Musculoskeletal Care of the Mature Patient
What’s the best hip or knee prosthesis? What about the type or length of that surgical incision? Is a 23-hour hospital stay for a joint replacement the best option?
Does anyone really know the answers to these questions? In a health care system that spends $2.5 trillion a year, less than one-tenth of 1% is spent on research to determine what treatment option works best. Does Direct-to-Consumer advertising improve patient education or simply increase profits for those who pay to market? Until contracted health care, a patient would be referred to an orthopedic surgeon by a family physician, a family member or a friend. Then came the era of managed care and choices were based on third party payer pre-certification and approval. More recently, the patient has looked to patient information educational initiatives as found on the internet or in the media. But now it is direct advertising such as Direct-to-Consumer marketing to be found every year at this time in the non-professional magazines as the National Inquirer, for sale when you check out at your drug and grocery store.
In April of 2009, an initiative was introduced within the American joint replacement community to create a United States total joint registry. Under development by the American Academy of Orthopedic Surgeons, surgeons will be provided with helpful implant survivorship data. It is important to be aware of the differences between clinical studies and registries. As compared to clinical studies, registries have the advantage of large patient populations, breadth of experience across large numbers of hospitals and surgeons; and immunity to the perception of bias resulting from investigators’ financial ties. On the other hand, registries are typically limited in their ability to measure endpoints beyond survivorship and to control for differences in patient population, patient risk factors and patient expectation.
On May 11, 2010, the Food and Drug Administration (FDA) announced an outreach program to educate health care professionals (including physicians, nurse practitioners, and physician assistants) about the role they play in assuring that prescription drug advertising is truthful and not misleading. The FDA seeks to increase their surveillance effectiveness by curtailing inappropriate prescription drug detailing and drug-sponsored dinners and speaker presentations. According to the Congressional Budget Office (CBO), spending on advertising to health care professionals exceeds direct-to-consumer advertising (DCTA) by nearly 3 to 1. The program will be rolled out in three phases. In Phase 1, the FDA will engage health care providers at medical conventions and partner with specific medical societies to distribute educational materials. The latter phases will build upon the FDA’s, collaborative efforts with physicians and update educational materials developed during the first phase of the programThe FDA seeks to collaborate with health care professionals to address misleading drug promotion, wherever it may occur, including DTCA. Unfortunately at this time, the program does not target medical devices or biologics.
I have been involved in data collection and clinical studies for over 35 years. My many scientific outcomes, patient satisfaction, and prosthetic performance studies leading to publications after total hip and total knee replacement continually provides me with information concerning what works and what doesn’t work. Recently, other criteria for prosthetic performance have been established by way of Product Recall announcements from the several orthopedic manufacturers. The latter is a retrospective announcement when a prosthesis fails to perform after FDA approval and the company is sent a warning letter by the government agency. Until this year, orthopedic companies have been preempted from legal redress for product liability but that protection has taken away by the Congress.
From the patient’s standpoint, be discerning about where you get your decision making input. A second opinion is worth the time and effort before deciding on the need for surgery, the surgeon and the type of implant.
