The Fauci Files: 9/24/99 Journal Science Zaps Fauci's IL-2 Patent

[fred]

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
of convenience...

fred
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Science, September 24, 1999, Volume 285, Number 5436, pp. 2039 - 2042  
 
AIDS THERAPY: 
 
Ambitious Clinical Trial Stirs Debate 
 
Jon Cohen 
 
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

question." 
 
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 
bloodstream. 
 
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," 
says Schooley. 
 
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" 
grant. 
 
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.