U.S. Ambassador Randall Tobias, head of the State Department Office of the Global AIDS Coordinator, on Wednesday defended U.S. AIDS policies in a speech at the XV International AIDS Conference that was delayed because of interruptions by protestors, Reuters reports (Hirschler [1], Reuters, 7/14). About 50 protestors stood in front of the stage chanting "Bush Lies, Millions Die" (Reuters, 7/14). The protestors also carried a placard that resembled a $15 billion check -- the amount that Bush pledged to spend over five years through his President's Emergency Plan for AIDS Relief -- but the check was made out to pharmaceutical companies and "right-wing extremists," according to the Associated Press (Associated Press, 7/14). The United States has been criticized throughout the conference for its support of funding for abstinence-only education as well as its policies on generic antiretroviral drugs, the AP/Atlanta Journal Constitution reports. Tobias said that the United States is spending nearly twice as much as all other donor governments combined. "At this point, perhaps the most critical mistake we can make is to allow this pandemic to divide us," Tobias said, adding, "We are striving toward the same goal -- a world free of HIV/AIDS. When 8,000 lives are lost to AIDS every day, division is a luxury we cannot afford." Tobias also said that although the United States is not against condom use, Uganda's "ABC" prevention campaign -- which stands for Abstinence, Be faithful and use Condoms -- shows that condoms are not the only effective means of preventing HIV transmission. "Abstinence works, being faithful works, condoms work," Tobias said, adding, "Each has its place" (Joshi, AP/Atlanta Journal-Constitution, 7/14).

Drugs
Tobias also responded to criticism over the Bush administration's refusal to use PEPFAR money to purchase generic antiretroviral drugs that have not been approved by FDA, according to Reuters. "It is a moral imperative that families in programs funded by the United States in the developing world have the same assurances as American families that the drugs they use are safe and effective," Tobias said (Reuters, 7/14). He added, "America will not have one health standard for her own citizens and a lower standard of 'good enough' for those suffering elsewhere" (AP/Atlanta Journal-Constitution, 7/14). Dr. Anthony Fauci, head of the NIH National Institute of Allergy and Infectious Diseases, also at the conference defended the requirement, saying that the drugs could be used if they pass a new FDA expedited review process (Maugh, Los Angeles Times, 7/14). U.S. officials in May created the expedited process to review new products that combine FDA-approved HIV/AIDS drugs into a fixed-dose pill and new co-packaging of existing treatments (Kaiser Daily HIV/AIDS Report, 5/21).

Trade Negotiations
Tobias also responded to allegations from European delegates and French President Jacques Chirac that the United States is pressuring developing countries to give up the right to make generic drugs -- including antiretroviral drugs -- in exchange for free trade agreements (Agence France-Presse, 7/14). Chirac in a written statement to the conference said on Tuesday that the U.S. methods concerning generic drugs in free trade negotiations have been "tantamount to blackmail" (Kaiser Daily HIV/AIDS Report, 7/13). U.S. trade officials are negotiating a series of agreements to strengthen patent protection of brand-name drugs, including antiretrovirals. In many countries, including the United States, generic drug makers often win approval for their drugs by proving that the products are equivalent to the brand-name drugs. However, new agreements sought by the United States would prevent countries trading with the United States from approving for five years generic drug applications if data submitted by the generic companies is based on data originally compiled by the brand-name manufacturer. The agreements would in effect grant temporary exclusivity to brand name drug makers (Kaiser Daily HIV/AIDS Report, 7/12). Lieve Fransen, head of the European delegation to the conference, on Wednesday said that Chirac's statement "represented very much the message from Europe in general," adding, "There is a danger that the [United States] would go into major bilateral trade agreements that don't follow the agreements that we have all made" about generic drugs (Agence France-Presse, 7/14).

A kaisernetwork.org webcast of Tobias' speech, as well as an exclusive kaisernetwork.org interview with Tobias is available online.

APM's "Marketplace" on Tuesday reported on the French criticism. The segment includes comments from Claude Barfield, resident scholar and director of science and technology policy studies at the American Enterprise Institute, and Ellen Shaffer, CPA director for the Center for Policy Analysis on Trade and Health (Palmer, "Marketplace," APM, 7/13). The complete segment is available online in RealPlayer.

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