[NVIC] NIH foisting experimental AIDS vaccine on the world.

[Guest guest]

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 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 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 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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