Tuesday, May 18, 2004
What's behind the Bush announcement about AIDS drugs?
This week, the FDA announced it was fast-tracking approval of AIDS drugs for use in places like Africa and the Caribbean. Sounds great, but it's not as altruistic as it sounds.
Africa and AIDS activists are assailing the proposal not only as a new attempt to delay the delivery of desperately needed, low-cost generic drugs to needy AIDS victims in Africa and the Caribbean, but also as an effort to undermine the World Health Organization's (WHO) own expedited approval process which has already authorized the use of generics by the World Bank, the UN Children's Fund (UNICEF), and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
"WHO was asked by its member states to establish an international standard called the pre-qualification process so that it could play the role of honest broker for both the global North and the global South (in certifying medications for use), said Paul Zeitz, director of the Global AIDS Alliance. "Now the U.S. is undermining the credibility of that international program."
Critics also charged that the administration's new FDA program appeared designed to give U.S. and western pharmaceutical companies a leg up on their competitors in developing countries whose generic drugs generally cost far less than their brand-name equivalents manufactured by "Big Pharma."
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"The concern we have about the 'fast-track' FDA approval is that there already is a recognized process which includes many of the exact same steps that the FDA uses," he told OneWorld. "Instead of reinforcing the (WHO's) pre-qualification process, they are slowing things down by creating a redundant and parallel U.S.-led review process."
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But they also charged that Bush appears determined to protect Big Pharma from competition by the generic manufacturers and they pointed to announcements shortly after Thompson's by major U.S. and western drug companies that they intended to introduce FDCs as well as evidence that the administration is doing the companies' bidding.
Three big U.S. pharmaceutical companies - Bristol-Myers Squibb Co., Gilead Sciences Inc. and Merck & Co, Inc. - announced Sunday night that they are jointly pursuing development of their own one-dose-a-day anti-AIDS drug, while British-based GlaxoSmithKline and Germany's Boehringer Ingelheim Corp. said they were also considering a co-packaging deal for FSCs.
posted by chris at 4:50 PM
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