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[e-drug] Importance of combo ARV drugs


  • From: e-drug@usa.healthnet.org
  • Date: Mon, 13 Aug 2001 03:40:41 -0400 (EDT)

E-DRUG: Importance of combo ARV drugs
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[crossposted from Pharm-Policy with thanks; NN]

THE IMPORTANCE OF COMBO-DRUGS: ANOTHER ARGUMENT
FOR COMPULSORY AND VOLUNTARY LICENCES

Brook K. Baker
August 9, 2001

CIPLA has once again stirred the imagination and hopes of
treatment activists and people living with HIV/AIDS by formulating a
new three-in-one anti-viral tablet combining stavudine, lamivudine,
and nevirapine. The public announcement of this breakthrough
emphasized the cost advantage of the new combo-medicine, only
slightly more than a $1 a day. However, the CIPLA breakthrough
should be analyzed in other terms as well, namely ease of
compliance. Emphasizing true ease of use is especially important
given disinformation campaigns by Big Pharma and G-7
governments (remember Andrew Natsios) about the "complexities"
of multi-pill AIDS treatment and the unlikelihood of "ignorant,"
"watchless," and uneducated Africans being able to comply with
multi-pill treatment regimes.

Lost in the midst of this racial slander are the barriers that
pharmaceutical patent-holders erect against easier to use combo-
medicines. In this context, it is important to remember that HIV
medicines are individually patented and that patent-holders have an
perverse economic interest in avoiding the creation of combo-
medicines. Let's take the CIPLA example. Britain's
GlaxoSmithKline holds the patent for lamivudine, Germany's
Boehringer Igelheim the patent on nevirapine and the US's Bristol-
Myers Squibb the patent on stavudine. Nothing in principle
prohibits these three companies from entering into voluntary cross-
licensing agreements to produce a three-in-one anti-viral tablet.
However, in practice, they do not want to dilute individual brand
recognition, nor do they want to indirectly promote the products of
a competitor. Although GlaxoSmithKline will combine its own HIV
products, neither they nor their competitors will combine medicines
with other manufacturers. As a matter of fact, none of the major
manufacturers currently cross license their medicines. As a
consequence, doctors and patients are left with the unwieldy task
of prescribing and taking multiple tablets a day, and then
monitoring compliance with overly complicated treatment regimes.

The logic of single-medicine pills makes sense in the twisted world
of global pharmaceuticals, where maximizing profit, maintaining
competitive advantage, and promoting brand recognition prevail, but
it does not make sense in the actual lives of AIDS patients in
developing countries where simpler regimes are crucially important.
Combo medicines can be distributed more easily and reliably;
they can ease patient compliance; and they can even reduce risks
of resale of drugs by desperately poor patients who might
otherwise be tempted to resell part of their treatment regime in the
hope that one out of three medicines might be enough. One three-
in-one pill twice a day will also be easier for health aids to monitor
if directly observed therapy is instituted on a broad scale.

To pursue the combo-medicine option, generic manufacturers and
developing countries should simultaneously seek multiple voluntary
and/or compulsory licenses so that they can manufacture and
register three-in-one medicines. Obviously, the desirable
combinations will change over time in response to new discoveries
and to assessment of emerging drug resistance, if any. However,
the significant cost advantage of high quality generic medicines will
be matched by an equally important combo-drug benefit if
treatment advocates and developing countries vigorously pursue
voluntary and compulsory licenses. Accordingly, activists must
act not only to reduce monopoly pricing barriers, they must also
act to eliminate the irrational single-medicine regime which
unnecessarily complicates treatment and drug protocol
complicance. Demands for multiple licenses that permit combo-
medicines are an important tool in the campaign for access to
affordable and easily usable HIV/AIDS medicines.


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