PHA-Exchange> US AIDS Czar Undermines WHO Initiative

[Claudio]

> US AIDS Czar Undermines WHO Initiative
> --------------------------------------
> By Sanjay Basu*
> Source: 
> PAMBAZUKA NEWS 149 - A Weekly Electronic Newsletter For Social 
> Justice In Africa
>  
> In May 2003, at its annual World Health Assembly, the World 
> Health Organisation (WHO) announced a modest proposal: that it 
> would provide the technical and organisational support to pro-
> vide 3 million people in poor countries with antiretroviral 
> treatment by the year 2005.
>  
> This "3-by-5 initiative" was minor in one sense, in that it 
> would provide treatment to only about 5 percent of those in 
> need. But in another sense, it was a major step forward, par-
> ticularly because the WHO proposed a novel manner of delivering 
> the anti-HIV medicines: combining the drugs into a "fixed-dose 
> regimen", a combination pill containing three drugs in one cap-
> sule, allowing an infected person to take only one pill twice 
> per day for a complete HIV-treatment regimen. Fixed-dose combi-
> nations are cheaper and easier to take than the existing HIV 
> treatment protocol; taking two fixed-dose combination pills a 
> day for a year costs $140 per patient, compared to about $600 
> per year for the normal regimen of six pills per day [1].
>  
> Previous excuses used to deny patients in poor countries access 
> to antiretrovirals centred around two common arguments: that 
> poor persons could not adhere to complex medication regimens and 
> would therefore improperly take the drugs leading to drug-
> resistant forms of HIV, and that the infrastructure in poor 
> countries is insufficient to support complex HIV care [2, 3].
>  
> Yet those who continue to state these excuses are almost univer-
> sally unfamiliar with the public health and biomedical data ac-
> cumulated over the last several years, which definitively demon-
> strates that in the most resource-poor settings - including the 
> poorest place in the western hemisphere (the central plateau of 
> Haiti) and the slums of southern Africa (such as the Khayelitsha 
> township in South Africa) - antiretroviral treatment has been 
> delivered with higher adherence, extraordinary success rates and 
> no evidence of drug resistance [4-9]. The success of these in-
> terventions has resulted in the exportation of these models 
> throughout the world - and physicians everywhere are now waiting 
> for the necessary medications to arrive.
>  
> The WHO's generic combination pill would have improved and sim-
> plified treatment to the point where these models would have 
> been even easier to adopt in most resource-poor settings.
>  
> Why had a combination pill not been designed before? Because HIV 
> treatment requires a number of different types of medications, 
> and these types are patented by different companies in the US 
> and UK. Ideal combination pills could not be produced when one 
> company owned the patent to a necessary chemical and another 
> company owned the patent to a secondary component.
>  
> The patents, of course, are believed to be necessary to give in-
> ventors a fixed monopoly time in a marketplace to recoup costs 
> on research and development (R&D). Yet, again, data demonstrate 
> that such costs are recouped well in advance of the 20-year pat-
> ents that the US Trade Representative is pushing on poor coun-
> tries through bilateral and regional trade agreements [12].
>  
> And the R&D claim ignores the fact that most AIDS drugs were 
> produced through public financing (even through the clinical 
> trials stages), and 85% of the basic and applied research for 
> the top five selling drugs on the market were produced through 
> taxpayer funding [13].
>  
> According to the industry's own tax records (obtained from the 
> Securities and Exchange Commission), Merck last year spent 13% 
> of its revenue on marketing and only 5% on R&D, Pfizer spent 35% 
> on marketing and only 15% on R&D, and the industry overall spent 
> 27% on marketing and 11% on R&D [14].
>  
> Meanwhile, all of sub-Saharan Africa constitutes only 1.3% of 
> the pharmaceutical market, so as one former pharmaceutical ex-
> ecutive put it, allowing generics to enter this market would re-
> sult in a profit loss to the patent-based industry equivalent to 
> "about three days fluctuation in exchange rates" [15, 16].
>  
> But the drug industry's fight for monopoly patent rights in this 
> market and middle-income country markets is serious, as the 
> growing inequality in poor countries under the context of neo-
> liberalism increases the market-share for more expensive patent-
> based drugs among the elite [17].
>  
> With all of this data accumulating, it would seem self-evident 
> that the WHO's move to make a generic combination pill would not 
> face much opposition. In reality, the new US AIDS "Czar", Ran-
> dall Tobias, the former CEO of Eli Lilly, has almost totally un-
> dermined the WHO plan.
>  
> While he and the White House initially pledged to support the 
> initiative, no monies have flowed to date, and Tobias appears to 
> be waiting until the program completely collapses from financial 
> instability [18].
>  
> Ironically, when President Bush claimed to pledge $15 billion to 
> global AIDS efforts during the State of the Union Address last 
> year (none of which has actually been apportioned to date), he 
> quoted the price of the WHO generic pill as a basis for claiming 
> that the US would support drug treatment for HIV-infected per-
> sons, since such treatment has become more affordable [19]. It 
> now appears that the US will only pay if US patent-based pharma-
> ceutical manufacturers are given the money - an effective sub-
> sidy of an already heavily-subsidized industry that is taxed at 
> only one-third of the rate of other equivalent industries [13, 
> 18].
>  
> While the pharmaceutical industry has been lobbying the White 
> House throughout this week to undermine the WHO initiative, To-
> bias has publicly stated that his concerns are not about the in-
> dustry's interests, but about the safety of generics and the 
> prospect that cheaper AIDS drugs would be smuggled illegally 
> into Northern countries. "We need to have principles," he told 
> the US Congress this week, "standards by which the purchase de-
> cisions can be made" [1].
>  
> The WHO has taken care of the safety standards concern by in-
> specting and making a list of "approved" generics whose safety 
> standards meet international guidelines [20]. But the US Depart-
> ment of Health and Human Sciences has now convened a conference 
> in Botswana on March 29 that will question the WHO's approval 
> process, drawing in "experts" from the patent-based industry to 
> claim that the process every major academic public health expert 
> in the field has supported is somehow inadequate and unsafe 
> [18].
>  
> The smuggling claim is more complex; while the company GlaxoS-
> mithKline did have a shipment of AIDS drugs diverted from Sierra 
> Leone early last year, it was later found that the shipment was 
> partly still in Europe and simply mis-warehoused by GSK, and 
> that the smuggling of the rest of the drugs took over a year for 
> GSK to discover [21].
>  
> Indian generic manufacturers have been shipping drugs for over 
> two decades without a single case of "diversion", and the fact 
> that generics create new formulations and new pill shapes, col-
> ours and boxes makes it easier for customs officials to detect 
> any form of diversion, as they would for any other type of ille-
> gal smuggling [22]. The EU has passed a customs regulation to 
> assist in preventing any future diversion; while the US could do 
> the same. Taking care of the problem this way would ironically 
> undermine Mr. Tobias' own arguments.
>  
> It appears clear that Randall Tobias' agenda is not driven by 
> data or rational thought, but by the industry whose combined 
> soft- and hard-money campaign donations top the list of con-
> tributors in the US election cycle [23]. Shining a light on the 
> Czar's activity may begin to expose his practices to scrutiny 
> and - as was done when he and the US Trade Representative tried 
> to undermine a WTO accord for generic drug procurement earlier 
> this year - may prevent disintegration of an important public 
> health initiative [24].
>  
> * Sanjay Basu is at the Yale University School of Medicine. 
> http://omega.med.yale.edu/~sb493/