A modest proposal: introduce bioethical review into the drug approval process

There has been raucous furor over the decision of Kathleen Sibelius, the Secretary of Health and Human Services in the Obama administration, to overrule the FDA’s approval of the drug known as Plan B One-Step as an over-the-counter drug. It has never previously transpired that the FDA has been overruled on a matter that falls under its jurisdiction such as this, and FDA Commissioner Margaret Hamburg issued a carefully worded response which, given that Sibelius is her boss, was remarkable for its forthrightness: Continue reading

Public expression and DSM-V

The bible of Psychiatry, The Diagnostic and Statistical Manual of Mental Disorders (DSM), is the standard reference text by which psychiatric disorders are classified.  Every now and then, the psychiatric community revises the manual; the current version, DSM-IV was published in 1994 and in 2000 revisions of the text were added (hence the clumsy term DSM-IV-TR) but the categories of psychiatric disease remained unchanged.  At the moment, a committee is hard at work developing a new version, DSM-V, and the issue has morphed from scientific enterprise to public melodrama.

Over at H-Madness, a blog devoted to the history of psychiatry, the historian Hannah Decker has a wonderful post detailing the trials and tribulations of the controversies currently embroiling the production of DSM-V.  Entitled A Moment of Crisis in the History of American Psychiatry, Decker’s post covers all of the usual territory, some of which we have discussed previously (here and here). It bears repeating that the biggest challenge to the endeavour is the lack of objective criteria for defining psychiatric diseases: until neuroscience provides this clinical specialty with concrete insights into the relevant changes in human neurobiology that accompany psychiatric disease, the field will continue to be on shaky ground, defining and redefining ‘syndromes’ composed of constellations of symptoms rather than clearly understood alterations which result in pathology. Continue reading

News from the medicalization of normalcy front

Ah, the medicalization of normalcy.  It never seems to end.

In yesterday’s New York Times, Natasha Singer has an article called “Sure, It’s Treatable. But Is It a Disorder?“.  The piece focuses upon drugs to treat premature ejaculation (PE), but the larger message is that drugmakers are now unabashedly in the business of transforming seemingly normal physiological variation into bona fide disease.  Singer tells us that,

The template goes something like this: Start with a legitimate quality-of-life issue — like fitful sleep or shyness — that does not yet have its own prescription medication and is debilitating to a few people a lot of the time. Next, position the quality-of-life issue as a medical condition with symptoms so common it covers vast numbers of people who had previously not identified themselves as having a health problem, or who thought they were just experiencing an occasional and normal annoyance. Continue reading

Psychiatry’s existential crisis

dsm_iv_21Simon Baron-Cohen, the Cambridge psychologist best known for developing the hypothesis that autism is caused by delays in the development of theory of mind, has an op-ed piece in today’s New York Times about the challenges facing the DSM committee as they proceed with developing DSM-V.  Apparently, the committee is considering subsuming autism and Asperger’s syndrome under the single diagnosis of autism spectrum disorder.  Baron-Cohen urges the committee not to do so.

What is notable about his argument is not that autism spectrum disorder does not exist, but rather that we know too little about it to be certain that this is a better way of characterizing the situation.  Without a firmer grasp of the relevant details, Baron-Cohen argues that we should not make changes in the DSM that may have far ranging consequences.  After all, DSM “is the bible of diagnosis in psychiatry, and is used not just by doctors around the world but also by health insurers.”

Later in his article he gets to the meat of the matter:

Part of the reason the diagnostic manual can move the boundaries and add or remove “mental disorders” so easily is that it focuses on surface appearances or behavior (symptoms) and is silent about causes. Symptoms can be arranged into groups in many ways, and there is no single right way to cluster them. Psychiatry is not at the stage of other branches of medicine, where a diagnostic category depends on a known biological mechanism. An example of where this does occur is Down syndrome, where surface appearances are irrelevant. Instead the cause — an extra copy of Chromosome 21 — is the sole determinant to obtain a diagnosis. Psychiatry, in contrast, does not yet have any diagnostic blood tests with which to reveal a biological mechanism.

Continue reading

Neurodiversity – A National Core for Neuroethics Journal Club

Brain in Head B&W-RBrain in Head B&W-L

A new feature of this blog will be to summarize the discussion that arises at our weekly journal club.  Today, we read two papers on neurodiversity.

The first paper was Glannon, Neurodiversity. Journal of Ethics in Mental Health (2007).  Here is the abstract:

The neurological and psychological traits that regulate our thought and behavior fall along a spectrum that extends from the normal to the pathological, from traits that enable us to perform mental and physical functions to traits that interfere with these functions. Yet many people have a constellation of both normal and pathological mental traits. Some even have traits associated with exceptional intellectual or artistic ability despite being diagnosed as having a neurological or psychiatric disorder. These cases raise medical, ethical and legal questions about which conditions should be diagnosed as mental disorders or pathologies, and whether it is always in one’s best interests to be treated for these conditions.

The second paper was Fenton and Krahn,  Autism, Neurodiversity and Equality Beyond the’Normal’. Journal of Ethics in Mental Health (2007). Here is the abstract:

“Neurodiversity” is associated with the struggle for the civil rights of all those diagnosed with neurological or neu- rodevelopmental disorders. Two basic approaches in the struggle for what might be described as “neuro-equality” are taken up in the literature: (i) There is a challenge to current nosology that pathologizes all of the phenotypes associated with neurological or neurodevelopmental disorders (e.g. Autism Spectrum Disorder (ASD)); (ii) there is a challenge to those extant social institutions that either expressly or inadvertently model a social hierarchy where the interests or needs of individuals are ranked relative to what is regarded as properly functioning cognitive capacities. In this paper, we explore some of the reasons justifying (i) which make it an important tool for achieving greater neuro-equality, while still recognizing its limitations for achieving this goal. Particularly, we explore how an appeal to functionality and neurological diversity can support a re-seeing of at least certain forms of ASD.

These are actually but two of an interesting series of papers in a special theme issue of the journal on the topic of neurodiversity (with a contribution from the Core’s own Daniel Buchman).

One of the features of our journal club is that members share with the group other papers that bear on the issue.

Given that the concept of neurodiversity has emerged from the autism field, it seems appropriate to begin with a quote from Ian Hacking’s paper “Humans, Aliens & Autism.”

The Diagnostic and Statistical Manual of Mental Disorders (DSM) classifies autism as a mental disorder, a pervasive developmental disorder, in fact. But it is not a kind of madness, or a mental disorder like bipolar disorder. In the highly contested world of autism, some argue that it is not a disorder at all, only a difference from other people. Hence, like black pride or gay pride, there is something akin to autism pride, which at present may be settling into a “neurodiversity movement.”

Members of this loosely defined faction agree that autism is a neurological condition, but so, after all, is the state of what they call neurotypicals. Most people who will read this essay are, despite our oddities, neurotypicals. It is also true that many people who will read it can, like its author, notice autistic traits in themselves. For millennia we neuro- typicals have refused to acknowledge neurodiversity and so (it is said) do not understand even ourselves.

There was a healthy discussion about the role that neurodiversity plays in providing fodder for evolution; essentially, a variant of the hypothesis that what we term psychiatric disease may in fact have some underlying evolutionary advantage, if not for the individual then for the group (i.e. Nesse & Ellsworth, “Evolution, emotions, and emotional disorders“.

This naturally led to a discussion of Thomas Szasz’ classic work “The Myth of Mental Illness“, in which he argues,

The notion of mental illness thus serves mainly to obscure the everyday fact that life for most people is a continuous struggle, not for biological survival, but for a “place in the sun,” “peace of mind,” or some other human value. For man aware of himself and of the world about him, once the needs for preserving the body (and perhaps the race) are more or less satisfied, the problem arises as to what he should do with himself. Sustained adherence to the myth of mental illness allows people to avoid facing this problem, believing that mental health, conceived as the absence of mental illness, automatically insures the making of right and safe choices in one’s conduct of life. But the facts are all the other way. It is the making of good choices in life that others regard, retrospectively, as good mental health!

The real-world implications of neurodiversity and the pathologicalization of normalcy was brought up when we again revisited the ongoing challenges that face us with the development of DSM-V, and its potential embrace of subthreshold and premorbid disorders as bona fide entities.  This topic has been previously discussed on this blog, with the overall DSM-V controversy being covered extensively over at Mind Hacks (here, here, here and here) and most recently in an update on the Stanford Center for Law and the Biosciences Blog.  The fear that an ever increasing number of individuals might fall under future DSM criteria led one wag to remark (with tongue firmly planted in cheek, I might add) that if we ultimately continue down this path, eventually 98% of the populace will fall under the DSM umbrella and then the remaining 2% will be included because they have Boringly Unproblematic Syndrome.

A completely different perspective came from discussion of Rose & Novas’ paper ‘Biological Citizenship‘.  We conclude with an extended quote of a pithy part of their argument.

Biological citizenship is both individualizing and collectivizing. It is individualized, to the extent that individuals shape their relations with themselves in terms of a knowledge of their somatic individuality. Biological images, explanations, values and judgements thus get entangled with a more general contemporary ‘regime of the self’ as a prudent yet enterprising individual, actively shaping his or her life course through acts of choice (Novas and Rose 2000). The responsibility for the self now implicates both ‘corporeal’ and ‘genetic’ responsibility: one has long been responsible for the health and illness of the body, but now one must also know and manage the implications of one’s own genome. The responsibility for the self to manage its present in the light of a knowledge of its own future can be termed ‘genetic prudence’ (c.f. O’Malley 1996). Such a prudential norm introduces new distinctions between good and bad subjects of ethical choice and biological susceptibility. This contemporary biological citizenship operates within what we term a ‘political economy of hope.’ Biology is no longer blind destiny, or even foreseen but implacable fate. It is knowable, mutable, improvable, eminently manipulable. Of course, the other side of hope is undoubtedly anxiety, fear, even dread at what one’s biological future, or that of those one cares for, might hold. But whilst this may engender despair or fortitude, it frequently also generates a moral economy of hope, in which ignorance, resignation and hopelessness in the face of the future is deprecated. This is simultaneously an economy in the more traditional sense, for the hope for the innovation that will treat or cure stimulates the circuits of investment and the creation of biovalue.

Biological citizenship also has a collectivising moment. As Paul Rabinow has shown, new forms of ‘biosociality’ and new ethical technologies are being assembled around the proliferating categories of corporeal vulnerability, somatic suffering, and genetic risk and susceptibility (Rabinow 1996). Biosocial groupings – collectivities formed around a biological conception of a shared identity – have a long history, and medical activism by those who refuse the status of mere ‘patients’ long predates recent developments in biomedicine and genomics. Many of these earlier activist groupings were fiercely opposed to the powers and claims of medical expertise. Some remain implacably anti-medical; others operate in a manner which, whilst not explicitly ‘opposed’ to established medical knowledge, prefers to remain ‘complementary’ to it. Nonetheless, we suggest, collectivities organized around specific biomedical classifications are increasingly significant. The forms of citizenship entailed here often involve quite specialised scientific and medical knowledge of ones condition: we might term this ‘informational bio-citizenship.’ They involve the usual forms of activism such as campaigning for better treatment, ending stigma, gaining access to services and the like: we might term this ‘rights bio-citizenship.’ But they also involve new ways of making citizenship by incorporation into communities linked electronically by email lists and websites: we might term this ‘digital bio-citizenship.’

Thus, as Heath, Rapp and Taussig (2002) have pointed out, citizenship in the contemporary age of biomedicine is manifested in a range of struggles over individual identities, forms of collectivisation, demands for recognition, access to knowledge and claims to expertise. It is creating new spaces of public dispute about the minutiae of bodily experiences and their ethical implications – a politics of embodied or somatic individuals. It is generating new objects of contestation, not least those concerning the respective powers and responsibilities of public bodies, private corporations, health providers and insurers and individuals themselves. It is creating novel forums for political debate, new questions for democracy and new styles of activism. In each case, the forms that these are taking are shaped by many factors that vary in different national contexts, notably their differing biopolitical histories and modes of government, their traditions of activism and their presuppositions about persons and their rights and obligations.

We welcome comments from readers

What is normal, anyway?

Asperger-Vienna-clinic

Hans Asperger (1906–1980) at work in the University Pediatric Clinic, Vienna performing a psychological test of a child.

Over at the Guardian, there is a delightful piece about an adolescent boy with a form of autism spectrum disorder known as Asperger’s disease. The entire article is worth reading for its insight into the life of an individual with Asperger’s, but one of the most telling lines emerges when the author tells us,

I begin to see what his mother means when she says Asperger’s can be more complex than the stereotypes suggest. “If there was a cure for Asperger’s,” she says, “I wouldn’t want it. Al’s just himself.”

Alex echoes his mother’s comments.

“I don’t think I’ve got a disability. I like being me.”

When patients say that they prefer the situation that they find themselves in, it is worth stopping and asking if the medicalization machine is moving too far too fast.

Hans Asperger first described the phenomenon in 1944, but the diagnosis of Asperger’s did not become official until 1992 when it was included in the International Classification of Diseases (ICD-10); in 1994, it was included in the Diagnostic and Statistical Manual of Mental Disorders, DSM-IV.  It is worth quoting from the ICD-10.

A disorder of uncertain nosological validity, characterized by the same type of qualitative abnormalities of reciprocal social interaction that typify autism, together with a restricted, stereotyped, repetitive repertoire of interests and activities. It differs from autism primarily in the fact that there is no general delay or retardation in language or in cognitive development. This disorder is often associated with marked clumsiness. There is a strong tendency for the abnormalities to persist into adolescence and adult life. Psychotic episodes occasionally occur in early adult life.

As it turns out, it seems likely that despite the ICD’s disclaimer of uncertain nosological validity for the diagnosis, there are indeed individuals out there with Asperger’s, and it is important to recognize them.  The important question is whether it should be considered a disease or not.  This question is raging as the field gears up for the arrival of DSM-V (I previously wrote about this here). In a broadside at the process that is being used to develop the new version of DSM, Allen Frances, the individual who chaired the DSM-IV Task Force, argues that the approach being taken is way off track.  The earnest group engaged in the herculean task of revisiting DSM push back. So it goes in academic medicine. [For a definitive historical look at DSM, I highly recommend Christopher Lane’s book Shyness.]

What concerns us is not squabbling over process or priority, but rather the impact that all of this has on individuals and society at large.  Amid a number of concerns, Dr. Frances rightly reserves his strongest objection to the potential of DSM-V to further medicalize normalcy.

Undoubtedly, the most reckless suggestion for DSM-V is that it include many new categories to capture the subthreshhold (eg, minor depression, mild cognitive disorder) or premorbid (eg, prepsychotic) versions of the existing official disorders. The beneficial intended purpose is to improve early case finding and promote preventive treatments. Unfortunately, however, the DSM-V Task Force has failed to adequately consider the potentially disastrous unintended consequence that DSM-V may flood the world with tens of millions of newly labeled false-positive “patients.” The reported rates of DSM-V mental disorders would skyrocket, especially because there are many more people at the boundary than those who present with the more severe and clearly “clinical” disorders. The result would be a wholesale imperial medicalization of normality that will trivialize mental disorder and lead to a deluge of unneeded medication treatments—a bonanza for the pharmaceutical industry but at a huge cost to the new false-positive patients caught in the excessively wide DSM-V net. They will pay a high price in adverse effects, dollars, and stigma, not to mention the unpredictable impact on insurability, disability, and forensics.

Dr. Frances’ goes on to say,

The incredible recent advances in neuroscience, molecular biology, and brain imaging that have taught us so much about normal brain functioning are still not relevant to the clinical practicalities of everyday psychiatric diagnosis. The clearest evidence supporting this disappointing fact is that not even 1 biological test is ready for inclusion in the criteria sets for DSM-V.

So long as psychiatric diagnosis is stuck at its current descriptive level, there is little to be gained and much to be lost in frequently and arbitrarily changing the system. Descriptive diagnosis should remain fairly stable until, disorder by disorder, we gradually attain a more fundamental and explanatory understanding of causality.

Here we get to the heart of the dilemma.  The field of psychiatry struggles to help patients, but the truth is that the neurosciences have yet to reveal the causes of psychiatric disorders.  Without objective criteria to guide them, physicians fall back on descriptors which are imprecise and therapies which do not treat the underlying (and still unknown) pathology. Lacking the confidence to distinguish normal behavior from diseased, the field inadvertently medicalizes normalcy.

And Alex, the boy with Asperger’s, finds himself squarely in the crosshairs of this raging dispute.