Did the VA Violate Patient Confidentiality or Is This Just A Larger Trend?

I saw this post originally on the Shrink Rap blog.  I encourage anyone interested to read the excellent analysis of this situation and a previous one on the Shrink Rap blog.  The original post mentioned that the VA decided that it was in the public interest to disclose confidential medical records of the VA Navy Yard Shooter.  The reader has a choice of two links off the Huffington Post (HP) blog including one that has added commentary from various sources and another is the continuous 7 pages of records that are being commented on.  The arrangement of documents shows the press adding outside color to what are some very plain descriptions of clinical notes about insomnia and some features of how electronic medical records are set up.  The content of the other 107 pages of patient records is unknown.  I have also seen the suggestion that the files were illegally obtained and given to the HP.  I hope this is a case of theft rather than a government sanctioned release of confidential medical documents.  If this was illegally printed off a secure medical record system, the last date and employee number of the person who printed it should be available for investigation.  But after I read the Huffington Post article I came across this:

"The AP obtained 114 pages of [patient] medical records under the Freedom of Information Act after requesting them a few weeks after the shootings. It is unusual for the government to disclose anyone's medical files, but the Veterans Affairs Department agreed that the public interest in the mass killing outweighed [patient] privacy rights in keeping his treatment records secret after his death. In the records the AP obtained, the government withheld the names of all the doctors and others who treated [patient] to protect their privacy."

If it is a case of actual release it is a dangerous precedent.  I know of no legal precedent that allows for a hospital to unilaterally release confidential patient records - even if a patient is deceased, but I am not familiar with exceptions under the Freedom of Information Act.  I have had personal experience trying to get government records and they were never disclosed to me.  Releasing records to the press is probably the worst case scenario.  The press has repeated demonstrated that when it comes to mental illness unless they are trying to write a Pulitzer bound story on the tragedy of mental illness they just don't get it.  Mental health headline stories in this country pay lip service to violence prevention, bash the psychiatric profession and psychiatrists whenever they get the chance, and consistently illustrate that they have no idea why there is a significant problem with untreated mental illness in this country.  How in the world would they be competent or objective enough to analyze any mental health records?

Speculating on the sparse documentation of a clinical encounter is not an accurate way to determine what happened.  Only people who believe "if it isn't written down it didn't happen" would buy that and none of them are experienced clinicians who spend time with patients.

Most psychiatrists are privacy advocates because we understand the sensitive material that is often contained in medical and psychiatric records and how critical that nondisclosure is for treatment.  It is common for people to stop in mid session and ask their psychiatrist: "This is confidential isn't it?  You can't tell anybody about this."  That happens after their psychiatrist has explained the boundaries of treatment and the confidentiality considerations.

I can't help but notice that this disclosure comes during a flurry of financial privacy breaches and warnings from the government to expect more.  Call me a conspiracy theorist, but it seems to me that there has been a concerted effort on the part of our government to compromise the privacy of Americans.  It started with using the Social Security Number as a unique identifier for financial purposes (ironic that the government did not disclose it here in a single case) followed closely by the invention of credit reporting agencies.  After decades of loose regulation and less financial privacy we now see personal data being stolen in millions of records at a time.  We are rapidly headed toward a time when there will be minimal security for personal data and the government seems to be managing that expectation.

Medical privacy is the only thing in the way and in that regard this comes as no surprise.

George Dawson, MD, DFAPA

Supplementary Note 1:  I got an e-mail today (February 3) telling me that TRAC (Transactional Records Access Clearinghouse) has filed a complaint against  Immigration and Customs Enforcement (ICE) and Customs and Border Protection (CBP) for multiple violations of the Freedom of Information Act (FOIA).  I have posted my experience here and how access seemed to very limited to the FBI data that I was interested in on health care fraud by the exorbitant cost they wanted to charge for a lot of information that was probably on a server and could be easily searched.  In this case, from my read of the documents they are just not disclosing the data.  The discrepancy between this non disclosure and the ease of disclosure of protected medical data is striking and somebody needs to find out what it means.  The press release and full text of the complaint is on TRACs web site.

Some Arguments on Drug Tolerance and Prohibition

I have extensive experience treating people with alcohol and drug use problems.  I am always amazed at the lack of knowledge about addiction and alcoholism in the general public and how that impacts public policy.  As a result I occasionally get involved in public forums to argue a few points.  As a matter of disclosure I am thoroughly independent and vowed not to vote for any major party candidates a long time ago.  That doesn't prevent people from sending me heated e-mails accusing me of either being a Democrat or a Republican.  Of course you can also be attacked for being a independent and being too much of an elitist to not accept the fact that only major party candidates can be elected.  I have never found that to be a compelling argument.  My latest post to the quoted excerpt follows.  You can read the entire sequence of posts by clicking the link at the bottom.  There are obvious limitations to engaging in this exercise and that should be evident by reading the exchange right up to the last post where I get the expected shot for being a psychiatrist.  Tiresome isn't it?

“Come again...Politicians are pushing for legalization?  Politicians have been spewing the “war on drugs” “tough on crime” protecting the “fabric of society” bullshit for the last 40-plus years.”

Sorry – I try just to stay to the facts.  If you read the actual history of drug use in this country we swing from periods of prohibition to drug tolerance.  We are currently swinging into a period of drug tolerance and I fully expect to see drugs legalized in some way or another in most states.  So I really don’t have a stake in this fight either way.  So you can lighten up.  I am not “on your side” but I can predict with certainty that it will happen.  You can Google “politicians who support drug legalization” as well as I can.  As more of them get on board you will hear an escalation in rhetoric on how they will tax and control it.

You can put any type of spin on it you want – more freedom, freedom from the war on drugs, ability to generate more taxes, ability to treat any problem you might have with medical marijuana, you name it – history shows the outcome will be the same.  If you are still serious about legalizing heroin and coca like you previously stated that experiment has already been done and the outcome will be the same.  That experiment is being done right now with diverted legal opioids (the source of synthetic heroin) and according to the CDC we are in about year ten of an opioid epidemic that is killing more people in many states than motor vehicle accidents – about 15,000 people a year.  If you consider that the drugs typically called synthetic heroin on the street are usually pharmaceuticals with known safe doses, that also illustrates the nature of the problem.  If you think that nobody will be looking for synthetic marijuana if marijuana is legalized – I know that is false per my previous post.  No matter how free you are to smoke marijuana, there are very few employers I know of that will tolerate it at work and none if you are in a job where your decision making can lead to substantial liability. 

The problem with the “war on drugs” and excessive incarceration of people with drug charges in many ways parallels the excessive incarceration of the mentally ill because we have a health care system that is politically managed.  The politicians realized a long time ago that you can save health care costs by incarcerating the mentally ill instead of treating them in medical settings.  It may not have been a conscious decision up front but they have done little to stop it after it was clearly underway.  The three largest mental hospitals in the US right now are county jails.  Addicts in many cases are treated even more poorly if they are incarcerated because they do not get medically supervised detoxification and go through acute withdrawal.

In any “war” somebody has to be blamed and denied resources.  I prefer Musto’s analysis of the US tending to blame other countries for our drug problems:  “That analysis avoids the painful and awkward realization that the use of dangerous drugs may be an integral part of American society.”  That is reminiscent of Mexico’s Past President Vincente Fox pointing out that Mexico’s problem with cartel violence is fueled by America’s massive appetite for drugs supplying the money.  On that basis he was a proponent of the legalization and control of marijuana argument.  That doesn’t address the massive appetite for drugs problem.

The problem with the politics of addictive drugs is that people generally don’t know much about addiction.  There is a significant portion of the population that is vulnerable and the only thing it takes in increased availability for them to start having significant problems.

So good luck with the new temporary American dream of increased access to intoxicants and enjoy it while you can.  Depending on exactly what gets legalized – I would predict that would be the next 20 – 40 years.  That is the usual time it takes to complete a cycle.

Minnesota Politics and Issues Forum

George Dawson, MD, DFAPA

David F. Musto.  The American Disease: Origins of Narcotic Control.  Third Edition.  New York, Oxford University Press, 1999: p 298.  

Additional Clinical Note 1: A couple of graphs from my other blog that show alcohol use patterns over time are available on my other blog for the United States and the United Kingdom.  Graphs of opioid consumption over the past decade by the UN drug control agency shows a linear increase in consumption and production.

Additional Clinical Note 2:  If you had the patience to follow the political thread you probably notice the marijuana advocate trying to tell me that I was saying there was an epidemic of synthetic marijuana abuse that occurred with the legalization of marijuana.  My argument was simply that marijuana users if they are screened for THC at work will switch to synthetic marijuana in order to avoid positive toxicology screens and job loss.  Now in the February 5, 2014 edition of JAMA a report from the CDC it turns out that there was an "outbreak" of synthetic marijuana use in Colorado in August and September that involved about 200 people.  There was a similar outbreak in Georgia in August of 2013.  In addition  to the medical characteristics I would encourage the CDC to collect data on how many people were smoking marijuana to avoid toxicology testing and how many people were unable to stop smoking marijuana in order to achieve that same goal. I sent the CDC a note on how to refine their methodology. 

Supplementary Material Note 1:  My response from the CDC.

The News Media and Mental Illness - A Continued Problem

Although the media can certainly pump up the volume on trivia like the DSM-5 their coverage of the critical day-to-day issues involving mental illness continue to be lacking in both depth and breadth.  It is weak.  From a depth perspective I will point to an article about a man convicted of shooting at people on the I-96 freeway in southeastern Michigan.  His reason for the shootings?  He thought he was getting coded messages from the Detroit Tigers to shoot people.  He also believed that military helicopters were hovering above his home and that his home contained "advanced technologies" that caused his daughter to develop a skin disease and his wife have a miscarriage.  The article contains a layman's description of a not guilty by reason of mental disorder defense and that defense was never advanced based on a judges ruling.  As a psychiatrist familiar with these criteria there is an overwhelming bias to convict people who are mentally ill and mentally compromised.  That is why the defense is generally a failure.  In this case the defendant did not have the opportunity to present that defense because as the article explains:

"Diminished capacity is a claim that says a defendant was unable to form specific intent required to commit a crime under the law by reason of mental illness, and as a result, the defendant’s responsibility in the alleged crime is diminished. The judge earlier ruled that the defense could not make this argument because it failed to give proper notice of a defense of insanity."

In other portions of the article we learn that he has been treated for an unnamed mental illness since 2009.  The symptoms are described as delusions that respond to medication and the delusions associated with the shooting incidents are currently in remission.  When the defendant is asked about whether he knew that firing a gun into an automobile might hurt someone.  His response was "In hindsight - yes".  I have not seen the final sentencing after a no contest plea but he faces up to 12 years in prison on firearms and assault charges after they decided to drop a terrorism charge.

From a breadth of coverage perspective, I will suggest a second article that points out the critical shortage in acute care inpatient beds with the capacity to address severe mental illness and aggressive behavior.  In those case Virginia State Senator Creigh Deeds discusses an incident where his son stabbed him and subsequently shot himself.  After the incident Senator Deeds states that the read his son's diary and it said that if he killed his father he would go directly to heaven.  In his taped discussion he talks about all of the relevant points that I try to cover here involving stigma, a lack of respect for providers, and diversion of resources to more areas of care that are viewed as more prestigious - like Cardiology.  Amazingly, Virginia apparently has a rule where you must be released from the emergency department if they can't find a psychiatric bed within 6 hours.  Based on his proposed reforms it doesn't seem like there has to be much of an effort to look elsewhere.  The sequence of events has been managed care companies shutting down psychiatric bed capacity by defunding it.  That is followed by states deciding to act like managed care companies and either shutting down their capacity or getting completely out of the field.  The end result is a pool of people who cycle in and out of short stays on inpatient units to overcrowded emergency departments to the street and back again.  Many permanently drop out of that cycle when they become homeless or go to America's newest mental hospitals - the county jail.  This is a problem everywhere in the United States.  I used to qualify that by saying it was a problem in areas of high managed care penetration.  Today that is everywhere.

Apart from the isolated pieces that are written with the obvious intent to get somebody a Pulitzer Prize, these stories are typical of what you see in the press.  The first article lacks basic information on what mental illness is and how decision making in a delusional state bears no resemblance to answering questions "in hindsight" after the delusions are gone.  It lacks psychiatric perspective.  Any newspaper reporter probably has access to acute care psychiatrists to tell them about those problems.  In that situation reporters always want a "diagnosis" of the person in the news and psychiatrists cannot speculate on that without having examined the patient and getting their release for that information.  But they can provide a rich perspective based on their clinical experience treating thousands of similar problems and the effect of delusions on a person's conscious state.  They can also provide an opinion on the mental illness defense in this country as well as the state of psychiatric services to treat the problem.  I know that I would be happy to provide those details.  At the minimum somebody in charge of journalism school curricula needs to examine how reporters can come out and ignore all of those facts.  I might even suggest objective criteria for coverage as at least 5 times the words used to cover the least relevant mental illness story that year.  I would give the least relevant story this year as anything having to do with the DSM-5.  On that basis a lot of additional writing needs to be done on these two stories.

In the case of Senator Deeds, his analysis of the problem in this brief soundbite is spot on.  He needs a broader platform to advocate for his plan and support against the people who are opposing him and the 6 hour rule in state of Virginia.  He should work the the American Psychiatric Association, receive their support, and have access to their social media venues.  The APA should come out with their own solution to this problem.  I cannot think of anything more absurd and more consistent with a managed business approach to treating severe health problems than this 6 hour rule.  At some point the patient and their severe problem is totally meaningless relative to business concerns.  And Senator Deeds is right.  That doesn't happen with any other medical problem in the emergency department.

It only happens with mental illness.

George Dawson, MD, DFAPA

Is Bullshit A Better Term Than Antipsychiatry?

I saw Professor Harry G. Frankfurt on David Letterman a few years ago.  He was there to explain his recently released book entitled On Bullshit.  He was joking with Dave about how somebody called him up one day and wanted to make one of his essays into a book.  When asked how that happens he said "Bigger fonts and wider margins."  I don't know if he was consciously trying to convey the idea that he was no bullshitter.  In the book he is listed as a renowned moral philosopher and Professor of Philosophy Emeritus at Princeton University.  The book is inexpensive and a quick read.  Imagine an essay stretched into a book the size of an address book in 67 pages of 12 point font and 1 inch margins.

Despite the catchy title and obvious magic of marketing, I really like this book.  First off, it is written by a professor of moral philosophy and I always like hearing from the experts.  Secondly, Professor Frankfurt looks at the differences between lying and bullshitting and all points in between. The opening line is classic:

"One of the most salient features of our culture is that there is so much bullshit." (p. 1)

In the opening paragraph he goes on to explain that study of bullshit has not attracted much attention because most people take it for granted that they can recognize it and not get taken in.  The result is a lack of theoretical understanding of bullshit.  His stated goal is to articulate what it is and what it is not.

I will let any interested reader acquire a copy of the book.  With its brevity I run the risk of reciting all of the high points in this post.  I will quote two more lines from the book because of the amount of information they convey:  

"The realms of advertising and of public relations, and the nowadays closely related realm of politics are replete with instances of bullshit so unmitigated that they can serve among the most indisputable and classic paradigms of the concept." (p. 22)

Professor Frankfurt goes on to develop the idea that the bullshitter can be imprecise and that unlike a liar he has no prerequisite that he knows the truth.  He is bluffing and faking his way through.  Bullshitters don't reject the truth, they pay no attention to it.  In the technical sense, bullshit is not false it is phony.   And perhaps the essence as it applies to a professional field (I have to use a third quote):

"Bullshitting is unavoidable whenever circumstances require someone to talk without knowing what he is talking about." (p. 63).

The last requirement is interesting because there are conscious and unconscious components.  The unconscious component is the innate ability that most people have to practice folk psychology.  It is the equivalent of a social brain.  We recognize certain patterns in people and how they behave that allow us to make predictions about their behavior.  I am quite sure that many people mistake that ability for being trained as a psychiatrist.  I base that a lot on what people tell me that they "observe" and "diagnose".  For all of the concern about the "medicalization" of the population - the average folk psychologist has a much lower threshold than any psychiatrist I have ever met.  For example, in various workplaces I have been warned by employee supervisors that three separate coworkers that I would be working with were "paranoid", "obsessive compulsive" and "borderline".  I did not see any characteristics that the amateur diagnosticians warned me about and in all three cases, I found these co workers to be excellent and had absolutely no problems working with them.  This is probably an extension of Dr. Frankfurt's work - the unconscious aspects of bullshitting but I expect that it correlates closely with some descriptions in a classic paper on prevarication.  

But in the case of talking without expertise, I am afraid that the unconscious aspects cover a very small part of the bullshitting spectrum.  You can go to any site where psychiatry is routinely criticized, attacked or vilified and you will see any number of posts by the anonymous posters who talk about their anecdotes and proclamations about psychiatry.  Many are bombastic.  None are challenged.  It is the general tenor of many of these sites that psychiatrists are basically incompetent assholes (yeah I said it) and should be barred from practicing medicine.  Psychiatrists only injure people and have never helped anyone.  If they produce any coherent arguments they generally fit the psychiatrist as bogeyman dynamic that I previously described.  Some people who have seen a psychiatrist may grudgingly admit it, but nobody ever seems to acknowledge that a psychiatrist did anything to help them.  The more erudite approach may be to critique psychiatry without acknowledging that psychiatrists in fact are better critics and have critiqued their own field.  If anyone is questioned they may produce the indignant response: "Are you calling me an antipsychiatrist?"  

Some of what passes for criticism actually ignores what really happened and attempts to cast modern psychiatry in a light that is based more on historical spin than what is applicable today.  Some of these efforts are actually considered to be "good" criticism, even though it is clear to any trained psychiatrist that the author knows little to nothing about the field.  You would think that anyone interested in developing a negative narrative about psychiatry would do the basic research of picking up a copy of  Shorter's A History of Psychiatry and reading about the ways things were before there was any psychiatry.  In his text Shorter describes severe mental illness as a death sentence (p. 2) and the following historical observation:  "In a world without psychiatry, rather than being tolerated or indulged, the mentally ill were treated with a savage lack of feeling.  Before the advent of the therapeutic asylum, there was no golden era, no idyllic refuge for those deviant from the values of capitalism.  To maintain otherwise is a fantasy." (p. 4).  But the ignorance of psychiatry extends far beyond the historical.  It is apparent that many of the critics have no knowledge of the current current psychiatric literature.  They often reference the New York Times as though it is authoritative.  They criticize highly technical subjects and it is apparent that they have not read a journal or a book from that field.  Like Frankfurt's definition they pay no attention to the truth.

Based on Professor Frankfurt's essay, I conclude that bullshit is a much more appropriate characterization of many of the misrepresentations of psychiatry.  I would also suggest it may be more politically correct than implying that the author is a member of a cult or a school of philosophy. (see the footnote at this link)

They are quite simply a bullshitter and bullshit remains as it always has been (even pre-Frankfurt) - bullshit.

George Dawson, MD, DFAPA

Harry G. Frankfurt.  On Bullshit.  Princeton University Press, Princeton, NJ, 2005.

WIll Integrity Save Psychiatry?

The answer is - it  depends on how it is applied.

In the last two days, I have seen the integrity argument pulled out.  Allen Frances is still using his bully pulpit on the Huffington Post, where it seems that anything critical of psychiatry is readily posted.  In this case, he used the text of a blogger and the timeline created by this blogger to illustrate how there was no disclosure of a conflict of interest by a group of researchers, one of whom was the chair of the DSM-5 Task Force.  The APA investigated this and acknowledged the non-disclosure of the conflict of interest.  Apparently the acknowledgement in the form of an apology from the research group and the investigation by the APA is not enough for these critics.  The blogger Dr. Nardo suggests that an "outside panel" be appointed to review his findings and the original materials again.  I cannot think of how an "outside panel" could be convened.  I have never really seen an objective analysis by an outside panel and wonder who might be selected.  And yes I am suggesting that any outside panel would naturally have a significant conflict of interest.  There appear to be many critics of psychiatry and only weak defenders.

He refers to a post by an anonymous web professional Neuroskeptic who summarized the state of things in his post as there being "no smoking gun."  He also concludes that the idea of a psychiatric critics benefiting from book sales with the same theme suggests "by which logic, every author in history has had a financial conflict of interest in their own ideas." As a student of conflict of interest that IS a logical conclusion, especially when I see links to two of Dr. Frances' books listed right below the Huffington Post article.  It is also an obvious fact that people routinely deny that applies to all human endeavors.  If I am heavily invested in any subject my "ideas" can be counted upon to be fairly subjective and consistent with my self interest whether that is academic or financial.  That is why I have read thousands of articles in Science, Nature, and medical journals in the past three decades and very few have panned out.  At a larger level it is why Ioannides could declare that most published research is false.  It is why you can count on seeing significant side effects from practically every medication approved by the FDA as safe and effective.  So yes, I am afraid that same standard applies to the critics as well as the people doing the heavy lifting and trying to prove something in the first place.  I would even take it a step further and suggest that the same transparency rules should be applied.  How much money can you make as a critic of psychiatry or the DSM?  My guess is plenty.

Both Dr. Frances and Dr. Nardo seem to be suggesting that all of the conflict of interest issues of academic psychiatrists and the way the APA handles them is sending psychiatry to hell in a handbasket.  This is a historically incorrect view of the dismantling of psychiatry in the United States.  Every day people in this country are getting inadequate psychiatric care.  It has nothing to do with the ethical behavior of academic psychiatrists.  It has a lot to do with the fact that the APA is not a very politically savvy organization and there are massive conflicts of interest interfering with the delivery of psychiatric care.  Here are a few scenarios:

1.  A depressed or psychotic but nonfunctional person is discharged from the emergency department because of a lack of "acute dangerousness" criteria.  The family is outraged but they are told: "Look there is nothing we can do because he/she is not imminently dangerous to themselves.  Upon further investigation the state has a "gravely disabled" criterion in the commitment statutes but it is practically never used.  They find that local hospitals and courts never use that criteria because the patients admitted are too difficult to treat and place.

2.  A person with acute alcohol and benzodiazepine withdrawal is sent home from the ER with a bottle of lorazepam and advised how to detoxify themselves.  They go home and take the entire bottle to get high.

3.  A person with alcoholism and depression is admitted for suicidal behavior.  She was intoxicated, depressed and staring at a handgun.  The next day the attending physician is contacted by a psychiatrist/utilization reviewer from the insurance company who has concluded the patient is no longer suicidal and they can be discharged.  He will no longer authorize payment for inpatient treatment. 

4.  A pharmacy benefit manager refused to refill a 2 week prescription by a patient's psychiatrist.  They have the pharmacist faxes a form to the psychiatrists office saying that they will only accept a 3 month prescription.  The psychiatrist takes time to explain first to the pharmacists and then 2 different people at the PBM (total time 30 minutes) the rationale for not giving a large supply of medication to a chronically suicidal patient.  The PBM refuses to change their position.

5.  A managed care company refuses to cover psychotherapy provided by a psychiatrist.  The psychiatrist explains that he is an expert in this type of therapy and the patient has been referred to him by the patient's primary psychiatrist.  The managed care company authorizes 3 "crisis sessions".  

6.  A person completes a PHQ-9 scale in their primary care clinic and they score an 18.  They see their primary care physician and say they would like to see a therapist.  They are told to take an antidepressant and to come back in two weeks to fill out another PHQ-9.  Total time of the visit is 5 minutes.

7.  A person is seen in their primary care clinic and in 20 minutes is told by their nonpsychiatric physician that they have bipolar disorder.  They are prescribed quetiapine, citalopram, and divalproex.  Within several days they are too sedated to function at work.

The are just a few examples of thousands of people everyday who are receiving grossly inadequate care based on a specific ethical principle of physician behavior.  That is the physician makes an assessment and prescribes care in what he or she believes is the best interest of the patient.  That is the contract.  There is no insurance company or government bureaucrat involved.  There is no restricted access to mental health care or pretending that primary care physicians are psychiatrists.  There is no remote "assessment" by a physician employed by a managed care company that prioritizes the financial well being of that insurance company or pharmacy benefit manager over the patient.  In fact,  I do not understand how that is ethical behavior at all.

That is the basis of the decline of psychiatry in this country.  It has taken a proportionately larger hit than any other specialty.  It is documented in detail on this blog and in E. Fuller Torrey's recent book.  The adventures or misadventures of academic psychiatrists are relevant only insofar as the APA seems to use the President of the APA as a position that academics cycle in and out of.  The idea that "psychiatrists in the trenches" are poorly represented by such a system is accurate with two possible exceptions that I can think of.  Psychiatrists in the trenches are also poorly represented by criticism of academic psychiatrists and their conflict of interest agreements and personal employment contracts.  It does nothing to address the central problems of the specialty, provides no tools that front line psychiatrist can use against all of the real conflicts of interest they face on a day by day basis, and is generally demoralizing.  Before any critics suggest that I am supporting a "whitewash" - put yourself in the position of a psychiatrist who has just put in a 12 hour day taking care of 20 inpatients and putting up with passive aggressive and aggressive MCO and PBM reviewers who have been wasting your time and interfering with your care.  You go home to read the paper and suddenly there is a major story of how unethical psychiatrists are - based on the appearance of conflict of interest.  You try to remember that last time you saw a CME event that was sponsored by a pharmaceutical company.  Then you check your files to make sure you have enough CME credits for relicensure.  As an added piece of information that same psychiatrist doesn't really care about Section 3 in the DSM-5 or the issue of dimensional versus categorical diagnoses.  They have not blinked an eye with the release of DSM-5 and won't in the future.

That is how the psychiatrist in the trenches experiences this academic exercise in conflict of interest.  I say if you want to pull out an ethical argument and use that to help front line psychiatrists, it needs to be focused on the obvious targets in managed care and the government bureaucracies that support them.

You know - the real forces dismantling psychiatry (very effectively I might add) over the past three decades.

George Dawson, MD, DFAPA

Why Has Suboxone Turned Into A Problem?

The short answer is that it is like very other drug and there was always the potential for a problem.  Any practicing physician realizes that when a drug is approved by the FDA for general release to the public there are all kinds of unintended consequences that are possible.  That is the basis of post marketing surveillance by the FDA.  There is invariably a lot of hype associated with the release of a drug, but as I have previously pointed out the FDAs approval process is not in place to guarantee a drug that is safe for everyone.  It is focused on a releasing a drug that is a potential tool for responsible practitioners.  That means any drug can potentially cause a small number of serious unexpected reactions (liver failure, cardiac arrhythmia)  that even the most experienced practitioners will not be able to predict.  There is also an implicit understanding that the practitioners prescribing the drug have a thorough understanding of its pharmacology, indications and contraindications.  Many practitioners advise against trying out a product that has just been released but that advice is tempered by the severity of individual circumstances and the hope of relief and also the general bias that new drugs are somehow better than the old ones.  That bias has been repeatedly disproven.

Suboxone prescribers have to take a special course in order to get a prescriber number in addition to their usual DEA number.  I took the Suboxone prescriber course about 7 years ago.  It was a total of 8 hours of lectures given in a convention center room in a hotel.  It was jointly sponsored by state medical association.  The morning sessions were largely a review of the pharmacology of the drug and the scope of the opioid addiction problem at the time.  The afternoon session focused on vignettes of patients with addictions of varying complexities and the exercise was to determine of Suboxone should be prescribed to that person and how the induction would be done.  That was the first suggestion that something was problematic.  There apparently were no contraindications to Suboxone.  The clear message was that it should be given to anyone with an opioid addiction no matter what their social circumstances or comorbid psychiatric diagnoses and addictions.  There was a definite implication that this was a drug that would revolutionize the treatment of opioid addiction.

 
Suboxone is a combination of buprenorphine and naloxone.  Buprenorphine is the active ingredient in terms of treating addiction.  In this post I will use Suboxone and buprenorphine interchangeably.  The pharmacological properties of buprenorphine that were interesting in terms of potential use for addiction included the fact that it was a opioid mu receptor partial agonist and antagonist at the kappa receptor.  The partial agonist effects relevant for addiction such as euphoria and sedation occur at the lower doses and the antagonist effects occur at higher doses.  The antagonist effects like preventing respiratory depression were thought to put a ceiling effect on this side effects and make it safer than pure mu receptor agonists that would produce dose related toxicities.  In the Suboxone course the mixed agonist/antagonist effects were described as producing less toxicity and less risk of abuse.  The naloxone component of Suboxone is a pure mu receptor antagonist.  In the course I took, the explanation for the combination of buprenorphine and naloxone was that it reduced the risk of intravenous drug use and that this had occurred in Europe and it resulted in several deaths.  The company also sold Subutex which was buprenorphine only and indicated for use in pregnant women.

The pharmacodynamics and pharmacokinetics in real life can differ quite a bit from the idealized cases that the initial marketing and advertising was based upon.  Like many medications it can be a life changing drug.  People can recover and break the cycle of addiction, recovery and relapse and go on to productive lives.  It is the outliers that physicians need to be most concerned about.  In real life there are always going to be people who get significant side effects even at low doses and cannot tolerate the drug.  There are also people who tolerate the drug at high doses and do not experience the ceiling effect of mu receptor antagonism.  The people are probably very low in number but they are significant because they are not protected by the ceiling effect that is supposed to be there from the drug.  Drug addiction always attracts or produces a significant number of people who become amateur pharmacologists and use the drug to facilitate their addiction.  The word gets out and suddenly buprenorphine has street value (about $1,000 for a 1 month prescription) and opioid addicts can use it when they run out of heroin or oxycodone.  In a few people it is their preferred opioid because it has a longer half life.

The politics of Suboxone are as complicated as you will find in the pharmaceutical industry.  There are plenty of conflicts of interest in terms of how the drug was initially marketed and plenty of crossover between regulators and the company who developed, marketed and sold it - Reckitt-Benckiser.  According to a New York Times article last fall, the company was granted a period of exclusive sales that ended in 2009.  After that they went on the offensive to suggest that their new product - a Suboxone film was superior to the generic tablets especially in the area of child safety.  They stopped selling the Suboxone tablets at that point.  Insurance companies can work any controversy to their advantage and people on buprenorphine maintenance have been cut off based solely on the amount of time they have been taking the drug.  There are no scientific guidelines for how long a person should take buprenorphine and like most drugs used for maintenance therapy there will never be a study that looks at that question due to the expense.  Most experts would agree that if you have a severe addiction and have recovered based on buprenorphine there is no reason why you would be cut off.  In fact discontinuing buprenorphine seems to present a more significant problem as dose is tapered to 2 mg and  lower.   We also have a familiar political theme in the issue of opioids with the government seeming to create the problems in the first place and now saying: "Trust us we have the solution."  That may have explained the desperation in the descriptions of how public health officials were trying to increase Suboxone prescribers to address a public health opioid epidemic that was a likely result of government initiatives to improve the treatment of pain.

Suboxone has become a problem for the same reason that every other drug becomes a problem - unrealistic expectations, conflicts of interest, and a knowledge deficit on the part of the practitioners.  The title of the New York Times article illustrates how the press can look at the dual nature of drugs and imply that there is a larger problem.  I don't know of two many drugs that do not have a "Dark Side".  The negative trends in buprenorphine use can be reversed but it will take more than the suggested strategy in the NY Times article.  Here are a few ideas:

1.  The CDC needs to get involved and look at Suboxone/buprenorphine related deaths and study it in the same manner that they studied methadone.  It would be very instructive to see exactly where Suboxone/buprenorphine falls on the spectrum of deaths/100 kg MME (milligram morphine equivalents).  The expectation of some in the article is that it is much safer, I would prefer to see the numbers.  Only the CDC has access to the detailed data to look at this issue.  I would take it a step farther and suggest that the CDC recalculate this table on an annual basis as a key metric in reversing the significant public health problem of accidental opioid overdose deaths.

2.  The physicians prescribing the buprenorphine need to be highly motivated and well versed in prescribing medications to individuals with addictions.  The NY Times article suggests that there are many who take an entrepreneurial approach to the prescription of buprenorphine with cash only practices that vary from $100 - $250 a visit.  I have no problem with cash only practices if there is a quality approach.  By definition that involves a lot more than handing someone a prescription in 5 minutes.  The problem is the rest of what happens during that time is poorly defined.  The original prescribing information said that the physician needed to refer the patient to counseling services.  In many presentations of research that I have seen there is a clear movement to illustrate that - counseling adds little to nothing to outcomes when buprenorphine is prescribed.  There are problems drawing that conclusion about this research given the modest outcomes of the buprenorphine treatment.

3.  At least part of the interview of any patient recovering from the severe addiction that occurs with opioids is assessing their functional capacity.  What are they doing on a day to day basis and is that routine consistent with both recovery and a lack of cognitive side effects from the buprenorphine?  Being able to corroborate that improvement with a third party makes it even more reliable.

4.  A big part of the unconscious aspects of addiction is the behaviors that are present to continue the addiction despite the best conscious efforts of the person affected.  Good examples include craving, lying, and hiding use from others.  That requires prescribing physicians to engage their patients at this level and not develop a law enforcement transference.  A lot of physicians don't know how to respond to an accusation of: "You don't trust me!" when there is a question of the need for a toxicology screen or a discussion of a positive toxicology.  The interpersonal aspect of treatment is very important and it received no attention in the standard Suboxone prescribing course.

5.  Continued work on a model of treatment looking at all of the potential positive factors is needed.  There is nothing worse in medicine than to treat a scientific topic like a political one and not have a rational approach to the person with the problem.  Like the original course I took, there are  people out there who say that buprenorphine prescribed out of a physicians office is all that is needed.  Is that the case when you have a person who takes two to three times the prescribed amount to get high?  Or the person who is crushing it and snorting or injecting it?  Or the person who is selling it on the street to get purchase heroin?  Or the person who can't function due to cognitive problems at 2 mg a day?  Or the person who is hospitalized for recurrent bowel obstructions due to severe constipation?  As the prescribing physician - are  you confident that you can accurately screen for these problems?  What about competing approaches like the long acting mu antagonist naltrexone injections?  Where does 12-step recovery like Narcotics Anonymous fit in?  Where do sober housing and residential treatment fit in?  And finally - where can a person get detoxified and should anyone be forced to go through acute opioid withdrawal when they are incarcerated?

All of these questions are currently unanswered.  But like most treatments in medicine, the solution is typically a lot more than a pill.  Drugs with addictive potential always add the complication of significant financial gain from a captive audience.        

George Dawson, MD, DFAPA

Deborah Sontag.  Addiction Treatment With A Dark Side.  New York Times. November 16, 2013.

SAMHSA.  Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction.  A Treatment Improvement Protocol.  TIP 40.

NICE.  Naltrexone for the management of opioid dependence. 2010.

NICE.  Methadone and buprenorphine for the management of opioid dependence.  2010.

Snorting Smarties

"Throughout the history of the United States, popular attitudes and legal responses regarding the consumption of mood-altering substances have oscillated from tolerance to disapproval and back again in cycles roughly the length of a lifetime."   David F. Musto, MD; Drugs in America, 2002 (p 3)


I heard about this story on my way in to work this morning.  Middle school kids crushing a particular brand of candy and snorting it.  I prefer the term insufflation but that is probably a bit too stodgy for a talk radio venue. I will let any readers who are interested in it Google it and look for relevant links and significant complications.  Before we go any farther I will say that I am unequivocally against snorting anything.   I am commenting on it here as an observation of two cultural phenomena - children's behavior mimicking adults and possibly predisposing them to the adult behavior and the cultural phenomenon of permissive versus prohibitive use of intoxicants.

I had an immediate association to a Psycritic blogpost that I responded to last night on whether marijuana legalization puts children and adolescents at risk.  Having lived through the era of an 18 year old drinking age, I would say that it definitely does.  The idea that you will now "tax and control" a newly legal intoxicant is a myth that only a politician or marijuana advocate would believe.  My high school class of predominantly 17 year olds was one of the first locked up in an all night graduation party in order to prevent drinking and driving deaths.  I don't imagine that anyone will be any more successful in keeping marijuana out of the hands of underage marijuana smokers than they were in keeping alcohol out of the hands of underage drinkers.

I found this behavior interesting because I observed a similar pattern of behavior among some of my classmates as early as the sixth grade.  People were smoking various materials that were not meant to be smoked.  They were ingesting materials that they believed would make them high, even when it was pharmacologically impossible.  Even before that I remember candy cigarettes.  They were in packs that resembled the real thing.  My father was a two pack a day smoker of high tar and high nicotine cigarettes and I had asthma so smoking even at a dress rehearsal level never interested me.  Candy cigarettes were frequently bought for children when I was growing up and everyone seemed to enjoy watching kids pretend to smoke.

It raises a larger question about addictive behaviors and whether modelling and rehearsing them can lead to practicing with the real thing.  A related question would be whether a society that is permissive about a particular drug would be more likely to support behaviors that mimic using the actual drug.  In the addiction field it is common to encounter these behaviors using both addictive and non-addictive compounds.  For example, many people in the first stages of stimulant, sedative,  or opioid addiction will start by crushing prescription tablets and smoking, snorting, or injecting them.  Using a prescription in this manner is typically not a good sign in terms of controlled use of a potentially addictive medication because all of these methods of use are designed to deliver high levels of drug to the brain in a shorter period of time.  That will often produce a temporary high after tolerance occurs to the oral form of the medication.  In some settings, non-addicting medications like antihistamines, antidepressants, and others will be smoked, injected, or snorted.  This can occur in correctional settings or situations where people may be trying to block out their conscious state and choose to produce a delirium consistent with that goal.  It can get to the point where medications in general are banned from a certain setting because there is a black market for them right in the prison even though they have no value out side of the prison setting.

Getting back to the mimicking of addictive behavior and whether it may predispose you to using the compound at risk it was investigated for smoking.  The authors of the study take a look at incomplete and indirect evidence and conclude that there is some evidence that candy cigarettes were possibly used as a marketing device by cigarette manufacturers.  In one survey 5.3% of adult smokers attributed their smoking to a past use of candy cigarettes.  I want to be clear that I am using the current trend of snorting candy as an example of mimicking addictive behavior with a substance that is meant to be eaten as candy.

I don't consider myself a crusader for one law versus another.  I have beaten my head against the wall on numerous political issues in the past and know that there are many hidden forces in this country that you can bet have much more leverage than I do either as a private citizen or a member of a medical professional organization.  There is one thing that you can count on in America and that is money will carry the day.  Politicians believing that there will be new tax revenue from the sales of an intoxicant is very reinforcing for them.  Their friends in the business world creating a monopoly product that people will line up to buy is another.  Don't forget that in 1884 Heroin was the brand name of an over-the-counter patent medication that was originally marketed by a pharmaceutical company.  At about the same time a competitor was selling 15 different brands of cocaine for smoking, injecting, and sniffing.  All of them were available over the counter without a prescription.  The restriction on that practice did not occur until the Harrison Act in 1914.

The coming rush to see who sells marijuana in this country will be an interesting one.  The outcome should be as predictable as the previous oscillations toward tolerance in this country.


George Dawson, MD, DFAPA


Klein JD, Forehand B, Oliveri J, Patterson CJ, Kupersmidt JB, Strecher V.  Candy cigarettes: do they encourage children's smoking? Pediatrics. 1992 Jan;89(1):27-31. PubMed PMID: 1728016.

Klein JD, Clair SS.  Do candy cigarettes encourage young people to smoke?  BMJ.2000 Aug 5;321(7257):362-5. Review. PubMed PMID: 10926600; PubMed Central PMCID: PMC1118335.