THE FAUCI FILES, 3( 39): Gene Therapy Studies Halted: HIV & Hepatitis
Contamination Feared
March 9, 2000
The following news release unambiguously reveals the junk in
the junk science of NIH-sponsored contemporary human
experimentation which has its parallels in nearly every
aspect of pharmaceutical-directed "research" that is
conducted or supervised by the bottom-rung "scientists"
who direct the National Institutes of Health on the
basis of outcome-directed "research" rather than what
best serves the health interests of the American people.
"But an autopsy report, which took several months to get
to Hutchins, concluded that the patient's melanoma was not
completely responsible for the death. It said one possibility
was that a buildup of fluids in the patient's abdomen that
had occurred during the treatment might have been
caused by the new genes and contributed to the death."
Unfortunately, when people with HIV die as a direct result
of the ART drugs (e.g. as was the case last week with the
Israeli Diva who died of ART (Anti Retroviral Therapy)
"organ failure"), they rarely receive autopsies that
formally record and report the true cause of death.
Once again, our medical research and treatment establishment has
demonstrated that it cannot be trusted.
Crooked Murdering Bastards!
W. Fred Shaw, Editor
THE FAUCI FILES
====================
Washington Post, 9 March 2000, Page A07
2 Gene Therapy Studies Halted
AIDS, Hepatitis Virus Contamination of Engineered Cells Feared
By Rick Weiss and Deborah Nelson
Washington Post Staff Writers
Researchers have halted two gene therapy experiments at a hospital in
Memphis because of fears that genetically engineered cells being
injected into children with cancer might be contaminated with the AIDS
and hepatitis viruses.
The self-imposed shutdown at St. Jude Children's Research Hospital
extends beyond a previous federal research suspension there, imposed by
the Food and Drug Administration last month. That suspension was
triggered by similar concerns about possible contamination of gene
therapy infusions, but involved a different experiment with other
children. Ultimately, those cells proved to be clean.
Paula Bowman, the doctor overseeing all three St. Jude studies, said
yesterday that the new concerns arose recently during an internal review
of her program, which is testing novel treatments for a common childhood
cancer called neuroblastoma. The two experiments newly in question call
for injections of laboratory-grown neuroblastoma cells that have been
genetically engineered to make them more visible to the immune system.
The cells that were given to patients were the offspring of a "master
batch" of cancer cells that had been tested for contamination, Bowman
said. But she has been unable to confirm that subsequent generations of
cells given to patients were also tested as required.
Bowman, who faced criticism last month for not telling federal officials
about the previous contamination risk for several months, said that this
time she notified the FDA immediately upon discovering the problem last
week. "As soon as we figured it out, we called the FDA," she said.
A total of 42 children have already been treated with the engineered
cells that are now in question, and some additional children have been
treated by a collaborator at Baylor College of Medicine in Texas. Of the
42, Bowman said, 21 are still alive. None is showing indirect evidence
of viral infection, such as elevated liver enzyme levels, but none has
been directly tested for infection.
Bowman said she was in the process of contacting the children's parents
to inform them of the oversight. She said she hopes to have test results
back within two weeks and, if tests show no evidence of contamination,
she intends to resume the treatments.
The FDA has said it is investigating the string of errors that led to
the first contamination scare, which included several violations of
research rules. Agency officials declined to comment on the new
problems.
Separately, a Florida university has halted a gene therapy experiment on
its campus after a leading researcher in the study declared that a
patient had "probably" died as a result of the gene treatment, instead
of from cancer as the researcher had initially believed.
The death, the cause of which is still uncertain and may never be fully
known, predates by about two weeks the death of Jesse Gelsinger, the
Arizona teen who died Sept. 17 in a University of Pennsylvania
experiment. Gelsinger's death and other subsequent revelations about
gene therapy experiments prompted a flurry of questions about whether
researchers are moving too quickly and need closer federal oversight.
The Florida experiment, sponsored by San Diego-based Vical Inc.,
involves a product called Allovectin-7, a substance made of DNA and fat
molecules that helps direct a patient's immune system to tumor cells. It
is being tested on patients with an advanced form of skin cancer, called
melanoma, or with persistent or recurrent tumors of the head and neck.
The death occurred in early September at the University of Arkansas, one
of several sites for the Vical study. The principal investigator there,
Laura Hutchins, initially declared the death unrelated to the treatment,
said Alan Engbring, director of investor relations for Vical.
But an autopsy report, which took several months to get to Hutchins,
concluded that the patient's melanoma was not completely responsible for
the death. It said one possibility was that a buildup of fluids in the
patient's abdomen that had occurred during the treatment might have been
caused by the new genes and contributed to the death.
That finding led Hutchins to reclassify the death last month as
"probably" related to the treatment, the only option between "unlikely"
and "definitely" on Vical's report forms. In response, a safety
committee at the University of South Florida--another site for the
study--shut down the trial late last month.
"This is a single center that in our opinion has overreacted," Engbring
said, noting that none of the other sites has halted enrollment. "I do
think we have a treatment that can help a lot of people."
Engbring said he has no explanation for why the autopsy report did not
reach Hutchins until January. He said the delay had nothing to do with
the December issuance of new stock that raised $117 million for the
company. A Dec. 21 Vical news release announced that a company-supported
data safety review board (which Engbring said had seen the autopsy
report) "found no safety issues to date" in the company's Allovectin
experiments.
Richard Heller, chairman of the University of South Florida's biosafety
committee, which suspended the campus's part in the study, said the
committee's action was prudent in the light of recent revelations about
scientific and ethical lapses in the gene therapy field. "Everybody felt
that with the atmosphere right now, we don't want to take any chances."
Vical recently submitted additional information, Heller said, and the
committee will consider reopening the study at its March meeting.
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