BRAVE NEW WORLD OF PSYCHO-PHARMACY
The obvious question then arises. Why is there a perception of benefit among the treated and those who are prescribing the therapy? The explanation Breggin offers is based on his belief that medication used in psychiatry actually disables the brain. The primary therapeutic effect is causing malfunctions of the brain and the mind which are then, among other things, misidentified as an improvement or benefit. Based on this, he evokes what he calls the spellbinding effect (Intoxication anosognosia). For example, the apathy or euphoria created by antidepressants is misinterpreted as an improvement in depression. In the case of antipsychotic drugs, the blunting of self-awareness and all emotions is seen as an improvement in the psychosis and the generalized sedation and suppression of brain function by the antianxiety drugs is seen a positive impact on anxiety. In fact, no specific improvements have taken place with regard to the underlying problem, but rather the brain has been partially disabled, which has resulted in an artificial change in the individual's mood, and at the same time rendering the patient less able to feel, perceive or express their underlying mental condition. These drugs impair both the ability to perceive the adverse effects of treatment and also the ability to appreciate psychological problems. Thus spellbinding is the natural result of treatment since drug therapy always impairs the activities of the patient's brain and thus the mind. Spellbinding also complicates if not invalidates the interpretation of studies since the patient is unable to provide a true evaluation of the results. Spellbinding may also account for the variation in study results and provide undesirable flexibility in interpretation. Breggin's book for the medical profession, Brain-Disabling Treatments in Psychiatry, contains a detailed, documented discussion of spellbinding and its consequences, as does his book Medication Madness. Finally, the perception of benefit may in some cases be based on a recovery or improvement that would have happened without treatment.13
While Breggin's view of the adverse impact of psychopharmaceutical therapy is to a large extent evidence based, this does not appear to be the case with the therapy itself as currently used, in spite of the fact that it is promoted as just that. Selective publication of trial results and its impact on the validity of meta-analyses is one of the problems.6 Fraudulent trials are another issue. Also, subjects in pharmacological treatment trials of depression may not be generally representative of patients encountered in routine clinical practice.14 Robert Whitaker also carefully develops and documents many of these problems in the 360 pages of his new book cited above. The book is hard to put down - spellbinding in the literary sense! One age group of great concern is the elderly, especially those confined to nursing homes. Just the events over a number of years leading up to this transition from free living to nursing home care can produce psychological problems that may trigger the use of psychiatric drugs. The occurrence of spellbinding in this context is especially disturbing given these patients may be quite fragile. If this treatment causes tardive dyskinesia it may be ascribed to the development of Parkinson's disease. If it causes what passes for cognitive problems, it may simply be ascribed to aging. In the arsenal of psychiatric drugs are a number with a high level of utility for making life easier for those providing care, but the end result is not pretty.
CHILDREN - A SPECIAL CASE FOR CONCERN
Children and adolescents are a special concern in this context. They are not able give informed consent. Psychiatric drugs are being used over a wide spectrum of ages, frequently off-label, while all the young patients are still undergoing active and critical mental development. Even toddlers are being medicated. Parents tempted or advised to put a child on a stimulant (e.g. Adderall, Desoxyn, Dexedrine, Focalin, Ritalin, Concerta, Daytrana, Vyvanse) should pay the high price and purchase Dr. Peter Breggin's book Brain-Disabling Treatments in Psychiatry. Then read chapter 11 titled Stimulant-Induced Brain Damage, Brain Dysfunction and Psychiatric Adverse Reactions. Breggin is particularly well qualified to comment on this subject. He has published papers on childhood stimulation for ADHD and its problems and has been involved in FDA panels debating the extent to which the public and physicians should be warned about what he views as frightening dangers associated with these drugs. The magnitude of the problem is clear. As of 2006, 4.5 million children aged 5-17 have been diagnosed with ADHD and over 56% were treated with medication.16 Even higher estimates of the treatment prevalence can be found.
Parents confronted with pressure to medicate their children with psychiatric drugs should also read the appropriate chapters in Peter Breggin's book Medication Madness. The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime. This is basically a case history book and a number of chapters relate to experiences of children and adolescents. Many of these histories are both powerful and quite disturbing, but it is this reality that parents must face when called upon to exercise their responsibility as surrogate informed consent providers for underage children. Parents with children on stimulants, antidepressants or antipsychotic drugs will find this book especially unsettling, as the subtitle suggests. If prompted by reading or non-professional advice to withdraw a psychiatric drug from a child, do it only under careful supervision from a trusted physician. Sudden withdrawal can precipitate a disaster.
There appears to be a serious issue with overdiagnosis of ADHD. Diagnosis is strongly influenced by classroom observations that lead ultimately to labelling and treatment. These observations are based in part on subjective comparisons across children in the same grade of school. Two papers recently addressed the problem of the greater likelihood of being labelled with ADHD if a child is young for their grade rather than old for their grade, a problem that arises because of the use of an age cut-off for admission. Many of these children do not have ADHD, they are merely acting their age!17,18 This is a serious issue because the label sticks and many are then medicated long-term.
Almost all studies involving either adults or children are very short term. Commenting on this in an article posed November 5 in the Huffington Post, Dr. Ronald Ricker, a psychiatrist and founder and director of the Linden Center, points to an ad in Clinical Psychiatry News, which concerned the new drug Intuniv for ADHD. The ad indicated that two clinical trials were run prior to FDA approval. One lasted six weeks, the other nine. He comments, "I think our children deserve a vastly more through evaluation by the FDA prior to approval of this or any drug. How one determines the actual usefulness and safety of a new drug in 6 to 9 weeks of clinical trials completely escapes me".
The only long-term randomized trial of stimulants focused on children looked at outcomes of short-term (14 weeks) intensive stimulant therapy against a placebo or behavior therapy or both and then conducted long-term follow-up. The study found that the end of 8 years there was no evidence of benefit for the use of stimulants in this age group as compared to non-drug interventions.19 In addition, the short-term benefit seen in the classroom, which is a significant part of the basis for regulatory approval and popularity among prescribers, parents and teachers, is based on the capacity of stimulants to suppress all spontaneous behaviour and to enforce obsessive behaviour. While this may solve a classroom problem, critics regard this as a highly undesirable result if it continues for any length of time. Also, there was no evidence of improvement in learning or educational performance associated with stimulant therapy4,19
Some studies directed at children may have been designed in a manner akin to fraud and produce meaningless results. A psychiatrist employed by a major drug company has pleaded guilty to committing research fraud in trials of an antidepressant where the subjects were children. She was accused by the FDA of enrolling children in a clinical trial even though she knew they did not have a major depressive or obsessive-compulsive disorder, the condition under study, and is serving a 13 month sentence in prison. She simply falsified records and psychiatric diagnosis. According to media reports, she was paid $5000 for each child enrolled.
Parents probably not generally appreciate it, but all but one ADHD medication is a U.S. Drug Enforcement Agency Schedule II drug which translates to being a category considered to have strong potential for abuse or addiction. Included in Schedule II are opium, morphine and cocaine. The one exception, Strattera, is marketed as a non-stimulant, but Breggin considers it more deadly than the Schedule II drugs.
The most serious questions involve the impact of stimulants on brain development and adverse side effects that seriously alter personality and attitudes. The common belief is that very little if anything is known regarding the impact on the developing brain.16 However, Breggin deals at length with this aspect and provides a number of examples strongly suggesting the potential for long-term brain damage and even cancer. Animal studies provide overwhelming evidence of profound risk. Furthermore, the adverse effects he lists and documents, some of which appear shortly after starting on medication, are shocking, given that stimulant drugs are so widely prescribed. He classifies them as impacting brain and mind function, cardiovascular function, gastrointestinal function, endocrine and metabolic function, and withdrawal and rebound. Over forty specific harmful effects are listed4 (Table 11.2). If in the first place the diagnosis was by and large nonsense, then the situation is even more shocking. In addition to Breggin's book, the book by Robert Whitaker mentioned above is highly recommended for a comprehensive and well documented view of the special case of children (see chapters 11 and 12).
Children are not only being given stimulants for ADHD, many of which are actually amphetamines, they are prescribed antidepressants and antipsychotics. Antipsychotic treatment of children ages 2 to 5 (not a misprint!) doubled between 1999-2000 and 2007. The disorders treated by this class of powerful drugs were pervasive developmental disorder or mental retardation, attention deficit/hypertension disorder (ADHD), the disruptive behaviour disorder and bipolar disorder.13,20 David Healy points out that new generation antipsychotics, which are as dangerous or more so than the original drugs are being given to preschoolers in North America to treat bipolar disorder while most of the rest of the world does not even believe this disorder really happens in children. For fifty years antipsychotic drugs were historically viewed as too dangerous to use outside secondary care and were largely restricted to those with chronic psychotic disorders where the benefits justified the hazards of treatment.13 A systematic review in 2004 which included published and unpublished (suppressed) studies found that risks of SSRIs outweigh benefits for children diagnosed with depression.5 A meta-analysis published in 2008 found no benefit associated with psychiatric drugs measured in terms of response for children under 12 years of age.9. While some evidence exists of benefit from fluoxetine in the treatment of major depression in children, the benefit vs. a placebo was "modest" and not seen in all efficacy variables nor within all types of statistical analysis.21 Studies of long-term effects were not done. But as discussed above, benefit appears to be an illusion, in part caused by spellbinding.4 The simple fact is that pediatric therapy with antidepressants or antipsychotics is not evidence based but rather, to quote David Healey, "eminence-based medicine".13 Healy and Le Noury, in their scathing critique of the treatment of pediatric bipolar disorder, which they describe as an object of study in the creation of an illness, comment "a number of forces appear to have swept aside traditional academic scepticism with the result that an increasing number of children and infants are being put on cocktails of potent drugs without any evidence of benefit".22
Another serious issue on the horizon that impacts children involves schizophrenia, a disorder that most frequently presents in the adolescent years or the 20-30 age group. There is currently considerable research and interest in identifying the early markers, either genetic, biochemical or psychological, that predict this disorder. The motivation is that this will lead to therapy, including a drug intervention protocol that would prevent progression.23 However, psychiatric drug therapy could be a prescription for disaster. As mentioned above, brain development is still occurring during adolescence. The neurological and physiological aspects of schizophrenia are poorly understood at best. In fact, partly for this reason some major companies have recently decided to pull out of psychiatric pharmacology altogether.24 Long-term (10-20 years minimum) studies of adverse effects are out of the question for any company in business to make money. The short-term nature studies that lead to drug approval in this context should be sufficient cause for parents to reject drug therapy or advise their older children that this is unwise. Consider Breggin's position. Tinkering with cerebral biochemistry with drugs appears to produce only damaged brains.
Finally, it is interesting to consider a private institution in California that among other things provides a home of last resort for severely damaged children. When they arrive, they are typically on several psychiatric drugs, firmly believe they can't live without them, and in many cases have been reduced to the zombie state. The approach taken by this institution is by Robert Whitaker.15 It involves gradual withdrawal from all drugs, a process that initially is difficult and challenging but when successful reclaims the individual.
RISK OF ADDICTION AND SUICIDE
Modern terminology seems to prefer dependence to addiction. Whichever term is used, psychiatric drugs that become addictive present a very serious problem, since there is frequently the need to continuously increase the dose level, which in turn increases the severity of side effects. Attempts to withdraw are accompanied by many of the same problems experienced by narcotic drug addicts. The problem of addiction arises principally with the stimulants such as Ritalin used to treat ADHD. The scenario plays out as one would expect from narcotic addiction. Consider the addicted adolescent. Parents and the doctor become alarmed and attempt to withdraw the drug. This drives the addict to stealing, forging prescriptions, finding illegal sources, etc. The prescription drug has become like a typical street drug, which is not surprising given that most ADHD drugs are amphetamines or behave biologically in the same way as this type of drug. As the patient spirals down into the depths of addiction, suicide becomes a real possibility. By then neither the doctor nor the parents have any control or way of dealing with the problem aside from temporary and perhaps forced confinement to a rehab center. In his book Medication Madness, Peter Breggin provides case histories that end in suicide. The patients were teenagers. In all fairness, it is true that many children and adolescents take stimulants without having to deal with addiction. However, judging the risk prior to the first prescription is probably impossible.
The risk of suicide is not restricted to stimulants used to treat ADHD. Both antidepressants and tranquilizers also have this unfortunate side effect and for antidepressants it is a major issue which requires black box warnings, the highest level of concern, mandated by the FDA. Incidentally, it is not uncommon for treatment with stimulant drugs to lead to antidepressant therapy. Medication Madness contains three case histories where antidepressants were associated with suicide, in either an adolescent or adult. Suicide is simply one manifestation of the potential for worsening mental conditions associated with this class of drug.
Breggin also points out in Medication Madness that it is impossible to diagnose underlying psychiatric disorders when a patient is abusing street drugs. Drug abuse or addiction mimics every possible psychiatric problem from ADHD to bipolar disorder and brief psychosis to anxiety disorder and sociopathic personality disorders. If the drug abuse or addiction is resolved, then it is frequently observed that the patient no longer fits into any psychiatric diagnostic category except substance abuse in remission. The point would appear to be that one does not treat addiction to or abuse of street drugs with psychiatric drugs and to do so may only make matters worse. Breggin also makes readers aware of the research indicating that a long-term study of children treated with Ritalin found that they have a seven-fold increased risk of using cocaine as a young adult. This strengthens the argument that stimulants are implicated in long-lasting abnormalities in the brains of children. Also he mentions cases where young patients who had their Ritalin stopped turned to cocaine which turns out physiologically to be the best substitute.
Medication Madness contains case reports of serious violence associated with psychiatric drugs but only very recently has this phenomenon been systematically studied. In a paper published in PLoS One (December 2010), Moore et al25 appear to be the first to subject government adverse event reporting databases to an analysis with this in mind. Their method identified drugs which were strongly disproportionally reported. Their method corrected for extent of clinical use, reporting rate, size of the patient population treated, and the magnitude of international sales. Violence was defined for the study as homicide, physical assault, physical abuse, homicidal ideation or a violence related symptom. Suicide and spousal abuse were excluded, as were aggression, belligerence and hostility. The results were impressive. The overwhelming majority of drugs do not stand above the crowd in terms of this approach to measurement of the prevalence of violence. But based on their data, the psychiatric drugs look like weeds standing almost alone above a field of grass and some of them are very large and impressive.
While varenicline (Chantix or Champix), a very heavily advertised aid for smoking cessation had the strongest association with violence by every measure, 11 antidepressant drugs, 6 sedative/hypnotics and three ADHD drugs were identified as having important or very strong associations with violence. The evidence was weaker or mixed for antipsychotic drugs and absent for all but one anticonvulsant/mood stabiliser. Psychiatric drugs that increase the availability of serotonin and dopamine dominated the list. This is also how varenicline works. Widely used mood stabilizers, which gave no indication for concern, do not function through this mechanism. It is interesting that many of the drugs implicated in violent behaviour also carry warnings regarding suicide, especially antidepressants. Among the ADHD drugs, amphetamines and atomoxetine ranked with the worst antidepressants but methylphenidate (Ritalin) was only about half as dangerous. This study did not look at multiple drug use, which might make the picture more alarming.
These results illustrate the large human variability in reactions to the brain altering actions of psychiatric drugs since millions are on these drugs but the incidence of violence is small. But it is obviously really bad when it happens. However, it is widely appreciated that the vast majority of adverse reactions go unreported. Some estimates are as high as 98-99%. However, this probably would not change the picture - higher grass, much higher weeds. These drugs will continue in use for the foreseeable future, and the only hope is that clinicians will become more aware of the problem, look for early signs and encourage those close to the patient to do likewise. This paper is in the public domain. Google T. J. Moore and PLoS One.
A CHALLENGED INDUSTRY
In a commentary in the journal Nature, Allison Abbott presented interesting insight into the challenges faced by the psychiatric drug designers.24 The development of psychiatric pharmaceuticals started over 50 years ago. A popular antipsychotic at that time was perphenazine, but its use was accompanied by horrible side effects. Later a new class of antipsychotic drugs, called second-generation, was introduced and presented as causing fewer side effects, especially associated with uncontrollable body movements. But some questioned that this new generation was really superior and a large government sponsored trial (CATIE) was carried out in the U.S. and reported in 2005. The results came as a shock to the profession and the industry. The trial made it clear that the new therapies barely differed from the old, as represented by perphenazine. The new drugs were just as effective in controlling delusions and hallucinations, but patients taking the new drugs remained confused, socially withdrawn and lacked drive, just as they did on perphenazine. Side effects associated with the new drugs were so bad that three-quarters of the trial patients dropped out of the CATIE trial during the 18 months of treatment, regardless of which drug they took.
The results of CATIE made it clear that it was time to go back to the drawing board. Several giant pharmaceutical companies declined to accept the challenge and have left the field altogether.24 Among other problems, the real challenge was in understanding the system with which they were dealing. As Thomas Laughren, the FDA's director of psychiatric drugs, pointed out, "we don't even understand schizophrenia at the biological level".24 Attempts to regain momentum and achieve real success have been mainly based on enhanced cooperation and information exchange between interested parties including academic groups, Big Pharma, and small biotech firms. For example, one consortium has developed a nose operated rodent touch-screen technology to facilitate animal studies. This is not an attempt to be funny. Some might say that this does not represent much progress in solving the fundamental problem that the brain/mind system is so complex and the networks so intertwined that one needs to be pathologically optimistic to see any light at the end of the drug discovery tunnel.
We are talking about an industry that had sales just for schizophrenia drugs in 2007 of $10 billion on the basis of 55 million prescriptions. By 2007 essentially the entire market was in the second generation antipsychotics. It is estimated that the disease affects about 1% of the world's population. That statistic in itself is food for thought. In 2009 the U.S. spent about $170 billion on mental health services with the tax payer picking up about 60% of the tab.15 A major component is medication.
THE BOTTOM LINE
Life circumstances can produce depression, anxiety, insomnia or some other reaction to the external circumstances. Children may exhibit behavioral problem, as they always have. These are normal human reactions or behaviours in many but of course, not all cases. Also, there are those exhibiting serious psychological disorders, some presenting crisis situations. Traditionally, a variety of non-drug approaches was used and many individuals returned to normal, or the individual simply dealt with the problem in their own way and most recovered. But in the modern era, the symptoms are viewed as suggesting brain pathology, and a disorder diagnosed with the aid of the current bible, the Diagnostic and Statistical Manual of Mental Disorders, called the DSMD-IV. Disorders are then frequently "treated", mostly by medication but much less frequently with non-drug approaches. In some cases the patient self-diagnoses a problem and convinces the family physician to prescribe some pills. The medication produces psychiatric effects, in some cases almost instantly, in other cases after longer use. These may be initially viewed as an improvement, but as time passes, this view may change and the patient's condition may appear to worsen. In spite of no justification, this is viewed as uncovering disorders already present at the initial diagnosis rather than the result of the action of the drug. The medication is seen as not working adequately, or not up to the real challenge, or not being given at an adequate dose, so the dose is increased and new drugs may be added. Problems may become more severe and are interpreted as indicating the need for additional drugs. Antidepressants may replace or supplement stimulants used for ADHD. The choice available within each class of drug is impressive. In this field, so-called polypharmacy appears to be the rule rather than the exception. But there is ample anecdotal evidence that just increasing the dose of the original single drug can for some patients rapidly bring about disaster, including violence and suicide, and this is in individuals with no prior indication of violent or suicidal tendencies or thoughts. When changes in medication make the patient worse, the answer is to play with dose and try more drug switching. At this point, the typical patient is on 3 to 5 drugs, which confirms the reality of a downward spiral.
The real problem, which started with the first prescription, perhaps for symptoms that were relatively mild, is not addressed but amplified. The patient has gone from being mildly symptomatic to disabled. Few following the mainstream standard of practice apparently ever stop to consider that this downward spiral is caused by the drugs prescribed or that side effects are a misnomer and really reflect the principal drug action.
The end result is apparently highly variable but the minimum long-term impact generally results in an individual who is significantly mentally, socially and emotionally altered without in many cases being aware of what has really happened. In some cases the individual becomes violent, commits crimes without even being aware of doing something wrong, tries or succeeds in committing suicide, injures or kills family members, co-workers or even strangers, and ends up either institutionalized, incarcerated, under the control of the courts or on disability assistance. Repeatedly it has been pointed out that most individuals involved in mass shooting episodes were taking psychiatric drugs. Nevertheless, what ever happens, frequently medications are continued if not increased in number or dose, or both. In many cases, the notion is not even entertained that the problems were started and caused by the initial drug treatment and that everything done subsequently simply exacerbated the problem.
It is the brave institution or physician, when confronted by patients "at the end of the road", that steps outside the mainstream and tests the drug elimination hypothesis by gradual drug withdrawal of all psychiatric medication. Some might view this as malpractice - a radical departure from the standard of care. Yet this may well be the only approach offering hope of recovery and a return to normal. The brain damage at this late stage in the therapy may be so extensive that recovery can only be partially achieved even if all drugs are removed. For case histories supporting the above picture in vivid detail, read Peter Breggin's book Medication Madness. The reader is warned than most cases he describes do not have happy endings and in each case history, generally more than one life is forever altered. As Breggin puts it, "Medication madness cuts a wide, deep swath of misery through the lives of family and friends". However, a balanced view is necessary. Obviously not everyone on psychiatric drugs by any means suffers from gross side effects described in the above scenario. It is not even clear that anyone knows the real numbers, and there are many degrees of seriousness and disability involved. Those going through life spellbound by drugs do not even know what has happened or why.
The view presented in the books cited above is very far removed from the mainstream. The big picture, which is one of significant long-term failure and harm for a significant number of those "treated" with drugs is in a blind spot and ignored aside from the occasional editorial and commentary in the peer-reviewed literature. There seems to be a problem with denial, of missing the big picture. The campaign to convince both the profession and the general public that a wide variety of psychological symptoms, many common to everyday life, in fact have a pathological (biological) origin in the brain, has been extraordinarily successful. As well, the notion that modern pharmaceutical science has the answer in safe and effective pills is now widely accepted.
This may seem like a long prelude to a review on alternative approaches, but the above perspective is essential to provide an incentive for individuals who have psychological problems to consider the contrarian evidence. The risk that psychiatric drugs may only make matters worse and result in permanent harm should be of paramount concern. The importance of seriously considering alternatives extends from individuals to parents under pressure from schools or physicians to medicate children with psychiatric drugs and to children watching their elderly parents becoming excessively medicated zombies through the use of psychiatric drugs.
If the standard of practice changed to employ mostly one or more of the various forms of psychotherapy, this would overwhelm the psychiatric community, might find many uncomfortable with providing such treatment and would be an admission of operating for several decades with a false paradigm. However, some psychologists also engage in non-drug therapy. Another very important issue involves looking for common medical disorders that trigger psychological problems. The most prominent are diabetes and thyroid gland dysfunction. Finally, there is diet which can induce psychological problems through allergies to certain proteins, reactions to neurotoxins commonly masquerading as food additives, excessive sugar intake, or last but far from least, through micronutrient (vitamin and mineral) deficiencies. The documented benefits of micronutrient or thyroid intervention in this context suggest that while biochemical imbalances of the sort that modern psychiatry postulates, e.g. involving serotonin or dopamine, have never been demonstrated prior to psychiatric drug treatment, there can be important imbalances associated with hormones and as well the micronutrients which supply essential cofactors for the myriad of enzyme controlled reactions that are essential for a healthy brain.
The information presented in this review is not intended to be medical advice nor should it be regarded as such. The reader is also advised that stopping taking psychiatric drugs is associated with significant risk and that withdrawal can be very dangerous and should be carried out only under the close supervision of a medical professional. Please consult your healthcare provider if you are interested in following up on the information presented in this review.