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."
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.
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.
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.
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.
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.
The story turned to two physicians for perspectives, one of whom stated some concern about "trading scheduled bleeding for unscheduled bleeding."
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.
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.
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.
We can’t be sure if the story relied solely or largely on a news release.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like