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J Wrist Surg 2013; 02(03): 197-198
DOI: 10.1055/s-0033-1341963
Commentary
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Emerging New Technologies and the Medical-Industrial Complex

Contributor(s):
Jesse B. Jupiter
1   Hand and Upper Extremity Section, Department of Orthopaedic Surgery, Massachusetts General Hospital, Boston, Massachusetts
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Publication History

Publication Date:
05 September 2013 (online)

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Perhaps no other area of fracture management has been influenced as much by the emergence of new technology as the fracture of the distal radius. Using Medicare data, Chung et al evaluated trends seen in the United States regarding the treatment of distal radius fractures in the older age population.[1] The authors compared four treatment methods (cast, percutaneous pin, internal fixation, and external fixation) over a 10-year period from 1996 through 2005. The rate of internal fixation of distal radius fractures in the older age population increased fivefold from 3% to 16% in 2005.

Yet in another study by Rozental and colleagues, 45 consecutive patients with displaced unstable fractures were randomized to closed reduction and pin fixation or open reduction with internal fixation (ORIF) with a volar locking plate.[2] While those treated with the locking plate had earlier return to motion, lower functional scores, and lower complications, at one-year follow-up the differences were minimal.

The combination of anatomically shaped implants using angular stable fixation applied onto the volar surface contributed to this rather dramatic change in management. The medical device industry quickly recognized the potential volume of sales, and, over a relatively brief time span, over 30 different manufacturers were marketing their versions of these implants. Design changes were made to meet specific fracture patterns as well as to attract new customers. Not surprisingly, with each new evolution in design has come increased cost.

The most recent implant development has featured the variable-angle locking screw system. Although this system offers the theoretical advantage of being able to reorient the screw if the original placement was intraarticular or the fracture pattern required unique screw placement, has there been sufficient clinical evidence of either its need or efficacy?

What about the issues of cost? Evaluating one manufacturer's prices, we can appreciate the variation in cost with three iterations of volar locking plates. The implant described as the “extraarticular” plate with standard locking technology, which is applicable for the vast majority of fractures in the older age group, sold in Massachusetts in 2012 for $1,338. The more sophisticated plate, known as the “two columns” implant, still using standard locking screws, sold for $1,858. Now we are encouraged to move to the latest technology, offering variable-angle locking screws with a similar anatomic design to the “extraarticular” plate, costing $2,271 (price cited in a personal communication with the Dupuy-Synthes regional manager; note that US prices vary regionally).

Is this a reflection of what some have termed “the medical-industrial complex”? This description is a spin-off from President Dwight D. Eisenhower's warning to the nation in his farewell address in January 1961, when he raised the specter of the growing influence of the military in our society, setting forth the concept of the “military-industrial complex.”[3] Eisenhower recognized that the defense industry was acquiring great political and economic power. He warned about the dominance of federal government funding, which had the potential of compromising the integrity of research and reducing the “scholar” to an “obedient employee.”

Given the three-trillion-dollar healthcare industry, consuming 18% of the U.S. Gross Domestic Product, it is not surprising that the medical industry has become the biggest and fastest-growing business in the United States. The industry reflects the coordinated activities of a vast number of enterprises including physicians, other health care providers, hospitals, insurance companies, and device and pharmaceutical companies.

Margaret Wente, writing in the Toronto Globe and Mail, observed that “ the failure of leadership … includes the entire health-industrial complex where rewards for high-tech medicine and 'breakthroughs' are extremely high. Medical corruption, influence peddling, and inflation of research results are serious problems.”[4]

Dr. Arnold Relman, former editor of the New England Journal of Medicine, as early as 1980 identified the potential risks associated with the corporatization of medicine as a threat to the authority of the physician. He argued that if physicians are to represent their patients' interest in the medical marketplace, they should have no economic conflict of interest.[5]

What might be a reasonable approach when new technology is introduced to the medical “marketplace”? One of the difficulties may reside in how the Food and Drug Administration (FDA) regulates medical devices, beginning with the Medical Device Amendment Act of 1976.[6] Part of the problem may have to do with the FDA classification of medical devices and the differing device approval processes. Class I medical devices such as tongue depressors or blood pressure manometers are exempt 95% of the time from regulation. Class II devices, such as the variable-angle screw plate, require what is known as premarket notification, may require premarket data and postmarket surveillance, and usually obtain approval with the 510(k) process, allowing for a less expensive and more expedited review. The Class III critical devices, such as pacemakers or heart valves, need premarket approval (PMA) supported by clinical investigations, which in turn require an Investigational Device Exemption (IDE) issued by an Institutional Review Board (IRB). In fact, more and more criticism is being directed at this approval process, with the Institute of Medicine Report in July 2011 concluding that “the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one.”[7]

As it relates to the variable-angle technology applied to the distal radius volar plate, one would hope that we will see prospective studies not only addressing the technology with regards to its safety but also critically analyzing how often the position of a screw must be changed, justifying its added expense.