A headline that ends in a question mark can often be answered with the word no. That adage applies here, in a story about a 62-person trial that tested whether leukemia drug imatinib, sold by Novartis and marketed as Gleevec, could be used to treat severe asthma. Published in the New England Journal of Medicine, the results of the 24-week “proof-of-principal” trial are too preliminary to draw conclusions about the drug’s usefulness for this purpose, so there’s marginal news value here.
Still, we appreciated that the story included cautious quotes from two independent experts and made it clear that the study was “very small” and that it will “take years of study to determine the usefulness of this drug in treatment.”
Millions of adult asthma patients have uncontrolled asthma, associated with lower quality of life and more healthcare use, according to the CDC. There has not been a significant shift in the availability of effective asthma therapies in recent decades. Stories about a potential new treatment are bound to attract a lot of readers and should include ample cautions about costs, limitations and potential harms.
We think this one warrants follow-up in a few years to see whether this drug actually proves safe and effective in larger trials and makes it to market. If not, that’s a story, too.
We were glad the story addressed costs, but actual figures would have been more helpful. It says imatinib “might provide a relatively inexpensive new treatment for asthma patients. Two generic versions of the drug were launched last year, which could make it less pricey than new-wave asthma drugs headed for the market, Israel added.”
While it may cost less than other options, this treatment isn’t what we consider inexpensive, even off-patent. Generic imatinib costs $96.53 to $276.53 per tablet, according to Drugs.com.
The story quotes a researcher saying the drug “reduced the ‘twitchiness’ of airways” by a third, which “was significant compared with the placebo group,” making airways less likely to reflexively constrict when exposed to an allergen or asthma trigger.
That’s a good start, but we wanted to know, by a third of what? Also, it’s not clear if this measurement–or any of the other benefits mentioned–resulted in fewer symptoms for patients, or just improved their lab values.
The story just barely passes the bar on this one, reporting that side-effects “were not as severe as expected.” It adds: “One person dropped out because of a sharp decline in white blood cells, which bounced back after the drug was discontinued. Another person dropped out because of leg cramps associated with the drug.”
It also quotes an independent expert saying the drug is “toxic.” For lay readers, that might be a confusing term.
Also, there’s no mention of the general risks of imatinib, which include infections, bleeding, liver problems, and heart problems. The fact that this is a type of chemotherapy could have been mentioned, too.
We applaud the words “small-scale clinical trial” in the lead, though we would have liked to see a researcher’s caution that further trials are needed higher up in the story. The story also notes that it was a six-month trial involving patients whose asthma was not controlled with steroids, and that patients were randomly assigned to the real drug or a placebo.
The story offers helpful quotes from two independent experts. One notes that “further studies will be needed to assess its utility in moderate asthma.” Another says: “This is a very early work that in no way should encourage asthmatics. … While it is a very interesting study for pulmonologists and immunologists, it is a very small study.”
The story doesn’t exaggerate the prevalence of severe asthma. It would have been useful to indicate how many people fall into this category. Some 18.4 million U.S. adults have asthma, or 7.6 percent of the adult population, and about half of those cases are uncontrolled, according to the CDC.
The story does not disclose that the study’s senior researcher, Dr. Elliot Israel, has worked as a consultant for Novartis, which makes Gleevec. It also didn’t mention who funded the study. In this case, it was primarily the National Institutes of Health.
We would have liked to see more discussion of the options for treating severe asthma besides the story’s fleeting mention of “new-wave asthma drugs headed for the market.”
The story tempers expectations when it quotes a researcher saying it will “likely will be three to four years before Gleevec could be approved for asthma treatment.” Further, it quotes an independent expert: “It will take years of study to determine the usefulness of this drug in treatment.”
The story gets at the potential significance, saying it may apply to patients “whose severe asthma isn’t controlled despite use of high-dose steroid medications are at risk of declining lung function and poor quality of life.” It also quotes one expert saying, “It has been a while since a new approach and treatment for severe asthma has emerged.”
The story does not appear to rely on a news release.