FDA approves first pill meant to end periods
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Rating
FDA approves first pill meant to end periods
Our Review Summary
This story was about FDA approval of another oral contraceptive that also suppresses or stops menstrual periods.
The story didn’t include any data and didn’t evaluate the quality of the evidence for Lybrel in any way. So it didn’t disclose that many women dropped out of the trials of Lybrel because of spotting or breakthrough bleeding. That’s important to include, since the story called this "the next generation of birth control pills."
The story says "most doctors aren’t worried about safety" because the drug is not really different from ones that preceded it. (Then why does it "herald the next generation" of such pills?) The story only says "Like all birth control pills, there can be side effects." But what did the studies show?
There was also no discussion (as another network included in its story) of concerns over "medicalizing" menstruation. Instead, the story focused on "lifestyle choice", and on "control and convenience." We think more time should have been spent focusing on what’s not known about long-term safety in such a medication.
The viewer is left with a confusing picture of a new version of a common type of prescription medication intended for contraception but now being described in consumer terms as a desirable convenience. Since existing monophasic pills can be used in the same fashion at lower cost (because of generic availability), the story needed to do a better job of portraying whether the formulation and "repackaging" into a daily use format will achieve the desired results."
Criteria
Not Satisfactory
There is no mention of the cost of Lybrel, not even a projection from Wyeth of what they may charge. Whatever the cost, the point should have been made that the same result can be achieved using cheaper generics.
Not Satisfactory
There was no discussion of data nor of the quality of the evidence for Lybrel – which seems important for a drug that the reporter says "heralds the next generation of birth control pills." If the benefit is "no more periods," then they shoul dhave reported how likely that is for the average user.
Not Satisfactory
The story says "most doctors aren’t worried about safety" because the drug is not really different from ones that preceded it. (Then why does it "herald the next generation" of such pills?) The story only says "Like all birth control pills, there can be side effects." But what did the studies show?
The studies showed that many women in the trials dropped out because of spotting or breakthrough bleeding. That was only alluded to, but the trial data were not given.
The "harms" of poor cycle control and uNPRedictable spotting and bleeding are very common and certainly impact quality of life and result in an outcome different from what the woman who selects this method is seeking. And that point was not emphasized in this story. There’s another risk beyond dissatisfaction with bleeding pattern – that is that women stop their contraception completely and are at risk of pregnancies from not contracepting or using an inferior method in the interval before they return to their provider to discuss dissatisfaction and arrange a change.
Not Satisfactory
There was no discussion of data nor of the quality of the evidence for Lybrel – which seems important for a drug that the reporter says "heralds the next generation of birth control pills." Essential evidence would seem to be what is the probability of success in stopping periods, which is the whole point of this pill schedule and marketing.
Not Satisfactory
There is no discussion about any of the oft-stated concerns about "medicalizing" menstruation. At least a competing network’s story had two interviews with women who felt it was better to let nature run its course.
Satisfactory
The story turned to two physicians for perspectives, one of whom stated some concern about "trading scheduled bleeding for unscheduled bleeding."
Satisfactory
The story mentioned that there are other birth control pills on the market that allow women to have only four periods a year. However, they still missed the point that any low-dose monophasic can be used in the same way.
Satisfactory
It’s clear from the story that the drug Lybrel has just been approved by the FDA. But it won’t be known for some time how many insurers will cover it because it is so similar to other products already on the market. Indeed, women can achieve the same result with cheaper, generic products.
Not Satisfactory
The story both states that Lybrel "heralds the next generation of birth control pills" and says "there is no real difference between this pill and the ones that preceded it." That’s too confusing. It is not even the case that combined levonorgestrel and ethinyl estradiol low-dose formulations are new. Likewise, continuous use is not new – physicians, especially ob-gyn’s, have been selectively assisting patients with continuous use regimens for decades.
Not Applicable
We can’t be sure if the story relied solely or largely on a news release.
Total Score: 3 of 9 Satisfactory
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