There was no sugarcoating it. Joseph Zuckerman, M.D., the President of the American Academy of Orthopaedic Surgeons, was surprised and disappointed.
A study just published in the New England Journal of Medicine found that 95 of 344 physicians making presentations at the Academy’s 2008 meeting in San Francisco failed to disclose their financial ties to industry.
This was at a meeting with a keynote address by Lew Morris, Chief Counsel, Office of Inspector General Department of Health and Human Services about federal investigations of industry/surgeon relationships. This was at a time when Congress was holding hearings titled “Surgeons for Sale” and a disclosure agreement was being reached between the U.S. Justice Department and the big five hip and knee device makers.
The findings of non-compliance with AAOS disclosure guidelines begs the question of whether or not physician self-reporting worked in 2008 to bring transparency to surgeon/industry relationships and gives additional fodder to “Sunshine” legislation proposed by Senators Chuck Grassley and Herb Kohl.
Self-Reporting Shortcomings
Mininder Kocher, M.D., MPH, an associate professor of orthopedic surgery at Harvard Medical School in Boston and a lead author of the study, says their findings showed self-reporting doesn’t necessarily yield complete transparency. “Disclosure is essential because such relationships may cause pro-industry bias, ” said Kocher after the release of the study.
Kocher and four colleagues looked at the 2007 payments made to physicians by Biomet, Stryker, DePuy, Smith & Nephew, and Zimmer. Those payments were made public as part of the deferred prosecution agreements with the government. The researchers then compared those payments to disclosures made by physicians presenting at the 2008 AAOS meeting or serving on boards or committees of the Academy.
Twenty-one percent of directly related payments and half of indirectly related payments weren’t disclosed, the study found. The 43 directly related payments not disclosed amounted to $4.3 million, while the 16 indirectly related ones totaled $7.8 million.
AAOS policy at the time required physicians to disclose the receipt of something of value from a commercial company or institution that related directly or indirectly to the subject of their presentations.
Presenter Confusion
The leading reason given for nondisclosure was that physicians believed their payments didn’t relate directly to the presentation topic. The study found this by sending a survey to the 91 physicians who didn’t disclose payments in the final program of the meeting. Thirty-six of the 91 physicians responded to the survey.
Survey recipients were asked to choose from a list of potential reasons for nondisclosure that included the following: the payment was unrelated to the presentation topic, the payment was unknown at the time of disclosure, the payment had been received after the disclosure deadline, the payment was not large enough to warrant disclosure, the payment was unintentionally omitted, the payment was intentionally omitted, the payment was disclosed but was mistakenly omitted from the annual-meeting program.
The study found that payments were more likely to be disclosed if they were directly related to the topic of presentation, exceeded $10, 000, and were directed to an individual recipient.
New AAOS Policies
Joseph Zuckerman, M.D., told OTW in an October 8 interview that the Academy put a new disclosure policy into place following the San Francisco meeting. Zuckerman is also a professor and chair of the department of orthopedic surgery at the New York University Hospital for Joint Diseases.
The current AAOS Disclosure Policy reads as follows:
The actions and expressions of Fellows or Members providing education of the highest quality or in shaping AAOS policy must be as free of outside influence as possible and any relevant potentially conflicting interests or commercial relationships must be disclosed. Because the AAOS depends upon voluntary service by Fellows and Members to conduct its educational programs and achieve its organizational goals, this disclosure policy has been designed to be realistic and workable.
2007: The Disclosure Period
Zuckerman said the 2008 meeting in San Francisco was happening in the midst of an evolution of disclosure policies during the time of the Justice Department agreements. However, noted Zuckerman, the 2008 meeting reflected the Academy’s disclosure policies of 2007.
Said Zuckerman, “2007 was the beginning of the ‘Disclosure Period.’ Medical centers and organizations, cardio and psychiatrists had issues [of disclosure].” We were in the midst of trying to ‘refine’ those policies.”
Transitioning to Online Disclosures
The AAOS leader said 2007 was also an important time because it was the last time AAOS members were allowed to submit their disclosure forms by paper. “In 2008, we transitioned to online disclosure. We took these steps without knowledge of this study and made the process tighter with respect to everyone disclosing their relationships, ” said Zuckerman.
By going to an online system, Zuckerman says, there are mandatory fields to be completed and the electronic form can’t be sent without filling out all the fields. This will also make it easier for the Academy to track those documents for the next meeting in New Orleans in the spring of 2010.
In addition, Zuckerman said there are no longer any distinctions made between presentations that relate directly or indirectly to the presenter’s relationship with a company, an item noted by physicians who had failed to report in 2007.
“It will now be left to the listener to decided for themselves if the presentation is related, ” added Zuckerman.
AAOS had symposia in 2008 and 2009 on industry relationships, and another is planned in 2010. The Academy is taking steps to educate members. For those not attending the meeting, multiple articles are being run in AAOS NOW, the Academy’s in-house publication.
“Things have clearly changed since 2008, which reflected the policies from 2007, ” Zuckerman reiterated.
No Retrospective Audits
Because some AAOS members violated Academy guidelines in 2008, we wondered if AAOS would try to find out who those physicians were. And would the Academy go back and audit the 2009 meeting in Las Vegas to measure compliance? Would what happened in Vegas stay in Vegas? [Sorry, we couldn’t help ourselves.]
Drs. Rankin and Zuckerman
Building Playground in
San Franciso/ AAOS photoZuckerman said the Academy has no plans to go back and audit the 2009 meeting to see if disclosures improved. “If someone didn’t disclose retrospectively, what action would we take? Going prospectively is part of a project team review.”
Board Report in December
Last June, the Board of AAOS appointed a Board Project Team, chaired by the immediate past AAOS Board Chair, Anthony Rankin, M.D., to conduct a “complete analysis and review” of all Academy disclosure policies “at every level of the organization with anybody involved in any Academy activity, ” said Zuckerman. The AAOS Board had a preliminary report at its September meeting and will receive a final report in December.
“I expect they would make recommendations to incorporate in 2010, ” said Zuckerman. He continued:
The last thing we want is to have any question related to our Annual Meetings or our members’ participation in the Academy. We want 100% compliance of disclosure…that’s something we’re going to work towards.
We asked Zuckerman if the Academy has considered a third-party audit of disclosures.
“At this point we cannot exclude any way to reach 100% compliance, but that’s not a specific approach we’ve discussed, ” he said.
Asked if he sees any parallels to NASS’ disclosure and divestiture policy which requires the disclosure of specific dollar amounts and possible divestiture of certain relationships with industry, Zuckerman said, “The requirements placed on any specific position you have is something the project team will address.” For example, at NYU, Zuckerman says the IRB policies require that if a physician is in a relationship with a company, the physician can participate in the study, but can’t be the principal investigator or be responsible for evaluating results.
Whether or not AAOS reaches its goal of 100% compliance will be hard to measure without auditing the public disclosures on company Web sites and the self-reported disclosures made by presenters on AAOS-mandated electronic forms.
However, the light shed on AAOS members by Kocher and his colleagues, and the new Academy disclosure guidelines, will certainly remove any excuses of confusion about the disclosure expectations for future presenters. We will watch closely for the AAOS Board Project Team report in December and see how the Academy responds to the “Disclosure Period.”
