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It’s been more than a decade since Dr. Jonathan Wright introduced the concept of bio-identical hormone replacement therapy (BHRT) with the book Natural Hormone Replacement for Women Over 45 (Wright JVW, Morgenthaler J. Smart Publications, 1997), at a time when only a handful of clear thinking, knowledgeable doctors had ever heard about bio-identical hormones.
Many women first learned the truth about HRT and BHRT from that first book; others later heard about it from TV celebrity Suzanne Somers, who described her personal experiences with a different version of BHRT in the first of a series of books. But the real stampede away from HRT and toward BHRT began in 2002 with the premature termination of a large, government-funded study—the Women’s Health Initiative (WHI)—the results of which confirmed that the risks of conventional HRT unquestionably outweighed its benefits.
In their new updated book, authors Wright and Lenard will bring to light many examples of “forgotten” or “ignored” scientific studies combined with up-to-date clinical experience that provide solid support for the safety and benefits of BHRT.
Smart Publications is very excited to publish the new BHRT book in early 2010! |
Preface from the book
The Handwriting on the Wall
By Lane Lenard, PhD
It’s been more than a decade since we introduced in written form the already over-a-decade-old concept of bio-identical hormone replacement therapy (BHRT) with our book Natural Hormone Replacement for Women Over 45 (Wright JVW, Morgenthaler J. Smart Publications, 1997), at a time when only a handful of clear thinking, knowledgeable doctors had ever heard about bio-identical hormones.1
It was also a time when Premarin® and Provera® (combined as Prempro®) were among the best-selling patent medicines in the world, earning their parent company, Wyeth Pharmaceuticals, billions of dollars per year. For women who wanted to alleviate the discomforts of menopause or to protect themselves from the long-term effects of the age-related decline in sex hormones, “hormone replacement therapy” (HRT) – as the patented, horse estrogen + alien-to-the-human body pseudohormone combination was marketed – was virtually the only solution conventional medicine had to offer.
Today, scientific research has proven, even to the FDA, that the combination of Premarin® + Provera® is good for little more than alleviating hot flushes for a couple of years at most. Beyond that limit, and despite the current recommended use of new, but unevaluated lower doses, the risks and uncertainties of conventional HRT make it virtually unusable even for that limited role.
Our little book pulled back the curtain concealing the true dangers of HRT, and at the same time introduced women and their doctors to the benefits of true hormone replacement using bio-identical human hormones – estrogens, progesterone, testosterone, and DHEA − that were molecularly identical to those the human body produces.
Many women first learned the truth about HRT and BHRT from our book; others later heard about it from TV celebrity Suzanne Somers, who described her personal experiences with a different version of BHRT in the first of a series of best-selling books. But the stampede away from HRT and toward BHRT really began in 2002 with the premature termination of a large, government-funded study – the Women’s Health Initiative (WHI) – the results of which confirmed that the risks of conventional HRT unquestionably outweighed its benefits. This study and its aftermath have proven to be a significant threat to Wyeth’s profits.
The news of HRT’s dangers probably came as no surprise to the millions of women who had started on it but quit after a few months, because they couldn’t tolerate its side effects or the “funny” way it made them feel. Then again, what would a woman expect when she puts horse hormones and alien pseudohormones into her body every morning?
By contrast, BHRT is a therapy that sells itself. When women start using it, they soon find how much better they feel (especially if they are experienced with conventional HRT), and they almost invariably stay on it and recommend it to their friends and family.
In the wake of the WHI disclosures, women entering their menopausal years have been flocking to BHRT in record numbers. This trend has not gone unnoticed at Wyeth, which has launched an unprecedented legal, lobbying, and public relations campaign to influence the FDA and the US Congress to – in effect – “eliminate the competition” for them. With the battle moving through the courts and the Congress, it’s anybody’s guess whether, once the dust settles, BHRT will even be legal in this country.
Surprised? You shouldn’t be.
Although HRT has repeatedly been proven to cause unnatural and dangerous changes and reactions in the body, it remains available in every pharmacy in the country. The fact that Premarin® and Provera® are still on the market, despite their proven tendencies to cause cancer, heart disease, and other serious disorders, tells us something about the cozy relationship between Wyeth and the FDA, the federal agency that’s supposed to be regulating its products for the good of all Americans, not just Wyeth.
The irony of Wyeth’s anti-BHRT campaign is that the company purports to be trying to protect women who, it claims, would be exposing themselves to BHRT’s alleged “dangers.” Yet, the only evidence Wyeth can produce about the BHRT’s alleged “dangers” is that drawn from studies of its own admittedly dangerous, FDA-“approved” HRT products, which bear no relation, chemically or molecularly, to bio-identical hormones. Wyeth’s argument goes something like this: “If our ‘hormone’ products are dangerous, so must theirs be,” as though HRT and BHRT were the same products.
Conspicuously absent from Wyeth’s arguments, though, is even the slightest evidence supporting the alleged “dangers” of BHRT. Along with the FDA, Wyeth refuses to acknowledge the existence or validity of the hundreds of scientific studies that have been published over the years that support the efficacy and safety of bio-identical hormones, not to mention the dangers of conventional HRT. They’ve recently gone so far as to declare that a benign and long-accepted form of estrogen (estriol), which is produced by every human body (in especially enormous volumes during pregnancy) and is essential to the proper use of BHRT, should be considered an “unapproved drug” and essentially banned from use in the US. This is in spite of the fact that Wyeth has marketed estriol in Europe for years as an “ideal treatment” for menopausal women). Their hypocrisy and dishonesty take the breath away. (For more about these medicolegal issues, see Chapter 12.)
Volumes of Research and Years of Clinical Experience
Given all the negative press Wyeth and the FDA have generated about BHRT, combined with the average physician’s ignorance or bias about it, it’s understandable for women to be a little hesitant about questioning their regular doctor about going on to try bio-identical hormones.
Are you worried about the supposedly unknown risks of BHRT? Certainly concerns about cancer and other serious disorders should always be addressed and the risks carefully monitored. Yet, despite what BHRT critics may allege, literal volumes of scientific research and decades of careful clinical experience vouch for its efficacy and safety. One important purpose of this book is to summarize and bring to light much of this “nonexistent” research and clinical experience.
Over the years, hundreds of comparable, but independent, studies of Premarin® and Provera® and bio-identical estrogens have been conducted – and continue to be conducted – in test tubes, in animals, and in actual human women. They may not always be the large, prospective, double-blind, placebo-controlled trials the FDA likes to hold up as the only kind that can provide valid data. In most cases they are smaller – but usually still well-controlled – studies designed to test some aspect of hormone function, efficacy, or safety, like cholesterol levels, blood clotting, heart function, liver function, propensity for causing cancer, or controlling bone metabolism. Their individual results may not show the “big picture,” but, taken together, they offer a remarkable view as to what that big picture is going to look like. Such studies rarely make headlines, but they do make valid scientific points, and they all have one thing in common: when trials are carried out under reasonably comparable conditions, in virtually every case, bio-identical hormones turn out to be clearly safer and more effective than Premarin® and Provera®.
If the devastating results of the Women’s Health Initiative came as a shock to the vast majority of conventional medicine practitioners, it’s because they had largely ignored these smaller studies – some decades old, but some quite recent – which have served as the handwriting on the wall that clearly predicted the WHI/HRT debacle and the resulting emergence of BHRT. The results and conclusions of most of these smaller studies are as valid today as they were the day they were published, but conventional medicine, controlled as it is by the patent medicine industry and the retrogressive, legalistic FDA, remains wedded to their dangerous but profitable HRT franchise, endlessly repeating the false mantra that there are no valid studies supporting the safety and efficacy of BHRT.
Recently, as the viability of conventional HRT as a big profit-maker has grown lesser and lesser, while the acceptance of BHRT has grown greater and greater, Big Pharma has begun to switch its emphasis to so-called FDA-“approved” bio-identical hormones − primarily commercial versions of the bio-identical estrogen estradiol. Individual compounding, they argue, is unnecessary and needlessly risky. This strategy ignores the facts that 1) the one-size-fits-all standard dose of these estradiol products is typically at least 4 times the amount the body can safely metabolize without raising the risk of breast cancer (See Chapter 9.); 2) the anticarcinogenic estrogen estriol − a mainstay in BHRT − is not only ignored, but is currently being actively and illegally suppressed by the FDA; and 3) no one has ever shown scientifically that carefully compounded hormones or other medications are any more dangerous than mass-produced commercial versions. This last point is a myth supported by a single, decade old, intentionally biased, FDA-sponsored, “limited survey,” the lack of scientific validity of which has been acknowledged under oath before a US Senate committee by the “researcher” who ran it. (See Chapter 12.)
A Note about Endnotes
As you read this book, you’ll no doubt notice a large number of endnotes – references to scientific studies that support all the factual statements and arguments we make. Such references, which are listed at the end of each chapter, are standard practice in the scientific literature, but are much less common in “consumer-oriented” books like this one. The conventional thinking is that “nonscientists” probably aren’t much interested in exactly how these statements are supported by scientific research; that hardly anyone is going to check back to see what those references actually say; and that they just clutter up the text. If that’s the case with you, please feel free to ignore the endnotes. However, at the same time, try to be aware that every time you see something like this1-3 in the text, it means that that particular statement is supported by 3 scientific studies, which you and/or your doctor are welcome to check out.
On the other hand, given the repeated misstatements by BHRT opponents that, since there is “no scientific support” for its efficacy and safety, it must be considered as dangerous as conventional HRT, we thought it essential to provide that scientific research in as much detail as feasible. That way, those critics, or those inclined to be influenced by them, can see just how wrong they have been. We welcome the opportunity to summarize this research for these critics and hope they will look up every reference listed in this book. If they do that, we would find it difficult to understand how they could stand by their negative position.
If after reading this book, you’re still hesitant about the safety of bio-identical hormones, think about this: How could the human species – including all of our ancestors – have survived if normal levels of women’s reproductive hormones predisposed them to fatal diseases? If natural or bio-identical human reproductive hormones (administered in physiologic doses (a physiologic dose duplicates the range of amounts naturally produced by human ovaries, neither more nor less), via a sensible route, and on a schedule the body has adapted to over decades of natural ovarian hormone secretion) increased women’s risks of heart disease or cancer much at all, as many critics contend today, the human species would likely have gone extinct long, long ago. Beyond such common sense reasoning, in the remainder of this book, we bring to light many examples of “forgotten” or “ignored” scientific studies combined with up-to-date clinical experience that provide solid support for the safety and benefits of BHRT.
Lane Lenard, PhD
Millstone Township, NJ
September 2009
- Alert readers will note that our previous book referred to “natural hormone replacement,” while now we talk about “bio-identical hormone replacement.” While the concepts remain unchanged, the terminology has been altered a bit in order to be more precise as to the source of the hormones and to avoid confusion with other products that may be “natural” but not necessarily bio-identical for humans. These include conjugated equine estrogens (eg, Premarin®), which are natural for horses but not for humans, as well as herbal products like black cohosh and dong quai and plant-based estrogens (phytoestrogens) like genistein, which are bio-identical for plants but not for humans.
Lane Lenard, PhD, has been a medical/science writer and editor for more than 30 years. During that time, he has been Articles Editor of Science Digest Magazine, Managing Editor of Sexual Medicine Today Magazine, and editor of several newsletters devoted to nutritional supplements and other health-related topics. Prior to becoming a writer, he earned a doctorate in neuropsycho-pharmacology from Rutgers University and worked for several years as a laboratory researcher for a major pharmaceutical company. He has authored several books and booklets including Why Stomach Acid Is Good for You in 2001 (M. Evans, New York, NY) and Maximize Your Vitality and Potency in 1998 (Smart Publications, Petaluma, CA, co-authored with Dr. Jonathan V. Wright. He lives with his family on 3 beautiful wooded New Jersey acres that used to belong to the Don of one New York’s Five Mafia Families.
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