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.

 

 

 

Report Premarin® ads on behalf of women and horses

PREMSTOPPERS — Premarin® is made from the estrogen rich urine of pregnant mares. The World Health Organization listed the conjugated equine estrogens (CEE) made from pregnant mare’s urine as a known carcinogen.

Numerous class action lawsuits filed by women over the years in the U.S. and Canada point to the cancer causing properties of CEE drugs. There are many examples of these types of lawsuits. Here is one.

In an article entitled, “Cancer linked to menopause drug in new report“, it states “In 2014, Pfizer, which in 2009 acquired Wyeth, has paid $1.7 billion to settle nearly all of the 10,000 hormone replacement therapy claims against the drug manufacturer. Pfizer said it makes no admission of liability in the American settlements”.

In the meantime, the USDA allowed Pfizer at some point during all of this to package their line of CEE drugs such as Premarin® with the wording “conjugated estrogens” in place of “conjugated equine estrogens”.

Premarin® sample package with words
Premarin® sample package with words “conjugated estrogens”. From Drugs.com.

Unbelievably this labeling fools even some doctors who are either in denial or merely pretending to be for the perks they receive for prescribing it.

Putting a stop to Premarin® ads is one way we can act on behalf of women and horses.

The Ads — Premarin® Cream

Most of the ads you currently see are for Premarin® Cream.

Premarin Cream® ads appear most often in magazines like Oprah, Good Housekeeping and Ladies Home Journal. We have contacted Oprah magazine many times and the ad disappears only to reappear. Oprah supposedly has and loves horses and is dedicated to women’s issues. So Oprah’s advertising of Premarin® does not add up, does it?

Premarin® Cream ads also appear on television and on YouTube as you will see below. You will also see them  in those quick advertising spots before the YouTube video you selected begins.

Take a look at this. There are more reasons not to take it, than to take it. Published on YouTube by David O’Neill.

LouisePatti commented on this video, “My dearest, most beautiful cousin, Debi, who was less than a year younger than I was died of cancer from taking some prescription hormonal cream. The last time I saw her she told me what had caused the cancer. I had just been prescribed this a few days earlier. She looked young and healthy the last time I saw her, but 2 months later, she had passed away. She might have saved my life, and God willing, she will help many others.”

The abuse and death of horses does not come into it of course. And yes, there are alternatives to Premarin®.

Take Action

It’s simple. Be our eyes and ears. When you see an ad for any Premarin® type product let us know using this special Contact Form and we will take it from there. You may want to take a quick look at it so you can see the type of information we need.

Share this page personally and publicly far and wide.

Thank you!

Learn More

• Learn more and share our Premstoppers campaign page on our website »

Premarin Horses Year in Review 2016, Tuesday’s Horse »

Featured Image

Trio of Premarin® foals rescued from Canada. Photo: Vivian Grant Farrell.

Last updated: 7:28 pm.

New Bucksport residents raise rescued Clydesdales

BUCKPORT, Maine (The Elsworth American)  — Earlier this month, a Texas couple moved to Silver Lake Road with a very large 5-year-old. His name is Butch, and he is a 2,700-pound Clydesdale horse, but don’t let the size scare you.

“You’ll see they are just very giant puppy dogs,” said David Doane, who takes care of Butch, six other horses, a mule and a cat along with his wife, Michelle Rhodes. The whole bunch moved to Bucksport from Texas earlier this month. “They would sit in your lap if they could figure out how to.”

Clydesdales are a large breed of horse used originally for pulling plows or hauling coal. Today the breed is famous for its appearance in Budweiser beer commercials, but it also plays a troubled role in the production of an estrogen-rich drug called Premarin, which is used to treat symptoms of menopause.

Premarin is made of the estrogen found in pregnant mare urine and, considering their size, Clydesdale mares produce a lot of urine. Several pharmaceutical companies put thousands of Clydesdale mares in pens, where they stayed for months at a time and urinated into bags. Once the mares delivered their foals, most of the foals were sold for slaughter, their meat shipped to consumers in Europe and Asia.

“It’s a nasty business,” Rhodes said. “They sell the babies to slaughter if people don’t adopt them.” Continue reading »

TAKE ACTION FOR PREMARIN HORSES
See Premstoppers » Report Premarin Ads »  Alternatives »

TUESDAY’S HORSE
Premarin Horses » March for Premarin Horses »

FEATURED IMAGE
David Doane smiles at Butch, one of his and his wife Michelle Rhodes’ seven horses. The gang, which also includes one mule and one cat, moved to Bucksport from Texas earlier this month. The Elsworth American.
PHOTO BY DAVID ROZA.

Distinguishing between bio-identical hormones and ones made with pregnant mare’s urine

PREMARIN HORSES — Virgina Hopkins M.A. writes in an article entitled, “The Definition of Bio-identical Drugs“:

Bio-identical hormones may be either from a natural source or synthetically made, and it’s more about the molecule being identical to the human molecule that our body normally makes, than whether it comes from a natural source.

With the exception of Premarin, which is extracted from the urine of pregnant mares, virtually all replacement and contraceptive hormones, in all forms, bio-identical or synthetic, are first extracted from soybeans or wild yams in a laboratory.

Those that are processed so that they exactly match the molecular structure of the hormones made by the human body have come to be called bio-identical, to distinguish them from synthetic hormones, which have a molecular structure that is not found in nature, and certainly not in the human body.

That Ms. Hopkins makes a distinction between Premarin® and other drugs used to treat menopausal and post-menopausal symptoms is an important one.

Premarin® tablet package. You can see it clearly states conjugated estrogens.
Premarin® tablet package. You can see it clearly states conjugated estrogens.

Some doctors are still telling patients that Premarin® drugs are no longer made with conjugated equine estrogens, but simply conjugated estrogens. These doctors are confused about this because that is how the FDA allows Pfizer to label these drugs on their packaging.

Conjugated estrogens can be made from plants.

Clearly. Premarin® drugs are made from pregnant mare’s urine and contain conjugated equine estrogens.

Beware. The World Health Organization has designated conjugated equine estrogens as known carcinogens.

RxList.com uses the phrase conjugated estrogens when referencing Premarin® drugs. However, if you look far enough on their website, you finally arrive at the drug’s description which makes the following statements:

Premarin® is a “mixture of conjugated estrogens purified from pregnant mares’ urine and consists of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. See http://www.rxlist.com/premarin-drug.htm.

Is you scroll up just above “Drug Description”, there is grey box with a list of side effects. The title sums it up. In all caps, bold letters it says:

WARNING
ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

Say No to Premarin® Drugs

Premarin® is prescribed in two forms — cream and tablet.

Premarin® is also used in others ways that you may never be made aware of, for example, during surgery to act as a coagulent in cases of heavy bleeding. Tell you doctor you wish never to be treated with any of the Premarin® family of drugs.

Premarin Horse Resources

As Jane Allin states, “Nothing has been, or ever will be, appealing or beneficial about the PMU industry and the Premarin family of drugs; they are clearly harbingers of death from both sides of the equation”.

Read more articles on this subject here at Tuesday’s Horse.

If you see an ad for Premarin® drugs, cream or tablet, make a note of where and when and please let us know. Thank you.

Read Jane Allin’s Special Reports on Premarin® drugs on our website.

Learn more about the mares used to make Premarin® drugs and what happens to their foals at Premstoppers on our website.

IMAGE CREDITS
Belgian Foal — Photographer unknown.
Premarin® tablets packaging — Drugsnow.com.