What
do schistosomiasis, cysticercosis, and lymphatic filariasis have in common?
Besides verging on the unpronounceable, they
are all classified as neglected tropical diseases (NTDs). NTDs are a set of
diseases – seventeen, by the World Health Organization’s count – that
collectively affect over a billion people, but have historically received
little attention. The most common NTDs, including those listed above, are
caused by parasitic worms or protozoa. Others, such as leprosy and trachoma,
are the result of bacterial or viral infections.
Though caused by a range of pathogens, NTDs
share some important characteristics. First, many are diseases of rural
poverty. Most neglected diseases affect the poor in the developing world,
particularly in Africa and Asia, but some have also been found in “pockets of
poverty” in the United States. For instance, hundreds of thousands of
Americans, most of whom are Hispanic immigrants, suffer from Chagas disease.
Second, most NTDs cause bodily impairment and disability (i.e., they have high
morbidity) but are not very lethal (i.e., they have low mortality). Some result
in blindness, others in unseemly swelling, and still others in impaired
cognitive development. Most patients do not die, but the morbidity often
hinders wage-earning capacity, thereby creating a vicious cycle of poverty.
These and other characteristics have
unfortunately led to neglected tropical diseases being, well, a bit neglected.
Since most policymakers live in urban centers, geographically separated from
the rural areas with high NTD prevalence, there has traditionally been limited
awareness of NTDs. Similarly, because NTDs cause more disability than death,
they have historically flown under the radar of many public health efforts.
Perhaps most importantly, the populations NTDs disproportionately affect have
little money to spend on medicine, resulting in what Peter Hotez, President of
the Sabin Vaccine Institute, calls “the business plan from hell.”
How can we change this status quo? What needs
to happen for the pharmaceutical industry, academic researchers, and other key
players begin investing more seriously in diseases that debilitate over a
billion people?
To some extent, the status quo has already
begun to change. It has not yet changed nearly enough, and there is ample room
for the pharmaceutical industry to invest more in NTDs, but it is important to
acknowledge how far the fight against neglected diseases has come.
The term “neglected tropical diseases” was
only coined in 2005; before that, each unpronounceable disease fought its own
uphill battle with limited success. WHO Director-General Margaret Chan
explained in 2007 the benefits of having a catch-all term: “When these diseases
are viewed together, we gain critical mass. We get a better grip on the scale
of the economic and social consequences as well as the health burdens.
Arguments for giving these diseases higher priority become more powerful, more
persuasive.”
Since the term was coined, there has been
considerable activity in the neglected disease space from governments, donors,
pharmaceutical companies, and nonprofits alike. The US government, the UK
government, and the Bill & Melinda Gates Foundation have collectively
pledged or spent over $200 million on NTD prevention and treatment by 2013.
Pharmaceutical companies have donated billions of doses of drugs to various NTD
control programs. Some, such as GSK and Merck, have also entered “patent pools”
to allow cross-licensing of NTD innovations. The Global Network for Neglected
Tropical Diseases has engaged in NTD advocacy and on-the-ground coordination
efforts. They also run a frequently updated blog, End the Neglect, that
discusses NTD news and reminds readers that “just 50 cents” will provide a
year’s worth of treatment against several NTDs.
There has also been a marked increase in NTD
product development. The nonprofit pharmaceutical company OneWorld Health,
which is partly funded through the Gates Foundation, conducts R&D for drugs
against kala-azar (visceral leishmaniasis) and hookworm. It also ties up with
for-profit pharmaceutical companies, such as Sanofi-Aventis and Anacor, to
develop and manufacture some of their medicines. “Pharmaceutical companies have
become more interested in NTDs than they were five to ten years ago,” said
Richard Chin, CEO of OneWorld Health. “They would have sent us to their PR
department before, but now they send us to their research department.”
Chin noted how their for-profit partners have
invested significant time and money into the partnerships: they put their
scientists on NTD projects at their expense and allowed OneWorld Health to
manufacture drugs in their facilities. Many other product development partnerships
(PDPs) for NTDs, such as PATH and the Sabin Vaccine Institute, seem to function
along similar lines.
These developments are impressive, especially
given the short time frame, but there is still a long way to go. This is
perhaps most evident in the product development space. Hotez believes the
pharmaceutical industry is “generally doing very well” in donating drugs,
manufacturing space, and time to NTDs, but says most have invested relatively
little in developing NTD drugs and vaccines themselves. Direct pharmaceutical
investment has greatly helped the fight against the “big three diseases” (that
is, HIV/AIDS, tuberculosis, and malaria): most recently, GSK invested in a
malaria vaccine that is in final rounds of a large-scale clinical trial.
Similarly, pharmaceutical companies can invest in drugs and vaccines that spur
improvements in NTD morbidity rates.
Given how NTDs are primarily diseases of
poverty, Hotez acknowledged that to an extent, getting pharmaceutical companies
to directly invest in them may be akin to “getting a square peg in a round
hole.” Even so, there are opportunities for the pharmaceutical industry to get
more directly involved.
In this regard, Hotez cited the existence of
new “pull mechanisms” intended to create incentives for private sector
involvement in diseases of poverty. Unfortunately, for a variety of reasons,
they have not yet worked in the NTD world. Priority review vouchers, which
entitle companies that invest in neglected diseases to FDA priority review for
another product, have not yet encouraged pharmaceutical companies to more
deeply invest in NTDs. Similarly, advance market commitments, or binding
contracts that guarantee viable markets for drugs, have not yet been used for
NTDs.
Donor-funded PDPs will continue conducting
vital research to end the disease burden of several common NTDs, with donations
from pharmaceutical companies. In the meantime, said Chin, “The expectations
for pharmaceutical companies seem to be broadening. People today are demanding
more from companies.” Hopefully these raised expectations, together with the
above-mentioned pull mechanisms, can soon compel pharmaceutical companies to
directly develop drugs and vaccines for the world’s poorest billion.
Sarika Bansal
Forbes
Business & Investment Opportunities
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