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Commentary & Opinion
"No Medical Justification" for Using Brand-Name Antiretroviral Drugs Instead of Generics, Letter to Editor Says

April 8, 2004

The assertion made by Presidential Advisory Council on HIV and AIDS International Subcommittee Chair Abner Mason in a San Francisco Chronicle opinion piece that generic antiretroviral drugs have not been proven safe and effective is "simply untrue," Dr. Omar Saleban, field coordinator for Doctors Without Borders in Homa Bay, Kenya, writes in a Chronicle letter to the editor (Saleban, San Francisco Chronicle, 4/7). Mason wrote that generic fixed-dose combination antiretroviral drugs "hol[d] great appeal for patients in Africa and across the globe" but are "unproven products." Although the drugs have passed the World Health Organization's "prequalification" system, they have not been approved by FDA and could cause "serious side effects and promote the development of resistant strains of HIV," Mason said (Kaiser Daily HIV/AIDS Report, 3/30). However, the WHO system "borrows drug regulatory experts from North America and Europe to inspect manufacturing sites and establish bio-equivalence," Saleban says, adding, "There is no medical justification for favoring 'brand-name' medicines over generics." Saleban concludes, "Mason and the U.S. government should be more interested in expanding treatment to the largest number of Africans possible than they are in protecting the interests of the brand-name pharmaceutical industry" (San Francisco Chronicle, 4/7).

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