TB or Not TB
NIH is among federal agencies that cut research funding following sequestration. The Centers for Disease Control and Prevention (CDC) cut funding 13% to the Tuberculosis Trials Consortium (TBTC), shrinking its budget to $9.2 million following a couple of years of smaller reductions from a peak of $10.6 million. The research group responded by shutting down two of its 20 clinical research sites—one at Duke University, the other in Rio de Janeiro.
Each site has an investigator who relies on TBTC to support between 10% and 20% of salary, as well as one or two study coordinators, 100% of whose salaries are supported by the consortium. When a site closes, they all lose their jobs. The Rio closing was especially troubling since overseas sites are especially counted on to draw heavy patient enrollment in trials, Neil Schluger, M.D., chairman of TBTC’s steering committee, told GEN.
“We do Phase II and Phase III trials. Our trials typically need several hundred patients to enroll. And we’d like to do that as quickly as possible to move our agenda along and answer important questions scientifically, and this just slows down our progress tremendously,” added Dr. Schluger, who is also chief, division of pulmonary, allergy, and critical care medicine at Columbia University Medical Center, where he is also professor of medicine, epidemiology, and environmental health sciences.
TBTC brings together researchers from CDC, domestic and international public health departments, academic medical centers, and selected U.S. Department of Veterans Affairs medical centers, to carry out research concerning the diagnosis, clinical management, and prevention of TB infection and disease.
Delayed by the cuts was a Phase IIb trial looking at high doses of Sanofi’s antibiotic Priftin (rifapentine) in the induction phase of chemotherapy for TB. Based on results of that trial, TBTC plans a Phase III trial assessing a shorter TB treatment regimen of three or four months from the current six months.
The consortium is also still enrolling patients for a study of a new 12-dose regimen for latent TB that could replace the standard 270-dose regimen. “We’re trying to look at the best way to deliver that regimen: Does it have to be by directly through therapy, or can it be delivered by self-administered therapy. That’s a 1,000-person trial that should finish enrolling in another month or so. But all of these things go more slowly when you don’t have enough sites,” Dr. Schluger said.
Younger researchers, he added, see their mentors and other established investigators struggling to get grants renewed and things like that, and wonder how much lower NIH and CDC funding will sink: “They say, ‘Why should I do this? How can anybody live this way? What’s the future in that?’ We really are in the process of losing a generation of people who otherwise might have pursued careers in research.”
And if that happens, the U.S. will lose more than simply leadership in research, but the brainpower needed to tackle the field’s most challenging questions, and as a result, lives that otherwise could have been saved.