The strong criticism of an independent source should have been front and center, with the promotional statements of the drug company president and researcher pushed lower down. The story includes many of the details we want to see in stories about medical research, and the independent source provided a powerful counterweight to the drug company president, but the overall presentation makes the trial results to be far more conclusive than they actually appear to be.
After many decades, the fibromyalgia syndrome is still somewhat of a mystery. The cause of the syndrome is not known and the available treatments are a bit less than desirable. In addition to the pain and increased sensitivity to pain, many sufferers have poor sleep. Cyclobenzaprine has been studied at higher doses with some improvement in pain and sleep but that improvement comes at a high cost in terms of side effects. A trial looking at lower doses aimed at improving sleep makes sense. However a trial with a total of 36 patients and limited success is of questionable value to the reader.
The reporter did ask about cost, and since the research is at such an early stage, it may be reasonable to accept the company president’s reply that he cannot estimate the cost. Since the drug is available for other uses, it would have been informative to include a range of prices for the pills already on the market for other conditions. For example, 5 mg tablets of generic cyclobenzaprine are listed as costing just $4 for 30 tablets at walmart.com. However, a new brand name formulation with a new FDA approved use may be sold at a different price than the available generics. We think that this easily identified information should have been included to provide readers with a benchmark.
While the story is accurate in reporting that researchers saw signs of improved sleep and reduced pain in the small number of fibromyalgia patients in this trial, the relative attention given to the self-promoting claims of the drug company president as compared to the dismissive comments of the independent source leave readers with an unbalanced view. If the independent expert says he is “not impressed with the findings” and that the new drug dose “is not going to change things substantially,” it’s hard to see how a headline, sub-head, and lead paragraphs all devoted to grand claims about the benefits of the drug can give readers a fair view of the potential benefits.
The story does report that some participants had headaches, dry mouth and drowsiness, and that this drug sometimes makes people drowsy during the day. However, since there were only 18 participants who took the active ingredient, the story would have been better if it had alerted readers that much larger numbers of patients would need to be studied in order to quantify the likelihood of less common adverse events.
The story does call the experiment “a small study” in the lead paragraph and later reports that the trial included only 18 participants in each of the placebo and active treatment arms. Readers are also given some of the specific results of the trial. However, readers are likely to get an inflated sense of the quality of the evidence. The headline, sub-head and prominently-placed comments of the drug company president/researcher all proclaim seemingly conclusive findings, while the limitations of the work and the need for further research is buried deep in the story.
The story reports a commonly-used estimate of the number of people who are diagnosed as having fibromyalgia. It does not include any statements that could be seen as encouraging the potential use of this drug in a wider population.
The story does report that the researcher quoted is the president of the company hoping to market this pill, and that the company funded the study. The story also quotes an independent source. But as noted above, the overall presentation is out of balance, because the boosterism of the company president is given top billing, while the skeptical comments of the independent source are almost entirely relegated to an addendum at the bottom of the story.
This story does report that this pill has not been compared to other treatments for fibromyalgia. But it fails to put this approach of attempting to improve sleep into context with treatments that directly address the pain and other major symptoms of fibromyalgia. Also, as mentioned above, the story does not tell readers that some of the same researchers (and others) have previously reported the results of larger studies of other drugs intended to improve the sleep of people with fibromyalgia. Nor does this story mention any of the common (non-drug) steps people with fibromyalgia can take to improve their sleep.
The story makes clear that while this drug is available as a muscle relaxant, the dose used in this fibromyalgia trial is not available. The story also reports that the drug is not approved for treatment of fibromyalgia, but it is being prescribed “off-label” by some doctors. Near the bottom of the story, the researcher and company president predicts the low-dose version of the drug could be available for fibromyalgia treatment by 2015. It is hard to see what support there is for such a prediction, given the preliminary nature of this small trial.
The story does report that this drug is already used as a muscle relaxant and that the relatively novel approach is the investigation into the relationship of sleep quality to fibromyalgia symptoms. However, it would have been helpful to also report that some of these same researchers and other have already published the results of larger trials testing drugs that may improve the sleep of people with fibromyalgia.
The story does not appear to rely on a news release.