This Wall Street Journal article describes the advent of a new oral medication, uliprital acetate, or UA, to treat severe bleeding and other symptoms associated with uterine fibroids. Although the article does a good job of putting Allergan’s new oral drug in context and noting alternative treatments (hysterectomy, myomectomy) and similar drugs in the pipeline, it offers no numerical context that women and their physicians might use to evaluate the relative benefits and risks of the newer treatment.
As the article aptly points out, uterine fibroids are a source of significant pain, bleeding, anemia, infertility and disability in tens of millions of women, most of them in their childbearing years. The symptoms and complications can seriously interfere with everyday life.
The causes of uterine fibroid have been intensively studied over the past decade. More is understood now about the important role of genetic and hormonal factors in development of fibroids.
For decades, the common treatment for uterine fibroids has been their surgical removal (where they often grow back) or hysterectomy. But some newer less invasive procedures such as uterine artery embolization and MRI-guided focused ultrasound have provided other treatment options.
Use of medication has been limited to hormone affecting medications that can cause drug-induced menopause. Thus, a pill like UA — already available in Europe — adds a treatment option that may be helpful. What is missing from the article are data documenting and explaining what proportion and kind of patient group the drug would most and least benefit; and other data to help women determine if UA is a good option for them.
The article does not offer any cost information.
The article offers general statements about the “dramatic” and rapid effects of UA from Allergan researchers, but does not provide any numerical context or offer summaries of research with that information.
The article notes the side effects of UA and potentially two other similar drugs in the pipeline. The main concern about these agents is the effects they may have on the endometrium (uterine lining) over time.
The evidence is generally AWOL. A personal testimonial from a celebrity with fibroids does not stand in for evidence one expects to see from a clinical trial or trials.
The article quotes one outside expert whose comments focused on the use of an injectable alternative to the oral drug, and the downsides of this alternative. But it also has a comment from Allergan’s researcher noting that longer-time follow up is needed for UA. These source’s commercial relationships are appropriately disclosed.
[Editor’s note: Following publication of this review, we learned that Allergan provides financial support to the White Dress Project. The story would have done well to acknowledge this relationship.]
The article mentions some alternative treatments in detail. One strength of the article is that it prominently points out that many women with fibroids who have no symptoms do not require treatment of any kind.
The article notes the new drug could be available in the US next year. The drug is already available in the US for another indication but is packaged in doses that are much larger than those used for fibroid treatments.
The article makes clear that the advantage of the new drug is that it is an oral medication, and is taken for a limited time.
However, ulipristal is not the first oral medication. There are some older oral hormonal medications, including pills in some cases, that have been tried. GnRH agonists (delivered by injection or nasal spray) such as Lupron have been used in limited situations to treat fibroids, but their use is limited by side effects related to medically induced menopause.
The story includes comments from two experts and it appears as though the second one had no involvement with the study.
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
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