International Health Officials in Botswana Begin Discussions About Low-Cost Generic Antiretroviral Drugs

International health officials on Monday began discussions in Gaborone, Botswana, about the "controversial" issue of using low-cost generic antiretroviral drugs in developing countries, the AP/Las Vegas Sun reports. Officials from HHS, the World Health Organization, UNAIDS and the Southern African Development Community are meeting at a two-day conference to discuss the safety, effectiveness and approval process for certain generic drugs used to treat HIV/AIDS (Motseta, AP/Las Vegas Sun, 3/29). The President's Emergency Plan for AIDS Relief -- which seeks to provide treatment to two million HIV-positive people living in 14 African and Caribbean countries -- states that procurement of drugs for the initiative "will have to fit within the parameters of existing federal and international law for the protection of intellectual property rights." Ambassador Randall Tobias, head of the new State Department Office of the Global AIDS Coordinator, has said that the Bush administration is open to the use of generic drugs but has concerns over their safety. The medications in question are fixed-dose combination antiretroviral drugs, including Cipla's Triomune and Ranbaxy Laboratories' Triviro, which combine stavudine, lamivudine and nevirapine into one pill that is taken twice a day. A regimen of the same three drugs purchased separately from patent holders GlaxoSmithKline, Bristol-Myers Squibb and Boehringer-Ingelheim requires six pills a day (Kaiser Daily HIV/AIDS Report, 3/29).

Standardized Principles
Although Triomune and Triviro have been approved by WHO -- which has a voluntary drug screening process through which pharmaceutical companies can submit both brand-name prescription drugs and unpatented generics for evaluation -- U.S. officials say they want the drugs to be approved based on internationally accepted principles, such as those used to approve malaria and tuberculosis medications, the AP/Sun reports. The officials have dismissed allegations that they are protecting the interests of large pharmaceutical companies by raising questions regarding the safety and effectiveness of the generic medications, according to the AP/Sun. "We know from a decade of clinical experience that if you do not maximally suppress the virus, you significantly increase the risk of resistance," PEPFAR Deputy Chief Medical Officer Mark Dybul said (AP/Las Vegas Sun, 3/29). In principle, PEPFAR guidelines require drugs to be approved either by FDA or through a mechanism established by PEPFAR. Although data collected by WHO for its approval process may be sufficient for PEPFAR to approve the drugs, the data are confidential. Therefore, U.S. officials are proposing that countries and organizations agree on a set of principles by which fixed-dose combination drugs for HIV/AIDS and other diseases could be judged (Kaiser Daily HIV/AIDS Report, 3/29). "It's not that we don't think the WHO system is sound. It's that we need to see the data ourselves," Dybul said (Wilson, "Morning Edition," NPR, 3/30).

Delays in Provision?
Critics of the U.S. plan fear that establishing another review system could delay the provision of antiretroviral drugs in developing countries, the AP/Sun reports. Ellen 't Hoen of Medecins San Frontieres' Campaign for Access to Essential Medicines said, "There are very clear signals that the U.S. government does not support ... the use of [generic] fixed-dose combinations." She added, "We are very worried that these arguments about the safety of the medicines ... will lead to loss of confidence in the products" that WHO has approved. "This is a political meeting disguised as a scientific meeting," William Haddad, chair of Brogenerics, a U.S.-based generic antiretroviral drug manufacturer, said, adding, "The organizers' purpose was to undermine the World Health Organization prequalification process" (AP/Las Vegas Sun, 3/29). Dr. David Bangsberg, a University of California-San Francisco researcher who has examined drug resistance in HIV-positive patients in the United States and Uganda, said that the concerns of the Bush administration are "misplaced," NPR reports. "The choice is between generic therapy and no therapy," he said, adding, "And we know what the natural history of HIV is in the absence of therapy. It will be important to monitor the outcomes of hundreds of thousands of people, but for every day we delay introducing therapy, those people will die" ("Morning Edition," NPR, 3/30).

The NPR "Morning Edition" segment, which is available online in RealPlayer, also includes comments from Dr. Eric Goemaere of MSF.

A webcast of a press briefing discussing the five-year plan for PEPFAR, along with other resources, is available online from kaisernetwork.org.