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Dr. Allen Frances: October 2011 Archives

October 2011 Archives

Several divisions of the American Psychological Association have just written an open letter highly critical of DSM-5. They are inviting mental health professionals and mental health organizations to sign a petition addressed to the DSM-5 Task Force of the American Psychiatric Association. (You can read the letter and sign up at http://www.ipetitions.com/petition/dsm5/.) It is an extremely detailed, thoughtful and well-written statement that deserves your attention and support.

The letter summarizes the grave dangers of DSM-5 that for some time have seemed patently apparent to everyone except those who are actually working on DSM-5. The short list of the most compelling problems includes: reckless expansion of the diagnostic system (through the inclusion of untested new diagnoses and reduced thresholds for old ones); the lack of scientific rigor and independent review; and dimensional proposals that are too impossibly complex ever to be used by clinicians. 

The American Psychiatric Association has no special mandate or ownership rights giving it any special sovereignty over psychiatric diagnosis. APA took on the task of preparing DSM's sixty years ago because it then seemed so thankless that no other group was prepared or willing to do it. The DSM franchise has stayed with APA only because its products were credible enough to gain widespread acceptance. People used the manual only because it was useful.

DSM-5 has strained that credibility to the breaking point and (unless radically changed) will be much more harmful than useful. We have reached a turning point that will soon become a point of no return. A near final version of DSM-5 must be ready by next spring and all final wording will be set in stone within a year. Time is running out if DSM-5 is to be saved from itself.

Rescue attempts and pushback are coming from numerous directions and are fast gaining in momentum. The American Psychological Association was preceded by an even harsher critique by the British Psychological Society. The Society of Biological Psychiatry has wondered why we need a DSM-5.  Experts in personality disorder have universally decried the proposed revisions in DSM-5. And the American Counseling Association will soon weigh in with its own statement on DSM-5.

Meanwhile DSM-5 has lived in a world that seems to be hermetically sealed. Despite the obvious impossibility of many of its proposals, it shows no ability to self-correct or learn from outside advice. The current drafts have changed almost not at all from their deeply flawed originals. The DSM-5 field trials ask the wrong questions and will make no contribution to the endgame. 

But the DSM-5 deafness may finally be cured by a users' revolt. The APA budget depends heavily on the huge publishing profits that accrue from its DSM sales. APA has ignored the scientific, clinical, and public health reasons it should omit the most dangerous suggestions — but I suspect APA will be more sensitive to the looming risk of a boycott by users.

Here are best-case and worst-case scenarios. Best case: APA opens up DSM-5 to external, independent review and only those suggestions that pass muster are included. DSM-5 becomes safe, usable, and widely used.

Worst case: DSM-5 stumbles along blindly as it has and includes most or all of its harmful suggestions. It loses its status as a useful and standard guide to psychiatric diagnosis, creating an unnecessary and unfortunate Babel of practice and research habits. And the American Psychiatric Association goes broke.

The Trustees and Assembly have thus far been almost completely passive in exercising their governance role over DSM-5. I believe they can wait no longer if they are to fulfill their responsibility to the public, to the mental health field, and to their membership. It is pretty much now or never.
Within the next three to five years, we will likely have biological tests to accurately diagnose the prodrome of Alzheimer's disease (AD). Much remains to be done in standardizing these tests, determining their appropriate set points and patterns of results, and negotiating the difficult transition from research to general clinical practice. And, given the lack of effective treatment, there are legitimate concerns about the advisability of testing for the individual patient and the enormous societal expense with little tangible benefit. Despite these necessary caveats, there is no doubt that biological testing for prodromal AD will be an important milestone in the clinical application of neuroscience.

How does this impact on the DSM-5 proposal to include a Minor Neurocognitive Disorder as a presumed prodrome to AD? Clearly the advancing science makes this proposal obviously premature and unnecessary. Any DSM-5 definition has necessarily to be based exclusively on extremely fallible clinical criteria that will have unacceptably high false positive rates — surely exceeding 50 percent. Why scare half the people taking the tests unnecessarily, especially when there is no effective treatment even for those who are true positives?

Accurate diagnosis for prodromal AD most certainly requires biological tests and, fortunately, these are now well within reach. No purpose can possibly be served by rushing ahead with a second rate clinical method of prodrome diagnosis when accurate biological testing will so soon be available. DSM-5 can make a far better choice. It has declared itself to be a 'living document' with plans for continuing, ongoing revision as new findings justify changes. Prodromal AD is the perfect diagnosis for implementing this plan. Hold off for now and then add an Alzheimer's prodrome only after the biological tests have proven themselves able to diagnose it accurately.

Sharon Kirkey of Postmedia News has published an important news story revealing that pediatricians can be just as reckless as psychiatrists in their recommendations for attention deficit disorder. Yesterday, the American Academy of Pediatrics released updated ADD guidelines that recommend medication treatment for preschoolers as young as age 4, despite the fact that such early use is not approved by the FDA. This radical suggestion will further the already problematic over-diagnosis of ADD and expand the inappropriate prescription of medication to young children. 

It is absolutely clear that medication can be very helpful for ADD in carefully diagnosed school-age kids who have moderate/severe problems and who have not responded to patient watchful waiting, parent training and behavioral interventions. But in busy practice settings, ADD is often inaccurately diagnosed and prematurely treated with medication — especially under the pressure of heavy drug company marketing to physicians and direct advertising to parents and teachers. 

Medication for preschoolers should be undertaken only under very special circumstances by people who are especially expert in ADD — like the creators of the AAP guidelines. But it is a great mistake to encourage such early use of medication in much less expert general practice, especially since preschoolers are difficult to diagnose accurately and may be more prone to harmful medication effects like loss of appetite, failure to gain weight appropriately, abdominal pain, headaches, agitation and disturbed sleep. And there are rare but dangerous cardiac risks. Safety in young children has not been studied nearly enough to inspire any confidence about short-term problems and long-term risks. This should be a treatment of very last resort in preschoolers, reserved for those with the most severe problems and delivered by those with the greatest expertise. 

Mark Wolraich, the lead author, is quoted as follows justifying the guidelines: "Because of greater awareness about ADHD and better ways of diagnosing and treating this disorder, more children are being helped. Treating children at a young age is important, because when we can identify them earlier and provide appropriate treatment, we can increase their chances of succeeding in school."

Clearly, he is touting the benefits (which certainly may be appreciable for some), but ignoring the risks (which may be appreciable for others), and the fact that very little research has been done to assess the accuracy of diagnosis and the safety of medication in very young children — especially in general practice settings. 

The AAP guidelines do take the useful precaution of recommending a first line trial of behavioral interventions in preschool children with stimulants to be used later only for those with moderate to severe symptoms which have not improved after behavior therapy. But experience suggests that these cautions will be widely ignored in busy everyday practice, especially because behavioral approaches are usually unavailable and medication is so highly promoted and readily available.

Thus, despite its caveats and good intentions, the AAP guideline will surely invite an inappropriate glut of medication for preschoolers. And we will be largely flying blind about its impact. Much more study and cautious consideration of the risks and unintended consequences should have preceded the issuance of prestigious guidelines so likely to greatly influence practice habits. 

How could the AAP experts in ADD go so far wrong? It really should be no surprise — the ADD experts working on DSM-5 are making precisely the same kind of expansive, reckless mistakes. These poorly conceived AAP guidelines confirm the folly of placing responsibility for important public health decisions solely in the hands of highly specialized experts who have worked only in university settings. Experts are almost always hopelessly naοve about how their guidelines will be misused in real life. We have already experienced a vast expansion in the diagnosis and medication treatment of ADD and these new AAP guidelines will encourage a further feeding frenzy of aggressive marketing by drug companies. 

The cautions included in the guidelines to protect against the first line use of medications will be routinely ignored, many young kids will be carelessly diagnosed and they will receive unnecessary medication. The evidence that drugs are safe in preschoolers and will be judiciously prescribed in everyday practice is ridiculously incomplete. The ADD diagnosis will doubtless often be made prematurely in very young children who will then receive unnecessary and potentially harmful medication. If any diagnostic or treatment guideline can possibly be misused it will be — especially once drug company marketing distorts its intended use. 

The recklessness of the AAP in producing this treatment guideline for ADD and of the American Psychiatric Association in reducing the thresholds for the DSM-5 diagnosis for ADD together prove that important public health decisions cannot be entrusted to narrowly focused professional organizations. Experts on any topic have an inherent intellectual conflict of interest that prevents them from performing properly balanced and unbiased risk benefit analyses. They consistently tend to exaggerate the benefits and ignore the risks of their suggestions — especially as these will play out in general practice. Experts drawn from pediatrics and psychiatry are needed to inform, but should not exclusively control, the development of the diagnostic and treatment guidelines for ADD. 

In my view, the AAP treatment guidelines and the DSM 5 diagnostic guidelines both need to be tightened before they will fit for use by the average practitioner. In their current form, both are far too expansive and far too risky. They are best ignored.

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