Truthiness in Advertising: Is Qlaira® Really a “Natural” Birth Control Pill?

New oral contraceptive, Qlaira®  is being marketed as “body-identical” but a closer look proves otherwise.

The headline of the “consumer media” press release from Bayer Healthcare says, “Natural hormone inspires new contraceptive pill.”

Really?! I thought. This could be exciting! But of course it was not to be.

Qlaira®, a new oral contraceptive approved for use in Europe is being marketed as a “natural” contraceptive because it contains a “body-identical” estrogen, another way of saying bioidentical. Bayer Schering Pharma, the manufacturer of Qlaira®, hasn’t made the actual leap onto the bioidentical bandwagon, but they apparently want to tap that market via misleading marketing. In the spirit of truthiness, they want to be natural but it just ain’t so. Qlaira®  contains an almost-bioidentical estrogen and a very synthetic not body-identical progestin. It’s like saying that a Twinkie is natural because it contains high fructose corn syrup.

Estradiol Valerate
The estrogen in Qlaira®  is estradiol valerate which is close to being bioidentical, or body-identical. Once the body removes the “valerate” part of the molecule, it becomes estradiol, a bioidentical estrogen.

Dienogest
The other hormone in Qlaira®  is dienogest, a progestin, which is a progesterone that has been tweaked in the laboratory to create a decidedly not body-identical hormone. Or to put it another way, dienogest is not found anywhere in nature—it is man-made.

Dienogest is a progestin with antiandrogenic effects, meaning that it reduces testosterone levels. It also has anti-mineralocorticoid effects, which means it can reduce the effects of bloating (water retention) often caused by excess estrogens. Like most of the progestins found in oral contraceptives, dienogest increases many of the blood factors that increase the risk of having a stroke.

Dienogest blocks the formation of ovarian follicles, which means that women using it do not ovulate, and therefore do not produce hormones, including estrogen, progesterone or testosterone. Thus, a woman taking Qlaira®  will have little or no testosterone (and possibly no sex drive as a result), no progesterone, and some estradiol. The dienogest will have some progesterone-like effects, but will not have the full spectrum of natural progesterone effects.

A German study examining the effect of high doses of dienogest on endometriosis found the women taking it had a significant reduction in breast size. This doesn’t necessarily mean that Qlaira will reduce breast size.

Qlaira®  Marketing
Bayer is so far focusing its marketing on the estradiol component of Qlaira®, which is unique. It is the first oral contraceptive to use an essentially natural estrogen. However, pretending that this makes it a “natural” contraceptive by ignoring the dienogest is misleading. It’s likely that if this product isn’t already in the U.S. FDA pipeline awaiting approval (possibly under a different name), it will be, and the marketing will undoubtedly follow the same twisted path. Buyer be aware.

Since this was first published, Qlaira has entered the FDA pipeline to be approved for sale in the U.S. Bayer will undoubtedly try to put one over on American women as well; when they start their marketing engines in the U.S., I hope you’ll help me expose the deceptive bioidentical label by writing/commenting to media outlets, from newspapers to TV to websites, that regurgitate Bayer press releases without checking the facts.

References

electronic Medicines Compendium (eMC): Information about UK-Licensed Medicines
http://emc.medicines.org.uk/medicine/21700/SPC/Qlaira

Okada H, Nakajima T, Yoshimura T et al, “The inhibitory effect of dienogest, a synthetic steroid, on the growth of human endometrial stromal cells in vitro,” Mol Hum Reprod 2001 Apr;7(4):341-7.

Sasagawa S, Shimizu Y, Nagaoka T et al, “Dienogest, a selective progestin, reduces plasma estradiol level through induction of apoptosis of granulosa cells in the ovarian dominant follicle without follicle-stimulating hormone suppression in monkeys,” J Endocrinol Invest 2008 Jul;31(7):636-41.

Schindler AE, Henkel A, Christensen B et al, “Dienogest and the breast. Gynecol Endocrinol 2009 Jun 2:1-3. [Epub ahead of print].

Shimizu Y, Takeuchi T, Mita S, “Dienogest, a synthetic progestin, inhibits the proliferation of immortalized human endometrial epithelial cells with suppression of cyclin D1 gene expression,” Mol Hum Reprod 2009 Jun 5. [Epub ahead of print].

Wiegratz I, Stahlberg S, Manthey T et al, “Effects of conventional or extended-cycle regimen of an oral contraceptive containing 30 mcg ethinylestradiol and 2 mg dienogest on various hemostasis parameters,” Contraception 2008 Nov;78(5):384-91.

Zimmerman H, Thebault JJ, Duvauchelle T et al, “Pharmacokinetics of Estradiol Valerate 2mg + Dienogest 2mg (Climodien 2/2) after Single and Repeated Oral Administration in Healthy Postmenopausal Women,” Clinical Drug Investigation 20, Number 2, August 2000 , pp. 123-134(12).