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Tuesday, March 11, 2008
The Wall Street JournalSorting Through the Choices For Menopause Hormones
Amid all the confusion over hormone-replacement therapy for women, one key aspect is often overlooked: Not all HRT products are the same.
The big Women's Health Initiative that has been generating headlines since 2002 studied women using Premarin and Prempro, both made by Wyeth, which were the state-of-the-art hormone drugs many years ago. Today, estrogen and progesterone are available in forms that are much closer to what women lose in menopause. While the Food and Drug Administration has said it thinks all HRT products pose the same risks, a growing number of doctors and patients prefer the newer varieties.
Bear with me for a brief biology lesson.
Women make three kinds of estrogen. The predominant one from puberty to menopause is 17-beta estradiol, which is involved in over 400 functions in the female body, from skin to hair, bones, heart and brain. The estrogen left after menopause is estrone, made primarily by body fat. Some researchers suspect that estrone may be responsible for the higher risk of breast and endometrial cancer in women who are obese.
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The weakest estrogen is estriol, produced by the placenta during pregnancy and not normally present in measurable amounts at other times.
Premarin, approved in 1942, is nearly 50% estrone. It's made from pregnant mare's urine and contains several horse estrogens not found in humans. Though sales have fallen sharply since 2002, when part of the WHI was halted out of concern for heart-attack risks, Premarin remains the best-selling estrogen in the U.S.
But a number of FDA-approved patches and gels that deliver solely 17-beta estradiol are gaining market share. Since "transdermal" forms don't have to pass through the liver, as Premarin does, they pose less risks for blood clots that can cause stroke and heart attack.
"If we'd had effective estradiol products back when Premarin was introduced, no one would have prescribed it," says Geoffrey Redmond, an endocrinologist who works with women's hormone issues in New York City.
"People are not driving 1942 cars anymore," says Elizabeth Lee Vliet, a women's health physician in Tucson and author of six books on menopause. "Why gynecologists have been so resistant to moving off horse-derived estrogen is beyond me. These estradiol products have been around for years."
Women who take estrogen and still have a uterus need to take progesterone to guard against endometrial cancer. But the synthetic version used in the WHI --medroxyprogesterone acetate, or MPA -- has been linked to unpleasant side effects such as moodiness, breast tenderness and bloating. "It's PMS in a pill," says Dr. Redmond. He also notes that in the WHI, the increased risk of breast cancer was found only in the women taking Prempro, which combines MPA and Premarin. Women taking Premarin alone had a 33% decrease in breast-cancer risk.
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A number of doctors have switched to Prometrium, a natural form of progesterone approved by the FDA in 1998, which has different pharmacological properties and fewer side effects.
Joe Camardo, Wyeth's senior vice president for global medical affairs, says Premarin and Prempro have demonstrated their safety and effectiveness over many years of experience. There may be "a bias toward believing that natural somehow is better," he says. But "it's not based on clinical trial data."
Indeed, since 2002, many women have flocked to "bio-identical" hormones made by compounding pharmacies, believing that they pose fewer risks than traditional hormones. These BHRT blends often contain high concentrations of all three estrogens and progesterone -- generally made from plant sources, as are the estradiol products. In January, the FDA warned seven such pharmacies to stop making unsubstantiated marketing claims that their products are safer and more natural than traditional hormones. The FDA also told compounding pharmacies to stop using estriol, since it isn't FDA approved.
BHRT proponents say that women should be able to choose whatever hormones they want to use. Actress Suzanne Somers has been an energetic booster. "My libido is rockin', my weight is perfect, my hair has shine and luster, my skin is less wrinkled than my contemporaries. I have energy, passion, my brain is sharp; no senior moments for me," she wrote in an email. "Before I started on bioidenticals, I could not make any of these claims. In fact, it was just the opposite."
"You look at this beautiful woman and everyone wants to look like her," says Michelle Warren, director of the Center for Menopause, Hormonal Disorders and Women's Health at Columbia University's College of Physicians and Surgeons. "But there's no quality control with these pharmacies, and no packaging information, so women assume there's no risk."
"It's like buying food from a street vendor compared to a restaurant that's been inspected," says Dr. Vliet. "I have moved away from using as much of the compounded products because they are less stable, less reliable, than the pharmaceutical grade."
To minimize such risks, the FDA is recommending that doctors who want to prescribe estriol file an investigational new drug application, which requires informing patients of drug risks and benefits and reporting any adverse events.
Email HealthJournal@wsj.com. Join a discussion of hormone issues at WSJ.com/Forums
Corrections & Amplifications:
Michelle Warren is a paid consultant for Wyeth, which makes replacement-hormone drugs for women, and is the Wyeth Ayerst-endowed professor of women at Columbia University Medical Center in New York. This Health Journal column about replacement hormones quoted Dr. Warren questioning the quality control and riskiness of "bio-identical" hormones made by compounding pharmacies, which compete with traditional hormone-replacement drugs, but didn't disclose her connections with Wyeth. Geoffrey P. Redmond, who was quoted in the column criticizing Wyeth's Premarin and Prempro, also serves as a consultant for several pharmaceutical companies.
Both Sodium Laureth Sulfate (SLES) and its close relative Sodium Lauryl Sulfate (SLS) are commonly used in many soaps, shampoos, detergents, toothpastes and other products that we expect to "foam up." Both chemicals are very effective foaming agents, chemically known as surfactants.
Unfortunately, both sodium laureth sulfate and its cousin are also very dangerous, highly irritating chemicals. Far from giving "healthy shining hair" and "beautiful skin", soaps and shampoos containing sodium laureth sulfate can lead to direct damage to the hair follicle, skin damage, permanent eye damage in children and even liver toxicity.
Although sodium laureth sulfate is somewhat less irritating than SLS, it cannot be metabolised by the liver and its effects are therefore much longer-lasting. This not only means it stays in the body tissues for longer, but much more precious energy is used getting rid of it.
A report published in the Journal of The American College of Toxicology in 1983 showed that concentrations of SLS as low as 0.5% could cause irritation and concentrations of 10-30% caused skin corrosion and severe irritation. National Institutes of Health "Household Products Directory" of chemical ingredients lists over 80 products that contain SLS and SLES. Some soaps have concentrations of up to 30%, which the ACT report called "highly irritating and dangerous."
Shampoos are among the most frequently reported products to the FDA. Reports include eye irritation, scalp irritation, tangled hair, swelling of the hands, face and arms and split and fuzzy hair. This is highly characteristic of sodium laureth sulfate and almost definitely directly related to its use.
Both SLS and SLES are known to have many effects that can potentially be detrimental to health. Among the possible dangers are the following:
The AJT report staes that "Other studies have indicated that Sodium Lauryl Sulfate enters and maintains residual levels in the heart, the liver, the lungs and the brain from skin contact. This poses question of it being a serious potential health threat to its use in shampoos, cleansers, and tooth pastes."
Skin Irritation
SLS is used routinely in clinical studies. This may suggest a level of comfort, however, the way in which it is used is disturbing. Despite being the number one active ingredient in virtually all soaps, shampoos and cleansers, the sole purpose of using SLS in clinical studies is to cause skin irritation that can then be used to identify the properties of other chemicals!
Amazing isn't it? For years, we have been applying known irritants to our skin on a daily basis. To quote the ACT report "The abbreviated symbol for Sodium Lauryl Sulfate is used around the world in clinical studies as a skin irritant. SLS is the universal standard, by which a measured percentage is evaluated to promote a given level of irritation and reaction. By this SLS standard level of irritation, it is then possible to evaluate the healing or modifying characteristics of any ingredient or formula used on the SLS irritated skin."
Most worryingly, irritation has been shown to occur at concentrations of 0.5%, which is 1/60th the concentration found in some hand soaps. Caveat emptor!In the last 100 years or so, many new health problems have come to light. These include PMS / PMT, the so-called "menopausal symptoms" which never used to exist, and more recently a massive drop in male fertility which threatens our continued existence in many western countries. SLS is most likely a major contributor to all of these problems due to its estrogen mimicking activity.
Estrogen is a hormone found quite normally in both men and women. Like all other hormones, it's circulating levels are rigidly controlled by the glands of the body due to the potent effect of its presence on virtually all cells. Not only does SLS irritate the skin, it is also absorbed through the skin (high levels of skin penetration may occur at even low concentration). Once in the body, the SLS molecule attaches to estrogen receptors, mimicking the effects of the hormone in various body systems.
The result is hormonal chaos. The body can no longer control it's own estrogen levels (or at least, what it sees as it's own estrogen levels - it can't tell the difference between endogenous estrogen and SLS) and therefore loses control of many normal endocrine (hormonal) functions.
In men, whose estrogen levels are normally extremely low, this massive increase causes breast enlargement, reduction of male hormone levels and a massive drop in both sperm count and sperm motility (ability of the sperm to fertilise an ovum). Gender confusion may also be related to SLS levels, either in the male himself or in his mother during pregancy.
In women, the reproductive system, which is totally controlled by estrogen and progesterone, goes haywire. Rapidly shifting estrogen levels and their effect on progesterone levels mean that the body is totally confused, leading to menstrual problems, menopausal symptoms and potentially infertility. Because this subject is so important, we have devoted a whole section of this site to womens health.
Eye Irritation / eye deformities in children
Have you ever got shampoo in your eyes? Yes, so have I - not pleasant is it? However, the potential effects of SLS on the eye are much more worrying. In animal studies, 10% SLS caused acute corneal damage. However, it is not just direct eye contact that is the problem. According to the American College of Toxicology, "tests show permanent eye damage in young animals from skin contact in non-eye areas".
In other words, because SLS is absorbed through the skin, it can cause PERMANENT eye damage WITHOUT ever directly coming into contact with your eyes. As a result, you would expect that childrens products would be SLS-free. Unfortunately not, most childrens shampoos contain just as much SLS as those for adults.
Thankfully, alternatives DO exist, contact us to find out about our natural shampoo and conditioner.
Protein Denaturing
Our cells are made from protein. The development of those cells is strictly regulated by the reproductive processes that are continually at work removing damaged and old cells and replacing them with healthy new ones. Virtually every cell in the body is replaced at least every 7 years.
SLS exerts its effects on proteins by forming a chemical bridge between the fat-soluble and water-soluble parts of the protein molecule. This disrupts the hydrophobic forces needed to maintain the protein structure and the molecule collapses, rendering it useless. This effect is usually irreversible.
The result of this is two-fold. Firstly, existing proteins are damaged, leading to an increase in the amount of healing required by the body. Secondly, new proteins can be damaged and cells disrupted while they are under construction. It is exactly this type of activity that can lead to the early stages of skin cancer.
In the skin, this process can be so severe, that skin layers may separate and inflame due to its (SLS's) protein denaturing properties.
Carcenogenicity
Quite apart from it's potential to cause pre-cancerous conditions by denaturing proteins, the estrogen mimicking effects of SLS also offers massive potential to cause cancer. It is known that many cancers, not least breast and ovarian cancer are directly related to estrogen levels, in fact some cancer cells actually secrete their own estrogen, which contributes to the growth of the tumor.
Clearly, by disrupting normal estrogen levels AND by causing similar effects at a cellular level as endogenous estrogen, SLS exhibits MASSIVE potential to both cause and worsen cancerous states. The incidence of breast cancer has increased several-fold in the last 50 years, both in women and in men. Currently, according to the American Cancer Society, men account for approximately 1% of all breast cancer cases. This subject is discussed in more detail in our womens health section.
There is also a third way by which SLS can potentially cause cancer. Carcinogenic nitrates can form in the manufacturing of Sodium Lauryl Sulfate or by its inter-reaction with other nitrogen bearing ingredients within a formulation utilizing this ingredient (many shampoos contain nitrate compounds). A single shampooing can produce more cancer-causing nitrates in the body than eating a pound of bacon, which is VERY high in nitrates!
Whether it is by these means or not, SLS in a known mutagen - it is capable of damaging the genetic material found every cell in your body. As mutagenicity has been strongly linked to cancer, this is a major concern.
IF you are worried about the effects of SLS on your health, please contact us and we will do our best to help and advise you on ways to limit both your exposure and your risk.
Take control of your health and exchange your toxin-filled household with SLS-free alternatives.
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