UCI Must Heed Research Rules
The disclosures about problems at UC Irvine’s medical center and a university laboratory grow ever more troubling. The university has conducted its own investigations of the problems, and federal agencies now have their own inquiry going. Chancellor Ralph J. Cicerone has made a good effort to acknowledge the university’s shortcomings.
The results of all inquiries need to be made public as soon as possible, and the university needs to reassure patients, researchers, investigators and the public funding the research that barriers are in place against recurrences.
Three years ago, the university was promoting its research into the use of treated white blood cells to attack cancerous cells. The school solicited donations from patients being treated with the experimental therapy and received $19,900 from nine cancer patients and their families. Another 18 patients were billed directly for the experimental therapies. The donations and billings may have violated Food and Drug Administration regulations.
Although UCI knew about the charges three years ago, it has only recently begun to reimburse the patients or families. That’s despite a letter written 20 months ago by a UCI official promising an “action plan” to give patients refunds. That’s delay, not action.
Experimental treatments cost money, and UC Irvine receives not only taxpayer funds but also private grants and money from companies that may profit from successful drugs.
Soliciting donations from patients has the aspect of making only wealthy patients eligible for new treatments. Someone suffering cancer is likely to scrape up any amount requested in a desperate attempt to benefit from a cure. That’s preying on the vulnerable, not promoting cutting-edge medicine.
UCI also has acknowledged running ads in three magazines announcing its cancer research. But FDA regulations bar advertising of unproven treatments. The violation of regulations was discovered not by the university but by a pharmaceutical company that underwrote the cancer research. The company, Meyer Pharmaceuticals LLC, also hired a consulting firm that uncovered the charges to patients participating in the trials.
Complicating the issue is the fact that Dr. John Hiserodt is a minority owner of Meyer and also was a teacher at the UCI College of Medicine and researcher in the cancer lab. The university shut Hiserodt’s lab after finding he sent unapproved treatments to Florida for a terminally ill girl.
The federal regulations are designed to protect patients. Hiserodt has been lauded as a brilliant researcher and teacher who may have been overcome by frantic pleadings for the experimental treatment. But the rules are necessary and must be heeded in the future. UCI should be sure it knows the regulations well, doesn’t violate them and doesn’t drag its feet in correcting wrongs.
