Since the release of President George W. Bush's Emergency Plan for AIDS Relief, the U.S. global AIDS coordinator and former CEO of Eli Lilly, Randall Tobias, and other Bush administration officials have made public remarks that question the quality of generic antiretroviral drugs and undermine international quality standards set by the World Health Organization.
Médecins Sans Frontiéres feels that the Bush administration will stand in the way of countries and programs wishing to use funds provided by the Bush plan to purchase affordable quality medicines in general, and triple "fixed-dose combinations" in particular, despite the fact that they are generally three to five times less expensive than the brand name versions.
These generic drugs have been certified by the WHO by meeting stringent international standards for quality, safety, and efficacy, and are manufactured by the same pharmaceutical labs that produce hundreds of generic medicines used by Americans every day.
Fixed-dose combinations of antiretroviral drugs are widely recognized as a key element to efforts to scale up AIDS treatment in developing countries. Based on Médecins Sans Frontiéres's experience delivering antiretroviral therapy in resource-poor settings, we have become strong advocates of triple fixed-dose combinations. Our clinical results thus far are encouraging.
WHO-recommended triple fixed-dose combinations are available only from generic producers because the patents of the three individual compounds are held by three different companies.
Despite mounting evidence, the Bush administration appears to be ignoring the fact that these newly adapted tools in the fight against AIDS exist today and are being widely used in treatment programs that are saving lives.
There is no medical or scientific basis for the Bush administration's attacks against WHO prequalified medicines, and the United States is isolated in its view that WHO-prequalification standards are not sufficient. We call upon the United States to join the international consensus by allowing its grantees to procure quality generics, including fixed-dose combinations, and by supporting the WHO prequalification project. We cannot stress enough how disruptive it will be if the United States fails to do so.
The only possible explanation we can imagine for the Bush administration's current position on procurement of quality-assured generic medicines is that it is more interested in protecting the interests of the pharmaceutical industry than it is in expanding antiretroviral treatment to the largest possible number of people.