I find I am surprising people when I say I will be shocked and disappointed if the FDA agrees with its advisors and rejects Flibanserin, a new drug from Boehringer Ingelheim, shown to help some women recover sexual desire.
And I’m shocked and disappointed by agencies and colleagues who are condescending to women, assuming they are unable to think through marketing hype to make decisions about their own health.
In my menopause care practice, the women I see who are experiencing difficulties with their sexuality are often deeply informed about their conditions even before consulting me for help. They do not rely on advertising or television to inform their own sexuality. They consult experts. They consult their physicians. They are perfectly able to sort fantasy from reality.
Their concerns about their lack of desire are real. Their experiences of desire leaving them are real. The effect that this has on their wellbeing is real. And there are very few tools available to help them.
Maybe Flibanserin as a treatment for Hypoactive Sexual Desire Disorder (HSDD) isn’t the perfect tool for every woman experiencing depleted sexual desire. But for some women, some of the time, clearly it helps. Help begets hope, and as a doctor, I’ll tell you that hope is as important as any pill in restoring good health.
I myself suspect that “HSDD” is an invention — a committee invented a new name for a cultural issue as old as time. There has never been and will never be a time in human history when the libidos of men and women match up perfectly forever. I am not interested in medicalizing what may be a woman’s normal or even beneficial biological response to stress and aging — our libidos may well drop for very good reasons.
Nevertheless, I have had women in my office, losing sleep, depressed, miserable, because the lack of intimacy where it is wanted often has a domino effect, destroying communication, trust, a couple, a family. For these women, overcoming our ancient biological responses to stress — in a modern world where stress is constant — is what they want and need, and as a doctor, I would like to be able to help them.
I really don’t think the pharmaceutical companies are the bad actors in this case. Human tensions create business opportunities. You can’t blame a pharmaceutical industry for doing what it does.
But I do worry that the FDA will overstep by taking this choice away. The side effects reported in the trials are not life-threatening. They are not ubiquitous. They are a risk many of my patients may be perfectly willing to take for any advantage, even a slight one.
We are able to make our own decisions about what is best for our health and our lives. Really.
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i use a combo of shea butter and aloe vera moisturizer. Works great. I use shea butter on my lips, around my eyes and nose (dry areas), My father swears by vasoline.
p.s. I dropped your name on Gina's post, Barb. ;)
The FDA has been doing this for years — and surely will not stop now. I don’t get what they get out of thinking women cannot think for themselves. Some kind of midieval macho thing. I have to disagree regarding the pharma companies — they cook the stuff, create uses, put side effect issues in tiny print and probably – the truth is — FDA simply does not have the staff to check out all the stuff pharma promotes. If a drug is said to cure A and after a while it doesn’t work — they then change the label and the use and call it Cure B.
I humbly disagree with you Barb — I do blame pharma for doing what it does — and — their bottom line is profit, profit, profit.
I absolutely agree with you 100%, Maggie.
It was a German pharmaceutical company who first tested Flibanserin for depression and, while not particularly successful for that, found it helped women’s libidos. (If I have my story straight) I wonder if the big U.S. pharma companies put pressure on the FDA to disapprove it because it wouldn’t be them reaping the benefits? Makes sense to me.
Thank you so much for this. I first became aware of Flibanserin earlier this year when I read about the results of the 2009 clinical trial in Germany. I was so hoping something might be on the horizon to help.
For me, aging has meant loss. . . . .loss of loved ones through death, loss of health, loss of looks, loss of old friendships. The list goes on and on. Loss of ability to organism is yet another. (And, yes, I have dropped 35 lbs, I exercise, I’ve been going to a counselor. I recently passed a physical with flying colors. Arthritis is a continuing problem, but I can handle it.) My husband of 35 years cares, but none of the foregoing seems to matter.
I wish there were more Dr DePree’s to advance the cause of those us who would like to hold onto something that brings us pleasure as we head toward the “last roundup.”
Dear Dr. DePree,
We appreciate your point of view on your blog posted on VIBRANT NATION. Women deserve sexual satisfaction…plain and simple. As you are aware, nearly 50 percent of all women have sexual concerns and difficulties. If such products as Flibanserin can help women begin to consider their options, all the better.
Meanwhile, there is new hope for women who are looking for a safe, natural alternative to sexual enhancement. As owners of Semprae Laboratories, marketers of Zestra, we are have spent many years speaking to women and understanding the language they use to describe their unmet needs. Recognizing these unserved needs of women, we have formed the company dedicated to female sexual health and wellness. Our core premise…better sex effortlessly.
Thanks to Zestra, many of these women are ready to break their silence about their sexual dissatisfaction. Until now, 90 percent of women have been reluctant to talk about it. Zestra is a topically applied botanical oil, with a patented blend of natural ingredients..and it’s hormone free and paraben free. And, two independent clinical trials we voluntarily conducted in 13 markets across the US…published in the Journal of Sex & Marital Therapy…documents Zestra’s effectiveness as the first topically applied, clinically proven product in this category to safely and significantly boost women’s libido and enhance sexual pleasure. The results are amazing…70 percent of women reported highly favorable results using Zestra. Women start feeling Zestra’s effects…the Zestra Rush, deep, pleasurable, and prolonged sensations, within minutes of applying it.
What is especially encouraging is the reaction we have received from thousands, from new moms to women entering menopause, who have discovered Zestra. Visit our link at http://www.zestra.com so you can read some of these personal accounts and listen to some of the recent press about the product (Dr. Oz, Oprah radio, WOR 710 AM). What’s exciting that at last, women have jumped into the conversation with their friends and their health care professionals…who have tried it and are recommending it to their patients.
Send us your email, and we will send you samples and complete details about this new breakthrough that is giving many women new hope. “It sends you to the moon, baby,” remarked one sexually satisfied Zestra user.
Sincerely,
Rachel Braun Scherl President Semprae Laboratories http://www.zestra.com
Mary Wallace Jaensch CEO Semprae Laboratories http://www.zestra.com
Yes, I know of your product and have recommended it. While my experience is that it can enhance arousal, it has not been particularly effective with libido.
email @ barb@middlesexmd.com
I agree completely–I tried Zestra a few years ago when I was having problems with sexual desire. Zestra did seem to improve the sensations of foreplay, but it had no effect on desire to HAVE sex, which was my big issue. Many women I know can still have orgasms, but they no longer have sexual desires, don’t think about sex, don’t have erotic dreams, and frankly just don’t care if they ever have sex again–with anybody!! And they mourn the loss of those feelings greatly. In addition, the loss of sexual desire puts great stress on their marriages. This is both a huge psychological and social issue for menopausal women.
I tried every pill, herb, cream, etc on the market when I was going through this myself, worked with both an internist, gynecologist, and psychologist and nothing helped me. But, I am thrilled to say that I am in my 60s now and my libido is restored. Sex is better than ever and my desire to have sex is as strong as it was in my 20s. Two things happened: I got a divorce at 63 and started dating, and I moved and had to change doctors and my new doctor put me on an estradiol patch and natural progesterone time-released pills.
I realize that new partners can definitely ramp up desire and that’s not an option for most, but I really believe the patch is what is mostly responsible for my restoration of desire. Not just foreplay, but intercourse just feels good again, whereas before it seemed I had lost all sensations in my vagina (except for discomfort). In addition, now all my menopausal symptoms are gone whereas before–even with HRT pills–I still suffered from sporadic hot flashes and night sweats, and always with dryness–skin, hair,nails, vulva. The hormones I use are bio-identical, and I encourage other women to discuss this option with their gynecologists. It’s not just my sex life that’s improved–it’s my mood, my energy, my sense of self and being alive, my feelings of youthfulness. These things are worth fighting for!!! Please note that I’m not currently in love so this is not the euphoria of new love speaking, but I’m having regular sex with caring partners and I’ve sustained these strong sexual feelings for 3 years now.
You bring up 2 really important factors in all of this, hormones and a new partner.
Many of my patients chose to use HT in menopause and over 95% are on bioidentical formulations with nearly all on transdermal (non-oral) estrogen. Oral estrogens happen to decrease your natural circulating testosterone levels, and we need all we can get! Last week I saw a patient back in follow-up. She initially presented to me about 6 weeks ago after having had a hysterectomy she could no longer have an orgasm, and had been placed on oral estrogen after the hyst. The only change I made was to a transdermal estrogen, and now she is once again back to having the ability to achieve an orgasm. The non-oral estrogen allowed her natural testosterone to rise. Point is, there are subtleties in this for many women and paying attention to subtleties can be extremely important in function. I would agree that for some women estrogen plays a really important role for them sexually, especially for comfort, and sometimes for desire.
Having a new, emotionally supportive partner is probably the biggest factor in improving libido; not practical for some of us!
Thanks for your input.
Thanks for your recommendations, Dr. DePree. We receive many testimonials daily. Here are but a few of many from women grateful to Zestra for its ability to boost their libidos.
“Over the years, my sex drive has diminished. I tried every OTC product I could find. While looking on the internet, I saw Zestra. I am so happy with this product.” Diane, Columbusi, OH
“WOW. I am just getting over brain surgery and all the medication I was taking put some effect on my body and sexual appetite. But I saw Zestra on TV and ordered the product. I was truly suprised. Thanks for this amazing product.” Alison F
“I haven’t had sex..for a while. I am a mom of four and 28 years old and on depression/anxiety medication which decreased my feelings of wanting sex….THANK YOU so much for making Zestra.”
Anne K, Kansas
Rachel B/ZESTRA
Barb~
There are natural alternatives that can help without resorting to harmful pharmaceuticals. Have you ever looked into bio-identical hormones/Wiley Protocol? If back on a natural cycle with natural hormones, libidos, stress, mood, and life will improve greatly.
I have concerns that the FDA does not regulate Big-Pharma enough, its all about the money, Big Pharma will find a way to get you to buy their drugs, even if its not helpful.
Yes, there are natural alternatives out there. Herbal extracts are produced using botanicals from nature that effectively help with this issue. Plants were put on this earth for a reason, and they have been used for generations by most cultures for health purposes. The key is to educate ourselves on herbs used in alternative medicine.
Yes there are many options. And over 95% of what I prescribe for patients are bioidentical and FDA approved. I have had failure after failure of compounded products because of variation in symptom relief for patients. While I will occasionally use compounded products and are open to that, I have found the consistency of the bioidentical pharmaceutical products is more acceptable to my patient population.
I agree, it would be wonderful to have a drug that works for women that truly have libido issues. Bodies that no longer respond physiologically to create sexual pleasure. However, this particular drug works on the brain to lower inhibition. The depression, loss of sleep, domino effect rarely starts from loss of libido, usually other way around. Drugs women take for depression lower libido, loss of sleep & malaise after menopause have been shown to be effected by hormonal inbalance. A good endocrinolist can usually change this with bio-identical hormonal treatments.
I educate women to how their libido’s function. Once they understand their personal sexual response cycle it is a rare women who cannot create a sexual awakening.
As I am sure you are aware. studies show that testosterone supplementation also helps women’s libido, however the last attempt to pass that through the FDA was also denied. Of course it is possible to cut down the male doses of testosterone, or go to a compounding pharmacy, but a simple patch in appropriate dosage was being offered. Are there risks? There are risks with Aspirin, ibuprofen tylenol. Some of the worst side affects come with anti depressants that they pass out like candy to menopausal women as a “cure all”. But to answer your question “why doesn’t the FDA want us to have sex” or even be sexy. It seems like crime for us over 50 and me reaching almost 60 are criticized for trying to look and feel our best. It is just not right for grandma to be sexy. With many women living into their 90s we do not need to be told by the govenment that we cannot be sexy or have sex. When will we be given the same consideration as men?? i.e. Viagra et al.
Yes I agree! I use a lot of testosterone in my practice after careful conversations with women about the lack of FDA approval, etc. But there is a significant amount of research available from outside of the US to reference (eg a great article in the New England Journal of Medicine in Nov ’08) about testosterone use in women. I will use a male product starting at 1/10th the dose recommended for men, and then I follow blood levels and try to achieve levels that are normal for women and not supraphysiologic.
In all of these discussions with women, I find different things work for different women. If we can have more safe options, we may be better able to help more women.
Maggie D is right on the button! But I need to ask if either of you has written the letters about governing the pharma when they act as if they are getting new software ahead of the market instead of drugs worse than the disease? About beefing up the FDA and blowing the whistle when former FDA biggies go to work for pharma or for lobbies?
Margaret Fleming
As a psychologist and sex therapist, I share your compassion for women who have lost their desire. As a psychotherapist who has worked alongside physicians in a variety of settings, I also understand how important it feels for the physician to have the right pill to cure the ill. However, there are many problems with this failed antidepressant. For one thing, it increases dopamine in the brain, which may have the side effect of increasing impulsivity. Thus, as with medications for Parkinson’s, I would expect to see women develop compulsive behaviors. Secondly, we both know that there will be a huge marketing campaign telling women that this is a medical problem. In some cases, that may be, but in most cases it is NOT a medical problem. Not at all. There can be underlying depression, anxiety, post traumatic stress from childhood sexual abuse or other trauma, pain disorder, body dysmorphic disorder, eating disorder, chronic illness, obsessive compulsive personality, in addition to the panoply of relationship difficulties, all things that I have researched for my upcoming book Sex, Love & Mental Illness: A Couple’s Guide to Staying Connected.
While you may have women in your office weeping about low libido, I have women who are learning about themselves as they explore their sexual and relationship development. We also talk about Basson’s circular model of desire, in which women in long term relationships don’t have a linear experience of desire, e.g., “I feel horny, so I want sex.” It’s more relational: I feel good about myself and my partner. My partner approaches me. Now I feel horny.” It takes away that feeling that you have to somehow produce a feeling that just isn’t there. And it puts responsibility on both partners to tend to their relationship, so that they can have a healthy sex life.
Yes, therapy takes time–in my practice, 12-24 sessions on average, sometimes longer, sometimes shorter. Yes, it costs money, but insurance covers mental health, and there are clinics in most every community that provide low or no cost. Physicians feel compassion, but have little time. The appropriate response is not necessarily a pill, but a referral.
“Risks women would be perfectly willing to take?” Are you kidding me? What about the women whose partners would pressure them into taking those risks? You think that wouldn’t happen? Women have been used by the drug companies as guinea pigs for far too long. I’m happy to see the FDA doing the due diligence they did not do when drug companies were touting the “safety” of Premarin only to have cases of breast cancer and strokes increase in many of the women who took it.
The decision to be on a medication, or enter therapy, or what ever the intervention may be are often complex, and I wouldn’t always claim to fully understand all of the motivations. But I would say the majority of the women I see are seeking options not only for themselves but probably even more so, for the loving relationship they find themselves in and the motivation to improve that sexually. Maybe some are being pressured by their partners to take risks, but I hope not. As a clinician, it is my responsibility to make sure they understand those risks.
By the way, if you read the WHI Study, the Premarin-only arm of that study (women who had had a hysterectomy) was not terminated in July of 2002, the Prempro arm was. The Premarin-only arm of the study continued for 18 more months and after 6.8 years of use there were 23% fewer breast cancers than the placebo arm! Somehow that didn’t make headlines, but read the study, it’s there. While I don’t prescibe Premarin because I think we have safer options, the media has not always been transparent or balanced. Tara Parker-Pope wrote a great reference for women ‘The Hormone Decision’ reviewing the media influence, etc.
I actually went so far as to sign up and get approved for a clinical trial for Flibanserin . After hearing about all the poking, prodding and questioning I would have to endure realizing that there was a 50% chance I would receive a placebo, I decided not to go through with it. The paperwork I received explained that if you got the drug and it worked, there was still no guarantee it would be approved and available after the trial. I think I had rather just deal with the situation as best I can rather than have a taste of a healty libido again only to have it taken away again. I would be interested to know just what side effects are associated with the drug. I was not given that information because they probably wanted me to discover those on my own during the trial. If available, I would try it.
There are clinical trials going on in my area for testosterone products for women. Recently I saw 2 women who dropped out of the study because they were sure they were on placebo and they wanted the real thing! It underscores how difficult it is to get great studies accomplished!
If you go to fda.gov and search Flibanserin you can find out alot about the clinical trials and the outcomes and side effects.
my husband does not believe that my no interst is menapause related so if there is something out there
lets get it the works