History Of Hormone Therapy
Humans have been using hormones for at least 2000 years. The first known preparations were made from dried human urine in China. The urine of teenagers was especially prized because of its high content of sex hormones. By the 1700’s and 1800’s scientists started grinding up the ovaries, testicles and organs from animals, putting them into potions. It took years before they were able to chemically extract the active ingredients. By the 1900s, Merck, a patent medicine company, produced estrogen from the desiccated ovaries of cows. It was given to women for menopausal symptoms. By the 1920s a derivative of amniotic fluid from pregnant cows was developed.
The hormone progesterone was first identified in the 1930’s. Unfortunately, production was expensive, requiring vast amounts of endocrine tissue (corpora lutea) from pigs. There was also the problem that most of the oral progesterone was metabolized in the liver before it reached the general circulation where it was utilized.
Ayerst Labs (now Wyeth Pharmaceuticals) introduced the first orally effective estrogen derived from the late pregnancy urine of women, since it contains very large amounts of the estrogen estriol. About the same time, the German company Shering had developed a similar product from human pregnancy urine. Unfortunately, these oral estrogens were not successful because they were expensive, requiring enormous amounts of urine from pregnant women, and women were reluctant to swallow medicines that smelled and tasted like urine.
Horse Urine Works
The companies switched their attention to horse urine which was abundant, less expensive and readily available. The urine from stallions (males) had the most potent estrogens, but collection was difficult. Pregnant mares (females) proved to be the best source for the huge volumes of urine required for production. In 1949, Wyeth-Ayerst introduced a drug composed of estrogenic compounds called Premarin (Pregnant mare’s urine). Women were ecstatic to have relief from hot flashes, vaginal dryness and atrophy, night sweats, depression and low libido. By the early 1970’s, Premarin was the gold standard treatment for menopausal symptoms and was heralded to protect against osteoporosis and cardiovascular disease.
Premarin Causes Cancer
In 1975 clinical studies reported a link between Premarin and uterine cancer. With declining sales and the looming possibility that Premarin could even be pulled off the market, the pharmaceutical companies had to respond. A few studies seemed to indicate that uterine cancer could be prevented if progestins, progesterone-like drugs, were prescribed along with Premarin. The basis for this was unopposed estrogen, a term used to describe estrogen that was not counter-balanced with progesterone. The cancer threat could be eliminated by balancing the negative effects of Premarin by taking Provera, a progestin. This became the new cure-all. In the next few years, Wyeth further capitalized on this combination with the introduction of two new estrogen/progestin drugs, Prempro and Premphase.
Hormone Replacement Therapy (HRT) Causes Harm
In 1993, the National Institutes of Health commenced a drug trial called the Women’s Health Initiative (WHI) to explore the effects of these estrogen/progestin drugs on the long-term health of menopausal women. Specifically designed to examine the prevention of heart disease and hip fractures, and associated change in risk for breast and colon cancer, the study did not look at the short-term risks and benefits of treating menopausal symptoms.
The study involved 16,608 healthy women aged 50-79 and was intended to run until 2005. In 2000 and 2001, investigators found increases in heart attacks, strokes and blood clots in the study participants. In 2002, the number of breast cancers had increased to the point that the study was abruptly halted. Results showed that women taking these drugs had increased risk of heart disease, breast cancer, stroke and blood clots. In 2003, additional results reported an increased risk of dementia or Alzheimer’s disease.
Bioidentical Hormones Ignored
During the time period when estrogen/progestin drugs (HRT) dominated the market (1949-2002), bioidentical hormones were also being manufactured.
In the 1940s, an easy and inexpensive way to produce bioidentical progesterone and estrogen was discovered. Diosgenin, a steroid precursor chemical, was extracted from wild yams and processed into bioidentical hormones. Even though they were now easily and cheaply produced, the pharmaceutical companies had no interest in bioidentical hormones because they could not be patented and therefore, were not profitable.
In the 1970s, studies reported that Premarin only therapy (unopposed estrogen) was giving women uterine cancer. To counteract the negative effects of Premarin and prevent uterine cancer, progesterone was needed. Instead of using bioidentical progesterone, pharmaceutical companies used Provera, a patented progesterone-like drug (progestin).
Even though history shows that these estrogen/progestin drugs would wreck havoc on women for several decades, it was not until 2002 that the WHI reported significant increases in blood clots, cancer, heart disease and stroke. All the while, bioidentical estrogen and progesterone hormones were readily available, but were rejected because they could not be patented for profit by the pharmaceutical companies.
Surge in Bioidentical Hormone Replacement Therapy (BHRT)
After the results of the WHI were published, the public was informed that hormones were carcinogenic. This struck fear into the hearts of women and the use of HRT dropped dramatically. There was no distinction made between HRT and BHRT. The message was simply that hormones were dangerous. Surprisingly, there were still doctors who ignored the WHI results and prescribed HRT with its documented health risks. And if women did not want to take HRT, they were told to just tough it out.
The negative results of the WHI were on HRT, not BHRT. BHRT had never been shown to cause harm. As information about BHRT became available to women, interest in BHRT increased significantly. Since bioidentical hormones have the same molecular structure of the hormones your body makes, it makes sense to use them. Your body recognizes them as human-identical hormones and metabolizes them just as if you had made them. BHRT is prescribed with doses specific to each individual patient. The hormones are compounded (mixed together) by a pharmacist, most often into a cream, suppository or sometimes into an oral lozenge that is taken sublingually under the tongue.
The HRT cartel, however, did not go away quietly into the night, and BHRT has been systematically attacked by the pharmaceutical companies and the medical organizations they support. They claim that BHRT carries the same risks as HRT and they rationalize that even though HRT has significant health risks, at least those risks are known and that is better than BHRT, with yet unknown risks.
History and science, however, have shown these allegations are untrue and that BHRT is safer than HRT. Bioidentical hormones have been produced and used safely by women for over 75 years. There is not one study that reports BHRT causes harm. In fact, the most recent meta-analysis of over 200 studies on BHRT shows that bioidentical hormones are safe and effective.
Today, a few bioidentical hormones are sold by pharmaceutical companies as branded products such as Prometrium (progesterone). The branding protects the product’s name from use by any other company, but the bioidentical hormones are the same hormones compounded by pharmacists. Other bioidentical hormones have been incorporated into patented medicines by pharmaceutical companies. It’s not the actual bioidentical hormone that is patented, because a naturally occurring substance cannot be patented. Instead, the delivery device, such as patch, cream, gel, etc. is patented.
In science, the gold standard of proof is a large, random, double-blind, prospective, placebo-controlled study that reports significant results. History has shown this to be very elusive in medicine. Experts in medicine and statistics have admitted that less than 15% of all medical procedures currently in use today have this gold standard study. That means that 85% of medical procedures used today are based upon clinical experience.
With respect to Hormone Replacement Therapy (HRT) there is only one gold standard study, the Women’s Health Initiative (WHI) study financed by a pharmaceutical company. The WHI study was abruptly halted in 2002 when the first results showed an increase in blood clots, cancer, heart disease and stroke among women taking HRT. This was not the first study to report adverse effects from HRT. Many other studies that preceded this gold standard study had shown negative effects.
What’s a Pharmaceutical Company to do?
Even with the WHI results, pharmaceutical companies still wanted to sell their HRT. Their strategy was to discredit competing Bioidentical Hormone Replacement Therapy (BHRT). The attack was two-fold. First publicize that there is no gold standard study on BHRT and second proclaim that BHRT must carry the same risks as HRT. The message was essentially to trust the evil that we know versus the evil that we do not know.
While it is true there is no gold standard study on BHRT, this ignores two important facts. The first is that bioidentical hormones cannot be patented by a pharmaceutical company and sold for profit, so there is no financial incentive to provide the funding for a gold standard study on BHRT. The second fact is that 85% of medical treatments and procedures in use today do not have a gold standard study.
To accept the assumption that BHRT carries the same risk as HRT, you must completely ignore hundreds of studies attesting to the safety and efficacy of bioidentical hormones. Dr. K. Holtorf, M.D., compiled a meta-analysis on 200 of these studies and reported the results, concluding that BHRT is safer and more effective than HRT. Dr. Jonathan Wright summarizes it best in his book, “a fair comparison of clinical and non-clinical research on HRT and BHRT clearly shows BHRT to be far safer and more effective. Not a single valid study of bioidentical hormones – and there are literally hundreds of relevant published reports going back decades - even hints at the possibility that bioidentical hormones, when properly used, are not superior in efficacy to Premarin, Provera, et al, or carry anywhere near the same risks.” (Premarin and Provera are common HRT hormones).
These attempts by the pharmaceutical companies and the medical organizations that they support to discredit BHRT are nothing new to this industry. The history of medicine is rife with examples of denial and wilful ignorance. For example, for decades the tobacco industry denied the connection to illness and death. They were supported by medical doctors who even did TV commercials hawking their cigarettes.
Another notable example was the practice of doctors washing their hands before contact with patients. This was championed by Dr. Ignaz Semmelweis, but it took the medical profession 50 years and the deaths of countless numbers of patients before they accepted this simple procedure. The medical community ridiculed and ostracized Semmelweis. He had a nervous breakdown and died in a mental institution. Today, of course, Semmelweis is revered as a pioneer of antiseptic policy.
It’s not really any different today. Promoters of products, medicines and procedures do not want to relinquish their power and control, even in the face of new and better information.
The most recent example of ignoring the evidence is the 2012 gold standard study completed on chelation therapy (the intravenous injection of amino acids to treat heart disease). The resulting surprise and comments were typical when the proof came in. “This study is shaking up thinking,” said Dr. George Wyse of the Libin Cardiovascular Institute, who was part of a Canadian chelation study presented in 2001 that suggested the therapy didn’t help patients. “I think we were all surprised,” he added. “It was like opening a door and throwing a hand grenade in and closing the door.” The part about the hand grenade is particularly amusing. Chelation has been used since the 1940’s. There are thousands of studies from all over the world attesting to its safety and efficacy. Millions of treatments are given every week throughout the world. Twenty years ago, the largest meta-analysis study showed that 87% of patients benefitted. It took the medical industry 70 years to get their gold standard study and everyone is so surprised! Fortunately, the nay-sayers were ignored for all those decades and millions of lives were positively affected by chelation treatment. Nevertheless, the promoters of heart surgery and heart drugs are vehemently attacking everything about the gold standard study.
Looks like a Duck, Quacks like a Duck
Since 85% of medicine does not have a gold standard study, preponderance of evidence becomes the de facto standard. There is overwhelming and sufficient evidence on BHRT to draw conclusions. There are hundreds of studies that have met the scientific standards of significance regarding BHRT. The importance of these individual studies cannot be discounted and when taken collectively, conclusions are clear. BHRT is safer and more effective than HRT.
To better explain preponderance of evidence, here’s a simple analogy. You are driving home and you see a horse running towards you on your street. You park at your house and find your front door wide open. Inside your house, you see hoof prints on your carpet and some horse manure. You don’t have an eye witness or a video of a horse in your house, but what would be the most logical conclusion here:
- there was a horse in your house
- there was a zebra in your house
- someone pulled a prank and made hoof prints on your carpet and left some horse manure
The preponderance of evidence points to (a).
BHRT Safer and More Effective
So while BHRT lacks that one large gold standard study, the preponderance of evidence is decisive. There are hundreds of studies showing that it is safer and more effective than HRT. Moreover, there is not one single study that shows harm from BHRT.
The Attack on Bioidentical Hormone Replacement Therapy (BHRT)
Don’t Bite the Hand that Feeds You
BHRT has been denounced by pharmaceutical companies, and the medical associations that they support, disparage bioidentical hormones in their publications and position statements. While there appears to be less direct financial incentive in Canada compared to the U.S., medical organizations in Canada are simply working lock in step with their American counterparts.
With the support of the pharmaceutical companies, medical associations have decreed that BHRT carries the same risks as Hormone Replacement Therapy (HRT) and that there have been no long-term studies to prove otherwise. There are claims that BHRT is not approved by the Federal Drug Administration (FDA) in the U.S. and Health Canada. In addition, doctors being interviewed as experts, though they lack experience utilizing BHRT, contend that BHRT does not get absorbed and provides no benefits.
There is absolutely no scientific justification for these assumptions that BHRT carries the same high risks and low benefits as patented HRT (Premarin, Provera). There are no studies that report this assumption. Manufactured by traditional pharmaceutical companies, bioidentical hormones are regulated and approved by the FDA and Health Canada. Doctors write prescriptions for the individual needs of the patient, and pharmacists compound the bioidentical hormones from the pharmaceutical companies into creams, gels, capsules, lozenges and suppositories. Compounding is not unique to BHRT, as pharmacists have been compounding pain medications, antibiotics, anesthetics, corticosteroids and other medicines for decades.
HRT Causes Harm
There is only one large comprehensive study that has ever been done on hormones and that study only looked at HRT. This study, The Women’s Health Initiative (WHI), was abruptly halted in 2002 because HRT increased the incidence of blood clots, cancer, cardiovascular disease and stroke. The results of the study, however, were not unique, as there had been many other previous studies reporting adverse affects of HRT.
BHRT Safe and Effective
Although there is no comparable large scale study on BHRT that does not mean that the risks are the same as HRT. The first bioidentical hormones were produced over 75 years ago and there are hundreds of studies attesting to their safety and efficacy. There is not one study that shows BHRT causes harm. Dr. K. Holtorf, M.D., recently compiled a meta-analysis of 200 of these studies and reported the results, concluding that BHRT is safer and more effective than HRT.
Bioidentical Hormones are a Threat to Profits
The drug companies have been desperately trying to stop the compounding of bioidentical hormones. It’s simply a matter that there is no money to be made in BHRT because it cannot be patented. The drug companies, however, can make money with their patented HRT. They have tried almost everything, including attacking the methodology of how pharmacists compound bioidentical hormones. Court judgments in the US in 2006, however, came down against the Federal Drug Administration (and consequently the drug companies) citing that they had no jurisdiction over compounded hormones. The Federal Drug Administration and Health Canada have approved bioidentical hormones for decades, but they cannot tell doctors and pharmacists how to deliver them to their patients.
The best known incidence of pharmaceutical duplicity was by Wyeth, the huge international drug consortium. In 2009, Wyeth aggressively promoted bioidentical estriol (used in BHRT) in Europe as the ideal therapy for menopausal women (they had apparently found a way to patent bioidentical estriol via a proprietary delivery method). At the same time in North America where they did not have a patent, Wyeth aggressively denounced the same bioidentical estriol as a potentially dangerous, unapproved drug and attacked compounding pharmacies for using it. How can the same bioidentical hormone be great for European women but not good for North American women? The business axiom “follow the money” seems appropriate in this case. When you can profit from it, it’s an amazing bioidentical hormone, but when you cannot profit from it, it’s a dangerous bioidentical hormone. In North America where Wyeth did not have a patent on bioidentical estriol and therefore could not profit from the sale of bioidentical estriol, Wyeth vilified the hormone and promoted its patented estrogen (HRT).
Patent System Flawed
To understand why the pharmaceutical industry has been attacking BHRT, you have to understand how the patent process works. The patent system has been a successful method to develop new medicines and technologies. It has been a significant contributor to much advancement made in medicine in the last 50 years. Medication research is expensive and the patent process covers drug development costs. It takes millions to bring a drug to market and a patent allows the company to sell that drug without competition for a specified number of years. This allows the company to recoup its costs and make a profit.
With respect to BHRT, however, the patent process does not work. Naturally occurring substances cannot be patented. Bioidentical hormones, therefore, cannot be patented because they are exact replicas of the hormones your body makes naturally. If a company cannot patent a bioidentical hormone, there is no reason to spend millions of dollars on research and development since there is no financial return.
To get a patent and make money from hormones, however, the pharmaceutical companies modify the chemical structure so that it differs from a bioidentical hormone. The pharmaceutical companies must produce HRT to comply with the patent process and generate profits for their shareholders.
Sell, Sell, Sell
Pharmaceutical companies are just like other public companies whose first responsibility is to their shareholders to make a profit. And just like any competitive company, pharmaceutical companies want to maintain and increase their market share. To effectively profit from the patent process, they market altered hormones (HRT) and attempt to block their competition (BHRT). Companies in other industries do this all the time when they hail the praises of their products and try to discredit competing products.
If we were talking about soft drinks or cars, then perhaps these competitive comparisons could be acceptable. If you didn’t like a particular soft drink or car, you could simply buy something else, but we are talking about hormones that have profound effects on your body. The situation is accentuated in medicine because the pharmaceutical companies have enormous clout and are trying to remove an important choice for patients.
Are the pharmaceutical companies doing anything wrong by attacking BHRT? From a business perspective the answer is no. They are simply looking after the financial interests of the company and shareholders just like any other company. The elephant in the room, however, is that HRT creates unexpected and unwanted effects in your body. What we should really be asking is whether it is right to market a product (HRT) with well documented and significant health risks and attempt to discredit a product (BHRT) that has not be shown to be harmful.