Increase in Demand for Two Antiretroviral Drugs Might Exceed Supply, Wall Street Journal Reports

The increasing demand for the antiretroviral drugs stavudine and efavirenz, both manufactured by Bristol-Myers Squibb, might soon exceed supply and lead to shortages for HIV-positive patients in developing countries, the Wall Street Journal reports. The potential shortages are largely being attributed to a "rapid increase" in purchases of the drugs by the five-year, $15 billion President's Emergency Plan for AIDS Relief, programs funded through the Global Fund To Fight AIDS, Tuberculosis and Malaria and other organizations treating HIV-positive people in developing countries, according to the Journal. In addition, supplies of the two drugs already are low in many developing countries because the World Health Organization recently withdrew its approval of generic versions of the drugs manufactured by two Indian generic drug makers. The withdrawal prompted the companies to remove the generic drugs from the market. Bristol-Myers Squibb and Merck, which markets efavirenz in developing countries, acknowledged the possible shortages and said the main priority is ensuring that patients continue to have access to the drugs, the Journal reports. However, some new patients might have to wait or use alternative treatments until the shortages are rectified, according to the Journal. Both companies said that the expected length of the shortages is unknown because demand for the drugs is continuing to increase. The "vast majority" of HIV-positive people in developing countries do not have access to antiretroviral treatment, according to the Journal (Davies, Wall Street Journal, 3/4). According to a December 2004 WHO report, 700,000 people in developing countries were on antiretroviral drugs at the end of 2004, compared with 440,000 as of June 2004. However, only about 12% of an estimated 5.8 million HIV-positive adults in developing countries who need antiretrovirals are receiving them (Kaiser Daily HIV/AIDS Report, 2/23).

U.S. Generic Drug Approval
The potential drug shortages have raised the question of whether the U.S. government will approve additional generic antiretroviral medications for international use, which could "ease shortages," HIV/AIDS advocates say, the Journal reports (Wall Street Journal, 3/4). On Wednesday, Ambassador Randall Tobias, head of the State Department's Office of the Global AIDS Coordinator, told the House Foreign Operations Subcommittee that FDA likely will approve more generic AIDS drugs in the next few months, allowing them to be included in PEPFAR. HHS in May 2004 announced plans for a new FDA fast-track review program to speed the delivery of low-cost antiretroviral drugs -- including fixed-dose combination drugs -- to nations covered under PEPFAR. The expedited process is meant to encourage drug makers to produce FDCs to improve access to drugs in remote areas in severely affected countries and ensure the drugs' safety (Kaiser Daily HIV/AIDS Report, 3/3). "People are very cognizant of the issue and are working to resolve the problems," Mark Dybul, deputy chief of PEPFAR, said, adding that the group is seeking bids from companies in order to manage supply issues and avoid future shortages.

Companies', Other Reaction
A Merck spokesperson said efavirenz shortages are expected to be "temporary and sporadic," and several generic drug companies have received approval to produce efavirenz, which could offset shortages, the Journal reports. "Our goal is to maintain uninterrupted supply for current patients, while accelerating production to meet the forecasted increase in demand from new patients," Merck said in a statement. Bristol-Myers Squibb said it is committed to helping HIV/AIDS patients everywhere and would not favor one country over another. "We will continue to supply HIV medicines at no profit in the developing world," BMS spokesperson Brian Henry said. The likely shortages demonstrate the need for improved forecasting and approval of more generic drugs, Kevin Frost, vice president of clinical research and prevention programs at the American Foundation for AIDS Research, said. Peter Mugyenyi, director of the Joint Clinical Research Center in Kampala, Uganda, said drug manufacturers and international aid organizations should have done a "better job of coordinating requests and supply," according to the Journal. "AIDS is not an overnight disease," he said, adding, "The numbers didn't just materialize. It's not acceptable to run short of the drug when huge numbers of people are dying." However, Anil Soni, executive director of the Friends of the Global Fight, said, "The good news is we're scaling up treatment" (Wall Street Journal, 3/4).

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