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Congressional Testimony on HIV Epidemic in Sub-Saharan Africa

February 24, 2000

Testimony of Peter Lurie, M.D., M.P.H.
Deputy Director, Public Citizen's Health Research Group
before the Senate Committee on Foreign Relations
Subcommittee on African Affairs

My purpose today is to describe the details of a straightforward six-point plan to address the HIV epidemic in sub-Saharan Africa. Certainly there is much more that can and ought to be done, but, in my opinion, these are the highest priority elements of any plan that seeks to reduce the terrible suffering wrought by this disease. Many of these elements have been shown to be extremely cost-effective and others would cost the U.S. government nothing to implement. Yet the administrations proposal is low on funds, short on specifics and omits entirely some of these six points.

1. Prevention of Mother-to-Infant Transmission

Recent data from U.S. government-funded studies demonstrate conclusively that short courses of antiretroviral drugs (as little as two doses of a drug called nevirapine in one study) can reduce mother-to-infant HIV transmission by up to 50%.[1] While we have been critical of the design of these studies (thousands of women were given inactive placebos during these trials even though longer courses of antiretroviral drugs were known to be effective in preventing mother-to-infant transmission),[2] there is now a golden opportunity to implement these findings and save tens of thousands of infants from otherwise certain death.

The study showed that $4 of nevirapine per mother can cut HIV transmission in half. Because not all HIV-infected mothers transmit HIV to their infants, this means that for every 10 HIV-infected mothers one treats, one prevents an HIV infection that would otherwise have occurred. In other words, $40 worth of drugs will save an infant's life. In contrast, we are accustomed in this country to spending up to $50,000 to extend the life of an older person by one year. In areas where a significant proportion of women are infected with HIV, it would probably be cost-effective to simply treat all pregnant women, without even testing for HIV.[3] Nevirapine is a remarkably cost-effective intervention and one that deserves much more than a nonspecific reference in the administration's proposed $100 million augmentation (to $325 million) in international AIDS spending. If you could do only one thing about the HIV/AIDS epidemic in sub-Saharan Africa, this would be it.

2. Treatment of Sexually Transmitted Diseases

For many years it has been known that the presence of sexually transmitted diseases (STDs) increases the transmission of HIV infection. In 1995, a study in Uganda demonstrated for the first time that treating these STDs can significantly reduce HIV transmission. After adjusting for a number of factors, the HIV transmission rates in communities randomized to receive an enhanced program of STD treatment, including a regular supply of medications, were 42% lower than in communities receiving usual STD treatment.[4] This intervention is also remarkably cost-effective: it costs $218 to prevent an HIV infection.[5]

Tragically, as is so often the case in sub-Saharan Africa and other developing countries, there is a huge gap between science and policy, largely for economic reasons. Large parts of sub-Saharan Africa do not enjoy the benefits of this cost-effective intervention, particularly the stable supply of pharmaceuticals. As in all areas in HIV prevention, efforts should be concentrated among those most at risk for infection: sex workers, migrants and adolescents.

3. Compulsory Licensing[6] and Parallel Importing[7]

Perhaps no issue has engendered more controversy than the debate over compulsory licensing and parallel importing. The raising of this issue by AIDS activist and consumer groups has produced an avalanche of misinformation from the pharmaceutical industry and the unseemly specter of the U.S. government interceding on behalf of multibillion dollar corporations at the expense of the lives of people in developing countries.

The industry has argued that the possible development of HIV strains resistant to the current antiretroviral drugs, due to difficulty complying with the often-complex drug regimens, might actually leave patients in developing countries worse off if they were treated.[8] This argument is without scientific merit or moral basis. For a patient to be worse off due to the development of viral resistance, one would have to believe that a patient who is partially adherent to anti-HIV therapy and who consequently develops a resistant HIV strain is in a worse situation than one who is not treated with anti-HIV drugs at all. But there is no evidence to support that assertion. Many patients who are not fully adherent with anti-HIV therapy do not develop drug resistance. And even for those who might develop resistance, the change to the viral genetic material that confers resistance is likely to be different than one that would confer greater disease aggressiveness. Mutant microorganisms generally reproduce less efficiently than non-mutants. A review in the Journal of the American Medical Association points out that, in the absence of therapy, strains from untreated people (which are primarily non-resistant) are likely to reproduce more rapidly than resistant strains and so will come to dominate the resistant strains over time.[9] There is also some evidence that HIV strains resistant to AZT are more difficult to transmit to uninfected people.[10] For the industry to argue that people in sub-Saharan Africa are best protected by us from the dangers of these drugs is paternalistic in the extreme.

Let us be clear: the compulsory licensing and parallel import proposals do not require any country to engage in these practices. Rather, countries are left to decide for themselves if they wish to use these legal mechanisms. But preventing compulsory licensing and parallel imports in blanket fashion robs developing countries of that choice.

Second, developing countries are not monolithic when it comes to public health capacity, and it is condescending to lump them all together in order to justify withholding effective treatments. Clearly there are enormous differences between developing countries and within them. For example, very impoverished African countries such as Zimbabwe, Zambia, Uganda, Botswana, Senegal and Cote d'Ivoire are planning to provide anti-HIV drugs for HIV-positive women to prevent HIV transmission to their infants.[11] Other countries, such as Brazil, already provide complex anti-HIV drug regimens to their HIV-positive populations.

Third, the compulsory licensing and parallel import mechanisms proposed by South Africa, for example, do not only involve AIDS drugs or those for infectious diseases. The "resistant strain" argument is thus being used to prevent improved access to lifesaving drugs even for non-infectious diseases such as heart disease and cancer. Drugs like simvastatin, to lower cholesterol, and ranitidine, for ulcers, could be substantially reduced in price.

Finally, let us remember that compulsory licensing and parallel importing can be implemented at no cost to the U.S. government.

Lurking in the background in this phony debate over resistant strains is the unstated concern that resistant HIV strains from the developing world will enter the United States. What the pharmaceutical industry is really arguing is that Africans should remain untreated so that Americans might live longer. This is reprehensible (as well as not scientifically supportable).

Certainly, pharmaceutical company pricing practices are not the only reasons that antiretroviral drugs are unavailable in most developing countries. The lack of health care infrastructure is a very important impediment to drug delivery. But pricing is an important, and in this case partially correctable, part of the problem. One reason that the HIV counseling and testing infrastructure in developing countries is weak is that, in the absence of affordable therapies, there are only limited reasons to improve it. But, if effective therapy were more widely available, there would be an incentive to improve the infrastructure to detect undiagnosed HIV infection.

The pharmaceutical industry has also argued that compulsory licensing and parallel importing will undermine the industry's research and development efforts and thus result in fewer drugs for HIV-infected people. Try making that argument to an HIV-infected person in sub-Saharan Africa who, in a world in which compulsory licensing and parallel importing are relatively infrequently invoked, has no access right now to potentially lifesaving medications. Why should it be any different next time? Below we indicate reasons why the pharmaceutical industry's claims on this issue are not to be believed:[12]

The Pharmaceutical Research and Manufacturers Association's (PhRMA) figures on research and development expenditures by U.S. drug companies are inflated and misleading. A significant and perhaps growing share of what PhRMA labels research and development is not spent "to develop and discover new medicines" [as their web site would have it], but instead go into "me-too" drugs with little or no therapeutic gain or into marketing research. Only about 30% of pharmaceutical company research and development is spent on the discovery of truly new medicines, and more than 50% of drug approvals are for "me-too" drugs offering little or no therapeutic gain.

High drug prices and the profits they produce are not needed to entice investors into a risky business because this is not a risky business. The pharmaceutical industry is the most profitable in the United States, whether measured by return on sales, assets or equity. Since 1989, pharmaceutical company return on equity has been at least 1.7 times the median of all U.S. industries. Between the 1970s and the 1990s, drug industry median rates of return on revenue and equity increased by double digits while they stagnated, increased modestly, or even declined for most other industries.

Profit, not research and development, is the top priority for major U.S. drug companies. The top ten firms reaped an average of 1.5 times more in profits than they invested in research and development in 1998.

Promotion and advertising, not research and development, is the pharmaceutical industry's fastest growing expenditure category. Direct-to-Consumer advertising is projected to total $2 billion for 1999. It increased by 43% for the first half of the year compared to the same period in 1998 — three times faster than the 14% by which PhRMA projected U.S. firms' research and development spending would grow.

U.S. taxpayers play an important role in funding pharmaceutical research and development. U.S. drug companies received a whopping $27.4 billion in income tax credits, including the research and experimentation credit, from 1990 to 1996. Taxpayer dollars have funded the basic research, as well as much of the preclinical and clinical research, for many of the cancer and important AIDS drugs (e.g., AZT, DDI) on the market. Yet, instead of directing the benefit to consumers domestically or abroad, the federal government lets private companies engaging in price gouging and profiteering from drugs developed with government funds.

Astonishingly, this administration has devoted itself to acting as a bagman for this highly profitable industry, at the expense of access to potentially lifesaving drugs for the people who need them most. Time and again, in South Africa, in Thailand and now in Brazil, the U.S. government has interceded on behalf of the pharmaceutical industry to either oppose compulsory licensing and parallel importing or to undermine a local generic drug industry. In January, the U.S. government even intervened to strike long-accepted language endorsing compulsory licensing and parallel importing from a World Health Assembly Executive Board resolution. President Clinton's claim in Seattle that the U.S. government would no longer oppose compulsory licensing and parallel importing provisions that are compliant with the Trade Related Aspects of Intellectual Property Rights (TRIPS) has had little impact on the ground, where harassment of foreign governments has continued. If the government were truly serious about not impeding TRIPS-compliant proposals, it would develop model language for developing countries to implement; these countries could then be assured that the U.S. government would not intercede. Instead, the current policy is just vague enough that countries will continue to shy away from these legal mechanisms, lest they anger the U.S., which for many is a major source of foreign aid and whose approval is often the key to loans from the World Bank and International Monetary Fund (IMF).

4. Treatment of Opportunistic Infections

It is not usually HIV itself that kills people with AIDS, but rather a series of infections and cancers that take advantage of the AIDS patient's weakened immune system. Fortunately, some of these opportunistic infections can either be treated or prevented using existing drugs that are either currently inexpensive or could be made so by compulsory licensing or parallel importing.

Fluconazole is a drug that treats an often-fatal complication of HIV infection, cryptococcal meningitis, rather than HIV itself. Its price could be dramatically reduced by either compulsory licensing or parallel importing. Two 150 mg fluconazole tablets sell for $23.50 in Italy, where its patent is protected, compared to $0.95 in India where the patent is not recognized. Other drugs for opportunistic infections that should also receive support are isoniazid, proved many times to reduce the rate of active tuberculosis in certain HIV-positive persons,[13] and trimethoprim-sulfamethoxazole.[14]

5. Debt Relief

Much attention has been focused upon the economic and social impact of the HIV/AIDS epidemic on African economies, but very little on the notion that specific economic policies have actually contributed to the severity of the epidemic. In an article published in the journal AIDS (see attachment) in 1995, we argued that the latter have been almost entirely overlooked.[15] In particular, we argued that, in exchange for loans from the World Bank and IMF, these institutions have imposed structural adjustment policies on developing countries: export-oriented economic models that also undermine the public sector in ways that are detrimental to controlling AIDS/HIV.

This may occur in four interlocking ways. First, these policies undermine rural subsistence economies by turning the agricultural sector over to large agribusiness and emphasizing exports, which tend to be based in cities. This encourages migration, with the resultant breaking up of stable sexual units. Increasingly, migration is recognized as an important risk factor for HIV infection. Second, transportation infrastructures designed to support the export economy rapidly shuttle people between urban and rural areas, promoting the spread of disease. Third, increasing urbanization and dislocation promote the sex and illicit drug industries. Fourth, these loan policies saddle developing countries with enormous debt payments, resulting in cutbacks in government health and social spending. This leaves declining resources for disease surveillance, condom distribution, education and STD treatment. User fees promoted by the IMF and World Bank reduce clinic utilization, including at STD clinics.

The recent efforts at debt relief for the most highly indebted developing countries are a step in the right direction. But relief is in part conditioned upon continued obedience to the structural adjustment model, the model that may be part of the problem in the first place. Only Senator Feingold's and Representative Jackson's bills appropriately address the issue of debt forgiveness.

6. Expanded U.S. Government Role

As I have indicated, several of the elements of this six-point plan can be implemented with little cost, particularly to the U.S. government. But that is not to say that expanded funding is not needed. Even the President's increased budget for international HIV/AIDS efforts is a decidedly anemic response to the magnitude of the problem. The President's budget is equivalent to less than $10 per person living with AIDS/HIV. Senator Boxer's bill would represent an improvement. If we are truly interested in stemming this terrible epidemic, the contribution of the world's richest country will have to go beyond mere words of support to encompass the kinds of concrete actions described in this testimony. Not to do so will undermine the U.S.'s claim to be a leader in the world fight against HIV/AIDS.


References

[1] Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet 1999;354:795-802.

[2] Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. New England Journal of Medicine 1997; 337:853-6.

[3] Marseille E, Kahn JG, Mmiro F, et al. Cost effectiveness of single-dose regimen for mothers and babies to decrease vertical HIV-1 transmission in sub-Saharan Africa. Lancet 1999;354:803-9.

[4] Grosskurth H, Mosha F, Todd J, et al. Impact of improved treatment of sexually transmitted diseases on HIV infection in rural Tanzania: randomised controlled trial. Lancet 1995;346:530-36.

[5] Gilson L, Mkanje R, Grosskurth H, et al. Cost-effectiveness of improved treatment services for sexually transmitted diseases in preventing HIV-1 infection in Mwanza Region, Tanzania. Lancet 1997; 350:1805-9.

[6] Compulsory licensing allows local production of patented medications with a royalty to be paid to the patent holder.

[7] Parallel importing allows countries to find the lowest price for a particular drug on the international market, rather than being required to purchase from the manufacturer at a higher price.

[8] World News Tonight with Peter Jennings (6:30 PM Eastern Time), July 8, 1999 (rush transcript).

[9] Hirsch MS, et al. Antiretroviral drug resistance testing in adults with HIV infection: implications for clinical management. Journal of the American Medical Association 1998;279:1984-91.

[10] Wahlberg J, et al. Apparent selection against transmission of zidovudine-resistant human immunodeficiency virus type 1 variants. Journal of Infectious Diseases 1994;169:611-4.

[11] Lurie M, Lurie P, IJsselmuiden C, Gray G. Denying effective antiretroviral drugs to HIV-positive pregnant women -- the national government's flawed decision. S Afr Med J 1999;89:621-3.

[12] The references for information in the next section are included in "Why the pharmaceutical industry's "R&D Scare Card" does not justify high and rapidly rising U.S. drug prices," Public Citizen's Congress Watch, January 26, 2000.

[13] Pape JW, Jean SS, Ho JL, Hafner A, Johnson WD. Effect of isoniazid prophylaxis on incidence of active tuberculosis and progression of HIV infection. Lancet 1993:342:268-72.

[14] Anglaret X, Chene G, Attia A, et al. Early chemoprophylaxis with trimethoprim-sulfamethoxazole for HIV-1-infected adults in Abidjan, Cote d'Ivoire: a randomised trial. Lancet 1999;353:1463-8.

[15] Lurie P, Hintzen P, Lowe RA. Socioeconomic obstacles to HIV prevention and treatment in developing countries: the roles of the International Monetary Fund and the World Bank. AIDS 1995; 9:539-546.

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