- The Washington Times - Thursday, April 24, 2008

ANALYSIS/OPINION:

Tomorrow, World Malaria Day 2008, offers a chance for those of us blessed to live in a nation largely free of entrenched infectious diseases to turn our attention and global health-policy agendas to the people in developing countries who spend each day suffering from these diseases.

Each year, 515 million people contract malaria. As many as 3 million — primarily young children in sub-Saharan Africa — die from it. But the morbidity statistics associated with malaria represent just one segment of the neglected disease spectrum. The overall numbers are even more numbing and difficult to comprehend.

Nearly one out of every six people worldwide is affected by a preventable and treatable disease such as malaria, cholera, tuberculosis, river blindness, dengue fever, or human African trypanosomoiasis (sleeping sickness). That fact translates into 1 billion men, women and children around the world who suffer from neglected diseases. More than a million of them die each year due to this neglect, and for too long they have been invisible casualties. Sadly, despite the fact that one billion people are affected by these diseases, less than one percent of the roughly 1,400 drugs registered between 1975 and 1999 treated these diseases.

In some cases, the treatments and medications for these diseases exist, but the affected populations face barriers to access. In other cases, the clinical knowledge and research capacity may exist for the creation of new therapies and diagnostic tools, but hurdles remain that halt progress on the research and development that must take place to deliver new therapies to those in need. To overcome these impediments, global health leaders must mobilize non-governmental organizations, humanitarian aid groups and public- and private-sector interests to develop innovative policy solutions to bring newer, more effective treatments to patients with neglected diseases.

We’ve taken small but significant steps to begin addressing this tragedy in Congress. Last year, for example, we added an amendment to the Food and Drug Administration Reauthorization Act that awarded a “priority review voucher” to any company that brings to market a treatment for a neglected disease. FDA priority review takes only six months, compared to 18 months under regular review — without altering scientific standards or the quality of evidence required. The condensed window can mean as much as $300 million in savings for the company, in exchange for investment in life-saving treatments that otherwise may not be developed.

But additional outside-the-box policy-making is needed. If we want new therapies when little real commercial market for them exists, public health experts and their private-sector partners should work with health leaders in our government to support and create incentives for the development of these much-needed therapies. Perhaps, much as the 1988 Orphan Drug Act spurred innovation in the orphan drug space, a similarly creative policy could facilitate action on neglected diseases as well. All options should be on the table.

Whatever the incentive’s specifics, we’re in dire need of new ways to leverage the knowledge and resources of public health and biopharmaceutical experts in this field, because we know effective solutions are within our reach. Nongovernmental organizations, humanitarian aid groups, private-sector interests and lawmakers need to join forces to advocate creative but practical solutions that can transcend the current dual obstacles of access and development.

Throughout the developing world, socioeconomic progress is stunted by neglected diseases that blind, debilitate, disfigure and kill too many. They are diseases that rarely grab headlines but permanently thwart human potential. And they are largely invisible and tragically silent, striking the politically voiceless and economically impoverished. With a coordinated effort, we can give them hope for a future unencumbered by neglected disease.

Sen. Sam Brownback is a Kansas Republican.


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