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[e-drug] US AIDS Czar Undermines WHO Initiative

US AIDS Czar Undermines WHO Initiative
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[cross posted from afro-nets with thanks BS]

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/
Please send comments to <editor@pambazuka.org>

References

1. Boseley, S., US firms try to block cheap Aids drugs, in The
Guardian. 2004.

2. Attaran, A., K.A. Freedberg, and M. Hirsch, Dead Wrong on
AIDS, in The Washington Post. 2001.

3. Mukherjee, S., Why cheap AIDS drugs for Africa might be dan-
gerous, in The New Republic. 2000.

4. Basu, S., K. Mate, and N. Johnson, Poverty's Pathologies:
Global Inequalities & the Lives of the Destitute Sick. 2000, In-
stitute for Health and Social Justice: Boston.

5. Binswanger, H.P., Willingness to pay for AIDS treatment:
myths and realities. The Lancet, 2003. 362(9390): p. 1152-53.

6. Farmer, P.E., et al., Community-based approaches to HIV
treatment in resource-poor settings. The Lancet, 2001.
358(9279): p. 404-9.

7. Farmer, P.E. Introducing ARVs in Resource-Poor Settings: Ex-
pected and Unexpected Challenges and Consequences. in 2002 In-
ternational AIDS Conference. 2002. Barcelona.

8. Individual Members of the Faculty of Harvard University, Con-
sensus Statement on Antiretroviral Treatment for AIDS in Poor
Countries. 2001, Harvard University: Cambridge.

9. Mukherjee, J.S., et al., Tackling HIV in resource poor coun-
tries. BMJ, 2003. 327(7423): p. 1104-1106.

10. McNeil, D.G., Africans Outdo Americans in Following AIDS
Therapy, in The New York Times. 2003.

11. Rosenberg, T., Look at Brazil, in The New York Times Maga-
zine. 2001.

12. Basu, S., Circumventing the Consensus: The USTR, public
health, and bilateral trade agreements, in Z-Magazine. 2003.

13. Young, R. and M. Surrusco, Rx R&D Myths: The Case Against
the Drug Industry's R&D "Scare Card". 2001, Public Citizen:
Washington D.C.

14. Mahan, D., Profiting from Pain: Where Prescription Drug Dol-
lars Go. 2002, Families USA: Washington D.C.

15. Gellman, B., A Turning Point that Left Millions Behind: Drug
Discounts Benefit Few While Protecting Pharmaceutical Companies'
Profits, in The Washington Post. 2000.

16. IMS Health, Five Year Forecast for the Global Pharmaceutical
Markets. 2002, IMS Health: London.

17. Agence France Presse, Cheaper drugs deal on the cards for
poor nations, in Mail & Guardian (SA). 2003.

18. Langley, A., AIDS drug plan faces collapse, in The Observer.
2004.

19. Basu, S., AIDS, Empire and Public Health Behaviorism. Inter-
national Journal of Health Services, 2004. 34(1): p. 155-67.

20. World Health Organization, Pilot Procurement, Quality and
Sourcing Project: Access to HIV/AIDS drugs and diagnostics of
acceptable quality. 2002, World Health Organization: Geneva.

21. Boseley, S. and R. Carroll, Profiteers resell Africa's cheap
AIDS drugs, in The Guardian (UK). 2002. p. A1.

22. Oxfam UK, Robbing the Poor to Pay the Rich? How the United
States keeps medicines from the world's poorest. 2003, Oxfam UK:
Oxford.

23. Pear, R., Drug Companies Increase Spending to Lobby Congress
and Governments, in The New York Times. 2003.

24. Basu, S., Doha Declaration Nearly Decided: The Fate Of Medi-
cine Access In Poor Countries, in Z-Magazine. 2003.

Visit the Advocacy and Campaigns section of Pambazuka News to
read more about the March 29 meeting in Botswana where activists
fear that generic medicine treatment will be discredited. Fur-
ther details: http://www.pambazuka.org/index.php?id=21087
_______________________________________________

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