November 20, 2004
Doctors Without Regrets - from the Seattle Times
By Eric Goemaere, Special to The Times --
Collin Levey's assertion that generic AIDS medicines are unsafe and ineffective
("Cheap drugs help no one if they're not effective," Times guest
column, Nov. 12) is deliberately misleading. Just like physicians in the
U.S., I treat patients with generic medicines every day and would never consider
using "inferior" or "untested" drugs, as Levey implies.
Using low-priced generic medicines, approved by national drug regulatory
authorities where we work, as well as by the World Health Organization (WHO),
has allowed Doctors Without Borders to treat more than 23,000 people with HIV/AIDS
in 27 countries, including 2,000 here in South Africa.
Our clinical results, which parallel those found in the U.S., have been published
in peer-reviewed medical journals and presented at international conferences.
Most importantly, for my patients and thousands of others, the availability
of treatment means that AIDS is no longer an automatic death sentence.
It is important to understand that AIDS treatment in South Africa and elsewhere
has only been possible because of dramatic drops in the price of antiretrovirals,
resulting from generic competition. Four years ago, the price of triple therapy
in South Africa was $15,000 per person per year. Today, it is $185. This has
created a seismic shift in the willingness and ability of the government to
scale up treatment.
The fact that several generic AIDS medicines were recently removed from the
WHO prequalification list is not evidence that the prequalification process
is weak. As the recent recall of Merck's Vioxx shows, regulating brand-name,
as well as generic, drugs requires constant vigilance. Unlike Vioxx, the generic
AIDS medicines were withdrawn from the WHO list to resolve important questions
about the paperwork demonstrating the drugs' bioequivalence — not because
of deadly side effects.
There is no doubt that the generic-drug manufacturers whose AIDS medicines
were delisted must adhere to strict international standards and submit new
data to WHO and drug authorities urgently. But the United States Food and Drug
Administration is not the global arbiter of drug quality. If we had waited
for the U.S.' stamp of approval, as the Bush administration is requiring in
the President's Emergency Plan for AIDS Relief, thousands of lives would have
been needlessly lost.
People with HIV/AIDS in South Africa and throughout the continent continue
to fight hard for access to affordable medicines. This is no "Western
spitball contest over drugs, pricing and intellectual property rights." For
our patients, and for millions of people with HIV/AIDS in developing countries,
it is a matter of life and death.
Dr. Eric Goemaere is head of mission for Doctors Without Borders (Médecins
Sans Frontières) in Khayelitsha, South Africa.
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