Leslie Carol Botha: The Pelvic Goldmine – what we cannot see – what is ‘taboo’ – is making Big Pharma a lot of money. My father who was in the pharmaceutical packing industry stated this best by telling me years ago: “Do not believe everything that is being advertised.” Truer words were never said. Paula Derry was written an excellent commentary about another drug fast tracked by Big Pharma and approved by the FDA for vaginal atrophy. We are at the crossroads of healing or medicating. That is the question of our time. Do you want to know how important a question it is? Open the door to your medicine cabinet and tell me how all of those drugs in their orange vials or pretty packages interact with each other. How many chemicals do you want in your bloodstream?
Never take a drug unless it is has been on the market for at least five years. Why? Because most new drugs are pulled off the market within that time frame.. because of all of the side effects. How do you spell ‘guinea pig’?
Read the entire article – and weigh the benefits with the common side effects that Derry listed. Can’t wait to see the TV ads on this one!
Medicating the Postmenopausal Vagina
Society for Menstrual Cycle Research
by Paula Derry
March 4, 2013
On February 26, 2013, the Food and Drug Administration issued a news release saying that it had approved a medication called Osphena to treat a problem called postmenopausal dyspareunia (pain during sexual intercourse associated with changes in the vagina after menopause). The medical website Medscape reported that the news release had been issued. How to read these announcements? It seems as though FDA approval should be enough to know that a medication is safe and effective. However, what are some guidelines in reading and evaluating this announcement?
First, some background: After menopause, when estrogen levels decline, tissues (cells) of the vaginal lining can become thinner, drier (thus providing less lubrication during intercourse), and less elastic or flexible.
This can result in pain during intercourse, feelings of burning or soreness, inflammation, and irritation.
There are a variety of solutions for dealing with this. Regular sexual stimulation (intercourse, masturbation) is recommended to keep vaginal tissues healthy. Water-based lubricants can help reduce discomfort during intercourse. Expanded views of sexual pleasure that don’t include intercourse might work around the problem. Leaving enough time to become aroused during intercourse (extended foreplay), communication between partners about when sex is painful and when not, can also help. Herbs like dong quai and black cohosh are recommended, especially by complementary/alternative practitioners, although the herbs lack a research base. A low-dose estrogen applied to the vaginal area (as a cream, tablet, etc.), is effective. Local application minimizes estrogen being absorbed into the bloodstream, traveling through the body, and having effects, some of them potentially negative, distant to the vagina. There is, however, controversy about some estrogen being absorbed.
Now, to the FDA announcement: The FDA requires proof of a medication’s safety and effectiveness before it is approved. According to the news release: “Osphena’s safety and effectiveness were established in three clinical studies of 1,889 postmenopausal women with symptoms of vulvar and vaginal atrophy. Women were randomly assigned to receive Osphena or a placebo. After 12 weeks of treatment, results from the first two trials showed a statistically significant improvement of dyspareunia in Osphena-treated women compared with women receiving placebo. Results from the third study support Osphena’s long-term safety in treating dyspareunia.”
Notice, first, that the drug’s effectiveness was tested for 12 weeks. This is not an unusual amount of time for such a study, but it is not very much time. Notice also that women treated with Osphena had a “statistically significant” improvement. As I discussed in a previous post, “statistically significant” means “unlikely to have occurred by chance.” In other words, there was evidence that Osphena really did have an effect, but we don’t know how big an effect—it might be very large or very small.