When facing a decision about knee surgery, wouldn’t you want to know if the physician-author of a study in a medical journal comparing the risks and benefits of various artificial knees had any financial conflicts of interest — like, um, receiving more than $1 million from a company that makes a particular artificial knee?
I know I would. Yet, such vital information is all too often missing, as a new study published online Monday in the Archives of Internal Medicine has discovered. After identifying orthopedic surgeons who had made at least $1 million from medical device companies in 2007, researchers found that nearly half of those surgeons failed to cite that financial relationship in scientific articles they published the following year.
“It’s quite clear. The system isn’t working,” said David Rothman, a co-author of the study and president of the Institute of Medicine as a Profession at Columbia University, in a phone interview. That’s worrisome, he said, because journal articles form a permanent scientific record that’s used by physicians, guideline committees, insurance companies and patients to evaluate treatment options.
The study’s finding doesn’t mean we should prohibit doctors who receive industry payments from publishing in journals, he said, but it does mean we need full transparency about such payments. “If someone has a stake in the game, we should know that,” he added.
Rothman has investigated similar conflict-of-interest issues before, but those earlier studies focused on drugs, not devices.
“The sums involved in the medical device world make the sums involved in the pharmaceutical world look bland and uninteresting,” he said. “The dollars involved here are just a different dimension.”
For their study, Rothman and his colleagues searched online public databases for payments to “consultants” from five orthopedic device companies (Biomet, DePuy [part of Johnson & Johnson], Smith & Nephew, Stryker and Zimmer) in 2007. They decided to narrow their focus to the 41 orthopedic surgeons who had received at least $1 million that year. Why? Partly because no one could rationally argue that such a sum wasn’t relevant to disclose.
Payments to the 41 doctors totaled $115 million, representing 62 percent of all such payments ($248 million) disbursed by the five companies in 2007. Much of the money received by the 41 orthopedic surgeons appears to have come from royalities on devices on which the surgeons held a patent, Rothman said.
The researchers then searched for articles published by these surgeons in orthopedic journals between Jan. 1, 2008 and Jan. 15, 2009. They discovered that 32 of the surgeons had published a total of 151 articles during that period. A sampling of these articles (3 to 5 for each surgeon) were closely evaluated. Fewer than half of the articles (44 of 95, or 46 percent) disclosed that the author had a financial relationship with a medical device company. The rate was a bit higher — 54 percent — when the surgeon who had received a device company payment was the first, sole, or senior author of the article. But none of the articles gave any indication of just how huge those payments were.
And here’s a surprising (and discouraging) finding: Journals with stringent disclosure policies were just as likely as those with more lenient policies to publish articles that failed to reveal conflicts of interest.
Rothman said journal editors and others (such as professional medical associations that have doctors sit on committees that formulate clinical guidelines) need to start spot-checking public databases for conflict-of-interest information.
“It might make people more scrupulous,” he said. “There’s that old phrase, ‘People who are watched behave better.’ ”
About 15 drug and device companies currently post payment information on their websites, Rothman said. Most are doing it as part of legal settlements with the Justice Department. But starting in March 2013, as a result of the health-care-reform legislation that President Obama signed into law in March, all drug and device companies must report physician payments worth more than $10. And they must do so in an easily searchable form.
“It will be a lot simpler then,” Rothman said. “But the question is, once we have this disclosure, what will we do with it?” One thing he hopes the new transparency will change: how physicians are selected for professional boards and committees that make recommendations regarding treatment.
The databases should help consumers, too. In the meantime, ask your doctors lots of questions.
“I would want to ask my doctor, “Is the knee you’re giving me the best knee for me, or the best knee for you?” said Rothman. “And then I’d get a second opinion.”