Learning from low income countries

Editor—Hogerzeil, who works for the World Health Organization in Geneva, contends that WHO selects essential medicines within a therapeutic class on the basis of comparative efficacy, safety, and cost.¹ His reference text, Essential Medicines,² is at variance with that contention.

WHO's choice to treat 3 million by 2005 is triple dose combination antiretroviral treatment from India. In the April listing, WHO says: “The Committee strongly recommends the use of three or four drug combinations... The use of fixed dose preparations for these combinations is also recommended, with assured pharmaceutical quality and interchangeability with the single products.”

The regulatory test to judge whether a drug is interchangeable is the presence of an originator product. Since none of the patent holders for the three separate originator antiretroviral drugs has produced an equivalent combination product, there is no comparator drug. An analysis of efficacy, safety, and cost has therefore scant scientific merit.

If the WHO system was working as well as Hogerzeil claims, then why have antiretroviral products that were on the WHO prequalified list been taken off, long after they have been in use throughout the developing world? Of the two Indian companies prequalified to supply combination drugs, one had its product delisted from the WHO list on 4 August 2004 for lack of proof of bioequivalence with the originator product. The other company is under a restriction from the Indian licensing authority to make no reference that the government has approved the drug. In November 2004 two Indian companies voluntarily withdrew their entire portfolio of AIDS drugs from the WHO system.

Of the 12 antiretroviral drugs on the list of essential medicines, five either have been withdrawn by various manufacturers or been taken off the list by WHO. Of the remaining one, four are manufactured only by originator companies.

The lesson here is that poor countries have followed the example of rich countries and voluntarily withdrawn their products—even though the agency that prequalified them failed to take remedial action.