GENE THERAPY: Heart Disease Trials Put Patients At Risk
Tufts University scientist Jeffrey Isner, whose "high-profile" gene therapy experiments attempted to grow new blood vessels in heart disease patients, failed to report the death of one trial participant and put other patients' lives at risk, according to the FDA. In a nine-page warning letter sent yesterday, officials raised "serious questions about the quality and safety" of the trials, which were suspended in late February pending a complete FDA inspection. The letter accuses Isner of waiting months to tell hospital officials about complications involving one patient, whose heart stopped after receiving a direct injection of genetic material, adding that even then, Isner did not mention the person had died, reporting only that the volunteer had required hospitalization. The FDA also charges that Isner did not investigate the patient's death properly, performing his own autopsy on the heart, even though he did not have hospital authorization or board certification for such action.
In a second incident, Isner purportedly enrolled a person diagnosed with a lung mass, despite the study's known dangers to patients suspected of having cancer. The patient's lesion doubled in the months after the treatment, leading the FDA to conclude that a "reasonable possibility exists that circulating (gene material) contributed to the tumor growth." The FDA alleges that Isner and his team, however, failed to investigate whether the gene therapy contributed to the tumor's spread and did not report the "severe" adverse event. Moreover, researchers allegedly accepted ineligible volunteers into the study and did not conduct the preliminary physical examinations or lab tests stipulated in the study's FDA-approved protocol (Nelson/Weiss, Washington Post, 5/3). In the letter to Isner, the FDA wrote, "[The violations] appear to be the result of a serious lack of knowledge of your responsibilities as principal investigator." The agency is giving the researcher 15 business days to respond with a plan for corrective action or face enforcement penalties. North Carolina-based Vascular Genetics Inc. sponsored the experiments, which were conducted at St. Elizabeth's Medical Center in Boston. Company officials said they already were working with Isner and the hospital to correct the problems and hope the FDA will allow research to resume (Adams, Wall Street Journal, 5/3).