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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Premarin and Prempro: The consequences of deception – A litany of litigation

Written by JANE ALLIN

Pfizer- Wyeth Marriage Made in Heaven Cartoon. Martha Rosenberg. Click to Enlarge.
Pfizer- Wyeth Marriage Made in Heaven Cartoon. Martha Rosenberg. Click to Enlarge.

In early July of 2002 the alarming news of the National Institutes of Health Women’s Health Initiative (WHI) study sent shock waves through the medical and scientific communities. Wyeth’s hormone combination replacement therapies (e.g. Prempro®), long believed to provide cardiovascular benefits to the millions of menopausal women who took them, now proved to be deadly carcinogens and cardiovascular antagonists.

With the reports that long-term use of HRT derived from conjugated equine estrogens increased the risk of invasive breast cancer, stroke, cardiovascular disease, heart attack, pulmonary embolism and blood clots, sales of these drugs quickly plummeted.

Closely on the heels of the WHI, the National Cancer Institute also shook the public with the news that estrogen alone (i.e. Premarin®) puts long-term users at increased risk of developing ovarian cancer. Doctors and their patients were aghast at the deception of Big Pharma and its lack of ethics in failure to disclose potentially life-threatening risks associated with their HRT drugs. How could this happen?

Through an exceedingly misleading and conspiratorial marketing campaign Wyeth managed to convince the world that menopause is a disease and requires medical intervention to mitigate its ravages on the female body. Needless to say what followed was, and is today, one of the most scandalous events to have occurred in the pharmaceutical industry which has led to an epidemic of mass tort litigation. Rather than accept responsibility for their heinous actions and provide compensation to their victims, Wyeth and now Pfizer, continue in their quest to defend their right to sell these carcinogenic concoctions.

Currently Pfizer has settled approximately half of the more than 10,000 lawsuits it has faced in product liability claims regarding Prempro and Premarin and their link to increased risk of breast cancer. Moreover in 2011 Pfizer added another $68 million to an already massive fund of $772 million to address and resolve the on-going cases.

What is appalling is despite the fact these hormone replacement therapies are clearly linked to a surfeit of disease and death Pfizer continues to appeal the trials and delay proceedings while turning massive profits from the very drugs at the center of the controversy, year after year. Many of the victims have already succumbed to breast cancer or other insidious illnesses affiliated with the use of these drugs however the emotional and physical scars of the survivors and their families live on. Heedless of the suffering, Pfizer/Wyeth remain steadfast in their litigation efforts without compassion or accountability. Profit over safety at all costs.

Pfizer’s mission:

“We dedicate ourselves to humanity’s quest for longer, healthier, happier lives through innovation in pharmaceutical, consumer, and animal health products. To achieve this purpose and mission, Pfizer affirm the values of Integrity, Leadership, Innovation, Performance, Teamwork, Customer Focus, Respect for People and Community.”

Partial and radical mastectomy, mutilated breasts, chemotherapy, radiation, cardiac surgery, exorbitant medical costs and death. I think not. Mission impossible.

The Lawsuits: In Review

2002 – 2006:

Prempro. Image by J B Reed / Bloomberg News.
Prempro. Image by J B Reed / Bloomberg News.

Prior to August of 2006 when the first Prempro® trial began, Wyeth and Pharmacia & Upjohn prevailed in a great majority of HRT hormone therapy cases previously set for trial through a combination of rulings by judges and dismissals by plaintiffs themselves to avoid being put to trial.

2006:

First Prempro trial begins in August of 2006 in Little Rock AR (Linda Reeves) but the trial is short-lived when a jury dismisses negligence by Wyeth in September.

At this time 5,000 lawsuits had been filed against Wyeth.

In October 2006, a jury awarded Jennie Nelson $1.5 million in compensatory damages, on the Phase I verdict. In 2001 Mrs. Nelson underwent a double mastectomy and chemotherapy and radiation for invasive breast cancer. A mistrial was later granted on the basis of juror ineligibility based on a motion by Wyeth.

2007:

In January 2007 a Philadelphia jury found that Prempro was responsible for Mary Daniel’s breast cancer and ordered Wyeth to pay $1.5 million in compensatory damages. The jury concluded that Wyeth was negligent in failing to provide adequate warnings about the risk of breast cancer associated with Prempro.

In February 2007 a jury in Philadelphia found that Prempro caused Jennie Nelson’s breast cancer and awarded her and her husband $3 million in damages. Nelson previously had been awarded $1.5 million by a jury in October 2006, but a mistrial was declared after the verdict had been returned.

In March a conference was held in Philadelphia to discuss future cases, two of which began in April, another in May and one in September. There were, at this time, a total of about 1814 HRT cases filed in Philadelphia.

According to an analysis published in April, statistics showed that the sharp drop in hormone use by menopausal women that began in 2002 as a result of the WHI study caused a dramatic decline in breast cancer cases strengthening the case that the trends are related.

In June, despite the jury awarding the Nelson’s $3 million in February of 2007, the first HRT case to reach trial ended with a Wyeth victory.

In response to an article published in the Wall Street Journal, “How NIH Misread Hormone Study in 2002”, WHI executives reply that the WHI investigators and the National Institutes of Health, which funds the WHI, are jointly responsible for all scientific articles arising from the study. Both parties stand by the original findings and conclusions.

A trial scheduled for September in Philadelphia is denied as a result of the two-year statute of limitations from bringing a personal injury claim.

However in October Wyeth was ordered to pay $134.1 million including $99 million in punitive damages, over its mishandling of menopause drugs and concealing the breast-cancer risks of its Prempro and Premarin drugs that helped cause three Nevada women’s cancer (Arlene Rowatt, Jeraldine Scofield and Pamela Forrester).

The October verdict was the largest related to Wyeth’s HRT drugs. A fourth woman settled before trial and passed away in April 2007 at the age of 59.

2008:

A trial scheduled for January 2008 was dismissed by a Minnesota judge who found that Patricia Zandi failed to provide valid scientific evidence to support her claim that she had developed breast cancer as a result of taking Wyeth’s Premarin and Prempro.

In February a district court judge in Nevada reduced the $134 awarded to Arlene Rowatt, Jeraldine Scofield and Pamela Forrester to $58 million citing that he felt concern that the amount awarded was “the rest of passion and prejudice” rather than reflective of appropriate compensatory settlement.

Wyeth and Pfizer were ordered to pay an Arkansas woman $27.12 million in March of 2008 determining that Prempro and Provera were the cause of the woman’s breast cancer and that the companies had shown reckless disregard. Wyeth’s share of the punitive damages came to $19.3 million.

In June a New Jersey Superior Court Judge issued a pre-trial ruling that federal law does not bar state product liability lawsuits against drug makers. With this ruling Ellen Deutsch’s lawsuit was allowed to proceed. This was the first Prempro case to reach the courts in NJ of the 2500 trials pending in the state and one of 10,000 filed nationwide.

By mid-July Wyeth settled lawsuits with two Nevada women, Vesta Woodhouse and Annie Woods, for an undisclosed amount.

2009:

In April The Texas Court of Appeals held that a lawsuit against drug manufacturer Wyeth could proceed. The court found that the claims were not preempted by federal law.

Ghost writing image.
Ghost writing image.

The unsealing of thousands of documents pertaining to the ghostwriting practices of Wyeth was ordered in July by a federal judge overseeing Prempro litigation.

In October a Philadelphia jury decided Wyeth should pay an Illinois woman $3.7 million in punitive damages without making a decision as to whether the company was at fault.

Again in November a court ruled in affirming a jury’s liability verdict based on the fact that the claims against the manufacturer of estrogen and progestin drugs are not preempted or barred by the statute of limitations.

Also in November there were two hefty verdicts in Pennsylvania, the first for $75 million and the second for $34 million in punitive damages regarding the link between breast cancer and HRT as well as finding that the drug maker willfully failed to warn patients of cancer risks associated with the hormone replacement drugs Premarin, Provera and Prempro.

In December Wyeth was ordered to pay the $75 million in punitive damages recommended by a jury in November. In the same month a New York trial court judge dismissed lawsuits brought by 23 women who claim hormone replacement therapy drugs manufactured by Wyeth caused them to develop breast cancer.

2010

In January of 2010 the largest individual HRT verdict was handed down by a Philadelphia. $78.75 million in damages was awarded to an Illinois woman who claimed Prempro caused her breast cancer.

In February the Prempro litigation in Philadelphia turned feverish with both sides continuing the fight it out in court. 8 out of the 11 cases that have gone to jury have been in favor of the plaintiffs however two of those verdicts were reversed on appeal, and post-trial motions are pending in other cases. Plaintiffs were successful in the first trail with a $9.45 million verdict in Philadelphia’s Common Pleas Court for Audrey Singleton, a retired school bus driver from Alabama. Pfizer said it would appeal.

However, no more than two days later, a different Philadelphia jury ruled in favor of Pfizer in another Prempro case. The plaintiff, Cheryl Foust, from Richmond Indiana, had been taking Prempro for about four years before she learned in 2003 that she had breast cancer. Foust died in 2005 at age 56.

The U.S. Supreme Court denied Wyeth’s petition for certiorari in a Prempro case earlier this week, allowing a new trial on punitive damages. In March 2008, Donna Scroggin won nearly $30 million – including $27 million in punitives – against Wyeth and Upjohn Co., subsidiaries of Pfizer Inc.

In August a Philadelphia PA Common Pleas Court jury denied that the two women’s breast cancer was linked to Prempro. In the same month Pfizer agreed to settle an Arkansas woman’s claims prior to inception of another trial over punitive damages.

The Pfizer/Wyeth trial litigation is turning into one of the longest-running mass torts in US history.

A Pennsylvania court ruled that plaintiffs in HRT liability trials should have been allowed to have juries decide when it was reasonable for them to have discovered that their breast cancer was linked to the use of Wyeth’s HRT drugs.

In September an Arkansas District ruled that expert witnesses lacked sufficiently reliable scientific data to testify that estrogen-only HRT medications can cause breast cancer.

According to a new federal study post-menopausal women who take Prempro are at increased risk of getting breast cancer as well as dying from it.

In October, a federal Arkansas jury rules for the defense in the case of 81 year old Margaret Wilson.

Year end brought another victory for Wyeth when a jury rejected a Virginia woman’s claim for damages saying that the drug company properly warned her about the risks of Prempro. The Nevada Supreme Court also ruled that liability claims regarding HRT drugs are governed by the law of the state the plaintiffs became ill regardless if they had taken the drugs in other states prior to the onset of their illness.

2011

The new year saw a Puerto Rico jury hold Pfizer accountable for $1.5 million in damages to a pharmacist who developed breast cancer after taking one of its HRT drugs.

In February Pfizer Inc. agreed to pay about $330 million to resolve claims that its Prempro menopause drug caused breast cancer, in the first large-scale settlements in eight years of litigation.

A Pennsylvania appellate court in June ruled that a jury’s $1.6 million verdict for a plaintiff in a Prempro case was to be reinstated along with a sealed punitive award against Wyeth. There was sufficient evidence to permit the jury to conclude that Wyeth’s failure to perform adequate tests of the risk of breast cancer was intentional, because it did not want confirmation of those risks and the resulting loss of sales and profits.

In July a US District Court in West Virginia denied a treating physician’s testimony as an expert alleging that HRT drugs caused the plaintiffs breast cancer.

Wyeth wins another victory in October when the 8th circuit rules that the plaintiff’s product liability claims over Prempro were properly dismissed as time-barred in New York.

In December after a jury in Philadelphia awarded $76 million in compensatory damages to three women who claimed that Wyeth’s HRT drugs caused their breast cancer, Wyeth settled the cases for a confidential amount.

As of year-end 2011 Pfizer and affiliates had settled almost half of the product liability claims involving their HRT drugs -Prempro, Premarin and Provera.

2012

In January a Pennsylvania appellate court ruled that evidence of Wyeth’s marketing campaign for “off-label” Prempro uses was admissible in a breast cancer victim case. That same month the court also ruled that a $28 million award of punitive damages was not excessive in one of the HRT liability cases.

A US District Court in Mississippi ruled that a lawsuit against Wyeth would not be barred as a result of the plaintiff’s failure to declare her claim as an asset in her bankruptcy case prior to obtaining a discharge of debts.

Sources:

http://lawprofessors.typepad.com/mass_tort_litigation/prempro/
http://www.aboutlawsuits.com/topics/hrt/
http://lawyersusaonline.com/blog/tag/prempro/
http://www.hrt-legal.com/tag/pfizer/
http://www.lawyersandsettlements.com/case/prempro.html
http://www.drug-injury.com/drug_injury/hormone-therapy-hrt/
http://menstruationresearch.org/tag/lawsuit/
http://www.joelbieber.com/practice-areas/drug-reactions/prempro-lawsuits/
http://www.premproadvisor.com/prempro-lawsuits
http://prempro.vanosteen.com/news.asp

Conjugated Equine Estogens: About the Horses

Premarin Foal
For every 150 women who stop taking Premarin, one mare is spared from the “pee line” and seven or eight “byproduct” foals will not be slaughtered for their meat.

The drugs made the basis of this article are manufactured with conjugated equine estrogens (CEEs), now commonly referred to as simply conjugated estrogens. Make no mistake, these drugs — including the drug Aprela currently awaiting FDA approval — are made with the estrogen rich urine taken from pregnant mares.

Once these mares are no longer able to conceive, they are disposed of typically at livestock auctions. Tens of thousands of byproduct foals are also sent to auctions where they fall prey to buyers hired to supply horses to slaughter plants. The horses are killed and their meat processed for human consumption. In some instances, foals are shipped live for slaughter for human consumption. Only a tiny percentage of these horses are rescued or bought and given another chance of life.

© Int’l Fund for Horses

See all posts on this issue >>

New Premarin Study: Benefits continue or dangers continue?

Cross-posted from Global News

Good news for women in their 50s — the health risks related to hormone therapy with estrogen, aimed at treating menopause symptoms, might go away after women stop the treatments, according to a study.

Research focusing on more than 7,000 women showed that while both stroke and blood clots increased during treatment with estrogen, there was no significant difference in health risks after 10 years between those who took hormones for treatment and those who hadn’t, the study — published in the Journal of the American Medical Association — said.

“But that doesn’t mean continuing to take them for five to 10 years won’t have some health risks emerge,” said Graham Colditz, at the Washington University School of Medicine, who wrote an editorial published with the study.

The study centered on some of the women who had also participated in the U.S. government-funded Women’s Health Initiative, the study that first raised concerns about the safety of hormone therapy.

In 2004, data from the WHI showed that taking estrogen by itself increased women’s risk of stroke and didn’t reduce their risk of coronary heart disease.

The 7,645 women in the study had all undergone hysterectomies before joining the WHI, and were assigned to a group that received estrogen pills. They were followed for 10 years — six of estrogen treatment with Premarin, and four years after ending the treatment.

During the treatment, their risk of stroke was 36 per cent more likely and blood clots was 47 per cent more likely in the estrogen group versus a group that took placebos.

But after 10 years, there was no significant difference between the groups in these conditions.

For women in their 50s, estrogen treatment even appeared to have some benefits over time, being linking to a 46 per cent drop in the risk of a heart attack and a 27 per cent drop in the risk of dying after 10 years.

Women in their 70s, though, did not get the same benefits, and for some conditions their risks rose if they took estrogen.

“If you’re a woman in your 70s, there’s very little reason to initiate estrogen,” said Andrea LaCroix for the Fred Hutchinson Cancer Research Center in Seattle and the lead author of the study.

The risk of breast cancer in this study appeared to be the same between women who took estrogen and those who didn’t, though other studies have found a link between breast cancer and hormone therapy.

Source: The Journal of the American Medical Association
http://jama.ama-assn.org/content/305/13/1305.abstract

About Premarin

Beware. The Premarin family of drugs contains pregnant mare’s urine, hence the name. In pharmaceutical terms, pregnant mare’s urine is referred to as conjugated equine estrogen, although recent labeling simply calls it “conjugated estrogen”, omitting “equine.” The Premarin family of hormone replacement therapy drugs is made by Wyeth, now a division by pharmaceutical giant, Pfizer.

About the Horses

To collect the urine, Premarin mares live a life of almost continual pregnancy. While in foal, the mares are made to stand for the duration of their pregnancies, placed in cramped stalls too small for them to turn around in or lie down, with rubber collection cups hooked tightly around their urethras. They are routinely denied free access to water to concentrate their urine.

Once Premarin mares have foaled, they are impregnated at the earliest opportunity, an dreturned to the “pee-line”. The foals, referred to as a “by-product” of the Premarin industry, are sent to auction with a high percentage ultimately going to slaughter.

The average lifespan of a Premarin mare is 12 years old. When Premarin mares are no longer able to bear foals, they in turn are sent to auction where they are vulnerable to killer buyers acting as middlemen for horse slaughter plants.

What You Can Do

Regardless of the “benefits continue versus dangers continue” question for humans, there are no benefits and the dangers continue for the mares and foals used and cast off by this pernicious industry.

  • Refuse to take Premarin and its family of HRT drugs, such as Prempro.
  • Send our Patient to Doctor letter to your treating physicians.
  • Talk with your doctor about taking one of the many humane alternatives to Premarin.
  • Alert the women in your life about this issue.

See our Fact Sheet to learn more >>

Pfizer wins on adequate warning in Prempro breast cancer suit

Expendable Flyer re Premarin and Prempro
Expendable Flyer re Premarin and Prempro

Bloomberg News reports:

Pfizer Inc.’s Prempro, a hormone once used by millions of women to ease menopause symptoms, almost doubled the death risk from breast cancer, a U.S. study found.

The findings from the U.S.-funded Women’s Health Initiative are the first to tie Pfizer’s hormone replacement therapy Prempro, already linked to higher breast cancer and heart disease rates, to increased mortality from tumors.

Pfizer, the world’s largest drugmaker, yesterday won its sixth of 13 jury cases over Prempro’s health risks an hour before the research was reported by the Journal of the American Medical Association. Previous studies suggested tumors fueled by hormone therapy were less aggressive and easier to treat. Pfizer gained Prempro in its $68 billion purchase of Wyeth last year. The hormones had annual sales of more than $2 billion before the study was halted in 2002, leading many women to stop treatment.

“You have more cancers, you have more advanced stage cancers and you aren’t having just more favorable cancers,” lead researcher Rowan Chlebowski, from the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, said in a telephone interview. “Women should think critically about if they need this, if their symptoms are significant and if they would persist.”

Source: http://www.bloomberg.com/news/2010-10-19/pfizer-hormones-almost-double-breast-cancer-death-risk-in-u-s-research.html

ABC News reports:

A federal jury has sided with Wyeth Pharmaceuticals in the latest lawsuit that accused the drugmaker of not disclosing a link between its hormone replacement therapy and a higher risk of breast cancer.

A Little Rock jury deliberated briefly Tuesday before siding with Wyeth, which argued that it adequately warned doctors and patients of the risks associated with its Prempro and Premarin drugs.

The case was brought by a woman and her husband, after she developed breast cancer. She had taken Prempro for 4 1/2 years.

Source: http://abcnews.go.com/Business/wireStory?id=11921219

Premarin and Prempro are made from pregnant mare’s urine. Thousands of mares are milked for their urine in tight stalls where they remain on their feet throughout their pregnancy. The cycle of quick re-impregnation continues throughout their shortened lifespans. Taken from the mares when only weeks old, their foals are typically sent to slaughter.

“We crush ’em and recycle ’em . . . just like aluminum cans.”

— PAT HOUDE, kill buyer and equine feed lot manager,
regarding Premarin foals and mares.

There are alternatives. You can help. Send your physician this Patient to Doctor letter.