I realize that the NEJM is a highly revered journal, beyond reproach, and is thoroughly peer-reviewed. It is frequently cutting edge and, to my mind, sometimes a bit far to “the left,” but always “Bostonian.” The original articles are always highly scrutinized by an excellent editorial staff and reviewers. So it is with great thought that I make any critical comments about the article “Conflict of Interest Disclosures Reported by Physicians” (NEJM, October 8, 2009). (See “Are orthopaedists trustworthy?”)


Published 11/1/2009

Disclosure is “good” for the soul

For a number of years I have been a reviewer for The Journal of Bone and Joint Surgery and the Journal of Pediatric Orthopaedics (I often wondered why), and now I have a chance to use these skills in reviewing an article from The New England Journal of Medicine (NEJM).

First of all, the objective part of the article cannot be challenged: only 71.2 percent of payments made to orthopaedists from five orthopaedic device companies were self-disclosed prior to the AAOS 2008 Annual Meeting. I think the first point that ought to be made is that the online reporting by the companies was done under very specific requirements imposed by the Department of Justice (DOJ) in 2007. In contrast, the disclosure statements made by the orthopaedists, although required by the AAOS, were self-reported.

I understand the authors’ method of determining relatedness: directly related payments (79.3 percent of which were disclosed), indirectly related payments (50 percent of which were disclosed), and unrelated payments (49.2 percent of which were disclosed). I also agree with the statements that those receiving more than $10,000—especially those receiving more than $100,000—were most likely to disclose and that payment to an individual physician was more likely to be reported than payments to a company or organization or with an “in-kind” component. All of this is hard to argue with, and it is what it is. We should have done better.

The AAOS has been constantly improving its disclosure policy over the years. It is progress, not perfection. I know of three problems—and I think I have a solution to each. One is compliance by the fellows (too much trouble). I think the authors are correct in suspecting that legislation requiring all drug and device manufacturers to publicly disclose payments to physicians will ultimately be passed. I am sure physicians would prefer self-disclosure to having disclosures made by a third party. This is what the AAOS is trying to achieve.

Second, although I believe most orthopaedists want to do the right thing, some are uncertain about what to disclose. At the time, each author was not required individually to report. The primary author on a paper, poster, or exhibit was asked to contact the other authors and get their disclosure information. This may have created some confusion.

In addition, in the follow-up survey conducted by the authors, 38.9 percent of responders said that their reason for not disclosing was that the payment was unrelated to the topic presented. The solution, I believe, is one the AAOS has already developed: to require each author to individually disclose all potential conflicts, regardless of whether or not the relationship is “relevant” to the presentation.

This eliminates both sources of confusion. First, one doesn’t have to decide what to disclose—one simply discloses everything. Second, one doesn’t have to decide how relevant the relationship is—one simply discloses everything. How much simpler—and more honest—can it be?

The third problem may have been that some researchers and educators simply did not disclose prior to the meeting itself. They may have included their disclosure on slides at the beginning of their presentation, as required, or admitted to conflicts under questioning by the session moderators, but because the disclosure was not included in the final program, the researchers could only assume that it was not made at all.

The AAOS has a mandatory disclosure policy; if you don’t submit the disclosure forms, your poster or paper will be removed, and, if you are a faculty member, you will be replaced. (See “Annual Meeting participant guidelines”)

I must admit that I am a bit underwhelmed and disappointed by the variables that were not controlled in the authors’ follow-up survey. When one considers the total number of orthopaedists who participated as presenters, faculty, board, or committee members, the 91 who did not disclose is a small number, and the response rate of 39.6 percent (36 physicians) may not be valid to come up with any conclusions of why orthopaedists did not disclose. Much was made of statistics in the findings, but little was said about the statistical validity of the survey, which was mailed more than a year after the date to disclose had passed.

I was also bothered by the way the survey questions were written. No one is going to answer “Intentionally omitted” when questioned about reasons for not disclosing. As you might guess, the number giving this answer in the survey was zero. This, coupled with the fact that those most likely to disclose payments were those who received large sums, would seem to indicate that the omission was not done to conceal payments but occurred as a result of misunderstanding. We should have known better.

Unfortunately, publication of this “exposé” may help further legislation, resulting in greater government oversight and involvement in medicine. Additionally, I use the term “exposé” because I believe the article went “over the top” in its reporting of the amount of money not disclosed. Was this really necessary, especially since the amount of money received is not disclosed at the Annual Meeting?

The image of the orthopaedic community and the AAOS have recently suffered because of the DOJ investigation. I think the article gave the orthopaedic community another “black eye” in a healthcare environment that is filled with monetary worry and concern. It could have been done better.

Ah, but it’s a new day. The AAOS continues to update and refine its disclosure policy, to close loopholes, and put some real bite in their punitive actions concerning disclosure at the Annual Meeting. We can’t afford to do otherwise, and I applaud our Education Council and Annual Meeting committees for their ongoing efforts to make educators as transparent as possible concerning disclosure, to make guidelines for disclosure clear and concise, and to eliminate commercialism and bias. It will get better.

I will conclude with my “Disclosure is good for the soul” prayer: Lord, we should have known better; we could have done better. But Lord, we are better than we used to be, and we will get even better—and that’s good for the soul.