Tuberculosis, one of the world's biggest killers, is spreading globally and gaining in virulence as some strains are learning to evolve into almost bullet-proof bugs dubbed "XDR-TB.
The X stands for "extreme" and often translates into an incurable, deadly disease.
"We desperately need better and faster-acting drugs for TB," said Dr. Peter Small, head of the tuberculosis program at the Seattle-based Bill & Melinda Gates Foundation.
To assist in this increasingly desperate endeavor, the Seattle philanthropy today announced that it has given $104 million to a non-profit, international organization called the Global Alliance for TB Drug Development (or, more commonly, the TB Alliance).
"When we formed about five years ago, there was not a single TB drug in the (research and development) pipeline," said Maria Freire, president of the TB Alliance. The organization has offices in New York, Brussels and Cape Town, South Africa.
Today, partly due to the first $25 million the Gates Foundation donated in February 2000 to help launch the initiative, Freire said the group and its partners have two new TB drugs in clinical trials and nine other candidate drugs under development.
The new Gates grant, she said, will help bring one of the new antibiotic drugs called moxifloxacin through phase 2 studies and into the large-scale phase 3 clinical tests needed before it can be widely distributed. Made by Bayer Healthcare, this antibiotic could significantly reduce the treatment time required to cure patients, experts believe.
"One of the key problems with the treatment is simply the length of time it takes to work," said Dr. Jaime Bayona, director of Socios en Salud (Partners in Health), a TB-focused program in Peru affiliated with Harvard University and the world-renowned health advocate Dr. Paul Farmer.
"These drugs (in use today) are over 40 years old," said Bayona. A routine TB case, he noted, typically requires an infected person to swallow nearly a dozen pills a day for six to nine months.
People often fail to complete this onerous regimen as they begin to recover, Bayona said, which can then spawn in the infected person a newly drug-resistant strain of TB -- a strain that can take years to cure, if it doesn't kill first.
Astonishingly, tuberculosis today infects one out of every three people in the world. It emerges as an active and stubborn bacterial infection in perhaps 10 million people per year, killing at least two million -- or one person every 15 seconds.
The World Health Organization has estimated that more than 400,000 cases of multi-drug resistant TB occur every year. A recent survey of labs worldwide by the WHO and U.S. Centers for Disease Control found evidence of some 50,000 XDR-TB cases.
But as Freire's organization has noted, fewer than half of all TB infections are ever diagnosed and perhaps 60 percent are now cured.
"XDR-TB has emerged worldwide as a threat to public health and TB control, raising concerns of a future epidemic of virtually untreatable TB," the CDC said in its March 2006 report on the spread of extreme drug-resistant TB.
This growing global health threat has been long in the making, added Small, because TB is largely a disease of poor people in poor countries. The drug industry has had little incentive to invest in developing new drugs for people who can't buy them, he said, so the biomedical research community also showed little interest.
"It was a vicious cycle ... outrageous, really," Small said. With the creation of the TB Alliance and its significant progress in finding promising drug candidates, he said "there's renewed optimism."
But both Small and Freire said it would take much more than $104 million from the Gates Foundation to beat the global resurgence of TB. Billions of dollars will be required to ultimately bring new drugs to market and get them distributed to the millions who need them.
Drug industry partners such as Bayer and GlaxoSmithKline, Freire said, have committed to making the drugs affordable in poor countries. Support for the effort is growing, she said, noting the TB Alliance also gets support from the Rockefeller Foundation as well as the aid agencies representing the Netherlands, Britain, Ireland and the United States.
At the last World Economic Forum, Bill Gates pledged to give $900 million to develop new drugs, new diagnostics and a new vaccine to fight TB.
"It's time for the whole world to contribute," said Dr. Marcos Espinal, executive secretary of the Geneva-based Stop TB Partnership, an umbrella organization coordinating many of the efforts to battle the age-old bacterial disease.