Following the acknowledgement reported by The New York Times (Feb. 10, 2010), that "Studies of teenagers identified as at high risk of developing psychosis, for instance, find that 70 percent or more in fact do not come down with the disorder," we wrote:

"Imagine the human tragedies that follow the mislabeling of 70% of children as severely mentally ill, who are then exposed to extremely toxic drugs that induce diabetes, cardiovascular disease, and a host of other severe adverse effects. Adding insult to injury, US taxpayers have been saddled with the cost of drugs that undermine the health of children who then require life-long care for drug-induced (iatrogenic) chronic diseases."

Dr Allen Frances, the chairman of psychiatry’s DSM-IV Task Force, who is professor emeritus at Duke University, strongly validates our alarm about the DSM-V Task Force recommendations–in particular the introduction of "psychosis risk syndromes." Indeed, Dr. Frances has been highly critical of the DSM5 Task Force for its failure to follow fundamental professionally valid standards when recommending adoption of new "diagnoses." 
 
"Every new diagnosis suggested for DSM5 requires (but has not yet received) a searching risk/benefit analysis and a thorough forensic review….    Among all the problematic suggestions for DSM5, the proposal for a "Psychosis Risk Syndrome" stands out as the most ill–conceived and potentially harmful. It aims to solve a pressing problem in psychiatry– the need for early identification and preventive treatment."

He notes that the concept of early intervention rests on 3 fundamental pillars–
"being able to diagnose the right people and then providing them with a treatment that is effective and safe. "Psychosis Risk Syndrome" fails badly on all 3 counts:
    1. It would misidentify many teenagers who are not really at risk for psychosis.
    2. The treatment they would most often receive (atypical antipsychotic medication) has no proven efficacy, but. . .
    3. It does have definite dangerous complications."

So, the elimination of the "bipolar" diagnosis for children, did not eliminate the mislabeling of children.
Indeed, Dr. Frances forthrightly states:

"DSM5 would create tens of millions of newly misidentified false positive “patients,” thus greatly exacerbating the problems caused already by an overly inclusive DSM4.[7] There would be massive overtreatment with medications that are unnecessary, expensive, and often quite harmful. DSM5 appears to be promoting what we have most feared–the inclusion of many normal variants under the rubric of mental illness, with the result that the core concept of "mental disorder" is greatly undermined."

The impact of DSM-V on the nation’s healthcatre budget would simply  leave no money for treating bone fide medical illnesses.  So, maybe, just maybe, the Obama administration will put the needed brakes on an irresponsible profession.

Below, we repost his recent critique within a series published in Psychiatric Times, and an excerpt from a comprehensive overall critique.

Contact: Vera Hassner Sharav

~~~~~~

Psychiatric Times
DSM5 and "Psychosis Risk Syndrome:" Not Ready For Prime Time
By Allen Frances, MD
March 19, 2010

    Among all the problematic suggestions for DSM5, the proposal for a "Psychosis Risk Syndrome" stands out as the most ill–conceived and potentially harmful. It aims to solve a pressing problem in psychiatry– the need for early identification and preventive treatment. Psychotic episodes create tremendous short-term impairment and may impact negatively on long-term prognosis and treatment efficacy. It would save great suffering if we could get there early and do something useful to reduce the lifetime burden of illness before too much damage is done.
   
    But good intentions are not enough. The whole concept of early intervention rests on 3 fundamental pillars– being able to diagnose the right people and then providing them with a treatment that is effective and safe. "Psychosis Risk Syndrome" fails badly on all 3 counts:
    1. It would misidentify many teenagers who are not really at risk for psychosis.
    2. The treatment they would most often receive (atypical antipsychotic medication) has no proven efficacy, but. . .
    3. It does have definite dangerous complications.

    First, let’s deal with the misidentification problem. Even in the most expert of hands (ie, in very highly selected research clinic settings), at least 2 of 3 people who get the diagnosis do not go on to become psychotic. Of great counterintuitive interest, the longer the research clinic operates, the lower its rate of correct identification becomes. With time and spreading reputation, the clinic attracts increasingly heterogeneous referrals– so that it is more difficult to discriminate from among them those who are truly at risk for psychosis.
   
    What would be the misidentification rate once the diagnosis became official and was applied in the real world? No one can say for sure, but two-thirds is certainly a lower limit of misidentification. There are several reasons to believe that the ratio of wrong diagnoses would actually be much higher:

        o The raters in general practice would be much less expert than specialists in research clinics
        o The "patients" would be closer to normal and harder to discriminate
        o Drug company marketing would influence parents and clinicians to be especially alert to any strangeness in teenagers.

    It has been estimated that the false-positive rate would jump from about 70% in specialty clinics to about 90% in general practice. This means that as many as an astounding 9 in 10 individuals identified as "risk syndrome" would not really be at risk for developing psychosis.
   
    Those supporting the diagnosis for DSM5 have attempted to fix this overwhelming problem by inserting a definitional criterion that the person must be seeking treatment. They hope this requirement would both reduce the rate of false-positives and ensure that those who are misidentified will need some form of treatment. Their preferred treatment for "risk syndrome" is cognitive/behavior therapy which might be helpful (and is unlikely to be harmful)– even for those who have been misidentified.
   
    This fix fails badly on both counts– ie, in reducing false-positives and in guaranteeing safe treatment. Under the best of circumstances, the overwhelming majority of "treatment seekers" will still be false-positive. Once the diagnosis is official and marketed, the problem will get much worse as a new army of "treatment seekers" is brought in by family members. Their perceived "strangeness" may come from many causes other than psychotic risk, including drug use; adolescent developmental issues and rebelliousness; culturally dystonic creativity; stable schizotypal personality; or normal eccentricity. A far more efficient signal to noise filter would have been to require that the individual must also have a close family member who has experienced psychotic episodes.

    Then we get to the worrying treatment issues. It is the height of unrealistic wishful thinking to assume that most of the misidentified patients will get cognitve therapy. Cognitive therapy is in short supply and largely unavailable–especially for this population. On the other hand, antipsychotic medications are fairly ubiquitous and already frequently given for off-label indications– particularly to kids on Medicaid. It has not yet been established that antipsychotic medications are effective in preventing psychotic episodes or in improving the life course in those who would meet the criteria for "risk syndrome." This is an area that to date has received little study and the few existing findings are equivocal.

    In contrast, the harmful effects of atypical antipsychotics are extremely well established and frightening. Teenagers starting at an average weight of 110 pounds gained an average of 12 pounds in 12 weeks– and one of the antipsychotics caused an 18-pound weight gain in this period. This raises the risk for diabetes, metabolic syndrome, and a shorter life span.

    To sum up:
        1. The "risk syndrome" would misidentify many (somewhere between 3 and 9) kids for every one correctly identified
        2. The treatment most likely to be offered has no proven efficacy, but can have extremely dangerous complications.

    This is a clearly the prescription for an iatrogenic public health disaster.

    The goal of early identification and proactive treatment in psychiatry is laudable– but elusive and not currently attainable. Prevention requires having a happy combination of accurate identification and effective and safe treament. Instead, we now have the opposite dangerous combination– wildly inaccurate identification with a likely ineffective but definitely risky treatment.

    The people who developed the "risk syndrome" suggestion for DSM5 are smart and have no conflict of interest motivation. How can they be promoting such a bad idea? The answer is that, like most experts, they have a blind spot when it comes to understanding the huge gulf between the real world and their rarified research experience. Perhaps in their hands, the false-positive rate can be kept to 2 out of 3 and the cognitve treatments given will be safe and generally helpful. It has been difficult for them to appreciate just how differently and destructively their pet suggestion would play were it to become prematurely official.

    "Psychosis Risk Syndrome" belongs in the DSM appendix reserved for new diagnoses that deserve further study– but that are not ready for prime time.

    [Editor’s note: This commentary also appears on the website of Psychology Today <> .]

                                        
Psychiatric Times.
COMMENTARY
Opening Pandora’s Box: The 19 Worst Suggestions For DSM5
By Allen Frances, MD | February 11, 2010

EXCERPT:

I have previously criticized the DSM5 process for its unnecessary secretiveness, its risky ambitions, its disorganized methods, and its unrealistic deadlines.1-6 Now, it is finally time to evaluate the first draft of the recently posted DSM5 product (at www.DSM5.org).

Poor and inconsistent writing
Perhaps it should occasion no surprise that a flawed process should yield a flawed product. The most fundamental problem is the poor and inconsistent writing. Admittedly, early Work Group drafts are often written imprecisely and with varying quality, but it is surprising that the DSM5 leadership has failed to edit for clarity and consistency. It would be a waste of effort, time, and money to conduct field trials before the new criteria sets receive extensive revision. The poor writing is also a bad prognostic sign, suggesting that the DSM5 text sections for the various disorders may eventually be equally inconsistent, variable in quality, and sometimes incoherent.

Higher rates of mental disorder
In terms of content, most concerning are the many suggestions for DSM5 that would dramatically raise the rates of mental disorder. These come in 2 forms:

1. New diagnoses that would be extremely common in the general population (especially after marketing by an ever alert pharmaceutical industry)

2. Lowered diagnostic thresholds for many of the existing disorders.

DSM5 would create tens of millions of newly misidentified false positive “patients,” thus greatly exacerbating the problems caused already by an overly inclusive DSM4.7 There would be massive overtreatment with medications that are unnecessary, expensive, and often quite harmful. DSM5 appears to be promoting what we have most feared–the inclusion of many normal variants under the rubric of mental illness, with the result that the core concept of "mental disorder" is greatly undermined.

Unforeseen consequences
A third pervasive weakness in the DSM5 options is their insensitivity to possible misuse in forensic settings….cut…

PROBLEMATIC NEW DIAGNOSES

The Psychosis Risk Syndrome is certainly the most worrisome of all the suggestions made for DSM5. The false positive rate would be alarming 70% to 75% in the most careful studies and likely to be much higher once the diagnosis is official, in general use, and becomes a target for drug companies. [8]

Hundreds of thousands of teenagers and young adults (especially, it turns out, those on Medicaid) would receive the unnecessary prescription of atypical antipsychotic drugs.9
There is no proof that the atypical antipsychotics prevent psychotic episodes, but they do most certainly cause large and rapid weight gains (see the recent FDA warning) and are associated with reduced life expectancy?to say nothing about their high cost, other side effects, and stigma.

This suggestion could lead to a public health catastrophe and no field trial could possibly justify its inclusion as an official diagnosis. The attempt at early identification and treatment of at risk individuals is well meaning, but dangerously premature. We must wait until there is a specific diagnostic test and a safe treatment.

Mixed Anxiety Depressive Disorder taps nonspecific symptoms that are widely distributed in the general population and would therefore immediately become one of the most common of all the mental disorders in DSM5. Naturally, its rapid rise to epidemic proportions would be ably assisted by pharmaceutical marketing. It is likely that medication would not be much more effective than placebo because of the high placebo response rates in milder disorders.10

Minor Neurocognitive Disorder is defined by nonspecific symptoms of reduced cognitive performance that are very common (perhaps almost ubiquitous) in people over fifty. To protect against false positives, there is a criterion that requires objective cognitive assessment to confirm that the individual has decreased cognitive performance, but getting a meaningful reference point is impossible in most instances and the threshold has been set to include a whopping 13.5% of the population (ie, the percent of population within the first and second standard deviation). Moreover, the suggestion for objective testing will probably be widely ignored in the primary care settings where the bulk of diagnosing will be done.

Medicalizing the expectable cognitive impairments of aging will result in much unnecessary treatment with ineffective prescription drugs and quack folk remedies. These will undoubtedly attain great popularity since there will likely be a very high placebo response rate.

Binge Eating Disorder will have a rate in the general population (estimated at 6%) and this will probably become much higher when the diagnosis becomes popular and is made in primary care settings. The tens of millions of people who binge eat once a week for 3 months would suddenly have a “mental disorder”? subjecting them to stigma and medications with unproven efficacy.

Temper Dysfunctional Disorder with Dysphoria is one of the most dangerous and poorly conceived suggestions for DSM5?a misguided medicalization of temper outbursts. The “diagnosis” would be very common at every age in the general population and would promote a large expansion in the use of antipsychotic medications, with all of the serious attendant risks described above. Apparently, the Work Group was trying to correct excessive diagnosis of childhood bipolar disorder?but its suggestion is so poorly written that it could not possibly accomplish this goal and instead would it would create a new monster.

The misapplication of this diagnosis would provide a blanket excuse for reduced personal responsibility and will lead to forensic nightmares. It is a nonstarter.

Paraphilic Coercive Disorder would expand the pool of sex offenders who are eligible for indefinite civil commitment because they have a “mental disorder” to include cases of sexual coercion. Paraphilic Coercive Disorder was initially considered for inclusion in DSM-III-R (under the name Paraphilic Rapism) but was rejected because it was impossible to reliably and validly differentiate those rapists whose actions are the result of a paraphilia from the large majority of rapists who are motivated by other factors (such as power). Given the facts (acknowledged in the rationale section) that most rapists are savvy enough to deny sexual fantasies and the unreliability (and unavailability) of laboratory testing, the diagnosis will inevitably be based only on the person’s behavior, leading to a potentially alarming rate of false positives with consequent wrongful indefinite commitment.11

Hypersexuality Disorder would be a gift to false positive excuse seekers and potential forensic disaster. Another clear nonstarter.

A Behavioral Addictions category would be included with the substance addictions section and would start life with one disorder, Pathological Gambling (transferred from Impulse Disorders section). Next in line might be a new category for Internet Addiction. This could provide a slippery slope leading to the back door inclusion of a variety of silly and potentially harmful diagnoses (ie, “addictions” to shopping, sex, work, credit card debt, videogames etc, etc, etc) under the broad rubric of “behavioral addictions not otherwise specified.” The construct “Behavioral Addictions” represents a medicalization of life choices, provides a ready excuse for off loading personal responsibility, and would likely be misused in forensic settings.

LOWERED THRESHOLDS

The greatest general impact would come from the suggestion to eliminate the “clinical significance” criterion required in DSM4 for each disorder that has a fuzzy boundary with normality (about two-thirds of them). These were included to ensure the presence of clinically significant distress or impairment when the symptoms of the disorder in mild form might be compatible with normality. Removing this requirement would reduce the role of clinical judgment as a gatekeeper in determining the presence or absence of mental disorders and thus would increase the already swollen rates of psychiatric diagnosis.

Attention Deficit/Hyperactivity Disorder. The DSM4 wording changes (along with extremely active drug company marketing) contributed to escalating rates of ADD – accompanied by the widespread misuse of stimulant medications for performance enhancement and the emergence of a large secondary illegal market.12 There are 4 suggestions for DSM5 that would make this existing overdiagnosis much worse.

•The first change is to raise the required age of onset from 7 to 12.[13]
•The second is to allow the diagnosis based only on the presence of symptoms, not requiring impairment.
•The third is to reduce by half the number of symptoms required for adults.

These 3 changes greatly reduce the specificity of the ADD diagnosis in adolescents and adults and will result in a further flood of false positives and of resulting stimulus misuse for performance enhancement.[14]

•The fourth change is to allow the diagnosis of ADD in the presence of autism. This might create the interaction of 2 false epidemics, encouraging increased stimulant use in an especially vulnerable population…..cut…

Autism Spectrum Disorder. Asperger’s disorder would be collapsed into this new unified category. Although this consolidation appeals to some experts, it remains controversial and presents serious problems. Those with Asperger’s (which is much less impairing) will be stigmatized by the association with classic autistic disorder. Moreover, in the average everyday practice conducted by non-experts, the spectrum concept will likely further fuel the “epidemic” of loosely defined autism that was already been triggered by the introduction of Asperger’s in DSM4.15

Medicalizing Normal Grief. DSM5 would reverse 30 years of diagnostic practice and allow the diagnosis of Major Depression to be made for individuals whose grief reaction symptomatically resembles a Major Depressive episode (eg, 2 weeks of depressed mood, loss of interest in activities, insomnia, loss of appetite, and trouble concentrating immediately following the loss of a spouse would be a mental disorder. This is radical and astounding change that may be helpful for some individuals, but will cause a huge false positive problem?especially since there is so much individual and cultural variability in bereavement. Of course, grief would become an extremely inviting target for the drug companies.

Pedohebephilia is one of the most poorly written and unworkable of the suggested criteria sets. Expanding the definition of pedophilia to include pubescent teenagers would medicalize criminal behavior and further the previously described misuse of psychiatry by the legal system. Certainly, sex with under-age victims should be discouraged as an important matter of public policy, but this should be accomplished by legal statute and appropriate sentencing, not by mental disorder fiat….cut….

CONCLUSIONS
…..cut…..

Unfortunately, Work Group members usually have a correspondingly huge blind spot missing the fact that every effort to reduce the rate of false negatives must inevitably raise the rate of false positives (often dramatically and with dire consequences). It is inherently difficult for experts, with their highly selected research and clinical experiences, to appreciate fully just how poorly their research findings may generalize to everyday practice especially as it is conducted by harried primary care clinicians in an environment heavily influenced by drug company marketing. They also consistently underestimate the costs and risks of medication treatment when it is given to those who don’t really need it. If we are ever to realize the wished for gains of early case finding, we must first have both specific diagnostic tests and safe and effective treatments. In contrast, the DSM5 suggestions display the peculiarly dangerous combination of nonspecific and inaccurate diagnosis leading to unproven and potentially quite harmful treatments.

I wish to emphasize that the problems in this DSM5 draft are not at all the fault of the Work Group members who have labored hard under very unpromising conditions. The DSM5 options are poorly conceived and executed because of the interaction of 4 unfortunate decisions made by the DSM5 leadership:

1. Requiring unnecessary confidentiality agreements that insulated the Work Groups from the usual and necessary corrective interaction with the field

2. Tightly restricting Advisors to a small and highly selected group

3. Establishing the expectation that Work Groups be innovative rather than risk/benefit conscious

4. Providing the Work Groups with remarkably little guidance, consistency, and editorial assistance.

Because of the secretive and closed nature of the DSM5 process, the expectable enthusiasms of the experts who comprise the Work Groups have not been balanced, as they must always be, with real world practical clinical wisdom and a careful risk/benefit analysis of the possible unintended consequences of every suggestion.

It would be reckless now to rely on the complacent assumption that all these problems will eventually come out in the wash. By its previous actions and inactions, the DSM5 leadership has sacrificed any “benefit of the doubt” faith that their process will be self-correcting in a way that guarantees the eventual elimination all of the harmful options.

There is, however, some cause for measured optimism regarding the future of the DSM5 process based on the fact that it does respond, albeit reluctantly, to external pressure. There have been significant and encouraging improvements during the past several months. A DSM5 Oversight Committee was finally appointed and has played a very beneficial role in correcting the most egregious problems in the previous methods and deadlines. The ill conceived plan to conduct field trials before having a public review of criteria was dropped and the unrealistic field trial and publication deadlines were each extended by a year. The additional time provided by the extended deadlines, if used well, would be sufficient to  produce a serviceable DSM5.

What needs to be done next? The responsibility (and opportunity) for rescuing DSM5 falls most heavily on the field at large and on the Oversight Committee. Now that the DSM5 drafts are finally open for wide review, it behooves the field to be active in identifying problems and providing the needed pressure to ensure they will be corrected. My recommendations for the Oversight Committee are:

1. Extend the period allotted for public review to 3 months.

2. Use this time to ensure the careful editing of each word of each item of every criteria set to provide the clarity and consistency that is now sorely lacking and is absolutely necessary before any meaningful field testing can begin.

3. Post field trial methods for public review.

4. Appoint 3 subcommittees reporting to the Oversight Committee (responsible, respectively, for monitoring forensic review, risk benefit analysis, and field trials.

5. Post the literature reviews and plans for ICD-11 harmonization.

Every future step in the preparation of DSM5 should involve active interaction with the field and with the Oversight Committee and its subcommittees. Unnecessary secrecy has caused the current problems and only full transparency and openness to outside input will solve them.

References
1. Frances A. A Warning Sign on the Road to DSM-V: Beware of Its Unintended Consequences. Psychiatric Times. 2009;26:1,4.
2. Frances A. Advice to DSM-V: Change Deadlines and Text, Keep Criteria Stable. Psychiatric News. 2009;26(10). 3. Frances A. Advice to DSM-V: Integrate with ICD-11.
http://www.psychiatrictimes.com/display/article/10168/1448330. Accessed February 11, 2010.
4. Frances A. Issues for DSM-V: the limitations of field trials: a lesson from DSM-IV. Am J Psychiatry. 2009;166:1322.
5. Frances A. Whither DSM-V? Br J Psychiatry. 2009;195:391-392.
6. Frances A. Alert to the Research Community—Be Prepared to Weigh In on DSM-V. Psychiatric Times. 2010;27(2).
7. Moffitt T, Caspi A, Taylor A, et al. How common are common mental disorders? Evidence that lifetime prevalence rates are doubled by prospective versus retrospective ascertainment. Psychol Med. 2009;Sep 1-11. [Epub ahead of print].
8. Yung A, Yuen H, Berger G, Francey S, Hung T-C, Nelson B, et al. Declining transition rate in ultra high risk (prodromal) services: Dilution or Reduction of Risk? Schizophr Bull. 2007;33:675-681.
9. Olfson M. Antipsychotic prescriptions for children and adolescents in the UK increased from 1993 to 2005. Evid Based Ment Health. 2009;12:30.
10. Fournier J, DeRubeis R, Hollon S, et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA. 2010;303:47-53.
11. Frances A, Sreenivasan S, Weinberger LE. Defining Mental Disorder When It Really Counts- DSM-IV-TR and SVP/SDP Statutes. Journal of the American Academy of Psychiatriy and the Law. 2008;36:375-384.
12. Wilens T, Adler L, Adams J, Sgambati S, Rotrosen J, Sawtelle R, et al. Misuse and Diversion of Stimulants Prescribed for ADHD: A Systematic Review of the Literature. Journal of the American Academy of Child & Adolescent Psychiatry. 2008;47:21-31.
13. Kieling C, Kieling R, Rohde L, Frick P, Moffitt T, Nigg J, et al. The age at onset of attention deficit hyperactivity disorder. Am J Psychiatry. 2010;167:14-16.
14. Bogle K, Smith B. Illicit methylphenidate use: a review of prevalence, availability, pharmacology, and consequences. Curr Drug Abuse Rev. 2009;2:157-176.
15. Autism and Developmental Disabilities Monitoring Network Surveillance Year 2006 Principal Investigators; Centers for Disease Control and Prevention (CDC). Prevalence of autism spectrum disorders – Autism and Developmental Disabilities Monitoring Network, United States, 2006. MMWR Surveill Summ. 2009;58:1-20.
16. Regier D, Kaelber C, Rae D, Farmer M, Knauper B, Kessler R, et al. Limitations of diagnostic criteria and assessment instruments for mental disorders. Implications for research and policy. Arch Gen Psychiatry. 1998;55:109-115.
17. Frances A. Categorical and dimensional systems of personality diagnosis: a comparison. Compr Psychiatry. 1982;23:516-527.
   

© 1996 – 2010 UBM Medica LLC,
                    
FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.