The letter came two days after The Washington Post reported that two research teams had failed to provide such notification for six patients who had died after receiving gene therapy in the past 19 months. The researchers said they had reported the deaths promptly to the FDA, which generally keeps such information secret, but not to the National Institutes of Health, which also oversees gene therapy but reviews injury reports publicly.
Gene therapy seeks to cure inherited diseases and cancer by giving patients new genes.
Because the science is still new and unproven, and because genetic manipulation is controversial, the field has been held to a higher standard of public scrutiny than conventional medical experimentation. Tufts University researcher Jeffrey Isner failed to report two deaths to ORDA in a study of gene therapy for heart disease. Ronald Crystal at New York Hospital-Cornell Medical Center didn't report four deaths to ORDA in a competing heart disease study, and an additional death in a study of blocked blood vessels in the leg. Crystal reported one other heart study death to ORDA but with an unusual request that it be kept confidential. They said they told the NIH about the deaths in summary reports recently requested by ORDA, and in response to a special appeal from the agency for any unfiled reports of deaths or illnesses.