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Contributions from
the Column
Tribune
Research for humanity
Youth in the fight against poverty
Bitter sugar politics
In fear of Asian competition
1/2005
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[ Pharmaceuticals ]
Research for humanity
When it comes to research, the pharmaceutical industry’s main interest lies in drugs with marketing potential in wealthy countries. Hardly any research is done on how to alleviate and prevent tropical diseases. Public authorities should respond by re-setting priorities for medical research with the goal of helping those most urgently in need.
[ By Jörg Schaaber ]
Sleeping sickness is one of the world’s most neglected diseases. People in East Africa continue to suffer and die, but no effective medication exists to combat this illness. The most up-to-date remedy is melarsoprol introduced in 1940. However, a large number of cases do not respond to treatment. Furthermore, the drug is so toxic that up to ten percent of patients die from side effects. Patients with the West African form of sleeping sickness are slightly better off. They can benefit from a more reliable and less dangerous medicine. Eflornithine is a by-product of cancer research. That it is also effective against sleeping sickness was discovered more or less by accident. But there is no guarantee that all patients will be treated with this drug. The liquid version used in West Africa is very corrosive; the damage it causes to production facilities makes it unattractive for industry.
Only under public pressure did Aventis, in 2001, agree to go on producing the drug for another five years and to make it available to the World Health Organisation (WHO) free of charge. Bristol-Myers Squibb (BMS) is contributing to the funding – after also coming under attack. BMS was producing an ointment version of eflornithine for the removal of unwanted facial hair, but not in the liquid form needed to fight sleeping sickness. Now the search is on to find companies that will manufacture the drug on a permanent basis.
The example of eflornithine is typical in the sense that its effects relevant for Africa were not actively looked for. Medical research largely ignores tropical diseases. Of the 1400 new drugs, which have been introduced in the past 25 years, less than one percent was aimed at needs of developing countries (Trouiller et al, 2002). Today, tuberculosis is the 8th most common cause of death worldwide. Despite its fast-increasing resistance to current drugs, hardly any new drugs have been developed to fight this killer disease. Some medications were developed against AIDS (the fourth most common cause of death) – not least thanks to state funding. This epidemic, of course, also affects rich countries.
Research priorities have little to do with relieving the burden of sickness and death. The Global Forum for Health Research (2000) established that less than 10 percent of current funding for research is devoted to the diseases that cause more than 90 percent of the healthy life years lost worldwide. The main cause for this disparity is the present system of incentives. Patent protection assures pharmaceutical companies of high prices and huge profits if they launch new drugs in wealthy countries. Research into prevention and non-medication treatment is neglected. Even though both are relevant to public health, there is no money in it. Nevertheless, the system does work for the rich countries to some extent. Every year, a large number of new drugs are released onto the market. Unfortunately, there is also a certain degree of inefficiency. According to the US Food & Drug Administration (FDA, 2003), only 23 percent of all new drugs offer significant improvement compared to existing products. Independent experts paint an even darker picture.
Important drugs are too expensive
Patent protection means that new drugs are often extremely expensive and make their manufacturers some of the world’s most profitable companies. High prices, however, imply that life saving options are unaffordable for most of the world’s sick. The AIDS crisis made the world aware of this fact for the first time. Despite patent protection having such serious side effects, the TRIPS (Trade-related Aspects of Intellectual Property Rights) Agreement of the World Trade Organisation has made patent protection globally binding.
One argument made for the patent system is that research needs to be funded. Pharmaceutical corporations tend to claim that there is no alternative. However, it needs to be made clear that developing drugs costs less than is usually claimed and, secondly, that a large proportion of the funding comes from public purses.
According to industry sources, 800 million dollars are needed to develop a new drug. This figure is not based on solid empirical data. The true amount is 115 to 240 million dollars (Global Alliance for TB Drug Development, 2001, Public Citizen, 2003). Moreover, a large share of the pharmaceutical industry’s revenue comes from public health care systems and insurance companies in rich countries. Additionally, governments and local authorities provide the funding for about half of all health research, with charitable foundations contributing a further eight percent. While public research is relatively successful (National Institutes of Health, 2000), it does not much help the world’s poor either. Public authorities tend to give priority to diseases prevalent in their own countries. They also fund research as a means to boost the economy; research into most economically lucrative drugs has largely been state-funded (Cockburn und Henderson, 1997).
Things do not have to be like this. In principle, public research could just as well concentrate on less lucrative markets, prevention and healthcare. There is a number of models for governments to increase their influence on research. The most established approach is for public institutions, pharmaceutical companies and scientific organisations to team up with a focus on a particular objective. For example, the cooperation of GlaxoSmithKline, the WHO, and British as well as African universities resulted in Lapdap, a new anti-malaria drug. No patent rights were applied for. However, such joint ventures do not change market structures to the advantage of poor countries. Knowledge, technology and production predominantly remain with multinational corporations.
Other public-private partnerships are the Global Alliance for TB Drug Development or the International AIDS Vaccine Initiative. However, the private sector’s influence on the objectives of such cooperations needs to be kept in check. After all, the Global Alliance for Vaccines and Immunisations has been accused of focussing on developing and introducing expensive new vaccines, rather than improving healthcare structures (Starling et al., 2001). According to most experts, however, a higher rate of immunisation with existing vaccines would have a greater impact than new drugs.
The Drugs for Neglected Diseases Initiative (DNDi) initiated by Médecins sans Frontières (MSF) has chosen a different approach. In an attempt to improve health research, the “doctors without borders” joined forces with five public research institutions in developing countries as well as with the Special Programme for Research and Training in Tropical Diseases (UNDP, World Bank and WHO). Raising additional funds is high on the agenda.
James Love and Tim Hubbard (2001) recommend “R&D plus” as a quite different and flexible system. The consumer advocate from the US and the genome analyst from Britain suggest international agreements should define minimum levels of health research according to national incomes. This system would take social criteria into account and create a large international source to finance meaningful research.
The present system of funding pharma research has unacceptable disadvantages for most people in the world. Additional money is needed, as are a redistribution of resources and more public control of research.
On the net:
Website of the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) http://www.who.int/intellectualproperty/en/
Literature:
Cockburn, Ian, Rebecca Henderson, 1997:
Public-private interaction and the productivity of pharmaceutical research. Cambridge: National Bureau of Economic Research, http://dsl.nber.org/papers/w6018.pdf, accessed on 27.12.2003
Trouiller, P. et al., 2002:
Drug development for neglected diseases: a deficient market and a public-health policy failure, in: The Lancet, No. 359, p. 2188-2194
FDA, 2003: NDAs Approved in Calendar Years 1990-2002 by Therapeutic Potentials and Chemical Types (updated 14 January 2003), http://www.fda.gov/cder/rdmt/pstable.htm, accessed on 15.11.2003
Global Alliance for TB Drug Development, 2001:
The economics of TB Drug Development. New York
Global Forum for Health Research, 2000:
The 10/90 Report on Health Research. Geneva: WHO
Love, James und Tim Hubbard, 2001:
Making drugs affordable: Replace TRIPS-plus by R&D-plus, in: ICTSD, No. 6, June 2004, p. 3-4
NIH, 2000:
NIH Contributions to Pharmaceutical Development. (Administrative Document February 2000.) Bethesda: National Institutes of Health
Public Citizen, 2001:
Tufts Drug Study Sample Is Skewed – True Figure of R&D Costs Likely Is 75 Percent Lower (Press release Dec. 4, 2001), Washington: Public Citizen
Starling, Mary, Ruairi Brugha, Gill Walt, Annie Heaton and Regina Keith, 2001:
New Products into Old Systems: The Global Alliance for Vaccines and Immunization (GAVI) from a country perspective. London: London School of Hygiene and Tropical Medicine and Save the Children UK
Jörg Schaaber
is a development sociologist and public health expert. He works for the NGO BUKO pharmaceutical campaign and edits the organisation’s newsletter.
jschaaber@bukopharma.de
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