As orthopaedic surgeons, we have all faced the hard sales—those times when an equipment representative spends time and effort to convince us that their product is just what our patients need. “Widget X is the greatest advance of the last 10 years in orthopaedic care; it will improve patient outcomes, make you more efficient in the operating room, and set you apart from the crowd,” we’re told.

For us, then, the critical question becomes “how can we differentiate fact from fiction?” On one hand, if we keep treating patients the way we were taught in residency, we will fall behind and miss important orthopaedic advancements. On the other hand, if we naively adopt every new product on the market, our patients and reputation will suffer.

We need to be able to recognize salesmanship and to differentiate it from science. The obvious salesman is the equipment representative, whose job it is to get us to use a specific product. We understand this role and typically are prepared to listen critically to any sales pitches. The problems arise when the salesman is disguised.

In 1980, Congress passed the Bayh-Dole Act, which permitted institutions and individuals that used federal grant money for research to capitalize on their research efforts, patent their inventions, and sell these inventions to industry. This simple piece of legislation was instrumental in ushering in a long and successful period of biomedical innovation in the United States. But it also meant that universities, physicians, and scientists all suddenly became potential salesmen. The interests of the ivory towers of academia and corporate America became shared and common. The line that divided the science from the salesmanship became blurred.

How to differentiate science from salesmanship
To tell the difference between scientists and salesmen, we must first know the affiliations of the persons distributing the scientific information. Most medical institutions, journals, meetings, and societies have aggressively implemented mandatory disclosure policies covering affiliations among researchers, writers, and presenters and the industry. These policies are not foolproof. A review of the presenter’s disclosures at the 2008 AAOS Annual Meeting, for example, found that 50 percent omitted listing research money and grants awarded from industry. Nearly one third failed to disclose direct payments.

The problem is that current disclosure policies have no teeth, although this is changing. The recently enacted healthcare reform legislation requires industry to report all payments (direct or indirect) to physicians and teaching hospitals. This will enable responsible groups to verify disclosures and potentially censure or otherwise penalize those who fail to disclose conflicts of interest and affiliations. For more on the AAOS disclosure policy, visit www.aaos.org/aboutdisclosure

We must also understand the concept of level of evidence. The AAOS has made a strong, concerted effort over the last 10 years to educate members on level of evidence. The Journal of Bone & Joint Surgery instituted a mandatory declaration of level of evidence in 2003 in all of its published research, and most peer-reviewed journals have a similar policy.

An understanding of this weighted system enables us to better judge the evidence and decide if we should change our practice methods. The local sales representatives may distribute an article that reports excellent results with their product, but if it is only a case series (Level IV evidence) involving physicians affiliated with the manufacturer, we may want to wait for more solid proof of effectiveness to become available. The research pages on the AAOS Web site have information on evidence-based medicine and levels of evidence.

Finally, we must know who sponsored the research being evaluated. The bias toward positive results for industry-sponsored research is undeniable. The results of hip implant research are favorable 93 percent of the time for sponsored research, but only 37 percent of the time for nonsponsored research. The results of knee implant research are favorable 75 percent of the time for sponsored research, but just 20 percent of the time for nonsponsored research. Spine implant research has similar result disparity.

Innovation and integrity
Creating an environment of innovation is important to keep the United States at the forefront of medical advancements, but maintaining scientific integrity is equally, if not more, important. In a busy orthopaedic surgery practice, salesmen play an important role by often being the first to introduce new advances in technology. Sales representatives also provide valuable support to get needed equipment to the operating room. Our responsibility to our patients and our communities is to recognize what is science and what is salesmanship.

Michael J. Fitzpatrick, MD, is a member of the AAOS Committee on Biomedical Engineering and the AANA Ethics Committee. He receives royalties from McGraw-Hill Publishers, research support from Synthes, USA, and owns shares in a surgery center.

References:

1. Gelberman RH, Samson D, Mirza SK, Callaghan JJ, Pelligrini VD Jr: Orthopaedic surgeons and the medical device industry: The threat to scientific integrity and the public trust. J Bone Joint Surg Am 2010;92(3):765-777.
2. Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M: Accuracy of conflict-of-interest disclosures reported by physicians. N Engl J Med 2009;361(15):1466-1474. Comment in N Engl J Med 2010;362(5):470.
3. Bhandari M, Busse JW, Jackowski D, et al: Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ 2004;170(4):477-480.
4. Shah RV, Albert TJ, Bruegel-Sanchez V, Vaccaro AR, Hilibrand AS, Grauer JN: Industry support and correlation to study outcome for papers published in Spine. Spine (Phila Pa 1976). 2005;30(9):1099-1105.

Additional Links:

AAOS disclosure policy

Levels of evidence