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.

Share

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

 

 

 

PMU Horses win two awesome new friends

Jane Allin and I, together with you, have been championing the cause of PMU horses for over a decade.

PMU horses are mares kept continually pregnant in order to collect their estrogen rich urine to make drugs like Prempro, Premarin and Duavee for the easing of menopausal symptoms. A tragic offshoot of this process are of course the mares’ byproduct foals. As Allin points out:

    Sadly, foals born to these mares are usually worth less than the urine their mothers produce. They are considered to be nothing more than a living byproduct of Premarin. To the PMU farmers, they are often worth more dead than alive.

NEW FRIENDS

Joining us in the battle to save PMU horses are two awesome new friends.

Rebecca

First, there’s a lovely lady called Rebecca who has gone to live in China with her husband sent to work there by his company.

Rebecca has been looking for a way to help PMU horses in a really big way and now she has it. Not only is Rebecca a professional photographer used to covering very difficult assignments, but also very well versed on the issue.

Inspired by the work of Jane Allin who uncovered that there are PMU horses in China, Rebecca is determined to locate some of these farms and document them. She is donating 100% of her time and we are helping her with her expenses. We are moved by her generosity and courage.

We couldn’t be more delighted and grateful.

Dr. Greene

An eminent women’s health care physician contacted us and offered to help in any way he can.

In particular, he likes the way we are alerting doctors to the true potential and significant dangers to patients treated with Premarin, Prempro and Duavee. He is for educating them more than ever.

We pointed out that we still have doctors responding to our Dear Physician Letter arguing that conjugated estrogens (how they are listed on the label) are not necessarily dangerous.

We responded that the estrogens in question are conjugated equine estrogens, a known carcinogen as declared by the World Health Organization.

Some doctors are shocked. Some doctors continue to argue that we are wrong because the the word equine is nowhere on the label.

Indeed it is not.

We point out that the word “equine” was omitted from packaging years ago and the FDA has done nothing about it.

Dr. Greene concurs with our plan to press the FDA to make the labeling of drugs reflect the true nature of these drugs — that they are made with conjugated equine estrogens. But will they listen to us, or anybody else for that matter?

He has a plan.

Dr. Green is writing a paper on the dangers of conjugated equine estrogens and drugs associated with them. He will use his paper to rally doctors on his side to make a strong case to outlaw the use of this ingredient. Full stop.

He justly observes that drugs made with conjugated equine estrogens are outmoded, outdated, totally unnecessary and most importantly of all a great potential danger to the health, safety and welfare of women and horses.

As his own work on this issue unfolds, Dr. Greene supports our work – especially this golden opportunity to expose PMU farms in China.

He is therefore guaranteeing to match your donations dollar for dollar to our Premstoppers Campaign from now through Friday, May 13, 2016.

THANK YOU

To all of you who have followed and supported our activities to keep this issue alive, thank you. You have helped make sure these horses are not forgotten.

FROM OUR WEBSITE

Visit our Premstoppers page »

TUESDAY’S HORSE

Side effects of raising awareness about the Premarin family of drugs and PMU horses »

FDA approved alternatives to Premarin derivatives. Are they safer? »

Report Premarin Ads »

Side effects of raising awareness about the Premarin family of drugs and PMU horses

There have been significant side effects to the work we are doing on behalf of the horses affected by the making of the Premarin family of drugs — Premarin (cream and tablet), Prempro, Premphase and Duavee.

BILLBOARD

Remember our billboard campaign? It’s a simple one. It says, “Warning: Premarin Contains Horse Urine”.

We placed these warning billboards near women’s hospitals. Horse lovers leafleted and talked to thousands of women and medical staff about the making of Premarin and how it impacts the lives of the pregnant mares it uses and what happens to so many of their foals.

Staff from these medical centers began telling our volunteers how Premarin is used in ways other than for the treatment of menopausal symptoms. It is a long list but here are two such examples:

Premarin is given to patients prior to and post hysterectomy surgery. Another example is using Premarin in conjunction with surgical procedures for patients who are deemed at risk of hemorrhaging — Premarin clots the blood.

There are many more. We will cover that soon in a separate post. If you have encountered any please let us know.

Social media advocates contributed too. You helped by sharing our post about our billboard. It reached well beyond the 10K+ notification for Facebook alone.

See https://tuesdayshorse.wordpress.com/2014/03/06/reach-thousands-save-thousands-with-premarin-billboards/

Image from PMU farm in Manitoba showing the collection bag used to collect the urine from pregnant mares used in the making of the Premarin family of drugs.
Image from PMU farm in Manitoba showing the collection bag used to collect the urine from pregnant mares used in the making of the Premarin family of drugs.

DEAR DOCTOR LETTER

Our Dear Doctor Letter has done more than just alert the medical personnel we sent it to. It has helped in all sorts of unforeseen ways.

For instance, we had physicians and even their family members contacting us telling us we were giving out misinformation concerning Premarin. They said that Premarin contained conjugated estrogens that were not dangerous. We stated that Premarin is made with conjugated equine estrogens – which are listed by the World Health Organization as known carcinogens – and the FDA allowed the producers of the Premarin family of drugs to omit the word “equine” some years ago.

A number of these doctors (or their relatives who called us to defend them) flat out refused to believe us, or so they said. Surely it’s not a big leap to see where the makers of these drugs got the name Premarin (Pregnant Mare’s Urine).

One doctor who at last acknowledged that the Premarin family of drugs are made with conjugated equine estrogens with the use of pregnant mare’s urine blurted out at the moment of awareness, “that means contain carcinogens and we shouldn’t be prescribing them”. He then concluded for himsef that in his mind at least there is no doubt to why these drugs no longer have the word equine in the labeling.

So what do we do with this information? We lobby the FDA to change the labeling to accurately reflect the drugs’ true nature. That is the plan. It is a steep mountain to climb but we are willing to climb it. But we may not be alone and will have some very important help. More on that later.

To those of who have sent this letter and to all the volunteers who printed and sent thousands more, we thank you.

Please continue to send this letter to your doctors particularly OB/GYNs. Print and mail or email as an attachment.
https://tuesdayshorse.files.wordpress.com/2015/12/dear_physician_ltr_cee_drugs_jan_2016.pdf

TELEVISION AND PRINT ADS

Thanks to your reporting, we have contacted television stations across the country for more than a year regarding the airing of Premarin cream commercials. They have, except in a few stubborn cases, either removed them and/or refused to renew them. We have also had a major impact regarding magazine and newspaper ads — print and online — via Twitter and Facebook.

This campaign, like so many, relies on the help of horse lovers like you. Congratulations on a job well done. Please continue to let us know when you see any type of ad for these products. We have a contact form here on Tuesday’s Horse specifically for this purpose. It’s in the dropdown box under Contact Us entitled Report Premarin Ads.

Rescued Premarin Foals. Image Vivian Grant Farrell.
Rescued Premarin Foals. Image Vivian Grant Farrell.

OUR MISSION CONTINUES

Our mission to help Premarin – or PMU – horses continues. The impact of the work we do is sometimes not immediately seen, difficult to sum up or give exact figures for. But what we are doing is having an effect.

Our campaigns have been so innovative and effective other groups and individuals have followed in our footsteps. The horses need us all.

We must continue our efforts for without us these horses have no hope, no voice and will continue to be subjected to the cruelties and death associated with the making of the Premarin family of drugs.

QUOTE

“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”.
– JANE ALLIN

RELATED READING

Premarin — The Drugs, the Women, the Horses
Alternatives
Reports

Pushing Premarin: Big Pharma, Big Bucks — Part 1

by JANE ALLIN

Image: PremarinVaginalCream.com
Don’t be fooled by the pretty flower. This drug is produced using pregnant mare’s urine. They removed the “equine” from “conjugated estrogens” long ago. Not good for marketing. Image: PremarinVaginalCream.com

It seems lately that everywhere you look there are ads for Premarin, Premarin Cream and the new kid on the block Duavee*, also derived from Pregnant Mare’s Urine.

These sinister advertisements have been materializing repeatedly in numerous US magazines and more recently as a TV ad on iSpot.tv (http://www.ispot.tv/brands/onI/premarin).

Pfizer seems intent on peddling these ghastly drugs and are busy infiltrating various media sources in an attempt to retain and grow a solid market share for these HRT therapies regardless of the inherent and proven risks they pose to menopausal women. This is by no means a mystery or surprise.

To start, Pfizer had a lackluster first quarter this fiscal year – a trend of enduring profit decline together with a dearth of blockbuster drugs emerging on the pharmaceutical front in the near and distance future. The primary causative element in this fiasco for Pfizer, and other leading pharmaceutical companies, is the loss of patent exclusivity of drugs in the forefront of patient care in the wake of chronically over-diagnosed diseases.

    Beginning in 2010, the pharmaceutical industry faced one of the biggest waves of drug patent expirations in history, a phenomenon referred to as the “patent cliff.” A significant number of top-selling drugs in the history of the pharmaceutical industry will experience patent expirations over the next 5 years, paving the way for lower-priced generics.” [1]

Once drugs lose patent protection, lower-priced generics have the capacity to capture 90% of their sales. This translates to billions of dollars loss in profits over the near term. Brand name drug companies such as Pfizer have been actively seeking ways to mitigate these enormous losses in revenue that have been or soon will be lost.

Some of these measures have included increased drug prices starting as far back as 2002 in anticipation of patent losses, contractual deals with generic drug makers for “authorized generics” that guarantee a portion of the sales, reductions in research budgets, staffing levels and partnering with other drug companies to share development costs. [2]

Just like Wyeth’s/Pfizer’s strategy and the relocation of the North American PMU industry, many are shifting more of their manufacturing and patient testing to low-cost countries such as China and India. Moreover sales tactics are now geared to infiltrate the untapped markets in these emerging counties to stabilize sales and offset the losses that will be incurred in North America and elsewhere.

And of course there are the ever-present advertising and marketing ploys. In 2012 alone, the $300 billion a year US pharmaceutical industry spent $3.1 billion on advertising prescription drugs directly to consumers. [3]

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” regardless of the fact that many of these so-called illnesses are treatable by lifestyle changes or, in effect, are not diseases at all.

Pill Popping Nation Chart

In practice many of these “conditions” have been created by poor lifestyle choices at the outset. But for many it’s simply easier to take drugs to combat the problem – America, the pill popping nation. In fact prescription drugs are the fastest growing sector of US healthcare costs. [4]

But rather than resort to developing new therapies that will potentially unleash breakthrough remedies to the insidious diseases that presumably haunt the prospect of life itself, they choose to rely on cloned drugs that are for the most apart novel because they have manipulated patent laws based on old research and old technology – a mere codicil to an existing patent.

Duavee is a prime example; the combination of two questionable drugs with risky side effects – Premarin + the SERM (Selective Estrogen-Receptor Modulator) bazedoxifene (currently not FDA approved) – an accident waiting to happen.

In fact, pharmaceutical companies spend proportionally more money are marketing than on R&D. And market them they do – at the expense of innovation and patient safety.

    Pharmaceutical companies have developed a business model that emphasizes new variations on existing drugs, rather than groundbreaking medical advances, a report in the medical journal BMJ states.

    “Prescription drug companies aren’t putting a lot of resources toward new, groundbreaking medication, according to a recent report in BMJ, a medical journal based in London. Instead, it’s more profitable for them to simply to create a bunch of products that are only slightly different from drugs already on the market, the report’s authors said.

    “[P]harmaceutical research and development turns out mostly minor variations on existing drugs,” the authors write. “Sales from these drugs generate steady profits throughout the ups and downs of blockbusters coming off patents.

The authors go on to say that for every dollar pharmaceutical companies spend on “basic research,” $19 goes toward promotion and marketing. And apparently it’s been working.

Drug company revenues climbed more than $200 billion in the years between 1995 and 2010, according to the website MinnPost. Meanwhile, in recent years, more than one in five Americans age 50 and up have had to cut down on their dosages or switch to cheaper generic drugs because the cost of medication is so high. [5]

Drug safety is no longer first and foremost in the quest to market pharmaceuticals. Reports of established and emerging drug therapies continue to raise disturbing questions in regard to their safety.

Ultimately the troublesome question remains as to the efficacy of the research provided to access the long-term risks associated with these drugs. Is the current system (i.e. FDA, Big Pharma, Physicians) equipped, or more aptly put, is it providing the necessary precautions and due diligence to ensure that the risks of any marketable drug are minimized?

Sadly, the answer is no.

Money and profit rule at the expense of ethics and moral conduct. The flaws outweigh perception and truth. And this kind of blasé attitude is applicable not only to new renditions of old drugs (e.g. Duavee) but rather to old drugs – such as Premarin and the like – because the primary engine that drives this industry is money. It is no secret that the pharmaceutical industry is without shame in promoting unsafe drugs at the expense of the consumer – you and me.

Even today, long past the damning WHI study, reports are still emerging that link the conjugated equine estrogens (CEEs) found in the Premarin family of drugs to increased risks of cardiac failure, strokes, cancers, pulmonary embolisms and dementia among other life-threatening diseases. This raises serious and disturbing questions regarding the current state of medication safety overall, not just for these HRT drugs.

Uncertainty arises as to the efficacy of the research conducted, how long it should take to assess long-term safety in addition to the accountability of the FDA, pharmaceutical companies and physicians and whether they are doing enough to minimize long-term risks. Yet, at the same time are still sanctioned by the FDA and marketed as “safe” albeit with some conditions that are intended to ease the minds of those who choose to take them and effectively erase all the bad from the past.

Such is the case for the ever-present Premarin and the newly concocted sister drug Duavee.

As far back as the 1970’s there was damaging evidence about the risk of cancers and cardio vascular disorders using CEEs (conjugated equine estrogens), long before the arrival of Prempro® in 1995 and finally the WHI which undisputedly linked HRT with increased cancer and cardio risks among others. 

These CEE-derived therapies are identical to the drugs on the market today – they haven’t been modified to make them any safer, nor have they any true generics to compete against them (see https://tuesdayshorse.wordpress.com/2014/03/27/daughters-of-premarin-the-generics).

No, Pfizer has the market cornered when it comes to horse pee and has worked determinedly (as did Wyeth prior to the takeover) to convince the public that Premarin is considered the “gold standard” for treating menopausal symptoms. A hangover from the old days despite the long ugly history for these drugs – adulterated with deception, conspiratorial marketing campaigns, fraud and most importantly death. Pfizer simply continues by sponsoring studies of its own drugs to support more favorable outcomes for their carcinogenic potions.

    It’s clear from the start that there is a deep conflict of interest in pharmaceutical companies sponsoring trials on their own drugs. Industry sponsors 90% of published clinical trials. A worrying statistic given that, as Goldacre shows, industry-sponsored trials are four times as likely to produce positive results than independently run experiments. . . . About 85% of clinical trials are now funded by the drug industry. They own that data. The docs don’t understand that they are getting a selected, filtered version of what the information is.” [6]

Apparently this is the reason that Premarin and its daughter products are considered safe despite the fact they are known carcinogens – an abysmal conflict of interest.

How comforting. And it is no different with the controversial drug Duavee.

To begin, the quest to gain approval for Duavee from the FDA started long ago when Wyeth Women’s Health talked about this drug coming to market by 2005. Repeatedly Wyeth and then Pfizer faced innumerable obstacles due to the inherent risks of two very contentious drugs – Premarin an established carcinogen and bazedoxifene implicated in the onset of strokes for example.

While studies have confirmed that Duavee is effective in relieving moderate to severe vasomotor symptoms (VMS), vulvar and vaginal atrophy (VVA) associated with menopause as well as the prevention of postmenopausal osteoporosis, the jury is still out on the safety aspect.

Most disturbing is the fact that bazedoxifene has failed to receive approval from the FDA and is itself not without issues. Clinical trials have indicated an increased risk of stroke in addition to higher incidences of deep vein thrombosis, retinal thrombosis, hot flushes and leg cramps compared to placebo-treated subjects. These are well-known side effects of SERMs which are also known to increase the risk of endometrial cancer. 

This together with limited safety data on Duavee does not bode well — cancer is an insidious disease and can take years to develop. This is exactly what happened with the Premarin® family of drugs — not just the combination Prempro® therapy. Yet word has it that this drug will soon be approved in the EU as well.

It comes as no surprise however that Pfizer has a proven track record of promoting drugs in ways not necessarily backed up by medical science.

Pfizer Headquarters in New York
Pharmaceutical Giant Pfizer Headquarters in New York (Photo by HENNY RAY ABRAMS / AFP / Getty Images)

The usual tactic employed is one in which insufficient details of clinical trials are published, frequently authored by individuals who will benefit financially from the companies whose drugs they are writing about – often these articles are deficient to the point of being misleading.

Case in point, in 2009, Pfizer was endemic to the largest health care fraud settlement ($23 billion) and criminal fine of any kind ever over its painkiller Bextra – since withdrawn.

    Besides heart attacks and other dangerous side-effects, Bextra had even been known to cause Stevens-Johnson syndrome, which begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed…

    “…and Pfizer’s CEO and board of directors knew this, but had their salespeople push it for profits anyway. The fine was paid with a single wire transfer (easy money!)

    “And no one went to prison….just like with the bankers.

    “Pfizer, as the corporation that manufacturers, markets, and distributes these miracles of modern medicine, takes on a more macabre quality. This is what happens when a company gets ‘too big to fail’. They stop thinking of their customers as real ‘people’, and they start becoming just ‘revenue streams’.” [7]

Is the marketing strategy of the Premarin family of drugs any different? I don’t think so.

Given the callousness and lack of accountability this incident and others like it demonstrate, how can any physician be lulled into a sense of assurance that these HRT regimens are safe and be comfortable in prescribing these to their trusting patients? The answer is simple – the power of persuasion, manipulative marketing practices and often kickbacks for promoting medications that will return tidy profits.

The free samples are for doctors to give their patients in the hopes that their next dose will come from a paid prescription, written by your friendly physician who, somehow or other, found the time to meet with the rep, while you continued to cool your heels in the waiting room.

“First, drug companies would not be so generous if their investments in giveaways did not net enormous returns. Pharmaceutical companies spend an estimated $20 billion a year on marketing to physicians, while prescription drug sales top $300 billion.

“And second, several studies determined that doctors, like all human beings, are subject to the natural tendency to want to give something back to a gift-giver, in a dynamic psychologists call reciprocity.

“In a 2000 article in the Journal of the American Medical Association, Dr. Ashley Wazana of McGill University in Montreal analyzed 29 studies on doctors’ prescribing behavior in Canada, Australia, New Zealand, Holland and the United States. Wazana noted, among other things, that:

    • Free samples made doctors “significantly” more likely to prescribe a specific drug
    • Freebies led doctors to ask the drug be placed on formularies† (hospitals’ official lists of drugs that can be prescribed)
    • Accepting a free trip to a drug-company-sponsored conference guided doctors to write more prescriptions of the company’s drugs, a spike of 80 to 190 percent
    • Doctors who ate pharma-sponsored meals “occasionally” were two to three times more likely to ask that the sponsor’s drug be placed on a hospital formulary.

While the traditional practices of trying to influence doctors with free samples, assorted freebies and exotic vacations to have them prescribe more of their drugs have diminished in scope, Big Pharma’s inducements didn’t disappear. They merely shifted.” [8]

* Duavee was originally submitted for FDA approval under the name Aprela. The name was changed in the “final hours” of the application.
† Formulary (meaning): An official list giving details of medicines that may be prescribed.
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[1] http://www.uspharmacist.com/content/s/216/c/35249/#sthash.wxnvT0QU.dpuf
[2] http://www.drugs.com/news/prices-plummet-wave-expiring-patents-32684.html
[3] http://prescriptiondrugs.procon.org/
[4] http://desdaughter.wordpress.com/2014/02/22/prescription-drugs-are-the-fastest-growing-sector-of-us-healthcare-costs/
[5] http://www.huffingtonpost.com/2012/08/09/pharmaceutical-companies-marketing_n_1760380.html
[6] http://www.forbes.com/sites/johnlamattina/2013/10/02/pharma-controls-clinical-trials-of-their-drugs-is-this-hazardous-to-your-health/
[7] http://bud-meyers.blogspot.ca/2011/11/drug-kingpin-pays-23-billion-fine-but.html

Read • Part 2 » • Part 3 »

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