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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 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

++++++++++++++++++++++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:]

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. ...


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.

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