Postmarketing studies: benefits and risks.

Abstract

OBJECTIVE: To consider the benefits and risks of large postmarketing outcomes studies, as demonstrated by studies of the statin drugs. METHODS: Literature review. RESULTS: The risks were that the statin studies had a strong coat-tail effect. Each new study was beneficial to all statins as well as the one studied. Economic analyses based on the results of the postmarketing studies concluded that the drugs were not cost-effective. Long-term postmarketing studies were slow to be put into perspective and did not immediately influence other researchers or clinicians. During that time, the sponsoring companies shouldered opportunity costs as well as the actual costs of the studies. The risk that one drug company would use another company's results instead of investing in their own research did not materialize. The benefits were that the studies definitively showed that the drugs and the lowering of lipids were safe and efficacious. The studies also expanded the indications for the drugs, generated goodwill in the medical and research communities for the sponsors, allowed sponsors to include specific claims in their advertisements, generated follow-up studies, spawned economic analyses that sparked interest in the medical and lay press, and had a major impact on clinicians' use of the drug. CONCLUSION: The risks and benefits of postmarketing studies may depend on the company's time perspective. In the short term, the risks may outweigh the benefits. Only companies that have a longer perspective may find it beneficial to undertake large postmarketing studies.