A US physician-scientist insists that current regulatory policies should be strengthened to ensure acceptable cardiovascular safety of medicines primarily developed for non-cardiovascular medical problems.
Dr. Jeffrey Borer, an authority in cardiovascular medicine and surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, recommends earlier testing of all drugs' cardiovascular effects.
He also stresses the importance of authorising regulatory bodies 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safety of new drugs has been highlighted by recent examples of drugs—anti-arthritis drugs and others—that were withdrawn from the market when unacceptable cardiovascular risks were discovered after regulatory approval," says Dr.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," he adds.
Even though a medicine has been developed to cure some other condition, he says, its possible effects on cardiac physiology/pharmacology should be tested in animal studies. Dr. Borer stresses that similar evaluations should begin in the earliest phases of drug testing in patients.
He says that the definitions of adverse cardiovascular events like heart attacks and strokes should be standardized for all observers before the drug is administered to any patient. Currently, the definition of adverse events is left up to each observer individually, limiting the strength of conclusions about cardiovascular safety.
Dr. Borer also suggests that regulatory bodies be given more teeth so that they can withdraw approval of medicines, if mandated post-marketing studies have not been performed.
He made these suggestions at the recent annual meeting of the European Society of Cardiology in Vienna.
A report on his recommendations has been published in the European Heart Journal.