This 189-word story failed on almost every count:
The company news release actually did a better job of explaining the study than did this news story. Rather than a simple business news story stating that the company has a new FDA application to extend the use of a previously approved drug for a new and potentially lucrative indication, the story becomes a PR bonanza. But not one that is helpful to consumers – or even to shareholders for that matter.
No discussion of cost – only of sales figures which aren’t much help to the individual consumer. Cymbalta is expensive.
How is a 50% reduction in pain measured? What are the potential flaws in such measurements or self-assessments? 31% of how many? These are critical lapses. These questions were better answered in a company news release than they were in the WSJ news story.
Absolutely no discussion of potential harms, which is unacceptable for a story based on a drug that already has a known risk profile and for which new claims are being made.
The story didn’t explain what it means to say that "31% of patients taking Cymbalata reported a 50% reduction in pain, versus 19% of patients taking placebo. Patients experienced significant relief in pain the first week and continued throughout the 13-week acute-therapy phase." How you define "reduction in pain" and "continued throughout" is crucial in understanding true benefit. What happened to the other 69% of patients who did not report such pain reduction? The story also failed to emphasize that this was a single study reported in a medical meeting, meaning it hasn’t gone through the peer review process yet. Read our primer on the flaws in such reporting.
The story said that the drugmaker said "a study showed the drug ‘significantly’ reduced chronic lower-back pain" and that the company "has been looking at the potential of Cymbalta for relieving the discomfort of fibromyalgia and osteoarthritis pain as well as back pain." The story never explained what "chronic lower back pain" meant in this study and therefore is too nonspecific with this often nonspecific diagnosis. Then, to let the company get away with the insinuation of progress against other conditions is unacceptable.
No independent source was interviewed.
No other options for treating chronic low back pain were mentioned.
If you piece together everything that this story said about Cymbalta, you could probably figure out that it’s approved for depression and not yet approved for fibromyalgia or back pain. Of course, physicians may prescribe previously approved medications for non-approved indications. Such stories may increase use of the medicine even before the FDA has considered it for this indication – which is just fine with the company, you can be sure.
We know it’s a depression treatment now in search of a broader market for various forms of pain control. What is truly novel about this approach is never explained. What is the mechanism of action that would make this novel? There are other medicines of a similar nature that have been tried for chronic pain.
This exact same quote appeared in the story and in the company news release: "Chronic low back pain can have a significant impact on a person’s ability to do the things they enjoy," said Vladimir Skljarevski, lead study author at Lilly Research Laboratories. "This research may offer hope to those dealing with this debilitating condition." Did he say the same thing exactly the same way twice? Why didn’t the story attribute the quote to the news story if it wasn’t gathered independently?