Incentives rise for TB drugs

Infected man spurs debate over payoff for new medicines

June 24, 2007|By Tricia Bishop | Tricia Bishop,Sun reporter

Tuberculosis has been flying under the American radar for decades now, as it has lost its status as a top killer in the U.S. and a particular problem in Baltimore. But when an infected Atlanta man launched a public health panic last month, it raised the deadly disease's profile anew.

There were about 14,000 TB cases in the country in 2005. But worldwide, particularly in the poorest regions of sub-Saharan Africa, there are 14 million people living with the deadly disease, which kills 2 million of them annually and is estimated to cost developing countries $12 billion a year. And it's morphing into new, drug-resistant forms, causing increasing concern among medical professionals.

Even so, no new TB drugs have been introduced in 30 years, in large part, some say, because pharmaceutical companies haven't seen blockbuster commercial potential.

The renewed attention to the disease, given the Atlanta case, is fueling a debate among some pharmaceutical companies and nonprofit advocates about how much money there is in treating TB and whether discussion about its limited potential is stifling drug development.

Diseases such as malaria and TB are relatively rare in the United States and other developed countries, but prevalent in poor parts of the world. That has led nonprofit foundations to step forward to fill in the gaps. The TB Alliance, for example, was created in 2000 and is considered a leader in the resurgence of research and development of TB drugs.

But Carol Nacy, chief executive of Rockville's Sequella Inc., believes TB drug development has been neglected because too many people assume that treating it is not a big moneymaker. Her company is one of a handful of drugmakers working to develop therapeutics for TB less because new treatments are needed and more because they say it's good for business.

"Is it a Viagra market? Probably not," she acknowledges. "Nobody wants to make a billion with TB, but you can make a reasonable return on your investment."

Nacy and some others -- industry analysts and other business professionals -- counter the claims of organizations like the TB Alliance over the monetary value of developing tuberculosis treatments.

They say there's an unrecognized market potential of between $350 million and $7 billion for each new drug. And until that's acknowledged, they argue, new cures won't reach the market because businesses won't develop them, new biotechs (like Nacy's) won't get funded by investors, and millions of people around the world will continue to die from a simple bacterium.

The TB Alliance, however, identifies only a fragmented market of about $315 million. That situation has helped it raise $200 million in donations for its work, the main goal of which is spurring new treatments. If the organization didn't exist, the TB Alliance said, few would be working in the space.

"There's never been the perception of a commercially viable marketplace that would induce companies to invest in research and development," said Al Hinman, a former CNN medical correspondent who now acts as a spokesman for the TB Alliance. Still, he recognized the need for company participation: They're the ones who find the new potential drug candidates.

Tuberculosis, which destroys body tissue, particularly in the lungs, was once a focus of the drug industry -- about 60 years ago when it was among the deadliest diseases in the United States and there wasn't a cure. But as antibiotic treatments were developed, its local prevalence fell, along with its place as a business booster.

Baltimore has actually led the country in TB control during the past 30 years, with rates falling from 50 cases per 100,000 people in the late 1970s to fewer than 10 cases per 100,000 today.

That would all be just fine if the current drugs were working well, but they're not.

"[They] were developed more than 40 years ago and are not working globally," Dr. Richard E. Chaisson, a Johns Hopkins University School of Medicine professor and director of the JH Center for Tuberculosis Research, wrote in an e-mail interview.

Today's standard treatment, though effective, requires taking a cumbersome and months-long combination of four antibiotics. It's a feat many patients never achieve simply because of the inconvenience, which means that the disease not only lives on, but has become stronger.

About 20 percent of all new TB cases are considered MDR, or "multidrug resistant," rendering standard therapy useless. Ten percent of those -- including Andrew Speaker's case -- are XDR, as in extensively drug resistant.

Speaker is the Atlanta lawyer who hopped a plane to Europe for his honeymoon last month, launching health officials into a public panic over potential spreading of the disease.

Speaker is now being treated in the United State, and he is expected to have surgery to remove an infected area about the size of a tennis ball from one of his lungs.

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