Sunday, September 30, 2018

Anti-ECT Rhetoric ........




There is probably no clearer example of the pernicious effect of rhetoric in psychiatry than what has happened with electroconvulsive therapy or ECT.  ECT has a demonstrated therapeutic and life saving effect for decades and yet it is a flashpoint for antipsychiatry groups.  I had the experience of being attacked for pointing this out and the people attacking me posted references from a book that was published in 1980 and it was debunked at the time of publication in a book report in the New England Journal of Medicine.  Ignoring what the facts are - often for decades is one of the rhetorical techniques. Interestingly that technique was pointed out in the book report.

There is no doubt that ECT is a very safe and effective treatment. The onset of action is also much faster than can be expected from medications of psychotherapy. But the most important aspect of the ECT recommendation is way it is recommended by clinical psychiatrists.  It is not recommended for everyone just because it is highly effective.  Clinical psychiatrists recommend ECT for treatment resistant depression. By definition, that means various treatment modalities have been tried and found to be ineffective.   That may have included many antidepressant trials. It is often forgotten these days that psychiatrists are seeing patients who have been treated for decades with antidepressants.  I often see people who have been taking the same antidepressant with dose modifications for 10-15 years or people who have been taking 5-9 different antidepressants over the same period of time.  Those antidepressants have been prescribed by various non-psychiatrists.  The majority of these patients have also seen psychotherapists and list the acronyms (CBT, DBT, IPT, ACT, REBT, etc) and specifics about the therapy. They are also clear that they were not helped by psychotherapy.

The process of being stuck in that situation by itself can lead to increasing hopelessness associated with the thought: "Am I always going to be depressed? Is there anything that can be done to get rid of this depression. Would it be better for myself and anyone else if I was just dead rather than hanging on like this?" In the case of more dangerous forms of depression, delusional thinking presents a greater level of danger in the form of suicide attempts and completions.  One of the ironies of depression is that the public perceives it as a minor condition that is easily treated.  That ignores the fact that most people that die from suicide are depressed.  Severe depression is a lethal condition and not a minor one. Ignoring severe depression and not treating it is an option only by denying that it exists.

A second group of people who need ECT as a life saving treatment are people with catatonia.  Catatonia is a potentially lethal condition that develops in association with other severe mental conditions - especially mood disorders.  Malignant or delirious catatonia had an extremely high mortality rate (80%) prior to use of ECT.  Death from catatonia typically occurred from severe food and water refusal, agitation leading to congestive heart failure, injuries from severe agitation, and in some cases autonomic dysregulation often seen as elevated body temperature with no evidence of infection.  This group of patients is hospitalized and cannot function outside of a hospital setting. Even inside a hospital they need very intensive monitoring to protect them from injury.  The fastest way to treat these patients, keep them safe, and help them to get out of the hospital is ECT.  In fact, it may be the only consistently effective therapy.   

People with severe medical problems who cannot tolerate antidepressant or antipsychotic medical constitute another group who can benefit immensely from ECT.  In many cases these patients are disabled by depression and do not appear to be recovering form their associated medical illness.  They may be in a coronary care unit and taking in inadequate amounts of food and fluids due to depression.  At the same time they may not be able to take medications due to an acute cardiac condition.   They can generally be safely treated with ECT.

A final important group of people are those with experience with ECT.  They typically have a form of disabling depression, know that most of the usual medications either do not work or cause unacceptable side effects.  They are also typically very functional people and know that they need to get back to work as soon as possible.  They request elective ECT for treatment.

Why should anyone want to deny ECT to people in the above groups when it is safe and effective?  Here is some of the rhetoric evident in any Internet discussion. 


1.  I don't like it and will never accept it!

You don't have to.  First it is only indicated for a limited number of severe conditions like treatment resistant depression, depression, catatonia, treatment refractory mania, psychosis, and high suicide risk. If you don't have any of those conditions no psychiatrist is going to recommend it to you.  But further - even if you have the conditions a psychiatrist may not recommend it because it is not available in the area.  Political rhetoric may have driven it out.  Other less effective treatments like ketamine infusions and transcranial magnetic stimulation (rTMS) may be recommended instead.

The second issue is informed consent.  You can decide you don't want it. Story over at that point.  I have no interest in talking anyone into it.  My job is to provide the latest information and the patient decides and consents or does not consent. 

2.  ECT causes brain damage!

Irrelevant based on the informed consent issue outlined above unless you are trying to make a political argument.  But more striking is the body of evidence that has accumulated that there is no evidence at all that ECT alters brain anatomy or leads to neuropathological changes. Denial or lack of scholarship are the most likely explanations of this problem.  Given the ease with which medical information can be accessed these days and the fact that many people making these arguments use antiquated and disproved data while ignoring the contradictory positive data - denial or intentional distortion of the data are the only obvious motives.

3.  There are important political and ethical considerations!  

Are there really?  Not when you look at the severity of the problem. Considering psychiatric illness and disease on par with other physical illnesses is difficult if you have never seen what happens on an acute care psychiatric setting where the most serious problems in psychiatry are treated.  In the current American healthcare system these patients are often committed and in some cases transferred to state hospitals if they do not get well.  In some cases, states have found it easier to close hospitals so that these extremely ill people are sent back to their families, to jail, or to the streets.  I routinely see patients who have had a severe psychiatric illness and were ill and unstable for decades.  In many cases they are chronically ill and never regain stability because of neglect or inability to treat them. All of those years of suffering and in many cases death could have been avoided with proper treatment early in the course. In many cases the proper treatment was ECT.

How does that compare with the rest of medicine? It does not. People with life threatening and/or disabling conditions are allowed access to high risk treatment options. A few examples can illustrate this point.  Cancer is a good example.  Chemotherapy agents are high risk medications that can lead to serious and in some cases lethal side effects. Giving informed consent for treatment with chemotherapy requires agreeing to accept the risk of congestive heart failure and many other serious and potential lethal side effects from those agents. The explosion of immunotherapy agents for autoimmune disorders provides similar risk.  Even more importantly, every patient consenting to the treatment are considered to be competent consentors.  In other words they are  considered able to understand the information, make rational decisions about it, and provide consent on that rational basis.  Patients consenting to ECT may not be competent cosentors based on vulnerability laws in states.  Consent is not considered to be competent necessarily based on status (on an inpatient psychiatric unit or outpatient clinic) or by specific statutes about diagnoses or recent behavior.  Those same rules do not apply to people giving consent for high risk medical or surgical treatments.  Keep in mind that ECT is portrayed as a high risk procedure - but in reality it is not.

4.  What about involuntary treatment with ECT?   

Some states have statutes that allow courts to decide on whether or not people who are civilly committed and have high risk psychiatric illness.  That is typically based on a hearing with opposing attorneys and a judge.  Unique state statutes provide the standards that must be met in those hearings.  The court typically hires examiners (psychologists, psychiatrists) to testify about diagnosis and recommendations.  Since ECT is a medical procedure psychiatrists may be required to examine the patient and testify about the recommendation.  These hearing may also be used because the patient is not competent to consent, but clinical competency is not a formal legal decision until it has been made by a court.  In these cases the state has an interest in preventing death and disability of its citizens. 

I have thought a long time about getting rid of involuntary treatment with ECT but how would that work?  The psychiatrist would be in a position that would be difficult to defend from a clinical standpoint.  Anyone with a severe disorder not responding to standard treatment needs to hear about ECT as an option.  Their treating psychiatrist needs to make sure that happens and that the discussion is documented as well as the patient's response. If involuntary treatment was not an option for severely ill people who were unable to consent, they would basically be maintained in a chronically disabled, high risk, or worsening course of illness. I don't think that is a decision that a psychiatrist can make because it is essentially one with a dubious basis.  At that level court intervention makes sense.

5.  What can be done to address ECT side effects if I get them?

First, like all medical procedures make sure the ECT is provided by an expert, working with an anesthesiologist who is used to providing general anesthesia for ECT.  Second, that expert needs to assess the results and side effects of those treatments on a treatment to treatment basis.  Modifications in techniques and side effect prevention need to occur on a regular basis if side effects are there.  In the case of voluntary ECT and significant side effects, stopping the treatment at any time is an option for the patient. In the case of involuntary treatment or substituted consent by a court involved family members or the patient can advocate for the same discontinuation.  The attending psychiatrist can also initiate discontinuing the treatment at any time based on side effects.

The perplexing issue is the number of people who write about numerous ECT side effects and that they have had a course of many treatments.  I ask myself, how does that happen?  Have they been told that they will get used to side effects?  Were the side effects ignored?  What happened?  Why didn't they just decide to stop? In those cases, the first step should always be to discuss the issues with the attending psychiatrist and psychiatrist performing the ECT.  If that is not effective, every state in the United States has multiple forums for investigation.  In the state of Minnesota, there is an Ombudsman for Mental Health and the Board of Medical Practice. Both of these agencies will exhaustively investigate any complaint brought to their attention. People are encouraged to complain about physicians and a national watchdog agency monitors how many complaints are made in each state and holds states with low complaint rates in a negative light.

More problematic is the political approach to ECT and how it has affected policy and has the potential to decrease the availability of this modality for very ill patients.  A recent editorial review pointed out how the process in the UK was factored into NICE guidelines that were restrictive and that those guidelines may adversely affect ECT practice in the US (1).  The restrictive nature of the NICE guidelines was apparently based in part on a flawed study suggesting more dissatisfaction and memory loss than expected.  A re-analysis of that data (3) describes the nature of those flaws that include in part:

"Two other studies selected individuals from user/advocacy groups generally biased against ECT and were probably overlapping. The significance of memory problems was not mentioned in any of the studies."

It is interesting that it took 9 years to reassess the original data and come to that conclusion and in the meantime it apparently was enough to alter ECT policy in the UK.

No other medical specialty allows political biases to affect practice standards, especially when it compromises the care of severely and potentially fatally ill patients. 

There is no reason why psychiatry should either.
 

George Dawson, MD, DFAPA 


 References:

1: McDonald WM, Weiner RD, Fochtmann LJ, McCall WV. The FDA and ECT. J ECT. 2016 Jun;32(2):75-7. doi: 10.1097/YCT.0000000000000326. PubMed PMID: 27191123

2: Rose D, Fleischmann P, Wykes T, Leese M, Bindman J. Patients' perspectives on electroconvulsive therapy: systematic review. BMJ. 2003 Jun 21;326(7403):1363. Review. PubMed PMID: 12816822.

3: Bergsholm P. Patients' perspectives on electroconvulsive therapy: a reevaluation of the review by Rose et al on memory loss after electroconvulsive therapy. J ECT. 2012 Mar;28(1):27-30. doi: 10.1097/YCT.0b013e31822d796c. Review. PubMed PMID: 22343578.

4:  FDA (Proposed Rule for reclassifying ECT devices):  Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy for Certain Specified Intended Uses AGENCY: Food and Drug Administration, HHS. ACTION: Proposed order.

5:  Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff.  







Sunday, September 16, 2018

To All Of The Opioid Epidemic Deniers........




I encountered an absolutely stunning piece the other day about how there really was no opioid epidemic.  The author's various arguments all centered on the basic idea that law enforcement and other special interest groups spread the lie about opioid use being epidemic so that they could increase law enforcement measures and make it more difficult for chronic pain patients to get access to opioids.  There are a lot of these conspiracy theories going around. There are active posters on Twitter who continue to beat the drum that this is a heroin or fentanyl problem and not a problem with prescription opioids. The same group will suggest that the problem is now benzodiazepine prescriptions - maybe even gabapentinoids! They make the false claim that "anti-opioid zealots" want to stop opioids for chronic non-cancer pain, even if it means that some of those pain patients will commit suicide. They continue to post debunked information about how a trivial number of pain patients become addicted to opioids if they are properly prescribed.

Time for a lesson about the opioid epidemic and how it evolved from the land of 10,000 lakes - my home state of Minnesota.  The graphics I am posting here are all from the Minnesota Department of Health and the Minnesota Department of Human Services.  In some cases the opioid involved overdose mortality is broken down into specific categories and in other cases it is just an aggregate number.  The first graphics I am going to post is on the epidemiology of admissions for substance use treatment from two time intervals for comparison.





These maps are county by county density plots of the rate of admissions from a particular county comparing 2007 to 2017.  There are certainly limitations using administrative data but on the other hand it is the only data available and I would not be surprised if there was not some reporting obligation by licensed treatment programs to the state.  The most significant limitation on admissions data is that services in the US are rationed and there are never enough openings or finances to treat the people who need it.  Treatment programs also open and close. There is the question about whether all admissions are captured.

Given those limitations it is clear that the rate of admissions form Minnesota counties of residents being being treated for heroin use, methamphetamine use and intravenous drug use (IVDU) have all increased significantly from 2007 to 2017. In fact, the total number of IVDU admitted in 2017 was about the same for both heroin (N=5148) and methamphetamine (4843) users.  By comparison, in 2007 the number for IVDU were about 20% of the current numbers with heroin admissions at 1008 and methamphetamine admissions at 798.  In a separate report speedballing or the injection of methamphetamine and heroin is discussed but there are no numbers given on people who are using both.

The first lesson from admissions data is that the total number of residents using this compounds per county and the rate of use per county are both increasing. The geography of the spread is also of interest.  Minnesota has 54 counties and only 7 are considered metropolitan or urban counties.  The rest are considered rural.  Large blocks of these rural counties have increasing numbers of residents being treated for heroin, methamphetamine, and IVDU.  To me that is an epidemic.

 Additional data looking at the epidemic in Minnesota comes from reference 2.  It is interesting because it is a direct comparison of deaths occurring in rural versus metro or urban counties.  It also looks at the types of drugs involved in the overdoses.



As can be seen in the above graphs, opioid and heroin overdoses both increased over the 16 years of the study period. In the Metro sample, the baseline rate of opioid overdose deaths was 43 Metro and 11 Greater Minnesota in 2000 and by 2016 this had increase to 256 and 138 respectively.  In the case of heroin overdose deaths the baseline rate was 1 Metro and 1 Greater Minnesota in 2000 and by 2016 the increases were to 110 and 40 respectively.  The rate of increase in opioid and heroin deaths in Greater Minnesota may have been impacted by the greater rate of increase in stimulant use and associated deaths.  This may imply greater availability of stimulants across a wider population area than opioids - but overdose deaths is an obvious problems for all of the compounds listed on these graphs.  According to my arithmetic that is a 9 fold increase in the death rate due to opioid and heroin overdoses over 16 years.

The final consideration is how is it that so many people started using heroin and fentanyl?  Many of the epidemic deniers seem to be suggesting that it just happened that way.  It was totally unrelated to opioid prescriptions.  If a clinician like me tells them that I have talked to hundreds of opioid users and I have heard initial use of heroin from exactly one person - they suggest that I don't know what I am talking about.  That is where this compelling graphic about opioid prescriptions comes in showing about an 8-fold increase in opioid prescriptions in the USA over about the last two decades. It would place opioid overdose deaths as about the 13th leading causes of death in the state.  Once an addiction starts, the economics of drug use is that most people can get heroin for considerably less than they can buy prescription opioids on the street.  That and the general characteristics of addiction lead to higher risk use of intravenous heroin and a greater potential for overdose.

Even though every data set has it's limitations, the alternate hypotheses by the epidemic deniers need to be considered as alternate explanations.  Conspiracy theories about people scheming to prevent the treatment of chronic pain and the "war on drugs" don't make any sense. If either explanation were true it would have to explain the explosion in opioid prescriptions in the 21st century and everything that unfolded since.

It does not.

The only reasonable public policy must stop these overdoses and explode the associated myth that excessive opioid prescribing is necessary for the treatment of chronic non-cancer pain.



George Dawson, MD, DFAPA


References:

1:  DAANES SUD Detox and Admission Trends CY1995-CY2017.  Minnesota Department of Human Services, 2018.

2:  Drug Overdose Deaths among Minnesota Residents 2000-2016.  Minnesota Department of Health Injury and Violence Prevention Section, 2018. Link


Graphics:

All graphics are from public documents from the Minnesota Department of Health and Minnesota Department of Human Services.

Saturday, September 1, 2018

Happy Labor Day 2018!






I have posted Labor Day greetings here since 2013 and did not want to miss this year. The previous posts highlight the problems of being a physician in the USA including being treated like production workers, mismanagement by managed care and their backer in the US government, the electronic health record as a physician burden, maintenance of certification and burnout.  There was continued concern over the past year about burnout and physician suicide. Like my last posts there was very little positive to report. Physicians are still laboring under a ridiculous productivity system that reimburses them a trivial amount with the expectation of physicians who can form their own independent groups and escape the burden of management by health care corporations.  Healthcare corporations in turn seem quite content to hire non physicians to replace the doctors who have left.  The question is:  "Have there been any bright spots?"

On the whole the answer is "No." In one of my previous posts I pointed out the number of young colleagues in Minnesota who were going into private practice and I considered that to be a plus.  Let's take a look at the scorecard:


1.  Physician productivity - physicians directly employed by healthcare companies or those who accept private insurance are still working under a rationed system that expects excessive productivity to make up for both insufficient reimbursement and the fact that physicians have to waste at least half of their time as clerical workers or working to legitimize and insurance or pharmaceutical benefit managers rationing decision.  I am seeing more paperwork rather than less and that is a hot topic on Physician Twitter.  In addition to prior authorizations and denial of care, these companies are now sending out notifications about prescriptions and prescription patterns.  They frequently get the prescribing physician wrong and they issue warning for medication  that are antiquated like: "Doctor did you know that your patient is on two medications form the same class?" Or "Doctor - did you know that your patient did not refill their antidepressant at the expected time?"  The vast majority of these warnings are irrelevant - but they want a return fax upon receipt but warn that all personal health identifiers must be shredded.  A new way to harass physicians with irrelevant faxes and mailings.

2.  EHR -  there have been no breakthroughs in the EHR.  It is still a repetitive stress disorder clickfest that produces unreadable documents.  The major EHR companies continue to have monopoly power and the ability to charge outrageous licensing fees for some of the poorest quality software ever written.  They have no incentives to change anything. At least members of Congress are no longer talking about how the enhanced productivity from this software will result in cancellation of medical inflation.  None of that has happened.  The only potential bright spot is that some regulators are talking about bringing some high tech companies into the area because the existing companies have done as poor a job at interoperability as they have about everything else. 

3.  Pharmaceutical benefit managers -  every physicians nightmare has stayed about as bad as ever with the exception of the forms I mentioned that seem to be a very crude attempt at saying they are engaged in pharmacovigilance.  Of course they are not because quality is a distant memory when you are monitoring a medication that the physician may not have wanted in the first place.  It may be a medication that the PBM got the patient to take because they denied the physician's first choice or erected a steep enough copay that the patient could not afford the physician's first choice.

4.  Managed care/Health Insurance companies - they continue to run the healthcare system in the USA as proxies for the irrational ideas from Congress.  The most irrational of these ideas is that a systems that has led to a 3,000% increase in administrators in the past 30 years can shortchange patients and physicians enough to in some cases turn a profit for shareholders.  The coexisting political myths that this is about "market choice" or "single payer/socialized medicine versus capitalism" don't help anyone but apparently reassure Congress that these proxies are doing what they want them to do. 

5.  Maintenance of certification - The American Board of Medical Specialties and the respective specialty boards continue to have a stranglehold on physicians with this arbitrary expensive and time consuming recertification process.  In combination with the work expectations and inefficiencies, MOC is a significant contributor to burnout and there has been no gain in patient treatment or outcomes related to this process.  Life long learning has been the mainstay of physician education rather than arbitrary exams that seem suitable for prep school rather then working professionals.  There have been some decided bright spots in this area.  The National Board of Physicians and Surgeons (NBPAS) has more visibility as an organization that supports the longstanding tradition of life long medical education as the standard for recertification.  It is gaining support in some states and some physicians in states where it is not formally supported have learned that they can get NBPAS certification and use it nonetheless.  Make no mistake about it - this is a hot political issue and there are many organizations with a clear interest in using MOC to sink physician autonomy once and for all.  To me this is reminiscent of when a manged care company took over a hospital I worded at and the physician department heads were either fired or replaced by administrators. Every politician and bureaucrat out there knows that the best way to squelch physician dissent is to work them to the point they have no time to do anything else. MOC burns bright as the last tool they need to make this happen.

6.  Burnout - number 1 - 5 above directly lead to physician burnout.  The only bright spot in this category is rhetorical.  Articles suggesting that self-management or a yoga deficiency are less likely to be advanced as causes of burnout.  Physicians are not longer accepting this propaganda and I was an early proponent rejecting those arguments.  The only meaningful way to improve on the burnout situation is by improving the work environment.  Now that we have rating scales for burnout, there is a real danger that we will see groups rated from year to year and any random fluctuation on a hardly used scale will be taken as a sign of improvement.  If there have been no concrete improvments in 1-5 above - be assured that burnout is unchanged.

The other bright spots here are the Cardiologists who have stepped up with both NBPAS and the Practicing Physicians of America initiative to go after the organizations behind this MOC movement from an antitrust and fraud perspective.  I never thought Cardiologists were that politically active but these initiatives have clearly changed my mind.  The incongruency in this process is that physicians everywhere belong to professional organizations often more than one.  Physicians in the trenches everywhere support traditional life long medical education and not the MOC appraoch and yet none of our expensive professional organizations will make that stand or for that matter take a stand on any of the above matters.  This is a classic example of what happens when a few special interests get in positions of power in professional organizations. 

That is the summary for this year. I am really hoping that the NBPAS and PPA can make differences and make the lives of physicians everywhere somewhat easier.  I did not touch on the subject of physician suicide.  It is a topic that requires a more detailed discussion and improving the work environment for physicians is likely to have an impact.

Every week I talk with doctors in very stressful circumstances who are trying to solve difficult problems.  None of them should have to work in the present work environment for physicians. 


George Dawson, MD, DFAPA