Lawmaker: NIH Sent Wrong Medicine
Lauran Neergaard,
AP Medical Writer

7:14 PM EST; February 23, 2000; Washington, D.C. (AP) -- The National Institutes of Health mistakenly shipped the wrong gene-based medicine to a university that administered it to six patients in a gene therapy experiment, a congressman said Wednesday. "Providing the wrong medication to patients is an act of inexcusable incompetence," Rep. Henry Waxman, D-California, wrote the NIH in asking what steps the government was taking to ensure it never happens again.

Georgetown University spokesman Paul Donovan said Wednesday that university researchers did not catch the error and consequently administered the wrong medicine to six cancer patients. But "all patients were immediately notified and no patient experienced any adverse effect," Donovan said. The National Cancer Institute, the NIH branch that made the error, agreed that no patients were harmed -- they received an experimental gene-based drug that would not work for their tumors, but that was being prepared for testing in patients with other types of cancer. "There was no safety issue," said Dr. Michaele Christian, NCI's associate director of cancer therapy evaluation.

But because drug mixups have the potential to be very serious, she said she already has taken steps to prevent future errors. The problem is the label on these vials of medicine is small and the first five letters of two drugs' names are identical, setting the stage for an easy mixup, she explained. So NCI is training workers who collect and ship the medicines to double check the full names, has strengthened the computer system that sorts these drug orders, and is hunting ways to make the drug labels safer.

Waxman's discovery of the problem came as part of an investigation into how the NIH oversees gene therapy, in wake of the September death of an Arizona teenager in a gene therapy experiment. Although people dying of incurable diseases have enrolled in gene therapy studies that proved unable to save them, 18-year-old Jesse Gelsinger is considered the first person actually killed by experimental gene therapy.

Waxman claimed Wednesday that NIH's records show no sign the agency investigated 38 other deaths in two gene therapy experiments. One was a 1996 death in a University of Pennsylvania Cystic Fibrosis study; the others were among 38 people with end-stage lung cancer enrolled in a Texas study. "This new information ... suggests that NIH's oversight has been inadequate," Waxman wrote Dr. Ruth Kirschstein, NIH's Acting Director. But Kirschstein responded that the NIH did investigate -- and found the gene therapy involved to be safe. "These cases were reviewed and appropriately addressed," she wrote Waxman late Wednesday.

Waxman's questions sparked fury from the Houston biotechnology company that funded the lung-cancer study. Those 38 deaths were caused by cancer, not gene therapy, insisted Introgen Therapeutics Vice President Dr. James Merritt, who said a separate government agency -- the FDA -- investigated each one, agreed the therapy was safe and consequently has allowed it to be tested in several hundred additional patients. Waxman's office noted that researchers are supposed to report deaths to the NIH as well as the FDA, so both agencies can investigate.

Merritt disagreed, saying he only told the NIH about the deaths to help scientists sort out gene therapy questions in wake of the Gelsinger case. "People who are reacting to these reports are unqualified to do so," Merritt said, adding that "it's sure galling" to be singled out for " diligent research."