THE FAUCI FILES, 3( 39): Gene Therapy Studies Halted: HIV & Hepatitis Contamination Feared

W. Fred Shaw fredshaw at primenet.com
Thu Mar 9 13:21:14 EST 2000


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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