By Christie Nicholson
Article published in The Columbia Journalist on March 7, 2006.
Despite the fact that tuberculosis takes one life every 15 seconds, its significance remains largely unknown and unrecognized. Experts agree it’s time to focus on developing new medications to replace the 40-year-old antibiotics.
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It was nearly eradicated over 40 years ago, but in recent years tuberculosis has made a shocking comeback. One third of the world’s population is infected with TB. In 2003 there were nearly 9 million new cases and 2 million deaths.
“TB is a latent bomb for the world that will impact all of us,” said Jeffrey Sachs, director of the United Nations Millenium Project. “And to have such dramatic gaps in treatment and funds between TB and AIDS is amazing.”
Despite the fact that TB takes one life every 15 seconds, its significance remains largely unknown and unrecognized. Experts agree it’s time to focus on developing new medications to replace the 40-year-old antibiotics.
The treatment regimen that nearly wiped out TB in the late 1960s now has created drug-resistant strains of the bacteria. Drug-resistant TB is one of the primary causes for the recent explosion of the disease in the developing world.
Every day, for six months, victims must take a cocktail of several antibiotics, rifampacin, isoniazid, pyrazinamide and ethambutol. Typically they feel better within the first two weeks, and so they stop taking their medication. The interruption leads to drug resistant TB that is more difficult to treat, if at all.
But the Global Alliance for TB Drug Development has started using a new strategy of private-public partnerships to get new medications into the pipeline. Public-private partnerships marry the large pharmaceutical company resources with the good will motivation of non-profit organizations.
“We have three goals to reach by 2010,” said Dr. Maria Freire, president and CEO of TB Alliance, today at a symposium called “Reversing the Tide: The End of Tuberculosis.” “To extend the pipeline of drugs, to streamline the development, and to get new drugs into the field.”
But according to a paper released in Science just this week, the public-private partnership may not be the best model for ridding the world of TB. Dr. Kevin Schulman, Professor of Medicine and Business Administration at Duke University, who led the study, says the TB Alliance will be unsuccessful.
His team replicated a pharmaceutical pipeline model for the drugs that TB Alliance intends to take through clinical trials, and found that there is less than a 5-percent chance of placing a new drug in the field by 2010. He said they will need to extend the timeline through to 2019 – and even then, there is only a 73 percent chance of success.
TB Alliance says that its recent partnership with Bayer Healthcare AG will take an already existing drug, moxifloxacin, through new clinical trials to treat TB. If the trials are successful, Bayer has promised to make it affordable in the most affected areas in Asia and Africa. The TB Alliance plans to cover the costs of the trials. The hope is that moxifloxacin will cut the treatment regimen from six months to two months, significantly decreasing the death rate as well as the occurrence of drug-resistant TB.
“The Bayer drug was not included in Schulman’s study,” said Gwynne Oosterbaan, assistant director of public affairs for the TB Alliance. “This is the most significant clinical trial for a TB drug in the last half century.”
Schulman said it would be great if moxifloxacin is approved within four years, but it is a drug that is already on the market. His study is still valid because it looks at the development of new drugs, he said.
“We did the study to make sure that this new public-private structure can be held accountable,” Schulman said in a telephone interview. “If we are going to use this strategy as a vehicle to new molecules, then we need to have realistic expectations for public health needs.”
The study estimated that the cost to bring new treatments to market could be over $400 million. But raising those funds may not pose a huge threat. The Bill & Melinda Gates Foundation plans to give $900 million for TB eradication over the next 10 years. And today Freire received a $14 million grant from three countries: England, Ireland and the Netherlands.
“There are no more woulds, coulds, or maybes,” said Freire. “Real progress is being made.”