaceutical Research and Manufacturers of America.

 

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

we sincerely regret that, " Millikin added, noting that Blumsohn

willingly discussed the research at two medical meetings.

 

Blumsohn counters that he presented only 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, "

he said. " These companies are using scientists, university scientists,

to give their research a veneer of university respectability and

credibility. "

 

The researcher's case made headlines in Britain, and was raised in

Parliament last December after the university suspended him. Blumsohn

said it was for speaking to the press; reports at the time quoted the

university as saying it had encouraged him to raise his concerns using

proper channels.

 

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 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.