"Approved by the Food and Drug Administration in 1994, the P.S.A. test is the most commonly used tool for detecting prostate cancer. The test's popularity has led to a hugely expensive public health disaster."
Richard J. Ablin, "The Great Prostate Mistake" (NY Times, 3/9/10)
In light of the hype that has formed around "biomarkers" this recent editorial from the doc that discovered PSA should be sobering. Over-use of this biomarker test has contributed to a situation where, it is estimated, 47 men receive unnecessary life-altering surgery for every one who is saved.
It is worth acknowledging this problem because much of the industry is working on tests that use biomarkers to predict, detect and/or monitor heart disease, various types of cancer, diabetes, neurological disorders and many other diseases. These biomarkers in many cases will be linked directly to whether drugs are given to patients (sometimes to prevent disease, not just treat it). Some of these tests will be used to screen the general population
We believe that this area of research is important and valid. In many cases biomarkers have been shown to be very effective health care tools (CRP, BNP, Glucose, etc) although many will argue how and when these markers should be used.
It’s important that we remain humble in the light of new discoveries. As exciting as it is to discover markers, we need to remember that only very large clinical trials can ensure biomarkers are actually telling us what we hope they are telling us. Funding diagnostic companies appropriately so that these trials can be performed must be next evolution in our industry. It is time to stop assuming, based on minimal data, that novel biomarkers are revolutionary tools for assessing and monitoring disease.
FDA has made it clear during our interactions that it's no longer enough to show a test can measure something. The days of simple marker claims are over. We've got to show that measuring and reporting a result is meaningful for the physician and patient. This isn't easy or cheap but it is the only way to avoid another PSA debacle.
