Sunday, March 30, 2014

A Lemon Law for Medications?

I always hear about expensive medications and what a racket that is for Big Pharma.  A recent exacerbation of asthma was an eye opener for me.  I have had to discard a lot of medications prescribed for me in the past because they either were not indicated (like an antibiotic for cellulitis when I really had gout) or medications that I thought were too risky (they shall remain nameless).

I posted some of my experiences with medications taken for asthma.  Over a two month period I took oral prednisone in addition to corticosteroid inhalers and beta agonist bronchodilators.  All of the medication was only moderately effective over a two month period and this necessitated switching between different preparations.  It also involved discarding some after only one or two doses due to intolerable side effects.  That trial and error came an a high cost.  Like most employees these days I have a high deductible health insurance plan.  That deductible is $3,000.  The final tab between the dates January 20, 2014 and February 25,  2014 was $3,000 out-of-pocket.   So I guess the good news is that I met my deductible for this year.

The drug costs are instructive. Some of the inhalers retail for $500 apiece. The out-of-pocket costs for a high deductible insurance plan varies from $50.65 to $251.03. The total out-of-pocket drug cost for one month of treatment for asthma was $1,284.92. The most important part was that about half of that cost was for medications that could not be tolerated or were ineffective and had to be discontinued ($565.72). This is a form of cost shifting that nobody ever talks about. I have over $500 worth of medication sitting on the shelf and ready to be discarded because it was ineffective or could not be tolerated. When I think about how many times I have prescribed a medication for a patient only to have the PBM fax me to say that they would only fill 90 days worth of the medication, I wonder about how many tens of thousands of these prescriptions are sitting out there unused.

What about really expensive medications? Some of those are about the equivalent in cost to a new car or several new cars. To give two examples of medications I recently learned about consider Olysio (simeprevir) and Sovaldi (sofosbuvir) new drugs for hepatitis C. Sofosbuvir costs $954.90 for a 400 mg tablet or a full course of therapy for $35,000 - $70,000. Simeprevir is $753.37 for a single 150 mg capsule. I have already read the cost-benefit analyses of theses medications and like most analyses of very expensive medications they seem justified. What happens when you take a very expensive agent like this and it is ineffective or you can't tolerate the side effects? Medicine may be the only area in American life where the customer underwrites the product cost no matter what. What other product works like that? Lemon laws protect car purchases. If you buy a new house, as part of that agreement you either sign an arbitration agreement or you are free to sue if something happens to that house. Most big ticket item retailers have return policies. With medications you are often left with an unused bottle staring at you from the medicine chest and reminding you of what it costs. It probably takes on a lot more importance now that the average employer plan leads to very high out-of-pocket costs.

I don't mean to imply that any of these products are ineffective.  My thoughts on what the FDA does in terms of drug approval are recorded here in this blog.  This all has to do with biological variability and balancing Type I versus Type II error.  Some of the medications I could not tolerate work exceedingly well for other people.  Some of the medications I take are toxic to others.  There are no medications that work well with minimal side effects across the entire population.

Is there a solution to this problem?  I think there is a very straightforward one.  Give the pharmacist the option of supplying a smaller portion of the prescription for the patient to test.  For example, a week of pills or an inhaler with a week of inhalations.  That would have saved me nearly $400 in unnecessary costs.  The environmental costs are also unknown.  There has only been recent interest in what happens to discarded pharmaceuticals when they enter our waste disposal systems and waterways.  That cost is currently unknown but needs to be considered.  This post also highlights the difference between biological products like prescriptions and non biological products like cars.  If a car is a lemon, that is independent of the biology of the owner.  Whether a prescription drug is a lemon or not is solely determined by biology.  

As the cost of health care is shifted back to the consumer, the financing needs to  be like any other expensive consumer good.  That would include some safeguard of value for the money.

George Dawson, MD, DFAPA

Thursday, March 27, 2014

Dr. Fischbach and the Pittsburgh Post-Gazette on the State of Psychiatry

I received a link to this excellent post by Marnin E. Fischbach commenting on two articles in the Pittsburgh Post Gazette on the shortage of psychiatrists, why people have difficulty finding a psychiatrist, and his broad overview of the importance of psychiatry.  From other sources I have learned that Dr. Fischbach has over 40 years experience as a psychiatrist.  It is good to find another psychiatrist who has confidence in their colleagues.  Even though most of my colleagues would agree, that is often not the public opinion stated by many psychiatrists.  Conflict of interest issues do not apply since it appears that Dr. Fischbach is not selling a book or trying to come across like somebody who can correct the deficiencies in his colleagues.

His subtitle is critical:

"If more people knew what psychiatrists really do, there would be more of them and better health care for everyone".

In his elaboration he discusses inaccurate portrayals in the media, the lack of "whiz bang technology" like some other specialties and how the general stigma of mental illness also attaches itself to psychiatrists.  His discussion of the value of psychiatrists has 5 significant points.  Those points include being "willing and able" to deal with the mental forces that affect the human condition, having the broadest understanding of all of the factors that affect those forces, diagnosing and treating borderland conditions because our work requires close attention and listening, being first and foremost physicians, and providing treatment that results in patients getting better.  None of these points should come as any surprise.  It is only in the context of media bias against psychiatry that they do.  

At the end of his essay he states: "I have much faith in our psychiatric profession and great respect for its practitioners."  That is a good note to end on.  The other theme in the essay was addressing the compensation of psychiatrists.  That was critical because it speaks to the shortage of psychiatrists and the two previous articles.  It also explains why psychiatrists refuse to accept insurance, but his article does not explain the underlying reason.  Most people do not understand that as far as most insurers go, psychiatry is "carved out" from all other medical specialities.  In terms of managed care organizations that means services that are either not covered or that are covered by a much different payment mechanism that other medical services.  It was actually part of the federal reimbursement scheme until new rules allowed the submission of standard medical billing codes.  It makes sense that if managed care companies expect you to accept minimal or in some cases trivial reimbursement that you would refuse to contract with them and accept patients who subscribe to that plan.  It is clear cut rationing of psychiatric services by insurance companies and the government.

The other area in Dr. Fischbach's essay that is impacted by similar rationing mechanisms is the collaborative care model.  As I have pointed out, this is an extension of rationing by both the managed care cartel and the government that will only result in psychiatry being further marginalized.  

Psychiatry is a vital and effective medical specialty.  The biases against psychiatry that he mentions and the biases noted in the original article are significant and in my opinion are a larger factor in reducing the number of psychiatrists than the compensation issue.  That is why those biases are addressed right here on this blog.  

I congratulate Dr. Fischbach on pointing out and elaborating these biases in his essay and and share his positive regard for our colleagues.  I encourage a read of his well written essay and a look at the links to the two articles that he is responding to.  Never forget that access to psychiatrists is restricted by both the government and the managed care cartel and one of the reasons they can do that is the longstanding stigma against mental illness.

George Dawson, MD, DFAPA

Marnin E. Fischbach.  The Importance of Psychiatry.  Pittsburgh Post-Gazette.  March 22, 2014.

Monday, March 24, 2014

The Problem With Making Medical Information More Like Financial Information

I have been an interested reader of financial information for the the past 40 years.  My uncle was an avid stock market investor when I was a kid and he got me interested in reading the Value Line investment  survey.  I still read it and base some of my decisions on it.  Over the years I have had some degree of success in investing, but it hasn't all been good.  One of my greatest successes was a defensive maneuver that resulted in me not losing anything during the stock market crash of 2008.  I have been a subscriber at one time or another to most of the significant investment magazines and newspapers in the United States.

It has been interesting to observe what has happened to what has come to be known as the financial services industry over my investing career because it has implications for the increasing business control over medicine.  I have already alluded to many on these implications on this blog including treating knowledge workers like production workers and creating an unhealthy work environment that results in a lack of empathy for the patients being treated.  But there are even larger implications.  Financial services industry friendly legislation has probably been the single largest contributor to the idea that the privacy of individuals is relative to the advantages gained by establishing credit reporting.  Credit reporting agencies were born out of the idea that data could be collected under a Social Security Number and released to any financial institution without the consent of the person behind that SSN.  That single idea violated a previous promise by Congress that SSNs would not be used as any type of national identifier and was single handedly responsible for creating a multi-billion dollar industry that basically buys and sells credit information and the identity theft industry - both the criminal side and the services to protect people from the criminals.  It is much harder to be an identity thief in a world that does not have credit information centralized on a SSN.

The driving force behind businesses everywhere is to create leverage that results in people needing to buy a product or service and make it so they can't get it anywhere else.  We hear a lot about competition and its importance in capitalism, but there is plenty of evidence that capitalism is not only lacking but that measures are often in place to severely restrict it.    It results in an industry that is set up to optimize gain from consumers while keeping them all at risk.  As an example, one of the "low risk" strategies for investing with some of these companies is to investment in index funds.  As retirement nears, the recommendation can be to put funds into an annuity or with an advisor who can determine withdrawal rates, reallocation, and future investment decisions.  In many cases the retiree is charged up to 1% for that service on top of whatever service charges and transaction fees are associated with the funds that are invested in.  There is always the disclaimer that there is no guarantee of income from the account and this is compounded by the fact that interest on cash and money market funds is at an all time low.  Very few investors can fund their retirement by interest on so-called safe investments and in the last decade we have witnessed the first losses on money market funds.  All things considered, regulation at all levels seems like it is clearly set up to favor the financial services industry.  They have a license to warn you that you can lose money even though you may be paying them to protect it - and that's OK.  In some extreme examples, investment banks have recommended purchases to customer that they were actively betting against.

I don't know how many people can see the trend, but it is pretty obvious to me.  As medical information gets more like financial information - it moves farther away from any reality basis and it becomes a vehicle for manipulation.  The whole point of collecting data from a medical and scientific standpoint is to look at underlying meaning specifically implications for health care.  The best example is lab data.  If I look at a patient's CBC with differential count and chemistry profile,  I have about 40 data points, any one of which could have significant health implications for the care of that individual.  If I look at various quality markers and screening scores that are being collected for business purposes that data varies from questionable to clearly invalid and yet physicians are being held "accountable" for what is essentially business quality data.  In other words, data that has no scientific basis and can be manipulated for a specific result.  The usual intent is to maximize business profits and make it seem like the business is much more critical to the provision of health care than the health professionals it hires.  As absurd as that last sentence looks, it is without a doubt one of the goals of most health care businesses.

Business information collected and manipulated for the sake of furthering business interests in the health care industry is no more valid than  what happens in the financial services industry.  Both types of information have evolved to place the consumer at risk all of the time and give them no clear reason for a making a decision in their own interest.  And in both cases, consumers have no choice but to participate.  We have a government mandated retirement industry that provides a windfall to financial services.  We now have a government mandated health care industry that is set to provide a windfall the large health care and pharmaceutical companies.  In both cases it is underwritten by the American consumer who is placed at financial risk all of the time in an economy of stagnant wages and significant unemployment.

George Dawson, MD, DFAPA

Friday, March 21, 2014

Compassion Fatigue? Or Sometimes You Eat The Shark And Sometimes The Shark Eats You

I passed a pamphlet for a conference on Compassion Fatigue today and thought to myself: "Why haven't I ever encountered the term compassion in medical school or at any point in my medical or professional training?"  If you look it up in a real dictionary there seems to be multiple meanings ranging from:  "A feeling of wanting to help someone who is sick, hungry, in trouble, etc."  to "a feeling of deep sympathy and sorrow for another who is stricken by misfortune, accompanied by a strong desire to alleviate suffering."  None of these definitions seems to capture what happens in medicine and how physicians are trained.  It seems like an undisciplined emotional reaction to human suffering.  That may seem a bit calloused to someone outside the field but would you want your surgeon operating on you in the throes of an emotional reaction?  Would you want your internist or psychiatrist recommending  medication for you during an emotional episode?  On the other hand, depending on what part of the definition I focus on,  I have already pointed out that in my opinion the overprescribing of medications is motivated at some level by "a strong desire to alleviate suffering."  More evidence that compassion may not be the best basis for medical decisions.

I can still recall the first patient that I was responsible for.  The very first patient I evaluated on Internal Medicine as a third year medical student.  He was not much older than me, but at that point he had a much harder life.  As he explained his symptoms to me and we did the examination, I found myself getting more and more anxious.  I realized that he had a very serious illness that he was not going to recover from.  I pulled all of the test results and x-rays together so I could present it in our team meeting in the morning.  I could barely get the information out to my chief resident and attending.  I was overcome with emotion.  My voice cracked.  I was tearing up.  My head was spinning.  I was focused on how unfair life was.  He was a young guy, just like me with the usual hopes, dreams, and relationships that we all have and through no fault of his own, he had developed a terminal illness.  I certainly wanted to help him, but there was nothing that could be done.  That happens so frequently in medicine, using the most emotional definition of compassion would render most physicians nonfunctional.  It tends to alter your focus.  The focus has to be on what is happening right here and right now and not the unfairness of the process.  The focus needs to be on the technical details or you can't provide competent care and tell people what they need to know.  As I have gotten older, I have an image for the process of unpredictable disease and death.  It reminds me of the war movie where the fleet is sunk and everyone is bobbing in the Pacific Ocean wearing life preservers.  Suddenly the sharks appear and people start to die on a random basis.  Whoever the sharks decide to kill.  A random horrific process.  That is my image.

It may explain the reaction of one of my attendings when I was a resident on a busy inpatient psychiatric unit.  I was reading the description of one of our consultants to him and the consultant used the adjective "unfortunate" to describe all of the medical problems the patient had sustained.  My attending glared at me and said: "Why is he unfortunate?"  It seemed like an obvious descriptor to me.  Anyone with all of these severe medical problems could be described as unfortunate, but I could not respond to him at the time.  It seems to me if the sharks get you or there is a near miss, unfortunate in the bad luck sense may be a good description.  He may have been thinking of another definition.  But I think he was most likely giving me the message that it is best to not even recognize the random walk through life and the fact that the shark can eat you at any time.  Without that element of denial, how can you function?  How can you function as a physician?

After you have talked with thousands of people about their traumas and adversities, you realize that most people suffer.  Personal biases make some people want to alleviate the suffering of some more than others.  Nobody wants to see children suffer.  There are some people who attract the ill wishes of others.  They are generally unlikable or they have perpetrated some kind of shocking crime.  There seems to be a likeability bias with compassion and that also makes it less useful for physicians.  Physicians are obliged to perform competent medical care irrespective of how well the person is liked.  There are often errors on the side of people who are very likeable.  Sometimes physicians and medical staff get very attached to  person based on their personality, physical characteristics, or demeanor.  You may want to help that likeable person more, but that doesn't translate into whether you can or not.

If you are trained to render assistance, save lives when you can and alleviate suffering where does the compassion that you had before medical school go?  Without invoking defense mechanisms it gets converted to other things that are adaptive in the profession.  Empathy and technical skill are good examples.  Empathy is probably a more accurate emotional appreciation of what is occurring in a person you are trying to help.  It is focused on that person and their emotional state and if reflected back to that person they would agree with the observations.  A better measure of burnout for physicians especially psychiatrists would be empathy fatigue rather than  compassion fatigue.  Seeing people as collections of symptoms and having no appreciation for the emotional side of their experience would be one example.  Seeing patients as an endless stream of problems that you need to fix rather than unique individuals would be another.  As the days get longer there are also the comparisons physicians make about how much time they spend taking care of others compared to how much time they spend with their families.  As the family time gets shorter it may be harder to empathize with increasing numbers of patients.

Whether it is compassion fatigue or burnout, these seminars all seem to teach the same things.  It is fashionable to refer to the skills as "tools".  Mindfulness techniques, cognitive behavioral therapy. relaxation techniques, meditation, diet, sleep, and exercise are all parts of the "toolkit."  Nobody ever seems to address the severely deteriorated work environment as a cause and ongoing factor.  Productivity demands on physicians in terms of the number of patients seen, the amount of documentation that needs to be done and the other aspects of being a good corporate citizen are a recipe for burnout and that is probably the most common job scenario for physicians these days.  Professional organizations seem to ignore that fact that if physicians are going to function the way they should and treat the whole person, a work environment without adequate time to talk with patients in one of the fast paths to burnout.

No amount of "tools" can reverse that.

George Dawson, MD, DFAPA

Supplementary 1:  In talking with people over the years and trying to help them stay on the job, the most significant problem is unreasonable employers.  People work in jobs where the job directly impacts their health.  The best example is alternating shifts and never being able to establish a regular sleep routine.  Hospitals are some of the worst offenders.  They have adopted policies that allow them to tell nursing staff that they need to work "mandatory doubles" when there are shortages.  The policies that have hospitalists working 7 days on and 7 days off are no better.  I have interviewed hospitalists about their cognitive efficiency on day 6 and 7 and have been told that it generally plummets.  They are taking twice as long to do the documentation and it is difficult to think.  I was in a similar position one year when I was running a 20 bed inpatient service with assistance of a physician's assistant.  I had to see everyone, everyday and managed both the medical and psychiatric diagnoses.  When I decided to stop doing that, I was replaced by two full time psychiatrists and an internal medicine specialist to take care of all of the medical problems.  Eventually those two psychiatrists felt it was too much work and a third psychiatrist was added to cover 4 of the 20 patients.  The adverse effect of a business model on employee health that operates on personnel expenses cut to the bone can not be overemphasized.  Hospitals and clinics will happily work medical staff to the point that it adversely impacts their health and lifestyle, adversely impacts their cognitive abilities at work, leads to burnout, and leaves them in a state where empathy is a thing of the past.

The only reason I quit running a 20 bed inpatient unit by myself was a colleague of mine who told me he did it for years - right up to the point he had his first heart attack.


Thursday, March 20, 2014

Public Sector Mental Health Continues to Be Squeezed Out Of Business

There was a story that shocked many in the local press earlier this week.  A local mental health center serving about 3,000 people in five counties shut its doors, leaving nobody to fill that void.  Although this appears to be scandalous news, it is really the logical progression of events that has been accurately described in E. Fuller Torrey's book.  It is the logical result of federal and state governments selectively rationing mental health benefits and closing down both inpatient bed and outpatient treatment capacity.

People always ask me: "Well - what should an ideal community mental health center look like?"  That is easy for me to answer because I was trained in community psychiatry, my first job out of residency was as the medical director of a community mental health center (CMHC) , and most of my career has been focused on helping patients who are largely in the public sector or certainly funded by those resources (Medicare/Medical Assistance).  I know exactly what an ideal CMHC needs to run and provide services to a broad range of people who do not have access to metropolitan style mental health services.  The vignettes provided in this article will also be addressed in the following points.

1.  The backbone of any CMHC should be services that focus on people with disabling mental illnesses and helping them live independently.  In the state where my original CMHC was located, statutes defined these conditions as schizophrenia, bipolar disorder, schizoaffective disorder, major depression, and borderline personality disorder.  Adequate resources to treat those conditions generally means nursing and case management services that can meet with people in their homes and in the community.  In the teams that I worked with over 20 years ago we also had a vocational rehabilitation component and we worked with a number of physicians and specialists to address medical problems.  In any treatment setting where a CMHC is responsible for treating all public patients over a county wide catchment area, there is of necessity a legal component.  That is typically focused on involuntary treatment like civil commitment, court ordered medications, guardianships, conservatorships and protective placement.  Depending on the size of the county it can also involve competency assessments for ability to proceed to a court hearing based on concerns about mental illness.

2.  A community trained psychiatrist with medical skills.  The psychiatrist involved should enjoy working with people with people who have severe mental illnesses and medical comorbidity.  The legal component of services means that this person also needs to be comfortable doing the necessary exams and court testimony.  Medical and neurological illnesses need to be recognized and treated.  In CMHC settings the psychiatrist generally has much more information available about the health of his or her patients and they know how to interview people to get it.  When I was a medical director I also provided consultation to nursing homes, hospital consultations, and I would also travel to patient homes with case managers to provide consultation in that setting.  A lot depends on geography and distances to the other facilities needing consultation.

3.  Psychotherapists are critical to the functioning of a CMHC.  It has been interesting to watch the government and managed care companies ration psychotherapy services as much as they ration access to psychiatrists.  Correct me if I am wrong but as far as I know there are no HMOs or MCOs offering standard research based psychotherapies for psychiatric diagnoses.  At the max, usually 2 or 3 "crisis counseling" sessions.  In some cases a generic dialectical behavior therapy (DBT) group where many people with personality disorders end up because more specific therapy is unavailable.  CMHCs could be leaders in the implementation of computer based therapies, and the argument against that would be the lack of information technology departments.  The argument in support of this would be the fact that all counties across the state could share the same resource.  With today's tech, it would be  easily scalable to support anyone who needed it.  It would be inexpensive, effective and a good way to not dilute the psychotherapy resources of the clinic.  The other major change int he past two decades has been the focus on psychotherapy for people with severe mental illnesses.  That should be a critical part of any CMHC function.
4.  Addiction treatment - many communities have more resources available outside of the CMHC for assessment and treatment or referral of addictions.  The CMHC resources need to be more focused on the issue of co-occurring disorders and probably chronic pain and co-occurring disorders.  This would be another opportunity for networking all of the CMHCs in a state to assure a standard of assessment, share treatment resources, consult on specific cases and assure that there is no deterioration in prescriber standards with regard to potentially addictive medications.

5.  Crisis intervention services - 24/7 availability is necessary to provide acute evaluations but more importantly to resolve crises in patients who are well known to treatment teams.  Ity reduces the likelihood of unnecessary hospitalizations when there are staff person available who know the  person in crisis very well.  It is much more efficient and patient centered than sending a person to an emergency department and asking them to start over there with professionals who do not know them.

In the CMHC I worked in we had a catchment area of about 100,000 people spread over a large rural county.  We had a little over 100 patients in our community support programs for the severely disabled.  We we staffed by 1 psychiatrist, 2 psychologists, 4 social workers, 1 occupational therapist,  4 psychotherapists, 1 RN, and 2 LPNs.

The progression noted in this article is very clear and it has been replicated thousands of times across the US.  Shut down the large hospitals and tell people that treatment will be available in the communities near their homes.  Then shut down community treatment.  You will notice that officials make it seem like this is some kind of mystery.

“We’re so tight in [psychiatric] beds that any change in the delivery system impacts the whole system,” said Assistant Human Services Commissioner David Hartford. “The agencies need to reorganize to get people the care they need.”

Sorry Commissioner but in case you didn't notice we are not talking about beds anymore.  All of the people involved here were living at home in their own beds.  Agency "reorganization" is not an option.  There are no agencies anymore and one that was providing a valuable service was just shut down.  The problem here is very clear, cost shifting by managed care and defunding by the state.  Corporate welfare in the form of a carve-out for psychiatric services.  Keep in mind that when the comprehensive and humanistic approach to community treatment is lost, the only alternative is going in to a large managed care clinic where the appointments are scheduled every 15-20 minutes, the focus is on a prescription, and the only thing the doctor knows about what is going on is exchanged in that visit and recorded in the electronic health record.  That is frequently a symptom checklist. 

I guess there is always the psychiatric hospital of last resort - the county jail.  At least until the Sheriff's department goes broke.

George Dawson, MD, DFAPA

Christopher Snowbeck.  Crisis mental health provider closes; 5 counties scrambling.  St. Paul Pioneer Press.  March 18, 2014.

Chris Serres.  Minn. mental health center shuts down, stranding thousands.  Minneapolis StarTribune.  March 17, 2014.

Supplementary 1: I e-mailed the author of the first article Mr. Serres to inquire about the recently released state report that he refers to in the article and got no response.  As far as I can tell it may be the "Health Services in State Correctional Facilities Report" available at this site.  The concerning highlights include the fact that there are units that provide intensive nursing and mental health services.  About 33% (67,456) of all of the health services encounters with staff are for mental health purposes.  That translates to 28% of the offenders receiving mental health services.  At some point in their stay 32% are diagnosed with a "serious and persistent mental illness" as defined by state statute.  The report provides an interesting overview of how mental health services are provided in Minnesota prisons and the special problems involved in treating mentally ill offenders.

Supplementary 2: According  to Minnesota Statutes 2013, 245.462, subd. 20(c)(4)(i), states that a person has serious and persistent mental illness if he or she is an adult and “has a diagnosis of schizophrenia, bipolar disorder, major depression, schizoaffective disorder, or borderline personality disorder.”

Tuesday, March 18, 2014

Enduring Problems Of The Electronic Health Record

I think the national debate is coming back to the more reasonable position that the heavily hyped electronic health records (EHR) will not save up hundreds of billions of dollars due to "efficiency."  But then again again any physicians not working as an administrator hyping the EHR could have told you this based on their experience over the past 10 years.   If I had to think of a reason, I would imagine it is the companies trying to build a moat around their businesses.  Software engineering can't possibly be this bad.  Wall Street jargon considers moats or barriers to direct competition with a company to be a good thing.  Let me illustrate with a real world example.

Let's suppose you are working in a clinic that is not online with the largest managed care (MCO) company in your area.  The only way you can get electronic access is to pay a huge licensing fee, but in many cases the software company will not even accept that licensing fee.  It will just conclude that that you are not big enough to do business with them.  At any rate, you need electrocardiogram information on a patient from that MCO because you are looking at a new abnormal ECG on that patient.  You need to know if the pattern on that ECG is new or it has always been there.  You request the records from the MCO.  They fax you 50 pages containing the lowest possible amount of information per page.  There are two one line references in that 50 pages to an electrocardiogram.  One says: "Prolonged QTc" and the other says "Normal".  There is no graphic information (the tracing) and no numerical information (the intervals with the associated times in milliseconds, the machine read out).  So after the work put in by you and your staff to request this data, you have just read through 50 pages and found absolutely nothing useful.  A review of all of the pages shows scant information on each page.  As an example, one entire page contains a chest x-ray report, when it could easily be printed on an area 1/20th that size.  Some entire sheets contain 1 or 2 lab values of 3 to 5 digit numbers.

I am convinced that the multimillion dollar licensed legacy wide EHRs are designed this way.  There is really no other explanation for providing such an abundance of low to no information records.    Their intention is obvious.  Make sure everyone is using their system and at some point make sure that the government is forcing people to use somebody's system.  All physicians should be using electronic prescribing right?  It is only a matter of time before politicians mandate access and an extremely expensive portal will be required.

There was a time when the medical record was coherent.  Maybe I was spoiled by reading what sounded like fine literature by comparison.  There was one Cardiologist in particular who wrote incredible notes for consults.  Reading those notes gave you all of the medical information you needed and it also left the impression that you had just read something written by a highly intelligent person.  Somebody you probably wanted to have a conversation with.  Somebody you could learn from.

What has happened to the medical record leaves a bad taste in my mouth.  It reminds me of when an EHR consultant was showing me their latest time saving way to create a choppy, incoherent progress note, and sign off on a billing document at the same time.  She assured me that the "compliance people" would find it completely acceptable for billing purposes.  When she asked me what of thought of their system she seemed taken aback by my response.

"I would be ashamed to sign my name on that note."

That was about ten years ago and the electronic health record has not changed much since.  It will still kick out a phone book sized print out containing minimal to no useful information.

George Dawson, MD, DFAPA

Monday, March 17, 2014

Turning the United States Into Radioactive Dust

I don't know if you noticed, but it appears that the post cold war era is over.  The Putin appointed head of a Russian news agency Dmitry Kiselyov went on Russian television this morning and stated that Russia is "the only country in the world capable of turning the USA into radioactive dust."  In case anyone wanted to dismiss that as being short of a threat, he went on to say the President Obama's hair was turning gray because he was worried about Russia's nuclear arsenal.  We have not heard that kind of serious rhetoric since the actual Cold War.  As a survivor of the Cold War, I went back and looked at what time period it ran for and although it is apparently controversial the dates 1947 to 1991 are commonly cited.  I can remember writing a paper in middle school on the doctrine of mutually assured destruction as the driving force behind the Cold War.  In the time I have thought about it since, some of the cool heads that prevented nuclear war were in the military and in many if not most cases Russian.  We probably need to hope that they are still out there rather than an irresponsible broadcaster who may not realize that if the US is dust, irrespective of what happens to Russia as a result of weapons, the planet will be unlivable.

I am by nature a survivalist of sorts.  And when I detect the Cold War heating up again I start to plan for the worst.  The survivalist credo is that we are all 9 meals away from total chaos.  So I start to think about how much food, water, and medicines I will have to stockpile.  What king of power generation system will I need?  What about heating, ventilation and air filtration?  And what about access?  There are currently condominiums being sold in old hardened missile silos, but what are the odds that you will be able to travel hundreds of miles after a nuclear attack?  If you are close to the explosion there will be fallout and the EMP burst will probably knock out the ignition of your vehicle unless you have the foresight and resources to store it inside a Faraday cage every night.  There is also the question of what happens to the psychology of your fellow survivors.  In the post apocalyptic book The Road - a man and his son are surviving in the bleakest of circumstances on the road.  We learn through a series of flashbacks that their wife and mother could not adapt to the survivalist atmosphere and ended her life.  In one scene, they meet an old man on the road and the man gets into the following exchange with him after the old man says he knew the apocalyptic event was coming.  It captures the paradox of being a survivalist (pp 168-169):

Man:  "Did you try to get ready for it?"
Old Man:  "No.  What would you do?"
Man:  "I don't know"
Old Man:  "People always getting ready for tomorrow.  I didn't believe in that.  Tomorrow wasn't getting ready for them.  It didn't even know they were there."
Man:  "I guess not."
Old Man:  "Even if you knew what to do you wouldn't know what to do.  You wouldn't know if you wanted to do it or not.  Suppose your were the last one left?  Suppose you did that to yourself?"

By my own informal polling there are very few people who want to unconditionally survive - either a man-made or natural disaster.  Many have told me that they could not stand to be in their basement for more than a few hours, much less days or months or years.

For the purpose of this post, I want to hone in on the rhetoric or more specifically the threats.  I have had previous posts on this blog that look at how this rhetoric flows from the history of warfare and dates back to a typical situation with primitive man.  In those days, the goal of warfare was the annihilation of your neighbors.  In many cases, the precipitants were trivial like the theft of a small number of livestock or liaisons between men and women of opposing tribes.  In tribes of small numbers of people, even when there were survivors if enough were killed it could mean the extinction of a certain people.  Primitive man seemed to think: "My adversaries are gone and the problem is solved."

Over time, the fighting was given to professional soldiers and it seemed more formalized.  There were still millions of civilian casualties.  I think at least part of the extreme rhetoric of Kielyov is rooted in that dynamic.  Many will say that is is propaganda or statements being made for political advantage and in this case there are the possible factors of nationalism  or just anger at the US for some primitive rhetoric of its own.  But I do not think that a statement like this can be dismissed without merit.  There were for example two incidents where Russian military officers exercised a degree of restraint that in all probability prevented a nuclear war.  In one of those cases the officer was penalized for exercising restraint even though he probably avoided a full scale nuclear war.  In both cases the officers looked into the abyss and realized that they did not want to be responsible for the end of civilization as we know it.

I don't think extreme rhetoric is limited to international politics.  It certainly happens with every form of intolerance at one point or another if that intolerance is rooted in race, religions or sexual preference.  That is especially true if there are physical threats and physical aggression.  Intolerant rhetoric can also occur at a more symbolic level.  We have seen extreme rhetoric on psychiatry blogs recently.  Rather than the annihilation of the United States, the posters would prefer the annihilation of psychiatry.  I would say it is a symbolic annihilation but it is clear that many of them want more than that.  It still flows from the sense of loyalty to tribe, the need to annihilate the opponents, the necessary rigid intolerance and the resulting distortion of rational thought.  Certainly self serving bias exists to some extent in everyone, and it may not be that apparent to the biased person.  It took Ioannidis to open everyone's eyes to that fact in the more rational scientific world.  It can serve a purpose in science where the active process often requires a vigorous dialogue and debate.  Sometimes people mistake science for the truth when science is a process.  In order for that dialogue and debate to occur in an academic field there has to be a basic level of scholarship in the area being debated.  Without it there is a digression to tribal annihilation dynamics and complete intolerance.  That is counterproductive and negates any legitimate points that the proponents might otherwise have.

In science, the risks are lower.  At the minimum it adds nothing to the scientific debate.  An irrational bias with no basis in reality is the most primitive level of analysis.  In the 21st century, nobody needs to be annihilated in reality or at the symbolic level.

George Dawson, MD, DFAPA

Cormac McCarthy.  The Road.  Vintage Books.  New York, 2006.

Sunday, March 16, 2014

Persecutory Delusions, Psychiatric Treatment, and Violence Prevention

For 23 years I ran an acute care inpatient service where the main focus was preventing violence and suicide.  That is the default function of inpatient units these days and it has been decided  by businesses and governments rather than organized psychiatry.  Organized psychiatry used to take an interest in quality care in hospitals but it has largely been abandoned to the hospitals and organizations that run them.  The regulatory bodies for inpatient care tend to focus on a number of parameters that are irrelevant to quality care.  With such a fragmented regulatory and administrative approach, the focus on quality of care depends solely on the personnel on each unit and how well they work together as a team.  The majority of patients are admitted these days because of concerns about aggressive behavior and suicide.  In my experience, good inpatient teams are highly successful in assessing and treating those problems.

One of the key treatment interventions is determining the people with the highest risk potential for the most intensive treatment interventions.  The treatment outcomes in terms of averting aggressive and suicidal behaviors are generally good.  Given the relatively rare occurrence of aggression or suicide post discharge the actual power of the treatment intervention is unknown.  The potential severity of outcomes precludes any placebo controlled clinical trials.  No human subjects committee would authorize a placebo arm and since many patients are on involuntary status or court holds.  No probate court judge would go along with it either.

The March 2014 edition of the American Journal of Psychiatry has some the most most extraordinary content I have ever noticed in that publication.  Among the articles is a paper called "Association of Violence With Emergence of Persecutory Delusions in Untreated Schizophrenia".  It adds significantly to the literature on psychosis and violence.  The study focuses on the United Kingdom Prisoner Cohort Study and it looked at risk factors for future violence in prisoners who were incarcerated for a violent crime after they were released.  It is a study that could be done on patients who were acutely hospitalized and released because of the naturalistic design and use of nonviolent participants as a comparison group.  That authors were interested in looking at whether the presence of psychosis predicted future violence and if there was any specific pattern of symptoms.  They were also interested in looking at the issue of whether or not treatment was helpful.

The sample consisted of 1,717 prisoner screened at baseline and 967 followed up (787 men and 180 women).  Selection was based on incarceration for at least 2 years for a violent crime and release date within 12 months of the start of the study.  All participants were given a number of structured research assessments to establish diagnosis.  At follow up, the diagnoses of the patients in the study included 94 meeting diagnostic criteria for schizophrenia, 102 for drug induced psychosis, and 29 for delusional disorder.  Only the subgroup with schizophrenia scored higher on psychopathy scores.  Violent behavior at follow up was established by self-report and a national computer police database that classified violence against persons.  According to that database 22.9% of participants were violent between release and follow up (mean 39.2 weeks).

 In terms of the relevant results, the delusional disorder and drug induced psychosis subgroups were no more likely than the the participants without psychosis to be violent at follow up.  Persons with untreated schizophrenia were more than three times as likely to be violent that the non-psychotic participants at follow up.  In that group those with persecutory delusions were more likely to be violent than those with other symptoms of psychosis.  The authors briefly review the indirect evidence supporting their findings including treatment non-adherence and risk of violence, risk of violence at first presentation of treatment rather than subsequent episodes, and psychosis as a risk factor for violence.  They point out that to their knowledge this is the only study of violent recidivism in prisoners that looks at the issue of psychosis as a risk factor.

The actual treatment provided in this case was critical.  In terms of violence prevention any treatment provided in prison only or in prison and on release was effective in preventing violence.  They point out that identification of more people needing treatment by their study methodology may have led to more active treatment of study participants.  They quote data on that fact that in prisons in the UK only about 1/4 of prisoners with severe mental illnesses are identified by mental health teams with that specific function and that of those identified only 13% are accepted into case management.  Overall in the UK less than 1/4 of prisoners who screen positive for psychosis are given a mental health appointment at the time of discharge.

The accompanying editorial by Large is interesting in reviewing the issue of screening versus not screening populations for psychosis and whether that prevent violence.  Several studies have concluded that "risk assessment is insufficiently sensitive to provide a basis for protection of the public."    Without looking at all of the references (I would expect to find significant flaws) the issue is really not a screening issue.  This study happens to appear like it is a screening, but the diagnostic approach is probably much more vigorous than most assessments in correctional settings.  The issue is that you have a person sitting in front of you telling you that they have persecutory delusions and are at risk for continued violence secondary to those delusions.  There is also a significant subgroup who are at personal risk for self harm related to these delusions that the authors either did not find or they did not comment on.  The Large commentary also focuses on antipsychotic medication as the treatment for psychosis and in the UK psychotherapy is also a treatment modality.  He makes the observation that treatment across the entire spectrum is important in that less treatment in the currently treat group will also result in more violence.

This study is useful in the US for several reasons.  County jails have become the largest psychiatric hospitals in the United States largely as a result of government and business policy.  Inpatient units may be useful for acute violence but there is an uneasy relationship with county jails.  Hospital policy may result in suicidal and acutely aggressive psychotic patient being treated in jail settings and using methods that would be seen as completely inappropriate in a medical or psychiatric setting.  Psychiatric follow up in jail settings is often fragmented and it is not uncommon to see medical treatment started and stopped based on the availability of medical staff or prescription medications.  I would consider the UK to be much more enlightened with regard to mental health policy than the US and to have more medically based resources for anyone with a psychosis diagnosis.  I can't imagine follow up numbers from American jails being any better than they are in the UK.

All of this creates a problem for the person with psychosis, persecutory delusions, and violent behavior.  The focus of much of the literature seems to be protecting the public from them but when you are their treating psychiatrist the arguments you are making to them is to protect them from their delusional thoughts.  That will not happen in a rationed, carved out environment that has shifted progressively more care for the severely mentally ill to correctional settings.  The other interesting  cultural phenomenon is that there is no coverage of this study or similar studies in the press.  Their bias seems to be to look at the sensational results of psychosis associated violent crime,  suggest that more treatment might be needed, attribute causation to being in the wrong place at the wrong time, and suggest that we all need to move on (lurch forward?) toward the next catastrophe.

This study provides a platform for a better approach to public policy and a more patient centric approach to violence prevention.

George Dawson, MD, DFAPA    

1: Keers R, Ullrich S, Destavola BL, Coid JW. Association of violence with emergence of persecutory delusions in untreated schizophrenia. Am J Psychiatry. 2014 Mar 1;171(3):332-9. doi: 10.1176/appi.ajp.2013.13010134. PubMed PMID: 24220644.

2:  Large MM. Treatment of psychosis and risk assessment for violence. Am J Psychiatry. 2014 Mar 1;171(3):256-8. doi: 10.1176/appi.ajp.2013.13111479. PubMed PMID: 24585326.



Monday, March 10, 2014

Satanic Ritualistic Abuse - Revisited?

Mickey Nardo, MD on his 1 BoringOldMan blog has been writing a lot about the issue of satanic ritualistic abuse or SRA as it has been abbreviated.  His key reference is an article in the Psychiatric Times by Richard Noll, PhD entitled When Psychiatry Battled the Devil.  Dr. Nardo details the fact that the original paper by Noll has been pulled apparently out of concerns about litigation.   I luckily printed it out and will add a different perspective to Dr. Noll's invitation to discuss the moral panic.

It was about 1989 and the era of satanic ritualistic abuse was born.  I was in the middle of running a public health clinic on the northern fringe of the United States at the time and did not see any cases until I moved south to the Twin Cities (Minneapolis-St. Paul, MN).  Showalter documents how the stories spread in the media until there was a fairly standard description of women "... forced to kill and eat babies at satanic ceremonies, about seeing children dismembered boiled an burned, about being drugged, tortured with cattle prods, branded with branding irons, raped with crucifixes and animal carcasses....." (p. 172).  As the stories intensified prosecutions occurred in some areas based on these stories.   After all, the alleged magnitude of these rituals would have left a significant amount of eye-witness and physical evidence.  But it turned out that was never found.  There were parallel phenomena of false prosecutions based on these accusations and ultimately malpractice cases against therapists making the diagnosis and proceeding with treatment on the basis of traumatic events that had never occurred and seemed to be introduced as a result of the therapy.

I started to see the initial traces of the multiple personality epidemic at my new job, and recall two distinct reactions from psychiatrists involved with these folks.  But before I get into that, a little background about psychiatric interviewing is in order.  In this era of rapid checklist diagnoses, it may be difficult to believe that psychiatrists are actually trained to interview people and question what they hear.  The questions naturally come up for a number of reasons.  The first has to do with how accurate the patient seems to be able to recall the history.  That leads to associated questions about any inability to recall the history. The second has to do with common distortions that patients have in their perception of reality.  Those distortions may occur at a neurotic or a psychotic level of consciousness.  In the initial interview the focus is on understanding the patient's mental state to the point that if it was repeated back to the person they would agree with the interpretation.  That interview process can be interrupted for any number of reasons along the way, ranging from cognitive disorganization to paranoid psychosis and aggressive behavior.  It is important to keep in mind that the interview is a dynamic process that has elements far beyond a checklist or list of symptoms in DSM-5.  Reading about confabulation is not the same thing as having assessed hundreds of patients with that problem.  That assessment flows from the initial question in the mind of the psychiatrist: "Is this confabulation?' and noting all of the features in the interview situation to support or refute that question.

Of the psychiatrists I was affiliated with at the time, a few believed that there was such a diagnostic entity as dissociative identity disorder but the majority (as in >90%) did not.  The psychiatric literature as early as 1988 doubted the existence of the disorder and suggested that it was iatrogenic. I can recall a journal club discussion we had about a British Journal of Psychiatry article that was not only skeptical of the diagnosis but suggested that it was iatrogenic.  It seemed like a geographically based movement and in order to make the diagnoses and treat people you had to be trained by very specific people.  Even though the diagnostic criteria were fairly straightforward it seemed like you needed the attend the appropriate seminars in order to make the diagnosis.  You definitely did if you expected to proceed with treatment and even then it was unclear about how much additional training was necessary.  I had the impression that most people affected had moderate to severe personality disorders and they could be approached using standard techniques.  That approach was highly successful in stabilizing people in acute care and transitioning them to outpatient settings.  The diagnosis could be reinforced by the time patients presented to a tertiary care center.  Any hint of skepticism on the part of the attending physician could precipitate intense reactions if the patients thought they were not believed.  That usually threatened any therapeutic relationship, created staff splitting, and great pressure on psychiatrists to accept the diagnosis and whatever the current treatment plan was at the time.  There was also the novelty of the diagnosis that held a certain fascination for anyone who could not see that there was more heat than light.

At the time I was dutifully reading was volume of the Annual Review of Psychiatry and completing the CME questions.  Volume 10 had an entire section on Dissociative Disorders with some optimistic introductory lines (p 143):

"Dissociation is here to stay.  The chapters that follow indicate there is a growing body of clinical observation and research documenting the prevalence, phenomenology, psychophysiology, and treatment of dissociation."  

What happened instead was a flattening of publications as indicated by this Microsoft academic search and the end of a specialty journal (click to enlarge)

Despite the solid review that SRA  probably did not exist, some bizarre reports began to surface.  According to Elaine Showalter's book  Hystories: hysterical epidemics and modern media:

"....almost half the patients.......were "reporting vividly detailed memories of cannibalistic revels and extensive experiences such as being used by cults during adolescence as serial baby breeders for ritual sacrifices."

My position on the subject has always been the position quoted by Elaine Showalter in her excellent book Hystories: hysterical epidemics and modern media.  That position is all of these events never happened.  But I took it one step further.  Near the end of the decade, I contacted the author to see if she had any updated information.  She did not and so I put in a Freedom of Information Act request for all of the information suggested in the book - specifically the results of of the investigations by Kenneth V. Lanning, then Special Agent of the FBI Behavioral Science Unit in Quantico, Virginia.  I have previously listed problems with FOIA requests to the FBI and this was no exception.  I was looking for the results of 300 case investigations that were all negative.  After sending in the request through proper channels I was told that the information did not exist.  In the 2000s, that  report surfaced on the Internet, but it is still difficult to find a reliable copy.

I invite any reader to place themselves in the position of interviewing a person making claims, like the statements made in paragraph two of this post.  Keep in mind that these patients are generally talking about local geography that everyone is aware of and the descriptions involve fairly massive abuse and homicide of large numbers of people.  Even an untrained interviewer should have a degree of skepticism based on the fact that there have not been large numbers of missing persons and when these reports invariably get to local law enforcement, no hard evidence of a crime can be found.  The reports did create considerable confusion among family members, prosecuting attorneys, inpatient staff and some psychiatrists but in the end even the psychiatrists who thought the SRA phenomenon was real realized that it was a distortion.

In answer to the idea that this era needs to be "reopened" I guess it depends on the intent.  If the intent to illustrate once again that some or all psychiatrists are fools - there is more than enough propaganda out there already for the detractors of psychiatry to use.  My perspective is that not only were the vast majority of psychiatrists not fooled by this phenomena there were articles at the time accurately describing the problem as a non-specific diagnosis and an iatrogenic problem and what to do about it.  I would also question the applicability of the term moral panic.  The phrase seems a bit too strong.  It could apply in very small areas, but the majority of people in any community were generally unaware of the stories that were being told to psychiatrists in that era.  If people were aware there would have been a larger buzz created by the media asking clinicians for examples and an analysis of the event.  I suppose it would have been interesting to see what the local investigative news team found out if they were directed to a site where ritualistic abuse was alleged to have occurred.  I would also not forget that in the majority of cases there were no attempted prosecutions.  I think the moral panic was forgotten because for most people it was under their radar rather than a cataclysmic event like the Influenza Pandemic of 1918 where people were dropping dead in the streets.  There were also psychiatrists at the time who investigated the issue of repression and false memory syndrome and became an asset to families affected by the hysteria.  I would Showalter's book for a good discussion of the cultural determinants of the problem (there were many).  If the suggestion is to reopen the issue with the appropriate perspective that it was a controversial and erroneous phenomenon that in some cases hurt individuals and families rather than a moral panic, that mistakes were made, and for the purpose of teaching appropriate evaluations and interviewing technique, then I am all for it.  In addition to diagnostic issues, the area of dissociation and trauma in general also have treatment implications.  Psychiatric residents need to know how to plan and conduct therapy on affected individuals, particularly since the main part of that treatment does not involve medications.  They also need to know how to interview people without introducing artifacts as part of the interview process.

If the Psychiatric Times has pulled the original article, it probably makes sense to write a book or a review article for a journal less concerned about litigation.  There are a number of public access online journals that I am sure would be willing to publish the article and probably consider a theme issue on the topic.

George Dawson, MD, DFAPA

Elaine Showalter.  Hystories: hysterical epidemics and modern media.  Columbia University Press.  New York, 1997.

Merskey H. Multiple personality disorder and false memory syndrome. Br J Psychiatry. 1995 Mar;166(3):281-3. PubMed PMID: 7788115.

Piper A Jr. Multiple personality disorder. Br J Psychiatry. 1994 May;164(5):600-12. Review. PubMed PMID: 7921709.

Supplementary 1:

From Merskey 20 years ago:

"It has been all right to treat patients on the basis of dynamic notions of repression so long as the concept was only one which was exchanged between therapist and patient and merely served to revise, in a positive fashion, the patient's view of himself or herself in the world. Using repression as an idea which works to the detriment of other people, disrupts families, wipes out the life savings of parents, abolishes their contact with children and grandchildren, and embroils some in painful legal battles, is another matter altogether and not compatible with the old principle "first do no harm"."

From  Piper 20 years ago:

"However, there is a profound difference between standard psychiatric interview procedures -where practitioners take great care not to bias patients' reports-and the techniques and treatment espoused by the leading contributors in the MPD field.  It is absurd to maintain that those techniques are not vehicles of grossly overt suggestion to patients.  It is equally absurd to believe that in any other branch of psychiatry, one would see a clinician prodding a schizophrenic patient to produce more voices, or taking part in a 4 hour interview with a patient who might possibly be bulimic to suggest more frequent binging."

Supplementary 2:   To this day I have not been able to locate a copy on any FBI report describing the investigation of 300 case reports of alleged SRA  activity.  My FOIA experience with the FBI is very negative and it is clear to me that if they don't want to give you information you will not get it.  If anyone has this report consider sending me a copy.

Supplementary 3:  The Psychiatric Times decided to publish an edited version of Nolls original article today.  That is certainly the preferable course.  Their rationale:

"Editorial Note: In light of the responses we have received regarding this article by Richard Noll, PhD, that was posted on our website on December 6, 2013, the article has been reposted with a modification. Additionally, we are posting responses from certain of the individuals mentioned in the article and from Dr. Noll in order to leave analysis of the article up to our readers"

Sunday, March 9, 2014

Pharmacosurveillance, Suicide and Antidepressants

I was board certified in geriatric psychiatry initially in 1991 and have been a member of the American Association of Geriatric Psychiatry since then.  Members receive the American Journal of Geriatric Psychiatry.  Treating depression in geriatric patients is a a very rewarding experience for psychiatrists because depression often masquerades as a severe medical problem like dementia, chronic pain, or Parkinson's disease.  Treating the underlying depression clears the manifestations that appear to be these other illnesses.  Even pure depression in an elderly patient can lead to significant medical compromise because of diminished physiological reserve and rapid compromise of nutrition or mobility as the result of sleep deprivation and inadequate intake.  That can occur as the result of discontinuing long standing antidepressant maintenance therapy.  The elderly also have some of the highest rates of completed suicide and that also factors in decisions about maintenance antidepressant treatment as well as effective psychosocial interventions to address that problem. 

In the January edition of the AJGP, Erlangsen and Conwell look at the relationship of completed suicide and antidepressant redemption in a nationwide cohort in Denmark.  The methodology of this study is not available in the United States.  Denmark has several registers based on a unique personal identifier for all of its citizens.  The authors looked at the Register of Medicinal Product Statistics and suicide as a cause of death in the Registry of Causes of Death for a cohort of people who were 50 years of age or older on January 1, 1996 through December 31, 2006.  Data on antidepressant use was identified and classified into tricyclic antidepressants, selective serotonin reuptake inhibitors and other types of antidepressants.  A treatment episode was considered to have occurred if a second prescription of antidepressants was filled and the patient appeared to be taking 0.75 tablets per day.

In terms of sheer number the study included 1,22,941 men and 1,346,973 women.  In the follow up period deaths by suicide numbered 3,061 men and 1,456 women.  As illustrated by Figure 1. below there is a decreasing number of those dying by suicide who redeemed antidepressant prescriptions.  In the 80+ year olds it was less than one in four women and less than one in eight men.  Trends were noted that percentage of men and women dying of suicide who took antidepressants decreased with increasing age.  This data is consistent with previous data that show that most elderly patient die by suicide are not in treatment at the time and they have clinically significant symptoms of depression.         

 (graphic removed by copyright manager - please see the original article)

This study is a good example of what kind of data is available with large databases across entire populations.  The limitations of the data are discussed by the authors including the fact that the pharmaceutical registry does not have any diagnoses and antidepressants have numerous indications.  They discuss why antidepressant redemption may not be the optimal proxy for antidepressant use.  In this case their study design considering only people who have redeemed the second antidepressant prescription to be in treatment.  That contrasts with some data suggesting the highest risk for suicide may occur in the initial days or weeks of antidepressant treatment.  They point out the usual qualification about association versus causality, but also conclude that "it is possible that antidepressants protect the oldest old from death by suicide" and point out the important public policy question of how to identify these patents.

There is a similar interesting study available that looks at a database that includes 3/4 of the population of the Netherlands (see reference 2).  It looks at the correlation between antidepressant use and both suicide and violence and concludes that there are significant negative correlations with both.  In other words increased antidepressant use led to decreased rates of suicide and violent behavior over the years 1994-2008.

When I read this study, I was also interested in what medical specialty is prescribing the bulk of the antidepressants.  I e-mailed one of the authors and asked that question.  The response was that the specific specialty of the prescriber was unknown but that bulk of antidepressants in Denmark were prescribed by primary care physicians and the likelihood of antidepressant prescription by primary care increases with patient age.  Psychiatric consultation was more likely to occur at a younger patient age.

In the United States we need pharmaceutical registries similar to the Danish registry.  We need a more factual basis to evaluate issues of pharmaceutical use over time, complications of prescription drugs, over prescription of drugs, and adequate drug utilization.  For example, with the recent concerns about stroke risk factor reduction in the elderly and stroke risk reduction from atrial fibrillation graphs similar to Figure 1. looking at all of the relevant medications may prove very useful.  Practically all pharmacy data in this country is proprietary and the largest database was developed to see if pharmaceutical representatives were having an impact on prescriptions written by individual physicians.  The  current development by individual states focused on the prescription of controlled substances is an opportunity to expand that data to identify important public health trends and reduce speculation.

George Dawson, MD, DFAPA

Figure 1. is reprinted from Am J Geriatr Psychiatry 2014 Jan; 22(1) Erlangsen A, Conwell Y. Age-related response to redeemed antidepressants measured by completed suicide in older adults: a nationwide cohort study, with permission from Elsevier. 

1:  Erlangsen A, Conwell Y. Age-related response to redeemed antidepressants measured by completed suicide in older adults: a nationwide cohort study. Am J Geriatr Psychiatry. 2014 Jan;22(1):25-33. doi: 10.1016/j.jagp.2012.08.008. PubMed Central PMCID: PMC3844115

2:  Bouvy PF, Liem M. Antidepressants and lethal violence in the Netherlands 1994-2008. Psychopharmacology (Berl). 2012 Aug;222(3):499-506. doi: 10.1007/s00213-012-2668-2. Epub 2012 Mar 7. PubMed PMID: 22395429; PubMed Central PMCID: PMC3395354

Tuesday, March 4, 2014

Can You Trust Your Physician?

I could not help but respond to the Psychiatric Times article with the same title that they e-mailed me this morning.  Trust in an interesting concept when you live in a country that is politically managed for laissez faire capitalism and the only protection that the average citizen has against various cartels is caveat emptor.  The vocal irrational biases against psychiatry should discourage blind trust of psychiatrists even further.  Early in my career, I stayed away from any interpretive approaches to a lack of trust and took a simple cognitive behavioral therapy (CBT) approach.  That goes something like this: "I don't think there is any basis for you to trust me or not trust me.  I would encourage skepticism and taking a look at what I actually do for you.  If you find the recommendations, discussions and treatments that I recommend are useful, that is more clearcut evidence that I might be helpful to you.  If not, certainly let me know and we will figure out what to do  about it".  Many of the people I have worked with over the years who had "trust issues" have found that to be a useful approach.

In reading the article, I find out that it is about the legal requirements involved in informing women about abortion. specifically the fact that in some states physicians are now required to tell women that a fetus will feel pain as it is aborted.  Additional states require women to pay for an ultrasound evaluation and view the fetal image before the abortion, advise women that abortion leads to an increase in breast cancer, and refer women for counseling after advising them that an abortion places them at risk for adverse mental health consequences.  The authors cite the scientific evidence to the contrary in all cases.  Can you trust a physician who is reciting abortion law boilerplate when they are advising you about that procedure?  Probably as much as you can trust a physician doing a safety assessment in a situation where they are prohibited by state law from discussing firearms that the patient may have at home.

 I don't think anyone should be surprised about the lack of science involved when politicians decide to manipulate physicians to do their bidding.  I currently live in one of the most liberal states in the United States and every year I get a letter informing me of the number of abortions performed every year and reminding me of my obligation to report if I perform an abortion.  It is a state law that all physicians receive this letter, even if they are psychiatrists who don't do any surgical procedures.  The intent of the letter is to clearly intimidate physicians into not performing abortions.

To quote the downside from the authors:  "These politically motivated laws undermine the concept that medical decision-making is based on scientific evidence. They force physicians to act as agents of the state government rather than put their patients’ interests first. They are intended to intimidate women so that they will not have abortions. They are corrosive to honesty in the physician-patient relationship, interfere with the physician’s responsibility to the patient, and violate medical ethical principles."

I think that any reasonable physician would agree.  I have been pointing out for decades that physicians have been agents of the state for a long time.  Colluding with managed care and all of its governmental variations is a clear example.  The entire managed care manual on when to discharge people from hospitals and how to do that has nothing to do with science.  The entire concept that all medications in the same drug class are equivalent has nothing to do with science.  Practically all of the rationing that occurs by the government and managed care companies has nothing to do with science.  But it doesn't stop there.  All state statutes having to do with the duty to warn have nothing to do with science and more to do with where the deep pockets are located.  In the original case precedent the perpetrator was detained and interviewed by the police and released before the homicide.  It was a clear example of the failure of the police to protect the victim and yet that was spun into the responsibility of clinicians to warn potential victims.  How much legislation is out there to create work for trial attorneys?

I was at a conference a few years ago where hospice care was being discussed as the latest innovation in hospital care.  When I thought about how people are assessed and discharged from acute care hospitals my question seemed obvious:  "Since there are care managers forcing discharges, isn't there a potential conflict of interest if hospice care is seen as the fastest way to discharge somebody from a hospital?"  The result was dead silence, a moment of confusion ("He really didn't ask that question did he?"), and then I was ultimately ignored as the speaker moved on.  With all of the focus on what are really trivial conflicts of interest in psychiatry, think about that for a moment.  A care manager representing the business interests of the hospital, the MCO/ACO, and the political interests of the politicians interfering with the practice of medicine has options available to them with the potential to short circuit care and provide less intensive care than might be recommended by a physician.

I was in a clinic recently where I was given an impressively long list of exceptions to patient privacy.  I picked up one of my electrical engineering journals the other day and was warned about how the Internet of Things (IOT) will be collecting all sorts of data on the average citizen, but that the owners of the data (Google, Facebook, etc), hope that the average citizen will see the worth in all of this information being in their hands.

Turning over all of this information and power over to the political and business classes is an obvious mistake.  Eliminating what has been described as a mandarin class - the physicians is another.  Unfortunately physicians and their professional organizations are completely inept at dealing with this problem and we are left with these inappropriate political intrusions and physicians acting like agents of the state and business cartels.

That means that politicians will not only try to manipulate who is born based on their ideology, but more importantly who has access to medical care and the level of intensity and who dies.  It is happening right now and it should be a lot scarier than a fictional robot time-traveling back from the future.

Remember the CBT approach to your physician, your health plan and your insurance company and make sure they are doing what you want them to do and not what some politician or business manager wants them to do.

George Dawson, MD, DFAPA

Sunday, March 2, 2014

Cognitive Enhancement IS Cheating

One of my colleagues posted a recent commentary from Nature on how the idea of the smart pill has been oversold.  The basic theme of the commentary is that there is no good evidence that treatment of ADHD with stimulants improves academic outcomes.  The author reviews a few long term studies and contends that differences between the medication and placebo seem to wash out over time and therefore there is no detectable difference.  Her overall conclusions seem inconsistent with her view that:  "For most people with ADHD, these medications — typically formulations of methylphenidate or amphetamine — quickly calm them down and increase their ability to concentrate. Although these behavioural changes make the drugs useful, a growing body of evidence suggests that the benefits mainly stop there..."

A question for any cognitive psychologists out there - is it possible to improve your concentration and have that not improve learning?  I can't imagine how that happens.  If you go from not being able to read 2 pages at a time to suddenly reading chapters at a time, how is that not enhanced cognitive performance?  If you go from staring out the window all day and daydreaming to being able to focus on what the teacher is saying how will that not lead to an improved outcome?  The idea that improved attention - a central factor in human cognition will not affect anything over time suggests to me that the measures being used for follow up are not very robust or that this is a skewed sample of opinion.   

For the purpose of cognitive enhancement, the typical users are students trying to gain an edge by increasing their study time.  Anyone who has experienced college and professional school realizes that here is a large amount of information to be mastered and it is not presented in an efficient way.  I can never recall a professor who advised us of the important guideposts along the way or gave us any shortcuts.  The usual message is study all of this material in depth every day or you will fall behind.  That approach in general is consistent with gaps in the ability to study either through the normal course of life or the competition for intellectual resources by 3 or 4 other professors who regard their courses as important.  That typically results in a pattern of cramming for specific key exams.  Although I have not seen any specific studies, stimulant medications are generally used for this purpose and in many cases the use is widespread.  There is a literature on the number of college students who may be feigning ADHD symptoms in order to get a prescription and that number could be as high as 50% (4,5). 

What  about the issue of stimulants acting as a smart pill in people who don't have ADHD?  In the most comprehensive review I could find on the subject (6) the authors review laboratory studies and conclude that in those settings stimulants enhance consolidation of declarative learning to varying degrees, had mixed effects on working memory, and mixed effects on cognitive control.  On 8 additional tests of executive function, the authors found that stimulant medication enhance performance on two of those tests - non-verbal fluency and non-verbal intelligence.  They have the interesting observation that small effects could be important in a competitive environment.  Their review also provides an excellent overview of the epidemiology of stimulant use on campuses that suggests that the overall prevalence is high and the pattern of use is consistent with cramming for exams.  They cite a reference that I could not find (7) that was a reanalysis of NSDUH data suggesting that as many as 1 in 20 stimulant users may have a problem with excessive use and dependence.     

Getting back to the theme of the Nature commentary, it is ironic that the smart pill theme is being called into question when it was the subject of a Nature article years earlier advocating for the use of cognitive enhancement.  In that article Greely, et al come to the somewhat astounding conclusion: 

"Based on our consideration, we call for a presumption that mentally competent adults should be able to engage in cognitive enhancement using drugs."

They arrive at that conclusion by rejecting three arguments against this practice.  Those arguments include that it is cheating, it is not natural and it is drug abuse.  Their rejection of the cheating argument is interesting because they accept the idea that performance enhancing drugs (PEDS) in sports is cheating.  They reject that in cognitive enhancement claiming that there would need to be a set of rules outlining what forms of enhancement would be outlawed and what would not (e.g. drugs versus tutors).  To me that seems like a stretch.  I think that sports bodies select performance enhancing drugs as a specific target because it clearly alters body physiology in a way that cannot be altered by any other means.  There is also plenty of evidence that the types of PEDS are dangerous to the health of athletes and associated with deaths.  Their conclusion about drug abuse: "But drugs are regulated on a scale that subjectively judges the potential for harm from the very dangerous (heroin) to the relatively harmless (caffeine).  Given such regulation the mere fact that cognitive enhancers are drugs is no reason to outlaw them."   That is a serious misread of the potential addictive properties of stimulants and the previous epidemics that occurred when the drugs were FDA  approved for weight loss, the epidemic of street use in the 1970s and the current and ongoing epidemic of meth labs and methamphetamine use throughout much of the USA.

These authors go on to outline four policy mechanisms that they believe would "support fairness, protect individuals from coercion, and minimize enhancement related socioeconomic disparities."  At first glance these lofty goals might seem reasonable if society had not already had in depth experience with the drugs in question.  The clearest example was the FDA approved indication of amphetamines for weight loss.  What could be a more equitable application than providing amphetamines to any American who wanted to use them for weight loss?  The resulting epidemic and reversal of the FDA decision is history.  A similarly equitable decision to liberalize opioids in the treatment of chronic pain had resulted in another epidemic of higher lethality due to differences in the toxicology of opioids and amphetamines. 

The contrast between these two commentaries in Nature also highlight a couple of the issues about the way medical problems and treatment is portrayed in the media.  This first is that you can't have it both ways.  Quoting a researcher or two out of context does not constitute an accurate assessment of the science involved.   Some of the authors in the first commentary are high respected researchers in cognitive science and they clearly believe that cognitive enhancement occurs and it should be widely applied.  Nature or any other journal cannot have it both ways.  Am more realistic appraisal of the problem is addressed in reference 6.   The second issue is that in both cases the authors seem blind to the addictive properties of stimulants and they are ignorant of what happens when there is more access as exemplified by the FDA misstep of approving stimulants for weight loss.  Do we really need a new epidemic to demonstrate this phenomenon again?  Thirdly, all of this comes paying lip service to non - medication strategies for cognitive enhancement.  We can talk about the importance of adequate sleep - a known cause of ADHD like symptoms and if we are running universities and workplaces in a manner that creates sleep deprived states, the next step is reaching for pills to balance an unbalanced lifestyle.  The new rules for residency training are a better step in the right direction.  Fourth, college is a peak time for alcohol and substance use in the lives of most Americans.  These substances in general can lead to a syndrome that looks like ADHD.  It is highly problematic to make that diagnosis and provide a medication that can be used in an addictive manner.  It is also highly problematic to think that treating an addicted person with a stimulant will cure them of the addiction and yet it happens all of the time.

There is plenty of evidence to suggest that cognitive enhancement is cheating.   Much of my career has been spent correcting the American tendency of trying to balance one medication against another and using medications to tolerate a toxic lifestyle or workplace.  It does not work and the current group of medications that are being put forward as cognitive enhancers are generally old drugs with bad side effect profiles particularly with respect to the potential for addiction.

If you want safe cognitive enhancers that can be made widely available, they have not been invented yet.  

George Dawson, MD, DFAPA

1: Sharpe K. Medication: the smart-pill oversell. Nature. 2014 Feb 13;506(7487):146-8. doi: 10.1038/506146a. PubMed PMID: 24522583.

2: Greely H, Sahakian B, Harris J, Kessler RC, Gazzaniga M, Campbell P, Farah MJ.
Towards responsible use of cognitive-enhancing drugs by the healthy. Nature. 2008 Dec 11;456(7223):702-5. doi: 10.1038/456702a. Erratum in: Nature. 2008 Dec 18;456(7224):872. PubMed PMID: 19060880.

3: Feldman HM, Reiff MI. Clinical practice. Attention deficit-hyperactivity disorder in children and adolescents. N Engl J Med. 2014 Feb 27;370(9):838-46. doi: 10.1056/NEJMcp1307215. PubMed PMID: 24571756.  

4: Green P, Lees-Haley PR, Allen LM., III The word memory test and the validity of neuropsychological test scores. J Forensic Neuropsychol. 2002;2:97–124. doi: 10.1300/J151v02n03_05

5: Suhr J, Hammers D, Dobbins-Buckland K, Zimak E, Hughes C.  The relationship of malingering test failure to self-reported symptoms and neuropsychological findings in adults referred for ADHD evaluation.  Arch Clin Neuropsychol. 2008 Sep; 23(5):521-30.

6: Smith ME, Farah MJ. Are prescription stimulants "smart pills"? The epidemiology and cognitive neuroscience of prescription stimulant use by normal healthy individuals. Psychol Bull. 2011 Sep;137(5):717-41. doi: 10.1037/a0023825. Review. PubMed PMID: 21859174 

7: Kroutil LA, Van Brunt DL, Herman-Stahl MA, Heller DC, Bray BM, Penne MA. Nonmedical use of prescription stimulants in the United States. Drug and Alcohol Dependence. 2006; 84:135–143.10.1016/j.drugalcdep.2005.12.011 [PubMed: 16480836]