Pellets are for Rabbits
I am seeing more and more menopausal women coming to my office who have been treated with pellet injections. The pellets are about the size of a grain of rice, and a doctor will implant them under the skin into the buttocks. The pellets contain a mixture of hormones that are marketed as being ‘bioidentical,’ free of side effects, and custom-designed for each woman’s needs. Moreover, they promise to improve virtually all aspects of a woman’s life.
How has pellet therapy come into the mainstream? What is it? Here are some tips on navigating the confusing information that you are likely to find on the Internet, and, unfortunately, in your doctor’s office.
Custom-compounded hormones in any form are not FDA approved for use.
These hormones, due to a loophole in the law, are exempt from the FDA requirement to prove efficacy and safety information. Practically speaking, this means that marketers can say just about whatever they want, and they do. Because of the lack of what is called ‘Phase IV reporting’ of side effects, there is no systematic collection of adverse reactions to these potent hormone concoctions, either. In one study comparing postmenopausal women using FDA-approved hormone therapy with those treated with estradiol and/or testosterone pellet therapy, the pellet therapy group experienced six times the number adverse side effects, including abnormal uterine bleeding and subsequent hysterectomy. There are often additional claims that these treatments must be safe because there have not been reports of harm. In other words, the purveyors of these treatments have almost no regulations imposed upon what they can allege their product will do. They also have no obligation to report to you any side effects or adverse long-term effects of there treatments. You, the consumer, take on all of the risk. It’s also important to point out that these pellets cannot be easily removed So if you have a side effect or problem and you want to get rid of it, you pretty much have to wait until it wears off.
Custom compounding is not reliable.
In 2012, More magazine completed an investigative report of bioidentical hormones produced by 12 compounding pharmacies nationwide. They found that there were substantial variations in what was prescribed and the finished product. The conclusion was that women may be putting their health at risk.
A more recent study had similar findings. Researchers tested prescriptions filled at 13 pharmacies for hormone capsules with 0.5mg of estradiol and 100mg of progesterone per gram and for creams with a similar hormone concentration. In fact, the capsules contained 0.365mg to 0.551mg of estradiol and 90.8mg to 135mg of progesterone per gram. And creams contained 0.433mg to 0.55 mg of estradiol and 93mg to 118mg of progesterone per gram. Getting the balance between estradiol and progesterone is critical. Women who get the incorrect medication dose in compounded hormones may be at increased risk for certain cancers and other serious health problems, the study authors write in the journal Menopause. There’s also a potential for compounded medicines to contain harmful chemicals or to be contaminated with bacteria, fungi or viruses, they note.
Some women may have no other alternative to compounding because of an allergy. If you decide to use a compounding pharmacy, for whatever reason, check whether the company is accredited by the Pharmacy Compounding Accreditation Board.
‘Bioidentical’ is a meaningless term.
I ask my patients who request ’bioidentical’ hormones to tell me what the term means to them, so I can better understand their wishes. Most of the time, what my patient tells me is that she prefers hormones that are chemically identical to the ones that are naturally found in a woman’s bloodstream. I take this to mean that she wants a treatment that is as physiologic as possible. There are a large variety of FDA-approved hormonal medications that meet this criterion.
It’s a lucrative market, and the marketers own Internet traffic on this topic.
We have all grown accustomed to looking everything and anything up on Google and expecting that, on balance, we are going to get the information we need. Sure, we may have to wade through a lot of chaff, but I know for myself that I usually approach an Internet search with confidence that I can find the wheat on my own. This is not always the case. As we just learned in the last Presidential election, information flow can be directed towards us in a way that influences how we think and that preys on our intellectual or emotional insecurities. Hormone therapy and menopause tend to be very fraught topics for women, and can bring up some negative issues associated with aging, loss of fertility, and risks of treatments. Make no mistake: the people who are marketing these non-FDA-approved treatments that require virtually no scientific backup know all of this. They are targeting your dollars as effectively as they can!
If it seems too good to be true, it probably is.
Bottom line: take a step back when you are reading a lot of testimonials from satisfied customers who report that everything—absolutely everything—that was wrong in their lives was made right by injecting an unapproved, unstudied, uncontrolled pellet full of hormones into their rear end. Take a deep breath, and then take a critical look at what is being said. There isn’t a medication in the world that provides:
Reverses the course of heart disease, diabetes, obesity, fibromyalgia, arthritis, and high cholesterol
Lowers your risk for Alzheimer’s disease, breast cancer, and osteoporosis
If you think I am exaggerating about the claims companies and people make, I took these claims off the book jacket of a doctor offering pellet therapy.
The doctors who promulgate these treatments often quote each other’s work, and it’s worth making an effort to look up the references used in their work. Studies and authors who quote themselves for most of the references, or who have a very limited group of the same people who are quoted over and over may be working in an intellectual echo chamber, and not hearing all the information. Signs of intellectual rigor include:
Randomized, clinical trials. Referencing and performance of randomized, clinical trials with control groups of women who did not get the treatment.
Careful assessment of the study endpoints. This is also critical when making claims about long-term safety and reduction of risks. For example, if all of the women who get breast cancer in a study drop out because they are sick and do not attend the followup visits, guess what happens when I report the risk of breast cancer over time? Magically, my research participants with cancer never get counted, and it looks like my treatment is highly beneficial! This is an especially dangerous path that can be followed when there is not an untreated control group that I am also following over the same period.
Publication in peer-reviewed journals. Are the studies that are being used to support these claims published in peer-reviewed journals? This is an easy thing to check. If not, the quality of the science is likely to be poor. Many marketers of custom compounded hormones want you to think that there is a medical conspiracy against them, so they can appear to be New Age mavericks who are being persecuted by some kind of medical ‘deep state’. Don’t believe it.
Save your pellets to feed to your rabbits. Meanwhile, talk to a board-certified endocrinologist, reproductive endocrinologist, or ob/gyn about your symptoms and concerns about hormone therapy and get a reality check.
For more information about non-hormonal options for managing your menopause symptoms, join the community at Lisa Health!
Dr. Nanette Santoro is a leading clinician and researcher in Reproductive Endocrinology. She is currently Professor and E Stewart Taylor Chair of Obstetrics & Gynecology at the University of Colorado School of Medicine. She also directed the Division of Reproductive Endocrinology at 2 medical schools: New Jersey Medical School and the Albert Einstein College of Medicine. She is the author of over 120 scientific publications and two books. Dr. Santoro’s major research interests include the reproductive endocrinology of premature, peri-, and postmenopause, infertility, and the physiology of gonadotropin-releasing hormone secretion. She has been involved with numerous large-scale industry- and government-supported clinical trials, including the Study of Women’s Health Across the Nation (SWAN), the Kronos Early Estrogen Prevention Study (KEEPS), and the Reproductive Physiology of Ovarian Failure, and is a co-editor of the Textbook of Perimenopausal Gynecology. Dr. Santoro received her medical degree at Albany Medical College and completed her residency at Beth Israel Medical Center and fellowship at Massachusetts General Hospital, Harvard Medical School.