[Surrogate end points--somewhere between essential and not worth discussing].
Surrogate markers are only acceptable in single exceptional cases to demonstrate a patient related true outcome in medical care. This is especially true in drug therapy. Although many surrogate markers are correlated with an outcome, only a few have been shown to capture the effect of a treatment on the outcome. The examples for aberrations in medical care are numerous: They include menopausal hormone therapy, the prevention of cancer or cardiovascular diseases with vitamins, the therapy of cardiac arrhythmias using a special type of drugs as well as the treatment of osteoporosis with fluoride. All these treatments caused more harm than good to the patients; and very often mortality increased. In summary, most of the surrogate markers are not worth discussing, and they should not be utilised to demonstrate patient related outcome; they may only be acceptable in rare cases and would then have to be rigorously validated to protect patients from harm.
Zentrum für Sozialpolitik (ZeS), Universität Bremen, Bremen. gglaeske@zes.uni-bremen.de
Gerd
G
Glaeske
D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use; D001145:Arrhythmias, Cardiac / Q000188:drug therapy; D015415:Biomarkers; D002318:Cardiovascular Diseases / Q000188:drug therapy; D004358:Drug Therapy; D064420:Drug-Related Side Effects and Adverse Reactions; D015914:Estrogen Replacement Therapy / Q000009:adverse effects; D019317:Evidence-Based Medicine; D005459:Fluorides / Q000009:adverse effects / Q000627:therapeutic use; D005858:Germany; D006801:Humans; D009369:Neoplasms / Q000517:prevention & control; D010024:Osteoporosis / Q000188:drug therapy; D017063:Outcome Assessment, Health Care; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care; D016032:Randomized Controlled Trials as Topic; D014815:Vitamins / Q000009:adverse effects / Q000627:therapeutic use
D000889:Anti-Arrhythmia Agents; D015415:Biomarkers; D014815:Vitamins; D005459:Fluorides