The Me-Too Drug Ripoff

antipharma

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

pmd

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

big pharma

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

menopause

(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

child taking pill

(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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Mainstreaming Natural Health Care

health care

(This is the 3rd of four posts on the effectiveness of “natural” or “alternative” health care.)

Third Party Coverage

Presently Germany, which has publicly guaranteed health care for all its citizens, is the only country to offer “natural” health care on a par with western medicine. However even in the US, where most health care funding is private, an increasing number of insurance companies offer coverage for “natural” or “alternative” health care. There is usually a requirement these services be offered in conjunction with traditional or “allopathic” care. The jargon used for these mixed mainstream-alternative health models is “complementary” or “integrative” medicine. Most insurance companies require that complementary and alternative medicine (CAM) providers be represented by a professional body with a formal accreditation process. There is also an expectation 1) that the accreditation body will establish clear treatment standards and 2) that all funding will be evidence and outcome-based. In other words, CAM providers must demonstrate a treatment actually works to be eligible for funding.

Some analysts are projecting that insurance coverage for natural health care will be even easier to access under Obamacare – at least for patients who can afford the higher premiums of silver, gold, and platinum plans. The uninsured and patients locked into Medicaid or bare bones bronze plans will be out of luck.

Natural Health Databases

The requirement for natural health services to be “evidence based” has led to the creation of a number of natural health research databases. Three of the most popular are the Mayo Clinic Alternative Medicine database, the NIH Complementary and Alternative Medicine database, and the Cochrane Complementary Medicine database.

The Mayo Clinic is a world famous “mainstream” medical center in Minnesota. Their database is by far the most comprehensive and user-friendly. The following statement on their home page summarises their philosophy:

“Exactly what’s considered complementary and alternative changes constantly as treatments undergo testing and move into the mainstream.”

The site provides up-to-date research summaries on a broad range of alternative treatment approaches. For example, here is what they have to say about aromatherapy:

Research on the effectiveness of aromatherapy — the therapeutic use of essential oils extracted from plants — is limited. However, some studies have shown that aromatherapy might have health benefits, including:

  • Relief from anxiety and depression
  • Improved quality of life, particularly for people who have chronic health conditions

Essential oils used in aromatherapy are typically extracted from various parts of plants and then distilled. The highly concentrated oils may be inhaled directly or indirectly or applied to the skin through massage, lotions or bath salts. Aromatherapy is thought to work by stimulating smell receptors in the nose, which then send messages through the nervous system to the limbic system — the part of the brain that controls emotions.

Many essential oils have been shown to be safe when used as directed. However, essential oils used in aromatherapy aren’t regulated by the Food and Drug Administration. When applied to the skin, side effects may include allergic reactions, skin irritation and sun sensitivity. In addition, further research is needed to determine how essential oils might affect children and how the oils might affect women who are pregnant or breast-feeding, as well as how the oils might interact with medications and other treatments.

I find the NIH and Cochrane databases less helpful. Both seem quite biased towards mainstream medicine and randomized controlled trials (RCTs). Many alternative treatment methods don’t lend themselves to RCTs because it’s virtually impossible to provide “sham” treatment (e.g. sham acupuncture, cupping, or aromotherapy) for the placebo group. Both NIH and Cochrane ignore the abundance of crossover design CAM studies in which the patient serves as their own control. In these studies, treatment is withdrawn once a clear response is established. It’s then reintroduced when symptoms recur.

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How Natural Health Care Affects Genes

yoga yoga

 (This is the 2nd of 4 posts regarding the effectiveness of “natural” or “alternative” health care.)

The Wall Street Journal article I mentioned in my last post also mentions other research into the mechanism by which plant-based diets, yoga, and meditation halt or even reverse the progression of prostate cancer, heart disease, diabetes, hypertension, and other chronic conditions. One study, published in the Proceedings of the National Academy of Science, provides evidence that only a few months of similar “natural” treatments permanently alters gene expression. It describes how genes associated with cancer, heart disease, and inflammation were downregulated or “turned off,” while protective genes were upregulated or “turned on.” Another study published in The Lancet Oncology reported that these changes also increased telomerase, the enzyme that lengthens the telomeres at the ends of our chromosomes. Telomeres control how long we live. No prescription medication has ever been shown to do this.

Popularity of Natural Health Care

A recent Discovery Channel special revealed that 40% of Americans employ use some form of “natural” medicine. At their website, they list the ten most common, in order of popularity, along with general comments about documented benefits and potential risks:

1. Natural supplements and herbal medicines – benefits best supported by research evidence include omega 3 for heart disease, arthritis, and depression; garlic for cholesterol reduction; and ginseng for heart disease. In the US, quality control can be a major issue with natural and herbal supplements, as they aren’t regulated and may contain heavy metals and other toxins. In New Zealand, the Natural Health and Supplementary Products Bill (awaiting its third reading) would establish standards for quality, strength, and purity.

2. Acupuncture – has the strongest evidence base, not only for pain relief, but to improve immunity and alleviate a range of chronic conditions. These are summarised in a recent  World Health Organisation report. Some of the most common conditions that respond to acupuncture include rhinitis* (works better than antihistamines), sinusitis, asthma, irritable syndrome, hypertension, obesity, high cholesterol, menstrual cramps, migraine, menopausal symptoms, and stroke recovery (restores limb function).

3. Spinal manipulation (chiropractic) – also has a growing evidence base of effectiveness in chronic pain and other chronic illnesses.

4. Meditation – research supports effectiveness in treatment of anxiety, depression, and chronic pain.

5. Therapeutic massage – strong evidence base for therapeutic benefit in cancer, HIV, fibromyalgia, and other chronic pain conditions.

6. Ayurveda – an ancient Indian method of healing which shows promise as a way to boost memory and focus, though research into this approach is extremely limited. Some supplements used in this approach can contain heavy metals or cause dangerous interactions with prescription medication.

7. Guided imagery – demonstrated effectiveness in depression, anxiety, and pain.

8. Yoga – studies show that regular yoga practice reduces stress, eases depression, helps control high blood pressure and diabetes symptoms, helps reduce inflammation and asthma symptoms, reduce back pain, and improve heart function.

9. Hypnosis –  shows promise for stress relief, pain management, headaches, dental pain and childbirth.

10. Homeopathy – very limited research base because the individualized treatments used make it hard to generate meaningful statistics.

*runny nose

To be continued.

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Natural Health Care: the Research Evidence

acupuncture

Politics Masquerading as Science

(This is the 1st of four posts on the effectiveness of “natural” or “alternative” health care.)

I find it ironic how eager mainstream doctors are to condemn natural health treatments for not being “evidence-based.” Especially when Western medicine can produce little or no scientific evidence regarding the long term effectiveness and safety of many of their treatments. This is particularly true of heart surgery and immunization protocols. We operate on hearts and vaccinate kids for reasons that have nothing to do with scientific evidence. At the same time, we hold “natural” or “alternative” health providers to a much higher standard of proof. This is for complex political reasons that have given organized medicine and Big Pharma a virtual monopoly over health and healing. It has nothing to do with science.

The Myth of Evidence-Based Medicine

Doctors seem to forget that most common Western remedies were incorporated into the medical armamentarium centuries ago without any “proof” whatsoever of their effectiveness or safety. There were no randomized controlled trials when doctors began using digitalis for heart failure, morphine for pain, or sudafed for nasal congestion. All, like many other drugs, are plant-based treatments* originally used by midwives and herbalists (women the Catholic Church condemned as “witches”).

It was only when pharmaceutical companies began to develop synthetics substitutes that drugs were subjected to randomized control trials. Likewise, the long term outcome of many surgical interventions is never studied before they are rushed into the marketplace. A recent Wall Street Journal article examines the cost effectiveness of two common cardiac procedures – coronary angioplasty and coronary bypass surgery.

According to the article, in 2006 American surgeons performed 1.3 million coronary angioplasties at an average cost of $48,399 each – at a total cost of more than $60 billion. The same year they performed 448,000 coronary bypass operations at a cost of $99,743 each – at a total of more than $44 billion.

Despite these costs, a randomized controlled trial published in the New England Journal of Medicine found that angioplasties and stents don’t prolong life or even prevent heart attacks in stable patients (i.e. 95% of patients who receive them). Likewise coronary bypass surgery prolongs life in less than 3% of cases.

The Bias Against Natural Health Care

The authors ask:  Why do Medicare and health insurance companies pay billions of dollars for dangerous, expensive, and largely ineffective heart surgeries – yet balk at paying for “natural” approaches that have proven to reverse and prevent the chronic diseases that account for at least 75% of health care costs (INTERHEART study, The Lancet, Sept 2004)?

Good question.

*Below are just a few common medicines based on ancient plant-based treatments:

  • Aspirin
  • Atropine
  • Curare
  • Theobromine
  • Taxo
  • Scopolamine
  • Reserpine
  • Quinjidine
  • Quinine
  • Papavarine
  • Physostigmine
  • Papain
  • L-dopa
  • Hyoscyamine

(To be continued.)

 

photo credit: SuperFantastic via photopin cc

Intestinal Bacteria and Chronic Illness

bacteria

(This is the second of 2 posts about a possible link between intestinal bacteria, obesity, and other chronic illnesses.)

The most enlightening article I’ve seen about micrbiota (gut bacteria) research is an April 2013 article from Mother Jones. It explores the possibility that insulin resistance (see previous post) is actually an “inflammatory” process caused by the production of “endotoxin” by unhealthy gut bacteria.

The Major Health Implications of Dysbiosis

Owing to a doubling of obesity rates since 1980, this strikes me as a reasonable hypothesis. The mass marketing of antibiotics by Big Pharma, Food Inc (in livestock feed), and Monsanto (in genetically modified organisms) has led to epidemic levels of dysbiosis (a derangement in gut bacteria) in the industrialized world. In addition to skyrocketing obesity rates, the developed world has also experienced a significant increase in other dysbiosis-related conditions, including cancer, diabetes, and degenerative and autoimmune disease. It would also explain why children born to obese mothers (we acquire gut bacteria from our mothers) are more likely to suffer from asthma, attention deficit disorder, and autism.

The article cites research from the University of Washington showing that foods high in saturated fats and sugar promote the growth of endotoxin-producing inflammatory bacteria. Endotoxin, in turn, causes inflammatory damage to the the hypothalamus, the brain’s appetite center. When this occurs, people lose the ability to feel full and eat to excess.

The Mother Jones article also references studies in which volunteers improved their insulin sensitivity, as well as losing weight, by reducing their level of “inflammatory” bacteria. They accomplished this by consuming diets rich in fermented foods containing healthy, anti-inflammatory bacteria.

Most interesting of all are studies showing that bariatric (weight loss) surgery helps some patients and not others depending on their ability to grow a healthier microbiota (gut bacteria colony) following their procedure.

The Care and Feeding of Intestinal Bacteria

After suffering a sudden onset of so-called “irritable bowel” syndrome 20 years ago, I have a strong personal interest in dysbiosis. The Sydney GI specialist I consulted says the only effective treatment for most IBS sufferers is to re-establish a healthy microbiota.

The end of the article offers a number of suggestions how to accomplish this. The bottom line is to consume a diet rich in 1) fermented foods with live bacterial cultures and 2) complex carbohydrate and fiber-rich foods these organisms thrive on. Studies show that treatment with whole foods is always preferable to taking probiotics. Fermented foods contain literally thousands of strains of bacteria that work collaboratively with one another. Probiotic capsules, in contrast, contain a dozen strains at most and are likely to be destroyed by stomach acid

Examples of helpful fermented foods include sauerkraut (only if it’s made via fermentation), miso (fermented soybean paste), kefir (a fermented drink), and some yoghurts. To ensure the bacterial cultures are live, it’s best to ferment these foods yourself or get them from a reliable health food store. It’s also essential to check the label to make sure they aren’t pasteurized (pasteurization kills bacteria).

The foods these bacteria like to munch on include onions, garlic, potatoes, bananas, yams, apples, oranges, whole grains, Jerusalem artichokes, legumes and cruciferous vegetables (cabbage, broccoli, and cauliflower).

Looking after the new bacteria in my intestine is almost like having a new pet to care for. I can already tell from my symptoms which foods they really like: yam, cooked apples, and avocado. Luckily I’m pretty keen on them myself.

photo credit: www.cihr-irsc.gc.ca via photopin cc