Virginia Hopkins Health Watch - Vol 3, Issue 4
Natural Hormone
& Nutrition News,
Drug Watch and More...
DEAR READER,
Let me preface this by saying that I’m no fan of the Food and Drug Administration (FDA). It’s a corrupt bureaucracy whose approval of a drug as “safe and effective” has almost entirely lost its meaning. The FDA is supposed to protect the consumer, but it’s more concerned with protecting drug company profits. OK, let’s move on.
Lately I’ve received a slew of e-mails shouting that the FDA is about to regulate vitamins and herbs as medicines and make them prescription-only, so I went to the FDA website and looked up the offending document, which is titled, “Guidance for Industry on Complementary and Alternative Medicine [CAM] Products and Their Regulation by the Food and Drug Administration.” I read the document, and can find nothing in it that remotely suggests the FDA is proposing to change anything or turn vitamins and herbs into prescription-only products or have them newly classified as medicines.
Most CAM products fall into a category that is regulated either by the FDA or the PHS (Public Health Service). The categories include “biological product, cosmetic, drug, device, or food (including food additives and dietary supplements).” The document is a well thought out and organized presentation of how CAM practices are organized under the FDA and PHS, and how the FDA decides which products go under which category under the existing Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Hundreds, if not thousands of new CAM products have come into the marketplace in the past few years, and the FDA is trying to clarify its regulation processes for those who sell the products. They’re inviting comments about the regulatory process—this is a good thing.
The Sky is Not Falling
Remember Chicken Little who ran around saying, “The sky is falling, the sky is falling!” when an acorn fell on his head? He whipped everyone else into a frenzy and as they all marched off to tell the king, the fox joined the group and… well, you know the rest. Or, at the risk of mixing metaphors, maybe you prefer the fable of The Boy Who Cried Wolf.
Before you forward an e-mail with a call to action to your list of friends, check it out. Be discriminating. Research it a little. Find out if it’s for real. Or send me an e-mail and I’ll research it for you, and if I can’t find the answer, I’ll find someone who can. If we keep crying wolf every time the FDA releases a document that mentions vitamins, pretty soon the wolf really will be creeping up on us and nobody will listen.
Here’s where to find the document online if you’re interested (it's a pdf file): Guidance for Industry on Complementary and Alternative Medicine [CAM] Products and Their Regulation by the Food and Drug Administration
BONE DENSITY AND PROGESTERONE CREAM STUDY
Dr. Leonetti is calling for more participants—let’s help her.
A few years back I wrote in the Hopkins Health Watch about Helene Leonetti, M.D., who was a great friend and colleague of Dr. John Lee. At that time, Dr. Leonetti had won approval from Lehigh Valley Hospital in Bethlehem, PA to begin a study titled “The Role of Transdermal Progesterone Cream in Increased Osteoblastic Activity and Delay of Osteoporosis in Women over 70 Years of Age,” which is to say, a study investigating whether progesterone maintains and builds bone in older women. This was a study that Dr. Lee had wanted done for years and he jokingly referred to it as “The Little Old Lady Study.”
Dr. Leonetti was successful in launching the study, thanks to her own substantial time and effort, help from ZRT Lab, the Progesterone Research Institute and others. Although she recruited over 100 women, some dropped out and she is looking for 28 more participants so she’ll have a total of 100. To participate in the study you must be 70 years and older, living within a few hours’ drive of Bethlehem, with the following qualifications:
- Non-smokers
- Not be taking thyroid replacement, hormone replacement
- Not taking anti-resorptive drugs (e.g. Fosamax, Actonel, Evista)
- Must be independent and responsible enough to commit to this regimen for at least one year.
Each woman will receive a baseline bone mineral density test and have blood drawn to measure TSH, FSH, and a lipid profile—at no cost to themselves. They will have progesterone cream and a calcium/magnesium supplement mailed to their home at no cost.
If you’re interested in participating or know someone who might be, please call Dr. Leonetti’s office at: (610) 882-3100.
Here’s where you can read more About Osteoporosis.
USING PROGESTERONE WITH BIRTH CONTROL PILLS AND PATCHES
An Interview with Dr. David Zava
A common question that appears in my e-mails is whether it’s OK to use progesterone cream while taking contraceptive pills or patches. Dr. Lee’s response was always, “Probably, but we need more information to be sure.” I recently had the opportunity to speak with Dr. Lee’s friend and colleague, Dr. David Zava, and asked him to give us an update on this topic. VH
Let’s answer this question by first looking at what the synthetic hormones in birth control pills and patches do in a woman’s body. Overall, they drop your estradiol [an estrogen], progesterone and testosterone levels, they interfere with cortisol levels and they increase the risk of insulin resistance. Women on birth control pills tend to gain wait around the waist, which is a hallmark of insulin resistance.
About 95 percent of the natural hormones found in the blood are inactivated by serum hormone binding globulin (SHBG). This is one of your body’s control mechanisms for maintaining hormone balance. Think of SHBG as a sponge that soaks up excess hormones. The synthetics found in birth control pills aren’t soaked up by SHBG so there’s no real regulation of them. Let’s take ethinyl estradiol, a synthetic estrogen, as an example. Unlike your natural hormones, it doesn’t bind to SHBG, so it remains available to the tissues. At the same time, it causes the liver to produce huge amounts of SHBG. That means ethinyl estradiol is freely available but the natural hormones, which do bind to SHBG, are very unavailable.
Contraceptive Chemicals Shut Down Your Own Hormones
In women, SHBG particularly soaks up testosterone, so women on birth control pills tend to have very low testosterone levels. Low testosterone can mean low libido, slow metabolism and weight gain, vaginal dryness and bone loss. If you’re taking birth control pills you’re probably missing out on the benefits of normal testosterone levels.
Synthetic hormones are also going to the brain and shutting down gonadotrophins, specifically the LH and FSH that regulate the menstrual cycle, so women taking birth control pills aren’t making their own estrogen, progesterone or testosterone, and they aren’t ovulating. If you suppress that part of the brain long enough it will shut down because you’re not asking it for anything. If you go off the birth control, it may take awhile to kick back in and in some women it never comes back. Meanwhile, your body is accustomed to making all this SHBG, so even if you do start making your own hormones the SHBG is soaking up every bit of them. Women who go off birth control pills can be extremely hormone deficient for weeks or months, sometimes years.
Synthetic Hormones have an Identity Crisis
A synthetic hormone is very schizophrenic. It doesn’t know which receptor it belongs to. Take medroxyprogesterone acetate (MPA) for example, a progestin [synthetic progesterone]. Yes it hits the progesterone receptors and acts something like progesterone, but it also hits glucocorticoid receptors and acts like a cortisol, which suppresses your adrenals. So I frequently see women on birth control with low cortisol. It has some cortisol activity but it’s not consistent. This is why women on birth control pills can get so tired and depressed. MPA also has some androgen [male hormone] activity as well as some anti-androgen activity. Pretty soon the body doesn’t know what it wants or needs because its hormone balancing systems aren’t working.
Your own natural hormones are very specific. Testosterone doesn’t see estrogen receptors or cortisol receptors, it only sees testosterone receptors. Estradiol doesn’t see progesterone or testosterone receptors. Mother nature made these hormones very unique for the receptors that they bind to and they don’t bother with much else—within physiologic ranges. If you start taking high doses of natural hormones it’s a different story, you’ll get side effects and hormone imbalance. MPA on the other hand will bind to all of them. It’s a mess and it’s why you get all the side effects. It’s just awful. It doesn’t happen to every woman, but when it happens it’s horrible.
Now we can get back to the question of whether you can use progesterone cream when you’re taking birth control pills. The progestin in the birth control pills goes to the brain and shuts down ovulation. No ovulation, no pregnancy. Meanwhile, the progesterone cream can help counter some of the side effects of the synthetic hormones. I’ve seen many women who are having side effects from birth control use progesterone cream and feel much better.
Dr. David Zava is the CEO of ZRT Labs, www.zrtlab.com and the co-author of What Your Doctor May Not Tell You About Breast Cancer.
WHAT’S A WOMAN TO DO ABOUT BIRTH CONTROL?
Your best choice depends on you.
For some women, the convenience of birth control pills or patches may outweigh the side effects and health risks that go with them. At the other end of the spectrum, women in stable relationships, with regular menstrual cycles and good body awareness may want to consider using the “rhythm method,” also known as “natural family planning” and “fertility awareness.”
In between the extremes of synthetic hormone contraceptives and the rhythm method are condoms, diaphragms, cervical caps, female condoms and the Today Sponge. All three involve spermicide, which is not the healthiest goop you can put in your body, but again, risks need to be measured against maturity, lifestyle and how serious the consequences of pregnancy are. The Today Sponge is easy to use, effective, inexpensive and available over-the-counter.
I have yet to meet a woman who used Depo Provera, the progestin shot that lasts three months, who didn’t come out at the other end of it feeling terrible. It takes some women a year or more to recover. It may seem like an irresistibly convenient form of birth control, but please read the full physician’s information sheet on side effects before considering it, and also read this article, Wake-up Call about Depo-Provera.
A great tool for women who are tracking their fertility, either to conceive or avoid conceiving, is the Fertile Focus microscope, a lipstick-size microscope used to look at saliva. A telltale ferning pattern in the saliva indicates fertility. I introduced this neat little gadget to one of my teenage goddaughters who was having PMS symptoms, and it turned out to be a wonderful tool for enhancing her body awareness and introducing her to the rhythms of her menstrual cycles. When she ovulated and that distinct ferning pattern appeared in the saliva, she had tangible evidence that an egg had popped—it was pretty exciting for her, and also sobering—it made the possibility of pregnancy much more real.
I’ve also known women who used a fertility microscope during the ups and downs of perimenopause to check whether they were ovulating. If they weren’t they used progesterone cream that cycle—a resourceful strategy for creating hormone balance.
I’ve put together some past Hopkins Health Watch articles on chemical contraceptives to help you sort out the risks: What Every Woman Should Know about Birth Control.
NEW RESEARCH
Testosterone and Prostate Cancer
Morgentaler, A, “Testosterone and prostate cancer: an historical perspective on a modern myth,” Eur Urol, 2006 Nov;50(5):935-9.
Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
Back in 2003 Dr. John Lee published his booklet, “Hormone Balance for Men.” The basic premise was Dr. Lee’s seemingly revolutionary stance that it’s not testosterone that causes prostate cancer, it’s estrogen dominance. Yes, men can also be estrogen dominant. Of course this stance was greeted with scorn by his colleagues because it's been commonly accepted in conventional medicine that testosterone causes prostate cancer. Of course the tide is now turning and this review from Harvard of the “testosterone causes prostate cancer” literature is the first wave.
According to an article in the Harvard University Gazette, the author of the study, Abraham Morgentaler, a urologist at Beth Israel Deaconess Medical Center and associate clinical professor at Harvard Medical School said, "We reviewed decades of research and found no compelling evidence that testosterone replacement therapy increases the incidence of prostate cancer or cardiovascular disease.”
In the review, Morgentaler reports that, “Multiple subsequent reports revealed no pCA [prostate cancer growth] progression with T [testosterone] administration, and some men even experienced subjective improvement, such as resolution of bone pain. More recent data have shown no apparent increase in pCA rates in clinical trials of T supplementation in normal men or men at increased risk for pCA, no relationship of pCA risk with serum T levels in multiple longitudinal studies, and no reduced risk of pCA in men with low T. The apparent paradox in which castration causes pCA to regress yet higher T fails to cause pCA to grow is resolved by a saturation model, in which maximal stimulation of pCA is reached at relatively low levels of T.”
Morgentaler concludes, “This historical perspective reveals that there is not now—nor has there ever been—a scientific basis for the belief that T causes pCA to grow. Discarding this modern myth will allow exploration of alternative hypotheses regarding the relationship of T and pCA that may be clinically and scientifically rewarding.”
BUYER BE AWARE
Yogurt Smoothie vs. Snickers Bar
I was in the supermarket the other day looking for an afternoon snack and thought one of those small-size liquid yogurts might be a good choice—protein, fruit, calcium, probiotics—how could I go wrong? But then I looked at the labels and the artificial sweetener-free brands had between 23 and 44 gms of sugar—that’s 5 to 9 teaspoons—yikes! To get a sense of that amount, imagine sitting at the breakfast table and helping yourself to 9 teaspoons of sugar in your morning cup of coffee or tea.
The worst offender was the supposedly healthy Stonyfield Farms, which had a whopping 44 gms of sugar in their 10 oz All Natural Peach Smoothie.
Many of the other yogurt drinks had less sugar thanks to artificial sweeteners. The artificial sweetener of choice among yogurt drinks is sucralose (e.g. Splenda), which may be perfectly safe but I’m not convinced yet because there are no independent or long-term studies of its use in humans, and it’s closely related in chemical structure to the organochlorine pesticides.
So I said to heck with healthy, I’m getting a Snickers bar. No, not really, but I did look at the Snickers label. Here’s a comparison:
| Nutrition Content | Snickers | Stonyfield All Natural Peach Smoothie |
| Calories | 280 | 250 |
| Total Fat | 14 gm | 3 gm |
| Cholesterol | 5 gm | 10 gm |
| Total Carbs | 35 gm | 49 gm |
| Sugar | 30 gm | 44 gm |
| Protein | 4 gm | 10 gm |
So in the all natural smoothie we get about 10% fewer calories, less fat and more protein, but more cholesterol, more carbs, and more sugar. What I personally care about most in a snack is not getting too much sugar, so for me the two are about evenly matched in terms of desirability, except that the Snickers comes with chocolate!
NEWLY POSTED ARTICLES
About Teenage Girls and Hormones
Infertility: Getting Pregnant and Staying Pregnant
Health Watch Q & A - Vol 3 Issue 4
Vaginal Dryness and Hormone Treatments. What causes vaginal dryness and how it may be treated, including progesterone as a lubricant and estriol to help balance hormones.