Dispute raises concerns on drug-funded studies

Missing data
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.

'Veneer of credibility'
“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.

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