Don’t Use Journal Articles for Device OK: Public Citizen
Public Citizen says that a provision in the 21st Century Cures legislation that would encourage FDA to rely on articles published in peer-reviewed journals to determine the effectiveness of a medical device is a bad idea. In its second report on specific provisions of the legislation, Public Citizen says that while peer-reviewed journals can provide valuable information related to using medical devices, the evidence in the studies is not validated by FDA and many peer-reviewed articles contain errors, omissions, misrepresentations, or fraudulent information. “Conflicts of interest between authors of peer-reviewed journal articles and device manufacturers may increase the likelihood of such problems occurring,” the advocacy group says.
While FDA already approves a very small percentage of high-risk medical devices based on information in peer-reviewed journals, the report says, the 21st Century Cures provision would pressure the agency to rely more on this practice. “We strongly recommend that Section 2222 be removed from the bill and that peer-reviewed journals not be relied upon as a basis for determining the effectiveness or safety of medical devices,” it says.
To support its position, Public Citizen describes case studies involving Medtronic Infuse and the CardioMEMS Champion Heart Failure Monitoring System. It says that initially the two devices were subjects of glowing reports in peer-reviewed journals, but later information raised doubts about their safety or efficacy.
“The 21st Century Cures Act would dangerously undermine the quality of FDA review in numerous ways,” the report concludes. “One provision, which would pressure FDA to grant approvals for the highest-risk devices based primarily on evidence summarized in peer-reviewed journal articles, rather than independently reviewing the underlying data, could prevent important safety and efficacy concerns from coming to light. This will potentially lead to larger numbers of ineffective and unsafe medical devices reaching the market. The requirement for a Class 3 high-risk device to gain PMA (premarket approval) should include the submission of rigorous and comprehensive clinical data, and not depend on the brief and potentially biased summaries published in peer-reviewed journals as the sole source of information about a high-risk device.”