Znet: US AIDS Czar Undermines WHO Initiative

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ZNet | Global Economics

US AIDS Czar

Undermines WHO Initiative

by Sanjay Basu; March 21, 2004

In

May 2003, at its annual World Health Assembly, the World Health Organization

(WHO) announced a modest proposal: that it would provide the technical and

organizational 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

centered 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 least 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]. These results are better than those we see at s Hopkins

and Massachusetts General Hospital, and they come from the creative thinking of

physicians who decided that greater " infrastructure " in the US often

meant fragmented care (going from one clinic for substance abuse treatment to

another clinic for HIV medications to another office for housing assistance,

etc.) and that the streamlined and simplified programs designed for

tuberculosis control in the 1960s and 70s (using even more complex medication

regimens than HIV treatment) could be re-used by training community health

workers to monitor HIV+ patients in local areas [10, 11]. 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 (and while combination pills do exist, they are generally not made

for ideal clinical use because they contain two or three drugs that are

combined because they are produced by the same company rather than being

combined based on clinical data, which has shown the need to combine pills that

happen to be manufactured by several companies) [1].

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

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 GlaxoKline 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, indicating gross mismanagement on the part of the company

[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, colors 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 this 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/

Recommended

Reading: Basu, S., AIDS, Empire and Public Health

Behaviorism. International Journal of Health Services, 2004. 34(1): p. 155-67.

Available online: http://www.globalpolicy.org/socecon/develop/2003/0802public.htm

--

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

dangerous, in The New Republic. 2000.

4. Basu,

S., K. Mate, and N. , Poverty's Pathologies: Global Inequalities &

the Lives of the Destitute Sick. 2000, Institute 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: Expected and

Unexpected Challenges and Consequences. in 2002 International AIDS Conference.

2002. Barcelona.

8.

Individual Members of the Faculty of Harvard University, Consensus

Statement on Antiretroviral Treatment for AIDS in Poor Countries. 2001, Harvard University: Cambridge.

9. Mukherjee,

J.S., et al., Tackling HIV in resource poor countries. 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 Magazine. 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 Dollars 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. International 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 Medicine Access In Poor Countries, in Z-Magazine. 2003.

---------------------------------------------------------------

Dr. S. Zeitz

Executive Director, Global AIDS Alliance

1225 Connecticut Avenue, NW, Suite 401

Washington, D.C., 20036

tel: 202-296-0260, ext 209

fax: 202-296-0261, cell: 202-365-6786

pzeitz@...

www.globalaidsalliance.org;

www.stopglobalaids.org

www.globalactionforchildren.org

" First they ignore you. Then

they laugh at you.

Then they fight you. Then you

win. "

-- Mahatma Ghandi