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. Incentive Plan Targets Neglected Diseases

Diseased cells.
by Christine Dell'amore
UPI Consumer Health Correspondent
Washington (UPI) Mar 09, 2006
In a new plan unveiled by economists Tuesday, drug companies would have a ripe incentive -- to the tune of a voucher worth more than $300 million -- to fight neglected diseases in the developing world.

In exchange for creating new and superior treatments for neglected diseases -- such as leichmaniasis or dengue fever -- companies will get a voucher that allows them to route another, potentially blockbuster drug through an accelerated process at the U.S. Food and Drug Administration.

"There is tremendous suffering from neglected diseases. We're trying to turn attention to the greater need for research and development," David Ridley, an economist and professor at Duke University in Durham, N.C., told United Press International.

Ridley announced the neglected-disease plan at a news conference on global health policy at the National Press Club in Washington. He and colleagues also detailed the voucher plan in the March/April issue of the journal Health Affairs.

Neglected diseases, mostly infectious and parasitic diseases, mainly target the poor. Often debilitating, they accounted for more than 50 percent of healthy years lost in Africa in 2002, based on a metric that measures a person's loss of healthy life due to illness. These diseases accounted for only 3 percent of healthy years lost in developed countries.

For instance, leichmaniasis, a parasitic disease spread by sand flies, affects 1.5 million people worldwide every year, manifesting itself in painful lesions that eat away at the nose and mouth.

Scientists know enough about diseases to combat them medicinally, but few drugs have emerged. That's because companies perceive no profit in fighting illnesses of the poor. If drug companies invest in a drug primarily for the poverty-stricken, for example, they can't recoup their costs in producing it, Ridley said.

In Ridley's plan, a blockbuster drug selected by a company would go through the FDA's priority review, which speeds up the usual yearlong process to an intense six months. An accelerated review at the FDA is valued at more than $300 million, although the drug company will have to pay the FDA $1 million as a user fee. The user fee allows the FDA not to slow other drugs in the queue. Blockbuster drugs that went through the priority review in the past include Viagra and Lipitor.

To receive the voucher, companies must meet certain criteria, such as choosing a treatment for a neglected disease that is superior to existing treatments, forgoing patent rights and finding at least one manufacturer for the product.

But the details of the voucher plan beyond the manufacture stage were vague; Ridley offered no concrete details about disseminating the drug to people in the developing world.

Although it's important to stress innovation in tackling neglected diseases, many of the strategies are overly simplistic, Peter Hotez, a parasitologist and the chair of the Department of Microbiology, Immunology and Tropical Medicine at George Washington University Medical Center, told UPI.

"It's not just drug development; it's also creating a mechanism for global access," said Hotez, who is currently heading the development of a new vaccine for hookworm, a neglected disease.

Hotez cited the example of the Hepatitis B vaccine, which took decades between development and actual dispersion into communities.

"There are no simple answers. The best strategy we have is to foster public-private partnerships, and ensure what the (Bill and Melinda) Gates Foundation calls 'global access' -- not just making the drug but making sure it's used," Hotez said.

Many at the news conference also voiced concern that the FDA may relax safety standards if they try to analyze drugs too quickly. Ridley responded that the FDA puts drugs through the same vigorous testing in the six-month process.

Others praised Ridley's idea as a novel approach.

Owen Barder, senior program associate at the Center of Global Development, remarked that global health professionals are leading the field in sophisticated policy to help the poor.

"Embracing markets as a way to solve problems is an important feature of how the global health community tackles problems. There are lessons here for how to solve other problems," Barder said.

To put the plan in motion, Ridley needs a legislative vehicle. Although he has no timeline yet, Ridley said he hopes to garner support from members of Congress after the midterm elections.

Overall, the voucher program could be ideal for a company that has an innovative idea but until now could not get anyone to finance it, Ridley said. "This is a win-win situation," he added.

Source: United Press International

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