Thursday, November 29, 2012

Freedom of Information is Not Exactly Free

I am still trying to figure out how to access information from the Freedom of Information Act (FOIA).  Some data acquired through this act  has proven to be valuable from a research standpoint.  I first became aware of this data a a research technique in the excellent studies by Kahn, looking at the issue of suicide in placebo controlled drug trials of antidepressant and antipsychotic medications.  These were excellent studies and I am surprised that they are not widely referred to whenever the issue of suicidal behavior secondary to a medication or suicidal behavior in drug trials is discussed.  Kahn, et al accessed their raw data through FOIA requests through the FDA.

I have been trying for a long time to access data from the FBI on the basis of an FOIA request.  I started out about 10 years ago and asked them for specific data pertaining to their pre-911 role of auditing physicians billing practices and determining whether or not a physician had committed "fraud" based on a mismatch between the billing statement and the document of the clinical visit.  I know that they had specific documents about this practice and even briefly published a journal detailing their strategies and tactics.  At one point that data was online and then it disappeared.  In order to have a closer look at FBI activity in the area of health care fraud I filed the original request that resulted in no data.  This year, I looked at the FBI reading room again and it discussed the wide availability of information in that venue that could also be copied and sent at a cost to the requester.  Using the FBI form and broadening the request to data pertaining to health care fraud, I completed the following form on the FBI web site on September 1, 2012 (click graphic to expand):

   I  think that it is fairly clear that I am interested in activities pertaining to health care fraud.   I received the following reply today (click graphic to expand):

That is quite a price tag.  $66,702.50 for 667,125 pages or $7,985 for 533 CDs.  I can't imagine that there is a lot of relevant data contained in these pages.  The documents I am looking for comprise no more than 200 pages.  Using their rates that is $20 of information.  The result when I specifically ask for information that I am certain they have is a denial.  If I try to broaden the search and look for myself they offer to send me what could be a small directory off a hard drive.  Figuring 14 kB per page that converts to about 8.9 GB.  The fact that they are willing to send CDs suggests to me that it is already sitting on a hard drive.  My point here is that all of this data could be sitting on a hard drive somewhere in a federal building and I could be searching it from home for free.

If data is declassified and available to the public, why jump through all of these hoops to get it?  If the data was available, I don't think it would be too hard to trace the FBI activity in health care fraud against physicians and get all of the facts out on the table.  As it stands both price tags in this FOIA request are too steep for me and that story will have to be written at another time.  As with many problems that occur with our government  that time is usually when anyone who cared about the issue, all of the politicians responsible for it, and the bureaucrats who actually administered it are long gone.

George Dawson, MD, DFAPA

Friday, November 23, 2012

Mayo Clinic Counterpoint to FDA on Citalopram

The Mayo Clinic came out with their recommendations on what to do about the FDA's warning about citalopram.  By their own description they are more liberal with regard to their citalopram recommendations and more conservative regarding escitalopram.  I have previously reviewed the problem here and concluded that there is really a lack of data available on the likelihood of electrocardiogram abnormalities during normal clinical use and if citalopram is as cardiotoxic as the FDA is describing it - we should treat it more like a standard antiarrhythmic drug and used flecanide as an example.

For all practical purposes that would include baseline ECGs, ECGs at the max dose and taking it up one more level from either the Mayo Clinic or the FDA - a stress test looking for QTc prolongation at higher heart rates.  The other elements in the Mayo recommendations based on history and physical examination and expecting some physician knowledge of drug metabolism are fairly standard.  I thought it was interesting that they did not mention checking plasma levels of the drug especially in complex cases (eg. a patient with cirrhosis) who only responds to higher than recommended doses of the drug.  Regarding the statements:  "Selective serotonin reuptake inhibitors cannot simply be substituted for one another, not even escitalopram for citalopram."  That is generally true and where are these guys in the battle against PBMs saying that these drugs are all equivalent?  I have not found any patient that responded selectively to citalopram and not escitalopram.  I have generally been able to convert patients to an equivalent amount of escitalopram the next day.

Both the Mayo Clinic and the FDA are silent on molecular approaches to solving this problem and screening patient for potential risk before they are started on either drug.  The Mayo Clinic offers testing for cytochrome P450 genotypes.  The genetic basis for hereditary prolonged QTc intervals has been a hot topic of research over the past decade.  It is probably time to expand the search for additional genotypes that place people at risk during specific drug therapies.  Until then we have only very approximate methods of determining the at - risk population and keeping them safe and the Mayo recommendations are more reality based than the FDA.

I think it would also be possible to estimate the risk associated with taking citalopram across the entire population.  In fact, at this point the FDA seems to have the data to estimate the risk of any QTc effect at all to the risk of torsade de pointes - the most significant arrhythmia.  I think it is very important for patients making the decision to have this number and if I can provide numbers on rare but serious antidepressant complications like serotonin syndrome, a federal agency with more perfect information and no patient care responsibility can do better.

George Dawson, MD, DFAPA

Sheeler RD, Ackerman MJ, Richelson E, Nelson TK, Staab JP, Tangalos EG, Dieser LM, Cunningham JL. Considerations on safety concerns about citalopram prescribing. Mayo Clin Proc. 2012 Nov;87(11):1042-5.

FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses.

Why I No Longer Support NAMI

For the past several years my wife and I have been regular donors to our state branch of the National Alliance on Mental Illness (NAMI).  We decided to do it initially as a memorial to family members who suffered from mental illness.  I just got two letters in the mail encouraging me to donate again.  One was a "Dear Friend" letter from NAMI reminding me of the plight of the mentally ill.  The other was from the Medical Director and CEO of the American Psychiatric Association.  Dr. Scully apparently thinks he is reminding me of how fragmented the system of care is and "The treatment system that confronts families seeking care is too often fragmented, unorganized and, despite the efforts of many, is uneven at best in its quality."  After working in that "system" for over 25 years and witnessing its decimation by the managed care industry - both letters are insulting.

The only time I was impressed with NAMI was during an attempt to secure resources for a patient in another state.  At that time I contacted NAMI in Illinois and was almost immediately faxed, about 50 pages of resources that my social worker and I could use to come up with a discharge plan.  The fragmented system often resulted in us spending long stress filled hours trying to piece together a plan that we hoped would work while we were being pressured to discharge the person to the street.  Managed care companies were not helpful.  I can still recall a patient with complicated problems.  The managed care company did not acknowledge the serious nature of the problem and wanted immediate discharge.  When we tried to get a discharge appointment for the patient the earliest appointment was 6 months away and they refused to give any priority based on the recent hospital discharge.  

A local NAMI walk for fund raising was disappointing.  Psychiatrists tended to walk with their own organizations, but the dimension that was unnerving to me was the corporate presence.  It seems that the no free lunch movement for doctors is not as concerned about corporate sponsorship of NAMI and any conflicts of interest that might arise.  Why would anyone raise the issue of conflict of interest?  There are two obvious issues.  NAMI has long been an advocate for access to psychiatric care and psychiatrists.  The managed care companies listed as sponsors have been the primary drivers in restricting access not just to psychiatric care but any kind of evaluation or treatment for mental illness or addiction.  In the Twin Cities they currently use case managers to control admissions and discharges.  Those case managers make those decisions based on proprietary guidelines that have little to do with the modern practice of psychiatry.

A second issue is pharmaceutical sponsors.  Psychiatry has been singled out for the appearance of conflict of interest whenever there have been sponsorship or payment of researchers or speakers by pharmaceutical companies.  The real effect of this sponsorship is on the public.  There is no clearer example than National Depression Screening Day.   This event began across the country over 20 years ago.  I was the organizer for two years for the Minnesota Psychiatric Society.  The event was sponsored nation wide by the company who had the most expensive and widely known antidepressant on the market.  It was a field day for the idea that antidepressant medications treat depression.  That bias is still present today and is probably one of the single greatest reasons why treatment of mental illness is typically reduced to a cure in a pill.

Despite my reservations, I decided to support NAMI with an annual check and was listed as a professional member of the organization.  NAMI is a politically powerful organization and I often heard that they had interests that were similar to psychiatric professional organizations.  Then a few months ago Minnesota Public Radio came out with a story on the Minnesota Security Hospital.  It is the state facility that is used to house and treat patients with severe mental illnesses who are also dangerous on an ongoing basis.  Most of the patients are there because they have been adjudicated after committing a violent crime or they are there for an evaluation.  There have been severe administrative problems that have resulted in the resignation of most of the psychiatric staff and an increased number of injuries to staff.

According to that report:

"Sue Abderholden, the executive director of the mental health advocacy group NAMI Minnesota, said despite the concerns, she thinks Barry and other officials are doing a good job of addressing serious, long-standing issues at the facility. She said the decrease in the number of psychiatrists is not necessarily a problem, as long as the facility hires qualified nurse practitioners. Ideally, she said, patients would always see the same provider, but she said that's not realistic for most facilities."

The opinion given in that story is certainly at odds with my opinion.  The state and NAMI seem to believe that psychiatrists are there to prescribe medications and can be easily replaced in that department.  I don't see anything that reflects psychiatric training in how to treat aggressive patients (what else is needed besides medication?) and what needs to happen from a systems or administrative standpoint.  Psychiatrists are the only staff with that kind of training and I wonder about whether they can use that training in a system that seems to suggest that an administrator can develop programs to deal with aggression.  The executive director's opinion seems quite consistent with that approach.  Wasn't that the problem in the first place?

I don't expect any support from NAMI.  Psychiatrists should be able to  support their own positions and members.  At the same time, I don't see any benefit to financially supporting an organization that has radically different goals than my professional goals and sees psychiatrists as easily replaced by people with much less training.  As far as the position of administrators dictating clinical care goes, that is a psychiatrist replaced by someone with no training.  If anyone can act like a physician - then physicians become superfluous.  It is tantamount to running the place with a managed care company and creating the illusion that serious care is being done by seeing people for a few minutes and talking about their medications.

The time has come to not renew my professional membership in NAMI.  With mental health parity still in question, any advocacy organization needs to have higher standards than a managed care company.

George Dawson, MD, DFAPA

Madeleine Baran.  More injured employees, fewer doctors at Minnesota Security Hospital.  August 29. 2012.

Thursday, November 15, 2012

ADHD - The Scientific Evidence versus the Political Hype

I attended a day long seminar by Russell Barkley, PhD.  It is part of my ongoing mission of seeing the experts in person who I have read and collected in my library over the past 30 years.  My earliest exposure to Dr. Barkley's work was the book Hyperactive Children that I acquired while I was in Medical School and used when I was treating children in the first clinic I worked in as a psychiatrist.  Interestingly he was working at the same medical school I had attended.  Dr. Barkley has an impressive surveillance system for current literature and in the seminar was presenting work that had literally been published or put into prepublication the day before.  His scholarship is impressive and he is one of the most widely published authors in the field.  He has a clear scientific approach and does not recommend treatments that have not gone through randomized and blinded clinical trials.  He gave many examples of ADHD treatments that seemed effective until the raters were blinded to the treatment or the methods were used by researchers who had no vested interest in the outcome.

All of his information was presented on PowerPoint as is the standard.  His PowerPoint slides were information dense, frequently presenting dimensions and data points from several studies on the same line.

A few of the highlights that you will not read in the New York Times:

1.  On the "overdiagnosis" issue - at this time about 40% of kids and 10% of adults with the disorder are treated.
2.  On the DSM issue - the categories of ADHD are going away.  Like categories of schizophrenia and autism spectrum disorder they are not unique entities.   This of course runs counter to the usual DSM criticism that there is a proliferation of diagnostic categories   Another positive was that the age of onset criteria is changing from age 7 to age 12.  Barkley points out that an age cutoff for a developmental process is arbitrary and suggested a further change to "onset in childhood or adolescence".  On the other hand, it does appear that the committee in charge is responding to political pressure from the government and insurance companies to not make any changes that would increase the prevalence of the disorder.  He presented clear criteria that would improve the diagnosis of ADHD in adults that will apparently not be included or possibly on a parenthetical basis.
3.  The problem with the treatment of children is not overtreatment, but that fact that most children who need treatment discontinue their medications as teenagers.
4.  The resulting complications of untreated ADHD are significant from an educational, public health, and psychiatric perspective.  As one example, untreated ADHD is associated with high risk of dropping out of school.  Every person who drops out and does not complete school represents a cost of $450K to the community.
5.  Stimulant medications have a 40 year record of use and there have been over 350 studies documenting the efficacy and safety.  They have the greatest effect size of any psychiatric medications and that includes up to 90% response rates across all stimulants.
6.  Response to treatment is robust and the best of any psychiatric disorder.  Evidence based studies show that patients treated with stimulants show improved outcomes across 20 parameters and that treatment with atomoxetine is associated with improvement across 23 parameters.
7.  These medications have an unprecedented safety record.
8.  There is a potential steep cost in many areas of not adequately treating the disorder.

It is very disappointing to hear that the DSM committee may be yielding to political pressure when it comes to implementing new evidence based DSM criteria particularly give the poor quality of these arguments.  A professional organization should be above political influence when it comes to scientific findings and this revision of criteria was supposed to be based on science.  The APA does have a long history of not providing any resistance to the managed care industry or government initiatives to reduce the quality of psychiatric care in favor of the managed care industry.  If true it will be ironic that the ADHD section of the DSM5 will be be directly influenced by the usual managed care forces and that they are aligned with all of the media rhetoric about the proliferation diagnoses and increased prevalence.

So the usual media hype is wrong - psychiatrists and pharmaceutical companies are not plotting to put more people on medication.  The government, managed care companies, and the anti-biological antipsychiatrists are trying to keep them off even when they are indicated.  In that political divide - the science is left out.

George Dawson, MD, DFAPA

Dr. Russell A. Barkley, PhD.  Official Web Site.

Dr. Russel A. Barkley, PhD.  Professional Workshop on ADHD.  ADHD Across the Life Span: Diagnosis, Life Course, Management, and Comorbidity.  Minnetonka, Minnesota.  Thursday November 15, 2012.

International Consensus Statement on ADHD (excerpt) - read this statement signed by scientists explaining that this diagnosis is not controversial and that the percentage of patients treated is about the same in the past decade.

Saturday, November 10, 2012

Being Flynn - Another Cinematic Portrayal of Alcoholism

My previous post looked at the accurate portrayal of alcoholism in the film Flight.  I recently saw Being Flynn starring Robert De Niro in the role of an alcoholic father and self proclaimed novelist.  This film is also a study of alcoholism.

Like Denzel Washington, De Niro accurately portrays the ways that alcoholism impacts the lives of some men.  In this case we meet De Niro's character Jonathan Flynn in a downward spiral.  We first meet his son Nick Flynn and learn through a series of flashbacks that the elder Flynn abandoned Nick and his mother for unclear reasons and he has not seen his father in about 18 years.   We first see Jonathan Flynn when he is driving a taxi.  He is drinking vodka on a regular basis.  We see him lose his job and then his housing and end up at a homeless shelter.  Nick is floundering as a poet and author.  He lacks direction and the flashbacks suggest that childhood adversity has played a big role.  He comes to be employed at a homeless shelter where his father eventually seeks shelter.

The trajectory of that story line is impacted by the fact that Jonathan is a very volatile and generally unlikable character.  Although it is certainly dangerous to live on the street, he has an aggressive attitude at times that is not warranted.  It is the reason he was evicted.  At other times he is able to keep quiet when he witnesses some street thugs beating one of his drinking buddies.  He uses a lot of expletives and at times seems incoherent.  In his interaction with Nick he is unapologetic and grandiose - describing himself as one of America's greatest authors.  When he allows Nick to read his manuscript, the first chapter shows some promise but the rest is incoherent.

Nick is on his own parallel journey.  He is lucky to get the job at the homeless shelter and initially blends in seamlessly with the staff.  The shelter staff and the environment at the shelter is expertly portrayed and very realistic.   The tension at the shelter between caring for desperate and sometimes disagreeable men and the required altruism is palpable.  Eventually Jonathan's disagreeable temperament creates a situation where Nick has to vote on whether to expel him.   He does despite a staff person trying to convince him not to send his father out on one of the coldest days of the year.  Jonathan predictably acts like he relishes the thought and that living on the street is nothing.  When we see what actually happens out there it is clear that his attitude is another manifestation of his pathology.  There is a time when we are not sure whether Jonathan will survive or not.

There are a number of fascinating articles available that look at the process of making this film.  The gold standard for any film is the book and many critics suggest reading that as a starting point.  The real Nick Flynn has some fascinating interviews talking about the evolution of homelessness in America.  When did it become acceptable?  The motion picture business is averse to producing any films that portray characters or themes that the general public would find to be distressing and the main reason is how that translates into box office numbers.

As I contemplated the Flynns' predicament I naturally thought about all of the homeless alcoholic men I have seen in the past 25 years.  At some point in time they all create the anger, frustration, and hopelessness portrayed in this film.  Many of them are not only grandiose and paranoid, but permanently delusional or amnestic.  The good news is that they are also a stimulus for the altruism apparent in the shelter staff in this film and eventually Nick Flynn himself.  This film is similar to Flight in that there are no proposed solutions.  The are no public policy statements.  It is an accurate depiction of real people dealing the the problem of addiction in their daily lives.  Despite those significant problems there are hopeful messages everywhere.  After reading an interview with the author, I am skeptical of the origins of those messages, but based on my experience they seem real.

I also had associations to what I consider to be some of the most important work in alcoholism.  The first was a study of inner city alcoholics by George Vaillant in the 1980s and several subsequent studies by the same author.  Most of the original articles online are available only with steep fees for a one time read.  It is probably easier to look at The Natural History of Alcoholism - Revisited in your local library.  It contains most of the important graphics from the research articles and Dr. Vaillant's views circa 1995.  The summary section looks at seven very important questions about the nature of alcoholism and the answers provided by prospective research on the problem.  In looking at this research, Jonathan Flynn probably most closely resembles the follow up study of 100 consecutive admissions to a detoxification unit in Boston.  At the end of 8 years of follow up, about 32% were abstinent, about 30 % were still drinking and 32% were dead or institutionalized.  One of Dr. Vaillant's characterizations of the recovery process in alcoholism:  "... alcoholics recover not because we treat them, but because they heal themselves.  Staying sober is not a process of simply becoming detoxified, but often becomes the work of several years or in a few cases even of a lifetime.  Our task is to provide emergency medical care, shelter, detoxification, and understanding until self healing takes place." (p384).  Self healing was evident in this film.

The other work that I routinely discuss with people I have seen for alcoholism and the associated comorbidity is the work of Markku Linnoila.  Dr. Linnoila was a prolific researcher in both basic and clinical alcoholism research.  He did some of the early studies looking at cerebrospinal fluid metabolites, especially serotonin metabolites and how they correlate with depression, aggression, and impulsivity over time when men consume alcohol.  These studies continue to provide a scientific basis for advising patients on basic dietary changes and in some cases pharmacological interventions that may assist in recovery.  An important aspect of the work of shelters like the one depicted in this movie is getting protein back into the diet of the homeless with alcoholism.

This film is harder to watch than Flight but it is no less accurate a depiction of how alcoholism can impact the person and their family.  It speaks to the spectrum of intervention necessary to provide safety and assist with recovery.

George Dawson, MD, DFAPA

Vaillant GE. Alcoholics Anonymous: cult or cure? Aust N Z J Psychiatry. 2005 Jun;39(6):431-6. PubMed PMID: 15943643.

Sunday, November 4, 2012

Zemeckis portrayal of addiction in "Flight"

I went to see Robert Zemeckis film Flight starring Denzel Washington as pilot Whip Whitaker yesterday.  Spoiler alert - if you are a person who likes to see new films knowing nothing about the plot - stop reading this post right here.  I work at a large residential addiction facility and ran into one of my colleagues in the lobby.  He told me he was there to see the film because it was a good film about addiction.  I was completely surprised.  Robert Zemeckis made the film that I have seen more times than any other - Forrest Gump.  I generally see anything that Denzel Washington does.  Like everybody else, I like his work and he does not make any bad movies.  His last transportation themed movie Unstoppable cast him the role of a wise engineer trying to stop a runaway train.  The trailers I had seen for Flight suggested a similar role.  I expected a heroic pilot with a similar outcome.

From the outset, it is obvious that Whip Whitaker has a tremendous problem.  He wakes up hung over, snorts some cocaine, drinks what is left of a beer and heads out the door with his pilots uniform on.  Almost incredibly he proceeds to inspect his commercial airliner, fly it through extreme turbulence, drinks some additional vodka in flight and takes a 26 minute nap before the critical scene in the movie where he performs a complicated series of maneuvers to save most of the crew and passengers from a mechanical failure.  Subsequent analysis proves that he is the only pilot who could have saved the plane.  But even those facts are not enough to preserve his fleeting hero status.

Throughout the film we see Whip drinking in an uncontrolled manner.  There is some ambivalence.  He gets out of the hospital post crash and goes to the family farm where he proceeds to dump out all of the beer and hard liquor.  He dumps out his stash of marijuana.  There is the implicit recognition that somewhere there are toxicology results that he is going to have to deal with.  As that part of the plot unfolds, he resumes drinking, smoking marijuana, and snorting cocaine with a vengeance.  In one scene he walks out of a liquor store with a case of beer and what appears to be a three liter bottle of vodka.  As soon as he gets into the car he is drinking the vodka like water and drives around with an open can of beer.  There are several scenes where the interpersonal toll of alcoholism is evident with his potential love interests, his son and ex-wife, and friends and business associates who are rooting for him.  The business associates have a common interest in seeing that he is exonerated for any crimes related to substance abuse.

This film succeeds in its depiction of alcoholism and how it hijacks the life of an otherwise highly successful pilot.  On the surface he is a "functional alcoholic."  His friend and former fellow Navy pilot describes him as a "heavy drinker" rather than an alcoholic   He appears to be successful in one aspect of his life but it does not take long to figure out even that is a charade.  He can't tolerate even the suggestion that he has a problem on the one hand and on the other makes the promise that he will stop and he can stop at any time.  He walks out of an AA meeting when the speaker asks people to raise their hand if they are an alcoholic.  There is a contrast between Whip and his girlfriend Nicole illustrating that addiction has no socioeconomic boundaries.  There were so many scenes in this film that captured the problems of addiction.

As an audience member you cannot help getting caught up in his fight with alcohol.  He is after-all the hero of this film and that is firmly established in the first 20 minutes.  You are hoping that he will not pick up another drink.  You are left with a situation where the hero will be dealt with according to technicalities.  His heroism does not count.  The only thing that matters is that he has an addiction.

This is a compelling film about addiction for families who deal with this problem on a daily basis and for those who do not.  It accurately portrays the central problems of addiction and recovery as not just avoiding punishment or making a conscious decision to stop.  It is a lot more than that and hopefully that message will be clear from watching this film.

George Dawson, MD, DFAPA

References (Doug Sellman has done a great job of distilling out the scientific points of addiction):

1. Sellman D. Ten things the alcohol industry won't tell you about alcohol. Drug Alcohol Rev. 2010 May;29(3):301-3. PubMed PMID: 20565523.

2. Sellman D. The 10 most important things known about addiction. Addiction. 2010 Jan;105(1):6-13. Epub 2009 Aug 27. PubMed PMID: 19712126.

3.  Alcohol Action New Zealand web site (various resources)

4.  Alcoholics Anonymous.  Grounded.  Alcoholics Anonymous World Services, New York City, 2001.