Menopause: Made in the USA

Part 2

Thanks to massive marketing by Premarin manufacturer Wyeth, the concept of menopause is pretty much limited to English speaking countries.

Historically 80% of Premarin sales have occurred in the US. Even in the US, the cessation of menstruation is a non-event in 75% of women, who experience no symptoms whatsoever. Most languages and cultures have no word for menopause. It’s actually quite common for women to experience improvement in their health and well-being when they stop having periods.

Cross Cultural “Menopause” Studies

There are interesting cross cultural studies of the “menopause” phenomenon. Non-western cultures typically view the cessation of monthly cycles asa milestone signaling transition to the role of community elder. The Filipino women Berger and Wenzel studied in Women, Body and Society: Cross-cultural Differences in Menopause were extremely pleased with their freedom from the inconvenience of menstruation. They saw it as an initiation into the joys of old age: better sex (estrogens suppress a woman’s sex drive, which is regulated by testosterone and oxytocin) and improved energy and mood.  Most of all they appreciated the new love and respect they enjoyed as elders.

As Berger and Wenzel’s and other cross cultural studies note, attitudes in the US and other English speaking countries are heavily influenced by a multibillion dollar PR industry that bombards women with messages glorifying youth, thinness and sexual attractiveness – and engendering frank terror of gray hair, facial wrinkles, weight gain and cellulite. Aggressive marketing preys on these insecurities to sell billions of dollars of plastic surgery, botox, wrinkle removing creams and lotions, age concealing make-up, hair coloring and diet products and programs.

Six Decades of False and Misleading Marketing

As revealed in internal documents uncovered in a few of the 5000+ lawsuits filed against Wyeth, the company’s culpability goes far beyond neglecting to inform menopausal women of cancer risks. They paint a very ugly picture of an aggressive public relations campaign to convince women and their doctors that estrogen replacement was the secret to eternal youth.

It was a win-win campaign. By 1992, Premarin was the most commonly prescribed drug in the US. Thanks to decades of marketing about the horrors of aging, post menopausal women were terrified of losing their sexual attractiveness without estrogen replacement. And because health “experts” were recommending it in medical journals, doctors were more than happy to overlook growing evidence that it causes cancer.

The NIH Shuts Down the WHI

Seventy percent of American women taking estrogen replacement discontinued it when the National Institute of Health shut down the Women’s Health Initiative (WHI) study in 2002 (see Wyeth and the Multibillion Dollar Menopause Industry). A year later this had resulted in a 7% decrease in new breast cancer cases – a total of  14,000 women spared the agony of a potentially fatal breast cancer diagnosis.

The study findings have also resulted in 5000+ cancer lawsuits against Wyeth for misrepresenting earlier cancer research to doctors – and their failure to inform women of the significant cancer risks associated with HRT.

Wyeth Fights Back

Wyeth’s response was to initiate a massive PR campaign discrediting the WHI study. They started with a letter to 500,000 doctors attacking the study, complaining that the women in the Premarin arm had other reasons for developing cancer – they were too old, too menopausal or weren’t checked for pre-existing heart disease.* This was followed by articles attacking the study in numerous medical journals. All were ghost written by the company and published under the names of doctors specializing in women’s health

Many of these doctors were affiliated with the notorious Council on Hormone Education at University of Wisconsin that Wyeth founded in response to the 2002 WHI study. In 2006 the Council was still offering a continuing medical education course promoting estrogen replacement called “Quality of Life, Menopausal Changes and Hormonal Therapy.”

Filing Suit: the Only Consumer Protection Against Big Pharma

Wyeth’s massive campaign to discredit the 2002 WHI study, at the expense of tens of thousands of women who would start or continue estrogen replacement, has clearly harmed their defense in the dozens or so of the 5000+ lawsuits that have made it through the courts.

The pharmaceutical company has yet to win a single lawsuit brought by women (or families of deceased women) who developed reproductive cancers as a result of taking Premarin or Prempro. Moreover there are still active information websites for affected women and/or families who have yet to file suit. If you or a loved one has developed breast, uterine or ovarian cancer as a result of taking Premarin or Prempro click here.

photo credit: DES Daughter via photopin cc

Wyeth and the Multibillion Menopause Industry

(Part I of a two part series on the dangerous and cancer causing campaign by Wyeth Pharmaceuticals to “medicalize” menopause for profit),

I have written previously (see The Multibillion Dollar Depression Industry and Drug Companies: Killing Kids for profit)  about the ingenious – and deadly – strategy by pharmaceutical companies of inventing fictitious illnesses to market highly profitable drugs that allegedly “treat” them. The technical terms for this are “medicalizing” or “disease mongering.” In her 2004 The Truth About the Drug Companies: How They Deceive Us and What To Do About It, Dr Marcia Angell talks about “generalized anxiety disorder,” “erectile dysfunction,” “premenstrual dysphoric disorder,” and “gastro-esophogeal reflux disorder (heartburn).” These are other common complaints that drug companies have reinvented as chronic illnesses requiring lifelong treatment.

Estrogen Deficiency Syndrome

Based on 30 years of research linking it to reproductive cancers, the marketing of so-called “estrogen deficiency syndrome” has been far more lethal. The condition is known as “menopause” in English-speaking countries. Other cultures have no word for it. The number of premature deaths from the so-called treatment – “hormone replacement therapy (HRT)” – is the millions.

In this case the culprit is a single company, Wyeth, which manufactures Premarin (conjugated estrogens extracted from pregnant mare urine) and Prempro, a combination of estrogen and progesterone (a second female hormone).

Estrogen, a hormone regulating the development and function of the female reproductive system, was first discovered in 1925. In the 1930s, the drug company Wyeth developed a process to extract conjugated estrogens from the urine of pregnant mares. They patented their product as the drug Premarin (PREgnantMAresurINe), which first appeared on the market in 1942.

From the beginning Wyeth marketed Premarin, not for temporary relief of menopausal symptoms, but as a lifelong treatment to help all women maintain “healthy” estrogen levels in later life. Obviously this is nonsense. A “healthy” or natural estrogen level in a post-menopausal woman is virtually zero.

Although the medical community (and Wyeth) have been aware of links between estrogen replacement and breast, uterine and ovarian cancer since the 1970s, this research was effectively concealed from the public. Until the frightening results of the Women’s Health Initiative (WHI) study hit the front page in 2002. Between 1993 and 1995, the National Institutes of Health enrolled 161,809 women in the double blind WHI study. In 2002 the NHI shut down the study. Although it was originally scheduled to finish in 2005, it was painfully obvious that the women taking HRT were experiencing a 26% increase in breast cancer (with the risk doubling after five years), a 41% increase in strokes and a 29% increase in heart disease.

1975: the First Study Linking Premarin with Cancer

The first study linking Premarin with uterine cancer appeared in 1975. It was replicated by other researchers in 1977 and 1979. Wyeth responded to these worrisome studies by promoting a small 1980 study that taking progesterone, a second female hormone, reduced the risk of uterine cancer with estrogen replacement.

Sadly, most doctors fell for Wyeth’s slick PR campaign. Thanks to all the free pens, watches, clocks, lunches and trips to overseas conferences, they conveniently overlooked the failure of Wyeth’s 1980 study to at cancer rates in women who took no hormone replacement or to study the possible role of combined treatment in inducing other hormone sensitive cancers, such as breast and ovarian cancer. Wyeth’s success in selling doctors on combined treatment would lead them to launch Prempro, a combination of Premarin and progesterone, in 1995.

The earliest studies linking Premarin with breast cancer appeared in early 1980. According to Nik Ismail in “Hormone Replacement Therapy and Gynaecological Cancers,” between 1975 and 1995, there were at least fifty studies linking estrogen replacement (also known as HRT) with breast and uterine cancer. Some were cross cultural studies revealing American women had more than ten times the incidence of breast cancer than Asian women, who don’t take estrogen replacement.

The Multibillion Dollar Wyeth Cover-up

Wyeth responded to the breast cancer studies with a new PR blitz. In addition to flooding doctors’ offices with literature claiming studies linking Premarin to cancer were “contradictory,” they promoted numerous company-funded studies allegedly showing that estrogen replacement prevents osteoporosis and hip fractures, dementia and heart disease. The spin Wyeth gave doctors was that the effect of reducing cardiovascular disease (heart disease and strokes) — the most common cause of death in Americans – outweighed the somewhat lower risk of developing breast cancer.

Ultimately the claim that Premarin and Prempro reduce elderly women’s risk of cardiovascular disease proved to be false. This was one of the main reasons the WHI study was stopped: the women in the Premarin/Prempro arm of the study were developing significantly more heart attacks, strokes and dementia.

The WHI points to some role for estrogen replacement in reducing osteoporosis. However no studies have ever controlled for long term fluoride ingestion or epidemic Vitamin D deficiency in elderly Americans – which both have a documented role in high US rates of osteoporosis and hip fracture.

The marketing blitz aimed at doctors was accompanied by an even more powerful PR campaign in Harper’s Bazaar, the Ladies Home Journal and other women’s magazines. The goal was to appeal to American women’s (largely manufactured) terror of aging by emphasizing the value of estrogen replacement in preserving sexual attractiveness by preventing the skin changes and vaginal drying associated with aging.

To be continued.

photo credit: tejamen1947 via photopin cc

Drug Companies: Killing Kids for Profit

(Thanks to the corporatization of health care, Americans pay double what other countries pay for health care but have much worse health. The recent Obamacare roll-out has heightened public awareness about the role of private insurance companies in sucking billions of health dollars out of the health care system. There is far less scrutiny of the role of Big Pharma in driving up health care costs.

This is the second of several posts on “disease mongering” by pharmaceutical companies  – i.e. the invention of fictitious diseases to market drugs that supposedly treat them.)

Practicing psychiatry for eight years in New Zealand has given me a unique perspective on childhood bipolar disorder. Also known as pediatric bipolar disorder (PBD), this is a condition virtually unknown outside of the US. Australian psychiatrist Dr. Peter Parry has undertaken detailed research into this condition, and a “conspiracy” by Eli Lilly and other drug companies to promote off-label use of antipsychotic drugs to children under 12. Yet another example of “disease mongering” by Big Pharma (see link) to encance their profits.

As well as publishing numerous papers on the PBD controversy, Parry also has a Powerpoint presentation he gives at grand rounds and conferences around the world. It includes internal Lilly and Janssen memos (available from his Healthy Skepticism website) about their innovative campaign to “medicalize” children’s misbehavior.

Thanks to their aggressive marketing of PBD to US doctors and parents, American children as young as two are being started on antipsychotics for extreme anger and behavioral problems

Breaking the Law: Good Business Practice

Prescribing “off-label” refers to using medication for an indication that hasn’t been approved by the FDA. As yet no antipsychotics have been approved for use in children. Moreover, it violates federal law for drug companies to market medications to doctors or the public for “off-label” uses. Yet because the fines imposed are minuscule, compared to the massive profit potential of off-label marketing, it’s considered good business practice to pay the fine and keep on doing it anyway.

Diagnostic Criteria for Bipolar Disorder

Parry’s slideshow starts with studies comparing US attitudes about BPD in the UK, Germany, New Zealand and Australia. Most foreign psychiatrists either don’t recognize pediatric bipolar disorder as a diagnosis or regard it as extremely rare. According to Parry, the discrepancy revolves mainly around an insistence (outside the US) that both children and adults manifest symptoms of true mania to be diagnosed bipolar. Over the past 10-15 years, an increasing number of industry-funded psychiatric researchers have been claiming that extreme temper outbursts, rages and rapidly changing moods are a “manic” equivalent in children.

They also claim that children with extreme mood swings will go on to develop true bipolar illness in adulthood, making early treatment essential. This despite studies showing that most kids with PBD  “outgrow” it as adults. (Although it seems more likely they never had it to begin with.)

What Parry finds particularly horrifying is that American child psychiatrists are diagnosing kids bipolar and starting them on antipsychotics without taking a developmental history to rule out the most common cause of extreme anger and behavioral problems – namely child abuse and attachment difficulties.

Putting Psychiatric Experts on the Payroll

That being said, he puts the blame for the dangerous fad of prescribing unapproved antipsychotic drugs for children squarely where it belongs: on multinational drug companies. In the US, most child psychiatrists are naturally uneasy prescribing dangerous antipsychotic medication for kids. They have to be egged on by esteemed researchers issuing stern warnings about ruining a child’s future life by “missing” a the diagnosis of bipolar disorder.

Too bad these self-proclaimed PBD experts are so careless about disclosing conflicts of interest, in the form of hundreds of thousands of dollars in of drug company research grants and consultant fees. This has only come out in subsequent lawsuits and ethical investigations.

Death and Other Dangerous Complications

The complications of antipsychotic treatment in children fall into four broad categories: death, severe medical complications, social exclusion and delayed emotional development.

1. Death

15 years of FDA adverse incident reports (which typically capture only 1% of adverse drug events) directly implicates antipsychotic use in children with scores of deaths:

2000-2004: 45 deaths (source)

2006: 29 deaths (source)

2.  Severe Medical Complications

Antipsychotics tend to cause massive weight gain – often as much as 100 pounds – a common cause of diabetes. In addition a disfiguring neurological disorder called tardive dyskinesia that occurs in 6-9% of children who take antipsychotics. The tics and writhing movements associated with tardive dyskinesia often persist permanently, even after the medication is stopped.

3. Social exclusion

Labeling a child with a mental illness, particularly if they are taking a medications that cause sedation, extreme weight gain and/or tics has an extremely detrimental effect on social relationships that are absolutely vital to normal child development.

4. Delayed emotional development

Sedating a child who has difficulty regulating anger and extreme moods only further delays the process of learning to regulate their emotions themselves.

Below a video from a mom whose son died from antipsychotic complications:

photo credit: me and the sysop via photopin cc