Sept. 14, 2010— -- It may not be obvious which study authors are being paid by medical device makers -- especially when the authors earn $1 million or more as consultants, according to new research.
Just 46 percent of the journal articles authored by highly-paid researchers disclosed their financial relationships with the orthopedic device industry, David J. Rothman of Columbia University and colleagues reported in the Archives of Internal Medicine.
Rothman's group examined information on payments by five orthopedic device companies to physicians in 2007 and compared financial disclosures in the recipients' journal articles. Of the 41 individuals who got more than $1 million that year, 32 had published articles relating to orthopedics between January 1, 2008, and January 15, 2009.
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These results show current disclosure policies by both journals and researchers are inadequate, Rothman told MedPage Today. That's troubling, he said, because the articles become part of the permanent scientific record used by practicing physicians, guideline committees, and patients to evaluate treatment options.
"This is a clear conflict of interest that [readers] would want to know about," Rothman said in an interview. "It doesn't mean it shouldn't be published … but readers should know that you have a real stake in this game."
Disclosure policies currently vary across journals, and they often lack specificity.
But there have been movements toward greater disclosure of payments to doctors from drug and device makers, with 15 companies now doing so on their websites.
Disclosure is expected to become even more widespread, with the enactment in 2013 of part of healthcare reform that requires industry to report all payments to physicians that are greater than $10 in a national, searchable database.
"We're entering a new game of public disclosure of income," said Rothman, who warns his medical students that their future earnings from industry will be public information.
Since some data are currently available, the researchers looked at 2007 physician payment information from five orthopedic device companies: Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer; the companies made a total of 1,654 payments totaling $248 million that year alone.
Payments to indivdual consultants were around $150,000 -- with a median of $13,850 -- indicating that a few very high-value payments skewed the distribution, the researchers noted.
Focusing on the 41 researchers who each received more than $1 million from a single manufacturer, compensation ranged from $1,042,238 to $8,862,500. One received more than $1 million from two different companies.
Rothman and colleagues searched for articles published by these researchers between Jan 1., 2008 and Jan. 15, 2009. That timeline would ensure that the authors had received the 2007 payment by the time the article had appeared in print.
They found that 32 of them published a total of 151 articles relating to orthopedics during that time. For the majority of articles (55 percent), the topic was directly related to company payments.
Disclosure of company payments varied considerably. Fewer than half the journal articles (46 percent) disclosed a financial relationship between the author and the device maker.
Only seven of 95 articles provided information on exactly how much money the doctor made.
And journal disclosure policy didn't seem to matter. Articles in those with more stringent policies were no more likely than those with more lax policies to reveal an author's relationship with industry.
Nor were there differences in disclosure based on the author's status as first, middle, or senior author.
The researchers concluded that current journal disclosure policies "do not yield complete or consistent information regarding industry payments.
This may be because journals don't solicit or don't publish complete financial disclosures. Or, authors may believe that payments from device makers are not relevant to research reports, they added.
To mitigate the situation, journals should collect comprehensive information about authors' commercial relationships, Rothman said. They should also figure out ways to publish the information contained in the upcoming 2013 national database of disclosures.
"We're urging the leadership of medical institutions and journals to start now," he said. "Start using the information that's publicly available."