[Ip-health] The Lancet-USA urged to accept generic AIDS drugs

[Rachel COHEN]

The Lancet
Volume 363, Number 9416
10 April 2004

Medicine and health policy


 USA urged to accept generic AIDS drugs




 Members of the US Congress, AIDS activist groups, and M=E9decins Sans
 Fronti=E8res (MSF) have accused the Bush administration of yielding to
 pressure from the pharmaceutical lobby, and looking for excuses to reject
 the use of generic antiretroviral drugs in its AIDS programme.


 In a letter to President Bush, Democrat congressman Henry Waxman,
 California, said: "These pharmaceutical companies are among your strongest
 political supporters, having contributed US$40 million to your political
 party over the last 5 years. They should not be dictating policy on US
 efforts to fight HIV/AIDS in Africa and elsewhere."


 US officials have dismissed the allegations, and instead, cited concerns
 about the safety and efficacy of generics.


 "We want drugs that are of the highest quality, safe, and efficacious at
 the lowest possible price", says Amy Black, a spokesperson from the Office
 of the US Global AIDS Coordinator. "That's been our policy from day 1,
 it's our policy now, and it's our policy going forward. It doesn't matter
 where the drugs come from."


 These aren't necessarily generics as we would use the term in the USA, she
 adds. "They have not been proven, and we have not seen the data that we
 would see if they had been approved in the US."


 In question is use of the fixed-dose combination drugs, manufactured by
 Indian companies Cipla and Ranbaxy Laboratories, which combine the
 recommended regimen of stavudine, lamivudine, and nevirapine into a single
 pill, at a fraction of the cost. Last year WHO drew up guidelines on
 appropriate HIV therapy in developing nations, and several combination
 therapies, including this one, were prequalified under these guidelines.


 The USA organised a meeting in Botswana last week with hopes of setting
 international standards to determine the safety and quality of
 antiretroviral drugs.


 But the real barrier, says Rachel Cohen, US Director of MSF's Access to
 Essential Medicines programme, is a patent barrier and not a quality
 problem. In some of the technical documentation that was brought to
 Botswana, lawmakers pointed out that some of the standards proposed by the
 USA even exceeded those of the FDA.


 "Clearly, they either support WHO prequalification as the stringent
 international standard for evaluating safety quality and efficacy, or they
 don't", says Cohen. "And at this point, they are completely isolated in
 their view that WHO prequalification standards are not sufficient to guide
 national drug regulatory authorities and purchasers in assessing drug
 quality."


 Roxanne Nelson




---
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/