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Financial disclosure policies bringing orthopedic journals under fire
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A wave of concern emanating from lawmakers, consumer advocates and practitioners themselves about the need for greater financial transparency between the orthopedic industry and physicians has propelled many peer-reviewed journals to once again review and strengthen their author disclosure policies.
Adding fuel to the fire is a recent study in the online edition of the Archives of Internal Medicine which found that nearly half the surgeons who made at least $1 million in payments from orthopedic device companies did not have that relationship published with their scientific articles. The Institute on Medicine as a Profession (IMAP) also reported that in 2007, the five major surgical implant companies made 1,654 payments to orthopedists totaling $248 million, including consulting and honorarium fees.
“Disclosure has been a big problem in our field for a long time,” said James H. Herndon, MD, a professor of orthopedic surgery at Harvard Medical School, who also serves as the chairman of the Board of Trustees for the Journal of Bone and Joint Surgery. But even before the study appeared, the board had started an active conflict-of-interest task force that works with management to address potential conflicts of authors, trustees and the editorial staff.
“I believe that people suspect there is a conflict of interest when there is not full disclosure,” Herndon said. “For instance, articles that have been supported by industry in the past have been shown to report more positive results than negative results. There has been some criticism of the literature because of that. At the same time, we know that industry support is very important and has helped advance orthopedics a great deal. So we are on a difficult course. But I believe full disclosure is helpful.”
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Image: Herndon JH |
From his perspective, Herndon believes the problem of disclosure has worsened over the years because of the escalating amount of money physicians are being paid by industry.
“This puts some question marks on our intentions,” he said. “If a patient is going to have a procedure performed and the surgeon has a financial arrangement with a company whose products he or she is using — especially when that surgeon is being paid large amounts — it is important that the patient be told of the surgeon’s relationship with the company. If not, the patient’s trust in his/her surgeon (and potentially the profession) is at jeopardy if the patient discovers the relationship and believes that money took priority over their care. The patient deserves to have that knowledge from disclosure.” Herndon underscored that the new federal health care reform act “makes it mandatory by 2013 that all financial payments made to physicians appear on a national online registry. In my opinion, that is the tipping point for full disclosure.”
Not all bad
“It is important to emphasize that not all conflicts of interest are necessarily bad, and in some cases it can be helpful,” said Mininder S. Kocher, MD, MPH, an associate professor of orthopedic surgery at Harvard Medical School. “Certainly, many advances that we have seen in orthopedics have happened because of positive interactions between orthopedic innovators and industry.” He also noted that a lot of research dollars now come from industry. “Disclosure of all conflicts is necessary to be completely transparent and to protect the trust in the doctor-patient relationship.”
Kocher is the senior author of a study on self-disclosure rates within the orthopedic community that was published last year in the New England Journal of Medicine. The study found a self-disclosure rate of only 71% at the 2008 American Academy of Orthopaedic Surgeons (AAOS) annual meeting, based on payments to physicians the previous year from five orthopedic manufacturers of mainly total hip and knee prostheses.
“This was a lower rate of disclosure than we had expected,” Kocher said. “Ideally, we hoped for 100% full disclosure. However, I do believe there is now increased scrutiny, even though there are some data that suggests industry-sponsored research is more likely to result in pro-industry findings.”
Adding to the problem, each publication or meeting may have different disclosure guidelines, which can become confusing, Kocher said. “This lack of uniformity is a problem. Are you disclosing all conflicts of interest? Sometimes you are asked to reveal only those conflicts that are directly related to your presentation, which leaves it open to interpretation.” The length of the conflict — be it over the last year or the last 5 or 10 years — and the dollar amount also varies with guidelines, as do whether compensation is though consulting vs. stock options vs. royalties.
According to Kocher, perhaps the solution is not to ask the physician himself for disclosure information, but rather the company through mandatory reporting of payments to physicians. “Vermont and Massachusetts have such laws,” he said.
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Lack of trust
“Nondisclosure is indeed a concern worth addressing in earnest. If nothing else, it is creating an increasing lack of trust in our discipline,” said Augusto Sarmiento, MD, a professor and chair emeritus in the Department of Orthopedics at the University of Miami in Florida, and past president of the AAOS. “Despite mechanisms to ensure compliance with disclosure of conflicts of interest with industry, I doubt how effective those measures have been. It appears to me that the number of flagrant violations continues unharnessed.”
Sarmiento said a major obstacle to increasing the rate of full disclosure is ascertaining the veracity of the disclosures. For oral presentations, “it should be made clear from the outset that future participation in programs will be denied if initial lack of integrity is discovered,” he said. Professional journals “should also be encouraged to develop or to stiffen their rules for acceptance of publications based on similar criteria.”
Sarmiento pointed out that “industry is as guilty as our profession” in inviting nondisclosure. “Long ago, the industry realized that there were many orthopedists ready to violate professional and ethical standards in order to benefit financially,” he said. “In less than two generations, industry has gained virtual control over orthopedic education and the power to dictate the practice of the profession in a major way.”
Overall, the transparency in orthopedics “is as good as that provided by tinted glass,” Sarmiento stated. “The often-stated response ‘my conflicts of interest have been resolved’ is meaningless as far as the orthopedic and lay communities are concerned, because they never learn how the conflicts were resolved. In some instances, kickbacks are camouflaged under the guise of ‘educational endeavors.’”
Sarmiento is encouraged, though, that the surgical implant industry is now posting payment information on their websites. “Hopefully, this will serve as a springboard for the structuring of a solid system that will discourage both surgeons and industry from making matters worse,” he said.
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Ghostwritten articles
Many journals and meetings “have worked hard to enact a strong disclosure policy in the face of increasing public and government scrutiny of the relationships between physicians and industry,” said Stuart A. Hirsch, MD, a clinical professor of orthopedics at Seton Hall School of Graduate Medicine in Newark, N.J. “However, we should also not tolerate articles or presentations that have been ‘company’ scripted – in effect, ghostwritten.”
Fortunately, many journals do not disclose to the peer reviewer any financial relationships. “So for the end-user, this is not a negative,” Hirsch said. Moreover, self-disclosure “should not prevent the author from being published and he should not consider that a threat to the publication of his work. Therefore, it is surprising we are not seeing full-disclosure in all cases.”
But has the pendulum swung too far the other way? In certain cases, yes, according to Steven R. Garfin, MD, who for many years has been a deputy editor for the peer-reviewed journal Spine.
“Transparency is important,” he said. “Yet some societies and journals are now requesting absolute monetary amounts or tight ranges of financial/time involvement. It seems more useful for this information to be included in select newspaper articles rather than in scientific presentations. With the NIH funding fewer studies, one increasingly common area for research support is through industry. This does not necessarily negate or taint the quality of the study. Unfortunately, sometimes that is the interpretation of some readers.”
Initially, disclosure was voluntary at Spine and “not something that many people, including the editorial board, considered,” said Garfin, a professor and chair of the Department of Orthopaedic Surgery at the University of California, San Diego and Orthopedics Today Editorial Board member. “Now disclosure is mandatory. Manuscripts are not reviewed any differently if the authors have specific industry-related affiliations. Reviewers are blinded as to authors’ disclosures.” – by Bob Kronemyer
A note from the editor
SLACK Incorporated, the parent company of Orthopedics Today, also publishes Orthopedics.
References:
- Chimonas S, Frosch Z, Rothman DJ. From disclosure to transparency: The use of company payment data. Arch Intern Med. Published online September 13, 2010. doi:10.1001/archinternmed.2010.341
- Okike K, Kocher MS, Wei EX, et al. Accuracy of conflict-of-interest disclosures reported by physicians. N Engl J Med. 2009;361:1466-1474.
- www.imapny.org
- Steven R. Garfin, MD, can be reached at 350 Dickinson St., MC 8894, San Diego, CA 92103-8894; 619-543-2644; e-mail: sgarfin@ucsd.edu.
- James H. Herndon, MD, can be reached at 55 Fruit St., White 542, Boston, MA 02114; 617-726-5117; e-mail: jherndon@partners.org.
- Stuart A. Hirsch, MD,can be reached at 720 U.S. Hwy 202-206 N., Bridgewater, NJ 08807; 908-722-2033; e-mail: shirsch@pol.net.
- Mininder S. Kocher, MD, MPH, can be reached at 300 Longwood Ave., Children’s Hospital Boston, Boston, MA 02115; 617-355-8423; e-mail: mininder.kocher@childrens.harvard.edu.
- Augusto Sarmiento, MD, can be reached at University of Miami, 10333 SW 72 Ave, Miami, FL 33156; 305-665-6798; e-mail: asarm@bellsouth.net.
Are orthopedic journals doing enough to disclose all relevant conflicts of interest of study authors?
 Douglas W. Jackson |
Perspective is necessary
The editorial boards of the first-rate scientific medical journals are certainly more aware of the extent of the conflicts of interest among authors that exist in the previous literature. They have instituted policies to reduce publication of those articles with identifiable bias and try hard to insure the readers are aware of all the possible conflicts. It is important that this start with the prepublication reviewers having this information as they do the most critical analysis of the methodology and built-in chance for bias in a given study.
It takes resources on the part of the journals to enforce and to some degree police conflict of interest. It starts with the journals providing a clear definition to the authors of just what constitutes a conflict as well as examples. Financial conflicts are the easiest to recognize and document, but there is a spectrum of possible conflicts - including academic promotions, personal and professional relationships and political and religious bias.
While conflicts of interest are not unethical or wrong, placing them in perspective is necessary to maintain credibility and public trust. In some articles, the list of possible conflicts noted in publications can exceed in number the academic pedigree of some authors. No statement by the author will absolve them of all the potential manifestations of conflicts of interest. The conflict can start with the submission for funding of a possible study that will eventually lead to publication. The marketing department of the company considering funding the project may not allow the funding of one arm of the study because it may possibly make their product look bad and this may be the critical arm of the project for clinicians. We are dependent on the author's integrity throughout the entire process. Fortunately, the majority of authors is scientifically responsible and will adhere not only to their high ethical standards, but also to what is expected by others. The raised level of awareness, recognition of some of the conflicts that have gone unnoticed and a genuine commitment to higher standards will benefit us all.
Douglas W. Jackson, MD is chief medical editor of
ORTHOPEDICS TODAY.
 Robert D. D'Ambrosia |
Information needs to be provided by industry
I think orthopedic journals are now doing a good job disclosing relevant financial disclosures. All orthopedic journal editors meet at least once a year, and every year the topic comes up for a discussion. However, I am not aware of any journal that cross-checks the information provided by authors with industry - we simply lack the resources to do so. Further hampering disclosure is the fact that not all industry makes their complete financial disclosures public, especially some of the smaller orthopedic companies. However, much of this information has become more transparent as a result of recent government audits.
Meanwhile, we as journal editors all have strict financial disclosure and conflict-of-interest documents that need to be filled out by all authors. These documents have become increasingly precise and most of the forms used today do not leave much room for omissions.
Furthermore, the 25% of the orthopedic surgeons who are in academic or institutional settings are well regulated in terms of their disclosure. On the other hand, the remaining 75% out in the community are not nearly as regulated, but most of these orthopedic surgeons do not publish in peer-review journals.
At Orthopedics, we updated our disclosure policy in June 2008. In March 2009, we implemented a new form that asks very specific information about financial compensation, including grant support. We are proud to say that our disclosure rate is 100%; we do not publish any article without full disclosure from the authors. In fact, at Orthopedics disclosures are obtained even prior to manuscripts being put into the peer review system.
Overall, I believe the orthopedic publications are currently doing all that they can within the financial means and publishing timeline with which we have to work.
Robert D. D'Ambrosia, MD, is editor in chief of
Orthopedics.
 Jack M. Bert |
"Difficult but necessary"
Disclosure is a difficult, but necessary, issue in the orthopedic industry if it any way affects our choice or procedure or implant when caring for a patient. The ethical dilemma occurs when a physician truly believes, based upon experience verified by scientific data, that the product he or she is using which that individual may have helped develop is best for the patient in the instance it was chosen. Other relationships with industry are irrelevant and in my opinion and are unnecessary to disclose to the patient. However, when recommending a specific procedure or implant, the physician should tell that patient why he has chosen the product that he or she is implanting. When I implant prosthesis or graft material in a patient, I tell that person why I have chosen that specific product or graft material and the success rate for that implant, whether it is a total knee or type of graft for an ACL repair. I have found that patients are becoming more sophisticated regarding implants and procedures and are able to Google results in some cases as well as we can. Thus, I believe it is important that we all do our best to remain transparent in our discussions regarding the most appropriate care that we can provide in any given situation.
Jack M. Bert, MD, is the business of orthopedics section editor of ORTHOPEDICS TODAY.