This story reports the results of a review of the new drug for female sexual dysfunction, flibanserin (Addyi). This is the first systematic review and meta-analysis studying the impact of flibanserin in women with HSDD. The CNN coverage of this large and exhaustive study had many shortcomings starting with the headline. It is hardly a ‘mixed’ review when you compare a weighty study that found very marginal effects of the drug in nearly 6,000 women, and put that up against a single compelling anecdote of a women who says her life was turned around by the drug. It’s also questionable to give so much weight to the comments of a clinician with known ties to pharmaceutical companies that make drugs for female sexual problems (and without disclosing those relationships).
This is an important piece of reporting because how a new drug performs in clinical studies on thousands of patients has a direct relevance to the women who would be encouraged to take the drug and the physicians who would want to prescribe it. Journalists need to be ultra cautious in reporting on such a ‘sexy’ topic and carefully weigh the comments of clinicians and patients who provide what seem to be ‘market-tested’ testimonials. Almost everything about the marketing and medicalization of female sexual dysfunction is controversial: the article acknowledges that controversy, but barely. Most thoughtful clinicians in this area see the problem as a multifactorial one, which may be affected by physiological changes, psychological issues, relationship factors, and/or cultural context. Any journalist weighing in on this subject must, even briefly, step back and ask: Given all these controversies, how can this study be covered in a way that readers, especially women, aren’t misled?
No cost information, whatsoever.
This rating is borderline as the article noted: “They said for women using the drug, the number of additional ‘satisfying sexual events’ averaged out to about 0.5 per month.” What would give this increased meaning is what the baseline was. If the baseline is zero or 0.5, maybe increasing that by half a satisfying sexual encounter might be meaningful. If the baseline is 10, does half an additional encounter make any difference? Later in the article we learn that “10% more patients” had meaningful sexual encounters, but what exactly does that mean? “10%” of what? The article tips decisively into Not Satisfactory territory with its unbalanced focus on unrepresentative anecdotes depicting women who had “life-changing” improvements.
We learn the drugs have side effects but nothing about the fainting, falls and somnolence that are known side effects of the drug.
The patient with the testimonial is quoted saying: “I should be able to choose whether the side effects are worth the benefit.”
We agree. But we also agree that anyone reading this article should get a sense of what those side effects are likely to be and how often they occur.
A systematic review is the highest form of evidence and it’s at the peak of the evidence pyramid. At the bottom of the pyramid is anecdote and opinion. And yet the story puts these two pieces of evidence on an equal footing and seems to give them equal weight. People who criticize systematic reviews and ‘tear them apart’ have to indicate why the review is faulty. Instead we get a conflicted clinician with known ties to an organization dependent on pharmaceutical money and pharmaceutical companies promoting drugs for female sexual problems saying that the study had “erroneous conclusions.” And the main reason given is that the review included unpublished studies — when withholding those studies from the review would have introduced a clear bias. This is completely unacceptable. If the studies are erroneous, we need to hear a plausible explanation as to why — preferably from someone who’s not conflicted by relationships with drug manufacturers.
There are many who would say that HSDD is a construction by the pharmaceutical industry keen to capitalize off women’s sexual health. Whether you agree with that perspective or not, if you are writing about a controversial condition, you must include some coverage of that controversy, otherwise you are at risk of further medicalizing and hyping a condition that maybe doesn’t, in most cases, warrant a medical treatment approach.
It was unfortunate not to have included the many and direct ties between those attacking the review (such as the International Society for the Study of Women’s Sexual Health, which is supported by pharmaceutical manufacturers) and one of their board members, Dr. Lauren Streicher, who has declared ties to Noven Pharmaceuticals, Inc and Shionogi & Co., Ltd. We know that patient testimony at the flibanserin hearings at the FDA was supported by Sprout, the maker of flibanserin, which gave financial support to those attending the hearings. But it is unclear if the patient mentioned in this story received such support.
The ‘alternative’ in the clinical studies was, presumably, a placebo, yet as some commentators have noted, the drug has never been tested against a more holistic approach that acknowledges the complexity of female sexuality and which address physical, psychological, and social factors.
The story notes that the drug has been on the market since October, 2015.
This is definitely a novelty and the article reflects that accurately.
Other than Dr. Lauren Streicher and the patient Jodi Cole who seem to keep appearing and reappearing in other stories on this study, there is no evidence of being overly-reliant on a press release.