A well written and well constructed story that has two major flaws. The story is based on the results of a presentation at a national meeting and the results have not been subjected to peer review. In addition, the lack of disclosure concerning the presumed non-affiliated expert’s link to the drug’s manufacturer is a major oversight.
Fibromyalgia is a somewhat controversial yet important disorder. Due in large measure to the lack of a clear cause of the disorder and the myriad of symptoms, treatments for fibromyalgia have been few and far between. So, the early report of a new drug that may provide relief is an important story. Unfortuantely the story highlights the report presented at an annual meeting. The study results have not been subjected to peer review and as such should be considered preliminary. Althought Xyrem have prove to be an important addition to treatment options, it is a bit early to claim victory over the disorder.
Costs of the regimen used in narcolepsy are discussed.
The most common side effects in the study were quantified for each Xyrem group. It also mentions the high potential for abuse and "date rape drug" association. While the story quotes a consultant to the drug manufacturer without support regarding the lesser abuse risks in narcolepsy, there’s evidence in the literature, such as in this article, to support the anecdote.
It would have been nice to read some of the important drug interactions that are possible with Xyrem. It has a boxed warning in its prescribing information.
The article was inches away from a satisfactory rating, in fact an above average rating, but it left out one point that is just too important to ignore. When results are presented at a conference, they’re considered preliminary because they have not gone through the full peer review of the publication process. It’s a major oversight to not point out the preliminary nature of the evidence and the lack of peer review.
Now for the good stuff: we’re given many key pieces of context about the evidence, including the placebo controlled nature, number of subjects, treatment groups, dosing regimen, the length of treatment, the baseline pain scores, and an explanation of the pain scale.
The story cites an advocacy group’s estimate of prevalence at 10 million. We’ve been unable to find a primary source for that estimate on the advocacy group’s website. A more objective source, 2008 published estimates, suggested a prevalence closer to 5 million. However, given the difficulty in obtaining accurate prevalence information for this disease, we don’t think there’s evidence of disease-mongering.
A source was interviewed, and conflicts of interest are identified, including the drug company that funded the study. Although we are told the source was not involved in the study per se, the story suggests that he is a consultant for the drug company. IF this is in fact the case, there is a question about the independence of the source. Furthermore, no source provides analysis of the research itself. The consultant is quoted downplaying the abuse observed for Xyrem in narcolepsy and the potential role of a new product in the management of this disease. We don’t necessarily dispute his underlying points, and there’s evidence in the literature supporting his characterization of the abuse. But these points would mean a lot more coming from someone who is an independent source.
The drug is sometimes used off-label for fibro, as we can deduce from the patient anecdote talking about her success with the drug. We’re also not sure this selective anecdote was appropriate to include: without any other quotes or independent analysis to balance it, it paints an overly heroic picture of the drug. As a bit of background, note that Jazz has gotten into trouble in the past in this arena: its subsidiary plead guilty to a federal indictment of promoting Xyrem for off-label uses, including fibromyalgia.
Perhaps a more minor issue, we’re not sure that the article ever says explicitly that Jones was the investigator on this study. It will be obvious to some readers, while others may feel she is an expert commenting on the research.
The story describes the 3 other medications currently indicated to treat fibromyalgia, noting that Xyrem has a unique mechanism of action. Readers would have also benefited from a discussion of the non-drug treatments for fibromyalgia, as well.
The story makes it clear that the drug is not approved for use in fibromyalgia but is indicated for use in narcolepsy.
We learn of prior studies of Xyrem in this population and the drug’s indicated use for narcolepsy. The investigator tell us the mechanism of action in fibromyalgia, although we’re not told what evidence is behind it. There’s also an sideways acknowledgement of off-label use via the patient quote, but we’ll discuss that more later.
While we don’t know what sources the article used, we didn’t see a press release out there that it cribbed from.