The recent approval of a drug for the treatment of endometriosis pain is shared in this story in a way that satisfies many of our review site criteria. The story is carefully written, with lots of detailed explanations of the drug’s potential benefits — and drawbacks.
Although some crucial information about funding and possible conflicts of interest is missing, the story otherwise affords the reader a readable and comprehensive “take” on the new drug. One clinical trial detail we think should have been included: The measured benefits for both the drug group and the placebo group.
Endometriosis, a condition in which tissue migrates from the uterus into the abdomen of women, is relatively common and can be debilitatingly painful. While there is no cure at present, efforts to control the pain include hormonal treatments and even surgery, which produce their own complications. This story describes a new non-hormonal drug that appears to avoid some—but not all—of those complications.
The story does a good job of describing the monthly cost ($850) for women who do not have health insurance. The inference is that insurers will cover the cost for others.
The story needed to include more information about the study results–in particular, how both the drug and the placebo performed in the trials.
As we learn from the NEJM study, the drug reduced pain for about half of the women who took it–but the placebo also reduced pain for about 35% of the women who took it. That’s a good detail to include as it provides a better sense of the drug’s effectiveness.
The text does an impressive job of sharing information about the debits of the drug, including bone loss and symptoms of menopause.
The double-blind, placebo-controlled trials are described, as are cautions, such as the short-term nature of the research.
The reader will find ample information about the unpleasant symptoms of endometriosis. In some areas, it comes close to disease-mongering, when pointing out very rare instances of women needing many surgeries, or a case study of one woman having endometrial tissue in her nose. However, endometriosis is a medical condition, and often under-diagnosed, so we’ll rate this satisfactory.
The scientist who led the two trials is clearly identified as such, but his consulting relationship with the company now marketing the drug is not mentioned, nor is the fact that that company, now positioned to benefit from selling the drug, paid for the studies.
A number of existing pain-reduction alternatives are mentioned, from hormonal treatments to surgery, and their debits discussed. It would have been helpful to try and articulate how many women find the current alternatives insufficient.
The text offers a likely date when this just-approved drug would become available at pharmacies.
Although the research report describing the trials was published in The New England Journal of Medicine more than a year ago, this story is pegged to a more useful (to readers) “new event,” the US Food and Drug Administration’s approval of the drug.
Abbvie, the company that funded the Stage 3 clinical trials of elagolix (brand name: Orilissa) and will now market the drug, made available an extensive news release on its web site. The Vox story contains a good bit of enterprise reporting and produced a story that is far more clear than the company’s effort.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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