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Doctors Without Regrets
November 20, 2004
November 20, 2004
By Eric Goemaere, Special to The Times --
Using low-priced generic medicines, approved by national drug regulatory authorities where we work, as well as by the World Health Organization (WHO), has allowed Doctors Without Borders to treat more than 23,000 people with HIV/AIDS in 27 countries, including 2,000 here in South Africa.
Most importantly, for my patients and thousands of others, the availability of treatment means that AIDS is no longer an automatic death sentence.
The fact that several generic AIDS medicines were recently removed from the WHO prequalification list is not evidence that the prequalification process is weak. As the recent recall of Merck's Vioxx shows, regulating brand-name, as well as generic, drugs requires constant vigilance. Unlike Vioxx, the generic AIDS medicines were withdrawn from the WHO list to resolve important questions about the paperwork demonstrating the drugs' bioequivalence — not because of deadly side effects.
There is no doubt that the generic-drug manufacturers whose AIDS medicines were delisted must adhere to strict international standards and submit new data to WHO and drug authorities urgently. But the United States Food and Drug Administration is not the global arbiter of drug quality. If we had waited for the U.S.' stamp of approval, as the Bush administration is requiring in the President's Emergency Plan for AIDS Relief, thousands of lives would have been needlessly lost.
People with HIV/AIDS in South Africa and throughout the continent continue to fight hard for access to affordable medicines. This is no "Western spitball contest over drugs, pricing and intellectual property rights." For our patients, and for millions of people with HIV/AIDS in developing countries, it is a matter of life and death.