Eudoxa

Early in the month of August this year came a puzzling decision by the WHO to remove three Indian-developed generic AIDS drugs from the list of approved medicines.

Three years after endorsing these drugs for use in the developing world, the WHO publicly acknowledged on the 4th of August that it could no longer vouch for the safety of these products - produced by Ranbaxy - or be certain that they were biologically similar to their patented equivalents.

This announcement followed another “delisting� of generic AIDS drugs (also by an Indian firm, Cipla) by the WHO just two months ago - dropping the drugs on the 27th of May.

These removals come at a time when the UN-agency has endured harsh criticism for its embattled ‘Roll Back Malaria’ initiative, which experts last spring proved to have caused malaria deaths to actually increase since 1998 by insisting upon cheap drugs -resulting in drug resistance.

Since these drugs comprise the therapeutic backbone of the WHO's 3x5 initiative, the ban on these Indian-made copy drugs jeopardizes this ambitious global initiative; and the health status of the thousands of AIDS patients who have taken these sub-standard products over the past 18 months remains uncertain. Using inferior AIDS medicines, can cause the HIV virus to mutate and create new strains resistant to all available drugs.

The WHO, according to various media accounts, is unlikely to meet the goals and expectations set forth in its once vaunted AIDS 3x5 initiative, and is facing accusations of “Enron-like� proportions after having recently acknowledged that many key objectives in the first 6 months have not been met.

This is not very a unfamiliar occurrence seen in retrospect for the organization, where their main goals always been set very high - some say unrealistically high.

There should be a public notification and explanation by the WHO to nations, world government institutions, non-governmental organizations and most importantly AIDS patients that drugs made by Ranbaxy and Cipla have been de-listed.

It is time for the WHO to take action, and to support a transparent analysis of all drugs approved under the WHO’s Pre-Qualification Project to ensure they meet safety and efficacy standards similar to regulatory regimes such as the European Agency for the Evaluation of Medical Products (EMEA) and the United States Food and Drug Administration (FDA). The WHO should strive to make certain that Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) are followed by corporations that submit applications for approval to the pre-qualification project.

Are the officials of the WHO ready to present an explanation on why generic AIDS drugs three years after being approved under the pre-qualification project were just now found to be non-compliant with international standards of good clinical practices? The recent developments underscore the need for a new and responsible leadership, and the integration of a higher degree of accountability, at the helm of what should be the world’s pre-eminent health agency.

About 95% of the 38 million persons infected with HIV live in the developing world. The WHO's medical and pharmaceutical efforts are of vital importance to them, and they deserve far better than bad decisions, missed deadlines and bogus AIDS drugs.