2. You cite the dramatic impact that new drugs have had in prolonging lives in this country. Why isn't this desirable internationally? Why shouldn't the drug companies do everything possible to repeat this success abroad, including negotiating lower costs while making reasonable profits? By saving lives, wouldn't they be ensuring a large market for their products, over long periods of time? Response: As a result of the pharmaceutical industry's tremendous investment in HIV/AIDS therapy, proper and careful use of drug treatment has had dramatic impacts, not just in the United States, but in many other countries around the world, including developing countries where the governments have made a commitment to investing in public health and HIV/AIDS treatment specifically. Of course it is desirable that every country around the world implement sound public health policies, including adequate resources, to decrease the mortality and morbidity caused by HIV. What is crucial to understanding how to repeat the successes in dealing with HIV/AIDS is the realization that no single entity, be it national government, individual health ministry, international organization, or pharmaceutical company, is responsible for or able to deliver the success referred to in your question. Therefore, the issue is not that "drug companies" in and of themselves should do everything possible to repeat this success abroad, because "drug companies" are not solely responsible for this success. Rather, as stated repeatedly by UNAIDS, "experience shows that the challenges of access to AIDS-related drugs can best be met when the government enters in partnerships with other sectors. . . . At the same time, strategic partnerships are necessary at international level. UNAIDS is currently working with its Cosponsors and several multinational pharmaceutical companies to improve access to drugs for persons living with HIV.” (Source: Access to drugs. UNAIDS Technical Update, October 1998, page 2. Emphasis added.) Clearly, the "drug companies" are working to repeat the success the United States and other countries have demonstrated is possible in the face of the deadly scourge of HIV/AIDS. 3. Isn't it true that some developing countries may lack expansive drug delivery systems because affordable drug treatments are not now available? If you provide the drugs, isn't it more likely that delivery infrastructures will develop? Response: It is true that the drug delivery systems in a number of developing countries are deficient. Again, as stated by UNAIDS, the obstacles to access to drug therapy are many, and include affordability, legal, infrastructural, distribution and cultural factors as serious impediments to drug delivery (UNAIDS, op. cit.) For example, no system can be effective without trained medical personnel. We do not believe it is likely that the availability of pharmaceutical products would significantly increase the availability of trained medical personnel or the patient support services that are needed to effectively administer long-term HIV/AIDS care, including that based on pharmaceutical administration. For example, in the United States there is one physician per 420 members of the population, and the average for OECD/high economies is also 420. In Malawi, there is one physician for every 45,740 members of the population, and the average for low-income economies is one physician for every 6,760 members of the population. (Source: Investing in Health, World Development Report 1993, the World Bank, Table 28, page 292. Data are 1990 figures.) It is difficult to understand how providing drugs, even free of charge, will increase the number of physicians per capita. Experience with major pharmaceutical donation programs, such as the Merck MectizanR to eliminate onchocerciasis (river blindness) and SmithKline Beecham's recent partnership with WHO to eliminate lymphatic filariasis (elaphantiasis) by donating several billion doses of albendazole, are instructive. In both cases, the respective companies are donating the medicines free of charge, thus eliminating any affordability obstacle. Massive global efforts involving numerous partners, including national governments, WHO, private voluntary organizations, donor organizations, etc., are still required to design and administer effective eradication programs. Just making the drugs available in and of themselves did not necessarily spur the creation of adequate infrastructure and treatment protocols to eliminate either disease. Most importantly, the announcement of the donation programs did not create the political will at the national level to eradicate either disease. The commitment to disease eradication had to be created at the international level, driven by multisectoral partnerships. And, as noted above, it is this model of multisectoral partnership that the industry is already engaged in with UNAIDS. Finally, the onchocerciasis and lymphatic filariasis examples are also instructive because in both cases the treatment protocol consists of providing each patient with only one dose, and only once every 12 months. As effective HIV/AIDS treatment is vastly more complicated, the solutions to effectively treating HIV/AIDS in poor countries with inadequate public health systems are just as if not more complex. 4. In your testimony, you call for partnerships involving drug companies, international organizations, and medical and patient groups. I think that those with AIDS represent a large group internationally – more than 34 million. What type of partnership do you recommend for those with immediate treatment needs? Response: A first step to establishing effective partnerships to address immediate treatment needs must be the explicit recognition by national governments that HIV/AIDS treatment is indeed a public health priority. UNAIDS has identified the establishment of political will as a principal challenge to delivering HIV/AIDS treatment: “[I]n some countries, healthcare infrastructure (chiefly the physical infrastructure of health-care facilities, both public and private) is too sparse to ensure adequate usage of drugs even if these drugs were to be imported at no cost. It will be a challenge in each country to objectively assess and prioritize the possible medical and public health interventions in the existing infrastructure (as well as to assess country's needs), and to decide where it should be strengthened or expanded." (UNAIDS, op. cit., p. 8. Emphasis in original.) Once the political commitment to HIV/AIDS treatment is established, there would seem to be many types of partnerships. This is precisely the focus of the UNAIDS pilot projects in a number of developing countries. As noted in the PhRMA testimony, Brazil provides an example of private/public partnership that addressed the need to provide immediate treatment to people living with HIV/AIDS. A pharmaceutical company worked with the Brazilian medical community to run clinical trials of a new antiretroviral drug. The company trained medical staff, expanded clinical facilities, and supervised treatment. As a result, many HIV/AIDS patients were successfully treated and demand for secondary and tertiary medical care decreased, with concomitant reduction in health care spending. With the transfer of information technology from the clinical trials, the Brazilian medical establishment was far better equipped to organize itself to deliver effective and appropriate HIV/AIDS treatment. (Source: U.S. International Response to HIV/AIDS, Department of State, January 1999, pp. 51-52.) 5. A recent AIDS Action report cites the 15 largest pharmaceutical companies as spending $68 billion on marketing, advertising and administration, and $24 billion on research and development. If pharmaceutical companies focused less resources on marketing and advertising, would that provide more funds for research and development and greater drug availability? Response: We are unfamiliar with the source of the $68 billion figure, but on its face it appears quite absurd. PhRMA survey, and data from IMS Health, Inc., indicate that American researchbased pharmaceutical companies spent about $6.1 billion on marketing in 1998 (see, attached chart). This represents slightly more than 6 percent of sales revenue, compared to almost 21 percent of sales revenue invested in R&D. On the issue of marketing generally, it is important to understand that unlike in other areas of commerce, efforts to market pharmaceutical products necessarily have a large educational component. Those marketing the products must often furnish a large number of health care providers with detailed information about the benefits of the products, when they should be used, and how they should be used. The amount of information necessary is more for newer products, especially those that treat newer diseases such as HIV/AIDS or rare diseases. Without this information, health care providers will not be able to use new products or may use them improperly. Pharmaceutical marketing is thus critical to the optimum use of pharmaceutical therapy, and as such is not a drain on R&D investment but rather is an investment in physician and patient knowledge. 6. In your testimony you mention that “54 medicines have been approved for HIV/AIDS and associated conditions.” How many of these medicines are readily available in the developing countries that need them most? Response: We have not conducted any surveys on the availability of these medicines on a country-bycountry basis. Consequently, we do not have comprehensive facts and figures on the global registration of these medicines. As we have emphasized, however, we note that the availability of HIV/AIDS therapies in a given country depends greatly on the political will to ensure that public health services and HIV/AIDS care is available to the population. The answer to the question of how many AIDS medicines are readily available to patients depends on how readily available the government and public health authorities have decided to make HIV/AIDS care, including but not limited to pharmaceuticals. |