E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER
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"Protecting the health and informed consent rights of children since
1982."
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"The Thai government has approached recruiting for the trial like the
U.S.
government did for the military during World War II -- with a call for
patriotism and a plea for people to think of the greater good."
BL Fisher Note:
The latest AIDS vaccine fiasco has the NIH foisting two experimental
AIDS
vaccines on
unsuspecting citizens of Thailand, who trust that American
doctors and the Thai government have their best interests at heart.
Even
though every experimental AIDS vaccine that has been created has
failed,
including one that will be used in this trial, government health
officials
and eager drug companies press on, determined to ultimately force
mandatory
use of an AIDS vaccine on the whole world. And the best part? Once a
bit of
the virus that causes AIDS has been injected into all of us, we will
all
test positive for HIV. For the greater good, of course.
http://www.montereyherald.com/mld/montereyherald/living/health/14646199.htm
Monterey County Herald, CA
Posted on Tue, May. 23, 2006email thisprint this
Biggest AIDS vaccine trial yet
Researchers air doubts about
U.S.-funded study in Thailand
By ARIANA EUNJUNG CHA
The Washington Post
CHONBURI, Thailand - Inside a ramshackle Buddhist temple here on the
country's southeastern coast, curious villagers gathered last fall as
part
of the United States' biggest gamble yet on stopping the AIDS pandemic.
The informational meeting was almost like a game show as attractive
young
hosts revved up the crowd, working up to the big question, boomed out
over
loudspeakers: Would the audience be willing to volunteer to test an
experimental HIV vaccine?
The villagers hesitated. No one moved for a full 60 seconds. Then,
tentatively, they approached the three stands set up at the front,
marked
''Join,'' ''Not Join'' and ''Unsure.''
For the past three years, such gatherings have been held all over
Thailand,
exhorting young adults to take part in the largest, most expensive,
most
resource-intensive AIDS vaccine trial
ever. Funded by the National
Institutes of Health, it ultimately will involve 16,000 people and last
3½
years.
But as the trial moves forward, at a cost of more than $120 million,
some
researchers are raising questions about its validity. They disparage
its
science, question its ethics and doubt its efficacy.
No luxury of time|
One of the chief dissenters is Robert C. Gallo, who helped discover the
human immunodeficiency virus. He scoffs at the notion that the trial
will be
successful. ''I thought we'd learn more if we had extract of maple leaf
in
the vaccine,'' he said derisively.
NIH scientists defend the study, arguing that even if the vaccine
doesn't
work, the trial may reveal new things about HIV. ''With 5 million new
infections each year, the luxury of time is absent,'' four researchers
wrote
in the journal Science.
When scientists identified HIV as the cause of AIDS 21 years
ago, they
predicted that a vaccine to prevent the infection would be ready long
before
a treatment for the symptoms could be developed. The opposite turned
out to
be true. Many people today, especially in wealthy countries, are
keeping the
virus in check with drugs, but a vaccine, desperately needed in poor
countries, has eluded modern medicine.
Despite years of effort, investment in the billions of dollars, and
dozens
of small tests in people around the world, there's still no scientific
proof
that a vaccine is even possible. HIV is a diabolical virus that
disables the
very immune responses a vaccine needs to trigger in order to work.
No cure|
And yet the need is so urgent that scientists have gone forward with
preliminary human tests of many vaccines on the basis of data they
acknowledge is weak. The one in Thailand is the largest.
The fact that no one has ever been cured of AIDS increases
the urgency
of
finding a vaccine. ''In contrast to virtually every other microbe we've
come
across, there isn't a documented case of anyone who... ultimately
cleared
HIV from the body completely. That's why more and more research is
being
directed at trying to stop infection from happening in the first
place,''
said Anthony S. Fauci, director of the National Institute of Allergy
and
Infectious Diseases, part of the NIH.
The U.S. government last year spent 22 percent of its $3 billion AIDS
research budget on vaccines and other preventive drugs, compared with
less
than 8 percent a decade ago. (Most of the rest is devoted to developing
treatments or a cure for those already infected.) Meanwhile, the Bill &
Melinda Gates Foundation this year designated up to $360 million for
AIDS
vaccine research, and Congress is encouraging more research with bills
that
would provide liability protection and
tax benefits for drug companies.
Tricking the body|
But the science is daunting and subjects hard to come by. Scientists
have
been forced to travel to remote corners of the world to find
communities
where the infection rate is high enough to show results in a reasonable
amount of time.
Thailand, where AIDS is a leading cause of death, has been among the
most
accommodating places. The NIH effort there involves two vaccines that
individually have been disappointing in previous trials. One of them,
developed by a once-revered scientist in the AIDS world, flopped
spectacularly after an expensive test funded by private investors. The
other
showed little promise in early trials. Researchers cling to the hope
that
using them simultaneously will attack different aspects of the disease
and
prove effective.
A vaccine is basically a trick: Take a germ or part of a germ, kill it
or
alter it so
that it doesn't cause disease, then inject it into the
body. The
body thinks it is being attacked and produces an immune response that
will
protect it when it is exposed to the real thing.
But because HIV comes in 11 subtypes that constantly mutate, it must be
treated differently. Enter Donald Francis, a longtime government
researcher
who is credited with helping to eradicate smallpox and develop vaccines
for
Ebola and hepatitis B.
In 2005 he founded Global Solutions for Infectious Disease, a nonprofit
organization that aims to develop an AIDS vaccine. Francis works in a
basement office south of San Francisco that looks more like a file room
than
a laboratory. After abandoning the VaxGen project, Francis and his
researchers struck out on their own. Four of the five researchers work
without pay, draining their personal savings to pay for their research
as
they apply for grants. Francis said recently that
he expects funding
from a
foundation in the coming month.
Francis is no longer involved in testing the VaxGen vaccine. But the
failure
of the big 2004 trial did not stop its inclusion in the current trial,
which
was begun by the U.S. Army and subsequently taken over by the NIH. Half
a
world away in Thailand, that effort continues.
The Thai government has approached recruiting for the trial like the
U.S.
government did for the military during World War II -- with a call for
patriotism and a plea for people to think of the greater good.
Dual responses|
The recruiters in December exceeded their goal of enrolling 16,000
volunteers. Test subjects will receive either a placebo or a
combination of
two vaccines -- Francis' and one by Sanofi Pasteur SA of Lyon, France,
that
targets T-cells. The study will conclude in 2009, after all
participants
have been followed for 3½ years.
The idea
behind the NIH trial is that maybe vaccines need to provoke
both
antibody and T-cell responses to protect the body from AIDS. Critics
say
that the potentially confusing inclusion of Francis' vaccine muddies
the
issue and that it should be dropped from the study.
Nearly two dozen prominent AIDS researchers wrote an opinion piece in
the
journal Science in early 2004 calling Francis' vaccine ''completely
incapable of preventing or ameliorating'' HIV infection and questioning
''the wisdom of the U.S. government's sponsoring'' the Thailand trial.
''There are adverse consequences to conducting large-scale trials of
inadequate (HIV) vaccines....One price for repetitive failure could be
crucial erosion of confidence by the public and politicians in our
capability of developing an effective AIDS vaccine.''
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