Statistics and FSD (part 2 of 2)06/14/2010 at 9:55 pm | Posted in Uncategorized | 5 Comments
Tags: experts, female sexual dysfunction, flibanserin, FSD, health, journals, media, medicine, sex, sexual dysfunction, sexual health, statistics
Last week I shared with you my interpretation of Sexual Dysfunction in the United States, a peer-reviewed journal article about sexual dysfunction that appeared in the Journal of the American Medical Association in 1999. The study is widely cited to this day, though it remains a source of consternation in discussions of sexual dysfunction due to some major problems the study had. To refresh your memory, one of the researchers involved with the article had financial ties to Pfizer (the maker of Viagra) and the statistics on the prevalence of sexual dysfunction (43% for women) may have been overstated, because the study did not take participants’ personal distress or lack thereof into consideration. This is not the only research paper on sexual dysfunction but it’s notable because it’s got the backing of the AMA and because of its scale, both in terms of sample size and how big of an impact it had on sexual dysfunction treatments.
But time flows like a river… and history repeats…
Almost 10 years later, another big research study on sexual dysfunction was published in the American College of Obstetricians and Gynecologists journal, Obstetrics and Gynecology. The article, Sexual Problems and Distress in United States Women: Prevalence and Correlates, is another one that’s free and available to all who have an internet connection. This study deals exculsively with female sexual dysfunction, and revises the prevalence of FSD to a much lower rate within the US – in the end, the prevalence rate is estimated to be about 12%. We’re going to be feeling reverberations from this study for quite awhile longer, although I have not seen as much criticism of this study as I did with the JAMA one. Still, like the JAMA article, there are a few potential problems with Sexual Problems and Distress in united States Women we should take a good hard look at.
First, the study was sponsored by Boehringer Ingelheim International GmbH – that’s the same company that is working on producing Flibanserin, a highly controversial drug that may increase women’s libido, and thus address one of the more common types of female sexual dysfunctions. You may have seen some hoopla about Flibanserin on the blogosphere starting around late 2009, and it hasn’t let up. In fact, I’m sure there’ll be more media hype and handwringing as the FDA considers approving Flibanserin. In fact, I know for certain that there’s more hoopla going on right now, because the New View Campaign has organized an online petition to the FDA to block approval of Flibanserin… Well-intentioned as this may be, it’s something that I cannot get on board with and I do not support.
But what Boehringer’s involvement with this study means is that, almost 10 years after the JAMA article, there’s still a conflict of interest in studying FSD! Additionally, all five researchers in this study had financial ties to pharmaceutical companies, as disclosed on p. 970.
Ultimately those conflicts of interest described above and in the JAMA article wind up hurting women with FSD, since such conflicts are taken as a sign that FSD simply must be fake and a source of E-Z money for big pharma. From there, you’ll get pundits, doctors & journalists seizing upon those conflicts of interest and dismissing what women with FSD say.
Unfortunately in this day and age, I am pessimistic that we will see many studies on sexual health that are completely free of commercial taint. Dr. Tiefer in Sex is not a Natural Act looked to academia as a safe haven for research to continue without conflicts of interest. Educators and professors can still apply for research grants, and generous donors still donate, but I have lost access to many scientific journal databases that I was able to get into while I was still in school – because there wasn’t room for all the databases in the school’s annual budget. Raises, new hirings, budgets, and promotions at my alma mater were frozen last year. Plus, academia brings its own set of institutionalized problems. So as far as academia being the alternative solution – well I guess I’m jaded because I’m not entirely convinced about that, either.
For a contemporary real world example of conflicts of interest in the world of women’s health, just check out this About page for the Overlapping Conditions Alliance. At the bottom, we can see that it’s sponsored in part by Pfizer. As someone who stands to benefit from this campaign, I like that this organization went to Washington D.C. to bring attention to women’s chronic pain conditions. But I can’t ignore the little Pfizer logo. I’m not sure we’re going to be able to be completely free & clear of private funding in producing research that impacts public health, and I don’t have a solution to that. I know to take research papers with private ties with a grain of salt, but that’s all I know what to do right now.
The second major problem I can see with this new study is that, this study on FSD deliberately excluded pain!
WTF?! It’s a study about FSD, how can you exclude pain from any definition of FSD? How and why would you do that? Here’s the stated reason why: “Sexual pain problems were not assessed, because a physical examination is required for evaluation of dyspareunia“ (Shifren et al, 2008).
WTF is this?! Wtf. What, you can’t listen to women who tell you that sex hurts? Why can’t you take their word at face value? If I tell you, “It hurts when I go to have sex,” I mean exactly that! Wtf, I need a doctor’s note to verify that my fucking crotch hurts?! Why won’t you listen to me?!?! Why doesn’t anyone believe me?! News flash: Not all women with dyspareunia can afford to go to a doctor, and often enough when they can afford to see one, the doctor dismisses any and all sexual complaints as “All in your head!” I’m not making it up, this is real! Why don’t you care about this?!
So yeah that’s… if you ask me, that’s a big, huge, major problem with the study. Reading that line threw me into rage-rage-rage mode. The researchers cite some earlier study, Assessment and management of women’s sexual dysfunctions: problematic desire and arousal when they make that dismissive claim, but of course I can’t access the full text of that study to see if that’s what Basson, Brotto et al really say. Why would you say that? I’m seeing the study cited only looked at arousal, desire and orgasm as well, so what, did they just decide not to look at pain too because it was too hard or something? The cynic in me thinks to myself that the current researchers have no interest in sexual pain because Flibanserin, the drug Boehringer was working on, will probably not address pain. Pain will not be looked at due to lack of profit, or something.
This makes no sense. The problematic JAMA study said that 7% of women had sexual dysfunction under the pain category, the Goetsch study found that something 15% of women going to a gynecology clinic met the criteria for vulvar vestibulitis. It’s not exactly a majority of women, but why would you ignore a significant chunk of the population like that? Like, why is pain irrelevant for this discussion of FSD? Seriously. You think pain never influences other areas of sexuality, like desire and orgasm?
ANYWAY, there’s two potential problems with the study right off the bat. So what does the the research say, anyway? What, if anything, can we learn from Sexual Problems and Distress in United States Women: Prevalence and Correlates?
There were some improvements defining FSD since the JAMA study was done all those years ago. Sexual Problems and Distress in United States Women: Prevalence and Correlates looked at how often sexual problems occurred, and took participants personal distress into account. Under current guidelines by the American Psychiatric Association and FDA, personal distress must be present in order to make a diagnosis of sexual dysfunction. Not everyone feels distressed when they experience sexual problems. This is one of the reasons that the rate of FSD was found to be much lower in this study (about 12% in the end) compared to the JAMA study (about 43%.) Is this revised, lower statistic satisfactory to those who have registered complaints about the 43% number? Is that sufficiently low enough to acknowledge as Real?
The way the research was conducted was by survey. Researchers mailed out surveys to over 50,000 households and got responses back from 31,581 women. (I know, and the researchers were also aware of, there are some concerns about asking participants to self-screen themselves in this way.) Unlike the JAMA study, this one did not exclude women who did not have recent partnered sexual activity. The survey included 14 items about problems with desire, arousal and orgasm, which you could answer on a 5-point scale for frequency. Personal distress was measured with 12 items about the participant’s feelings, like guilt, worry, frustration, unhappiness, etc. You could have a personal distress score ranging from a low of 0 to a high of 48. If your score was 15 or above, you were considered to have sexual distress, and if you reported a sexual problem AND scored a 15 or higher on the distress scale, then you were considered to have FSD. (Shifren et al, 2008). That means it was possible to report distress sans problems, and if that was the case, you did not have FSD according to these researchers. You needed to have both distress AND a problem at the same time. One possible alternative to this classification I can think of would have been to simply ask participants whether or not they considered themselves to have sexual dysfunction. I don’t know if this alternative would have yielded better results, but I like leaving room for self-identification.
Interestingly, the results found that the rate of self-reported problems regardless of distress was around 44.2% (Schifren et al, 2008.) That’s not too far off from the 43% found in the JAMA study. This is what I was referring to towards the end of my last post, when I said we’d see a similar number again. Problems with low desire were reported most frequently, then low arousal and problems with orgasm. Another interesting note, the survey asked women about how satisfied they were with their orgasms – check out the little footnote under table 2 on page 974. However, not all of the participants were distressed by a problem, and so they did not all have FSD. They just had problems. Which maybe weren’t even all that big of a deal or considered a problem at all to the individuals – just to the researchers for the purposes of this study. Sometimes stuff happens. Sexual distress was found in 22.8% of participants, but not all of those participants experienced a sexual problem. And sexual problems + distress, the combination required to come to a conclusion of FSD, was found in 12% of the respondents. (Schifren et al, 2008). These are the overall results; the results are more specific if you break it out by age.
The researchers went on to break out the results by demographics like age, education and health. Women with good self-assessed health were less likely to experience distressing sexual problems. Some health problems that were more likely to be associated with FSD were depression, thyroid problems, anxiety and urinary incontinence. (Schifren et al, 2008). I’m wondering if use of antidepressants influenced the response, since sometimes antidepressants can cause sexual side effects, but then, so too can depression.With urinary incontinence, I’m wondering if the pelvic floor muscles were weaker in women who experienced this? In evaluating sexual problems across race, shown on table 4, white women were the default against which other races were measured. I think there may be something problematic with that.
The likelihood of feeling distressed by more than one of the three sexual problems in question was low, which surprises me. Distress + low desire + either low arousal OR problems orgasming only happened to 5% of respondents, and distress + problems happening in all 3 areas of interest only happened to 2.3% of women. (Schifren et al, 2008) I was shocked to read that; honestly I was expecting there to be more overlap. I’m probably thinking of the overlap sometimes seen between vulvodynia and other chronic health problems like IBS, IC, fibromyalgia, etc. So then I’m wondering of course, what percentage of women would report feeling distress accompanied by all four problems – the fourth being pain? I wonder, how did sexual pain influence the rates with which women reported low libido, arousal, and orgasm… these things can overlap too, you know. If only the researchers had asked about it…
Furthermore, if theoretically a woman reported having sexual pain plus some other problem like low desire, but low desire is in and of itself not acknowledged as a genuine problem by doctors and experts, then what is a patient’s course of action? Address the pain only by whatever means necessary without touching the desire? Or is it then acceptable to extend a medical option to address desire (or orgasm, or self-lubrication) as well? Is the expectation that the woman’s sex drive will naturally increase with non-medical intervention? What if it doesn’t, but she wants it to?
Unfortunately this study does not tell me the % of women who sought medical assistance for their sexual concerns. Recall from the JAMA study, that about 20% of women had sought medical assistance for sexual problems. I’m very curious to know which 20%. If 20% of women in the JAMA article sought medical assistance, and 22% of respondents to this survey reported feeling sexual distress (which may or may not have been accompanied by a complication,)… how much overlap is there? How many of those 20% who sought help for their problems in the JAMA article would meet the criteria for FSD described here?
So there you are… That’s another big study on FSD, and more recent to boot. But don’t just take my word for it, it’s available online so you can see for yourself. But again – no pain. The researchers had zero interest in sexual pain for this study so I have no idea how the results would have changed, if at all, if pain were taken into consideration. And again, unfortunately, conflicts of interest.
Ultimately, women with FSD will be directly effected by research and statistics, as well as by subsequent handling of research findings, say by the media or pharmeceutical research companies. There is also overwhelming concern that women without FSD will be impacted by these journal articles. These concerns are not invalid either – concerns about disease mongering, pathologizing natural fluctuations in libido, abuse at the hands of overzealous doctors and cruel partners. One thing that worries me to this day though, is that in these sorts of conversations, I’ve frequently seen women who would genuinely benefit and who maybe genuinely need medical intervention to address problems in their sex lives, become invisible or dismissed, either due to a relatively small proportion of the population meeting stricter criteria for FSD (and thus not be worth worrying about,) or because these women have bought into the media hype.
I believe that women with FSD have the potential to gain improved treatment through well controlled studies, but when the methodology or numbers are skewed or questionable, problems ensue. It’s not just problems with the numbers themselves, though that certainly is worth looking into. Media response matters, too.