People
infected with HIV/AIDS since the pandemic began: 40 million
People who have died of
AIDS: 20 million
People who died of AIDS
in 2001: 3 million
A microbicide is a compound
that women can apply vaginally or rectally to protect themselves from being
infected by HIV and other sexually transmitted diseases. A microbicide could be produced as a gel,
cream, suppository, film, or in the form of a sponge or vaginal ring that
slowly releases the active ingredient over time. It could be a contraceptive, too. There are several microbicides
under development in laboratories and clinics around the world, but none are
available yet because the research is severely under-funded. Experts project that a safe and effective
topical microbicide could be on the market by 2007, with sufficient funding and
political will.
AIDS is the fourth largest
killer in the world today, and the most infectious disease. Just under 5000 women become infected with HIV every day, almost 90% of
them in developing countries. Women account for almost half of all new HIV
infections, bearing a disproportionate burden of the AIDS epidemic. Many women are sexually powerless, and
therefore vulnerable to HIV infection:
they cannot require that their partner wears a condom, they cannot be
sure that he’s monogamous, and too frequently, they cannot say no.
Microbicides would allow
women to take control of their sexual lives.
For women at risk of HIV infection, the answer is clear and supported by
good science: microbicides could save their lives.
The goal of developing a
safe, effective microbicide depends on more than just good science,
however. Political will must be
galvanized to create an encouraging environment for testing, approving and
eventually distributing microbicides, especially in poor countries. But most importantly at this stage, the
global community must invest more time and money into making the promise of
microbicides, a reality.
A Rich Development Pipeline
After more than a decade of
research and development, the microbicides field looks increasingly
bright. Almost 60 products are poised
for further testing. Three of those
are close to entering Phase III clinical trials this year: Carragard™ a gel derived from seaweed;
Pro2000, a polymer; and BufferGel™, another gel.
Despite dramatic progress in
product development, there is still no definitive clinical proof that a
microbicide will work, perhaps because such proof is time-consuming and
expensive to gain. New preventatives are not as easy to prove as new
treatments. A treatment either cures an
infection or it doesn’t, whereas preventatives stop the infection from being
transmitted. Microbicides will not
cure AIDS, but they will stop transmission of the HIV virus that causes AIDS
and proving that will require expensive, large-scale clinical trials.
No
major pharmaceutical firm has made a significant investment in developing a microbicide
product, and funding from governments and foundations has fallen far short of
the investment that experts believe is now needed to bring a microbicide to
market.
The
Case for Investment
The most likely scenario
suggests that a first generation microbicide that meets the basic needs of
women in both the industrialized and the developing world could have a global
market size of US$900 million by 2011, and a third generation microbicide might
have sales in excess of US$1.8 billion
by 2020.
These are conservative
estimates. The peak market size estimates assume that less than 10% of sexually
active women around the world will use the product. However, if the products
are able to meet a broader set of needs, including those for vaginal hygiene
and general protection against infection, there is potential to far exceed
these forecasts, with a peak market as large as US$5 billion.
Direct development costs are
estimated at US$775 million over the next five years for the entire portfolio
of existing product leads; current investment is estimated to be only US$230
million. The universities, small companies, and nonprofit organizations that
are currently developing products are doing so with limited funding from a
handful of government and foundation donors.
Public and private investment
in microbicide research and development must expand dramatically ― and
quickly ―if the promise of microbicides is to be realized. Not only is
such investment likely to pay off monetarily in the long run, but it is likely
to stem the tide of AIDS.
Averting Millions
of Infections
Asia: more than one million
newly infected people this year
India: soon may have
the largest number of people in one country living with HIV/AIDS
China: by 2010 may have 20
million HIV infected people
Eastern Europe: infection rates rising
faster than anywhere else in the world
Researchers
at the London School of Hygiene and Tropical Medicine have used epidemiological
models to estimate the number of HIV infections that could be averted as a
result of microbicide use—and the numbers are impressive. Depending on how
many–and how often–women use a microbicide before sex, researchers estimate that between 2.5 and
3.7 million HIV infections could be averted over the next three years.
The cost savings to the
global health system of averting 2.5 million HIV infections between 2002 and 2005 is estimated at US$2.7
billion. The savings would be realized when microbicide use reduces the burden
of care and treatment required of strained health systems in poor countries.
Preventing HIV infection will
also avert productivity losses in local economies, such as absences from the
workplace due to illness, and the training of replacement workers. A conservative
estimate of the productivity benefits associated with averting 2.5 million HIV
infections between 2002 and 2005 is US$1 billion.
The numbers are as clear as
the science: microbicides make good
economic sense.
Preparing
for Microbicide Access and Use
If microbicides are to have
the impact they promise, women who are at the highest risk of infection must
have access to them as quickly as possible.
Those women live in the poorest regions of the world, so all access and
distribution strategies must start there.
Product
positioning
Microbicides could be introduced as an HIV preventive, a
contraceptive, a vaginal hygiene product, or a product to enhance sexual
pleasure. The introduction and marketing strategy will set a social norm for
acceptance and use. For example, if initial promotion efforts are aimed
exclusively at “high-risk” individuals, such as prostitutes, microbicides could
be stigmatized and rejected by other groups.
Reducing
product and distribution costs
Cost should not be a barrier to microbicide use, because
the women who need them most are likely to be too poor to purchase them. Affordability must be considered and
addressed at every step of the process—pre-clinical development, clinical
testing, licensing, management of intellectual property rights, production,
introduction, delivery, and use.
Experience tells us that advances in health care rarely
become widely available in developing countries until more than a decade after
their approval in the United States or Europe. Given that most large-scale
clinical trials of microbicides will need to take place in developing countries
where the largest numbers of people are at the highest risk of infection, the
“trickle down” theory simply won’t work for microbicides.
Global
Advocacy for Microbicides
A global
advocacy plan to accelerate microbicide development:
Strengthen existing
advocacy initiatives
Expand advocacy,
outreach, and resource mobilization in Europe
Elevate the profile of
microbicides among government officials and other political leaders
Build the capacity of
NGOs to undertake microbicide-related activities, especially in the countries
where clinical trials will take place
Recruit new scientists
to the field and elevate the issue’s stature within the scientific community
Use the media to raise
awareness, manage scientific failure, and mobilize political will
Microbicide advocates face
the challenge of having to mobilize interest around something that does not yet
exist. This complicates microbicides advocacy, as compared with treatment
activism which posits that existing life-extending HIV drugs should be made
available to everyone who needs them.
Vaccines and drug treatments
share the advantage of being concepts readily recognized by the public and
policymakers. In contrast, the notion of a vaginal microbicide is an entirely
new conceptual category: in fact, the very word “microbicide” is new to most
vocabularies. Advocacy plays a role in
all phases of microbicide development, from de-mystifying the terminology, to
helping to structure the research agenda, to ensuring that community
perspectives are included in the design of clinical trials, and inevitably, to
convincing those in power that significant increases in financial investment
must be made immediately.
Unlike other areas of
science, where profit motives are sufficient to propel innovation, microbicides
will become a reality only if sufficient political will is galvanized to
stimulate substantial increases in funding.
Scientists tell us that microbicides are feasible, women tell us that
they will use them, and the epidemic shows no signs of abating. The time for microbicides is now.
The
Rockefeller Foundation Microbicide Initiative
In
2000, The Rockefeller Foundation invited key players—international scientists,
research organizations, pharmaceutical industry representatives, United Nations
agencies, advocacy groups, and donors—to come together to find ways to
accelerate microbicide research and development. Expert Working Groups were established to examine the key
elements needed to bring microbicides to market, and they issued five reports:
1.
A
scientific road map for understanding microbicides and accelerating their
development
2.
A
pharmaco-economics study of the potential market size and the expected return
on investment for microbicide products in the long run
3.
An
assessment of the potential public health impact of microbicides and the
millions of infections they could help avert
4.
A
framework to ensure consumer access to the products
5.
A
plan of action for advocacy for microbicide research, development, and
access.
Copies of these papers will be available at:
www.rockfound.org
The microbicide initiative is directed by:
George
Brown, Associate Director—Health Equity,
The Rockefeller Foundation.
Chairs of the working
groups are:
Science:
Chris Elias, PATH;
Pharmaco-Economics:
Paula Cobb,
The Boston
Consulting Group
Public Health:
Charlotte Watts,
The London School of Hygiene and Tropical
Medicine
Access: Elizabeth McGrory,
Population Council, and Geeta Rao Gupta, ICRW–International Center for Research
on Women
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