Tuesday, October 23, 2012

Conflict of interest and psychiatry - what's missing?

A new article looking at conflict of interest in psychiatry was presented on another blog to suggest that new rules are required to improve transparency. The article takes a look at six cases and the process used by Sen. Charles Grassley to publicize these cases. The article suggests that the reason for publicizing these cases was in order to support Grassley legislation (Physician Payment Sunshine Provision).  According to the article it was attached to the Patient Protection and Affordable Care Act and was never voted on alone. 

These cases were repeatedly publicized in the popular media and some of the problems with these cases and Grassley's analysis were never adequately discussed.  The clearest example is the case of Alan F. Schatzberg, MD of Stanford University. He was the chairman of the Department of psychiatry and when Grassley investigated the matter at the level of Stanford University and several pharmaceutical companies. You can read the exact details in this paper but the bottom line is that Stanford University has always maintained that it handled potential conflicts of interest in an appropriate manner consistent with their policies. They actually published a statement on their web page at the time.  He remained the department head and although he was apparently temporarily removed as the principal investigator on a federal grant but he was later reinstated. The authors of the article in this case suggest that exposing the conflict of interest had negligible effect on the outcomes in this case, but the fact is the case was handled according to university policy.

There are really two key elements in this paper that are critical. The first is why Grassley went after psychiatry in the first place. The article suggests this occurs because his aide Paul Thacker "Combed  the media for stories of influential physicians with industry ties. He then requested the physicians conflict of interest disclosures from their AMCs and compared them to payment schedules obtained from companies."  I had always wondered why physicians from other specialties were never mentioned or consultants from other departments. It is fairly well known that scientists and engineers can make substantial incomes to supplement their university salaries based on their expertise. So why was the "media combing" restricted to psychiatry?

If I had to speculate, I would suggest that media bias against psychiatry is a well known fact. It has actually been investigated and the frequency of negative press that psychiatry receives relative to other specialties is well known. (see paragraph 4)  The popular press has an automatic media bias against psychiatry and it should come as no surprise that prominent psychiatrists are investigated and reported more frequently than other specialists. This is why “combing the media” is really not a legitimate research method. It should be fairly obvious that prominent university affiliated physicians of all specialties have similar conflicts of interest and that the business stake in other specialties is probably significantly higher.

The second element that should be obvious to anyone skeptical of Congress is Grassley's quote in the article "The whole field of medicine is connected by a tangled web of drug company money. For the sake of transparency and accountability should the American public know who their doctor is taking money from?"  That sounds like there is an obvious answer in there somewhere but the U.S. Congress is the best case in point that transparency is essentially meaningless. There is probably no better example than Sen. Grassley himself.  You don't have to look too far to find campaign donations that align with the votes and the Senator's denial (see paragraph 8) that there is any connection.

These simple facts are left out of the Journal article and that represents a serious flaw to me. Is the U.S. Congress is a shining example of disclosure becoming a license to do whatever you want to do? If that is the case you really don't have the basis to suggest that transparency will allow the "power of sunlight to disinfect". It clearly does not have that effect in Congress.  That is at the minimum an appearance of a conflict of interest on par with any scenario described in this article.  When I point this out - the usual rebuttal is that doctors should have a higher standard when it comes to the appearance of conflict of interest.  Is that really true?  Should a doctor who already has a fiduciary responsibility to a patient and the patient's well being have a higher conflict of interest standard than one of the 100 most important law makers in the country?

The other issue here of course is that psychiatrists are conveniently thrown under the bus. Despite the qualifier in this paper is that "Nor did Grassley ever assert that psychiatry was more problematic than other specialties." (p 5).  You really don't have to make an assertion when psychiatry is apparently the only field you are investigating. That bias is totally consistent with one of the themes of this blog. 

When all else fails you can more easily scapegoat psychiatrists.  So why look for anybody else?

George Dawson, MD. DFAPA

Chimonas S, Stahl F, Rothman DJ. Exposing conflict of interest in psychiatry:
Does transparency matter? Int J Law Psychiatry.
2012 Oct 1. pii: S0160-2527(12)00072-6. doi: 10.1016/j.ijlp.2012.09.009.
[Epub ahead of print] PubMed PMID: 23036364.

Sunday, October 21, 2012

The Besieged Minority

October 25 marks the 10th anniversary of the death of Senator Paul Wellstone.  There was an article commemorating this date  in the St. Paul Pioneer Press today.  Senator Wellstone was a favorite and perhaps my only favorite politician after he voted against HJ Res 114: "To Authorize the Use of the United States Armed Forces against Iraq."  His actual statements about the logic of going to war that are linked to this page is the best example of a rational analysis at a time when there was near mass hysteria to go to war.  And compared to all of the evidence that Iraq had weapons of mass destruction that they were somehow going to use against the US, only his analysis has stood the test of time.  Senator Wellstone is always recognized for his fighting for social causes but I think he also deserves a great deal of recognition for this analysis on the appropriate threshold for the use of force in a high degree of uncertainty.  His analysis in favor of peace.

The article describes the Paul Wellstone Mental Health and Addiction Equity Act of 2007 as his signature legislative accomplishment.  His son Dave lobbied for five years to pass this bill after his father's death and the title of this post is excerpted from a quote from his son:"My dad said that folks with mental illness and addiction were a besieged minority."

Paul Wellstone was certainly right about that.  Anyone who comes from a family with mentally ill or addicted members can attest to the lack of resources and assistance to address those problems.  Those same people can also attest to the uneven insurance coverage or in many cases a complete lack of insurance coverage.  When managed care arrived on the scene about 20 years ago a lot of people had the appearance of mental health and addiction coverage only to see it disappeared when needed based on the managed care company's tactics.  An example would be discharging a person with severe mental illness or addiction in a few days because the "acute" symptoms had resolved and they were no longer "dangerous".

Unfortunately these practices have really not changed.  In many cases they are worse.  Each managed care company has what it calls "medical necessity" criteria.  The best example is acute inpatient care.  A reviewer or case manager reads the chart and decides that the person is no longer suicidal or potentially aggressive to other and decides that they can be discharged.  The discharges occur at a convenient time that allows for somebody to make a profit.  The person's overall stability in terms of their ability to function or whether their personality function has been restored is never taken into account.   The likelihood that they will immediately relapse to a life threatening addiction that has only partially been addressed is not taken into account.  The issue of co-occurring addictions and mental illnesses are not taken into account.  The issue of whether that person is capable of managing any associated medical problems like diabetes is not taken into account.  People are frequently discharged with as many symptoms and problems as they were admitted with.

Practically every outpatient psychiatrist I have talked and corresponded with about this problem has given me the opinion that inpatient psychiatry is for all practical purposes - worthless.  In the meantime, one of the country's largest managed care companies reported last week that their profits were up 26%.

Apart from the loss of Paul Wellstone and the activity of Wellstone Action as far as I can tell there is no current politician out there to make sure that the intent of this legislation will ever be realized.   There is no doubt that federal and state law is extremely business friendly and overtly hostile toward physicians working in the health care system.  The deck is clearly stacked in the direction of health care businesses and the new legislation promoted by President Obama will make things even worse.  Unless there are some valid protections at the level of patient and physician interaction - business decisions based on health company profits will  always trump clinical decisions.  There is no better example than what has happened and continues to happen to psychiatric care over the past two decades.

In the meantime I will remember Paul Wellstone on October 25 and wish that he was still the most unique guy in the US Senate.

George Dawson, MD, DFAPA

Bill Salisbury.  Living On In Those He Inspired.  Pioneer Press. Sunday October 21, 2012.




Sunday, October 7, 2012

Why Psychiatrists Should Agree with David Healy

One of the big media stories today is about David Healy's address to the American Psychiatric Association's Psychiatric Services meeting.  Like many of the psychiatrists turned critic his celebrity and notoriety status depend a lot of the amount of controversy that he is associated with and he comments on that in the opening remark.  If you carefully read through this article, you will find that the financial conflicts of interest alluded to in the article are largely historical at this point.  The elephant in the room for these critics is that practically all antidepressants are generics these days and they are no longer marketed by pharmaceutical companies.

I was an early adopter of maintaining  clear boundaries with pharmaceutical companies and for the past 20 years or so - did not see detail salespeople, did not accept food and did not accept any gifts.  On the other hand, I have always found pharmaceutical companies to be a rich source of data in addition to the usual FDA approved package insert.  As an example, I am looking at a disc sitting on my desk right now entitled "Iloperidone unsolicited slides - for education use only."  I gave a lecture on newer atypical anti psychotics several years ago and contacted the scientific divisions of three pharmaceutical companies looking for basic science data on the new drugs and they all supplied me with complete clinical trials data and basic science information on the receptor profiles that I wanted.  I will also call them up with possible adverse events and get detailed information about that frequently via fax the same day.

Healy appeared to have made a controversial remark about psychiatrists committing "professional suicide" by their affiliation with pharmaceutical companies.  In his previous remarks he make the comment about professional suicide as a preface to the second paragraph below:


"Healy noted further that when data surfaced showing a link between antidepressant use and risk of suicide in children, the APA issued a statement proclaiming that “we believe that antidepressants save lives.”

“What I believe they should have said is that the APA believes that psychiatrists can save lives because it takes expertise to manage the risks of risky pills,” he said; if psychiatrists’ only role were to dole out drugs, then less-trained physician’s assistants could easily replace them, he noted."

I have seen the comment on his blog at least 6 months ago and there should be complete agreement with this statement.  Just in the past month I have had to diagnose and address drug induced liver disease, serotonin syndrome, eosinophilia, antidepressant associated hypertension, and spent a considerable larger amount of time making sure that antidepressants could be safely prescribed and that they were not making pre-existing medical problems worse.   Recognizing those problems goes beyond the diagnostic process to coming up with a plan to monitor and treat it.  A considerable amount of my time is, if not most of my time is spent managing side effects and protecting the health of my patients.

Although Healy takes positions that I would consider to be inaccurate, in this case he is dead on.  It is professional suicide to collude with the idea that the treatment of any mental illness resides in a pill.  Marketing genius maybe, but certainly not reality.  Drugs don't treat and cure depression, psychiatrists do and it goes far beyond selecting a medication.  Monitoring the patient for these complications and recognizing rare complications takes time and that time needs to be available - even in visits that are supposed to be focused on "medication management".

George Dawson, MD, DFAPA




Confusion about Capitation versus Fee-For-Service versus National Health Care

This is from the Shrink Rap blog this morning the consensus is that capitated care is better than fee-for-service care.  What is wrong with that picture?

Starting out with the much maligned fee-for-service (FFS) -  most medical and psychiatric services are not delivered in that context.  You can safely say that FFS, disappeared a long time ago.  According to a 2012 Medscape survey of 24,216 physicians across 25 specialties only 4% worked in cash only or concierge style practices. That means that everyone else is subject to varying degrees of insurance company discounting.  From my years of providing inpatient care for example,  there is a standard DRG payment based on a global discharge or admission diagnosis.  For the most common psychosis DRGs the standard payment is $4,500 no matter how long a person is stays in the hospital.

The same thing happens on the outpatient side.  I have discussed this more extensively is a previous post.  Looking at the commonest outpatient billing code - actual reimbursement for providing services can be as little as $22.45 per visit.  In the case where bills are submitted with CPT codes (common to all of medicine) Medicare pays 50% of the usual and customary charge for psychiatry compared with 80% for the rest of Medicine.  A lot depends on contracting arrangements since a contract can limit a psychiatrist to billing only a 90862 code and the company can also decide that they disagree that services were provided and either deny payment or demand repayment of a significant amount of money based on a review of the documentation.

The business adaptation to this on the hospital and managed care side (if they own the hospital) is to hire case managers to get patients out of the hospital within 3 or 4 days.  Some of these systems have confabulated their own "guidelines" that allow them to do this that are totally independent of any professional standards.  So if you are a managed care business and you own the hospital you are winning at two levels - you already shift the risk to the providers and hospitals by the Medicare style DRG payment and you do it a second time by insisting that they go along with the business decision to discharge the patient from the hospital.

Strictly speaking, the examples of discounted fees are technically not capitation.  Discounted fees still allow for some elasticity within the system because there is still a fee paid per service event.  Capitated systems of care like behavioral health carve outs can be set up to pay a set fee for managing a specific population.  For example, a system of care is under contract for providing all services to a specific group of employees for a rate that is negotiated irrespective of actual patient visits.

The best way to understand capitated care is that it is designed to provide insurance companies a significant financial incentive for rationing care.  That incentive comes directly out of the total amount of money available for health care spending   Psychiatry, mental health, and addiction services were the easiest targets due to insitutionalized stigma, lack of a vocal constituency, and the political ineptness of psychiatrists.  It is anybody's guess about how much a managed care company can make for denying or rationing care but some estimates of the margins have been as high as 20-40%.

One thing is for certain.  Capitated care is not a comprehensive national health system.  It takes hundreds of billions of dollars out of the health care system and diverts it to CEOs and stockholders.  Contrary to the political opinion it does not contain the cost of health care inflation.  One of the readers of the Shrink Rap blog pointed out that in a national system of health care you might be able to get an expensive medication like aripiprazole but you would have to wait longer.  In our current system of capitated care if your managed care company decides - you will not be able to get it at all.

That is probably the best example of the difference.

George Dawson, MD, DFAPA



Sunday, September 30, 2012

"Doctors don't label"

In a rare statement of clarity amid the usual sensational spin this comment jumped out at me:

"Doctors don't label...Doctors diagnose, take care of, and treat.  That's not to say that something cannot be stigmatizing, but 'labeling' kind of gets right into the antipsychiatry component of it."  William T. Carpenter, MD  - Clinical Psychiatry News September 2012; p 3.


Dr. Carpenter is right and every psychiatrist knows it.  Psychiatrists don't label.  Psychiatrists diagnose.  Psychiatrists are very aware of the limitations of diagnosis given the the sociocultural and medical  contexts.  The psychiatric orientation is to be helpful to patients and the diagnosis is the focus of that treatment.  Furthermore, all psychiatric diagnosis and treatment is supposed to be confidential and there is no group of physicians who has tried to hold the line more against government and insurance companies eroding patient-physician confidentiality than psychiatrists. 


A significant part of this article about the content of a letter from the Society for Humanistic Psychology (Division 32 of the American Psychological Association).  Read the letter and draw your own conclusions.  The points of contention listed in the letter have been exposed in several other media contexts.  As I read through the letter there are several problems:


"This document was composed in recognition of, and with sensitivity to, the longstanding and congenial relationship between American psychologists and our psychiatrist colleagues."


I don't think that this is an accurate statement.  When I started out in psychiatry and was in my third year of residency the American Psychological Association decided to get more aggressive politically and their target was basically American psychiatry.   I won't rehash all of that ugliness but simply point out that things were far from congenial and in many areas remain problematic.   Much of those political efforts were based on the idea that organized psychiatry had an inordinate amount of control  over the treatment of mental illness.  Any observer - biased or unbiased should recognize that psychiatrists and physicians in general have been marginalized and the American Psychiatric Association is politically ineffective and weak.  Of course any other group of mental health providers is in the same boat. 


"Given lack of consensus as to the “primary” causes of mental distress, this proposed change may result in the labeling of sociopolitical deviance as mental disorder."


This is a comment on the new DSM5 definition of a mental illness, specifically that the new definition does not explicitly say that deviant behavior and conflicts with society are not mental disorders.  The current version states that these conflicts need to be the result of dysfunction within the individual.  It is hard for me to see a situation where this is relevant to the practice of psychiatry.  Is there really a case where I am going to diagnose a person in this situation with a mental disorder?  Definitely not and the reason is that I have been confronted with the situation many times before and pointed out that the conflict was not the product of a mental illness.  The authors here have focused primarily  on a lower threshold for diagnosis and how they are not confident about the clinical decision making skills of practitioners - but do not comment on the threshold part of the definition.  


"Increasing the number of people who qualify for a diagnosis may lead to excessive medicalization and stigmatization of transitive, even normative distress."


The risk of "medicalization" needs to be considered for a moment.  What is "medicalization"?  The implication of this letter at a practical level is that it involves an excessive use of medications.  Suspending the poor quality of many of those studies for a moment, what is the real driver of medication use in today's practice environment?  The minority of people taking any kind of psychiatric medication see psychiatrists.  The managed care industry and the government are clearly the driving force.  Current "evidence based" approaches are linked directly to medication use.  A checklist diagnosis and rating scale approach has been used to rapidly treat patients with antidepressants in primary care settings.  That approach alone has easily outpaced any DSM5 modifications.  Direct to consumer drug advertising compounds the issue of getting as many people on medications as possible.  You don't even have to read the DSM5 to see that medicalization has little to do with medical doctors.  In fact, managed care companies would clearly like to replace as many doctors as possible with "prescribers" who can fill prescriptions according to these protocols.  The pharmaceutical and managed care industries are far more interested in distilling psychiatric treatment down to a pill or a capsule than psychiatrists are.


The associated idea that psychiatrists may be the initiators of this medicalization or at least collude with it ignores psychiatric innovation that does not involve the prescription of medications.  On this blog alone, I have posted excellent examples of work done by Greist and Gunderson on innovative and highly successful non medication approaches to significant problems.  Dr. Greist's ideas have been presented to a wide audience that includes pharmaceutical companies.  His ideas about how to make effective psychotherapy widely available have been successfully applied in other countries.  Ignoring psychiatric innovation outside  of psychopharmacology is a curious phenomena, but it definitely makes it easier to see psychiatrists as the "medicalizers".  I am sure that both Greist and Gunderson would not see medications as the primary treatment for anxiety disorders or borderline personality disorder.


Once again, the focus on problems in the DSM5 leading to medicalization and stigmatization is clearly overemphasized.  There is no group of people more aware of the limitations of the current diagnostic system than psychiatrists.  There is no group of people better equipped to compensate for these deficiencies.  There is no group of people more aware of the stigma of mental illness and addiction.  Psychiatrists have a unique perspective in observing first hand how health care systems institutionalize stigma and use it to reduce the resources dedicated to treat these problems.  There should be no doubt that the DSM5 is being produced in what is considered the best interest of the American Psychiatric Association.  There should also be no doubt that the critiques of the process have their own interests and their opinions should be evaluated in that context.


George Dawson, MD, DFAPA

Wednesday, September 26, 2012

Why antidepressants are not addictive


I recently noticed that a blogger posted his theory on the addictive properties of antidepressants. He pointed out that people get "psychologically addicted" and that using the term "addiction" for physical addiction seemed too restrictive. His supporting evidence is a newspaper article about how Glaxo Smith Kline dropped its claim on a patient information pamphlet for paroxetine saying that the drug was "not addictive".  David Healy is quoted as saying "If there is withdrawal, then there is physical dependence. There will be some people who will never be able to halt this drug, there will be some for whom halting will not be awfully difficult and some for whom it is a real issue". The article goes on to say that although SSRIs are not like opiates they are "more comparable to the benzodiazepines such as diazepam, which is now prescribed only with great caution because of withdrawal problems".

Working in the addiction field this entire line of thinking is rhetorical. There is significant psychiatric comorbidity in people with addictions with anywhere from 40-75% having co-occurring disorders. Most of those co-occurring disorders are anxiety disorders and depression and they are well known triggers for relapse as well as initiating drug and alcohol use in the first place. Contrary to public denial,  addictive disorders have huge liabilities in terms of morbidity and they are often lethal illnesses.  My goal is to reduce the risk of relapse by treating the co-occurring disorder while the person is being treated for addiction. SSRI medications are one of the mainstays of treating anxiety and depression these days. They are effective medications. I would not be prescribing them if they caused "psychological addiction". Furthermore, many treatment programs for addiction teach the concept of cross addiction and nobody studying that concept would want to take an SSRI if it caused any kind of addiction.

A better starting point would be to look at more comprehensive definition of what an addiction is. That starting point would be the October 2011 definition issued by the American Society of Addiction Medicine.  Paragraph 2 of the short definition will suffice and reading those four lines should make it very clear that the use of antidepressant medications does not lead to addiction. The real hallmark of addictions is uncontrolled use and there is no evidence that modern antidepressants are used in an uncontrolled manner.  Additional evidence is that antidepressants have absolutely no street value and therefore are in the majority of 34 million chemical compounds listed in Chem Abstracts of which only about 322 are addicting.

If your doctor has recommended that you take an antidepressant medication certainly be aware of the fact that there may be discontinuation symptoms. Discontinuation symptoms are not an addiction.  Needing to take an antidepressant for a chronic mood or anxiety disorder is not an addiction.  Contrary to Dr. Healy's opinion there are a number of nonpsychiatric medications can be discontinued and cause severe discontinuation symptoms.  The term "physical dependence" suggests an addiction or the inappropriate use of a potentially addicting drug where in fact that is not the case with antidepressants.  Comparing antidepressants to other clearly addictive compounds like benzodiazepines or opioids is not an accurate comparison across any dimension.  I agree that any person considering an antidepressant drug needs to be aware of the fact that mild to moderate symptoms can respond to psychotherapy as well as medication.  ANY medication can lead to rare but very serious complications.  Any person considering treatment with medications needs to be working with a physician who is skilled in the use of these medications and who can address any potential side effects.  My personal experience in treating people who have severe anxiety and depression is that they reach a point that anyone with a severe chronic illness reaches in making a decision about medication. That point generally involves asking themselves: "What else am I going to do?".

As physicians we can never minimize the importance of that question.

Response to Dr. Willenbring


I wrote this response to Mark Willenbring's post on his blog.  I reposted it here because the links do not work in the reply section of his blog in case anyone is interested in the references:
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I generally agree with what you are saying.  I think the no fault aspect of the illness is very difficult for many to grasp - most importantly the policy makers and health plan administrators.  I think it is captured very well in the latest ASAM definition.  I think that Sellman’s Top Ten list and the responses to it are also instructive especially item 7 “Come back when you are motivated” is no longer an acceptable therapeutic response’ is part of your message.

From a systems standpoint, the lack of a full array of services to treat addiction is striking.  Over the course of my career I have seen detox services essentially moved to mental health units and then to the street.  I wrote a post about this several weeks ago that was read by current detox staff who agreed with it.    It is hard to believe that in many if not most cases people with addictions are sent home from the ED, sent home with a handful of benzodiazepines, or sent to a facility with no medical coverage for a complex detox process.  I think the test of any health care system is whether a primary care doc can ask themselves if they have a safe detox procedure for any of their regular patients who are addicted to opioids and benzodiazepines and needs surgery.

Medical systems in general have a very poor attitude toward people with addictions.  I think that these healthcare systems and their personnel are much more likely to take a moralistic attitude toward addicts and not treat them well.  I have seen that theme repeated across multiple care settings.  Many rationed care settings disproportionately reduce resources necessary to treat addiction.  I think it is safe to say that most cardiology patients with suspicious chest pain get a $10,000 evaluation and reassurance or appropriate treatment.  Most patients with addictions do not even get a $300 evaluation.  They may actually see a physician who provides them with medications that fuel their addiction.  Institutionalized stigma plays a big role in that.  There are no billboards in the Twin Cities advertising state-of-the-art addiction treatment.  There are many advertisements for heart centers.

I am less pessimistic about the effects of 12-step recovery and time in a residential setting whether it is a high end recovery facility or a state hospital.  I think if you are in a setting where there is no active treatment or sober environment you are probably wasting your time.  I have seen people who were declared hopeless recover with time away from alcohol and drugs on the order of months.  Vaillant’s study of severe alcoholism is a great example of the different paths to recovery and there are many.  His subsequent analysis of how AA might work suggests that affiliation rather than blaming may be the most curative element.  AA is difficult to study but I think that the message is positive and embodied in #3 of the Twelve Traditions.  Up to that point the founders were looking at the issue of exclusion but decided against it because alcoholism was a life threatening disease and they could turn nobody away. 

George Dawson, MD, DFAPA