[Ip-health] Nature: Projects set to tackle neglected diseases but they do little to alter the process of drug development.

Judit Rius Judit.Rius at newyork.msf.org
Tue Jan 7 13:36:28 PST 2014


Projects set to tackle neglected diseases
But they do little to alter the process of drug development
Erika Check Hayden
07 January 2014 
Kala-azar, the most deadly parasitic disease after malaria, afflicts 
hundreds of thousands of the world’s poorest people in tropical countries 
such as India, Brazil and Sudan. Spread by sandfly bites, the disease can 
be fought with existing treatments — but these are expensive and 
inconvenient, and sometimes have toxic side effects.
Yet commercial work aimed at finding better drugs for kala-azar has 
largely been abandoned. Pharmaceutical companies say that poor customers 
cannot afford to pay the high prices needed to recoup development costs. 
Critics say that eight proposals, endorsed last month by reviewers for the 
World Health Organization (WHO) to break the stalemate for this and other 
neglected diseases, are noble, but no solution. The measures will do 
little, they say, to solve a broader problem: the disparity in spending on 
research and development for diseases of the rich and those of the poor.
The proposal to combat kala-azar (also known as visceral leishmaniasis, or 
VL) would combine groups already working on drugs for the disease into a 
single organization, the VL Global R&D & Access Initiative. This would 
seek to develop durable oral drugs that do not require cold storage or 
intravenous delivery. The non-profit plan will be considered by the WHO 
executive board at a meeting on 20–25 January at the organization’s 
headquarters in Geneva, Switzerland.
But critics are upset that novel and more risky ideas that would have 
helped to unlink the cost of drug development from prices were eschewed in 
favour of the eight shortlisted proposals, which were seen as more viable 
because they build on existing efforts and focus on specific diseases. 
“The proposals that were brought forward were not as strong as we had 
hoped in identifying alternative pathways to traditional research and 
development through commercial channels,” says Nils Daulaire, assistant 
secretary for global affairs at the US Department of Health and Human 
Services. “That was, frankly, disappointing.”
In response to this criticism, the WHO has asked the backers of the eight 
projects — five of which focus on developing vaccines or medicines for 
specific neglected diseases, one on fever diagnostics and two on basic 
research — to explain this month how they will test methods for funding 
the work. The responses will help the executive board to decide which 
projects to endorse. Then, at a World Health Assembly meeting in Geneva in 
May, countries will be asked to commit funds for the schemes.
The projects are part of an attempt to salvage a decade-long effort to 
create new funding mechanisms for neglected diseases. Despite campaigning 
from advocacy organizations such as the Drugs for Neglected Diseases 
Initiative in Geneva, and hefty donations from groups such as the Bill & 
Melinda Gates Foundation in Seattle, Washington, drug development is still 
disproportionately focused on diseases of the rich, such as heart disease 
and cancer.
Three times in the past decade, countries have failed to sign treaties 
that would commit them to fund drug development for neglected diseases. 
When the latest attempt was quashed in November 2012, diplomats agreed 
instead to back a series of demonstration projects that would test new 
funding mechanisms and be reviewed in 2016.
But critics worry that the eight shortlisted pilot projects are not 
actually testing new ways of funding, and that more innovative ones have 
been shelved. One proposal, rejected last month, would have used two tools 
— milestone payments and patent pools — to spur the development of 
tuberculosis medicines. Milestone payments would reward early-stage 
successes of potential drugs, such as proof of activity in humans. 
Recipients of the payments would then place intellectual property on these 
potential drugs into a patent pool. Drug developers could license these 
patents at low cost and would agree to put further patents back in the 
pool. Another rejected proposal involved taxing antibiotic use to fund the 
development of antimicrobials.
In their deliberations, reviewers were asked to score the projects’ 
public-health impact and scientific merit ahead of their novelty. Some 
neglected-disease advocates say that those priorities should have been 
reversed. Now that the more innovative projects have been dropped, “we’re 
not going to get to the place in two years’ time where we can say how well 
a completely different approach to research and development can work”, 
says Katy Athersuch, an advocate for affordable medicines with the 
non-profit organization Médecins Sans Frontières (also known as Doctors 
Without Borders), based in Geneva.
Paying for the projects in the traditional way — by garnering direct 
support from donor nations — may be difficult enough. A 2012 WHO report 
recommended that all countries spend 0.01% of their annual gross domestic 
product on neglected diseases, which would roughly double spending on 
these illnesses to US$6 billion per year. Only the United States is 
currently doing this, and emerging economies such as China, Brazil and 
India have yet to increase their spending.
If the WHO endorses some of the eight projects later this month, it will 
be a critical time to see if nations step up to pay for them, says 
John-Arne Roettingen, a global-health researcher at Harvard School of 
Public Health in Boston, Massachusetts. He says: “This will be the first 
test of whether countries are willing to put their money on the table.”

Judit Rius Sanjuan
U.S. Manager of the Access Campaign
Medecins Sans Frontieres/ Doctors Without Borders (MSF)
333 7th Avenue, 2nd Floor
New York, NY 10001 USA
Office: +1 212 655 3762 // Mobile: +1 917 331 9077
Email: judit.rius at newyork.msf.org // Twitter: juditrius

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