Some writers read a lot more into that statement than was actually there. Science 2.0 — a website that claims it houses “The world’s best scientists, the Internet’s smartest readers” — had this headline, “NIMH Delivers A Kill Shot To DSM-5.” Psychology Today made the claim, “The NIMH Withdraws Support for DSM-5.” (The DSM-5 is the new edition of the reference manual used to treatment mental disorders in the U.S.)

So is any of this true? In a word, no. This is “science” journalism at its worse.

NIMH’s Research Domain Criteria

For the past 18 months, the NIMH has been working on a different categorization system to classify mental disorders, to help further its research efforts (the NIMH is primarily a research-driven organization). It’s called the Research Domain Criteria project:

NIMH has launched the Research Domain Criteria (RDoC) project to transform diagnosis by incorporating genetics, imaging, cognitive science, and other levels of information to lay the foundation for a new classification system.

The proposed classification system works under these assumptions:

• A diagnostic approach based on the biology as well as the symptoms must not be constrained by the current DSM categories,

• Mental disorders are biological disorders involving brain circuits that implicate specific domains of cognition, emotion, or behavior,
• Each level of analysis needs to be understood across a dimension of function,
• Mapping the cognitive, circuit, and genetic aspects of mental disorders will yield new and better targets for treatment.

In short, the NIMH is trying to find a new categorization system that takes into account more of the biology, genetics, brain circuitry and neurochemistry that we’ve discovered in the past three decades’ worth of research is becoming increasingly relevant to understanding mental disorders.

Does it Replace the DSM-5?

Will this replace the DSM-5? No, because as Dr. Insel notes, “This is a decade-long project that is just beginning.” If the NIMH effort ever replaces the DSM, it will be a long time from now.

Somehow, though, Science 2.0 and Psychology Today believe this letter suggests the NIMH has “withdrawn” support for the DSM-5, or has delivered a “kill shot” (whatever that is!). Are these kinds of characterizations accurate — or indeed, helpful?

We reached out to Bruce Cuthbert, Ph. D., the director of the Division of Adult Translational Research at the National Institute of Mental Health for clarification.

“As with most shifts in science, changes in research priorities require a transition,” said Dr. Cuthbert.

“Because almost all clinical researchers today grew up with the DSM system both clinically and in research, it will take some time to get a “feel” for the relationships between DSM disorders and various kinds of RDoC phenomena (both in terms of the types of symptoms, and in overall severity), learn how to write grant applications with the new criteria, and evolve new review criteria. So, there will be a period of some time while these crosswalks are worked out.

“I also should point out that these comments reflect [only] our translational research portfolios.

“Our Division of Services and Intervention Research mostly supports research conducted in clinical settings that is relevant to current clinical practice and services delivery. Thus, [...] grants in these areas will continue to be predominantly funded with DSM categories for some time.”

That’s a far cry from the entire NIMH withdrawing support for the DSM-5. The NIMH is simply saying (in my opinion), “Look, we’re unhappy with the validity of the DSM and its lack of support for biomedical markers for mental disorders. We’re working on a different schema, especially targeted at researchers. It may have greater relevance someday — that’s our hope and vision.”

Why a New Diagnostic System?

But then again, researchers in mental illness have been promising biomarkers for at least two decades as well — with little notable progress to show for their efforts.¹

Why is a new diagnostic system needed?

“For psychiatric disorders, we cannot effectively use very much of the knowledge we have gained about the brain and behavior over the last 30 years because of our symptom-based diagnostic system. In other words, the categories defined by symptoms simply do not map onto all the knowledge that we have gained about brain circuits, genetics, and behavior,” replied Dr. Cuthbert.

“We know that many different mechanisms are involved in any one DSM disorder (heterogeneity), while any one mechanism (fear, working memory, emotional regulation) is typically involved with many different disorders. [This] heterogeneity frustrates attempts to develop new treatments.”

Indeed, as John Horgan over at Scientific American wrote,

Ironically, some pharmaceutical companies that have enriched themselves by selling psychiatric drugs are now cutting back on further research on mental illness. The “withdrawal” of drug companies from psychiatry, Steven Hyman, a psychiatrist and neuroscientist at Harvard and former NIMH director, wrote last month, “reflects a widely shared view that the underlying science remains immature and that therapeutic development in psychiatry is simply too difficult and too risky.”

Pharmaceutical companies say that, on average, a marketed psychiatric drug is efficacious in approximately half of the patients who take it. Dr. Cuthbert from the NIMH suggests that, “One reason for this low response rate is the artificial grouping of heterogeneous syndromes with different pathophysiological mechanisms into one disorder.”

So the NIMH’s regrouping appears to be as much of an effort to spur new drug development as it is an effort to rethink the classification system of mental disorders. Which is a bit odd, if you think about it, since there is a rich research foundation showing that non-medication treatments — such as psychotherapy — work equally well (if not better) for the treatment of many mental disorders.

If these were pure medical diseases with clear and readily defined biomarkers, that shouldn’t be the case. After all, positive thinking can’t cure cancer.²

“Thus, mental disorders are an area where we must transcend the current symptom-based system if we are to advance,” concludes Dr. Cuthbert. “Among other things, if you have to wait until a full-blown set of symptoms is present before you can define a disorder (and there is no quantifiable data regarding risk states, as there is for, say blood pressure), then prevention is — by definition — impossible.”

This is simply untrue, in my opinion. There is a solid and growing research base already demonstrating that we can detect mental illness through a number of early screening and symptom measures and implement prevention measures. Other studies demonstrate significant correlations with certain characteristics — signs that can also be used to implement effective prevention.

“The research process will necessarily involve complex science to understand how we can relate more neuroscience-based measures to more specific and quantitatively-defined symptoms and clinical outcomes,” says Dr. Cuthbert from the NIMH. “This does not necessarily mean, however, that the diagnostic systems of the future will necessitate such a complex battery. As with biomarkers in other areas of medicine, a subsequent phase will be to find assessments that can be obtained feasibly in clinical settings (although this is unlikely to mean, as is the case now, that all disorders can be diagnosed simply sitting in a clinician’s office).”

Is It All About the Money?

Horgan suggests, perhaps, some ulterior motives for NIMH’s statement:

NIMH director Insel doesn’t mention it, but I bet his DSM decision is related to the big new Brain Initiative, to which Obama has pledged $100 million next year. Insel, I suspect, is hoping to form an alliance with neuroscience, which now seems to have more political clout than psychiatry. But as I pointed out in posts here and here on the Brain Initiative, neuroscience still lacks an overarching paradigm; it resembles genetics before the discovery of the double helix.

I’m not as skeptical as Horgan, but do believe the timing of Dr. Insel’s letter is a little curious — right before the launch of the DSM-5, and right after the public commitment of $100 million to brain research.

What is clear is that the NIMH is not withdrawing support for the use of the DSM-5 anytime soon. It is the reference manual all researchers and clinicians use today to speak the same language of mental illness. Without the same reference frame, research — and treatment — would become impossible.

Further Reading

Scientific American: Psychiatry in Crisis! Mental Health Director Rejects Psychiatric “Bible” and Replaces with… Nothing

Science 2.0′s article: NIMH Delivers A Kill Shot To DSM-5

1. David Kupfer, who chairs the DSM-5 Task Force, told Pharmalot: “The promise of the science of mental disorders is great. In the future, we hope to be able to identify disorders using biological and genetic markers that provide expreciseact diagnoses that can be delivered with complete reliability and validity. Yet this promise, which we have anticipated since the 1970s, remains disappointingly distant. We’ve been telling patients for several decades that we are waiting for biomarkers. We’re still waiting.”
2. Although, to be fair, positive thinking can definitely help in its overall treatment.

A class-action lawsuit against the APA was thrown out earlier last year on technical grounds (but with prejudice, suggesting a new lawsuit has a harder road to climb).

Despite that, a new lawsuit was recently filed in federal court in California “accusing the group of misleading its members into paying a fee used to fund its lobbying arm as part of their annual dues.”

Law360 has the story:

To fund the [APAPO lobbying] group, the APA started assessing the so-called special fees, which were included on its annual membership dues statement with the instruction that any members who provide any health-related services “must pay” the fees, Grossman claims. These special fees were significant, ramping up to about $140 in 2011 — or about half of the APA dues themselves — according to the complaint.

This was backed by information on the group’s website and in a public statement, reiterating that the special fee was mandatory and that the only reason the fee was assessed separately was for tax reasons, due to APAPO’s separate tax status as a lobbying group, the suit alleges.

However, after a number of APA members discovered in 2010 that the special fee was only mandatory for membership in APAPO and began to spread the information to other members, the group had a turnaround, admitting its prior fee statements “[did] not make clear” that the fee was only for APAPO membership and that its 2011 dues statements would “be modified to clarify this point,” according to Grossman.

According to the APA, it continues to lose membership too, suffering an 8 percent decline in 2011 and nearly a 2 percent decline in 2012. Other professional organizations, including the Association for Psychological Science and the American Psychiatric Association, continue to see their membership ranks increase during the same period.

Given the APA’s confusing messaging and lack of apology about the issue, it’s not surprising to find that APA members have voted with their feet.¹ According to financial statements on the APAPO website, the special assessment fees received in 2011 dropped 14.5 percent — significantly more than the drop in overall APA membership for that year.

While we don’t want to see the APAPO go away, we do want to see the APA apologize for misrepresenting the fee for nearly a decade to its own members — and repay it to any member who felt misled.² An ethical and responsible organization shouldn’t need a lawsuit as a prod in order to do the right thing.

Read the full article: Psychologists Group Sued Over Misleading Membership Fees

1. Every time we and others asked the APA about the confusing messaging, spokespeople gave a canned response about the assessment being “mandatory” to be a member in the APAPO — one of those typical legal/PR answers that doesn’t answer the question.
2. The APA can afford to fund APAPO entirely on its own — without the “special” assessment. They clearly have the money, between the generous compensation packages they pay their top executives, the $11.4M profit reported in 2010, and the $9.3M profit reported in 2011. The APAPO’s annual budget is only $5M.

Ya have to admire psychologists who endlessly lobby state legislatures for the right to extend prescription privileges to their profession (with a little additional training). They won’t take repeated defeat as a sign that perhaps their efforts are… insane?

Illinois is the latest state to hand psychologists seeking prescription privileges a defeat, with NAMI Illinois siding on the side of not supporting the bills in front of the Illinois legislature. After intense lobbying by both sides of this issue, they concluded, “NAMI Illinois opposes SB 2187 and HB 3074 in its current form to expand prescriptions privileges to psychologists.”

When will psychologists learn?

The movement that is supported by some psychologists to gain prescription privileges is called RxP. The rationale behind the movement is that, in some communities in the U.S., psychiatrists are few and far between. With too few psychiatrists, patients often have little choice but to wait weeks or months for an appointment, or travel long distances to see another psychiatrist. Psychologists argue that their existing training prepares them to take an additional set of courses (which can be taken exclusively online) and training (supervision under a physician) that results in them being high-quality prescribers — equivalent to a medical doctor.

NAMI Illinois’ statement is worth a read, so we’ve posted a copy of it here. But here’s a highlight:

If we don’t fully address integrated health care needs, mental health needs become moot if people continue to die so early from physical causes. NAMI Illinois cannot advocate for the creation of more silos that hinder full integration of physical and mental health care needs.

Exactly. Instead of working with the profession of psychiatry to help address the shortage of psychiatrists, psychologists seek to circumvent that profession entirely by pushing for professionals with little medical background or knowledge to become medical prescribers.

This is a misguided, failure-ridden effort that has been going on now for more than three decades — with very little success to show for it. The bills are introduced into a number of state legislatures each and every year. Each and every year, they get defeated or never get voted out of committee.

And Illinois is not alone. Ohio’s legislators appear disinclined to keep reintroducing the same bills that keep failing, year after year, according to an update sent out by Janet Shaw, MBA, the executive director of the Ohio Psychiatric Physicians Association:

It appears Senators Burke and Seitz are no longer inclined to reintroduce last year’s bill in its current form.

Instead, Senator Burke suggested, and Senator Seitz agreed, that psychologists in Ohio who want to prescribe medications go the route of becoming a physician assistant since the training is similar and duration the same (approximately two years), to the psychopharmacology programs for psychologists, and since the scope of practice for a physician assistant already allows them to prescribe in Ohio.

I agree. Psychologists — like all mental health professionals who don’t hold a medical degree — already have a path to gaining prescription privileges. It’s called “go to medical school” and become a medical doctor, a registered nurse practitioner, or physician’s assistant. There is virtually nothing unique or special about a doctoral degree in philosophy (the Ph.D., which most psychologists hold) that gives them a leg up on the medical training necessary to prescribe.

Psychologists should be working with psychiatrists to understand how best to address the dearth of psychiatrists in certain geographical areas in the U.S., instead of trying to steal their profession away from them.

Psych Central remains steadfastly against psychologists gaining prescription privileges. It is a waste of psychologists’ time and efforts, and minimizes their specialized expertise and training in being uniquely qualified in the understanding of human behavior.

Yet, Kaiser Permanente’s health maintenance organization in the state — rather than abide by the regulation — regularly made patients wanting mental health care wait longer than the 10 business days. In fact, in one case from 2010, the California Department of Managed Health Care (DMHC) fined Kaiser $75,000 for unreasonably delaying a child’s autism diagnosis for almost 11 months! The new report found that anywhere from 17 to 40 percent of patients waited longer than 14 days for an appointment.

Last week, the DMHC was again at Kaiser’s doorstep, finding that Kaiser kept two sets of appointment records to try and circumvent this regulation — a paper appointment calendar and an electronic health record calendar. The DMHC cited Kaiser for “serious” deficiencies in how it manages and provides mental health care services to its patients.

Kaiser Permanente is one of those enormous health care providers that seems to have lost the plot — providing reasonable and timely health care for its customers.

The latest Kaiser investigation by the DMHC was begun based upon a lengthy and detailed report (PDF) published in November 2011 by the National Union of Healthcare Workers — which represents 2,000+ health care employees at Kaiser. In other words, this is Kaiser’s own staff blowing the whistle on the horrible clinical practices they were forced to implement for their patients.

Here’s what the new DMHC report published last week concluded:

• Kaiser committed “systemic access deficiencies” by failing to provide its members with timely access to mental health services. Instead, large numbers of Kaiser’s patients were required to endure lengthy waits for appointments in violation of California’s “timely access” regulations.

• Kaiser’s internal record-keeping system contained numerous problems – including a parallel set of “paper” appointment records that differed from the HMO’s electronic records – that hid patients’ lengthy wait times from government inspectors.
• Kaiser failed to adequately monitor and correct its violations of state law. Records show that Kaiser was aware of its violations, but failed to take action to correct the problems.
• Kaiser provided “inaccurate educational materials” to its members that had the effect of dissuading them from pursuing medically necessary care and violated state and federal mental health parity laws.

This last point is particularly egregious because Kaiser — in multiple materials across multiple provider sites — suggested there were limits on mental health coverage visits. These limits haven’t been allowed — by law — since the federal mental health parity regulations went into effect in 2010. If you have a mental disorder diagnosis, your coverage is the same as it is for other health conditions. Yet in 2011, Kaiser was apparently still saying things like,

“We offer brief, problem solution focused individual counseling. Research shows many people improve in a single visit. For others, 3 to 6 visits can produce desired changes.”

and

“Health Plan contracts for up to 20 visits per calendar year with various copayments.”

If you read this, it may have dissuaded you from even seeking care, thinking your care would be arbitrarily limited by Kaiser (and not by what’s in your best treatment interests).

Of course, Kaiser claims that since the beginning of 2012, it has worked on fixing these problems. How convenient… yet this isn’t the first time Kaiser has been fined by the DMHC, so let’s just say that I’m a little skeptical of their “fixes.”

“The department feels these findings are really serious. Because of that, we are doing the immediate enforcement referral, which is unusual,” said Shelley Rouillard, chief deputy director of the Department of Managed Health Care.

Kaiser, get your act together. It’s shameful that you treat patients with mental health concerns as second-class citizens in California, and you don’t listen to your own employees. Instead, they have to turn to the regulatory agency in order to have their concerns addressed. In my opinion, that demonstrates a business organization that is clearly broken.

If you’re a patient of Kaiser’s HMO mental health system in California, I feel for you. The report linked above details practices that suggest Kaiser’s mental health patients are getting sub-standard care by overworked, underpaid, and unappreciated clinicians.

Read the full story: Kaiser mental health service reprimanded

Read the full DMHC Final Report: Routine Medical Survey of Kaiser Foundation Health Plan, Inc. Behavioral Health Services (PDF)

My dad was a psychiatrist/ psychoanalyst of the old school. Which is to say he was brilliant, but also a man of his particular age. Which is to further say his fury was directed at the APA for taking homosexuality as a diagnosable mental illness out of the manual. It was 1973.

Hardly aware of what he was so upset about, I did hear him dramatically declare that he was withdrawing his membership in the APA. My dad loved being a psychoanalyst and he loved being a physician but he wasn’t that crazy (you should forgive the word) about being a psychiatrist. His prescription pad gathered dust as he focused on talk therapy. So his threat to quit the APA wasn’t idle. But it wasn’t like he was giving up his beloved couch.

By the time I got to graduate school, the DSM had gone through at least four more mutations. Partly because of my experience with my dad, but also because my mom was addicted to the Merck Manual of Diagnosis and Treatment (in which every twinge or sore throat could become a sign of impending doom), I maintained a skeptic’s view of the DSM.

If the DSM really is the behavioral health professional’s “bible,” then I am a doubting Thomas.

I’m comfortable with that. Take the latest edition, the DSM-5, finalized just aweek ago by the APA. I’m not overly excited about it because:

1. The DSM is subject to the times.

For homosexuality to be taken out of the DSM in 1973, it had to have been in there in the first place, probably starting in 1952 when the manual was first compiled. Certain diagnoses, just like some humans, can have their 15 minutes of fame. With problems such as hoarding, which was added to the DSM-5 lexicon, I have to wonder: Why? Do we really need more diagnoses when the condition was fine where it was, as a subtype of obsessive-compulsive disorder?

2. The DSM is subject to politics.

Stakeholders — including drug companies, insurance companies and researchers seeking grants — all have a serious interest in what is deemed a diagnosable mental illness.

3. A little knowledge can be a dangerous thing.

From Homeland (bipolar) to The United States of Tara (dissociative identity disorder), I get the uneasy feeling that having a mental illness can be romanticized. When a character feels flat I imagine screenwriters in Hollywood asking themselves, “What will spice them up? Let’s look up something in the DSM!”

This is no joke when there are plenty of people who seriously suffer from these disorders and stigma is still such an issue. No matter how responsibly the media present mental illness, there is still the danger that the regular person will assume they know everything when they only have one part of the elephant.

Do not get me wrong. I am not saying the DSM should be chucked out the window, baby, bathwater and all. When I need to wade through differential diagnoses to get a clearer picture of what is going on with a patient, so that I can develop an appropriate treatment plan, I have turned to the DSM many times; but I was trained many years to be able to do that. If looking at the DSM doesn’t help, I call on a colleague who is much better at diagnostics than I am or once in a while I will do some strategic psychometric testing. This is how many clinicians on the ground use the DSM. Researchers need an even more fine-tuned instrument upon which to base their methodologies. It is all in the service of helping the patient, not in the questionable pleasure of labeling them.

The DSM has its place. It has gone a long way toward helping mental health professionals speak the same language. It has helped researchers define mental health issues. It provides understanding of psychiatric conditions and helps many to understand themselves better. It is certainly better than nothing. I have great respect for the Herculean effort the committees of knowledgeable professionals had to put into this thing. They are the best in their fields, but they, like my dad, are creatures of their time and culture.

The DSM is a tool, like a hammer, or maybe more like a good Swiss Army knife. You can use it to open a can of beans or you can cut yourself.

It is not the Bible. Otherwise we’d be on Bible No. 1352 by now. God help us.

Want to learn more?
To read more on the specifics of the newly approved DSM-5 click here.

Disorders that will be in the new DSM-5 — but only in Section 3, a category of disorders needing further research — include: Attenuated psychosis syndrome, Internet use gaming disorder, Non-suicidal self-injury, and Suicidal behavioral disorder. Section 3 disorders generally won’t be reimbursed by insurance companies for treatment, since they are still undergoing research and revision to their criteria.

So here’s a list of the major updates…

Overall Changes to the DSM

According to the American Psychiatric Association’s statement, there are two major changes to the overall DSM — the dumping of the multiaxial system, and rearranging the chapter order of disorders. Most clinicians only paid attention to Axis I and II, so it’s no surprise the Axis system was never a big hit. The current chapter order has always been a bit of a mystery to most clinicians, so it’s good to know there’s some thought going into the new order of chapters.

Chapter order:

DSM-5’s 20 chapters will be restructured based on disorders’ apparent relatedness to one another, as reflected by similarities in disorders’ underlying vulnerabilities and symptom characteristics.

The changes will align DSM-5 with the World Health Organization’s (WHO) International Classification of Diseases, eleventh edition (ICD-11) and are expected to facilitate improved communication and common use of diagnoses across disorders within chapters.

Removal of multiaxial system:

DSM-5 will move to a nonaxial documentation of diagnosis, combining the former Axes I, II, and III, with separate notations for psychosocial and contextual factors (formerly Axis IV) and disability (formerly Axis V).

Specific Disorders

Autistic disorders will undergo a reshuffling and renaming:

“[Autism] criteria will incorporate several diagnoses from DSM-IV including autistic disorder, Asperger’s disorder, childhood disintegrative disorder and pervasive developmental disorder (not otherwise specified) into the diagnosis of autism spectrum disorder for DSM-5 to help more accurately and consistently diagnose children with autism,” according to an APA statement Saturday.

The rest of this update comes from the APA’s news release on the changes:

Binge eating disorder will be moved from DSM-IV’s Appendix B: Criteria Sets and Axes Provided for Further Study to DSM-5 Section 2. The change is intended to better represent the symptoms and behaviors of people with this condition.

This means binge eating disorder is now a real, recognized mental disorder.

Disruptive mood dysregulation disorder will be included in DSM-5 to diagnose children who exhibit persistent irritability and frequent episodes of behavior outbursts three or more times a week for more than a year.

The diagnosis is intended to address concerns about potential over-diagnosis and overtreatment of bipolar disorder in children. Will children now stop being diagnosed with bipolar disorder, which has been a recurring concern among many clinicians and researchers? We will see.

Excoriation (skin-picking) disorder is new to DSM-5 and will be included in the Obsessive-Compulsive and Related Disorders chapter.

Hoarding disorder is new to DSM-5.

Its addition to DSM is supported by extensive scientific research on this disorder. This disorder will help characterize people with persistent difficulty discarding or parting with possessions, regardless of their actual value. The behavior usually has harmful effects — emotional, physical, social, financial and even legal — for a hoarder and family members.

Pedophilic disorder criteria will remain unchanged from DSM-IV, but the disorder name will be revised from pedophilia to pedophilic disorder.

Personality disorders:

DSM-5 will maintain the categorical model and criteria for the 10 personality disorders included in DSM-IV and will include the new trait-specific methodology in a separate area of Section 3 to encourage further study how this could be used to diagnose personality disorders in clinical practice.

Posttraumatic stress disorder (PTSD) will be included in a new chapter in DSM-5 on Trauma- and Stressor-Related Disorders.

DSM-5 pays more attention to the behavioral symptoms that accompany PTSD and proposes four distinct diagnostic clusters instead of three. PTSD will also be more developmentally sensitive for children and adolescents.

Removal of bereavement exclusion:

The exclusion criterion in DSM-IV applied to people experiencing depressive symptoms lasting less than two months following the death of a loved one has been removed and replaced by several notes within the text delineating the differences between grief and depression. This reflects the recognition that bereavement is a severe psychosocial stressor that can precipitate a major depressive episode beginning soon after the loss of a loved one.

Specific learning disorder broadens the DSM-IV criteria to represent distinct disorders which interfere with the acquisition and use of one or more of the following academic skills: oral language, reading, written language, or mathematics.

Substance use disorder will combine the DSM-IV categories of substance abuse and
substance dependence. In this one overarching disorder, the criteria have not only been combined, but strengthened. Previous substance abuse criteria required only one symptom while the DSM-5’s mild substance use disorder requires two to three symptoms.

The APA board of trustees also outright rejected some new disorder ideas. The following disorders won’t appear anywhere in the new DSM-5:

• Anxious depression

• Hypersexual disorder
• Parental alienation syndrome
• Sensory processing disorder

Although clinicians are “treating” these concerns, the board of trustees felt like there wasn’t even enough research to consider putting them in Section 3 of the new DSM (disorders needing further research).

So there you have it. What do you think about these final decisions for the DSM-5?

Read the full list of changes from the APA: American Psychiatric Association Board of Trustees Approves DSM-5 (PDF)

Read the full article: Psychiatric association approves changes to diagnostic manual

When we touch, how often we touch and how we respond to touch is influenced by a wide variety of factors.  Each culture has varying norms about what is acceptable social touch. Families and social groups within a culture have their own norms. A 2012 study in the Journal of Personality and Social Psychology, for example, found that men are more likely to touch women than vice versa.

And each individual has a personality style that may influence their comfort level with touch in social situations.

Social touching (for example, a pat on the shoulder)  is an important part of our interactions with others.  It can be calming, create bonds, express concern and solidarity, reduce anxiety and provide reassurance.

But social touch also can have negative effects. It can produce anxiety and provoke irritation and anger. If you tend to be anxious in social situations, touch is likely to spark feelings of self-consciousness and embarrassment, according to a 2001 study. 

Our perception of the context of the social situation and the meaning of the touch also has an impact on how welcome the touch is and how we behave once touched. George W. Bush famously created controversy around social touch when he massaged the shoulders of German Chancellor Angela Merkel. The causes of the storm of criticism were many.  Bush may have considered it a simple act of affection, but others considered the shoulder rub a violation of appropriate norms, an attempted display of power or even sexual harassment.

So when does social touch create a sense of camaraderie, bringing people together, and when does it cause friction and irritation?

According to a study reported on in The Wall Street Journal, situation is critical.  In one study, participants competed with each other in a game for prize points.  After the game, they could award competitors points.  Those who had been patted by their opponents were less generous with their points.

Researchers in the study suggest that when we receive social touch in a competitive environment, we perceive it as a sign of dominance, which makes us bristle and behave less generously.

In a second study, participants were told to cooperate while completing a puzzle.  In this case, those who were patted were more generous with awarding points after the game, suggesting that social touch enhanced a sense of connectedness and cooperation.

Power, dominance, and competition all matter.  When you’re in a work environment and you want people to come together, you may want to consider the context of a friendly pat.  It may cause people to erect barriers, rather than break them down.

They do this in insidious and subtle ways, suggesting a patient can’t do the things others without mental illness can do. Like hold down a job, get into independent housing, interact in social situations or even just go back to school and get a degree.

They also do this in more direct ways, by suggesting to their patients applying for a job or going back to school that, “If they don’t ask about mental illness, don’t volunteer that information.” Why not?

Why are mental health professionals helping to contribute to discrimination and stigma about mental illness by making these suggestions?

I had this insight while Graham Thornicroft, Ph.D., a professor of Community Psychiatry at King’s College London, was giving his keynote. He put up a slide that questioned what we mean when we talk about stigma:

What is stigma?

1. Problem of knowledge = ignorance

2. Problem of attitudes = prejudice
3. Problem of behavior = discrimination

Item 1 is really lot less of a problem nowadays than it was 20 years ago. With the advent and widespread use of the Internet, everyone has access to so much information about these concerns.

Items 2 and 3 are what we are really dealing with today when we talk about the “stigma” of mental illness. It’s really a problem of attitudes and behavior, of prejudice and discrimination.

The last place in the world you would expect to find such problems in attitude and behavior are with the very professionals tasked with treatment of mental illness. And yet such prejudice and discrimination is rampant amongst the profession.

Time and time again, I hear stories of therapists and psychiatrists treating people with things like bipolar disorder and schizophrenia telling their patients all the things they can’t do. Instead of being an encouraging support, they are a wet blanket on an individual’s hopes and dreams (yes, people with bipolar disorder and schizophrenia have hopes and dreams just like the rest of us).

Many Professionals Contribute to the Prejudice and Discrimination of Mental Illness

Both healthcare and mental health professionals regularly contribute to reinforcing the prejudice and discrimination that exists for people with mental illness. Perhaps they do so in a paternalistic manner, hoping to spare their patient the pain of rejection or some people’s attitudes in the real world. But patients don’t want paternalism and don’t need to be coddled. They want support, hope and encouragement.

Perhaps the professional honestly believes the patient is simply “too sick” to participate fully in society. But since there’s no objective measure of what this statement is being measured against, it boils down to this — one person’s opinion.

Here’s some of the statements patients have heard uttered from their therapists’ and psychiatrists’ mouths, and my response:

You can’t hold down a job, it requires a regular commitment. While many people in acute psychiatric distress may indeed have troubles going to a job, usually such features are episodic (and less of an issue when a person is stabilized with a treatment regimen that works for them) — not a permanent character trait of that individual. Many employers are more than happy to make allowances for people with mental illness, if only they’re told ahead of time.

You can’t go back to school and get a degree, it’s too stressful. While people with a mental illness should work to avoid stress, the same could be said of everyone. Once a person finds a treatment that works for them, they should have and be encouraged to experience all that the world has to offer — including an education of their choosing.

You can’t live on your own. While some people make benefit from the routine and familiarity of a group home or living at home with their parents, most people with mental illness don’t need the rigid structure and supervision of such places. Virtually anyone can live independently, as long as they are given the support and encouragement to do so.

You can’t become a therapist or doctor. This is the most frustrating form of discrimination I hear from graduate schools. I’m not sure it’s based on reality, but consider this scenario. A graduate school has two equal candidates vying for one slot. One has disclosed a history of mental illness and successful treatment, while the other has not. Which do you believe the graduate program is going to choose?

Anyone with mental illness can do anything they want in life. The key is finding a successful treatment regimen that works for them, whether it’s medication or psychotherapy or some combination of the two.

Instead of encouraging people to not “bring it up if they don’t,” we should all be talking openly and honestly about mental illness. We are a long ways from the dark times when mental illness can’t be discussed. The people who are often holding us back from the light are sometimes the very mental health professionals who are supposed to be helping.

Encouraging people to hide or be ashamed of their mental illness does not help anyone.

There’s a profession that does something like this. They’re called publishers, and they publish tripe such as “Us Weekly” and “Star” magazine. They take a piece of gossip and write an entire story based upon nothing more than speculation, imagination and hype.

So I found it more than a little disappointing (but perhaps not surprising) to find a representative of the mental health profession, Dr. Keith Ablow, on Fox News Sunday night doing just that. He spoke during a “Medical A-Team” segment where a group of doctors talked about the vice-presidential debate.

Should a psychiatrist be discussing differential diagnoses of the Vice President of the United States — especially if they’ve never even met the man?

Of course, he prefaces his comments with a standard disclaimer media doctors often try to use to make it sound more ethical:

“I did not evaluate Joe Biden…”

Well, if you did not evaluate Joe Biden face-to-face, and you apparently know nothing about him (Dr. Ablow later claimed Biden’s blood alcohol level should also be checked, although it’s well-known that Biden doesn’t drink alcohol), what are you doing babbling about him on national TV?

Here’s the clip:

Now, tell me if that fits within the spirit of the American Psychiatric Association’s ethical principles:

3. On occasion psychiatrists are asked for an opinion about an individual who is in the light of public attention or who has disclosed information about himself/herself through public media. In such circumstances, a psychiatrist may share with the public his or her expertise about psychiatric issues in general. However, it is unethical for a psychiatrist to offer a professional opinion unless he or she has conducted an examination and has been granted proper authorization for such a statement.

Dr. Keith Ablow acknowledges he’s never seen Joe Biden in a professional capacity. Yet, Dr. Ablow is discussing differential diagnoses about Biden as though he had. He’s suggesting specific psychiatric diagnoses to examine, without any knowledge or history of Biden’s medical or psychiatric background.

Instead, he’s doing it based on a single, solitary public performance. Would anyone feel comfortable being judged by a medical professional like Dr. Ablow based upon a single incident like this?

I should take all of the public interviews Dr. Ablow has given on Fox News, and in a purely hypothetical exercise, determine what sets of diagnoses we should consider giving him. I will be quick to say, “I’ve never examined Dr. Ablow, but… here are a set of differential diagnoses we should consider for him.”

But I won’t, because I don’t believe we should be playing armchair psychiatrist or psychologist or whatever from afar in this manner. It does nothing to help illuminate the debate, or to offer any actual insight into a person’s behavior. If anything, it only brings attention to yourself.

And perhaps that was the goal all along.

Read the full article: Fox News' Dr. Keith Ablow: Joe Biden May have Dementia

Is this downward trend specific to the American Psychological Association, or are other professional organizations suffering similar losses?

And what’s to blame for this precipitous loss of members in a single year? A few factors come to mind.

The APA’s 2011 Loss of Members

The APA is the largest professional association representing psychologists. It is, however, by no means the sole voice of psychologists. According to the U.S. Bureau of Labor Statistics, there are approximately 174,000 psychologists in the U.S. — which includes master’s level professionals. So the APA represents about 44 percent of psychologists in the U.S. — 75,746 of whom are full-fledged APA members with doctoral degrees.

When asked to comment about the decline in membership, the APA declined to answer our questions.¹

Here is some speculation as to the reasons behind the decline:

1. It’s the economy. Indeed, one of the first items to go in a tough economy is a person’s membership in different clubs and organizations. However, since professional dues are a tax write-off (meaning it helps reduce the professional’s tax liability), it’s unclear how many professionals gave up their membership due to the economy alone. A professional may, however, trim their membership if they are members of a number of professional organizations and keep only the one or two they truly feel are most beneficial to their career.
2. Lack of perceived benefits. This is something many professional and non-profit organizations struggle with. Since all organizations offer virtually the same set of benefits and perks (like discount magazine subscriptions), you may not keep a membership in an organization where you don’t feel like you’re getting your money’s worth.
3. Graying of members without replacements. Although more new psychologists than ever are joining the profession every day, not nearly as many are joining the APA. Instead, they’re focusing on smaller organizations from the get-go that seem to better cater to their interests (see comment from the APS executive director below). Less than 13 percent of new APA members join a specialty division (where the actual networking takes place), and the average age of the APA member today is over 54 years old.
4. Torture. The APA took what seemed like forever to come out and say that torture was wrong and shouldn’t be practiced by APA members. They had to keep revising their statementto satisfy the APA’s critics, and it was a PR disaster that just wouldn’t die. This may account for some of the initial downward trend in the late 2000′s.
5. The practice assessment controversy.For nearly two decades, the APA has been charging some of its members — those who are in clinical practice — a “practice assessment” fee. This fee was thought to be mandatory by most members who paid it, because of the way it was worded and appeared on a member’s annual dues statement. It was used to fund a separate, independent political lobbying organization associated with the APA.In 2010, it came out that the mandatory practice assessment wasn’t mandatory after all. It makes sense that some clinical members may have been upset about this perceived deception, and spoke with their wallets.²

The American Psychological Association is not alone in this downward trend on membership numbers, however. The American Psychiatric Association — the professional association of U.S. psychiatrists — is also suffering.

“APA has experienced a decline in membership over the past few years, from 35,899 total members in January 2009 to 33,387 in January 2012, an approximately 7 percent loss in three years,” Susan Kuper told Psych Central. Kuper is the Directory of Membership for the American Psychiatric Association.³

“There are several variables contributing to the membership loss, including an increase in membership dues in 2010 (the first increase in almost 15 years) as well as the general state of the economy.”

The Association for Psychological Science, an organization founded in 1988 largely made up of research psychologists, hasn’t seen the same downward trend. In fact, their membership numbers keep going up-up-up: Overall growth since 2007 is 16.3 percent with an average annual growth of just over 4 percent.

• 2011 – 23,500
• 2010 – 23,300
• 2009 – 22,700
• 2009 – 22,700
• 2008 – 21,500
• 2007 – 20,200

“We also see huge growth in things like journal submissions,” Alan Kraut, Executive Director of the Association for Psychological Science, said. “I am guessing APA scientists have gotten older and fewer – just take a look at the average age of those in Division 1 (General) or 3 (Experimental) – whereas our growth is particularly in younger psychologist scientists.”

Touting Its Members and Non-Members as The Same

When this article was first researched, it seemed a bit ironic that, for an organization that promotes professional ethics, the APA continued to proudly state — without any qualifications up until a few days ago — that the “APA has more than 150,000 members and 54 divisions in subfields of psychology” on its website’s About page:

Snapshot of the APA “About” page one year ago,
and similarly up to a few days ago.

After we pointed out the discrepancy in how the APA describes itself and its membership numbers, the page’s wording changed:

Snapshot of the APA “About” page today.

This is still technically inaccurate, since student affiliates are not APA members. And since we didn’t point out that the discrepancy exists throughout APA’s website, you can still find it on the APA History page (for the moment):

We think that it’s incumbent upon the APA to be honest and transparent about the size of its organization, because its size denotes representation and unity. Counting student affiliates — who are not APA members and have little say in how the APA is run — as a part of the representation without clearly delineating the difference is disingenuous.

The APA’s true size today is an organization consisting of 84,339 members.⁴ That’s nothing to be ashamed of — it’s a big professional association representing the guild interests of many psychologists. It’s downward decline is not necessarily a sign of a permanent trend — but it is a disturbing one that signals the changing times.

With access to social media and other communications modalities not as readily available 20 years ago, some of the APA’s purpose — helping like-minded professionals socialize and network with one another — is going away, replaced by profession-neutral organizations.

The APA’s challenge is to repurpose itself, showing that it can adapt to the changes in the profession. It also wouldn’t hurt it to become more transparent and responsive to its members’ concerns.

Edited on July 14, 2012 to add detail.

1. In the past, the APA’s Public Affairs office has readily responded to our requests for comment.
2. Some members were so upset, they filed a lawsuit against the APA, which was dismissed earlier this year.
3. The APA’s membership numbers reflect a total that’s actually higher than the reported number of psychiatrists in the U.S. — about 23,000 — by the U.S. Bureau of Labor Statistics, probably because the statistics don’t capture self-employed workers.
4. Full disclosure: I’m still a member of the APA.

She found out that any doctor within the Partners system could access her record — including her sensitive psychotherapy notes — with no reason whatsoever. And she only discovered this privacy issue because her new internist initially refused to prescribe her needed medication because of “concern” about her psychiatric history — a history he had access to and read without the patient’s prior knowledge.

There’s a couple of problems here. But it’s a teaching moment for others implementing system-wide electronic health records. Psychotherapy notes enjoy special status in the health care community, and that special status should continue even in the age of electronic access.

There are a few issues this case illustrates.

Nobody in the article quoted seemed to recognize the differentiation between psychotherapy notes and progress notes. Psychotherapy notes enjoy specific HIPAA protections, whereas progress notes do not.

Progress notes in a hospital setting generally follow a standardized format, such as SOAP — Subjective, Objective, Assessment, and Plan. This method was developed in the medical setting to standardize entries in the patient file, as follows:

• Subjective: “Patient complained of …” (how’s the patient feeling this week, in general terms?)

• Objective: Blood pressure, lab results, results of physical examination (in psychotherapy, the only objective measures that may be put here from session to session are the results of a symptom inventory scale or the like)
• Assessment: Clinical diagnosis of symptoms (how’s the patient doing this week?)
• Plan: Prescriptions, treatments recommended, etc. (how’s the patient’s progress with respect to their overall treatment plan?)

If a psychiatrist or therapist is using the SOAP format in an electronic medical record, there usually is little detailed information given in such notes. Well-trained mental health professionals recognize patients’ privacy needs, and keep the details of each psychotherapy sessions out of SOAP notes (especially details that aren’t pertinent to others).

Psychotherapy notes, on the other hand, are usually segregated from the official patient record. In many clinics and hospitals, if a professional keeps psychotherapy notes (not all do), they can be kept in the professional’s possession, or in a separate file in their office. Psychotherapy notes contain more detailed and personal information about each patient’s session. This helps a therapist keep track of a patient’s progress more easily, and th e details of each patient, each week they are seen.

If a doctor or therapist isn’t properly trained on these differences, they may be confusing the two and actually writing psychotherapy notes into the patient’s medical record.

If an electronic health record (EHR) is offered within a hospital system, the EHR is required to separate out psychotherapy notes from the regular medical record. It’s not clear whether access should be restricted to such notes to other medical personnel, but many privacy advocates believe that is HIPAA’s intent. There is little reason an untrained internist should be allowed to access psychotherapy notes — they have neither the experience, licensure nor training to properly understand such notes.

Instead, what is more likely to happen is what apparently happened in the case of Julie and Mass. General:

She wanted him to manage her medications for bipolar disorder while she found a new therapist. He gave her a cursory exam and encouraged her to see a psychiatrist, she said in an interview. The doctor told her he had read the notes and was not comfortable prescribing her medications, although he eventually agreed to do so.

The article doesn’t make clear whether he read simply the patient’s psychiatric progress notes or the more detailed and should-be-protected psychotherapy notes.

At Partners, apparently in an effort to help transparency for their medical staff (but not telling their patients), “patients can ask that notes be restricted, but the organization evaluates the requests on a case-by-case basis.” Huh? So what you tell your psychotherapist in confidence, and then transmitted by your unwitting mental health professional into the medical record, becomes fodder for any doc who happens to have access to the Partner’s system?

But Dr. Thomas Lee, head of Partners’s physician network, said segregating psychiatrists’ notes fosters that stigma. “Schizophrenia and Parkinson’s disease are both biochemical disorders of the brain. Why is one considered mental health and the other medical?’’

Lee, of course, is not a psychologist or psychiatrist, so he has no special understanding of mental health concerns (he’s a cardiologist). I’m sorry… I respect my cardiologist’s opinion when it comes to concerns about my heart. I have less respect for his understanding of the complex nature of mental disorders and how society perceives them, because he makes a blatantly false statement about schizophrenia.

Schizophrenia is not some pure “biochemical disorder of the brain.” We now know through decades’ worth of research that it’s an incredibly complex disorder, with no specific genome identified, and none forthcoming on the horizon. It’s no more a pure “biochemical” disease than obesity is.

To suggest, “Hey, docs don’t discriminate or have any prejudice against these disorders because they’re all just biochemical” is either incredibly naive, or just an overly simplistic argument to make.

Partners’ privacy protections for psychiatric notes appear to be set to the wrong default. By default, psychotherapy notes should be off-limits to other medical professionals. If they need to access them, the EHR should have an option that allows them to request access, which is then reviewed and approved (or not) by the patient’s treating therapist. Or how about this? The request is reviewed and approved by the patient first.

It is, after all, their life.

Read the full article: As records go online, clash over mental care privacy

Therapists can easily lose track of their own issues, ignore their own problems, and at times have difficulty shutting off the therapeutic process.

In order to be a good therapist, it is necessary to take care of ourselves — our clients depend on it. Just because we know everything there is to know about stress management doesn’t mean that therapists can’t become mentally exhausted. If you are feeling “depersonalization” toward your clients or possibly yourself, you could be experiencing emotional fatigue.

Here are some ways that I like to keep balanced.

I use my colleagues’ expertise regularly. We go to lunch and consult each other on difficult cases. We bounce around different techniques and approaches that could heighten the therapeutic process.

I belong to many professional organizations and am very involved in my community. I feel that if I have the support of my community, then I am not alone in my journey. I enjoy volunteering and giving back to my community whenever possible. It makes me feel good to see that I have helped others with a small donation of my time.

I enjoy spending time with my family. Going to the beach and reading or walking is especially refreshing. I have two Labrador retrievers who demand a lot of attention. I find a great escape just going out into the backyard and throwing the Frisbee for an hour.

My family enjoys going on vacation. I take two trips a year with the family and then one with just my husband.

My practice is in my hometown. I have developed many friendships over the years. I enjoy spending time with many different groups of people. I am very thankful for the friendships that I have made.

In college, I had different goals. I could do and wanted to do everything that came to my mind. I achieved more things in one day than most people did in a week. My priorities have changed. I have a family now and I find it necessary to relax. Now, I want to balance giving and getting – attention to my family, friends, spouse, community, and solitude.

As a mental health professional, self-care is a minimum standard of professional practice. Your clients deserve to be served by a healthy, well-balanced health care professional. Every mental health professional has vulnerabilities, weaknesses, and needs. Take time today to identify yours.

In an opinion piece published in Sunday’s New York Times, researcher Leeat Granek shares the results of two studies that suggest to her that, “Not only do doctors experience grief, but the professional taboo on the emotion also has negative consequences for the doctors themselves, as well as for the quality of care they provide.”

A different study released by the JAMA journal, Archives of Surgery, last week found that residents don’t get as much sleep as ordinary professionals get — which directly impacts their ability to concentrate and be mentally attentive.

Combined, these studies add to the picture that’s been painted for years by research — that doctors believe they are somehow “super human” and beyond the reach of normal human needs, for both their body and their mind. It’s a disturbing picture, and one that the medical education establishment needs to remedy sooner rather than later.

In the op-ed piece, researcher Granek summarizes the results of her study:

We recruited and interviewed 20 oncologists who varied in age, sex and ethnicity and had a wide range of experience in the field — from a year and a half in practice in the case of oncology fellows to more than 30 years in the case of senior oncologists. Using a qualitative empirical method known as grounded theory, we analyzed the data by systematically coding each interview transcript line by line for themes and then comparing the findings from each interview across all interviews to see which themes stood out most robustly.

We found that oncologists struggled to manage their feelings of grief with the detachment they felt was necessary to do their job. More than half of our participants reported feelings of failure, self-doubt, sadness and powerlessness as part of their grief experience, and a third talked about feelings of guilt, loss of sleep and crying.

While I agree that there very well may be a “professional taboo” on professionals expressing grief — and this is true of virtually all health and mental health professionals — I’d argue that, in the U.S. anyway, expression of grief isn’t exactly something most people do well to begin with.

Visit anyone’s viewing for a snapshot of how Americans handle their grief:
some people cry, others nod in awkward silence, still others make small talk. Very few people feel comfortable in their grief, and fewer still in expressing it.

So maybe it’s not a surprise that doctors don’t do it very well at all, either.

But what makes it different for doctors is that their lack of skills in dealing with their grief could very well impact their job and decision-making — negatively impacting other people’s lives too:

Even more distressing, half our participants reported that their discomfort with their grief over patient loss could affect their treatment decisions with subsequent patients — leading them, for instance, to provide more aggressive chemotherapy, to put a patient in a clinical trial, or to recommend further surgery when palliative care might be a better option. [...]

Unease with losing patients also affected the doctors’ ability to communicate about end-of-life issues with patients and their families. Half of our participants said they distanced themselves and withdrew from patients as the patients got closer to dying.

Doctors (and therapists, too!) have a responsibility to acknowledge and appropriately cope with their own grief reactions. And heck, if they don’t have the skills to do so, they should learn them.

In the second study, 27 orthopedic surgery residents wore a wristwatch-type of measurement to gauge how often they slept. The average amount of daily sleep for the residents was just over 5 hours, with individual amounts ranging from 2.8 hours to 7.2 hours.

This lack of sleep is not good for their mental attention span:

The authors found that, overall, residents were functioning at less than 80 percent mental effectiveness due to fatigue during a mean of 48 percent of their time awake. Residents were also functioning at less than 70 percent mental effectiveness due to fatigue during a mean of 27 percent of their time awake.

Most docs are good people trying to do good in this world. But the more they act like they aren’t human and don’t have the same human needs and feelings the rest of us do, the more harm they bring to their patients.

Read the NY Times article: When Doctors Grieve

It’s a good step forward as the military struggles with the hundreds of thousands of returning vets who have increasing mental health needs. Most of the new hires — about 1,400 — will be clinicians that work directly with vet patients.

But let’s also put this into some perspective, too. According to its website, the VA operates 172 hospitals across the United States, and 837 outpatient clinics. That’s 1,009 places where a vet can go to get help. That means that, on average, each clinic or hospital will get 1.4 new clinicians.

One and a half new clinicians per facility? Not nearly as impressive.

It’s not like the VA has been sitting on its hands over the past few years. It has tried to meet the rising mental health demand of returning soldiers from the wars in Afghanistan and Iraq, but it simply hasn’t really kept pace:

The veterans department says that it has worked hard to keep pace with the tide of new veterans needing psychological care, increasing its mental health care budget by 39 percent since 2009 and hiring more than 3,500 mental health professionals.

The department says it has also established a policy to do mental health evaluations of all veterans not in crisis within 14 days, a goal it says it meets 95 percent of the time.

However, the inspector general’s report is expected to question the validity of that claim.

That inspector general’s report is going to claim the VA is basically fudging the numbers, to show that it meets its “on time” goal 95 percent of the time. The reality is that it’s nowhere close to that number in a significant number of high-traffic, high profile facilities.

Is a 39 percent increase sufficient? It ultimately depends upon what the utilization rates are for mental health services by returning soldiers. I couldn’t find any data that sheds light on this number, so all we can do is look at other factors demonstrating that supply is not keeping up with demand. Things like wait times to obtain service — something the inspector general’s report will help with.

That report could be published as soon as next week. We’ll keep you updated.

Read the full article: Veterans Affairs Dept. to Increase Mental Health Staffing

Antidepressants have been especially hard hit when looking at the FDA pre-approval research. In fact, in Lesley Stahl’s recent 60 Minutes report on antidepressant research, she walked away completely baffled by the meaning of it all. What does it mean when researchers find such negative findings that were never published?

Let’s find out…

In the current research, scientists examined 24 FDA pre-marketing studies for eight second-generation antipsychotics (also referred to as atypical antipsychotics):

• aripiprazole (Abilify)

• iloperidone (Fanapt)
• olanzapine (Zyprexa)
• paliperidone (Invega)
• quetiapine (Seroquel)
• risperidone (Risperdal)
• risperidone long-acting injection (Consta)
• ziprasidone (Geodon)

The researchers then compared the results in the FDA’s review documents to the results presented in medical journals. Ideally, they would expect to find 24 published studies, but instead they could only find 20:

[... F]our premarketing trials submitted to the FDA — which yielded unflattering results — remained unpublished. Three showed the new antipsychotic drugs had no significant advantage over a placebo.

In the fourth, the drug was superior to a placebo, but it was significantly inferior to a much less expensive competing drug, the researchers note.

Just 17 percent of studies were not published, which is actually lower than the industry average for new drug approvals winding their way through the FDA process.

And this isn’t nearly as bad as the data — 40 percent of the studies were never published — surrounding antidepressants:

In 1998 Moore used the Freedom of Information Act to pry such data from the FDA. The total came to 47 company-sponsored studies—on Prozac, Paxil, Zoloft, Effexor, Serzone, and Celexa—that Kirsch and colleagues then pored over. (As an aside, it turned out that about 40 percent of the clinical trials had never been published. That is significantly higher than for other classes of drugs, says Lisa Bero of the University of California, San Francisco; overall, 22 percent of clinical trials of drugs are not published. “By and large,” says Kirsch, “the unpublished studies were those that had failed to show a significant benefit from taking the actual drug.”)

In just over half of the published and unpublished studies, he and colleagues reported in 2002, the drug alleviated depression no better than a placebo. “And the extra benefit of antidepressants was even less than we saw when we analyzed only published studies,” Kirsch recalls. About 82 percent of the response to antidepressants — not the 75 percent he had calculated from examining only published studies — had also been achieved by a dummy pill.

The important thing to keep in mind is that pre-marketing research is conducted primarily in order to get a drug through the FDA process. It is not the final word on a drug’s effectiveness, it is simply a bureaucratic hurdle drug companies must cross in order to get their drug on the market.

Once on the market, dozens — and in the case of antidepressants, hundreds — of additional studies are carried out. These studies, which are often more varied, independent, and done by a wider range of researchers, eventually make up the majority of a drug’s efficacy research.

So the silver lining on this latest research is that the percentage of studies never published is actually lower than the industry average, and significantly lower than the number of studies never published before antidepressants were approved.

Read the full news article: Publication Bias May Give MDs an Incomplete Picture of Antipsychotics

Reference

Turner, E.H., Knoepflmacher, D., & Shapley, L. (2012). Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database. PLoS Medicine, 9(3): e1001189. doi:10.1371/journal.pmed.1001189