We Can Each Decide

In October, I traveled to Washington DC to participate in a public meeting and scientific workshop on female sexual dysfunction. The meetings came about because questions had been raised about whether the FDA was paying enough attention to women’s sexual health, and whether they’d set the bar higher for products for women than for comparable products for men (think Viagra or the 25 other prescription drugs for erectile dysfunction [ED]). ABC’s 20/20 found the meetings newsworthy enough to do a segment on the pursuit of “pink Viagra.”

I’m a pragmatic, Midwestern menopause care provider. I see women who are at all points of the spectrum from mild discomfort to despair. I make recommendations and write prescriptions for quite a range of options—from use of lubricants and vibrators to off-label testosterone. I certainly know that there’s no one-size-fits-all solution, no silver bullet, no magic pill that’s going to make every woman’s sexual experience legendary—or even comfortable.

As we’ve said before, women’s sexual desire, arousal, and response are complicated. Emotional security and intimacy, sexual history, and relationship satisfaction can make an already-complex reality even more difficult to untangle. Every woman deserves an individual approach. Every woman deserves a health care provider who can capably represent the options for treatment, when that’s needed—including describing the benefits and drawbacks. Every woman deserves to make her own choices to govern her quality of life—including her sex life.

So I watch with interest the discussion that’s transpired since the October meetings, reinforcing the messages I heard there. Sexual dysfunction is as real for women as for men. Yes, it’s true that some women find relief without pharmaceuticals. Yes, it’s true that there’s a profit motive for pharmaceutical companies. Yes, there’s a hazard in “medicalizing” women’s sexuality; we are not only biological systems. Yes, it often seems “pharma” is marketing out of control; I know I’ve seen enough ED commercials to last me the rest of my life.

And yet—if the FDA is charged with looking out for all of us, why wouldn’t that include women? And if they’re concerned with all health conditions, why wouldn’t that include sexual health? And if a pharmaceutical option is developed, and found by fair and rational standards to be both effective and healthful, why shouldn’t that option be made available to women who might choose to take advantage of it?

The FDA is accepting comments from the public—especially seeking insight from women who’ve suffered from sexual dysfunction—until December 29. You can read the questions in the FDA’s document online, and then submit your comments by clicking on the blue button at the right on this page on Regulations.gov.

Your story can help make clear what #WomenDeserve.


5 Responses

Dr. Barb
Dr. Barb

July 06, 2015

Dan, Agreed, this is a very complex issue for women. On the other hand, there are plenty of women in great loving, emotionally-supportive relationships that respond to stimulation readily, but they lack desire. Having an option to offer these women to continue to enjoy the benefits of a great sex life would be so hugely appreciated. But not all. We, in the health care field fully recognize that there isn’t a simple solution for this condition of low desire, but that is true for so many conditions we treat. (Have you noticed how many antihypertensives or antidepressants on the market?) Let us, with our patients, have a conversation about the options and then consider treatment risks/benefits and then determine proper next steps. Having a medication as an option would be a great addition for our currently limited list of options.

If 12 years in clinical trials of over 11,000 women is ‘pushing to get approval which may not be in the best interest of the public’, what is a reasonable time for trials, how many more years, how many more women in trials will it take to satisfy ‘the public’? Trust me, the last thing we want as physicians, is to put patients in harms way, and I for one, would never knowingly do that. Are there relative risks to everything we do? Yes, including food consumption, driving to work. It is all about personal decision-making, incorporating risks/benefits and costs (to name a few) and I believe that educated women can make such a decision for themselves.

Dan
Dan

July 06, 2015

Reblogged this on Frankly Speaking and commented:
I just finished reading this post. It is the first time I have decided to reblog something on my blog. I feel this issue is too important for me to do a quick write about it and then add a link you may or may not click.
It is my understanding that a “pink Viagra” is a much more complex drug to create than the “little blue pill.” Men often have the desire but the equipment fails to function properly. The pill creates the ability to function though this is not always a sure thing.

It seems much of the problem for women is lack of desire. Whether pre-, peri-, or postmenopausal they often do not feel desire. Lack of desire, being a complex emotional issue is a totally different from the physical issue of a lack of blood flow to a penis. You are essentially talking about creating a psychotropic aphrodisiac, not just adding lube to make things go smoother. This is really no simple task when you consider all the anti-depressants and their sides effects. For drug manufacturers there will be a push to get approval which may not be in the best interest of the public as the drug may have detrimental side-effects. Viagra is just such a drug. It was originally purposed for another use and the men on it reported this desirable side-effect bonus. For women, the side effects may not be as desirable with what ever drug is finally approved and marketed.

Like Viagra, the cost per unit may place it well out of the reach for most consumers. Less customers means an even higher price to receive the desired return on investment for the drug companies. We have to be careful what we wish for here and not get into too big a rush. I won’t deny though that much of the sexual dysfunction research and budget is aimed at men and that is why a am reblogging this post.

Dan
Dan

July 06, 2015

Barb- It really isn’t fair the way they market the drugs. They woo the consumer hoping they will pressure the PCP who pharma hopes will cave instead of losing a patient. “Well, it may not be effective but it can’t hurt them so I’ll keep them happy and prescribe.” I think they underestimate the integrity of the physicians. I know my former pharmacist-now-doctor was so cautious of internal damage that when he saw no improvement for nail fungus with Lamasil after 6 months he wouldn’t continue it. It may have been because of my age too, but I respected and appreciated his concern. I know I am trusting him with mine and my families members’ lives because of the medical nature particular to the patient/doctor relationship, but when I say I trust him with my life, it goes deeper than that. I trust him to help me make decisions that are in my best interest about things that are of a more elective nature too. I feel like he has my back beyond concerns of his personal legal liability at risk. He’s a great guy. When I see how hard he works and is encumbered by insurance companies and “managers”, I appreciate him all the more and am glad I decided NOT to be a doctor after high school. I love science, but I like autonomy more. I went for the creative arts.

Dr. Barb
Dr. Barb

July 06, 2015

Fortunately pharma doesn’t prescribe the meds; once developed, they market them (and educate as well). So in the end the physician, together with the patient, can determine whether a drug is indicated for a treatment.

Dan
Dan

July 06, 2015

Barb,

It’s not the doctor’s I have the issue with, It’s big pharma looking for a rapid ROI. I’m not saying something new could be another Fen-phen either. Perhaps didn’t make my point well. I agree it would be nice to have an option or two or three. I just think it’s important that women understand that ED and lack of desire are NOT different sides of the SAME coin and a solution for them will likely be more complex and individualized. It won’t be like the class of ED drugs for men I suspect. My PCP is a former pharmacist (Who would decide to go to medical school around 40 yrs?) and I have the utmost respect for him and my wife’s gyn/ob. I’m not saying there’s no need, just that to expect a medical miracle at first blush may be expecting too much for the complexities at hand. I think women should be very alert to their bodies when they begin treatment and not take any adverse feelings as being just part of adjusting to the drug. They need to let their doctors know, especially empathetic female doctors, what they are feeling that is not normal to them. I guess I’m just a belt and suspenders type. I’m not against your point at all. I had not idea of he length of the current and past trials. I sense your frustration for your patients. It’s akin to the way I feel about $10-20 a dose ED drugs that should have gone generic 2 years ago. Men or women, this is about more than having sex, it’s about marital quality of life for many people.

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