|
Get AfricaFocus Bulletin by e-mail!
Format for print or mobile
USA/Africa: Health Unilateralism
AfricaFocus Bulletin
Jan 6, 2004 (040106)
(Reposted from sources cited below)
Editor's Note
"As the U.S. government plods slowly towards expanded funding for
its largely bilateral global AIDS initiative (President's
Emergency Plan for AIDS Relief) and as it sends successive waves
of teary-eyed politicians on fact-finding tours to AIDS
orphanages in Africa, it has been working hard behind the scenes
to undercut multilateral AIDS initiatives."
So argues law professor Brook Baker of the AIDS activist
organization Health GAP in a newly released paper. The paper
defends the World Health Organization's new plan for rapid
expansion of AIDS treatment to treat 3 million people by the end of
2005. Baker notes that U.S. representatives and pharmaceutical
companies have raised doubts about the plan, privately questioning
such technical components as the WHO's recommendation to provide
anti-retroviral therapy in a single fixed-dose generic pill.
Notably, these questions appear so far to be debated behind the
scenes rather than publicly. Yet such details are likely to
determine whether programs to provide treatment actually move onto
a fast track in 2004 or not.
Speaking on December 11 in Washington, U.S. Global AIDS Coordinator
Randall Tobias stressed the "new paradigm" of cooperation among
different U.S. agencies working on AIDS within the same country.
But he made no reference either to the World Health Organization or
to the Global Fund to Fight AIDS, TB, and Malaria. See
http://usinfo.state.gov/gi/Archive/2003/Dec/15-328001.html for
Tobias's full speech.
This issue of AfricaFocus Bulletin contains excerpts from Baker's
paper, and a link to the full document with more detail and
footnotes. Another issue of the Bulletin today includes a variety
of recent updates, including excerpts from the World Health
Organization's new report reasserting the goal of "health for all."
For more detailed information on WHO policies on essential drugs
and medicines, see http://www.who.int/medicines/
++++++++++++++++++++++end editor's note+++++++++++++++++++++++
U.S.'s Misguided and Bad-Faith Attack on the WHO's 3-by-5 Plan
Brook K. Baker,
Northeastern University School of Law and Health GAP
December 18, 2003
[Excerpts only; full paper, with footnotes, is available at:
http://lists.essential.org/pipermail/ip-health/2003-December/005750.html]
As the U.S. government plods slowly towards expanded funding for
its largely bilateral global AIDS initiative (President's
Emergency Plan for AIDS Relief) and as it sends successive waves
of teary-eyed politicians on fact-finding tours to AIDS
orphanages in Africa, it has been working hard behind the scenes
to undercut multilateral AIDS initiatives including the Global
Fund to Fight AIDS, TB, and Malaria and the WHO 3-by-5 plan
(three million people on antiretroviral therapy by the end of
2005). ...
Jealous of the WHO's leadership role, desirous of unilateral
credit, and eager to tout the gentle flip side of its brutal War on
Terror, the Bush Administration has embarked on a subtle
disinformation campaign, coordinated with its business ally, Big
Pharma, to try to undermine the role of low cost,standard quality
generic medicines in the battle against AIDS and to discredit
efforts to rapidly increase capacity to deliver antiretroviral
therapy by relying less on medical experts and more on
community-based health workers.
In mounting its attack on the WHO's historic enterprise, the U.S.
has wrapped itself in the mantle of medical ethics and questioned
key components of the WHO plan including: (1) "overly
simplistic" recommendations for simplified and standardized
front-line combination therapies, including fixed-dose
combination medicines; (2) reliance on the WHO's
pre-qualification program to identify presumptively safe and
efficacious AIDS medicines, particularly Cipla's Triomune; (3)
advocacy for free treatment rather than co-payments; and (4)
reliance on a new corps of community health workers for much of
the direct care delivery. In essence the U.S. government is
saying that it has a unique vision for a platinum-standard
program of AIDS treatment and that anything less is third-rate
and violates medical ethics. Coincidentally, the U.S. bemoans
that African countries have minimal capacity to deliver such high
quality care and thus the U.S. is justified in its go-slow
approach to appropriations and planning....
There is an extraordinary match between the talking points pursued
by Administration spokespersons at the WHO and the well-worn
talking point of PhRMA and other industry mouthpieces. Big Pharma
has consistently slandered the quality of "pirated" generic
products to preserve the illusion of the superiority of their
patent-protected and monopoly-priced medicines. It has tried to
impose higher-than-necessary regulatory standards on drug
registration authorities in developing countries through
harmonization schemes and otherwise. And, it has relentlessly
pursued heightened intellectual property protections in
multilateral, regional, and bilateral trade agreements -
protections that would limit compulsory license and parallel
importation rights, extend patent terms, deny access to clinical
trial data, and undermine exportation of generic medicines to
countries that can't make them on their own.
Certainly it is appropriate for health officials and experts to
question the WHO's 3-by-5 plan in good faith. Though the U.S.
attacks are undoubtedly advanced in bad faith, it makes sense to
review the merits of the expressed concerns, always weighing in
the background the reality of 8000 deaths a day.
Fixed-dose combinations
There are two central and interrelated benefits that arise from
the use of FDCs [fixed-dose combinations] in the administration of
Highly Active Antiretroviral Therapy (HAART) in developing
countries. The first is a lower overall pill count that
predictably increases adherence to treatment regimes. The second
is that FDCs have been shown to increase compliance because
patients can take all their required medicines on a regular and
fixed schedule rather than having to cope with a more complicated
schedule of multiple pills on differing time schedules. The impact
of reduced pill count and of simplified dosing schedules is to
decrease the incidence of resistance of the AIDS virus to ARV
treatment.
The World Health Organization has emphasized the importance of
developing innovative strategies for enhancing adherence to
antiretroviral therapy because it is a life-long therapy.[1] It
is widely accepted, including by surveys by pharmaceutical
manufacturers, that a main obstacle to patient compliance with
HAART is too many pills and complicated dosing schedules. [2]
...
In addition to referencing the benefits of fixed-dose
combinations produced by major pharmaceutical manufacturers,[5]
the WHO acknowledges that fixed-dose formulations have been
produced by generic manufacturers, "which [formulations] may
facilitate simplified regimens, decrease cost and promote
adherence if they can be legally used and their quality and
bioequivalence has been demonstrated."[6] ...
The clinical benefit of increased adherence resulting from the
use of fixed-dose combinations is the decreased incidence of
resistance of the AIDS virus to individual medicines and to
entire classes of medicines. ...The advantage of triple-therapy is
that it attacks HIV in three ways at the same time, meaning that a
mutation that is resistant to one medicine is unlikely to be
simultaneously resistant to the other two.
Why the U.S. Picks on Cipla's Triomune
Cipla of India has twice ruptured the complacency of Big Pharma
with respect to its patent monopolies on AIDS medicines, first on
February 7, 2001, when it announced a price heard round the world
- a standard package of ARVs for as little as $350/year to NGOs
and $600/year to governments in Africa[14] and a second time on
August 7, 2001, when it announced the formulation of a new
three-in-one antiretroviral tablet, Triomune, combining
stavudine, lamivudine, and nevirapine.[15] The public
announcement of these breakthroughs emphasized the cost and
therapeutic advantages of the new fixed-dose combination
medicine, only slightly more than a $1 a day - a fifth or sixth
of the cost of the then cheapest treatment with brand-name drugs
that extra pills and more complex dosing schedules. Since
Cipla's historic announcement, other Indian companies have begun
to produce fixed-dose combination ARVs,[16] as have companies in
Thailand,[17] and China,[18] and prices of these treatments have
continued to decreased over time.[19] This fall, a new benchmark
price has been established by four generic producers, three
Indian and one South African - less than $140 per year for WHO
preferred fixed-dose combination medicines. [20] Accordingly,
standard quality FDC generics are now available for a penny on
the dollar of what the major pharmaceutical companies charge in
rich markets.
Given the therapeutic importance of FDCs, it is important to
understand why so few proprietary pharmaceutical manufacturers
have produced combination ARVs and, more to the point, why none
of them have done so with a competitor's product. In this
context, it is important to remember that HIV medicines are
individually patented and that patent-holders have a perverse
economic interest in avoiding the creation of FDCs and in
delaying product improvements.[21] 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
fixed-dose ARV tablet, especially since this combination is both
efficacious and inexpensive; indeed, the WHO recommends it as a
first-line combination for resource poor settings.[22] However,
in practice, the proprietary manufacturers have not wanted to
dilute individual brand recognition, nor have they wanted to
indirectly promote the products of a competitor. ...
WHO Pre-Qualification Project
The U.S. delegation and Big Pharma could not mount a credible all
out assault on the concept of fixed-dose combination medicines
and on the idea of Cipla's Triomune, so instead they are
attacking the WHO Pre-Qualification Project, at least to the
extent that it "improperly" pre-qualified Triomune. By punishing
Cipla and subtly undermining WHO pre-qualification standards, the
U.S./Big-Pharma team continue to hype the superior quality of
proprietary, patented drugs and to freeze its most loathed
generic competitor out of the rapidly expanding global market for
ARVs.
Because poor quality medicines can have serious health
consequence, all treatment advocates and program designers must
be concerned that there are exacting quality standards during
both the production and distribution process. If medicines do
not contain the correct active ingredients in correct quantities,
if medicines contain harmful substances, or if quality and
efficacy deteriorate because of improper handling or expiration,
patients will be exposed to substandard or even dangerous
therapies that can lead to treatment failure, drug resistance,
and even death. The issue of drug quality is particularly
important in AIDS therapy because the therapeutic range of most
ARVs is quite narrow and because of the life-threatening
consequences of non-therapeutic dosing. ...
Because of the importance of product safety and efficacy and
because the documented risks of substandard and counterfeit
medicines, pharmaceutical products procured with multilateral and
bilateral resources in pursuit of the 3-by-5 goal should
certainly be authorized by the relevant national drug regulatory
authority (NDRA) in the country in which they will be used.
However, in addition, they should be separately evaluated for
safety, quality, and efficacy, if the relevant NDRA does not have
the capacity to enforce appropriate standards. In this respect,
the WHO Pre-Qualification Project can play an important role in
identifying AIDS medicines which are bio-equivalent to standard
products and which are produced according to Good Manufacturing
Processes.[24] ...
The essence of the U.S. attack on Triomune's pre-qualification at
the WHO is that the WHO pre-qualification project cut too many
corners and, more subtly, that registration should instead, if
possible, be based on registration at a strict NDRA, like the
FDA. ...
In an ideal world, drug companies would have cross-licensed their
medicines to each other (rather than merely protect their patent
kingdoms), conducted relevant clinical trials, and thereby
produced fully satisfactory evidence on the superiority of
fixed-dose combinations, particularly when one takes into account
patient compliance. ... However, in the imperfect world we live in,
the WHO was left to a slightly less optimal alternative - it had to
establish pharmacokentic bio-equivalence of generic fixed-dose
combinations against evidence derived from the individual
products,[27] a procedure that had previously been allowed even in
the U.S. with respect to GlaxoSmithKline's combo drug Trizivir.
...
Where pre-existing evidence of a comparable product is lacking, the
WHO appoints experts who perform a rigorous and comprehensive
evaluation of products to confirm compliance with international
standards. In this regard, investigators perform dossier
evaluations and conduct site inspections of manufacturing
facilities. Dossiers are evaluated for compliance with WHO
recommendations and guidelines regarding the assessment of
multi-source products.[28] Assessment teams included three
specialists on quality issues and two on
bio-availability/bio-equivalence. In addition, inspections are
performed for individual products at individual manufacturing sites
to assess compliance with Good Manufacturing Practices as
recommended by the World Health Organization.[29] The team of
inspectors includes a leader inspector from countries that are
members of the Pharmaceutical Inspection Co-operation Scheme, a WHO
expert from its Quality Assurance and Safety: Medicines team, and
an inspector for the local NDRA. Only after this rigorous process
did the WHO pre-qualify multiple generic ARVs including fixed-dose
combinations.[30]
Free treatment vs. user fees and cost recovery
One would have thought that the neo-liberal ideology of
cost-recovery and user fees, brought to an art form by the World
Bank and the IMF, would have been sufficiently discredited that
no one would seriously propose that poor people living with
HIV/AIDS would have to choose drugs over food, shelter, and
schooling. Evidence that co-payments had reduced use of family
planning and SDI clinics prompted Congress to adopt legislation
ordering the Executive to oppose user fees for health and
schooling at the World Bank and IMF. The wisdom of that ban was
confirmed by a recent study showing that financial constraints,
including though not limited to the out-of-pocket cost of
antiretrovirals, have been reported as the most significant
barrier to antiretroviral adherence in patients living with
HIV/AIDS in Botswana prior to the introduction of free
treatment.[31] Even with the costs of medicines going down to
$140 a year, the costs of treatment are likely to be overwhelming
for the vast majority of patients in sub-Saharan Africa who earn
less than $2 a day. What portion of their meager salary should
destitute Africans pay to source life-saving medicines? What
child should they keep home from school, which daily meals should
they skip?
The WHO has undoubtedly selected the correct standard in urging
that antiretroviral therapy be offered free as part of a rich
package of public health services in developing countries. Where
medical aid schemes cover the costs of treatment and drug
purchases, certainly some cost recovery will occur. But what you
don't want to do, in the middle of an escalating pandemic, is
impose fees that deter treatment for a life-long condition.
Hopefully, some sound minds in Washington will realize the
absurdity of imposing failed user fees and co-payments on poor
people in developing countries.
Community health workers
The last U.S. attack on the WHO 3-by-5 plan involves a critique
of excessive reliance sub-physician health workers and on
40,000-60,000 new community health workers, workers to be
recruited, trained, and deployed as part of the WHO's 3-by-5
plan. ...
Instead of waiting on strategies to retain existing physicians
and nurses who are being recruited to Northern health sectors in
record numbers and to recruit a greatly expanded corps of highly
trained AIDS physicians, the WHO has adopted a two-part strategy
for using non-physician health care workers. Key decisions
concerning when to start therapy, whether to substitute drugs
because of adverse side effect, whether to switch regimens
because of treatment failure and drug resistance, and when to
stop therapy will be made by nurse practitioners or physician's
assistants working under the supervision of doctors; harder cases
will be referred to physicians in district hospitals. Reliance
on non-physician resources even for these important decisions
will be aided by WHO's adoption of standardized and simplified
treatment regimes and by wholesale training of existing health
sector workers. ...
Conclusion
Although it is important to respond to each of the U.S. attacks
against the WHO 3-by-5 plan on the merits, it is equally
important to understand the politics behind this attack. In
essence, at the behest of its pharmaceutical masters, the U.S. is
arguing that brand-name, patent medicines preferentially be used
to fight global AIDS. At the alter of neo-liberal orthodoxy, it
insists that user-fees should be imposed, that poor consumers
will appreciate what they are forced to pay for, even though
study after study has shown that user fees, on the ground, impede
rather than enhance access to treatment. And, at the behest of
conservative elements of the medical establishment, it argues
that scale-up should be scaled back - that it is better to go
slow than to practice less than ideal care, even though ideal
care is decades away. The WHO 3-by-5 plan will certainly need to
be fine-tuned and improved over time. Excessive compromises on
quality should not be made at the alter of expediency and
operational deficiencies should be quickly corrected. But the
WHO has launched an initiative where few have dared tread -
it is replacing rhetoric and hollow, platitudinous expressions of
concern with a pragmatic and bold plan for action. Rather than
stand by and watch millions die needlessly every year, the WHO
has overcome its own historical lethargy and is finally beginning
to meet its mandate as a global public health institution. We
can not let the U.S. succeed in undermining this new commitment
with its nit-picking and bad faith concerns.
Note: This paper was originally distributed on two mailing lists,
which provide coverage of this and related issues. The IPhealth
list also has archives available to non-subscribers.
For more information:
Ip-health mailing list
Ip-health@lists.essential.org
http://lists.essential.org/mailman/listinfo/ip-health
and
e-3x5 mailing list
e-3x5@healthnet.org
http://list.healthnet.org/mailman/listinfo/e-3x5
AfricaFocus Bulletin is a free independent electronic publication
providing reposted commentary and analysis on African issues, with
a particular focus on U.S. and international policies. AfricaFocus
Bulletin is edited by William Minter.
AfricaFocus Bulletin can be reached at africafocus@igc.org. Please
write to this address to subscribe or unsubscribe to the bulletin,
or to suggest material for inclusion. For more information about
reposted material, please contact directly the original source
mentioned. For a full archive and other resources, see
http://www.africafocus.org
|
