Amid the AIDS Crisis, Advocates Battle Resurgence of Tuberculosis

April 1, 2001

To the Western mind, the word "epidemic" automatically conjures the specter of AIDS. But tuberculosis -- a disease once banished to the time of the Bronte sisters and Thomas Mann's "Magic Mountain" -- threatens to cast an equally dark shadow over modern global health issues.

Nearly eradicated in the 1940s, tuberculosis has roared back at alarming rates around the world in recent years, this time in new, drug-resistant forms and often together with AIDS. This year alone, the World Health Organization expects 8.4 million people to develop the disease and two million to die of it, making tuberculosis the world's leading cause of death from a single infectious disease.

In the quest to develop a new class of affordable tuberculosis treatments, a number of drug makers, health organizations and government agencies formed the Global Alliance for TB Drug Development last year. The Bill and Melinda Gates and Rockefeller foundations tossed in most of the $40 million (45.6 million euros) to get it started. But Global Alliance is no wimpy advocacy group. Its chief executive, Giorgio Roscigno, calls it a public-private partnership, but says it will be run like a pharmaceutical company, overseeing a collection of research efforts and striking business alliances with drug makers.

"We're not 'funding' anything," says Mr. Roscigno, a former international medical director at Aventis SA. "We want to own this project in order to leverage this ownership to provide affordability."

In an effort to circumvent the desperate price wars that loom over efforts to treat AIDS in Africa and other developing nations, Global Alliance will cooperate with private business to research and develop a low-cost TB treatment program.

In an interview with the Wall Street Journal Europe reporter Vanessa Fuhrmans, Mr. Roscigno talks about the resurgence of tuberculosis, the challenge in developing new drugs and the efforts Global Alliance is making to tap market economics and persuade pharmaceutical companies to help develop them.

Q: Why the resurgence in tuberculosis now, when antibiotics seemed to bring the disease under control 50 years ago?

A: Tuberculosis has been controlled mainly in Europe and the United States in the last part of the 20th century because of social improvements, better health conditions and, of course, developments on the antibiotics front. And that has given these countries a false sense of safety. We thought we had things controlled, and so many hospitals were closed, research efforts stopped. But with that sort of neglect combined with the rise of AIDS, we are entering an alarming epidemic situation... . In the new millennium, nearly two billion people -- one-third of the world's population -- are infected with the bacterium that causes TB. Not all of them will develop the disease, but one could estimate that about 100 million to 200 million might develop active TB during their lifetimes.

Q: How has the rise of AIDS contributed to the epidemic?

A: Developing active TB is very much related to the immune system. Once a person develops AIDS, the chances become rampant ... Tuberculosis used to be a typical disease of old age because that's when immune systems tended to weaken, but that was before the HIV-era. That's particularly true in developing countries, where millions of people are co-infected with both AIDS and TB. It's a deadly combination, particularly because of the multidrug-resistant strain of tuberculosis that now exists. And this strain can travel very easily to the U.S. and other developed countries.

Q: What's key in developing a new drug?

A: Time. Among our members it's been reaffirmed that there's not only the urgent need to develop new drugs, but to shorten treatment by at least two months. Because treatment of tuberculosis is so long, about six to nine months, most people in the bush or other remote places have trouble getting to a clinic or hospital every day for that long of time. Any irregularity in treatment might result in new, more resistant strains of TB.

That brings us to our own raison d'etre. If with innovation in genetics and biotechnology we can target new drugs and shorten treatment, then that would result in decreased costs for treatment programs, more availability and the ability to better control the treatment program because it's shorter. The drug we're looking for should be able to shorten TB treatment, be effective against multidrug-resistant TB and improve treatment of latent TB infection.

Q: The Global Alliance plans to research and develop its own TB drug?

A: Research will be done by us and will be outsourced to pharmaceutical companies and scientific institutions. But we're not funding anything. We want to own this project in order to leverage this ownership to provide affordability ... It's a public-private partnership, but we will work as a pharmaceutical company that has an unwavering commitment to the global good. Our modus operandi will be an aggressive industry paradigm. We want to strike cooperations and deals.

Q: Is there a commercial incentive for pharmaceutical companies to develop or help develop new drugs?

A: Well, there hasn't been a new class of TB drugs in the last 25 to 30 years. Why? One reason is because there was a belief that there was no need. The other was a certain neglect by pharmaceutical companies because of their focus on more profitable areas. But this is a market failure -- that pharmaceutical companies never perceived tuberculosis as a potential market is based on incomplete information.

Since we established the Global Alliance we've tried to rectify that gap in perception. We are releasing a pharmaco-economic report in May that analyzes the market for tuberculosis drugs: Where it exists; how much is needed to invest; and what the social and financial returns are. I don't want to pre-empt it, but I can say that one of the preliminary findings is that a new tuberculosis drug that would reduce treatment from six to two months could capture 300 million to 400 million sales per year... . Currently the market is $500 million.

Q: How quickly will research begin?

A: On one level, we are already talking about collaborating with three large research-based pharmaceutical companies to see how we can develop new drugs together. With one, we're interested in what they're already developing; with the other two, it's possibly developing completely new compounds because they have the expertise and the political willingness.

We've also received 103 letters of interests for funding from scientific institutions, public-private research groups and pharmaceutical companies. We've narrowed that down to 21 and will further screen those to pick our first investments. By the second half, we'd like to have in our portfolio at least one project in early discovery, two to three projects in preclinical testing and another two to three in the clinical trials stage.

Q: It sounds as if the structure of Global Alliance was inspired in part by the problems concerning AIDS drugs -- the battle pharmaceutical companies and governments of developing nations are now waging over patent protection and drug costs.

A: There is no direct connection to the model. But I would say that if a similar effort would have been done in the development in AIDS drugs 10 years ago, when the AIDS epidemic in Africa and other developing countries was becoming apparent, we most probably wouldn't face today the dramatic situation we have concerning affordability.