And because SAM-e has not been studied extensively in the United States, many doctors are leery. Beware, says Dr. Gilbert Ross of the American Council on Science and Health, a conservative watchdog group. The Food and Drug Administration has not rigorously evaluated SAM-e, let alone approved it. And the studies that researchers have conducted are not of the magnitude the FDA would require for a drug approval. In dozens of European trials involving thousands of patients, it has performed as well as traditional treatments for arthritis and major depression.
Research suggests it can also ease normally intractable liver conditions.
SAM-e doesn't seem to cause adverse effects, even at high doses. And doctors have prescribed it successfully for two decades in the 14 countries where it has been approved as a drug. Until recently, few Americans had heard of the stuff. An Italian firm developed it as a pharmaceutical in the early 1970s but lacked the will or the resources to make a run at a drug approval in the United States. Then, this spring, two U.S. vitamin companies, GNC and Pharmavite, started importing large quantities of SAM-e to sell as a supplement.