FDA Guidelines Targeted Children for HIV Vaccine Experiments

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[sSRI-Research] FDA Guidelines Targeted Children for HIV

Vaccine Experiments_ Africa-AIDS Number

 

 

 

FDA Guidelines Targeted Children for HIV

Vaccine Experiments_ Africa-AIDS Number

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

 

FYI

 

This is an action alert to prevent the abuse of children who are

sought as guinea pigs in HIV-AIDS vaccine trials!

 

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

212-595-8974

veracare

 

 

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/AR2006040502

517_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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