Letter to the Editor
Mr. Hans Hogerzeil of WHO/Geneva contends that the WHO selects essential medicines within a therapeutic class “on the basis of comparative “efficacy, safety and cost.” His reference text, Essential Medicines, WHO Model List (revised April 2003), is at variance with that contention.
WHO’s drug of choice to treat 3 million by 2005 is the triple dose combination ARV from India. In the April listing, WHO states: “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 ARVs has produced an equivalent combination product, there is no comparator drug. Thus, an analysis of efficacy, safety and cost has scant scientific merit.
If the WHO system was working as well as Mr. Hogerzeil claims, then why have ARV products that were on the WHO pre-qualified list, been taken off, long after they have been in use throughout the developing world? Of the two Indian companies pre-qualified to supply combination drugs, one had its product delisted from the WHO list on August 4, 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 Of the 12 ARVs on the Essential Medicines list, five either have been withdrawn by various manufacturers or delisted by WHO. Of the remaining, 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The lesson here is that poor countries have followed the example of rich countries and voluntarily withdrawn their products-even though the agency which pre-qualified them failed to take remedial action.