Are Placebo Trials a Wave of the Future in Medical Devices?
In the wake of a study (reported in the "The New England Journal of Medicine") that arthroscopic surgery in patients delivered no better results than did a placebo procedure, industry executives are asking, "What role should placebo trials play in assessing the clinical value of medical devices or device-driven procedures?
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The lead investigator on the SYMPLICITY HTN-3 trial says sham-controlled trials are sometimes ethically necessary to prevent patients from undergoing ineffective treatments and warns there may be other medical devices on the market that are not as effective as previously thought.
DIRECT, the first placebo-controlled trial of a laser myocardial revascularization technology, did not prove any benefit from the therapy, an announcement that has stirred a hornet's nest of controversy in the TMR/PMR industry. Laser companies and physicians who perform the procedures have been in damage control mode since the announcement. The event has exacerbated the challenges that laser companies were already facing in the early adoption phase of a new treatment paradigm. PLC Systems and Eclipse Surgical feel confident that their technologies are sufficiently different from that used in the DIRECT trial and are striving to reassure physicians, patients and investors. In its efforts to convince skeptical physicians or those put off by the DIRECT results, PLC is banking on its perfusion data and its positive 5-year results for its surgical TMR approach. Eclipse hopes positive results from its clinical trial will help it get approval for the first interventional approach.
Like other hand sanitizer manufacturers, WillSpeed Technology claims its GermBloc “kills 99.99% of germs.” Plaintiffs in a proposed class action filed in Massachusetts federal court allege the claim “grossly overstates” the product’s efficacy, deceiving consumers and endangering them with false confidence.