reason enough…

Posted on Wednesday 16 April 2014

In the comments to [what really matters…], Dr. Carroll mentioned a post on the Danny Carlat Blog back in August 2010 about the Dan Markingson case, actually two posts ["Making a Killing": New Carl Elliott Article in Mother Jones, Was the CAFE study manipulated by AstraZeneca? Maybe Not.]. Both of these posts, and particularly the comments to the second give a pretty full version of the story. In an article in the Pioneer Press in May 2008 [Patient's suicide raises questions], the attempt to file a suit against the Institutional Review Board was described as follows:
A judge ruled in February that as a state agency, the university and its IRB are immune from the lawsuit. The legal ruling didn’t allow questions to be explored about who’s ultimately responsible for the safety of research subjects and whether the university did everything reasonable to protect Markingson from harm. According to the U’s human subjects protection guide, the IRB’s first charge is "to protect human subjects involved in research at the university from inappropriate risk"…

The lawsuit by Markingson’s mother, Mary Weiss, alleged that the IRB’s trust was misplaced in the so-called CAFE study, led by Dr. Stephen Olson, a U psychiatrist. A central allegation was whether Olson had too much power over Markingson, and too many conflicts that obscured his clinical judgment. Olson recruited Markingson into the study at the same time he served as Markingson’s treating doctor and advised a Dakota County judge on whether Markingson should be committed to a psychiatric hospital.

Had the IRB followed its own guidelines, it would have discouraged Olson from recruiting his own patient. The IRB Web site states that "doctor-patient relationships between the investigator and participants should be avoided, when possible, to eliminate any power-based coercion"…
While it’s an obvious point, Dan Markingson’s suicide was ten years ago. One might ask why people won’t just let it go – let the "sleeping dog lie" and move on? The drug companies have run out of tricks and currently aren’t even looking at the CNS drug market. Why continue to cover this same ground over and over? Dan Markingson’s suicide? Paxil Study 329? the case of Rebecca Riley? Ghost-writing? Guest authorship? TMAP? the ways that clinical trials have been mispresented? the complicity and/or collusion of way too many academic psychiatrists?

In some ways, the way the University of Minnesota has tried to deal with the Markingson case [refusing to let it to see the light of day, denying all allegations, trying to limit any investigation to the present corrections] turns out to be a microcosm of how American Psychiatry is dealing with the overall problem of corruption in the ranks in the specialty. If you look at the APA Convention program for next month’s meeting, none of these unpleasant and shameful topics made it to the program. Yet the theme for the meeting addresses them:

So we’re interested in Changing The Practice and Perception of Psychiatry, but we’re not mentioning why it needs to be changed? Like the President of the University of Minnesota, the APA is saying "look at us now, not then." For that matter, the pharmaceutical industry is doing something similar. They’re finally giving in to Data Transparency but presenting it as a magnanimous act rather than a position they’ve been forced to occupy.

I know of no situation in the history of medicine that matches what happened in psychiatry in these last twenty plus years. Fundamental medical values like trust and honesty were repeatedly pushed aside. How can we now ask people to change their perceptions, if we’re not even honest enough to acknowledge why they have them? The reason to keep bringing up things like Dan Markingson’s suicide is because they happened – that’s reason enough. In medicine, sometimes we learn from the living, but often-times, we learn the most from the last autopsy.
  1.  
    April 16, 2014 | 10:45 AM
     

    I don’t want to a total downer, but when the APA says “changing the practice and perception of psychiatry,” with the “practice” part they are referring to increasing use of evidenced-based treatments and integrated care, and the “perception” part is wanting the public, other doctors, and med students to see psychiatrists as “real doctors” and scientists.

    Alas, it has nothing to do with the the reasons for change that most of us reading this website believe are important.

  2.  
    April 16, 2014 | 10:59 AM
     

    Double alas!

  3.  
    Steve Lucas
    April 16, 2014 | 11:03 AM
     

    One of my many frustrations with all of medicine is this tendency to look back, not forward. Looking at these case studies one does not have to guess why they went so terribly wrong and why people were put in the positions they were put in risking their health and possible death.

    When you ask the above question you are told people did not know, or it is part of the scientific process. Nonsense! A little forward looking thought would show many of the studies and standards used today are harmful.

    Doctors need to quit trying to drive the medical car by looking in the rearview mirror and do what they are suppose to do, THINK!

    Steve Lucas

  4.  
    wiley
    April 16, 2014 | 1:43 PM
     

    It’s not too much to ask leaders in any field to address their most damaging practices, especially when those practices involve bad science in a field that insists on its scientific grounding and expects trust from the general public on behalf of that.

    Most people can be convinced that accidents happen and that in medicine, there are often hard choices in which there are no really good choices. But the only thing worse than engaging in fraudulent and manipulative practices leading to the death of a test subject, is not showing any evidence that anyone has learned from it, and not making any effort to compensate for the pain and grief they’ve caused. No one has the right to demand or to expect trust, in fact, that alone leads to reasonable suspicions that one is not worthy or trust.

    None of these people are adult enough to stand up and take responsibility for Dan Markingson’s death and the conditions leading up to it? Then none of them should be in a position of responsibility, especially not in a position that risks the lives of test subjects. They should be forbidden to work on research projects until they’ve demonstrated that they’ve learned what went wrong with the study that killed Dan Markingson and they’re committed to not repeating it.

  5.  
    April 16, 2014 | 2:14 PM
     

    i don’t know how many of these are even real research projects.
    i don’t know how many people my age, give or take ten-fifteen years, know what it is to be a doctor. they don’t respect it either. they just want to get paid and it gets me very mad.

    to dr lucas: how can we expect doctors to think, when the very institution that breeds them isn’t teaching real medicine. it’s disappointing but that’s what’s happening. of course there are many great doctors, but i find many of those are much older than me; they also respect their profession more.

    it’s time to strip people of their right to practice and their M.D. they are engaging in blatant behaviour. it seems to me that they’re just looking for excuses to cashout taxpayer money using “science” (medicine is the jewel, ofc). if it wasn’t that, maybe we’d have something to show for all those taxpayer dollars being sucked up by the selfish beaurocrats at THE EXPENSE OF MEDICINE’S REPUTATION.
    it makes all doctors look bad when they aren’t protecting “the art” (IN MY OPINION)

    sorry for the rant

  6.  
    Steve Lucas
    April 16, 2014 | 4:46 PM
     

    Two things happened today:

    One, I ran across this gem about the U of M.

    http://opinion.foxnews.mobi/quickPage.html?page=34606&content=103352381&pageNum=-1

    It seems to be an epidemic where professors who do not like what a student says attack the student or suggest that the students are in some way deficient. This is of course all the fault of Fox news, why I have never figured out.

    The second thing was my wife came home and told me about a friend’s husband who spent five days in the hospital and almost died. It seems he was constipated, went to the doctor, and the doctor prescribed an anti-depressant. The result was he was transported with a bowel blockage, abscess, and major infection.

    While I appreciate the promotion, and would travel for an honorary doctorate, I am a MBA whose interest in medical marketing was sparked by an undergraduate course taught by the sales manager of a drug wholesaler many decades ago. The decline in medical ethics by hospitals and drug companies, combined with the drive for profit, while the lack of any real economic understanding has left me appalled.

    Maybe that is the point, make the money now and worry about the rest later.

    Steve Lucas

  7.  
    wiley
    April 16, 2014 | 5:35 PM
     

    Well, Steve, I think any person is capable of losing perspective and becoming dishonest when given sufficient motivation for doing so, and sufficient reason not to question or push back against what is considered to be “settled” in any environment or pursuit. Any of us in a situation in which other person’s lives depend on us could fall short. The feelings that come with a such a failure or the threat of such failure should have a safe place to go, but the responsibility remains the same.

    It’s a fact that even scientifically trained persons are as capable and guilty of irrational bias as anyone else, even when they’re specifically trained in statistics. The assumption that a person who is a scientist is a fundamentally rational person who acts and thinks logically at all times is simply bunk. When people in the sciences are allowed to operate without challenge due to emotional reasons— and the desire for money and prestige is emotional — then we can easily end up with bad science and a refusal to address a failure as the failure it is because not doing so is more rewarding. It’s a systemic problem.

    It’s best that checks be put into place before anyone gets hurt and before too much practice is poisoned by suppositions that have little to no scientific evidence to back them up. It’s even better when an environment encourages scientists to check themselves regularly and invite others to do so— like patients and those close to patients. To pretend that one is scientifically minded and immune to influence is to deny that one is human; which has a tendency to lend itself to grave human error.

    The people who other people’s lives depend on have a heavy burden to bear and that is not to be taken lightly, nor is the doctor to be held responsible for every outcome. But an error of this magnitude should be as thoroughly investigated as any plane crash or iatrogenic death— immediately. Years of foot-dragging and failure to investigate suggests that the people involved are too childish, reticent, and lacking in character to have anyone’s life and/or well being in their hands— especially when the person at risk suffers from diminished capacity.

    A lot of hospital administrators have learned that more than money or winning, survivors of iatrogenic harm want the error acknowledged, and they want an apology. Many have learned from experience that distancing behavior only invites anger from survivors and more motivation to sue for larger amounts. It’s a sad fact in our society that a sincere apology is too often met with a, ‘you damned well better be sorry’ response, but when issues of substance and profundity are on the table, most people just want the harm to be acknowledged and for the hospital to acknowledge their error. That also assures the survivors that the hospital will correct the errors they’ve acknowledged and that the survivor need not feel obligated to fight on behalf of future victims.

  8.  
    April 16, 2014 | 8:31 PM
     

    Re:How can we now ask people to change their perceptions, if we’re not even honest enough to acknowledge why they have them?
    This is exactly my question.
    Here is the beginning of a letter I wrote to AJP in 2009:
    TO THE EDITOR: The field of medicine is being called to account for its practices and involvement with the pharmaceutical industry. It is striking how few academic physicians have come forward to take responsibility for the roles they have played in inflating the benefits of many of the drugs prescribed today. Such practices have been described in detail in a number of recent books (T, 2). Neither faculty nor academic institutions have responded adequately to those serious and substantive challenges to their integrity.
    http://www.ncbi.nlm.nih.gov/pubmed/19651753

    It just seems that these same people want to move along as if nothing ever happened.

  9.  
    Arby
    April 16, 2014 | 9:06 PM
     

    What happened at the University of Minnesota started years ago, but it sure hasn’t ended. Every time the subject comes up, I think of this article The slow torture of Mary Weiss. I’m sorry if this is redundant; I don’t recall if I read it here first or at MIA.

    While looking for the article, I came across this The Silence of the Bioethicists. It is a very disturbing article about those at Ground Zero of this tragedy who are remaining silent while Carl Elliot is hung out to dry.

    In the past few months, I have been trying to figure out why in cases like this only one individual speaks up/fights something so obviously wrong/criminal/evil. It doesn’t make any sense to me. Well, at least here, I have seen one of his colleagues speak out in his defense.

  10.  
    Arby
    April 16, 2014 | 9:25 PM
     

    Steve,

    I am a student that once had my grade impacted because I didn’t believe in the communist ethics of a professor. Funny that there is tenure to protect a professor’s beliefs but none for his/her student’s.

    If you don’t mind my asking, what was it in the class that got you interested in medical marketing? I am just curious if it was a common theme to all marketing/business or if there was something unique about it.

    Maybe that is the point, make the money now and worry about the rest later.

    That is always the point, and the only point, that I have ever seen in business. I’ve never met a senior executive that would not do anything to be one of the few to get the brass ring, and they all bank on getting out before the ride ends. Do you remember this quote “As long as the music is playing, you’ve got to get up and dance.”? He was one of my ‘fearless leaders’ at one time. Yes, they are still dancing at Citi. Dancing on the graves of those whose lives they ruined.

  11.  
    wiley
    April 16, 2014 | 10:29 PM
     

    Who you going to believe, Sandra? Them or your lying eyes?

    Interesting, Arby. “Contemporary bioethicists look at the Tuskegee research scandal and question why so many individuals remained silent in the face of wrongdoing. “It was a different time, a different place.” We look at the past and we think we are distinguishable from those who responded to injustice with silence and apparent indifference. But are we?”

    No. We aren’t. Why do people keep thinking this? We are the same humans with the same propensity to err in favor of our interests, even when it harms others, when we believe that our aims are more important than other’s concerns. It’s not like we’ve evolved into another species since the nineteen seventies. The difference between humans who would not make such mistakes is probably greater than the differences between Homo sapiens and Homo neanderthalensis. All our delusions about being able to make things “fail safe” and being able to transcend our bodies are the same animistic yearnings of our ancestors wrapped up in a sci-fi bow.

  12.  
    Steve Lucas
    April 17, 2014 | 5:12 AM
     

    Arby,

    What made the class so interesting was the instructor. We covered the math and moving standards to increase sales along with data collection of doctors prescribing practices. This was about sales management so we covered how to keep sales people in line and ethics. The business classes at the time included a great deal of psychology as part of managing a staff or facility. Motivation was a key word.

    The instructor was older and while wanting to polish the apple made the very big point you do not lie. This was the early 70’s so it was still an important point and by the time I graduated with my MBA the ethics part of business had gone by the way side in an effort to make your numbers.

    I also had my grades hacked by instructors who did not like my questioning their teachings. A graduate marketing instructor was a drunk and I had a problem with that which resulted in my receiving a lower grade backed up by the dean. Another graduate instructor hacked my grade because I did not show the proper respect; after all he was a Ph D.

    My education was different in that all of my instructors were working professionals, many lawyers. The students were also all working and mostly older. No gulf or art, just a broad range of business classes.

    Steve Lucas

  13.  
    April 17, 2014 | 3:57 PM
     

    Sandy, I’m still looking for a way to clone you.

  14.  
    wiley
    April 17, 2014 | 8:26 PM
     

    O.K. the Minnesota Congress passed a law that might prevent someone with homicidal/suicidal ideation from being put into a study the way Dan Markingson was, but that has no effect on subjects in other states.

    People under state civil commitment will be prohibited from participating in a psychiatric clinical drug trial while the order is in effect, under a new law signed May 11 by Gov. Tim Pawlenty.

    The law, sponsored by Rep. Karla Bigham (DFL-Cottage Grove) and Sen. Don Betzold (DFL-Fridley), will allow a patient to participate if the treating psychiatrist submits an affidavit citing its benefit to the person. However, the treating psychiatrist must not be the psychiatrist conducting the drug trial. The law is effective Aug. 1, 2009.

    Many psychiatric drug trials already say patients at risk of suicide or of hurting others should not be recruited, Dr. Carl Elliott, professor at the Center for Bioethics at the University of Minnesota, told a House committee. While participation in a drug study carries risk, patients under civil commitment may not understand what they are signing up for, he said.

    Dr. Elliot won that one, but it’s just one effort to address one part of the problem in one state. What might be more beneficial is the policy that Dartmouth college is using:

    “The investigator who conducts clinical investigations with both drugs and devices commits to personally conduct or supervise all aspects of the investigation.”

    Such that,

    “When tasks are delegated by the investigator, the investigator is responsible for providing adequate supervision or those to whom tasks are delegated and the investigator is accountable for regulatory violations resulting from failure to adequately supervise the conduct of the study.”

    http://med.dartmouth-hitchcock.org/clinical_trials/delegation_of_authority.html

    Though I’m sure any institution that wants to could find loopholes, given explicit responsibility for all aspects of a study sounds like a good start. How could Olson ever get away with having a social worker evaluate the test subjects? It’s almost as if he thinks psychiatrists aren’t necessary.

    With greater power, greater responsibility should be required. Now that the ACA has passed, and there are likely going to be fewer and fewer homeless people and poor people participating in studies, might now be a good time to rethink strategies for testing the therapeutic values and risk/benefit of drugs?

    The double-blind random placebo can be milked too easily and only involves short term prescribing for the primary benefit of drug companies. Most of the early psyche meds were discovered during research on something else. Though there have been developments that improve the lives and functioning of some, no doubt; it seems that there isn’t a structure sufficient to study their effects and alternatives in the people who are prescribed them for the long and short terms.

    If we want to avoid the costs of harmful drugs, we need to pay the costs of earnest research.

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