Tuesday, October 30, 2012

Who Runs My Drug Plan?

The real issue in pharmaceuticals used to treat mental illness is the business practices that looms as an obstacle between the psychiatrist prescribing the medication and the patient who wants to receive the medication.  I have posted about the managed care practices - specifically pharmacy benefit managers (PBMs) that get in between physicians and patients. That previous post shows a diagram from an internal memo that reveals some perspective on the PBM attitude.  The goal for them is to come up with a business argument that will either improve profits for the managed care company or justify the billions of dollars in costs that PBMs add to the health care system every year.

The National Community Pharmacists Association fights back against PBMs from this web site.  A lot of what you find is relevant for pharmacists also applies to physicians - especially wasting physician time, indirectly affecting reimbursement, and disrupting the patient-physician relationship by dictating medications that need to be prescribed that are financially advantageous to the PBM.

Some of the details provided on this site are very interesting.  One example is a $10 price spread on up to 4 billion prescriptions per year.  I once read that PBMs made up an $80 billion per year industry and it is easy to see how they can get there.  In fact, the volume strategies that they use are very similar to the financial services industry.  In both cases, political advantage has added businesses that levy another tax on consumers and do not provide any added efficiency.  It is easy to see how managed care strategies fail to contain health care inflation when the intermediaries with government advantages are set up to maximize profits and waste the time of physicians and pharmacists.  

If you are a physician, watch the "Fed Up With Phil" video and ask yourself if it isn't time to get rid of health care middlemen that are increasing costs and in many cases detracting from the quality of health care?  If you are a physician, isn't it time that you or your professional organization starting putting up web sites like this one to educate the public about managed care and all of its problems?  Isn't it time that we stopped wasting our time and money with politicians?

George Dawson, MD, DFAPA

Sunday, October 28, 2012

The diagnosis of anosognosia

Follow up on another blog today where the author proclaims "It is not possible to diagnose anosognosia in schizophrenic patients on brain scan."

No kidding.  Here is another shocker and you can quote me on this - it is not possible to diagnose anosognosia in stroke patients based on a brain scan.  Quoting an expert: "Anosognosia refers to the lack of awareness, misbelief, or explicit denial of their illness that patients may show following brain damage or dysfunction.  Anosognosia may involve a variety of neurological impairment of sensorimotor, visual, cognitive, or behavioral functions, as well as non-neurological diseases."  I  encourage anyone who is interested in this topic to find a copy of this book chapter listed in the references below.  The author thoroughly discusses the fascinating history of this disorder, specific protocols used to make the diagnosis, various neurological subtypes with heterogeneous lesions and the fact that no specific mechanism has been determined.

In a more recent article available online, Starkstein, et al provide an updated discussion in the case of stroke.  They discuss it as a potential model of human awareness, but also point out the transient nature and difficulty in developing research diagnostic criteria.  They provide a more extensive review of instruments used to diagnose anosognosia and conclude: "Taken together, these findings suggest that lesion location is neither necessary nor sufficient to produce anosognosia, although lesions in some specific brain areas may lower the threshold for anosognosia. Strokes in other regions may need additional factors to produce anosognosia, such as specific cognitive deficits, older age, and previous strokes."

The experts here clearly do not base the diagnosis of this syndrome on imaging.  It is based on clinical findings.  For anyone interested in looking at the actual complexity in the area of anosognosia in schizophrenia I recommend reading these free online papers in the Schizophrenia Bulletin in an issue that dedicated a section to the topic in 2011.  You will learn a lot more about it than reading an anti-biological antipsychiatry blog.  But of course you need to be able to appreciate that this is science and not an all or none political argument.

George Dawson, MD, DFAPA.

Patrik Vuilleumier. Anosognosia in Behavior and mood disorders in focal brain lesions.  Julien Bogousslavsky and Jeffrey L. Cummings (eds), Cambridge University Press 2000, pp. 465-519.

E. Fuller Torrey on the New Anti-biological Antipsychiatry

This post by E. Fuller Torrey was noted on another blog especially the phrase "the new anti-biological antipsychiatry".  Torrey explains anosognosia both as a biological phenomenon and why it may be "deeply disturbing" to the new antipsychiatrists.  Basically it represents the difference between social behavior based on choice versus social behavior based on brain damage.  The former  might be a civil rights issue but the latter is a medical problem that benefits from identification, study, and treatment.  Torrey is also clear about the consequences of no treatment, facts that the antipsychiatrists conveniently often leave out of their arguments or more conveniently blame on treatment.

There is a lot of technical information apart from the data on anosognosia that is ignored by the new anti-biological antipsychiatry.  There are studies on the prefrontal cortex that go back for decades and the implications for social behavior and the neurobiology of everything from addiction to dementia.

Here is a link to the original blog post by Duncan Double entitled: "E. Fuller Torrey attacks 'The new antipsychiatry.'"  Defending against attacks by the new antipsychiatry is more like it.  Dr. Double laments the fact that at times he is seen as an antipsychiatrist, even though he essentially maintains many of the positions of mainstream antipsychiatry.   He includes a variation of the old antipsychiatry argument that if you don't have a specific test for a disease - the disease does not exist.  That opinion fails to take into account studies about what is or is not a disease as well as a massive literature of biological psychiatry.  It also fails to take into account the fact that these arguments are political in nature and have very little to do with science.

A good example is the chemical imbalance red herring.  Any psychiatrist trained since the 1970s is aware of the complex neurobiology of human behavior.  I can recall reading Axelrod's paper in Science over 30 years ago.  Since then there have been eight editions of The Biochemical Basis of Neuropharmacology and five editions of the ACNP text Neuropsychopharmacology.  Since then a psychiatrist has won the Noble Prize for contributions in neuroplasticity and wrote a seminal article on neuroplasticity and learning in psychotherapy.  That is apparently ignored by the anti-biological antipsychiatry crowd and those who would characterize the field as prescribers versus therapists.  The Internet is currently full of diagrams of cell signalling pathways with the associated proteins and genetics.  The idea that chemical imbalance reflects some central central theory of biological psychiatry or represents anything beyond pharmaceutical company marketing hype reflects a gross misunderstanding of the field.

Any psychiatrist who tries to respond to these crude arguments is at a disadvantage for a couple of reasons.  It is certainly seems true that the antipsychiatrists political stance is really not conducive to scientific discourse.  Suggesting that the appearance of conflict of interest invalidates psychiatry is an obvious example.  Discounting the amassed research on the neurobiology of mental illness is another.  A political argument is well outside the scope of hypothesis generation and testing.  Dismissing the science by attributing it to the "worldview" of a single person is consistent with that political approach.  

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