MoxifloxacinWords
---Chaisson's Changes: Bringing Bayer (and beyond) to TB---
What worked for Grandpa may work for a lot of us, but it won’t work for Richard Chaisson. As principal investigator of CREATE, the Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic, he’s spent the past five years fighting to reduce tuberculosis – killer of 1 person every 15 seconds --throughout the world. But Chaisson’s been fighting a stagnant system. There has been no new tuberculosis medication for 40 years. “People working on TB don’t ever change,” he explained. “They don’t believe in change.”
Yet, change has come. It’s come on the shoulders of giants like the Bill and Melinda Gates Foundation, who funded CREATE in 2004, and, more recently, it’s come from Bayer Pharmaceuticals. The drug manufacturer has agreed to take an unusual step and give its most promising antibiotic –moxifloxacin- to TB patients in developing nations. Ultimately, the driving force behind these efforts, including Bayer’s decision to join in the fight against TB, has been Chaisson himself, the same man who claims that at one point, “tuberculosis was just a hobby.”
Today, Chaisson directs the Johns Hopkins Center for Tuberculosis Research, but his interest in infectious diseases was born in the early 1980s, with HIV. At that time, Chaisson was doing his medical residency at an AIDS clinic in San Francisco. “It was a perfect time to be studying infectious diseases” he said, “ because all of sudden- woah! AIDS just popped up.”
Something else popped up, too. A link between HIV, the newest invader on the immune scene, and TB, an epidemic of ancient proportions. Chaisson observed that many patients had both diseases. “AIDS patients were especially vulnerable to TB since their immune systems had already been compromised by the HIV virus,” he explained. “There was a huge overlap between TB and AIDS, yet research in the area was severely neglected.”
Now, neglect is the last thing that HIV/TB studies suffer, with Chaisson at the helm. Most recently, he persuaded Bayer to permit their best-selling, patented antibiotic to be tested against tuberculosis. Bayer makes about $500 million a year from this drug, moxifloxacin, and would stand to lose a lot of money by establishing a market in poor countries. In fact, when Chaisson first approached Bayer about using moxifloxacin, “they weren’t interested at all,” he said. But that soon changed.
With the formula for moxifloxacin in hand, courtesy of a Physician’s Desk Reference, Chaisson went to the Food and Drug Administration and applied for an IND, or Investigational New Drug application. An IND is required to gain FDA approval when studying new indications of a drug, as Chaisson would be doing by testing “moxi” against TB, versus pneumonia or sinusitis, for example. Bayer got wind of Chaisson’s effort, and changed their tune.
“When Bayer discovered that the studies were going to happen,” he explained, “they decided that they needed to be part of the process. So, they joined forces with those of us studying the drug through the TB Alliance.”
Chaisson explained that while academic researchers would have continued to study the drug with or without Bayer, the Global Alliance would only study the drug if Bayer joined in, so that the drug could be made available at an affordable price if it proved effective. “The Alliance really did something of great value with Bayer's cooperation and support,” he said.
Now, Bayer is actively engaged in the trials, which involve thousands of patients in eight nations, including Brazil, Zambia, Uganda and Spain. They are donating the drug and the placebo, overseeing the toxicity reporting, and will ask the FDA for approval after the studies are done. According to Chaisson, “now that Bayer is part of a partnership with the TB Alliance and others, including our group at Johns Hopkins, it doesn’t have to invest as much or risk as much as it would have otherwise.”
The partnership between Bayer and the TB Alliance was formed on October 18th. The trial will study the potential of moxifloxacin to shorten standard treatment time from 6 months to 4. It’s already been shown to do this in mice. If the antibiotic shortens TB treatment in humans, Bayer will make millions of doses and sell them, at reduced prices, to poor countries.
This effort is well worth it. TB infects one in three people in the world, killing 5,000 people a day. It has emerged as the leading killer of HIV-positive people, too, and many doctors believe that HIV cannot successfully be fought without also fighting tuberculosis. Chaisson’s energy is relentless, and it seems that in targeting TB years ago in San Francisco, he could not have directed it to a more worthwhile pursuit.
.MGW.
What worked for Grandpa may work for a lot of us, but it won’t work for Richard Chaisson. As principal investigator of CREATE, the Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic, he’s spent the past five years fighting to reduce tuberculosis – killer of 1 person every 15 seconds --throughout the world. But Chaisson’s been fighting a stagnant system. There has been no new tuberculosis medication for 40 years. “People working on TB don’t ever change,” he explained. “They don’t believe in change.”
Yet, change has come. It’s come on the shoulders of giants like the Bill and Melinda Gates Foundation, who funded CREATE in 2004, and, more recently, it’s come from Bayer Pharmaceuticals. The drug manufacturer has agreed to take an unusual step and give its most promising antibiotic –moxifloxacin- to TB patients in developing nations. Ultimately, the driving force behind these efforts, including Bayer’s decision to join in the fight against TB, has been Chaisson himself, the same man who claims that at one point, “tuberculosis was just a hobby.”
Today, Chaisson directs the Johns Hopkins Center for Tuberculosis Research, but his interest in infectious diseases was born in the early 1980s, with HIV. At that time, Chaisson was doing his medical residency at an AIDS clinic in San Francisco. “It was a perfect time to be studying infectious diseases” he said, “ because all of sudden- woah! AIDS just popped up.”
Something else popped up, too. A link between HIV, the newest invader on the immune scene, and TB, an epidemic of ancient proportions. Chaisson observed that many patients had both diseases. “AIDS patients were especially vulnerable to TB since their immune systems had already been compromised by the HIV virus,” he explained. “There was a huge overlap between TB and AIDS, yet research in the area was severely neglected.”
Now, neglect is the last thing that HIV/TB studies suffer, with Chaisson at the helm. Most recently, he persuaded Bayer to permit their best-selling, patented antibiotic to be tested against tuberculosis. Bayer makes about $500 million a year from this drug, moxifloxacin, and would stand to lose a lot of money by establishing a market in poor countries. In fact, when Chaisson first approached Bayer about using moxifloxacin, “they weren’t interested at all,” he said. But that soon changed.
With the formula for moxifloxacin in hand, courtesy of a Physician’s Desk Reference, Chaisson went to the Food and Drug Administration and applied for an IND, or Investigational New Drug application. An IND is required to gain FDA approval when studying new indications of a drug, as Chaisson would be doing by testing “moxi” against TB, versus pneumonia or sinusitis, for example. Bayer got wind of Chaisson’s effort, and changed their tune.
“When Bayer discovered that the studies were going to happen,” he explained, “they decided that they needed to be part of the process. So, they joined forces with those of us studying the drug through the TB Alliance.”
Chaisson explained that while academic researchers would have continued to study the drug with or without Bayer, the Global Alliance would only study the drug if Bayer joined in, so that the drug could be made available at an affordable price if it proved effective. “The Alliance really did something of great value with Bayer's cooperation and support,” he said.
Now, Bayer is actively engaged in the trials, which involve thousands of patients in eight nations, including Brazil, Zambia, Uganda and Spain. They are donating the drug and the placebo, overseeing the toxicity reporting, and will ask the FDA for approval after the studies are done. According to Chaisson, “now that Bayer is part of a partnership with the TB Alliance and others, including our group at Johns Hopkins, it doesn’t have to invest as much or risk as much as it would have otherwise.”
The partnership between Bayer and the TB Alliance was formed on October 18th. The trial will study the potential of moxifloxacin to shorten standard treatment time from 6 months to 4. It’s already been shown to do this in mice. If the antibiotic shortens TB treatment in humans, Bayer will make millions of doses and sell them, at reduced prices, to poor countries.
This effort is well worth it. TB infects one in three people in the world, killing 5,000 people a day. It has emerged as the leading killer of HIV-positive people, too, and many doctors believe that HIV cannot successfully be fought without also fighting tuberculosis. Chaisson’s energy is relentless, and it seems that in targeting TB years ago in San Francisco, he could not have directed it to a more worthwhile pursuit.
.MGW.
posted by Meagan G at
5:48 PM
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