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US Repeats Concerns on Safety of Generic Anti-Retro Virals in Global AIDS Battle - 2004-03-18

The U.S. Global AIDS Coordinator says a meeting in Botswana later this month, expected to involve more than 100 countries, the United Nations and numerous organizations, will be crucial to establishing regulatory standards as the basis for purchasing anti-AIDS drugs. Randall Tobias spoke before a congressional committee examining the Bush administration's budget for AIDS in 2005. Controversy is ongoing about funding and drugs employed in the AIDS battle.

Mr. Tobias says the meeting will involve the United Nations UNAIDS organization, the Southern Africa Development Community (SADC), and others to develop principles that can be used by authorities in individual countries.

The new U.S. effort to fight AIDS in 14 African and Caribbean nations is a $15 billion, five-year program for prevention and treatment, including contributions to organizations and the public-private Global Fund on AIDS, Malaria and Tuberculosis.

Mr. Tobias was responding to questions about the controversial issue of generic anti-AIDS drugs, known as Anti-Retro Virals, distributed to HIV sufferers in pills called "fixed dose combinations."

U.N. and World Health Organization (WHO) officials have said a plan to provide three million HIV-infected patients in Africa with drugs by 2005, focusing on this "fixed dose" method, could collapse because of a lack of money.

The United States has declined to endorse the combination methods, saying they have not yet been proven safe or reliable, and Mr. Tobias repeated concerns about safety.

He said, "We have been reading stories lately about some problems with some drugs around the world where people with the best of intentions have made acquisitions of drugs that have turned out to not have the consistency, and the safety and effectiveness that people had hoped. I think it is very, very important that we move rapidly but with certainty that we're not endangering people's lives."

U.N. officials and representatives of non-government organizations (NGO's) say sufficient standards are already in place on which to base decisions to purchase medications.

Mr. Tobias, formerly chairman of the large pharmaceutical company Eli-Lilly, says more work needs to be done.

"My intention is to quickly get a set of principles established by experts in the field, in place that we can all be comfortable with to provide the basis for making those decisions," he said.

Critics allege the U.S. position on generic "fixed-dose combination" drugs is being dictated by large drug companies determined to protect their brand names, and say Washington is imposing unreasonable intellectual property requirements to protect these company's investments.

A group of private health and religious organizations Thursday renewed allegations the Bush administration favors brand name drugs produced by large drug companies over over "generic" drugs that have proven safe and effective.

They also criticized what they call "the narrow approach" in the U.S. anti-AIDS strategy.

"The question[s] that we would have again [are] we using our money effectively," asks Dave Bryden who represents the Global AIDS Alliance. "Are we going to be purchasing generic medications? Are we going to take into account the realities of how women experience this epidemic? And are we going to be able, as a country, to meet our obligations to the United Nations? In 2001 we promised a certain amount. The U.N. has just come out again this week saying we are off target, in meeting our goals that we set out for ourselves in 2001."

In his testimony Thursday, Randall Tobias said prices charged by large companies have been coming down, adding the goal remains to make large quantities of safe and dependable drugs available as inexpensively as possible.