The Women’s Health Initiative

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All Estrogens are not the same and Provera (progestin) is the real bad guy.

The Women’s Health Initiative, (WHI), is a study released in 2001, and is a good example of how the government skews data to support their cost-cutting by eliminating medications used commonly by women. To understand the problem the government was trying to fix, you have to understand that estrogen in the form of Premarin was the drug that was at the top of the list of expenses for Medicare. Medicare has a fixed amount of money to spend, and must find areas to eliminate costs so they can use that money in other areas. Since Premarin was taking up so much of Medicare’s budget, the question was “How do we get women to stop taking it? What can we do to stop this loss of money on the most “unimportant” part of the population, post-menopausal women?” What do you think they figured out?

It is my belief that the hormone Premarin, which is not the same as other estrogens and is made from urine from pregnant horses, was used as the “fall guy” for all estrogens. And, the study was set up to fail, to scare women out of taking estrogens! Why? Research shows that women won’t stop taking a medication that works if they are told, simply, “don’t take it.” Government researchers knew that if Medicare just stopped paying for estrogens it would trigger big image problems from the AARP, and they knew that a sure-fire way to stop us from doing something wass to scare us with Breast Cancer! Well they were right, because when the study was released to the press, the exodus from HRT was similar to the Israelites fleeing from Egypt!

How could this happen in the land of the free? We all know that America is freer for some of us more than others, but women were abruptly put in our place by the NIH (National Institute for Health), and its inaccurate study. Medicare saved millions of dollars by stopping the prescriptions from us for hormones of all types because of our fear of breast cancer. And they got a bonus! Post-menopausal women stopped going to the doctor yearly to get their prescriptions and well-woman exams, so they saved on mammograms and pap smears as well. For women it meant more late diagnosis breast cancer, but not because of HRT, but because they didn’t get yearly check ups anymore! But Medicare saved money, and so did insurance companies!

You have to be aware that the study was conducted using a series of manipulations: 1). poor patient selection, picking women who were obese and women who were too old to start HRT; 2). poor interpretation of data where Estradiol or Premarin were blamed for increased breast cancer, heart attack and stroke when the study with just Premarin had lower incidence of all 3 diseases. The Provera arm of the study did have a higher rate of these problems, but that is synthetic progesterone, not estrogen; 3). The press release was sent to the public before the study was available to doctors in practice! To me, that was an obvious set-up for doctors and for women. You heard about it as a patient, got frightened, called your doctor’s office, and we were not prepared with an answer because we hadn’t even seen the study.

I have read the study and it was very poorly done. When the NIH, a well funded, government organization does a poorly planned study, I ask the question, “Why?”

Here are the details. The WHI was supposed to be a study of menopausal women, and generally menopausal women require hormone therapy within the first ten years after menopause. This study was set up to fail in that it required participants to be women who had never tried or used any kind of estrogen, ever. The result was a study group made up of women who, in general, were obese (because obese women don’t have symptoms of menopause as severely as non-obese women, and more often than not don’t require estrogen for symptoms.) However, obese women do have other health problems related to their obesity that cause complications of oral hormone replacement. The thinner you are, the less estrogen you make in the fat, therefore your menopause symptoms are more intense. Not using patient’s weight as a control in this study, the group was made up of women who were at risk for blood clots, heart disease, and stroke before they even started the study. These women had never been given estrogen before, so they were inclined to have plaque building in their vessels for ten to twenty years. Because estrogen dissolves plaque in our vessels, (one of the ways it protects us from heart disease), when these women started taking estrogen they already had plaque and higher lipids than the average woman. As a result, there was a higher number of strokes reported on the Premarin and Provarin side, but NOT on just the Premarin (estrogen only) side.

However, when women just took Premarin alone, there was not a higher risk of stroke. That indicates the Provarin is probably the “bad guy.” But was that reported to us? No. Premarin was the reported problem. We were also told that Premarin is the same as every estrogen. Premarin is not the same – it is made from the urine of pregnant horses. It is not like human Estradiol; it is not bio-identical and it is oral. Yet they took what they discovered and generalized it over all estrogens. This included bio-identicals, which are quite different.

The study was divided between Premarin (estrogen) and Provera (progesterone) for people with a uterus, and Premarin alone for women without a uterus. Women in both groups were started on Premarin, then one part of the study had to be stopped because of the high numbers of breast cancer in the study with Premarin AND Provera! . However, this was not the Premarin alone group in the study. The women on only Premarin didn’t have a higher risk of breast cancer. In fact, the incidence of breast cancer in women taking Premarin (estrogen) alone was lower.

Most obvious in this study was the way the outcome was skewed in the press release. To me this confirms what the group conducting the study wanted to prove in the beginning, but didn’t. Most studies are set up knowing certain things about the problem they are investigating, but not aiming at a certain outcome. This allows a well planned study to succeed or fail based on the facts and not the pre-assumption of the sponsoring group.

This study had an average age of 69. That means they had people in their 80s on estrogen for the very first time, putting them at risk for a lot of things. (Generally, after age 75, doctors do not start people on estrogen if they have never taken it before.) The study also included people who were well past menopause. So, obesity, older age, never having taken hormones, and other risks like diabetes and high triglycerides increased the risk of the problems.

However, on the front page of the paper, the public was wrongly informed and stopped taking Premarin and all other estrogen. The findings were the opposite of the press release allegations! In addition to my impression after I read the story, I have practiced GYN for over 25 years, and when a study comes out that is the opposite of what my patients experience every day, I KNOW the study is wrong!

My findings in my practice are that if you use bio-identical hormone pellets, which are not oral and are exactly like what your body makes before menopause, then you decrease your risk of stroke and heart disease. Medical studies, and most of my patients, say that replacing estrogen in any form increases your ability to think and remember things. The addition of testosterone to this regimen improves this outcome for a longer period of time and delays or prevent Alzheimers and Dementia by around 20 years! Lastly, I find, (and the studies before the WHI backup the fact), that breast cancer is not associated with the use of Estradiol. It is related more to genetics, obesity, fatty diet, smoking, drinking alcohol, low Vitamin D and sedentary lifestyle. Anyone who has taken my bio-identical estrogen pellets can attest to this.

You probably don’t know that cardiology journals, endocrine journals, and OB/GYN journals, have all retracted the results of the WHI study and have said that estrogen is in fact, good for women and it keeps us healthier after menopause; it does not make us less healthy. But, retractions are always much less effective than the original headline, so this didn’t make the news.