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Double-Edged TB Drug

A cheap pain reliever that can kill drug-resistant, tuberculosis-causing bacteria may never be tested.

By | September 12, 2012

image: Double-Edged TB Drug Scanning electron micrograph of Mycobacterium tuberculosis bacteria, which causes tuberculosisWikimedia Commons, NIAID

An inexpensive, over-the-counter pain reliever can kill the bacteria that cause tuberculosis (TB)—even the drug-resistant varieties—according to a new study published online in the Proceedings of the National Academy of Science this week (September 10), yet it’s not a promising candidate for drug trials.

Researchers at the Weill Cornell Medical College designed a screen to find drugs that target dormant TB bacteria—triggered by certain lung conditions, dormancy is a key strategy Mycobacterium tuberculosis uses to evade drugs and cause lethal infections in nearly 1.5 billion people per year. The researchers found that the anti-inflammatory drug oxyphenbutazone, developed to treat arthritis in the 1970s, is activated in lung conditions that induce dormancy, and can kill dormant, active, and even resistant bacteria.

But the researchers are skeptical the drug will ever be given to a TB patient. “It is difficult today to launch clinical studies on a medication that is so outdated in the United States,” Weill microbiology professor and the senior author Carl Nathan said in a press release. “No drug firm will pay for clinical trials if they don't expect to make a profit on the agent. And that would be the case for an off-patent drug that people can buy over the counter for pain in most of the world.”

Another hurdle for the drug is that it can’t be tested in mouse models because the animals metabolize the drug to an inactive form faster than humans do—too fast to treat TB infection.

“This makes testing the drug for TB use in humans problematic since the FDA requires preclinical animal testing studies for safety and efficacy,” Nathan said in the release. "Yet there is a long track record of oxyphenbutazone's relatively safe use in hundreds of thousands of people over decades."

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Comments

Avatar of: Melanie

Melanie

Posts: 1

September 12, 2012

I think we can't be as selfish and said that we can't used it, cause if it really kill the Mycobacterium, we can safe lots of lives, here in my country is one of the most letal disease, and also in Africa. So why don't do more research on it!

Can you send me more information please, my mail is melani_zapata08@hotmail.com

September 13, 2012

If oxyphenbutazone has been in use since the 1970s, the safety profile, contraindications, and drug interactions are better known than drugs involving a NDA. It seems ludicrous for an agency to require any pre-clinical testing (and likely that European regulators that work on a science-based model would agree), As a medical device professional , I know that the system can be very inflexible and protecting public safety is a very important and difficult job. In this case, there is a huge public safety benefit (with low risk) to rapidly producing a protocol for efficacy and dose response studies in the major TB treatment centers with NIH funding. Especially with a drug that has such a long history, you are starting near the end of the race course and physicians are going to be monitoring TB patients closely anyway. Recent articles have said TB is on the rise again. No brainer.

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