[Ip-health] Response: Bush Critics Imperil Africa's AIDS Victims

[B.Baker@neu.edu]

James K. Glassman opinion piece of April 13, 2004, "Bush Critics Imperil
Africa's AIDS Victims" is wrong on the science and politics of fixed-dose
combination AIDS medicines.  Glassman argues that three-in-one, fixed dose
combination antiretroviral drugs produced in India by Cipla and Ranbaxy
have not been tested in their combined form against the simultaneous
administration of identical branded drugs taken in separate dosage forms.

This is a blatant misrepresentation of the stringent WHO Prequalification
Project which required such proof of bioequivalence before adding the FDCs
to its pre-qualification list in December of 2003.  Like stringent
regulatory agencies in the U.S. and Europe, the WHO required Cipla to
produce evidence from so-called crossover studies, where each patient
received medicines in both a combined form and via simultaneous
administration of individual doses.  Those studies concluded that the FDCs
in question were bioequivalent - meaning that bioavailability (the rate of
aborption of each component into the blood stream and the rate of
elimination of the drug from the body) was statistically equivalent between
the two forms of administration.  This is the same kind of proof lthat the
Food and Drug Administration accepted from GlaxoSmithKline when the FDA
approved its three-in-one AIDS drug Trizivir.

The simple scientific truth is that bioequivalent FDCs present no more
danger of provoking resistance than does the co-administration of three
separate pills.  To argue otherwise is to engage in pseudo-science and
disinformation.  In fact, the Cipla fixed-dose combination ARVs are
superior to the single-dose pills sold by the proprietary drug industry
because they enable patients to take one pill twice a day rather than three
pills twice a day.  FDCs are easy to procure and distribute and easier for
doctors to prescribe and patients to use - thereby delaying rather than
accelerating resistance.

Glassman also misrepresents the most important pricing data.  The best
price for brandname ARVs in single-dose forms is currently $562 a year.
Doctors Without Borders is currently purchasing those same ARVs in combined
dosage form for approximately $280 a year.  And the Clinton Foundation
holds forth promise that price will go even lower to $140 a year once
assured bulk purchases are arranged.  In the very near future, the world
will be able to buy equivalent medicines for four times as many people.  Is
Glassman arguing that not treating these people somehow brings them the
advantage of U.S.-style "high quality treatment?"

Glassman, a paid fellow at the conservative American Enterprise Institute,
concludes his analysis with a praise-song for the U.S. drug industry,
arguing that it has no reason to black AIDS drugs from getting to poor
Africa countries.  That line is hard to swallow for people living with AIDS
in South Africa where 39 big drug companies sued the Mandela government for
three long years (1998-2001) trying to block access to more affordable
medicines.  It's hard to swallow  for countries decimated by AIDS who had
to wait nearly two years (Nov. 2001 - Sept. 2003) for the U.S.T.R. and drug
companies' belated acquiesence to a procedurally burdensome compulsory
licensing scheme.  Finally, his praise is full of rich irony as advocates
fight PhRMA's efforts to rescusitate tired quality arguments to undermine
bioequivalent generic drugs and as PhRMA fights to establish intellectual
property rules that would prevent generic companies from utilizing
bioequivalence data at all to register a generic during the life of a
patent.

Make no mistake about it.  Mr. Glassman is a shill for industry and an
apologist for a unilateralist administration which is willing to provoke
therapeutic chaos on the ground in order to simultaneously subsidize big
drug companies and freeze out generic competitors.

Professor Brook K. Baker, Health Global Access Project
Northeastern University School of Law
400 Huntington Ave.
Boston, MA 02115
617-373-3217
b.baker@neu.edu