Sex after Menopause should not be painful, but OSPHENA™ is not the answer. This drug should never have been approved by the FDA and in spite of the False Advertising claiming that it is a “Non-Estrogen,” it acts just like Estrogen, activating Estrogen Receptors causing the same side-effects as Estrone and Estradiol. The good news is that Estriol, the safe, natural, Bio-Identical Hormone, actually works better AND reduces your health risks.
OSPHENA™ is the latest drug approved by the FDA for the “Treatment of Atrophic Vaginitis due to Menopause.” It is an Estrogen look-a-like drug, which means it is a synthetic copy of Estrogen that so closely resembles Estradiol that it binds to the same Receptors and causes some of the same actions, and side-effects.
On the “black box” WARNING that will feature prominently on the prescribing information insert for physicians about OSPHENA™, the lists of risks include the following: uterine cancer, strokes or blood clots, unusual vaginal bleeding, heart attacks, severe liver problems and breast cancer.
Other bothersome side effects that showed up in clinical trials included twice the rate of urinary tract infections, three times the rate of hot flashes, and 14 times the rate of yeast infections as the women on the placebo.
How did Osphena Get FDA Approval?
Critics note that the two 12-week trials that satisfied the FDA were funded by the drug’s developers, Shionogi, Inc. and QuatRx, a practice that is common but should give the public reason to question the credibility of the company and the FDA. Two of the lead authors conducting the research, David J. Portman and James A. Simon, list so many consultancies, speakers’ bureau affiliations, and board memberships with pharmaceuticals (including Shionogi and QuatRx) that the disclosures take up half of the study’s first published page in Menopause, the journal of the North American Menopause Society.
Casting additional dispersions, The New York Times reported that Gloria A. Bachmann, another lead author of the FDA Clinical Trials, had signed her name to ghostwritten papers, between 1998 and 2005, that downplayed the risks of estrogen without disclosing that the drug company Wyeth had paid for them.
I believe that this drug should never have been approved and would certainly not have been approved, were it not for the financial connections of the principal board members of the manufacturer and the principal researchers.
OSPHENA™ claims in its advertising that it is “the only FDA approved, NON-ESTROGEN, oral pill that actually improves certain vaginal tissue and significantly relieves moderate to severe painful intercourse due to menopause.”
That statement is a half-truth, which means it is a half-lie. OSPHENA™ isn’t an estrogen; but it sure acts like one, and like estrogen-alone therapy, OSPHENA™ increases the risk of endometrial cancer. Stroke and deep vein thrombosis are also increased risks while taking the drug, albeit low ones compared to estrogen-alone therapy, says the FDA. These risks are detailed in a prominent black box warning on the drug.
Shortcomings of OSPHENA™ Clinical Trials
Some experts have questions about the clinical trials that led to the approval of OSPHENA™
• Two 12-week trials were funded by the drug’s developers; the lead authors have strong ties to the companies. Not unusual for drug trials but not exactly an unbiased effort.
• The degree of improvement after 12 weeks was less than half a percent.
• Benefit didn’t far outweigh harm, concluded another reviewer. Roughly, only 14% of the study’s subjects improved (over placebo), while another14% had significant adverse effects.
Alan Cassels, who researches drug policy at the University of Victoria and co-authored the book Selling Sickness with Ray Moynihan, looked over Osphena’s application and studies. “I’m amazed it got approved,” he said. While investigators report a statistically significant improvement for women’s “most bothersome symptom,” at 12 weeks that difference was less than half a percent between the women taking the drug and those on placebo. “You can make it sound very statistically significant, as they’ve done,” he said. “But how does that translate into something meaningful for a person’s life?” A company spokesman disagree but did not elaborate.
Barbara Mintzes, who studies drug marketing at the University of British Columbia, also studied the original FDA application for Osphana. She said that while roughly 14% of women (over placebo) had an alleviation of symptoms, a similar percentage of women also experienced an adverse event, like an infection. “This is not a positive ratio of benefit versus harm,” she wrote in a detailed email to Newsweek. Ideally, she says, you’d want to see the benefit outweigh the harm “by a good margin.” “These are very disappointing results—no one wants to take a medicine that is equally likely to make them worse as to make them better.” Shionogi disputes this analysis.
The truth is that OSPHENA™ should never have been approved by the FDA and would not have been had it not been for biased and greedy connections and less than honest motives that put huge financial profits above the health and safety of millions of women. It causes significant increased risk of serious illness, including uterine cancer, strokes or blood clots, unusual vaginal bleeding, heart attacks, severe liver problems and breast cancer. The risks greatly outweigh the meager benefits.
The truth is that Penn Pharmaceutical Services, Ltd., the maker of OSPHENA™ copied the wrong drug when they made OSPHENA™. They should have simply manufactured Estriol, the Bio-Identical Hormone that is known as the weak Estrogen compared to Estradiol and Estrone. Estriol targets the vaginal tissue specifically, but they couldn’t because God holds the patent for Estriol. And without a patent, there is no money and hence no interest by Big Pharma, even though it has been proven to work better than OSPHENA™, Vagifem®, ESTRACE®, and all other synthetic or Bio-Identical forms of Estradiol.
What Does Dr. Hansen Prescribe for Vaginal Dryness and Painful Sex?
“Estriol, coined the “weaker” of the three endogenous estrogens, has significant therapeutic effects, some of which are little known to clinicians. Estriol provides numerous clinical benefits, commanding the attention of researchers dating as far back as 1966 and continues to garner substantial consideration as a valuable and viable therapeutic agent. Some of the most common and effective treatments that employ estriol include: hot flashes, insomnia, skin enhancement, vaginal atrophy and reduced frequency of urinary tract infections. Most recently, estriol has shown the potential to treat individuals with Th1-mediated autoimmune illnesses, including multiple sclerosis and rheumatoid arthritis. This review article will update the clinical effects and benefits of estriol and further clarify the documented advances which support the substantial therapeutic benefits of estriol for autoimmune conditions. The availability of compounded estriol preparations will also be addressed.” (Source: Journal of Restorative Medicine, Volume 2, Number 1, October 2013, pp. 45-52(8): Controversial Issues Related to Bio-Identical Estrogen Therapy and its Broader Clinical Applications)
(For More Information about the Safety and Benefits of Estriol, click here…)