Our Review Summary
The story suffers from the absence of disinterested expert opinion, of particular value when the studies reported were not peer-reviewed and were industry-sponsored. There is incomplete information about side-effects, and the main effect of the drug, to reduce pain in fibromyalgia, is not described in sufficient detail to inform the concerned reader of possible clinical benefit. It is an interesting story from the point of view of potential expansion of market by adding another disease "niche" for the drug, but the story does not inform the health care consumer about the likelihood or size of benefit of the drug, nor of the drawbacks.
It was surprising to see that no independent experts were quoted. The story appears to rely heavily on Pfizer input:
- "The New York drugmaker said…"
- "Pfizer is expecting…"
- "Pfizer is betting heavily…"
- "Pfizer presented data…"
- "Pfizer says the dizziness tends to wear off."
- "Pfizer will release results…"
Criteria
Not Satisfactory
There is no information about the costs of this medication.
Not Satisfactory
The story provided information from a single study showing a dose response to the medications. This was a large study (750 patients). While providing information about the drug's effect on pain, the reader is not left with sufficient information about whether this amount of pain reduction was sufficient to change the quality of life for the patients studied. In addition, the story did not provide information about the length of time patients took the medication in order to obtain the benefit that was described.
Not Satisfactory
Although the story presented information about one side effect, dizziness, it did not do an adequate job address potential harms associated with treatment.
From the company's own website, it was possible to learn that:
The most common adverse events occurring during all controlled clinical trials for patients taking LYRICA vs those taking a placebo were dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention).
These might be important to patients or investors.
Not Satisfactory
The evidence provided in this story comes from abstracts presented at two recent scientific conferences. The story should have mentioned that this means that the results have not yet undergone peer review and since both were presentations by the drug company that manufactures the drug, they should be viewed with some skepticism.
While the studies were described in some laudable detail, such as mentioning random allocation and a placebo-control, important information was lacking. All effects were reported as relative rather than absolute changes, and the duration of the first study was not mentioned. Whether results reached statistical significance was not disclosed. Without these sorts of descriptors, it is hard for the reader to assess the strength of evidence, especially without the assurance of a peer-review process.
Satisfactory
The story provided an estimate of the number of individuals with fibromyalgia, and included the doubts of some about the existence of this condition.
Not Satisfactory
No independent experts are quoted. The story appears to rely heavily on Pfizer input:
- "The New York drugmaker said…"
- "Pfizer is expecting…"
- "Pfizer is betting heavily…"
- "Pfizer presented data…"
- "Pfizer says the dizziness tends to wear off."
- "Pfizer will release results…"
Not Satisfactory
While the story did mention that fibromyalgia is traditionally treated with a 'cocktail of off-label drugs including antidepressants and painkillers', this is really not an adequate description of the the treatment options. In fact, one of the drugs that may be included in this 'cocktail' is the very drug that is being reported on.
Satisfactory
The story explained that Lyrica is available for the treatment of pain, but that it is not yet approved for fibromyalgia.
The story stated that "Pfizer is expecting word form the Food and Drug Administartion on its application this year". However a search through www.clinicaltrials.gov shows that there are two phase III (trials to look at effectiveness of a treatment) trials of this drug for the treatment of fibromyalgia that are currently recruiting patients. This would suggest that it will take more time than till the end of this year before the FDA will make a decision about approving this use of the drug.
Nonethless, we'll give the story the benefit of the doubt on this criterion.
Satisfactory
This is about a drug company developing a new market for a product already developed – which the story clearly explains. The story further explains that there is currently no FDA-approved treatment for fibromyalgia.
Not Applicable
We can't be sure if the story relied solely or largely on a news release. However the story used the same statistics that appeared in a Pfizer news release about the estimated number of Americans with fibromyalgia, and the numbers presented in the article for the data presented at the American Academy of Neurology meeting.
Total Score: 3 of 9 Satisfactory
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