Purchasers of Premarin, Prempro, or Premphase in California between Jan 1995 and Jan 2003 could get money from class action settlement

Mutli image Premarin artwork for Tuesday's Horse.

SAN DIEGO, May 11, 2020 /PRNewswire/ — The following is being released in the matter of Krueger v. Wyeth, Inc. et al, by Wyeth and Wyeth Pharmaceuticals Inc. and the law firms of Rushall & McGeever, Beasley Allen, P.C., and Gary Holt & Associates, P.A. (Counsel for the Plaintiff-Class).

Counsel for the Plaintiff-Class has reached a class action Settlement in the amount of $200 million with the pharmaceutical company Wyeth and Wyeth Pharmaceuticals Inc. (“Wyeth”) regarding the prescription hormone replacement therapy medications Premarin, Prempro, and Premphase.

What is this case about? The lawsuit claims that Wyeth violated California laws by misstating the benefits and/or failing to disclose the risks of Premarin, Prempro, and Premphase purchased in California between January 1995 and January 2003.  Wyeth denies it did anything wrong. 

Who is included? An individual is included in this Settlement as a Class Member if they:

  • Lived in California between January 1995 and January 2003;
  • Bought Premarin, Prempro, and/or Premphase in California between January 1995 and January 2003; and,
  • Are not claiming any personal injury from the use of Prempro, Premarin, and/or Premphase.

What Can a Class Member Get from the Settlement? There are two options to get money from the Settlement. Read on »


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Breast cancer, menopause and yes, rhubarb

Rhubarb. Image from LiveStrong.com.

by JANE ALLIN

October is National Breast Cancer Month. What better opportunity to remind women of the dangers posed by the use of HRT and the inherent cruelty foisted upon the innocent mares and their foals by the PMU industry?

Despite advances in medical technology over the years, Pfizer continues to promote their conjugated equine estrogen drugs (e.g. Premarin, Prempro, Duavee) based on antiquated science – science that has since been proven to be flawed.

In fact, the findings of the WHI study was listed as one of the top ten medical advances of the decade in an article published in 2009; “The Top 10 Medical Advances of the Decade: From genome to hormones, doctors pick the top medical advances of the decade.” [1]

“And then the world changed, the National Heart Lung and Blood Institute, which was sponsoring a placebo-controlled trial of hormone replacement therapy in more than 161,000 healthy women, announced that it was shutting down the study because HRT increased the risk of heart attack, stroke, blood clots, and breast cancer.

It was the “oops” heard round the world.” [2]

Why are these drugs still here 14 years after the fact? Why haven’t the FDA and other drug agencies around the world pulled these from the market?

Time and again the antagonistic effects of conjugated equine estrogens have proven to be potent carcinogens that give rise to a variety of cancers and other life-threatening diseases, breast cancer included.

The FDA and other governing bodies such as the European Commission in the EU continue to endorse these drugs as safe therapies for women of menopausal and post-menopausal age despite the unequivocal dire warnings on the packaging cautioning women of substantial risks that should, in any dutiful context, prevent these drugs from being marketed.

And not to forget the pitiful existence of the mares and their by-products – the innocent foals born into a precarious world where their fate is sealed if there are no takers. Now of course, this malevolent industry has moved across the globe to countries where animal welfare is decidedly worse than the loathsome state of affairs in North America.

PMU Farm in Xinyuan County, China (2012).
PMU Farm in Xinyuan County, China (2012).


But there are of course options – alternatives to the use of drugs containing equine-derived hormones. The Horse Fund has compiled a list of such options (see http://horsefund.org/pmu-alternatives-to-cee-drugs.php) as well as the safety aspects of FDA-approved prescription versions of HRT that are not derived from pregnant mare’s urine. [3]

RHUBARB

One natural alternative that crops up (pun intended) on occasion, yet is not mentioned in either of these articles, is “rhubarb”.

Rhubarb is said to be a very “old” plant, meaning that documented knowledge of the plant goes back as far as 2,700 years in China. The roots were said to have medicinal value and were a prized commodity for treating a variety of ailments. [4]

In many cultures, herbs and foods that contain so-called phytoestrogens have been used to treat symptoms of climacteric complaints – that is, complaints associated with the transition between premenopause, perimenopause and early postmenopausal stages. Examples include black cohosh, soy and red clover; rhubarb is also classified as a phytoestrogen.

Phytoestrogens are known to have distinct actions on what are known as estrogen receptors (ERs) which are activated by the hormone estrogen. As an example, estrogen receptors are over-expressed in around 70% of breast cancer cases, referred to as “ER-positive”, which can lead to proliferation of mammary cells. Moreover, estrogen metabolism creates genotoxic waste – chemical agents that damage the genetic information within a cell causing mutations which may lead to cancer.

There is growing evidence that phytoestrogens could have a protective effect on the initiation or progression of breast cancer by inhibiting pathways important for cell growth and proliferation. The characterized mode of phytoestrogen action is estrogen receptor (ER) binding which effectively blocks estrogen from binding to the ER and reduces the risk of cell propagation. Their metabolic actions are much more complicated than this simple explanation and the science behind their effectiveness is challenging to address. [5]

Essentially this is what a SERM’s (Selective Estrogen Receptor Modulator) function is.

Several reports have indicated that experimental data supports the theory that ERr from the rhubarb plant and/or its constituents do in fact exhibit(s) SERM-like properties. [6]

SERMs block the effects of estrogen in the breast tissue, for example, as well as other tissues in the body that have estrogen receptors (e.g. bones, uterus). Recall that the bazedoxifene component of Duavee is a SERM, although it is not naturally derived, nor has it been officially approved by the FDA as a stand alone drug.

Several scholarly articles can be found online that describe the efficacy and safety profile of rhubarb extracts in the treatment of menopausal symptoms such as hot flashes, sweating, sleep disturbances, and mood swings.

In each of these, a pill containing the extract (ERr) significantly reduced vasomotor and other menopausal symptoms. ERr was first introduced to treat menopausal symptoms in 1993 and has had no severe adverse effects reported with its use.

In an article published in Menopause in 2006 “Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731 – trade name Phytoestrol N) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial.” Authored by Heger et al, the effectiveness of the rhubarb extract ERr 731 to treat menopausal symptoms was validated by a multicenter, prospective, randomized, double-blind, placebo-controlled, clinical trial on 109 women with climacteric complaints receiving either a daily dose of 4 mg of ERr 731 or a placebo. [7]

The primary outcome criterion for the efficacy of ERr 731 was the change of the Menopause Rating Scale II (MRS II) total score compared to the placebo after 12 weeks. The MRS II is a health-related quality of life developed in the early 1990’s that measures the severity of age-/menopausal-related complaints by rating a profile of 11 different symptoms. [8]

These symptoms include; hot flashes/flushes, heart discomfort, sleep problems, depressive mood, irritability, anxiety, physical and mental exhaustion, sexual problems, bladder problems, dryness of vagina and joint and muscular discomfort. [9]

Additionally, the MRS II score was accompanied by secondary outcome criteria which included physical examinations to assess the safety of ERr 731 (e.g. vaginal smear, pap smear, transvaginal ultrasound, endometrial biopsy, breast palpitation, body weight).

The treatment outcome after the intake of ERr 731 or placebo for 12 weeks was assessed by both the investigators and participants according to the Integrative Medicine Outcome Scale (IMOS) – a 4-point (investigator) and 5-point (patient) verbal rating scale ( complete recovery (patient-only), major improvement, moderate change, no change, and deterioration). Results are shown in the figure below.


imos


More detailed results, including the MRS II scores, are shown in the paper. [10]

Clearly the rhubarb ERr 731 extract is effective in significantly reducing symptomatic climacteric complaints when compared to the placebo.

Throughout the trial no abnormalities in breast tissue were observed which support those of long-term treatment with ERr 731 in everyday practice.

Moreover, women who took the ERr 731 experienced no vaginal bleeding and spotting which are common side effects due to an estrogen-dependent stimulation of the endometrium, nor was there any evidence of endometrial hyperplasia in the treated women.

CONCLUSION

Neither clinical nor experimental results detected any adverse effects of ERr 731 (e.g. uterine and endometrial growth and proliferation) which suggests that ERr 731 exerts SERM-like activites.

Overall, the trial results show that ERr 731 is a highly effective, well-tolerated, and safe herbal medicinal product in the treatment of climacteric complaints in the transition through the various stages of menopause as an alternative to traditional HRT. [11]

The demand for safe and effective estrogen-free medications is ever-increasing given the risks associated with conventional HRT, particularly those derived from conjugated equine estrogens.

In the end what matters most is that women become informed from a health and risk perspective with the realization that there is no need for PMU farming operations, whether that be here in North America or on the fledgling farms in lands far away.

PFIZER MARCHES ON

Unfortunately Pfizer, and now their counterparts in foreign jurisdictions, continue to deceitfully market these drugs as the panacea to every woman’s natural menopausal transition.

Sadly, those farms in China, India and other places where they may exist, are, in general, without the same level of oversight from advocates of animal welfare, unlike here in North America where the plight of animals, whether that be livestock or the use of animals for other human profit, such as the PMU horses, has an ever-increasing base of concerned citizens.

PMU Farm in Xinyuan County, China (2012).
PMU Farm in Xinyuan County, China (2012).


Foremost because the industry outside of North America is, relatively speaking, new, secondly because animal welfare issues appear to be less front and center and last, but not least, because many people in these countries are likely unaware of the risks associated with these drugs derived from pregnant mare’s urine.

This of course is changing as time progresses.

At one point North America, and the EU for example, were in the same position. It took decades for the truth to surface and yet Pfizer still manages to market these drugs, considered carcinogens, to physicians and their patients alike without moral compass from all perspectives – horse or human.

After all, to Big Pharma it is all about corporate welfare and shareholder satisfaction no matter what the cost.

Save a horse – go out and eat some rhubarb, just don’t eat the leaves. [12]

rhubarb-leaves

END

[1] http://www.medpagetoday.com/InfectiousDisease/PublicHealth/17594
[2] http://www.medpagetoday.com/InfectiousDisease/PublicHealth/17594
[3] https://tuesdayshorse.wordpress.com/2015/11/10/fda-approved-alternatives-to-premarin-derivatives-are-they-safer/
[4] http://www.rhubarbinfo.com/history and http://www.botanical.com/botanical/mgmh/r/rhubar14.html
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3074428/
[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2837008/
[7] file:///M:/My%20Documents/Photography%20tutorials/Efficacy_and_safety_of_a_special_extract_of_Rheum_.pdf
[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534786/
[9] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534786/
[10] file:///M:/My%20Documents/Photography%20tutorials/Efficacy_and_safety_of_a_special_extract_of_Rheum_.pdf
[11] file:///M:/My%20Documents/Photography%20tutorials/Efficacy_and_safety_of_a_special_extract_of_Rheum_.pdf
[12]http://www.compoundchem.com/2015/04/16/rhubarb/

© THE HORSE FUND

FEATURED IMAGE
The Health Benefits of Rhubarb“, Livestrong.com.

RELATED READING
A Look at a PMU Farm in China and It’s Not all About Pfizer; Tuesday’s Horse
Premstoppers Campaign; The Horse Fund

Class action lawsuit in Canada says Premarin and Premplus caused breast cancer

The claim that the Premarin family of drugs have carcinogenic properties is not news.

However a class action lawsuit is pending in Canada that has the potential of proving this to be true in a high number of cases, revealing important facts and figures previously uncovered.

Pfizer are maintaining of course that these drugs do not cause cancer if taken as directed. But that statement concerns the drugs as they are sold today.

Mary Ormsby, reporting for The Toronto Star, writes:

    Popular menopause drugs made in part from estrogen found in the urine of pregnant horses have caused breast cancer in thousands of Canadian women, according to allegations in a new report by the Canadian Cancer Society’s top epidemiologist.
    “The body of evidence to date overwhelmingly points to a causal connection between the use of Premplus and the development of invasive breast cancer in women,” the society’s Prithwish De wrote in a report to be filed in a Canadian class-action lawsuit against drug manufacturer Wyeth Canada, now owned by Pfizer.
    The drug manufacturer states that its products are “safe and effective when used as directed” and they do not cause breast cancer. A trial date is set for October in a Vancouver court.
    According to the report, hormone replacement therapy was the main risk factor in an estimated 12,000 new Canadian breast cancer cases detected between 1994 and 2006 at a time when Wyeth’s products, Premarin and Premplus, dominated the market. The drugs remain on the market, but in more recent years they have contained strong warnings and are also prescribed in lower doses.

As in previous class action lawsuits Pfizer (and before that Wyeth) have been able to settle these types of cases, reportedly hand out millions of dollars and get sealed Judgments so that the details are not available for public consumption.

What boggles the mind is why Pfizer persist with these drugs made from the urine of pregnant mares. Yes there is the first obvious reaction — the sales of the Premarin family of drugs makes the pharma giant billions of dollars.

But Pfizer (and previously Wyeth) have had decades to replace these troublesome menopausal drugs and find a safer one that does not use animal waste.

Litigation is an ongoing problem for Pfizer.

DrugWatch reports:

    Today, Pfizer operates in 180 countries and employs more than 110,600 people worldwide, with revenue topping $65 billion in 2011. It operates in five areas: Primary Care; Specialty Care and Oncology; Established Products and Emerging Markets; Animal Health; and Consumer Health Care and Nutrition.
    But the company has had more than its share of controversy, including four settlements over charges of illegal marketing in the last decade alone – one totaling $2.3 billion – and countless personal injury lawsuits. Pfizer’s portfolio of problem drugs includes Zithromax, Chantix, Lipitor, Geodon, Trovan, Bextra, Celebrex, Lyrica, Effexor and Zoloft.

Hmm, how interesting they do not mention any of the Premarin family of drugs as a problem drug. Why is that?

Well, they are problem drugs in our estimation.

For women, yes, but for our purposes it is a huge problem involving the abuse and deaths of the mares and foals used.

Mares are kept constantly pregnant until they can get pregnant no more, cast off and replaced, standing for hours, day after day in narrow stalls, so that every last drop can be captured. Then there are the byproduct foals. A small percentage may find homes but many are cast off like their worn out mothers, often meeting a brutal and tragic end.

Hayworth and Molly Premarin flyer.
Remember this from 2010? That figure is even higher now.

Learn more on about these drugs, the women and the horses »
Alternatives »

Pushing Premarin: Big Pharma, Big Bucks — Part 2

by JANE ALLIN

Safety: Big Pharma, Bad Medicine

Premarin foals in feedlot.
Premarin foals in feedlot.

Despite Pfizer’s aggressive marketing strategies, the sad fact is that these drugs derived from horse urine are the same drugs they always were – the drugs that took the lives of thousands of unsuspecting women and continue to exploit and abuse the PMU mares and their foals.

They have the same risks they have always had and the package warnings list even more risks than before as a result of Wyeth’s past indiscretions and failure to sufficiently warn the public of the dangers. Yet they’re deemed safer because of this very reason – make the consumer aware, we aren’t hiding anything – honest.

And, while it’s true that the “recommended” prescribed dosages may be lower along with guidelines that advise reducing the length of time a woman remains on HRT, in effect nothing has changed – they are still recognized as carcinogens by the WHO and other regulatory bodies.

    In women, a recent study has evaluated the potential of HRT to induce DNA damage in peripheral blood leukocytes of postmenopausal women using the comet assay (Ozcagli et al. 2005). Significant increases in DNA damage were observed among women receiving 0.625 mg/day conjugated equine estrogens or conjugated equine estrogens plus medroxyprogesterone acetate as compared to the control group that had never received HRT. Finally, the excessive production of ROS in breast cancer tissue has been linked to metastasis of tumors in women with breast cancer (Malins et al. 1996; Malins et al. 2006; Karihtala and Soini 2007; Benz and Yau 2008). These and other data provide a mechanism of estrogen-linked tumor initiation/promotion by redox cycling of estrogen metabolites generating ROS, which damage DNA.” [1]

ROS stands for “Reactive Oxygen Species”. Various carcinogens, such as CEEs, may partly exert the effect of oxygen derived species (e.g. superoxide radical) by generating reactive oxygen species (ROS) during their metabolism. Oxidative damage to cellular DNA can lead to mutations and may, therefore, play an important role in the initiation and progression of multistage carcinogenesis.

Science says 0.625 mg/day can induce DNA damage and cancer. Today Premarin tablets are still available in dosages of 0.3 mm, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg. And physicians continue to prescribe various doses depending on the severity and nature of menopausal symptoms. By comparison Premarin cream contains 0.625 mg per dosage and Duavee 0.45 mg together with 20 mg of bazedoxifene, a drug yet to be approved on its own by the FDA. Is a dosage of 0.45 mg really safer than 0.625 mg? And what about Premarin cream at the same 0.625 mg level?

And let’s not forget about the innocent bystanders, not just the vulnerable women who opt to take these drugs for relief of menopausal symptoms, either of their own volition or on the advice of their doctors.

What many may not be aware of is that creams, lotions and other topical skin products can be absorbed through the skin and into the systemic circulation resulting in unexpected complications.

Since the release of the damaging WHI results demonstrating the risks involved with the Premarin family of drugs, the use of topical hormones such as Premarin cream have escalated. When HRT drugs are applied topically rather than taken orally they avoid the “first-pass” effect through the liver which is generally considered a “safer” route.

    The advantage of this route of administration is that oestrogen is delivered directly to oestrogen-depleted tissues with similar efficacy to oral oestrogen, with the hope of avoiding significant systemic absorption and consequent side-effects. Given some concerns surrounding the safety of systemic HRT, particularly on breast tissue and the coagulation cascade, topical HRT offers a more targeted approach.” [2]

At the same time there are limited studies on the effects of topical estrogens and, in practice, systemic absorption is lower but not negligible and increases with increased doses of estrogen. [3]

And it isn’t simply the women who use Premarin vaginal cream who are at risk – their partners are also exposed to the estrogens in this topical HRT during intercourse which can pose harmful and unwelcome side effects.

According to the North American Menopause Society, vaginal creams such as Premarin should not be used right before sex because the partner may absorb the estrogen hormone through his skin (Journal of Reproductive Medicine, Jan. 2008).

Over time estrogen could have a feminizing effect on a man. [4]

    A few months back I received an email from a reader whose husband was inexplicably gaining weight and growing breasts. She ordered a blood spot hormone test for him, and his results showed low testosterone and high estradiol (estrogen), which certainly explained his symptoms. After a bit of digging, we figured out that she was using a vaginal estradiol cream within a few hours of when she and her husband had intercourse. In fact, she considered it a vaginal lubricant. I suggested she switch to a low dose estrogen patch, and recently heard from her that within a matter of weeks her husband had started losing the weight, and after a couple of months his breasts were back to normal and by the way, so was his sex drive.” [5]

Another word of caution for any and all estrogen-containing topical products.

    Transferring estrogen to children can have serious consequences. For boys, who again are already over-exposed to estrogenic chemicals in the environment, even small amounts of estrogen can block normal development of male characteristics and stimulate weight gain and breast growth. For girls, exposure to excess estrogen can cause early puberty and menstruation, a known risk factor for breast and ovarian cancer later in life.” [6]

And if that’s not enough, even your canine and/or feline family is affected by topical estrogens. An article in the New York Times reports the following:

    Veterinarians around the country are reporting a strange phenomenon: spayed dogs and cats, even some puppies and kittens, are suddenly becoming hormonal.

    In female pets, the symptoms resemble heat: swollen genitals, bloody discharge and behavioral problems. Male animals are showing up with swollen breast tissue and hair loss. Standard treatments and even repeated operations have had no effect.

    Now vets have identified the culprit. The pets were all owned by women who used hormone creams on their hands, arms and legs to counter symptoms of menopause. Animals who licked or cuddled their owners, or rubbed up against their legs, were being inadvertently exposed to doses of hormone drugs.” [7]

Is it really worth it to take any form of estrogen for the relief of menopausal symptoms – Premarin or others?

Other synthetics carry with them the same or similar warnings associated with their use although it has been repeatedly cited in scientific literature that estrogens derived from pregnant mares urine pose a significantly greater risk due to the conspicuous fact that equine estrogens are foreign to humans but, wait for this . . . not horses. What a concept.

http://www.cancer-help.com/smartnutrition.old/ias-esnatri.htm
http://www.cancer-help.com/smartnutrition.old/ias-esnatri.htm

First note the disparities between the concentrations of estrone and estradiol and of course the presence of the equine estrogens found exclusively in horses – clearly problematic in relation to the safety profile of these drugs.

And a closer look renders CEE-derived HRT products even more sinister:

    Premarin contains at least 10 estrogens that are the sulfate esters of the ring B saturated estrogens: estrone, 17beta-estradiol, 17alpha-estradiol, and the ring B unsaturated estrogens: equilin, 17beta-dihydroequilin, 17alpha-dihydroequilin, equilenin, 17beta-dihydroequilenin, 17alpha-dihydroequilenin, and delta-8-estrone. Bioassays and estrogen receptor binding studies indicate that all 10 estrogens are biologically active. Moreover, individual components, such as equilin sulfate, delta-8-estrone sulfate, 17beta-dihydroequilin sulfate and estrone sulfate, have potent estrogenic effects. Since all of the estrogens present in Premarin have estrogenic activity, the pharmacological effects of Premarin are a result of the sum of these individual activities.” [8]

The extract of pregnant mare’s urine is nothing less than a dangerous cocktail of alien hormones with demonstrated and lethal side-effects.
The upshot is that, unlike the horse, the female human body does not have the necessary enzymes and co-factors required to metabolize equine estrogens nor does it have the ability to deal with the significantly higher concentrations of Estrone and Estradiol contained in any of the Premarin drugs. Certainly these disproportionate and foreign hormones must create a hormonal imbalance that can have serious antagonistic consequences.

    As two leading reproductive physiologists point out, when women take Premarin, ‘Levels [of equilin] can remain elevated for 13 weeks or more post-treatment due to storage and sloe release from adipose [fat] tissue. In addition, metabolism of equilin to equilenin and 17-hydroxyequilenin may contribute to the estrogen stimulatory effect of [conjugated estrogen] therapy.’ Another metabolite of equilin, 17-dihydroequilin has been found to be eight times more potent than equilin for inducing endometrial growth, a possible precursor to cancer (3). As a result, Premarin produces “estrogenic effects” which are much more potent and longer lasting than those produced by natural human estrogens.” [9]

The bottom line – CEEs still cause cancer and a host of other illnesses. Why on earth are these archaic medications still on the market? Simply put, they shouldn’t be.

    Equilin metabolites appear to have stronger carcinogenic effects than comparable oestradiol metabolites. Oestradiol is now available in pure form, crystalline or as oestradiol valerate, and it seems more sensible to replace the oestradiol deficiency by giving the exact hormone rather than an extract of uncertain composition. Since CEE offers no advantage over physiological oestradiol, it is hard to understand why substitution with a pharmacologically poorly defined oestrogen mixture is still practised. From the point of view of clinical pharmacology, the use of an oestrogen extract should now be considered inappropriate.” [10]

Exactly, there is absolutely no longer any need for these risky equine estrogens.
__________
[1] http://goo.gl/IVnZOd
[2] http://www.patient.co.uk/doctor/hrt-topical
[3] Same as 2.
[4] http://www.webmd.com/menopause/low-dose-vaginal-estrogen-for-dryness-and-atrophy
[5] http://www.virginiahopkinstestkits.com/hormone_transfer.html
[6] Same as 5.
[7] http://well.blogs.nytimes.com/2010/10/25/when-hormone-creams-expose-others-to-risks/?ref=science
[8] http://www.ncbi.nlm.nih.gov/pubmed/9421201
[9] http://www.smart-publications.com/articles/dont-let-your-doctor-give-you-horse-urine-for-menopause
[10] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2014957/#b4

Read Part 1 » • Read Part 3 »

© The Horse Fund

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