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Medical Practice and Government Regulation

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In July, the Food and Drug Administration issued a warning about serious complications associated with the use of surgical mesh in gynecological surgical procedures. Based on 1,500 reported complications between 2008 and 2010, the letter advised surgeons to consider the risks of using mesh and recommended that patients be fully informed of potential complications. The mesh was approved for use 10 years ago and has been placed in thousands of women. Complications include perforation of the intestine, hemorrhage and death. Still more disconcerting, the FDA warning points out it is not clear that surgery with surgical mesh is any more effective than alternative procedures without mesh, and use of it may expose patients to greater risks, including impairment of quality of life and the possibility for multiple surgeries to remove it. Furthermore, they warn it may not be possible to remove the mesh entirely and complications may never be completely resolved.

The FDA summarizes the adverse events reported through its Manufacturer and User Device Experience database as well as from peer-reviewed literature. This warning ends with the recognition that rigorous comparative effectiveness research is now essential to prove product safety and efficacy.

It was as a result of a spate of public health disasters associated with a few new drugs and medical devices in the 1970s that public attention was focused on the potential for these kinds of problems. At that time, laws were passed to protect the public. In the 1990s Congress enacted additional regulations to the original statutes.

This is hard to believe, but the standard for approval of medical devices is safety and effectiveness, which is interpreted to mean a new device is equivalent to a previously-approved device. The implicit assumption is if a new device is equivalent to a previously-approved similar device, it will be as safe and effective as that one. Recently, on several occasions, the FDA and the courts disagreed with that assumption, which is at the very least confusing. However, we have a system in which a new device can enter the market because it is substantially equivalent to another device that may have been approved only because (again) its manufacturer showed it was substantially equivalent to yet another previously-approved device. This could and may already have resulted in a cascade of approvals going back to devices that might never have been assessed for safety or effectiveness. To top it off, a new device without any single product to which it is similar can be cleared by having various characteristics that are equivalent to individual traits of two, three or more different previously cleared devices and those devices do not even have to have been marketed! In this case, there may be no real-world experience to provide a basis for assessing safety or effectiveness.

Recently, a committee of the FDA decided this house of cards should be replaced with an integrated, pre-marketing and post-marketing regulatory process where a database is created to permit ongoing evaluation of the safety and effectiveness of a device. The experience with the use of surgical mesh in gyn surgery demonstrates that the only hope for capturing the information needed to maximize the likelihood of uncovering significant risk of serious complications quickly is rigorous post-marketing surveillance. The realization that such a program is sorely needed for all devices and drugs led the FDA to establish the new Risk Evaluation and Mitigation Strategies, REMS.

Recognizing that 90 percent of adverse drug reactions go unreported and that such events reported by physicians is the primary way drug safety is monitored in the U.S. by the FDA, the Physicians Desk Reference network, which is an organization that is a link between physicians and drug manufacturers, has established a mechanism to report such events that is a simple, free online service for reporting adverse drug events -- https://www.rxevent.org/.

As a reaction to the thousands of lives damaged or ended and billions of dollars spent as a result of widely-used, unproven methods and with the acknowledgment that so much of medicine is based on subjective and highly idiosyncratic interpretations of treatment responses, the journal Evidence-Based Medicine (http://ebm.bmj.com/) was founded in 1995 as part of the British Medical Journal group. Evidence-Based Medicine systematically searches a wide range of medical journals, applying strict criteria for the validity of research. Experts critically review the most clinically-relevant articles and summarize them, including commentary on their clinical applicability.

Effective regulation is in its infancy.