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Unreported Death in Gene Study Draws FDA Warning

WASHINGTON, May 04 (Reuters Health) - Failure to report a fatality in a gene therapy clinical trial and the possible aggravation of lung cancer in a subject inappropriately enrolled in the study are the most serious charges in a warning from the US Food and Drug Administration (FDA) to Dr. Jeffrey Isner, lead investigator at St. Elizabeth's Medical Center, Boston, Massachusetts.

The warning issued on Wednesday is the latest setback in the promising, but largely uncharted, area of genetic research. The FDA's letter cites a cardiovascular study in which genetic material was injected directly into the hearts of patients with heart disease and other circulatory disorders, in an attempt to spawn new blood vessels.

The study was being sponsored by the Boston hospital in conjunction with Vascular Genetics, Durham, North Carolina, which Isner cofounded. The June 1998 death involved a subject who went into cardiac arrest after receiving a genetic injection, experienced multiple organ failure and died 4 months later.

The FDA charged that Isner delayed notifying the institutional review board (IRB) overseeing the study until 1999. When Isner eventually informed the IRB of the adverse event, he reported only that the subject was hospitalized for 2 months, omitting the fact that the patient had died, according to the warning.

The letter also charged that Isner performed an unauthorized autopsy on the deceased patient's heart without board certification for such procedures.

In the other incident, a trial subject diagnosed with a lung mass was enrolled in the study against protocol, which excluded cancer patients.

Not only were there no records showing that the patient or his personal physician were informed of the condition, which follow-up X-rays confirmed, but when the patient reported for follow-up gene therapy 3 months later, tests revealed that the tumor had doubled in size, the warning alleged.

Yet trial researchers did not investigate whether the gene therapy may have been linked to the cancer's spread, a possibility that the FDA expressly raised in its warning. In addition, the tumor's rapid growth was initially noted in records as "severe," requiring immediate FDA notification, but was subsequently downgraded to a "mild" adverse event.

The FDA's letter cites a number of other enrollment violations, as well as a failure to perform the entry tests and physical exams required by the protocol for study participation. The FDA gave Isner 15 days to respond with a plan for corrective action.

The warning is the most recent, but not the first, FDA censure of Isner's gene therapy experiments. The agency suspended four other trials lead by Isner in February, pending completion of its investigation.

Neither Isner nor Vascular Genetics' President John Cumming were available for comment.

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