Jill Wechsler
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During the past few years, it has become good business and good politics for pharmaceutical companies to invest in the research
and development (R&D) of drugs and vaccines to treat a host of deadly diseases plaguing the poorer nations of the world. The
Bill and Melinda Gates Foundation deserves much credit for putting this important issue at the top of the agenda for donor
nations, nonprofit organizations, and pharmaceutical manufacturers. The spread of the AIDS epidemic around the world and the
looming pandemic flu crisis have brought home the threat of health problems in distant continents, prompting wealthy governments
to focus more on global biomedical research and treatment programs.
The challenges for pharmaceutical manufacturers are considerable. The industry's high profits and research successes boost
pressure to devote more corporate resources to third-world medical needs. But, such initiatives often require new skills and
knowledge and need different procedures for conducting research. Despite much public attention, the level of support from
national governments remains fairly meager and uncertain.
In the past, pharmaceutical companies often gave away available drugs for third-world diseases, but this has not encouraged
investment in research on needed treatments that have little market value in industrial states. A more recent strategy has
been to establish artificial commercial markets. US and European governments have offered tax breaks and patent extensions
to push R&D. They also have provided advance purchase commitments (APCs) to "pull" new products to market. But, analysts now
consider these tactics only minimally effective because they often yield treatments with low value for patients in poor countries.
Some products still are too expensive for widespread purchase and have dosing and distribution requirements that undermine
access and compliance.
New landscape
Promoting global drug quality oversight
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Although governments and international agencies continue to back the push–pull drug development model, there is growing support
for new partnership arrangements that aim to speed drug research by reducing the risk for pharmaceutical companies. This approach
has altered the landscape for developing new drugs to treat neglected diseases, according to an important study by a research
group at the London School of Economics headed by Mary Moran, MD. Published in September 2005 by the Wellcome Trust, the report
documents how public–private partnerships (PPPs) during the past five years have spurred R&D on new treatments for third-world
health conditions such as malaria, tuberculosis (TB), leprosy, leishmaniais, schistosomiasis, dengue fever, and others.*
Although pharmaceutical companies developed only a handful of new drugs to treat neglected diseases in the previous 25 years,
Moran finds that from 2000 to 2004, partnerships involving large and small companies and nonprofit organizations launched
63 research projects that should translate into nine or 10 new drugs by 2010. This investment has occurred largely outside
normal government health funding programs and has been supported substantially by Gates, the Rockefeller Foundation, and other
private donors.
In the 1990s, multinational pharmaceutical companies closed down neglected disease research, according to Moran. Now, they
are joining PPPs such as Medicines for Malaria Venture, the TB Alliance, Drugs for Neglected Diseases, and the Institute for
OneWorld Health (iOWH) and investing their own resources in this area to address objectives such as:
- reaching major emerging markets in India and China and gaining access to highly skilled researchers through partnerships with
local pharmaceutical companies;
- deflecting criticism over industry's failure to address the global HIV–AIDS pandemic as well as life-threatening diseases
not found in Western nations;
- eventually developing spin-off products with commercial value in Western markets.
In addition, a growing number of niche biotechnology companies regard small infectious disease markets similarly to orphan
drug development. R&D partnerships provide the means for many small companies to parlay expertise in genomics, bioinformatics,
and other innovative technologies into new development programs and also to license out intellectual property to larger partners.
