Just a few days before his visit to Africa, President Bush announced yesterday that Randall Tobias, the former chairman and CEO of Eli Lilly Co., will take the new position of “Czar” in charge of U.S. global HIV/AIDS funding (1).

The move to position a drug company executive centrally in global health policymaking is nothing new for this administration, but the openness of this gesture to the industry suggests that there is little shame in reversing the progress of the last several years, particularly in the realm of medicine treatment access.

The issue of drug access for the poor–who are the prodiment population affected by HIV/AIDS worldwide–has resulted in a strong consensus within the public health community: that far from being dichotomously opposed to prevention, AIDS antiretroviral treatment is both an issue of social justice and actually assists prevention by allowing patients to seek care and receive something other than a death sentence in return. Brazil’s model treatment program has long served as an example; although initially deemed “cost-ineffective” by the World Bank, the Brazilian measure to offer treatment as a complement to prevention activities, and to administer antiretrovirals to all HIV-positive citizens as a constitutional right, has decreased AIDS mortality by over 50%. Brazil’s manner of measuring “cost-effectiveness” has been to calculate the cost to Brazilian society of letting millions perish; the cost-savings of the treatment program in economic terms has also included saving the expense of repeatedly hospitalizing AIDS patients who do not receive antiretrovirals and therefore need to be treated frequently for secondary infections. Measured this way, the 80% fall in hospitalisations as a result of the program saved hundreds of millions of dollars, and–more importantly–millions of lives (2). The program was recently declared by the new WHO Director-General to be a model for the rest of the world (3).

Brazil’s program uses generic drugs, for quite simple reasons. AIDS therapies from the patent-based pharmaceutical industry in the U.S. and U.K. cost $10,000 to $12,000 a year per patient. But generic anti-AIDS drugs can cost as little as $300 per patient per year (1). And the idea that generic use would undermine the patent-based industry and its R&D ignores all available data. According to the industry’s own tax records (obtained from the Securities and Exchange Commission), Merck this 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 (4). Meanwhile, all of sub-Saharan Africa constitutes only 1.3% of the pharmaceutical market, so as one former executive put it, providing generics to this market would result in a profit loss equivalent to “about three days fluctuation in exchange rates” (5). But the drug industry’s fight for this market is serious, as the growing inequality in poor countries manufactures a new market among the wealthy and a sector for industry expansion (6).

The new AIDS Czar, Tobias, has been part of the crew seeking to preserve this market at the expense of public health. The president has hailed him as a man who “has shown the ability to manage complex organizations and to navigate government bureaucracies,” and indeed this is true (1). When he was CEO of Lilly (and since his departure from the company), Lilly and the rest of the patent-based drug industry has lobbied the U.S. Trade Representative (USTR) through what is called the “Special 301” watch list (7). The USTR, even after signing WTO agreements that allow the use of generics for public health reasons, decided to enforce stricter rules than those allowed by the WTO (after being pressured by Edmund Pratt, former CEO of Pfizer and advisory to Ronald Reagan, 8).

Every year, the patent-based industry submits a recommended list of countries to receive trade sanctions from the U.S. (7); every year, the USTR’s office produces its own recommendations, which have whole paragraphs plagiarized from the drug company document (9). Not only did this process result in the USTR’s attempts to bring Brazil to a WTO dispute settlement body over its model AIDS program (an attempt that stopped only after massive public protest from NGOs and AIDS activists, 2), but also prevented Thailand, Argentina, Kenya and a number of other countries from using generics (10). Only with sustained protest did countries like Uganda feel safeguarded enough to begin importing generic drugs, with profoundly positive results for public health (11).
Because so many countries, unlike Brazil but like Uganda, are too poor to manufacture their own medicines, WTO ministers at the November 2001 WTO meeting in Doha, Qatar, agreed to a public health resolution that would allow the exportation of generics to these poor countries. The agreement, called the Doha “Declaration on the TRIPS Agreement and Public Health” (referring to the Trade Related Aspects of Intellectual Property Rights Agreement, or TRIPS) reaffirmed safety measures already specified in existing WTO guidelines–including measures that allowed countries like Thailand, South Africa and Brazil to produce drugs when the prices of patented medicines were out of reach (rendering the U.S. threats against those countries a violation of WTO rules). In paragraph 6 of the Doha Declaration, the ministers also included a key statement that countries too poor to have their own drug manufacturing capacity (which includes most least developed countries, those with the highest burdens of disease) could import generics (12). TRIPS rules, ironically, prevent the exportation of generic drugs, so this paragraph of the Doha Declaration would allow for wealthier countries to produce generic drugs for least developed countries, not just for themselves.

The Declaration appeared quite straightforward at the time–but during the drafting of its implementing text in December 2002, the USTR–Mr. Robert Zoellick–became the only member of the WTO (reportedly under direct White House pressure) to prevent the execution of the deal in its stated form (13). Although he had already signed his name to the Doha Declaration in November 2001, the USTR would only agree to allow its implementation if most developing countries were excluded from the Declaration’s mandate and if complex legal mechanisms were constructed that would effectively prevent any least developed country from actually being able to import generic medicines (14). Ironically, had his proposal been accepted at the time, countries affected by the recent SARS epidemic would have been unable to take public health measures to stop the outbreak. But this was easily ignored by the USTR, who continues to block a deal on Doha implementation.

The US position, supported by Tobias’ company and others, would effectively secure the continuing global drug price monopoly for the U.S. industry. The industry ties were not covert–at the World Economic Forum in Davos, the Pfizer Corporation announced to the business press that it had taken over the negotiating seat from the USTR and was directly negotiating with the WTO council (which itself is supposed to remain neutral, 15). The talks on implementation were deadlocked as Pfizer and other companies intervened–and the discussion may continue to be deadlocked until (and possibly beyond) the Cancun ministerial conference of the WTO this September.

Announcing that Tobias would be an “AIDS Czar” just before this September meeting sends a clear message to the rest of the world: that the US position will remain steadfast even in the face of 24,000 people who die daily from treatable illnesses (16). Generic drugs were a proposed part of the Bush “$15 billion” AIDS plan announced during the State of the Union address. It is important to put the $15 billion number in quotation marks, because in fact it represents only a few hundred million in new monies, spread over five years, and excluding 36 of the highest burden African countries (17). Much of the money appears to be pulled away from existing global health programs in other areas, and while Bush cited that the drugs being used would cost $300/patient/year (referring to generics, as no patent-based medicine is marketed at this price, 1), no generics appear to have been purchased to date. Indeed, the entire proposal appears to be a means of sending all AIDS monies through bilateral USAID programs–known to “shift” their funds towards anti-abortion, abstinence-only initiatives–and undermine sustained U.S. contributions to the efficient and effective Global Fund for AIDS, TB and malaria. The Global Fund is facing an immediate fiscal shortfall of $700 million in 2003 alone, primarily as a result of the lack of G7 country commitments (18).

Mr. Tobias, in response to his appointment as the new AIDS Czar, said that “the statistics that describe the H.I.V./AIDS pandemic are really nearly incomprehensible” (1). He should know: as he has been part of the process that has rendered them such.
It is important for AIDS activists to take strong stands and push Tobias to break his industry ties, and to create monitoring mechanisms to watch his progress closely as the September WTO conference nears and as U.S. funds for AIDS are distributed. Some AIDS groups have been complicit to the process, most notably the Elizabeth Glaser Pediatric AIDS Foundation, whose Republican board has consistently undermined the efforts of other AIDS groups. The Vice President of Glaser went out of his way to complement Tobias, saying that he has “management acumen and the ability to pull a lot of levers” (1). Indeed he does have such abilities; but the direction that the levers are pulled in will be the key point of contention.

As Bush visits Africa next week, he will likely push forward his trade deal with the South African Customs Union. Along with restricting the use of generic drugs (again, in excess of WTO rules) through this agreement, the “free trade” framework put forward by Bush for southern Africa essentially bribes the wealthy agricultural landowners and cocoa industry middle-men into signing a deal that is likely to increase rates of TB and HIV among the poor. Epidemiologists and physicians have agreed that the number one epidemiological correlate to AIDS (and TB, and a number of other infectious and non-infectious diseases) is poverty (19). We saw the nasty effects of NAFTA on the health of Mexicans, and now the South African Customs Union deal will import that to a number of African countries.

Migration-induced HIV and TB outbreaks, as a number of studies have shown, often result from economic policies that destroy rural farms and break up families as laborers travel to cities to find work (19, 20, 21). Export-based agricultural policies leave commodities like cocoa flooding markets, dropping prices, and subsequently ruining rural farms (21). Marriages split as males tend to find work in cities, and women lose their source of income and often enter into prostitution for work. AIDS and TB, in this way, spread among the poorest (19, 20, 21). The data is irrefutable, the trends are robust, and the implications have been seen in East Asia and Latin America as well as in sub-Saharan Africa. The policies fueling the AIDS crisis explain why “behavior change” programs for AIDS are failing at a rate of 3 to 1 (22). The excessive focus on “individual behavior” in public discourse on AIDS neglects the fact that most people in the world–according to broad surveys–know how HIV is transmitted (19, 21, 23). People scratch their heads at the continual prevalence of “risk behaviors” in spite of this, but it’s not so surprising. If there’s no food on the table, and prostitution is the only work available, doesn’t prostitution make sense (19)? If Anglo American destroys agricultural systems to set up a mine, and laborers from hundreds of miles away travel there for pittance, spending six-to-seven days a week in all-male barracks, what happens when the company decides to “keep the workers happy” by supplying them with alcohol and prostitutes on breaks (22)? The issue is not so much “behavior” as much as the conditions under which such behavior occurs.
Tobias, the new AIDS Czar, is unlikely to address these factors, as he has been part of the pool of persons who designs the very industries that perpetuate the problem (23). But AIDS organizations need to be strong in the face of his rhetoric, and continue to push not only on the issue of treatment access, but on the broader consequences of market-based approaches to public health.


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For further information, see www.geocities.com/medicinepolicy

References:

(1) Bumiller, E. Bush Chooses U.S. Executive for AIDS Job. NYTimes, July 3, 2003.

(2) Rosenberg, T. Look at Brazil. NYTimes Magazine, http://www.nytimes.com/library/magazine/home/20010128mag-aids.html

(3) Basu, S. Patents & Pharmaceuticals. ZNet, http://www.zmag.org/content/showarticle.cfm?SectionID=13&ItemID=3694

(4) Families USA. Profiting from pain: Where prescription drug dollars go. http://www.familiesusa.org/site/DocServer/PPreport.pdf?docID=249

(5) Gellman, B. An Unequal Calculus of Life and Death. The Washington Post, December 27, 2000, http://home.cwru.edu/activism/READ/WP122700.html

(6) Gereffi, G. The Pharmaceutical Industry and Dependency in the Third World. Princeton: Princeton University Press, 1983.

(7) Pharmaceutical Research and Manufacturer’s Association of America. PhRMA 2003 Intellectual Property Protection Objectives. http://www.phrma.org/international/resources/2003-03-31.376.pdf

(8) Oxfam UK. Formula for Fairness: patient rights before patent rights. Oxfam Briefing Paper: http://www.oxfam.org.uk/cutthecost/downloads/pfizer.pdf

(9) PhRMA comments on the USTR Special 301 actions. http://www.phrma.org/mediaroom/press/releases/02.05.2002.404.cfm

(10) Mayne, R. US bullying on drug patents: one year after Doha. Oxfam Briefing Paper: http://www.oxfam.org.uk/policy/papers/33bullying/33bullying.pdf

(11) Smith, M. Generic competition, price and access to medicines. Oxfam Briefing Paper: http://www.oxfam.org.uk/policy/papers/26generic/26generic.html

(12) World Trade Organization. Declaration on the TRIPS Agreement and Public Health. http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

(13) Elliott, L. & C. Denny. US wrecks cheap drugs deal. Guardian UK, 21 December 2002. http://www.guardian.co.uk/international/story/0,3604,864071,00.html

(14) Doctors Without Borders. Reneging on Doha. Briefing Paper: http://www.accessmed-msf.org/documents/renegingondoha.pdf

(15) Forbes. Pfizer’s McKinnell says drug patent talks progress. 28 January 2003.

(16) Donnelly, J. None of them had to die. The Boston Globe, January 31, 2003.

(17) Basu, S. On the Bush AIDS Plan. Znet,

(18) Health Gap Press Statement.

(19) Farmer, P. Pathologies of Power: Health, Human Rights and the New War on the Poor. Berkeley: U Cal Press, 2003.

(20) Bello, W., Poh, L., & Cunningham, S. A Siamese Tragedy: Development and Disintegration in Modern Thailand. London: Zed Books, 1998.

(21) Kim, J-Y., Millen, J., Gershman, J. & Irwin, A. Dying for Growth: Global Inequality and the Health of the Poor. Boston: Common Courage Press, 2000.

(22) Campbell, C., Mzaidume, Y. How can HIV be prevented in South Africa? A social perspective. British Medical Journal, 324(7331):229-32, 2002.

(23) Farmer, P., Leandre, F., Mukherjee, J.S., Claude, M., Nevil, P., Smith-Fawzi, M.C., Koenig, S.P., Castro, A,, Becerra, M.C., Sachs, J., Attaran, A, & Kim, J-Y. Community-based approaches to HIV treatment in resource-poor settings. Lancet, 358(9279):404-9, 2001.

(24) Quoting HealthGAP’s recent analysis of Tobias: “Eli Lilly is a top Republican party donor: Lilly contributed more than $1.5 million to Republican campaigns during the 2002 election cycle, and spent $234,000 in mailings to shareholders on behalf of Bush’s campaign in 2000. Lilly recently collaborated with Senate Majority Leader Bill Frist (R-TN) and other key Republicans to insert a rider in the eleventh hour to the Homeland Security Bill that would give the drugmaker immunity from families suing Lilly with charges its vaccines causes autism. Outcry over the rider resulted in its repeal in February 2003.” (http://www.globaltreatmentaccess.org/content/press_releases/03/070203_HGAP_PS_GWB_EPAR_Tobias.html)

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