Questionable actions by medical researchers at two universities in Ohio have drawn scrutiny to their work, and accusations that their ties to the medical industry represent a conflict of interest.
According to an article in Friday’s Wall Street Journal, the Food and Drug Administration has sent a letter of warning to Randall K. Wolf, a heart surgeon at the University of Cincinnati, finding a host of violations of rules designed to protect patients undergoing clinical trials that he ran. In the trials, which tested an experimental device, made by AtriCure Inc., to treat irregular heart fluctuations, four patients died, although it’s not clear if the deaths were connected with the rules violations. The FDA warning also criticized Dr. Wolf, a strong supporter of the device, for not disclosing his many financial ties to AtriCure, including stock options, royalties, and consulting payments. He declined to comment to the Journal.
Meanwhile, at the other end of Ohio, an orthopedic surgeon affiliated with Case Western Reserve University and the Cleveland Clinic is said to have taken a range of steps to promote the use of a costly medical procedure to treat spinal fractures caused by osteoporosis, without disclosing that he had received rich stock options and other emoluments from the company that makes the treatment, according to an article in Sunday’s Plain Dealer. The researcher, Isador Lieberman, did not tell patients about his ties to the company, nor did he disclose it in articles he wrote and speeches he gave to promote the procedure, the Plain Dealer said. The newspaper, which said Dr. Lieberman refused to be interviewed, noted that the U.S. Justice Department was investigating conflicts of interest among orthopedic surgeons, although not specifically Dr. Lieberman.