FDA Calls Halt On Untested Diabetes Therapy

After the issuance of a US Food and Drug Administration warning letter, Loran Medical Systems has suspended its controversial treatment for diabetic patients, consisting of injections of fetal and rabbit pancreatic cells imported from Russia.

The FDA took the action after an inspection of the company's plant in California last year revealed that the firm was in violation of regulations governing the importation of biological products and the conduct of clinical trials.

Last April, the agency advised the company that it considered the imported cells were a drug and thus the procedure was subject to regulatory approval. Still, the company injected 32 patients with the cells in three trials, and charged each $20,000 for the procedure, which some experts have described as unproven and ineffective.