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nale in white hat.gif
From white hats to camo hats. S. Terry Canale, MD

AAOS Now

Published 9/1/2011

Where have all the “white hats” gone?

A cliché of old movies is that the good guys (such as Tom Mix, Roy Rogers, Gene Autry, and the Lone Ranger) all wore white hats and the bad guys wore black hats. For more than 75 years, the orthopaedic specialty has been building a reputation in medicine as the “white hats.” I like to say that orthopaedics has been the “darling” and the envy of all medicine.

It is, I’m sure, because of what we do. Each orthopaedic specialty—foot, hand, shoulder, spine, hip, knee, sports, tumor, and pediatrics—has made significant contributions, both in techniques and treatments, that enable people to stay mobile and enjoy a better quality of life. As the U.S. population curve increasingly skews toward older ages, the work we do helps keep people “young.”

If the old motivational saying, “you are what you do,” is true, the popularity, success, and impeccable reputation of orthopaedics rest on our patient care efforts. Good marketing, communications, and public relations programs within the AAOS haven’t hurt either.

But for the past several years, orthopaedics has been under fire, and mud’s been thrown at us from all directions because some folks have failed to disclose their close ties with industry and have published biased reports on research sponsored (and potentially influenced) by industry. Suddenly my white hat has turned brown, and I have turned it in for a “camo” helmet. (See my photos.)

Is the criticism of our members justified? In a small number of cases, the answer is “yes.” Are those accused in the media considered guilty before being completely heard? The answer generally is “yes.” But what is important—and what’s not being heard—is that just a few black hats are ruining the reputation of the whole “ranch.”

This is not an easy problem that can be solved by just saying, “Form a posse and round up and get rid of the rascals.” (I define “rascals” as troublemakers with charm.) Orthopaedics needs researchers, inventors, and consultants—but they have to wear white hats. That’s how the field got to where it is today.

This is a big deal, a big problem for the many caused by a few. Tainted research and insufficient reporting of disclosures can influence the future of medicine and orthopaedics in a big way, and we can’t afford to look the other way.

It often is said that to move forward, one needs to live in the solution—not in the problem (defining the problem is part of the solution). I think the following two problems, both of which involve researchers, consultants, and those receiving royalties, must be solved:

  • Lack of disclosure and lack of transparency when presenting results in any forum
  • Fabrication or falsification of results

The disclosure issue
Eliminating (solving) the disclosure problem would seem to have an easy fix: just don’t accept for presentation or publication works of those authors who don’t or won’t disclose. As for what needs to be disclosed to be completely transparent, several organizations, including the AAOS and the International Committee of Medical Journal Editors, have developed definitions.

nale in white hat.gif
From white hats to camo hats. S. Terry Canale, MD

Personally, I think that everything that has a bearing on the results or issues presented needs to be disclosed. If you are writing a “hand” article, I personally don’t care whether you are a member of the AAOS, sit on the editorial board of Clinical Orthopaedics and Related Research, or do woodcarving as a hobby. I do care if you are receiving income in any form (consulting fees, royalties, stocks) from a company that has some relationship to your presentation or publication.

The relationship isn’t necessarily “wrong,” but it and the amount of reimbursement should be disclosed and transparent. There’s nothing wrong with being a consultant or receiving royalties from a company as long as these relationships are disclosed and transparent. Thus, when I hear or read results, I am aware of all the disclosed information and I can determine for myself (just as the journal editors and the reviewers for the U.S. Food and Drug Administration can determine for themselves) the validity or bias of the research.

AAOS Now will not publish work by authors who are not willing to disclose. I believe all orthopaedic publications are moving in this direction, as evidenced in interviews with Jeffrey S. Fischgrund, MD, editor of the Journal of the AAOS, and Eugene J. Carragee, MD, editor of The Spine Journal. (See “Was rhBMP-2 research tainted?” page 1 and the subhead “JAAOS: When in doubt, disclose,” near the bottom of page.)

The accuracy issue
The second problem is harder to solve. How do you round up those “black hats” who falsify results and give all of orthopaedics a black eye? Most journals make an attempt to detect basic flaws in study results (especially if the results look too good to be true), but in most cases, falsification may be impossible to detect without examining each patient in a study or each step of an experiment.

Because fraud generally is about money, many editors try to follow the money to determine whether the results may be biased. But until recently, this was almost impossible to do. Several studies have been discredited, but not until after the information was solidly “set in stone” in the orthopaedic literature, and all that could be done was to publish a retraction in the publication.

One question does come up: Should articles and presentations that are “industry-sponsored” (with appropriate disclosure) be treated differently than those not sponsored by industry? I don’t know the answer, but I would vote “yes, they should be looked at more rigorously.” Solid research will stand up to the strongest scrutiny. Sorry, but that’s my opinion. Everything in life is not fair and equal for everyone; sometimes the white hats get shot at, too.

My bottom line
So what is my bottom line? Disclosure should be thorough, complete, all-encompassing, and totally transparent (let the publication determine what is relevant) or don’t expect to present or publish. To set the tone, here’s my disclosure. As an editor of Campbell’s Orthopaedics, I get royalties from the publisher, Elsevier Health Sciences, which vary by year depending on the number of copies sold. Over the past 3 years, I’ve received $17,350. I direct the “salary” I receive as editor-in-chief of AAOS Now to the Campbell Foundation, so I don’t see a penny of it. I’m a board member of the Orthopaedic Research and Education Foundation, the Campbell Foundation, and the Memphis Bioworks Foundation (a local nonprofit seeking to create a bioscience center of excellence), which amounts to nothing.

If I can be that clear, so can everyone else and “it didn’t hurt a bit.” Disclosure should be an “iron-clad” requirement at every level in every association, as well as for publications and presentations. Industry-sponsored results should be scrutinized to determine if that sponsorship has affected the results and we should be prepared to accuse, expose, and prosecute those responsible for fraudulent claims (if warranted).

The AAOS has adopted Standards of Professionalism (SOPs) on Research and Academic Responsibilities that address this issue. The SOPS establish mandatory standards, and actually call upon orthopaedic surgeons to publicly acknowledge the source of all relevant funding or consulting arrangements and to report and to expose those physicians who engage in fraud or deception.

This may seem radical, but it is a big problem, caused by a few, that is giving a bad reputation to orthopaedics. We have spent so much time and effort to favorably influence public opinion about our specialty, and our reputation shouldn’t be ruined by a few who take industry favors and dollars! Hi-yo, Silver—away!