Hormone Replacement Therapy Side Effects: Women's Health Initiative

Conventional HRT finally gets the negative press it deserves.

Excerpts from the John R. Lee, M.D. Medical Letter

Last month I received an e-mail from a woman who had read one of my books and as a result had gone to her doctor and asked to be taken off of PremPro and put on natural hormones. His response was, Now why in the world would you want to do that? When she tried to explain he interrupted her, ended the visit, and left her with another prescription for PremPro. Since then, as most of you know, there have been two major studies published showing that conventional hormone replacement therapy (HRT or ERT) does more harm than good. This woman, and millions like her, deserve an apology at the very least. The first study published is from the huge Women’s Health Initiative (WHI), a portion of which was ended after five years (three years early) because of a clearly greater risk of invasive breast cancer, heart disease and strokes among women using PremPro [Premarin (equine estrogens) plus Provera (a synthetic progestin)].

The second study is from the Breast Cancer Detection Demonstration Project, part of a nationwide breast cancer screening program, and it showed that estrogen-only hormone replacement (ERT) increases the overall risk of ovarian cancer by more than 3-fold. Given what we’ve known for at least twenty years about unopposed estrogen’s cancer-promoting properties on a woman’s reproductive system, the concept of giving only estrogen to women without a uterus should never have taken hold in medical practice in the first place.

I'll go into the WHI study in more detail shortly, but first I’d like to put these studies into a broader perspective: conventional medicine needs to change its attitudes towards women, and it needs to disentangle itself from the big drug companies.

What We Already Knew

It’s been evident for over a decade that HRT is only marginally effective for treating osteoporosis, and that it causes heart disease, breast cancer and strokes. I wrote about this in my first self-published book about progesterone in 1993. Why has it taken conventional medicine so long to catch up to the obvious? Drug company money and politics, what else? The two studies mentioned above were so large that the evidence could no longer be ignored, but in the meantime tens of thousands of women have been killed or permanently harmed by taking HRT. Conventional medicine, which trumpets that it is evidence-based, allowed millions of women to be given HRT without evidence that it was safe or effective. The practice of medicine in America has been hijacked by the big drug companies, who control everything from medical education, to continuing education credits, to which studies are published in our largest medical journals. Let’s get real here: drug companies are in business to make money, not to heal people. It’s the job of medicine to heal, and to the extent that American medicine allows itself to be controlled by drug companies it is not about healing, and is needlessly harming millions of people every year.

And then there are antiquated medical attitudes towards women. About a month ago there was an article in the New York Times about perimenopause (the years just before and after menopause). It began with the fact that Oprah had done a show on perimenopause symptoms with Dr. Christiane Northrup, and had received so many e-mails afterwards that her website server had crashed. In other words, thousands of women could relate strongly enough to the information presented that they felt inspired to send an e-mail to Oprah. For every woman who sent in an e-mail, there were undoubtedly many others who felt the same way. And yet, the rest of the Times article focused on quoting doctors who belittled the concept of perimenopause symptoms and claimed they don’t exist. The implication is that all those women were just making up their problems. This is a perfect example of how conventional medicine treats women with an attitude that says, “We know better than you do what you re experiencing and if it doesn’t fit our picture it’s all in your head, and we’ll anesthetize you emotionally with anti-depressants, or tranquilize you with anti-anxiety drugs.”

The same type of mistreatment has occurred with millions of women over the past two decades who have been put on conventional HRT, complained to their doctors about side effects such as weight gain, anxiety and insomnia, been told it’s all in their heads, and given anti-depressants such as Prozac or anti-anxiety drugs such as Xanax. Little did they know they were also being given heart disease, cancer and strokes. It’s likely that American doctors as a group are feeling somewhat chagrined that they’ve been handing out HRT like candy, only to find out that it can be deadly and wasn’t even effective anyway (except for controlling hot flashes and night sweats). However, their response in the media has not been encouraging. In the past two weeks I have read or heard doctors in the media claim that:

…it’s only 8 out of 1,000 women who are affected, which is a very small number, (The 40,000 women who have died or been seriously harmed in the past decade by HRT, and their families, may not agree.);

and … it’s still fine to use HRT on a short-term basis, (Do these doctors believe that cancer just suddenly appears one day out of the blue? It takes breast cancer years to develop into a noticeable mass.);

and … there are no alternatives to HRT that work, (Clearly they haven’t tried any alternatives.).

I know that to long-time readers of my books and newsletters this may be repetitive, but it needs to be said over and over: women need to take their health into their own hands; they need to trust their intuition about what s right for them; and they need to assertively insist that their doctors listen to them. The good news is that a door has been opened for women to bring information about natural hormones to their doctors. For many doctors, it’s going to take a lot of courage to admit they’ve been misinformed, but they can make up for the harm they’ve done by opening their minds to other possibilities and looking outside of the drug company standard of care for answers. Some doctors are going to be defensive and never shift gears, but many will now be open to learning about natural hormones.

Million Woman Study in the UK, Published in The Lancet, Gives New Insight into HRT and Breast Cancer

A study in The Lancet (August 8, 2003) involving over a million women in the United Kingdom gives new types of evidence that conventional HRT (estrogen and progestin combinations) is associated with a substantially greater risk of breast cancer and a greater risk of dying from it. This is the largest study of its type, and the first to report an increase in risk of death from breast cancer for HRT users compared with women who have never used HRT. The Million Women Study was set up to investigate the effects of specific types of HRT on getting breast cancer and dying from it.

Some 1,084,110 UK women aged 50 to 64 years were recruited into the Million Women Study between 1996 and 2001, and provided information about their use of HRT and other personal details, and were followed up for cancer incidence and death.

The study found that all types of HRT, including estrogen and progestin combinations, and estrogen alone, increased the risk of breast cancer. Women who took combination hormones at the time the study began in 1996 had a 66 percent increased risk of developing breast cancer and a 22 percent greater risk of dying from it by 2002. Women taking estrogen only HRT had a 30 percent increased risk of breast cancer.

This study also showed what others haven’t shown as conclusively, which is, women using the combination HRT had a higher risk of dying from breast cancer. Use of HRT by women aged 50 to 64 years in the UK over the past decade has resulted in an estimated 20,000 extra breast cancers, 15,000 of these associated with the estrogen and progestin combinations. The longer the women were on the HRT, the greater their risk of breast cancer.

The only good news in the study was that the risk of breast cancer declined gradually after women stopped using it, and within five years of quitting it they had the same risk as women who had never taken it. Many and varied claims have been made that different combinations of estrogens and progestins are safer than others, or that different delivery methods, such as the patch or oral hormones are substantially safer. None of these claims were validated in this study.

Dr. Lee emphasizes to his readers that conventional HRT contains synthetic progestins and not natural progesterone, and that there is no evidence that using natural progesterone as he recommends, increases the risk of breast cancer, and plenty of clinical evidence that it probably protects against breast cancer.

HRT Does not Improve Quality of Life in Women Without Menopausal Symptoms

Last summer the Women’s Health Initiative (WHI) rocked the world of conventional hormone replacement therapy (HRT) when one arm of the study was halted early because of clear increased health risks to women using PremPro. (See the July and August 2002 issues of the John R. Lee, M.D. Medical Letter for details.) Now, further analysis from this study published in the New England Journal of Medicine is showing that when women who don’t have menopausal symptoms are put on PremPro, the most commonly used form of HRT, they do not experience an increase in their quality of life compared to women on a placebo. What can one say to this? Duh? If it ain’t broke, don’t fix it? However, this research was presumably done because of the habit that conventional doctors had, prior to last summer, of putting every woman over the age of fifty on a one-dose-fits-all HRT regimen. The broad consequences of that mechanistic mindset are estrogen dominance and progestin side effects, and the specific consequences, as we saw in the WHI, can range from weight gain and mood swings to fatal blood clots and breast cancer.

Editorial comments on the newly published research suggested that only women with menopausal symptoms should be put on PremPro, but that’s hardly the point. The point is that doctors should be measuring saliva hormone levels first, and then giving only what is deficient, in small, physiologic doses of natural hormones. (N Engl J Med. Published online March 17, 2003)