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Omitting All-Important Developmental History

Understanding why foreign psychiatrists are scandalized by their American colleagues' cavalier attitude towards pediatric bipolar disorder (and prescribing dangerous antipsychotic drugs to young children) requires an understanding of the importance of developmental history in assessing emotional and behavioral problems in children. A developmental approach to diagnosis assumes that a child’s difficulties are strongly influenced by their immediate environment. If children with extreme rages and temper outbursts come from a chaotic home where parents are constantly yelling and screaming, these problems must be recognized as a ''developmental'' problem, rather than mental illness. In other words, a negative family environment has caused some aspects of the child’s emotional development to be delayed. Diagnosing a child with a mental illness when the problem really lies with the parents is commonly known as scapegoating. It does both the child and the family a great disservice.

A developmental approach to diagnosis also assumes that all babies are born without the ability to regulate anger and other extreme emotions. In infancy and early childhood, parents help children regulate their emotions through soothing and calm limit setting. Through constant repetition of this process, children eventually learn to regulate extreme emotion on their own. Where a problem commonly develops is when parents themselves have never learned emotional regulation and respond to children’s anger and distress by becoming angry themselves.

At times delays in the ability to regulate extreme emotion occur for reasons other than inconsistent parenting. The two most common are trauma (physical, emotional and/or sexual abuse) and attachment difficulties (the child fails to bond appropriately with the primary caregiver).

The Dangers of Checklist Diagnosis

In Europe and here in the South Pacific, child psychiatrists maintain that to establish the presence of a mental illness such as pediatric bipolar disorder (PBD), the treating psychiatrist must first demonstrate (by taking a careful developmental history) that the child previously had an ability to regulate extreme mood swings, which they lost when the so-called “mental illness'' developed. Clearly this isn’t being done in the US, as many PBD aficionados claim that developmental and school history are irrelevant and make the diagnosis based on mood checklists alone. A checklist approach to diagnosis is extremely dangerous in children. The tendency for all children under stress to manifest extremes in mood and behavior (as all parents of young children will agree) makes it impossible to define the limits of normal mood and behavior.

What foreign and some American child psychiatrists find particularly horrifying is the large number of children in the US foster care system - who clearly have developmental issues, resulting from abusive and neglectful homes - receiving the diagnosis of PBD and being put on antipsychotics to control anger and behavioral problems. In most cases, this involves a cocktail of three to four drugs, as antipsychotics have little therapeutic effect in kids other than sedation. Typically, in addition to the antipsychotic, children will be given an anti-seizure medication (used commonly in adult bipolar patients), an antidepressant, lithium, and/or clonidine (a blood pressure medication that calms children by dropping their blood pressure).

Why Are American Psychiatrists Diagnosing PBD?

Dr Peter Parry puts the blame for the dangerous fad of prescribing unapproved antipsychotic drugs for children squarely where it belongs: on multinational drug companies and US insurance companies. While internal memos (see slides 91-94 and 98-100) show that drug companies deliberately set out to expand sales of antipsychotics by persuading doctors to prescribe them off-label in children, the intrusion of for-profit insurance companies into US health care delivery has played a major role in perpetuating the barbaric practice. Even where a child has severe emotional problems, insurance companies refuse to pay for psychiatric visits or hospitalization without a diagnosis of mental illness. Moreover only drug treatment is covered, even if the difficulties result from family problems.

Psychiatric Researchers on the Drug Industry Payroll

Meanwhile child psychiatrists who feel uneasy prescribing dangerous antipsychotic medication to children are lambasted on by eminent “researchers,” who issue stern warnings about ruining a child’s future by “missing” the diagnosis of pediatric bipolar disorder (PBD). Unfortunately most neglect to disclose that they have a conflict of interest, in the form of hundreds of thousands of dollars in research grants and consultant fees from the drug companies who produce antipsychotics. This has only come out in subsequent lawsuits (see http://www.psychsearch.net/lawsuits.html) and ethical investigations (http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/).

In addition to pressure from insurance companies and PBD “experts,” child psychiatrists and pediatricians also experience major pressure from parents, owing to massive direct-to-consumer marketing – in the form of dozens of books, magazine articles and TV documentaries promoting PBD as the true explanation for severe behavioral problems – and a magic pill as the easy answer. Many parents, convinced by all the media hype, feel justified in demanding doctors prescribe these wonder drugs for their kids. Pity the poor child psychiatrist who stands firm on recommending the appropriate, evidence-based treatment - a lengthy course of family or behavioral treatment that isn’t covered by insurance.

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 : As Dr Parry points out in his slideshow, fifteen years of FDA adverse incident reports (which typically capture only 1% of adverse drug events) reveal that antipsychotics are directly implicated in the death of scores of children:

2006: 29 deaths http://www.nytimes.com/2007/05/10/health/10psyche.html?pagewanted=1

2. Severe Medical Complications : Antipsychotics tend to cause massive weight gain – often as much as 100 pounds – which commonly leads to diabetes. In addition a disfiguring neurological disorder called tardive dyskinesia occurs in 6-9% of children who take antipsychotics. The tics and writhing movements associated with tardive dyskinesia often persist permanently, even after 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 their social relationships, which 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.

Do Child with PBD Grow Up Bipolar?

The main argument used for aggressive diagnosis and treatment of PBD is that treating bipolar illness early gives a child a better chance of leading a normal adult life. However now that increasing numbers of children with so-called PBD are in their twenties and thirties, it turns out that the vast majority “outgrow” PBD in adulthood. These results have led some American researchers to reach the same conclusion developmental psychiatrists and psychologists reached a decade ago: that the extreme mood swings being labeled PBD are actually a developmental problem that improves with brain maturation. See http://www.sciencedaily.com/releases/2008/10/081006180654.htm and http://www.sciencedaily.com/releases/2009/09/090929141530.htm

Wyeth and the Multibillion Dollar Menopause Industry

(April 1, 2011)


I have written previously 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.” Dr Marcia Angell, in her 2004 The Truth About the Drug Companies: How They Deceive Us and What To Do About It, also talks about “generalized anxiety disorder,” “erectile dysfunction,” “premenstrual dysphoric disorder,” and “gastro-esophogeal reflux disorder (heartburn)” as examples of common complaints that drug companies have reinvented as chronic illnesses requiring lifelong treatment (see http://www.cmaj.ca/cgi/content/full/171/12/1451).

Estrogen Deficiency Syndrome

The marketing of so-called “estrogen deficiency syndrome,” which in English-speaking countries is known as “menopause” in (non-western cultures have no word for it) and “hormone replacement therapy (HRT)” has been the most lethal, in lights of thirty years of research linking it to reproductive cancers. The number of premature deaths linked to HRT is estimated in 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 a second female hormone progesterone.

Although the medical community (and Wyeth) have been aware of links between estrogen replacement and breast, uterine and ovarian cancer since the 1970s, the research was effectively concealed from public view – 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 (NHI) enrolled 161,809 women in the double blind WHI study. In 2002 the NHI shut down the study, originally scheduled to finish in 2005, when it became clear 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 (see http://www.theepochtimes.com/n2/content/view/9804/).

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, as a “healthy” or natural estrogen level in a post-menopausal woman is virtually zero.

1975: the First Study Linking Premarin with Cancer

The first study linking Premarin with increased uterine cancer appeared in 1975. It was replicated by other researchers in 1977 and 1979. These results were entirely consistent with the discovery of estrogen receptors in the early seventies and the finding that stimulating these receptors caused tumor growth in tissue culture and laboratory animals.

Wyeth responded to these worrisome studies by promoting a small 1980 study showing that progesterone, a second female hormone, reduced the risk of uterine cancer with estrogen replacement. Unfortunately most doctors fell for Wyeth’s slick PR campaign (and a lot of free pens, watches, clocks, lunches, and trips to overseas conferences). They conveniently overlooked the failure of 1980 study to look at cancer rates in women who took no hormone replacement or to study the possible role of this combination in inducing other hormone sensitive cancers, like breast and ovarian cancer. In fact, their success in selling doctors on the combination, led Wyeth to launch Prempro in 1995, which combined Premarin with progesterone.

The earliest studies linking Premarin with breast cancer appeared in early 1980. As Nik Ismail points out in “Hormone Replacement Therapy and Gynaecological Cancers,” between 1975 and 1995, there were at least fifty studies linking estrogen replacement (HRT) with breast and uterine cancer. Some were cross cultural studies revealing that American women had more than ten times the incidence of breast cancer than Asian women, who don’t take estrogen replacement (see http://www.gfmer.ch/Books/bookmp/113.htm).

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 women’s risk of cardiovascular disease proved to be false. In fact this was one of the main reasons the WHI study was stopped: the women in the Premarin/Prempro arm of the study were developing cancer at higher rates – and experiencing significantly more heart attacks, strokes and dementia.

The role of estrogen replacement in reducing osteoporosis is supported by the WHI and other studies. However thus far, no studies have controlled for long term fluoride ingestion (from public water fluoridation schemes) 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, appealing 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.

Menopause: Made in the USA

Historically 80% of Premarin and Prempro sales have occurred in the US. Even in the US, the cessation of menstruation is a non-event in 75% of women, producing no physical symptoms whatsoever. Most cultures have no word for menopause. In Chinese medicine, so-called menopausal symptoms are considered symptomatic of an underlying “imbalance” and disappear following a few days of herbal treatment. Even untreated, the hot flashes, night sweats, mood swings and insomnia some women experience rarely last longer than a few months. Many women report a significant improvement in health and well-being when they stop having periods.

There are interesting cross cultural studies of the “menopause” phenomenon. Non-western cultures typically view the cessation of monthly cycles as a 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 (http://www.ldb.org/menopaus.htm) 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 (contrary to popular misconception, estrogens suppress sex drive, which in women is regulated by testosterone and oxytocin) and improved mood and energy. However most of all they appreciated the new love and respect they enjoyed, as an elder, outside the family. I see this attitude here in New Zealand in the Maori culture, where senior women receive the title of “kuia” or “whaia,” both designating immense esteem, prestige, and influence over community affairs.

As Berger and Wenzel’s and other cross cultural studies show, 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 very effectively on the insecurities these messages create to sell billions of dollars of wrinkle removing creams and lotions, age concealing make-up, hair coloring, botox, diet products and programs and plastic surgery.

Six Decades of False and Misleading Marketing

As revealed in internal documents uncovered in a few of the 5000+ lawsuits cancer victims have filed against Wyeth, the drug 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 – by preventing age-related skin changes.

The result of Wyeth’s public relations effort was to make Premarin was the most commonly prescribed drug in the US in 1992. Yet by the mid-nineties, even the mainstream media was starting to take note of the preponderance of studies linking estrogen replacement to cancer. In 1995 this resulted in a Time magazine article (Wallis, C. “A Risky Elixir of Youth” Time. (26), 46-56, 1995), followed by a Tom Brokaw feature on NBC nightly news.

The NIH Shuts Down the WHI Study

Seventy percent of American women taking estrogen replacement in 2002 stopped when the National Institute of Health shut down the WHI study. This resulted in a 7% decrease in the first year alone of new breast cancer cases – a total of 14,000 women spared the agony of a potentially fatal breast cancer diagnosis (see http://www.theepochtimes.com/n2/content/view/9804/).

Wyeth’s response to all the negative publicity was to initiate yet another 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 (I find this ironic – in 2002 Wyeth was still aggressively promoting Premarin to prevent heart disease). This was followed by articles attacking the study in various medical journals – articles published under the names of doctors specializing in women’s health which were actually ghost written by the company (see http://www.theepochtimes.com/n2/content/view/9804/).

Many of the doctors were affiliated with the notorious Council on Hormone Education at University of Wisconsin (where forty-four of the sixty-four doctors have financial ties to Wyeth) Wyeth founded in response to the 2002 WHI study. In 2006 the Council even began offering a continuing medical education course for doctors called “Quality of Life, Menopausal Changes and Hormonal Therapy” – heavily promoting estrogen replacement.

Consumers’ Only Protection Against Big Pharma

Wyeth’s massive campaign to discredit the 2002 WHI study, at the expense of tens of thousands who would start or continue estrogen replacement as a result of these misguided efforts, has clearly harmed their defense in a few dozen of the 5000+ lawsuits that have made it through the courts.

Wyeth 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:

http://injury-law.freeadvice.com/drug-toxic_chemicals/prempro-lawsuit.htm

Medicalizing the Menstrual Cycle

(May 23, 2011)


In another classic example of drug companies “medicalizing” common complaints with non-medical causes, Eli Lilly has managed to turn premenstrual syndrome (PMS) into a profit-making commodity almost as lucrative as childhood bipolar disorder.

In 1994, the American Psychiatric Association (APA) included premenstrual dysphoric disorder (PMDD) in their diagnostic manual as a “possible mental disorder requiring more research.” Although DSM IV lists PMDD as a strictly ''research'' diagnosis, Eli Lilly immediately seized on it as a genuine disorder and devised a marketing strategy to profit from it.

The Difference Between PMS and PMDD

Approximately 80-90% of women worldwide report physical and emotional changes in the seven to ten days prior to the onset of menstruation. For the majority of women, these consist of minor physical changes similar to those of early pregnancy (water retention, breast swelling and tenderness and abdominal bloating). Approximately one third of women note mental and emotional changes (aka PMS) - depression, anxiety, fatigue, irritability, insomnia, difficulty concentrating - that have a minor impact on their daily functioning. Although the APA has yet to agree PMDD even exists as a disorder, there are numerous claims in psychiatric and women’s health literature that some women with PMS (3-8% of all women) suffer from it. By definition, a woman can only qualify for a PMDD diagnosis if she experiences a ''marked'' decrease in normal functioning due to premenstrual mood changes. A rigorous Swedish study recently ascertained that the true percentage of women experiencing a ''marked'' decrease in functioning before their period closer to 1.3% (http://www.nytimes.com/ref/health/healthguide/esn-pms-ess.html)

A Golden Marketing Opportunity for Eli Lilly

Once the patent on a drug expires, other manufacturers are free to produce much cheaper generic versions of the drug, resulting in plummeting sales of the original brand name drug. Lilly, who was facing the expiration of its patent (in 1999) on Prozac, exploited the inclusion of PMDD in the 1994 DSM IV by re-branding Prozac as a feminine pink and purple tablet called Sarafem. In 2001, the FDA approved Sarafem for ''PMDD,'' on the basis of double blind studies involving several hundred women. Lilly reported a 60% response rate in women who took it for five cycles, with greater effectiveness in women who took it continuously throughout the month (as opposed to 7-10 days before their period).

This high response rate is extremely puzzling, given that thirty years of double blind studies using fluoxetine to treat depression have an average response rate of 38%. In fact statistical analysis of all randomized controlled reveal that the average response rate of all SSRI antidepressants (i.e. Prozac, Zoloft, Paxil, citalopram, etc) is only slightly higher than the placebo rate (33-37%). Moreover as I have written previously (see “Marketing Serotonin Deficiency”), there is absolutely no scientific evidence that serotonin deficiency (the alleged condition SSRI's are prescribed for) actually causes depression.

Skillful Marketing Adds Billions to the US Health Care Bill

Charging three dollars per dose for their pink and purple Sarafem tablets (in contrast to forty-one cents a pill for generic fluoxetine), Lilly launched a massive marketing campaign to convince women they suffered from PMDD. Given the soaring cost of health care in the US (the main reason millions of Americans go without health care), it strikes me both unethical and immoral to trick doctors and women into wasting nearly a billion dollars on pink and purple pills with a fancy name, when generic fluoxetine would have been equally effective at a fraction of the cost. Nevertheless in 2001, the year Serafem came out, nearly 100,000 prescriptions were sold, reaping Lilly $85 million in profits. The high number of prescriptions suggests that doctors prescribed it out indiscriminately for premenstrual complaints, rather than limiting treatment to women with the severe symptoms allegedly associated PMDD.

After Lilly’s phenomenal success, psychiatrists and drug researchers seized on a handful of studies to claim that serotonin deficiency was the cause of PMS. This, in turn, led other SSRI manufacturers to jump on the bandwagon to get their drugs approved for PMDD.

Natural” and “Alternative” Treatments for Premenstrual Syndrome

What I find really fascinating about the PMS/PMDD controversy is that PMS one of the few women’s health “conditions” in which there are more double blind placebo trials of “alternative” or “natural” treatments than medication trials. The three “alternative” treatments that have shown clear effectiveness in randomized controlled trials are omega 3 supplements, megadose Vitamin D and the chaste tree berry.

Omega 3 oil is the most studied in PMS-related mood changes, largely owing to its proven efficacy in depression and large cross cultural studies revealing that populations (for example Asians and Norwegians) who consume large amounts of fish (a primary source of omega 3) have an extremely low incidence of depression.

Vitamin D, though less well studied in PMS, has also proved helpful for depression in double blind studies, especially in elderly depressives, many of whom suffer from documented Vitamin D deficiency. There are a handful of studies showing that 1,000 – 2,000 international units of Vitamin D (with or without calcium) are also helpful in alleviating premenstrual symptoms. I don’t believe this is a coincidence, given Asian women’s extremely low incidence of mood-related PMS. The same oily fish that are a rich source of omega 3 are the only natural food source (as opposed to sunlight exposure) of Vitamin D.

Three double blind studies in the British Medical Journal, the Archives of Gynecology and Obstetrics and the Journal of Women’s Health and Gender-based Medicine reveal that chaste berry helps approximately 52% of women with PMS. Chaste berry is an herbal remedy used by Hippocrates in ancient Greece for pre-menstrual symptoms. It’s believed to work by lowering prolactin (a pituitary hormone influencing milk production). High prolactin levels are a recognized, but infrequent, cause of depression.

Is PMS Really a Nutritional Deficiency?

The obvious question raised by the omega 3 and Vitamin D studies – since both are basic nutrients required for healthy human functioning – is whether PMS is really a nutritional deficiency, rather than a true medical condition. A search of the research literature reveals the question has received little study in conventional medical circles. Although western medicine acknowledges the research proving the effectiveness of omega 3 and vitamin D in alleviating PMS symptoms, doctors persist in talking about “treating” PMS symptoms with these supplements, rather than addressing the likelihood that they address an underlying nutritional deficiency. Western doctors have become so fixated on illness treatment (mainly with drugs) that they tend forget their historic health promotion role. The problem is compounded by the sad reality that most medical research is funded by drug companies, who have absolutely no profit incentive to fund nutrition studies.

The Official FDA Position on Omega 3 Fatty Acids

In 2004 the FDA gave “qualified” approval of the role of omega 3 as an essential nutrient in preventing cardiovascular disease (heart disease and stroke). However for some reason, they still refuse to acknowledge its importance in maintaining healthy immune function, as well as preventing and alleviating arthritis, depression and PMS, schizophrenia, and dermatitis. In contrast, Canadian and European regulatory agencies recognize the role of omega 3 in preventing all these conditions.

Both the American and Canadian Dietetic Association recommend a minimum weekly omega 3 intake of two servings of fish for healthy cardiovascular function. Depression studies suggest somewhat higher consumption (three times a week) is necessary to prevent depression. However dieticians caution against eating more than two servings, owing to contamination of global fish stocks with mercury, lead, nickel, arsenic and cadmium as well as other contaminants (PCBs, furans, dioxins, and PBDEs).

These toxins can be avoided by using fish oil that is independently certified as contaminant free (and carry NSF and NNFA quality seals). Good advice for people who can’t afford or tolerate fish oil is that they stick to small fish at the lower end of the food chain (sardines, anchovies, mackerel and wild salmon), as toxins accumulate at much higher levels in large fish (such as tuna and sword fish). Pregnant women and children under five shouldn’t eat tuna at all, owing to the danger of exposing developing brains to mercury.

The Official FDA Position on Vitamin D

Obviously the FDA acknowledges the role of Vitamin D as a nutrient. Here the controversy is over the minimum daily requirement – with endocrinologists and geriatricians (specialists who work with the elderly) recommending a daily dose of 1,000 IU (1,000 IU equals. 0.025 mg) in summer (when people get more sunlight) and 2,000 IU in winter. Doctors used to believe that the only function of Vitamin D was to enhance calcium absorption. However, it also plays a significant role in central nervous system and immune function, as suggested by studies showing that healthy Vitamin D levels prevent depression, improve immunity, and reduce the incidence of colon, breast and prostate cancer, multiple sclerosis, autoimmune disorder, hypertension, diabetes, schizophrenia and asthma.

Take Home Message: Try Natural Remedies First

In light of all the above studies, common sense would dictate that women who suffer from PMS should try a combination of omega 3 and 1,000-2,000 IU of Vitamin D for a minimum of six months before resorting to either Sarafem or generic fluoxetine. Both have potentially serious long term side effects. Owing to their effect on serotonin receptors in the brain, SSRI’s can be very difficult to stop. Moreover they are associated with a loss of bone density, which increases the risk of osteoporosis and hip fracture, as well as a possible link to breast and ovarian cancer (see http://www.medscape.com/viewarticle/740875).

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