GSM – Now That Trips off the Tongue

When I was in my late fifties, I went to the gynecologist convinced I had a yeast infection.  The burning sensation in my vulva was not responding to over-the-counter treatments.  That was because I did not have an infection.  Instead, I had the beginnings of what was then called vaginal atrophy, and has since been renamed Genitourinary Syndrome of Menopause, or GSM.  What I needed was not an anti-fungal.  What I needed was vaginal estrogen, a cream made with estradiol, a hormone that treats the condition with minimal absorption into the rest of the body.

I was incredulous.  What the devil was this condition?  Why didn’t anybody talk about it?  Somebody sits you down for “The Talk” when you start menstruating.  Where was “The Talk” about this?  The doctor gave me a couple sample tubes of estrogen cream and said, “Be sure you don’t use this as a lubricant for intercourse.  Not good for your partner.”  When I used up the samples and had to buy it, the copay for one tube was forty dollars.  Forty dollars!  I was outraged.  This was a chronic condition, and I was going to use this medication for a long time.

When I tried the stuff, I loved it.  I even wrote a poem about how great estradiol was.  And estradiol would be great for a lot more women if they could afford it.

Estimates are about half of peri- to post-menopausal women have this condition that nobody talks about.  And of the women who do have it, only about half receive treatment for it, for several reasons including lack of information and the high cost of medication.  The symptoms of GSM can include burning and irritation of the vulva, dryness, discomfort with intercourse, urinary incontinence, and changes in the vulva biome leading to recurring urinary tract infections.  Nothing anybody would stand in line for.  And the reason this happens?  The affected structures share a common origin when we are embryos, and then are similarly affected as our estrogen levels drop with age.  Tissues can thin and we can lose elasticity, flexibility, and blood supply.

The good news is that GSM can be treated with vaginal moisturizers, water based vaginal lubricants, and most importantly, vaginal estrogen creams.  These creams are preferred to oral hormone replacement therapy because, although steroids are notorious for crossing cellular boundaries, when we use the creams more estrogen stays local where it’s needed.  As a result, women who use vaginal estrogen cream do not have the slightly increased risk of breast cancer, heart disease, or blot clots that can result when taking oral estrogen after menopause. (There are differences of interpretation about the link between oral HRT and cancer.  For more on the arguments in favor of oral HRT, please see the book Estrogen Matters cited below.)

GSM treatment with vaginal estradiol cream will be the focus of this three-part blog series.  This first part is an overview.  Part Two tells more about how we are being ripped off.  Part Three has suggestions for what we can do about it. And I live in hope that now we have a woman as Vice President, issues such as these will get more attention – at least once the big issues of the year are resolved.

Estradiol:  What it is; how long it’s been around; what it costs and why.

Estradiol is a steroid and a human sex hormone that is present in men and women.  In women, it is the most important form of estrogen and is key to development.  It has a simple chemical structure, and there is no patent on estradiol.  If you buy pharmaceutical grade estradiol from a chemical supply house, you will pay $70 for a gram, which is enough to make a hundred-year supply of estrogen cream.

The forty dollar copay that outraged me half a dozen years ago was nothing compared with what I’m paying now.  The price of estradiol has gone up 400% in the past four years, and even with AARP health insurance on top of Medicare, I’ve been paying over $100 in copay per tube.  That cost is prohibitive for a lot of women who need it, especially those who are retired.  There are 55 million women in the United States over the age of 51, which is the average age of menopause.  Over half of those women experience GSM, and half of those women remain untreated, often due to the cost of medication – which means close to fifteen million women are suffering in silence.  This is an epidemic of a painful yet treatable condition.

The Roots of the Untreated GSM Epidemic

One of my favorite articles on the subject is fifty years old.  “Senate Panel Cites Mark-Ups on Drugs Ranging to 7,079%” was published in a front-page article  New York Times article on December 8, 1959.  Anti-trust investigators including Senator Estes Kefauver of Tennessee questioned executives from Schering Corporation about a seven thousand percent markup on certain estrogen hormone drugs.  For ethinyl estradiol, the markup was 2757 percent.

“Do you think this is a fair markup?” asked Senator Kefauver.

“These drugs are not an important part of our business,” Schering’s president replied.

“They are important to the people who need them,” said the Senator.

Without insurance, estradiol cream now retails for around $400 per tube.  While I do not have access to the manufacturing costs for estradiol cream, we can estimate the markup by comparing that retail cost with another vaginal cream that also contains an off-patent steroid hormone.  Vagisil for Sensitive Skin is a vaginal cream that contains hydrocortisone and is manufactured and tested under FDA Good Manufacturing Practices, just like estradiol cream.  The manufacturers of Vagisil are presumably making a profit at their retail price of $8 per tube, a 5000% difference versus the retail price of estradiol cream.  A 5000% markup is in the same ballpark as the markups that led to a Senate anti-trust investigation half a century ago.

So it is no surprise that there are new price fixing allegations about estrogen.  I’ll talk more about that in Part 2 of this blog, coming later this month.

To Learn More about the Topics in Part One:

1959 New York Times Article about Senate Price Fixing Investigation:

Article about GSM as a new name for vaginal atrophy:

Book advocating why taking hormones in menopause can improve women’s well-being without raising the risk of breast cancer:

Coming Up Next:

Part Two:  Estradiol – The Scam What Am.

Part Two examines the “research” rationale for high estradiol prices, and why it doesn’t hold water.  Then we will talk about why FDA approval of generic estradiol has not significantly improved the pricing for this product, and why even women with insurance pay so much for estradiol.

Part Three:  Take Care of Your Rose – What Pissed-Off Grannies with Vulvas Can Do

Part three looks at actions we can take at an individual level, how we can educate ourselves and how we can break the silence and organize for change.