Current regulatory policies should be strengthened to ensure acceptable cardiovascular safety of drugs developed primarily for non-cardiovascular medical problems, according to a recent presentation made by Dr. Jeffrey Borer, an authority in cardiovascular medicine and surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City.
His recommendations include earlier testing of all drugs' cardiovascular effects and giving regulatory bodies the authority to mandate continuing evaluation of drug effects, even after approval for marketing.
"The importance of evaluating the cardiovascular safety of new drugs has been highlighted by recent examples of drugs—anti-arthritis drugs and others—that were withdrawn from the market when unacceptable cardiovascular risks were discovered after regulatory approval," says Dr. Borer. "It is clear that drugs intended for non-cardiovascular problems must be more fully scrutinized than in the past in order to allow doctors and patients to be assured that risks are well defined and that they do not outweigh the benefits provided by the drugs for the individual patient. The primary strategy to achieve this goal is increasing formal observations in both pre- and post-approval studies."
Specific recommendations include:
Analysis plans should be designed to incorporate all data collected during development, including results of so-called observational studies (which do not employ randomization to eliminate study bias, and which do not employ "control" groups for comparison) in order to increase statistical power to find problems if they exist. Currently, this kind of analysis plan is not usually employed.
Dr. Borer's presentation was made at the recent annual meeting of the European Society of Cardiology in Vienna, and was drawn in part from his article in the Aug. 2007 issue of the European Heart Journal. This paper summarizes the conclusions of a group of co-authors—including cardiologists, biostatisticians, FDA and EMEA (European Medicines Agency Home) regulators and representatives from the NIH and the pharmaceutical industry—who had met previously at a Cardiovascular Clinical Trialists roundtable in Paris to consider these issues.
Jeffrey S. Borer has been an FDA advisor since 1977 and served three terms as Chair of the FDA's Cardio-Renal Drugs Advisory Committee between 1982 and 2004. He is director of the Howard Gilman Institute for Valvular Heart Diseases at NewYork-Presbyterian/Weill Cornell and the Gladys and Roland Harriman Professor of Cardiovascular Medicine and professor of cardiovascular medicine in cardiothoracic surgery at Weill Cornell Medical College.
The Howard Gilman Institute for Valvular Heart Diseases at NewYork-Presbyterian/Weill Cornell helps cardiologists, cardiothoracic surgeons and other physicians take advantage of the most current concepts in the evaluation and treatment of heart valve diseases and provides state-of-the-art patient care. The Institute's co-directors, Dr. Jeffrey S. Borer and Dr. O. Wayne Isom, are leaders in their fields and direct a team of clinical cardiologists, surgeons and research scientists who are at the cutting-edge of this emerging public health concern.
Materials provided by New York- Presbyterian Hospital/Weill Cornell Medical Center. Note: Content may be edited for style and length.
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