E-drug: BMJ: The world's most neglected diseases
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[Copied as fair use. KM]
BMJ 2002;325:176-177 ( 27 July )
Editorials
http://bmj.com/cgi/content/full/325/7357/176
The world's most neglected diseases
Ignored by the pharmaceutical industry and by public-private partnerships
Infectious diseases can be considered "neglected" when there is a lack of
effective, affordable, or easy to use drug treatments. As most patients with
such diseases live in developing countries and are too poor to pay for
drugs, the pharmaceutical industry has traditionally ignored these diseases.
Over the past decade, however, the public sector, by creating favourable
marketing conditions, has persuaded industry to enter into public-private
partnerships to tackle neglected diseases such as malaria, HIV, and
tuberculosis. Yet some infectious diseasesthe world's "most neglected"
diseasesare still being ignored not just by the pharmaceutical industry but
also by public-private partnerships.
Why have these partnerships ignored the most neglected diseases, such as
kala-azar, Chagas' disease, and sleeping sickness? This question was
explored at a recent meeting in New York, organised by M�decins sans
Fronti�res.1 The answer lies in the social contract that exists between the
public and private sectors.
The public sector has decided to make it public policy to leave drug
development in the hands of the pharmaceutical industry. This industry in
turn invests almost exclusively in developing drugs that are likely to be
marketable and profitabledrugs for conditions such as pain, cancer, heart
disease, and baldness. Public policies, such as tax incentives and patent
protection, are geared towards this market driven private investment. As a
result, out of 1393 new drugs marketed between 1975 and 1999, only 16 were
for neglected diseases,2 yet these diseases accounted for over 10% of the
global disease burden. In contrast, over two thirds of new drugs were "me
too drugs" (modified versions of existing drugs), which do little or nothing
to change the disease burden.
The pharmaceutical industry only enters into public-private partnerships
when it sees at least some potential market for its drug. For example,
although people with malaria in the world's poorest countries cannot afford
to pay for new malaria drugs, Western travellers can. Similarly, patients
with tuberculosis or HIV in Africa or India cannot afford to purchase new
treatments. However, many patients in the United States or Europe, whose
health expenditure is covered partly by government run health insurance
programmes, can pay for these treatments.
When the pharmaceutical industry sees enough of a market, the public sector
then has sufficient leverage, or bargaining power, to persuade the private
sector into a partnership. The bargaining power involves creating favourable
conditions that make it attractive for industry to invest in drug
development. For example, the public sector might reduce the costs of
research and development through grants, tax credits, or public support for
clinical trials, or it might create a purchase fund, in which donors ensure
that there is a pot of gold ready to buy the new drug once it is developed.
Examples of this type of approach are the Medicines for Malaria Venture, the
International AIDS Vaccine Initiative, and the Global Alliance for TB Drugs
Development.
When it comes to the world's most neglected diseases, however, these present
absolutely no market opportunities. Without such opportunites, there is no
incentive for the pharmaceutical industry to invest in drug research and
development. The patients have no purchasing power, no vocal advocacy group
is pleading for their needs, and no strategic interestsmilitary or
securityare driving concern about these conditions. This is why no
public-private partnerships exist specifically for the most neglected
diseases. The figure shows how these diseases fall totally outside the
global pharmaceutical market.
For example, sleeping sickness, which claims thousands of lives annually in
Africa, can be considered as a most neglected disease. Current drug
treatments are in scarce supply, difficult to administer, and often toxic.
Melarsoprol, which was developed over 50 years ago, kills up to 10% of
people who are given the drug, and in some regions drug resistance means it
is ineffective in a third of patients.3 An effective, less toxic drug, has
been developedeflornithinebut the company that developed it stopped its
production in 1995, citing commercial failure. African patients could not
afford to buy the drug. Eflornithine became available again five years later
in the United States, when it was found to reduce unwanted facial hair in
women.4 The injustice of American women depilating their faces while
thousands in Africa were dying of a treatable illness finally led the
original makers to restart production of the drug.5 It is currently
available through a donation programme until 2006, though a long term
producer is yet to be found.
M�decins sans Fronti�res believes that the best hope of treating the world's
most neglected diseases is for the public to accept responsibility for drug
development, taking it out of the marketplace and into the public sector.
The organisation has launched an initiative on drugs for neglected diseases,
founded only by public sector and non profit partners, such as the Pasteur
Institute, the Special Programme for Research and Training in Tropical
Diseases (a project undertaken jointly by the United Nations Development
Plan, the World Bank, and the World Health Organization), the Indian Council
for Medical Research, and the Brazilian government pharmaceutical
organisation Fiocruz. The initiative is testing the idea that a drug
research and development network can be established in the developing world,
with a centralised management structure, and its feasibility study will be
published later this year. Philippe Kourilsky, the director general of the
Pasteur Institute, believes that the initiative will do "nothing short of
creating a global, not-for-profit pharmaceutical industry." If the
initiative proves viable, it is likely to engage with the pharmaceutical
industry on specific projects, since industry has great expertise in the
development of drugs. The initiative, however, will not rely on market
forces; it will define its needs, and then rely on public investment to meet
them.
Will the strategy of taking medicines out of the marketplace work? Few
precedents for truly international public initiatives exist (the Human
Genome Project is an example), and the public investment will need to be
massive. There will need to be concerted political attention to make
available the necessary financial and technical resources. Right now there
is little other hope for those dying of the world's most neglected, yet
curable, infectious diseases.
Gavin Yamey, assistant editor.
BMJ, (gyamey@bmj.com)
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1. Yamey G. Public sector must develop drugs for neglected diseases. BMJ
2002; 324: 698.
2. Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing R, Ford N. Drug
development for neglected diseases: a deficient market and a public-health
policy failure. Lancet 2002; 359: 2188-2194.
3. Legros D, Ollivier G, Gastellu-Etcegorry M, Paquet C, Burri C, Jannin J,
et al. Treatment of human African trypanosomiasispresent situation and needs
for research & development. Lancet Infect Dis 2002; 2: 437-440.
4. MacDonald R, Yamey G. The cost to global health of drug company profits.
West J Med 2001; 174: 302-303.
5. Boseley S. Drug firm wakes up to sleeping sickness. Guardian, May 7
2001.
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