Why Drug Companies Seem To Make Only Small Changes To Existing Drugs

See Critics of 'Me-Too Drugs' Need to Take a Chill Pill: A medicine that differs slightly from another can have a big health benefit by Henry I. Miller. Dr. Miller, a physician and molecular biologist, is the fellow in Scientific Philosophy and Public Policy at Stanford University's Hoover Institution. He was the founding director of the FDA's Office of Biotechnology.Excerpts:

"Second, even if two drugs are each effective in 40% of patients with a particular symptom or disease, each of them may not work in the same 40%. If the drugs are effective in different populations, the unavailability of the second drug could deprive a large number of patients of the medicine they really need.

Practicing physicians know that for certain conditions—such as treating pain or the symptoms of multiple sclerosis, or to prevent blood clots—patients whose conditions seem indistinguishable from one another sometimes do better on different drugs. Having alternatives—"me-too drugs"—is in the best interests of patients."

"Fourth, in a study in the journal Nature Reviews Drug Discovery in 2011, Joseph DiMasi and Laura Faden of the Tufts Center for the Study of Drug Development persuasively debunked the myth that drug companies purposely produce duplicative me-too drugs. They closely examined drug-development patterns and timing and found that the process is best viewed as "a race in which several firms pursue investigational drugs with similar chemical structures or with the same mechanism of action before any drug in the class obtains regulatory marketing approval." In other words, companies are not starting out to develop a me-too product any more than a marathon runner starts a race intending to be an also-ran"