David Brownstein M.D.
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 Results of WHI: The Bad
There was a 29% increase in coronary heart disease in the prempro?group.
Results of WHI: The Ugly
A 41%o increase in stroke and a remarkable 2,100%) increase in pulmonary embolism (i.e., lung blood clots) was found in the treated (i.e., prempro? group. In addition the prempro?group had a 26% increased risk of breast cancer.
The Implications of WHI
The WHI was supposed to be an 8.5-year study. However, the research was stopped early, at 5. |
Melody Petersen
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 More than 40 percent of American women between the ages of fifty and seventy-four were taking prempro or a similar drug in 2002, when a large government study found that the pills raised a woman's risk of breast cancer, heart attack, and stroke. Upon learning of the study's results, millions of women threw away their pill bottles. The number of prescriptions written for prempro fell by more than 65 percent. But that was not the end of the tale. |
David Brownstein M.D.
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| This means that half of the women received conventional hormone replacement in the form of prempro?(Premarin?and Provera? and half received a placebo (no active drug).
The outcomes the researchers were looking for included increases or decreases in breast cancer, heart disease, stroke, pulmonary embolism, colorectal cancer, endometrial cancer, hip fracture, and death due to any cause.
The study was supposed to last 8.5 years. The researchers halted the study at 5.2 years because the overall risks of conventional hormone replacement therapy outweighed the overall benefits. ţPrempro ? |
Melody Petersen
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| In 2006 this became clear when another chapter was added to the story of prempro and the other estrogen pills, which the industry has promoted to women as age-defying elixirs since the 1940s.
More than 40 percent of American women between the ages of fifty and seventy-four were taking prempro or a similar drug in 2002, when a large government study found that the pills raised a woman's risk of breast cancer, heart attack, and stroke. Upon learning of the study's results, millions of women threw away their pill bottles. |
David Brownstein M.D.
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| Prempro? group. In addition the prempro?group had a 26% increased risk of breast cancer.
The Implications of WHI
The WHI was supposed to be an 8.5-year study. However, the research was stopped early, at 5.2 years, when the authors of the study realized that the risks of conventional hormone replacement therapy outweighed the benefits.
The results of the WHI made national headlines. It was the final blow to the widespread use of conventional hormone replacement therapy. Women were flocking to their doctors asking them what to do with their hormone replacement therapy. |
J. Douglas Bremner
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 The Women's Health Initiative (WHI) involved the random assignment of 16,608 postmenopausal women to estrogen and progestin (equine estrogen and medroxyprogesterone, or prempro) vs. a placebo from 1993 to 1998. Women on prempro had a statistically significant 24% increase in their risk of heart attack or cardiac death. HRT also increased the risk of breast cancer by 24%,1 and doubled the risk of pulmonary embolus (blood clot in the lung). |
David Brownstein M.D.
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| In addition the prempro?group had a 26% increased risk of breast cancer.
The Implications of WHI
The WHI was supposed to be an 8.5-year study. However, the research was stopped early, at 5.2 years, when the authors of the study realized that the risks of conventional hormone replacement therapy outweighed the benefits.
The results of the WHI made national headlines. It was the final blow to the widespread use of conventional hormone replacement therapy. Women were flocking to their doctors asking them what to do with their hormone replacement therapy. |
J. Douglas Bremner
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| The Heart and Estrogen/Progestin Replacement Study (HERS) involved randomized blinded treatment of 2,768 postmenopausal women with a history of heart disease for four years with estrogen plus progestin (conjugated estrogens and medroxy-progesterone, or prempro) or placebo and two years of follow-up. HRT had no protective effect against recurrence of heart disease. |
Tori Hudson, N.D.
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 A recent study showed that the common dose of prempro led to a decrease in CoQIO and vitamin E levels in the blood, thereby increasing menopausal cardiovascular risk factors in women who use HRT.200 Use of statins to treat high cholesterol has been associated with muscle pain and decreased exercise tolerance that has been correlated with a reduction in CoQIO.201-204
MHMBMMMMMMMMMMMMHHM^
CoQIO
50-150 mg per day
Calcium. Calcium is most well known for its effects on bone health, but it can also be used to treat elevated cholesterol and hypertension. |
C. W. Randolph, M.D.
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 In July 2002, the National Institutes of Health (NIH) halted a large study examining the effects of a widely used synthetic hormone, prempro, which combines the altered molecular structures for both estrogen and progesterone. The study, which was one of five major studies in a large clinical trial called the Women's Health Initiative, was discontinued because the synthetic hormones were found to increase a woman's risk of breast cancer as well as heart disease, blood clots, and stroke. Later findings also linked synthetic hormone replacement to an increased risk for Alzheimer's disease. |
Bill Sardi
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 In March of 2003, the FDA approved a lower dose of prempro, the most popular hormone fountain of youth' for menopausal women, now seems to increase the risk of breast cancer even when taken for only oneyear." [Jerusalem Post June 25, 2003; J Am Med Assoc 289: 3243-53, 3254-63, 2003]
Due to the negative scientific studies, the use of estrogen therapy in Canada dropped an astonishing 32% from 2001 to 2002. [J Am Med Assoc 289: 3241-42, 2003] In the United States, hormone replacement therapy declined by about 30%. |
Gerald E. Markle and Frances B. McCrea
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 Even so, Wyeth Pharmaceuticals, which produces prempro, the most popular brand of HRT, projected profits of about $1.5 billion for 2004.
For us, the story of ERT, and then the almost repeat story of HRT, is frustrating. Numerous clinical studies show that there is little or nothing to be gained from estrogen treatments, and much to be lost. Yet a confluence of interests—pharmaceutical companies pushing drugs for diseases that they invented, professional imperialism, and the cultural stereotyping of aging women—has too much momentum to stop. |
Hyla Cass, M.D.
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 While we hear daily of new drug miracles, more often, it's the latest debacle: Baycol, a drug for lowering cholesterol, withdrawn because of deaths and transplants due to severe liver damage; Vioxx, for arthritis, withdrawn because of heart disease-related complications; and hormones such as prempro, once seen as a boon to all post-menopausal womankind, now viewed as posing an unacceptable risk of breast cancer and heart attack.
How can this happen? As physicians, we take the Hippocratic oath to "first, do no harm. |
| The silver lining about the Vioxx debacle (not to mention the ones involving prempro, Baycol, and several other drugs) is that it raised public consciousness about the fact that prescription drugs can have risks. Any drug powerful enough to have substantial effects on a disease process will be powerful enough to cause harm.
Potential sources of conflict of interest that might allow dangerous drugs to hit the marketplace and be marketed to billions of consumers are getting more media attention. |
Stacy Malkan
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 The researchers believe the reason is that millions of women abandoned hormone replacement therapy after a large federally funded study reported that women who regularly took the menopause drug prempro (a combination of estrogen and progestins) were more likely to develop heart problems and breast cancer. Soon after the findings emerged, many women stopped using the hormones and breast cancer rates began falling, the statistics show.6 The findings raise the question: could reducing exposure to other sources of external synthetic estrogens further reduce breast cancer rates? |
C. W. Randolph, M.D.
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| The list of synthetic hormones on the market today includes such brand names as Premarin, prempro, Menest, Ortho-est, Activella, and Femhrt. There are many others.
Synthetic hormones have shapes that are not found in nature. They fit poorly with the body's hormone receptors and therefore produce unnatural chemical reactions and striking alterations in biological activity. Their RBA is often much less than 100 percent, which results in side effects and health risks. Premarin, for instance, is metabolized horse estrogen with a low affinity for binding with any human hormone receptor. |
| Synthetic hormone repla cement drugs such as Premarin, prempro, Femhrt, Menest, Ortho-Est, Activella, and many other brand names, as well as birth control pills, contribute to the development or worsening of estrogen dominance.
Many doctors routinely continue to prescribe synthetic hormone replacement therapy for menopausal symptoms, such as hot flashes, night sweats, insomnia, and moodiness. These prescription drugs are composed of synthetic estrogen or a synthetic estrogen and progestin combination. |
J. Douglas Bremner
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| Women on prempro had a statistically significant 24% increase in their risk of heart attack or cardiac death. HRT also increased the risk of breast cancer by 24%,1 and doubled the risk of pulmonary embolus (blood clot in the lung). There was about a 50% increase in ovarian cancer that was not statistically significant, mainly because ovarian cancer is much less common than breast cancer, and no increase in uterine cancer. HRT had no effect on cancer when all cancers were combined, and it reduced the risk of osteoporotic fracture.2 It did, however, increase the risk of stroke by 31%. |
David Brownstein M.D.
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| The Women's Health Initiative research study showed a 29% increase in cardiovascular disease in the group that took prempro? This study confirmed the earlier studies on the ineffectiveness of conventional hormone replacement therapy in preventing cardiovascular disease.
In addition, WHI showed that there was no benefit for stroke prevention. Instead, women who took conventional hormones had a 41% increased risk of stroke compared to women who did not take the hormones. It is even more alarming that a 2,100%) increased risk for pulmonary embolism was observed. |
| Examples of synthetic hormones include Provera*, prempro? Premarin? birth control pills, etc.
THE LOCK AND KEY MODEL OF HORMONES
The hormones in our bodies work via a "lock and key'" model. When a hormone is released from its gland the hormone (the "key") binds to its receptor (the "lock"). This binding is analogous to a key being put in the ignition of the car. When the hormone binds to its receptor, a chemical reaction takes place. Natural, bioidentical hormones have a perfect fit in these receptors. The "key" fits perfectly in its complimentary "lock". |
Melody Petersen
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| This was the first full year after women had stopped taking prempro in droves.
Researchers said they finally understood why women in some of the most affluent areas of the country, places like Marin County, California, had for years suffered from higher rates of breast cancer than places not as wealthy. The affluent women, they said, had been more likely to take the prescription hormones. For decades, doctors had been unwittingly fueling the rate of breast cancer in the United States by writing prescriptions for the estrogen pills. |
| Six months after that December 2000 video, government researchers announced they had shut down a study of prempro after finding it caused a higher risk of breast cancer, heart disease, and stroke. While the drug would remain on the market, the news startled millions of women who had believed the daily pills would keep them vigorous, sexy, and young.
Robert Chandler and Gianfranco Chicco were two of the industry's top experts on producing buzz about pharmaceutical products. They operated a global public relations firm from an office in the heart of Manhattan's meatpacking district. |
| The number of prescriptions written for prempro fell by more than 65 percent. But that was not the end of the tale.
In December 2006 researchers tracking the incidence of cancer in the United States announced that they were astonished by statistics they had pulled together for 2003. After rising steadily for decades, the number of women diagnosed with breast cancer had suddenly plummeted in 2003 by 7 percent. Some fourteen thousand fewer women, they said, had been diagnosed with breast cancer in 2003 than in the previous year. |
| And in a video paid for by Wyeth-Ayerst, the maker of the hormone replacement therapy prempro, Lauren Hutton boasted she "started looking a lot better" after she began taking the drug. "I can go into a room and pretty much tell who is and who isn't taking estrogen," the supermodel said. The pills, she added, even helped her sex life. With menopause, "you get irritable so you don't feel like doing anything," she said. "You don't even want to go to the movies, much less have sex. But once I got it all worked out, I sometimes go to the movies two or three times a day. |
Hyla Cass
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| While we hear daily of new drug miracles, more often, it's the latest debacle: Baycol, a drug for lowering cholesterol, withdrawn because of deaths and transplants due to severe liver damage; Vioxx, for arthritis, withdrawn because of heart disease-related complications; and hormones such as prempro, once seen as a boon to all post-menopausal womankind, now viewed as posing an unacceptable risk of breast cancer and heart attack.
How can this happen? As physicians, we take the Hippocratic oath to "first, do no harm. |
| The silver lining about the Vioxx debacle (not to mention the ones involving prempro, Baycol, and several other drugs) is that it raised public consciousness about the fact that prescription drugs can have risks. Any drug powerful enough to have substantial effects on a disease process will be powerful enough to cause harm.
Potential sources of conflict of interest that might allow dangerous drugs to hit the marketplace and be marketed to billions of consumers are getting more media attention. |
J. Douglas Bremner
See book keywords and concepts |
| Common brand-name examples of HRT include Premarin (estrogen from a horse), Provera (progesterone), and prempro (combination). About 20% of women will develop uncomfortable, and sometimes unbearable, hot flashes during the perimenopausal period. Some women develop other or additional symptoms, such as problems with rational thinking or depression, all of which can be treated successfully with HRT. Other hormones, like testosterone, can be used for purposes such as treating low libido in women. |
David Brownstein
See book keywords and concepts |
 Results of WHI: The Bad
There was a 29% increase in coronary heart disease in the prempro group.
Results of WHI: The Ugly
A 41% increase in stroke and a remarkable 2,100% increase in pulmonary embolism (i.e., lung blood clots) was found in the treated (i.e., prempro) group. In addition the prempro group had a 26% increase risk of breast cancer.
The Implications of WHI
The WHI was supposed to be an 8.5-year study. However, the research was stopped early, at 5.2 years, when the authors of the study realized that the risks of conventional hormone replacement therapy outweighed the benefits. |
Dr. Timothy Scott
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 This new and improved pill, prempro, was perfect for all those women who had never had a hysterectomy. The women like my mother who had already had that surgery could stay on Premarin since there was no uterus in which cancer could develop.
At the time progesterone was added, no one realized that, although the added progesterone did decrease endometrial cancer, it also significantly increased the rate of breast cancer. |
| We will never know how many women have or will get breast cancer as a result of taking prempro or the higher dosage of Premarin that used to be the standard, but my mother must be added to that total, whatever it is. |
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