There is an important study on the emergency department (ED) and health care policy in the January 17 edition of the journal Science. It looks at the question of whether not health insurance increases or decreases ED use. This has been a political football for years. The debate has been that increased insurance enrollment would prevent excessive ED utilization but the evidence has been sparse. Some surveys have shown that the uninsured view the high cost of ED services and the financial repercussions are a deterrent. On the increased utilization side is the economic argument that prepaid services lower the cost and therefore increase the use of all medical services across the board. Another variable is the overall economy. In an economic downturn, people use less goods and services including medical services.
Mapped onto the ED utilization problem is the EMTLA law or The Emergency Medical Treatment and Labor Act. This law states that no person requiring medical stabilization can be turned away from an ED based on ability to pay. A variety of mechanisms shifts the cost of care to the facility and physicians providing the care. In the case of psychiatric services, EDs are obligated to find an open bed to transfer the patient. In most states the majority of hospitals with EDs do not have psychiatric units, and that can result in patients being held for long periods of time until a bed opens up or transfer to beds across the state. More radical solutions to that problem have included discharging a person untreated back out to the street or discharging them after a certain time interval if a bed could not be identified.
The scope of the problem of psychiatric services in the ED has not been well studied. Some of the large studies suffer from an inadequate look at diagnoses, crisis care, patient flow and disposition and outcomes. Before this study, I could not find any studies with adequate detail about diagnoses. The other consideration is selection bias. In most metropolitan areas, emergency services brings patients with psychiatric crises to identified hospitals with the largest psychiatric services. These services typically have large capacity and become catchment areas for large areas of the states they are located in. They can also be overwhelmed due to various factors that affect patient flow. Most of these factors are directly related to the closure and rationing of psychiatric services in acute care but also residential facilities, clinics and community support services for the severely disabled.
The design of this study is interesting because it is randomized based on a political initiative. In 2008, Oregon started a limited expansion of Medicaid. They drew 30,000 names from a pool of 90,000 people. There were 8 drawings between March and September 2008. Previous studies on outcomes by the same authors showed that Medicaid assignment led to reduce depression and improved general health but it did not impact several general measures of general health, employment, or earnings. In this study they looked at 12 hospitals that are the catchment area for Portland and surrounding suburbs. These hospitals have half of the annual admissions in the state. The study ran for 18 months, and was an intent-to-treat analysis of the randomly selected Medicaid enrollees and the non-selected matched on demographic variables.
The primary result of the study showed that Medicaid enrollment was associated with a significant use in ED services. The increase was 41% relative to the control group. There was no difference in the number of visits resulting in admission but increases in most other types of visits, including those that would be treatable in an outpatient clinic. For some reason these differences were detected in administrative but not self reported data. The authors look at three potential reasons for those differences. The discussion of study limitations focuses primarily on the fact that the low income population studied may differ significantly from other low income populations and limit its generalizability. The author's also comment on how establishing primary care can logically increase the likelihood of ED utilization. The commonest scenario there is a patient with with either risk factors or chronic illnesses that calls their primary care clinic and is advised to go to the ED because of the anticipated length or complexity of the required evaluation. That factor could not be studied with the available data. In the case of psychiatric services that is typically a change in mental status, suicide risk , aggressive behavior or need for intoxication or detoxification.
One of the features of this study of interest to psychiatrists is the supplementary data. Table S10 lists "Select Conditions (control sample only)" for a total of 17,498 ED visits separated by category. A total of 1346 or 8.4% of all visits were for "Substance abuse and mental health issues." Of that sample, 3% were mood disorders, 2% alcohol related disorders, 1.5 % anxiety disorders, 0.9% schizophrenia and psychotic disorders, and 0.8% substance related disorders. In looking at visits per condition increased ED utilization occurred for injuries, headaches, and chronic conditions but not mood disorders or substance use or mental health disorders. It is not possible to see the distribution of ED visits by hospital and with what is known about these distributions on metro areas it is likely that a few of the 12 hospitals had most of these visits.
In the weeks to come, I anticipate that there will be an active debate on the economic and political implications of this study. From a psychiatric perspective it does not really capture the scope of the problem of how we got to the current predicament of discharging people with psychiatric and substance use problems untreated from emergency departments. Nobody seems to consider that the ED problem exists as a result of rationing at multiple levels and a physician productivity model that values a stereotypical low to moderate complexity visit. Most clinics and even urgent care settings have limited flexibility to assess some of the suggested ED problems like new chest pain even though in this study 93.1% of the chest pain assessed was nonspecific and 3.5% represented an acute myocardial infarction. A few conclusions that I come to:
1. This study is well done, unique and seems to have a highly significant finding that increased insurance to a low income population leads to increased ED utilization rather than less. Caution is needed in the interpretation of that data. A major weakness of any study like this is the fact that it is all of the data is administrative rather than clinical. This is a major weakness of practically every data set used to establish health care policy in the past starting with the RAND studies on overutilization of hospitalizations and procedures relative to what was determined by the PROs of the 1990s. These studies showed that when the data was reviewed by non-biased reviewers with no conflict of interest, there was minimal to no overutilization. It is probably time to consider that we need better data.
2. All elements in the system are not equivalent - no 2 EDs are the same. In any state you can walk into an ED attached to a Level 1 trauma center and burn unit or one that is staffed by moonlighting physicians or residents who may not be emergency medicine specialists. That will naturally affect referral patterns and overcrowding phenomenon. Detailed patient flow pattern in and out of the busiest EDs with enough granular data about that phenomena is probably more important in addressing the problem than a look at a single global insurance decision. Data in this study and others suggests that the increased ED use is based on rational decision making about medical conditions and previous surveys on wanting to avert a financial catastrophe.
3. Targeted interventions to reduce ED use is specific populations are highly effective. Assertive Community Treatment (ACT) teams for people with chronic mental illness are a good example. In these interventions teams have their own crisis programs independent of EDs as well as medical staff who are available to the patients 24/7. Their goal is also to avoid psychiatric hospitalizations and they are very good at that. As clinics are acquired and consolidated under various managed care organizations the likelihood of consulting with a person from your primary care clinic after hours decreases significantly and that probably means more contact with the ED.
4. Urgent Care facilities are a logical extension of primary care clinics after hours and there is currently no psychiatric equivalent. A clinic with adequate multidisciplinary mental health staff would seem like a better options than being seen in an ED. There currently do not appear to be any facilities like this for mental health other than county government based crisis lines that vary considerably form county to county.
Despite all of the considerations I have listed above and more, I do not expect a more sophisticated look at this issue. Our politicians are incapable of it and the conflicts of interest related to the business side of medicine will typically carry the day. There will be some ideological arguments about economic theory but in the end, what is good for business will carry the day.
Increased utilization of the ED is looking better and better for business every day.
George Dawson, MD, DFAPA
1: Taubman SL, Allen HL, Wright BJ, Baicker K, Finkelstein AN. Medicaid increases emergency-department use: evidence from Oregon's Health Insurance Experiment. Science. 2014 Jan 17;343(6168):263-8. doi: 10.1126/science.1246183. Epub 2014 Jan 2. PubMed PMID: 24385603.
2: Fisman R. Health care policy. Straining emergency rooms by expanding health insurance. Science. 2014 Jan 17;343(6168):252-3. doi: 10.1126/science.1249341. Epub 2014 Jan 2. PubMed PMID: 24385605.
Sunday, February 23, 2014
Saturday, February 22, 2014
Doubling Down on The Miserable Patient
The need for managed care and the efficiency of the electronic health record are two of the biggest myths in the American health care system today. Here is what really happens.....
I have had the occasion to be a miserable patient for the past 6 weeks. That is what happens when you have asthma and nothing works or at least nothing seems to work very well. Throughout the course of the illness I have dutifully kept my primary care physician up to date, but so far I have ended up seeing 6 different physicians over that time. I received prescriptions for three different inhalers, a nebulizer machine, and two different varieties of nebulizers - albuterol and levalbuterol. Hundreds of dollars of medications not covered by my health insurance that don't work or cause significant side effects. The levalbuterol was prescribed because it was supposed to have fewer side effects and it worked out just the opposite and caused significant side effects with a heart rate up to 140 beats per minute. I needed to take these treatments 3 times a day followed by another inhaler. This is a story of what should be a very simple task of getting enough medicine to keep breathing and in this case it is the albuterol sulfate nebulizer solution. For anyone not familiar with this product it comes in disposable 3 ml plastic vials. You just crack it open and pour it into a nebulizer machine and inhale the solution until it is gone in about 5-10 minutes.
The nebulizer ampules come packaged inside a foil envelope inside a box. The prescription on the other side of this box reads: "Nebulize 1 vial every 6 hours as needed for wheezing or shortness of breath." Assuming that I continue to use them at a rate of 3 vials, that is about 90 per month. About a week into it, I noticed I had just a couple of vials left and called the pharmacy to get more. This is how it went (M=me, P=pharmacy, from memory and not a transcript):
M: Yes - I am calling to refill a prescription for albuterol nebulizer solution (details given)
P: Sorry but you have no refills on that prescription we will have to fax your doctor (reads MD name)
M: That was the urgent care doctor, my doctor's name is Dr. Smith (details given)
P: Well we will have to fax him then.
M: I think you may have made a mistake on the original prescription since the paperwork I have from urgent care says that I should have gotten 75 vials and I only got 25 (see lower left corner of the label)
P: No that is correct, we dispense them by volume rather than number. The insurance company mandates that we do it that way - like cough syrup.
M: That doesn't make any sense to me. Each one of these vials is supposed to be a single dose and if I am taking three a day that is 90 vials per month.
P: The only other way to get more vials is if your doctor writes "90 vials" on the prescription that he sends us.....
M: He already wrote 75 and you gave me 25.
P: No he has to write "75 vials" and spell out "vials".
At that point, I leave both a voicemail and an e-mail through the health plans messaging system for my personal physician to send in a new prescription for 75 vials of the solution. The next day we are having one of the largest snow storms of the year and I am commuting 80 miles a day on glare ice and no visible road surface. My commute time is 2 to 3 times normal. I call ahead to make sure the prescription will be ready:
M: I am calling about that albuterol nebulizer solution.
P: We got the prescription from your doctor, but the insurance says they won't approve it because it is too early.
M: What do you mean it's too early? I am using it exactly as directed and you are only giving me 1 weeks worth of medication at a time. How can it be too early?
P: Well that's what they are saying....
M: Look - I need this medicine to breathe.
P: OK the medicine is approved.
I am questioning what is happening here. I know she was not on line with the "insurance company". Why did she suddenly change her mind on giving me a medication that I am essentially paying for out of pocket? Do they have a secret directive that tells them to only give up the medicine if the patient appears to be in respiratory distress? Why does the high deductible insurance have anything to say about this anyway? They are policing my prescriptions for non-addicting medication and they have become an obstacle to my health care. It made me think about all of the "Dear Dr." letters that are sent out by pharmaceutical benefit managers (PBMs) and managed care organizations (MCOs) where they claim their want to "partner" with physicians to improve the overall health care of the patient. It is typically advice about drug interactions. They rarely have the drugs right and never have the accurate prescribing physicians correct. Is this how "partnering" improves my health? Was she just bluffing to keep insurance company money off the table? Are big retail pharmacies that intimidated by managed care?
I didn't have time to figure it out. The snow was still coming down and there was a question about whether or not I was going to make it with four wheel drive. An hour and a half later I pulled up to the pharmacy drive through and picked up a thoroughly stapled bag containing the vials. I tore it open in the parking lot and my suspicions were confirmed. There was another box of 25 - 3 ml vials, not the 75 I had requested or the "75 vials" that my physician was supposed to have ordered. Two days of work going through the most sophisticated electronic health record available and nothing had changed.
This is one isolated example of a sequence of events that probably repeats itself tens of thousands of times per day. It doesn't take much to realize that the combination of obstacles and ineffective medications that occurs by this process is a windfall for both the managed care industry and the pharmaceutical industry. If you decide that you want to investigate it and find out exactly what went wrong, that is a full time job. If you want to file a complaint with the state (What - a wheezing asthmatic needs nebulizer solution?) you may not ever be able to get that accomplished. From working both sides of the prescription process, all that I know is the system is set up to obstruct care. These unnecessary processes waste everyone's time and money. It doesn't matter if there is an electronic health record if it means the patient is driving 40 miles back and forth to the pharmacy per month instead of 10, making another 6 calls through time consuming automated telephone queues and paying another 3 copays. This activity is all based on the false premise that an electronic health record, an algorithm or a business strategy is more important to your health care in the long run than your physicians input.
Nothing could be further from the truth.
George Dawson, MD, DFAPA
Supplementary 1: It is one week since the original post and the pharmacy/insurance company insisting on dispensing me one week of nebulizer solution instead of one month as requested. I called in for a refill yesterday and asked if it would be for one week or one month. The pharmacist told me exactly the same thing they did last week - they have to submit a request to my physician for the correct number of ampules.
To briefly review, that request has been made by me four times (twice to MD office by phone and secure e-mail and twice to the pharmacy). They did tell me I could pick up another weeks worth of the medication while I wait for the larger prescription. I went ahead and did that and have not heard anything on the other prescription 24 hours later.
I have had the occasion to be a miserable patient for the past 6 weeks. That is what happens when you have asthma and nothing works or at least nothing seems to work very well. Throughout the course of the illness I have dutifully kept my primary care physician up to date, but so far I have ended up seeing 6 different physicians over that time. I received prescriptions for three different inhalers, a nebulizer machine, and two different varieties of nebulizers - albuterol and levalbuterol. Hundreds of dollars of medications not covered by my health insurance that don't work or cause significant side effects. The levalbuterol was prescribed because it was supposed to have fewer side effects and it worked out just the opposite and caused significant side effects with a heart rate up to 140 beats per minute. I needed to take these treatments 3 times a day followed by another inhaler. This is a story of what should be a very simple task of getting enough medicine to keep breathing and in this case it is the albuterol sulfate nebulizer solution. For anyone not familiar with this product it comes in disposable 3 ml plastic vials. You just crack it open and pour it into a nebulizer machine and inhale the solution until it is gone in about 5-10 minutes.
The nebulizer ampules come packaged inside a foil envelope inside a box. The prescription on the other side of this box reads: "Nebulize 1 vial every 6 hours as needed for wheezing or shortness of breath." Assuming that I continue to use them at a rate of 3 vials, that is about 90 per month. About a week into it, I noticed I had just a couple of vials left and called the pharmacy to get more. This is how it went (M=me, P=pharmacy, from memory and not a transcript):
M: Yes - I am calling to refill a prescription for albuterol nebulizer solution (details given)
P: Sorry but you have no refills on that prescription we will have to fax your doctor (reads MD name)
M: That was the urgent care doctor, my doctor's name is Dr. Smith (details given)
P: Well we will have to fax him then.
M: I think you may have made a mistake on the original prescription since the paperwork I have from urgent care says that I should have gotten 75 vials and I only got 25 (see lower left corner of the label)
P: No that is correct, we dispense them by volume rather than number. The insurance company mandates that we do it that way - like cough syrup.
M: That doesn't make any sense to me. Each one of these vials is supposed to be a single dose and if I am taking three a day that is 90 vials per month.
P: The only other way to get more vials is if your doctor writes "90 vials" on the prescription that he sends us.....
M: He already wrote 75 and you gave me 25.
P: No he has to write "75 vials" and spell out "vials".
At that point, I leave both a voicemail and an e-mail through the health plans messaging system for my personal physician to send in a new prescription for 75 vials of the solution. The next day we are having one of the largest snow storms of the year and I am commuting 80 miles a day on glare ice and no visible road surface. My commute time is 2 to 3 times normal. I call ahead to make sure the prescription will be ready:
M: I am calling about that albuterol nebulizer solution.
P: We got the prescription from your doctor, but the insurance says they won't approve it because it is too early.
M: What do you mean it's too early? I am using it exactly as directed and you are only giving me 1 weeks worth of medication at a time. How can it be too early?
P: Well that's what they are saying....
M: Look - I need this medicine to breathe.
P: OK the medicine is approved.
I am questioning what is happening here. I know she was not on line with the "insurance company". Why did she suddenly change her mind on giving me a medication that I am essentially paying for out of pocket? Do they have a secret directive that tells them to only give up the medicine if the patient appears to be in respiratory distress? Why does the high deductible insurance have anything to say about this anyway? They are policing my prescriptions for non-addicting medication and they have become an obstacle to my health care. It made me think about all of the "Dear Dr." letters that are sent out by pharmaceutical benefit managers (PBMs) and managed care organizations (MCOs) where they claim their want to "partner" with physicians to improve the overall health care of the patient. It is typically advice about drug interactions. They rarely have the drugs right and never have the accurate prescribing physicians correct. Is this how "partnering" improves my health? Was she just bluffing to keep insurance company money off the table? Are big retail pharmacies that intimidated by managed care?
I didn't have time to figure it out. The snow was still coming down and there was a question about whether or not I was going to make it with four wheel drive. An hour and a half later I pulled up to the pharmacy drive through and picked up a thoroughly stapled bag containing the vials. I tore it open in the parking lot and my suspicions were confirmed. There was another box of 25 - 3 ml vials, not the 75 I had requested or the "75 vials" that my physician was supposed to have ordered. Two days of work going through the most sophisticated electronic health record available and nothing had changed.
This is one isolated example of a sequence of events that probably repeats itself tens of thousands of times per day. It doesn't take much to realize that the combination of obstacles and ineffective medications that occurs by this process is a windfall for both the managed care industry and the pharmaceutical industry. If you decide that you want to investigate it and find out exactly what went wrong, that is a full time job. If you want to file a complaint with the state (What - a wheezing asthmatic needs nebulizer solution?) you may not ever be able to get that accomplished. From working both sides of the prescription process, all that I know is the system is set up to obstruct care. These unnecessary processes waste everyone's time and money. It doesn't matter if there is an electronic health record if it means the patient is driving 40 miles back and forth to the pharmacy per month instead of 10, making another 6 calls through time consuming automated telephone queues and paying another 3 copays. This activity is all based on the false premise that an electronic health record, an algorithm or a business strategy is more important to your health care in the long run than your physicians input.
Nothing could be further from the truth.
George Dawson, MD, DFAPA
Supplementary 1: It is one week since the original post and the pharmacy/insurance company insisting on dispensing me one week of nebulizer solution instead of one month as requested. I called in for a refill yesterday and asked if it would be for one week or one month. The pharmacist told me exactly the same thing they did last week - they have to submit a request to my physician for the correct number of ampules.
To briefly review, that request has been made by me four times (twice to MD office by phone and secure e-mail and twice to the pharmacy). They did tell me I could pick up another weeks worth of the medication while I wait for the larger prescription. I went ahead and did that and have not heard anything on the other prescription 24 hours later.
Thursday, February 20, 2014
The Proud Critics of Psychiatry
I received an e-mail first thing this morning from a person who identified himself as Peter C. Gøtzsche, MD. It looked official, but if this was not sent by Dr. Gøtzsche, all he has to do is send me an e-mail and I will delete this post. For those unfamiliar with why he might be sending me e-mails he is the author of the "Psychiatry Gone Astray" post that I critiqued. The body of the message was straightforward and said:
" Incidentally, I found out that some one has written about you and the way you treated my paper about the 10 myths in psychiatry. See attached"
The attachment read: "Asshole of the Day - George Dawson, MD" The proud author of that post made this statement after a completely respectful response to him on this blog.
Anyone who has been around the Internet and knows about malicious code would have to be a fool to click on an abusive attachment like this and put their data and identity at risk. Although this is a very simple message it says a lot about the way people expect to treat psychiatrists and get away with it. Dr. Gøtzsche had sent me an earlier e-mail saying he had responded to my criticism of his criticism of psychiatry. At this point I have not read it for various reasons including the low volume of web traffic from the Healy web site, the fact that I have been physically ill and exhausted, and my focus on other areas such as the recent series I am attempting to post on the reality of dangerous drugs.
Implicit in the e-mail is that his original "paper" had been treated poorly. I put "paper" in quotes here because as far as I am concerned it is a blog post. Where I come from a paper is published in a referred, peer reviewed journal. It is certainly possible to get rhetorical criticism against psychiatry published in that format, but even then it would not be beyond criticism. I also disagree with any implication that his opinions were treated poorly. It is called arguing and as every scientist, philosopher, and rhetorician knows there are at least two sides to every story. Practically all of the psychiatry critics don't seem to understand that these arguments can be done without taking things personally and using emotional invective. What many people don't seem to grasp is that it is also part of the scientific method. Arguments, theories, speculation, conjectures, etc. all have to withstand scrutiny over time. Even though every top scientist and mathematician expects these challenges, apparently only the critics of psychiatry consider themselves to be above criticism.
There is an asymmetry to the position that psychiatrists should not object to being criticized no matter how irrational, unscientific, or personal the criticism is. The implicit contention here is that the blog post was "treated" poorly but what about the way psychiatrists are treated and their work with people who have conditions that are treated by nobody else? And as I pointed out in my original criticisms, why do none of these critics ever look at closely at their own fields and the huge problems that exist there?
These dynamics are why there is such a blizzard of unscientific and unreliable criticism of psychiatry on the Internet and in the popular press. This is what happens if you are a psychiatrist who dares to speak out against it and not get into the usual patterns of silence or taking the position that you are somehow better than your colleagues.
My message to these people, no matter who they are is quite simple. If I have not been deterred by 35 years of irrational and mean spirited criticism - name calling is certainly not going to stop me now.
So to all of the proud critics of psychiatry - flame away! But don't expect me to engage you in a "debate". Anyone with an ounce of self respect knows that is not what is going on here.
George Dawson, MD, DFAPA
Supplementary 1: The other important disclosure that I have relative to the critics is that I have no conflict of interest or appearance of conflict of interest. I have no book to sell. I am not invested in pharmaceutical or medical device makers apart from mutual funds where I have no control over the investment decisions. I have never been paid for my commentary or writing and don't see that ever happening. I am not a paid spokesman for any commercial or professional organization. This is a completely noncommercial blog with no advertising. If I post copyrighted material here I have to pay for those rights out of my own pocket. I have no relationships with any pharmaceutical companies. I do not consider myself to be a celebrity and I am therefore not trying to enhance my celebrity status and in fact will be he first to admit that hardly anybody reads this blog. This entire blog is written in my spare time and yes I have a day job. I encourage a similar analysis of any critic of psychiatry you might be listening to.
" Incidentally, I found out that some one has written about you and the way you treated my paper about the 10 myths in psychiatry. See attached"
The attachment read: "Asshole of the Day - George Dawson, MD" The proud author of that post made this statement after a completely respectful response to him on this blog.
Anyone who has been around the Internet and knows about malicious code would have to be a fool to click on an abusive attachment like this and put their data and identity at risk. Although this is a very simple message it says a lot about the way people expect to treat psychiatrists and get away with it. Dr. Gøtzsche had sent me an earlier e-mail saying he had responded to my criticism of his criticism of psychiatry. At this point I have not read it for various reasons including the low volume of web traffic from the Healy web site, the fact that I have been physically ill and exhausted, and my focus on other areas such as the recent series I am attempting to post on the reality of dangerous drugs.
Implicit in the e-mail is that his original "paper" had been treated poorly. I put "paper" in quotes here because as far as I am concerned it is a blog post. Where I come from a paper is published in a referred, peer reviewed journal. It is certainly possible to get rhetorical criticism against psychiatry published in that format, but even then it would not be beyond criticism. I also disagree with any implication that his opinions were treated poorly. It is called arguing and as every scientist, philosopher, and rhetorician knows there are at least two sides to every story. Practically all of the psychiatry critics don't seem to understand that these arguments can be done without taking things personally and using emotional invective. What many people don't seem to grasp is that it is also part of the scientific method. Arguments, theories, speculation, conjectures, etc. all have to withstand scrutiny over time. Even though every top scientist and mathematician expects these challenges, apparently only the critics of psychiatry consider themselves to be above criticism.
There is an asymmetry to the position that psychiatrists should not object to being criticized no matter how irrational, unscientific, or personal the criticism is. The implicit contention here is that the blog post was "treated" poorly but what about the way psychiatrists are treated and their work with people who have conditions that are treated by nobody else? And as I pointed out in my original criticisms, why do none of these critics ever look at closely at their own fields and the huge problems that exist there?
These dynamics are why there is such a blizzard of unscientific and unreliable criticism of psychiatry on the Internet and in the popular press. This is what happens if you are a psychiatrist who dares to speak out against it and not get into the usual patterns of silence or taking the position that you are somehow better than your colleagues.
My message to these people, no matter who they are is quite simple. If I have not been deterred by 35 years of irrational and mean spirited criticism - name calling is certainly not going to stop me now.
So to all of the proud critics of psychiatry - flame away! But don't expect me to engage you in a "debate". Anyone with an ounce of self respect knows that is not what is going on here.
George Dawson, MD, DFAPA
Supplementary 1: The other important disclosure that I have relative to the critics is that I have no conflict of interest or appearance of conflict of interest. I have no book to sell. I am not invested in pharmaceutical or medical device makers apart from mutual funds where I have no control over the investment decisions. I have never been paid for my commentary or writing and don't see that ever happening. I am not a paid spokesman for any commercial or professional organization. This is a completely noncommercial blog with no advertising. If I post copyrighted material here I have to pay for those rights out of my own pocket. I have no relationships with any pharmaceutical companies. I do not consider myself to be a celebrity and I am therefore not trying to enhance my celebrity status and in fact will be he first to admit that hardly anybody reads this blog. This entire blog is written in my spare time and yes I have a day job. I encourage a similar analysis of any critic of psychiatry you might be listening to.
Monday, February 17, 2014
Dangerous Medications - Part One
Some of the most common rhetoric used against psychiatrists is that the drugs that psychiatrists prescribe are somehow more dangerous than other drugs. There are numerous problems with the argument including the fact that psychiatrists don't really influence what medications are approved by regulators and the majority of the so-called psychotropic medications (up to 80%) are prescribed by primary care physicians. There are the associated arguments that they are overprescribed and ineffective and I will address those at another time. What is the evidence about dangerousness? I have previously commented on the issue of whether or not the medications used by our field cause a person to become homicidal. I will restrict this post just to the issue of medication complications and whether or not regulatory action needs to be taken against a medication.
The areas of pharmacovigilance and pharmacoepidemiology offer some insights into the area of drug dangerousness, but at this point there are few good studies available in public access formats. One study done in Wales showed that over a 5 year period there were about 100,000 incident reports related to medications or about 9.7% of all patient safety incidents. The incidents resulted in severe harm or death in 822 patients (0.9%) of the medication related incidents. The majority of reports were skewed toward reports from hospitals (75%) as opposed to primary care clinics. Looking only at the severe and fatal outcomes by drug class (Table 8) 2/13 drugs could be classified as medications used to treat mental illness. Benzodiazepines and antipsychotics were ranked 6th and 12th respectively. The top 5 drugs starting with number one were opioids, antibiotics, warfarin, heparin, and insulin. Any physician working on hospital safety committees is aware of the number of complications due to anticoagulation. To add further context the total population of Wales in 2011 was about 3 million people, but the total prescriptions per drug class or the critical denominator to determine any true complication rate is unknown.
Unfortunately in the US, we have no complete systems for pharmacovigilance. We have a long standing data base that has been around for decades that was used primarily to monitor physicians prescribing practices for pharmaceutical companies. Pharmaceutical representatives would detail physicians (introduce product information) and this company would sell the information about whether the detailing resulted in increased prescriptions of that product. Occasionally data from this large data base makes it out into the medical literature, but there is a serious question about how well marketing information works for pharmacovigilance. There is publicly available data from the Centers for Disease Control (CDC) indicating that there are about 50,000 deaths per year attributable to medications. The majority of these deaths are accidental and intentional overdoses and there is no granularity to look at common severe side effects like anaphylaxis. A third source of data is proprietary databases from health care companies, hospitals, and government agencies. Those sources often lead to questions about the generalizability of the conclusions from those studies.
A potentially useful regulatory measure is the number of medications that have been identified as problematic in post marketing surveillance and removed from the market for safety reasons. The best review I could find on that topic is reference 2. The paper looks at market withdrawals of new molecular entities (NMEs) approved by the FDA between the years 1980 and 2009. Of a total of 740 NMEs during that period, 118 (15.9%) were discontinued. Twenty six drugs out of 118 were withdrawn due to safety reasons or a total of 3.5% of the original approvals. Nervous system drugs represented a total 104/740 approved drugs and a total of 6.7% of the discontinuations as a percentage of the approvals. Safety withdrawals were a total of 3 drugs or 2.9% of the total approvals in this therapeutic class. The bottom line is that a total of 1 drug used for psychiatric indications out of 740 NMEs in the last 3 decades was a medication was withdrawn for safety reasons.
The authors go on to provide a high degree of granularity with a complete list of all NMEs that were withdrawn for safety reasons and they are listed in Table 3. The three nervous system drugs listed are nomifensine (an antidepressant), levomethadyl acetate ( a drug used to treat opioid dependence), and pergolide mesylate (a drug used to treat Parkinson's Disease and restless leg syndrome). The study apparently does not look at the issue of drugs where the manufacturer voluntarily discontinued sales. As an example, Bristol Myers Squibb discontinued sales of Serzone (nefazodone) in 2003 due to a low incidence of hepatotoxicity with serious outcomes like liver failure and the need for transplantation. The conclusion of this article is that the majority of of drug discontinuations are due to commercial reasons and not safety. They noted a trend for decreasing NMEs over time and an associated decrease in drug discontinuations.
Part of the problem with the perception of drug dangerousness, especially with medications used for psychiatric indications seems to be the idea that they should be devoid of side effects. That is certainly the ideal scenario, but that is not the approach taken by regulatory bodies like the FDA. Like any regulatory body that depends on politicians for funding there will always be a variety of political influences. In some cases the bureaucratic structure may be prioritized over scientific review. The paper by Qureshi, et al is a good example of a certain threshold of severe side effects that may lead to drug discontinuations for those reasons, but any inspection of current approved medications and their rare but serious side effects shows that there are plenty of concerns out there for commonly prescribed drugs in all classes. The regulatory concern is that many of these medications are useful for the people who really need them. When any medication is applied over a population of people, there is a likelihood of rare but very serious side effects. That is not a reason to call the drug dangerous, especially if there are people who benefit from taking it. There is also a likelihood of common side effects that are less dangerous but adversely impact quality of life. It is also easy to see the problem politically. In other words there is some kind of conspiracy driving the prescription of some medications as opposed to others.
The reality is that the patient has a decision to make and as I have pointed out before, I have really never encountered a person (including myself as a patient) who takes that decision lightly. There are additional interpersonal and psychological factors. My personal bias as a physician is that the primary goal of treatment is minimal to no side effects and that tolerating side effects is a decision made by the patient but informed by the physician. It always needs to be balanced against any therapeutic effect of the medication.
George Dawson, MD, DFAPA:
1: Cousins DH, Gerrett D, Warner B. A review of medication incidents reported to the National Reporting and Learning System in England and Wales over 6 years (2005-2010). Br J Clin Pharmacol. 2012 Oct;74(4):597-604. doi:10.1111/j.1365-2125.2011.04166.x. Review. PubMed PMID: 22188210; PubMed Central PMCID: PMC3477327.
2: Qureshi ZP, Seoane-Vazquez E, Rodriguez-Monguio R, Stevenson KB, Szeinbach SL. Market withdrawal of new molecular entities approved in the United States from 1980 to 2009. Pharmacoepidemiol Drug Saf. 2011 Jul;20(7):772-7. doi: 10.1002/pds.2155. Epub 2011 May 14. PubMed PMID: 21574210
The areas of pharmacovigilance and pharmacoepidemiology offer some insights into the area of drug dangerousness, but at this point there are few good studies available in public access formats. One study done in Wales showed that over a 5 year period there were about 100,000 incident reports related to medications or about 9.7% of all patient safety incidents. The incidents resulted in severe harm or death in 822 patients (0.9%) of the medication related incidents. The majority of reports were skewed toward reports from hospitals (75%) as opposed to primary care clinics. Looking only at the severe and fatal outcomes by drug class (Table 8) 2/13 drugs could be classified as medications used to treat mental illness. Benzodiazepines and antipsychotics were ranked 6th and 12th respectively. The top 5 drugs starting with number one were opioids, antibiotics, warfarin, heparin, and insulin. Any physician working on hospital safety committees is aware of the number of complications due to anticoagulation. To add further context the total population of Wales in 2011 was about 3 million people, but the total prescriptions per drug class or the critical denominator to determine any true complication rate is unknown.
Unfortunately in the US, we have no complete systems for pharmacovigilance. We have a long standing data base that has been around for decades that was used primarily to monitor physicians prescribing practices for pharmaceutical companies. Pharmaceutical representatives would detail physicians (introduce product information) and this company would sell the information about whether the detailing resulted in increased prescriptions of that product. Occasionally data from this large data base makes it out into the medical literature, but there is a serious question about how well marketing information works for pharmacovigilance. There is publicly available data from the Centers for Disease Control (CDC) indicating that there are about 50,000 deaths per year attributable to medications. The majority of these deaths are accidental and intentional overdoses and there is no granularity to look at common severe side effects like anaphylaxis. A third source of data is proprietary databases from health care companies, hospitals, and government agencies. Those sources often lead to questions about the generalizability of the conclusions from those studies.
A potentially useful regulatory measure is the number of medications that have been identified as problematic in post marketing surveillance and removed from the market for safety reasons. The best review I could find on that topic is reference 2. The paper looks at market withdrawals of new molecular entities (NMEs) approved by the FDA between the years 1980 and 2009. Of a total of 740 NMEs during that period, 118 (15.9%) were discontinued. Twenty six drugs out of 118 were withdrawn due to safety reasons or a total of 3.5% of the original approvals. Nervous system drugs represented a total 104/740 approved drugs and a total of 6.7% of the discontinuations as a percentage of the approvals. Safety withdrawals were a total of 3 drugs or 2.9% of the total approvals in this therapeutic class. The bottom line is that a total of 1 drug used for psychiatric indications out of 740 NMEs in the last 3 decades was a medication was withdrawn for safety reasons.
The authors go on to provide a high degree of granularity with a complete list of all NMEs that were withdrawn for safety reasons and they are listed in Table 3. The three nervous system drugs listed are nomifensine (an antidepressant), levomethadyl acetate ( a drug used to treat opioid dependence), and pergolide mesylate (a drug used to treat Parkinson's Disease and restless leg syndrome). The study apparently does not look at the issue of drugs where the manufacturer voluntarily discontinued sales. As an example, Bristol Myers Squibb discontinued sales of Serzone (nefazodone) in 2003 due to a low incidence of hepatotoxicity with serious outcomes like liver failure and the need for transplantation. The conclusion of this article is that the majority of of drug discontinuations are due to commercial reasons and not safety. They noted a trend for decreasing NMEs over time and an associated decrease in drug discontinuations.
Part of the problem with the perception of drug dangerousness, especially with medications used for psychiatric indications seems to be the idea that they should be devoid of side effects. That is certainly the ideal scenario, but that is not the approach taken by regulatory bodies like the FDA. Like any regulatory body that depends on politicians for funding there will always be a variety of political influences. In some cases the bureaucratic structure may be prioritized over scientific review. The paper by Qureshi, et al is a good example of a certain threshold of severe side effects that may lead to drug discontinuations for those reasons, but any inspection of current approved medications and their rare but serious side effects shows that there are plenty of concerns out there for commonly prescribed drugs in all classes. The regulatory concern is that many of these medications are useful for the people who really need them. When any medication is applied over a population of people, there is a likelihood of rare but very serious side effects. That is not a reason to call the drug dangerous, especially if there are people who benefit from taking it. There is also a likelihood of common side effects that are less dangerous but adversely impact quality of life. It is also easy to see the problem politically. In other words there is some kind of conspiracy driving the prescription of some medications as opposed to others.
The reality is that the patient has a decision to make and as I have pointed out before, I have really never encountered a person (including myself as a patient) who takes that decision lightly. There are additional interpersonal and psychological factors. My personal bias as a physician is that the primary goal of treatment is minimal to no side effects and that tolerating side effects is a decision made by the patient but informed by the physician. It always needs to be balanced against any therapeutic effect of the medication.
George Dawson, MD, DFAPA:
1: Cousins DH, Gerrett D, Warner B. A review of medication incidents reported to the National Reporting and Learning System in England and Wales over 6 years (2005-2010). Br J Clin Pharmacol. 2012 Oct;74(4):597-604. doi:10.1111/j.1365-2125.2011.04166.x. Review. PubMed PMID: 22188210; PubMed Central PMCID: PMC3477327.
2: Qureshi ZP, Seoane-Vazquez E, Rodriguez-Monguio R, Stevenson KB, Szeinbach SL. Market withdrawal of new molecular entities approved in the United States from 1980 to 2009. Pharmacoepidemiol Drug Saf. 2011 Jul;20(7):772-7. doi: 10.1002/pds.2155. Epub 2011 May 14. PubMed PMID: 21574210
Friday, February 14, 2014
Heat Map of Psychiatric Criticism
On my drive home today I got the idea of a heat map of psychiatric criticism based on the principles outlined in my previous post. I have started one as shown in the diagram below. The heat zones on the map are general areas corresponding to the parameters outlined in the previous post on rhetoric. In other words red and redder would correspond with more irrational and rhetorical criticism. Green and greener would be more rational criticism and less rhetorical. See the previous post for supporting arguments.
I have started out with a few examples in each zone. I would like to be exhaustive here so send me your favorite one liners about the profession or your most hated psychiatrist and I will try to place it on the heat map. Just a heads up, no personal attacks or identifiers will be tolerated. It may be hard to believe but this is nothing personal. I hope to provide a simple graphical solution to the question of what is and what is not appropriate psychiatric criticism.
I also thought about a couple of reasons why this is important. Several years ago a friend of mine called me up and asked me a question about the American Board of Psychiatry and Neurology. He wanted to know what year it was incorporated. I told him I thought it was on my certificate and I would call him later. When I got home I looked at the certificate and sure enough it read: "Incorporated 1934". I called him with the information and asked him why that was important. He is a social worker and told me that he was at a major DSM training course attended by social workers and the speaker (who was not a psychiatrist) suggested that psychiatry was such an illegitimate field that they were not even one of the original specialties and decided to form the ABPN later in order to seem more legitimate. And this was a guy who was teaching a DSM course! In another similar session, the presenter (also not a psychiatrist) compared the validity of psychiatric diagnoses referring to the Robins and Guze criteria to the validity of drapetomania. For anyone not familiar with this definition, it refers to the idea by a 19th century quack that a slave running away is somehow a mental illness. It really has no connection at all to the idea that there are valid mental illnesses that can be diagnosed and treated. And yet here we have a professional making this comparison. The term was also used in a periodical that is valued for its intellectual appeal, but the interview is embarrassing to read especially the tortured attempt to connect it to DSM-5. My speculation is that the people who use this term have an additional agenda. It is clear that there are are many uses of the loose application of this rhetoric and gaining political advantage is often an overlooked one.
As I look at my initial attempt, I am realizing that I need to figure out a way to group all of the statements at the top firmly in the red zone so that none of them touch the transition area to the green zone.
George Dawson, MD, DFAPA
Supplementary 1:
Here is a working list to consider (click to enlarge all graphics on this page). This is the second version and as of today (2/16/2014) no outside suggestions. The image below is formatted to print or store as a single 8.5 x 11 inch page:
I have started out with a few examples in each zone. I would like to be exhaustive here so send me your favorite one liners about the profession or your most hated psychiatrist and I will try to place it on the heat map. Just a heads up, no personal attacks or identifiers will be tolerated. It may be hard to believe but this is nothing personal. I hope to provide a simple graphical solution to the question of what is and what is not appropriate psychiatric criticism.
I also thought about a couple of reasons why this is important. Several years ago a friend of mine called me up and asked me a question about the American Board of Psychiatry and Neurology. He wanted to know what year it was incorporated. I told him I thought it was on my certificate and I would call him later. When I got home I looked at the certificate and sure enough it read: "Incorporated 1934". I called him with the information and asked him why that was important. He is a social worker and told me that he was at a major DSM training course attended by social workers and the speaker (who was not a psychiatrist) suggested that psychiatry was such an illegitimate field that they were not even one of the original specialties and decided to form the ABPN later in order to seem more legitimate. And this was a guy who was teaching a DSM course! In another similar session, the presenter (also not a psychiatrist) compared the validity of psychiatric diagnoses referring to the Robins and Guze criteria to the validity of drapetomania. For anyone not familiar with this definition, it refers to the idea by a 19th century quack that a slave running away is somehow a mental illness. It really has no connection at all to the idea that there are valid mental illnesses that can be diagnosed and treated. And yet here we have a professional making this comparison. The term was also used in a periodical that is valued for its intellectual appeal, but the interview is embarrassing to read especially the tortured attempt to connect it to DSM-5. My speculation is that the people who use this term have an additional agenda. It is clear that there are are many uses of the loose application of this rhetoric and gaining political advantage is often an overlooked one.
As I look at my initial attempt, I am realizing that I need to figure out a way to group all of the statements at the top firmly in the red zone so that none of them touch the transition area to the green zone.
George Dawson, MD, DFAPA
Supplementary 1:
Here is a working list to consider (click to enlarge all graphics on this page). This is the second version and as of today (2/16/2014) no outside suggestions. The image below is formatted to print or store as a single 8.5 x 11 inch page:
Wednesday, February 12, 2014
The Jerk Store Called
In response to a number of posts to my last post, I decided to take an idea posted by Dr. Steven Reidbord and run with it - but at his request I used a different descriptor than the one he suggested. From my early days as a psychiatrist the general idea in our culture is that you basically listen to all of the criticism of psychiatry no matter how nonsensical it is and put up with it. Act as though it is true. In fact, go ahead and make public policy based on it!
One of the most frequent rationalizations for that passive behavior is that there are always some imperfections and therefore just about any criticism is justified - shut up and take it. At some point it becomes obvious that line of logic excludes most reality. When Dr. Reidbord requested that I not use his brilliant metaphor, the only other thing I could think of was the term "jerk". That reminded me of the Seinfeld episode "The Comeback" and George Costanza's failed retort about the Jerk Store so I thought I would include it here. The following post has otherwise been vetted by a philosophy professor and it looked good to him.
So here goes:
4. It is possible to distinguish jerks from psychiatrists and treat each class accordingly.
So if the basis of your psychiatry bashing lies in arguments 1 - > 3.
The jerk store called and ...........
One of the most frequent rationalizations for that passive behavior is that there are always some imperfections and therefore just about any criticism is justified - shut up and take it. At some point it becomes obvious that line of logic excludes most reality. When Dr. Reidbord requested that I not use his brilliant metaphor, the only other thing I could think of was the term "jerk". That reminded me of the Seinfeld episode "The Comeback" and George Costanza's failed retort about the Jerk Store so I thought I would include it here. The following post has otherwise been vetted by a philosophy professor and it looked good to him.
So here goes:
The Jerk Argument
It is a given that the the class of psychiatrists like all major subgroups of people and workers contains some jerks. In this case a jerk can be defined as whatever a hater of psychiatry likes it to be.
Possible conclusions:
1. All psychiatrists
are jerks.
2. Psychiatrists are inherently
evil whether they are jerks or not, jerks are not really any worse.
3. All psychiatrists
should be treated like jerks whether they are jerks or not.
4. It is possible to distinguish jerks from psychiatrists and treat each class accordingly.
5. It is inaccurate
at best to generalize to the entire class of psychiatrists what is observed in
the jerks.
1-> 3 are positions of the various psychiatry bashers
whether they are antipsychiatrists or not, or formal antipsychiatry
philosophies or not. That encompasses a
full range of cults, lone critics with an axe to grind, academics, competing professionals, critics with a book or column to sell, and scandal
mongers. It may even contain some
critics with a legitimate criticism but they end up including these additional
invalid arguments in the body of their work.
These positions contain various logical fallacies and are unsupported at
that level. It is also interesting to
contemplate that these initial conclusions are never applied to any other medical specialty and ideally are not applied to any group of people. Think about substituting any other societal group in those sentences as see what you come up with. Since they are illogical arguments the only
possible conclusion is that psychiatrists as a group are clearly discriminated
against and the basis for that discrimination is irrational.
Jerk logic also has implications for the way that the
government and healthcare organizations treat psychiatrists. The government and managed care attitude toward
psychiatrists is probably most accurately captured in 3. Every regulation
and interaction with a managed care company reinforces that idea. It could also be argued that the managed care
industry is in the business of converting psychiatrists into jerks. That is true if they are employed by the managed
care companies directly or indirectly working on the "medication management" assembly line.
My positions are best represented by 4 and 5. That is the evidence I focus on in this
blog. I have debated with myself about
whether I should fight the bashers head on, but they generally not really
interested in debating logic, scientific evidence, or any evidence contrary to
their argument. Per my previous post they are engaged in sophistry and will post endless fallacious arguments and say that ain't so. So fighting them by definition
is futile and they can aggregate to any number of psychiatry bashing sites on
the Internet where they can revel in their rhetoric.
So if the basis of your psychiatry bashing lies in arguments 1 - > 3.
The jerk store called and ...........
George Dawson, MD, DFAPA
Supplementary 1: As I was preparing this post I noticed this post popped up on the Shrink Rap blog entitled Are Psychiatrists Evil? and that dovetails nicely with my small study in rhetoric. There are several previous posts here that examine this rhetoric in different ways like The Myth of the Psychiatrist as Bogeyman and Why Do They Hate Us?
Supplementary 2: Per this previous post - the antipsychiatry philosophies follow per the reference below. It is also a good example of a potential critic with something useful to say but using invalid arguments of the form given in the body of the above post. A standard tactic is falsely claiming that psychiatrists hold a certain position and then attacking that position as though it is true.
Fulford KWM, Thornton T, Graham G. Oxford Textbook of Philosophy and Psychiatry. Oxford University Press, Oxford, 2006: 17.
"Some of the main models advanced by antipsychiatrists, mainly in the 1960s and 1970s, can be summarized thus:
1. The psychological model...
2. The labeling model...
3. Hidden meaning models...
4. Unconscious mind models...
5. Political control models..." <-Foucault is located here. (p. 17)
Supplementary 3: Of course it is always important to recognize the bullshitters - Is Bullshit A Better Term Than Antipsychiatry?
Supplementary 1: As I was preparing this post I noticed this post popped up on the Shrink Rap blog entitled Are Psychiatrists Evil? and that dovetails nicely with my small study in rhetoric. There are several previous posts here that examine this rhetoric in different ways like The Myth of the Psychiatrist as Bogeyman and Why Do They Hate Us?
Supplementary 2: Per this previous post - the antipsychiatry philosophies follow per the reference below. It is also a good example of a potential critic with something useful to say but using invalid arguments of the form given in the body of the above post. A standard tactic is falsely claiming that psychiatrists hold a certain position and then attacking that position as though it is true.
Fulford KWM, Thornton T, Graham G. Oxford Textbook of Philosophy and Psychiatry. Oxford University Press, Oxford, 2006: 17.
"Some of the main models advanced by antipsychiatrists, mainly in the 1960s and 1970s, can be summarized thus:
1. The psychological model...
2. The labeling model...
3. Hidden meaning models...
4. Unconscious mind models...
5. Political control models..." <-Foucault is located here. (p. 17)
Supplementary 3: Of course it is always important to recognize the bullshitters - Is Bullshit A Better Term Than Antipsychiatry?
Saturday, February 8, 2014
An Obvious Response to "Psychiatry Gone Astray"
David Healy has what I consider to be inconsistent viewpoints. I have previously critiqued his viewpoint on the "addictive" qualities of antidepressants (they clearly are not) and whole heartedly endorsed his position that pills don't treat depression - psychiatrists do. He recently posted what I would refer to as a screed written by a Danish internist on (what else?) all of the problems with psychiatry. The obvious lack of symmetry here is striking. You won't find a psychiatrist anywhere posting a similar piece about internal medicine, even though it could be easily done and would probably be more evidence based. In that regard this physician has slightly more credibility that the typical layperson screed against psychiatry - but not much more. What follows is my point by point refutation of the "myths". They are mythical in that they are from the mind of the author - I know of no psychiatrist who thinks this way.
Myth 1: Your disease is caused by a chemical imbalance in the brain -
Myth 2: It’s no problem to stop treatment with antidepressants -
Myth 3: Psychotropic Drugs for Mental Illness are like Insulin for Diabetes -
Myth 4: Psychotropic drugs reduce the number of chronically ill patients -
Myth 5: Happy pills do not cause suicide in children and adolescents -
Myth 7: Happy pills are not addictive -
Myth 8: The prevalence of depression has increased a lot -
Myth 9: The main problem is not overtreatment, but undertreatment -
Myth 10: Antipsychotics prevent brain damage -
Myth 1: Your disease is caused by a chemical imbalance in the brain -
This is a red herring that is frequently marched out in the media and often connected with a conspiracy theory that psychiatrists are tools of pharmaceutical companies who probably originated this idea. What are the facts? Psychiatry has at least a century old tradition of researching all possible etiologies for mental health problems. Psychiatrists were among the first people to look at the effects of social deprivation in orphanages, the effects of acute grief and loss, the effects of psychological trauma, the effects of a full gamut of psychotherapies, and the effects of family and environment. The biopsychosocial formulation of Engel in 1977 was an advance detailed in Science magazine. Any comprehensive psychiatric formulation covers all possible etiologies (as an obvious example see Systematic Psychiatric Evaluation by Chisolm and Lyketsos). In addition there are many clinical methods where the diagnostic formulation is essential for the treatment plan for psychotherapy based treatment. By definition that formulation would have few biological references. So the alleged myth fails at the clinical level.
It fails even worse at the neurobiological level. Chemical imbalance rhetoric always seems to ignore one huge fact and that is Eric Kandel's classic article on plasticity in 1979 in the New England Journal of Medicine. Certainly any psychiatrist who saw that article has never bought into a "chemical imbalance" idea and I can recall mocking the idea when pharmaceutical companies presented it to my colleagues and I in medical school. So why don't we hear: "Your disease is caused by plasticity?" Probably because they gave Eric Kandel the Nobel Prize for it.
Another red herring. I have trained psychiatrists, internists, family physicians and medical students and taught them psychopharmacology. A general principle of psychopharmacology is no abrupt changes in therapy and most drug prescribing information suggests that. I routinely address this issue as part of informed consent and advise people that there may be difficulty discontinuing antidepressants and describe the potential symptoms. This criticism from an internist has a certain degree of asymmetry to it. Certainly there are medications prescribed by internists that cause both acute withdrawal and discontinuation symptoms. My impression is that many adults who see internists are basically going along with life long therapy in many cases for conditions that could be treated by psychosocial measures. It is quite easy to criticize if you are never faced with the prospect of discontinuing therapy.
The author here conflates the certainty of insulin deficiency with pathophysiological certainty in medicine and how that correlates with prescribed treatment. Certainly that is not the case in diabetes mellitus Type II or the recent example I provided with an asthma exacerbation. In fact the pathophysiology in those heterogenous groups are about as accurate as endophenotypes in psychiatry. Am I getting prednisone for my asthma because I am deficient in prednisone? Am I getting it because of some specific pathophysiological mechanism rather than a shotgun approach to shut down all of my inflammatory signalling? Was predisone prescribed only based on the purported pathophysiological mechanisms? The answer to all three questions is - of course not. If the author is really concerned about medication side effects, I can't think of any psychiatric medication that is the equal of prednisone but I am certainly not going to suggest that it should not be prescribed.
I don't know of anyone who has actually suggested this and from an internal medicine perspective does it make sense? Here are a few additional comparison statistics on asthma and hypertension for example. There is a 10% prevalence of asthma in the developed world. Only 1 in 7 has their symptoms in good control. People continue to die of asthma possible as many as 1/250 deaths world wide. In the case of hypertension, 31% of Americans have it and another 30% have prehypertension. Only 47% have adequate blood pressure control. There is really not much evidence that medications prescribed by internists are much more effective than what he refers to as "psychotropic drugs" and that is borne out in a previous analysis and my own recent experience with the health care system.
I find this argument also demeaning to anyone with a severe psychiatric disorder who is interested in staying out of hospitals and being able to function or trying to avoid a suicide attempt. Being able to adhere to that kind of plan depends on multiple variables including taking medications. It is reckless to suggest otherwise and any psychiatrist knows about severe adverse outcomes that have occurred as a result of stopping a medication. The author conveniently plugs his book at this point.
The author reveals his antipathy to medication used by psychiatrists here by referring to antidepressants as "happy pills." I know of no psychiatrist who I have ever met who calls antidepressants "happy pills" and in fact most of us are engaged in trying to find an effective medication with minimal side effects. David Healy himself describes this as one of the primary functions of psychiatrists. On the actual suicide issue, psychiatrists goal is preventing suicide. Suicide is a possible outcome of all clinical encounters and psychiatrists follow this symptom closely.
Saying that happy pills are a cause of suicide is the equivalent of saying that "sugar medicine" (insulin) is a cause of hypoglycemia that harms children and therefore it should not be prescribed.
Myth 6: Happy pills have no side effects -
The author has one legitimate point in that depression screening is not a good idea but in his zeal to criticize everything psychiatric he has to whip that into "happy pills have no side effects". Of course they do and I have elaborated my clinical method on how to approach that in detail. He goes on to make an anecdotal argument about single study results versus "what the company says." In fact, companies have to rigorously record side effects in clinical trials and all of that is recorded in the FDA prescribing information. Looking at standard FDA reported data for sexual side effects (his example) the number for all SSRI antidepressants is 9-37% and not the 5% figure suggested by the author. (see page 1684 of Drugs Facts and Comparisons 2013).
This is interesting because of David Healy's confusion on this subject. It indicates a serious lack of knowledge about addiction because there are no behavioral features of antidepressant medications or animal models that describe these drugs as addictive. They have no street value and they will not make you high. The authors comparison to amphetamine is completely off the mark and consistent with his general lack of knowledge of addiction.
He has to attach epidemiological data on depression in order to attack the argument that increasing antidepressant use is not a problem because of the increasing prevalence. He offers a sarcastic comment as evidence and misses both the issue of why antidepressant prescriptions are increasing and the real data on the prevalence of depression. Even if his argument is correct, since 80% of antidepressants are prescribed by primary care physicians wouldn't this be "Primary care gone astray?"
On the epidemiology issue I would encourage a quick look at an actual text on the issue like Textbook of Psychiatric Epidemiology, 3rd Edition.(p 292) The authors look at 30 national and international studies and do not conclude that there is an increasing prevalence of depression, but that variation is likely due to methodological differences and sociocultural factors.
On the epidemiology issue I would encourage a quick look at an actual text on the issue like Textbook of Psychiatric Epidemiology, 3rd Edition.(p 292) The authors look at 30 national and international studies and do not conclude that there is an increasing prevalence of depression, but that variation is likely due to methodological differences and sociocultural factors.
More sarcasm as evidence here. I debunked the arithmetic used in this argument in an earlier Washington Post piece. This is also a huge disservice to people with severe mental illness and addictions in this country who have been thrown out of treatment, received useless hospital treatments, and restricted from medications by managed care. The primary prescribers of antidepressants (by far) are primary care physicians and it is certainly possible that they are prescribing too many antidepressants. But don't blame psychiatrists for that.
More rhetoric. In this case he is using a research hypothesis and suggesting that this has something to do with clinical psychiatry. Despite significant obstacles, psychiatric research at the neurobiological level continues and studies on imaging are a large part of that process. One of the major areas has to do with brain volumes and their implications. The author presumes he knows what the outcome of that research will be. He also talks about antipsychotic medication with the arrogance of a person who does not have to treat acutely psychotic people and incredibly talks about these drugs killing people. In fact, the number one killer of people with severe mental illnesses is tobacco smoke and there is ample evidence that they get suboptimal primary care.
At the end of this refutation what have we learned? I am more skeptical than ever of David Healy and his web site. I thought he did good work with his investigation of SSRIs and his analysis of the role of psychiatrists as opposed to medications was accurate. But I can't ignore the fact that he places this screed on his web site. He also lists himself as a "scientist" and this screed contains surprisingly little science. It is essentially all rhetoric and politics.
It is one thing to ridicule psychiatrists but the obvious concern here is that it stigmatizes people who need treatment especially treatment with medication who are actively denied treatment in the U.S. on an ongoing basis. The author here uses a familiar dynamic that I have described in the past. He suggests that internists (like the author here) have clearly superior methods or pathophysiological mechanisms than psychiatrists but they don't. In terms of the accusation of overprescribing, it is well know in the US that the 20 year CDC initiative to control antibiotic overprescribing is a failure. Some authors believe that this heralds a new "post antibiotic era" where untreatable infections will become the rule.
It is one thing to ridicule psychiatrists but the obvious concern here is that it stigmatizes people who need treatment especially treatment with medication who are actively denied treatment in the U.S. on an ongoing basis. The author here uses a familiar dynamic that I have described in the past. He suggests that internists (like the author here) have clearly superior methods or pathophysiological mechanisms than psychiatrists but they don't. In terms of the accusation of overprescribing, it is well know in the US that the 20 year CDC initiative to control antibiotic overprescribing is a failure. Some authors believe that this heralds a new "post antibiotic era" where untreatable infections will become the rule.
It seems to me that internists have enough to focus on in their own specialty before criticizing an area that they obviously know so little about. It also seems that if you claim your web site is scientific, you should probably put a little science on it. The author here also states that he is affiliated with the Nordic Cochrane Center and I think that anyone who considers the output of that Institute should consider what he has written here and the relevant conflict of interest issues.
George Dawson, MD, DFAPA
Supplementary 1: About a month after this post was completed Ronald Pies, MD came out with an article in the Psychiatric Times entitled Nuances, Narratives, and the “Chemical Imbalance” Debate. He presents very similar arguments to the ones presented here and concludes that it is time for the critics using this false argument to give it up. I also like his characterization of "a recent online polemic posing as investigative journalism" and how the "chemical imbalance hypothesis" is used to mischaracterize psychiatry. He also provides a link to a 2011 article that he wrote that contain the following quote:
"I am not one who easily loses his temper, but I confess to experiencing markedly increased limbic activity whenever I hear someone proclaim, “Psychiatrists think all mental disorders are due to a chemical imbalance!” In the past 30 years, I don’t believe I have ever heard a knowledgeable, well-trained psychiatrist make such a preposterous claim, except perhaps to mock it. "
Supplementary 1: About a month after this post was completed Ronald Pies, MD came out with an article in the Psychiatric Times entitled Nuances, Narratives, and the “Chemical Imbalance” Debate. He presents very similar arguments to the ones presented here and concludes that it is time for the critics using this false argument to give it up. I also like his characterization of "a recent online polemic posing as investigative journalism" and how the "chemical imbalance hypothesis" is used to mischaracterize psychiatry. He also provides a link to a 2011 article that he wrote that contain the following quote:
"I am not one who easily loses his temper, but I confess to experiencing markedly increased limbic activity whenever I hear someone proclaim, “Psychiatrists think all mental disorders are due to a chemical imbalance!” In the past 30 years, I don’t believe I have ever heard a knowledgeable, well-trained psychiatrist make such a preposterous claim, except perhaps to mock it. "
Readers of this blog have heard seen me say this many times before. It is good to see these opinions being offered in the more mainstream media. It is also good to see Dr. Pies taking calling a critic on what is rhetoric rather than reality. Well done.
Supplementary 2: I have an updated post on the issue of how medical syndromes and psychiatric syndromes are far more similar than different and how there is a complete lack of criticism relative to psychiatry. (added on September 3, 2015).
Supplementary 2: I have an updated post on the issue of how medical syndromes and psychiatric syndromes are far more similar than different and how there is a complete lack of criticism relative to psychiatry. (added on September 3, 2015).
Friday, February 7, 2014
Medical Knowledge Goes A Long Way - Or Does it?
"Exacerbation of both COPD and asthma, which are basically defined and diagnosed by clinical symptoms, is associated with a rapid decline in lung function and increased mortality." - Frontiers in Microbiology October 1, 2013.
For starters this is a lengthy and somewhat obsessive look at a personal episode of illness and the implications it has for some of the common threads on this blog ( overidealization of general medicine, dislike of psychiatry, inaccurate comparisons of psychiatry to the rest of medicine, wild criticism of psychiatry, etc.). So if you are not into that - this would be a good place to stop and move on...........
I have been off work 9 out of the past 10 days with an upper respiratory infection leading to an exacerbation of asthma. At least that is one theory. I first noticed it when I stepped off my ergometer trainer about 2 weeks ago and noticed that I did not seem to be able to take a deep breath and I was wheezing mildly. I saw an Internist the next day who did a history and examination and got a chest x-ray and an electrocardiogram - both of which were normal. She decided to double the dose of a corticosteroid inhaler that I was using and told me to increase double the dose of the albuterol inhaler I was using. She said she would not add oral prednisone at this point. When I got home I realized that my corticosteroid inhaler was empty and I needed a new one. The office was contacted and sent a prescription for the previous dose rather than the new dose. When I called and asked them to read the documentation, the note mentioned an even higher dose that was not possible with the inhaler I was using. The inhaler cost $187 for one month so I figured it was easier just to start using it rather than wait for them to sort of all of the communication problems, especially because the physician was not available for another several days and I was still wheezing.
Two days passed and my breathing seemed slightly better so I went into work. By mid afternoon the inability to take in a deep breath came back and I went to an Urgent Care clinic through my health plan right after work. The new doctor repeated the history, physical, and chest x-ray (again negative). He prescribed a more intensive course of therapy with a 12 day prednisone taper starting at 60 mg/day and a nebulizer machine with ampules of 2.5 mg albuterol. He told me to keep taking both inhalers and add both of these. When I got home I took the prednisone and assembled and used the nebulizer.
I will digress to say that I am a firm believer in the absolute need to control blood pressure and pulse. I measure my blood pressure and pulse four times a day or more depending on the circumstances. White coat hypertension probably happens but how many people know what their blood pressure is once they get back home? I know from personal experience that a hostile work environment can drive both your pulse and blood pressure through the roof not just for days but for weeks to months. The only time I am comfortable being hypertensive is when I am exercising because it it physiological, I have been monitored doing it by sports physiologists and they were happy with it, and I know there is a compensatory post exercise response that controls BP and pulse in the long run. I take what most physicians agree is a homeopathic amount of antihypertensive but my BP is never greater than the CDC recommended cut off blood pressure of 120/80. It is usually 10 points less. That belief comes from seeing many people over the years who had decades of untreated hypertension that either they or their physician seemed to attribute to something else. Psychiatrists are occasionally in the situation of treating patients with extremely high blood pressures like greater than 200 systolic and 120 diastolic who refuse treatment. They are usually being seen by psychiatrists because of the need to get a court order for them to be treated and that often takes several weeks, putting the patient at risk all the while. I have seen the full spectrum of blood pressure related problems and there is only one logical conclusion that blood pressure needs to be well controlled.
I am also a student of respiratory viruses and a veteran of two different avian influenza task forces. The task force experience left me quite pessimistic about our ability to fight off any actual pandemic for a reason that is quite striking - the denial that there is an airborne route of infection. Everyone on the task force was focused on hand washing and controlling fomites and there was very little focus on what was needed to contain airborne infections, probably because we learned that capacity would be overwhelmed on the first day of the pandemic. At that point we are basically in a slightly better position than we were in the influenza epidemic of 1918. At one point they showed us a couple of plastic covered pallets of Tamiflu in a government warehouse somewhere. I stopped attending when they started to talk about where the dead bodies would be stored.
But my interest is also in the area of common everyday respiratory viruses. When you are working in a hospital with 1970s era ventilation systems (contain the air to save heat) you witness the staff around you and yourself and the patients get ill in mini-epidemics 3 - 4 times a year. All with the same symptoms of varying severity. Some will end up on antibiotics and some will end up on Medrol dose packs or both. It happens whether you wash your hands or not. At some point I started to e-mail the Minnesota Department of Health and inquire about the respiratory surveillance of flu and flu like illness. At some point they got tired of my email and put it all online. The bottom panels show (with a lag time) the likely viral culprits based on various identification methods. Rhinovirus and adenovirus are among the usual suspects. Reading my copy of Gorbach, Bartlett and Blacklow confirms the syndromes.These are the kinds of trends I would see every year. I consulted with a top expert in airborne viruses in building. He had done the first studies to confirm that viruses can be sampled in the airflow of buildings and that they are typically airborne viruses. For two years, I studied the airflow and filtering characteristics of buildings and how older ventilation systems might be modifiable to reduce the risk of respiratory infect by airborne viruses. I looked at the specific air flow characteristics of the building I worked in. I surveyed the employees on each unit showing a high clustering of upper respiratory infections and and flu like illnesses. During that entire time I got numerous respiratory infections with no exacerbations of asthma, but according to the following graphic - it was just a matter of time (click to enlarge):
After the initial nebulizer treatment my systolic and diastolic blood pressure was up about 30% and I was feeling somewhat agitated and anxious. I had only had one nebulizer treatment in my life and it was about 20 years ago. I looked at the doses and found the inhaler contained 180 mcg of albuterol compared to the 2.5 mg in the nebulizer with greater bioavailability. In other words the nebulizer delivered 14 times the dose and I was told to use it up to 6 times a day. I slept about 2 hours that night.
The next day I ran a drug interaction search on my revised list of medications and several potential drug interactions were noted - a couple of them significant. I logged into my health plan and sent my personal Internist a note with several question on the interactions with drugs and my existing medical morbidities. He called me up concerned that I might have the flu, but I had just seen him and been referred for an extensive immunology evaluation for the flu shot and got it. I told him about my experience with the nebulizer and he chuckled: "In the ER they might give you this very 1 - 2 hours but of course you are hooked up to a monitor and they are checking your blood every hour." At this point I have not had a single blood test. He suggested that I try a new inhaler - levalbuterol and the equivalent nebulizers. They were supposed to have fewer side effects. I spaced the treatments out exactly 8 hours and five minutes after the third treatment my heart rate shot up to 140 beats per minute and a blood pressure of 147/103. I took some medication that I knew would bring it down in about 45 minutes, but also prepared to call 911 if it continued to climb. Gradually over the course of 30 minutes my blood pressure and pulse recovered.
So what can be concluded by my latest foray into the healthcare system?
1. Medical knowledge may not lead to any improvements. As far as I can tell nobody is very receptive to the idea that respiratory viruses exist and that while hand washing is helpful it will not necessarily protect you against some of the worst viruses. The unreceptive parties occur at all administrative levels and seem content with watching employees get recurrent viral infections and use their paid time off. Is that a form of cost shifting?
2. Syndromal diagnoses are alive and well in medicine and not just psychiatry. I have talked with 4 physicians during this week long bout of illness and none of them have a clear diagnosis other than an exacerbation of asthma. The asthma we are talking about is not a specific type or subtype that may have implications for treatment - but the good old heterogeneous type. As heterogeneous as just about every known psychiatric diagnosis. The first physician thought the likely cause was dry winter air. By the time I had seen the second physician I had some additional symptoms to suggest a URI. Only my personal physician seemed concerned that I may have influenza and called me back a second day to make sure that I had not developed a fever. I had vital signs determined, peak flow meters, oxygen saturations, 2 chest x-rays and an electrocardiogram. None of the tests was a biological test for asthma or whether there was an underlying infectious agent. None of the tests were positive or could quantitate my illness. Recall that a typical argument rolled out about psychiatric diagnoses is that there is no specific test and that they are all syndromes. I learned that clinics in my health care system no longer do the rapid test for influenza because it is not considered to be accurate. In all cases I was being treated based on a syndrome and nothing else.
3. Could a more specific diagnosis be worthwhile? Most certainly since there is some evidence that rhinovirus is a common cause of asthma exacerbations and may also be a cause for asthma in childhood. There is also evidence that rhinovirus can replicate its RNA in the lower respiratory tract for up to 16 days post infection. It was only recently discovered that rhinovirus inhabits the lower respiratory tract and can replicate there. The biological test that was done for influenza is no longer used because it was inaccurate, would that be useful to know? I have a previous post here about asthma endophenotypes. Is there an endophenotype for rhinovirus induced asthma? Is it caused by epigenetic mechanisms? These are all parallel questions that psychiatric researchers are working on right now with most major psychiatric disorders.
4. Cost shifting to the patient is paramount from several sources. I purchased 3 - $200 inhalers in 3 days that were not covered by my insurer. The first one was an error because it would have covered 2 weeks of treatment and it did not match the documentation in the original note. In all three cases the pharmacists warned me about the high cost of the inhaler, but when I asked them if there was a generic substitution they said there was none. The current albuterol inhaler also has no generic apparently because it is the only environmentally friendly one. That is the difference between a $50 copay and a $4 copay. There is also an angle from the perspective of ethical purism and pharmaceutical manufacturers. Is this a case to be made for samples? Should a patient try a sample of the inhaler in their doctor's office to make sure they can tolerate it and know the price before going to the pharmacy? That way there would be an assurance that the patient could tolerate and afford a very expensive medication. I currently have $400 of inhalers that will be used twice and are otherwise worthless to me. The other scenario that is difficult to contemplate is a person being forced to drive away from the pharmacy without a medication due to the surprise cost or copay.
5. There was minimal discussion of side effects and contingencies but scripting was noted. Scripting is a public relations initiative where health care personnel are trained to ask questions that the patient may be asked about in a satisfaction survey. For example at the end of the visit the physician says: "Do you have any additional questions for me today?" A week later you get a survey to rate the physician on whether or not he asked that question. In the meantime no warnings about prednisone or what to do if I got hypertension or tachycardia from the albuterol. I was told that I might expect some palpitations and that might be expected because "there was more medicine in there than from the inhaler". The levoalbuterol was supposed to solve the problem but it resulted in significant tachycardia and I later learned it was pulled from a hospital formulary because it did not "work as advertised". That is the optical isomer did not protect against side effects like tachycardia.
6. Pattern matching is implicit and probably carries the day. I have previously written about the importance of pattern matching in medical diagnosis and it was probably a significant factor in all of my physician encounters. They looked at me and could tell I was not acutely ill - I did not need to go to a hospital. There are various ways of phrasing it but that conclusion was uniform. The pattern matching also probably drives a lot of the questions that flowed from the patterns of asthma exacerbation in their previous patient encounters.
7. Complex medical diagnoses are a process. On this blog I have pointed out why a checklist screening is generally an inadequate approach. There is probably no better example than logging in to your health care system's triage software and realizing that your problem is not listed among the choices. In this case information changed over time from asthma due cold air to asthma due to a viral exacerbation. The treatment was also significantly and expensively changed along the way.
8. Asthma and related conditions are a huge public health problem. The prevalence of asthma is about 10% in developing countries and it accounts for 1 of every 250 deaths worldwide. Only 1 in 7 people with asthma have it well controlled. Public health interventions seem like a last resort. Trying to get people interested in the true nature of airborne viruses and how to prevent these cyclical infections is practically impossible as far as I can tell. I have corresponded with the head of the Cochrane Collaboration section on Physical interventions to interrupt or reduce the spread of respiratory viruses who cautioned me that no one knows how URIs spread or how many of the interventions work! Even World Health Organization (WHO) initiatives seems to leave out the all important aspect of building design and airflow. There seems to be a distinct medical bias when it comes to respiratory infections. The only potentially useful and very cost effective public health interventions that I may have availed myself of are the pneumococcal vaccine polyvalent (Pneumovax) vaccine and the influenza vaccine.
A related issue is how much epigenetics comes into play, specifically epigenetic modifications that occur to environmental exposure of let's say - rhinovirus. Is it possible that exposure to rhinovirus causes more long term health problems for kids than exposure to cigarette smoke? If that is even possible, why aren't we doing more about it?
9. The elegant hypothetical molecular mechanisms of disease don't translate well to clinical medicine in the case of asthma any more than they do with mental illnesses. Skeptics and critics of psychiatry (most of whom seem to know nothing about molecular biology) frequently use this rhetoric without understanding how little these mechanisms apply in other major diseases. Cytokine signalling alone has been described as "having such staggering complexity that the long term behavior of system is essentially unpredictable." Brain complexity is far greater. The use of prednisone to shut down inflammation is more of a shotgun approach to shutting down inflammation rather than anything to do with disease specificity. Given the fact that endophenotypes are not actually diagnosed at this point and viral infections often are associated with acute onset of asthma, it would seem that there is not a lot of diagnostic specificity beside the syndromes. There is also the question of the time course of improvement. People have ideas about how quickly medication prescribed by a psychiatrist should take to work. Very few of those ideas are accurate. On the other hand here I am on day 16 of treatment for asthma and I am still ill. Aren't real treatments that are based on elegant biological mechanisms supposed to work faster than that?
In the end I am reminded that psychiatry is no different than the rest of medicine that deals with complex heterogenous conditions. Diagnoses are imprecise, there is a focus on patterns, there are very few pathognomonic or gold standard tests, and the management of side effects of medications is as important as treating the underlying problem - at least in non acute situations. Information transfer between the patient and physician is imperfect and nobody seems to be working on ways to optimize it. If anything the critical time domain is being restricted by businesses and governments. Those same businesses and governments seem completely disinterested in non medical approaches to reducing disease burden like building design. There are plenty of false positives and the best assurance you can get is from a single physician who knows you the best. Despite all of the medical care I have received these past two weeks, I think about all of the decisions I had to make on my own and ask myself: "How do people with no medical training decide what to do in this situation and how do they know what information is relevant?"
It must be mind boggling.
Despite all of the technology and medical knowledge a lot of the information transfer still comes down to what happens between the patient and the doctor. There has to be enough time for that to happen. It has to be meaningful and the patient should know what to do if problems occur.
That is true for doctors of all specialties.
George Dawson, MD, DFAPA
Supplementary Information 1: The supplementary material here is a graphical primer on allergic asthma and how exacerbations of asthma may occur. Rather than an airborne allergen a respiratory virus triggers the cascade of events that leads to the flare up (top figure). That fact is still only recently being elucidated. For example, rhinovirus is a common initiator and it has only recently been demonstrated that rhinovirus replicates in the lower respiratory tract and that rhinovirus RNA can be present for as long as 16 days. As indicated by the tables that follow, cytokine signalling in asthma is complex. The authors show here it may involve up to 22 separate cytokines. Corticosteroids like prednisone and prednisolone inhibit gene expression via transcription factor NFκB to decrease the activity of cytokines. They also reduce the activity of nitric oxide, prostaglandins, leukotrienes, and adhesion molecules by similar effects on on synthesis and decrease lymphocyte activity.
Supplementary Information 2: I have a post available that looks at the early addition of prednisone, but there is a lot of additional information. The following table is the actual course of treatment that I received from four different physicians (color coded) over the course of two weeks. It is posted here for discussion purposes only and should not in any way be construed as medical advice. The disclaimer for this blog applies in that nothing here is for the purpose of medical treatment or advice.
For starters this is a lengthy and somewhat obsessive look at a personal episode of illness and the implications it has for some of the common threads on this blog ( overidealization of general medicine, dislike of psychiatry, inaccurate comparisons of psychiatry to the rest of medicine, wild criticism of psychiatry, etc.). So if you are not into that - this would be a good place to stop and move on...........
I have been off work 9 out of the past 10 days with an upper respiratory infection leading to an exacerbation of asthma. At least that is one theory. I first noticed it when I stepped off my ergometer trainer about 2 weeks ago and noticed that I did not seem to be able to take a deep breath and I was wheezing mildly. I saw an Internist the next day who did a history and examination and got a chest x-ray and an electrocardiogram - both of which were normal. She decided to double the dose of a corticosteroid inhaler that I was using and told me to increase double the dose of the albuterol inhaler I was using. She said she would not add oral prednisone at this point. When I got home I realized that my corticosteroid inhaler was empty and I needed a new one. The office was contacted and sent a prescription for the previous dose rather than the new dose. When I called and asked them to read the documentation, the note mentioned an even higher dose that was not possible with the inhaler I was using. The inhaler cost $187 for one month so I figured it was easier just to start using it rather than wait for them to sort of all of the communication problems, especially because the physician was not available for another several days and I was still wheezing.
Two days passed and my breathing seemed slightly better so I went into work. By mid afternoon the inability to take in a deep breath came back and I went to an Urgent Care clinic through my health plan right after work. The new doctor repeated the history, physical, and chest x-ray (again negative). He prescribed a more intensive course of therapy with a 12 day prednisone taper starting at 60 mg/day and a nebulizer machine with ampules of 2.5 mg albuterol. He told me to keep taking both inhalers and add both of these. When I got home I took the prednisone and assembled and used the nebulizer.
I will digress to say that I am a firm believer in the absolute need to control blood pressure and pulse. I measure my blood pressure and pulse four times a day or more depending on the circumstances. White coat hypertension probably happens but how many people know what their blood pressure is once they get back home? I know from personal experience that a hostile work environment can drive both your pulse and blood pressure through the roof not just for days but for weeks to months. The only time I am comfortable being hypertensive is when I am exercising because it it physiological, I have been monitored doing it by sports physiologists and they were happy with it, and I know there is a compensatory post exercise response that controls BP and pulse in the long run. I take what most physicians agree is a homeopathic amount of antihypertensive but my BP is never greater than the CDC recommended cut off blood pressure of 120/80. It is usually 10 points less. That belief comes from seeing many people over the years who had decades of untreated hypertension that either they or their physician seemed to attribute to something else. Psychiatrists are occasionally in the situation of treating patients with extremely high blood pressures like greater than 200 systolic and 120 diastolic who refuse treatment. They are usually being seen by psychiatrists because of the need to get a court order for them to be treated and that often takes several weeks, putting the patient at risk all the while. I have seen the full spectrum of blood pressure related problems and there is only one logical conclusion that blood pressure needs to be well controlled.
I am also a student of respiratory viruses and a veteran of two different avian influenza task forces. The task force experience left me quite pessimistic about our ability to fight off any actual pandemic for a reason that is quite striking - the denial that there is an airborne route of infection. Everyone on the task force was focused on hand washing and controlling fomites and there was very little focus on what was needed to contain airborne infections, probably because we learned that capacity would be overwhelmed on the first day of the pandemic. At that point we are basically in a slightly better position than we were in the influenza epidemic of 1918. At one point they showed us a couple of plastic covered pallets of Tamiflu in a government warehouse somewhere. I stopped attending when they started to talk about where the dead bodies would be stored.
But my interest is also in the area of common everyday respiratory viruses. When you are working in a hospital with 1970s era ventilation systems (contain the air to save heat) you witness the staff around you and yourself and the patients get ill in mini-epidemics 3 - 4 times a year. All with the same symptoms of varying severity. Some will end up on antibiotics and some will end up on Medrol dose packs or both. It happens whether you wash your hands or not. At some point I started to e-mail the Minnesota Department of Health and inquire about the respiratory surveillance of flu and flu like illness. At some point they got tired of my email and put it all online. The bottom panels show (with a lag time) the likely viral culprits based on various identification methods. Rhinovirus and adenovirus are among the usual suspects. Reading my copy of Gorbach, Bartlett and Blacklow confirms the syndromes.These are the kinds of trends I would see every year. I consulted with a top expert in airborne viruses in building. He had done the first studies to confirm that viruses can be sampled in the airflow of buildings and that they are typically airborne viruses. For two years, I studied the airflow and filtering characteristics of buildings and how older ventilation systems might be modifiable to reduce the risk of respiratory infect by airborne viruses. I looked at the specific air flow characteristics of the building I worked in. I surveyed the employees on each unit showing a high clustering of upper respiratory infections and and flu like illnesses. During that entire time I got numerous respiratory infections with no exacerbations of asthma, but according to the following graphic - it was just a matter of time (click to enlarge):
After the initial nebulizer treatment my systolic and diastolic blood pressure was up about 30% and I was feeling somewhat agitated and anxious. I had only had one nebulizer treatment in my life and it was about 20 years ago. I looked at the doses and found the inhaler contained 180 mcg of albuterol compared to the 2.5 mg in the nebulizer with greater bioavailability. In other words the nebulizer delivered 14 times the dose and I was told to use it up to 6 times a day. I slept about 2 hours that night.
The next day I ran a drug interaction search on my revised list of medications and several potential drug interactions were noted - a couple of them significant. I logged into my health plan and sent my personal Internist a note with several question on the interactions with drugs and my existing medical morbidities. He called me up concerned that I might have the flu, but I had just seen him and been referred for an extensive immunology evaluation for the flu shot and got it. I told him about my experience with the nebulizer and he chuckled: "In the ER they might give you this very 1 - 2 hours but of course you are hooked up to a monitor and they are checking your blood every hour." At this point I have not had a single blood test. He suggested that I try a new inhaler - levalbuterol and the equivalent nebulizers. They were supposed to have fewer side effects. I spaced the treatments out exactly 8 hours and five minutes after the third treatment my heart rate shot up to 140 beats per minute and a blood pressure of 147/103. I took some medication that I knew would bring it down in about 45 minutes, but also prepared to call 911 if it continued to climb. Gradually over the course of 30 minutes my blood pressure and pulse recovered.
So what can be concluded by my latest foray into the healthcare system?
1. Medical knowledge may not lead to any improvements. As far as I can tell nobody is very receptive to the idea that respiratory viruses exist and that while hand washing is helpful it will not necessarily protect you against some of the worst viruses. The unreceptive parties occur at all administrative levels and seem content with watching employees get recurrent viral infections and use their paid time off. Is that a form of cost shifting?
2. Syndromal diagnoses are alive and well in medicine and not just psychiatry. I have talked with 4 physicians during this week long bout of illness and none of them have a clear diagnosis other than an exacerbation of asthma. The asthma we are talking about is not a specific type or subtype that may have implications for treatment - but the good old heterogeneous type. As heterogeneous as just about every known psychiatric diagnosis. The first physician thought the likely cause was dry winter air. By the time I had seen the second physician I had some additional symptoms to suggest a URI. Only my personal physician seemed concerned that I may have influenza and called me back a second day to make sure that I had not developed a fever. I had vital signs determined, peak flow meters, oxygen saturations, 2 chest x-rays and an electrocardiogram. None of the tests was a biological test for asthma or whether there was an underlying infectious agent. None of the tests were positive or could quantitate my illness. Recall that a typical argument rolled out about psychiatric diagnoses is that there is no specific test and that they are all syndromes. I learned that clinics in my health care system no longer do the rapid test for influenza because it is not considered to be accurate. In all cases I was being treated based on a syndrome and nothing else.
3. Could a more specific diagnosis be worthwhile? Most certainly since there is some evidence that rhinovirus is a common cause of asthma exacerbations and may also be a cause for asthma in childhood. There is also evidence that rhinovirus can replicate its RNA in the lower respiratory tract for up to 16 days post infection. It was only recently discovered that rhinovirus inhabits the lower respiratory tract and can replicate there. The biological test that was done for influenza is no longer used because it was inaccurate, would that be useful to know? I have a previous post here about asthma endophenotypes. Is there an endophenotype for rhinovirus induced asthma? Is it caused by epigenetic mechanisms? These are all parallel questions that psychiatric researchers are working on right now with most major psychiatric disorders.
4. Cost shifting to the patient is paramount from several sources. I purchased 3 - $200 inhalers in 3 days that were not covered by my insurer. The first one was an error because it would have covered 2 weeks of treatment and it did not match the documentation in the original note. In all three cases the pharmacists warned me about the high cost of the inhaler, but when I asked them if there was a generic substitution they said there was none. The current albuterol inhaler also has no generic apparently because it is the only environmentally friendly one. That is the difference between a $50 copay and a $4 copay. There is also an angle from the perspective of ethical purism and pharmaceutical manufacturers. Is this a case to be made for samples? Should a patient try a sample of the inhaler in their doctor's office to make sure they can tolerate it and know the price before going to the pharmacy? That way there would be an assurance that the patient could tolerate and afford a very expensive medication. I currently have $400 of inhalers that will be used twice and are otherwise worthless to me. The other scenario that is difficult to contemplate is a person being forced to drive away from the pharmacy without a medication due to the surprise cost or copay.
5. There was minimal discussion of side effects and contingencies but scripting was noted. Scripting is a public relations initiative where health care personnel are trained to ask questions that the patient may be asked about in a satisfaction survey. For example at the end of the visit the physician says: "Do you have any additional questions for me today?" A week later you get a survey to rate the physician on whether or not he asked that question. In the meantime no warnings about prednisone or what to do if I got hypertension or tachycardia from the albuterol. I was told that I might expect some palpitations and that might be expected because "there was more medicine in there than from the inhaler". The levoalbuterol was supposed to solve the problem but it resulted in significant tachycardia and I later learned it was pulled from a hospital formulary because it did not "work as advertised". That is the optical isomer did not protect against side effects like tachycardia.
6. Pattern matching is implicit and probably carries the day. I have previously written about the importance of pattern matching in medical diagnosis and it was probably a significant factor in all of my physician encounters. They looked at me and could tell I was not acutely ill - I did not need to go to a hospital. There are various ways of phrasing it but that conclusion was uniform. The pattern matching also probably drives a lot of the questions that flowed from the patterns of asthma exacerbation in their previous patient encounters.
7. Complex medical diagnoses are a process. On this blog I have pointed out why a checklist screening is generally an inadequate approach. There is probably no better example than logging in to your health care system's triage software and realizing that your problem is not listed among the choices. In this case information changed over time from asthma due cold air to asthma due to a viral exacerbation. The treatment was also significantly and expensively changed along the way.
8. Asthma and related conditions are a huge public health problem. The prevalence of asthma is about 10% in developing countries and it accounts for 1 of every 250 deaths worldwide. Only 1 in 7 people with asthma have it well controlled. Public health interventions seem like a last resort. Trying to get people interested in the true nature of airborne viruses and how to prevent these cyclical infections is practically impossible as far as I can tell. I have corresponded with the head of the Cochrane Collaboration section on Physical interventions to interrupt or reduce the spread of respiratory viruses who cautioned me that no one knows how URIs spread or how many of the interventions work! Even World Health Organization (WHO) initiatives seems to leave out the all important aspect of building design and airflow. There seems to be a distinct medical bias when it comes to respiratory infections. The only potentially useful and very cost effective public health interventions that I may have availed myself of are the pneumococcal vaccine polyvalent (Pneumovax) vaccine and the influenza vaccine.
A related issue is how much epigenetics comes into play, specifically epigenetic modifications that occur to environmental exposure of let's say - rhinovirus. Is it possible that exposure to rhinovirus causes more long term health problems for kids than exposure to cigarette smoke? If that is even possible, why aren't we doing more about it?
9. The elegant hypothetical molecular mechanisms of disease don't translate well to clinical medicine in the case of asthma any more than they do with mental illnesses. Skeptics and critics of psychiatry (most of whom seem to know nothing about molecular biology) frequently use this rhetoric without understanding how little these mechanisms apply in other major diseases. Cytokine signalling alone has been described as "having such staggering complexity that the long term behavior of system is essentially unpredictable." Brain complexity is far greater. The use of prednisone to shut down inflammation is more of a shotgun approach to shutting down inflammation rather than anything to do with disease specificity. Given the fact that endophenotypes are not actually diagnosed at this point and viral infections often are associated with acute onset of asthma, it would seem that there is not a lot of diagnostic specificity beside the syndromes. There is also the question of the time course of improvement. People have ideas about how quickly medication prescribed by a psychiatrist should take to work. Very few of those ideas are accurate. On the other hand here I am on day 16 of treatment for asthma and I am still ill. Aren't real treatments that are based on elegant biological mechanisms supposed to work faster than that?
In the end I am reminded that psychiatry is no different than the rest of medicine that deals with complex heterogenous conditions. Diagnoses are imprecise, there is a focus on patterns, there are very few pathognomonic or gold standard tests, and the management of side effects of medications is as important as treating the underlying problem - at least in non acute situations. Information transfer between the patient and physician is imperfect and nobody seems to be working on ways to optimize it. If anything the critical time domain is being restricted by businesses and governments. Those same businesses and governments seem completely disinterested in non medical approaches to reducing disease burden like building design. There are plenty of false positives and the best assurance you can get is from a single physician who knows you the best. Despite all of the medical care I have received these past two weeks, I think about all of the decisions I had to make on my own and ask myself: "How do people with no medical training decide what to do in this situation and how do they know what information is relevant?"
It must be mind boggling.
Despite all of the technology and medical knowledge a lot of the information transfer still comes down to what happens between the patient and the doctor. There has to be enough time for that to happen. It has to be meaningful and the patient should know what to do if problems occur.
That is true for doctors of all specialties.
George Dawson, MD, DFAPA
Supplementary Information 1: The supplementary material here is a graphical primer on allergic asthma and how exacerbations of asthma may occur. Rather than an airborne allergen a respiratory virus triggers the cascade of events that leads to the flare up (top figure). That fact is still only recently being elucidated. For example, rhinovirus is a common initiator and it has only recently been demonstrated that rhinovirus replicates in the lower respiratory tract and that rhinovirus RNA can be present for as long as 16 days. As indicated by the tables that follow, cytokine signalling in asthma is complex. The authors show here it may involve up to 22 separate cytokines. Corticosteroids like prednisone and prednisolone inhibit gene expression via transcription factor NFκB to decrease the activity of cytokines. They also reduce the activity of nitric oxide, prostaglandins, leukotrienes, and adhesion molecules by similar effects on on synthesis and decrease lymphocyte activity.
