FDA Guidelines Targeted Children for HIV Vaccine Experiments_ Africa-AIDS Numbers Overstated_WashPos

The FDA has just issued Guidelines for vaccine manufacturers interested in testing all manner of HIV vaccines in children–e.g., "DNA vaccine, live
viral vectored vaccine, adjuvanted vaccine."

These guidelines are meant to facilitate vaccine licensure. It should be noted that years of HIV-AIDS vaccine trials failed to produce a single safe
and effective HIV vaccine.

The guidelines acknowledge the likelihood of a high rate of "false positive" results, stating: "The potential implications for the pediatric subject of a
false positive HIV test will require age-appropriate discussion at entry and throughout study enrollment."

It is entirely unclear how "age-appropriate discussion" is a safeguard for children who falsely test positive, are then exposed to the risks of
experimental vaccines, when they are in fact not infected? Who will bear responsibility should these healthy children suffer harm?
 
Children are being targeted for high risk experiments despite FDA’s acknowledgement that there is a lack of understanding about scientific
fundamentals:
"Given the current stage of development of preventive HIV vaccines and the lack of understanding about immunity to HIV, scientific and ethical issues
are paramount when considering the timing, design, and conduct of studies of HIV vaccine candidates in pediatric populations."
 
That "lack of understanding" exists after years of testing HIV vaccines-including the illegal testing of Phase I vaccines in children in
foster care. [1]  
The vaccine test results have all been negative. NO safe and effective HIV vaccine exists–not for adults, not for children.

Even as the FDA acknowledges the current lack of basic scientific understanding about HIV immunity, the agency is intent on giving the green
light to vaccine manufacturers to turn children into human guinea pigs.

There is absolutely no evidence demonstrating that children who are proposed as test subjects are at special risk of developing AIDS. Indeed, the Center for Disease Control reports the following numbers of AIDS cases in children:

In 2004, the number of AIDS children under 13  was 48; in children aged 13 to 14, the number was 60; in children aged 15 to 19, the number was 326.

The cumulative number of AIDS cases in children–since the ‘epidemic’:  
in children under 13, the number is 9,443*; in children 13 to 14, the number is 959; in children 15 to 19, the number is 4,936. *clearly the under 13
year number refers to mother to infant transmitted cases).

As for Africa: a front page report in the Washington Post (April 6) provides stunning evidence debunking the dire projected numbers of HIV infected people in Africa.

The dire prediction had been inflated by the UNAIDS agency that skewed the numbers, supplanting science in favor of the AIDS advocacy
industry.

"In the place of previous estimates provided by the World Health Organization, outside researchers say, the UNAIDS agency produced reports
that increasingly were subject to political calculations, with the emphasis on raising awareness and money."

"From a research point of view, they’ve done a pathetic job," said Paul Bennell, a British economist whose studies of the impact of AIDS on African
school systems have shown mortality far below what UNAIDS had predicted.
"They were not predisposed, let’s put it that way, to weigh the counterevidence. They were looking to generate big bucks."

Given the lack of scientific evidence to support the exposure of children to risks, pain and discomfort of experimental HIV vaccines, FDA’s effort to
open the gate for vaccine manufacturers to use children as test subjects of experimental human vaccines is nothing less that government-supported
enslavement of children.

This is a demonstration of how the FDA’s ethical standards are a reflection of this industry’s unethical conduct.  The FDA would legitimize the
pharmaceutical industry’s unethical drug and vaccine experiments on disadvantaged infants and children.  A shocking case example was reported by
The Washington Post.
See: Pfizer Faulted 1996 Clinical Trials In Nigeria: Unapproved Drug Tested
On Kids:  http://www.ahrp.org/cms/content/view/162/29/

  Public comments are sought about these new guidelines.

See:     1. BBC documentary, Guinea Pig Kids, produced by Jamie Doran
    2. OHRP letter of determination, May 23, 2005 http://www.hhs.gov/ohrp/detrm_letrs/YR05/may05c.pdf

Contact: Vera Hassner Sharav
veracare@ahrp.org

http://www.fda.gov/Cber/gdlns/pedhiv.htm  
FDA Press Release: Development of Preventive HIV Vaccines for Use in Pediatric Populations

ROCKVILLE, Md., May 5, 2006-FDA is issuing guidance providing
recommendations to sponsors regarding data to support the: 1) Initiation of
pediatric studies of a preventive HIV vaccine under a United States (U.S.)
investigational new drug application (IND); and 2) licensure of a preventive
HIV vaccine for pediatric use. The guidance also provides recommendations to
investigators and institutional review boards (IRBs) who are involved with
these pediatric studies.

This guidance specifically addresses issues regarding development of a
preventive HIV vaccine for use in healthy U.S. pediatric populations.

The guidance is available on the FDA web site at
http://www.fda.gov/cber/gdlns/pedhiv.htm. Copies of this guidance are also
available from the Office of Communication, Training and Manufacturers
Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD
20852-1448, or by calling 1-800-835-4709 or 301-827-1800.

Written comments on this guidance may be submitted at any time to the
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments. You should identify all comments with
the title of this guidance, Development of Preventive HIV Vaccines for Use
in Pediatric Populations.

Richard Klein HIV/AIDS Program Director Office of Special Health Issues Food
and Drug Administration  
~~~~~~~~~~~~~~~

http://www.washingtonpost.com/wp-dyn/content/article/2006/04/05/AR2006040502517_pf.html
How AIDS in Africa Was Overstated: Reliance on Data From Urban Prenatal
Clinics Skewed Early Projections
By Craig Timberg
Washington Post Foreign Service
Thursday, April 6, 2006; A01

KIGALI, Rwanda — Researchers said nearly two decades ago that this tiny
country was part of an AIDS Belt stretching across the midsection of Africa,
a place so infected with a new, incurable disease that, in the hardest-hit
places, one in three working-age adults were already doomed to die of it.

But AIDS deaths on the predicted scale never arrived here, government health
officials say. A new national study illustrates why: The rate of HIV
infection among Rwandans ages 15 to 49 is 3 percent, according to the study,
enough to qualify as a major health problem but not nearly the national
catastrophe once predicted.

The new data suggest the rate never reached the 30 percent estimated by some
early researchers, nor the nearly 13 percent given by the United Nations in
1998.
The study and similar ones in 15 other countries have shed new light on the
disease across Africa. Relying on the latest measurement tools, they portray
an epidemic that is more female and more urban than previously believed, one
that has begun to ebb in much of East Africa and has failed to take off as
predicted in most of West Africa.

Yet the disease is devastating southern Africa, according to the data. It is
in that region alone — in countries including South Africa, Botswana,
Swaziland and Zimbabwe — that an AIDS Belt exists, the researchers say.
"What we know now more than ever is southern Africa is the absolute
epicenter," said David Wilson, a senior AIDS analyst for the World Bank,
speaking from Washington.

In the West African country of Ghana, for example, the overall infection
rate for people ages 15 to 49 is 2.2 percent. But in Botswana, the national
infection rate among the same age group is 34.9 percent. And in the city of
Francistown, 45 percent of men and 69 percent of women ages 30 to 34 are
infected with HIV, the virus that causes AIDS.
Most of the studies were conducted by ORC Macro, a research corporation
based in Calverton, Md., and were funded by the U.S. Agency for
International Development, other international donors and various national
governments in the countries where the studies took place.

Taken together, they raise questions about monitoring by the U.N. AIDS
agency, which for years overestimated the extent of HIV/AIDS in East and
West Africa and, by a smaller margin, in southern Africa, according to
independent researchers and U.N. officials.
"What we had before, we cannot trust it," said Agnes Binagwaho, a senior
Rwandan health official.

Years of HIV overestimates, researchers say, flowed from the long-held
assumption that the extent of infection among pregnant women who attended
prenatal clinics provided a rough proxy for the rate among all working-age
adults in a country. Working age was usually defined as 15 to 49. These
rates also were among the only nationwide data available for many years,
especially in Africa, where health tracking was generally rudimentary.

The new studies show, however, that these earlier estimates were skewed in
favor of young, sexually active women in the urban areas that had prenatal
clinics. Researchers now know that the HIV rate among these women tends to
be higher than among the general population.

The new studies rely on random testing conducted across entire countries,
rather than just among pregnant women, and they generally require two forms
of blood testing to guard against the numerous false positive results that
inflated early estimates of the disease. These studies also are far more
effective at measuring the often dramatic variations in infection rates
between rural and
urban people and between men and women.

UNAIDS, the agency headed since its creation in 1995 by Peter Piot, a
Belgian physician, produced its first global snapshot of the disease in
1998. Each year since, the United Nations has issued increasingly dire
assessments: UNAIDS estimated that 36 million people around the world were
infected in 2000, including 25 million in Africa. In 2002, the numbers were
42 million globally, with 29 million in Africa.

But by 2002, disparities were already emerging. A national study in the
southern African country of Zambia, for example, found a rate of 15.6
percent, significantly lower than the U.N. rate of 21.5 percent. In Burundi,
which borders Rwanda in central East Africa, a national study found a rate
of 5.4 percent, not the 8.3 percent estimated by UNAIDS.

In West Africa, Sierra Leone, just then emerging from a devastating civil
war, was found to have a national prevalence rate of less than 1 percent —
compared with an estimated U.N. rate of 7 percent.

Such disparities, independent researchers say, skewed years of policy
judgments and decisions on where to spend precious health-care dollars.
"From a research point of view, they’ve done a pathetic job," said Paul
Bennell, a British economist whose studies of the impact of AIDS on African
school systems have shown mortality far below what UNAIDS had predicted.
"They were not predisposed, let’s put it that way, to weigh the
counterevidence. They were looking to generate big bucks."

The United Nations started to revise its estimates in light of the new
studies in its 2004 report, reducing the number of infections in Africa by
4.4 million, back to the total four years earlier of 25 million. It also
gradually decreased the overall infection rate for working-age adults in
sub-Saharan Africa, from 9 percent in a 2002 report to 7.2 percent in its
latest report, released in November.
Peter Ghys, an epidemiologist who has worked for UNAIDS since 1999,
acknowledged in an interview from his office in Geneva that HIV projections
several years ago were too high because they relied on data from prenatal
clinics.

But Ghys said the agency made the best estimates possible with the
information available. As better data emerged, such as the new wave of
national population studies, it has made revisions where necessary, he said.
"What has happened is we have come to realize that indeed we have
overestimated the epidemic a bit," he said.

On its Web site, UNAIDS describes itself as "the chief advocate for
worldwide action against AIDS." And many researchers say the United Nations’
reliance on rigorous science waned after it created the separate AIDS agency
in 1995 — the first time the world body had taken this approach to tackle a
single disease.
In the place of previous estimates provided by the World Health
Organization, outside researchers say, the AIDS agency produced reports that
increasingly were subject to political calculations, with the emphasis on
raising awareness and money.

"It’s pure advocacy, really," said Jim Chin, a former U.N. official who made
some of the first global HIV prevalence estimates while working for WHO in
the late 1980s and early 1990s. "Once you get a high number, it’s really
hard once the data comes in to say, ‘Whoops! It’s not 100,000. It’s 60,000.’
"

Chin, speaking from Stockton, Calif., added, "They keep cranking out numbers
that, when I look at them, you can’t defend them."
Ghys said he never sensed pressure to inflate HIV estimates. "I can’t
imagine why UNAIDS or WHO would want to do that," he said. "If we did that,
it would just affect our credibility."
Ghys added that studies now show that the overall percentage of Africans
with HIV has stabilized, though U.N. models still show increasing numbers of
people with the virus because of burgeoning populations.

Many other researchers, including Wilson from the World Bank and two
epidemiologists from the U.S. Agency for International Development who wrote
a study published last week in the Lancet, a British medical journal,
dispute that conclusion, saying that the number of new cases in Africa
peaked several years ago.

Some involved in the fight against AIDS say that tallying HIV cases is not
nearly as important as finding the resources to fight the disease. That is
especially true now that antiretroviral drugs are more affordable, making it
possible to extend millions of lives if enough money and health-care workers
are available to facilitate treatment.
"It doesn’t matter how long the line is if you never get to the end of it,"
said Francois Venter, a South African doctor and head of Johannesburg
General Hospital’s rapidly expanding antiretroviral drug program, speaking
in an interview in Johannesburg.

But to the researchers who drive AIDS policy, differences in infection rates
are not merely academic. They scour the world looking for evidence of
interventions that have worked, such as the rigorous enforcement of condom
use at brothels in Thailand and aggressive public campaigns that have urged
Ugandans to limit their sexual partners to one.
Programs deemed successful are urged on other countries and funded lavishly
by international donors, often to the exclusion of other programs.

Rwanda, a mountainous country of about 8.5 million people jammed into a land
area smaller than Maryland, has relied on approaches similar to those used
in Uganda, and may have produced similar declines in HIV. UNAIDS estimated
in 1998 that 370,000 Rwandans were infected, equal to 12.75 percent of all
working-age adults and a substantial percentage of children as well. Every
two years since, the agency has lowered that estimate — to 11.2 percent in
2000, 8.9 percent in 2002 and 5.1 percent in 2004.

Dirk van Hove, the top UNAIDS official in Rwanda, said the next official
estimate, due in May, would show an infection rate of "about 3 percent," in
line with the new national study. He said the U.N. estimate tracked the
declining prevalence.

Rwandan health officials say their national HIV infection rate might once
have topped 3 percent and then declined. But it’s just as likely, they say,
that these apparent trends reflected nothing more than flawed studies.

Even so, Rwanda’s cities show signs of a serious AIDS problem not yet tamed.
The new study found that 8.6 percent of urban, working-age women have HIV.
Overall, officials say, 150,000 Rwandans are infected, less than half the
number estimated by UNAIDS in 1998.

Bruno Ngirabatware, a physician who has treated AIDS patients in Kigali
since the 1980s, said he has seen no evidence of a recent decline in HIV
infection rates.
"There’s lots of patients there, always," he said.

C 2006 The Washington Post Company

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