Kaiser Daily HIV/AIDS Report Summarizes Opinion Pieces, Editorial on Generic Fixed-Dose Combination Antiretroviral Drugs
Several sources recently have published opinion pieces on the use of generic fixed-dose combination antiretroviral drugs in the President's Emergency Plan for AIDS Relief. FDC antiretroviral drugs, including Cipla's Triomune and Ranbaxy Laboratories' Triviro, combine three different medicines into one pill that is taken twice a day and costs as little as $140 per person per year. A regimen of the same three drugs purchased separately from the companies that hold the patents would require about six pills a day and cost about $562 per patient per year. The drugs have been approved a World Health Organization prequalification system, but U.S. officials want to ensure that the drugs will not contribute to the development of drug-resistant HIV strains through widespread or improper distribution and use and are proposing guidelines for reviewing FDCs (Kaiser Daily HIV/AIDS Report, 4/9). Summaries of two opinion pieces and an editorial appear below:
- Jeremiah Norris, Tech Central Station: Using U.S. funds to purchase FDC antiretrovirals whose "clinical benefits have not been established through independently validated trials or post-marketing surveys" would endorse a treatment "double ... standard: an unproven [drug regimen] for poor Africans, and a proven [drug regimen] for more well-to-do citizens in Western countries," Norris, an adjunct fellow at the Hudson Institute, writes. Generic FDCs do have "several attractive features" because the regimen requires fewer pills; patient adherence would be higher; and shipment, storage and distribution would be faster, Norris says. However, the drugs have not been approved by regulatory agencies in the United States, Europe, Canada, Japan or Australia, Norris says. FDCs should be "submitted ... for independent clinical validation from a recognized, stringent authority," Norris concludes (Norris, Tech Central Station, 4/21).
- Carol Adelman, Tucson Citizen: Faith in WHO's prequalification system "[h]ardly" is deserved because the agency "doesn't do its own drug testing nor can it certify the safety testing done by others," Adelman, a fellow at the Hudson Institute and a former assistant administrator at USAID, writes. "The controversy over the price of AIDS drugs and the constant focus by WHO on cheap generics, regardless of whether they've been shown to work, has already caused real damage," Adelman says, citing a recent WHO-supported Global Fund to Fight AIDS, Tuberculosis and Malaria grant that paid for generic malaria drugs, which were later discovered to be "ineffective." Adelman concludes that Congress should "look closely at what they are prescribing for AIDS patients, lest their leap carry the victims of AIDS to their deaths" (Adelman, Tucson Citizen, 4/22).
- Nation: The Bush administration's "war on AIDS" has been "characterized by unilateralism, disregard for international consensus and corporate cronyism," a Nation editorial says. Although Bush cited prices for generic drugs during his 2003 State of the Union address when he announced PEPFAR, the first round of U.S. grants under the program does not authorize the use of generics. Administration officials participated in a meeting last month in Botswana to discuss authorizing the use of FDC antiretroviral drugs for the plan, but it was "merely an attempt to use sham science to protect Big Pharma -- following earlier, failed attempts to use patent law to accomplish the same thing," the Nation says. The editorial says that FDC antiretrovirals "are a crucial component" of "almost all international AIDS plans," including WHO's 3 by 5 Initiative. Although the international community supports the initiative, its success "largely depends on the Bush administration," the editorial says, asking, "Will it pony up the U.S. fair share of funding and authorize the use of generic drugs, or will it continue its go-it-alone, pro-drug industry policies?" (Nation, 4/26).