However, we were pleased to see that story raised some appropriately skeptical concerns about the potential harms of headache prevention drugs. We also applaud the story’s inclusion of an unconventional patient anecdote — someone who tried multiple medications, experienced no benefit, and ultimately opted for lifestyle changes to manage her symptoms. A discussion of costs, and a more thorough evaluation of the evidence underlying the medications discussed in the story, would have been welcome additions to the coverage.
In recent years, government panels and medical societies have come under fire for issuing treatment guidelines that favor the drug industry. There has been a call for these groups to recruit more members who do not have industry conflicts and whose recommendations are free of potential commercial bias. (See this New York Times story for background.) The American Academy of Neurology and American Headache Society clearly are aware of and this trend, and appear to support it, since they acknowledge in the guideline document that “Significant efforts are made to minimize the potential for conflicts of interest to influence the recommendations of this CPG. To the extent possible, the AAN and AHS keep separate those who have a financial stake in the success or failure of the products appraised in the CPGs and the developers of the guidelines.”
But can we accept that statement at face value, when five of the six authors on this guideline have relationships with drug companies who are presumably developing or marketing headache treatments, and their disclosure statements — even in tiny text — run nearly as long as the “clinical context” section that is supposed to help readers evaluate the evidence? It’s a question that any journalist covering this story would do well at to at least raise with his or her readers.
Costs were not discussed. As the guidelines state, “overall cost is a consideration when prescribing medications; cost may influence compliance, especially long-term.”
The story quotes one of the guideline authors who says that “about 80% will get relief …— defined as a headache reduction of at least 50% — after trying three or four drugs, alternative remedies and lifestyle changes.”
This may well be true, but we think the 80% figure puts the benefits in the best possible light and misplaces the emphasis. If it takes 3 or 4 drugs, alternative remedies and lifestyle changes to achieve a benefit for 80% of people, clearly a much smaller number of people are likely to experience a clinically significant benefit from any individual treatment.
A close call here, but the story does mention that treatment can “take a lot of trial and error and careful dosing” — enough context to merit a satisfactory rating.
This story doesn’t sugar coat the side effects of these drugs. A spokesman for a patient group notes that many patients “spend months or years taking medicines that don’t work and make them miserable.”
The story lists drugs found to have the “strongest evidence” and other drugs that patients “can consider.” There is no discussion of how these ratings were developed or what kinds of studies represent “strong” evidence. There is also no mention of limitations of the studies that formed the basis for the guidelines. The guidelines themselves note, for example, that migraine prevention studies were usually of short duration (often only 12–16 weeks), and so the long-term efficacy of these therapies is uncertain.
One of the story’s sources describes migraine as “one of the most disabling conditions known to man,” which struck us as a bit dramatic. However, there’s no doubt that migraine causes great suffering, so we’ll let this one pass without a flag.
The story did a good job of explaining that only a minority of patients have headaches severe enough to warrant consideration of preventative treatment.
The story included an independent expert source and had some valuable input from a patient advocate group. It also included the perspective of a patient — a rarity in health stories — who said she didn’t get much benefit from her medication and experienced signficant adverse effects.
Unfortunately, however, the story failed to mention the extensive commercial conflicts of the panel that wrote the guidelines, including the author quoted in the story, Dr. Stephen Silberstein. Here is what he disclosed to readers in the guidelines text: “Dr. Silberstein is on the advisory panel of and receives honoraria from AGA, Allergan, Amgen, Capnia, Coherex, Colucid, Cydex, GlaxoSmith-Kline, Lilly, MAP, Medtronic, Merck, Minster, Neuralieve, NINDS, NuPathe, Pfizer, St. Jude Medical, and Valeant. He is on the speakers’ bureau of and receives honoraria from Endo Pharmaceuticals, GlaxoSmithKline, and Merck. He serves as a consultant for and receives honoraria from Amgen and Novartis. His employer receives research support from AGA, Allergan, Boston Scientific, Capnia, Coherex, Endo Pharmaceuticals, GlaxoSmithKline, Lilly, MAP, Medtronic, Merck, NINDS, NuPathe, St.Jude Medical, and Valeant Pharmaceuticals.”
The story is mainly about medications, but it does note that avoidable triggers can play a role in promoting migraines in some people. It also quotes a patient who says she’s getting better results with diet, yoga and other lifestyle changes than with medications. We’ll call it satisfactory.
It’s apparent from the story that these drugs are widely available.
The story didn’t oversell the novelty of these drugs.
The story was not based solely or largely on a press release.