Tag Archives: clinical trials

Tackling tuberculosis

5 Aug

Global health has been on my mind again recently. An article I wrote for Nature Reviews Drug Discovery (subscription required) examines efforts to find new drugs for tuberculosis.

Scanning electron micrograh of TB bacterium/ image: CDC/Dr. Ray Butler, credit: Janice Haney Carr

Scanning electron micrograph of TB bacterium/ image: CDC/Dr. Ray Butler, credit: Janice Haney Carr

TB is a wily organism that finds a way to wall itself off in the body. Under the best circumstances, knocking out “the best” TB, the drug susceptible variety, requires 6 to 9 months of antibiotics. That’s a long time to stay on drugs, particularly in a developing country where the health clinic could be miles away. But if people start treatment without completing it, drug resistant disease can develop. With multi-drug resistant (MDR) or extensively drug resistant (XDR) disease, that prognosis is far more uncertain. The treatments being given in these cases don’t have much scientific validation to show that they work. In some cases of XDR TB, doctors are cutting out portions of diseased lung tissue from patients because there’s not much else that they can do.

My article mostly talks about the drug discovery challenges: how do you find a new drug for an old disease particularly when half a century ago we thought this problem was solved. But there’s another piece of this story that didn’t make it into the article: how do you then do the clinical studies to test these drugs among the people who need these drugs most?

In countries where health care systems are already taxed and where doctors and nurses may not be trained to carry out clinical trial protocols, there’s an additional wrinkle. TB treatments– somewhat uniquely– are written into health care policy in countries around the world. Almost all other diseases  have recommended treatments, but the final decision belongs with the medical professionals who see the patients. What does that mean for TB clinical trials? Many more layers of red tape to set up a clinical trial. Not only do researchers have to work out trial protocols with the hospitals, they also have to get approvals from local and national authorities to modify the existing TB treatment protocols. I was amazed at the amount of coordination that’s involved.

Learn more about the search for new TB treatments at the Global Alliance for TB Drug Development.

Data and writing– unpublished or unpublishable?

17 Jun

Scientists, writers and even science writers share a common plight: there’s always a subset of their work that lies fallow, tucked in a notebook, lingering on a hard drive. The question remains whether that work should remain on a dusty shelf, or whether it actually belongs among “the published.”

When I was in graduate school, I worked with a graduate student from Korea, who generated gobs of data, much of it that wasn’t leading to clear conclusions. He threatened to start his own scientific journal, The Journal of Unpublishable Data. We all chuckled and commiserated.

I believe in generating quality work, whether now as a writer, or in my past as a scientist. We all want oohs and aahs rather than questions and nit-picking. But here’s the flip side: talking about our struggles and our foibles often helps us get to the elusive goal that we’re trying to reach. If you put too much out there, you risk being criticized or scooped. Hold too much in, and you might be missing the opportunity to grow.

As a scientist, I remember particularly sticky situations in my graduate work where others had done similar chemistry, and as it turned out, I spent months trying to do something that someone else out there probably could have told me wasn’t possible. But to the victor go the spoils, failed experiments typically lie secret in notebooks somewhere unless you somehow run into the person who attempted it and who can say, sagely, “Nope, that’s never going to work. And this is why.”

A couple of weeks ago, I covered a meeting that included a first for me, a senior researcher who gave a keynote talk about a herculean research effort in search of a drug target. It was an extremely difficult problem, but the net result? They failed, but they learned a lot. I wish more published science talked about the lessons learned in those types of situations. I think all sciences could benefit from a rethink of what’s considered “publishable.” One of the biggest problems with medical evidence right now is the fact that the results of failed clinical trials often never see the light of day. Such results may not grab headlines, but they’re often an important part of the story, particularly if a drug or device turns out to have unexpected side effects or doesn’t fulfill its promise.

But I’ve digressed from the parallel to writing. I’ve written about blogging as a way for me to workshop my writing. I have a variety of article ideas that have never landed a home, essays that didn’t sell. Not all writing, ideas, and scientific results should see the light of day. We all have chaff that needs to go out with the garbage, or that needs to lie fallow until we have greater context for what it means. With so much information spinning by us, I’m still figuring out how to balance my competing urges as a writer. Should I let an idea simmer so that the flavors continue to meld and combine? Or should I just get it out there and get feedback on it?