09/26/17

Demolishing ADHD Diagnosis

© Lightsource | stockfresh.com

The Harvard psychologist, Jerome Kagan, sees ADHD as more of an invented condition than a serious illness. Further, he thinks it was invented for “money-making reasons” by the pharmaceutical industry and pro-ADHD researchers. He believes the drastic increase in the number of children diagnosed with ADHD has more to do with “fuzzy diagnostic practices” and relabeling. Fifty years ago, a 7-year-old child who was bored and disruptive in class was seen as “lazy.” Today he is seen as suffering from ADHD.

Every child who’s not doing well in school is sent to see a pediatrician, and the pediatrician says: “It’s ADHD; here’s Ritalin.” In fact, 90 percent of these 5.4 million kids don’t have an abnormal dopamine metabolism. The problem is, if a drug is available to doctors, they’ll make the corresponding diagnosis.

In his interview with Spiegel Online, Kagan went on to say that the inflated diagnosis of ADHD and other so-called childhood mental health disorders means more money for the pharmaceutical industry, psychiatrists and the people doing research. “We’re up against an enormously powerful alliance: pharmaceutical companies that are making billions, and a profession that is self-interested.” As he said, he’s not the only psychologist who is saying this.

Parenting expert and family psychologist, John Rosemond, agrees with Kagan. In 2009 he co-authored The Diseasing of American’s Children where they argued that ADHD and other childhood behavior disorders “were inventions of the psychological-psychiatric-pharmaceutical industry.” They went further than Kagan in saying that ADHD does not exist; that it is a fiction. In his April 9, 2017 article, “ADHD Simply Does Not Exist,” Rosemond referred to Kagan’s declaration on ADHD, noting that he and other psychologists studied Kagan’s books and research papers on children and child development when they were in graduate school. In The Diseasing America’s Children, Rosemond said:

Science depends on verifiable, objective evidence and experimental results that can be replicated by other scientists. Where ADHD is concerned, neither verifiable, objective evidence nor replicable experimental results exist to support the claims of the ADHD establishment.”

Rosemond and his co-author, Bose Ravenel, believe that childhood behavior disorders like ADHD are manifestations of “dysfunctions of discipline and lifestyle” endemic to modern family culture. Once these problems are identified, they can be easily corrected. And once corrected, the errant behavior “usually recovers to a state of normalcy within a relatively short period of time.” They believe children do not need a psychologist when they misbehave, they need discipline—“firm, calm and loving discipline.”

In Debunking ADHD, educational psychologist Michael Corrigan said ADHD is a negative label that does not exist. “Not unlike the many wonderful stories about unicorns, fairies, and leprechauns, the diagnosis of ADHD is a brilliant work of fiction.” He noted that many of the common childhood behaviors (or supposed symptoms) associated with ADHD are also used to identify giftedness in children. When these behaviors are harnessed and focused, they can help children become “incredibly creative, insightful, and successful individuals in adulthood.” If children don’t learn to harness the power of the behaviors ADHD and giftedness have in common, “such behaviors when displayed might seem annoying and immature.” He said:

My biggest reason for writing this book is my desire to show you that the practice of medicating children for acting like children in the name of ADHD is, in two words, wrong and dangerous. Despite the grandiose claims of the mega-pharmaceutical companies selling ADHD drugs to concerned parents, prescribing pills to young children trying to learn how to become young adults is just a quick fix void of any long-term benefits.

Corrigan described eating lunch with a group of children who had just taken their ADHD medication at school. They were now supposedly “good to go” (sufficiently medicated) for an afternoon of learning. It was the longest lunch period he had ever experienced. “Comparing the kids at my table to others in the cafeteria, and slowly watching these playful, creative, energetic, and funny children go from kids being kids to near expressionless robot-like entities, made me sick to my stomach.”

The total number of children on ADHD medication “skyrocketed” from 1.5 million in 1995 to 3.5 million in 2011. “Sales of prescription stimulants quintupled from 2005 to 2015.” The rising rate of ADHD diagnosis has been described as “an unreal epidemic” and a “national disaster of dangerous proportions” by well-known professionals like Allen Frances and Keith Conners. Frances was the chair of the DSM-IV. Conners, now an emeritus professor of medical psychology at Duke University, “spent much of his career in legitimizing the diagnosis of ADHD.”

Allen Frances was one of four authors of an article in the International Journal of Qualitative Studies on Health and Well-Being, “ADHD: A Critical Update for Educational Professionals.” When the DSM-IV was published in 1994, the prevalence of ADHD was estimated to be 3%. Since then, parent-reported ADHD diagnosis increased to 7.8% in 2003; 9.5% in 2007; and to 11% in 2011. Nearly one in five high school boys had been diagnosed with ADHD and around 13.3% of 11-year-old boys were medicated for ADHD.

Teachers and other school personnel are often the first to suggest a child might be “ADHD.” Research suggested teachers felt insecure about dealing with behavioral problems and hesitated to accept responsibility for students with special needs. Frances and his coauthors described six scientifically grounded issues that educational professionals should be aware of when they are confronted with inattention and hyperactivity in the classroom.

First: birth order matters. Several studies have shown “That relative age is a significant determinant of ADHD diagnosis and treatment.” The youngest children in the classroom are twice as likely to be diagnosed with ADHD and receive medication. They suggest teachers take the child’s relative age into account when judging the child’s behavior. “Seeing ADHD as the cause of inattention and hyperactivity is in fact a logical fallacy as it is circular.”

Second, there is no single cause of ADHD. “There are no measurable biological markers or objective tests to establish the presence or absence of ADHD (or any other given DSM syndrome).” ADHD is a description of behavior and is based on “criteria that are sensitive to subjectivity and cognitive biases.” Multiple factors have been associated with ADHD, without necessarily implying causality. Those factors include: divorce, poverty, parenting styles, lone parenthood, sexual abuse, lack of sleep, artificial food additives, mobile phone use and growing up in areas with low solar intensity. “All these factors and more may play a role when a particular child exhibits impairing hyperactive and inattentive behaviours, and there is no conclusive cause of ADHD.”

Third, most children exhibiting “ADHD behavior” have normal-looking brains. Studies that do show small differences in terms of brain anatomy do not apply to all children diagnosed with ADHD. Individual differences refer to slower anatomical development. “They do not reveal any innate defect as is illustrated by the fact that many people with an unusual anatomy or physiology do not experience ADHD related problems.” Also, the test subjects in many brain-related studies are rigorously screened and don’t represent all individuals diagnosed with ADHD.

The samples do not comprise an accurate representation of their respective populations, meaning an average child with a diagnosis of ADHD and an average “normal” child. This problem is particularly urgent since the DSM 5 has lowered the age of onset criterion, as well as the impairment criterion compared to the previous version, the DSM-IV. Alongside the lowered threshold, the potential to generalize earlier research findings has lowered as well.

Fourth, the claims of ADHD being inherited may be overestimated.  The claims vary widely and are subject to debate because of methodological issues used in calculating the heritability coefficient in twin, familial and adoption studies. There is significant difficulty separating genetic influences from environmental ones, such as poverty, parenting styles and divorce, in these studies. “In genetic association studies that really analyse genetic material and that are more powerful when separating the influence of genetics from other etiologic sources, associated genes show only very small effects.” When combined, they explain less than 10% of variance.

This means they occur only slightly more often in diagnosed individuals than in controls, and they do not explain nor predict ADHD behaviours. For educational professionals, this is important to consider as an ADHD label might give a false sense of security with regard to the alleged (genetic) cause of a child’s behaviour and the preferred cure (medication).

Fifth, medication does not benefit most children in the long run. Follow up studies of the long-term effects of the MTA (Multimodal Treatment of Attention Deficit Hyperactivity Disorder) study showed a convergence of outcomes over time between medicated and non-medicated children. Other studies also report either no long-term benefits, or even worse benefits. “While medication may help a small group of children in the long run, most will not benefit from long-term pharmaceutical treatment.”

The sixth and final issue that educational professionals should be aware of when confronted with inattention and hyperactivity in the classroom is the reality that a diagnosis can be harmful to children. A CDC MMWR Report indicated only 13.8% had severe ADHD, with 86.2% having mild (46.7% or moderate (39.5%) ADHD. The authors pointed out a DSM diagnosis opened the door for additional reimbursement to the school for treatment and school services, perhaps promoting a search for pathology in relatively mild cases. “The question is whether in these mild cases the merits of a confirmed diagnosis—such as acknowledgement of problems and access to help—outweigh possible demerits.” Some known disadvantages of a diagnosis are: lower teacher and parent expectations that turn into self-fulfilling prophecies, prejudice and stigmatization of diagnosed children, a more passive role towards problems, difficulties getting life and disability insurances later on in life, and others.

The Allen Frances article linked above was the most accepting of ADHD as a legitimate “neuro-developmental disorder.” Yet it cautioned there was no single cause for ADHD, medications to “treat” ADHD did not have long-term benefits, and there was a problem with its over diagnosis. Jerome Kagan thought 90% children were wrongly diagnosed with ADHD because of “fuzzy diagnostic practices and relabeling.” Michael Corrigan, John Rosemond and questioned the validity of ADHD as a neuro-developmental disorder. Corrigan said it pathologized normal childhood behavior; and medicating these children was wrong and evil. It’s time to demolish the ADHD treatment empire.

Additional articles on ADHD can be found on this website here: “National ADHD Epidemic,” “Misleading Info on ADHD,” “Tip of the ADHD Iceberg,” and “Is ADHD Simply a Case of the Fidgets?” You can also read a longer paper: “ADHD: An Imbalance of Fire Over Water of a Case of the Fidgets?

02/24/17

Misdiagnosing Substance Use

© adiruch | 123rf.com

Allen Frances doesn’t like the DSM-5 and you can hear him say so here.  He said our mental health system was in a mess. And he is afraid that with DSM-5, it will get even worse. “People who are essentially normal are being diagnosed with mental disorders they don’t have.” Small changes in the diagnostic system can result in tens of millions of normal people qualifying for a diagnosis. He used himself as an example, stating how he would qualify for several of the DSM-5 disorders. Typical symptoms of grief over his wife’s death, lasting beyond two weeks, would have signified him as having a Major Depressive Disorder.

Anther mistake was combining what had been two different diagnoses of substance use in the DSM-IV—Substance Abuse and Substance Dependence—into one: Substance Use Disorder. Substance Abuse was when someone had recurrent, but intermittent, trouble from recreational binges. Substance Dependence was a continuous and compulsive pattern of use, often with tolerance and withdrawal. The majority of substance abusers “never become addicted in any meaningful sense.”

The two DSM IV diagnoses have radically different implications for treatment planning and for prognosis. Artificially lumping them together in DSM-5 forces inaccurate diagnosis, loses critical clinical information, and stigmatizes as addicts, people whose substance problem is often temporary and influenced by contextual and developmental factors.

Hasin et al., “DSM-5 Criteria for Substance Use Disorders: Recommendations and Rationale,” presents the rationale used by the DSM-5 workgroup for substance use disorders for its changes, particularly combining abuse and dependence into one disorder. They recommended the combination as well as dropping one diagnostic criteria (legal problems) and adding one (craving). Two criteria are required to diagnose a Substance Use Disorder. The number of criteria met will indicate mild (2 to 3 criteria), moderate (4 to 5), and severe disorders (6 or more). The following chart, taken from the article, illustrates the changes from DSM-IV to DSM-5.

Frances is not alone in seeing value with two distinct types of substance use disorder. Carleton Erickson in The Science of Addiction noted how the distinction allowed for the differentiation between individuals with drug-related problems who could stop using when they wished (substance abusers), and others who had the disease of chemical dependence. Chemically dependent people have a dysregulation of the mesolimbic dopamine system and generally cannot stop using drugs without intensive intervention into their drug use problems. “According to these criteria, drug abuse in intentional, ‘conscious,’ or voluntary. Drug dependence is pathological and unintended.”

In his article, “DSM-5 Made a Mistake Eliminating Substance Abuse,” Allen Frances indicated the DSM-5 workgroup for substance use disorders based its rationale for dropping Substance Abuse on studies suggesting the distinction was hard to make. He said the results of the studies were not definitive. Moreover, their interpretation was flawed by what he said was a basic DSM-5 misunderstanding of the nature of psychiatric diagnosis. “All DSM disorder overlap with other DSM disorders and also frequently with normality.” Fuzzy boundaries among near diagnostic neighbors are common and not a sufficient excuse to collapse clinically valuable distinctions.

Carleton Erickson’s discussion of the degrees of severity with drug problems helps to illustrate this misunderstanding. He indicated there were mild, moderate and severe forms of both drug abuse and drug dependence. Most people don’t think in terms of severity with substance use problems. You either have a problem or you don’t; you either abuse drugs or you don’t. He then illustrated their relationship to drug-seeking behavior as follows.

Drug Abuse

Drug Dependence

Drug-Seeking

Mild

Little/None

Moderate

Some

Severe

Mild

A Lot

Moderate

Even more

Severe

All the Time

The overlap referred to by Frances occurs between severe drug abuse and mild drug dependence. The inability of psychiatric diagnosis to make a clear distinction here seems to have led to the decision to collapse the abuse and dependence diagnoses into one category in the DSM-5.

I think another overlap between drug abuse and drug dependence happens with regards to self-control. A distinction is necessary between self-control of thoughts, feelings and behavior when drinking and control of the drug intake itself. Any substance use can lead to a loss of self-control over an individual’s thoughts, feelings and behavior. When that loss of control results in recurrent, intermittent trouble, there is a drug abuse problem. The severity of this type of loss of self-control and the related intermittent trouble varies.

Not everyone who abuses a drug experiences the classic sense of losing of control over how much of the drug they use. A loss of control over drug intake—a continuous and compulsive pattern of use—is only evident within drug dependence. And again, the severity of this loss of control over drug intake varies. So I’d adopt Erickson’s degrees of severity with drug abuse and dependence problems as seen below.

Loss of Self-Control in Abuse

Loss of Control over Drug Intake in Dependence

Mild

Moderate

Severe

Mild

Moderate

Severe

A substance abuse problem with severe trouble related to loss of self-control may be indistinguishable from a substance dependence problem with mild loss of control over drug intake. Both people would look at their severe “trouble” and attribute it to drinking or drugging too much. Given an equal motivation to avoid further “trouble,” the substance abuser would likely have an easier time maintaining abstinence. Carleton Erickson said chemical dependence is not a “too much, too often, withdrawal” disease; it’s a “I can’t stop without help disease.” There is a pathological, compulsive pattern to substance use.

There does seem to be a “fuzzy boundary” between Substance Abuse and Substance Dependence. Nevertheless, the distinction still carries some clinical and diagnostic value. I agree with what Allen Frances said: “The change was radical, creates obvious harms, and provides no apparent benefit.” What should clinicians do? Frances suggested they simply ignore the DSM-5 change. He said it was appropriate and clinically preferable to continue making the distinction.

There is nothing sacred or official about the DSM-5 choices — I know because I made the choices for DSM-IV. The ICD coding system is official; the DSM codes are just one groups’ fallible adaptation of them. It is of great significance that the official coding in ICD-10-CM does not follow the DSM-5 decision to eliminate Substance Abuse. Instead, ICD-10-CM retains the DSM-IV terminology and continues to provide separate Substance Abuse and Substance Dependence codes for each of the major classes of substances.

The ICD-11 workgroup, currently in the final stage of development before field tests, will continue to separate Substance Dependence and Harmful Substance Use. The guidelines for dependence are revised and simplified into three diagnostic features: impaired control over substance use; increasing priority in life and physiological features. Severity qualifiers were suggested only for alcohol intoxication. They also introduced a new diagnostic category, with no equivalents in ICD-10 or DSM-5: single episode of harmful use. Frances commented:

The DSM-5 mistake thus places it out of line with ICD-10, ICD-11, previous DSM’s, and well established clinical practice. Clinicians remain truer both to clinical reality and to ICD coding when they ignore the new DSM-5 lumping of substance use disorders and instead continue to distinguish Substance Abuse from Substance Dependence. DSM’s are explicitly meant to be used only as guides, not worshiped as bibles. Clinicians are free to ignore DSM whenever it makes mistakes that go against clinical common sense and the International coding system.

10/18/16

Dancing with the Devil

© choreograph | stockfresh.com

© choreograph | stockfresh.com

I once knew a woman who had an anxiety disorder. She also abused benzodiazepines. She was able to conjure up a panic attack in a doctor’s office and walk out with a prescription for the benzo of her choice. At one time, she had four concurrent prescriptions for these anti-anxiety medications. Another person I know of has a ten-year history of using benzodiazepines at close to the maximum recommended dose. When he had an unexpected short-term hospital stay, the treating physicians were reluctant to continue prescribing benodiazepines at such a high level while he was in the hospital. When he returned home, in case his medical issue resulted in another unexpected stay, he put together an emergency hospital kit with various things—including extra benzodiazepines.

A study published in the American Journal of Public Health in April of 2016 found that benzodiazepines were the second most common drug in prescription overdose deaths for 2013. Given the common knowledge of the potential dangers of benzodiazepines and people becoming more aware of opioids, Marcus Bachhuber and a team of researchers thought that their study would show a steady of declining pattern for prescribing benzodiazepines. But they found exactly the opposite. Between 1999 and 2013 there was an increase of 30% among adult Americans who filled a benzodiazepine prescription. In addition, the amount of medication within a prescription doubled over the same time period.

Bachhuber was quoted by CNN as saying the study’s findings were very concerning. The risk of overdose and death from benzodiazepines alone is said to be generally lower in otherwise healthy adults. But in combination with other drugs like alcohol or opioids, they can be lethal.

Future research should examine the roles of these potential mechanisms to identify effective policy interventions to improve benzodiazepine safety. In particular, as underscored by several recent reports, interventions to reduce concurrent use of opioid analgesics or alcohol with benzodiazepines are needed.

The overdose problem with benzos has been overshadowed by the problems with prescription opioids. Writing for CNN, Carina Storrs said: “The current study could help shine a light on the problem of benzodiazepine abuse and overdose.” Dr. Gary Reisfield, a professor of psychiatry at the University of Florida, referred to the problem with benozdiazepines as a “shadow epidemic”:

Much attention has been paid to the explosion of prescription opioid prescribing and the associated morbidity and mortality. Much less attention has been paid to the shadow epidemic of benzodiazepine prescribing and its consequences.

A 2015 study by Jones and McAninch found that emergency department visits and overdose deaths involving opioids and benzodiazepines increased significantly between 2004 and 2011. Overdose deaths from combining the two classes of drugs rose each year from 18% in 2004 to 31% in 2011. This rate increased faster than the percentages of people filling prescriptions and the quantity of pills in the prescriptions.

As Dr. Indra Cidambi wrote in “Are We Ignoring an Escalating Benzodiazepine Epidemic?”,  she observed with increasing alarm the rising rate of concurrent use/abuse of benzos among opiate users. She pointed to two possible factors driving this trend. First, some opiate abusers use benzos to “spike” the euphoria from their opiates. Second, patients often receive their prescriptions from two different physicians. She said that it is “notoriously difficult” for doctors to refuse to prescribe these two medications.

Unfortunately, and ironically, pain and anxiety are neither verifiable nor quantifiable through medical testing! Consequently, self-reported symptoms by patients are the sole basis on which prescriptions for these medications are written, enabling individuals addicted to these medications to obtain them fairly easily.

Dr. Cidambi recommended the establishment of a national database for physicians to verify whether or not a patient has been prescribed one of these medications before prescribing or filling a prescription for the other. Second, she said physicians should develop limited, short-term treatment plans from the beginning to treat noncancerous pain with opiates and anxiety with benzodiazepines.

Studies have shown the decreasing efficacy of long-term treatment for pain with opioid medications, and evidence-based treatment protocols for benzodiazepines clearly indicate that long-term use of benzodiazepines is not recommended.

In “Benzos: A Dance with the Devil,” Psychiatrist Kelly Brogan described some of her work helping patients taper off of benzodiazepines. A woman who had been placed on Remeron (an antidepressant) and Klonopin (a benzodiazepine) for eight years said of her original prescriber: “He never once told me there might be an issue with taking these meds long-term. In fact, he told me I probably needed them after I tried stopping them cold turkey and felt so sick I thought I was dying.” Brogan said no one ever discussed with this woman or her patients the true risks, benefits and alternatives to psychiatric medications like benzodiazepines, “perhaps because we as clinicians are not told the full story in our training.”

She went on to quote from a paper by another psychiatrist, Peter Breggin, on the risks of benzodiazepines, which include: cognitive dysfunction that can range from short-term memory impairment and confusion to delirium; “disinhibition or loss of impulse control, with violence toward self or others, as well as agitation, psychosis, paranoia and depression.” There can also be severe withdrawal symptoms, ranging from anxiety and insomnia to psychosis and seizures after abruptly stopping long-term larger doses. The person can re-experience their pre-drug symptoms as they taper. These so-called rebound symptoms of anxiety, insomnia and others serious emotional reactions can be more intense than they were before drug treatment began. And don’t forget dependency or abuse.

Psychiatrist Allen Frances, the former chair of the DSM-IV, recently wrote: “Yes, Benzos Are Bad for You.” He introduced his article by saying that he was going to say some very negative things about benzodiazepines in the hope that doctors think twice before prescribing them and patients are discouraged from taking them. Benzos were wonder drugs in the 1960s. Anyone remember the 1966 song, “Mother’s Little Helper,” by the Rolling Stones? These drugs were reputed to be safe, and so were used for a variety of “ills,” such as anxiety, alcohol use disorders (yes, really), to take the edge off of agitation in dementia, and to help people sleep. “Initially we were pretty oblivious to the risk of addiction.” So benzodiazepines quickly became the most prescribed medications in America.

A second craze began in the 1980s with the release of Xanax. Frances said the dose to treat panic disorder was “dangerously close” to the dose leading to addiction. “This should have scared off everyone from using Xanax, but it didn’t.” It remains a best seller, with its own “brand” that now leads to fentanyl be pressed into counterfeit Xanax pills. See “Buyer Beware Drugs” and Paul Gaita’s article on fake Xanax laced with fentanyl.

The real wonder of the benzos is that sales continue to boom, despite their having so little utility and no push from pharma marketeering (because patents have run out – thereby decreasing costs and profits.) Between 1996 and 2013, the percentage of people in the U.S. using benzos jumped more than one-third from an already remarkable 4.1 to 5.6 percent. Especially troubling is that benzo use is ridiculously high (nearly one out of ten) in the elderly, the group most likely to be harmed by them.

Frances said the beneficial uses of benzodiazepines can be counted on the fingers of one hand: short-term agitation in psychosis, mania and depression; catatonia; “as needed” use for times of special stress, like fear of flying, or for sleep. While they should be used very short term, in real life most people take them long term—“in doses high enough to be addicting, and for the wrong reasons. . . . Benzos are very easy to get on, almost impossible to get off.”

In addition to the harm from overdoses, Frances described the painful and dangerous withdrawal symptoms, which he said are a “beast.” Common symptoms are irritability, insomnia, tremors, distractibility, sweating and confusion. “The anxiety and panic experienced by people stopping benzos is usually much worse than the anxiety and panic that initially led to their use.”  Concurrent use or abuse of alcohol or other drugs, like opioids, complicates withdrawal even further.

The most insidious issues with benzos for Frances, is how they effect brain functioning. Especially with the elderly, ongoing benzo use can be devastating. Many elderly begin their downward spiral to death and disability from falls—that happen from their benzo use! He said: “If you meet an elderly patient who seems dopey, confused, has memory loss, slurred speech, and poor balance, your first thought should be benzo side effects — not Alzheimer’s disease or dementia.” See “Sedating Seniors” for more information on this topic. It’s been over 30 years since he last prescribed a benzo for anxiety.

The tough question is what to recommend for those many unfortunates already suffering the tyranny of benzo addiction. Should they stay the course to avoid the rigors and risks of withdrawal or should they make the great effort to detox? This is an individual decision that can’t be forced on someone. But the longer you are on them, the harder it gets to stop, and the cognitive side effects of benzos create more and more dysfunction as your brain ages. The best bet is to stick with a determined effort to detox, however long and difficult, under close medical supervision. On a hopeful note, some of the happiest people I have known are those who have overcome their dependence on benzos.

So it was encouraging to see that the FDA will require class-wide changes in drug labeling to bring attention to the dangers of combining opioids and benzodiazepines. The changes will include boxed warnings on nearly 400 products with information on the risks of combining these medications. The FDA Commissioner, Robert Califf said: “It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together.” He implored health care professionals to carefully and thoroughly evaluate on a patient-by-patient basis whether the benefits outweigh the risks when using these drug classes together.

Used alone or in conjunction with opiates, benzodiazepines are potentially lethal and addictive. A too sudden withdrawal from benzodiazepines can be fatal, where the same is rarely true with opiates. They work quickly and effectively for anxiety and sleep problems and yet they can have a multitude of side effects, including addiction. Did I say they are addictive? Using benzodiazepines has become a dance with the devil for too many unsuspecting individuals … those that are still alive to regret it, that is.

This article previously appeared on the addiction and recovery website “The Fix” under the title of “Dangerous Dance.”

05/31/16

To Be or Not to Be Bipolar

53409894_sOn The Oprah Winfrey Show in October 2007, Sinéad O’Connor disclosed that she had been diagnosed with bipolar disorder in 2003. The website, “Famous Bipolar People,” said Sinéad had suffered from depression and had thoughts of suicide since the age of 23. She also experienced voices urging her to harm herself. The voices got so loud, she said, she took herself to hospital. She was put on antidepressants, which helped. “These all confirmed that she had bipolar disorder.” Then a few years ago, she went public with an announcement that she had been misdiagnosed with bipolar disorder for eight years.

During her interview with Oprah, she said she didn’t think she was born with bipolar disorder. She thought her illness was caused by a number of outside pressures. “I believe it was created as a result of the violence I experienced.” She was scared to take the medication at first. But she realized that she had nothing to lose, so she tried them. “It was brilliant because I felt this huge hole. And when I took the meds, within half an hour, it was literally like I felt concrete coming in to fill the hole.” She said she thought she had died and then was ‘born again’ as a result of taking the meds.

But after spending eight years on the medications, she realized her depression was still there. Additionally, “some of the same problems she’d had before being medicated were persisting.” And she received complaints about her weight from people in the music business. By the way, weight gain is one of the side effects from antipsychotic medication. When she mentioned her weight problem to her doctors, they suggested taking her off of the bipolar meds as a remedy.

Writing for About Health, Angel Rouse said O’Connor was alarmed with the casualness of the suggestion and aware that simply stopping meds could be dangerous. So she sought outside opinions, eventually getting three additional ones. Their conclusion was that she was not bipolar. Rather, she actually suffered from PTSD. She revealed that when she cancelled her tour in 2012, she had tried to stop taking her medication cold turkey. Ironically, as a result of that attempt, she struggled with bipolar problems of mania and depression for nearly a year. Interviewed for the Irish Mirror, she said:

The illness was in fact what happens when you don’t go about coming off these meds properly. I’m delighted to be able to say that after ten years of poisoning myself with these drugs and having to live with the extremely difficult side-effects of them I can shortly begin the very, very slow indeed, process of getting them out of my system and my life and getting my life back.

Sinéad O’Connor is not a unique case. The NAMI (National Alliance on Mental Illness) website claims that 2.6% or 6.1 million American adults have a bipolar disorder. NAMI referenced this “mental health fact” on data they took from the National Institute of Mental Health (NIMH), which in turn cited this article by Kessler et al. from JAMA Psychiatry on the prevalence, severity and comorbidity of DSM-IV disorders. See Table 1 in the article for the reported percentage. But if Sinéad O’Connor could be misdiagnosed as having a bipolar disorder and mistakenly placed on potentially harmful medications that are seen as necessary to stabilize and control the bipolar ‘illness,’ how many others are similarly misdiagnosed? Regarding the medications she was on, O’Connor told the Irish Mirror:

They are extremely debilitating drugs. Tiring to the extreme. Ironically, extremely depressing. They can cause suicidal or self-harm type thinking. They can mess up your menstrual cycle very badly and cause you to be incapacitated for a week before. . . . [They] f**k up your liver, your kidneys, your eyes, your appetite, your entire way of thinking and generally your entire life.

Within his seminal book, Anatomy of an Epidemic, Robert Whitaker described “The Bipolar Boom” in chapter nine. He related a talk given by Fredrick Goodwin at the 2008 annual meeting of the American Psychiatric Association (APA). Goodwin said the illness has been altered since 1990. There was more rapid cycling; more mixed states; more lithium treatment failures than when he’d coauthored Manic-Depressive Illness. “The illness is not what Kraepelin described anymore, and the biggest factor, I think, is that most patients who have the illness get an antidepressant before they ever get exposed to a mood stabilizer.” Whitaker said not everyone speaking agreed that antidepressants had been disastrous for bipolar patients, but no one questioned Goodwin’s assessment that bipolar outcomes had noticeably worsened since 1990.

On his website, Whitaker noted that before 1955, bipolar illness had been a rare disorder. Only 12,750 people were hospitalized with the disorder that year. There were only about 2,400 “first admissions” that year in the country’s mental hospitals. Outcomes were fairly optimistic. Seventy-five percent of these first-admissions were projected to recover within 12 months. And only 15% of first-time admissions were expected to become chronically ill. And at least 70% were projected to return to work and have active social lives.

Today, bipolar illness is said to affect one in every 40 adults in the United States. A rare disorder has become a very common diagnosis. There are several reasons for this. First, many drugs–both illicit and legal–can stir manic episodes, and thus usage of those drugs leads many to a bipolar diagnosis. Second, the diagnostic boundaries of bipolar illness have been greatly broadened.

Allen Frances is a psychiatrist and the author of Saving Normal. He was also the chair for the DSM-IV, which expanded the criteria in diagnosing bipolar diagnosis by adding the bipolar II category. In Saving Normal, he described a dilemma when the APA was revising bipolar diagnosis for the fourth edition of the DSM. Patients with “hypomania,” less-than-full-manic episodes, didn’t fit neatly into the unipolar or bipolar depression categories. The bipolar II category was seen as a compromise that would lessen the dangers of classifying them as having unipolar depression and treating them with antidepressant medication that could trigger a manic episode.

We knew that bipolar II would expand the bipolar category somewhat into unipolar territory, but we did not think that it would double. Undoubtedly, our decision resulted in more accurate diagnosis and safer treatment for many previously missed truly bipolar patients. But like all fads, it overshot and had led to unnecessary medication for many unipolar patients who have been misdiagnosed as bipolar on very flimsy grounds and are now receiving unnecessary mood stabilizing drugs.

Whether you agree with Frances’ assessment that adding bipolar II resulted in more accurate diagnosis and safer treatment for many, don’t miss that he also said it led to misdiagnosis and unnecessary medication.  If you follow this link, also given above, to Robert Whitaker’s website, Mad in America, you will find a series of journal articles describing how substance abuse can be related to developing bipolar disorder; the effects of antidepressant use on bipolar disorder and how these drugs can worsen long-term bipolar outcomes; and the deterioration of bipolar outcomes in the modern era.

For a postscript, I want to return to note one last piece of information on Sinéad O’Connor. While she has cast off her diagnosis of bipolar disorder, it isn’t finished with her. Many websites, like that of “Famous Bipolar People” mentioned above, still list her as one of their own. There was a concluding note in the “About Health” article on Sinéad O’Connor that said: “In spite of her having stated clearly on several occasions that she does not have bipolar disorder, O’Connor continues to be included at many sites that compile lists of famous bipolar people.”

Famous Bipolar People, if Sinéad had said it’s over between the two of you, accept it and move on. There are plenty of more fish in the sea. You still have Kay Redfield Jamison. She’s written two books that touch on bipolar disorder, An Unquiet Mind and Touched with Fire. And both have been made into movies. The movie, Touched with Fire, is a fictional love story about two people with bipolar disorder who meet in a psychiatric hospital and fall in love. The trailer has a slight Romeo and Juliet feel to it; two young lovers who family and friends try to keep apart. So there will be plenty of new discussions about who is and who isn’t bipolar related to the movie. Just let go of Sinéad; let her go and move on.

12/31/15

Medieval Alchemy

© algolonline | 123rf.com

© algolonline | 123rf.com

Three years after the publication of the fourth edition of the DSM in 1994, the US became the only country in the world to allow direct to the consumer advertising of pharmaceuticals. Now there’s New Zealand. Soon after the approval, pharmaceutical advertising was everywhere in the US. Over the next decade, from 1997 to 2007, drug companies tripled their spending on marketing. Everyday problems were being portrayed as unrecognized psychiatric disorders. The chair of the DSM-IV, Allen Frances, admitted they had failed to anticipate how easily their manual could be utilized to promote pharmaceutical sales. They were not able to stem the flood of “false demand” instigated by the marketing done by drug companies. “Within a few years, it was clear the drug companies had won and we had lost.”

We should have been far more active in educating the field and prospective patients about the risks of overdiagnosis. There should have been prominent cautions in DSM-IV warning about overdiagnosis and providing tips on how to avoid it. We should have organized professional and public conferences and educational campaigns to counteract drug company propaganda. None of this occurred to anyone at the time. No one dreamed that drug company advertising would explode three years after the publication of the DSM-IV or that there would be the huge epidemics of ADHD, autism, and bipolar disorder—and therefore no one felt any urgency to prevent them. . . . We missed the boat. (Allen Frances, Saving Normal, p. 74)

Frances said the evidence for this diagnostic inflation is clear. There has been a fortyfold increase in childhood bipolar disorder. Autism diagnoses have increased twentyfold. “Attention deficit/hyperactivity has tripled; and adult bipolar disorder doubled.” The result has been huge profits for the drug companies.

At the very top of the Pharma hit parade are the antipsychotics at a resounding $18 billion a year. Antidepressants produce a hardy $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 $59 million a year. Now with direct-to-consumer advertising and heavy marketing to doctors, sales have been juiced up to a hefty $8 billion a year. And because primary care doctors love to prescribe them, antianxiety agents are eight in sales among drug classes—even though they probably do much more harm than good. (Saving Normal, p. 105)

Patients regularly misdiagnosed themselves and asked their doctor for “the magic pill that would correct their chemical imbalance,” just as the advertisements suggested. And as requested, doctors prescribed the medications. “Patients who requested a drug they had seen advertised were seventeen times more likely to walk out of the office with a prescription.” Primary care physicians (PCPs), such as general practitioners, obstetrician-gynecologists and pediatricians, now prescribe most of the psychiatric drugs in the US.

Using data from August 2006 to July 2007, Ryan DuBosar noted in “Psychotropic drug prescriptions by medical specialty” that 59% of the psychotropic prescriptions were written by PCPs. Breaking down the drug by class, PCPs prescribed 37% of the antipsychotics, 52% of the stimulants, 62% of the antidepressants and 65% of the anxiolytics (anti-anxiety meds). Frances said: “Too often, drugs are used promiscuously in a way that approximates the quackish practice of medieval alchemists.”

On November 17, 2015, the American Medical Association (AMA) adopted a new policy that calls for a ban on direct to the consumer advertising of prescription drugs. The new policy calls for a physician task force and launching an advocacy campaign to promote prescription drug affordability.

The AMA Board Chair-elect, Patrice Harris, said the vote reflects concerns among physicians about Pharma’s commercially-driven promotions and the impact of marketing costs in escalating drug prices. She said direct-to-consumer advertising also created a demand for new and more expensive drugs, even when these drugs may not be appropriate. “Patient care can be compromised and delayed when prescription drugs are unaffordable and subject to coverage limitations by the patient’s health plan. In a worst-case scenario, patients forego necessary treatments when drugs are too expensive.”

Reporting for Reuters, Susan Kelly noted that the AMA did not say how the ban could be overturned. There have been a series of court decisions determining that the ads are a form of commercial speech protected by the U.S. Constitution. PhRMA, the largest trade group for the pharmaceutical industry in the US, said the ads increase consumer awareness of available treatments for diseases. PhRMa spokesperson, Tine Stow said: “Providing scientifically accurate information to patients so that they are better informed about their health care and treatment options is the goal of direct-to-consumer pharmaceutical advertising about prescription medicines.” REALLY?

Allen Frances said that Big Pharma seems to feel it is above the law. “Almost all of the companies have absorbed huge fines and even criminal penalties as punishment for their illegal sales practices. He published a chart in Saving Normal that he referred to as the drug company hall of shame. It contained information on fines and settlements by Pharma for off-label promotion (which is illegal at this time) as well as shady marketing and fraudulent misbranding. The sum total of the fines between 2004 and 2012 was $12.06 billion.

Yet a Pharma company has been in court attempting to assert that it has “a constitutional right to share certain information about its products with doctors.” The drug companies have been increasing their pressure on the FDA to relax its guidelines around off-label marketing. See “Pharma Goes to Court” for more on this issue.

Frances said it is our fault that we allowed drug companies to prey on our weakness. “Diagnostic questions should be decided by what is best for the patient, not what is best for the doctor or the APA [American Psychiatric Association] or Pharma or the consumer group.” All this could be reversed if we had the political will to do so. He proposed fourteen ways to tame Pharma. The top six were:

  • No more direct-to-consumer advertising on TV, in magazines, or on the internet.
  • No more drug company-sponsored junkets, dinners, promotional gifts, or continuing medical education for doctors or medical students.
  • No more financial support for medical professional organizations.
  •  No more beautiful salespeople congregating in the doctors’ waiting room.
  • No more free samples.
  • No more off-label marketing.

These changes strike at the heart of Pharma’s marketing strategy, so it won’t be easy to get Congress to approve the changes. Pharma outspends all other industries in its lobbying efforts. Since 1998, the pharmaceutical industry has spent $3,201,510,687 lobbying Congress. So far in 2015 Pharma has spent $178,863,490. Annually they outspend all other industries. You have to go back to 2005 to find annual spending under the to date figure for 2015. See OpenSecrets.org for more information on this issue.

10/14/15

Antipsychotic Big Bang

© sakkmesterke | 123rf.com

© sakkmesterke | 123rf.com

Duff Wilson wrote in “Side Effects May Include Lawsuits” that antipsychotics were a niche product for decades. Yet they have recently generated sales that have surpassed that of “blockbusters like heart-protective statins.” In the 1990s, pharmaceutical companies began marketing them for much broader uses than the original FDA approved uses for more serious mental illnesses, like schizophrenia and bipolar disorder. A Scientific American article reported that pediatric prescriptions for atypical antipsychotics rose 65%—from 2.9 million to 4.8 million—between 2002 and 2009. And a New York Times article noted that federal investigators have found widespread overuse of psychiatric drugs by older Americans with Alzheimer’s disease.

There are two more facts to introduce you to about neuroleptics or atypical antipsychotics. First, in 2008, antipsychotics sales reached $14.6 billion, making them the biggest selling therapeutic class of drugs in the U.S. Second, each of the following pharmaceutical companies that marketed antipsychotics has been investigated for misleading marketing under the False claims Act. All their neuroleptics—Risperdal (risperidone; Johnson & Johnson), Zyprexa (olanzapine; Eli Lilly), Seroquel (quetiapine; AstraZeneca), Geodon (ziprasidone; Pfizer), and Abilify (aripiprazole; Bristol-Myers Squibb and Otsuka)—are now off patent.

The primary use off-label use of neuroleptics for the elderly and with children has been for behavioral control. A recent study commissioned by the Pennsylvania Department of Human Services found that children between the ages of 6 and 18 who were in foster care was four times higher than other youth in Medicaid. More than half of these youth had a diagnosis of ADHD. “This is concerning, as the majority of these youth did not have another diagnosis that clinically indicated the use of antipsychotics.” Risperidone was the most frequently prescribed antipsychotic medication among the youth. However, Abilify and Seroquel grew to exceed risperodone over the course of the study. Zyprexa was the least commonly used antipsychotic among all youth.

A trade group for nursing homes, The American Health Care Association, indicated that while antipsychotics helped some dementia patients who have hallucinations or delusions, “They also increase the risk of death, falls with fractures, hospitalizations and other complications.” The American Psychiatric Association, among others pointed to a JAMA Psychiatry study that showed mortality risks increased in patients given antipsychotics to reduce their symptoms of dementia. Another study published in Health Policy said the benefits and harms of using antipsychotic medications in nursing homes should be reviewed.

Antipsychotic medication use in nursing home residents was found to have variable efficacy when used off-label with an increased risk of many adverse events, including mortality, hip fractures, thrombotic events, cardiovascular events and hospitalizations.

Another “add on” area for neuroleptic use is when it is used with an antidepressant for “treatment resistant” depression. On BuzzFeed, Cat Ferguson reported how the sale of antipsychotics such as Abilify, and Zyprexa “skyrocketed” as they were approved to treat depression as an add-on medication. Seroquel is not FDA approved to treat major depression, but along with Abilify and Zyprexa is approved to treat bipolar depression in adults. Zyprexa and Seroquel are approved for some indications of bipolar disorder in adolsecents, but Abilify is only used off label with bipolar children, having “low or very low evidence of efficacy.” See the Psychopharmacology Institute for more information on these drugs and their approved and off-label uses.

Ferguson quoted a few psychiatrists expressing concern about the antipsychotic boom, and there are some surprises given other stands they’ve taken. Allen Frances, the former chair for the DSM-IV, agreed there has been heavy marketing of antipsychotics. He thought they are prescribed too quickly for depression and without clear indication of their efficacy. He added there seemed to be pressure from the pharmaceutical companies. He said: “These drugs should have a narrow indication, and instead they’ve become the highest revenue-producing drugs in America.”

Over the past few years Allen Frances has become an outspoken critic of some psychiatric practices, including the overuse of antipsychotics and antidepressants. He’s also been critical of the DSM-5. He’s even written Saving Normal to address his concerns with psychiatry and psychiatric practice. Search for his name here to find several articles where he is mentioned.

I was surprised and encouraged to see Jeffrey Lieberman, the chair of psychiatry at the Columbia University College of Physicians and Surgeons express concern with the over prescribing of antipsychotics. Lieberman has positioned himself as defender of psychiatry and psychiatric practice, recently publishing Shrinks. You can also search his name here to see other articles interacting with his book and position on psychiatry. Lieberman said that antipsychotic medication should be used sparingly in treating nonpsychotic disorder, including depression. He said: “I think there’s the possibility that antipsychotics are overprescribed, not just for depression, but in other areas.”

My point is that when two prominent psychiatrists with opposing views on many areas of psychiatry and psychiatric practice agree that antipsychotics are overused, pay attention. Both Frances and Lieberman have pointed out elsewhere how pharmaceutical marketing strategies contribute to this problem, but some pharma companies and representatives put the blame back on doctors. An Eli Lilly spokesperson said pharmaceutical companies aren’t responsible for how their drugs are used by doctors. “Physicians make prescribing decisions, not pharmaceutical companies. . . . While certainly we inform doctors of the benefits and risks of our medicine, it’s really up to physicians to prescribe the right medicine.”

But this attempt to deflect responsibility onto physicians is a cop out when you consider the marketing done by pharmaceutical companies for their products. In this YouTube advertisement for Abilify as an antidepressant add-on, you see how Bristol-Myers Squibb actively encouraged individuals to “ask your doctor if Abilify is right for you.” Pay attention to the fact that the first thirty seconds verbally describes how Abilify can help, while the rest of the 90-second commercial has the woman and her family going on a picnic while the adverse side effects are described.

Another problem is that all clinical trials for drug approval are done over short periods of time—six or eight weeks—antipsychotics included. But what are the long-term consequences of antipsychotics? As Dan Iosifescu, the director of the Mood and Anxiety Disorders Program at Ichan School of Medicine at Mount Sinai Hospital said, “It’s just a fallacy to take short-term data and extrapolate it for long term.” His bottom line is that antipsychotics tend to be helpful in the short term, but can have major consequences in the long term.

Thomas Glasen, writing in Schizophrenic Bulletin, weighed the pros and cons of medication treatment for psychosis. In the case for medication, he noted that the benefits of medication were profound. The therapeutic power of antipsychotic medication had been validated in countless studies and was now the primary treatment of schizophrenia. “In today’s climate, treating schizophrenia without medication mobilizes high anxiety among treaters for the safety of their patients from irrationality and for the safety of themselves from litigation.” However, in the case against medication, Glasen said:

Antipsychotics obscure the pathophysiology of psychosis by altering the neurobiology of the brain and the natural history of [the] disorder. . . . Medication can be lifesaving in a crisis, but it may render the patient more psychosis-prone should it be stopped and more deficit-ridden should it be maintained.

So how do individuals on long-term antipsychotics do? In Anatomy of an Epidemic, Robert Whitaker described Martin Harrow’s presentation of a long-term study funded by NIMH on sixty-four individuals diagnosed as schizophrenic between 1975 and 1983. Whitaker had just reviewed a series of studies questioning whether there was a long-term benefit to the use of antidepressants before discussing the Harrow study. He then said: “If the conventional wisdom is to be believed, then those who stayed on antipsychotics should have had better outcomes.” Harrow found that after two years, there was evidence that the off-med group was doing slightly better than the group on drugs.

Then, over the next thirty months, the collective fates of the two groups began to dramatically diverge. The off-med group began to improve significantly, and by the end of 4.5 years, 39 percent were “in recovery” and more than 60 percent working.

The outcomes for the medication group worsened and this divergence continued. At the fifteen-year follow up, 40 percent of those off drugs were in recovery and more than half were working; only 28 percent suffered from psychotic symptoms. “In contrast, only 5 percent of those taking antipsychotics were in recovery, and 64 percent were actively psychotic.” The 2007 Harrow study can be found here. Harrow said that not only was there a significant difference in global functioning between the two groups, 19 of the 23 (83%) schizophrenic patients with uniformly poor outcome after fifteen years were on antipsychotics.

symptomsHarrow et al. (2014) continued his study and reported data in Psychological Medicine at the twenty-year stage of his follow-up schedule. Here he investigated whether multi-year treatment with antipsychotics reduced or eliminated psychosis; and whether the results were superior to individuals in the non-medicated group. The data showed that the pattern noted above by Whitaker in Harrow’s 2007 report continued: “A surprisingly high percentage of SZ prescribed antipsychotic medications experienced either mild or more severe psychotic activity.”  The figure to the left, originally from the 2014 Harrow et al. report, shows that 68% of the medication group experienced psychotic activity, while only 8% of the off-med group experienced any psychotic activity. The source of the figure was a slide reproducing the Harrow data in a presentation by Robert Whitaker at the “More Harm than Good” conference sponsored by the Council for Evidence-Based Psychiatry (CEP). The slides and videos of the presentation can be found here.

Harrow et al. thought the high percentage of the medication group experiencing psychotic activity was influenced by two factors. One was the high vulnerability to psychosis of many schizophrenic patients, leading to a high risk of psychosis. But that begs the question of how the medication group in the study had such a high number of patients “at risk of psychosis.” Given the above data, their second factor seems to have been the more important factor: prolonged use of antipsychotics (or partial dopamine blockers) may produce a medication-generated build-up of supersensitive dopamine receptors or excess dopamine receptors.

The production of excess or supersensitive dopamine receptors would then be an iatrogenic, drug induced effect from the long-term use of antipsychotics. The brain increases or sensitizes the receptors, thus compensating for the blockade of original receptors in the postsynaptic neuron. Again, drawing from Whitaker’s presentation slides at the CEP conference, it would look like this:

dopamine

The above presentation of Harrow’s data and the discussion from Whitaker’s CEP presentation seem to affirm Glasen’s thesis that antipsychotics could alter the neurobiology of the brain. Antipsychotics reduce the activity of dopamine systems, stimulating the increase of receptors. When the antipsychotic is tapered or withdrawn, this would not immediately diminish the number of additional dopamine receptors produced by the brain to compensate for the dopamine blocking action of the antidepressant. With decreased antipsychotic levels, the result would be increased activation of the postsynaptic neurons because of the greater number receptors to absorb dopamine.

The person’s symptoms could intensify through the increased absorption of dopamine because of this disregulation of the dopamine system. In other words, tapering off of antipsychotics could activate symptoms like mania, paranoia and hallucinations because of the chemical imbalance produced by the medication. The experience of mania from a too sudden withdrawal of an antipsychotic is in this view, likely a withdrawal or discontinuation symptom instead of proof that the person needs to remain on an antipsychotic because they have a chemical imbalance. Robert Whitaker’s conclusion in Anatomy of an Epidemic was:

What the scientific literature reveals is that once a person is on an antipsychotic, it can be very difficult and risky to withdraw from the medication, and that many people suffer severe relapses. But the literature also reveals that there are people who can successfully withdraw from the medications and that it is this group that fares best in the long term.

09/16/15

The Quest for Psychiatric Dragons, Part 2

© Olesia Sarycheva |123rf.com

© Olesia Sarycheva |123rf.com

The fallout from the Rosenhan study couldn’t have come at a worse time for psychiatry. Spitzer was in the midst of trying to put out one fire with the crisis brought about by gay activism against the APA. Then Rosenhan demonstrated that “psychiatrists could not distinguish the sane from the insane” from another angle.

Pseudopatients were admitted into psychiatric hospitals, but were not identified as such by hospital staff. The problem with the unreliability of psychiatric diagnosis was now front-page news, just as Spitzer and one of the coauthors of his 1967 article on the kappa statistic, Joseph Fleiss, were about to publish their own critique of psychiatric diagnosis. Their study, “A Reanalysis of the Reliability of Psychiatric Diagnosis,” became another classic article in the psychiatric literature.

The Spitzer and Fleiss study was received by the British Journal of Psychiatry on January 17, 1974, and published in the October 1974 issue of the BJP. The Spitzer and Fleiss article was received by the BJP about a month after the APA decision to remove homosexuality from the DSM-II and a year after the Rosenhan study was published.

Applying the kappa statistic in the re-analysis of five previous studies of diagnostic reliability, Spitzer and Fleiss said: “The reliability of psychiatric diagnosis as it has been practiced since at least the late 1950s is not good.” They were confident that developing structured interviews and specifying all diagnostic criteria “will result not only in improved reliability, but in improved validity, which is, after all our ultimate goal.” In The Selling of DSM, Stuart Kirk and Herb Kutchins said: “This article carefully and dramatically sets the stage for DSM-III. It reinterprets and denigrates the past, refers to innovations being currently developed by the authors and others, and predicts success in the future.”

The historical context suggests to me that the one-two punch of the gay activists and the Rosenhan study caught Spitzer and the other psychiatric researchers by surprise. These two events not only raised questions about the unreliability of psychiatric diagnosis, but they did it in a way that was easy to grasp by the public. They also publicly embarrassed psychiatry. How could trained psychiatrists not be able to tell whether someone was faking their symptoms? How could homosexuality be voted out of being a mental disorder? What implications do these two events have for diagnosing other so-called mental disorders?

Psychiatry now faced serious threats to its credibility, perhaps to its very existence. As Whitaker and Cosgrove noted in Psychiatry Under the Influence, the APA did recognize how the rampant criticism threatened their profession. “The public did not have a ‘strong conception of psychiatry as a medical specialty,’ and failed ‘to recognize a psychiatrist’s special competence in mental health care.’”

After his achievements in removing homosexuality from the DSM-II, and being appointed the chair for the DSM-III, Spitzer took on Rosenhan. Spitzer published his critique of Rosenhan’s study in the Journal of Abnormal Psychiatry in October of 1975, “On Pseudoscience in Science, Logic in Remission, and Psychiatric Diagnosis.” Spitzer’s article was originally received on November 1, 1974, less than a month after he and Fleiss published their article. He revised and resubmitted it on April 14, 1975. Several other articles on Rosenhan’s study were published in the same issue of the Journal of Abnormal Psychiatry. Spitzer now defended psychiatry and to a certain extent, diagnosis. Kirk and Kutchins noted that Spitzer was in the awkward position of defending psychiatric diagnosis, while he was in the process of restructuring it.

His rhetoric was clever and forceful. He characterized Rosenhan’s study as “pseudoscience,” playing to Rosenhan’s reference to his “pseudopatients.” Spitzer also referred to Rosenhan’s discussion of the pseudopatients discharge diagnosis as schizophrenia in remission as “logic in remission.” Kirk and Kutchins said:

Some of Spitzer’s criticisms of the design of the study were warranted, although his zeal to discredit Rosenhan sometimes led him simply to disregard or distort basic observations. . . . The importance of Spitzer’s comments are not what they tell us about Rosenhan’s study, but what they tell us about Spitzer’s new enterprise, the making of the DSM-III.

First he sought to invalidate Rosenhan’s basic point, namely the criticism of psychiatric practices that could not distinguish the sane from the insane. According to Spitzer, “A correct interpretation of [Rosenhan’s] own data contradicts his own conclusions. In the setting of a psychiatric hospital psychiatrists are remarkably able to distinguish the ‘sane’ from the ‘insane.’” Secondly, he used his article to redefine the problem of psychiatric diagnosis as one of reliability, and cited his own article, “A Reanalysis of the Reliability of Psychiatric Diagnosis,” and its recommendations in support of this conclusion. “Recognition of the serious problems of the reliability of psychiatric diagnosis has resulted in a new approach to psychiatric diagnosis.” In effect, Spitzer was saying to his audience of psychiatrists and other mental health professionals, “We already knew about the problem and have been working on a solution.”

Spitzer then reworked his article and published the revision in the Archives of General Psychiatry: “More on Pseudoscience in Science and the Case for Psychiatric Diagnosis.” The article was accepted for publication on December 12, 1975 and published in the April 1976 issue. In the introductory comments of his 1976 article, Spitzer observed that partly because of the prestige of Science, the journal in which it was published, and partly because it said what many others wanted to hear, “The [Rosenhan] study was widely acclaimed in the popular news media. . . . As a consequence, this single study is probably better known to the lay public than any other study in the area of psychiatry in the last decade.” And he was right.

In February of 1980, as the DSM-III was about to be published, Spitzer et al. published an article in The American Journal of Psychiatry that reviewed the achievements and changes in psychiatric diagnosis within the DSM-III. They also claimed the reliability problem had been significantly improved. “For most of the diagnostic classes the reliability was quite good, and in general it was much higher than that previously achieved with DSM I and DSM II.” As it turned, out this was not true. In their book, The Selling of DSM, and in an article, “The Myth of the Reliability of DSM,” Stuart Kirk and Herb Kutchins demonstrated how the standards for interpreting reliability were dramatically shifted in order to make it easier “to claim success with DSM-III, when in fact, the data were equivocal.”

David Rosenhan died on February 6, 2012 after a long illness. His obituary published in American Psychologist commented: “The lessons he cared most about offering, in the classroom as in his research, were about human dignity and the need to confront abuse of power and human frailties.” Robert Spitzer retired in December of 2010. According to Jeffrey Lieberman in Shrinks, it was because of a severe and debilitating form of Parkinson’s disease. But the fight over the legitimacy over psychiatric diagnosis continues and Robert Spitzer has been one of the critics of the recent revision process for the DSM-5. Joining him in this dispute is Allen Frances, the chair of the DSM-IV Task Force.

Writing for Wired, Gary Greenberg noted that the DSM-5 battle comes at a time when the authority of psychiatry “seems more tenuous than ever.” The director of the National Institute of Mental Health (NIMH), Thomas Insel, announced the NIMH wouldn’t be using the DSM to structure its research. “Some mental health researchers are convinced that the DSM might soon be completely revolutionized or even rendered obsolete.” Other psychiatrists privately fret that “the DSM-5 will create ‘monumental screwups’ that will turn the field into a ‘laughingstock.’” None of them were willing to go on record with their concerns for fear of retaliation. Reflecting on the ongoing debate over psychiatric diagnosis, Allen Frances was reminded of medieval maps that had notations such as “dragons live here” in places where their knowledge was lacking. “We have a dragon’s world here. But you wouldn’t want to be without that map.”

07/15/15

Pathologizing Grief

© Kzenon | stockfresh.com

© Kzenon | stockfresh.com

In January of 2015, an article on “Complicated Grief” was posted in The New England Medical Journal blog. The author described complicated grief as “intense grief after the death of a loved one that lasts longer than expected according to social norms and causes functional impairment.” While it was said that psychotherapy is a first-line treatment, the author reported that antidepressant medication is commonly used. This is just the latest stage in a rather complicated refashioning of grief from a normal human experience into a mental disorder.

The symptoms of complicated grief were said to be: “persistent, intense yearning, longing, and sadness.” Along with these “symptoms” can be a sense of disbelief or failure to accept the reality of the person’s death. Persistent thoughts or images of the deceased can occur. Ruminating on the circumstances of the death, with feelings of anger or guilt was said to be common. Avoiding situations that remind the person of the loss is common. Holding on to the deceased by repeated reminiscing, viewing, touching or smelling the deceased person’s belongings can occur as well.

People with complicated grief often feel shocked, stunned, or emotionally numb, and they may become estranged from others because of the belief that happiness is inextricably tied to the person who died. They may have a diminished sense of self or discomfort with a changed social role and are often confused by their seemingly endless grief.

Complicated grief is not a psychiatric diagnosis, although you wouldn’t know that from reading the above description. It explicitly uses diagnostic-like language in its discussion in an attempt to gain legitimacy for “Prolonged Grief Disorder” to be included in the International Classification of Diseases, 11th edition, due for release in 2017. The boat has passed on inclusion in the DSM, which went through its own controversy over grief when the DSM-5 removed the bereavement exclusion (BE) from the existing Major Depression Disorder (MDD) in 2013.

Within the DSM, the bereavement exclusion meant that a diagnosis of MDD could not be made if the loss of a loved one was a better explanation for the observed symptoms of depression. However, the time frame to avoid the grieving process from qualifying as MDD has been progressively shrinking. Within the DSM-III, the BE was one year; within the 4th edition, it was two months. Now in the DSM-5, bereavement is no longer an excuse. If you meet the diagnostic criteria for MDD over a two-week time period, you are just as depressed as anyone else, according to the DSM.

Joanne Cacciatore, who has specialized in the psychotherapeutic treatment of grief and bereavement for almost twenty years, has been an outspoken critic of these changing guidelines and pseudo-diagnoses. In March of 2012 she wrote an essay opposing the proposed elimination of the BE from the DSM-5. Her eloquent essay reached 100,000 readers in two weeks. She stated her opposition to both of the above ‘time limits’ for grief, and pointed to the historical movement of the DSM to medicalize normal human emotion. She said:

We should not, ethically or morally, medicalize grief.  To do so is to medicalize love.  We rarely mourn for that which we do not love. I can only begin to imagine what the sages, and mystics, and shamans of the past might think of a society which does so.

Allen Frances was also openly critical of the DSM-5 and its changes with regard to bereavement. In his own blog on the Huffington Post in March of 2012, he published Dr. Cacciatore’s open letter to the Board of Trustees of the American Psychiatric Association. She pointed to the arbitrariness of the two-week time frame, stating that it not only contradicts common sense, but rests on weak scientific evidence. To her knowledge there was no empirical evidence to support it.

One thing in which the literature is clear: long-term psychological distress is common in this population and other populations suffering traumatic deaths. In my experience both as a researcher and clinician in the field and also as a bereaved parent, the DSM-5 proposal is radical, unnecessary, challenges what it means to be human, and for some may be dangerous.

But the APA was not moved. Frances tried again in January of 2013, as the DSM-5 was preparing to go to press at the end of the month. He said: “The American Psychiatric Association has just four more weeks to reverse this dreadful mistake that flies in the face of clinical common sense and is unsupported by the limited available science.” He put together his own top ten list of harmful changes in the DSM-5, and medicalizing grief was number two. In case you aren’t aware, Dr. Frances’ credibility in voicing these concerns come from his long career as a psychiatrist and as the person selected by the APA to chair the DSM-IV. He said:

After 40 years and lots of clinical experience, I can’t distinguish at two weeks between the symptoms of normal grief and the symptoms of mild depression — and I challenge anyone else to do so. This is an inherently unreliable distinction. And I know damn well that primary care doctors can’t do it in a 7-minute visit. This should have been the most crucial point in DSM-5 decision-making because primary care docs prescribe 80 percent of all antidepressants and will be most likely to misuse the DSM-5 in mislabeling grievers.

Returning now to the essay “Complicated Grief,” let’s look at Dr. Cacciatore’s response. She commented how the bereaved were again at risk of being diagnosed and “treated” for “absolutely normal feelings and experiences” after a painful and traumatic loss. Responding to the above description of complicated grief, she said:

Ha! Social norms? Around grief? Talk about pathology! Western culture’s “social norms” and expectations around grief, especially when traumatic, are as abnormal and avoidant as any society could get. The average bereavement leave is three days, many bereaved parents are medicated within days or weeks after a traumatic loss (even in the presence of data to suggest these medications can be harmful and iatrogenic), and mourners are expected, and then pressured, to get back to ‘life-as-usual’ often within weeks or mere months, even after traumatic death. And our social networks often fail as others’ tolerance wanes in the months and years that follow.

Perhaps there is better guidance for conceiving a time frame for grief and bereavement in the book of Ecclesiastes (3:1-8) than in the DSM. There the Preacher said there is a season and a time for everything under heaven. Notice that he doesn’t try and quantify “season” or “time.” A time to be born and a time to die; a time to weep and a time to laugh; a time to mourn and a time to dance; a time to keep silent and a time to speak. When weeping turns to laughing, when mourning is replaced by dancing, then the season of grief has run its course. However, when individuals attempt to pathologize human emotion by blurring the line between grief and psychiatric disorder, it is a good thing that people like Joanne Cacciatore and Allen Frances choose to speak up and not remain silent.

03/18/15

Modern Alchemy with Antidepressants

19867524_sA study published in the open access journal, PLOS One by Sugarman et al. once again replicated previous studies showing that there was very little clinical difference between an antidepressant and placebo. In a way this is old news. One of the study’s authors, Irving Kirsch previously reported these findings. You can read more on this antidepressant research here and here. I’ve also looked at a 60 Minutes broadcast that interviewed him in “Thor’s Psychiatric Hammer: Antidepressants.” Kirsch has also published a book on the topic: The Emperor’s New Drugs: Exploding the Antidepressant Myth. But here is the significance of the Sugarman et al. study. It was the first evaluation to use “a complete database of published and unpublished trials sponsored by the drug’s manufacturer.”

In 2004, GlaxoSmithKline  (GSK) was required as part of a lawsuit settlement to post online the results of all clinical trials involving its drugs. The 2004 lawsuit was because the company had withheld data on the ineffectiveness and potential danger of Paxil (paroxetine) when given to adolescents and children. But it doesn’t seem GSK learned their lesson. In 2014 the company agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its antidepressant drugs, Paxil and Wellbutrin for unapproved uses and failing to report safety data about Avandia. So Sugarman et al. were able to use the data GSK made available to do the research reported here.

The current analysis is the first evaluation of the efficacy of an SSRI medication in the treatment of multiple anxiety disorders, and the first to utilize a complete database of published and unpublished trials sponsored by the drug’s manufacturer. Our results indicated that paroxetine presented a modest benefit over placebo in the treatment of anxiety and depression, with mean change score differences of 2.3 and 2.5 points on the HRSA [Hamilton Rating Scale for Anxiety] and HRSD [Hamilton Rating Scale for Depression], respectively.

The study’s results found that individuals receiving placebo reported 79% of the magnitude of change with the individuals receiving paroxetine. This was consistent to previously reported magnitudes of 76% for placebo compared to paroxetine. Replicating this previous finding, namely greater than 75% of the drug response, suggested that: “the magnitude of the placebo effect is especially large in the treatment of anxiety and depression.” Given the similarities between paroxetine and other SSRIs, it is possible that similar magnitudes of placebo effects will be found with them. Further research is required to support this proposition. Nevertheless, “the current analysis indicates that the published literature represents an overestimate of the true efficacy of paroxetine in the treatment of anxiety.”

The glass-half-full reporting of the differences between drug and placebo have emphasized that statistically significant differences were found. The problem is, those differences were so small, that their clinical significance was questionable. According to the criteria of NICE, the National Institute of Health and Clinical Excellence, “the mean difference between paroxetine and placebo in the current analyses fell short of clinical significance for the treatment of both anxiety and depression.” Sugarman et al. reviewed these concerns and concluded that changes of three points or less on the HRSD did not correspond to a clinically detectable change and appeared to be “of marginal clinical significance.”

So paroxetine has only a slight benefit over placebo in treating symptoms of anxiety and supports previous work indicating that it has just a modest benefit over placebo when treating depression. Given the known side effects with standard medications used to treat anxiety and depression, their use as a first-line treatment for these problems seems questionable. “The obvious alternative for the treatment of both anxiety and depression is psychotherapy intervention.” But direct comparisons have not generally shown a significant difference between depression treatment modalities (medication or psychotherapy). Similarly inconclusive findings were noted for anxiety treatment.

Allen Frances said there were two differences between medieval alchemy and the pharmaceutical industry today. First is the well-oiled, massively financed, worldwide, and devastatingly effective marketing machine. Second is the requirement for a DSM diagnosis.

A significant portion of the $12 billion spent each year on antidepressants in the United States rewards the drug companies for promoting the overly widespread use of what to many patients are no more than highly advertised, oversold, and very expensive placebos prescribed for a fake diagnosis. (Allen Frances, Saving Normal)

In 2010, there was a study published a Scandinavian psychiatric journal with the provocative title: “Antidepressant Medication Prevents Suicide in Depression.”  It concluded from studying 18,922 suicides in Sweden between 1992 and 2003, “that a substantial number of depressed individuals were saved from suicide by postdischarge treatment with antidepressant medication.” Sixteen months after publication, it was formally retracted by the authors for “… unintentional errors in the analysis of the data.”

Psychologist Phillip Hickey reported that after a five month legal battle, he was able to get access to the correct data. The original study found that among completed suicides treated for depression in psychiatric care in the last five years before their suicide, 164 (15.2%) had antidepressants in their blood when they committed suicide. The corrected data indicated that 603 (56%) had antidepressants in them when they committed suicide. The “unintentional error” was huge—an increase of 439 people (268%).

And yet, the study’s author said that no conclusion from the study could be drawn “regarding antidepressants’ effects on suicide risk in any direction.” In other words, you couldn’t conclude that antidepressants prevented or facilitated suicide risk. Hickey reported that at the time of writing the original article, its author has financial ties to Lundback, Eli Lily and GSK (GlaxoSmithKline).

In another study, found in The British Journal of Psychiatry, a team of UCLA researchers randomized 88 participants into double-blind groups for 8 weeks of treatment (placebo or medication) with supportive care; and a separate group receiving supportive care alone. Expectations of medication effectiveness, general treatment effectiveness and therapeutic alliance were also measured. The groups receiving medication or placebo plus supportive care were not significantly different. However, both had significantly better outcomes than the supportive care alone group. Expectations of medication effectiveness were predictive of only the placebo response. Therapeutic alliance predicted participant response to both medication and placebo.

The lead author of the study, Andrew Lechter, said that the results indicated that if you think a pill is going to work, it probably will work. He noted that belief in the effectiveness of the medication was not related to the likelihood of benefitting from it. “Our study indicates that belief in ‘the power of the pill’ uniquely drives the placebo response, while medications are likely to work regardless of patients’ belief in their effectiveness.” He speculated that factors like direct-to-the-consumer advertising could be shaping peoples’ attitudes about medication. “It may not be an accident that placebo response rates have soared at the same time the pharmaceutical companies are spending $10 billion a year on consumer advertising.”

It seems that Lechter is saying that the drug response was independent of the expectations of medication effectiveness, while the placebo response was driven be the prior expectations of the participants, as they were influenced by factors like direct-to-the-consumer advertisings. If true, this would seem to challenge, to a certain extent, the results noted above and in Kirsch’s previous research. Replication of the results is needed before Lechter’s conclusions from his research are accepted. It should be pointed out that paroxetine (Paxil) was approved by the FDA in May of 1996, while direct-to-the-consumer advertising of medications did not begin until 1997. Therefore, it would not have had an effect upon the paroxetine data reported above. I would also feel more comfortable with Lechter’s interpretations of his data if he didn’t have as extensive an association with the pharmaceutical industry. See the “Declaration of interest” in the linked abstract from The British Journal of Psychiatry.

 
01/12/15

Can Addicts Stop Using Without Help?

Image by kikkerdirk

Image by kikkerdirk

Maia Szalavitz wrote on Substance.com that she stopped shooting coke and heroin when she was 23. “I quit at around the age when, according to large epidemiological studies, most people who have diagnosable addiction problems do so —without treatment.” Although she personally got treatment help, her article was about people who stop without treatment or assistance from self-help, 12-Step programs. It was provocatively titled: “Most People with Addiction Simply Grow Out of It: Why Is This Widely Denied?” She’s currently finishing her sixth book, Unbroken Brain, “which examines why seeing addiction as a developmental or learning disorder can help us better understand, prevent and treat it.”

Szalavitz referenced an epidemiological study, which suggested that a significant proportion of individuals achieve remission from addiction at some point in their lifetime. This study by Lopez-Quintero et al. found that “half of the cases of nicotine, alcohol, cannabis and cocaine dependence remitted approximately 26, 14, 6 and 5 years after dependence onset, respectively.” An article by Gene H. Heyman reviewed four studies, including the Lopez-Quintero one, and suggested that: “most addicts were no longer using drugs at clinically significant (emphasis added) levels by the age of 30.” According to Heyman:

The idea that addiction is a disease characterized by compulsive (involuntary) drug use goes hand in hand with the belief that addicts require lifelong treatment and that treatment is necessary for recovery. However, the epidemiological results indicate that most addicts do not take advantage of treatment; nevertheless, most quit. The logical inference is that remission from drug dependence does not require treatment.

The implications of Heyman’s and Szalavitz’s interpretation of the research studies they cited has far reaching consequences, particularly for the addiction treatment industry. So I want to take a look at these epidemiological studies that led them to conclude that most addicts quit drug or alcohol use (or enter remission) on their own. Heyman’s review article looked at four national epidemiological surveys of the prevalence of psychiatric disorders. Szalavitz seems to cite references to these same four studies or other articles by Heyman. So my interaction will be with the discussion in Heyman’s article: “Quitting Drugs: Quantitative and Qualitative Features.”

Hyman presented data from four large national epidemiological studies that reported high remission rates of diagnosed substance-related disorders. The studies and their remission rates were as follows: 76% for NCS, the National Comorbidity Survey; 83% for the NCS-R, the National Comorbidity Survey Replication; and 81% for the NESARC, the National Epidemiological Survey on Alcohol and Related Studies. Another study, the Epidemiological Catchment Area (ECA) survey reported a lower remission rate of 57%, but had combined the criteria for substance abuse and substance dependence into one category. He concluded: “The results do not support the often heard claim that addiction is a chronic, relapsing disease.”

Now I also have problems with defining addiction in pure medical/disease model terms and would be happy to see a more socially and cognitively nuanced definition of addiction become mainstream. But those self-generated remission rates seemed awfully high. How was this remission quantified?

First, let’s look at a critique of epidemiological miscounts by Allen Frances. Frances was the chair appointed by the American Psychiatric Association for the fourth edition of the DSM, the Diagnostic and Statistical Manual of Mental Disorders used by the epidemiological researchers to quantify their definition of “remission.” He initially pointed to an article by Regier et al., “Limitations of Diagnostic Criteria and Assessment Instruments for Mental Disorders” published in the journal, Archives of General Psychiatry in 1998. The Regier et al. article abstract raised concerns with “significant differences in mental disorder rates from 2 large community surveys”—the ECA and the NCS, two of the studies cited and discussed by Heyman.

Frances also presented his critique of epidemiological studies that use DSM diagnoses in Saving Normal. There he pointed to the “inherent limitations” of defining clinical cases in epidemiological studies. They used lay interviewers who make “diagnoses” by symptom counts, with “no consideration of whether the symptoms are severe or enduring enough to warrant diagnosis or treatment.” As a consequence, the judgment of a clinician is missing. “This results in rates that are always greatly inflated.” Symptoms “that are mild, transient and lacking in clinical significance” are mistakenly diagnosed as symptoms of psychiatric 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. (Saving Normal, p. 86)

Another problem with these studies was how they defined “remission.” Remission was simply not reporting the required number of symptoms to meet the diagnosis over the previous year. Remission had a broader meaning than just “quitting” or abstinence.

The diagnostic criteria for substance abuse and dependence found in the DSM-IV were used by all the studies reported in Heyman. The ECA study, as noted above, included individuals who were “substance abusers” and “substance dependent.” The other studies only looked at those who were “substance dependent.” Remission for the ECA study was defined as no reported symptoms, while in the others, it was defined as two or less. This was based upon the separate criteria needed for each diagnosis—only one from the list for substance abuse, but three for substance dependence.

In Mad Science, Kirk, Gomory and Cohen noted how the DSM’s diagnostic criteria are the de facto definitions of mental disorder in the U.S. However, they said that describing a set of behaviors and labeling them as symptoms or diagnostic criteria does not establish the presence or absence of an illness or disorder.

Descriptive diagnosis is a tautology that distracts observers from recognizing that DSM offers no indicators that establish the validity of any psychiatric illness, although they may typically point to distresses, worries or misbehaviors (Mad Science, p. 166).

So the importance of clinical judgment, pointed to by Frances, in making a diagnosis of the existence or remission of substance dependence or substance abuse is essential. Following the critique of Frances and Regier et al. and their concerns with inconsistencies and limitations of using diagnostic criteria in epidemiological studies, the reported incidence rates of both substance dependence AND remission are likely to be greatly inflated in the studies reviewed by Heyman.

The conclusion that large populations of individuals with diagnosable addiction problems (substance dependence, according to Heyman) can stop or remit without help in such high percentages is suspect. In addition, the “diagnosis” of individuals as substance dependent in these studies is probably inaccurate for many of them. It is likely that many of those labeled as substance dependent in the studies were only substance abusers. According to Carlton Erickson in The Science of Addiction, substance abusers are more likely to make changes in their substance use because of “significant impairment or distress in their life as a consequence of their use.” They may quit on their own, without treatment. They may even go back to moderate or controlled drinking or mature out of the habit.