Military Vaccine Studies: On Trial (not vaxs on military but by the military on people)

[Guest guest]

Military Vaccine Studies: On Trial (not vaxs on military -hopefully -but by

the military on people)

" The controversy of the canarypox/gp120 trial has far deeper roots than

just the trial per se. Those roots go back to the basic issue of the lack

of social value given to vaccines over treatment. The lack of social value

is translated by industry as lack of potential profits. Therefore industry,

where the skills to make vaccines reside, has been lukewarm at best to

putting in the effort to make a vaccine. "

yeah, right

maybe its not working because:

vaccines don't work

they haven't a clue about the immune system

HIV doesn't (or hasn't been proven) to cause AIDS (even though they again

say it has been proven in this article)

See my AIDS pages http://www.nccn.net/~wwithin/AIDS.htm

Sheri

http://www.technologyreview.com/articles/05/01/issue/cohen0105.asp

Military Vaccine Studies: On Trial

By Jon Cohen January 2005

Page 1 of 2 next

U.S. Military HIV Research Program

Headquarters: Rockville, MD

Budget: $21 million per year

The case: U.S. Defense Department AIDS researchers dodged open debate when

they pushed forward a costly AIDS vaccine trial. This came back to bite them.

The question: Why did the canarypox/gp120 trial become so controversial?

What would a better way to design vaccine trials?

Don Francis, founder former CEO, VaxGen:

The controversy of the canarypox/gp120 trial has far deeper roots than just

the trial per se. Those roots go back to the basic issue of the lack of

social value given to vaccines over treatment. The lack of social value is

translated by industry as lack of potential profits. Therefore industry,

where the skills to make vaccines reside, has been lukewarm at best to

putting in the effort to make a vaccine.

The relative absence of industry has left a void that should have been

filled by government. But the lack of social value (consumer interest) led

government to stress treatment (like industry) over prevention and vaccines

were given less attention. In addition, the assignment of organizational

responsibility in government was given to individuals with almost no

experience in vaccine development. This led to more confusion, stupid

decisions, and chaos.

Putting all of this together with the HIV-specific vaccine challenges of no

animal model and no recovered patients necessary to fully understand the

correlates of protection, made this situation even worse.

With these above elements was added crazed academic researchers, devoid of

any wisdom or experience in vaccine development, who saw their role in life

to obstruct the rather dull, long process of vaccine evaluation. These,

again inexperienced, people called for a candidate vaccine with a " proven "

ability to protect. In the field of vaccine evaluation, this is silly.

As for a better way to design trials, I think the trials themselves are

well designed. The issue is the candidate vaccine. There are too few

candidates, too few chimpanzee studies to evaluate them and too few

knowledgeable people to make vaccines and test them.

Peggy ston, Assistant Director for HIV/AIDS Vaccines, National

Institute of Allergy and Infectious Diseases:

Open, transparent, collaborative discussions about major decisions serves

one better in the long run. We at the NIH have a history of being open --

which sometimes is very painful -- and it involves a broader group of

stakeholders than DoD is used to, and for a very good reason.

Anthropologists will tell you that when resources are limiting -- or

perceived to be -- people will fight more. The timing of this dispute did

not escape our attention. [NIH's budget increased by less than four

percent in 2004, less than one-third as much as the percentage increases

enjoyed in each of the preceding five years.-ed.]

Thirty-eight million people around the globe are infected with HIV, and

8,000 of them die each day from AIDS. Although anti-HIV drugs can extend

lives, they have serious limitations, and the vast majority of infected

people still do not have access to them. So it is hard to overstate the

need for an AIDS vaccine that c an slow the virus’s spread and ultimately

safeguard the world’s population.

Scientists in academia, government, and the pharmaceutical industry have

spent the last 18 years testing three dozen different AIDS vaccines in

human studies. Time and again, high hopes have given way to crushing

disappointments, and the field has been roiled repeatedly by bitter

disputes about the best way to move forward. If the different players

worked in isolation, as private companies often do, the tensions might not

matter much. But in the world of international vaccine research, there’s a

constant tussle for resources and influence among government agencies,

universities, drug companies, health ministries, networks of clinics, and

the communities that agree to participate.

Keeping this tussle from devolving into self-defeating conflict depends on

consultation and coordination among all parties. But that’s easier said

than done, as was dramatically illustrated by an AIDS-vaccine trial

launched in Thailand in 2004 with U.S. government backing. The study—the

largest, most expensive AIDS vaccine trial in history—has turned out to be

a model of bad communication, scientific disagreement, international

face-saving, and clashing bureaucratic interests. Many leading AIDS

researchers have publicly decried the trial as a near-certain failure and a

waste of scarce resources.

GO TO WEBSITE FOR GRAPHIC showing Trial Period of HIV Vaccines

The trial combines two different vaccines, and although critics don’t

particularly like either of them, they dislike one more than the other—and

that has become the main point of contention. The controversial vaccine,

called gp120, was once the darling of the field, but it fell out of favor

more than a decade ago, after disappointing test results. It survives

because indefatigable corporate and government scientists have brought it

back time and again, arguing that it deserves yet another study to assess

its worth. General scientific opinion would have dictated otherwise.

The saga began in the summer of 1993, when a protein called gp120 enjoyed

frontrunner status in a spirited race to develop an AIDS vaccine. The

protein sticks out from the surface of the HIV virus like the hooks in

Velcro, allowing it to latch onto and infect human cells. Biotech stars

Genentech and Chiron believed that injecting the surface protein into

people would stimulate their immune systems to create antibodies against

it, theoretically protecting them if they contracted the virus. The U.S.

National Institutes of Health (NIH) planned to bankroll efficacy trials.

Then gp120’s fate suddenly turned. In test-tube experiments reported in

October 1993, antibodies taken from vaccinated people proved unable to stop

HIV from infecting human cells. After consulting widely with critics of the

approach, NIH decided in June 1994 to abandon plans for the

multimillion-dollar efficacy trials.

The decision spelled the end of the gp120 programs at both companies, but

out of the ashes of the Genentech effort rose VaxGen, which raised millions

of private dollars to stage two new efficacy trials. Though no less a

personage than Nobel laureate Baltimore, who in 1998 headed NIH’s

AIDS Vaccine Research Committee, expressed serious doubts about gp120’s

utility, VaxGen charged that its critics put too much faith in their

theories and not enough in the good old trial-and-error empiricism that had

guided research on other vaccines.

As the VaxGen studies progressed, AIDS vaccine researchers moved on to the

next big thing: the “prime boost.” A “prime” shot would produce killer

cells, which target and destroy the cells invaded by viruses, while a

second “boost” shot would trigger an antibody response.

The lead candidate for the priming shot came from Aventis Pasteur, where

scientists stitched HIV genes into a harmless bird virus called canarypox.

For the antibody boost, researchers turned once again to gp120. Although

this struck some as illogical, no other potential antibody-boosting vaccine

had yet proven its safety in hundreds of humans, and gp120’s proponents

further reasoned that the two vaccines might somehow synergize with each

other. The HIV Vaccine Trials Network, an NIH-funded group of academic

researchers, and the U.S. Military HIV Research Program, run from the

Walter Army Institute of Research in Silver Spring, MD, drew up plans

for two separate efficacy trials of the canarypox/gp120 strategy.

GO TO WEBSITE FOR CHART SHOWING Vaccine Trials: Beyond HIV (cervical cancer

(HPV), Melanoma, Pancreatic Cancer, Prostate Cancer, Smoking Cessation,

Strep Throat)

Backroom grumbling about these two new trials grew audible in January 2002,

when AIDS immunologist of Cornell University’s Weill Medical

College in New York City wrote a stinging commentary for Nature magazine.

had no quarrel with the prime-boost idea, but he questioned most

every other aspect of the proposed trials. charged that NIH and the

military behaved like rivals and felt compelled to “shadow” each other. He

further argued that it “would surely be prudent” to wait for results from

the VaxGen gp120 efficacy trials then under way before launching new studies.

The next month, the HIV Vaccine Trials Network pulled the plug on its

prime-boost study after small human trials of the canarypox vaccine showed

that it wasn’t very good at stimulating killer cells. The military,

however, stood by its decision to conduct its own $119-million prime-boost

study in collaboration with Thailand’s Ministry of Public Health, Mahidol

University, and the Thai Royal Army. In fact, the leading proponents of the

Thai trial, including army colonel McNeil, met quietly with outside

consultants in Geneva in November 2002 to consider whether the design of

the study should change if gp120 also failed as a solo agent. No, the group

concluded, reasoning that the prime-boost strategy deserved to be tested

anyway.

Predictably, the results of VaxGen’s efficacy trials, released in 2003,

showed that gp120 conferred no more protection against HIV than a placebo.

With solid evidence that their skepticism was warranted, gp120’s

detractors—including Gallo, whose lab first proved that HIV caused

AIDS, and Neal son, the former head of the Office of AIDS Research at

NIH—cranked up their objections to including the vaccine in the prime-boost

study. In a Science magazine opinion piece published in January 2004,

Gallo, son, , and 19 other prominent AIDS researchers assailed

the Thai trial and specifically complained about their exclusion from the

Geneva meeting. The process “lacked input from independent immunologists

and virologists who could have judged whether the trial was scientifically

meritorious,” they wrote.

McNeil and three other gp120 proponents replied in another Science opinion

piece that the trial couldn’t be stopped, since the United States had

already made commitments to industry, the Thai government, and the people

who had started to receive the vaccines. In a separate letter, an official

at the Thai Ministry of Public Health added a revealing detail: the

government of Thailand felt that the country would benefit from the study

regardless of the results, since its scientists were gaining experience

with HIV, its laboratories were being modernized, and general awareness of

HIV/AIDS was rising.

And that, more or less, is where the controversy stands today. Last

September, Thai and U.S. military scientists reported that they had

enrolled more than 5,500 Thai volunteers in the study and that they would

meet their goal of 16,000 participants within another year, with the entire

study planned to conclude in 2009.

When scientific institutions seek robust criticism up front—as NIH did in

1994—it doesn’t guarantee that everyone will walk away happy. But

permitting this kind of dialogue does bow to a truth that seems to have

escaped the Defense Department researchers in charge of the Thai trial: the

later objections surface, the more they hurt. Had the prime-boost study’s

organizers invited a few well-known, sharp-edged basic researchers to take

part in the study’s design, they might still have decided not to change

their basic plan. But they wouldn’t have had nearly two dozen leading

scientists in the field publicly accusing them of playing ostrich.

Indeed, when the stakes are as high as they are in the search for an AIDS

vaccine, it’s worth striving to keep the peace in constituent communities,

even if it means inviting your enemies to the table. But that’s a battle

plan that simply runs counter to the culture at the Department of Defense.

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Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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