PROP Petitions the FDA on Opiates

Physicians for Responsible Opioid Prescribing (PROP) has petitioned the FDA to modify the warnings about opioids.  They cite the well known dimensions of the current epidemic including a four fold increase in opioid prescribing and a four fold increase in opioid related overdose deaths.  They also cite  numerous references about the real risks of prescribing opioids for chronic non cancer pain with very little guidance.

PROP highlights a big problem in medical research and associated public policy and that is the biasing influence of the pharmaceutical industry and a few people at the top.  The Institute of Medicine was instrumental in highlighting the issue of chronic pain and framing it as a discrete disease.  Although not mentioned specifically by PROP, the Joint Commission (then known as JCAHO) promoted pain recognition and treatment in the year 2000.  As this excerpt shows that initiative did not go well.

"In 2001, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) introduced the concept that pain was the “fifth vital sign,” in an effort to increase the awareness of pain in the hospitalized patient, and by design, improve the treatment of that pain. Unfortunately, the current emphasis on pain assessment as the fifth vital sign has resulted in the potential overmedication of a group of patients (139)" (see ref 1).

Without going into detail at this time, I think that are recurrent patterns of federal and state governments, the managed care industry, and the pharmaceutical industry and their affiliated organisations driving practice patterns and treatment guidelines based on very little evidence.  That culminates in broad initiatives like the PPACA that are widely hyped as advances in medical treatment, but they are basically an experiment in medicine founded on business and financial rather than scientific principles.  There may be no better example than the practice of prescribing opioids for chronic non cancer pain.   

Another contrast for this essay is the comparison with what has been years of psychiatric criticism based on the same principles.  The basic argument from the media, antipsychiatrists, generic psychiatric critics, and grandstanding politicians has been that the pharmaceutical industry has been able to financially influence psychiatrists to prescribe drugs that are at the best worthless or at the worst downright dangerous (their characterizations).  That despite the fact that black box warnings on psychiatric medication may be held to a much higher standard than other medication even if they target the same level of morbidity and mortality.  After all, there is no known psychiatric medication that is mass prescribed and has resulted in overdose deaths at the rate that people are currently dying from prescribed opioids.

Just a few weeks ago, the FDA posted a number of initiatives on their web site focused on the prescription of extended release opioids.  My read through the most detailed document shows that it does not touch on the principles outlined by PROP.  The idea that this is strictly a matter of educating physicians is an oversimplification.  This is a matter of creating initiatives that governments and sanctioning bodies insist that physicians follow and then coming up with other rules when the original ideas fail.

George Dawson, MD, DFAPA

1.  Trescot AM, Helm S, Hansen H, Benyamin R, Glaser SE, Adlaka R, Patel S, Manchikanti L. Opioids in the management of chronic non-cancer pain: an update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines. Pain Physician. 2008 Mar;11(2 Suppl):S5-S62. Review. PubMed PMID: 18443640.

Politics and Prescribing: The Case of Atomoxetine

Prior authorizations for medications have been a huge waste of physician time and they are a now classic strategy used by PBMs and managed care companies to force physicians to prescribe the cheapest possible medication. The politics for the past 20 years is that all of the medications in a particular class (like all selective serotonin reuptake inhibitors) are equivalent and therefore the cheapest member of that class could be substituted for any other drug. The managed care rhetoric ignores the fact that the members of that class do not necessarily have the same FDA approved indications. It also ignores basic science that clearly shows some members of the class may have unique receptor characteristics that are not shared by all the members in that class. Most of all it ignores the relationship between the physician and the patient especially when both have special knowledge about the patient's drug response and are basing their decision-making on that and not the way to optimize profits for the managed care industry.

The latest best example is atomoxetine ( brand name Strattera.).  Atomoxetine is indicated by the FDA for the treatment of attention deficit hyperactivity disorder. It is unique in that it is not a stimulant and that it is not potentially addicting. Many people with attention deficit hyperactivity disorder prefer not to take stimulants because they feel like they are medicated and it dulls their personality. In that case, they may benefit from taking atomoxetine. The problem at this time is there are no generic forms of atomoxetine in spite of the fact that there are many good reasons for taking it rather than a stimulant. As a result physicians are getting faxes from pharmacies requesting a "substitute" medication for the atomoxetine. Stimulants are clearly not a substitute. Some people respond to bupropion or venlafaxine but they are not FDA indicated medications for attention deficit hyperactivity disorder. Guanfacine in the extended release form is indicated for ADHD in children, but it is also not a generic and is probably at least as expensive.  There is no equivalent medication that can be substituted especially after the patient has been out of the office for a week or two and a discussion of a different strategy is not possible.

I am sure that in many cases the substitutions are made and what was previously a unique decision becomes a decision that is financially favoring the managed care industry. I would like to encourage anyone in that situation to complain about this to the insurance commissioner of your state.  It is one of the best current examples I can think of to demonstrate the inappropriate intrusion of managed care into the practice of medicine and psychiatry.

George Dawson, MD, DFAPA

Colorado Mass Shooting Day 2

I have been watching the media coverage of the mass shooting incident today - Interviews of family members, medical personnel and officials.  I saw a trauma surgeon at one of the receiving hospitals describe the current status of patients taken to his hospital.  He described this as a "mass casualty incident".  One reporter said that people don’t want insanity to replace evil as a focus of the prosecution.

In an interview that I think surprised the interviewer, a family member talked about the significant impact on her family.  When asked about how she would "get her head around this" she calmly explained that there are obvious problems when a person can acquire this amount of firearms, ammunition, and explosives in a short period of time.  She went on to add that she works in a school and is also aware of the fact that there are many children with psychological problems who never get adequate help.  She thought a lot of that problem was a lack of adequate financing. 

   

I have not listened to any right wing talk radio today, but from the other side of the aisle the New York Times headline this morning was "Gunman Kills 12 in Colorado, Reviving Gun Debate."  Mayor Bloomberg is quoted: “Maybe it’s time that the two people who want to be president of the United States stand up and tell us what they are going to do about it,” Mr. Bloomberg said during his weekly radio program, “because this is obviously a problem across the country.”

How did the Presidential candidates respond?  They both pulled down the campaign ads and apparently put the attack ads on hold.   From the President today: " And if there’s anything to take away from this tragedy, it’s a reminder that life is fragile.  Our time here is limited and it is precious.  And what matters in the end are not the small and trivial things which often consume our lives.  It’s how we choose to treat one another, and love one another.  It’s what we do on a daily basis to give our lives meaning and to give our lives purpose.  That’s what matters.  That’s why we’re here."   A similar excerpt from Mitt Romney: "There will be justice for those responsible, but that’s another matter for another day. Today is a moment to grieve and to remember, to reach out and to help, to appreciate our blessings in life. Each one of us will hold our kids a little closer, linger a bit longer with a colleague or a neighbor, reach out to a family member or friend. We’ll all spend a little less time thinking about the worries of our day and more time wondering about how to help those who are in need of compassion most."

These are the messages that we usually hear from politicians in response to mass shooting incidents.  At this point these messages are necessary, but the transition from this incident is as important.  After the messages of condolences, shared grief, and imminent justice that is usually all that happens.  Will either candidate respond to Mayor Bloomberg's challenge?  Based on the accumulated history to date it is doubtful.
  
A larger question is whether anything can be done apart from the reduced access to firearms argument.  In other words, is there an approach to directly intervene with people who develop homicidal ideation?  Popular consensus says no, but I think that it is much more likely than the repeal of the Second Amendment.

George Dawson, MD, DFAPA

Barack Obama. Remarks  by the President on the Shootings in Aurora Colorado.  July 20, 2012

Barack Obama.  Weekly Address: Remembering the Victims of the Aurora Colorado Shooting.  July 21, 2012.

Mitt Romney.  Remarks by Mitt Romney on the Shooting in Aurora, Colorado.  NYTimes July 20, 2012. 

Mass shootings - How Many Will Be Tolerated?

I have been asking myself that question repeatedly for the past several decades.  I summarized the problem a couple of months ago in this blog.  In the 12 hour aftermath of the incident in Aurora, Colorado I have already seen the predictable patterns.  Condolences from the President and the First Lady.  Right wing talk radio focused on gun rights and how the liberals will predictably want to restrict access to high capacity firearms.  Those same radio personalities talking about how you can never predict when these events will happen.  They just do and they cannot be prevented. One major network encouraging viewers to tune in for more details on the "Batman Massacre." 

We can expect more of the same over the next days to weeks and I will not expect any new solutions.  Mass shootings are devastating for the families involved.  They are also significant public health problems.  There is a body of knowledge out there that has not been applied to prevent these incidents and these incidents have not been systematically studied.  The principles in the commentary statement listed below still apply.  

It is time to stop acting like this is a problem that cannot be solved.

George Dawson, MD, DFAPA

A Commentary Statement submitted to the StarTribune January 18, 2011 from the Minnesota Psychiatric Society, The Barbara Schneider Foundation, and SAVE - Suicide Awareness Voices of Education

On the Validity of Pseudopatients

Every now and again the detractors and critics of psychiatry like to march out the results of an old study as "proof" of the lack of validity of psychiatric diagnoses.  In that study,  8 pseudopatients feigned mental illness to gain admission to 12 different psychiatric hospitals.  The conclusion of the study author was widely seen as having significant impact on the profession, but that conclusion seems to have been largely retrospective.  I started my training about a decade later and there were no residuals at that time.  I learned about the study largely through the work of antipsychiatrists and psychiatric critics.

Several obvious questions are never asked or answered by the promoters of this test as an adequate paradigm.  The first and most obvious one is why this has not been done in other fields of medicine.  It would certainly be easy to do.  I could easily walk into any emergency department in the US and get admitted to a Medicine or Surgical service with a faked diagnosis.  I know this for a fact, because one of the roles of consulting psychiatrists to Medicine and Surgery services is to confront the people who have faked illness in order to be admitted.  Kety (9) uses a more blunt example in response to the original pseudopatient experiment (1):

"If I were to drink a quart of blood and, concealing what I had done, come to the emergency room of any hospital vomiting blood, the behavior of the staff would be quite predictable. If they labeled and treated me as having a bleeding peptic ulcer, I doubt that I could argue convincingly that medical science does not know how to diagnose that condition. "(9)

I also know that this happens because of the current epidemic of prescription opiate abuse and the problem of drug seeking and being successful at it.  An estimated 39% of diverted drugs (7) come from "doctor shopping."  By definition that involves presenting yourself to a physician in a way to get additional medications.  In the case of prescription opioids that usually means either faking a pain disorder or misrepresenting pain severity.  So it is well established that medical and surgical illness well outside of the purview of psychiatry can be faked.  And yet to my knowledge, there is hardly any research on this topic and nobody is suggesting that medical diagnoses don't exist because they can be faked.  Does that mean the researchers consider the time of these other doctors too valuable to waste?  More likely it did not fit a preset research agenda.

The second obvious question has to do with conflict of interest.  It is currently in vogue to suggest that psychiatrists are swayed in their prescribing practices by incentives ranging from a free pen to a free meal.  Compensation as a company employee or to give lectures is also thought of as a compromising incentive. The free pen/free meal incentive is pretty much historical at this time.  What about intentionally misrepresenting yourself?  What is the conflict of interest involved at that level and how neutral can you stay when you are trying to escape detection in order to prove a point?  A vague script like a mono-symptomatic presentation of schizophrenia should suggest that the intent is to escape detection.  How should a person with a vague script act when they are face to face with a real clinician?  The logical conclusion is that they would be as evasive as possible even if they were adhering to that protocol.

The bottom line is that the pseudopatient experiments were seriously flawed out of the box.  Continuing to promote them as meaningful reflects a serious lack of scholarship in reading the relevant literature and a need to suspend the reality that in fact mental illness does exist, that distinctions can be made among various types of mental illness, and that those distinctions are useful to psychiatrists trying to help people with those problems.

George Dawson, MD, DFAPA

1: Rosenhan DL. On being sane in insane places. Science. 1973 Jan 19;179(4070):250-8. PubMed PMID: 4683124.

2: Fleischman PR, Israel JV, Burr WA, Hoaken PC, Thaler OF, Zucker HD, Hanley J, Ostow M, Lieberman LR, Hunter FM, Pinsker H, Blair SM, Reich W, Wiedeman GH, Pattison EM, Rosenhan DL. Psychiatric diagnosis. Science. 1973 Apr 27;180(4084):356-69. PubMed PMID: 17771687.

3: Bulmer M. Are pseudo-patient studies justified? J Med Ethics. 1982 Jun;8(2):65-71. PubMed PMID: 7108909; PubMed Central PMCID: PMC1059372.

4: Spitzer RL, Lilienfeld SO, Miller MB. Rosenhan revisited: the scientific credibility of Lauren Slater's pseudopatient diagnosis study. J Nerv Ment Dis. 2005 Nov;193(11):734-9. PubMed PMID: 1626092

5: Spitzer RL. More on pseudoscience in science and the case for psychiatric diagnosis. A critique of D.L. Rosenhan's "On Being Sane in Insane Places" and "The Contextual Nature of Psychiatric Diagnosis". Arch Gen Psychiatry. 1976 Apr;33(4):459-70. PubMed PMID: 938183.

6: Zimmerman M. Pseudopatient or pseudoscience: a reviewer's perspective. J Nerv Ment Dis. 2005 Nov;193(11):740-2. PubMed PMID: 16260928.

7: Inciardi JA, Surratt HL, Cicero TJ, Kurtz SP, Martin SS, Parrino MW. The "black box" of prescription drug diversion. J Addict Dis. 2009 Oct;28(4):332-47.  PubMed PMID: 20155603; PubMed Central PMCID: PMC2824903.

8: Millon T. Reflections on Rosenhan's "On being sane in insane places". J AbnormPsychol. 1975 Oct;84(5):456-61. PubMed PMID: 1194506.

9: Kety SS. From rationalization to reason. Am J Psychiatry. 1974 Sep;131(9):957-63. PubMed PMID: 4413516.

SAMHSA Aligned with Managed Care

When you have been as sensitized as I have to the rebranding of mental health services as "behavioral health" by the managed care industry - seeing a government agency promoting that brand is difficult to take.  I got an e-mail from SAMHSA this morning that does exactly that. The subsequent spin on behavioral health and health care reform needs to be read to be believed.  It is something that only a government bureaucrat or managed care administrator could actually believe.

This is an interesting excerpt: "Twenty years ago, even some in the behavioral health field didn't think recovery was possible."  Maybe that was why they were telling me that people in the throes of detoxification were now stable after three days.  Insisting that subscribers to their managed care insurance should be discharged home and that they could go to outpatient treatment despite repeated failures is certainly consistent with that statement.

Their spin on the PPACA is even more incredible with this summary statement: "Providers will also face new payment mechanisms such as capitation, episode rates, and team based payments rather than based on services provided."  That statement alone is proof that nobody at SAMHSA seems to understand that capitation was the primary mechanism that managed care used to dismantle mental health and addiction services to the abysmal level that they currently exist at.   Either that or they understand perfectly. 

This web page confirms what I have been saying for the past twenty years.  The government, in this case the federal government has been colluding with the managed care industry to marginalize the expertise of professionals and to continue to disproportionately ration care to anyone with a mental illness or an addiction.  The managed care industry and federal and state governments can spin that anyway that they want, but they can't get rid of the dismal record of the past 20 years or the fact that the government is now obviously promoting it.

More PPACA News

More news on the Affordable Care Act (ACA) in the New York Times today. I certainly want to applaud the New York Times for including another article that is fairly positive in terms of content regarding psychiatry and mental illness. On the other hand it is probably not a realistic appraisal of the impact the ACA will have on increasing the quality and availability of mental health services in the United States.

As I posted a couple of days ago the predominant business paradigm in healthcare is the main obstacle to reform, not the laws regulating healthcare or the payment mechanism. As long as the health care system is run by people who have no expertise and are making essentially business decisions we can expect the ongoing triple whammy of more health care inflation, poorer healthcare quality, and a lack of innovation.

This opinion piece is interesting because it includes a comment about what was supposed to be the great leveler of the healthcare landscape - the Mental Health Parity and Addiction Equity Act of 2008.  Similar opinion pieces were written about this law as soon as it came out in 2008. It was a cause for celebration among psychiatrists and advocacy groups. And then slowly over time it became clear that reality did not match the enthusiasm, even by a long shot.

The same process is occurring as I write this about the ACA.  Through a process of being favored by politicians and regulation, managed care companies have always been able to use purely subjective guidelines often under the rubric of "medical necessity" to deny care to people with mental illness or addictions.  There is absolutely no reason to expect that will not continue to happen.

Let me be clear about the types of problems I am referring to.  I am referring to people with significant disability due to major mood disorders, psychotic disorders, and addictions who have life-threatening problems and no real access to solutions other than spending a few days in a hospital ward that is poorly equipped to help them and the hope that they can make it to a 10 or 15 minute equally meaningless outpatient appointment anywhere from one to four weeks down the road. These people frequently have associated medical problems and no resources like a stable income or housing.

The proponents of the ACA will tell you that these people will now be seen in integrated outpatient primary care clinics and the quality of their care will improve. The logical question is why have the resources to help them been denied for the past 20 years and what is the likelihood that dynamic will change with an additional 15 to 20 million people in the system?
Psychiatric illness on a par with all other medical disorders?  I don't think so.  Not as long as a faceless managed care bureaucrat with no accountability can throw you out on the street, deny a medication that you need for an "equivalent" medication, or tell you that the treatment for your problem involves an endless series of "medication checks" with a "prescriber". 

George Dawson, MD, DFAPA

Richard Friedman.  Good News for Mental Illness in Health Care Law.  New York Times July 9, 2012.