EXPERIMENTAL DRUGS: ‘Vulnerable’ Patients Not Safeguarded
The West Coast office of Friends Research Institute has been ordered to halt federally funded research on new patients at its renowned drug addiction treatment centers in the Los Angeles area, the Los Angeles Times reports. The U.S. Office for Protection From Research Risks ordered the halt in late February after an ethics probe surrounding "one of the nation's leading addiction specialists," Dr. Walter Ling, found that between 1991 and 1996 "vulnerable people taking part in studies were not adequately safeguarded." The suspension order allows current patients to continue receiving medical care through the clinics, but prevents researchers from signing up any new patients for the studies that "range from special counseling sessions to experimental medications intended to ease cravings for heroin, cocaine and methamphetamine." Street addicts and poor people are often attracted to the studies because they offer free medical care, but a letter risk officials sent to Friends said that Friends researchers exaggerated benefits of the studies while minimizing their risks to patients. The 14-page disciplinary letter listed 16 violations of federal policies, including repeatedly making medical research decisions without a doctor's presence, poor record-keeping of proper drug doses and failing to discuss with patients existing treatments they could use in place of experimental ones.
The Times reports that the risk office's "move is the second strong statement in recent months from government regulators suggesting that perhaps thousands of Los Angeles-area people have been subjected to biomedical studies that did not meet ethics standards." Research at a Veterans Affairs hospital in West Los Angeles last month was suspended for similar patient concerns and "[i]ronically, Ling played an indirect role" in the suspension of research there. Ling said the problems at the Friends West Coast clinic cited by the risk office all involved administrative procedures that did not harm patients, and that Friends had hired two consultants to help improve research management. Also, the "standard of practice has really changed a great deal in the last few years," said Ling, explaining that "his work was caught up in a wave of newly stringent attitudes toward regulating clinical research." A risk official "acknowledged that Friends had recently taken steps to correct the problems," but said "the procedural shortcomings were severe and systematic, undermining confidence in the group's ability to protect human subjects" (Monmaney, 4/20).