Religious Groups Get Chunk of AIDS Money

By RITA BEAMISH, Associated Press Writer 19 minutes ago

New groups are springing up to win a piece of President Bush's $15 billion AIDS program, with traditional players and religious groups joining forces to improve their chances in a competition that already has targeted nearly a quarter of its grants for faith-based organizations. The administration is putting out a call for new community and church groups to get involved in HIV prevention and care in 15 target countries, most in sub-Saharan Africa. It is reserving $200 million specifically for groups with little or no government grant experience.

Groups that have deep local ties in the countries and focus on abstinence and fidelity - instead of just condoms - are faring well.

"The notion that because people have always received aid money that they'll get money needs to end," Deputy Global AIDS coordinator Mark Dybul said in a recent interview with The Associated Press. "The only way to have sustainable programs is to have programs that are wholly owned in terms of management personnel at the local level."

Those on the ground in Africa say Bush's 3-year-old effort is reshaping prevention efforts.

"You have community organizations, some that have operated for decades, asking for money and you have lots of new organizations popping up," said Sarah Lucas, a development assistance expert who recently toured four countries on the U.S. target list for HIV/AIDS grants.

Award recipients so far include a Christian relief organization famous for its televised appeals to feed hungry children, a well-known Roman Catholic charity and a group run by the son of evangelist Billy Graham, according to the State Department.

The outreach to nontraditional AIDS players comes in the midst of a debate over how best to prevent the spread of HIV. The debate has activated groups on both ends of the political spectrum and created a vast competition for money. Conservative Christian allies of the president are pressing the U.S. foreign aid agency to give fewer dollars to groups that distribute condoms or work with prostitutes. Secular organizations in Africa are raising concerns that new money to groups without AIDS experience may dilute the impact of Bush's program.

"We clearly recognize that it is very important to work with faith-based organizations," said Dan Mullins, deputy regional director for southern and western Africa for CARE, one of the best-known humanitarian organizations. "But at the same time we don't want to fall into the trap of assuming faith-based groups are good at everything," he added.

Religious organizations last year accounted for more than 23 percent of all groups that got HIV/AIDS grants, according to State Department estimates. Some 80 percent of all secular and religious grant recipients were based in the countries where the aid is targeted.

Among those winning grants were:

_Samaritan's Purse, which is run by Graham's son, Franklin. It says its mission is "meeting critical needs of victims of war, poverty, famine, disease and natural disaster while sharing the Good News of Jesus Christ."

_World Vision. The 56-year-old Christian organization is known for its TV appeals - some with celebrities such as game show host Alex Trebek - that asked people to support a Third World child.

_Catholic Relief Services. It was awarded $6.2 million to teach abstinence and fidelity in three countries; $335 million in a consortium providing antiretroviral treatment; and $9 million to help orphans and children affected by HIV/AIDs. The group offers "complete and correct information about condoms" but will not promote, purchase or distribute them, said Carl Stecker, senior program director for HIV/AIDS.

_HOPE. The global relief organization founded by the International Churches of Christ recently brought comedian Chris Rock to South Africa for an AIDS prevention event. AIDS grants support HOPE in several countries.

_World Relief, founded by the National Association of Evangelicals. It won $9.7 million for abstinence work in four countries.

Most of the money in Bush's initiative goes to treatment programs, earning the administration praise for delivering lifesaving drugs and care to millions of HIV-infected patients.

For prevention, Bush embraces the "ABC" strategy: abstinence before marriage, being faithful to one partner and condoms targeted for high-risk activity. The Republican-led Congress mandated that one-third of prevention money be reserved for abstinence and fidelity.

The U.S. government provided more than 560 million condoms abroad last year, compared with some 350 million in 2001.

Condom promotion to anyone must include abstinence and fidelity messages, U.S. guidelines say, but those preaching abstinence do not have to provide condom education.

The abstinence emphasis, say some longtime AIDS volunteers, has led to a confusing message and added to the stigma of condom use in parts of Africa. Village volunteers in Swaziland maintain a supply of free condoms but say they have few takers.

"This drive for abstinence is putting a lot of pressure on girls to get married earlier," said Dr. Abeja Apunyo, the Uganda representative for Pathfinder International, a reproductive health nonprofit group based in Massachusetts. "For years now we have been trying to tell our daughters that they should finish their education and train in a profession before they get married. Otherwise they have few options if they find themselves separated from their husbands for some reason," Apunyo said.

An AIDS program pastor in Uganda explained his abstinence teaching to unmarried young people. "Why give an alternative and have them take a risk?" asked the Rev. Sam Lawrence Ruteikara of the Anglican Church of Uganda, a U.S. grant recipient. "This person doesn't have a sexual partner, so why should I report too much, saying that in case you get a sexual partner, please use a condom. I am saying, please don't get a sexual partner - don't get involved because it is risky."

U.S.-backed programs have spread abstinence and faithfulness education to more than 13 million people in Uganda, according to the State Department. Officials promote the nation as an "ABC" model, with its HIV infection rate down by more than half in a decade.

Rep. Chris Smith, R-N.J., said that on a tour of Uganda in January he saw pro-abstinence rallies and skits praising Bush, and U.S.-supported groups conducting house-to-house testing, care and counseling. "The good news about the faith-based groups is not only the passion they bring to the work, but it is the moral authority and the extended numbers of volunteers they can mobilize to get the word out," Smith said.

But Smith believes the administration is wrongly supporting some nonprofit groups. He and several other congressional conservatives wrote to Bush and the U.S. Agency for International Development, or USAID, contending that several large grant recipients were pro-prostitution, pro-abortion and not committed enough to abstinence priorities. The letters followed a briefing last year by Focus on the Family, run by Christian commentator James Dobson. The group's sexual health analyst, Linda Klepacki, said even some religious groups emphasize condoms over abstinence.

"We have to be careful that the president's original intent is being followed where A and B (abstinence and faithfulness) are the emphasized areas of the ABC methodology," she said.

Six congressional Democrats, in a letter last week to Secretary of State Condoleezza Rice, accused the conservatives of a distortion campaign that undermines a balanced approach to fighting AIDS. "Their attack is based on a narrow, ideological viewpoint that condemns condoms and frames any attempt to reach out to high-risk populations as an endorsement of behaviors that these critics oppose," said Rep. Henry Waxman (news, bio, voting record), D-Calif.

USAID has declined to renew funding for two major AIDS-fighting consortiums, CORE and IMPACT, headed by organizations the conservatives targeted.

CORE, whose lead partner is CARE, is losing its central source of money, meaning its work survives only if it can win grants from individual USAID missions in target countries.

Family Health International, the lead organization of IMPACT, brought hundreds of local and religious groups into its $441 million project, but was told the administration wants new partners, said Sheila Mitchell, senior vice president of FHI's Institute for HIV/AIDS.

Dybul said the changes are in keeping with the shift to local groups. Any suggestion of political motivation is "inaccurate and offensive to people doing this work," he said. Millions of grant dollars still go to the groups that were criticized. One grant was delayed when Sen. Tom Coburn, R-Okla., complained last year about renewing $14 million to Population Services International, a leading nonprofit condom distributor.

The group's bingo-style games that teach Guatemalan prostitutes about safe sex misused funds "to exploit victims of the sex trade," Coburn said. But Sen. Larry Craig (news, bio, voting record), R-Idaho, then wrote to praise PSI's work as "provably effective and efficient."

USAID divided the grant; condom distribution was separated into the smaller part so that religious groups could apply for the other part. PSI eventually won the larger grant. The second is outstanding.

Although administration critics frequently cite PSI as a group that fell from favor under the new initiative, "we have not been eviscerated," said Stewart Parkinson, a senior program analyst. The group lost U.S. grants in Uganda and Tanzania but retained others. And Parkinson said he had no indication of political motivation. - news.yahoo.com

Mengele's Legacy Lives On: Inhumane Experiments on Children in America

by John W. Whitehead - 4/18/2005 - The Rutherford Institute

Inevitably, when we hear about humans being experimented on, our minds turn to the Auschwitz concentration camp and the infamous Nazi Angel of Death, Josef Mengele. Seen as immoral and scientifically dubious, Mengele's work included placing human beings in pressure chambers, freezing them to death, testing drugs on them and castrating them. He also injected children with lethal germs, removed their organs and limbs and performed sex change operations on them. His primary interest was twins. The Nuremberg Code, created as a reaction to the horrors of Mengele's work, provided directives for human experimentation to protect the experimental subject from even remote possibilities of injury, disability, or death. Above all else, the Code stressed that it is necessary to obtain voluntary, informed consent from the patient.

Despite the existence of this code and subsequent medical ethics codes, Mengele's legacy lives on. This time, the culprit is none other than the United States government through its involvement in numerous questionable and immoral human research programs. Lest you think that the scientific community and government agencies would not carry out immoral experiments on humans, particularly children, think again. For example, the federal Environmental Protection Agency's forays into human experimentation recently came to light after the Washington Post reported that the EPA had approved a two-year study in which families who use pesticides in Duval County, Fla., would be paid to continue using them and to monitor their children's exposure. Each family would be paid $970 in order that scientists might discover how children's bodies absorb hazardous chemicals. Although scientists may not know the full effects of these poisonous chemicals, they do know that children are at greater risk than adults. Yet rather than advising parents to keep children away from pesticides, the government is paying them to poison their children. Thankfully, after U.S. Senators Barbara Boxer (CA) and Bill Nelson (FL) threatened to block the full-time confirmation of Stephen Johnson, the EPA's acting administrator, if the experiment were not cancelled, Johnson ended the Florida pesticide program on April 8, 2005.

However, the pesticide study is not the only unethical experimentation in U.S. history. It is simply the most recent case. At a prenatal clinic at Vanderbilt University Hospital from 1945-49, nearly 830 poor, pregnant Caucasian women were given a drink containing radioactive iron. They were told the drink would be good for their fetuses. Within an hour, the radioactive material was circulating in the blood of the unborn babies.

The list of criminal experiments does not stop at endangering the unborn. During the 1940s and 1950s, the U.S. government was involved in many radioactivity tests in which humans, especially young children, were used as guinea pigs. Most notable was the MIT and Quaker Oats-sponsored testing at the Fernald School in Waltham, Mass., in which mentally retarded students were fed cereal containing radioactive iron in order to trace iron absorption. However, neither the students nor their parents were informed of the use of radioactive materials or the possible health risks.

From 1948 to 1954, Johns Hopkins conducted an experiment on 582 third graders, testing the effects of Nasal Radium Irradiation. Although it is now known that this procedure places the participant at greater risk for cancer, the government still has not contacted the participants to warn them of this risk. During the 1950s and 1960s, mentally retarded children between the ages of 3 and 11 at Willowbrook State School were intentionally infected with hepatitis. The early test subjects were fed extracts of the feces of an infected patient, and later subjects were injected with the virus in order for researchers to be able to study the hepatitis virus. In the 1960s, the D.C. Children's Center in Laurel, Md., used mentally retarded children as test subjects. They were given a diet pill called NeoBazine, which contains thyroxin, a drug that causes tremors, nervousness, insomnia and tachycardia. The FDA later found that this drug was not safe for use.

As recently as 1989-1991, Kaiser Permanente of Southern California and the Centers for Disease Control treated 1,500 poor black and Latino inner-city children in Los Angeles with experimental measles vaccines. The same vaccination was given to infants in Mexico, Haiti and Africa by the World Health Organization. It was discontinued after a large number of those tested died.

In a series of articles written for the New York Press in July 2004, Liam Scheff reported on experiments at Incarnation Children's Center in New York, where AIDS drugs were being tested on HIV-positive children, the majority of whom are orphans. Although the HIV test is not always accurate, once the children test positive, they are considered terminal patients and subjected to debilitating and experimental drugs. Despite the fact that these drugs can be torturous for the children, those carrying out the experiments seem to feel justified in doing so because the children will most likely die anyhow.

For some reason, people are more apt to allow cruelty in the name of medical research. Yet human experimentation makes a mockery of the Hippocratic Oath, which doctors swear to uphold. There is obviously no true moral viewpoint here. The Golden Rule of treating others with the concern and kindness you would like them to show you seems to have fallen on deaf ears in certain sectors of the medical industry. And one can only wonder, "What kind of mind operates on this level?"

When the world learned the truth about Josef Mengele's horrific experiments, he was immediately branded a monster. However, a few years later, similar experimentation was being sanctioned by the powers that be in America and carried out on unsuspecting American citizens. As the Alliance for Human Research Protection points out, these barbaric practices continue even today, "while government agencies maneuver to weaken legal protections prohibiting the exposure of human beings to experimental drugs, vaccines and procedures without their voluntary informed consent." And with the demise of investigative reporting, these human rights violations are rarely published and gain little public notice.

Unless we reaffirm our commitment to the dignity and rights of all human beings-and teach this principle in our homes and schools and continue into the highest levels of our public institutions and government, such experiments will continue. And we will have little right to condemn or object to the inhumane practices of other countries.

Constitutional attorney and author John W. Whitehead is founder and president of The Rutherford Institute and author of the award-winning Grasping for the Wind. He can be contacted at johnw@rutherford.org.

Panel Faults Pfizer in '96 Clinical Trial In Nigeria
Unapproved Drug Tested on Children

THE WASHINGTON POST By Joe Stephens Sunday, May 7, 2006; A01 source

A panel of Nigerian medical experts has concluded that Pfizer Inc. violated international law during a 1996 epidemic by testing an unapproved drug on children with brain infections at a field hospital.

That finding is detailed in a lengthy Nigerian government report that has remained unreleased for five years, despite inquiries from the children's attorneys and from the media. The Washington Post recently obtained a copy of the confidential report, which is attracting congressional interest. It was provided by a source who asked to remain anonymous because of personal safety concerns.

The report concludes that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to nearly 100 children and infants. Pfizer selected the patients at a field hospital in the city of Kano, where the children had been taken to be treated for an often deadly strain of meningitis. At the time, Doctors Without Borders was dispensing approved antibiotics at the hospital.

Pfizer's experiment was "an illegal trial of an unregistered drug," the Nigerian panel concluded, and a "clear case of exploitation of the ignorant." The test came to public attention in December 2000, when The Post published the results of a year-long investigation into overseas pharmaceutical testing. The news was met in Nigeria with street demonstrations, lawsuits and demands for reform.

Pfizer contended that its researchers traveled to Kano with a purely philanthropic motive, to help fight the epidemic, which ultimately killed more than 15,000 Africans. The committee rejected that explanation, pointing out that Pfizer physicians completed their trial and left while "the epidemic was still raging."

The panel said an oral form of Trovan, the Pfizer drug used in the test, had apparently never been given to children with meningitis. There are no records documenting that Pfizer told the children or their parents that they were part of an experiment, it said. An approval letter from a Nigerian ethics committee, which Pfizer used to justify its actions had been concocted and backdated by the company's lead researcher in Kano, the report said.

The panel concluded that the experiment violated Nigerian law, the international Declaration of Helsinki that governs ethical medical research and the U.N. Convention on the Rights of the Child.

Five children died after being treated with the experimental antibiotic and others showed signs of arthritis, although there is no evidence the drug played a part. Six children died while taking a comparison drug.

The panel recommended that Pfizer be "sanctioned appropriately" and directed to issue "an unreserved apology to the government and people of Nigeria." The company should also pay an unspecified amount of restitution, the report said. The panel recommended that Nigeria enact reforms to prevent a recurrence.

Aspects of the affair remain mysterious, such as why the report remains confidential. The head of the investigative panel, Abdulsalami Nasidi, said in a brief telephone conversation from Nigeria, "I don't really know myself" why the report was never released. "I did my job as a civil servant," said Nasidi, who is quoted in the report as saying he has been the target of unspecified death threats.

A New York City attorney for the families of the children, Elaine Kusel of Milberg Weiss Bershad & Schulman, said her firm had spent years looking for the report, of which they believed there were only three copies. They tracked one to a Nigerian government safe, but it was reported stolen, she said. Another copy was reported to have been held by an official who died. "It sounds like a mystery novel here, like John le Carré," Kusel said.

The current Nigerian health minister, Eyitayo Lambo, did not respond to calls and e-mail messages from a reporter. Dora Akunyili, director of the Nigerian drug control agency, said she did not know why the report remained confidential but added that her agency had independently concluded that "these people did not have authority to conduct the trial."

Executives at Pfizer, the world's biggest drug company, said they had not seen the report. After reviewing a copy, they responded in a two-page statement: "The Nigerian government has neither contacted Pfizer about any of the committee's findings nor are we aware that the committee has approved a final report. Therefore it would be inappropriate for the company to respond to specific points in the document.

"However, as we have stated repeatedly over the past several years, Pfizer conducted this trial with the full knowledge of the Nigerian government and in a responsible way consistent with Nigerian law and Pfizer's abiding commitment to patient safety."

Pfizer said it had previously tested the drug in thousands of patients and found it effective. Local nurses explained the experiment to Nigerian parents, it added, and obtained their "verbal" consent. The company said that Trovan demonstrated the highest survival rate of any treatment at the hospital.

"Trovan unquestionably saved lives, and Pfizer strongly disagrees with any suggestion that the company conducted its study in an unethical manner," the statement said.

At the time of the Nigerian experiment, Pfizer was developing Trovan for release in the United States, where it was expected to gross up to $1 billion a year. The FDA never approved Trovan for use in treating American children. After being cleared for adult use in 1997, the drug quickly became one of the most prescribed antibiotics in the United States. But Trovan was later associated with reports of liver damage and deaths, leading the FDA to severely restrict its use in 1999. European regulators banned the drug.

After The Post published its report, Nigeria's health minister at the time, Tim Menakaya, appointed a blue-ribbon panel of medical experts to look into Pfizer's actions, saying, "Let me assure you that my ministry will take all necessary steps to obtain details of this incident and make them known to the general public." The committee collected hundreds of documents and interviewed at least 26 people.

Pfizer had told authorities that a Nigerian doctor directed the experiment. The committee, however, found that researchers from Pfizer's U.S. office controlled the trial, and the inexperienced Kano doctor, Abdulhamid Isa Dutse, was the principal investigator "only by name." Publications listed Dutse as the lead author of articles on Trovan, but the committee found that depiction "did not sufficiently reflect his role." Dutse indicated he was kept in the dark about the experiment's results and said he did not see at least one publication until the committee showed it to him.

"He was shocked that Pfizer could publish such data without showing him or intimating him with details," the report said, concluding that Dutse was "naive and exploited." The report quoted Dutse as saying that Pfizer's motive was far from philanthropic. "I have trusted people and am disappointed," Dutse told the committee. "I regret this whole exercise, I wonder why on earth I did this."

Dutse admitted that he created a letter after the experiment purporting to show that the test had been approved in advance by a Nigerian hospital's ethics committee. He then backdated the letter to March 28, 1996 -- a week before Pfizer's experiment began.

Pfizer used the letter as a key justification for the trial in discussions with reporters and submitted it to the FDA. U.S. regulations require the sponsors of foreign medical research seeking FDA approval to show that the tests have been reviewed in advance by an ethics committee.

The Post previously reported that the hospital had no ethics committee in March 1996 and that the letterhead stationery used was not created until months after the experiment's conclusion.

In a statement last week, Pfizer said that after that article appeared, the company investigated and found that the letter was "incorrect." "Obviously this should not have occurred and the company very much regrets that it did," the statement said. "It is important to point out, though, that Pfizer thought proper procedure had been followed at the time of the clinical study."

The former director of Nigeria's version of the FDA said the agency had been unaware of the experiment. He told the panel that he "viewed the conduct of the trial by Pfizer as an act of deception and misuse of privilege."

The report said the treatment of two children during the experiment represented unspecified "serious deviations" from the trial's protocol and concluded that those deviations compromised their care. One was a 10-year-old girl identified only as Patient No. 0069, who was given the experimental antibiotic for three days as her condition deteriorated. She died without receiving any other antibiotic.

Last week, Rep. Tom Lantos of California, the senior Democrat on the International Relations Committee, described the report's findings as "absolutely appalling" and called on Pfizer to open its records.

"I think it borders on the criminal that the large pharmaceutical companies, both here and in Europe, are using these poor, illiterate and uninformed people as guinea pigs," Lantos said.

Lantos said he expected to introduce a bill requiring U.S. researchers to give regulators details of tests they plan in developing countries. "It's the only ethical thing to do," Lantos said. The bill is similar to one his committee approved in 2001 that did not make it out of the House. "There should be a lot of bipartisan support for it. This outrages people."

The report's findings also breathe new life into a lawsuit against Pfizer, according to Kusel, who represents 30 Nigerian families. "It's great news, I'm very excited," she said when told of the committee's conclusions.

The families sued Pfizer in federal court in New York in 2001, alleging that the company had exposed the children to "cruel, inhuman and degrading treatment."

A U.S. judge dismissed the suit last summer, saying U.S. courts lacked jurisdiction. Kusel is appealing. "A report like this does not get suppressed without someone high up being involved," she said.