Daniel Carlat, MD

 is both good news and bad news. The good news is that he thinks I’m talented and erudite. The bad news is that he doesn’t like the book, summing it up as a “book of scandals and debates, and a polemic of sorts-a ‘trahison des clercs’-rather than an intellectual discussion about psychiatry.” Erudite or not, I had to look up “trahison des clercs.” It means “a compromising of intellectual integrity, especially for political reasons.” Ouch.

Well, I can agree with Dr Haldipur on one thing. 

 is not an intellectual discussion about psychiatry. Instead, it is a call to arms-an effort to shake us out of our complacency and to get us thinking about solutions.

There is an old joke about 2 elderly women who are at a resort in the Catskill Mountains. One of them says, “Boy, the food at this place is really terrible.” The other says, “Yeah, I know; and such small portions!”

In psychiatry, we are unfortunately in a similar situation. Psychiatrists are now primarily 15-minute psychopharmacologists, rushing patients through the office to increase reimbursements. This is insufficient time to properly evaluate and treat patients with 

 much less
to squeeze in some psychotherapy. Thus, the care we are providing, while not descending to the level of the food at the Catskills resort, is often suboptimal.

You can see the punch line coming a couch away.

The second problem with modern psychiatrists is that there aren’t enough of us. The Health Resources and Services Administration recently documented a “critical shortage” (meaning that only half of patient needs are met) of psychiatric prescribers in 75% of all counties in this country. The shortage will worsen-because psychiatrists are relatively old and are retiring faster than they can be replaced, and because health care reform will add some 30 million new patients to the insurance rolls.

These 2 problems constitute the “Trouble with Psychiatry” to which I refer in 

. It is not something that I made up, nor is it a problem that I publicized for fame and fortune, as implied by Dr Haldipur. It is the elephant in the middle of the room, and psychiatrists are studiously ignoring it.

 is my effort to detail these problems in language understandable by the general public. It is a mashup of memoir, historical research, and strongly held opinion. In the last few pages of the book, I offer a list of solutions. Much has been made of the fact that I included prescribing psychologists on that list. But actually, the solution that I endorsed most forcefully is to tweak psychiatric training so that it is shorter and more relevant to what we actually do.

It is time for us to be honest with ourselves and to admit that most of us use only a fraction of our medical training in our day-to-day work. Few of us do physical exams after residency. When we discover a possible medical problem during our interviews, we don’t deal with it ourselves-we turf the patient to a primary care physician for evaluation and treatment. For most psychiatrists, medical school and internship is a 5-year lesson in medical triage. We learn all our psychopharmacology and psychotherapy during our 3 years of residency and during our years of psychiatric practice.

Dr Haldipur points out correctly that there are exceptions. Some psychiatrists, especially in the public sector, keep up with their medical skills and treat their patients’ basic medical problems. There will always be such medically oriented psychiatrists, and there will always be a need for some psychiatrists to go through the entire traditional medical training process.

But we must provide another option for psychiatric training . . . one that is tailored specifically for the skills that we use on a daily basis. What would that training look like? Like colleges of dentistry, optometry, and podiatry, it would likely be a 4-year postgraduate program, with the option of additional subspecialty training. It would certainly involve a thoughtful integration of psychology, psychopharmacology, and medicine. Creating such a program would be a complicated task. The first step would likely be an exploratory committee formed within the American Psychiatric Association. The committee might even include the participation (horror of horrors!) of our psychology colleagues from the “other” APA.

 with the story of a medical student who chooses psychiatry because he is so impressed with our willingness to debate controversial issues. I pray that we will not disappoint that student now.

Unhinged: The Trouble With Psychiatry-A Doctor’s Revelations About a Profession in Crisis

Articles

 From my standpoint as the author of Unhinged, Dr Haldipur’s review is both good news and bad news.

A Response by Daniel Carlat

Houston, we have a problem. There is a critical shortage of psychiatrists. And the problem is not in Houston alone-- it includes the entire state of Texas, and every other state in the union (Mid-town Manhattan, Boston-- Beacon Hill, and Sacramento Street in San Francisco might be exceptions).

According to the most recent of studies commissioned by the government, America is shy about 45,000 psychiatrists. And the shortage will get worse, because many psychiatrists are reaching retirement age.

Before commenting on possible solutions, let's get a better fix on where this rather astounding number comes from. After all, labor statistics are politically charged quantities because they are often used as ammunition for various stakeholders to win funding for pet programs. So it's important to be skeptical.

The underlying data were published as a series of 3 articles in the 

 The research was commissioned by the Health Resources and Services Administration and was done by researchers at the Cecil G. Sheps Center for Health Services Research at the University of North Carolina at Chapel Hill. Here I'll focus on the study by Konrad and colleagues,

since it provides a good overview of the entire project. To facilitate ease of reading, I am not including all the references to other studies discussed in the original paper. I urge interested readers to peruse the original article for more details.

These researchers started with what they considered to be the most reliable recent estimates of the prevalence of mental illness in this country--the National Comorbidity Survey Replication (NCS-R) of 2001. That study was a random house-to-house survey of more than 9000 people. The authors did not want to simply use the NCS-R's figures at face value because that would have included many people whose mental illnesses are not particularly severe. Instead, they identified only those people who were functionally impaired and who had what they defined as "serious" mental illness--bipolar disorder, major depressive disorder, agoraphobia, generalized anxiety disorder, panic disorder, posttraumatic stress disorder, social phobia, or specific phobia.

You'll notice some glaring omissions here--most notably schizophrenia, substance abuse, and ADHD. Why weren't these included? There are various reasons, some having to do with the quality of the data they had to work with. The NCS-R data, oddly enough, did not include enough questions to reliably diagnose schizophrenia, so the researchers decided they could not come up with reliable prevalence numbers for schizophrenia. What about substance abuse? While the NCS-R data included substance abuse, there is little reliable data on how many substance abuse clinicians are out there, so they omitted this diagnosis from their analysis. And then there were a number of diagnoses the authors considered not serious enough to include--such as ADHD, conduct disorder, oppositional defiant disorder, dysthymia, and a few others.

The bottom line is that given the exclusion of many patients with disorders that required some kind of treatment, the study results are necessarily very conservative. Whatever shortage of services they discover will need to be amplified to make up for these uncounted patients. Nonetheless, using their particularly strict and conservative criteria, they estimated that the 1-year prevalence of "serious mental illness" in the US is 3.9%. The authors note that this estimate is very close to other recent estimates of the prevalence of significant disabling mental illness.

How much mental health treatment do these patients need? Using more data from NCS-R, the researchers stated that "about half of adults with serious mental illness used services; they typically spent 10.54 hours per year (95% confidence interval (CI), 5.46 to 15.63) with nonprescriber mental health professionals and 4.38 hours per year (CI, 3.40 to 5.37) with primary care physicians or prescriber mental health professionals."

Do these numbers sound right? Essentially, they are saying that patients with serious mental illness have about 1 therapy visit per month, and about 20 minutes per month of psychopharm-oriented visits with some prescriber. It sounds fairly realistic as an average, considering that some "stable" patients probably never see a therapist and just see their psychiatrist every 3 months or so for a medication refill, while on the other end of the spectrum, there are very ill patients who have at least weekly therapy sessions and biweekly psychopharmacological visits.

So how many mental health providers are needed? Now that the researchers estimated the number of patients with mental illness, the number of hours of care needed on average by each patient, and the amount of care provided by the average full-time clinician (I don't have the space to detail how they got that statistic, but it was derived from various surveys of practice patterns from the APA and other sources), they could calculate the bottom line--how many clinicians does the US need to treat its mentally ill citizens? They estimated that we need 25.9 psychiatrists per 100,000 population. This is an average number, which varies by county--typically, poorer people need more psychiatric time, so the need for help is greater in poorer counties.

The problem is that we only have roughly 10 per 100,000 practicing full-time psychiatrists in the US, or about 30,000 total. That's 15 per 100,000 too few, and assuming a population of about 300 million, we arrive at the estimated shortage of 45,000 psychiatrists. This is a very rough estimate to be sure--let's call it 45,000 plus or minus 15,000. Either way, it represents a mental health services crisis.

So--what are we going to do to solve this problem? I'm not sure, but here are some potential options:

1. Let's get the primary care physicians (PCPs) to absorb our excess patients. 

Sorry, but as family practitioner and writer Michael Victoroff once told me, "that donkey is overloaded already." PCPs are dealing with longer wait lists than psychiatrists and they are coping with a vast array of illnesses to manage. Outcomes research has shown that PCPs don't do the best job of treating psychiatric problems. For example, a recent study found that the mental health care dropout rate from PCPs was 32%--more than double the dropout rate from psychiatrists.

These data are hardly surprising, since PCPs have barely enough time to hand out a pill and refer to a social worker, psychologist, or psychiatrist. And the psychiatrist will often be either unavailable or will refuse the patient's insurance.

That means expanding residency programs. That's a nice idea, but who is going to foot the bill? Medicare pays for the vast majority of residency slots in the US, and the going rate is upwards of $100,000 per slot. Is Medicare planning to shell out 45,000 3 $100,000 = $4.5 billion to solve the mental health access problem? Unlikely--in fact, we were lucky that President Obama's health care reform package is allocating $168 million to create only 600 more primary care physician residency slots. Most psychiatry residency directors feel lucky if they can simply hold on to the reimbursed positions they have now.

3. Let's train more advanced practice nurses and physician assistants. 

That might work over the long term, because the economics are more feasible. Physician extenders' training is shorter and less expensive, their incomes are lower, and they typically are more likely to work for underserved populations. One problem: they get very little training in psychology or psychotherapy--limiting their ability to properly diagnose and treat tough cases.

4. Let's give medically trained psychologists prescriptive authority. 

Though unpopular among psychiatrists, this is an increasingly viable solution. Psychologists with 2-year psychopharmacology masters degrees have been prescribing safely for 20 years in the military and for slightly less than a decade in New Mexico and Louisiana. (For a thorough review of this issue, see the recently published book 

Pharmacotherapy for Psychologists: Prescribing and Collaborative Roles

Our APA maintains an active and expensive lobbying program in order to defeat prescriptive authority legislation as it surfaces yearly in dozens of states. It may be time for us to reconsider whether this is money well spent. In my opinion, our battle against psychologists prescribing represents a short-sighted attempt to defend our professional turf at the expense of our primary responsibility, which is enhancing our patients' access to high-quality care.

Dr Carlat is associate clinical professor of psychiatry at Tufts University School of Medicine in Boston and editor in chief of 

--a monthly newsletter on psychopharmacology. The Carlat Psychiatry Blog (

) is consistently ranked as one of the 10 most influential health blogs. Dr Carlat is also a regular contributor to "The Couch In Crisis" blog on 

Konrad TR, Ellis AR, Thomas KC, et al. County-level estimates of need for mental health professionals in the United States. 

Olfson M, Mojtabai R, Sampson NA, et al. Dropout from outpatient mental health care in the United States. 

Pharmacotherapy for Psychologists: Prescribing and Collaborative Roles.

Washington, DC: American Psychological Association; 2010.

 Olfson M, Mojtabai R, Sampson NA, et al. Dropout from outpatient mental health care in the United States. 

Houston, we have a problem. There is a critical shortage of psychiatrists. And the problem is not in Houston alone-it includes the entire state of Texas, and every other state in the union (Mid-town Manhattan, Boston’s Beacon Hill, and Sacramento Street in San Francisco might be exceptions).

45,000 More Psychiatrists, Anyone?

Houston, we have a problem. There is a critical shortage of psychiatrists. And the problem is not in Houston alone--it includes the entire state of Texas, and in fact every other state in the union (Mid-town Manhattan, Boston’s Beacon Hill, and Sacramento Street in San Francisco might be exceptions.)

According to the most recent set of studies commissioned by the government, America is shy about 45,000 psychiatrists. And the shortage will get worse, because psychiatrists are aging and many are reaching retirement age.

Before commenting on possible solutions, let’s get a better fix on where this rather astounding number comes from. After all, labor statistics are politically charged quantities because they are often used as ammunition for various stakeholders to win funding for pet programs. So it’s important to be skeptical.

, researchers started with what they considered to be the most reliable recent estimates of the prevalence of mental illness in the U.S.-- the National Comorbidity Survey Replication of 2001. That study was a random house-to-house survey of over 9000 people. The authors did not want to simply use the NCSR’s figures at face value, because that would have included many people whose mental illnesses are not particularly severe. They identified only those people who were functionally impaired and who had what they defined as “serious” mental illness--bipolar disorder, major depressive disorder, agoraphobia, generalized anxiety disorder, panic disorder, posttraumatic stress disorder, social phobia, or specific phobia.

You’ll notice some glaring omissions here, most notably schizophrenia, substance abuse, and ADHD. Why weren’t these included? Various reasons, some of them having to do with the quality of the data they had to work with. The NCSR data, oddly enough, did not include enough questions to reliably diagnose schizophrenia, so the researchers decided they could not come up with reliable prevalence numbers for schizophrenia. What about substance abuse? While the NCSR data included substance abuse, there is little reliable data on how many substance abuse clinicians are out there, so they omitted this diagnosis from their analysis. And then there were a range of diagnoses the authors considered not serious enough to include, such as ADHD, conduct disorder, oppositional defiant disorder, dysthymia, and a few others.

The bottom line is that given the exclusion of multiple patients with disorders requiring some treatment, the study results are necessarily very conservative. Whatever shortage of services they discover will need to be amplified to some degree to make up for these missing patients. Nonetheless, using their particularly strict and conservative criteria, they estimated that the one year prevalence of “serious mental illness” in the U.S. is 3.9%. This estimate is very close to other recent estimates of the prevalence of significant disabling mental illness.

So how much mental health treatment do these patients need? Using more data from NCSR, the researchers stated that “about half of adults with serious mental illness used services; they typically spent 10.54 hours per year (CI=5.46–15.63) with nonprescriber mental health professionals and 4.38 hours per year (CI=3.40–5.37) with primary care physicians or prescriber mental health professionals.” Do these numbers sound right? Essentially they are saying that patients with serious mental illness have about 1 therapy visit per month, and about 20 minutes per month of psychopharm-oriented visits with some prescriber. It sounds fairly realistic as an average, considering that some “stable” patients probably never see a therapist and just see their psychiatrist every 3 months or so for a med refill, while on the other end of the spectrum there are very ill patients who have at least weekly therapy sessions and biweekly psychopharm visits.

So how many providers are needed? Now that the researchers had estimated the number of patients with mental illness, the number of hours of care needed on average by each patient, and the amount of care provided by the average full time clinician (I won’t bore you with how they got that statistic), they could calculate the bottom line--how many clinicians does the U.S. need to treat its mentally ill citizens? They estimated that we need 25.9 psychiatrists per 100,000. This is an average number, which varies by county- - typically, poorer people need more psychiatric time, so the need is greater in poorer counties.

The problem is, we only have about 9/100,000 practicing full time psychiatrists in the U.S., or about 30,000 total. That’s 15/100,000 too few, and assuming a population of about 300 million (our population is actually about 309 million right now, but we’ll round down), we arrive at the estimated shortage of 45,000 psychiatrists.

So--what are we going to do to solve this problem? I’m not sure, but here are the options often proposed. 
 

1. Let’s get the primary care doctors to absorb all our excess patients. Sorry, but as family practitioner and writer Michael Victoroff once told me, “that donkey is overloaded already.” PCPs are dealing with longer wait lists than psychiatrists and they are coping with a vast array of illnesses to manage. Plus, outcomes research has shown that PCPs don’t generally do a great job treating psychiatric problems (though there are many exceptions here and there). How could they? All they have time to do is to hand out a pill and refer to a therapist or a psychiatrist. And the psychiatrist will often be either unavailable or will refuse the patient’s insurance.

2. Let’s churn out more psychiatrists. That means expanding residency programs. But guess who pays for residents? Medicare, and the going rate is about $100,000 per residency slot. Is Medicare planning to shell out 45,000 X $100,000 = $4.5 billion to solve the mental health access problem? Not on your life. Most residency directors feel lucky if they can hold on to the reimbursed slots they have now, much less dreaming for more. 
 

3. Let’s train more advanced practice nurses and PAs. That might work over the long term, because the economics are more feasible. NP training is shorter and cheaper, their incomes are lower, and they typically are more likely to work for underserved populations. One problem: They get very little training in psychology or psychotherapy. And that impacts their ability to properly diagnose and treat tough cases. 
 

4. Let’s give medically-trained psychologists prescriptive authority. That won’t work, because the APA has marshaled millions of dollars of money they can’t afford to block this solution. 
 

Any other ideas for solving the mental health crisis in this country? The public is expecting us to come up with something, because we’re the experts.

1. Konrad TR, Ellis AR, Thomas JC, et al. County-level estimates of need for mental health professionals in the United States. Psychiatr Serv. 2009;60:1307-1314.

Houston, we have a problem. There is a critical shortage of psychiatrists.

Two events occurred last week that will have significant ramifications for psychiatry. On March 23, The 

 was signed into law by President Obama. The act was embedded in the larger healthcare reform package, so it didn’t receive a lot of fanfare, but it is huge. The Sunshine Act will require that all drug and device companies report all payments made to physicians and teaching hospitals. All payments will be available on the Health and Human Services website, which will publish unprecedented detail about such payments, including the precise nature of the “service” provided, the date of each check, and the name of the drug or device that a promotional talk supported.

Thus, for example, if you are on AstraZeneca’s speakers bureau, your talk won’t simply be classified as “professional education”-instead, your patients will learn that you were paid $2000 on a particular date for marketing activities in support of Seroquel. This granularity of information constitutes true transparency, as opposed to the rather 

 provided on the physician payment registries posted voluntarily by some companies.

The second, related, event occurred the day after the Sunshine Act became law. Thomas Insel, the Chief of NIMH, published a 

Journal of the American Medical Association

, entitled "Psychiatrists' Relationships with Pharmaceutical Companies: Part of the Problem or Part of the Solution?" While acknowledging (as we all should) that some collaboration between physicians and pharma is a good thing, Insel concluded that industry influence has radically skewed psychiatric practice in favor of the most expensive drugs, even when evidence shows that cheaper generics work as effectively. He also bemoaned the fact that effective psychotherapeutic techniques are "woefully underused and frequently not reimbursed."

Finally he called on organized psychiatry to lead the way to reform:

"The focus on financial conflicts of interest in psychiatry is an opportunity to take the lead in setting new standards for interactions between all medical disciplines and industry. Academic leaders, professional societies, and patient advocacy groups could turn the tables of public trust by developing a culture of transparency for psychiatry's collaborations with industry, including the clear separation of academic-clinical missions from industry marketing."

As it turns out, at our Annual Meeting in New Orleans this May, we have the opportunity to show the public that psychiatry is, indeed, committed to the highest ethical standards. The American Psychiatric Association’s Assembly will vote on whether to approve the recommendations contained in a report written by Dr. Paul Appelbaum and his Work Group on 

Relationships Between Psychiatrists and Pharmaceutical and Medical Device Industries

. The bottom line recommendations of the report are:

1. Psychiatrists should not accept gifts from industry (except for medication samples).

2. Psychiatrists should not give company-sponsored promotional talks, nor should they attend such events, unless they are accredited by the ACCME (the organization that creates and monitors the standards in continuing medical education).

3. Psychiatrists should not participate in “consulting” meetings if they are actually promotional meetings in the guise of consultation.

Many of these provisions have already become policy at the major academic medical centers in the U.S. For example, the major Harvard Medical School hospitals have banned industry gifts and forbid faculty from giving promotional talks. Johns Hopkins, Stanford and several others have followed suit.

Inexplicably, these recommendations have been rejected twice at APA Assembly meetings, where APA members have taken umbrage at the implication that their opinions could be swayed by a free lunch or by a few thousand dollars in payments for drug talks. But the drug companies themselves understand the promotional value of the smallest of gifts, and an increasingly critical public has little patience for doctors who claim that they are impervious to marketing.

I urge all psychiatrists to show their support for the Appelbaum recommendations. You can find out who your Assembly representatives are through your district branch’s website. Give them a ring or send them an email. Let them know that it’s time for psychiatry to take back the ethical high ground.

Two events occurred last week that will have significant ramifications for psychiatry. On March 23, The Physician Payments Sunshine Act was signed into law by President Obama. The act was embedded in the larger healthcare reform package, so it didn’t receive a lot of fanfare, but it is huge.

Insel and Obama Want Transparency-Let’s Oblige

, Dr Steven Moffic proposed that only psychiatrists be allowed to certify 

 diagnoses. While I disagree, I commend Dr Moffic for raising this controversial topic, which inevitably brings up a number of basic issues challenging our profession. Some of these issues include the differences between psychiatrists and psychologists, whether psychologists should be able to earn prescription privileges, and whether it makes sense for psychiatry training to begin with medical school. While I won’t be able to cover each of these issues in this post, I do plan to blog about them over the next months.

 that the following cautionary statement be made in the 

“This diagnostic manual is derived mainly from the expertise of psychiatrists. Given the importance of general medical knowledge in making an accurate psychiatric diagnosis, the appropriate use of this manual is for psychiatrists to certify the official diagnosis. The exception would be those who are specially trained and supervised by the American Board of Psychiatry and Neurology.”

 was derived mainly from the expertise of psychiatrists, in the sense that is a product of the 

 and that each version has been written primarily by psychiatrists. But how true is it that “general medical knowledge” is important in using 

 diagnosis is primarily a list of behaviors and psychological symptoms, none of which require medical training to recognize. In fact, with a few exceptions, such as alcohol withdrawal, there are no 

 disorders listing either lab tests or physical exam findings as criteria for the diagnosis. Therefore, for the vast majority of the 300-plus diagnoses included in 

 require medical training in order to rule out a medical condition that may be secretly mimicking an apparent psychiatric disorder. But when psychologists and social workers make a psychiatric diagnosis, they generally ask patients if they have seen their primary care doctor to rule out an organic cause. I do not believe that medical school is required to train therapists to ask this question, nor to ask about certain common symptoms that are red flags for medical illness.

Furthermore, we psychiatrists are hardly immune from missing occult medical issues. Our practices tend to be much busier than those of therapists, and many psychiatrists do brief 30- to 45-minute evaluations and spend 15 to 20 minutes with patients for psychopharm follow-up visits. In such settings, it is likely that medical issues (not to mention psychosocial issues) are missed regularly. Whether we, in fact, do a better job of “catching” hidden medical problems than our therapist colleagues is an empirical question, and I am not aware of any research that has attempted to answer this question.

At any rate, it is indisputable that the 

 diagnostic work in psychiatry is psychological, and is not medical. During a 

 diagnostic interview, I might spend 5% of my time-if that-calling upon my medical school knowledge to rule out a medical problem. The other 95% of my time is spent obtaining a social and psychiatric history, and doing a detailed mental status exam. This work does not require stethoscopes, blood tests, or PET scans. It requires mind-to-mind contact with my patient-again, something that psychologists and social workers are quite skilled at.

, when he writes, “If we gradually obtain neuroimaging and/or genetic markers to improve diagnosing, it would seem that the diagnostic process will become even more of a medical one, most suitable for psychiatrists.” While true, we remain far from obtaining those markers.

 Dr Thomas Insel, who is the chief of NIMH, characterized the current state of psychiatric knowledge this way: “Despite high expectations, neither genomics nor imaging has yet impacted the diagnosis or treatment of the 45 million Americans with serious or moderate mental illness each year.” He added: “While we have seen profound progress in research…the gap between the surge in basic biological knowledge and the state of mental health care in this country has not narrowed and may be getting wider.”

Someday, I have no doubt that we will understand the neurobiology of the disorders we treat, and we would then be on solid ground requiring medical school for the diagnostic process. Until then, I suggest that we resist the temptation to turn 

 into another front in the larger turf war some of us are waging in order to protect our profession.

1. Insel TR. Translating scientific opportunity into public health impact: a strategic plan for research on mental illness. Arch Gen Psychiatry. 2009;66:128-133.

In his recent blog posting, Dr Steven Moffic proposed that only psychiatrists be allowed to certify DSM diagnoses. While I disagree, I commend Dr Moffic for raising this controversial topic, which inevitably brings up a number of basic issues challenging our profession.

The Art of Sharing DSM

A controversial treatment, an industry-funded article with no financial disclosures, a ghostwriter, a lead author who is editor-in-chief of the journal and who is later hired by the company funding the article, and a lucrative order of 10,000 reprints-these were the potent ingredients of what the 

 recently termed an "egregious set of events" that involved the journal 

In July 2005, the FDA approved a new type of therapy for treatment-resistant depression: vagus nerve stimulation (VNS). However, the approval process incited controversy because the scientific team that was assigned to review the device rejected its approval unanimously 3 separate times. The reviewers were unimpressed with the efficacy research underlying the device, since the only reported placebo-controlled trial showed no significant difference between active and sham VNS. In each case, however, the director of devices for the FDA overruled the review teams' decision. The ultimate approval of VNS became so controversial within the FDA that the Senate Finance Committee investigated the process and published a highly critical report in February 2006.

Given the already controversial background, one might have thought that 

 would have been particularly cautious about reporting industry disclosures in a recent review article on VNS.

 The article, which listed 9 coauthors, reviewed the evidence regarding VNS and concluded that it was "a promising and well-tolerated intervention" for treatment-resistant depression; the review made no mention of the FDA controversy.

 broke the story that 8 of the 9 contributing authors were paid consultants for Cyberonics, the maker of VNS.

 revealed a series of other embarrassing pieces of information:

The lead author, Dr Charles Nemer-off, was also the editor-in-chief of Neuropsychopharmacology.

	Shortly after the article was published, Nemeroff was hired by Cyberonics to chair its new VNS Therapy Mechanism of Action Advisory Board, the purpose of which is to seek FDA approval for new indications for VNS.

	Cyberonics purchased 10,000 reprints of the article from Neuropsychopharmacology.

 The first draft of the article was not written by any of the authors listed, but was ghostwritten by a medical writer hired by Cyberonics.

When interviewed by newspaper reporters about the lack of disclosure, the journal's publisher (Nature Publishing Group) said that those relationships had, in fact, been disclosed to the journal and that it was the editors who were at fault, rather than the authors. However, since the lead author was also the editor-in-chief, it appeared that the authors could not be fully absolved of responsibility for the error.

Dr Nemeroff responded to reporters' questions by saying that he had "recused" himself from the review process; however, he acknowledged having read the final draft before publication. About a month later, he resigned as editor-in-chief of 


This unfortunate controversy drives home the point that the relationship between academic psychiatry and industry has become alarmingly incestuous. When an influential psychiatrist is simultaneously a journal editor, an industry advisory board chairman, and the first author of an industry-funded article published in his own journal, there must be something wrong with the system.

But what about the specific issue of disclosure? How could disclosures have been improved in this case so that readers would not have felt that they were being hoodwinked? If the journal had published the authors' financial relationships with Cyberonics, as well as with any other company involved in the antidepressant market, would this have been enough?

Remember, the purpose of disclosure is to give readers the information they require in order to make their own decision about the potential for bias. Typical disclosure statements such as "Dr X discloses that he has consulted with Companies A, B, and C" are a good start, but in many cases they do not tell the whole story. The whole story, in fact, is that different companies pay experts different amounts of money to do different things. Further, in many cases, the identified authors of journal articles are not the actual authors; they merely review and edit the work of an industry-paid professional writer, as was the case in the review article on VNS.

Thus, an argument can be made for 2 new disclosure requirements: authorship disclosures and compensation disclosures.


It is clear that a significant proportion of major journal articles-both original research and review articles-are ghostwritten by writers who are funded by the pharmaceutical industry.

 The most well-documented example of this in psychiatry surfaced in the context of a lawsuit against Pfizer. Researchers identified all articles published on the topic of Zoloft (sertraline) from 1998 to 2000. Of the 96 published papers, 55 (57%) were ghostwritten by a medical information company, and 41 (43%) were not. Among the ghostwritten articles, 100% reported clinical results favorable for Zoloft, but only 44% of nonghostwritten articles reported similar findings.

This study implies that approximately half of all major journal articles published in the field of psychiatry are ghostwritten and that these articles are more likely to present information that is favorable to the sponsoring company, bringing up the possibility of prosponsor bias. Thus, it seems crucial for readers to be fully informed about the authorship of all articles in addition to author affiliations.

Ghostwriting is not necessarily a corrupt practice. Busy researchers would find their productivity hobbled if they had to personally write the first draft of an article for every study they conducted. Experienced medical writers are experts at synthesizing scientific data and communicating it to a wider medical community.

The issue, as always, comes down to the need for full disclosure. In the VNS review, the medical writer who wrote the first draft was mentioned at the end of the paper in an acknowledgment section sandwiched between the article and the references. It stated: "We thank Sally Laden for editorial support in developing early drafts of this manuscript. We maintained complete control over the direction and content of the paper. Preparation of this report was supported by an unrestricted educational grant from Cyberonics Inc."

To the uninformed, this acknowledgment implies that Laden had an unspecified and presumably minor editorial role, but that the identified authors actually wrote the paper. An "unrestricted educational grant" connotes a process in which authors are paid to write anything they want to write, without any content requirements from the funding company.

However, nothing could be further from the truth. In fact, according to 

 Cyberonics began the process of writing the article by hiring Laden and providing her with the materials on which to base the first draft. These materials were derived from Cyberonics-funded advisory board meetings, which presumably consisted of clinical data and background literature endorsing the value of VNS for depression. Ms Laden wrote the first draft and then circulated it to the authors; according to her, this draft then went through "many revisions" before publication.

The crucial question, of course, is who actually wrote the article? Was it Laden, who synthesized the literature and wrote the first draft? Was it the Cyberonics marketing team, who decided on what materials to base the article? Or was it the identified authors, who reviewed and commented on drafts written by Laden?

Listing academic psychiatrists as the sole authors lends the article an aura of legitimacy that is crucial for successful promotion. But one could easily argue that the article should have listed Sally Laden as the first author and Cyberonics as the second author and relegated the 9 identified authors to the acknowledgment section. This would have more accurately reflected the editorial process that led to its publication and  would have fully disclosed the extent of industry influence over the content of the final manuscript.


It is clear that the amount paid by companies to physicians for promotional work varies widely, depending on the type of work and the qualifications of the physician.

Many psychiatrists give occasional promotional talks, or know colleagues who do, and are familiar with the going rate of $1000 to $1500 to speak at a local dinner program. However, at higher levels of academia, payments may be much larger. Precise figures are hard to come by, but an indication of the scale of such payments was reported by The Boston Globe in 1999, when court documents revealed that the chairman of Brown University's psychiatry department earned $444,000 in industry consultant fees in 1997 and $556,000 in 1998.

 This was all personal income to the recipient, not money passed on to the department for academic use.

Of course, just because a physician is well paid for industry work does not necessarily mean that his or her articles and talks are commercially biased. However, common sense dictates that as the financial stakes grow higher, the risk that a researcher's opinions may be altered-even if unconsciously-by the prospect of financial windfall becomes greater.

Therefore, some type of disclosure regarding compensation seems reasonable. In the VNS review, it would have been informative to know how much Cyberonics had paid each of the members of the advisory board. Such information helps the reader judge the likelihood of the opinions expressed in the review article being biased, both by the authors' past financial gain and the promise of future gain.


Conflicts of interest, financial and otherwise, are a fact of professional and personal life and will never go away. It is up to journal editors and professional associations to decide how best to minimize any potential damage to scientific communication that conflicts of interest can create.

Adequate disclosure is a good way to minimize the negative effects of conflict of interest, but--as we have seen in this review--there is much disagreement about what constitutes adequate disclosure. My own perspective is informed by my responsibilities as editor of a newsletter that eschews pharmaceutical funding, and thus my opinions are oriented to more, rather than less, disclosure. A proposal of what I feel editors should request from authors can be found in the 

Clearly, psychiatry is in crisis. Many of our top academic leaders appear willing to sell themselves to the highest corporate bidder. However, since this is a crisis of ethics, it will not be resolved easily. A good start is to require meaningful disclosures so that readers can begin to regain their trust in the integrity of psychiatric opinions.

This is part 2 of a 2-part article on conflict of interest in psychiatry. Part 1, "Conflict of Interest in Psychiatry: How Much Disclosure is Necessary?" was published in the November issue of Psychiatric Times.

Dr Carlat is assistant clinical professor of psychiatry at Tufts University School of Medicine in Boston and is editor-in-chief of The Carlat Psychiatry Report. He reports no conflicts of interest concerning the subject matter of this article.

 Our conflicted medical journals. Editorial. The New York Times. July 23, 2006; sect 4:11.


 US Senate Committee on Finance. Review of the FDA's approval process for the vagus nerve stimulation therapy system for treatment resistant depression. February 2006. Available at: 

http://finance.senate.gov/press/Gpress/02_2006 report.pdf

 Nemeroff CB, Mayberg HS, Krahl SE, et al. VNS therapy in treatment-resistant depression: clinical evidence and putative neurobiologic mechanisms. Neuropsychopharmacology. 2006;31:1345-1355.


 Armstrong D. Medical reviews face criticism over lapses. Wall Street Journal. July 19, 2006;B1.


 Waters R. Medical journal to correct Cyberonics device article. Bloomberg News. July 18, 2006.


 Is this the perfect storm of corruption? ACNP journal. Alliance for Human Research Protection Web site. Available at: 

http://www.ahrp.org/cms/content/view/295/55/

 Leading research institutions initiate mechanism of action studies on vagus nerve stimulation (VNS) therapy for treatment-resistant depression. Cyberonics press release. May 23, 2006. Available at: 

http://www.cyberonics.com/PressRelease_detail.asp?ID=32A90EDE-A8C6-4AAB-A709-C0C432DFF3CA

 Armstrong D. Medical journal editor Nemeroff steps down over undisclosed ties. Wall Street Journal. August 28, 2006;B7.


 Mathews AW. At medical journals, writers paid by industry play big role. Wall Street Journal. December 13, 2005;A1.


 Healy D, Cattell D. Interface between authorship, industry and science in the domain of therapeutics. Br J Psychiatry 2003;183:22-27.


. Bass A. Drug companies enrich Brown professor. Boston Globe; October 4, 1999:A1.  

In July 2005, the FDA approved a new type of therapy for treatment-resistant depression: vagus nerve stimulation (VNS). However, the approval process incited controversy because the scientific team that was assigned to review the device rejected its approval unanimously 3 separate times. The reviewers were unimpressed with the efficacy research underlying the device, since the only reported placebo-controlled trial showed no significant difference between active and sham VNS.

Vagus Nerve Stimulation and Depression: Conflict of Interest's "Perfect Storm"?

Just how "hot" is the topic of conflict of interest in psychiatry? The answer was brought home to me dramatically this past May at the APA meeting in Toronto. During the meeting, I had the opportunity to chair a symposium titled "Pharmaceutical Industry Influence in Psychiatry." My copresenters and I showed up well ahead of time to meet and prepare introductions. As we gazed out at the empty seats, we joked that there would be at least 5 people in attendance since, after all, there were 5 presenters.

How wrong we were. As the time to begin approached, a slow trickle rapidly became a rush of attendees. Every available seat filled quickly, and a large crowd stood in the rear and hovered in the hallway outside the room.

In retrospect, I shouldn't have been surprised. Over the past several months, psychiatry has been subject to several embarrassing exposs related to conflict of interest. These events provided painful lessons on what constitutes financial conflict of interest and what should be disclosed.

In this article, I will begin by discuss ing the notion of conflict of interest in medicine and then zero in on 2 examples of conflict of interest in psychiatry. These examples provide good jumping-off points for delving into major controversial issues concerning how much authors and researchers should disclose regarding their financial relationships with commercial enterprises.

 published the classic article defining conflict of interest in medicine in 1993. A clinical ethicist at Harvard University, Dennis Thompson, defined conflict of interest as "a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain).

In medicine, a typical scenario involves the physician who receives money from a pharmaceutical company for research, consulting, or speaking. The conflict is between 2 different interests or desires. One desire is to produce scientifically valid research or, in the case of a speaker, to communicate accurate and relevant medical educational material. The potentially conflicting interest is the desire to make money from the pharmaceutical company.

Obviously, there are times when these 2 interests coincide. Often, for example, speakers will choose to speak strictly on behalf of medications that they sincerely believe are superior. Even if this is true, however, a potential conflict of interest still exists because the audience will never know whether the promise of a check at the end of the dinner program has altered the speaker's opinion of the featured product.

We usually focus on financial conflicts of interest (hereafter referred to as COI) because they are easy to identify and quantify. Other common COI in medicine include the desire for academic advancement and for media coverage. In all cases, COI can bias the content of research articles, review articles, and educational lectures. In recent years, several studies have been con ducted, both in psychiatry and in medicine at large, that documented the ways in which financial COI appear to influence the outcome of medical research.

Recently, for example, Perlis and colleagues

 examined all clinical trials that were published in 4 of the major psychiatric journals from 2001 to 2003. Of 162 randomized placebo-controlled studies, those that reported COI were 4.9 times more likely to report positive results for the sponsored product than other studies. Other reviews have documented similar relationships between sponsorship and positive research outcome in several other medical specialties.

To be fair, however, the fact that industry sponsorship leads to results favorable to the sponsor does not necessarily mean that the research has been biased. It may be, as suggested recently in a Newsweek interview with Dr Ezekiel Emanuel, head of the department of clinical bioethics at the NIH Clinical Center, that drug companies invest their resources preferentially in clinical trials that are most likely to be positive.

 In this view, the correlation between sponsorship and outcome has less to do with bias and more to do with choosing promising drugs to study, as well as having the resources to conduct the large clinical trials that are needed to yield significant results. Indeed, in the Perlis study,

 industry-sponsored studies generally enrolled higher numbers of subjects than nonsponsored studies, implying greater statistical power to measure any differences between treatments.

 of industry-sponsored studies of anti-psychotics detailed specific techniques used by companies to manipulate re search design in order to ensure positive results. The techniques included underdosing competitors' medications, devising study inclusion criteria so that the subjects enrolled were more likely to respond to the sponsor's product, and selectively reporting data so as to minimize the side effects.

Thus while still controversial, potential sponsorship bias is seen as an important issue in academic medicine. Over the past 2 decades, medical journals have responded to this problem by requiring authors to disclose their financial COI when they submit manuscripts. However, there continues to be much variation and debate about how much information authors should disclose and when they should disclose it.

Antidepressants and pregnancy: an embarrassment for 


In retrospect, the issue of antidepressant use in pregnancy is so rife with controversy that the 

Journal of the American Medical Association (

 should have seen this one coming a mile away.

 published a study on depressive relapse during pregnancy. Conducted and written by major luminaries in the field of perinatal psychiatry, this naturalistic multisite study tracked depressive symptoms and antidepressant use in 201 pregnant women, all of whom had histories of depression but who were euthymic and taking antidepressants at the beginning of the observation period. The results were striking: 68% of women who stop ped taking antidepressants relapsed during the pregnancy, whereas only 26% of those who continued their medication did.

While the article did not ignore the potential perils of prenatal exposure to antidepressants, the authors concluded the abstract with a statement endorsing their use: "Women with histories of depression who are euthymic in the context of ongoing antidepressant therapy should be aware of the association of depressive relapse during pregnancy with antidepressant discontinuation."

At the end of the article, the funding source was reported as the National Institute of Mental Health and 2 of the 13 authors-Dr Newport and Dr Stowe-reported financial ties to drug companies. The following was associated with their names: "None of the other authors reported disclosures."

On February 8, Dr Adam Urato, an obstetrician/gynecologist and faculty member at Tufts University, read the article with interest and was struck with the disclosure. Since he frequently advises patients on antidepressant use in pregnancy, he had followed the research closely and recalled that some of these authors had disclosed industry relationships in other articles. In a letter to 

 published in the July 12 issue, he catalogued the industry relationships of the authors and pointed out that 9 had been paid by antidepressant drug makers, while only 2 reported disclosures.

By this time, the story was already out--the 

published a front-page story entitled "Financial Ties to Industry Cloud Major Depression Study."

 That article not only reported the missing disclosures, but detailed the many controversies about antidepressant use in pregnancy, including recent FDA warnings linking SSRI use with pulmonary hypertension, seizure risk, and-in the case of paroxetine-cardiac malformations. The implication was that antidepressant drug makers had influenced the most prominent researchers in the field to gloss over the risks of using antidepressants in pregnancy and to instead highlight the benefits. The fact that they did not disclose their relationships made them appear even guiltier of commercial bias.

But did conflict of interest really exist?

, 4 of the authors explained why they did not submit disclosures. The research, they pointed out, was not funded by industry.

 Yes, the individual researchers receive money from drug companies, but the published study was not a clinical trial of any particular drug, so no particular company stood to benefit from the results. For these reasons, said the authors, "we concluded that there was no inherent conflict of interest with respect to any of our financial associations with industry."

How credible is this response? The core question here is whether the authors' relationships with industry might have influenced the way they designed, conducted, or interpreted their research. Did the researchers have a financial incentive to modify their research in any way? In order to answer this question, we would have to know whether their research results are likely to lead directly to future payments from the relevant companies.

In fact, there are several possible scenarios in which the authors could financially benefit from the results:

 They may receive research funding from a range of drug companies wanting to demonstrate the value of their own products in preventing relapse during pregnancy.

 They may be invited to serve as paid consultants. The role of "consultant" varies, but a major role is to advise companies about what sort of research studies might yield results beneficial to their future marketing efforts.

 They may be invited by companies to conduct lucrative continuing education activities-such as giving lectures, participating in conferences, and authoring sponsored articles-in order to disseminate their research findings.In fact, there is evidence that some of the authors of the 

 article are already deriving additional income in this way. An industry-funded medical education enterprise, the Massachusetts General Hospital Psychiatry Academy, now offers a symposium titled "Psychotropic Drug Use During Pregnancy," which is conducted by some of the 

Just how “hot” is the topic of conflict of interest in psychiatry? The answer was brought home to me dramatically this past May at the APA meeting in Toronto. During the meeting, I had the opportunity to chair a symposium titled “Pharmaceutical Industry Influence in Psychiatry.” My copresenters and I showed up well ahead of time to meet and prepare introductions. As we gazed out at the empty seats, we joked that there would be at least 5 people in attendance since, after all, there were 5 presenters.

Daniel Carlat, MD

Articles

A Response by Daniel Carlat

45,000 More Psychiatrists, Anyone?

45,000 More Psychiatrists, Anyone?

Insel and Obama Want Transparency-Let’s Oblige

The Art of Sharing DSM

Vagus Nerve Stimulation and Depression: Conflict of Interest's "Perfect Storm"?

Conflict of Interest in Psychiatry: How Much Disclosure Is Necessary?