POSTMARKETING OUTCOMES STUDIES- BENEFITS AND RISKS
Author(s)
Garfield FB, Caro JJ, Caro Research, Boston, MA, USA
To consider the benefits, financial risks and opportunity costs of large postmarketing outcomes studies as demonstrated by studies of the statin drugs. METHODS: Literature Review. RESULTS: Benefits: The studies definitively showed that the drugs and lowering 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 them to include specific claims about the drugs in their advertisements, generated follow-up studies and spawned economic analyses that extended interest in the drugs in both the medical and lay press and had a major impact on the clinicians' use of the drug. Risks: The studies had a strong coattails effect. Each new study was beneficial to all the statins as well as the one studied. Economic analyses after some of the studies concluded that although the drugs effectively lowered cholesterol and prevented clinical events, use of the drugs was not cost effective. Many studies took a long time and it often took even longer for the results to be assimilated, put into perspective and influence other researchers and 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. All the major pharmaceutical companies with statins conducted their own postmarketing outcomes studies. CONCLUSION: How a company weighs the risks and benefits of strategic studies may depend on its time perspective. In the short term, the risks may outweigh the benefits. Only those companies that have a longer perspective may find it beneficial to undertake a large postmarketing study.
Conference/Value in Health Info
1998-05, ISPOR 1998, Philadelphia, PA, USA
Value in Health, Vol. 1, No. 1 (May/June 1998)
Code
MGB3
Topic
Study Approaches
Topic Subcategory
Post Marketing Studies
Disease
Multiple Diseases