The story focuses on treatment options available for women who are experiencing health problems related to uterine fibroids, with a particular focus on a technique called Sonata, or sonography-guided transcervical ablation.
The story relies heavily on an anecdote–tracking one patient’s experience with the experimental procedure–but provides a good overview of the surgical treatment options available for women with uterine fibroids, and even includes a tricky discussion around costs.
According to the National Institutes of Health, “Most American women will develop fibroids at some point in their lives” — but many will be unaware that they even have them. But because they are so common, if even a small percentage of women with fibroids experience related health problems — such as heavy menstrual bleeding or pelvic pressure — fibroids can have a significant health impact. As NIH notes, “More than 200,000 hysterectomies are performed each year for uterine fibroids.” And “annual direct health care costs for uterine fibroids exceed $2.1 billion.” New treatment options to address common (and costly) health issues are certainly worth covering.
The story pulls off a difficult trick: addressing cost in a meaningful way when it’s not clear what the price tag will be. The story tells readers “Sonata’s manufacturer declined to say what the procedure might cost once the trials are complete and it is approved.” The story also explains that “because it’s still under investigation in the U.S., it’s not covered by insurance.” And the story also quotes an independent expert as saying that “If insurance doesn’t pay for Sonata, no one is going to get it.” The story also notes that a comparable procedure cost tens of thousands of dollars.
The story doesn’t quantify benefits, instead focusing on one patient’s experience with the technique and noting that it “has been getting positive reviews so far” in a U.S. clinical trial. The story also notes that Sonata was approved in Europe. A 2015 paper in the journal Gynecological Surgery offers information on outcomes for 50 patients in a “FAST-EU” trial for Viz-Ablate (which appears to be another name for Sonata). For example, 12 months after the procedure, 38 of 48 patients had reduced menstrual bleeding by at least 22 percent (which study authors described as the threshold mark for being “meaningful” to most women). The Sonata trial is designed to measure effectiveness (defined as more than 50% reduction in blood loss) and safety in a U.S. population.
Sonata is in the midst of an ongoing phase II clinical trial, designed to assess both effectiveness and safety of the procedure. But the story still makes a good effort to address risks and related concerns. For example, the story states that “such minimally invasive procedures require a lot of skill to perform safely” and quotes an expert as saying “You need a really experienced surgeon….Will it translate to the average ob/gyn?” In addition, the story notes that, while uterine fibroids are rarely malignant, in a small number of cases they can be cancerous — and “because tissue is not removed with the Sonata method, it cannot be biopsied.”
With a little more digging, the reporter might have found the Gynecological Surgery paper mentioned above. In that trial of 50 patients, there were 34 “adverse events.” Most were not severe, but incorporating some of that information would have made the story even stronger.
The same problems we discussed under benefits apply here. The focus is on one patient’s experience, with a note that the technique is approved in Europe and is the subject of an ongoing clinical trial in the U.S.
ClinicalTrials.gov indicates this is a Phase 2 trial for efficacy and safety that will enroll approximately 150 patients. The primary endpoints are more than 50% reduction in menstrual blood loss, and the need for surgery within one year after the procedure due to treatment failure. The article missed an opportunity to inform the reader what phase the trial is in (i.e. this study will be the first step in establishing how effective and safe it is; the next step is comparing it to other available treatments).
The story does a good job of avoiding disease mongering, saying that fibroids often cause no symptoms and that they only rarely affect fertility or can be cancerous.
The story includes two independent sources and clearly identifies those sources who are affiliated with the industry-funded Sonata trial or the manufacturer of the technology used in Sonata.
This is a real strong point for the story. The story not only describes multiple other surgical options, as well as hormone treatments, but notes that many patients can wait until menopause, when changing hormone levels can mitigate problems associated with fibroids.
The story makes clear that Sonata is undergoing clinical trials and is otherwise unavailable in the United States — though it is approved in Europe.
This ties in to what we said above regarding alternatives. By explaining several surgical interventions that address uterine fibroids, the story clearly articulates what is novel about the Sonata approach. Well done.
The story does not appear to be based on a news release.