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HEALTH NEWS

AIDS Drug Controversy Grows as Rev. Jackson Calls for Congressional Investigation

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Contributed by Ron Gara|  17 December, 2004  13:31 GMT

Saying that "research standards and drug quality that are unacceptable in the U.S. and other western countries must never be pushed onto Africa," Rev. Jesse L. Jackson, Sr., founder and president of the Rainbow/PUSH Coalition, has called for a Congressional investigation into the activities of the National Institutes of Health's AIDS Division with respect to the AIDS drug nevirapine.

Rev. Jackson's comments were a response to reports earlier this week by the Associated Press that have sparked a growing controversy over the safety of the drug.

AP disclosed that a woman participating in a nevirapine study funded by NIH died of liver failure in 2003. Doctors had continued use of the drug, failing to catch signs of complications.

Safety Report Rewritten

Additionally, the news service reported that documents showed the government's chief of AIDS research, Dr. Edmund Tramont, rewrote a safety report on nevirapine to change its conclusions. He deleted negative information about a U.S.-funded study that determined nevirapine could be used safely in single doses to stop the spread of AIDS to African babies from their mothers, according to AP.

Rev. Jackson says in a statement that he read of Dr. Tramont's action "with outrage and disbelief," noting that in his revision, Tramont reportedly omitted thousands of severe reactions to nevirapine -- including death and long-term resistance to the drug. "This was not a thoughtful and reasonable decision, but a crime against humanity," Rev. Jackson says.

Rev. Jackson maintains that the Bush administration must be held accountable for allowing the drug to be shipped to Africa for use among AIDS patients there, referring to the decision as a failure of U.S. moral leadership.

The AP reported that NIH supported Tramont's decision to rewrite the safety conclusions and stood by its 2002 conclusion that the drug was safe in single doses.

Long-Term Resistance Following Single Dose

Nevirapine has been used widely in Africa to prevent transmission of the disease from pregnant women to their infants. "The White House said Tuesday that President Bush remains confident in his decision to send hundreds of thousands of doses of nevirapine to Africa in summer 2002," AP reported.

However, NIH subsequently acknowledged concern that "the single doses administered to African mothers and babies may have caused long-term resistance in hundreds of thousands of African patients," according to AP, "that will keep them from using a whole class of AIDS drugs to treat their disease in the future." The agency now says it no longer recommends nevirapine as the drug of first choice to protect newborns if other medications are available, AP reported.

Jackson: U.S. 'Adding to Agony'

"The U.S. Office of Human Research Protections acknowledged to the Ugandan government in summer 2002 that the NIH's research on that country's pregnant mothers and newborns violated federal safety protection rules," AP reported.

"I call upon both houses in Congress to open a thorough investigation of this catastrophe and hold the NIH and the Bush administration responsible for spreading this deadly drug," says Rev. Jackson. "With more than 5,000 Africans dying a day from HIV/AIDS, the U.S. should double its efforts in fighting this pandemic instead of adding to the agony."

The Associated Press reported that Senate Finance Committee Chairman Charles Grassley has asked the Justice Department to investigate NIH's conduct in the case.

 
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