Few diseases need new medicines as much as tuberculosis, with most patients diagnosed by a method more than a century old and treated with drugs more than 40 years old. Yet global investment in new tools declined last year, a new report found.
While the dropin funding wasn’t huge, it comes at a time of a worsening epidemic of drug-resistant TB, which public-health authorities say can’t be confronted effectively without new tools.
Funding for research and development of new drugs, vaccines and rapid diagnostic methods for the infectious airborne disease declined 4.6% in 2012 to $627.4 million after rising annually every year from 2005 to 2011, said the Treatment Action Group, a New York-based AIDS research and policy think tank that also focuses on TB issues.
Most of last year’s cuts came from private-sector donors, the group said, warning that reductions are likely this year as well, because major public-sector donors such as the U.S. government have been hit with budget cuts and across-the-board spending reductions called sequestration.
“It’s a pretty grim landscape,” said Mark Harrington, TAG’s executive director. “We’re worried last year’s trend will accelerate.”
The first major new TB drug in more than 40 years was approved for use in the U.S. late last year, but its debut has been slow. Only a handful of people have gotten the drug in the U.S., with 15 24-week courses of bedaquiline shipped for drug-resistant TB, according to its maker, a unit of Johnson & Johnson. It is still awaiting regulatory approval outside the U.S., where most of the world’s estimated 450,000 annual cases of drug-resistant TB occur.
A second drug, delamanid, made by Otsuka Pharmaceutical Co., failed to get the green light from a European Union committee in July; the company is appealing. And while a new rapid diagnostic test has helped to pinpoint cases of drug-resistant TB around the world more quickly, TB experts say they need a test that doctors can use to diagnose patients in the examination room and begin treatment right away. Currently, most cases are diagnosed via the longtime sputum smear microscopy method.
More drugs are in clinical trials, but the funding declines slow research, said Mel Spigelman, president and chief executive officer of the TB Alliance, a nonprofit organization that develops new TB drugs.
The decline in investment for R&D is part of an uncertain picture overall for funding against TB, which killed an estimated 1.3 million people in 2012, but draws far less overall investment than HIV/AIDS, which was linked to the deaths of 1.6 million people that year. A group of health experts urged President Barack Obama in an Oct. 22 letter to propose an increase in his fiscal 2015 budget for TB programs at the U.S. Agency for International Development, a major provider of TB technical assistance. His fiscal 2014 budget proposed a 19% cut to $191 million.
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Other countries have trimmed their TB budgets or plans. India, which has the largest number of TB patients in the world but also faces a large budget deficit, spent only $91 million in the first year of a planned five-year, $1.05 billion spending program that began in 2012. Meanwhile, the world’s largest international funder of TB programs, the Global Fund to Fight AIDS, Tuberculosis and Malaria, won’t know exactly how much it has to spend on the disease until after a replenishment conference in December.
The largest global funder of TB R&D, the National Institute of Allergy and Infectious Diseases, increased its budget 7.3% in 2012 to $169.1 million, but now, “if we have a continuation of sequestration I doubt very seriously it will be increased,” Director Anthony Fauci said. Sequestration also cut the budget this year of a consortium that studies new drug regimens and is funded by the Centers for Disease Control and Prevention.
Among the companies and organizations that cut 2012 spending on TB R&D were Otsuka, the third-largest funder, with a $5 million reduction; Pfizer Inc., PFE +0.42% down $6.4 million; and AstraZeneca AZN.LN +0.33% PLC, down $2.9 million. Another company that TAG said provided its financials confidentially cut back by $8.3 million. Investment from the Bill & Melinda Gates Foundation, the second-largest funder, fell less than 1% to $111.6 million; a spokesman said that was due to fluctuations in grant cycles.
An Otsuka spokesman, Marc Destito, called the Japanese company’s 2012 spending reduction a “blip” and not a sign of waning interest in TB, representing an “interim period” between clinical trials of its TB drug, delamanid. The reduction to $60.1 million may also reflect currency fluctuations with the yen, he said. “Our commitment is steadfast when it comes to TB R&D,” he said.
Pfizer has licensed its TB drug candidate to a closely held company, Sequella, and is focusing its R&D on vaccines, a spokesman said. “Our R&D focus in infectious diseases has shifted from treatment to prevention,” the spokesman said.
AstraZeneca which the TAG report said spent $10.3 million in 2012, is pressing ahead with a TB drug candidate called AZD5847, with a Phase II trial launched late last year. “AZD5847 is part of our commitment to conduct research and collaborate across industry, academia and government to develop novel treatments for TB and help stop the spread of the disease,” said the spokeswoman. She said that year-to-year fluctuations in drug investments can occur, depending on the state of a particular trial.
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