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The Role of Biological Tests In Psychiatric Diagnosis

By Dr. Allen Frances on May 22, 2013 6:47 PM | 0 Comments
May has been a dispiriting month for psychiatry and a sad and worrying time for our patients. Three of the leading mental health organizations have squabbled among themselves -- promoting silly and competing 'paradigm shifts' while ignoring the unmet needs of our patients.
 
The mischief started with DSM 5 and its rogues' gallery of untested diagnoses that turn everyday life problems into mental disorders. Per DSM 5, people who don't need help will often get it (to their detriment), while those desperately in need of help will continue to be shamefully neglected. And to crown the irony, APA gets to collect fat publishing profits for producing a manual that is both unnecessary and unsafe.
 
Then, to compound the mess, the National Institute of Mental Health issued an inflammatory press release criticizing all of current psychiatry -- for being brainless and invalid. NIMH made it sound like psychiatric diagnosis without biological testing is worthless.
 
This was mindless. DSM 5 certainly deserves to be roasted, but the NIMH sneak attack was a unfair and inaccurate broadside against all of psychiatric practice. NIMH was trumpeting its new research agenda to support its request to Congress for an expanded brain research budget (the only thing it really cares about). The statement failed to admit that NIMH won't possibly be able to deliver any real progress in clinical care in this decade (and perhaps for many more). NIMH was taking down current psychiatric diagnosis, but offering nothing in its place.
 
Then the British Psychological Society joined the silly season by also suggesting that we suddenly discard our current system of psychiatric diagnosis -- this time in favor of a psychosocial paradigm that would make obsolete the valuable (if limited) old timers like schizophrenia and bipolar disorder. Of course, no details were offered and indeed no new model of psychosocial diagnosis actually exists. A mirror image of NIMH wishful thinking about the future with no relevance to pressing present needs.
 
To bring some wisdom and perspective to this whirlwind of silliness, I turned to Barney Carroll -- one of the great pioneers of biological psychiatry and perhaps the world's leading expert on the role of biological testing in psychiatry.
 
Dr Carroll writes:
 
Here is a recent quote from the Director of NIMH: "The weakness (of DSM-5) is its lack of validity. Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure."
 
After a few awkward days, the chair of DSM-5 issued this agreement: "In the future, we hope to be able to identify disorders using biological and genetic markers that provide precise diagnoses that can be delivered with complete reliability and validity."
 
Patients receiving services are left to wonder whether (currently unavailable) laboratory tests are essential to the validity of their psychiatric diagnoses and the value of their treatments? Is psychiatry lost now in the wilderness without them?
 
Having biological tests is not a precondition for recognizing clinical disorders. It would be great to have them, but much good diagnostic work can be done without tests and their lack is not unique to psychiatry. The availability of biological tests is neither necessary nor sufficient for good patient care.
 
So many conditions in medicine are diagnosed without any conclusive diagnostic tests. Think migraine. Think multiple sclerosis. Think chronic pain. Indeed, clinical science correctly recognized many diseases long before laboratory tests came along for confirmatory diagnostic application. Think Parkinson's disease, Huntington's disease, epilepsy ... it's a long list.
 
We need also to be clear that laboratory tests are not an automatic gold standard of evidence for validity. Indeed, in many medical specialties, indiscriminate screening with laboratory tests has caused more harm than good.
 
Laboratory measures are the servants of clinical science, not the other way around. Most laboratory tests will helpfully revise diagnostic probabilities, rather than conclusively rule in or rule out a diagnosis. Clinical judgment must always be used in their interpretation.
 
Disease constructs take form through iterative attention to signs, symptoms, course of illness, response to treatments, family history, and laboratory data. This process of convergent validation has given us an A-list of psychiatric diagnoses that are candidates for future biological tests: psychosis, mania, melancholia, obsessive-compulsive disorder, vascular depression, crippling anxiety, panic disorder, dementia, autism, delirium, catatonia, and more.
 
The fact that we have not nailed the pathophysiology of these conditions does not invalidate the diagnoses. We knew about Huntington's disease and correctly diagnosed it for 110 years before its genetic basis was discovered.
 
Psychiatric diagnosis is certainly imperfect -- but so is much of diagnosis throughout medicine. And whatever the current limitations, psychiatric diagnosis is useful and essential. There are no 'paradigm shifts possible til we learn a lot more. To imply otherwise is misleading and confusing to patients.
 
Thanks Barney for clearing the fog with your common sense and deep experience. I would have said just the same things, but no one would have any reason to believe them. Your words carry unique authority given your lifelong commitment to establishing biological tests in psychiatry.
 
The biological reductionism espoused by NIMH and DSM 5 is not only naïve and wrong -- it is bad for patients. As Hippocrates said: "It is more important to know the patient who has the disease than the disease the patient has." Knowing a person will always go well beyond knowing the lab test result. A Bio-Psycho-Social model is essential in all of medicine, but especially in psychiatry.
 
The NIMH and DSM 5 are eagerly chasing the holy grail of biological reductionism. But the brain will reveal its elusive secrets only in very small packets and only with the passage of many decades. Don't look for home runs or walks -- be satisfied with singles and be prepared for many strikeouts.
 
Using a polio analogy, the NIMH director once said that he wants his institute to develop vaccines, not iron lungs. His ambition is to understand the biological roots of mental illness and to root them out. I fear that focusing on an over promised golden age in the future takes our eye off the obvious needs of patients in the present.
 
The delivery of mental health services in the US trails far behind most of the rest of the developed world. We have one million psychiatric patients in prison, most of them for nuisance crimes committed because they did not receive adequate care or housing in the community.
 
The NIMH seems to be totally indifferent to their needs and does nothing to promote their cause. It silently allows our country to engage in a barbaric mismanagement of the mentally ill that was abandoned elsewhere two centuries ago. NIMH would do well to promise less for the future and instead deliver more in the present. And DSM 5 should not have added new and questionable disorders at the fuzzy boundary with normal that distract attention and pull resources away from the unmet needs of the really sick.
 
We need biological research to improve the care of patients in the future, but we shouldn't be so dazzled by the (over)promise of neuroscience that we callously neglect our patients who are suffering now.

The British Psychological Society Enters the Silly Season

By Dr. Allen Frances on May 16, 2013 1:41 PM | 0 Comments
The British Psychological Society has issued a press release that rivals the sillyness of DSM 5 and the National Institute of Mental Health.
 
Mental health practitioners and patients are poorly served by the organizations most entrusted to represent them.
 
We have entered a silly season of interacting absurdities committed by the American Psychiatric Association, the National Institute of Mental Health, and the British Psychological Society.
 
It started with DSM 5 including untested new diagnoses that will mislabel millions of the worried well and distract resources away from people who really need help.
 
Then, NIMH got into the act with a press release that recklessly renounced all DSM diagnosis as invalid. But NIMH failed to admit that it has nothing to offer in its place except the promise of a future biological understanding of mental illness -- something that will take decades to deliver, assuming it can ever be delivered at all. Clearly, NIMH was puffing up its research agenda to gain congressional support for President Obamas brain initiative -- a greatly oversold (but nonetheless worthwhile) endeavor.
 
But no one at the institute paused to calculate the possible harmful impact on patients -- who might assume that psychiatry doesn't know what it is doing, so why stick with needed treatment.
 
And NIMH should be called NIBR (National Institute Of Brain Research) since it consistently fails to live up to the Mental Health part of its name and seems totally oblivious to the current needs of the patients it is meant to help.
 
Example-NIMH never issues similarly bold press releases to decry the fact that patients are suffering from draconian budget cuts and our disorganized nonsystem of mental health care. It should, but doesn't, draw press attention to the one million psychiatric patients now languishing in prisons because of nuisance crimes that could have been prevented had they ready access to community treatment and decent housing.
 
And now the British Psychological Society has joined the parade of extremist posturing. BPS proposes its own radically different (but equally quixotic) paradigm shift -- renouncing the brain as a source of mental illness and questioning whether schizophrenia and bipolar disorder are useful constructs for current diagnosis and treatment.
 
As substitute, BPS provides an empty and vague promise that mental health problems might somehow be framed in a completely new paradigmemphasizing primarily psychological and social causations. All very pie in the sky stuff with no real world foundation.
 
This triad of Alice Through The Looking Glass foolishness would be funny were it not so sad and dangerous. Absurd NIMH biological reductionism finds its mirror reflection in absurd British Psychological Society pscho-social reductionism. Leaders of powerful organizations (who should know better) seem to be suggesting that complicated mental health problems can be reduced to their contrasting simple answers. But each has nothing substantive on offer -- just dueling inflammatory and inaccurate press releases that muddle the issues and mislead the public.
 
We need to return to a three dimensional model of mental illness that attends to the biological, to the psychological, and to the social.
 
We need a diagnostic system that focuses on the basic disorders that can be assessed reliably and treated effectively.
 
We need additional resources so that people who need treatment can get it.
 
We need leaders who bloviate less and do more to meet the current unmet needs of patients -- leaders who are not so enchanted with their utopian grand designs for the distant future that they lose interest in the urgent problems we face in the present.
 
Ambition has blinded the leaderships of DSM 5, the NIMH, and the BPS. Each has prematurely promised a grandiose paradigm shift when none is remotely possible. Paradigm shifts emerge from new scientific findings -- not from wishful thinking or public posturing. A little Hippocratic humility would be most welcome.
 
Humpty-dumpty institutional pride has led to a free fall in credibility with grave collateral damage to patients and practitioners. Patients confused by these ridiculous controversies may well lose faith and miss out on needed treatment. Practitioners (who are themselves generally humble and competent folk) deserve leadership that is not so arrogant and bumbling.
 
It is past time to have just one thing in mind in preparing diagnostic manuals or statements to the press. Will this help or hurt our patients' access to quality care? All three organizations have very badly flunked this test.
 
So I offer two simple pleas to the American Psychiatric Association, to the National Institute Of Mental Health, and to the British Psychological Society. First, spare us your paradigm shifts. Second, do whatever you can right now to promote better care for our patients.

NIMH vs. DSM 5: No One Wins, Patients Lose

By Dr. Allen Frances on May 14, 2013 11:42 AM | 0 Comments
The flat out rejection of DSM 5 by National Institute of Mental Health is a sad moment for mental health and an unsafe one for our patients. The APA and NIMH are both letting us down, failing to be safe custodians for the mental health needs of our country.
 
DSM 5 certainly deserves rejecting. It offers a reckless hodgepodge of new diagnoses that will misidentify normals and subject them to unnecessary treatment and stigma.
 
The NIMH director may have hammered the nail in the DSM 5 coffin when he so harshly criticized its lack of validity.
 
But the NIMH statement went very far overboard with its implied promise that it would soon find a better way of sorting, understanding, and treating mental disorders. The media and internet are now alive with celebrations of this NiMH 'kill shot'. There are chortlings that DSM 5 is dead on arrival and will perhaps take psychiatry down along with it.
 
This is misleading and dangerous stuff that is bad for the patients both institutions are meant to serve.
 
NIMH has gone wrong now in the very same way that DSM 5 has gone wrong in the past -- making impossible to keep promises. The new NIMH research agenda is necessary and highly desirable -- it makes sense to target simpler symptoms rather than complex DSM syndromes, especially since so far we have come up empty. And the new plan will further, and be furthered, by the big, new Obama investment in brain research. But the likely payoff is being wildly oversold. There is no easy solution to what is in fact an almost impossibly complex research problem.
 
Isaac Newton said it best almost 250 years ago, "I can calculate the motions of the heavens, but not the madness of men." Figuring out how the universe works is simple stuff compared to figuring out what causes schizophrenia. The ineffable complexity of brain functioning has defeated past DSM hopes and will frustrate even the best NIMH efforts.
 
Progress in understanding mental disorders will necessarily be slow, retail, and painstaking -- with no grand slam home runs, just occasional singles, no walks, and lots of strikeouts. No sweeping explanations -- no Newtons, or Darwins, or Einsteins.
 
Experience teaches that there is very little low hanging fruit when you try to translate the results of exciting basic science into meaningful clinical advances. This is true in all of medicine, not just psychiatry. We have been fighting the war on cancer for forty years and are still losing most of the battles.
 
If it has been so hard to figure out how simple breast tissue goes awry to become cancerous, imagine how many orders of magnitude more difficult will it be to eventually understand the hundreds or thousands of ways neurons can misconnect to cause what we now call schizophrenia.
 
We have learned many remarkable things about how our bodies work. But it is much easier to understand normal functioning than to figure out all the ways it can become abnormal. The NIMH effort may (or may not) be the wave of the future, but most certainly, it can have no impact whatever on the present.
 
Meanwhile, APA and NIMH are both ignoring the very real crisis of mental health misallocation in this country. While devoting far too many resources to over-treating 'the worried well,' we have badly shortchanged the severely ill who desperately need and very much benefit from our help. Only one third of severely depressed patients get any care and we have one million psychiatric patients languishing in prisons because they had insufficient access to care and housing in the community. As President Obama put it, it is now easier for the mentally ill to buy a gun than to get an outpatient appointment -- tragic on both counts.
 
APA and NIMH are both on the sidelines, doing nothing to help restore humane and effective care for those who most need it. DSM 5 introduces frivolous new diagnosis that will distract attention and resources from the real psychiatric problems currently being neglected. NIMH has turned itself almost exclusively into a high power brain research institute that feels almost no responsibility for how patients are treated or mistreated in the here and now.
 
We are spending fortunes on unnecessary drugs for the worried well while slashing budgets for the care of the really sick. A meta-analytic comparison of treatment effectiveness across medical specialties showed that psychiatry was well above average. But we have to provide the treatment to those who really need and can benefit from it.
 
With all its well-recognized limitations, well done psychiatric diagnosis remains essential to effective psychiatric care. Diagnosis is reliable enough when it is targeted to real psychiatric disorders, is done by well-trained clinicians, and is not provided prematurely to provide a code for insurance reimbursement.
 
The single biggest cause of diagnostic inflation and unnecessary treatment is that eighty-percent of prescriptions for psychiatric drugs are written by primary care doctors who have insufficient training and too little time in their seven minute visits to be accurate -- and when both doctor and patient are unduly influenced by saturation drug marketing.
 
So what is a patient or potential patient or parent to make of the confusing struggle between NIMH and DSM5 debacle?
 
My advice is to ignore it. Don't lose faith in psychiatry, but don't accept psychiatric diagnosis or treatment on faith -- particularly if it is given after a brief visit with someone who barely knows you. Be informed. Ask lots of questions. Expect reasonable answers. If you don't get them, seek second, third, even fourth opinions until you do.
 
A psychiatric diagnosis is a milestone in a person's life. Done well, an accurate diagnosis is the beginning of increased self-understanding and a launch to effective treatment and a better future. Done poorly it can be a lingering disaster. Getting it right deserves the kind of care and patience exercised in choosing a spouse or a house.
 
Remember that psychiatry is neither all good nor all bad. Like most of medicine, it all depends on how well it is done.

 

Hippocratic Humility

By Dr. Allen Frances on May 9, 2013 12:43 PM | 0 Comments
Hippocrates: a conventionalized image in a Rom...
The greatest doctor who ever lived was a very humble guy. Hippocrates is the father of medicine because he introduced the naturalistic conception of disease -- you got sick because your organs weren't working properly -- no spirits, no curses, no angry gods.
 
But he also set a precious example of physicianly humility too often since forgotten. On a nearby Greek island, the doctors treated their patients aggressively -- in ways that often did more harm than good. This led Hippocrates to formulate the most robust and enduring finding in all of medical history -- the 'rule of thirds' states that one third of patients get better on their own; one third don't respond to treatment; and just one third really benefit from it. This has been part of medical student lore for almost 2500 years and holds up remarkably well across time, specialties, and diseases.
 
It follows that the goal of medicine is to diagnose and treat only when there is a favorable risk/benefit ratio -- to let people heal themselves when they can; to console those for whom there is no effective treatment; and to reserve risky treatments for those who need and can benefit from them.
 
It is, of course, difficult to predict course -- and treatment response is often trial and error. But the obvious conclusion of Hippocrates' teaching is to be humble about the doctor's ability to treat and prevent illness. First and foremost -- Do No Harm.
 
Dr. Diane O'Leary, an author and philosopher, believes physicianly humility is now in short supply. She writes:
 
Hippocrates' sense of humility is valuable for all physicians -- as a matter of principle and ethics, but also of simple number crunching.
 
There are roughly 30 million people in this country with rare diseases. That's roughly 1 in 10 Americans asking their doctors for help with ailments likely to lead to diagnostic uncertainty. This is twice the number of people with cancer.
 
Since there are nearly 7000 rare diseases on current listings, it's not humanly or statistically possible for doctors to be familiar with most of them. Without humility - without awareness that diagnostic knowledge is always limited - doctors can't begin to care for the 1 in 10 people with rare disease.
 
Given these numbers it should not be easy for doctors to assume that symptoms they are unable to explain have psychiatric causes - but it is, in fact, easy. It is standard practice.
 
Because common diseases do also present in unusual ways, easy psychiatric explanations can be threatening not just for those with rare diseases, but for everyone. When doctors treat their inability to understand symptoms as evidence of patients' psychiatric problems, lack of humility stands in the way of sound diagnostic reasoning.
Dr. O'Leary's specific call for physician humility in the face of 'unexplained' medical problems' touches on the broader need for humility in all aspects of medical and psychiatric treatment.
 
  • The poorly conceived DSM 5 Somatic Symptom Disorder substitutes a false psychiatric certainty that misleadingly covers medical uncertainty about the appropriate diagnosis. It is better to admit what we don't know than cover it with meaningless labels.
  • Psychiatry needs to contain its recent enthusiasm for diagnosing as mental disorders all problems of life.
  • Researchers need to trim their exaggerated claims that we will soon solve the elusive mystery of how brain makes mind and behavior. The process of translating the exciting results of basic neuroscience into accurate diagnostic tests or improved treatments will be a very slow and lead up many blind alleys.
  • Doctors need to stop making snap diagnoses and starting premature treatments after first meetings with people they have just met and barely know. Watchful waiting beats intrusive diagnostic and treatment exuberance whenever the patient's problems are mild and bearable.
  • Primary care doctors need to accept their limitations in delivering psychiatric treatment -- it makes no sense for them to be prescribing 80% of psychiatric medicine. Not every patient has to leave the office with a pill.
  • And patients need to accept physician uncertainty and humility. Don't push doctors for quick answers that will be wrong and harmful. Don't you expect or ask for a pill for every problem. Trust to time, resilience, and support from family and friends to solve the expectable and transient problems of life.
 
Psychiatric diagnosis and treatment are often life changing events -- usually for the better, sometimes for worse, sometimes a tie score. Sorting out who is who in the rule of thirds requires patience and humility -- both currently in short supply.
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