Saving Normal : An Insider's Revolt Against Out-of-control Psychiatric Diagnosis, Dsm-5, Big Pharma, and the Medicalization of Ordinary Life (9780062229274)

by Frances, Allen

  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.

  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.

  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.

  Disease Mongering by Big Pharma

  Big Pharma is really big and incredibly successful. Worldwide sales exceed $700 billion each year—half in North America and one fourth in Europe.16 And the profit margin, at a whopping 17 percent, is among the highest of any industry.17 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

  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. 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.

  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.

  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

  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 bu
t 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.

  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.

  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

  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.”

  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.

  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

  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 b
igger 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.

  DRUG COMPANY HALL OF SHAME

  PREPARED BY MELISSA RAVEN PHD

  Placebo Response Sells Pills

  The word placebo comes from the Latin meaning “I please.” And do placebos ever please. The “placebo effect” refers to people getting better because of positive expectations independent of any specific healing effect of the treatment. The placebo effect is very effective—people routinely get great results from treatments that have nothing whatever to do with their illness. It is probably fair to say that placebo is the greatest broad-spectrum wonder drug ever invented—cheap, effective for almost all but the most severe of man’s ills, and with very few side effects.

  But the placebo effect also causes a very serious problem—it keeps people taking expensive, and sometimes harmful, pills they don’t need for conditions they don’t have. The history of medicine is littered with dreadful treatments that were often much more dangerous than the diseases they were meant to cure. Magical thinking has allowed doctors to inflict (and patients to accept) great harm while claiming illusory benefits—the doctor’s orders dutifully followed even when completely ineffective or quite hurtful. Long-suffering patients have been given emetics to help them vomit up their sickness; purgatives to help them defecate it; leeches to suck it out; and skull holes to release it. They were dunked to the point of almost drowning; subjected to high fevers; wrapped in cold packs; and spun in special chairs or from ropes hanging from the ceiling. All sorts of substances we now fear greatly as highly toxic poisons were once treasured as healing nostrums. The placebo effect is the only way to explain this rogue’s gallery of what now seem obviously silly, even sinister treatments that have caused millennia of needless additional suffering to people who were already sick enough to begin with. The placebo effect is a kind of medical magic that gives doctors an undeserved authority and accounts for their frequent belief in really bad treatments.