US AIDS CZAR UNDERMINES WHO INITIATIVE
Sanjay Basu
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 provide 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, particularly 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 capsule, allowing an infected person to
take only one pill twice per day for a complete HIV-treatment
regimen. Fixed-dose combinations 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 universally
unfamiliar with the public health and biomedical data accumulated
over the last several years, which definitively demonstrates 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 interventions 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 simplified
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
inventors 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 patents that
the US Trade Representative is pushing on poor countries 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 executive put
it, allowing generics to enter this market would result 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 neoliberalism
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", Randall Tobias, the
former CEO of Eli Lilly, has almost totally undermined 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 persons, since such
treatment has become more affordable [19]. It now appears that the US
will only pay if US patent-based pharmaceutical manufacturers are
given the money - an effective subsidy 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, Tobias has
publicly stated that his concerns are not about the industry'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 decisions can be made" [1].

The WHO has taken care of the safety standards concern by inspecting
and making a list of "approved" generics whose safety standards meet
international guidelines [20]. But the US Department 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
GlaxoSmithKline 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, colours and
boxes makes it easier for customs officials to detect any form of
diversion, as they would for any other type of illegal 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 contributors 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.
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