Wednesday, December 3, 2014

Sex, Lies and the Little Pink Pill

Well, the critics are at it again.  This time, she is a patient suffering from HSDD herself and was at the FDA public hearing last month and was actually at my table for a period of time!

Her opinion is, once again, clearly biased against pharma and is even snarky in tone throughout her piece.  Last time I checked, no one was forcing anyone to participate in a "movement" against their will...any more than the critics were forced to come speak out against an FDA approved medical option.

I still proudly wear my button and scarf, just as others wear pink ribbons, red bracelets, etc...

It is one thing to disagree with what others are passionate about but I don't appreciate those critics distorting facts and pushing their own agenda while insulting and wrongly accusing those that personally are experiencing HSDD, had the wonderful opportunity to have the symptoms alleviated just to later have the rug pulled out from under us.

My mother taught me three valuable lessons early in life:

  • Consider the source ( of information - either WHO is giving it or the VALIDITY of it )
  • Check you facts ( verify that your information is factually grounded and credible )
  • Never attempt to take a spec from someone's eye before I remove the LOG from my own ( do not speak on behalf of someone else when you have not walked in their shoes )
Here's a link to her "opinion" and my response below.  



Sex, Lies and the Little Pink Pill


I continue to be stunned by the PDA (public display of anger) published in media by women with regards to the approval of a drug to treat low desire in women. From the LA Times to the Washington Post, critics continue to lash out, grossly distorting facts and misinterpreting intent about a clinical drug trial on which they were not even a participant. I was raised on three principals and I feel these critics would do well to follow these rules: consider the source (of information), check your facts (there is published data which discredits your claims) and don’t try to speak as an expert about something for which you are not (if you are suffering with HSDD but were NOT on the trial, do not attempt to speak about its effects).

The most recent attack came from a woman in Allentown, PA who was, in fact, a patient panelist at the recent FDA hearings in Silver Springs, MD… I was also at the meeting as an actual patient on an actual clinical trial for an actual drug being studied to treat low desire in women. It is this willful and misguided active opposition to flibanserin (by someone who has NEVER taken it) which I find distressing. 

To say that a pharmaceutical company hopes to “convince women with sexual problems that a drug called Flibanserin will cure them” is absurd. .  Being one of those women myself, and being raised here in the Bible belt, I would say the campaign is geared more toward empowering women to share their experiences and seek help.  We live in a culture where women are supposed to be soccer moms and June Cleaver, not passionate women who actually initiate and enjoy a healthy sex life. Most women I know are hesitant to speak about sex, have bought into the idea that sex after babies is for the benefit of their husbands and quite frankly, this is wrong.  You cannot turn the TV on without seeing a Viagra or male Low T advertisement.  Informing women that there is a potential therapy that may help them, to me, is just cause.

The  claim that “Flibanserin has not been shown to have a significant effect relative to placebo, and there are safety concerns about long-term side effects” is factually wrong.  According to published trial data, Flibanserin not only demonstrated a highly statistically significant difference over placebo on three key endpoints but also was well tolerated with side effects not unlike those found when using Advil.  Further, Flibanserin has been studied in over 11,000 women making it one of the most studied women’s health products in history.

Here’s where I can offer personal perspective. In terms of the three primary endpoints of the study, I reported YES, YES to YES to all three!  In fact, while on Flibanserin, I definitely had an increase in my sexual desire, experienced a significant drop in the distress caused from the loss of sexual desire and happily increased the frequency of satisfying sex. Who better to ask about the effects of Flbanserin than my (now) husband?  He enjoyed all the same benefits as I did and will tell you emphatically that the dramatic change from obligatory sex to my inner kitten initiating sex was like a fruit cake… it was the gift that kept on giving!

Although Ms. Hicks may have arrived in MD in her 10 year old car, there were other critics who were compensated to speak out against a medical option for HSDD.  The truth is, I read about the FDA hearings on twitter and signed up that very day, booked a hotel and purchased by plane ticket LONG BEFORE eventhescore.org became involved. My husband and I went because we were lucky enough to have enjoyed the benefits while I was on the trial. For the record, I, too, had cereal for breakfast.

The calculation that 5 of the 8 panelists were part of the PR campaign is exactly what you said… YOUR calculation.  Regardless, they were HSDD patients like yourself so does it even matter? Yes, I am a white, middle class woman in a stable relationship (at the time of the trial but am now married) who tried off label testosterone after the flibanserin trial ended, to no avail.  Of course women with more serious medical issues or emotional based relationship issues were excluded from the trial.  If a woman is bouncing from man to man her lack of desire is more likely rooted in an emotional issue.  Lack of desire in the absence of emotional issues within a stable and happy relationship is true HSDD. A vast majority of prescription and over the counter drug labels reflect the same disparity.  Not many companies are willing to enroll patients with known medical issues into a clinical trial and logically so!  Pregnant women are almost always excluded, patients with heart troubles, risk for stroke…

I do agree that the use of testosterone by women is risky.  Potentially serious and life altering side effects can occur but the side effects reported on flibanserin were nuisance side effects: headache, fatigue, nausea and dry mouth.  Further, they were transient and guess what?  Read the product label for ADVIL which carries the same nuisance side effects but far more potential for serious adverse events. Consider this.  The FDA just approved a drug for men with curved penises and the number one side effect?  RUPTURED Penis!  Seriously? And you are worried about a headache or a touch of nausea?

Yes, you could give women a little pink heart shaped placebo pill and it may work for some, for a while.  Same can be said for anti-depressants, weight loss drugs, anti-age skin creams… almost every drug ever studied shows a high placebo effect in the short term.  But the honeymoon will end which is why the over the counter industry for libido enhancing products is booming.  Women will pay insane amounts of money on unfounded, unproven promises of increased desire. They’ll work temporarily, but soon she is back ordering off the internet or visiting her local supplement shop for something to help.  God forbid she actually tell anyone!

Lastly, Ms. Hicks, no one will force a woman to get a prescription and pay for it.  You certainly don’t accuse pharmaceutical companies of forcing men to buy Viagra which is outrageously expensive.  They buy because they choose to.  They make a decision with their doctor to try an FDA approved medical option.  Yes there are risks (blue vision, heart rate issues…) but the benefits of satisfying sex far outweigh those and at least men have several choices.

In conclusion, hypoactive sexual desire disorder is a very real and common condition for women. Perhaps it is a silent disorder because women are either afraid to talk about it or more importantly, there is no FDA approved medical option for them.  Therapy may work but for many, like myself, my lack of desire is not rooted in emotional distress.  It causes emotional distress but having been together for ten years, we are very active in romancing each other, speaking each other’s love languages and most importantly still have an insane physical attraction to each other. We are a well -oiled machine that happens to be missing a spark plug.  All the moving parts in order and working, but that spark would help “start things up”.
All I know is I will be the first in line to get a prescription when the FDA finally gives its stamp of approval for flibanserin. That is, if my husband doesn’t beat me to it! 

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