Much of U.S. Healthcare Is Broken: How to Fix It (Chapter 2, Part 1)

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Editor’s Note: Over the next several months, Mad in America is publishing a serialized version of Les Ruthven’s book, Much of U.S. Healthcare is Broken: How to Fix It. In this blog, he begins a discussion on depression and antidepressant drugs. Are they as effective and safe as psychiatry claims? Each Monday, a new section of the book is published, and all chapters are archived here.

Antidepressants: Are they as effective and safe as doctors tell us?

Since the 1950s, society has witnessed an almost exponential growth in the use of antidepressant drugs (ADMs). These drugs have often become the sole treatment for a variety of behavioral health disorders including clinical depression, anxiety disorders, obsessive compulsive disorder, and other approved and off-label uses of these drugs. Off-label use occurs when an FDA-approved drug for one condition is used for one or more non-FDA-approved condition(s).

White pills bounce out of clear bottle on blue background

At first, general physicians were very skittish about prescribing the first-generation drugs—the tricyclic antidepressants such as Elavil and others—due to their potential for death from overdose. Next came the second-generation ADMs in the late 1980s—the selective serotonin reuptake inhibitor antidepressants (SSRI) such as Prozac, Paxil, Zoloft and others. General physicians, reacting to the marketing that these second-generation drugs were both safer and more effective than the earlier ones (not true), began prescribing these drugs to 20% or more of their patients as the sole treatment for a variety of mental disorders.

The cost of these drugs was projected to be $62 billion in 2020, not including physician office visits to prescribe and monitor the patients on these drugs. Drug therapy of these disorders was said to cost less than, for example, treatment by a doctoral-trained psychologist. This is not true, as we will see.

The increasing popularity of these supposed “feel-good” drugs was driven by the marketing of them rather than by the scientific evidence, which over the past 75 years or so has found that these drugs are neither as safe nor as effective as their prescribers or the drug makers claim. In marketing any product, from laundry detergent to prescription drugs to luxury automobiles, marketers know the key is to keep it simple, and the pharmaceutical industry certainly has learned this lesson well. The marketers presented a belief, endorsed by most psychiatrists, that depression is a disease caused by a chemical imbalance in the brain, at first specifically a deficient amount of serotonin at the brain synapses.

In “theory,” the SSRI restored the balance and the patient was better, if not cured. To think that a complex disorder such as clinical depression could be reduced to such a simplistic explanation might seem foolhardy to many of us trained in science, but such a theory has become the conventional wisdom for the general public, most of the media, general physicians, and psychiatrists alike. Even Dear Abby, who, in responding to a reader with probable emotional difficulties, recommended a visit to a counselor and their doctor for possible medication!

There are a number of chemical neurotransmitters in the brain, and to think that one chemical, serotonin, is responsible for clinical depression stretches one’s imagination and credulity, although such skepticism has not affected the market and popularity for these drugs. The believers in the chemical theory of depression continued to accept the chemical imbalance theory even when other newer types of antidepressants affecting other neurotransmitters joined and competed against the SSRI club. These additional types include serotonin norepinephrine reuptake inhibitors (e.g., Effexor) and monoamine oxidase inhibitors (e.g., Nardil) among others.

If things continue as they have been, we may end up with as many different types of antidepressant drugs as there are different neurotransmitters and their combinations in the brain! Currently there are about 36 unique and FDA-approved antidepressant drugs.

If a depressed patient does not respond to an SSRI, and perhaps after several dose increases of the SSRI, the physician can turn to four to five other neurotransmitters for “re-balancing”! Physicians should know from the FDA-submitted placebo-controlled outcome studies of the several classes of antidepressant drugs (from the tricyclic antidepressants to the norepinephrine types) that no one type is more or less effective than the others.1 The various types of ADMs are all marginally more effective than placebo in the FDA-submitted trials, a fact which should call into question the chemical imbalance theory of depression.

First, low serotonin at neuron brain synapses was seen by psychiatry and the drug industry to be the cause for depression and the SSRI was its cure. However, when the non-SSRI ADMs came into play, the serotonin theory had to be revised, but the “theory” or myth was expanded to the idea that the depression can arise from one of several different neurotransmitters! I suspect an MBA rather than a scientist in the drug industry came up with this “theory,” a theory that has a tremendous impact on the industry’s cash register.

When Mrs. Jones’ SSRI antidepressant fails to cure her “chemical imbalance” (about two-thirds of the time), her physician tells her that her depression must arise from another neurotransmitter and the good news is that we have another drug for her particular depression. If that fails, Big Pharma has another solution, a combination of two or more neurotransmitters to restore Mrs. Jones’ particular chemical imbalance! Someone should have told Big Pharma that ADMs all have significant adverse side effects and if one combines two different types of ADMs the side effects are compounded considerably. (I am sure Big Pharma knows this.)

Let’s say all antidepressant treatment for a patient fails completely. Then, “My dear, you have what is called treatment-resistant depression (TRD),” and psychiatry still holds out a treatment answer in terms of a variety of both drug and non-drug biological/mechanical treatments which will be discussed later in this chapter.

To see how much psychiatry and general medicine are committed to the belief in a chemical treatment of depression (and other mental disorders as well), one only has to look at the scores of bio-mechanical treatments recommended for TRD. When two-thirds of ADM users are still depressed after one or two drug treatment failures, and from the FDA clinical trials, knowing that one-third of depressed patients remit their depression on inert placebo alone, one would think that at least some of these professionals would look at such data and say “Hey, I don’t think these ADMs are very good at treating clinical depression!”

Strong, deeply held beliefs in many areas are tremendously resistant to change (this is true of people in general) and this phenomenon of resistance to change holds as well in the area of drug treatment of the behavioral health disorders.

Is depression really on the increase?

According to researchers, the diagnosis of clinical depression has soared. Prior to the introduction of the SSRIs (Prozac being the first), depression was considered to affect 100 people per million. Following the introduction of the SSRIs, the prevalence rates for depression were considered in the range of 50,000 to 100,000 per million, a 500 to 1,000 percent increase! According to the World Health Organization, 280 million people in the world are said to be suffering from depression, more than those with either heart disease or AIDS, and depression is projected to be the world’s second most debilitating “disease” by 2020!  Depression is undoubtedly a major health problem, but I believe the soaring “increase” is a fiction and not real. I suspect the “increase” is probably the result of the soaring antidepressant drug sales prescribed by non-psychiatric physicians who are, in my mind, not qualified to make such a diagnosis and prescribe treatment.

Prior to the SSRIs, psychologists and other mental health professionals, including psychiatrists, considered many depressions to be a self-limiting disorder, meaning that even without treatment, the depression will often subside perhaps due to favorable changes in the depressed person’s behavior or favorable environmental changes. The goal of psychotherapy, however, was to speed the recovery and more importantly to keep the depression from returning. Therapists have known that some people are more prone to episodes of depression because of self-defeating attitudes (such as perfectionistic tendencies) that need modification through psychotherapy or behavioral treatment.

How can one account for such an enormous increase in the prevalence of the disorder? Is it communicable or in the water? I believe the “apparent” increase is due to the effects of skillful marketing and tens of thousands of patients who are misdiagnosed with major depressive disorders (MDD) and diagnosed and prescribed antidepressants by general physicians whose only training in mental health disorders has been a six-week rotation in psychiatry during the internship. Since the advent of the SSRIs, any patient who expresses even normal everyday mood or stress problems to their physician is offered the drug and, along with the drug, a diagnosis. I suspect that only a small percentage of those on antidepressants warrant a diagnosis of MDD, which requires that the depressive symptoms must last for at least two weeks. As we will observe later, people with mild depression are excluded from FDA depression clinical trials because these medications are no better than an inert placebo for treating mild depression.

The marketing of these drugs to general physicians and the public at large has been so successful that physicians are convinced that the failure to prescribe these drugs would be considered negligent, even legally indefensible! The popularity of any therapy, however, may have little or nothing to do with its effectiveness.

Today, physicians in general, and their antidepressant drug-treated patients, both claim these drugs are lifesavers in curing their depression. So, with such strong provider and patient satisfaction, it is not surprising than about 10% (and growing) of Americans take these antidepressant drugs. However, we must remember that for over 3,000 years bloodletting providers and their patients were equally impressed with the results of bloodletting! Later, I will address how in the history of medicine so many bogus treatments emerged and often have a long shelf life.

Psychiatry, of course, had its origins in both non-brain causes and behavioral treatment of the mental disorders, but psychiatry, for the most part starting in the second half of the 20th century, made a complete paradigm shift about the causes and treatment of mental disorders. From Freud, psychiatry looked to poor rearing of the child and early or later adverse life events as the cause of mental disorders. But in the 1950s, psychiatry began to move more and more to defective brain chemistry as the principal origin of mental disorders.

In viewing mental disorders as having a biophysical, rather than psychological or behavioral origin, psychiatry became more like non-psychiatric physicians in the way medicine was practiced. Previously, psychiatry had always been something of a stepchild of medicine, but now both were often on the same page talking about schizophrenia as a disease of the dopamine system and depression as a disease of the serotonin system! Correcting and restoring brain chemistry balance has become psychiatry’s Holy Grail from the 1950s onward, and when a drug seems to fail, simply raise the dosage! If that does not work, simply switch to another drug to address another brain system in the depressed patient.

The general public likes the chemical imbalance theory of depression because if they ever get the “disease” there is offered a quick and easy cure: Just take a pill and it will go away, a cure that requires no other action on the patient’s part except to take the medication for a lifetime. Psychiatry likes the chemical imbalance theory of depression, and the diseasing of other mental disorders as well, which brings psychiatry back into general medicine, i.e., making a diagnosis and having a drug or other biological “cure” for the mental disease.

When psychiatrists had a full schedule of psychotherapy patients, their income was very limited and substantially less than their non-psychiatric physician colleagues. Drug therapy of the mental disorders and inpatient psychiatric treatment enabled psychiatrists to match the incomes of their non-psychiatrist physician colleagues.

Moreover, the disease theory of mental disorders places psychiatry in dominance over the field of clinical psychology because psychiatrists are better trained than psychologists in the biological and physical sciences. Non-psychiatric physicians embrace the chemical imbalance theory of depression—and mental disease as well—because it gives them the “right” to treat the mental disorders of their patients as much as or more than any other mental health professionals.

On the other hand, if depression is even a combination of bio- and psychosocial influences, then physicians have decreased credibility in treating depression and other behavioral health disorders. With a brain disease “theory” of mental disorder, non-psychiatric physicians have the “right” to treat these disorders since the answer for these disorders is to change brain chemistry and not to directly to help change the patient’s behavior. Some think that mental disorders do change brain chemistry, but rather than addressing the bio-psycho-social causes of the brain changes of the disorder, including the changed brain chemistry, psychiatry’s approach is to change and manipulate brain chemistry. If I am right in my conceptualization of the mental disorders, treating the disorder with drugs is treating it on the back end rather than the front end.

In some of the following pages, I address how much of modern medicine is often concerned with treating health problems on the back rather than the front end, which is often the source for both poor quality and the high cost of treatment.  However, in back-end treatment of the mental disorders, psychiatry becomes much more like their physician colleagues.

The National Alliance on Mental Illness (NAMI) and other mental health support groups like the chemical imbalance theory of depression—including other mental disorders as well—because it seemingly eliminates the stigma of these disorders and becomes just the same as any other medical problem and treated in much the same way with drugs or other biomedical solutions. However, the variety of mental health disorders are diagnosed solely on the person’s behavior, which is not true for most if not all of the diseases and, unlike “real” disease, mental disorders do not have any tissue damage connected to the mental disorder itself.  However, tissue damage could be a consequence of the drug treatment of the mental disorders.

As has been pointed out, many different groups have joined the depression-drug treatment bandwagon. With the proliferation of these drugs in society, and hundreds of thousands of users from one month of age to the elderly, it might be worthwhile to look at any scientific proof of their efficacy in treating depression. The only means of establishing the drug’s true efficacy is through scientifically sound, randomized, double-blind, drug-placebo controlled studies, including the FDA-submitted randomized antidepressant drug-placebo controlled clinical trials.

Before looking at some of the FDA drug-placebo depression outcome studies, psychologists and others believe that the FDA guidelines for these studies allow practices that are biased in favor of finding a positive drug effect over placebo when indeed there may not be a positive drug effect at all. For one, in these placebo-controlled studies, mildly depressed subjects, derived from the Hamilton Depression Rating Scale (or HAM-D), are eliminated in favor of including only the moderately and severely depressed. Mildly depressed patients are excluded from these studies because the drug industry has found there is absolutely no drug efficacy at all with mildly depressed patients. In a disease such as cancer, does the FDA clinical trials exclude those with only mild cancer?

Despite this, perhaps 80% of the ADM market is composed of the worried well and the mildly depressed who do not meet the criteria for MDD and are not candidates for antidepressant medication. Viewing depression as a disease leads to many unfortunate physician practices in this area. How can one explain a physician giving a one-month-old baby a brain-impairing antidepressant drug? Can this be justified in the physician’s mind that since depression is a brain disease it may have been in existence since birth as a number of other diseases and might the baby’s health problem be responsive to antidepressant medication? To me, such reasoning is pretty farfetched, but such prescribing to a baby implies the physician must have some “theory” in mind such as “depression is a life-long brain disease.”

In the FDA antidepressant drug clinical trials, all selected depressed subjects undergo a 10-day placebo washout period, which excludes all subjects from the study who remit or improve with the placebo alone! The remaining group subjects are then randomly assigned to a placebo or treatment group.

All patients are told prior to the start of the study that patients will randomly be placed in a placebo group or a drug treatment group and under full disclosure rules all subjects are informed about the drug’s side effects, such as dry mouth and others. Since these are inert placebos, control subjects may be aware that they are not receiving the drug (which lessens the power of the placebo) and may have less hope for a good outcome than patients who may be aware of their inclusion in the drug treatment group (because of awareness of drug side effects).

Because of the differential side effects of those on the drug versus placebo, the psychiatrist raters may also be aware to which group the patient may belong, and such information may unconsciously influence his or her ratings of the patient’s condition in favor of a drug effect. With this caveat in mind, Chapter 2, Part 2 will look at some of the scientific findings with regard to drug treatment outcomes in these FDA depression clinical trials.

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To see the list of all references cited, click here.

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Mad in America hosts blogs by a diverse group of writers. These posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.

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5 COMMENTS

  1. “Someone should have told Big Pharma that ADMs all have significant adverse side effects and if one combines two different types of ADMs the side effects are compounded considerably. (I am sure Big Pharma knows this.)”

    “I’m sure Big Pharma knows this,” as well as all the “medical doctors” – including the psychiatrists – know this as well. Since all doctors are literally taught in med school about anticholinergic toxidrome, and the antidepressants are anticholinergic drugs.

    https://en.wikipedia.org/wiki/Toxidrome

    Psychiatry is basically an iatrogenic illness creation Ponzi scheme, based upon already medically known ways to make people “manic,” “psychotic,” and have “hallucinations” … with their drugs.

    https://www.amazon.com/Anatomy-Epidemic-Bullets-Psychiatric-Astonishing-ebook/dp/B0036S4EGE

    Thank you for speaking the truth, Dr. Les. And a Merry Christmas, and happy holidays to all.

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    • Thank you Someone else/a probable kindred sole for responding to this segment. Critics of the quality and cost of the current health system have an extremely difficult task at reform because the powerful entities are quite happy with the current system. For 22 years my company managed behavioral healthcare for large employer self-insured health plans and this is the only current entity (see Chapter 7) that has any potential to substantially lower the cost of care by improving the quality of care. However, employers of self-insured employee health plans need to know how and why major changes are required and my book is a recipe to accomplish the task. I invite other serious critics of current healthcare to join me in this endeavor.

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  2. To speak incessantly of “behavioral health,” as the author does, is a gross misapplication of medical terminology. Behavior cannot be properly described in terms of health or illness except in a strictly metaphorical sense, which itself is conditioned by the mores of a particular social milieu at a specific moment in time
    “Drapetomania”, to cite just one glaring example, was coined by a nineteenth-century physician to characterize the supposedly pathological conduct of slaves who sought to flee from their bondage. Does this alleged “disorder” now exist in the capacious DSM?

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    • Joel thanks for your comment. I agree I speak incessantly about behavioral health and health behaviors because patient behavior is obviously not of great concern to medically trained health providers. Behavior should be a primary concern in treating preventable diseases and other preventable health problems but the medically trained look for strictly bio physical solutions to health problems because these are consistent with medical training.

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      • Not entirely true in my experience.

        Some providers do care about behaviour because behaviour can put patient’s at riskt even under the simplest procedures. A blood sample, a sample of gastrointestinal fluid, etc…

        And treating “preventable” diseases, and “preventable health problems”, whatever that means in a particular case (!?), do collide, literally, with the freedoms, with the morality and the law of preventing bad outcomes in the population. Let alone the uncertainties, not risks, for this individual to do a simple blood test…

        Let alone, with the uncertain, not risky, outcomes of ONE, this, person “preventable” whatever.

        So, to my mind, you are kind of handwaving without clearly stating, at least in this comment, what exactly is in the balance…

        Just preventable…

        In the abstract? or in this person? at what cost?, with which risks?, what are the uncertainties?. What will be the benefits for THIS person?.

        After all, in some jurisdictions, no one is to be forced to a treatment for the benefit of another.

        So, if 1 in 72 patients under a treatment, the best treatment we now know will benefit from it, what do we tell the other 71, who will not only not get a benefit, but in some cases will get a harm?. Without knowing, on top, who will that be, either way.

        That is for the benefit of someone ELSE to receive the benefit of THEIR personal risk?. For the benefit of the population?.

        What are the obligations under the law?, under morality?, what morality?. What medical science?.

        This review?, this controlled randomised trial?, this consensus statement?. This meta-analysis?.

        Because, say, 8yrs ago, THAT consensus statement now says something different?.

        Do we require all women to undergo a mamography?. On what evidence?, is that evidence convincing enough to FORCE them ALL?.

        Do we force all women to have one to hold public office?. To be a teacher?, to care for a minor?.

        Because, it… is… preventable?.

        And not preventing it when one is responsible and it is preventable, is exactly irresponsible?. And being DEMONSTRABLY irresposable kinda should disqualify someone to do some things…

        Or the opposite: none should have them, the risk benefit is almost zero and there is certainty on the uncertainty of the benefit?.

        Is the “preventable” enough to say: “talk to your doctor”?.

        Really?.

        Would you say go talk to the “standard” psychiatrist to prevent a suicide?. To prevent homelesness?, unemployment?. Without further ado?.

        So, invoking “preventable” without specifications and qualifications, sounds, at least hyperbolically, irresponsible to me, precisely because not of the risks, but because of the UNCERTAINTIES in each specific case.

        And, to land on relevance, neither your comment, nor so far the published part of your book specifies enough to decide, to form a judgement, to have an informed opinion.

        Respectfully…

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