Clinical Trials Insufficient

Dr. Topol contends that the cardiovascular risks of the various coxib drugs were not well-studied in clinical trials.

"Based on data available in 2001 for celecoxib and rofecoxib," he says, "my colleagues and I concluded: 'It is mandatory to conduct a trial specifically assessing cardiovascular risk and benefit of these agents. Until then, we urge caution in prescribing these agents to patients at risk for cardiovascular morbidity,' Dr. Topol says. 

"Unfortunately, no such trials were ever initiated and the official warnings for the coxib drugs took years to materialize," he points out. 

FDA Needs More Authority

"Importantly, providing more authority to the FDA (Food and Drug
Administration) to shape and require the execution of vital trials is perhaps the most important lesson from the coxibs," Dr. Topol writes.

"...[L]egislation is needed to empower the FDA to require industry to conduct trials that are deemed necessary to ensure the safety profile of a drug. Had coxib trials been conducted five years ago in patients with established cardiovascular disease, when the benefit and risks were indeterminate, clinicians would have quickly learned the risk and potentially avoided a major cardiovascular calamity," Dr. Topol suggests.

"The combination of mass promotion of a medicine with an unknown and suspect safety profile cannot be tolerated in the future. An aggressive position going forward is necessary for not only ensuring the safety of prescription medicines, but also to restore a solid foundation of public trust," Dr. Topol advises.