I will go further than Dr. Nasrallah’s editorial did to endorse off-label use. Our diagnostic categories are 19th century superstitions. Only individual target symptoms have concrete reality. FDA approval studies have parametric statistics based on the bell-shaped curve. These studies represent the population at large. The consecutive series of single-case, on-off experiments have nonparametric distributions. These FDA parametric studies have no relevance to individual care. The FDA serves as a screening tool for potentially useful medications. When applied to individual patients, FDA approval studies are irresponsible, garbage science.
HMO or clinician prescribing that is limited to FDA-approved drugs represents gross malpractice. A better indicator of the standard of care is clinician prescribing patterns recorded by prescription databases. Any use of medication by more than 10% of clinicians at least is a minority standard of care.
Physicians are motivated by patient success. Repeat and widespread prescription is the best indicator of clinical validity.
David Behar, MD
Bethlehem, PA