The Pill Is Killing Women. Why Wont The FDA Talk About It? – The Federalist

If you’ve watched TV in the last week, you’ve likely seen a commercial for a novel form of birth control called Phexxi. You could hardly miss it, starting as it does with “Welcome to my vagina,” and starring actress Annie Murphy from the wildly popular Emmy award-winning Canadian sitcom “Schitt’s Creek.” As the bubbly Murphy struts about in a cavernous pink bedroom, she promises that Phexxi is something that women have always wanted: an effective, “in the moment,” hormone-free method of birth control.

Phexxi was approved by the FDA over a year ago, but only in the past week has its manufacturer, Evofem, begun marketing the product in earnest. With this shiny new campaign, Evofem is betting on the recently heightened search among women for non-hormonal birth control options.

Deadly Risks and Side Effects

And it’s a good bet, as many women, like Annie Murphy herself, are waking up to the reality that the synthetic hormones found in most methods of contraception come with side effects and risks that are at best annoying, and at worst, dangerous. In fact, many women are increasingly unhappy with the birth control options available to them, fed up with side effects like headaches, weight gain, and more. And those are just the risks and side effects they know about.

When compared to women who are not on the pill or other forms of hormonal contraception, the population of women on hormonal contraception exhibits increased risk (higher prevalence rates) for the following conditions: breast cancer (19-37 percent higher risk), blood clots and other cardiovascular risks (80 percent), cervical cancer (60-220 percent), bone fracture (7 percent for COCs, and 40 percent for progestin-only), certain autoimmune diseases (Crohn’s Disease: 44 percent, Ulcerative Colitis: 18 percent, Lupus: 19-130 percent, Interstitial Cystitis: 131 percent), female sexual dysfunction, depression (10 percent for COCs, and 20 percent for progestin-only), and even attempted suicide (97 percent) and completed suicide (208 percent). When compared to women who are not on the Depo-Provera “birth control shot,” women on Depo exhibit a 40-49 percent higher prevalence for Human Immunodeficiency Virus (HIV), the virus that causes Acquired Immunodeficiency Syndrome (AIDs). In other words, the Depo shot appears to increase a woman’s susceptibility for contracting HIV. (Data supporting all of the relative risks deduced in this paragraph by the lead author of the citizens petition, Dr. William V. Williams, can be found in the complete citizens petition, which is available for download here.)

Furthermore, an estimated 300 to 400 American women die every year from vascular diseases like heart attacks, strokes, and blood clots alone that are exacerbated by hormonal contraceptives. To put that into perspective: Meningitis killed 45 individuals (of all ages) in 2017, and most U.S. states mandate meningitis vaccination for college and university students (and let’s not even get into the number of college-aged individuals for whom the COVID-19 vaccine is now required, despite how low their risk of serious illness is).

Now, that litany of risks and side effects doesn’t sound quite right, does it? After all, women are constantly assured that birth control is safe and effective, and many are baldly told by their doctors that whatever symptoms they experience while on it are “in their heads,” or that “the pill doesn’t do that.”

FDA Ignores Concerns While Approving Iffy Products

But in 2019, the non-profit women’s health organization Natural Womanhood and a group of doctors and researchers put together a 90-plus page citizens petition to the FDA citing the robust, scientific evidence for every single one of the risks I listed above. They submitted this petition to the FDA two years ago, asking for greater transparency and evidence-based warnings about the risks of hormonal birth control in prescribing information and in product informational inserts.

After a cursory request for a few additional pieces of information from the FDA (which was promptly provided to them by the research team), Natural Womanhood has heard nothing in response but crickets. This is despite the petition garnering over 150 public comments, many of them from the families of young women who have died as a direct result of their use of birth control.

Women are, quite literally, dying for better birth control. Hence the perennial search for “hormone-free birth control,” and why the Phexxi site is emblazoned with “Hormone Free” in big, bold letters under a confident-looking Murphy. But even hormone-free Phexxi comes with its complications: it’s a gel that works by altering vaginal pH to make it extra inhospitable to sperm, which is why women who have recurrent urinary tract infections (UTIs) are discouraged from using Phexxi, and why the most commonly reported side effects are “vaginal burning, vaginal itching, vaginal yeast infection, urinary tract infection, vaginal area discomfort, bacterial vaginosis, and vaginal discharge.”

“Women also reported genital discomfort, pain while urinating, and vaginal pain,” continues Phexxi’s safety information panel. “Some male partners reported genital discomfort.” But hey, nothing like itchy, burning genitalia to get folks in the mood, right?

Additionally, Phexxi is about 93 percent effective with perfect use and about 86 percent effective with typical use, putting it roughly in the same efficacy range as condoms. (The other popular hormone-free option of birth control — the copper IUD — is 99 percent effective, but comes with its own significant risks and side effects, including a nasty habit of breaking and migrating in women’s bodies).

What the FDA Would Do If It Cared About Women’s Health

It’s interesting that the FDA has chosen to ignore the petition I mentioned above, yet has continued to approve birth control products like Phexxi in the meantime. Is it because they know, on an as-yet publicly unacknowledged level, that women both want and need safer, non-hormonal options for family planning? Or is it that they just want there to be as many products on the market as possible for preventing pregnancy — side effects and risks be damned?

After all, the Johnson & Johnson vaccine was at least temporarily yanked from the market after being linked to far fewer cases of blood clots than is typical for hormonal birth control use (yes, even if a woman isn’t a smoker or over age 35). Yet birth control seems destined to remain a sacrosanct, permanent fixture of our Pharma landscape, and without transparent acknowledgment from public health officials that it might be a possible source of a myriad of issues, from increasing rates of anxiety and depression in teen girls, to our autoimmune epidemic, to skyrocketing breast cancer rates, just to name a few.

If our public health officials really cared about giving women all of the options and information needed to prevent pregnancy, they’d speak more honestly about fertility awareness methods (FAMs) — the only truly side effect-free forms of effective family planning available — instead of actively discouraging their use, and wrongfully maligning them as the ineffective, outdated “rhythm method.” (By the way, many modern FAMs have both perfect and typical use rates that far outpace Phexxi’s.)

But at the very least, the FDA should better inform women and their doctors about the evidence-based risks and side effects of hormonal contraception. Then physicians might stop gaslighting women into thinking that their negative experiences on birth control are imaginary.

If you’d like to help better protect women and be part of the movement to light a fire under the FDA when it comes to the harms of synthetic hormones, I encourage you to sign and share Natural Womanhood’s petition today.