Gene tests may have exposed kids to HIV, hepatitis virus

In this story: Trials closed to new patients Failure to test virus fluid raises queries FDA results awaited RELATED STORIES, SITES

From staff and wire reports

MEMPHIS, Tennessee -- St. Jude Children's Research Hospital said Friday two of its patients had been exposed to tests that may have infected them with HIV, the virus that causes AIDS, or hepatitis C, which can cause a fatal liver disease.

The children were undergoing experimental treatment for a relapse of neuroblastoma, an often fatal brain cancer.

A similar vaccine was used later at Baylor College of Medicine in Houston, but officials there say pre-tests showed no evidence of contamination.

And suggestions that any of the children were exposed to HIV are highly questionable, FDA officials said Friday.

Both hospitals have closed the trials to new patients, pending FDA testing.

Hospital officials also delayed telling the families of those treated for possible infection. Doctors said they did not want to raise unnecessary concern.

"We've conducted the trial in the safest way we know, and, as far as we can see, no patients have been harmed," said St. Jude lead investigator Dr. Laura Bowman.

The Food and Drug Administration called suggestions of initial contamination so tenuous that it would not have alarmed the children's families by telling them until ongoing tests settle the issue.

Questions about the safety of the experiments were raised last year as the Memphis research center was checking the quality of its gene therapy program.

Bowman checked the fluid in which viruses used in the experiment are grown. The fluid, called seed stock, was received by the laboratory in 1995, but she said it was not until last year that she discovered it had never been tested for use in humans.

"We looked for documentation of it, and it wasn't there," Bowman said.

When the testing lapse was discovered and the seed stock finally was tested for impurities, the results indicated it contained a genetic marker for HIV, and for HCV, a virus that causes a form of hepatitis, Bowman said. A second test also yielded positive results.

However, results from both tests, Bowman said, were "very, very, very, very iffy." It could be that the positive results from both tests were "false positives," she said.

Neuroblastoma is "one of the most devastating childhood cancers," Bowman said. "Which is why these kinds of therapies are so important." She called the vaccine test "very promising."

The same suspect material from St. Jude was also used by researchers at Baylor College on six children, two of whom later died of cancer.

But Dr. James Patrick, Baylor's dean of research, said St. Jude researchers ordered the wrong tests. He said Baylor retested the suspect material and found no trace of HIV or hepatitis C.

FDA results awaited

St. Jude spokeswoman Lin Ballew said, "We are waiting for the results from the FDA. They will have the final answer regarding the right test, the wrong test, any test."

The FDA's results are expected to be completed within two weeks.

Medical Correspondent Eileen O'Connor and The Associated Press contributed to this report.

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