ProPublica Vital Signs

It has been a while since ProPublica came out with a list of physicians who receive money from the pharmaceutical or medical device industry.  They began posting their new list of physicians who get the greatest reimbursement to the outrage of some who saw their Twitter post.  They also posted their updated Vital Signs search engine that allows anyone to search for how much money a physician receives as payments from the pharmaceutical or medical device industry.  I was able to locate my profile (it is not always easy) and it is readable. I do it when they post an update just to make sure there are no errors.  I don't accept money from anybody and also don't attended sponsored free CME courses because that is also listed as a benefit from whoever is sponsoring the course.

Although they are using a practice address I have not had for over 9 years (it is blurred but available on the ProPublica site) - when I was at that site I saw many Medicare and Medicaid patients.  At one point those were the only patients I was treating.  The disclaimers written on this page need clarification.  I am currently working 4 days a week and for me that is at least a 45-50 hour week and seeing full schedules of patients. The reason ProPublica has no information on my medical practice is that I receive no payments from the medical device or pharmaceutical industry, but you don't know that for sure by reading this information and the disclaimers. The introduction to the new database update gives an example of the reporter searching on the names of his primary care MD and the consultants he has seen.  He looks at the report of payments in terms of royalty or licensing fees, promotional speaking, consulting, travel  and lodging reimbursement, and food and beverage reimbursement.  What he does not say is what these figures mean to him.

I have written about this database in the past in terms of what it does and does not mean.  Over the past decade these payments were used as an easy way to discredit physicians, in some cases entire specialties.  Psychiatry and psychiatrists were at the top of the list, despite the fact that according to ProPublica they were ranked well below most other specialties in terms of medical industry payments.  The furor seems to have diminished as physicians are now subject to more rigorous payment reporting than politicians. In modern society - it seems that the illusion of transparency is all that is required to satisfy the moral outrage of the public.  After all - we have politicians who are actively engaged is legislating issues that affect their top campaign contributors.  There could probably not be a more significant conflict of interest and nobody bats an eye.

Despite the unrealistic idea that physicians are easily influenced and are in lock step to treating their patients according to orders from the pharmaceutical and medical device industry - this database serves a symbolic purpose.  That is - personal treatment from your physician will somehow be better now that all of these payments are known. You might make value judgments about physicians on that basis, but it would probably be a mistake. Physicians should be paid for their work and their intellectual property.  As a group they end up giving far too much of it away. And the largest conflict of interest affecting personal medical care is not mentioned in this database.  That is how your insurance company, managed care organization, or pharmaceutical benefit manager rations your care and tells your physician what they must prescribe, what tests to order, and how they can treat you if they want to remain an employee or get reimbursed.  Don't expect to see those numbers anytime soon. And by the way - that rationed care adds at least a trillion dollars to the health care budget - just as a jobs program for administrators and it skims an unknown (but probably large) percentage off the treatment your physician really wants to provide.

In the meantime - remember that this blogger is beholden to no one.

George Dawson, MD, DFAPA



Supplementary 1:

I discussed some critical issues when a Presidential appointee stood to make massive profits while in the Executive Branch.  Although that deal fell through, the President himself has made an estimated $2.3 billion in profits while sitting in the Oval Office.  This is the same President that provided massive tax cuts to businesses and massive rollbacks in environmental regulations on businesses. In the meantime, physicians accepting $10 worth of pharmaceutical or medical device company pizza are reported to the payments database.

Should $10 worth of pizza be a red flag for anything?

Foreign Policy Implications Of The Business Takeover Of Medicine

Don't worry.

This post is not about the current Presidential election.  I have no horse in the race.  Nobody to vote for.  I have been a staunch 3rd party voter for a long time and there is not even a third party candidate that I would currently vote for.  I know that opens me up to criticism from major party partisans who commonly accuse independents of either losing them the election or being too arrogant to hold their nose and vote like everybody else.  I trust my nose more that I trust that kind of rhetoric.  The current campaign highlighted everything that is wrong with the political process including a lack of focus on real issues, a lack of inspiring candidates,  and plenty of dishonesty on both sides.  I want to focus on one real issue and that is national security.  And I want to get at it from a perspective that is described primarily on this blog.

Early in the 21st century, I involved myself in a lot of political debates.  As an example, I was very active in the debates about whether the United States should have invaded Iraq under President George W. Bush.  At the time there was the unfounded belief that Iraq had weapons of mass destruction and a push to invade even though UN weapons inspectors under Hans Blix had really not found any positive evidence.  Minnesotans is a state with active political dialogues.  Senator Paul Wellstone and his fellow Democrat and current Governor Mark Dayton were two of the few Senators who voted against authorizing the use of force in Iraq and the rest is history.  Unnecessary wars, massive military spending, and an ongoing drone war carried on by the Obama administration.  The longest continuous period of warfare in the history of the USA.  The end result is that we are in a continuous war against terrorists,  continuous cyberwarfare against China and Russia, and we are current seeing significant military build ups by those same countries.  All of this against the backdrop of President Eisenhower's remarkable farewell address to the nation televised January 17, 1961.  The relevant sections include (my emphasis added):

"..........A vital element in keeping the peace is our military establishment. Our arms must be mighty, ready for instant action, so that no potential aggressor may be tempted to risk his own destruction.

Our military organization today bears little relation to that known by any of my predecessors in peacetime, or indeed by the fighting men of World War II or Korea.

Until the latest of our world conflicts, the United States had no armaments industry. American makers of plowshares could, with time and as required, make swords as well. But now we can no longer risk emergency improvisation of national defense; we have been compelled to create a permanent armaments industry of vast proportions. Added to this, three and a half million men and women are directly engaged in the defense establishment. We annually spend on military security more than the net income of all United States corporations.

This conjunction of an immense military establishment and a large arms industry is new in the American experience. The total influence -- economic, political, even spiritual -- is felt in every city, every State house, every office of the Federal government. We recognize the imperative need for this development. Yet we must not fail to comprehend its grave implications. Our toil, resources and livelihood are all involved; so is the very structure of our society.

In the councils of government, we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the military industrial complex. The potential for the disastrous rise of misplaced power exists and will persist.

We must never let the weight of this combination endanger our liberties or democratic processes. We should take nothing for granted. Only an alert and knowledgeable citizenry can compel the proper meshing of the huge industrial and military machinery of defense with our peaceful methods and goals, so that security and liberty may prosper together........"      


Eisenhower was a genius -  decades ahead of the current thinking on conflict-of-interest and its problematic results.  Going beyond the famous reference to the military industrial complex, Eisenhower's speech was about balance, conservation, and mutual respect. Disarmament described as being necessary because another war could destroy civilization. It was a speech made by a military expert turned statesman - balanced and very reasonable.

But despite Eisenhower's best intention, the American military has marched on with three unnecessary wars in my lifetime and continued record amounts being spent on the machinery of war.  In 2105 the US spent $596 billion dollars - more than the next 7 nations combined.  The Department of Defense is the largest single employer in the world.  The defense budget has long been the subject of cost overruns and overspending.  The word corruption is rarely used appropriately in American politics, but what would Eisenhower call  a $640 toilet seat?  From that same timeline - cost overruns alone add an additional 25% to the cost of weapons systems.  It seems clear that top down management massive budgets in a political atmosphere dominated by funding concerns, lobbyists, and special rules that favor the major parties is a recipe for inefficiency at best and corruption at the worst.

Parallels between what happens to the military budget and healthcare funding are undeniable.  In health care - the politics is clearly on the side of large businesses that were put in place as proxies by the federal government for containing costs - despite the clear evidence that has not happened.  Professional organizations also lobby they are generally ignored relative to business interests.  Per capita health care spending in the US is roughly 40% more than the next highest nation with no incremental increase in quality and much worse access to health care.  All of this mismanagement flows from politicians and bureaucrats at federal and state levels who talk about the constant need to reform health care.  The only notable reforms have been the use of large health care companies as inefficient proxies for government control,  selective rationing of specific areas of health care like psychiatric and addiction services, ballooning administrative costs, and placing an intense, costly level of administrative control over the physicians who are delivering the service.  Instead of learning from the past 30 years, the managers at all levels are doubling down with more requirements and regulations.  We have an endless supply of $640 toilet seats in the health care system and at the same time entire states where a person cannot get adequate treatment for an addiction or a psychiatric problem.  The government and business side of the equation needs to cling to the myth that this type of management is necessary, despite the fact that it was unequivocally demonstrated in 1998 that it was not and the more important long term trend that these business managers add no value to the system as all - apart from what they can make up as advertisements.

Does that sound like a system that can manage foreign policy or military strategy?  Somewhere along the line Americans are led to believe that we have competent military leaders who are advising Congress and the Executive branch.  In order to accept that advice a lot of political demagoguery that occurred in the election campaigns must be set aside.  A lot of past mistakes must be acknowledged and corrected.  A lot of the accusations about immoral and criminal behavior do not inspire the confidence of Americans or other citizens around the world. The scare tactics about whose finger is a safer finger to put on the nuclear button needs to be stopped and a more sober discussion about stepping back from high alert nuclear status and disarmament needs to happen.  Warfare and aggression should never be the default position.

The major difference between the military and healthcare funding is that the financial drain on the averagae family for military funding is less transparent that healthcare.  With costs being transferred to the working class under high deductible plans, the average retired couple paying and average $250K in retirement for healthcare, and now exploding costs for Obamacare, working class families are tired of paying excessive amounts for healthcare.  Any head of household who has survived the tech bubble stock market crash, the housing bubble crash, and the associated Wall Street scandal where hardly anyone was prosecuted and all of the major players were essentially unfazed.  Everybody knows some working class person who ended up fined or sent to jail for cheating the IRS.  It is also common knowledge that these infractions are trivial compared with tax breaks and questionable financing by the affluent.

Although the major parties have certainly played a role in orchestrating this dramatic fiasco - they don't bear complete responsibility.  At many levels American culture is poorly equipped to deal with tough problems.  There is a love of technology but a focus on impoverished data sets.  There is a limited understanding of current problems and potential solutions.  The best solutions are rarely reached by political compromise and the end to those arguments typically results in wrapping oneself in the flag and declaring that there has never been a better system (or country) invented.

Rather than putting it all behind us and uniting behind the next President like we all traditionally do - I hope this ugly campaign gets Americans contemplating the larger issues instead of what is commonly referred to as "the narrative".  We need to get back to the real story itself rather than the narrative.  The issues are there and they are not going away just because some politician is trying to buy your vote with money, a job, an empty promise, or special interest politics.  The issues are there no matter how we get "handled" by the managerial classes.

That is what we all have to keep in focus.



George Dawson, MD, DFAPA  


Supplementary 1:

I filed the above piece on Election Day, at least 8 hours before the New York Times election site started to predict that Donald Trump had a "greater than 95% chance" of winning the Presidential Election.  Since then I have been shocked at the number or reasonable people who are outraged by the election result and suggesting that this election is an indictment of the American character.  I won't list the specifics but they are easily viewed elsewhere.  Maybe I am just a hardened Minnesotan who can still clearly remember when professional wrestler named Jesse Ventura shocked the major parties in the state by being elected Governor.  Looking at the debates he had with those candidates - the outcome should have been predicted.  Both the Democrat and the Republican in that race found themselves agreeing Ventura on most of the major topics.  As I drove into work the next day, I listened to a major party legislator predict a catastrophe due to a professional wrestler rather than a career politician.  And guess what?  No catastrophe - in fact - a seamless transition.  The Governor's Office ran well.  Ventura's  only error (and it was a big one) was not to make the most of this victory and prove once and for all that the major parties can be superfluous in the process.

The failure of the polls to predict the election result, is instructive for any students of sampling and statistics.  If the sample is inadequate, don't print the headlines based on the inadequate sample.  I don't think the second question about that has been answered yet.  That question would be whether enough people are "off the grid" or uncooperative with the sampling process enough to make these polls predictably unpredictable.  Is it safe to say it was a failure of Big Data?

From what I know about the political process I see this playing out a few ways:

1.  Trump makes a seamless transition to office in a manner very similar to Ventura.  It will actually be easier for a Trump transition because he is technically a Republican,  even though many Republicans clearly dislike him.  Ventura was a member of the Independence Party and both parties disliked him and yet he was able to form a reasonable cabinet and nobody noticed that there was not a Democrat or a Republican in office.  He maintained a populist position by provided tax rebates.  The real potential for damage from a Trump administration will be a ballooning federal deficit, but even then it is a matter of degree.  There is no way that any Democrat or Republican will establish a precedent of actually paying for the expenditures on their watch.

2.  I have been stunned by the naivete that some people have about how men talk.  Trump's 'locker room" talk is what I am referring to.  I had a discussion last week about this very issue.  One opinion was that this kind of talk was a "generational thing" - in other words done only by dinosaurs like me.  I have certainly talked with men of all ages who refer to women in a crude manner.  I certainly don't use those terms myself and never have.  I don't "approve" of these references, but I also realize that men who talk that way are certainly not waiting on my approval.  I know this type of discussion exists.  I also know the meta-language involved.  In other words, the language has different meanings in different contexts like most language does.  I will let the linguists come up with a detailed analysis, but at the common sense level it is clear that a lot of people could ignore it.

3.  Trump has been conciliatory in his early remarks since the win.  The key question at this point is whether he can maintain that demeanor.  If he does not become antagonistic and uncompromising he has a great opportunity to seen what he can accomplish. From the political debates, it was clear that the Trump campaign was more about process and rhetoric that it was about content and a mastery of the issues.  He needs to take a lesson from Governor Ventura about what not to do when you unexpectedly get into office.

4.  Most but not all of the pundits seem to have missed the point that a lot of the Trump emotionality was directed at the working class and the working class has not fared well in American politics for decades.  Wages are flat, unions have disappeared, health care costs have increased and were set to explode with Obamacare.  Against that backdrop, the major parties have really done nothing but shore up Wall Street.  The working class has been a traditional mainstay of the Democrats.  As my grandmother used to say" "They are for the little guy!"  That has not seemed to be the case to me for a long time.

5.  Most Trump supporters do not take him literally - this is my speculation and it is in direct opposition to opposition to other more radical theories of the motivations of Trump supporters.

Just a few early observations about why a Trump presidency is not necessarily a catastrophe and also - how it happened.....        



        

Conflict Of Interest, Primitive Defenses, And Celebrity Death

I don't think there is any good way to say it.  Minnesota's greatest celebrity died recently.  I am not going to use his name or picture on this blog.  It seems fairly obvious that he would not want that.  There was the expected and understandable outpouring of emotion from his tens of millions of fans.  And then he became a projective test for anyone who wanted to sell their idea or opinion or get exposure in the press.  Some of those ideas and exposures included:

1.  The opioid epidemic - he is another statistic.
2.  Opioids are bad drugs and they can kill you.
3.  We could have saved him if he went into treatment.
4.  We could have saved him with Suboxone.
5.  Public scorns buprenorphine (Suboxone) - a medication that could have saved him.
6.  We could have saved him with a treatment intervention.
7.  His problem wasn't addiction at all it was chronic pain.
8.  We could have saved him by treating his chronic pain.
9.  The doctors prescribing these medications need to be disciplined.
10.  The people designated to save him - should have saved him.
11.  His death was "pathetic".
12.  That publicity rights legislation that exceeds copyright protection is necessary for the heirs.

None of these ideas are my ideas and I am sure that by the time you read it - this list is incomplete and outdated.  This is what I have heard or read about his death since it happened.  Some of the dynamics are familiar to me.  The gossip columnists and sites trying to show that they have special contacts and insight and therefore may be more important than other gossip sites.  The insiders proclaiming special knowledge that only a person very close to the celebrity could have.  The very human tendency for some to celebrate the death of those with special talents and capabilities that none of the rest of us have.  Death seems like the ultimate revenge of the mediocre and personality disordered - the final verification that a high flying person dies just like the rest of us.  The entire debacle reminds of a sentence I read somewhere (the reference eludes me): "Only a primitive man celebrates the death of his enemy."  How primitive would the man need to be in order to feel elevated by the death of a superstar?  I realize that these more drastic formulations may be rare.  What fuels all of the controversy?  Some may say morbid curiosity.  They are compelled to look at adverse outcomes whether it is a car wreck on the side of the road or a celebrity death under various circumstances.  It still comes around to what one of my psychoanalytic supervisors described as the most primitive underlying and unspoken thought: "Better him than me!"  The first time an analyst told me that I was somewhat taken aback and then over time I noticed that he was right.  I expected to hear this kind of attitude from non-professionals but not from physicians.  It turned out that I could hear that attitude from a broad spectrum of people.

My biases tend to be at the other end of the spectrum.  I see special capabilities as a celebration of what human beings can do.  Whether that is in athletics, entertainment, art, or my co-workers doing the job in a way that nobody else can do it.  Individual talent and unique capabilities are there to be celebrated and not envied.  I discussed this in an earlier post where the concept is that even people who aren't soccer fans can appreciate the greatness of Pele and just by watching him realize that we are all lifted up by that performance.  Envy seems like a marker that we should all use to determine our own sense of self and our own boundaries.    

In today's conflict-of-interest morality analysis anyone wanting to capitalize on the reputation of the celebrity to sell their wares escapes criticism.  The people involved will say that this is the price of celebrity and if you did not want everything that went along with celebrity you should have avoided it.  You are protesting too loudly when your privacy is invaded in real life or after you die.  There is another argument that the fans are entitled to this information.  To me that would depend on who is dispensing it and what was their reason.  There are numerous analyses of this problem from the perspective of defense mechanisms and the study of life satisfaction based on the level of those defenses.  Defense mechanisms may be interesting to psychiatrists and other mental health professionals but I don't think that they have to be brought out for this discussion.  At some point in life everyone needs to take a close look at how they interpret both misfortunes and good fortunes of others.  What does it really mean to them?  What does it indicate about their philosophy of life?  What does it mean about their life satisfaction?  When you do that - I think that most reasonable people stop for accidents because they are there to help.  They are not spectators.  Human consciousness has the unique property of allowing us to imagine good and bad things happening to us without having to see the real thing happening to somebody else.

I hope that at some point the culture can move past the all too predictable sequence of self aggrandizement and the obvious conflict-of-interest that occurs when a celebrity dies.  Human life and human achievement is worth celebrating and just like a single person can make us all better or at least feel better - it doesn't take much to bring us back down.  In order to break out of these predictable patterns, it takes a conscious awareness of better ways to be or exist in life and that includes examining and rejecting reasons for continuing the old patterns.

I will personally remember his shining star and some of the accolades from the top performers in his field.  He was truly one of a kind and his art was uplifting to me.  


George Dawson, MD, DFAPA

Ioannidis - Why His Landmark Paper Will Stand The Test of Time

John P. A. Ioannidis came out with an essay in 2005 that is a landmark of sorts.  In it he discussed the concern that most published research is false and the reasons behind that observation (1).  That led to some responses in the same publication about how false research findings could be minimized or in some cases accepted (2-4).  Anyone trained in medicine should not find these observations to be surprising.  In the nearly 30 years since I have been in medical school - findings come and findings go.  Interestingly that was a theory I first heard from a biochemistry professor who was charged with organizing all of the medical students into discussion seminars where we would critique research at the time from a broad spectrum of journals.  His final advice to every class was to make sure that you kept reading the New England Journal of Medicine for that reason.  Many people have an inaccurate view of science, especially as it applies to medicine.  They think that science is supposed to be true and that it is a belief system.  In fact science is a process, and initial theories are supposed to be the subject of debate and replication.  If you look closely in the discussion of any paper that looks at correlative research, you will invariably find the researchers saying that their research is suggestive and that it needs further replication.  In the short time I have been writing this blog asthma treatments, the Swan Ganz catheter, and the diagnosis and treatment of acute bronchitis and acute chronic obstructive pulmonary disease are all clear examples of how theories and research about the old standard of care necessarily change over time.  It is becoming increasingly obvious that reproducible research is in short supply.

Ioannidis provided six corollaries with his original paper.  The first 4 regarding power, effect size, the greater the number of relationships tested, and the greater the design flexibility are all relatively straightforward.  The last two corollaries are more focused on subjectivity and are less accessible.  I think it is common when reading research to look at the technical aspects of the paper and all of the statistics involved and forget about the human side of the equation.  From the paper, his 5th Corollary follows:

"Corollary 5: The greater the financial and other interests and prejudices in a scientific field, the less likely the research findings are to be true. Conflicts of interest and prejudice may increase bias, u.  Conflicts of interest are very common in biomedical research [26], and typically they are inadequately and sparsely reported [26,27].  Prejudice may not necessarily have financial roots.  Scientists in a given field may be prejudiced purely because of their belief in a scientific theory or commitment to their own findings.  Many otherwise seemingly independent, university-based studies may be conducted for no other reason than to give physicians and researchers qualifications for promotion or tenure.  Such non-financial conflicts may also lead to distorted reported results and interpretations.  Prestigious investigators may suppress via the peer review process the appearance and dissemination of findings that refute their findings, thus condemning their field to perpetuate false dogma. Empirical evidence on expert opinion shows that it is extremely unreliable [28]"  all from Reference 1.

The typical conflict of interest arguments that are seen in medicine have to do with financial conflict of interest.  If the current reporting database is to be believed they may be considerable.  A commentary from Nature earlier this month (5) speaks to the non-financial side of conflicts of interest.  The primary focus is on reproducibility as a marker of quality research.  They cite the facts that 2/3 of members of the American Society for Cell Biology were unable to reproduce published results and that pharmaceutical researchers were able to reproduce the results from 1/4 or fewer high profile papers.  They cite this as the burden of irreproducible research.  They touch on what scientific journals have done to counter some of these biases, basically checklists of good design and more statisticians on staff.  That may be the case for Science and Nature but what about the raft of online open access journals who not only have a less rigorous review process but in some cases require the authors to suggest their own reviewers?  A central piece of the Nature article was a survey of 140 trainees at the MD Anderson Cancer Center in Houston, Texas.  Nearly 50% of the trainees endorsed mentors requiring trainees to have a high impact paper before moving on.  Another 30% felt pressured to support their mentors hypothesis even when the data did not support it and about 18% felt pressured to publish uncertain findings.  The authors suggest that the home institutions are where the problem lies since that is where the incentive for this behavior originates.  They say that the institutions themselves benefit from the perverse incentives that lead to researchers to accumulate markers of scientific achievement rather than high quality reproducible work.  They want the institutions to take corrective steps toward research that is more highly reproducible.

One area of bias that Ioannidis and the Nature commentators are light on is the political biases that seem to preferentially affect psychiatry.  If reputable scientists are affected by the many factors previously described how might a pre-existing bias against psychiatry, various personal vendettas, a clear lack of expertise and scholarship, and a strong financial incentive in marshaling and selling to the antipsychiatry throng work out?  Even if there is a legitimate critic in that group - how would you tell?  And even more significantly why is it that no matter what the underlying factors - it seems that conspiracy theories are the inevitable explanations rather than any real scientific dispute?  Apart from journalists, I can think of no group of people who are more committed to their own findings or the theory that monolithic psychiatry is the common evil creating all of these problems than the morally indignant critics who like to tell us what is wrong with our discipline.  Knowing their positions and in many cases - over the top public statements why would we expect  them sifting through thousands of documents to produce a result other than the one they would like to see?  

I hope that there are medical scientists out there who can move past the checklists suggested to control bias and the institutional controls.  I know that this is an oversimplification and that many can.  Part of the problem in medicine and psychiatry is that there are very few people who can play in the big leagues.  I freely admit that I am not one of them.  I am a lower tier teacher of what the big leaguers do at best.  But I do know the problem with clinical trials is a lack of precision.  Part of that is due to some of Ioannidis' explanation, but in medicine and psychiatry a lot has to do with measurement error.  Measuring syndromes by very approximate means or collapsing some of the measurements into gross categories that may more easily demonstrate an effect may be a way to get regulatory approval from the FDA, but it is not a way to do good science or produce reproducible results. 


George Dawson, MD, DFAPA




References:  

1:  Ioannidis JPA (2005) Why Most Published Research Findings Are False. PLoS Med 2(8): e124. doi:10.1371/journal.pmed.0020124

2:  Moonesinghe R, Khoury MJ, Janssens ACJW (2007)  Most Published Research Findings Are False—But a Little Replication Goes a Long Way. PLoS Med 4(2): e28. doi:10.1371/journal.pmed.0040028

3:  Djulbegovic B, Hozo I (2007)  When Should Potentially False Research Findings Be Considered Acceptable? PLoS Med 4(2): e26. doi:10.1371/journal.pmed.0040026

4:  The PLoS Medicine Editors (2005) Minimizing Mistakes and Embracing Uncertainty. PLoS Med 2(8): e272. doi:10.1371/journal.pmed.0020272

5:  Begley CG, Buchan AM, Dirnagl U. Robust research: Institutions must do theirpart for reproducibility. Nature. 2015 Sep 3;525(7567):25-7. doi: 10.1038/525025a. PubMed PMID: 26333454.

Lancet Psychiatry's Inconsistent Look At Conflict Of Interest

The opening paragraphs of this editorial piece seemed promising, especially these lines:

It's not just about the money. In mental health, reputational interests exist alongside potential financial conflicts. There might also be deep-rooted interests based on professional identity. Our specialty sometimes resembles a field of conflict, or maybe some particularly ill-tempered football league—psychiatrists versus psychiatrists, psychiatrists versus psychologists, behavioural psychologists versus psychoanalysts, pill pushers versus therapists, and, as a forthcoming attraction, ICD versus DSM—a world of factionalism, rifts, ideology, personal philosophy, and ego (or should that be id?). (ref 1)

Unfortunately things rapidly fell apart after that point.  The above statements capture much of the position I have advocated on this blog from day one.  Anyone who is not aware of the purely political factors affecting some of the conflicts outlined in these sentences is extremely naive.  If anyone needs a more extensive scorecard, please refer to the graphic at this link.  On the other hand, the problem may be that I have a restrictive view of what the authors here refer to as "our specialty".  They seem to include a lot of other people than just psychiatrists.  Midwestern psychiatry may be a different culture than the rest of psychiatry.  I think we tend to view ourselves as physicians first and then psychiatrists.  We may be more comfortable talking with medical and surgical colleagues and medical knowledge is valued rather than denigrated.  We don't claim medical knowledge for the political advantage of seeming to be like other doctors.  We know a lot of medicine because we treat a lot of people with psychiatric and medical problems and consult in acute care settings.  Some of the conferences I see advertised and a few I have attended suggest to me that there are psychiatrists out there who do not have that interest in all things medical and neurological and may be more comfortable talking with non-physicians.   When I think about "our specialty",  I am thinking about those hundreds of medically oriented psychiatrists who I know who want to talk about taking care of people with severe illnesses.  People who are comfortable in hospitals and medical clinics.  People who know about the brain, labs, brain imaging, EEGs, and all things medical.

You might think that this is just another "faction" of a fractionated specialty, but it has been surprisingly seamless to me.  I trained in three major University settings in their core hospitals and affiliated Veteran's Hospitals.   When I got out, I practiced in community hospitals and clinics before coming back to a University affiliated tertiary care center.  The knowledge base of what needed to be diagnosed and treated was uniform across all of those settings.  I could expect highly competent psychiatrists available in those settings to consult with and for cross coverage.  The focus was always excellent clinical care and avoiding mistakes.  It did not resemble the confederacy of dunces described in this editorial and frequently in the popular press.  The practical issue is that practicing in acute care settings focuses the type of care that needs to be delivered.  People need to get better, and they need to get better in a hurry.   All of the debates wash out in the bright light of pragmatism.  If your plan cannot be enacted and result in clear improvements, you don't last long in that environment.  The potential complications alone will make you look bad.  The results of a clinical trial of a medication in completely healthy adults is irrelevant.

Turning the management of the world's most expensive health care system over to a for-profit industry capable of skimming hundreds of billions of dollars off the top for what amounts to a rationing scheme is a uniquely American solution, so I would not expect a lot of recognition in a British journal.  Medical journals make it seem like we are all practicing the same brand of medicine independent of cultural and political constraints.  I doubt that the editors in these situations will prove any more savvy than American editors who seem to ignore the fact that, managed care and everything that involves dwarfs the pharmaceutical industry in terms of conflicts of interest affecting the care of patients at least in the United States and that pro-managed care articles deserve at least as much scrutiny as papers written about pharmaceuticals.

The authors use about 1/3 of their space to criticize Rosenbaum's New England Journal of Medicine series on conflict of interest and the term pharmascolds.  They get one point correct, good research should not be ignored irrespective of who is funding it.  Like other critics of Rosenbaum, they wax rhetorical in their criticism and side step the numerous valid points that she makes.  They suggest that they should be focusing on a larger number of conflicts of interests ranging from the potential financial gains from various non-pharmacological innovations to "professional vendettas" but provide very little insight into how that might occur other than continuing to "question, query, probe, and interrogate" beyond the usual financial conflict disclosure.

On that procedure, I will say good luck to them and editors everywhere.  The Institute of Medicine inspired approach (2) of considering the appearance of conflict of interest and conflict of interest to be equivalent and unevenly applying that to one industry while completely ignoring the insidious effects of another has done very little to  "strike the right balance between addressing egregious cases and creating burdens that stifle relationships that advance the goals of professionalism and generate knowledge to benefit society."

There is no better example than a health care system that systematically discriminates against mental illness and addiction and does that on the basis of questionable research based on business rather than scientific principles.  The editors could start to expand their probing to spreadsheet research that looks at the purported "cost effectiveness" of managed care or collaborative care and question any associated reported quality measures.  It is always amazing how new research compares a relatively trivial case management intervention to "care as usual", when that terrible care was the product of early research on how care can be rationed.   A good starting point might be a requirement analogous to "refusing to publish non-research articles on depression from authors who have received unrelated funding from pharmaceutical companies that market antidepressant." by refusing to publish opinion pieces from opinion leaders in the business of rationing mental health services.  Refusing to publish research articles that compare rationed to less slightly rationed care would be another.

If medical research is really supposed to be generating knowledge that benefits society, where are the state-of-the-art models for psychiatric care that can set this standard?  That is what editors everywhere should be looking for.  

George Dawson, MD, DFAPA

Ref:

1:  Conflict Resolution.  The Lancet Psychiatry 2015, Volume 2, No. 7, p571, July 2015

2:  IOM (Institute of Medicine). 2009. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: The National Academies Press.

Moral Bias

Lisa Rosenbaum's final installment of her three-part conflict of interest series in the NEJM is out and full text is available online for free.  My associations and observations in response to the first two can be found here and here.  As a student of bias and rhetoric, reading Dr. Rosenbaum's series has been a breath of fresh air both on its own merit, but also relative to the grim anti-industry and anti-physician bias that permeates the popular press and medical settings these days.  The hypocritical nature of many of these comments was always obvious to me, but there was only very qualified support for anyone who did not see all physicians (especially psychiatrists) as tools of the pharmaceutical industry.  But the types of moral and ethical biases that Rosenbaum highlights goes far beyond the issue of free lunch from a pharmaceutical rep.  It shakes the very foundation of a system of evaluation based on weak empirical evidence or pure politics as I have pointed out many times on this blog.  At some level it is such a stunning expansion of many of the old NEJM editorials, it seems surrealistic that these articles have been published.  But on the other hand, the page below this last article invites readers to participate in a poll on the ".....suitability of three potential authors to review articles for the Journal."  Combined with the fact that these articles have a series editor that suggests to me that this may be all part of a social media-like initiative to attract interest to the NEJM.  On that basis, I expect a full gamut of future authors including the more typical opinions equating the appearance of conflict of interest with conflict of interest and suggesting zero tolerance for contact with industry.

This article starts out with commentary on the medical school "anti-pharma animus".  The organization of American medical students apparently grades medical schools on the basis of how free from pharmaceutical company influence their conflict of interest policies and environment are.  She gives a quote from a medical student to illustrate the mind-set involved in at least some members of this movement, namely the need for "pure" information to medical students.  Some early critics of Rosenbaum's article cite this as anecdotal data but that misses the point.  Her point is that this kind of mind-set exists and it is one of a number of mind-sets that makes the ethical climate around conflict of interest an unreasonable one.  She also points out that the rhetoric associated with this statement clearly indicates that this is a moral argument and at that point the psychology of moral arguments may apply.  From the perspective of medical education, is it better to take an insular approach and suggest that all research can be assessed by looking at the funding source or should medical students be taught to read and critique research independent of funding source?  A study quoted one of Rosenbaum's previous article suggests that internists are able to look at research abstracts and classify them according to research rigor, but that the introduction of funding source forces a re-evaluation with a bias against industry funded research.

The article progresses to talk about the psychology of moral argumentation at that point and a set of arguments that I have summarized in the table above.  I think it is also instructive to address one of the early arguments about the Rosenbaum essays and that has to do with evidence and the use of evidence in arguments.  In order to look at that, it requires a quick look at the type or argument, whether it is a scientific or non-scientific argument and whether the corresponding type of evidence exists.  I think there is no doubt that Rosenbaum's arguments are moral arguments rather than scientific ones.  As such they seek to address the ethical climate around conflict of interest.

There are two aspects of the concept of ethical climate that are missing from Rosenbaum's analysis.  The first is the ethical climate as a way to control physicians.  The best example during my career has been managed care and the research that supported it.  Like today's collaborative care research, the early managed care research was focused on the idea that it was more "cost-effective" than fee-for-service or treatment as usual.  In both cases (collaborative care and managed care), the research was generally done by advocates of the proposed methods.  Thirty years later, any objective analysis on the effect of managed care on psychiatric services will show that it has been devastatingly negative.  Bed capacity has been shut down, the criteria for inpatient care is "dangerousness" rather than any specific medical indication, people are clearly discharged from hospitals based on optimizing meager DRG based payments rather than medical indications, detoxification and addiction services have practically been eliminated from most hospitals,  only a small percentage of hospitals have psychiatric services, state hospital systems have also been shut down, and the only place where psychiatric care has increased has been county jails and prisons.  That entire system wide change for the worse was based on a moral argument of cost-effectiveness rather than scientific research.  Once that ethical landscape was established physicians could simply be shouted down with the slogan: "Times have changed - you are no longer in charge."  I doubt that any physician who heard that slogan was ever in charge of anything.  It was political rhetoric, designed to elicit an emotional reaction in the people taking over and the physicians they ultimately came to control.  Nobody thought that cost effectiveness was the same thing as cost shifting to correctional systems.

The second aspect is the explicit control of physicians by managed care companies and a conflict of interest that greatly exceeds that of any other industry.   Rosenbaum's three articles are all focused on the pharmaceutical or medical device industries.  There is no mention of the managed care industry or its spinoffs, despite the fact that it controls the medical care of over 80% of Americans.  As I have consistently pointed out, the theoretical concerns of the affiliations of authors on research papers about drugs or medical devices is nothing compared with a managed care company that tells your physician that you need to be discharged from a hospital or use a particular medicine that the physician is not recommending.  In the case of psychiatric care, that company is free to make even more life altering decisions such as denying a patient with a drug addiction any functional detox services, deciding that a patient with significant suicide risks can be treated on an outpatient basis, or maintaining a person in a disabled state with minimal treatment options for a complete recovery.  The regulatory environment that concentrates that much power in an industry that can generate profits by denying care is a complex story, but it all started with an ethical environment  that blamed physicians for the high cost of health care.  That physicianscold environment has too many elements in common with the pharmascold environment to ignore.  In both cases there is a predominate moral bias that greatly oversimplifies the problem and at least in the case of managed care leads to clear long term adverse consequences.              

The good news is that these articles have been published along with the evidence that moral reasoning can be seriously flawed and associated with biases.  Rosenbaum's focus has clearly been on the relationship between physicians and the pharmaceutical or medical device industry.  She has discussed her personal experience as a Cardiologist and how it has affected her largely in terms of interventions, statin therapy, and as a potential consultant to the industry.  Psychiatry has been an easier target for the same biases and rhetoric that she lists in her article.  I pointed it out in a Washington Post article where the narrative was clearly skewed to fit the idea that psychiatry was corrupted by Big Pharma and attempting to make it easier to diagnose depression in order to sell more antidepressants.  That article included selected information to make it seem like the American Psychiatric Association was the only professional organization to make advertising profits from Big Pharma.  The suggested quid pro quo for advertising revenue should be absurd to anyone familiar with advertising but it was not to this reporter.  But the real issue was that the DSM does not recommend treatment anyway and the majority (80%) prescribers who treat depression don't use a DSM-5 or even care about what it says.  Less formal approaches adopt a similar scolding moralistic tone toward psychiatry that is possible only by ignoring the deficiencies in other medical fields and idealizing them while devaluing psychiatry.

I think that Rosenbaum's articles are must reads, especially for psychiatrists who may be unfamiliar with rhetoric, moral reasoning, and politics.  That may be why physicians in general have been inept in mounting any kind of a counterattack against political strategies that work by changing the ethical climate.  These articles provide some points for discussion.   Watching the counterattacks will also be instructive.      


George Dawson, MD, DFAPA

1: Rosenbaum L. Beyond moral outrage--weighing the trade-offs of COI regulation. N Engl J Med. 2015 May 21;372(21):2064-8. doi: 10.1056/NEJMms1502498. PubMed PMID: 25992752.

Bias Cuts Both Ways

Lisa Rosenbaum's second article (1) in a series of three appeared in the New England Journal of Medicine this week.  It continues the theme that bias is more complicated than following the money (or pens or pizza slices).  It was interesting to note the response to the original article.  On at least one blog a poster apparently Googled Dr. Rosenbaum in order to point out all of her potential conflicts of interest.  It probably would have been more relevant to look at the standard International Committee of Medical Journal Editors disclosure form on file at the NEJM.  But it does provide a good example of one of the references in this week's piece - financial disclosure (or in this case suspicion) as an ad hominem approach to evaluating science.  In a similar vein, one of the authors of a previous NEJM editorial pointed out that the science has to stand on its own merit independent of disclosures or credentials.

The initial part of the article points out a fact that has always seemed pretty obvious to me.  Association is often used to suggest that there are significant meaningful conflicts of interest.  The oft quoted statistic is that 94% of physicians have "relationships with the industry".  This includes counting drug samples or donuts in the workplace as a significant relationship.  One of my previous employers decided that all hospital employees should participate in "donut rounds" and not just the physicians.  I viewed this as a pseudo-egalitarian managed care tactic, but by definition that means that 100% of the employees at that hospital had a "relationship with the industry".  The article also points out that physicians who request drugs be included in a formulary are also more likely to have industry relationships than not.  I have a history of being on two separate Pharmacy and Therapeutics (P&T) Committees of a major healthcare system and a major hospital where the overriding biases were drug cost and deals with pharmaceutical companies.  There were major changes on a year to year basis due to price differences in the cost of commonly prescribed drugs and they were often based on the flawed assumption that all drugs in the same class are equivalent.  On the other hand if an exclusive deal could be made, that company might also be able to combine that with a preferred deal for a more common drug.  It was a curious situation where decisions that were supposed to be science based were not.   The P&T Committee was biased by the managed care industry operating strictly on a cost basis.

I decided to part ways with the P&T Committee on the day we were presented with forms to fully disclose all of our finances to assure there were no conflicts of interest.  The usual hype about how we were all cherished guardians of the public trust was included.  I thought about it for a second and looked around the room.  There were approximately 15 MDs and 4 PharmDs on the committee.  Some of the brightest and most well read staff in the organization.  I ran the hypothetical through my mind: "What are the odds that if I owned stock in XYZ Pharmaceutical that I could convince my 20 colleagues that it was a good idea to put their most expensive drug on the formulary just based on my word?  What are the odds that I could overcome the predominate bias of the financial well being of the company that employed all of us?  What are the odds that if I accomplished those first two unattainable goals that I would actually see a profit in my XYZ Stock?"  I also thought about the drug approvals that we did based solely on public relations considerations.  Drugs that were practically worthless, but that were demanded by advocates for incurable diseases.  The explicit decision was that we did not want to run afoul of some of the very vocal advocates for those illnesses.  It would be bad public relations and press.  I looked back at the 5 page disclosure form and decided that I was not going to play that game.  I was not going to pretend for one second that I needed to be vetted by an organization that apparently saw itself as destined for sainthood.  I walked away at that time.  I had long been familiar with the other bias listed in the Rosenbaum article and how any disclosure at a CME presentation could result in mockery or discreditation.  It is difficult enough to present the pertinent information to an audience who may want to be entertained without being the butt of jokes as a sponsored presenter.  Any way you look at it my behavior was a reaction to a modern day witch hunt mentality and I was not about to be declared a witch.  Even beyond that, I was not the only "clean" person in the room.  Getting heavy handed about a conflict of interest disclosure as a public relations gimmick after many of us had already figured it out 20 years ago was more than a little insulting.

Rosenbaum also discusses a previous study from the NEJM (2) that as far as I can tell has not received press anywhere else.  In this study, the authors designed identical fake clinical trial report abstracts of studies with varying methodological rigor.  The studies had three possible funding disclosures - the pharmaceutical industry, the NIH or none.  In this experiment the internists involved in the study were less likely to read the entire report, less likely to prescribe the study medication, and less likely to see the experiments as rigorously conducted if they were sponsored by industry rather than the NIH.  They were half as likely to prescribe medications recommended in an industry sponsored trial than an NIH sponsored trial.   The authors were naturally concerned that physicians would be skeptical of even high quality but industry sponsored trials and that might slow the acceptance of that information in clinical practice.

In an interesting study done by the industry that same year,  a team (3) at the biotechnology firm Amgen  examined 53 studies that were considered to be 'landmark' preclinical studies in the field of oncology.  The goal was to see if they were reproducible.  The findings could be confirmed in only 6 or 11% of these papers.  The non-reproducible research led to hundreds of secondary articles and in some cases led to research that exposed patients to agents that resulted directly from the original research.  A team (4) at Bayer HealthCare did a similar review of preclinical studies to identify potential drug targets and concluded that only 25% of the work was reproducible.   That same article referenced the general industry rule that up to 50% of published results from academic settings cannot be reproduced in an industrial lab.  The Amgen and Bayer HealthCare studies suggest that is really an underestimate of what amounts to academic bias.  A common criticism leveled by Big Pharma critics is that they have benefited from all of the taxpayer funded basic science research at the NIH.  These studies suggest that there are plenty of problems with that research independent of funding stream and that they are less rather than more likely to lead to drug discovery.

In addition to unique information to examine the issues of bias (the author lists many more),  she also points out the origin of the word Pharmascolds (5) as those who "vilify the medical products industry and portray academics working with it as traitors and sellouts".  The authors here describe an inadequate public response from both the companies and the physicians who were criticized.  The full text of the reference is available online.

This is another highly informative article by Rosenbaum which demonstrates that analyzing conflict of interest is not as easy as some members of the press and some professional critics make it out to be.  She gives a great example of an 85 year old woman who needs an aortic valve replacement and what the considerations might be based on the characteristics and biases of two different Cardiologists assessing this situation.  It is even more complex in a setting where some would be quick to refer the woman to a hospice service.  In my experience outlining all of the potential biases in that situation is a significant task and one that few physicians would attempt.

Some day a more measured discussion of conflict of interest might provide a better approach.  Until then be skeptical of any critics who suggest that it is inappropriate for a physician to have a relationship with the pharmaceutical or medical devices industry just based on the face of it.  And for any physicians out there who want to take the most conservative path to avoid unwarranted criticism, stay out of the Sunshine Act database.

        


George Dawson, MD, DFAPA        
                   

1:  Rosenbaum L. Understanding bias--the case for careful study. N Engl J Med. 2015 May 14;372(20):1959-63. doi: 10.1056/NEJMms1502497. PubMed PMID: 25970055.

2:  Kesselheim AS, Robertson CT, Myers JA, Rose SL, Gillet V, Ross KM, Glynn RJ, Joffe S, Avorn J. A randomized study of how physicians interpret research funding disclosures. N Engl J Med. 2012 Sep 20;367(12):1119-27. PubMed PMID: 22992075.

3: Begley CG, Ellis LM. Drug development: Raise standards for preclinical cancer research. Nature. 2012 Mar 28;483(7391):531-3. doi: 10.1038/483531a. PubMed PMID:22460880.

4:  Prinz F, Schlange T, Asadullah K. Believe it or not: how much can we rely on published data on potential drug targets? Nat Rev Drug Discov. 2011 Aug 31;10(9):712. doi: 10.1038/nrd3439-c1. PubMed PMID: 21892149.

5:  Shaywitz DA, Stossel TP.  It's time to fight the 'pharmascolds'.   Wall Street Journal.  April 8, 2009.    http://www.wsj.com/articles/SB123914780537299005 accessed on May 17, 2015.

Indignation Bias

"Moral indignation in most cases is 2% moral, 48% indignation, and 50% envy." - Vittorio De Sica


The New England Journal of Medicine has started a new series on conflicts of interest that should prove to be enlightening if the rest of the articles are as good as the first one.  In this article, Lisa Rosenbaum, MD  takes on typical cases that appear to be straightforward conflict of interest cases and thoroughly debunks the common thought process.  She provides a clear link between the outrage over the behavior of the pharmaceutical industry and an indignation based approach to regulation and conflict of interest considerations.

In the first example she looks at the issue of the 2013 cholesterol guidelines and the expansion of the target population for statin therapy.  There was the standard New York Times editorial by two physicians who concluded that the guideline "would benefit the pharmaceutical industry more than anyone else."  They referenced an article by one of the authors on the frequency of statin side effects that was later withdrawn due to an overestimate of the frequency of side effects.  They challenged the credibility of  the guideline writers suggesting that they needed to be free from "influence, conscious or unconscious".  Rosenbaum reviews the checks and balances in place for the writing of this guideline in a manner reminiscent of my analysis of a Washington Post commentary on the DSM-5 diagnosis of depression.  In both cases, the safeguards in place are overlooked, the benefit to the pharmaceutical industry  overestimated, and the authors of these critical articles are never challenged.  She asks the important question: "So why the rush to conclude that the guidelines were an industry plot?"  It is also interesting from the perspective of psychiatry where the field would never get that kind of break.  The question for psychiatry is:  "Why the rush to judgment to conclude that the guidelines were a plot between psychiatrists everywhere and industry?"

The Jesse Gelsinger case was examined next.  Mr. Gelsinger was an 18 year old man with ornithine transcarbamylase deficiency.  He volunteered for a research protocol examining gene therapy for the disorder.  The ethical considerations included the fact that the researchers were advised that it was not ethical for them to test the protocol in affected babies who might benefit if it was successful because that would be considered coercion.  There was also an issue relating to the reporting of a complication of the therapy by basic science researchers.  Rosenbaum points out that after Jesse Gelsigner's death due to the research, the popular explanation for what happened was that the lead researcher had an equity position in a gene-therapy company.  There were numerous safeguards in place including a lack of a direct connection between sponsorship of the trial, a university prohibition of the lead researcher in patient enrollment or interaction,  and that same researcher asking a colleague to be the lead investigator in that trial.  The research had also been approved by more than one Institutional Review Board (IRB).  Most IRBs require a review of the scientific merit of the research before considering it on ethical grounds.   Since this was a protocol for the first human experiment in gene therapy, the vetting was unusually rigorous:

"The OTCD gene therapy protocol and the associated consent document underwent extensive review including IRBs at three institutions, the Recombinant DNA Advisory Committee, the Oversight Committee of the General Clinical Research Center of the University of Pennsylvania, and the FDA."  (reference 2)

 Please read the entire paper on line for the complexities of this case.  For the purpose of the NEJM article the relevant section had to do with Wilson recommendations of why the appearance of conflict of interest maybe all that counts.  After disclosing everything that he did  to minimize financial conflicts of interest Wilson concludes:

"I conclude that it is impossible to manage perceptions of conflicts of interest in the context of highly scrutinized clinical trials, particularly where there is a tragic outcome....." (reference 2, p 155).

That is where Rosenbaum's article gets interesting.  She introduces a concept that gets very little play in clinical medicine and one that has not had much play in psychology until the past decade and that is emotional reasoning.  There are physiological and evolutionary reasons why emotions play a large role in day to day reasoning.  In patients with a pathological loss of emotional reasoning there are significant problems in day-to-day decision making.  Diagnostic reasoning in medicine on the other hand is often described as a purely intellectual  process.  Psychiatrists  encounter this in our colleagues.  I can recall for example, confronting a Cardiology resident with the fact that her agitated patient did not have an acute exacerbation of bipolar disorder like she suspected and  did not need transfer to Psychiatry, but in fact had just had a stroke and was aphasic.  "What the hell do you know about strokes?  What do psychiatrists know about neurology?"  she stated forcefully as she rapidly escalated herself.   I calmly back pedaled and said: "Get your attending to confirm the findings and the diagnosis and if he doesn't - call me back.  But right now your patient has aphasia and has right upper extremity weakness and needs to go to the Neurology service."  Within an hour that patient was under the care of the Neurology service.  My point being that level of emotion or in this case emotional biasing really doesn't show up in any of the case records or diagnostic reasoning in the New England Journal of Medicine.  Everything is cool, dry, and pure Bayesian analysis.

Rosenbaum likes the work of a social psychologist Robert Zajonc who was one of the pioneers in this area.  If most decisions begin with a feeling, what persisting feeling may be there in the case of decisions about conflict of interest.  She had previously cited numerous legal infractions and penalties against most of the major pharmaceutical manufacturers.  It should not be surprising that the persistent emotional decision making involving that industry is going to be rather negative and miss the complexities and information that runs counter to that emotion.  I think back to one of the basic admonitions of grandmothers everywhere from my generation: "If there is one thing I can't stand it is a liar!"  I reflected on that over the course of my years in medicine as I realized that the reality is that everybody lies and they lie all the time.  But if you are indoctrinated to that rule and you have a definite emotion associated with it, you should be able to predict the direction of the decision.  You only have to look as far as Cognitive Appraisal Theory (4) for the predictable results when anger is that emotion.  To make it real, in the case of ongoing problem with the pharmaceutical industry you will see their responsibility as high and any adverse outcomes as being totally in their control.  You will be very certain about your decision, irrespective of what the reality is.  One example previously mentioned is the idea that the new cholesterol guidelines would be a windfall for the pharmaceutical industry when the vast majority of the prescriptions are for generic statins.  There will be a contamination effect on everyone associated with those companies and as long as the underlying emotion persists the associates will be predictably condemned with the same level of certainty and any negative events will be perceived as being under the complete control of the individuals involved.  There can be no unanticipated adverse outcomes or complications.        

The most concerning aspect of this kind of emotional bias is that people seem to be completely unaware of the fact that they have been swept up in it.  To them, their decisions all seem reality based.  The biasing effect in emotional reasoning has the same predictable effect in paranoid psychotic states, road rage, and Little League parents.  It is certainly alive and well in practically all aspects of public opinion when it comes to psychiatry.  Many blogs and Internet sites seem nothing more than a lens to focus rageful commentary against the profession, and further indignation if any psychiatrist dares to speak out against many of these practices.

I think indignation bias explains a lot, particularly attitudes toward psychiatry but also overly rigid thinking in the case of complex decisions and unpredictable negative outcomes.  It has allowed an irrational connection between Big Pharma and psychiatry and for many people to profit from focusing anger against the profession.  And per Dr. Rosenfeld it is not conducive to rational regulations of the industry, but it seems that at least the marketing end of those businesses seem content to see their "pushback" as being the cost of doing business.  Even marketers could benefit from educating themselves about the negative future effects of emotional decision-making against their industry.


George Dawson, MD, DFAPA


References:


1:  Rosenbaum L. Reconnecting the Dots - Reinterpreting Industry-Physician Relations. N Engl J Med. 2015 May 7;372(19):1860-1864. PubMed PMID: 25946288.

2:  Wilson JM. Lessons learned from the gene therapy trial for ornithine transcarbamylase deficiency. Mol Genet Metab. 2009 Apr;96(4):151-7. doi: 10.1016/j.ymgme.2008.12.016. Epub 2009 Feb 10. PubMed PMID: 19211285.

3:  Lerner JS, Li Y, Valdesolo P, Kassam KS. Emotion and decision making. Annu RevPsychol. 2015 Jan 3;66:799-823. doi: 10.1146/annurev-psych-010213-115043. Epub 2014 Sep 22. PubMed PMID: 25251484.

4:  Lerner JS, Keltner D. 2000. Beyond valence: toward a model of emotion-specific influences on judgment and choice. Cogn. Emot. 14(4):479.



Supplementary 1:  According to UpToDate, the gene therapy trial mentioned in the above reference was cancelled after the death of Jesse Gelsinger.  He was the 19th patient in the trial and metabolic correction of the other 18 patients did not occur.  (Topic 2923)

Supplementary 2:  Image used at the top of this post is a Shutterstock standard license download.

Supplementary 3:  Quote from Vittorio De Sica is from Stereophile June 2015, p 125.

The Ethical Climate

I thought that I would comment on the recent Legislative Auditor's Report (LAR) entitled "A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case Special Review".   This review focused primarily on ethical and conflict-of-interest requirements in laws, policies, and guidelines rather than the clinical care given.

I felt compelled to comment on this report for several reasons.  First and foremost I am a Minnesota psychiatrist and I practice psychiatry.  That gives me first hand knowledge and experience in several nuances of the report that will be obvious in my commentary.  Second, I have an interest in quality psychiatric care and research.  Third, I have no conflicts of interest to report in this matter.  I have an appointment in the University of Minnesota Department of Psychiatry largely through my teaching of medical students and residents at a peripheral campus.  My primary affiliation in terms of residency training was the Hennepin-Regions program not affiliated with the University.  The last resident I was involved in supervising was from that program and over one year ago.  Teaching has always been considered to be a requirement of my work without any additional compensation.  Like practically all physicians my actual source of income was productivity-based defined as the number of patients I see.  I have not received a check from the University of Minnesota since I was a resident there in 1984.  I have no conflicts of interest with regard to any industry and encourage anyone to try to find me on the Big Pharma database.

My 23 years of working in an acute care setting in this state uniquely qualifies me to address issues involving civil commitment, stays of commitment, and competency to consent.  There are literally a handful of people with those qualifications in the state and I know most of them. I have also been a Peer Review Organization Reviewer in both Minnesota and Wisconsin and have experience on Human Subjects Committees, Institutional Review Boards, and Pharmacy and Therapeutic Committees for both hospitals and major healthcare organizations.  As far as I know,  I may be the only psychiatrist in the state with that combination of experience.  I list these qualifications for two reasons: they are immediately relevant to this review and they also speak to the comment from the Board of Medical Practice about how they retain their consultants.  I have offered to be their consultant on two occasions and they did not even acknowledge that I had applied.

I also need to preface my remarks to say that I have no knowledge of this case other than what is reported in the documents that I am commenting on.  There is a lack of original documents such as the FDA report that was mentioned in the LAR report.  A search on the FDA web site revealed only a PowerPoint document that ended with a description of different types of competency.  I know none of the people involved and have no working relationships with them.  I have no relatives or business associates with those relationships.

Finally, I want to acknowledge the reason for this report and investigations and that is the death of Dan Markingson.  Of all physicians, psychiatrists have the lowest threshold for the prevention of patient death.  Nobody is supposed to ever die while they are under our care.  We are the only physicians who are supposed to make an assessment of patient risk every time we see that person.  I am reviewing reports and conclusions that are far removed from the original event.  I am acutely aware of the shock to the family that occurs with these events and the effort that it takes to try to prevent them.  I want to be very clear that I am not trying to second guess or offend anybody in this report.  After reviewing hundreds or thousands of hospital records, I am fully aware of the fact that records are an inadequate substitute for the events as they actually occurred and that reviewing events in a retroscope generally changes everything.  I am also acutely aware of the fact that in the case of severe mental illness, you may only get one chance to do things correctly and the right way may be very unclear.


1.  The facts of the case are the facts of the case:

The concerns about "transparency" don't make any sense to me.  I don't think that the material facts of this case have changed since the outset.  Any time a suicide occurs in the state of Minnesota that triggers a coroner's investigation.  That coroner or investigators from the coroner's office get in contact with the doctors involved in treating the patient.  In this case there was also a malpractice case that was settled out of court, but prior to settlement this would have produced an exhaustive amount of information and detail and in a malpractice proceeding, details and opinions are gathered that are most unfavorable to the treating physicians.  The only persistent arguments in this case involves what was disclosed and when and the manner in which it was disclosed.  Many of the disclosures themselves were far from the original events and did not involve the principle parties.  It is clear from the Legislative Auditor's Report (LAR), that for the bulk of their report they read existing reports and made determinations about the adequacy of those reports and whether or not they agreed with the authors of those reports.  In some cases they submitted questions to the treating psychiatrist and interviewed the head of the Institutional Review Board.  The bulk of the report is focused on the University's Board of Regents and responses from the two past Presidents of the University in this matter.  They are basically accused of being : "...defensive, insular, and unwilling to accept criticism about the Markingson case either from within or outside the University."

2.  The Board of Medical Practice:

There should be no doubt at all that the Board of Medical Practice (BMP) is the supreme authority for physician investigation and discipline in the state.  There should be no doubt that it also has the lowest threshold for proceeding with action against any physician in the state.  The notion that in this case they were unduly influenced by a consultant with conflicts of interest is problematic.  The Executive Director of the BMP at the time of this investigation was an attorney and the remaining staff are state employees who have been investigating physicians for decades.

The process of how those investigations typically go is also instructive.  Any person in the state can make a complaint against a physician for any reason.  That triggers a letter from the BMP to that physician demanding that they personally respond and send all of the relevant records in 2 weeks or risk disciplinary action.  Once the physician response and records are obtained the BMP looks at all of the available data and determines whether any action is taken on the complaint.  They do not assess the merit of the complaint or screen complaints. They provide no safeguards for the privacy of the physician being investigated.  As a result there are thousands of complaints that are thoroughly investigated but never acted on.  Complaints are technically dismissed without action but all of the data is collected and kept on file in case there are future complaints.  The physician is notified about whether or not they are in violation of the Medical Practice Act or not.  The BMP is also insulated from political influence.   Board Members are appointed by the Governor but after that are not accountable to any politicians.

Dismissing a BMP investigation because a consultant has a conflict of interest seems to miss the mark to me.  Any physician in the state knows that of all of the possible investigations the BMP is the most rigorous and certainly carries more real weight and consequences for their career than any other professional investigation in the state.  The threshold here should be does the BMP have a conflict of interest?


3.  The Legislative Auditor's Report represents a point of view:

The document strikes me as being less than neutral.  The lack of neutrality starts with the description of a medication as a "powerful drug".  Where does a statement like that come from in a document put together by nonphysicians?  I have prescribed as much risperidone as anyone and don't consider it to be a "powerful drug".  In fact, most descriptions of a psychiatric medication that start like that are written by people who either don't know much about medication or are going to start talking about psychiatric medications or psychiatrists from a particular point of view and generally one that is not favorable.  The news media picked up on a letter from former Governor Arne Carlson and this report and in both cases characterized them as "blasting" various elements of the University.  Gov. Carlson's letter is mentioned in this report.

In the discussions of the issue of competency to consent to research, the opinion of the Ombudsman for Mental Health and Mental Retardation figures prominently as well as the efforts of the Minnesota Legislature to ban committed patients from pharmaceutical research.  They also apparently tried to ban patients under a stay of commitment (similar to this specific case) but did not because:

"......National Alliance on Mental Illness Minnesota objected. According to a press account, the organization contended that “mentally ill patients benefit from experimental drugs or treatments when traditional therapy fails them.”

I think that a lot of people reading the report, might miss that important fact in the fine print.  In other words, the premier advocacy organization for patients and families with severe mental illnesses, did not want patients on stays of commitment to be banned from research.

It seems fairly clear to me that the LAR, doubts anything that Dr. Olsen has to say about the lack of financial incentives for him to enroll patients into the study.  They suggest that there may be more to it, but it should be easy to investigate.  I would think that the salaries of University employees are public record.  There does not seem to be a similar level of skepticism applied to anything that supports their main contentions.    

4.  This is an adversarial proceeding:

That should be evident but the various critics and commentators write like they are unaware of it.  When you take that perspective you grant yourself the tone of an ultimate moral authority.  There is no reason for considering any facts that contradict your facts.  There is no reason for considering any other point of view.  An attorney who was representing the University at the time was quoted and then criticized for omissions.  I thought that was standard and accepted behavior of attorneys.  Moreover in any adversarial process in the US,  I would expect one party to make the other party look as bad as possible and the party on the defensive to try to make themselves look as good as possible.  I would further speculate that at some point before the malpractice lawsuit that lawyers were telling just about everyone involved what to say or more probably not to say anything.  To criticize those comments as being "misleading" or the fact that people on the defensive in a legal case are "unwilling to discuss it" seems more than a little disingenuous to me.  All semblance of honest exchange generally evaporates with civil legal involvement and the decision to decide things on the "facts" of the case - potentially in a courtroom proceeding.  Saying that somehow those attitudes will drastically change after a lawsuit has been settled would also be disingenuous.  I know that are new approaches suggested in how these emotionally charged situations can be handled including acknowledging that mistakes had been made.  I wonder if any of the authors of those articles have ever been in a situation where there has been an unexpected death of their patient, where the expectation is that patient should not die even though they are in a much higher mortality group than their peers, and where at various points in their career they will be in contact with peers who can claim that they have never lost a patient?  Can you make any adequate decision at all in that state of mind?  I would suggest that you cannot and you will not be able to as long as the emotional turmoil continues.


5.  The issue of competency in the State of Minnesota:

One of the main points of contention in the articles in this case is whether Mr. Markingson was competent to consent to participate in a research project and whether that consent and his continuing cooperation was coerced rather than voluntary consent.  Numerous authors in the documents do not seem to recognize who is considered competent to consent in the State of Minnesota.  From the Minnesota Statute 253B.23 Subd 2:


"Subd. 2.Legal results of commitment status. (a) Except as otherwise provided in this chapter and in sections 246.15 and 246.16, no person by reason of commitment or treatment pursuant to this chapter shall be deprived of any legal right, including but not limited to the right to dispose of property, sue and be sued, execute instruments, make purchases, enter into contractual relationships, vote, and hold a driver's license. Commitment or treatment of any patient pursuant to this chapter is not a judicial determination of legal incompetency except to the extent provided in section 253B.03, subdivision 6."

In the interest of space considerations, I would invite any reader to click on the link to 253B.03.Subd 6. to read about the exceptions for medical care.  It should be clear from reading that statute that committed patients are competent consenters and that there is a hierarchy of substituted consent. There also seems to be confusion about the issue of civil commitment and court ordered antipsychotic medication with competency.  This is a common problem in acute care psychiatric settings when a committed patient needs an acute medical treatment.  These patients are considered to be competent to make these decisions.  In the case where their opinion agrees with the medical or surgical consultant there are no problems.  In the case where there is an acute life threatening problem like bleeding and they disagree the issue of competency comes into play.  In the State of Minnesota the hierarchy of substituted consent is problematic in practice.  Absent interested family members it requires an additional and separate hearing from the civil commitment hearings.  It also generally requires that the patient or family retain private legal representation for that purpose.  That creates a hurdle significant enough in most cases to prevent the timely provision of acute medical and surgical care.

I have heard the argument that the University was concerned about being "right" rather than doing the right thing.  That seems rhetorical to me.  As a physician you have no choice but to follow the laws in the state.  The issue was also commented on the LAR report by judges on pages 5, 8 , and 28 (specific judges in the case were not named).  The judges in all cases described Mr. Markingson as competent or stating that there was no evidence that he was not competent.  I really cannot think of more compelling evidence in favor of competency to make decisions than a decision by a judge hearing the actual case.

On the issue of the consent form.  I have not seen the consent form.  I have only seen a form that was a checklist of sorts to determine competency.  The LAR report includes highlights of reports from two different psychologists that may have implications for competency.  Psychiatrists are trained to assess patients for general and specific competence.  General competency has to do with the ability to function and handle one's affairs on a day to day basis.  Gutheil and Appelbaum suggest that this includes a mix of current awareness, an ability to assess the current facts of a situation, an ability to adequately process risk/benefit information, and day-to-day functioning (3).  Specific competence is more focused and the person needs to be able to elaborate their thought process and demonstrate that they are reasoning in a logical manner.  The same authors have an action guide (p. 255) about what needs to be down to complete either type of competency evaluation.  The bottom line is that it takes time and I doubt that any antipsychotic trial would use that standard.  If they did there would be two problems.  The first would be reliability problems between psychiatrists doing those evaluations.  The second would be that there would be a significant number of people screened who would not pass the evaluation.  I was not able to find any literature looking at this issue (that is rigorous competency evaluations in patients with psychosis who were research candidates).   A more objective evaluation of general competency could be done, and the approach to specific competency for consent to research needs a lot more work.  These competency issues are really no different for patient enrolled in research projects outside of the field of psychiatry.  A good general validated approach to the issue of specific competency to consent to pharmaceutical research would benefit that entire field.

That said, as an investigator I cannot recall any consent form that did not clearly say that the research subject could quit at any time and that their decision to quit would not in any way affect current or future medical care that they would receive in the health care system.  That is all part of a standard research consent.  


6.  Pharmaceutical research and "evidence-based" medicine in general:  

The mechanics of the project are familiar to me from my participation on research projects as an investigator.  Practically all studies have research coordinators that do not have any medical credentials.  They are necessary because of the sheer amount of paperwork involved in drug trials. The research coordinators are the representatives of the study to families and on the other end of the spectrum they are responsible for the protocol paperwork that is submitted to the FDA.  There appears to be no uniform qualification for these research coordinators and it does not appear to be career path work.

Research now appears to reflect clinical practice and that is not a good thing,  In some of the research that I participated in in the 1980s, the initial phase of antipsychotic trials were done for a specified period of time in an inpatient unit.  The thinking was that disrupting a patient's maintenance medication could lead to acute exacerbations of psychosis.  It certainly did that in the research that I was involved with.  Even in the case of known medications, dose equivalency is always an issue when changing from one medication to another.

In this case the study involved a trial of medications (quetiapine, risperidone, and olanzapine) that had already been approved by the FDA.  The question of whether that study was even necessary could have been answered by any acute care inpatient psychiatrist.  By the time of the original study I had already treated hundreds of patients with all of the study medications in acute care inpatient settings.  Looking at one of the publications, the authors describe a sample size of 400 patients (4).  Like most acute care psychiatrists I have treated multiples of that number and there were no surprising results from this study.  At some level the idea that all of these double blind studies using human subjects needs to be challenged.  It comes from the highest levels of so-called "evidence-based" medicine.  Reading thorough the Cochrane Collaboration about any antipsychotic drug (or practically any medications for any indication) - you will see the same conclusions - inadequate methodology and further study is necessary.  That is not true and at this point I would see those conclusions as approaching the level of a fallacy.  Do I really need a large multi-center study to tell me that people who do not respond to a medication or don't tolerate it may not want to take it?  That information is not only useless to me, but I have already made the necessary changes a lot faster than any research protocol can change during day to day clinical care.  Today's so-called "evidence based" world doesn't give clinicians on the front lines nearly enough credit.  If I had to wait for the blessing of the Cochrane Collaboration I would be incapable of doing my work.

Given the effort required to design and run these trials and the difficulty in recruiting patients is the research question in this study that important?  I would suggest that it is not as evidenced by the fact that physicians like me in clinical practice already know the answers and we are a lot faster on our feet than "evidence-based medicine".  This is currently problem at the national level and it is not just a local problem in Minnesota.  It also has significant political implications.

I pointed out this issue in an e-mail to one of the top epidemiologists in the world a few months ago - so far no response.


7.  The care of people with severe mental illnesses in general:

The outline that I provided on the elements of good psychiatric care as advice to residents still applies here.  There are some additional considerations that can only be honed by years of experience in these settings.  Foremost among then is recognizing the life threatening nature of severe mental illness.  A lot of people with no direct responsibility and concern for the patient's well being do not have this concern or deal with it in the abstract.  We live in a culture where there is not only a bias against this idea but even the idea that mental illnesses exist.  It should not be surprising that people find it difficult to accept the idea that severe mental illnesses exist,  but also that they represent a high level of risk to the individual.  Even people who should know better have a hard time keeping that latter concept in clear focus.  When I do an assessment, I am looking for anything possible that will allow me to look at future risk and what I can do to minimize it.  But even then, we currently lack a technology that can produce the degree of certainty that most of us would like.  The most important aspect of this kind of care is open communication with the patient and as many friends and family as possible.  It is not a 9 to 4 job.  The lines of communication with the clinician or physicians covering for them need to be open at all times.  Any acute changes need to be carefully assessed.  In this age where people with severe problems are dismissed from emergency departments, there has to be a plan for respite care or emergency hospitalization that will work.   In the ideal settings those places need to be hospitable and supportive.  

The ethical climate:

Blackburn describes some characteristics of ethical climates:

"Human beings are ethical animals.  I do not mean that we naturally behave particularly well nor that we are endlessly telling each other what to do.  But we grade and evaluate, and compare and admire, and claim and justify.  We do not just "prefer" this or that, in isolation.  We prefer that our preferences are shared; we turn them into demands on each other.  Events endlessly adjust our sense of responsibility, our guilt and shame and our sense of worth of our own and that of others.  We hope for lives whose story leaves us looking admirable; we like our weaknesses to be hidden and deniable....." (p. 5)

Ethical climates are interesting.  An ethical climate can lead to the establishment of a totalitarian regime or a rich humanitarian culture.  They basically generate their own reality.  The most read post on this blog was about the issue of conflict of interest and it basically has to do with an attempt to construct or continue a certain ethical climate.  Various ethical environments are applied more selectively to psychiatry than any other medical speciality.   In this investigation I can easily argue selective attention to some of the elements in my above commentary and ignoring other elements creates a particular ethical environment despite the fact that the authors seem to agree with the main points of some of the investigations and reports that they attempt to discredit.

In that process a lot is lost in the translation - not the least of which is that we have a report that seeks to establish the Office of the Ombudsman for Mental Health and Developmental Disabilities as a monitor for drug studies in the Department of Psychiatry when there is no evidence that they are equipped to do the job.  This is apparently being done because of the way the administrations reacted to and disclosed various investigations into the original incident.  Further, the same report has disenfranchised the state's primary agency in charge of investigating and disciplining physicians based on a conflict of interest that was fully disclosed to the BMP before the consultant was hired.

It all comes down to the question: "Is this a fair analysis of the problem or is this a case of an ethical environment being engineered to produce a certain result?"

This is more than a moot question given the concrete recommendations of the report.


George Dawson, MD, DFAPA




1:  Legislative Auditor's Report entitled "A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case Special Review".  March 29, 2015.

2:  Simon Blackburn.  Being Good - A Short Introduction to Ethics.  Oxford University Press, New York, 2001.

3:  Thomas G. Gutheil, Paul S. Appelbaum.  Clinical Handbook of Psychiatry and The Law, 3rd ed.  Lippincott Williams and Wilkins, Philadelphia, 2000.

4:  Perkins DO, Gu H, Weiden PJ, McEvoy JP, Hamer RM, Lieberman JA. Comparison of Atypicals in First Episode study group. Predictors of treatment discontinuation and medication nonadherence in patients recovering from a first episode of schizophrenia, schizophreniform disorder, or schizoaffective disorder: a randomized, double-blind, flexible-dose, multicenter study. J Clin Psychiatry. 2008 Jan;69(1):106-13. PubMed PMID: 18312044.