|
|
 S. Africa Attacks U.S. Over AIDS Drug
By ALEXANDRA
ZAVIS, Associated Press Writer JOHANNESBURG, South Africa - President Thabo Mbeki's ruling party published a stinging attack Friday on top U.S. health officials, accusing them of treating Africans like "guinea pigs" and lying to promote a key AIDS drug. The criticism reinforces fears of doctors and activists that new questions about the testing of nevirapine could halt use of the drug that's credited with protecting thousands of African babies from catching HIV from their mothers. The article, published in the online journal ANC Today, was responding to Associated Press reports this week that U.S. health officials withheld criticism of a nevirapine study before President Bush launched a 2002 plan to distribute the drug in Africa. Documents obtained by AP show Dr. Edmund C. Tramont, chief of the National Institutes of Health's AIDS division, rewrote an NIH report to omit negative conclusions about the way a U.S.-funded drug trial was conducted in Uganda, and later ordered the research to continue over the objections of his staff. Tramont's staff worried about record-keeping problems, violations of federal patient safeguards and other issues at the Uganda research site. "Dr. Tramont was happy that the peoples of Africa should be used as guinea pigs, given a drug he knew very well should not be prescribed," the article said. "In other words, they entered into a conspiracy with a pharmaceutical company to tell lies to promote the sales of nevirapine in Africa, with absolutely no consideration of the health impact of those lies on the lives of millions of Africans." Smuts Ngonyama, an African National Congress spokesman and editor of the journal, said the article was an opinion piece by a member and didn't reflect official party policy. He wouldn't identify the author. In the United States, the Rev. Jesse Jackson called for a U.S. congressional investigation and demanded nevirapine no longer be distributed in Africa. "This was not a thoughtful and reasonable decision, but a crime against humanity," Jackson said Thursday in Chicago. "Research standards and drug quality that are unacceptable in the U.S. and other Western countries must never be pushed onto Africa." 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." Tramont has also argued that Africans in the midst of an AIDS crisis deserved some leniency in meeting tough U.S. safety standards. Some 70 percent of the 45 million people worldwide infected with HIV live in sub-Saharan Africa. Studies have shown that a single dose of nevirapine to an infected woman during labor and another dose to her newborn can reduce the chances of HIV transmission by up to 50 percent. Nevirapine is also used in combination with other drugs to prolong the lives of AIDS patients. Subsequent research has confirmed the safety and efficacy of nevirapine in protecting newborns, according to the World Health Organization. But there's evidence women who receive a single dose during pregnancy can develop resistance to the drug that can compromise their future AIDS treatment. WHO recommends nevirapine be used in combination with other drugs where possible a strategy that has reduced transmission to less than 1 percent in wealthier countries. But it says resistance concerns must be weighed against the practicality of administering a single dose of nevirapine in impoverished African countries. Doctors and AIDS activists in Africa are worried governments may now halt use of single-dose nevirapine before alternatives are available. "It's an issue affecting people's lives," said Dr. Saul Onyango, who was involved in the testing in Uganda. "A lot of damage has already been done." Activists in South Africa accused the Health Department and ruling party officials this week of putting out misleading statements that could frighten patients off their treatment. "There is to date not a single life-threatening adverse event associated with this regimen which is widely used in the developing world," the Treatment Action Campaign said. In July, South Africa's Medicines Control Council recommended that nevirapine only be used in combination with other drugs because of the resistance concerns. The Health Department this week welcomed U.S. concerns about the quality of nevirapine research in Uganda, saying it supported its cautious attitude to the drug.
Until this year, Mbeki's government refused to provide
anti-retroviral drugs through the public health system, citing safety and
cost concerns. A coalition of doctors and AIDS activists won a 2002
Constitutional Court order requiring the government to immediately expand
a pilot nevirapine program to all infected pregnant women. Christine Maggiore Thank you for your December 17 article on the AIDS drug Nevirapine. While the piece sheds some light on a very important discussion, please note that there is more to the Nevirapine story than current media reports suggest. A body of well-referenced evidence indicates the most compelling concern with Nevirapine is not the potential for drug resistance, but the high incidence of severe and life-threatening effects. Three years ago, the US Centers for Disease Control issued warnings on short course use of Nevirapine for healthcare workers after 22 medical professionals treated with the drug suffered severe, life-threatening liver damage, including one case that required a liver transplant. (Reuters, January 4, 2001) These dire drug reactions were emphasized again in a recent issue of the science journal HIV Medicine which noted that more than two-thirds of healthcare workers taking limited doses of Nevirapine experience severe adverse events including liver failure. (Feldt, T et al, HIV Medicine, 2004) Speaking more directly to the topic of Nevirapinešs use among expectant mothers, in July of 2002, Dr. Sam Mhlongo (head of the department of Family Medicine and Primary Care at the Medical University of South Africa) presented the Medicines Control Council in SA with a fact sheet that raise serious questions about the drugšs efficacy and safety. As Dr. Mhlongo notes, although only healthy mothers were accepted into HIVNET 012, the single trial upon which use of Nevirapine for pregnant women is based, 80% experienced clinical or laboratory abnormalities while 7% of their infants died after just one exposure of Nevirapine. As you may know, the US FDA approved Nevirapine only for administration among adults; it is not licensed for use by pregnant women in the US, Europe, Canada or any other industrialized nation. In fact, manufacturer Boehringer Ingleheim (BI) withdrew its FDA application for single dose use of Nevirapine in expectant mothers after failing to comply with FDA requests for original data from the HIVNET 012 trial. In response to FDA inquiries, BI admitted they could locate only 100 of the 645 medical case files in HIVNET012. Other alarming irregularities with this trial continue to surface. In 1998, high rates of severe hepatic and dermatological toxicities among Nevirapine user (all life threatening and some fatal) led the European Agency for the Evaluation of Medicinal Products EAEM) and Canandašs Therapeutic Products Programme (TTP) to limit Nevirapinešs use to only adults demonstrating immunological deterioration. In 2000, both the EAEM and the TTP issued special safety alerts on Nevirapine. I urge you to conduct further investigation into these and other disturbing facts on Nevirapine and perhaps provide an answer to the pressing question touched upon in your article: If Nevirapine is not acceptable for women and children in the US, what justifies its use among women and children in Africa? Please let me know if I may forward you the data cited in this note along with contact information for Dr. Mhlongo and other experts that have particular insight into this important issue. With thanks for your interest, Christine Maggiore |
|
Home |
The Facts | $Your Disease$
| Quiz |
Newsletter |
In The News |
Speeches |
|
Copyright Š
2008 The FAIR Foundation. All rights reserved |
