New study damns results of WHI report on Premarin family of drugs

by JANE ALLIN

New Study

Another new study published September 12, 2017 in the Journal of the American Medical Society (JAMA) has made headlines claiming that HRT is not the villain it was once thought to be.

Per the investigators, a statistical review of the results of the damning 2002 WHI study showed that the women taking the hormones did not die earlier or have higher incidence of chronic illness than those taking a placebo.

In fact, to the contrary, this new study asserts that these women experienced a profusion of benefits as a result of taking the HRT – improving the quality of life, preventing osteoporosis, heart disease and Alzheimer’s, and of course a satisfying sex life among other advantages.

An author who penned an article in the Huffington Post by Erika Schwartz MD, self-described as a physician who is a hormones and prevention expert, even goes so far as to tout them as miracle drugs. Laughable at best.

“Hormones are great for you. You are better off with any kind of HRT (bioidentical estradiol, testosterone, conjugated equine estrogen, etc.) than nothing. The WHI study was a most horrific insult to women’s health in recent history. It hurt and still does millions of women. Women are suffering because money was more important than pure science and honest medical discourse.” [1]

Pfizer World Headquarters. Reuters.
Pfizer World Headquarters. Reuters.

How was money more important than science and honest medical discourse? If anything, the WHI resulted in huge losses in profits for Big Pharma, notably Wyeth, now a wholly owned subsidiary of pharmaceutical giant Pfizer.

Moreover, Wyeth was guilty of covering up the truth about HRT and its link to increased incidences of cancer, heart disease and other life-threatening ailments in pursuit of higher profits at the expense of women. A classic example was the use of ghostwriters hired by Wyeth for this very reason.

“The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.” [2]

In any case, the study: “Menopausal Hormone Therapy and Long- term All-cause and Cause Specific Mortality; The Women’s Health Initiative Randomized Trials” in its entirety is available here  and a brief overview and summary of results can be found here.

The study was an observational follow-up of more than 27,000 postmenopausal women aged 50 to 79 years who were enrolled in the 2 WHI randomized clinical trials between 1993 and 1998 and followed up through December 31, 2014 – a cumulative total of 18 years.

These two trials — the original WHI study, and a second WHI study published two years later — found that taking estrogen plus progestin (Prempro) HRT increased a woman’s risk of heart disease and breast cancer while taking estrogen alone (Premarin) increased the risk of stroke, dementia, and other health dangers including endometrial cancer.

Trio of Rescued Premarin Foals. Photo: Vivian Grant Farrell
Trio of Rescued Premarin Foals. Photo: Vivian Grant Farrell.

The new study published in JAMA on September 12, 2017 strongly supports the claim that hormone therapy with CEEs (conjugated equine estrogens) in combination with progesterone (e.g. PremPro) and CEEs alone (Premarin) are not associated with “all-cause” mortality. In other words, they are trying to convince women that HRT therapy is not harmful, will not kill you nor shorten your life – those women who took the drugs to alleviate the symptoms of menopause were no more likely to be dead after 18 years than those who didn’t.

“Among postmenopausal women, hormone therapy with CEE plus Progestin (PremPro) for a median of 5.6 years or with CEE alone Premarin for a median of 7.2 years was not associated with risk of all-cause, cardiovascular, or cancer mortality during a cumulative follow-up of 18 years.”  [3]

Specifically, HRT taken for 5 to 7 years was not associated with risk of long-term “all-cause” mortality.

So they say.

Yet in the same breath, they continue to advise restrictions on its use based on the age of onset of menopause, the lowest dose possible, for the shortest duration possible, not to be taken with existing risk of cancer and heart disease, blah, blah, blah . . .

“Although these findings lend support to practice guidelines endorsing use of hormone therapy for recently menopausal women with moderate-to-severe symptoms, in the absence of contraindications, the attenuation of age differences with longer follow-up and potential health risks of treatment would not support use of hormone therapy for reducing chronic disease or mortality. Moreover, it is unclear whether benefits would outweigh risks with longer duration of treatment.” [4]

As with other prescription medications and the plethora of warnings, contraindications and precautions, how safe are these drugs, particularly given past studies other than the WHI trials have also shown them to be harbingers of heart disease, cancers and other maladies?

As a matter of fact, according to their analysis, the researchers found that there was indeed a “statistically significant” increase in breast cancer incidence in women who took the combination CEE and Progestin HRT (Prempro) – the same findings as the WHI and other independent studies of which there are many.

“Total cancer mortality did not differ significantly between intervention and placebo groups in either trial despite the increased incidence of breast cancer with CEE plus MPA34 and concerns about an increased risk of hormone-sensitive cancers with both regimens”. [5]

Yet this “critical finding” is obscured in the blanket statements in the many articles circulating the Internet that extol the benefits of HRT as a direct result of this study.

Sadly, often these warnings are not passed on to the unsuspecting patient and are glossed over, even by their physicians. One need only listen to the sweeping comments made by Erika Schwartz, MD, the hormone expert who authored the paper referred to above; “Principal Investigators of 2002 WHI Study Reverse Findings — HRT vindicated in new JAMA article”.

Not only does she recommend all forms of HRT to her patients, as well as making the ridiculous statement that women are suffering because money was more important than science when in fact, money had nothing to do with it — sales of Premarin and its derivatives plunged after the results were released — she has this little rant to add:

“Now oddly media coverage hasn’t really done this report justice. It has been casually covered as a ray of hope but not as the wake-up call it MUST be. While in 2002 the media frenzy killed HRT, the JAMA report was interpreted as light reassurance for HRT. That’s just not right. There is no doubt here. HORMONES DO NOT HARM WOMEN, the medical establishment dogma does.” [6]

Seriously?

The researchers themselves have underscored the limitations of the study, caution the interpretation of the results and warn that cause-specific mortality analyses should be considered exploratory. If that isn’t from the horse’s mouth what is?

So, what to make of this? What prompted these original researchers to revisit this 25 years after the fact? To right a perceived wrong in the hope that the whole debacle of the HRT debate goes away once and for all? To help lessen the stigma so that there will be a resurgence of sales of the Premarin family of drugs?

Your guess is as good as mine, but I am betting it has everything to do with Pfizer’s bottom line.

There is no reason to think that a new study is right and all the previous studies are wrong. But if they are profit driven this is exactly what the drug companies want people to believe.

Class Action Lawsuits

And what about all those class-action lawsuits? Are they suddenly moot? These were massive suits involving thousands and thousands of women, some surviving and others dying. If these drugs don’t cause cancer why on earth did Wyeth/Pfizer lose these lawsuits, many of which were unlawful death suits? Do people really think that companies such as Wyeth and Pfizer have no leverage? Money talks.

The science is there but it seems that there is always some new study funded by these mammoth pharmaceutical companies to cast doubt on the findings if they are not in support of pushing their drugs that make lucrative profits — money before patient safety. In fact, for this study, Pfizer was paid for consultancy and review activities.

Conflict of interest? You be the judge.

As Peter Gotzsche M.D., Director of The Nordic Cochrane Centre and author of “Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Health Care” points out:

“Much of what the drug industry does fulfills the criteria for organized crime in US law,” Dr. Gotzsche said in a recent interview. “And they behave in many ways like the mafia does, they corrupt everyone they can corrupt, they have bought every type of person, even including ministers of health in some countries . . . The drug industry buys the professors first, then chiefs of departments, then other chief physicians and so on, they don’t buy junior doctors.” [7]

Menopause Lane Street Sign. Author unknown.
Unattributed Google search result.

Lies, Damn Lies and Statistics

The approach to this study is not new and similar studies have been made in the past — for example, one in 2013:

Menopausal Hormone Therapy and Health Outcomes During the Intervention and Extended Poststopping Phases of the Women’s Health Initiative Randomized”. (http://jamanetwork).

One of the key points is that in these studies the results of the WHI are broken down by age groups, rather than individuals treated as a single cohort. The other principal factor is that the statistical analysis used in both the current and 2013 study was hypothesis testing (statistical significance) using “P values”. And in each case, the conclusions were the same — HRT is safe (with some restrictions).

While this age-stratified analysis is a good approach, what of the actual statistical method used to arrive at the conclusions?

Without going into detail about hypothesis testing and the use of “P values” to predict the significance of an event, this statistical method and its applicability to medical research has been shown repeatedly that conclusions based on calculating “P values” are frequently false. Just as statistical significance does not always mean a result is real, lack of statistical significance (which they are using in this study) does not mean that there is no effect.

In fact, observant experts have been pointing out serious flaws in standard statistical testing for decades. In recent years, the depth of the problem has become more apparent and better documented, yet the medical community continues to employ these methods simply because these methods have been embedded in the scientific process. In effect, it is not just medical research, but all research fields, that often draw erroneous conclusions.

Even the researchers warn of caution when interpreting these results:

“Finally, the nominal P values presented here should be interpreted cautiously, as multiple outcomes and subgroups were examined. Thus, cause-specific mortality analyses should be considered exploratory.” [8]

And yet, this new study is being promoted as leading-edge “feel-good” news for menopausal women across the globe via social media without recognition of the caveats associated with the results. Reckless endangerment at its best.

Yes, ladies, you can breathe a sigh of relief. Or not.

“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.” [9]

In truth, the best solution to determine the safety of HRT on the health of menopausal women would be to repeat the experiment without the flaws that existed in the original WHI studies. Unfortunately, often studies are too complicated, lengthy or expensive to repeat.

Or, as in this case perhaps, the drug company does not want to pursue a wholly comprehensive study as it will further affect sales if found to negatively impact the health of patients, just as it did originally – why take the time and money if only to find that HRT does in fact cause heart disease, cancer and the like.

That is both a financial risk and a precarious risk where damning results could leave a stain on the brand name and negatively affect profits if the results are published. However, drug companies publish only a fraction of the studies they fund — the ones that promote their drugs. Unwanted results are not published.

Sadly, doctors must rely on academic peer-reviewed medical journals to learn about prescription drugs and pass these findings onto their patients in the way of prescription medications. What choice do they have?

“Pharmaceutical companies know this and have worked hard to sway the leadership. Now the question comes up if we can trust the data that the leadership relies on. One wonders how deep the deception goes. In fact, the heavy influence of pharmaceutical dollars inspired the former editor-in-chief of the New England Journal of Medicine, Dr. Marcia Angell, to conclude, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.”  [10]

In the News

It is always tempting for journalists and scientists alike to report a finding that is contrary to popular belief. This is no exception.

For years after the damning result of the WHI study, and to this day forward, HRT has been a controversial subject. When a study emerges that defies previous findings, often the magnitude of the effect is overstated and the less likely the research findings are to be true.

Then there is the enticing phrase “Contrary to previous scientific belief . . .”.

“Ordinarily, “contrary to previous belief” should be a warning flag that the result being reported is likely to be wrong. Instead it is usually a green light to go with the story. So the general criteria of newsworthiness—a first report, in a hot field, producing findings contrary to previous belief—seem designed specifically to select the scientific papers most likely to be bogus.” [11]

Add to this, the HRT media campaigns by Pfizer and others that underplay the dangers of cancer and heart disease. These types of studies that shine a positive light on the use of HRT to control symptoms of menopause clearly add more arsenal to their strategy. Billions are spent on direct-to-consumer ads promoting drugs that Big Pharma say are intended to raise awareness of treatment options.
The truth is, direct-to-consumer advertising is used to drive choice rather than inform it – the ‘driving’ typically in the direction of expensive brand-name drugs. [12]

The only two countries in the world that allow direct-to-consumer advertising are the U.S. and New Zealand.

Survey’s carried out in both countries have shown that when a patient asks for a specific drug their family physician is likely to prescribe that drug over others such as generics or alternatives, for example.

But it is more insidious than this since the ugly truth is that doctors are being enticed by pharmaceutical companies to prescribe their drugs.

In a gullible nation that has been brainwashed by Big Pharma, and their physicians who receive 95% of their information from this very source, there is little difficulty persuading the masses that drugs are the answer to any “condition” although many of these so-called illnesses are treatable by lifestyle changes or, in effect, are not diseases at all. [13]

Such is the case for the ubiquitous Premarin family of drugs.

Prescription drugs are killing us. Arnold Seymour Relman. Image Source: True Activist.
“The medical profession is being bought by the pharmaceutical industry, not only in terms of practice of medicine but also in terms of teaching and research.” Arnold Seymour Relman. Image Source: True Activist.

So, I leave you with this.

“The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.” – Arnold Seymour Relman (1923-2014), Harvard Professor of Medicine and former Editor-in-Chief of the New England Medical Journal [14]

[1] [6] http://www.huffingtonpost.com/entry/principal-investigators-of-2002-whi-study-reverse-findings_us_59bf0771e4b06b71800c3aed

[2] http://www.nytimes.com/2009/08/05/health/research/05ghost.html?pagewanted=all

[3] [4] [5] [8] https://preview.thenewsmarket.com/Previews/JOUR/DocumentAssets/483786.pdf

[7] [10] https://www.thedailybeast.com/big-pharma-is-americas-new-mafia

[9] https://www.acsh.org/news/2015/05/19/science-publication-is-hopelessly-compromised-say-journal-editors

[11] http://nautil.us/issue/4/the-unlikely/sciences-significant-stats-problem

[12] http://www.who.int/bulletin/volumes/87/8/09-040809/en/

[13] https://tuesdayshorse.wordpress.com/2014/07/23/pushing-premarin-big-pharma-big-bucks-part-1/

[14] http://www.collective-evolution.com/2016/05/14/pfizer-vp-comes-clean-tells-the-truth-about-pharmaceutical-companies-video/

© The Horse Fund

WHI — Women’s Health Initiative

The Women’s Health Initiative (WHI) was initiated by the U.S. National Institutes of Health (NIH) in 1991. The Women’s Health Initiative, which consisted of three clinical trials (CT) and an observational study (OS), was conducted to address major health issues causing morbidity and mortality in postmenopausal women.

Related Reading

Further reading on the use of “P values” and other sources of statistical error:

“Why Most Published Research Findings are False” http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124

“A Dirty Dozen: Twelve P-Value Misinterpretations” http://exp-platform.com/Documents/2017-08%20KDDMetricInterpretationPitfalls.pdf

“Science’s Significant Stats Problem” http://nautil.us/issue/4/the-unlikely/sciences-significant-stats-problem

Don't sweat the latest report damning WHI report on Premarin. Take an alternative.
Don’t sweat the latest report damning WHI report on Premarin. Take an alternative.

Women — Don’t Sweat It

Don’t sweat it concerning these drugs and the confusion surrounding them. Work with a health care professional to find the right alternative for you. Here are some good alternative avenues for you to explore.

More at Tuesday’s Horse

• Horse pee reduces breast cancer. Say what? by Jane Allin
https://tuesdayshorse.wordpress.com/2013/06/13/horse-pee-reduces-breast-cancer-risk-say-what/

Premarin Horses

March for Premarin Horses featured image.
Pfizer’s Premarin family of HRT drugs is made from the urine of pregnant mares.

The Premarin family of drugs is made from the estrogen rich urine of pregnant mares. Hence the name Pregnant Mare’s Urine.

The conjugated equine estrogens produced from the urine of pregnant mares to make these drugs have been declared known carcinogens by the World Health Organization.

See all posts on Premarin Horses »

Learn how more about how these horses are used and what happens to cast off mares and byproduct foals at Premstoppers at http://horsefund.org/premstoppers-home.php.

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Please share far and wide, on behalf of women and horses.

 

 

 

Turn your back on Premarin type drugs and seek alternatives for symptoms of menopause

October is Breast Cancer Awareness Month and as it draws to a close we urge women to please turn your backs on Premarin type drugs — tablets and cream — and seek another treatment for menopausal symptoms.

There are alternatives.

Work with your doctor to find something to help you other than drugs made from pregnant mare’s urine — for your sake as well as the innocent mares and their byproduct foals.

Crazily I have had doctors argue with me that the Premarin family of drugs are not made with conjugated equine estrogens derived from the urine of pregnant mare. The absence of the word “equine” on the packaging is proof enough for them.

Of course “equine” was removed some years ago. Yes, we heard about it and we know how and why. I assure them that the key component of the drugs taken from the estrogen rich urine of pregnant mares remains the same. End of discussion.

I share this with you in case you encounter this argument yourself whether it be with a physician trying to prescribe it to you or when trying to warn someone who is taking it.

THE ALTERNATIVES

Jane Allin put together a list of alternatives to drugs such as Premarin, Prempro, Duavee and Duavive (See also pdf version at the end of this post).

Duavee by the way is the name given to Aprela when it was approved by the FDA during the last federal government shutdown and is being peddled in Europe under the name Duavive.

We asked Jane to review her report on alternatives and give us any updates. This is what led to Jane’s recent post on Tuesday’s Horse regarding the helpful properties of rhubarb. See Breast cancer, menopause and yes, rhubarb.

This in turn launched me on a vegan rhubarb recipe hunt which you can find here. See No need to sweat menopause when you can chill with some rhubarb.

Other than that there are no notable changes.

Please keep reporting those Premarin television and magazine ads!

Thank you.

PDF
Alternatives to Drugs Made with Conjugated Equine Estrogens by Jane Allin (pdf, 7 pp)

FURTHER READING
Premstoppers Home »
Reports Regarding Premarin Horses »
Images of PMU Horses; Images from PMU Farm in China »

Daughters of Premarin — The Generics

BY JANE ALLIN

Further to the reference of generics in the “Alternatives To” report, I think a separate word on the availability of generic Premarin® and its daughter drugs is warranted to clear up any confusion for those seeking to avoid products manufactured from the urine of pregnant mares.

Premarin has a long and interesting history when it comes to FDA approval of generics, a history mired in the ruthless and bloodthirsty battle of Big Pharma patent wars.

Many years ago, in 1986, the effectiveness of Premarin’s®, and other short-term acting estrogens, ability to diminish bone loss associated with osteoporosis was granted approval by the FDA. What was once a drug that was prescribed for the relief of menopausal symptoms now became the panacea for a long-term chronic problem. [1] And with this came a huge untapped market.

At this time there were certified generics that were interchangeable with Premarin®. However because of the ramifications of long-term use, the science behind the drugs prevailed.

While Premarin® provided slow-release bioavailability, the generics were immediate release. This disparity in mode of release would turn into a long battle between the generic manufacturers, Wyeth-Ayerst and the FDA. [2]

To make a long story short, the outcome of detailed analysis showed that the bioavailability of generic versions was not equivalent to Premarin® and in 1991 the FDA withdrew approval of all ANDAs (Abbreviated New Drug Applications) proclaiming that none of the synthetics on the market could be considered generic versions of Premarin®. [3]

Because of the lucrative market potential, two generic manufacturers – Duramed and Barr – set out to develop products that solved the bioavailability problem and submitted ANDAs for FDA approval. Both met the requirements of adsorption efficiency however Wyeth had been conducting its own research and contested FDA approval on the grounds that the generic drug lacked one of the estrogens, called delta 8,9 (dehydroestrone sulfate), present in Premarin®. Nevertheless, in 1994, the FDA unanimously ruled that delta 8,9 (dehydroestrone sulfate) was an impurity and not a required ingredient of a generic version.

Duramed applied for FDA approval of Cenestin in September 1995, and Barr followed the next July. [4]

What happened next effectively blocked any competitor from manufacturing a generic Premarin®. Propaganda and political persuasion tactics were used to coerce the FDA and in 1995 Wyeth-Ayerst successfully petitioned the FDA to require the presence of delta 8,9-dehydroestrone in any generic version of Premarin®. [5] Together with Wyeth-Ayerst’s patent on synthetic delta 8,9-dehydroestrone, this shut out the competitors.

Eventually Duramed filed a NDA (New Drug Application) for its synthetically derived estrogen Compound Cenestin which is still available on the market today along with a variety of other synthetic products, none of which contain pregnant mare’s urine.

Premarin® lost its patent in February 2012 and the patent for Prempro® held by Wyeth Pharmaceuticals, does not expire until early 2015.

Despite Premarin’s® patent expiration there seems to be no interest in manufacturing a generic version from pregnant mare’s urine. [6] In any case, it would be challenging for another pharmaceutical company to synthesize a medication that is similar enough to Premarin® to receive the approval of the FDA, similarly so for Prempro® as it contains the same natural conjugated equine estrogens as Premarin®.

The so-called Premarin generics are the lab-synthesized versions manufactured from plant sources not pregnant mare’s urine (see “Alternatives to Drugs Made with pregnant Mare’s urine). [7]

As a reminder, these drugs carry with the same serious risks as the Premarin® family of drugs.

Some will say that generic Premarin® is available online without prescription, particularly from Canada. However be wary of any medications that tout themselves as being a safe generic version of Premarin®. Congressional testimony from the US FDA points out the dangers of inadequately regulated foreign Internet sites which have also become portals for unsafe and illegal drugs. This excerpt specifically targets Canadian generic websites. [8]

A recent example illustrates some of the dangers associated with the purchase of prescription drugs from rogue pharmacy sites. Within the last six months, FDA has examined two web sites having identical web pages headlined “Canadian Generics” which were identified through spam e-mails sent to consumers. FDA has purchased prescription drugs from both of these sites, and has found that these drugs and the manner in which they are sold pose potential threats to the health and safety of consumers.

There is at least one Canadian flag on every page of these sites, as well as the words “Canadian Generics.” The web sites say, “Order Canadian to get the biggest discounts!” Both of the URLs from which the orders were placed suggest the sites are located in, and operated out of, Canada. Despite these representations, however, we determined there is no evidence that the dispensers of the drugs or the drugs themselves are Canadian. The registrants, technical contacts, and billing contacts for both web sites have addresses in China.”

There is currently no therapeutically equivalent version of Premarin® available in the United States. In other words, there is no approved generic for Premarin in the US.

The drug policies and generic approval practices in other countries may vary. What is a generic in one country may not be approved as one in another.

Fraudulent online pharmacies may attempt to sell an illegal generic version of Premarin®. These medications may be counterfeit and potentially unsafe.

If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. [9]

CONSULT YOUR DOCTOR
Always consult your doctor before embarking on any change in medication
_______________

[1] http://pubs.acs.org/subscribe/archive/mdd/v03/i08/html/kling.html
[2] Same as at 1.
[3] Same as at 1.
[4] http://www.sagepub.com/jowett5estudy/cases/77821_c2.pdf
[5] Same as at 4.
[6] http://www.drugs.com/availability/generic-premarin.html
[7] https://tuesdayshorse.wordpress.com/2014/03/25/alternatives-to-drugs-made-with-pregnant-mares-urine/
[8] http://www.fda.gov/newsevents/testimony/ucm113635.htm
[9] Same as at 6.

Alternatives to drugs made with pregnant mare’s urine

BY JANE ALLIN

As part of of the The Horse Fund’s campaign against the manufacture and use of the Premarin family of drugs – Premarin, Prempro and Duavee – we have compiled a list of alternatives to drugs made with pregnant mare’s urine (conjugated equine estrogens).

We encourage you to go online to further acquaint yourself with the effectiveness and safety of these compounds. There is a wealth of information out there, but beware of false claims and err on the side of caution.

And, as always, please consult with your doctor before you use these or any other alternatives for the relief of menopausal symptoms.

LIFESTYLE CHANGES

Probably the simplest and most natural approach to the treatment of menopause is to adopt a healthy lifestyle in regard to diet, exercise and stress management. Not only will this help alleviate symptoms but the benefits will ensure that you remain healthy now and in the future.

Nutrition: It should go without saying, avoid refined and processed foods, choose more whole foods, fresh fruit, vegetables and complex carbohydrates. Avoid high fat dairy products and meats and supplement these items with healthy fats such as olive oil, nuts, seeds and lean cuts of meat or fish. Additionally, practice portion control and avoid empty calorie foods.

Exercise: Exercise is vital to keeping symptoms in check. Exercise directly affects hormonal activities in the body by raising the level of endorphins, for example, to maintain emotional stability and suppress anxiety. Moreover, the benefits are unsurpassed: maintenance of muscle and joint strength, increased metabolism, reduced weight, improved cardiovascular health, increased cognitive function, maintenance of bone integrity, and the list goes on.

Stress Management: It is a well known fact that stress induces more severe hot flashes. There are many stress-reduction techniques available to manage the burden of everyday anxiety – rest, relaxation, varied leisure activities, and most importantly self-affirming thoughts to maintain self-image and confidence.

Lifestyle Solutions: Common sense solutions that include dressing in layers, lowering room temperatures, consuming cool drinks, and avoiding alcohol and caffeine. For those women who are overweight, weight loss can also help.

DIETARY PHYTOESTROGENS

Dietary phytoestrogens are naturally occurring substances (e.g. Isoflavins) found in fruits, vegetables, and whole grains such as soybeans, alfalfa sprouts, and oilseeds (such as flaxseed).

There is some evidence that they have a weak estrogen-like effect that may reduce the intensity and frequency of hot flashes. However an authoritative review of placebo-controlled studies of plant-based estrogens found no convincing evidence that they were helpful in curbing menopausal hot flushes.

One exception was genistein, a substance in soy, which the researchers said warranted further study (http://goo.gl/mivG1p).

Eating natural foods that contain these compounds is safe but there are also non-prescription supplements on the market for which there is no long-term safety data.

PRESCRIPTION DRUGS

There is also convincing evidence that some prescription drugs such as SSRIs, SNRIs, Gabapentin, Clonadine (Catapres) and Pristiq, which are not licensed for treating menopausal symptoms do in fact alleviate hot flashes and night sweats. These are powerful drugs yet in severe cases some doctors may be willing to prescribe one of these treatments, with the patient’s consent.

Megace and Megace ES are synthetic female hormones belonging to the progesterone group used for stimulating appetite and treating breast cancer. The mechanism of appetite stimulation or suppression of cancer is not clearly understood and was FDA approved in 1993.

HERBAL MEDICINES

Herbal medicines are readily available however caution is advised since they can contain powerful ingredients that may contraindicate other prescription drugs and/or may have adverse effects on certain individuals.

Some examples include:
— Black Cohosh for hot flashes and sweating
— Kava to reduce anxiety
— Ginko to decrease the risk of onset of dementia and
— St. John’s Wort as an anti-depressant.

No substantiated medical studies are available for these medicines and most do not have to comply with the stringent safety, quality and manufacturing regulations that govern conventional medicines.

IN THE NEWS

As time progresses many women – and doctors – are looking for safer and more humane alternatives to conventional HRT.

In 2010 a non-hormonal supplement called Amberen, manufactured by Lunada Biomedical, was touted as the next cure-all for relief of menopausal symptoms. Claiming to have a double-blind, placebo-controlled clinical study to back its effectiveness, it contains 100% natural ingredients, all on the FDA’s approved Generally Recognized As Safe (GRAS) list. To date there are mixed reviews on its effectiveness – some it works for, some it doesn’t.

Osphena – touted as the new female Viagra – was FDA approved in 2013 for the treatment of painful sex due to vaginal atrophy associated with menopause.

Osphena is a SERM (selective estrogen receptor modulator) that acts as an estrogen agonist/antagonist – the same class of drugs as bazedoxifene. However it carries with it risky side effects: stimulation of the lining of the uterus that can lead to uterine cancer, increased risk of blood clots, hot flashes and drug interactions.

Moreover in early June 2013 the U.S. Food and Drug Administration approved the drug “Brisdelle” (paroxetine) for the treatment of hot flashes due to menopause.

Brisdelle contains the selective serotonin reuptake inhibitor paroxetine mesylate, making it unique from all other FDA-approved treatment for hot flashes which contain the hormones estrogen or progestin.

Brisdelle, manufactured by Noven Pharmaceuticals, is the first non-hormonal treatment to be approved by the FDA for hot flashes associated with menopause.

BUYER BEWARE

1. Bio-identical Hormones

The term Bioidentical Hormone Replacement Therapy (BHRT) or “natural hormone therapy” is poorly defined and without a precise medical definition.

Bio-identical hormones are synthesized in the lab from plant sources and as the term implies are pharmaceuticals that closely mimic natural hormones produced in the body since they possess the same molecular structure as endogenous hormones.

There are two classifications of bioidentical hormones; (1) FDA-approved and; (2) compounded in pharmacies based on hormone levels measured in saliva and blood tests (not FDA approved).

The terminology is confusing and the FDA considers “BHRT” to be a marketing term. The lack of distinction between FDA-approved bioidentical hormones (often referred to as synthetics) and compounded bioidentical hormones has resulted in considerable misunderstanding regarding exactly what BHRT is.

The vast majority of advocates of BHRT are referring to the compounded versions where hormones are custom-mixed by a pharmacist – unapproved drugs.

In addition to estrogen and progesterone, these compounded drugs may contain other hormones such as testosterone, DHEA and adrenal hormones extracted from animal glands. http://www.health.harvard.edu/newsletters/Harvard_Womens_Health_Watch/2011/September/bioidentical-hormones-help-or-hype

Often promoted as being safer than conventional HRT derived from pregnant mare’s urine, are these claims of a safer alternative justified?

This includes both FDA-approved and compounded hormones. A Harvard Women’s Health Watch article illustrates that there is much evidence to suggest they are not. http://www.health.harvard.edu/newsletters/Harvard_Womens_Health_Watch/2011/September/bioidentical-hormones-help-or-hype

  • In contrast to mainstream thought, compounded BHRT hormones are drugs – just not approved.
  • As much as it may seem that these hormones are safer than the Premarin® family of drugs, there is no solid evidence to prove this. Some of these drugs have been approved by the FDA because data collected from trials has proven their effectiveness in relieving menopausal symptoms and reducing the risk of osteoporosis. However there have been no long-term studies like the WHI performed to assess their safety profile.
  • FDA-approved bioidenticals come with black box warnings analogous to those for conventional HRT. Because compounding pharmacies are not required to detail the risks of their bioidenticals (i.e. they are not approved) they may therefore create the illusion of being safer than commercially marketed drugs.
  • Overall, FDA-approved and compounded bioidenticals contain the same hormones. The difference between the two is the accuracy of preparation. Where FDA-approved versions are measured precisely under rigid control, compounded bioidenticals lack these specifications. Random testing has shown that the indicated potency of compounded hormones varies substantially.
  • Blood and saliva tests to measure a woman’s hormones is only a snapshot in time and are not particularly useful for setting hormone levels which can fluctuate from hour to hour. In menopausal women hormones levels are particularly unstable without a “normal” concentration. Accordingly dosage may be inappropriate for treating symptoms.

2. FDA-Approved Hormone Therapy

Contrary to popular belief the FDA has yet to approve any “true” generic as a substitute for Premarin® and its daughter products (i.e. Prempro®, Premphase®). In other words no prescription drugs used to treat menopausal symptoms, other than the Premarin family, contain pregnant mare’s urine.

Currently the vast majority of FDA-approved HRT prescription drugs are synthetic bioidenticals often referred to as “Synthetics” (i.e. hormones identical on a molecular level to endogenous hormones that are synthesized in the lab from natural plant sources) – these are not the versions produced at a compounding pharmacy which are not FDA approved.

What’s important however is that these drugs carry with them the same risks and warnings associated with drugs derived from conjugate estrogen estrogens, whether that be estrogen alone or combined with progestin.

In pre- and postmenopausal women, estrogens can increase the risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs.

Estrogen, when used with a progestin, can increase the risk of heart disease (such as heart attacks), stroke, serious blood clots in the lungs/legs, dementia, and cancer of the breast/ovaries.

If you are concerned about these risks, there are basically three categories of FDA- approved synthetic bioidentical HRT products on the market as shown below along with their common brand names.

PRODUCT BRAND NAME
Estradiol / Norethindrone (Estrogen/Progestin Combinations): Activella, Jevantique
Synthetic Conjugated Estrogens, Estradiol, Esterified Estrogens: Estrace, Cenestin, Climara, Dinigel, Enjuvia, Estrogel, Minivelle, Ogen, Vivelle-Dot, Evamist, Menostar, Menest, Femring, Vagifem
Esterified Estrogens / Methyltestosterone (Estrogen/Androgen Combination): Menogen, Estratest, Covaryx, Essian, Syntest D.S., Syntest H.S.

CONSULT YOUR DOCTOR

In any case, it is important to separate fact from fiction and be astutely aware of the consequences of clinically unproven medications. Apart from the unmistakable benefits of lifestyle changes, before considering any of the alternatives listed please consult your doctor.

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