With gratitude to Dr. Bolaji Aluko, we bring this to your notice. He appends a note:  "Dear Africans:  Conspiracy theories are sometimes termed paranoid.  But to be paranoid does not mean somebody is not REALLY after you."

http://www.news24.com/News24/South_Africa/Aids_Focus/0,,2-7-659_1637381,00.html

"Documents obtained by the AP show that Dr Edmund C Tramont, chief of the NIH's Aids division, rewrote an NIH safety report on nevirapine to omit negative conclusions, and later ordered the research to continue over the objections of his staff.

'A crime against humanity'
17/12/2004 12:52  - (SA) 

Chicago, Illinois - The Reverend Jesse Jackson called for a congressional investigation into reports that US health officials withheld research from the White House that showed an Aids drug distributed to hundreds of thousands of Africans posed serious risks.

He also said the US government should immediately halt the drug's distribution in Africa.

"This was not a thoughtful and reasonable decision, but a crime against humanity," Jackson said on Thursday. "Research standards and drug quality that are unacceptable in the US and other Western countries must never be pushed onto Africa."

He likened the drug's distribution in Africa to the US government's 40-year syphilis experiment using poor blacks in Tuskegee, Alabama, after World War II.

The Associated Press reported on Monday that the National Institutes of Health knew about problems with the drug, nevirapine, as early as 2002, but did not tell the White House before President Bush launched a plan that summer to distribute the drug throughout Africa.

Documents obtained by the AP show that Dr Edmund C Tramont, chief of the NIH's Aids division, rewrote an NIH safety report on nevirapine to omit negative conclusions, and later ordered the research to continue over the objections of his staff.

Dr H Clifford Lane, the NIH's No 2 infectious disease specialist and one of Tramont's bosses, has said an internal review cleared Tramont of scientific misconduct. He said Tramont changed the report because he was more experienced than his safety experts and had an "honest difference of opinion."

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http://msnbc.msn.com/id/6725677/

AIDS drug test stirs Africa controversy
Dangers may halt use of drug to protect babies

The Associated Press
Updated: 6:26 p.m. ET Dec. 16, 2004

KAMPALA, Uganda - Doctors and AIDS activists in Africa are worried governments may halt use of an AIDS drug that has protected thousands of babies from HIV infection in reaction to new concerns about the drug's testing and effect on pregnant women.

The Associated Press revealed this week that testing of the drug nevirapine at Uganda's Mulago Hospital failed to meet international standards and that pregnant women who take the drug once to inhibit passing HIV to their babies may develop resistance to it that can limit drug therapies to combat the deadly disease.

Dr. Saul Onyango, a medical officer involved in the testing, said Thursday that officials were worried about the fallout.

"It's an issue affecting people's lives. A lot of damage has already been done and we need to do damage control," Onyango said.

Risks of debate

Dr. Francis Miiro, a key researcher, has dismissed concerns about the testing as discrimination against African scientists and insists the drug works safely.

In South Africa, the Treatment Action Campaign, which lobbied for access to anti-retroviral drugs in that country, warned that reopening debate about the Uganda study could frighten patients off their treatment, even though subsequent research has confirmed nevirapine is safe and effective.

"I don't see a problem with Nevirapine at all," said the group's leader, Zackie Achmat, who found out he was HIV-positive in 1990. "I use it twice daily."

Doctors working in the public health system, which serves the vast majority of South Africans, have privately expressed fears they will be pressured to stop using single-dose nevirapine for pregnant women before alternatives are available.

"I'm of the view that we should use nevirapine till a better situation can be created," said Dr. Ashraf Coovadia, head of the pediatric HIV clinic at Johannesburg's Coronation Mother and Child Hospital. "To halt the program would cause damage to what we have already achieved."

Worries that drug will be withdrawn

Comment on radio talks shows in South Africa following publication of the AP stories in the local press have included worries that authorities will pull the drug.

President Thabo Mbeki's government has been criticized for its sluggish response to the AIDS crisis. Until this year, it refused to provide anti-retrovirals through the public health system, citing safety and cost concerns.

In July, a South African regulator recommended a halt to the single-dose nevirapine regime for pregnant women, saying a "cocktail" of drugs should be used instead even though such drugs are expensive and available mostly in the United States and other wealthy nations.

On Wednesday, the Health Department said U.S. concerns about the quality of nevirapine research in Uganda supported its cautious attitude to the drug and it was reviewing its guidelines on mother-to-child HIV transmission.

A spokesman, Sibani Mngadi, said the drug is still distributed by hospitals for now.

"It is part of a public health program which cannot be stopped just because this research is continuing," Mngadi said.

Studies show that a single dose of nevirapine to an infected woman during labor and another dose to her newborn baby can reduce the chances of HIV transmission by up to 50 percent.

Nevirapine can cause rashes, liver toxicity and even death in some patients who use the drug on a daily basis to treat HIV, but no serious reactions have been reported after a single dose.

But a South African study found that 39 percent of HIV-infected women who get a single dose of nevirapine go on to harbor virus that is resistant to the drug.

Political problem

In Uganda, the official in charge of community health services said the issue had become a political one in the country, often praised for its efforts to stop the spread of AIDS.

"The issue is highly contentious, that's why some people don't want to be quoted," Dr. Sam Okware said. "It's been going on for two and a half years."

In a letter obtained by AP, U.S. health officials told Uganda's government in July 2002 that the research had violated federal patient safety rules. The memos show U.S. officials knew about the problems as early as January 2002, but chose not to tell President Bush before he authorized shipping the drug to Africa later as part of a $500 million initiative.

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http://www.dailynews.co.za/index.php?fSectionId=501&fArticleId=2344861

Nevirapine Africa research hides flaws  
December 14, 2004

Washington: Weeks before President George Bush announced a plan to protect African babies from Aids, top US health officials were warned that research on a key drug was flawed and that severe reactions including deaths may have been underreported, government documents show.

The 2002 warnings about the drug, Nevirapine, were serious enough to suspend testing for more than a year, let Uganda's government know of the dangers and prompt the drug's maker to pull its request for permission to use the medicine to protect newborns in the United States.

But the National Institute of Health (NIH) chose not to inform the White House as it scrambled to keep its experts' concerns from scuttling the use of Nevirapine in Africa as a cheap solution.

The documents show that NIH officials dismissed the problems with the Nevirapine research in Uganda as overblown. NIH's Nevirapine research in Uganda was so riddled with sloppy record keeping that NIH investigators couldn't be sure from patient records which mothers got the drug.

Less than a month after Bush announced a $500 million (R2.8 billion) plan to push Nevirapine across Africa to slow the Aids epidemic, the Health and Human Services Department sent a nine-page letter to Ugandan officials identifying violations of federal patient protection rules by NIH's research. Africa accounts for more than two-thirds of the world's Aids cases, with 27 million infected.

Because of the problems, NIH shut down the Ugandan research for 15 months, from 2002 to 2003, to review the science and take corrective actions. NIH officials said that they remain confident after re-reviewing the Ugandan study and other research that Nevirapine can be used safely in single doses by African mothers and children to prevent HIV transmissions during birth. But they acknowledged their Ugandan research failed to meet US standards.

As a result, NIH recently asked the National Academy of Sciences to investigate its science in the case, and has spent millions in the last two years improving its safety monitoring and record keeping.

One lesson already derived from a closer review of the Ugandan research is that even single doses of Nevirapine can create instant resistance, meaning patients may not be able to use the drug or others in its class again when their Aids worsens.

Nevirapine is known to have lethal effects like liver damage and bad rashes when taken over time.

How the drug works on Aids

The drug: Nevirapine, an Aids drug pronounced Nee-VERA-peen, is made by Boehringer Ingelheim Corp and is marketed under the brand name Viramune. There are two generic versions, Nevimune, made by Cipla, and Nevirex, made by Aurobindo Pharma.

How it works: Nevirapine, a non-nucleoside reverse transcriptase inhibitor, blocks an HIV protein that the virus uses to make new viral particles.

How it is used: Nevirapine is generally taken once or twice a day in combination with other anti-Aids drugs, such as AZT or didanosine.

Experimental use:Nevi-rapine was tested in Uganda, Kenya and Thailand to see if a single dose to a mother in labour and one later to the newborn could prevent HIV transmission from an infected, pregnant woman to her baby.

Resistance problems: Studies found that birthing mothers who received Nevirapine could develop an

HIV virus resistant to some HIV drugs, including Nevirapine.
This could make their later Aids treatment less effective.

Side effects: Liver toxicity occurs in some patients. About 16% of patients develop a skin rash. Other common side effects include nausea, fatigue, headache, vomiting, diarrhoea and abdominal and muscle pain. - Sapa-AP

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