CZAR UNDERMINES WHO INITIATIVE
2003, at its annual World Health Assembly, the World Health
Organisation (WHO) announced a modest proposal: that it would provide
technical and organisational support to provide 3 million people
countries with antiretroviral treatment by the year 2005.
"3-by-5 initiative" was minor in one sense, in that it would
treatment to only about 5 percent of those in need. But in
sense, it was a major step forward, particularly because the
proposed a novel manner of delivering the anti-HIV medicines:
the drugs into a "fixed-dose regimen", a combination pill
containing three drugs in one capsule, allowing an infected person to
one pill twice per day for a complete HIV-treatment
Fixed-dose combinations are cheaper and easier to take than
existing HIV treatment protocol; taking two fixed-dose
combination pills a day for a year costs $140 per patient, compared
$600 per year for the normal regimen of six pills per day
excuses used to deny patients in poor countries access to
antiretrovirals centred around two common arguments: that poor
could not adhere to complex medication regimens and would
improperly take the drugs leading to drug-resistant forms
and that the infrastructure in poor countries is insufficient
support complex HIV care [2, 3].
who continue to state these excuses are almost universally
unfamiliar with the public health and biomedical data accumulated
last several years, which definitively demonstrates that in
resource-poor settings - including the poorest place in the
hemisphere (the central plateau of Haiti) and the slums of
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].
success of these interventions has resulted in the exportation of
models throughout the world - and physicians everywhere are now
for the necessary medications to arrive.
generic combination pill would have improved and simplified
to the point where these models would have been even easier
in most resource-poor settings.
Why had a
combination pill not been designed before? Because HIV
requires a number of different types of medications, and
types are patented by different companies in the US and UK.
combination pills could not be produced when one company owned
patent to a necessary chemical and another company owned the
a secondary component.
patents, of course, are believed to be necessary to give
a fixed monopoly time in a marketplace to recoup costs on
and development (R&D). Yet, again, data demonstrate that
costs are recouped well in advance of the 20-year patents that
Trade Representative is pushing on poor countries through
and regional trade agreements .
R&D claim ignores the fact that most AIDS drugs were produced
public financing (even through the clinical trials stages),
of the basic and applied research for the top five selling
the market were produced through taxpayer funding .
to the industry's own tax records (obtained from the
Securities and Exchange Commission), Merck last year spent 13% of its
on marketing and only
R&D, Pfizer spent 35% on marketing and only 15% on R&D, and the
overall spent 27% on marketing and 11% on R&D .
Meanwhile, all of sub-Saharan Africa constitutes only 1.3% of the
pharmaceutical market, so as one former pharmaceutical executive put
allowing generics to enter this market would result in a profit
the patent-based industry equivalent to "about three days
fluctuation in exchange rates" [15, 16].
drug industry's fight for monopoly patent rights in this
and middle-income country markets is serious, as the growing
inequality in poor countries under the context of neoliberalism
the market-share for more expensive patent-based drugs
of this data accumulating, it would seem self-evident that
move to make a generic combination pill would not face much
opposition. In reality, the new US AIDS "Czar", Randall Tobias, the
CEO of Eli Lilly, has almost totally undermined the WHO plan.
and the White House initially pledged to support the
initiative, no monies have flowed to date, and Tobias appears to be
until the program completely collapses from financial
Ironically, when President Bush claimed to pledge $15 billion to
AIDS efforts during the State of the Union Address last year
which has actually been apportioned to date), he quoted the
the WHO generic pill as a basis for claiming that the US
support drug treatment for HIV-infected persons, since such
has become more affordable . It now appears that the US
pay if US patent-based pharmaceutical manufacturers are
money - an effective subsidy of an already heavily-
subsidized industry that is taxed at only one-third of the rate of
equivalent industries [13, 18].
pharmaceutical industry has been lobbying the White House
throughout this week to undermine the WHO initiative, Tobias has
stated that his concerns are not about the industry's
interests, but about the safety of generics and the prospect that
AIDS drugs would be smuggled illegally into Northern
countries. "We need to have principles," he told the US Congress this
"standards by which the purchase decisions can be made" .
has taken care of the safety standards concern by inspecting
making a list of "approved" generics whose safety standards meet
international guidelines . But the US Department of Health and
Sciences has now convened a conference in Botswana on March 29
question the WHO's approval process, drawing in "experts"
patent-based industry to claim that the process every major
public health expert in the field has supported is somehow
inadequate and unsafe .
smuggling claim is more complex; while the company
GlaxoSmithKline did have a shipment of AIDS drugs diverted from
Leone early last year, it was later found that the shipment
partly still in Europe and simply mis-warehoused by GSK, and that
smuggling of the rest of the drugs took over a year for GSK to
generic manufacturers have been shipping drugs for over two
without a single case of "diversion", and the fact that
create new formulations and new pill shapes, colours and
makes it easier for customs officials to detect any form of
diversion, as they would for any other type of illegal smuggling
EU has passed a customs regulation to assist in preventing
future diversion; while the US could do the same. Taking care of
problem this way would ironically undermine Mr. Tobias' own
appears clear that Randall Tobias' agenda is not driven by data or
thought, but by the industry whose combined soft- and hard-
campaign donations top the list of contributors in the US
light on the Czar's activity may begin to expose his
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
public health initiative .
Basu is at the Yale University School of Medicine.
send comments to