E-drug: Malarone donations in Kenya
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[copied from the Lancet as fair use; WB]
http://www.thelancet.com/newlancet/reg/issues/vol355no9216/menu
_NOD999.html
Sustainability, affordability, and equity of corporate drug donations:
the case of Malarone
Lancet 2000; 355: 1718 - 1720
R Shretta, R Brugha, A Robb, R W Snow
Correspondence to: Ms R Shretta (e-mail: rima@wtrl.or.ke)
The fostering of a new era of public-private partnership is widely
regarded as being fundamental to supporting the development of
new tools to combat diseases of global importance.1 About 1
million people may have died from the direct consequences of
Plasmodium falciparum in Africa during 1997.2 Furthermore, the
repeated clinical consequences of infection place a burden on
households, the health service, and ultimately the economic
development of communities and countries. The Roll Back Malaria
initiative3 aims to halve malaria mortality by the year 2010. This
optimistic goal has been conceived at a time when existing,
affordable therapies are rapidly failing, health-service provision is
weak and fragmented, immediate prospects of widespread
vaccination are few, and poverty continues to beset most
populations in African states. Supporters of Roll Back Malaria,
economists,4 and industry5 all support the building of a new
commitment to malaria control between the private and public
sectors. The umbrella of public-private partnerships covers a
diverse range of initiatives from new drug and vaccine development
to donation programmes.
The Lancet has already opened a debate about the consequences
of corporate drug donations, particularly after the announcement in
November, 1996, by Glaxo-Wellcome of their proposed global
donation of 1 million treatment courses of Malarone for the
management of uncomplicated malaria where first-line therapies
have failed.6-10 Several important issues pertaining to the
emergence of resistance, patients' compliance, practicalities of
diagnosis, and management of first-line therapeutic failures have
already been aired6-8 in the wake of such a donation-programme
brokered between the international community and national
ministries of health.9 Currently Malarone, a fixed combination of
atovaquone 250 mg and proguanil 100 mg, costs US$42 per adult
treatment course, making it the most expensive antimalarial in a
very small drug armoury for malaria management in endemic
countries. Previous debates have suggested that the high price of
Malarone would deter indiscriminate use outside programme
conditions, limiting the spread of resistance. There are, however,
much wider implications of drug donations for national drug policies
and long-term spending choices which require widening of the
discussion. This paper considers these implications within the
context of the Malarone Donation Programme in Kenya.
The Kenya context
The situation in Kenya is typical of that in many sub-Saharan
African countries. Economic growth remains marginal, investment
and support for the health sector is declining, and the cheap
mainstay of malaria management for 50 years, chloroquine, began
its precipitous decline in efficacy during the 1980s. After a painful
and protracted process of decision making, national policy was
changed in 1997, resulting in the replacement of chloroquine with
sulphadoxine-pyrimethamine as the recommended first-line
therapy. Translation of this policy shift into effective practice has
yet to be fully realised, and there is early evidence of sulphadoxine-
pyrimethamine failure across the country.11 Both the scientific and
public-health communities in Kenya recognise that urgent attention
must be given to deciding upon alternative effective and affordable
drugs to manage the growing problem of sulphadoxine-
pyrimethamine failures, and eventually to replace this drug. The
Kenyan Ministry of Health welcomed the opportunity to explore the
potential role of Malarone through pilot schemes starting in Siaya
District in April, 1999, the underlying assumption being that the
pilot projects, if successful, would pave the way for a national
strategic plan.
Malarone was registered in Kenya in 1998--a prerequisite for its
use in Siaya District. The International Advisory Committee, which
was set up to advise the Malarone Donation Programme,
recommended that the drug should not be made available to the
private sector. By 1999, however, GlaxoWellcome (East Africa)
was under considerable pressure from local private physicians, who
argued that Malarone was now a nationally registered antimalarial,
to make it available. The committee agreed to Glaxo-Wellcome
supplying the private sector on demand, but without active product
promotion. The inevitable consequence is that the drug has
assumed a dual monetary value--free-of-charge within the public
sector and highly priced within the private sector.
Controls may be adequate under pilot project conditions, but under
national programme conditions, leakage from the public-health
sector to providers of private medical services is a likely outcome.
The monthly salary of a government clinical officer in Kenya is
about US$310, which is less than the cost of eight adult Malarone
treatment courses. Other public-sector health workers with access
to drugs earn much less. The high price will merely increase the
value of the drug, and hence the rewards in the event of leakage, as
well as demand by those who can afford it. The likely result will be
inequitable access to a limited supply of drugs. Although
mefloquine, halofantrine, and artesunate derivatives--all nationally
registered drugs for the management of malaria in Kenya--also cost
50-100 times more than sulphadoxine-pyrimethamine, none of
these drugs are available within the public sector. Thus, a dilemma
similar to the one posed by Malarone is avoided.
Presently, the public-sector supply of sulphadoxine-pyrimethamine
through the Essential Drugs Programme is dependent on bilateral
funding from the Department for International Development, UK.
Nevertheless, shortages of the drug continue in some health
facilities, and ensuring adequate financial support, procurement,
and distribution of essential drugs remains a perennial problem for
the Kenyan Ministry of Health. If a parallel drug-supply system
were established (entailing increased administrative costs) to
prevent leakage, continued shortages of sulphadoxine-
pyrimethamine would put considerable pressure on peripheral
health workers to administer Malarone as the first-line treatment.
Sustainability and affordability
Glaxo-Wellcome's donation of 1 million treatment courses of
Malarone remains a global commitment. The actual quantity
available for Kenya has not been stated, which makes it difficult to
translate into a rational and sustainable malaria-control policy. This
task will become increasingly difficult if wider use is advocated after
the successful outcome of the pilot phase. As yet, there are no
models or data to predict the projected demands for second-line
therapies against changing patterns of first-line therapeutic failure.
Nevertheless, in Kenya, there are an estimated 3�5 million children
younger than 5 years living in areas of stable malaria endemicity,12
and on average, each child will experience one "true" clinical attack
of malaria per year.2 This estimate is conservative, given that
routine fever management includes most febrile events associated
with malaria infection, and that fever and infection are both common
events. Presently, on the Kenyan Coast, over 16% of clinical
infections fail to clear by day 7 with sulphadoxine-
pyrimethamine.13 Even assuming that one uses conservative
estimates of clinical failure, that there is access to formal
government health services which provide microscopic diagnosis,
and that sulphadoxine-pyrimethamine is used for fever
management by the year 2003, it is conceivable that over half a
million treatment courses of Malarone would be required each year
just for Kenya's children living in areas of stable malaria risk. This
number would absorb most of Glaxo-Wellcome's global
commitment. Beyond the donation it would cost the government of
Kenya about US$10�5 million per year to support this strategy at
current paediatric drug costs. The government's total recurrent
budget allocation for essential drugs was US$10�6 million during
1997-98.14
The Merck Mectizan (ivermectin) donation programme for the
control of onchocerciasis, and the SmithKline Beecham
albendazole donation programme for the control of helminth
infection, were conceived with an indefinite commitment or until the
drugs are no longer required in all endemic countries. Mectizan and
albendazole are usually distributed in single-round, mass
treatments. These programmes provide little insight into how new
antimalarials, which need to be incorporated into routine health-
service delivery systems, can be responsibly donated to endemic
countries in Africa. Resource-constrained ministries of health, such
as Kenya's, require guidance on the long-term implications of the
Malarone Donation Programme. The latest WHO Guidelines on
Drug Donations15 need to be redefined to address the potential
impact of long-term drug donations which require changes to
national clinical management, drug policies, and revised economic
commitments.
Ensuring equity
Kenya must soon make difficult decisions about which drugs will
replace existing first-line therapies, and about how to manage
present drug failures. Malarone is an exciting possible solution for
the growing national problem of first-line treatment failures. The
government of Kenya will have to consider revising policy on
recommended antimalarial drugs for use in the public sector, and
costs will increase hugely from cents to dollars per treatment
course. Consideration must be given to relative prices and
availability in the public and private sectors. Failure to do so may
result in inequitable access, thus disadvantaging the poor. In our
view, fair pricing and availability should be prerequisites of drug
donations, and will require imaginative thinking by agencies
involved in public-private partnerships. The choices facing the
Kenyan government will depend as much on how to use scarce
resources as on efficacy. Whether or not to include a drug that
costs tens of dollars per treatment course in a national strategy is
a moot point. Correct choices and long-term strategies require
evidence-based technical guidance, assurances of sustainable
commitment, and imaginative negotiations between international
donors, WHO, and the pharmaceutical industry to ensure that
Africa's poor can have access to effective and affordable drugs to
manage malaria. How to bridge the gulf between high production
costs and limited resources of endemic countries facing growing
antimalarial drug resistance, while maintaining equity in access to
drugs between the private and public health sectors is a major
challenge for Roll Back Malaria.
There is understandable enthusiasm among international policy
makers about the potential of public-private partnerships. Drug
donations, such as Malarone, can be seen as genuine goodwill
gestures by a well-intentioned pharmaceutical industry. The
implications of drug donations for national policy, a country's
capacity to fund these changes after the end of a donation, and the
possible commodity-value effects in poorly resourced public
sectors should remain high on the agenda of those responsible for
fostering the new ethical era of public-private partnerships.16
We thank Glaxo-Wellcome; the Task Force for Child Survival and
Development; the Ministry of Health, Government of Kenya; and all
the other stakeholders for their time given to the interviews and
access provided to information. This project was part of a master's
thesis at the London School of Hygiene and Tropical Medicine and
we are particularly grateful to Gill Walt for her incisive comments.
RWS is funded by the Wellcome Trust as part of their Senior
Fellowships Programme (#033340). This paper is published with
the permission of the director of the Kenya Medical Research
Institute.
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