Article preview reprinted from IN VIVO - August/September 2009
The lines separating politics and the medical device industry have long been erased as industry, regulators and insurers wrangle over critical issues like innovation, product approval and compensation for medical care. But the New England Journal of Medicine tossed itself into the tangle last month by publishing two clinical trials that called into question the efficacy of vertebroplasty, the increasingly common procedure that involves the percutaneous injection of bone cement in the core of a fractured vertebra. Read more...
Critical Vertebroplasty Studies Raise Questions
Article preview reprinted from IN VIVO - August/September 2009
The lines separating politics and the medical device industry have long been erased as industry, regulators and insurers wrangle over critical issues like innovation, product approval and compensation for medical care. But the New England Journal of Medicine tossed itself into the tangle last month by publishing two clinical trials that called into question the efficacy of vertebroplasty, the increasingly common procedure that involves the percutaneous injection of bone cement in the core of a fractured vertebra.
Surgeons swear by the procedure which is said to give recipients a new chance at life as chronic pain disappears by the time the patient's feet hit the hospital floor. But the two clinical studies--conducted over the past four years in Australia and the US--charge that such anecdoctal evidence isn't proof enough. In fact, the reports' writers say the patients in their trial who underwent vertebroplasty fared no better than those in the "controlled intervention" or sham group who merely underwent a simulation of the procedure. Patients in the sham and treatment groups endured identical steps right up to the injection of a local anesthesia into the spine. After that, one group received the injection of cement; the other merely got a smell of the stuff and some skillful pressing on the back to give the impression of the surgery.
The results? In both studies, patients who underwent vertebroplasty and the sham arms reported nearly identical reductions in pain and improvements in mobility at regular intervals over a six-month span. The results of the two studies tapped into the deep and growing reservoir of discontent and questions over the rising costs of health care. The NEJM reports acted as a lightning rod, bringing down a barrage of reports implying that people may be undergoing vertebroplasty unnecessarily. The NEJM studies seemed to reinforce the belief of critics, including President Obama himself, that health care costs can be contained by stopping unnecessary treatments. One network news report ran an earlier interview with President Obama who, speaking generally on the issue of controlling health care costs said, "There is a whole lot of care that is not improving health and my main focus is on how we can stop putting money into things that are not making people healthier—" the clear implication being that vertebroplasty might be one of those things "not making people healthier."
The potential ramifications of those charges put the orthopedics industry--both device makers and doctors--on the defensive. A number of interventional radiologists groups issued statements disagreeing with the conclusions and the methodologies of the study. "This was an extremely interesting study, but the results are far from conclusive due to several weaknesses in the method used. Additional research is definitely indicated," Mubin I. Syed, MD, a neuro, diagnostic, interventional and vascular radiologist, stated. Among the complaints put forth by Syed and others were that the study populations were too small to draw any conclusions. The US study enrolled 131 patients, the Australian study only 78. Roughly half the patients in each study underwent surgery.
-Tom Salemi
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