The Me-Too Drug Ripoff

In addition to the billions of health care dollars drug companies waste on disease mongering (see earlier posts), billions more are wasted on developing and marketing hundreds of “me-too” drugs. By definition, a “me-too” or “copycat” drug is a very slight variation of a drug already on the market.

The main downside of me-too drugs that they drive up health care costs  – the exorbitant cost of medical care is the main reason millions of Americans can’t afford a doctor when they’re ill. Other drawbacks of Big Pharma’s fixation with copycat drugs include the neglect of hundreds of potentially treatable illnesses and hundreds of cases of premature death and/or permanent disability related to inadequate safety profiling. Nearly all the major drug recalls in the last few years have involved copycat drugs that were assumed safe because they were chemically similar to medications already on the market.

An Issue First Raised by Ralph Nader

To the best of my recollection, Ralph Nader was the first to raise the issue of “me-too” drugs in his 2000 presidential campaign. Dr Marcia Angell, Harvard Senior Lecturer in Social Medicine, also covers the subject extensively in The Truth About the Drug Companies: How They Deceive Us and What To Do About It (2004) and in “Excess in the pharmaceutical industry” in the Canadian Medical Association Journal

According to Angell, it’s quite common for a drug company to manufacture their own copycat drugs when their patent is about to expire. The idea is to persuade doctors not to opt for cheaper generics when brand named drugs lose their patent protection. She gives the example of AstraZeneca reformulating the ulcer drug Priloxec to bring out Nexium, a nearly identical replacement. The company also shrewdly increased the price of Prilosec to get people to switch.

Three virtually identical cholesterol lowering drugs, Provochol, Zocor and Lipitor were introduced soon after Lipitor (introduced in 2002) became the best selling pharmaceutical in history . The latter was the first statin, a class of drugs that inhibits cholesterol formation in the liver. There are now eight virtually identical statin medications, excluding combination medications that contain it.

Billions Spent on Marketing Identical Drugs

OF all the drugs the FDA approved between 1993 and 2003, 78% were similar to already marketed drugs. Even more shocking, 68% weren’t even new compounds but a reformulation (change from capsule to tablet, short to long acting, etc) or a recombination of existing drugs.

Angell also laments the billions of dollars drug companies spend persuading doctors (and now patients through direct-to-consumer advertising) that their new me-too drug is more effective or safer than the older versions on the market. In most cases, they do this without a shred of scientific evidence. The FDA only requires pre-approval trials to compare me-too drugs to placebo and not to existing medications.

Big Pharma’s View on Me-Too drugs

Pharmaceutical companies want us to believe that me-too drugs enhance health care delivery. They allege that copycat drugs lower prescription costs by increasing competition. They also assert that doctors need a range of back-up drugs when the first-line medication doesn’t work or isn’t tolerated.

The claim about lowering prescription costs is utter rubbish. Copycat drugs are always priced the same or higher than the older drugs they supposedly compete with. And drug companies never, ever market their me-too drugs to doctors or patients on the basis of cost savings. As the price for brand name prescription drugs soars through the roof, only the easy availability of quality generics keeps prescription costs affordable for patients.

To justify the value of providing doctors a range of similar drugs to choose from, drug industry analysts give the example of the numerous copycat SSRIs available for treating depression. In doing so, they claim that some patients who fail to respond to Prozac, may respond to Paxil, Zoloft, Celexa, Priligy, Lexapro, Zelmid, Viibyrd or Upstene.

This is yet another marketing claim unsubstantiated by scientific research. After prescribing SSRIs for 25 years, I, like most of my colleagues, have never found a differential response to different brands. In fact my clinical experience coincides very closely to a recent literature review of SSRI effectiveness. This meta analysis revealed that only 35-38% of patients (only slightly higher than the rate of placebo response) get a positive response to any SSRI. The other 60+% fail to improve or experience horrible side effects.

What the Congressional Budget Office Found

In 2004, Angell could only estimate what drugs companies were spending on marketing, as this is considered proprietary corporate information. However in 2008, the Congressional Budget Office investigated and came up with the following findings:

• Drug companies spent approximately $20.5 billion on promotional activities (10.8% of total revenue) in 2008.
• Drug marketing costs, which grew rapidly between 1988 and 2006 had slowed and had been steady for three years at 10-11%. The CBO felt this was directly related to decreased rate of new drugs coming to market.
• In 2008 drug companies spent only slightly more on promoting new drugs than they did marketing copycat drugs.

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Medicalizing the Menstrual Cycle

I have blogged previously (see Menopause: Made in the USA) about the negative effects of the “corporatization” of health care in the US. “Disease mongering” is a particularly nasty one. This occurs when pharmaceutical companies “medicalize” common conditions in order to market drugs that supposedly treat them.

Thanks to skillful marketing, Eli Lilly has turned premenstrual syndrome (PMS) into a profit-making commodity nearly as lucrative as menopause and “childhood bipolar disorder” (see Drug Companies: Killing Kids for Profit).

In 1994, the American Psychiatric Association (APA) included premenstrual dysphoric disorder (PMDD) in their diagnostic manual “as a possible mental disorder requiring more research.” They have continued the diagnosis in DSM V. 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 7-10 days prior to the onset of menstruation. For most women, these consist of minor physical changes similar to those of early pregnancy (water retention, breast swelling and tenderness and abdominal bloating).

Approximately 1/3 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 approximately 3-8% of women suffer from it. By definition, a woman can only qualify for a PMDD diagnosis if they experience a “marked” decrease in normal functioning due to premenstrual mood changes. A rigorous Swedish study ascertained that the true percentage of women experiencing a “marked” decrease in functioning before their period closer to 1.3%.

A Golden Marketing Opportunity for Eli Lilly

Once the patent on a drug expires, other manufacturers are free to produce cheaper generic versions, resulting in plummeting sales of the original brand name drug. In 1999 Lilly, facing the expiration of its patent on Prozac, exploited the new “diagnosis” of PMDD 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).

Hopefully psychiatrists aren’t quite so gullible as the FDA, given Prozac’s limited effectiveness in treating depression. Thirty years of double blind studies reveal that depressed patients who take Prozac have an average response rate of 38-40%. In fact, statistical analysis of all randomized controlled trials reveal that all SSRI’s (i.e. Prozac, Zoloft, Paxil, citalopram, etc) are only slightly more effective than a placebos, which works 33-37% of the time.

Skillful Marketing Adds Billions to US Health Care Bill

Charging three dollars per dose for their pink and purple Sarafem tablets (in contrast to 41 cents per dose for generic fluoxetine), Lilly launched a massive marketing campaign to convince women they suffered from PMDD. In 2001, the year Serafem came out, nearly 100,000 prescriptions were sold, reaping Lilly $85 million in profits.

Given the soaring cost of health care in the US (the main reason millions of Americans go without medical care), it strikes me as 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 1/9 the cost.

Research Evidence for “Natural” Treatments

What I find really fascinating about the PMS/PMDD controversy is that it’s 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, Vitamin D and the chaste tree berry or chasteberry. In fact, much of this research suggests that PMS-related mood changes may actually represent a nutritional deficiency of omega 3 and/or Vitamin D.

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) consuming large amounts of fish (a primary source of omega 3) in their diets have an extremely low incidence of depression.

Vitamin D, has also proved helpful for depression in double blind studies, especially in elderly depressives suffering from documented Vitamin D deficiency. Other studies show that 1,000 – 2,000 international units of Vitamin D is helpful in alleviating premenstrual symptoms.

This finding correlates with an extremely low incidence of PMS in Asian women. The same oily fish that are a rich source of omega 3 are the only natural food source of Vitamin D (the majority of us derive Vitamin D from exposure to sunlight).

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 chasteberry helps approximately 52% of women with PMS. Chasteberry 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.

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 in later life, and possibly linked to breast and ovarian cancer

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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.

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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.

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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:

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The Multibillion Dollar Depression Industry

(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 first of several posts on “disease mongering” by pharmaceutic companies  – i.e. the invention of fictitious diseases to market drugs that supposedly treat them.) 

Marketing Serotonin Deficiency

With the release of Prozac back in 1987, the pharmaceutical industry began systematically indoctrinating doctors with the theory that depression is caused by a genetic deficiency in a brain neurotransmitter called serotonin. Big Pharma then spent the next 25 years reaping billions of dollars from marketing high-priced SSRIs to treat this so-called deficiency.

There are several obvious flaws in the theory that depression is a genetic brain disorder. The first is the skyrocketing increase in depression and suicide triggered by the 2008 meltdown. The prevalence of a genetic illness should follow the same predictable growth curve as population. The second is the total absence of so-called “serotonin deficiency” in lower mammals. The third and most obvious is the extremely low response rate to SSRIs and other antidepressants. Only 50% of patients who take them ever achieve full recovery.

The Learned Helplessness Model of Depression

The absence of “serotonin deficiency” in lower animals means that depression has to be artificially created to research prospective antidepressants. Most of this animal research is based on the “learned helplessness” model. In a common experiment, mice are dropped into a large vat of water and the researcher times how long they keep swimming before they give up. After taking a dose of Prozac, they swim longer before giving up.

There is something incredibly sad about the drug companies’ persistence in torturing small animals. If the medical profession is serious about addressing the immense suffering caused by the costly and disabling condition, surely they need to start addressing some of the other known causes – for example, nutritional deficiency, derangements in intestinal bacteria and the total degradation of family and community life.

Depression Caused by Poverty and Malnutrition

Doctors have known for half a century that specific nutritional deficiencies can cause depression. Western countries are particularly known for depression-linked deficiencies in omega 3 and Vitamin D. Cross-cultural research shows that Asian and Scandinavian countries consuming quantities of fish (which contains both omega 3 and Vitamin D) have extremely low rates of depression. The phytonutrients found in fresh fruits and vegetables also seem important in preventing depression, though the evidence is less strong.

Owing to recent skyrocketing food costs, I feel a little silly advising low income patients to eat more oily fish and fresh vegetables. I also feel angry and disgusted about a corporate-driven health policy whereby Medicaid, Medicare and Obamacare happily pay for a Prozac prescription (to help their friends at Big Pharma) but not to subsidize fresh, organically grown food for low income patients with obvious nutritional deficiencies.

Depression Caused by Unhealthy Gut Bacteria

Pioneering gastroenterology research suggests that the microbiome (the resident bacteria in our intestines) also plays a major role in brain function. The overuse of antibiotics, in medicine and factory farming, has killed off normal bowel flora in a large segment of the industrialized world. This, in turn, has led to a near epidemic levels of irritable bowel syndrome and inflammatory bowel disease. Surprisingly both conditions have links to arthritis, obesity, autoimmune diseases, and so-called “brain” diseases, such as depression, anxiety, migraines, and even autism.

Recent studies suggest that treating this type of depression can be as simple as taking probiotics or eating fermented foods, such as yoghurt and sauerkraut. Yet because these treatments aren’t medication-based, they aren’t covered by health insurance, Medicare or Medicaid.

Human Misery, Stress and Social Isolation

Obviously the worsening depression, along with epidemic levels of foreclosures, bankruptcies and evictions, is a far bigger culprit than nutritional deficiencies or gut bacteria in the recent exponential increase in depression and suicide. The best way to trigger depression in higher mammals is through massive, unrelenting environmental stress. Surely the pharmaceutical companies know this, or they wouldn’t be using learned helplessness in their animal research, would they?

It’s also striking that the current economic depression has hit people a lot people harder than the Great Depression of the 1930s. This seems to relate to the overall breakdown of family and community life. Prior to World War II, the family and social networks people belonged to exerted a protective effect during stressful times. Human beings, like other primates, such as apes, monkeys and gorillas, are fundamentally social beings. We are all hard wired to have strong social needs and function very poorly when they go unmet.

Recent neurophysiologic research shows that the human brain produces specific “feel good” neurochemicals (e.g. oxytocin, endorphins, and dopamine) to reward people for social activity. Social isolation appears to produce a deficit in these chemicals.

The Absence of Social Needs Research

Research into non-pharmaceutical treatments for depression is unlikely to occur in the US, where Big Pharma oversees the vast majority of medical research. For obvious reasons, drug companies have no incentive to investigate treatments that don’t involve a product they can sell for profit. It hasn’t helped that Obama has slashed research budgets for National Institutes of Health and National Institutes of Mental Health.

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