The Fauci Files: 9/24/99 Journal Science Zaps Fauci's IL-2 Patent
fredshaw at primenet.com
Sat Sep 25 17:31:59 EST 1999
It looks like The Fauci Files effort has paid off. Here's some
of the "fallout" from my reporting on NIAID Director Anthony
"Mussolini" Fauci's IL-2 hoax treatment, patent scam, lies,
deceptions and OBVIOUS financial conflicts that have intentionally
derailed ALL scientific aspects of HIV treatment research
and have ended 2 decades of HIV research with dead-end sham
"treatments" that have done far more harm than good.
The current issue of the journal Science is a rather
embarassing event for The Diminutive Dictator of NIAID,
as some of the facts and controversies can no longer
be overlooked and ignored, even by writers like Jon Cohen.
By the way, for the past decade of DOZENS of NIAID-sponsored
and funded clinical trials, IL-2 has only accelerated and
created more disease and death than one could possibly imagine.
And guess who was directing the AIDS Death Circus all that time?
"Some researchers believe (the latest IL-2 sham trial's)
flexible design and relatively healthy subjects may blur
any results. And numerous other logistical, procedural,
and ethical questions have also dogged this trial since it
was first conceived 3 years ago..."
Gee, and Toni Fauci married the Head Nurse of his deadly IL-2
human experiments at NIAID and sent her to school to earn her
Ph.D. in Medical Ethics. A marriage of convenience to a degree
Science, September 24, 1999, Volume 285, Number 5436, pp. 2039 - 2042
Ambitious Clinical Trial Stirs Debate
The National Institute of Allergy and Infectious Diseases (NIAID) last
week decided to fund what will likely be the largest and most expensive
trial of an AIDS treatment the institute has ever backed. During the
next 5 years, the $43 million study will follow 4000 HIV-infected people
who are already taking anti-HIV drugs to see whether adding an
immune-system messenger called interleukin-2 (IL-2) can help prevent
disease and death. The study, which went through a stringent but unusual
review process because NIAID director Anthony Fauci holds a patent on
the treatment, will involve 210 sites in 18 countries, creating an
enormous new clinical trials network that will include some of the
world's leading AIDS clinicians. "It's tremendously ambitious,"
acknowledges Jack Killen, head of NIAID's Division of AIDS. "But this is
about as good a shot as we're going to get at answering a very important
Whether the so-called Esprit trial is likely to yield meaningful results
is, however, being fiercely debated within the AIDS research community.
Some researchers believe its flexible design and relatively healthy
subjects may blur any results. And numerous other logistical,
procedural, and ethical questions have also dogged this trial since it
was first conceived 3 years ago, including whether the costly study is
needed when smaller IL-2 trials are already planned in sicker subjects.
Small-scale studies have shown that genetically engineered IL-2
significantly boosts levels of CD4 cells in HIV-infected people. (CD4s
are the main white blood cells that HIV selectively destroys.) "We have
seen changes in CD4 counts, but we don't know what they mean
clinically," explains NIAID's clinical director Clifford Lane, who
pioneered this treatment strategy and shares the patent with Fauci and
NIAID's Joseph Kovacs. (The patent is assigned to the government, and
Chiron, the maker of engineered IL-2, has a license; the researchers are
entitled to a maximum of $150,000 of any payments each year, which Fauci
donates to charity.) Specifically, none of the trials have yet shown
that the CD4 increases result in longer, healthier lives, and the
treatment does not seem to decrease the amount of HIV in a person's
The trial aims to mimic the diverse ways IL-2 would be used in the real
world. In the first 6 months, 2000 people already taking any combination
of anti-HIV drugs will give themselves injections of IL-2 for 5 days
every 8 weeks. After those three cycles, physicians will use their
discretion to determine the frequency of subsequent cycles of IL-2
treatment, which can cause flulike symptoms. Another 2000 people who are
taking only anti-HIV drugs will serve as the control group. "This will
give some pretty clear information," asserts Lane.
Others aren't so sure--including the peer-review group that ultimately
gave the trial a thumbs-up. "A lot of people are skeptical about whether
it will be possible at the end of a large trial like this to sort out
the cause and effect when people cycle through different treatments,"
acknowledges Killen. And the link may be further blurred because Esprit
will recruit people who have suffered relatively modest immune damage
from HIV and thus are more likely to respond to the immune booster; to
be eligible, HIV-infected people must have at least 300 CD4 cells per
millimeter of blood at the trial's start. (The normal range is 600 to
1200.) As a result, it may take longer than 5 years to see enough
AIDS-related disease and death to determine conclusively whether IL-2
helps. "You could be holding your breath a long time," says Robert
Schooley of the University of Colorado Health Sciences Center in Denver,
who heads the AIDS Clinical Trials Group (ACTG), an NIAID-supported
network that conducts most trials of AIDS drugs.
The fact that ACTG will not be running this trial is another point of
contention. James Neaton of the University of Minnesota, Minneapolis, a
biostatistician who is Esprit's principal investigator, says he couldn't
interest ACTG. "People I worked with [in the ACTG] wanted to
participate, but they couldn't get approval from the executive
committee," says Neaton. Schooley explains that not only would the
expense overwhelm the ACTG's budget, but ACTG is already conducting a
smaller scale trial of IL-2 in sicker patients. "Our feeling is it
really offers more to people with advanced disease," he says. (Indeed,
Chiron last month launched a large efficacy trial of the treatment in
people with 50 to 300 CD4s.) Schooley also questions whether patients
with relatively high CD4 counts will choose this toxic and expensive
drug. "If you have 700 CD4s, you're going to do well for a long time,"
Neaton also considered another NIAID-sponsored clinical trials network,
the Community Programs for Clinical Research on AIDS (CPCRA), but it did
not have enough sites to recruit the needed number of patients. So, on
advice from NIAID, he turned to a mechanism that is rarely used to fund
large clinical trials: He submitted an investigator-initiated, "R01"
To help avoid the perceived conflict-of-interest issues raised by
Fauci's patent, the ad hoc "study section" of peers set up to evaluate
the proposal was convened by the National Cancer Institute, not NIAID.
"I can tell you for a fact that Tony had no influence whatsoever on the
process of review or the decision about the funding of this," says
Killen. Lane, who did help design the trial, says National Institutes of
Health lawyers gave him a waiver for that purpose.
Unlike ACTG and CPCRA, study sections evaluate proposals behind closed
doors. But interviews with members of the study section and documents
provided by Neaton suggest that it received a rigorous review. When the
study section first evaluated the proposal in June 1998, it gave it a
score of 322, which put it in the unfundable 59.3 percentile. Among the
many concerns listed by the study section was "whether the study as
currently designed will result in interpretable data." Another sensitive
topic was that some testing would be done in poor countries that may not
be able to afford IL-2 if it is found to work: Three treatment cycles
cost at least $5000.
The same study section considered a revised proposal 8 months later, and
although it still noted "several weaknesses," it deemed the trial design
"significantly improved." This time around, it earned a priority score
of 178, placing it in the 18.1 percentile, an excellent ranking. On 16
September, NIAID formally announced that it would fund the trial.
Leading clinicians in the United States (including those with the
CPCRA), Canada, Europe, Australia, Greece, Israel, Thailand, and
Argentina will participate.
Even if the treatment itself doesn't pan out, Neaton thinks the trial
could have an important benefit: to show how "large, simple trials" that
mirror real-world situations can answer tough questions. "I'm hoping to
make this a model for how other research is done," he says.
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