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 countriesand are too
poor to pay for drugs, the pharmaceutical industryhas 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 partnershipsto tackle
neglected diseases such as malaria, HIV, and tuberculosis.Yet some
infectious diseasesthe
world's "most neglected" diseasesarestill being ignored not just by the pharmaceutical industry but
also by public-privatepartnerships.
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, organisedby Médecins sans
Frontières.1 The answer lies in the socialcontract that exists between the public and privatesectors.
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 developingdrugs that
are likely to be marketable and profitabledrugs
forconditions 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
accountedfor over 10% of the global disease burden. In contrast,
over twothirds of new drugs were "me too drugs" (modified versions
ofexisting drugs), which do little or nothing to change the diseaseburden.
The pharmaceutical industry only enters into public-private partnerships when
it sees at least some potential market for itsdrug. For example,
although people with malaria in the world'spoorest countries cannot
afford to pay for new malaria drugs,Western travellers can.
Similarly, patients with tuberculosisor HIV in Africa or India
cannot afford to purchase new treatments.However, many patients in
the United States or Europe, whose healthexpenditure is covered
partly by government run health insuranceprogrammes, can pay for
thesetreatments.
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 bargainingpower involves
creating favourable conditions that make it attractivefor industry
to invest in drug development. For example, the publicsector might
reduce the costs of research and development throughgrants, tax
credits, or public support for clinical trials, orit might create a
purchase fund, in which donors ensure that thereis a pot of gold
ready to buy the new drug once it is developed.Examples of this type
of approach are the Medicines for MalariaVenture, the International
AIDS Vaccine Initiative, and the GlobalAlliance for TB DrugsDevelopment.
When it comes to the world's most neglected diseases, however, these present
absolutely no market opportunities. Without suchopportunites, there
is no incentive for the pharmaceutical industryto invest in drug
research and development. The patients haveno purchasing power, no
vocal advocacy group is pleading for theirneeds, and no strategic
interestsmilitary or
securityare drivingconcern 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 neglecteddisease. Current drug
treatments are in scarce supply, difficultto administer, and often
toxic. Melarsoprol, which was developedover 50 years ago, kills up
to 10% of people who are given thedrug, and in some regions drug
resistance means it is ineffectivein a third of patients.3
An effective, less toxic drug, hasbeen developedeflornithinebut
the company that developed itstopped its production in 1995, citing
commercial failure. Africanpatients could not afford to buy the
drug. Eflornithine becameavailable again five years later in the
United States, when itwas found to reduce unwanted facial hair in
women.4 The injusticeof American women
depilating their faces while thousands in Africawere dying of a
treatable illness finally led the original makersto restart
production of the drug.5 It is currently availablethrough a donation programme until 2006, though a long term produceris yet to befound.
Médecins sans Frontières believes that the best hope of treating the world's
most neglected diseases is for the public toaccept responsibility
for drug development, taking it out of themarketplace and into the
public sector. The organisation has launchedan initiative on drugs
for neglected diseases, founded only bypublic 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 DevelopmentPlan, the World Bank, and
the World Health Organization), theIndian Council for Medical
Research, and the Brazilian governmentpharmaceutical organisation
Fiocruz. The initiative is testingthe idea that a drug research and
development network can be establishedin the developing world, with
a centralised management structure,and its feasibility study will be
published later this year. PhilippeKourilsky, the director general
of the Pasteur Institute, believesthat the initiative will do
"nothing short of creating a global,not-for-profit pharmaceutical
industry." If the initiative provesviable, it is likely to engage
with the pharmaceutical industryon specific projects, since industry
has great expertise in thedevelopment of drugs. The initiative,
however, will not rely onmarket forces; it will define its needs,
and then rely on publicinvestment to meetthem.
Will the strategy of taking medicines out of the marketplace work? Few
precedents for truly international public initiativesexist (the
Human Genome Project is an example), and the publicinvestment will
need to be massive. There will need to be concertedpolitical
attention to make available the necessary financialand technical
resources. Right now there is little other hopefor those dying of
the world's most neglected, yet curable, infectiousdiseases.
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[Medline].
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[Medline].
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