Wednesday, December 15, 2004

More Shame...

Jeebus:

Although NIH officials were warned that a Ugandan clinical trial using the antiretroviral drug nevirapine was "flawed" months before President Bush announced an initiative to reduce mother-to-child HIV transmission in Africa and the Caribbean, they did not inform the White House of the risks associated with the drug's use in pregnant women.

According to documents obtained by the Associated Press, poor record keeping might have underreported severe reactions to the drug, including deaths, the AP/Globe reports. In March 2002, NIH received data from a Ugandan study that prompted the agency to suspend the trial for more than a year and warn Uganda's government of the risks associated with nevirapine, according to the AP/Globe.

However, NIH officials did not inform the Bush administration of the drug's risks as it "scrambled to keep its specialists' concerns from scuttling the use of nevirapine in Africa as a less-expensive solution," according to NIH documents, the AP/Globe reports.

The documents show that Dr. Edmund Tramont, director of the National Institute of Allergy and Infectious Diseases Division of AIDS, and other NIH officials regarded the problems with the trial as "overblown" and did not immediately report safety concerns about the drug to FDA, according to the AP/Globe. However, the data did prompt Boehringer Ingelheim -- the drug's manufacturer -- to withdraw its FDA application to market the drug in the United States for the prevention of vertical HIV transmission (Solomon, AP/Boston Globe, 12/14).


Golly, I guess if it involves black people, why have traditional ethical safety concerns? Another black eye.

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