04/16/2013

In today’s New York Times (Tuesday April 16, 2013) there’s an article by Denise Grady which reports recommendations of the United States Preventive Services Task Force (USPSTF) who published a draft form of their recommendations for public comment concerning the drugs raloxifene (Evista) and tamoxifen (Nolvadex). As many of you are aware, I have published extensively on these drugs and participated in studies for both. Tamoxifen has been used for several decades, initially for women with breast cancer to prevent recurrence, and then more recently for women at high risk for breast cancer to prevent it in the first place. It is associated, however, with a small increased risk of uterine cancers. I was the first to describe an unusual ultrasound appearance of the uterine lining in some post-menopausal women who take tamoxifen. I was involved in the original studies for raloxifene (Evista) in order to prove that this drug was not tamoxifen-like in the uterus. As a result in 1997 raloxifene was first approved for prevention and treatment of osteoporosis and then in 2009 based on further study it was approved for breast cancer prevention in high risk women. I actually spoke before the FDA at the time that Evista was in the approval process. I’ve also authored the committee opinion on tamoxifen’s effects for the American College of Obstetricians and Gynecologists.

I’m taking this opportunity to write this email blast to my patients (and any of their friends to whom they want to disseminate this) because of some serious misstatements in the article in today’s Times. Evista (raloxifene) does NOT increase the risk of stroke as was reported in the article. Large studies of raloxifene in women with osteoporosis, in women at high risk of heart disease, and in women at high risk of breast cancer have NEVER shown any increase in stroke. What is true is that in the women with high risk of heart disease, in those women who did suffer a stroke there was a slight statistically significant increase in chance of dying. This was not true in osteoporotic women or women at high risk for breast cancer who were not also high risk cardiac patients. Furthermore, today’s article says that both of these drugs can cause “vaginal problems like dryness and pain that can damage a woman’s sex life”. This is not, in fact, true. Post-menopausal women are subject to increasing degrees of vaginal atrophy (dryness) which in fact can lead to painful sex. Evista does not make this any worse. However Evista does not make this any better. Thus, many of my patients on Evista are given a local vaginal estrogen cream, tablet, or ring to treat the natural vaginal atrophy that occurs in menopause. These women can do so with great impunity because if any of this local vaginal estrogen is in fact absorbed (and I believe it is not) the Evista is protecting their breasts by locking up the receptors.

Finally for those of you who follow my email blasts carefully, you will notice in the past I’ve had some differences with the United States Preventive Services Task Force. Their failure to recommend more than 400 I.U.’s of Vitamin D, and their failure to acknowledge the usefulness of transvaginal ultrasound in the early detection of ovarian cancer were in my mind rooted in some poor science and I have previously addressed this. While I currently applaud the USPSTF for their current stance,  I wonder why it took them 4 years to come out with this recommendation since the data on which it is based has been well known and published for at least the last 4 years.