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big pharma cartoonA new report due to be published in the May issue of the American Journal of Psychiatry shows that antidepressants aren’t all they’re cracked up to be.

But, faithful readers, you already knew that. Right?

The report is part of the National Institute of Mental Health-funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project – the largest study of the treatment of depression conducted in the United States. It showed that findings from clinical studies used to gain FDA approval of antidepressants are not applicable to most patients with depression.

Researchers at the University of Pittsburgh Graduate School of Public Health compared symptoms and outcomes in depressed patients who met phase III study inclusion criteria to those who did not. Phase III studies for antidepressants determine the effectiveness of the drug in comparison to a placebo.

The inclusion criteria for these studies aren’t standardized or subject to any federal guidelines. Typically this means that patients with milder forms of depression, chronic depression, or other psychiatric or medical conditions in addition to short-term depression are excluded from studies.

In other words, the majority of “real world” patients with depression who end up taking antidepressants are excluded from clinical studies. It should be obvious why this is a problem. In a normal, clinical setting many patients with depression do also have other illnesses, such as diabetes, chronic fatigue syndrome or irritable bowel syndrome (IBS). It’s not unusual for them to have anxiety and insomnia, as well. In fact, it wouldn’t be presumptuous to expect that a depressed person might be suffering from a number of conditions that are either contributing to or caused by their illness.

Yet the only people that “qualify” for the clinical trials which determine whether antidepressants get approved by the FDA are those with short-term depression, no history of depression, no other psychiatric conditions such as anxiety, and no physical illnesses like heart disease or diabetes. This is the only subgroup of the general population for which we have any data on the efficacy of antidepressants.

By the same token, this means is that we have almost no clinical data on how antidepressants work for the “real world” patients who are most likely to be taking them. Indeed, after assessing 2,855 patients treated with citalopram (Celexa), the study authors found that fewer than one in four, or 22.2%, of the patients met the usual criteria for inclusion in phase III clinical trials.

According to study lead author, Stephen Wisniewski, Ph.D., professor of epidemiology and co-director of the Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health, “This raises major concerns about whether results from traditional phase III studies can be generalized to most people with depression, who also often suffer from anxiety, substance abuse and other medical and psychiatric problems.”

When Wisniewski and his colleagues looked at the efficacy of antidepressants in those who did not meet phase III inclusion criteria – meaning the majority of people who take the drugs in real life – they found that their outcomes were much worse than those who did qualify for the trials. The depression remission rate in the patients who met the criteria was 34.4 percent, compared to only 24.7 percent in the ineligible group.

So, here’s the bottom line: antidepressants are nowhere near as effective as research suggests.

And that is really bad news for the drug companies, because research already suggests that antidepressants aren’t very effective at all. In fact, as I explained in a previous article, antidepressants are no more effective than placebo for most people. If antidepressants are no more effective than placebo in the patients that do meet phase III criteria, and we know that antidepressants are less effective for patients who don’t meet phase III criteria (the vast majority of “real world” depression patients), then couldn’t we assume that antidepressants are less effective than placebo for most patients?

Yes, we could.

For more information on this topic, check out this index of my articles (as well as selected off-site resources) on depression and antidepressants.

bandaidDrugs comprise the major treatment modality of scientific medicine. A recent article in the New York Times revealed that over half of Americans regularly take prescription drugs for chronic health problems. Sadly, many people don’t realize that the drugs they’re taking could be making their condition worse.

Most drugs don’t cure illness. They just suppress symptoms. Unfortunately, drugs also suppress functions. Though drugs provide symptom relief in the short term, over time they may worsen the underlying condition because they interfere with our body’s self-healing mechanisms. For example, many people take ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) to cope with arthritis and inflammatory conditions. While NSAIDs are effective in reducing pain and inflammation in the short-term, they are also known to reduce blood flow to cartilage. Since blood carries all of the nutrients and immune substance necessary for tissue repair, NSAIDs can actually worsen the original problem when taken chronically.

The second problem is that, by definition, drugs correct a specific imbalance by causing at least one other and often several other imbalances. When a drug is introduced into the body to address a malfunction in one biochemical pathway, that drug inevitably interacts with many other pathways.

The mapping of these pathways in recent genetic research underscores the danger of pharmaceutical drugs. The diagram below shows the interactions among a small set of cellular proteins found in a fruit fly. Proteins encased in ovals are grouped according to specific pathway functions. Connecting lines indicate protein-protein interactions. Protein interconnections among the different pathways reveal how interfering with one protein may produce profound “side effects” upon other related pathways.1

protein map
Complicating the phenomenon of so-called “side effects” is that biological systems are redundant. The same protein molecule may be used in several different systems of the body, but it has a completely different function in each of them.

Histamine is a perfect example of this. Histamine is a chemical that initiates the cell’s stress response. When histamine is present in the bloodstream of the arms and legs, it starts a local inflammatory reaction in those tissues. But if histamine is present in the blood vessels of the brain, it enhances the growth and function of specialized neurons there.

One of the most amazing features of the body’s signaling system is its specificity. When you have a poison oak rash on your arm, histamine is released in that specific area only to activate an inflammatory response to the allergen. Likewise, if you’re under significant stress, histamine is released only in the brain to enhance the function of neurons.

Unfortunately, pharmaceutical drugs have no such specificity. When you take an antihistamine to deal with the itchiness of an allergic rash, the drug is distributed systemically. It affects histamine receptors wherever they are located throughout the whole body. So, while the antihistamine will curb the blood vessels’ inflammatory response and reduce the allergic symptoms of the rash, it will also enter the brain and affect nerve function – which causes drowsiness.

The recent hormone replacement therapy (HRT) debacle is a tragic example of the inherent risks of pharmaceutical drugs.  Estrogen is best known for its function on the female reproductive system.  However, more recent studies have shown that estrogen also plays an important role in the normal function of blood vessels, the heart and the brain.  That ‘s why synthetic estrogen hormones that were prescribed to alleviate menopausal symptoms ended up causing cardiovascular disease and neural dysfunctions such as strokes.

No matter how “targeted” drugs are, they are still relatively crude, blunt instruments when compared to the body’s highly sophisticated immune system. Prescription drugs are are much more like sledgehammers or shotguns than the “magic bullets” they are made out to be.

In the next article, we’ll take a closer look at the consequences of side effects caused by prescription drugs. Until then, I welcome your questions and comments!

  1. Lipton, B. H. (2008). The Biology of Belief: Unleashing the Power of Consciousness, Matter, & Miracles (illustrated edition.). Hay House.

failureThe U.S. spent 16 percent of its Gross Domestic Product (GDP) – a cool $2 trillion – on health care in 2005.1 Considering this enormous expenditure, we should have the best medicine in the world. We should be reversing disease, preventing disease, and doing minimal harm. However, careful and objective review shows the opposite.

The U.S. ranks just 34th in the world in life expectancy and 29th for infant mortality. Of 13 countries in a recent comparison, the United States ranks an average of 12th (second from bottom) for 16 available health indicators.2

40 million people in this country do not have health insurance. The exorbitant cost of health care seems to be tolerated based on the assumption that better health results from more expensive care, despite studies that as many as 20% to 30% of patients receive contraindicated care.3

Even worse, a recent study by Dr. Barbara Starfield published in 2000 in the prestigious Journal of the American Medical Association demonstrated that iatrogenic incidents (events caused by medical intervention) are the 3rd leading cause of death in this country, causing more than 250,000 deaths per year. Only heart disease and cancer kill more people.

Dr. Starfield estimates that, each year, medical errors and adverse effects of the health care system are responsible for:

  • 116 million extra physician visits
  • 77 million extra prescriptions
  • 17 million emergency department visits
  • 8 million hospitalizations
  • 3 million long-term admissions
  • 199,000 additional deaths
  • $77 billion in extra costs

As grim as they are, these statistics are likely to be seriously underestimated as only about 5 to 20% of iatrogenic incidents are even recordedanalyses which have taken these oversights into consideration estimate that medical care is in fact the leading cause of death in the U.S. each year.

Starfield believes that a major contributor to the poor performance of the United States on health indicators is the high degree of income inequality in this country. Countless studies in the medical literature document the adverse effects of low socioeconomic position on health. New research suggests the adverse effects not only of low social position but, especially, low relative social position in industrialized countries.6

Perhaps the words “health care” have given us the illusion that medicine is about health. In fact, western medicine is not a purveyor of healthcare but of disease-care. When the number one killer in a society is the health care system, that system has no excuse except to address its own urgent shortcomings. Unfortunately, until this happens partaking in allopathic medicine itself is one of the highest causes of death as well as one of the most expensive ways to die.

  1. Park, A. America’s Health Check Up. 11/20/2008. Time Magazine Online.
  2. Starfield B. Primary Care: Balancing Health Needs, Services, and Technology. New York, NY: Oxford University Press; 1998.
  3. Schuster M, McGlynn E, Brook R. How good is the quality of health care in the United States? Milbank Q. 1998;76:517-563
  4. Leape LL. Error in medicine. JAMA . 1994 Dec 21;272(23):1851-7.
  5. injuryboard.com. General Accounting Office study sheds light on nursing home abuse. July 17, 2003 . Available at: http://www.injuryboard.com/view.cfm/Article=3005. Accessed December 17, 2003
  6. Wilkinson R. Unhealthy Societies: The Afflictions of Inequality. London, England: Routledge; 1996.

devolutionResearch by an Iowa State University scientist due to be published this month in the journal Proceedings of the National Academy of Sciences indicates that cholesterol-lowering drugs (statins) may lessen brain function.

The results of the study show that drugs that inhibit the liver from making cholesterol may also keep the brain from making cholesterol, which is vital to efficient brain function.

“If you deprive cholesterol from the brain, then you directly affect the machinery that triggers the release of neurotransmitters,”, said Yeon-Kyun Shin, the lead researcher. “Neurotransmitters affect the data-processing and memory functions. In other words – how smart you are and how well you remember things.”

Cholesterol is abundant in the tissue of the brain and nervous system. Myelin, which covers nerve axons to help conduct the electrical impulses that make movement, sensation, thinking, learning, and remembering possible, is over one fifth cholesterol by weight. Even though the brain only makes up 2% of the body’s weight, it contains 25% of its cholesterol.

We now know that the formation of synapses, or connections between neurons, is directly dependent on the availability of cholesterol.

The formation of these synapses are what give us the ability to remember and learn. The benefits of sleep for memory formation and learning are in part a result of increased cholesterol synthesis during sleep.

“If you try to lower the cholesterol by taking medicine that is attacking the machinery of cholesterol synthesis in the liver, that medicine goes to the brain too. And then it reduces the synthesis of cholesterol which is necessary in the brain,” said Shin.

This study is yet another strike against statin drugs, which have numerous side effects and are not effective in reducing mortality for the vast majority of the population. Please see my recent article, The Truth About Statin Drugs, for more on why statins are probably not a good idea for you and your loved ones.

person sleepingIn Part I and Part II of this series, we examined drug-free alternatives to treating depression including exercise, psychotherapy, light therapy, St. John’s Wort and acupuncture. We have learned that all of these treatments are at least as effective as antidepressants in the short term, and some (exercise and psychotherapy) are more effective in the long-term. All of these treatments have far fewer side effects, risks and complications than antidepressants. In fact, the only “side effects” of exercise and psychotherapy are positive ones: improved physiological and mental health!

Today we will look at other lifestyle-based approaches to treating depression without drugs. As I mentioned in the previous article, because 70% of research is funded by drug companies, many of these non-drug approaches have not been studied as extensively as antidepressant medication.

Nevertheless, there is enough data from clinical and epidemiological studies to support the following strategies – especially since they are superior to antidepressants from a “cost/risk – benefit” analysis. In other words, though some of the approaches I will propose in this article have not been exhaustively proven according to the standards of Western science, there are several lines of evidence supporting their effectiveness and without exception they have beneficial side effects and improve the quality of patient’s lives.

What’s more, all of these approaches can be combined together along with the treatments mentioned in the two previous articles to obtain the maximum effect. Based on the available evidence which we have extensively reviewed, these non-drug treatments should without a doubt be the first line of defense (as well as the second, third, fourth, etc.) in treating depression.

Nutrition

At some point in the future, I hope to dedicate an entire post (or perhaps more) to the subject of nutrition and depression. I personally believe that inadequate nutrition is a significant contributing factor to the continuously rising rates of depression in this country. Consequently, I also believe that proper nutrition can be one of the most effective treatments for depression.

For now, I will go over what I feel are the most important aspects of nutritional causes and treatment of depression, and hopefully address the subject in more detail later.

SUGAR

Diabetes is correlated with higher rates of depression. In 2005, researchers discovered a positive connection between higher levels of insulin resistance and severity of depressive symptoms in patients with impaired glucose tolerance, before the occurrence of diabetes. Based on these findings, it was suggested that insulin resistance could be the result of an increased release of counter-regulatory hormones linked to depression; however, this has not been confirmed.

Sugar can increase fasting levels of glucose and can cause reactive hypoglycemia. Sugar can also cause a decrease in your insulin sensitivity thereby causing an abnormally high insulin levels and eventually diabetes. Based on the study results above, this is one mechanism by which sugar could contribute to depression.

There is no doubt that increased sugar intake leads to hormonal changes that can lead to emotional instability. Therefore, people who are depressed (and all people, in fact) should significantly decrease their sugar consumption.

OMEGA-6 / OMEGA-3 RATIO

Anthropological evidence suggests that the intake of omega-6 (n-6) and omega-3 (n-3) polyunsaturated fatty acids (PUFA) during the Paleolithic era was roughly equal, whereas the present n-6 to n-3 PUFA in western countries has ben estimated to be between 10 and 25 to 1. The n-6 to n-3 PUFA imbalance has been due mainly to the increase in vegetable and seed oil use and the rise in consumption of processed foods (which contain these oils).

Two major studies have provided direct evidence for the role of the n-6 to n-3 PUFA ratio in depression. The studies found that depression is associated with significantly decreased total n-3 PUFA and increased n-6 to n-3 PUFA ratio (Maes et al. 1996; Maes et al. 1999) . A supporting study carried out in 1998 also found a significant depletion in total n-3 PUFA, and in particular DHA, in the erythrocyte membranes of depressed patients.

Epidemiological data show the trend in decreasing dietary n-3 PUFA consumption and the increasing evidence of depression, both over time and between nations (Hibbeln et al. 1995). Further investigation suggests that the significance lies in the increase in n-6 to n-3 ratio, rather than simply low n-3 intake alone, as these two fatty acids compete in binding to enzyme systems that produce chain elongation and further desaturation. A diet high in n-6 fatty acids prevents the incorporation of n-3 PUFA into cell membranes and phospholipids (Spector et al. 1985).

All polyunsaturated fatty acids – including n-3 PUFA – have been shown to make lipoproteins more vulnerable to oxidative damage (Reaven et al. 1991), and oxidative damage is a significant risk factor for heart disease, cancer and many other conditions. As mentioned above, n-6 consumption actually prevents the incorporation of n-3 into our cells. Therefore, rather than increasing our consumption of n-3 PUFA to treat depression, as is often suggested, it makes more sense to dramatically decrease our consumption of n-6 PUFA. This will help our bodies to incorporate the small, but adequate amount of n-3 PUFA we get in a whole-foods based diet. Avoiding n-6 PUFA (primarily found in vegetable and seed oils, and in animals fed vegetables high in n-6 like pigs and chickens) will not only alleviate depression, but also benefit our health in many other ways.

VITAMIN D

In a 1998 controlled experiment, Australian researchers found that vitamin D (400 and 800 IU), significantly enhanced positive affect when given to healthy individuals. Forty-four subjects were given 400 IU cholecalciferol, 800 IU cholecalciferol, or placebo for 5 days during late winter in a random double-blind study. Results on a self-report measure showed that vitamin D3 enhanced positive affect a full standard deviation and there was some evidence of a reduction in negative affect. The authors concluded: “vitamin D3 deficiency provides a compelling and parsimonious explanation for seasonal variations in mood” (Landsdowne & Provost, 1998).

In another study in 1999, the vitamin D scientist, Bruce Hollis, teamed up with Michael Gloth and Wasif Alam to find that 100,000 IU of vitamin D given as a one time oral dose improved depression scales better than light therapy in a small group of patients with seasonal affective disorder. All subjects in the vitamin D group improved in all measures and, more importantly, improvement in 25(OH)D levels levels was significantly associated with the degree of improvement (Gloth et al. 1999).

According to the Vitamin D Council:

To further strengthen the case that vitamin D deficiency causes some cases of depression, evidence should exist that the incidence of depression has increased over the last century. During that time, humans have reduced their sunlight exposure via urbanization (tall buildings and pollution reduce UVB ), industrialization (working inside reduces UVB exposure), cars (glass totally blocks UVB), clothes (even light clothing blocks UVB), sunblock and misguided medical advice to never let sunlight strike you unprotected skin.All these factors contribute to reduce circulating 25(OH)D levels.

Klerman and Weissman’s claim that major depression has increased dramatically over the last 80 years is one of the most famous (and controversial) findings in modern psychiatry. Something called recall bias (a type of selective remembering) may explain some of the reported increase, but does it explain it all?

If you suffer from depression, get your 25(OH)D level checked and, if it is lower than 35 ng/mL (87 nM/L), you are vitamin D deficient and should begin treatment. If you are not depressed, get your 25(OH)D level checked anyway. If it is lower than 35 ng/mL (87 nM/L), you are vitamin D deficient and should begin treatment.

Recommended intake is up to 5,000 IU per day of vitamin D through exposure to sunshine and/or supplementation. See this article on vitamin D to learn to calculate how much vitamin D is produced given a certain amount of exposure to sunlight, and to learn more about vitamin D supplementation. It is important to remember that D works synergistically with A & K2, so if you increase your intake of D you must also increase your intake of A & K2 to avoid D toxicity.

Finally, I’d like to share with you a comment I received from a reader about how he/she has cured depression with nutritional intervention. Note that I endorse just about every suggested step, with the exception of the significant increase in n-3 intake. Based on the evidence above, I suspect that his/her improvement was a result of the decrease in n-6 PUFA more than it was the increase in n-3 PUFA.

I suffered from depression, for many years–it was so bad that often I thought that the only answer for my life would be to end it. Thoughts of suicide danced through my mind frequently.

Early March 2008 I changed my diet completely:

–eliminated all processed foods

–eliminated all white foods; most important, eliminated sugar, which is the “white devil”

–eliminated all foods containing soy and corn; so I don’t eat the meat of animals that have been fed grains

–two years prior to March 2008 I stopped drinking sodas/soft drinks

–only meats that have been traditionally raised; meat from ruminants that have been grass fed; chickens that have been pastured (I get them with the head and feet); meat from pigs that have not been raised in confinement (I know the people who “produce” the pork that I eat–they feed their pigs food that is in season and local, and they allow their pigs to be pigs, and never slaughter them before their time)

–eliminated all the bad fats

–added good fats: coconut oil, palm kernel oil, [raw] butter from grass fed cows, lard (from the pigs described above), beef bone marrow fat (from grass fed and pastured cows), olive oil

–eat a tin of sardines (with the skin and bones) weekly

–eat wild Alaskan salmon weekly

–cut out grains; although, occassionally, I have a jones for those carbs, so I’ll eat some brown rice; sometimes I’ll have a bowl of steel-cut oats, which I have soaked overnight, and when I eat it, I add lots of butter and raw cream to it

–stopped eating out; I cook all of the meals that I eat

–only eat raw milk cheeses

–eggs from hens that have been pastured

–drink this mixture daily: raw milk, raw cream, 4-6 raw egg yolks, some unsulphured organic blackstrap molasses

–daily supplements of: cod liver oil, evening primrose oil, wheat germ oil, kelp powder, dessicated liver

–vegetables and fruit

–drink only when thirsty

–stopped wearing sunblock/sunscreen lotions; get out in the sun daily for 20-plus minutes

–exercise daily; I ride my bike everywhere (I live in San Francisco) or I walk

Following the reader’s advice will not only relieve depression, it will dramatically improve all aspects of your physical, emotional and mental health.

Adequate sleep and rest

Recent studies have definitively linked insomnia with depression and increased suicidal behavior. A research abstract that was presented on June 12 at SLEEP 2008, the annual meeting of the Associated Professional Sleep Societies, found a link between poor sleep and suicidal behavior among children and adolescents with depressive episodes. 83.8% of the depressed patients in the study had sleep disturbances, and there was a significant association between suicidal behavior and the presence of sleep complaints.

Another recent study confirmed the persistent nature of insomnia and the increased risk of subsequent depression among individuals with insomnia. According to the study, 17% – 50% of subjects with insomnia lasting just two weeks or longer developed a major depressive episode reported in a later interview.

Other research has indicated that insomnia can cause depressed mood and adversely affect endocrine function (Banks 2007).

Most Americans are chronically sleep deprived. The foundation’s 2001 national “Sleep in America” poll reported that almost seven out of 10 Americans experienced frequent sleep problems, and that most were undiagnosed. The same poll in 2003 found that 67 percent of older adults had frequent sleep problems and only one in eight had been diagnosed.

This alone could explain the epidemic increase in depression over the last several decades. But when sleep deprivation is added to other factors such as increased intake of n-6 PUFA, increased stress, the use of antidepressant drugs, the breakdown of family, community and other social support structures, it isn’t difficult at all to understand why so many of us are depressed.

The American Academy of Sleep Medicine (AASM) offers the following tips on how to get a good night’s sleep:

  • Follow a consistent bedtime routine.
  • Establish a relaxing setting at bedtime.
  • Get a full night’s sleep every night.
  • Avoid foods or drinks that contain caffeine, as well as any medicine that has a stimulant, prior to bedtime.
  • Keep computers and TVs out of the bedroom.
  • Do not go to bed hungry, but don’t eat a big meal before bedtime either.
  • Avoid any rigorous exercise within six hours of your bedtime.
  • Make your bedroom quiet, dark and a little bit cool.
  • Get up at the same time every morning.

Stress Management

An increasing amount of evidence (along with common sense) indicates that chronic stress directly contributes to depression. Please see my recent article for more information about this.

I am not aware of any well-designed clinical trials examining the effects of stress reduction on depression. However, logic dictates that since stress is a cause of and contributing factor to depression, managing stress is an important aspect of treating depression.

One study published in 1995 showed that meditation can improve mood. Another small study demonstrated that mindfulness-based cognitive therapy (MBCT) significantly improved depression and reduced relapse. A series of studies and case studies have shown that biofeedback can also be effective for depression and mood disorders.

The reality is that there are many ways to manage and reduce stress, from yoga to meditation to mindfulness-based stress reduction to progressive relaxation techniques. The important thing is not which method you choose, but that you commit to something and do it on a regular basis.

Prayer & Spiritual Practice

You’re not going to see much scientific research into the role of prayer and spiritual practice in treating depression. Nevertheless, for as long as people have been “depressed” they have used their relationship with God, nature, a “higher power” or whatever guiding principles they embrace to get through difficult times.

People who are depressed often feel isolated, alienated or alone. A strong faith in God or in the interconnectedness of all life can re-establish a sense of belonging and support. Prayer and spirituality can also re-frame the depression one is experiencing in a larger and less “personal” context.

In my previous article called The Heart of Depression, we examined how cultural, religious and spiritual beliefs in these traditional societies provide a context in which symptoms of depression and other mental illness can be understood outside of the label of medical disease or pathology. Possession and rites of passage are two examples of such contexts.

The words and labels we use to “frame” our experience have tremendous power. In the U.S. today, depression is viewed as a sickness that must be cured, as a pathology, as a “biological disease”. There is little doubt that the people who seek treatment for depression are suffering. But should psychological and emotional suffering always be viewed as “something to get rid of”?

Great religious and spiritual traditions from around the world view suffering as an avenue to greater understanding of oneself, life and God. Suffering can be viewed as a signal drawing our attention to issues in our life that need to be addressed.

Spirituality and prayer can help people who are suffering to understand their experience in a more empowering and self-validating context than what is offered by mainstream medicine. When one views their suffering as an opportunity for growth and evolution, rather than as a disease requiring treatment with drugs, it is far more likely that lasting, positive change will occur.

In the next and final article (for a while, at least) in my series on depression and antidepressants, I will summarize everything we’ve covered so far and offer my recommendations for treating depression holistically.

bicyclistThe most widely prescribed drugs in the U.S. are not for pain management, cholesterol lowering, heartburn or hypertension.

They’re for depression.

Last year doctors wrote $232.7 million prescriptions for antidepressants. That’s an increase of 25 million prescriptions since 2003 and translates into an estimated 30 million patients in the United States who spent $12 billion on antidepressants in 2007.

With numbers like these, a person might make these assumptions:

  • Antidepressants are effective treatments for depression
  • There are few, if any, effective alternatives to antidepressants

As reasonable as these assumptions would be based on the popularity of antidepressants, they are both wrong.

In my preceding articles in this ongoing series on depression and antidepressants, I’ve presented clear evidence that antidepressants are not effective for treating depression.

In this article and the following two, I will present evidence that several non-drug treatments for depression are at least as effective as antidepressants, with few (if any) of their side effects, risks and costs.

As you may recall from the previous articles in this series, recent meta-analyses have shown that antidepressants have no clinically meaningful advantage over placebos. What I have not yet pointed out is that the effectiveness of antidepressant drugs has probably been overstated due to methodological factors in the studies.

In the studies performed on antidepressant drugs, the people taking the drugs also received supportive weekly visits with doctors or researchers along with the medication. The resulting “therapeutic alliance” may have enhanced the efficacy of these drugs and given an inaccurate picture of their effectiveness in a managed care environment where antidepressants are often delivered in conjunction with infrequent visits to a physician or mental health professional.

We know from placebo research that the contact which occurs between the patient and practitioner can be a powerful treatment in itself. Therefore, the supportive visits that patients received during the drug trials could have easily amplified the effect of the drug and made it seem far more effective than it would be in a “normal” clinical situation where visits to a physician or psychiatrist are not regular or frequent.

With this in mind, it is very likely that antidepressants are less effective than placebos in normal clinical practice. Indeed, researcher Joanne Moncrieff has repeatedly pointed out that the term “antidepressant” is a misnomer. The drugs collectively referred to as “antidepressants” do not specifically treat depression (any more than placebo), and therefore should not be called “antidepressants” at all.

What are the alternatives, then, to treating depression? Imagine having a choice between five treatments. Treatment A produces a therapeutic response but also a large number of adverse effects including diarrhea, nausea, anorexia, sweating, forgetfulness, bleeding, seizures, anxiety, mania, sleep disruption and sexual dysfunction. Treatments B, C, D & E produce therapeutic responses similar to Treatment A, but with far fewer adverse effects and costs. Treatments B & C, in fact, have no adverse effects at all and have been shown to be significantly more effective than Treatment A in the long-term.

This is not, of course, simply a hypothetical question. Treatment A corresponds to the selective serotonin reuptake inhibitors (SSRIs) that have become so overwhelmingly popular. Treatment B is psychotherapy, which is as effective as antidepressants in the short term (even for serious depression), and is more effective in the long term. Treatment C is exercise, which has been reported to have lasting therapeutic benefits in the treatment of major depression with no “side effects” except for improved physiological and mental health. Treatment D is light therapy, which has been recently assessed in several clinical studies and is just as effective as antidepressant medication. Treatment E is St. John’s Wort, an herb that has been extensively studied and shown to be similar in efficacy to antidepressants with 10 times fewer adverse effects.

As depression researcher David Antonuccio points out, “whether one subscribes to the Hippocratic dictum ‘first do no harm’ or takes a cost-benefit approach to treatment, it is impossible to ignore the fact that antidepressants are not medically benign treatments. Antidepressants have serious side effects (listed above) as well as medical risks (including increased risk of dying) when combined with other medications – as is often the case in clinical settings. Antidepressants have been shown to cause potentially permanent changes to the brain that can predispose a patient to depression in the future, and the withdrawal symptoms of SSRIs are substantial for many, if not most, patients.

A frequent argument made by supporters of antidepressants is that patients with serious depression need antidepressants to stave off suicide. However, there is no evidence whatsoever that antidepressants reduce the risk of suicide or suicide attempts in comparison with placebo in clinical trials. On the contrary, in a recent analysis of the data that compensated for erroneous methodologies, Dr. Grace Jackson found that antidepressants increased the risk of suicide by two to four times in adults, and by three times in children (Jackson 2005, p.122)

It has also been demonstrated that recent sharp increases in antidepressant use have been accompanied by increased prevalence and duration of depressive episodes and rising levels of sickness absence (Patten 2004). Naturalistic studies have also shown that depressive episodes are more frequent and last longer among antidepressant users than among nonusers, and that sickness absence is more prolonged (Moncrieff 2006). Finally, long-term follow-up studies show very poor outcomes for people treated for depression with drugs, and the overall prevalence of depression is rising despite increased use of antidepressants (Fombonne 1994).

Please allow me to summarize the research and simplify the preceding paragraphs:

Antidepressants don’t work. If anything, they make things worse.

Now that we have firmly established the ineffectiveness and dangers of antidepressants, let’s look more closely at the alternatives. We will evaluate each treatment based on Antonuccio’s criteria above:

  • Does the treatment do any harm?
  • How do the “costs” compare with the “benefits”?

and we will also compare their efficacy with that of antidepressants.

Psychotherapy

Several studies show that psychotherapy (particularly cognitive therapy, behavioral activation, and interpersonal therapy) compares favorably with medication in the short-term, even when the depression is severe, and appears superior to medications over the long term (Antonuccio 2002). When medical cost offset, relapse and side effects are considered in a cost-benefit analysis, psychotherapy can be very cost-effective – particularly in a psychoeducational (e.g. therapist-assisted bibliotherapy) or group format (Antonuccio et al. 1997). Finally, studies show that most patients prefer psychotherapeutic intervention to drugs when given the choice. (Unfortunately, they are rarely given the choice; today, fewer than 10% of psychiatrists offer psychotherapy to their patients.)

It is important to note that several studies have shown that combined treatment (psychotherapy + medication, exercise + medication) produces inferior results when compared to the non-drug modality alone (Hollon et al. 1992). The failure of this combined approach is not surprising when one considers the counter-productive effects of invasive chemical interventions (e.g. suppression of REM sleep, elevation of cortisol, induction of mania).

Unfortunately, the mental health profession remains largely ignorant to this “tragedy of its own making”:

“Some investigators have argued that the relatively high relapse rate after drug treatment indicates that depression should be treated like a chronic medical disease requiring ongoing, long-term medical treatment indefinitely. This logic appears tautological: Drug treatment results in a higher relapse rate than cognitive-behavioral therapy; therefore, the patients should be maintained on drugs to prevent relapse.” (Antonuccio 1995)

Exercise

Several studies have shown that aerobic exercise is at least as effective as antidepressants in treating depression. For example, one recent study published in the American Journal of Preventative Medicine in 2005 indicated that the “public health dose” (5x/week frequency burning 17.5 kcal/kg/week) of exercise led to remission rates of 42%. For the sake of comparison, the Collaborative Depression Study, conducted by the National Institute for Mental Health, indicated remission rates of 36% for cognitive behavioral therapy and 42% for antidepressant medication.

A frequent criticism of exercise as a treatment for depression is the supposed lack of compliance in patients. The argument is that people who are depressed are too depressed to exercise. While this may be true in some cases, adherence rates in exercise studies were comparable to many medication trials, where rates vary from 60%-80%. Thus, evidence does not support the notion that exercise is not a feasible treatment for depressed patients.

Another benefit of exercise as a treatment for depression is that the only “side effects” are improved physiological and mental health. In contrast to antidepressants, exercise has no adverse effects whatsoever. Instead, it has a moderate reducing effect on anxiety, can improve physical self-perceptions and in some cases global self-esteem, and can enhance mood states and – in older adults – improve cognitive function.

In a study published in Psychosomatic Medicine in 2000, another important advantage of exercise over antidepressants was revealed. Participants in the exercise group were less likely to relapse than participants in the two groups receiving medication. Other studies have confirmed this effect, demonstrating that aerobic exercise is especially helpful in the prevention of relapse and recurrence of depression.

Once again, as was the case with psychotherapy, there was no benefit when combining antidepressant drugs with exercise. In fact, the opposite was the case, at least with respect to relapse for patients who initially responded well to treatment. According to the authors of the study:

“This was an unexpected finding because it was assumed that combining exercise with medication would have, if anything, an additive effect.

The authors go on to speculate on why antidepressant drugs would decrease the exercise’s beneficial effects on depression:

“One of the positive psychological benefits of systematic exercise is the development of a sense of personal mastery and positive self-regard, which we believe is likely to play some role in the depression-reducing effects of exercise. It is conceivable that the concurrent use of medication may undermine this benefit by prioritizing an alternative, less self-confirming attribution for one’s improved condition. Instead of incorporating the belief “I was dedicated and worked hard with the exercise program; it wasn’t easy, but I beat this depression,” patients might incorporate the belief that “I took an antidepressant and got better”.

It is also possible that the metabolic and physiological effects of antidepressants described above (suppression of REM sleep, elevated cortisol levels, etc.) could counteract the positive benefits of exercise to a certain degree.

In part II of this article I will discuss light therapy, St. John’s Wort and acupuncture as treatments for depression. In Part III I will examine other lifestyle modifications that can both prevent and treat depression, such as proper nutrition, stress management, getting adequate sleep, the experience of pleasure and prayer or spiritual practice.

man on bench

Today’s article is the sixth in an ongoing series on antidepressants and depression. It’s long, so you might want to print it out or go grab a cup of tea. If you are visiting the blog for the first time, or you haven’t had a chance to read the previous articles, you might find it helpful to do so before diving into this one.

The treatment of depression with drugs is based on the enormous collective delusion that psychiatric drugs act by correcting a chemical imbalance in the brain. As a result, a large percentage of the population has been convinced to take drugs in order to deal with the problems of daily life. Everything from break-ups to job difficulties to worries about the future have been transformed into “chemical problems”.

The myth that depression is caused by a chemical imbalance has permeated public consciousness, changing the way we view our lives and ourselves. We have become, in the words of sociologist Nicholas Rose, a society of “neurochemical selves”, recoding our moods and ills in terms of the supposed functioning of our brain chemicals and acting on ourselves in light of this belief.

This is reflected in the growing market for non-prescription products claiming to “enhance serotonin levels” in health food shops and on the Internet, and the cascade of claims that everything from chocolate to exercise makes you feel good because it “balances brain chemicals”. It also largely explains the 1300% growth between 1990 and 2000 in prescriptions of selective serotonin reuptake inhibitors (SSRIs), the most popular class of antidepressant drugs.

Yet, as I have explained in a previous article, there is no evidence to support the notion that depression is associated with an abnormality or imbalance of serotonin (or any other brain chemical), or that antidepressants work by reversing such a problem. Moreover, recent meta-analyses (Kirsh et al. 2008; Kirsh et al. 2004) suggest that antidepressants have only a small advantage over placebo, and that this advantage is most likely clinically meaningless. It has never been demonstrated that antidepressants act in a specific, disease-centered manner, nor have antidepressants ben shown to be superior to other drugs with psychoactive properties (Moncrieff & Cohen, 2006).

In spite of the complete lack of evidence supporting their use, one still often hears the familiar refrain “yes, but drugs are necessary in some cases!” This statement may in fact be true, but not because drugs have been demonstrated to be effective for certain types of depression or with certain patients. Instead, drugs may be necessary in a society where traditional social support structures which play a therapeutic role have completely broken down.

Studies have shown that most individuals with a healthy social support network are able to easily handle major stressors in life. When that network is underdeveloped or non-existent, it is far more likely that depression will occur (Wade & Kendler, 2000).

It has been observed, for example, that schizophrenia and other mental disorders occur less frequently and have a much more favorable prognosis in so-called “Third World” countries than in the West (Sartorious et al 1986). The influence of culture has been mentioned as an important determinant of differences in both the course and outcome of mental illness.

In developing countries strong connections between family members, kin groups and the local community are more likely to be intact. In addition, cultural, religious and spiritual beliefs in these societies provide a context in which symptoms of depression and other mental illness can be understood outside of the label of medical disease or pathology. Possession and rites of passage are two examples of such contexts.

In the West, however, these traditional support structures have been replaced by new cultural norms that do not offer support or therapeutic value to people experiencing mental distress. Among the socio-cultural factors identified by researchers as having a negative influence in Western societies are: extreme nuclearization of the family and therefore lack of support for mentally ill members of the kin group; covert rejection and social isolation of the mentally ill in spite of public assertions to the contrary; immediate sick role typing and general expectation of a chronic mental illness if a person shows an acute psychotic reaction; and the assumption that a person is insane if beliefs or behavior appear somewhat strange or “irrational”.

Therefore, in the West depression is far more likely to occur because of the breakdown of strong family and community support structures, the stigmatization of mental illness, the belief (perpetuated by drug companies) that all mental illness is “chronic”, and the lack of any cultural, religious or spiritual support for people who do not share the consensus view of reality. Statistics measuring the prevalence of depression around the world bear this out. According to the World Health Organization, if current trends continue, by the year 2020 depression will be the leading cause of disability in the West.

In contrast, in developing countries that have not yet fully adopted Western culture transient (i.e. temporary) psychotic reactions and brief depressive episodes are more common than chronic mental illness. When an individual begins to experience distress, the surrounding family and community respond with sympathy, support and traditional therapeutic resources. Surrounded by a rich support structure, the individual is able to return relatively quickly to healthy mental functioning – without drugs.

The cultural differences in the incidence of and response to mental illness suggests something that may be entirely obvious to you but has been largely forgotten in contemporary discussions about depression: that it cannot be properly defined or understood without considering the social context in which it occurs.

In other words, depression is both an individual and a social disease.

Unsurprisingly, epidemiological evidence has tied depression to poor housing, poverty, unemployment and precarious or stressful working conditions. Imagine, for example, a single parent working two low-paying jobs trying to support her child with no family or close friends nearby to help and little time to spend with them even if they were present. Or consider a child that spends most of his days in a school that doesn’t value his style of learning, eats a steady diet of sugar and processed food and lives with an alcoholic parent who is verbally and perhaps physically abusive. It makes perfect sense that both of these individuals could frequently feel sad, hopeless and even desperate. But are these individuals “depressed”?

Even if we agree that the intense feelings they are experiencing could be labeled as “depression”, perhaps a more relevant question might be this: is depression always a pathology? Or is it possible that much of what we call depression is simply a natural and entirely human response to certain circumstances in life?

This is exactly what Allan Horwitz and Jerome Wakefield argue in their book “The Loss of Sadness: How Psychiatry Transformed Normal Sorrow into Depressive Disorder“. The authors point out that the current epidemic of depression has been made possible by a change in the psychiatric definition of depression that allows the classification of normal sadness as a disease, even when it is not.

Horwitz and Wakefield define normal sadness as having three components: it is context-specific; it is of roughly proportionate intensity to the provoking loss/stimulus; and it tends to end roughly when the loss or situation ends, or else it gradually ceases as coping mechanisms adjust individuals to new circumstances.

The hypothetical examples I gave above of the single parent and the child living in an abusive home environment undoubtedly meet Horwitz & Wakefield’s criteria for “normal sadness”. The feelings occur in a specific context and are roughly proportionate to the circumstances. And though we can’t know this for sure since our example is hypothetical, one might assume that if the conditions of their lives were more favorable they may not feel so sad, hopeless and desperate. Nevertheless, in the West today both of these individuals would almost certainly be labeled as depressed and treated with psychoactive drugs.

While I appreciate the importance of Horwitz and Wakefield’s distinction between normal sadness and depression, I believe it is incomplete. In their framework, there must be some stimulus such as the death of a loved one, the loss of a job or the end of a relationship in order for someone to “escape” the depression label. Yet such events are not the only causes of discontent.

Regardless of economic status people in the West live in increasing isolation and alienation from each other, their communities and the natural world. Phone and email have replaced face-to-face interaction. The impersonality of big-box chain stores and strip mall outlets have replaced the intimacy and familiarity of the local corner store. The pace of life has become so fast that most people feel they are struggling just to get by. And even though we are far richer as a nation now, studies show that people today are not as happy as they were in the 1950s.

Sociologist Alain Ehrenberg has recently suggested that depression is a direct result of the new conceptions of individuality that have emerged in modern societies (Ehrenberg 2000). In societies that celebrate individual responsibility and personal initiative, the reciprocal of that norm of active self-fulfillment is depression – now largely defined as a pathology involving a lack of energy or an inability to perform the tasks required for work or relations with others. The continual incitements to action, to choice, to self-realisation and self-improvement act as a norm in relation to which individuals govern themselves, and against which differences are judged as pathologies.

Another way to speak of this change is as an increase in psychological stress. It is difficult to accurately compare stress levels today to those of the past, but sociologists like Juliet B. Schorr at Harvard University have observed that Americans (and likely people in all Western societies) are working longer hours, often with less pay, and have far less time for leisure. Since recent studies have identified a causal link between work stress and depression, one can safely make the assumption that the increase in work hours together with the decrease in leisure time could very well be contributing to the epidemic of depression.

Consider a middle-class individual living in an “exurban” housing tract 100 miles from their workplace. Each day they commute for two hours in each direction, fighting traffic all the way. Their job lacks any relevance or meaning to them and is simply done to make money and survive, without any joy or satisfaction. They have little control or agency at work and spend there day performing trivial tasks that do not challenge or engage them. They do not know their neighbors, they are disconnected from nature, and perhaps they have recently gone through a painful divorce.

If this person is experiencing apathy, sadness and a lack of enthusiasm for life, does that mean they are depressed? And even if we do label their condition as “depression”, can we truly understand or treat them successfully without addressing the circumstances (or root causes) of this person’s so-called depression?

There is little doubt that the people who seek treatment for depression are suffering. But should psychological and emotional suffering always be viewed as “something to get rid of”? Despite claims made by the companies who market antidepressant drugs, suffering cannot be pulled out of the brain like a splinter from the foot. Great religious and spiritual traditions from around the world view suffering as an avenue to greater understanding of oneself, life and God. Suffering can be viewed as a signal drawing our attention to issues in our life that need to be addressed.

If we simply use chemicals to diminish these signals and numb ourselves from their effects, we lose the opportunity to grow, evolve and heal. According to world-renowned psychiatrist David Healy, when strong feelings are suppressed by rejecting them or with drugs, people become “binded” to their own psychological or spiritual state. Psychiatric drugs blunt and confuse essential emotional signals and make it very difficult for people to know what they are really feeling. And because the pharmacological effects of drugs impair mental functioning, they can reinforce the patient’s sense of helplessness and dependence upon chemicals – even when those chemicals are preventing them from full recovery.

People who are depressed have lost touch with their hopes and dreams. Yet they wouldn’t be depressed if they did not still have a vision for a better life. If drugs are used to obliterate the feelings of discontent or suffering, the connection to that vision for a better life may be lost.

One might legitimately wonder, then, whether it is wise to attempt to treat such complex human and social problems with chemicals. Such a treatment strategy can only be useful if the goal is to perpetuate the status quo, to continue with “business as usual” at all costs, rather than addressing the psychosocial problems that are at the root of the discontent.

The message that drugs can cure our problems has profound consequences. Individual human beings with their unique life histories and personal characteristics have been reduced to biochemical entities and in this way the reality of human experience and suffering is denied (Moncrief 2008). People have come to view themselves as “victims of their own biology”, rather than as autonomous individuals with the power to make positive changes in their lives.

At another level such an exclusive focus on drug treatment allows governments and institutions to ignore the social and political reasons why so many people feel discontented with their lives. This is not surprising, of course. Both governments and corporations stand to benefit from maintaining the status quo and are often threatened by social change.

The “disease-centered” model of depression is presented as objective, unassailable fact, but it is instead an ideology (Moncrieff 2008). All forms of ideology convey a partial view of human experience and activities that is motivated by a particular interest; in this case, the interest of multinational pharmaceutical companies. The best selling drugs today are those that are taken indefinitely. This has fueled the drug companies’ efforts to label depression as a chronic, lifelong disease in spite of epidemiological studies which indicate that, even when untreated, depressive episodes tend to last no longer than nine months.

In her article called “Disease Mongering in Drug Promotion“, Barbara Mintzes describes the effort of pharmaceutical companies to “widen the boundaries of treatable illness in order to expand markets for those who sell and deliver treatments”. This phenomenon is known as “disease mongering”, and involves several tactics including the introduction of new, questionable diagnoses; the promotion of drugs as the first line of defense for problems not previously considered medical; the expansion of current definitions of mental illness; and the inflation of disease prevalence rates.

In a blatant example of the last strategy, pharmaceutical companies have estimated in their promotional literature that up to one-third of people worldwide have a mental illness. This ridiculous (and in my opinion, transparent) claim is not supported anywhere in the scientific literature. Peer-reviewed studies put the figure at significantly less than 5%.

It should be obvious that drug companies would be the first to benefit from such grossly overstated estimates of the prevalence of depression. In fact, executives in the pharmaceutical industry have even admitted as much. Thirty years ago Henry Madsen, the CEO of Merck, made some very candid comments as he approached his retirement. Suggesting he’d rather Merck to be more like chewing gum maker Wrigley’s, Gadsen said that it had “long been his dream to make drugs for healthy people.”

Sadly, Madsen’s dream has been realized with the advent of not only antidepressants, but also statins, antacids and other drugs sold to essentially healthy people. These medications are now the top-selling drugs around the world. (Madsen’s sense of morality may have been skewed, but he certainly was a visionary businessman.)

The field of psychiatry has largely collaborated with the pharmaceutical industry in defining intense and painful emotions as “disorders”. Diagnoses like “panic disorder” and “clinical depression” give a medical aura to powerful emotions and make them seem dangerous, pathological, unnatural or out of control. In an astute observation of this state of affairs, psychiatrist Steven Sharfstein remarked in the March, 2006 issue of Psychiatric News that the biopsychosocial model of depression has been replaced by the “bio-bio-bio” model.

It has now become common practice for psychiatrists to prescribe drugs on their very first visit with a patient, and to tell that patient that they will likely need to take drugs for the rest of their lives. Such a prognosis is offered in spite of the fact that no attempt has been made whatsoever to try proven, non-drug treatment alternatives such as psychotherapy and exercise!

The increasing rates of depression and poor long-term treatment outcomes clearly indicate that the current drug-centered strategy is not effective. For real progress to be made the psychological, social, economic and political roots of depression must be addressed. This will require a coordinated effort on the part of patients, physicians, communities and politicians. It will not be easy, because we are fighting deeply entrenched beliefs about the “biochemical” nature of depression as well as a $500 billion dollar pharmaceutical industry that is not likely to willingly give up the $20 billion in sales represented by antidepressants.

There is no doubt that the systemic changes I am describing are far more difficult to implement than administering a drug. Nevertheless, we must begin if we hope to heal ourselves, our culture and our world.

In the final article of the series, I will present proven non-drug alternatives for treating depression. Stay tuned!

Please remember to always seek the guidance of a qualified psychiatrist when attempting to withdraw from psychoactive drugs. It is very dangerous to stop taking the drugs abruptly or to begin the withdrawal process without supervision. Psychiatrist Peter Breggin is considered to be one of the foremost experts in psychiatric drug withdrawal, and he has written a book (linked to below) for helping patients wean off of drugs. If you are considering stopping your medication, I recommend you read this book and discuss it with your doctor.

Recommended books

  • Your Drug May Be Your Problem: How and Why to Stop Taking Psychiatric Medications, by Peter Breggin

pile of pills I just came across a recently published study which revealed that SSRIs (the most popular class of antidepressants) can cause gastrointestinal bleeding. The first thing I always do when reading a study is check to see who the authors are, where they receive funding from and who the sponsor is.

So you can imagine my surprise when I learned that this study, which casts antidepressants in an unfavorable light, was sponsored by a large pharmaceutical company (AstraZeneca).

Could drug companies be experiencing a change of heart? A pang of conscience? Could this mark a new era of integrity and honesty in the reporting of results from drug trials?

Not so much.

Being the skeptic that I am, I thought for a moment about why a drug company would sponsor and then publish a study investigating the side effects of antidepressant when the results are so clearly negative? We know from my previous article on conflicts of interest in the medical field that drug companies are under no obligation to publish study results – and often they do not when the results are unfavorable.

One reason came immediately to my mind: what if that company happened to manufacture a drug that could be used to counter the side effects antidepressants? And what if their study not only demonstrated the side effect antidepressants, but also the effectiveness of their drug in mitigating or treating that side effect?

Turns out that’s exactly what’s happening here. AstraZeneca is the manufacturer of Nexium, one of the most popularly prescribed medications for heartburn. Nexium works by inhibiting the production of acid in the stomach.

Now, check out how the study was designed. There were three groups. The first group was people taking SSRIs only. The second group was people taking SSRIs and NSAIDs (ibuprofen, aspirin, etc.) and other anti-inflammatory drugs known to be harmful to the stomach lining. The third group took SSRIs along with acid-suppressing agents (agents like Nexium, for example).

People taking the SSRIs were more likely to have G.I. bleeding than people on placebo, and those taking both SSRIs and anti-inflammatory drugs were even more likely to bleed than people on SSRIs alone.

But guess what? Acid suppressing agents (like, um, let’s say… Nexium) were associated with a reduced risk of upper GI bleeding in those taking SSRIs.

We can see where this is leading, right? The solution to the G.I. bleeding caused by SSRIs is not to stop taking the SSRIs. The solution is to take another drug! In this case, a drug that is manufactured by the company who sponsored the study.

Unfortunately, this vicious cycle of medication use is very common. A common scenario might be someone takes an SSRI for depression, but it causes anxiety. So the doctor prescribes something for anxiety. Unfortunately, many medications for anxiety also cause constipation. But there’s a pill for that too, which the doctor also prescribes. Then the patient finds they’re getting some acid reflux (a side effect of some of the medicines for constipation), so the doctor prescribes an acid-suppressing agent.

You might be laughing (or crying) as you read this, but I am not exaggerating. This is very often how it works, especially in the elderly who now take an average of 6-8 medications every day.

And this is bound to continue to happen as long as research is primarily sponsored by pharmaceutical companies. The author of the study, Dr. García-Rodríguez, has received “unrestricted research grants from Pfizer Inc., AstraZeneca and Novartis Pharmaceuticals Group”.

There’s no way to prove that Dr. Garcia-Rodriguez’s work is being unduly influenced by his close connection with drug companies. But common sense, as well as many published scientific studies, indicates that this is very likely. For example, several studies have shown that researchers who produce data that is contrary to the interests of the pharmaceutical industry risk legal, professional, or even personal attack – directly or indirectly financed by the industry. (Bosley, 2002; Healy, 2002; Monbiot, 2002).

Fortunately, many influential leaders are calling for changes to be made to the way medical research is performed and distributed. But they are facing the opposition of a $500 billion dollar industry with more lobbyists than there are members of Congress. It’s not going to be easy.

dollar signIn a recent post, I discussed the consequences of the massive conflicts of interest that exist between researchers, doctors and the pharmaceutical industry in the U.S. and abroad.

On June 8th the New York Times published an article underscoring these consequences and illuminating the risks that inevitably come with financial ties between researchers and drug companies.

The article revealed that Dr. Joseph Biederman, a world-renowned child psychiatrist at Harvard, accepted at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but did not disclose any of this income to university officials. By failing to report this income, Dr. Biederman and colleagues may have violated both federal and university research rules designed to prevent conflicts of interest.

Dr. Biederman is one of the most influential researchers in child psychiatry. Although many of his studies are small and often financed by pharmaceutical companies, his work has nevertheless directly contributed to a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a concurrent rise in the use of powerful antipsychotic medicines in children.

We know from my previous post that it has been shown that studies funded by pharmaceutical companies are more likely to show positive results for the drug. We also know that the veracity of clinical trials which are the basis of approval of new drugs by the FDA has been called into question in recent studies because of three major flaws: conflicts of interest on the part of investigators (like Biederman); inappropriate involvement of research sponsors (drug companies) in study design and management; and publication bias in disseminating results (if a study has negative results, the drug company doesn’t publish it).

When a researcher like Dr. Biederman is paid millions by a drug company to study it’s product, we must wonder whether we can expect his work to be objective and accurate. But when that researcher repeatedly lies about the money he received, the integrity of his work should be in serious doubt.

In one revealing example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with Harvard University. When asked to check again, he said he received $3,500. But Johnson & Johnson told Congressional investigators that Mr. Biederman was paid $58,169 in 2001.

The consulting arrangements of Dr. Biederman’s entire research group at Harvard were already controversial because of the researcher’s advocacy of unapproved (”off-label”) uses of psychiatric medicines in children. Dr. Biederman and his colleagues have promoted the aggressive diagnosis and treatment of childhood bipolar disorder with antipsychotic drugs – although these drugs have never been approved for such use. In fact, neuroleptic drugs have not been approved for use in children at all.

As a result of Dr. Biederman’s promotion of both the diagnosis and treatment for childhood bipolar disorder, antipsychotic drug use in children has exploded. Roughly half a million children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age, according to Medco Health Solutions, a pharmacy benefit manager.

The dramatic increase in antipsychotic prescriptions in children has occurred despite the lack of evidence that these medication improve children’s lives over time. On the contrary, it is well known that children are susceptible to the weight gain and metabolic problems caused by the drugs. Children typically gain twice as much weight in the first six months on atypical neuroleptic drugs (risperidone, olanzapine, etc.) as they should through normal growth, adding an average of 2 to 3 inches to their waistline. This is mostly abdominal fat, which also increases their risk of diabetes and heart disease.

There is also some evidence which suggests that these drugs may cause permanent changes to the structure and function of the brain (Breggin 1997). In other words, they cause brain damage.

The research of Dr. Biederman’s group, which has served as the basis for the rise in bipolar diagnoses and antipsychotic use in children, has been widely criticized by other psychiatrists and researchers.

The studies published by Dr. Biederman’s group were so small and “loosely” designed that they were largely inconclusive. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale, which is well below the 50 percent change that most researchers use as the standard.

Controlling for bias in these types of studies is particularly important, given that the scale is subjective and depends on reports from physicians, parents and children.

More broadly, psychiatrists have said that revelations of undisclosed payments from drug makers to leading researchers are especially damaging for psychiatry.

“The price we pay for these kinds of revelations is credibility, and we just can’t afford to lose any more of that in this field,” said Dr. E. Fuller Torrey, executive director of the Stanley Medical Research Institute, which finances psychiatric studies. “In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money.”

I couldn’t have said it better myself.

veggie basket In today’s article we’ll discuss how to prevent heart disease without drugs. If you haven’t already read Part 1 of this series, which examined the problems with statin drugs, and Part 2, which debunks the myth that cholesterol causes heart disease, you might want to do that before reading this article.

Last week I mentioned the INTERHEART study, which looked at the relationship between heart disease and lifestyle in 52 countries around the world. What this study revealed is that approximately 90% of heart disease could be prevented by simple changes to diet and lifestyle.

Let’s just make this crystal clear: 9 out of 10 cases of heart disease are completely preventable without drugs. With sales of statin drugs reaching close to $30 billion this year with Lipitor alone bringing in close to $14 billion, this might come as some surprise. But the pharmaceutical companies are, quite literally, invested in people taking their cholesterol-lowering drugs in spite of the complete lack of evidence that lowering cholesterol prevents heart disease.

In order to understand the changes we need to make to prevent heart disease, we have to briefly examine what causes it. By now you know that the answer is not “cholesterol”. In fact, as I mentioned briefly in last week’s article, the two primary contributing mechanisms to heart disease are inflammation and oxidative damage.

Inflammation is the body’s response to noxious substances. Those substances can be foreign, like bacteria, or found within our body, as in autoimmune diseases like rheumatoid arthritis. In the case of heart disease, inflammatory reactions within atherosclerotic plaques can induce clot formation.

When the lining of the artery is damaged, white blood cells flock to the site, resulting in inflammation. Inflammation not only further damages the artery walls, leaving them stiffer and more prone to plaque buildup, but it also makes any plaque that’s already there more fragile and more likely to burst.

Oxidative damage is a natural process of energy production and storage in the body. Oxidation produces free radicals, which are molecules missing an electron in their outer shell. Highly unstable and reactive, these molecules “attack” other molecules attempting to “steal” electrons from their outer shells in order to gain stability. Free radicals damage other cells and DNA, creating more free radicals in the process and a chain reaction of oxidative damage.

Normally oxidation is kept in check, but when oxidative stress is high or the body’s level of antioxidants is low, oxidative damage occurs. Oxidative damage is strongly correlated to heart disease. Studies have shown that oxidated LDL cholesterol is 8x greater stronger a risk factor for heart disease than normal LDL.

Since there may be some confusion on this point, I want to make it clear: normal LDL cholesterol is not a risk factor for heart disease in most populations, but oxidated LDL cholesterol is. This points to oxidation as the primary risk factor, not cholesterol. Why? Because when an LDL particle oxidizes, it is the polyunsaturated fat that oxidizes first. The saturated fat and the cholesterol, hidden deep within the core of the lipoprotein, are the least likely to oxidize.

It follows, then, that if we want to prevent heart disease we need to do everything we can to minimize inflammation and oxidative damage.

Top four causes of oxidative damage & inflammation

  1. Stress
  2. Smoking
  3. Poor nutrition
  4. Physical inactivity

By focusing on reducing or completely eliminating, when possible, the factors in our life that contribute to oxidative stress and inflammation, we can drastically lower our risk for heart disease. Let’s take a brief look at each risk factor.

Stress

In the INTERHEART study, stress tripled the risk of heart disease. This was true across all countries and cultured that were studies. The primary mechanism by which stress causes heart disease is by dysregulating the hypothalamic-pituitary-adrenal (HPA) axis. The HPA axis is directly intertwined with the autonomic nervous system, and it governs the “fight-or-flight” response we experience in reaction to a stressor.

Continued activation of this “fight-or-flight” response leads to hyper-arousal of the sympathetic nervous system, which in turn leads to chronically elevated levels of cortisol. And elevated levels of cortisol can cause both inflammation and oxidative damage.

Stress management, then, should be a vital part of any heart disease prevention program. In fact, some researchers today believe that stress may be the single most significant factor in the cause and prevention of heart disease. There are several proven methods of stress reduction, including mindfulness-based stress reduction (MBSR), acupuncture and biofeedback. It doesn’t matter which method you choose. It just matters that you do it, and do it regularly.

Smoking

I assume that you are already well aware of the dangers of smoking, so I won’t spend much time on this one. For the purposes of this discussion, I will point out that smoking as few as 1-4 cigarettes a day has been shown to increase the risk of heart disease by 40%. But smoking 40 cigarettes a day increases that risk by 900%.

So if you smoke and you’re concerned about heart disease – quit.

Nutrition

Over the past century we’ve seen a consistent decline in the consumption of traditional, nutrient-dense foods in favor of highly processed, nutrient-depleted products. The flawed hypothesis that cholesterol causes heart disease has wrongly identified health-promoting foods like meat, organ meats, eggs and dairy products as harmful, and replaced them with toxic, processed alternatives such as chips, white breads, pastries, crackers, cookies, frozen foods, candy and soda.

There are two ways that nutrition contributes to heart disease: too much of the wrong foods, and not enough of the right ones.

The average American gets 57% of his/her calories from highly refined cereal grains and polyunsaturated (PUFA) oils. The #3 source of calories, behind grains and PUFA, is sugar and high-fructose corn syrup. Refined grains, polyunsaturated oils and sugar are all major contributors to both inflammation and oxidative damage.

Not only do refined carbohydrates, vegetable oils and sugar contribute to inflammation and oxidative damage, they are also completely devoid of micronutrients that would protect us from these processes. Meats, fruits and vegetables are all high in antioxidants that prevent oxidative damage, and rich in other micronutrients that play important roles in preventing heart disease.

More than 85% of Americans are not getting the federally recommended five servings of fresh fruit and vegetables each day. The intake of dark leafy green or yellow/orange veggies for the average American is equivalent to 18g – one-half of one small carrot. Iceberg lettuce, tomatoes, french fries, orange juice and bananas constitute 30% of fruit and vegetable intake for most Americans.

Many people know that the “Standard American Diet” is extremely unhealthy. But what most do not know is that the so-called “heart-healthy” diet that has been vigorously promoted for decades actually contributes to heart disease! The “heart-healthy” diet is high in refined carbohydrates and polyunsaturated oils, which, as we have seen, cause inflammation and oxidative damage.

On the other hand, saturated fats (which have been demonized by the medical mainstream) such as butter, coconut oil, lard, tallow and ghee are protected against oxidation and possess many other important health benefits. These fats are the ones we need to be eating to protect ourselves from heart disease.

It is extremely important to buy organic meat, eggs and dairy products that come from animals that have been raised on fresh pasture rather than in commercial, factory feedlots. See this article and this one for more information on why this is so essential.

Finally, it must be pointed out that not all “organic” products are healthy. Most packaged food (including organic cereals, crackers, chips and so-called “nutrition bars”) are full of highly refined carbohydrates, sugar, and vegetable oils. And by now, I don’t need to tell you what that means!

So what would a truly heart healthy diet look like, then? Download my Guidelines for Natural Prevention of Heart Disease to find out.

Physical Inactivity

Physical inactivity is likely a major causative factor in the explosive rise of coronary heart disease in the 20th century. During the vast majority of evolutionary history, humans have had to exert themselves to obtain food and water. Even at the turn of the 20th century in the U.S., a majority of people had jobs that required physical activity (farmers, laborers, etc.) Now the majority of the workforce has sedentary occupations with little to no physical activity at all.

Currently more than 60% of American adults are not regularly active, and 25% of the adult population is completely sedentary. People that are physically inactive have between 1.5x and 2.4x the risk of developing heart disease.

On the other hand, regular exercise reduces both inflammation and oxidative damage. Even relatively low levels of activity are protective – as long as they are consistent. A public review at Harvard University showed that 30-minutes of moderate physical activity on most days of the week decreases deaths from heart disease by 20-30%.

The best strategy for people struggling to find time to exercise is to make it part of their daily life (i.e. riding a bike or walking to work, choosing the stairs over the escalator or elevator, etc.)

When combined, the four strategies listed above will significantly reduce your chances of getting heart disease – without taking a single pill of any kind.

If you already have heart disease, or you are at high risk for heart disease (overweight, high blood pressure, diabetic, etc.), then you may need additional support. See my

Recommended articles

 

capsulesA recent article in the New York Times revealed that over half of Americans are taking prescription medication for chronic health problems.

The numbers were gathered last year by Medco Health Solutions Inc., which manages prescription benefits for about one in five Americans.

The data indicates that 51 percent of American children and adults were taking one or more prescription drugs for a chronic condition, up from 47 percent in 2001. The use of drugs to treat health problems was seen in all demographic groups:

  • Almost two-thirds of women 20 and older
  • One in four children and teenagers
  • 52 percent of adult men
  • Three-quarters of people 65 or older

28 percent of women and 22 percent of men over 65 take five or more medicines regularly.

Exactly what medications are people taking? In 2006, the top five drugs by sales were Lipitor, Nexium, Prevacid, Advair Diskus and Singulair. Lipitor lowers cholesterol, Nexium & Prevacid lower stomach acid, and Advair Diskus and Singulair address asthma and allergies respectively.

The drugs on this list reveal much about the weakness of the mainstream medical model. Cholesterol and stomach acid are both normal, protective substances in the body. Cholesterol is no more the cause of heart disease than stomach acid is the cause of GERD or ulcers. But one of the fundamental flaws of western medicine is its tendency to treat the symptom or effect rather than the cause. Unfortunately for patients, doing so can actually make things worse, not better.

Cholesterol plays many essential roles in the body, and and lowering it arbitrarily not only doesn’t prevent heart disease, but can actually increase the risk of dying from a heart attack in elderly people. Likewise, stomach acid is crucial in protecting us from the pathogens we might otherwise ingest with food. Stomach acid is also required for protein digestion. It is well-established in the scientific literature that the primary cause of ulcers is a bacterium called h. pylori – not stomach acid. And there is also evidence suggesting that GERD (gastro-esophageal reflux disease) is caused by low – not high – stomach acid.

But I digress.

The scariest part of this study is the surge in children’s use of medicines to treat weight-related problems and other illnesses previously considered adult problems. Medco estimates about 1.2 million American children now are taking pills for Type 2 diabetes, sleeping troubles and gastrointestinal problems such as heartburn.

The majority of these conditions – diabetes, sleeping troubles and gastrointestinal issues – can be treated by simple diet and lifestyle changes. These changes have none of the adverse effects and risks of drugs, and their benefits extend far beyond the potential therapeutic action of the medications.

Medication has improved and even saved the lives of many in this country and around the world. Yet there’s a difference between drugs that are “medically necessary” and drugs that are prescribed in lieu of other less harmful and risky – but more labor intensive – interventions such as diet and exercise.

But as Dr. Robert Epstein, cheif medical officer at Franklin Lakes, N.J.-based Medco said, ‘We’ve become a couch potato culture (and) it’s a lot easier to pop a pill” than to exercise regularly or diet.

I couldn’t have said it better myself.

One reason for the increase in medication use is the pharmaceutical industry’s “relentless advertising”. Since that is unlikely to change anytime soon, experts say the proportion of Americans on chronic medications can only multiply.

“Unless we do things to change the way we’re managing health in this country … things will get worse instead of getting better,” predicted Daniel Jones, a heart specialist and dean of the University of Mississippi’s medical school.

Luckily, we don’t have to wait around for that to happen. As individuals we can take responsibility for our own health care using diet, exercise and lifestyle changes. We can choose to use “alternative” modalities such as acupuncture and homeopathy to keep us healthy. And we can take action to reduce stress and promote emotional and psychological well-being.

Recommended Links

  • Americans Taking Prescription Drugs in Greater Numbers

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