Investigating the Investigator

For only the second time in its history, the Food and Drug Administration last week struck a physician's name from its approved list of researchers who are entitled to test new, investigational drugs on human subjects. The target of the FDA's action was Dr. Albert M. Kligman, a Philadelphia dermatologist, along with "all investigators associated with" three incorporated laboratories of which he is president and director.

Only last year Dr. Kligman, a full professor in the University of Pennsylvania School of Medicine, published what was then hailed as "the most thorough study yet made" of DMSO, the controversial drug solvent that has been billed as a remedy for everything from arthritis to athlete's foot (TIME, Sept. 17, 1965). It developed that Dr. Kligman and his labs were investigating new drugs for no fewer than 33 manufacturers, and the FDA's Dr. Frances O. Kelsey, of thalidomide fame, began to wonder how thoroughly and carefully Kligman & Co. could do all that work. A check of the DMSO study showed that Dr. Kligman reported tests on three groups of prison volunteers, but prison records turned up only two groups. In the Kligman report, these tests ran for 24 and 26 weeks, but prison records showed only 16 weeks.

The FDA charges that one prisoner had a severe reaction to DMSO, but that this was not acknowledged in the Kligman report, that Dr. Kligman al lowed his comparison subjects to take other investigational drugs, instead of a dummy (placebo), thus rendering his conclusions meaningless, and that he reported blood tests on patients who were not even in the hospital at the time he claimed. Dr. Kligman has the right to ask the FDA to review its action.

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