Nearly half the surgeons who made at least $1 million in payments from orthopedic device companies did not have that relationship published in their scientific articles, according to a study released today in the on-line edition of the Archives of Internal Medicine. The study shows that readers are not being adequately informed about conflicts of interest even when the funds involved are significant.
The study, conducted by researchers at the New York-based Institute on Medicine as a Profession (IMAP), is the first of its kind to use company records to check on the accuracy of disclosure information listed in medical journals. The five manufacturing firms studied disclosed the dollars they paid to consultants in a public database. IMAP researchers searched the database and compared the list to the financial disclosure information, if any, listed in the journal articles.
"The findings raise troubling questions about undisclosed payments or royalties and other fees from medical device companies that could lead to biased scientific conclusions," says senior author David Rothman, president of IMAP, a think tank based at the Columbia University College of Physicians & Surgeons in New York City. He co-authored the study with IMAP colleagues Susan Chimonas, associate research scholar and Zachary Frosh, research associate.
The authors note that journal editors typically don't check multiple databases that are now available and simply rely on the honor system. They expect a researcher to disclose all conflicts but do not verify if the information is complete and accurate.
Rothman and colleagues argue that full disclosure in medical journal articles is vital. "These articles constitute a permanent scientific record that is used by practicing physicians, guideline committees, purchasers and patients to evaluate treatment options. Journal editors, reviewers and readers must be fully informed about authors' industry relationship to consider the potential for bias," they write.
IMAP compared 2007 physician payment information from five orthopedic device companies with disclosure of company payments in journal articles. These five companies (Biomet, DePuy Orthopedics, Smith & Nephew, Stryker, and Zimmer) made a total of 1,654 payments that amounted to $248 million in 2007 for consulting, honoraria or other payments for services. The analysis also showed that payments to 41 orthopedic surgeon researchers ranged from just over $1 million to a high of $8.8 million, representing 62 percent of all company expenditures.
These highly paid orthopedic consultants became the focus of the analysis because of the size of their payments. The IMAP team homed in on 95 articles published in the scientific literature after researchers received their large payments and found that fewer than half of the journal articles disclosed a financial relationship between the author and company.
In no case did journal articles reveal how substantial the payments were to the authors. Almost all of articles were directly related to a device, like a hip implant, made by the company. This study focused on orthopedic surgeons but other studies suggest other medical specialists also fail to have their industry ties published.
Rothman says consumers should be concerned. "Patients have a real stake in transparency. You want to make sure that the surgeon is choosing the device that is best for you and that your doctor is not getting biased information."
Growing data show patients are increasingly wary of physician industry ties. A recent study by Consumer Reports showed that half of patients thought that gifts from drug companies influenced their doctor's choice of drugs.
Rothman says editors and others need to start using the company's data bases to get information about physician-industry relationships. No less than 15 drug and device companies are now putting payment information on their websites, says Rothman, a practice that will be accelerated by the Patient Protection and Affordable Care Act. Under the new health reform law, all drug and device manufacturers will have to report payments to physicians in a searchable public database by 2013. Editors, consumers, deans of medical schools and others will then be able to search for any doctor's name and a list of payments from drug or medical device manufacturers.
Having a sunshine policy enshrined in law will make a big difference in promoting transparency, says Rothman. "The next generation of physicians should know that every nickel they take from industry is going to be made public."
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"From Disclosure to Transparency, The Use of Company Payment Data", September 13 issue of the Archives of Internal Medicine .