Potential Problems with The Use of Surrogate Markers in Drug Approval

A report in the Milwaukee Journal Sentinal highlights some of the problems with relying on surrogate markers such as tumor size for cancer drugs or blood cholesterol levels for heart disease. These markers are usually unrelated to other significant health measures such as Surrogate measures allow for shorter and cheaper clinical trials that do not encourage drug manufacturers to consider extending lifespan, improving overall patient health or quality of life. The FDA is allowing for the acceleration of new drug approvals based on these surrogate measures if it believes these measures are “reasonably likely” to predict a clinical benefit–whether or not that benefit has been demonstrated in trials. Many researchers feel that this approach has allowed many drugs to enter the market that do not actually improve patient health or even overall survival.