WHO To Announce Details of Plan To Treat Three Million People by 2005
The World Health Organization this week is scheduled to release the first details of its plan to provide antiretroviral drugs to three million people by 2005, the Washington Post reports (Vedantam, Washington Post, 10/25). WHO Director-General Dr. Jong-Wook Lee on Sept. 22 during a U.N. General Assembly special session on HIV/AIDS in New York City announced WHO's commitment to the "three-by-five" plan and declared the lack of access to antiretroviral drugs a global health emergency. The new strategy will use rapid response techniques to deliver antiretroviral treatment and will provide emergency response teams to governments requesting assistance in expediting drug delivery (Kaiser Daily HIV/AIDS Report, 9/25). WHO is expected to release a list of "first-line" medications to be used in developing countries, including the eventual endorsement of antiretroviral drugs that combine three medications into one pill, the Post reports. Such an endorsement is expected to be controversial because three-in-one pills could violate multiple patents, according to the Post. WHO also is expected to recommend treating patients at the first sign of AIDS-related illnesses, instead of waiting for tests to confirm that a patient is HIV-positive, and allowing nurses and community organizations to dispense antiretroviral drugs.
'Fixed-Dose' Combination Pill
Health experts say that a "fixed-dose" three-in-one generic combination pill is easy-to-use and affordable and could be used to effectively treat about 80% of patients, according to the Post. The biggest advantage to a single pill regimen would be high drug-adherence rates, Peter Graaff, an antiretroviral drug policy expert at WHO, said. However, Graaff added that some patients on fixed-dose medicines may experience side effects from only one of the three drugs, making it difficult for health care workers to switch patients to a different regimen. Combination pills also could encounter opposition from the pharmaceutical industry because they could violate several patents, according to the Post (Washington Post, 10/25). World Trade Organization negotiators on Aug. 30 reached an agreement to allow developing countries to issue a compulsory license in order to import the generic drugs if the country confirms that it cannot domestically manufacture the drugs itself (Kaiser Daily HIV/AIDS Report, 9/26). However, negotiating such compulsory licenses for combination drugs is expected to be much more complicated than for single drugs, the Post reports.
The threat of compulsory licensing for combination drugs could prompt brand-name pharmaceutical companies to develop their own combination medicines or license other manufacturers to produce them, according to Thomas Kanyok, who works for a WHO program that develops drugs for poor countries. Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers Associations, said that generic fixed-dose combination drugs have not been sufficiently tested and that WHO's endorsement could encourage the production of counterfeit drugs. Paulo Teixeira, director of HIV/AIDS at WHO, said that using combination pills would be the best way to quickly increase the number of people receiving antiretroviral treatment, although he said that WHO could proceed with the three-by-five plan without the fixed-dose combination pills. Even with the pills, reaching WHO's target of providing three million people with antiretroviral drugs by 2005 would require 100,000 people to start the medication each month, a goal that is "unrealistic," several WHO officials said privately, according to the Post. However, the plan is expected to "spur a long-overdue international effort" to increase drug access to the more than five million people who need antiretroviral drugs but who are not receiving them, the Post reports (Washington Post, 10/25).