Last updated: April 1, 2004

ACT UP/HEALTH GAP DIRECT ACTION TARGETS BUSH AND BIG PHARMA FOR BLOCKING GENERICS

by Michael Kink and the Staff of Housing Works


In Washington today a dozen AIDS activists chained themselves to the headquarters of the Pharmaceutical Manufacturers of America, in protest of this weeks Bush Administration's moves this week to ban the use of generic medications from world wide assistance programs such as the Global Fund to
fight AIDS, Tuberculosis and Malaria, and the President's own bilateral AIDS relief program.

The activists took action today to oppose the Bush Administration's maneuvers to restrict access to generic AIDS medications in developing nations during a US-convened a meeting this week (29-30 March) in Botswana. This two-day meeting, the "Conference on Fixed-Dose Combination (FDC) Drug Products" will be used to dispute the quality of clinically proven medications already used widely worldwide. White House Global AIDS Coordinator Randall Tobias has repeatedly provided misleading testimony over the last month before Congressional Committees, casting doubt on the quality of WHO approved generics.

"Under the cover of an ostensibly humanitarian program, Bush is using his AIDS plan to ensure big pharma's market dominance and destroy the access to generics," reported Health GAP's Jen Cohn. "Bush campaigns on AIDS and compassion, but his program is merely a slush-fund to reward drug company
campaign donors."

The State Department is insisting the U.S. FDA or similar wealthy country drug regulatory authority perform new assessments of the safety and efficacy of generic medicines, rejecting the WHO's internationally supported pre-qualification program which assures the quality and safety of medications. The protocol of the WHO program mimic FDA standards, however, patent barriers prohibit the approval of generic AIDS drugs by the agencies deemed acceptable to Bush officials an intentional Catch-22. The WHO has approved dozens of generic AIDS medications for use by numerous national governments, UNICEF, the World Bank, the Global Fund to Fight AIDS, TB, and Malaria, and groups such as M⁄decins Sans Fronti∂res (MSF).

Unwelcome media coverage and a slew of letters from US Members of Congress last week led to countries including the European Union withdrawing from the meeting. In a letter to President Bush, Senators McCain and Kennedy warn, "We should wait no longer to provide safe and effective low-cost medications to the developing world, and again, urge you to reconsider the Administration's actions. Make no mistake, delays will cost lives."
Representatives Brown, Waxman and Lee expressed similar concerns. A letter protesting the meeting and the President's push to restrict generics was endorsed by more than 360 NGOs from 67 countries.

White House officials are particularly opposed to the use of fixed-dose combinations (FDCs) of antiretroviral medications, which combine drugs from multiple originators into single pills. FDCs promote adherence, decrease the risk of resistance and facilitate stock and procurement management. WHO
recommended FDCs now available are one pill, taken twice daily. FDCs are the least expensive option: a generic triple combination costs less than $140 per person per year. In the developing world, the same combination from brand-name companies costs a minimum of $562 per person per year and must be
taken in the form of six pills a day.

"President Bush is a drug company puppet," said Asia Russell from Health GAP. "He plans to force millions of people with HIV/AIDS to accept higher pill burdens and waste tax money to create a slush fund for big pharma. If Bush would use the WHO's quality-assured generics, we could treat four times as many people in need."

By denying quality assured generics under PEPFAR, and requiring poor countries to establish parallel systems for affordable generics, the White House is attempting to lock developing countries into to using only branded drugs. Health GAP activists noted that the Kerry campaign has opposed limitations on the
use of affordable generic AIDS drugs for developing countries.