[Ip-health] NPR-Morning Edition-Analysis: Safety and effectiveness of generic AIDS drugs

[Rachel COHEN]

National Public Radio - Morning Edition  - March 30, 2004

Analysis: Safety and effectiveness of generic AIDS drugs

BOB EDWARDS, host:
President Bush's emergency plan for AIDS relief anticipates providing drugs
for up to two million people over the next five years. That would go a long
way toward meeting the World Health Organization's goal of treating three
million people by 2005. But the goal would require that the cost of
treatment be kept at $300 a year a patient, and the only way to do so is
with inexpensive generic drugs. A meeting in Botswana this week sponsored
by the US and the WHO is examining the safety and effectiveness of generic
drugs. Critics say it's a ruse to protect the brand-name drug industry.
NPR's Brenda Wilson reports.

BRENDA WILSON reporting:
In countries in sub-Saharan Africa, the cheapest, most widely used
anti-AIDS drugs are two- and three-drug cocktails that come in one pill and
can be taken twice a day. They're called fixed-dose combinations. They've
been a godsend for Dr. Eric Goemaere of M=E9decins Sans Fronti=E8res or Doc=
tors
Without Borders. He works in a township of about a million poor South
Africans just outside Cape Town, where more than a fifth of the adults are
infected with HIV.

Dr. ERIC GOEMAERE (Doctors Without Borders): Those numbers force you to
simplify as much as possible. We need to have every single clinic being
able to deal with those things, and certainly not doctors, because there
are simply no doctors available, but nurses being able to say to the
patient, `Listen, you take this pill in the morning, this same one in the
evening.'

Dr. MARK DIEBEL (Global AIDS Initiative): We have the highest respect for
what these organizations are doing, what Medicins Sans Frontieres and
others are doing.

WILSON: Dr. Mark Diebel is the chief medical officer for the president's
Global AIDS Initiative. Diebel says he would like to be assured of the
quality of fixed-dose combinations. They're made by manufacturers of
generic drugs, not by brand-name ma! nufacturers who won't share compounds
and put them in one pill. Even though generic fixed-dose combinations have
been approved by WHO, Diebel says that's not good enough for the US
government.

Dr. DIEBEL: It's not that we don't think the WHO system is sound. It's that
we need to see the data ourselves.

WILSON: He says that if it turns out the generic compounds are not the
equivalent of separate
brand-name anti-AIDS drugs, there's a greater risk of treatment failure and
drug resistance.

Dr. DIEBEL: None of these programs are out far enough to tell us whether or
not the risk of resistance over time is higher in these individuals. This
is the precise reason we don't use two drugs. We use three drugs in
combination because early on, we treated people with two drugs. Most of
them did very well for the first year and a half, two years. It wasn't
until after that time point that they started having problems. And that's
our concern, and then it's going to be too late.

WILSON: But Goemaere of Doctors Without Border! s says taking all the
required pills is one of the main safeguards against resistance. For the
poor in rural and urban areas, the fixed-dose combination is key to that.

Dr. GOEMAERE: I'm convinced that the biggest danger for creating resistance
is the patient take a sufficient dosage or stop ...(unintelligible) pills.
That's the main reason--and it's a bit of irony--the main reason why we see
so much.

WILSON: In fact, having a simple fixed-dose may explain why the poor in
sub-Saharan Africa are better at taking their medicine than AIDS patients
in North America and Western Europe and, therefore, have less drug
resistance. Dr. David Bangsberg of the University of California-San
Francisco has compared drug resistance in patients on the streets of San
Francisco with Ugandans. And in Uganda, he says...

Dr. DAVID BANGSBERG (University of California): Most patients have never
seen HIV therapy before and their virus is quite sensitive and likely to
respond! well to therapy. Every study that has looked at how well patients
ar e adhering to their medications in sub-Saharan Africa has found
exceptional levels of adherence and near complete viral suppression.

WILSON: At a time when it's estimated that six million people in developing
countries need treatment they can't get, Dr. Bangsberg says the issues
raised by the Bush administration are misplaced.

Dr. BANGSBERG: The choice is between generic therapy and no therapy. And we
know what the national history of HIV is in the absence of therapy. It will
be important to monitor the outcomes of hundreds of thousands of people,
but for every day we delay introducing therapy, those people will die.

WILSON: Over the next few days, groups like Doctors Without Borders and
members of the president's initiative are meeting in Botswana to discuss
setting up a system for determining the safety and effectiveness of
fixed-dose combinations. The Bush administration insists that won't delay
treatment while this issue is being resolved.

Brenda Wilson, NPR News.

EDWARDS: The time is 19 minutes past the hour.

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Record Number: 200403301002
---
Rachel M. Cohen
U.S. Director, Campaign for Access to Essential Medicines
Doctors Without Borders/M=E9decins Sans Fronti=E8res (MSF)
333 Seventh Avenue, 2nd Floor * New York, NY * 10001-5004 * USA
Tel: +1-212-655-3762
Mobile: +1-917-331-9077
Fax: +1-212-679-7016
E-mail: rachel.cohen@newyork.msf.org

http://www.doctorswithoutborders.org/
http://www.accessmed-msf.org/

* * URGENT * *
Please visit http://www.msf.org/arjan/petition/usa.htm and sign MSF's
petition calling for the release of our colleague Arjan Erkel who was
kidnapped in August 2002 in Dagestan, a republic of the Russian Federation.
Thank you!
*  *  *  *  *  *  *  *  *  *