The Florida Psychotherapeutic Medication Guidelines

This month's Journal of Clinical Psychiatry has a lead article about medication guidelines for adults with major depressive disorder.  Is is an apparent function of the Florida Medicaid Drug Therapy Management Program For Behavioral Health.  It is hard to imagine a title with more inappropriate terms for what psychiatrists do with medications.  At least until I read the title of the article: "Florida Best Practice Psychotherapeutic Medication Guidelines (FPG) for Adults with Major Depressive Disorder."  Here is a little insight into what I have difficulty with.  Treatment with medications is not psychotherapy.  Psychotherapy almost always needs to accompany medication treatment at one level of intensity or another.  But providing medication alone is not psychotherapy.  That is an important distinction because one of the common misconceptions is that a medication will solve common life problems like interpersonal problems at work or home and it will not.  The second issue is the idea of medication "management".  As one of my colleagues used to say: "Pharmacists manage medications we treat patients".  The term should also be anathema to any psychiatrist who was around when billing and coding guidelines were invented.  The term came to mean 10-15 minute appointment that reduced psychiatric treatment to a brief discussion of a medication.  They were two of the lowest reimbursement codes in the coding scheme and they handily allowed psychiatric treatment to be split off from the rest of medicine and reimbursed at a lower rate.  And finally the term behavioral health.  This is a long standing business term to indicate a managed care environment with business supervision rather than a mental health environment with psychiatric supervision.  All of these terms suggest that managed care companies and the government have more to do with these guidelines than psychiatrists.

Sure enough, looking at the partners for this project the majority are behavioral health organizations or managed care companies followed closely by government organizations, other associations, and three psychiatry departments out of 24 organizations.  The article itself describes the process as being the result of a multistakeholder Florida Expert Panel.  The stakeholder word always makes me cringe.  Whenever I have seen it in medicine and psychiatry nothing good has ever come of it.  There are only two stakeholders in medical treatment - the physicians and the patient.  I can stretch that to the family if they are still actively involved.  I don't want to see anybody else in the room.

The  authors detail their rationale for yet another guideline.  They state:

"Notwithstanding the public health priority of MDD, as well as increasing public, academic.  and policy attention given to MDD, misdiagnosis or delayed diagnosis and failure to incorporate appropriate measurement based care are significant modifiable deficiencies in current practice."

If only that were true.  In a state where there is widespread PHQ-9 screening. the screening tool suddenly becomes the diagnosis.  Measurement based care suddenly becomes the collection of meaningless cross sectional scores from clinics all over the state listing a diagnosis of MDD.  If only real life worked like intensive clinical trials out to prove a hypothesis.

They go on to list several other reason for their guideline.  They cite the American Psychiatric Association (APA) guideline as a "conflation" of empirical evidence and expert consensus - suggesting that nothing is sacred about expert consensus and that the patients seen by experts may not be the same as patients seen by other physicians.  They suggest that guidelines derived from pharmacological trials may be limited by suggesting that they may have limited generalizability due to trail designs and conditions that rule out certain conditions, but don't discuss other problems in experimental design.  They discuss limited long term follow up and measurement of functional capacity as a limiting factors.  Given that the authors don't really intend to correct any of these criticisms it is difficult to see that as a rationale for the new guideline.  Instead they say that their consensus process was their overarching principle in writing the FPG along with providing guidance (especially to primary care physicians) to provide safe and effective treatment for depression.

The authors use a hierarchical approach to tiers of treatment without using an algorithm.  Level 1 is initial treatment and Levels 2, 3, and 4 are basically used if the initial levels of treatment are ineffective or not tolerated.  There are few surprises for any psychiatrist who is used to treating depression, especially referrals from primary care physicians.  Given the stated concerns about the biasing effects of clinical trials sponsored by pharmaceutical companies for specific FDA indications, there were not many qualifiers about the addition of an "atypical antipsychotic approved for major depressive disorder (ie. aripriprazole, brexpiprazole)" at Level 2.  Level 2 is basically a failure of Level 1 antidepressant monotherapy.  In fairness switching to another antidepressant monotherapy at Level 2 is a suggested option.  The clear concern that the authors have about second generation antipsychotics in their scheme is metabolic rather than neurological side effects.  I have found a significant number of neurological side effects from aripiprazole including Parkinson's syndrome, akathisia. and tardive dyskinesia from these medications.  Nowhere in the paper are the diagnostic skills listed as important for the physicians.  In the emphasis about measurement based care there are no rating scales for drug induced neurological disorders.  The question of safer augmentation strategies are not discussed.

With regard to the issue of weight gain as a medication side effect, a strategy listed is "select medications that have a low relative risk of weight gain and metabolic syndrome".  A couple of related issues come up including the fact that a significant number of patients walk into the clinic with high BMI, but they are there for the treatment of depression.  Should the diagnosis of obesity and/or metabolic syndrome be made and managed along with the depression?  What about the patients who gain significant weight on either aripiprazole or brexpiprazole?  They definitely exist. What about clinicians who have developed successful strategies for using atypical antipsychotics with minimal to no weight gain?

There are also the very common problems of insomnia associated with depression that does not resolve with antidepressant therapy and significant anxiety with or without panic attacks.  Major depression with psychotic features and major depression with mixed features were discussed as important variants and special interventions not commonly used in primary care were included like electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS).  It was acknowledged that lack of patient acceptance and availability of these treatments might result in using various medication combinations that may be less effective.  Vagal nerve stimulation was recommended as a level 4 treatment and I have serious reservations about that being effective for anyone.  

All in all the FPG is what I would expect from a collection of stakeholders, some of whom were listed as representatives of managed care companies.  Rather than have these stakeholders rehash strategies that have been around for 20 years, there was an opportunity to design a comprehensive system of care for patients with depression and there is no evidence that has happened.  There is a reason why people don't go in to psychiatry and some of those reasons don't bode well for the assumption that everyone in the system will now be doing comprehensive assessments like psychiatrists.  A system of mental health care designed by stakeholders could possibly develop state- of-the-art resources for neuromodulation (TMS, ECT, deep brain stimulation), sleep studies, monitoring the cognitive effects of depression and antidepressants, detoxification and addiction treatment, and reasonable inpatient and residential resources.  That same system would have designed in timely assessments of difficult problems like MDD with psychosis by psychiatrists.  Adequate numbers of psychotherapists or pilot programs looking at computerized cognitive behavior therapy for sleep, depression, and anxiety would be more useful that one or two crisis oriented sessions with no specific orientation.  A blanket statement about the utility of evidence-based psychotherapies without adequate numbers of therapists to carry it out is not helpful in any way.

We need system redesign by stakeholders, not stakeholders making more guidelines while pretending that they know something about quality.
    



George Dawson, MD, DFAPA

Synopsis:

If certain stakeholders in a system, have:

-all of the money
-all of the power
-sophisticated electronic health records that are set up more for administrative than clinical purposes.

They may have an obligation to design the system to optimize care rather than telling the people delivering the care what they can do in a poorly integrated system of rationed resources by applying strategies that are already well known.  

References:

1: McIntyre RS, Suppes T, Tandon R, Ostacher MJ,  . Florida Best Practice Psychotherapeutic Medication Guidelines for Adults With Major Depressive Disorder. J Clin Psychiatry. 2017 Jul;78(6): 703-713.

2: Ostacher MJ, Tandon R, Suppes T. Florida Best Practice Psychotherapeutic Medication Guidelines for Adults With Bipolar Disorder: A Novel, Practical, Patient-Centered Guide for Clinicians. J Clin Psychiatry. 2016 Jul;77(7):920-6. doi: 10.4088/JCP.15cs09841. PubMed PMID: 26580001.

3: Gartlehner G, Gaynes BN, Amick HR, Asher GN, Morgan LC, Coker-Schwimmer E, et al. Comparative Benefits and Harms of Antidepressant, Psychological, Complementary, and Exercise Treatments for Major Depression: An Evidence Report for a Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016;164:331-341. doi: 10.7326/M15-1813.

4: Qaseem A, Barry MJ, Kansagara D, for the Clinical Guidelines Committee of the American College of Physicians. Nonpharmacologic Versus Pharmacologic Treatment of Adult Patients With Major Depressive Disorder: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016;164:350-359. doi: 10.7326/M15-2570.

A Psychiatrist Reads the Washington Post

There are an endless number of ways that the appearance of conflict of interest can be spun to make any organization look bad.  The obvious question is why that always seems to occur with psychiatry?  The arguments all follow the general form that a financial benefit resulting from work related to the pharmaceutical industry disqualifies those experts from writing objective research about medication or rendering opinions about the treatment of psychiatric disorders in general. That is the theme of the latest article from The Washington Post entitled “Antidepressants treat grief? Psychiatry panelists with ties to drug industry say yes."  It is an old story with little variation and I add some commentary based on the organization of the article.

"In what some prominent critics have called a bonanza for drug companies, the American Psychiatric Association this month voted to drop the old wording against diagnosing depression in the bereaved, opening the way for more of them to be diagnosed with major depression and thus, treated with antidepressants.”

This statement assumes that this practice is not occurring right now. In fact, it is widely known that the diagnosis of depression is not rigorously made in primary care settings. It is highly likely right now that patients suffering from grief as well as psychological adaptations to acute stress are being treated with antidepressants. There is no reason to believe that the patients being treated in primary care resemble the patients with a diagnosis of major depression in clinical trials of antidepressants.

"The change in the handbook, which could have significant financial implications for the $10 billion  US antidepressant market, was developed in large part by people affiliated with the pharmaceutical industry, an examination of financial disclosures shows.”

The previous statement talks about a "bonanza for drug companies" and builds on this image in the second statement. It ignores the fact that most commonly prescribed antidepressants are currently generics and available for as little as four dollars per month. The only two major antidepressants at this time that are not generics are Cymbalta (duloxetine) and Vibryd (vilazodone).  Where does the "10 billion dollar" figure come from?  If you read the entire article on page 5, that figure was from IMS America a company that tracks total prescriptions from American retail pharmacies.  Anyone knowing the applications for antidepressants would know that they are prescribed for many conditions other than depression including headaches, hot flashes, and chronic pain. The total retail sales figure is unlikely to reflect either drug company profits or the amount of depression being treated.

A little arithmetic is always instructive. If we assume that a physician prescribes a generic antidepressant for a patient that costs four dollars per month that translates to a total cost of $48 per year. The $10 billion/year figure quoted here would represent 208 million prescriptions or 66% of the entire population of  the U.S. taking antidepressants 12 months out of the year.  Even if we take $2 billion out of the $10 billion figure for Cymbalta and Vibryd, that results in 53% of the population taking antidepressants 12 months out of the year. Those figures are 5-8 times higher than any actual estimation of antidepressant use.  The $10 billion dollar figure is certainly eye-opening but there is plenty of evidence that it is not remotely accurate and will not have the purported impact on the pharmaceutical industry.

"About 80% of the prescriptions for antidepressants are written by primary-care physicians and others, not psychiatrists, a fact that makes the APA handbook particularly important. Faced with a patient complaining of depression-like symptoms, a general practitioner may be likely to rely on the Association's handbook for advice.”

This statement reveals the authors lack of knowledge about the practice of medicine and about the DSM that he is criticizing. The DSM is strictly a diagnostic manual and it contains no treatment recommendations. Primary care physicians are not avid readers of the DSM and that has probably led to the practice of using a DSM-based checklist – the PHQ-9.  This practice has not been promoted by the APA or the pharmaceutical industry (although the PHQ-9 is copyrighted by Pfizer pharmaceuticals).  Using a checklist to make a rapid diagnoses (in minutes) and rapidly treat large numbers of patients is promoted by managed care organizations and HMOs. That is probably the single greatest factor contributing to antidepressant prescriptions but it is ignored by the author - probably because it challenges his contention that this is all driven by conflict of interest in psychiatry rather than the business world.  It is cheaper for HMOs to treat depression with medications rather than detailed psychiatric assessments and psychotherapy.

"The Association itself runs on a budget of about 50 million a year, and for years industry funding has been critical to its operations. Today, about 14% of the Association's budget comes from pharmaceutical companies, mainly in the form of advertising at annual meetings and publications."

The author does a good job of providing no context here. Is the APA any different from other medical specialty organizations? Does advertising create a conflict of interest? Is any other print media outlet held to that standard? There is information available in those areas.   An Institute of Medicine report focused on conflict of interest showed that the APA's revenue from the pharmaceutical industry was in the middle of the pack with regard to medical specialty societies. As an example, the year that report was done the APA reported that medical companies supplied 28% of their annual income.  The American Academy of Family Physicians reported that 42% of their annual income was from pharmaceutical companies (p 220).  That same report (Recommendation 6.1) noted that increasing work for the pharmaceutical industry correlated with a 7% reduction in real physician wages and recommended that there was nothing wrong with “consulting arrangements based on written contracts for expert services to be paid for at fair market value”.   Depending on the expert involved, restricting the amount to $10,000 per year could practically mean anywhere from 2 to 10 presentations per year or about 2 1/2 weeks of contract work. 

“Other members of the committee have numerous ties to drug companies, too, and not simply conducting research, according to disclosures from last year. One was holding stock in Glaxo Smith Kline, one was a consultant to Servier and another consultant to Pfizer;  one had a grant from AstraZeneca and another a grant from Pfizer and AstraZeneca.”

This is a paragraph from a poorly written section illustrating ties between the 11 member Mood Disorders Work Group set up to draft the guidelines on major depression. There is some explanation of the selection criteria and conflict of interest criteria.  It discusses conflictof interest criteria that the APA designed and made explicit in response to this article.  It provides no context other than an off hand remark by the chairman that he probably regrets making. The article provides no reasonable context for expected reimbursement for experts as consultants to industries or the fact that this is a common practice in many academic departments on any major university campus. In some of those industries, the professional organizations actually make an effort to make sure that businesses are well represented in any process that involves making standards.

"The current handbook-the revised version will be published in the Spring-recommended against diagnosing major depression in the bereaved when the symptoms are milder and of less than two months duration. This is known as the "bereavement exclusion".  (If the signs of depression are severe-the patient has thoughts of suicide, for example-major depression is supposed to be diagnosed)….. The new handbook removes the bereavement exclusion."

There is really nothing new and nothing drastic as anticipated with removing the "bereavement exclusion". To provide a clear example I will quote a text copyrighted in 1982:

"There are many publications that deal with treating psychiatric patients who report recent and remote bereavement. It is possible to find a real or imagined loss in every patient's past. However, for the most part, because there is little evidence from reviewing normal bereavement that there is a strong correlation between bereavement and first entry into psychiatric care, those bereaved who are seen by psychiatrists should be treated for their primary symptoms. This is not to say that the death should not be discussed, but because these people represent a very small subset of all recently bereaved, they should be treated like other patients with similar symptoms but no precipitating cause. A physician seeing a recently bereaved with newly discovered hypertension might delay treatment one or two visits to confirm its continued existence, but treat it if it persists. So the psychiatrist should treat the patient with affective symptoms with somatic therapy but only if the symptoms are major and persist unduly. A careful history of past and present drug and alcohol intake is indicated. Then, the safest and most appropriate drugs to use are the antidepressants. Electroconvulsive therapy is indicated in the suicidal depressed." (Paykel p413-414).

Any psychiatrist worth his or her salt knows the difference between grief and depression and they should know the literature on treating grief, the natural history of grief, and the research on proven non-medical treatment of grief including Interpersonal Psychotherapy (IPT) and grief counseling. When you are seeing a psychiatrist, you are seeing an expert who should know the literature on grief, depression, and the differential diagnosis of depression.  Nothing in this article indicates that.  In fact, quotes are provided to suggest that the APA and psychiatry in general has an interest in redefining “the range of acceptable emotion” rather than using clinical research done by psychiatrists to limit suffering and prevent suicide.

I think the reality here indicates that there is no scandal.  The importance of the DSM-5, the appearance of conflict of interest, and the potential windfall for the pharmaceutical industry appear to be seriously overestimated.  Organized psychiatry is certainly not responsible for what happens  in primary care clinics under the direct guidance of business organizations.  There is a responsibility to establish professional standards for patients referred to psychiatrists for the assessment and treatment of complicated depressions that may occur during bereavement. The suggestion that medications may be useful in some of these situations and the importance of treating depression in bereavement has been around for at least 30 years.

George Dawson, MD, DFAPA

Peter Whoriskey.  Antidepressants to treat grief? Psychiatry panelists with ties to drug industry say yes. The Washington Post, December 26, 2012.

Clayton PJ. Bereavement in Handbook of Affective of Disorders.  Eugene S. Paykel (ed). The Guilford Press. New York. 1982  pages 413-414.

APA Reiterates Stringent Rules on Accepting Pharma Support.  Psychiatric News.  Monday December 31,2012.

Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice; Lo B, Field MJ, editors. Conflict of Interest in Medical Research, Education, and Practice. Washington (DC): National Academies Press (US); 2009. Available from: http://www.ncbi.nlm.nih.gov/books/NBK22942/  

 

Psychiatrists work for patients - not for pharmaceutical companies

That should be obvious by anybody reading this post but it clearly is not. I have already established that there is a disproportionate amount of criticism of psychiatry in the popular media compared with any other medical specialty. The most common assumption of most of those critics is that psychiatrists are easily influenced by pharmaceutical companies or thought leaders who are working for pharmaceutical companies. There are many reasons why that assumption is incorrect but today I want to deal with a more implicit assumption that is that there is a drug that is indicated and effective for every medical condition.

In the field of psychiatry this marketing strategy for pharmaceuticals became prominent with the biological psychiatry movement in the 1980s. Biological psychiatrists studied neuropsychopharmacology and it followed that they wanted to apply their pharmaceuticals to treat human conditions. At the popular level initiatives like National Depression Screening Day were heavily underwritten by pharmaceutical companies and the implicit connection was that you could be screened and be treated with a medication that would take care of your depression.

From the perspective of a pharmaceutical company this is marketing genius. You are essentially packaging a disease cure in a pill and suggesting that anyone with a diagnosis who takes it will be cured. The other aspects of marketing genius include the idea that you can be "screened" or minimally assessed and take the cure. We now have the diagnosis, treatment, and cure neatly packaged in a patent protected pill that the patient must take.  The role of the physician is completely minimized because the pharmaceutical company is essentially saying we have all the expertise that you need. The physician's role is further compromised by the pharmaceutical benefit manager saying that they know more about which pill to prescribe for particular condition than the physician does. That is an incredible amount of leverage in the health care system and like most political dimensions in healthcare it is completely inaccurate.

The pharmaceutical company perspective is also entirely alien to the way that psychiatrists are trained about how to evaluate and treat depression.  Physicians in general are taught a lot about human interaction as early as the first year in medical school and that training intensifies during psychiatric residency. The competencies required to assess and treat depression are well described in the APA guidelines that are available online.  A review of the table of contents of this document illustrates the general competencies required to treat depression. Reading through the text of the psychopharmacology section is a good indication of the complexity of treating depression with medications especially attending to side effects and complications of treatment and decisions on when to start, stop, and modify treatment. Those sections also show that psychopharmacology is not the simple act that is portrayed in the media. It actually takes a lot of technical skill and experience.  There really is no simple screening procedure leading to a medication that is uniformly curative and safe for a specific person.

The marketing aspects of these medications often create the illusion that self-diagnosis or diagnosis by nonexperts is sufficient and possible. Some people end up going to the website of a pharmaceutical company and taking a very crude screening evaluation and concluding that they have bipolar disorder. In the past year, I was contacted by an employer who was concerned about the fact that her employee had seen a nonpsychiatrist and within 20 minutes was diagnosed with bipolar disorder and treated with a mood stabilizer, an antidepressant, and an antipsychotic medication. Her concern was that the employee in question could no longer function at work and there was no follow-up scheduled with the non-psychiatrist who had prescribed medication.  Managed care approaches screening patients in primary care settings increase the likelihood that these situations will occur.

The current anti-psychiatry industry prefers to have the public believe that psychiatrists and their professional organization are in active collusion with the pharmaceutical industry to prescribe the most expensive medications.  In the case of the approximately 30 antidepressants out there, most are generic and can be easily purchased out-of-pocket.  Only the myth that medications treat depression rather than psychiatrists keeps that line of rhetoric going.

George Dawson, MD

American Psychiatric Association.  Practice Guideline for the Treatment ofPatients With Major Depressive Disorder, Third Edition. 2010