Saving Normal CHAPTER 3. Diagnostic Inflation

← Saving Normal An Insider’s Revolt against Out-of-Control Psychiatric Diagnosis, DSM-5, Big Pharma, and the Medicalization of Ordinary Life

Saving Normal CHAPTER 3. Diagnostic Inflation

Author: Allen Frances Publisher: New York, NY: HarperCollins. Publish Date: 2013 Review Date: Status:⌛️

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Medical research has made such enormous advances that there are hardly any healthy people left.

ALDOUS HUXLEY

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The hype for prevention has been everywhere. Breakthroughs in medical science are breathlessly announced daily. New tests are constantly being devised and the thresholds of abnormality of old tests lowered—creating hordes of new patients. Doctors order expensive batteries of every conceivable test on every patient, just to be on the safe side. Advertisements promote the benefits of screening and the terrors of letting disease go unfettered. The screening scare tactics have been an enormous financial success for their promoters, but the evidence shows that with few exceptions (e.g., screening for lung cancer in smokers or colon cancer in everyone), the testing is often not good for the patients—not really improving outcomes, while further burdening them with aggressive, expensive, and unnecessary treatments. And the waste to society runs to hundreds of billions of dollars a year that could be better used treating really sick people who are currently not insured. Preventive medicine is a terrific goal gone badly astray because it became industrialized and enslaved by profit and hype.

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Sanity is beginning to prevail. Recently, nine professional societies have initiated a “Choosing Wisely” campaign, publishing a list of forty-five previously heralded tests and procedures that had been vastly oversold.2 Prostate cancer screening is no longer recommended—it failed to save lives and resulted in much needlessly aggressive surgery. Breast cancer screening has been much truncated. No more CT scans for headaches or X-rays for back pain. And it turns out that bronchodilators and oxygen don’t work for most people with chronic obstructive pulmonary disease.3 The list is long and telling. Evidence-based medicine is demonstrating that the push to prevention has been excessive, premature, and not evidence based.

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Early identification of illness suffers from the “needle in the haystack” problem. Screening tests routinely set their bar low so as not to miss people who need identifying but in the process inevitably wind up mislabeling lots of people who don’t.4,5 The benefits to the few, if any, are outweighed by the harms to the many. Some of the misleading hype for early intervention comes from the good faith enthusiasm of medical researchers and practitioners eager to help patients fight disease. But best advice for them comes from the White Rabbit in Alice in Wonderland: “Don’t just do something, stand there.”

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“Choosing Wisely: Five Things Physicians and Patients Should Question” (2012) ABIM Foundation, http://choosingwisely.org/?page_id=13.

3. Paul Enright, “A Homeopathic Remedy for Early COPD,” Respiratory Medicine 105 (2011): 1573–75.

4. U.S. Preventive Services Task Force, “Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement,” Ann Intern Med 151, no. 10 (2009): 716–26.

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And the profit motive also plays a part. Fifty years ago, President Eisenhower presciently predicted the economic and social damage that would be caused by a too-powerful military-industrial complex.6 In a parallel development, we have witnessed the explosive growth of a too- powerful medical-industrial complex comprising Big Pharma, insurance companies, testing laboratories, equipment and device makers, hospitals, and doctors—all eager to expand the market by creating a new reservoir of allegedly “about-to-be-sick” well people who need testing and treatment to avoid ever becoming sick in the future.

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R. Harris, “Overview of Screening: Where We Are and Where We May Be Headed,” Epidemiologic Reviews 33, no. 1 (2011): 1–6.

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The United States spends almost twice as much on per capita medical care as the rest of the world.7 This is a terrific drain on our economy and our $2 trillion investment has paltry returns. We get mediocre medical outcomes, excessively test and treat those without need, and fail to provide adequate care for many in great need. You probably couldn’t design a less efficient or less equitable system if you tried hard to do so.

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Andrew J Bacevich, “The Tyranny of Defense Inc.,” The Atlantic (January/February 2011) http://www.theatlantic.com/magazine/archive/2011/01/the-tyranny-of-defense-inc/308342.

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Meanwhile we neglect what are the best forms of prevention—i.e., promoting exercise, proper diet, moderation in alcohol use, abstention from tobacco and drugs. These extremely useful and remarkably cheap prevention measures aren’t profitable for the medical-industrial complex and therefore lack its powerful and well-financed sponsorship. The biggest improvement in the health of our country in the last thirty-five years came from the relatively inexpensive campaign to reduce smoking—not from the enormously expensive efforts of the medical-industrial complex. A similar campaign to reduce overtesting and overtreatment would save us money and make us healthier. Let’s hope that “choosing wisely” helps to correct the excesses of preventive medicine.

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And let’s hope that the snake oil of premature preventive medicine doesn’t spread to psychiatry. Those who promote the value of wider boundaries for psychiatric disorder make the argument that identifying and treating the mildly mentally ill will help them avoid later becoming the severely mentally ill, drawing support from the presumed glowing success that has been achieved by medical screening and early intervention.8 But there is a serious fly in this ointment—early intervention in medicine is mostly a flop and provides a terrible model. Psychiatry is wrongheadedly copycatting the very worst aspects of American medicine—the combination of harmful excess for some, combined with heartless neglect for others.

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Organisation for Economic Co-operation and Development, “Why Is Health Spending in the United States So High?”(2011); http://www.oecd.org/unitedstates/49084355.pdf.

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P. D. McGorry, “Is Early Intervention in the Major Psychiatric Disorders Justified? Yes,” BMJ 337 (2008): a695.

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theory has it that we are not sicker than before, just better able to spot previously missed sickness. Some part of diagnostic inflation is surely desirable—picking up previously missed cases. But only a part, and probably a small one. Diagnostic labels can’t be applied with surgical precision to accurately distinguish those who truly need a diagnosis from those who don’t. At the extremes of severe illness and complete health, the distinction is indeed obvious. But the boundary between mental disorder and normality is so fuzzy that whenever we quickly expand the use of psychiatric labels to identify some few people who do need help, we misidentify many others who don’t.

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Human nature is stable and resilient. There has been no real epidemic of mental illness, just a much looser definition of sickness, making it harder for people to be considered well. The people remain the same; the diagnostic labels have changed and are too elastic. Problems that used to be an expected and tolerated part of life are now diagnosed and treated as mental disorder. The application, or withholding, of a sickness label in these boundary situations determines how we see ourselves as individuals and as a society. If we create an overly broad definition and apply it liberally, we readily recruit an army of new “patients,” many of whom will have been much better left to their own devices. We are not a sicker society in any real sense—even if we see ourselves that way.

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there are other societal trends that do promote the sense that we are getting sicker. Our world is homogenizing—we have increasingly less tolerance for individual difference or eccentricity and instead tend to medicalize it into illness. The youngest boy in the class isn’t the most active because he is just a young boy—instead he must have ADHD and should be put on a pill.11

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And our society is becoming increasingly perfectionistic. Falling short of complete happiness or failing to have a worry-free life is too often translated into mental illness. Our goals are set too high and our expectations are unrealistic—especially when it comes to our kids.

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Fashions in psychiatric diagnosis have recently become almost as fickle as the popularity of rock stars, trendy restaurants, and travel destinations. Because there are no biological tests or clear definitions that distinguish normal from mental disorder, everything in psychiatric diagnosis depends on very easily influenced subjective judgments. Whenever rates of a mental disorder jump explosively, the safe bet is always on fad. Assume that many, if not most, of the newly identified “patients” are really “normal enough.” They have been mislabeled and will likely be overtreated.

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Psychiatric fads start when a powerful authority gives them force and legitimacy. The DSM system, and the “experts” who fashioned it, have been the main fashion setters—the driving force in identifying new mental disorders and defining milder forms of those that had been previously described. Unfortunately most experts suffer from an intellectual conflict of interest that biases them toward diagnostic inflation. Focused on their specialized research, they miss the big picture—always worrying so much about not having a diagnosis for a patient who needs one that they ignore the risk of mislabeling someone who doesn’t.

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There is also an emotional element. Experts become true believers who really come to love their pet diagnoses and want to see them grow. While each one presses for only a small expansion, their aggregate pressure blows up the inflationary balloon. In my thirty-five years of herding experts, not once has anyonet ever suggested raising the bar to narrow the scope of his pet area.12

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The media and the Internet feed on and feed fads. In the wired modern world, false epidemics can be spread like wildfire fueled by the 24/7 coverage. Some of the spotlight is extremely valuable—leading to better public understanding and acceptance of mental disorder, but many stories breathlessly hype diagnostic inflation. “Autism is one in eighty!!!” “The test and cure for Alzheimer’s are just around the corner!!!!” “Does your child have ADHD?? “Bipolar is underdiagnosed says Harvard doctor!!!!” And the Internet provides wonderful support, social interaction, information, and destigmatization for people with psychiatric symptoms—but also undercuts normality, as essentially healthy people incorrectly self-identify themselves as sick in order to gain the comforts that come with admittance to the group. Celebrities also play their part as exemplars of diagnoses and endorsers of treatments.

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Of course, the biggest promoter of recent fads has been drug company marketing. But that is a sad story in itself that we will get to soon.

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Human nature being what it is, the prevalence of any psychiatric diagnosis will rise artificially whenever it is a gatekeeper to something valuable. In a simpler world, psychiatric diagnosis was once based only on perceived clinical need. But now that it has gained powerful (and unwelcome) influence on many administrative and financial decisions, these decisions have also reciprocally obtained a powerful influence on the rates of diagnosis. Diagnostic inflation is promoted whenever a physician provides an “up-diagnosis” to help a patient gain access to something valuable—like disability benefits or school services. If autism, ADHD, or pediatric bipolar disorder is a prerequisite to being admitted to a small class with lots of individual attention, equivocal cases get shoehorned into these categories, and soon an epidemic is born.

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In like fashion, “mental disorder” increases whenever there is high unemployment. Some of the people laid off will get a new diagnosis because they have developed symptoms, others because it will make them eligible for disability. Because veterans’ benefits require a diagnosis of PTSD, PTSD gets overdiagnosed. There is a paradox—trying to help by providing a diagnosis may wind up hurting. Many returning vets from Iraq and Afghanistan are having trouble landing jobs because of the stigma associated with their diagnosis of PTSD. And overdiagnosis distorts allocations across the system, reducing resources and benefits for those who most need them.

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The most senseless driver of diagnostic inflation is the way medical insurance works in the United States. To get paid, the doctor must make an approved diagnosis. This is intended to prevent frivolous visits. But the unintended effect is just the opposite of prudent cost control. A premature rush to a reimbursable psychiatric diagnosis often results in unnecessary, potentially harmful, and often costly treatment for problems that would have disappeared on their own. It would be a lot cheaper and better for insurance to reimburse the doctor for watchful waiting and counseling, rewarding him for not jumping to diagnostic conclusions that are very costly in the long run. This perfectly sensible solution is the policy in the rest of the world.

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Every so often, the newspaper will report that rates of psychiatric disorder are climbing, sometimes dramatically. The best current examples are autism and attention deficit disorder. Don’t believe the numbers. The “rates” have been generated by psychiatric epidemiologists, using a method that is inherently flawed and systematically biased in the direction of overreporting.

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How can an entire field of scientific endeavor have gone so far astray? It comes down to simple dollar-and-cents considerations. Epidemiological studies have to sample huge numbers of people in the general population, usually using telephone interviews. It would be too expensive to employ clinicians in so extensive an endeavor—so the studies rely on the cheap labor provided by lay interviewers who have no clinical experience and no discretion in judging whether symptoms are clinically meaningful. They make their diagnoses of psychiatric disorders based on symptom counts alone with no consideration of whether the symptoms are severe or enduring enough to really warrant diagnosis or treatment.

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This results in rates that are always greatly inflated. Psychiatric symptoms in mild form are widely distributed in the general population—from time to time, almost everyone will have some sadness or anxiety, and others may have difficulty concentrating or be a bit eccentric. But isolated or mild symptoms alone do not define psychiatric disorder—they must cohere over time in a specified way and also cause significant distress or impairment. Epidemiologic studies routinely ignore these crucial requirements. They mistakenly diagnose as psychiatric disorder symptoms that are mild, transient, and lacking in clinical significance.13

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Brian Deer, “How the Case Against the MMR Vaccine Was Fixed,” BMJ 342 (2011), http://www.bmj.com/content/342/bmj.c5347.

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L. Batstra and others, “Childhood Emotional and Behavioral Problems: Reducing Overdiagnosis Without Risking Undertreatment,” Dev Med Child Neurol 54, no. 6 (2012): 492–94.

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R. L. Morrow and others, “Influence of Relative Age on Diagnosis and Treatment of Attention-Deficit/Hyperactivity Disorder in Children,” CMAJ 184, no. 7 (2012): 755–62.
Peter Parry, “Paediatric Bipolar Disorder (Pbd) and Pre-Pubertal Paediatric Bipolar Disorder (PPBD)—a Controversy from America,” (2009) Black Dog Institute,http://www.blackdoginstitute.org.au/docs/PaediatricbipolardisoderacontroversyfromtheUSA.pdf.
A. Frances, Editorial: “Problems in Defining Clinical Significance in Epidemiological Studies,” Arch Gen Psychiatry 55, no. 2 (1998): 119.

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Results generated in this rough-and-ready way are no more than an upper limit on the prevalence of any given mental disorder. They should never be taken at face value as a true reflection of the real extent of illness in the community. Unfortunately, the exaggerated rates are always reported without proper caveat and are accepted as if they are an accurate reflection of the real prevalence of psychiatric disorder. Disraeli exaggerated only a tad when he said: “There are three kinds of lies: lies, damned lies, and statistics.”

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The epidemiologists are good bean counters, but they are not clinicians and probably don’t know any better. Pharma is less innocent—the results are used to promote the misleading notion that psychiatric disorder is everywhere. The National Institute of Mental Health also likes high rates because they support budget requests to Congress—if mental disorder is everywhere, we should be spending a lot more to research its causes.14

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Before the 1950s, the psychotropic drug business was small, and the available drugs were terrible. The opiates and the barbiturates were popular with patients but were nonspecific in their effects and caused big-time problems with addiction and overdose. Bromides, paraldehyde, chloral hydrate, and Miltown were all pretty useless and had hard-to-take side effects. By the time I began prescribing psychiatric drugs in the 1960s, these old medicines had been mostly superseded by the newly discovered and specific wonder drugs in psychiatry—Thorazine for psychosis, lithium for mania, and Elavil and Nardil for depression. But giving these medicines to patients was still a relatively new thing and a big deal. I trained on the first unit in the United States to use lithium, and we were frankly scared to death of it—an overdose could kill patients or destroy their kidneys, and we were not yet completely sure what were the most effective doses and the safest blood levels. It turned out that the Thorazine doses we were using were way too high and transformed our agitated patients into drugged zombies. The antidepressants available at the time were all extremely risky for use with suicidal outpatients—just a week’s worth of pills could be lethal. And they made life miserable for many of the patients taking them—mouth forever parched, bowel movements few and far between, and fainting on standing up a frequent risk. Because the medicines could cause arrhythmias, a fancy cardiac workup had to precede their initiation. Nardil required extremely strict dietary precautions because it interacted dangerously with many foods and with red wine—a little blue cheese, fava beans, or Chianti could be deadly. All of the first psychotropic drugs were so risky and unpleasant to take that only the sickest patients received them, and only well-trained psychiatrists felt comfortable prescribing them.

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The next new wave of “wonder” drugs came in the 1970s. The benzodiazepines, Librium and Valium, changed everything and set a new tone—from now on Pharma’s emphasis would be on developing and marketing medications that produced less intrusive side effects and were less likely to cause death from overdose. This allowed the focus of care to shift away from the very small cohort of really sick patients to the wider world of the worried well. Before long a large percentage of the U.S. population was taking easy-to-take psychiatric medicine. And because treating patients with “benzos” required no great expertise, primary care physicians took over most of the prescribing. These drugs soon were so wildly successful they became part of the American way of life, and the drug companies realized that psychiatric medicines would become their gold mine. Of course, it turned out that Librium and Valium (and even more, their dreadful younger sib Xanax, introduced in the 1980s) were really quite addicting and not so benign in overdose, particularly when mixed with alcohol or other drugs that depress respiration. They were a great boon to the drug companies, but not to the patients.

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Next came the inexorable march of the SSRI antidepressants in the late 1980s and early 1990s—a classic marketing success story. Prozac became a knockout best seller, even spawning a best-selling book by a psychiatrist touting its value not only as an antidepressant but also as a cosmetic drug that could make you better than well.15 Every year or two thereafter, a new SSRI would appear—Zoloft, Paxil, Celexa—and each would also in turn become a runaway best seller. The marketing of these easy-to-use drugs was closely tied to the marketing of what were (according to the drug companies) easy-to-make psychiatric diagnoses. Soon the SSRIs were also prescribed for panic disorder, generalized anxiety, social phobia, OCD, PTSD, eating disorders, premature ejaculation, and compulsive gambling, and as a general pick-me-up. Sure, there were side effects—some frequent (like reduced sexuality); some rare but dangerous (like agitation, suicidality, and violence). But SSRIs fit so neatly into everyday life that 20 percent of women now take them. Diagnostic inflation will always be an inevitable consequence of an aggressively marketed, easy-to-take pill.

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Substance Abuse and Mental Health Services Administration, “Results from the 2009 National Survey on Drug Use and Health: Mental Health Findings,” (Rockville, MD, 2012).
Peter D. Kramer, Listening to Prozac (New York: Penguin, 1993).

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The newer generation of atypical antipsychotics (Risperdal, Zyprexa, Seroquel), introduced in the mid-1990s, are an even more astounding and frightening marketing triumph. Initially they seemed a big step forward—not in efficacy, but in having a much more favorable side effect profile. A patient on traditional antipsychotics had an absolutely characteristic look, easily spotted from far down the hallway—the fixed stare, rigid posture, tremors, abnormal movements, and drooling were dead giveaways. Switched to an atypical, the patient looked and often felt much more normal. Soon these much easier to give and easier to take drugs were climbing to the top of the charts, beating all sales records. This couldn’t have been accomplished within the confines of the narrow schizophrenia market. First, the drug companies had to get an indication for bipolar disorder and then they had to advertise a conception of bipolar disorder so broad as to be unrecognizable. Antipsychotics were soon being prescribed promiscuously, even by primary care physicians, to patients with garden-variety anxiety, sleeplessness, and irritability. The paradox is that dangerous drugs capable of causing massive obesity, diabetes, heart disease, and a shortened life span now account for $18 billion a year in sales. Primary care physicians are prescribing potentially dangerous medications, outside their competence, for people who should not be taking them. Proof again that drugs that are too easy to give and too easy to take will be taken far too often, especially when the lots of money is behind them. In retrospect, the unpleasant side effect profiles of early psychiatric drugs had the value of preventing their overuse and of keeping diagnostic inflation in check.

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Why so big and why so successful? The companies justify their high prices and enormous returns by touting their research efforts to advance medical science and improve patient care. This is mostly fluff. Pharma spends twice as much money ($60 billion) on promotion as on research, and too often they fund the wrong kind of clinical research, done in the wrong way, and with the wrong motives—avoiding lines of inquiry that might actually teach us something important, in favor of surefire “experimercials” that are mostly intended to promote marketing, not discovery.18

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The surest guarantee of profit is to “me-too” over and over again. Developing a drug that might make a real difference for patients is financially risky. The smarter play for exec bonuses and shareholder dividends is to fiddle slightly with existing compounds—just enough to make them patent-ready lookalikes of compounds already on the gravy train. Companies can double the life of their monopoly patent protection by making the most trivial of changes—turning a right-handed drug to a left-handed one that has identical effects or changing slightly the duration of action.

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The second surest way to raise revenue and extend patents is to find new market worlds to conquer for an existing drug—by doing research that will get it used by kids or for a diagnosis different from the one originally approved. The market geniuses guide the research effort, not the science types, and the result is predictable—great sales, lousy discovery.

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To make matters worse, the research is often performed poorly and presented in an incredibly biased way. The data are proprietary and closely guarded; negative results are routinely buried; tiny, trivial, or chance positive findings are hailed as the second coming; investigators are corrupted; and sometimes scientific papers are ghostwritten by company hacks. Side effects and complications are measured perfunctorily and barely reported. There is never a fair risk/benefit/cost calculus—the benefits are exaggerated, the risks minimized, the costs ignored. Drug pricing has no relation to real cost or value and instead reflects Pharma’s monopoly position in the market and its dominance over politicians. At its worst, Pharma research is a deceptive shell game meant to seduce and mislead, rather than enlighten doctors and the public. The claim that drugs are so expensive because they require so much research is pure smoke screen.

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A quick review of the last sixty years shows that the drug companies do not have an enviable research record in psychiatry. The most exciting period of discovery in psychopharmacology occurred in the 1950s—and drug company research had absolutely nothing to do with it. The first antipsychotics, first antidepressants, and first mood-stabilizing drugs were all found by pure lone ranger serendipity, a tribute both to the observational skills of their discoverers and to the home-run effectiveness of the drugs. An alert French surgeon noticed that a drug called Thorazine, used preoperatively to prevent nausea, also happened to calm down his patients and made them indifferent to the stress of the procedure. He passed this nugget on to his psychiatrist brother-in-law, and before long the first specific antipsychotic was born. MAO inhibitors that were used to treat tuberculosis were noted to also cheer up the patients, and we had our first antidepressants. And lithium had an unexpected calming effect on laboratory animals that led to its use in mania. None of these breakthroughs was expensive or industrial —all were the product of a good set of eyes and a prepared brain. Like penicillin, the first drug in each class worked so well you didn’t really need a double-blind study with hundreds of patients to know that you were on to something big. None of the subsequent sixty years of drug company research has ever once come up with a new product that exceeded the efficacy of the early drugs that were discovered in this way by accident.19

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S. J. Williams, P. Martin, and J. Gabe, “The Pharmaceuticalisation of Society? A Framework for Analysis,” Sociol Health Illn 33, no. 5 (2011): 710–25.

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Rick Newman, “Why Health Insurers Make Lousy Villains,” US News & World Report, Money Section, August 25, 2009, accessed September 25, 2012; http://money.usnews.com/money/blogs/flowchart/2009/08/25/why-health-insurers-make-lousy-villains.
M. A. Gagnon and J. Lexchin, “The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States,” PLoS Med 5, no. 1 (2008), http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050001.
Jeffrey Lieberman and others, “Effects of Antipsychotic Drugs in Patients with Schizophrenia,” New England J Med 353 (September 22, 2005): 1209–33.

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Unfortunately, all the low-hanging fruit was picked at the beginning of drug development and the pickings since have been slim and mostly cosmetic. Although late to the starting gate, Pharma quickly caught on to the commercial potential of psychotropic drugs. Many new products were developed and brought to market in the 1960s. The tricyclic antidepressants were an extremely valuable addition to clinical care but had severe limitations as moneymakers because of their troubling side effects and potential for lethal overdose. The real blockbuster breakthrough to the big bucks came when Valium and Librium became household staples. It is an open question whether they contributed more harm or good to patients—they calmed people down but often addicted them and caused all sorts of withdrawal problems. But Pharma had learned a great lesson from them—the real money was in the “user-friendly” medicines that would appeal to a mass consumer market. The SSRIs introduced in the 1980s were the perfect vehicle—no more effective than their predecessors, but much more easily tolerated and safe in overdose. Similarly, the newer antipsychotics were no more effective than their predecessors and carried much worse long-term risks, but were easier to take. This bears repetition—never once has Pharma created a product that exceeded the effectiveness of the drugs available sixty years ago. It has hit many marketing home runs, but usually strikes out when it comes to research. Not an enviable research record after all this time and all this ballyhoo.

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Pharma’s skills lay elsewhere—it is really ingenious and remarkably effective when it comes to marketing and lobbying. Sixty billion dollars a year will go a long way to sell products and buy politicians. In recent decades, the drug companies have efficiently hijacked the medical enterprise by exerting undue influence on the decisions made by doctors, patients, scientists, journals, professional associations, consumer advocacy groups, pharmacists, insurance companies, politicians, bureaucrats, and administrators. And the best way to sell psychotropic pills is to sell psychiatric ills. Drug companies have many methods of doing this: TV and print media adverts; co-opting most physicians’ continuing medical education (often provided at the most expensive restaurants and the nicest resorts; doctors in training and medical students come cheaper—a pizza will do); bankrolling professional associations, journals, and consumer advocacy groups; invading the Internet and social networking sites; recruiting celebrity endorsements. And at one per seven doctors, the drug company sales force (consisting of the most beautiful people this side of Hollywood) has sometimes outnumbered the patients in the waiting room.

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Only a very few people have severe mental illness, many more have mild mental illness, but the real mother lode of market share is the worried well. Pharma wants to strip-mine that mother lode and has achieved fantastic revenues by promoting the idea that many of life’s expectable problems are mental disorders due to a “chemical imbalance” that can be solved with pill popping. The most creative advertising brains and the most extensive market research help push product into places it had never been before. The pitch to customers is that life is perfectible, if only they will take the simple brain-toning steps to perfect it. The subliminal promise is that beyond curing illness, pills can also help achieve a better way of life through chemistry. If you go to the dentist to correct your less-than-perfect teeth, why not go to the doctor to correct your less-than-perfect brains? No one ever need settle for less than happiness and success. Selling new lifestyles works well for selling cars and beers and perfumes and designer clothing—so why not for selling pills? The message is illustrated with compelling graphic images: the rain stops and the sun shines through when you take an antidepressant; the sad sack becomes the confident leader; the couch potato a well-muscled runner. For kids, the cute little frowning rock becomes the cute little smiling rock. The ads always enjoin us to “Ask your doctor.” Of course, the companies have already wired the doctor with a similar message and have provided him with handy free samples to speed you out of the office immediately after you have popped the crucial question.20

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F. S. Sierles and others, “Medical Students’ Exposure to and Attitudes About Drug Company Interactions: A National Survey,” JAMA 294, no. 9 (2005): 1034–42.

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Many doctors are witting or unwitting agents in the pervasive drug company marketing campaign to sell new diagnoses. “Education” and “research” can become sheep’s clothing covering what is really a wolfish marketing pitch. A large stable of psychiatry’s “thought leaders” are recruited to help drumbeat the wondrous benefits that accrue from drugs and to downplay the harms. Things are becoming better now, but for a time Pharma used thought leaders to exert dominance over psychiatry’s educational and research programs. The dozens of industry-sponsored symposia at the annual meeting of the American Psychiatric Association offered the best speakers and the only food and attracted the biggest audiences. Most of weekly grand rounds held at hospitals and medical schools throughout the country were funded by Pharma and led by big-name faculty conveniently supplied by its “speakers’ bureaus.”

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I know about the “thought leader” issue firsthand because I used to be one. My participation with the pharmaceutical industry goes back thirty years and has taken a variety of forms. In the 1980s, I was vice-chair of the APA program committee responsible for organizing its annual meetings. I went along with a group decision to accept drug- company-sponsored symposia—made on the grounds that the topics and speakers offered would be of interest to the membership—not anticipating that before long these would become so popular as to completely overshadow the rest of the meetings and so biased as to be more commercial than disinterested science. For fifteen years I was director of an outpatient clinic at Cornell that occasionally performed drug- company-sponsored research studies. Many of the thousand or more talks I have given over the years were financed directly or indirectly by drug company money. I developed a series of expert consensus guidelines that were industry funded. And as chair of psychiatry at Duke University I presided over a department that had extensive industry sponsorship for a number of its research and educational programs. In none of these activities did I ever once say or publish anything I did not believe to be completely accurate, and I often said and published things that made drug company representatives wince with pain. I always recognized the risk that hidden strings could be attached and don’t think I was ever restrained by them to present things in a biased way. But in retrospect, it was unseemly to have participated in so many activities that could be construed as indirect drug marketing. And I saw the slippery slope facing those who had a deeper involvement and fewer scruples.

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If everyone has the ill, then all must take the pill.21 Already huge, the market in psychotropic drugs is constantly growing. When the adult market seemed saturated, the drug companies expanded their customer demographics by pushing product onto children—it is not by accident that all the recent epidemics of psychiatric disorder have occurred in kids. And children are particularly choice customers—bring them on board early, and you may have them for life. At the other end of the life cycle, companies targeted the elderly, selling antipsychotics like hotcakes in nursing homes. Pharma has not been constrained by the fact that children and the elderly are the two most difficult demographic groups to diagnose accurately or that they are the most vulnerable to harmful drug side effects or that excessive use of antipsychotics in nursing homes results in increased mortality. And, even more troubling, it is the very most vulnerable of kids who get the most medicine—those who are economically disadvantaged or in foster care.22

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R. Mojtabai and M. Olfson, “National Trends in Psychotropic Medication Polypharmacy in Office-Based Psychiatry,” Arch Gen Psychiatry 67, no. 1 (2010).
J. S. Comer, M. Olfson, and R. Mojtabai, “National Trends in Child and Adolescent Psychotropic Polypharmacy in Office-Based Practice, 1996–2007,” J Am Acad Child Adolesc Psychiatry 49, no. 10 (2010).

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Seven percent of Americans are now addicted to a legal psychotropic drug.23 Prescription drug abuse has become a bigger problem than illicit drug abuse. If there is a conceivable way to sell a new diagnosis so that people will incorrectly believe they have it, drug companies will have figured it out and will do it successfully—if sometimes illegally. Big Pharma seems to feel above the law. Almost all of the companies have absorbed huge fines and even criminal penalties as punishment for their illegal sales practices.24 Drugs are approved by the Food and Drug Administration only for the treatment of those mental disorders for which studies indicate there is sufficient efficacy and safety. Although doctors are given the discretion to prescribe a medicine “off-label” for other uses, it is strictly illegal for drug companies to encourage them to do so. The drug company “Hall of Shame” (see below) shows how flagrantly Pharma flouts the law. A seemingly hefty fine of $1.3 billion may be no more than affordable chump change and the cost of doing business, considering the enormous revenues that can be earned through shady marketing. Only much bigger fines and tighter regulations can tame this beast. And doctors should be cautioned that off-label prescribing is out of control, is often harmful, and sometimes constitutes a form of malpractice.

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Substance Abuse and Mental Health Services Administration, “Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings,” NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2012.
Tracy Staton and Eric Palmer, “Pharma’s Top 11 Marketing Settlements” Fierce Pharma (June 26, 2012) http://www.fiercepharma.com/special-reports/top-10-pharma-settlements/top-10-pharma-settlements.

143

In veiled form, placebos are already the great, if unrecognized, success story of drug company marketing. A good deal of medication use in psychiatry (and in medicine) is based on the tried-and-true leveraging of the placebo effect. There are only two differences between now and shaman times or medieval alchemy. First, the marketing of what are essentially expensive placebo products has become well-oiled, massively financed, worldwide, and devastatingly effective. Second, you now need to have a DSM diagnosis to get a prescription for an expensive pill that often has no more usefulness than would a placebo—a great boost to diagnostic inflation. And the crowning irony is that, like wine tasting, it may be that the higher the price, the more effective the otherwise useless pill. How great for the drug companies.

148❗️

In the early 1980s, about a third of Americans qualified for a lifetime diagnosis of mental disorder.45 Now about half do.46 And Europe is catching up fast at well over 40 percent.47 Some people think these are underestimates—more carefully done prospective studies actually double the lifetime prevalence. If you believe the results, our population is almost totally saturated with mental disorders. One study found that by age thirty-two, 50 percent of the general population had already qualified for an anxiety disorder; more than 40 percent for mood disorder; and more than 30 percent for substance dependence.48 And another study moved even closer to the proposition of almost ubiquitous sickness—by the tender age of twenty-one, more than 80 percent of young adults had already met criteria for a mental disorder.49 The trumpeting of inflated rates has fueled drug company claims that we are underdiagnosed and undertreated—keeping the vicious cycle spinning.

368

L. N. Robins and others, “Lifetime Prevalence of Specific Psychiatric Disorders in Three Sites,” Arch Gen Psychiatry 41, no. 10 (1984): 949–58.
R. C. Kessler and others, “Lifetime Prevalence and Age-of-Onset Distributions of DSM-IV Disorders in the National Comorbidity Survey Replication,” Arch Gen Psychiatry 62, no. 6 (2005): 593–602.
R. de Graaf and others., “Prevalence of Mental Disorders and Trends from 1996 to 2009. Results from the Netherlands Mental Health Survey and Incidence Study-2,” Soc Psychiatry Psychiatr Epidemiol 47, no. 2 (2012): 303–13.
T. E. Moffitt et al., “How Common Are Common Mental Disorders? Evidence That Lifetime Prevalence Rates Are Doubled by Prospective Versus Retrospective Ascertainment,” Psychol Med 40, no. 6 (2010): 899–909.
W. Copeland and others, “Cumulative Prevalence of Psychiatric Disorders by Young Adulthood: A Prospective Cohort Analysis from the Great Smoky Mountains Study,” J Am Acad Child Adolesc Psychiatry 50, no. 3 (2011): 252–61.

148

Evidence of diagnostic inflation is everywhere. There have been four explosive epidemics of mental disorder in the past fifteen years. Childhood bipolar disorder increased by a miraculous fortyfold50; autism by a whopping twentyfold51; attention deficit/hyperactivity has tripled52; and adult bipolar disorder doubled.53 Whenever rates skyrocket, some portion of the rise represents previously missed true cases—people who really need the diagnosis and the treatment that follows from it. But more accurate diagnosis can’t explain why so many people, especially kids, suddenly seem to be getting so sick.

369

C. Moreno, G. Laje, C. Blanco, H. Jiang, A. B. Schmidt, and M. Olfson, “National trends in the outpatient diagnosis and treatment of bipolar disorder in youth,” Arch Psychiatry 64 (2007):1032–39.
CDC estimates 1 in 88 children in United States has been identified as having an autism spectrum disorder (accessed October 8, 2012); http://www.cdc.gov/media/releases/2012/p0329_autism_disorder.html.
B. Bloom, R. A. Cohen, and G. Freeman, “Summary health statistics for U.S. children: National Health Interview Survey, 2010,” National Center for Health Statistics. Vital Health Statistics, Series 10, no. 250 (2011); http://www.cdc.gov/nchs/data/series/sr_10/sr10_250.pdf.

149

Psychotropic drugs are now among the very top best sellers for the drug companies. Their stock prices would be cut by more than half were it not for the antipsychotics, antidepressants, stimulants, antianxiety agents, sleeping pills, and pain meds Each year, 300 million prescriptions are written for psychiatric drugs in the United States alone.54 At the very top of the Pharma hit parade are the antipsychotics at a resounding $18 bi ll i o na ye a r . A n t i d e p ress an t s p ro d u ce aha r d y$ 12 billion a year, despite the fact that many are now off patent and sold in cheaper generic versions. Fifteen years ago, stimulants were a rounding error in drug company sales at a measly $50 mi ll i o na ye a r . N o ww i t h d i rec t - t o - co n s u m er a d v er t i s in g an d h e a v y ma r k e t in g t o d oc t ors, s a l es ha v e b ee nj u i ce d u pt o ah e f t y$ 8 billion a year.55 And because primary care doctors love to prescribe them, antianxiety agents are eighth in sales among drug classes—even though they probably do much more harm than good.

369

T. A. Ketter, “Diagnostic features, prevalence, and impact of bipolar disorder,” J Clin Psychiatry 71, no. 6 (June 2010): e14.
Richard A. Friedman, “A Call for Caution on Antipsychotic Drugs,” New York Times, Health Section, September 24, 2012 (accessed September 25, 2012); http://www.nytimes.com/2012/09/25/health/a-call-for-caution-in-the-use-of-antipsychotic-drugs.html?_r=1.

150

The biggest puzzle is the huge success of antipsychotic drugs. Despite their dangerous side effects and narrow indications, they are being given out like candy. Antipsychotics have proven usefulness only in treating the disabling symptoms of schizophrenia and bipolar disorder, but this has not stopped drug company seduction promoting their general use for anyone having trouble sleeping, or run-of-the-mill anxiety, or depression, or irritability, or eccentricity, or the temper tantrums of youth, or the crankiness of old age. More than 3 million Americans are already on board, with a (shareholder satisfying) growth rate of 20 percent a year. The number of prescriptions for antipsychotics has doubled in ten years, up to 54 million and counting. Off-label use has also doubled—undeterred by the big fines that don’t seem so big when you consider the ill-gotten gains they enable. How could this happen? Big bucks. An advertising budget of $2.4 billion per year spent on Abilify and Seroquel has catapulted these two very so-so and not-so-safe drugs to fifth and sixth place as revenue producers among all of the many medicines sold in America. The full court press on primary care doctors has them inappropriately prescribing an antipsychotic for 20 percent of all their anxiety disorder patients.56, 57, 58 This massive misuse of antipsychotics is crazy and shameful—a triumph of marketing might over common sense and good medical practice.

369

B. L. Smith, “Inappropriate Prescribing,” American Psychological Association; http://www.apa.org/monitor/2012/06/prescribing.aspx (accessed September 19, 2012).
Michael Kleinrock, “The Use of Medications in the US: Review of 2012,” IMS Institute for Health Informatics, p. 28 (accessed September 25, 2012); http://www.imshealth.com/imshealth/Global/Content/IMS%20Institute/Documents/IHII_UseOfMed_report%20.pdf.
Jonathan S. Comer, Ramin Mojtabai, and Mark Olfson, “National Trends in the Antipsychotic Treatment of Outpatients with Anxiety Disorders,” Am J Psychiatry 168 (2011): 1057–65.

151

There is no way of knowing what should be the optimal level of prescription drug use in our society. Enthusiasts argue that the high rates of pill taking reflect the advances in psychiatric diagnosis and treatment—providing benefits heretofore unavailable to people previously ignored and in need. To some degree, this is true. But I have no doubt there has been a wild overshoot of false demand promoted by false drug company advertising, gullible doctors, careless prescribing habits, and the wholesale transfer of psychiatric diagnosis and treatment to untrained and harried primary care doctors. We have become a pill-popping society, and very often it is the wrong people who are popping the wrong pills as prescribed by the wrong doctors.

151

Its undue influence over medical practice is not Big Pharma’s fault; it is ours. A drug company does not begin life or maintain itself as a nonprofit or charitable entity chartered with the goal of promoting public health in the most efficient and effective way. Quite the opposite. A drug company is a multinational corporation whose main goals are profit, market share, and survival. In any conflict between shareholder greed and customer need, bet on the shareholder. This is the predatory nature of the beast—it is not the tiger’s fault it is a carnivore. But it is our collective fault for allowing the drug companies free rein to prey on our weakness. Government, doctors, patients, the media, advocacy groups—all were largely bought off by drug company money and power. Drugs used well are a powerful tool of psychiatry and a godsend for the patients helped. But too often, drugs are used promiscuously in a way that approximates the quackish practice of medieval alchemists. Thomas Sydenham must have had in mind trigger-happy prescribers when he said: “The arrival of a good clown exercises a more beneficial influence upon the health of a town than twenty asses laden with drugs.”

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G. Caleb Alexander and others, “Increasing Off-Label Use of Antipsychotic Medications in the US, 1995–2008,” National Institutes of Health (January 6, 2011); doi: 10.10021pds.2082.
Centers for Disease Control and Prevention, “Drug Overdose Deaths—Florida, 2003–2009,” MMWR Morb Mortal Wkly Rep 60, no. 26 (2011).

154

Merriam-Webster defines the word stigma as an identifying mark, a specific diagnostic sign of disease, or a scar or spot on a plant or animal. Some dictionaries even use “the stigma of mental illness” as the best specific example of the disadvantages suffered by those who are marked. Being “normal” and fitting in with the pack are a key to survival. Evolution has wired into human nature an uncharitable wariness and lack of compassion for those who are different and don’t satisfy tribal standards.

155

Having a mental disorder label “marks” someone in ways that can cause much secondary harm.67 Stigma takes many forms, comes from all directions, is sometimes blatantly overt, but can also be remarkably subtle. It is the cruel comment, the unkind smirk, the extrusion from the group, the lost job opportunity, the rejected marriage proposal, the ineligibility for life insurance, the inability to adopt a child or pilot a plane. But it is also the reduced expectation, the helping hand when none is needed or wanted, the solicitous sympathy that one cannot really be expected to measure up. And the secondary psychological and practical harms of having a mental disorder come only partly from how others see you. A great deal of the trouble comes from a change in how you see yourself—the sense of being damaged goods, feeling not normal or worthy, not a full-fledged member of the group.

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N. R. Silton and others, “Stigma in America: Has Anything Changed? Impact of Perceptions of Mental Illness and Dangerousness on the Desire for Social Distance: 1996 and 2006,” J Nerv Ment Dis 199, no. 6 (2011): 361–66.

155

It is bad enough that stigma is so often associated with having a mental disorder. But the stigma that comes from being mislabeled with a fake diagnosis is a dead loss with absolutely no redeeming features. Labels can also create self-fulfilling prophecies. If you are told you are sick, you feel and act sick, and others treat you as if you are sick. The sick role can be enormously useful when someone truly is sick and needs respite and care. But the sick role can be extremely destructive when it reduces expectations, truncates ambitions, and results in a loss of personal responsibility.68

371

R. Smith, “In Search of Non-Disease,” BMJ 324, no. 7342 (April 13, 2002): 883–85.

155

And when a society allows the overdiagnosis of a significant proportion of its individuals as “sick,” it becomes an artificially “sick” society rather than a resolutely resilient one. Our ancestors lived through wars and privations unimaginable to us—without resorting to an overdose of labels and an overuse of pills.

156❗️

Diagnostic inflation is an ever-present danger at the boundary between psychiatry and the law. “I would rather be hung as a man than acquitted as a fool.” So screamed Charles Guiteau ❗️to the jury during his trial for the assassin of President James Garfield in 1881.69 He was renouncing the insanity defense offered by his lawyers—preferring instead to be seen as a messenger of God sent to save the United States from an evil administration. Better to be convicted as a criminal than absolved as a mental patient because this would reduce the credibility of his claims. Setting a precedent that continues to this day, many doctors testified on both sides of this landmark case—some seeing Guiteau as crazed, others as a sane, if misguided, criminal.

371

Charles Rosenberg, The Trial of the Assassin Guiteau (New York: The Notable Trials Library, 1996).

156

This debate rages on with no solution. Are political terrorists like the Unabomber or the Norwegian mass murderer Anders Breivik best considered political criminals or mental patients? When assassins strike public figures or innocent bystanders, the media always questions whether they are crazy, never wonders how much they were egged on by venomous political discourse or how they so easily got that semiautomatic. Many (perhaps most) political assassins and mass murderers are on the fuzzy boundary between the merely strange and the legally insane. Depending on your perspective, they can plausibly be seen as either violent political or religious extremists or as delusional psychotics. The adversarial testimony of expert psychiatric witnesses on both sides of this divide invariably cancels out. Ultimately it is a societal, not a medical, choice, whether to consider such individuals mad or bad. Most defendants would, like Guiteau, much prefer to be punished than treated—lest their message be muffled. I would agree with them. Except in the clearest cases to the contrary, diagnostic inflation should be tamed in the courts. Bad should usually trump mad.

Notes

Amount: 12

🔮 The Cosmos