[e-drug] Lancet article supports generic ARVs

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: Lancet article supports generic ARVs
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http://www.thelancet.com/journal/vol365/iss9467/full/llan.365.9467.analysis_and_interpretation.32954.1

Ensuring the safety of HIV/AIDS generics

Welcome news on the international HIV/AIDS front arrived recently when the US Food
and Drug Administration (FDA) approved Aspen Pharmacare's triple-antiretroviral
regimen.1 Tentative FDA approval for this South African company qualifies its triple
combination therapy for purchase with funds allocated by the US President's
Emergency Plan for AIDS Relief (PEPFAR). But the continuing criticism of generic
drugs to treat HIV and the ongoing imbroglio around the use of single-dose
nevirapine for the prevention of mother-to-child transmission reminds us that
life-saving medicine remains politicised in a realm where politics has no place.2 

Late last year, Indian manufacturer Ranbaxy withdrew its antiretrovirals from WHO's
list of prequalified drugs.3 This decision followed two other incidents in which WHO
was forced to remove HIV generics produced in India from its list because of
non-compliance with clinical and laboratory procedures and data-handling at the
contracted research organisation.4,5 Although nothing to date has suggested that the
drugs themselves were ineffective, these incidents have contributed to a climate of
uncertainty about the quality of available generic drugs. 

This is the wrong time for such a critique. Generics provide the best promise for
the greatest number; as the HIV epidemic escalates, these low-cost formulations
offer hope that lives can be saved in places where, as recently as 2 years ago, the
scarcity of treatment for HIV assured premature death for millions. And most
evidence to date indicates that generic HIV drugs are as safe and as effective as
their brand-name counterparts. Brazil's massive treatment-access programme, which
has dramatically reduced mortality by use of generic drugs, is but another example.6

Despite Aspen's approval, the value of generics continues to be contested by those
who refer to them variously as "dubious", "cheap", and "deadly".7,8 Arguing that
generics are not examined as carefully as branded drugs produced by global
pharmaceutical companies, critics--including some in the US Government--have fuelled
a controversy with tragic implications for treating those living with HIV in
developing countries, and has created obstacles to the purchase of generics with
PEPFAR funds.9 

While it is tempting to dismiss these objections as the by-product of undue
sympathy to the global pharmaceutical industry, the absence of an independent review
system for all HIV generics on the market has become an anachronism and a powerful
impediment to the humanitarian goals of treatment scale-up. 

There can be no question that people with HIV, whether they live in developed or
developing countries, have a fundamental right to know that the drugs they are
taking are safe and effective. If unsafe drugs foment drug resistance and new
strains of the virus, the need for regulation and ongoing testing is particularly
acute. Around the world, much of the generics marketplace operates outside rigorous
governmental or agency review. Producers of generic HIV drugs are proliferating. In
Asia there are now 27 manufacturers with escalating production capacity.10 Some make
drugs for domestic use, some seek to export; many pursue both markets. In countries
like China, India, and Thailand, expanding treatment-programmes are met by
in-country manufacturers who often have a cosy relation with their governments.
Often wholly or partly state-owned enterprises, these companies can simply sell
drugs to their own government, fostering an intimacy between manufacturers and
governments that is itself a recipe for disaster. 

Because these manufacturers have little incentive to participate in a voluntary
regulatory process like those at the FDA or WHO, the time has come for ongoing
market review, which would include a network of clinical facilities linked to
laboratories able to evaluate drug quality. This process need not depend on the
companies that make the drugs, nor the governments that buy them, because most of
the generics manufactured today can easily be purchased at pharmacies in the
countries where they are being sold. It must also be a continuous process, because
the quality of drugs produced could fluctuate over time without vigilant oversight.

It is only a matter of time before a story breaks of patients being given HIV drugs
that turn out to be nothing more than sugar pills, or worse. When that occurs, many
will demand the withdrawal of unproven HIV generics from programmes worldwide,
leaving developing countries with mounting disease burden scrambling to find
alternatives. 

On the other hand, if generic drugs turn out to be largely equivalent to their
brand-name counterparts, the enormous sums that PEPFAR is still spending on
brand-name drugs will have been a monumental waste of resources, paid for with far
too many lives. Given the number of people who could be reached if PEPFAR allowed
the purchase of generic drugs from a wider array of manufacturers, it is shameful
not to put a system in place that would satisfy the desire to ensure safety and
efficacy and treat the greatest number of people. 

As the HIV-infected population continues to climb, governments and multilateral
agencies are racing to provide treatment to the estimated 6 million who will die
without immediate access to antiretroviral drugs. The Global Fund to Fight Aids,
Tuberculosis and Malaria, WHO, and PEPFAR are attempting a dramatic scale-up with
the most humanitarian of goals imaginable. We must do all that we can to help. 

Kevin Robert Frost 

American Foundation for AIDS Research, New York, NY 10005, USA
kevin.frost@amfar.org 

I am Vice President, Global Initiatives, at the American Foundation for AIDS
Research (amfAR) and the Director of TREAT Asia. 

1 McNeil, DG Jr. A path to cheaper AIDS drugs for poor nations. New York Times Jan
26, 2005: A9. 
2 Solomon J. Officials knew of AIDS drug risks. Associated Press, Dec 14, 2004. 
3 Whalen J. Generic maker pulls HIV drugs from WHO use. Wall Street J Nov 10, 2004:
B1. 
4 Verjee N, Roundell T, Voda V. Need to know. The Times (Lond) Nov 20, 2004: 66. 
5 D'Silva J. Indian pharma's in need of some global AIDS. Econ Times (New Delhi)
Oct 30, 2004. 
6 Buckley S. Brazil becomes model in fight against AIDS. Washington Post Sept 17,
2000: 22. 
7 Mason A. Slouching towards drug resistance. San Francisco Chron Dec 1, 2004: B11.
8 Adelman C. Deadly medicine. Wall Street J Eur Dec 9, 2004. 
9 Brown D. Bush's AIDS program balks at foreign generics. Washington Post March 27,
2004: 3. 
10 American Foundation for AIDS Research. Expanded availability of HIV/AIDS drugs
in Asia creates urgent need for trained doctors. TREAT Asia Special Report, July,
2004: 4. http://web.amfar.org/treatment/specialreport/ NeedforTrainedDoctors.asp
(accessed Feb 10, 2005).