Editor`s Opinion: Product Safety and Business Interests: Déjà vu…

    The year was 1999. The Prescription Drug User Fee Act to accelerate the drug approval process was 7 years old and the Food and Drug Administration (FDA) was busy implementing the 1997 FDA Modernization Act that included sweeping changes in medical device regulation and product safety monitoring.¹

That year, more than 90% of medical devices, including almost all the products with which Ostomy Wound Management readers are familiar, were reclassified as “Class I exempt.” No more pre-market notification submissions. No more submission of data and waiting for the FDA to review product claims and labeling — most devices were now considered “not substantially important in preventing impairment of human health.”¹ Although the future looked bright for device manufacturers, some clinicians and lawmakers saw dark clouds on the horizon.

    Since the Prescription Drug User Fee Act was implemented, the medical community has voiced concerns about the soaring number of new drug compound approvals, the increasing number of drug recalls, the diminishing capacity of the FDA to monitor drug safety, and the lack of an independent drug safety board. Few listened.^2,3 Concerns also were voiced on the Senate floor when the 1997 FDA Modernization Act (Bill S830) was debated. For example, Senators Kennedy, Bingaman, and Reed warned, “The provisions contained in the bill will weaken the FDA and weaken patient protection from unsafe medical devices.”⁴

    Mindful of the above scenario and while awaiting the FDA’s final ruling to reclassify most wound care products, I worried about the potential effects of these changes on the safety and effectiveness of the products we use. Thus, the editorial message in March 1999 concluded with the following: “Only time will tell if everyone manages to find the right balance between safety, effectiveness, and the interest of business.”⁵

    Six years have passed and the scales are still not in balance. Moreover, the 1992 and 1997 laws have become headline news. “Federal drug regulators are virtually incapable of protecting America from unsafe drugs” said Dr. David Graham, the reviewer in the FDA’s Office of Drug Safety during testimony before the Senate Finance Committee last November.⁶ Furthermore, according to a report in the Wall Street Journal, some 66% of FDA drug reviewers are “not at all” or only “somewhat” confident that the agency adequately monitors the safety of approved drugs.⁷ Of course, all drugs have side effects and most medications are prescribed with an eye toward their risk-benefit ratio. But if the truth about the risk side of this equation is not adequately assessed (or if it is suppressed or concealed), neither the prescribing provider nor the patient can make an informed decision. Reports that researchers were intimidated after publicly raising questions about the safety of some drugs and concealment of clinical data (data that could have saved thousands of lives) have rekindled the debate about the need for an independent drug safety review board and mandatory registration of all clinical trials.^6,8,9

    For years, clinicians, researchers, medical journal editors, and representatives from the pharmaceutical industry have discussed the need to establish a clinical trial registry. The registry now exists (see www.clinicaltrials.gov) but participation is voluntary. Proponents of mandatory registration believe that only mandatory registration will address the effects of concealing negative data on clinical practice, protect research subjects, and increase the availability of information to researchers, physicians, research participants, and the public.⁹ While the debate over mandatory versus voluntary registration continues, the number of trials publicly registered will most likely continue to increase because member journals of the International Committee of Medical Journal Editors (ICMJE) have decided they are not going to wait for the results of more debates or changes in the law. Instead, they announced that as condition of consideration for publication, trials must have been registered at or before the onset of patient enrollment.¹⁰ In other words, the results of studies not registered from day 1 will not be accepted for review and publication in the major medical journals. The policy takes effect this summer and may be the beginning of a new era in drug clinical trials.

    Meantime, should we worry about device safety more than we did before?⁵ Evidence-based reviews continue to indicate that data substantiating the effectiveness of many commonly used devices in wound, ostomy, and skin care remain scant. We continue to “rely on the skill of clinicians to detect problems and their willingness to report them.”⁵ Furthermore, it has been suggested that the recent recall of 18,500 flawed defibrillators (which are not “exempt” from FDA review), indicates that FDA’s lax oversight of prescription drugs also may pertain to its medical devices unit.¹¹ Is this latest “incident” an anomaly, or does it represent the tip of a medical devices iceberg — an iceberg that is much more difficult to see than the consequences of a failing defibrillator? Now, as in 1999, only time will tell. My advice to clinicians remains unchanged: “Let the buyer beware.”

1. van Rijswijk L. Recommendations to change the FDA classification of various wound dressings. Ostomy Wound Manage. 1999;45(3):31–33.

2. Wood AJJ, Stein CM, Woosley R. Making medicines safer — the need for an independent drug safety board. NEJM. 1998;339:1851–1853.

3. McGinley L. Think tank with ties to Gingrich unveils plans to replace FDA. Wall Street Journal. February 2, 1995.

4. Committee on Labor and Human Resources. Food and Drug Administration Modernization and Accountability Act of 1997 Senate Report. 105th congress, July 1, 1997. From: Senate Reports Online via GPT Available at: http://www.wais.access.gpo.gov. Accessed January 5, 1998.

5. van Rijswijk L. Product safety and business interests: a delicate balance. Ostomy Wound Manage. 1999:45(3):4–6.

6. Harris G. FDA failing in drug safety, official asserts. New York Times. November 19, 2004.

7. Wilde Mathews A. Second opinion: as drug-safety worries grow, looking overseas for solutions; French vigilance centers spot problems, and UK traces issues with “green cards”: a high-tech prescription pad. Wall Street Journal. (Eastern edition). December 31, 2004.

8. Topol E. Failing the public health — Rofecoxib, Merck, and the FDA. NEJM. 2004;351:1707–1709.

9. Steinbrook R. Registration of clinical trials — voluntary or mandatory? NEJM. 2004;351:1820–1822

10. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. NEJM. 2004;351:1250–1251.

11. Meier B. Flawed device places FDA under scrutiny. New York Times. December 15, 2004. Available at: http://www.nytimes.com. Accessed December 16, 2004.