only weakest links…

Posted on Friday 3 May 2013

A commenter recently asked "who is your audience?" He was apparently bumfuzzled by my choice of topics [Emil Kraepelin’s politics: all ears…, an open question…]. It’s a good question, but I don’t know the answer [and I’m still cogitating about Kraepelin]. I’m old now, so I guess I write about what I’m thinking about. But I take his point, and will try not to ‘start in the middle" so much.

This one is easy to introduce. There’s something of a conflict brewing between two people I like – Ben Goldacre and David Healy. Goldacre is an epidemiologist associated with the Cochrane Group who is well versed in the way PHARMA has regularly manipulated clinical trial data the their advantage, and he has developed a presentation style that gets his point across effectively. He started the AllTrials campaign to get the subject level data from all clinical trials published. His strategy is to right the wrongs that have plagued us all – distorted, manipulated clinical trials used for marketing.

While many of us are excited about this project, There are some worrisome aspects along the way. For example. GSK signed on with much fanfare, but want to set up an independent panel to decide who gets the data. The same with Roche. And we’re not hearing the "Hell No!" we want to hear coming from the AllTrial people. And they keep talking about "Study Reports." We don’t want metabolized data. We want the real thing – raw patient level data. But these are political times and watching Dr. Goldacre in the hearing [Ben vs. Roche…], I was encouraged that he’s not going to be pushed around for long.

Dr. Healy comes to the table from a different vantage, more like a soldier with a history in combat. He has been a pioneer in vetting these industry clinical trials for well over a decade – having lost a posh job for saying that SSRIs could cause akathisia – an aggressive agitation with violent thoughts and actions [suicide, homicide]. He has been an active voice in court cases – settlements against PHARMA. And there have been times when he was the only voice when a chorus was needed. He could hardly be seen as opposing the kind of reform advocated by Dr. Goldacre and others. His points are not easy to summarize, but I’ll have a shot:
  • Beware of the Wolf in Sheep’s clothing: Given  the past consistent behavior of the pharmaceutical industry, it make sense to look at everything they say as suspect, or worse. Dr. Goldacre called GSK signing on to AllTrials a cartwheel moment. But the motives of PHARMA remain the same – to sell the most drugs. So "yes" to data transparency, "but we’ll decide who gets it" and probably add in confidentiality agreements etc. Semi-transparency at best, more like Pseudo-transparency. And two companies [AbbVie and InterMune] have stopped data release by the EMA for the moment, on claims of confidentiality [what don’t they understand about the word “All”?…]. So there’s a cynicism in Dr. Healy’s take on things, born from  experience – the wisdom of a veteran.
  • Beware of the primacy of Clinical Trials: Clinical Drug Trials hardly reflect actual practice conditions. They’re done on recruited, paid subjects. Some may have been on a waiting list, yet the have to be certified ill when they enter the study. Many studies have been done overseas in unspecified cultural or economic circumstances. In some cases, one can question whether the data has been doctored. And Clinical Drug Trials are often of short duration and have high drop-out rates. At best, they might answer the questions, "Does this drug have anti-something properties? Are there prohibitive short-tern adverse effects?" But because they have demonstrated documented efficacy, that information becomes digitized – yes/no. "Is Paxil effective in depressed adolescents?" There’s nothing in the trial data that suggests that a doctor can answer the t.v. question, "Ask your doctor if some drug is right for you?" Who knows? The only way to know is to try it [which is, of course, the reason for the ads]. Well designed studies that allow calculation of effect size might give have a Number Needed to Treat or an odds ratio, but that’s only valid under the study conditions. So Clinical Trials are weak instruments, only really definitive if they’re negative.

    But beyond the intrinsic problems with the Clinical Trials themselves, it creates the scenario in my overused diagram above. Diagnosis by Manual; Treatment by Algorithm; based on Evidence from [jury-rigged] Clinical Trials. It’s a chain constructed of only "weakest links."

    "Your doctor" [the one you are supposed to "ask"] isn’t in this equation. This is like Managed Care and the Pharmaceutical Industry would like for medicine to be – predictable, routinized, known at a level that could be handled by algorithm. If one argues against this formula, it is countered with all sorts of things that imply that this is a self-serving argument incompatible with the tenets of Evidence-Based Medicine – doctors just justifying their existence. The question comes down to would you prefer to have as your interface with the world of medicine your physician or your insurance carrier [whose primary goal is cost containment] and your pharmaceutical company [whose bottom line  is corporate profits].

    I didn’t say that in any way like Dr. Healy does [Brand Fascism], but the conclusion remains the same. Evidence-Based Medicine and Randomized Clinical Trials are, at their best, only information to consider. Extrapolating them to their current primacy has created an open conduit for bad science, corruption, and contributed to a general decline in medical care – proxy doctors operating in a domain controlled by various industrial interests, particularly in psychiatry. It’s a simple truth.
So I still agree with both Drs. Goldacre and Healy. Clinical Trials have been a mess and need to be cleaned up and accurately reported – no matter what. I hope if the drug companies attempt to undermine their efforts as Dr. David Healy predicts they will, that Drs. Ben Goldacre, Fiona Godlee, Iain Chalmers, Peter Doshi, Tom Jefferson, et al will see it happening and not be taken in. But like Dr. Healy, I tire of the metaphors of Evidence-Based Medicine, Randomized Clinical Trials, and Practice Guidelines  being used as a gold standard – an argument against clinical judgement. I’ve heard them enough where I can run through them in my head any time I need to hear them. Medicine is hardly advanced to a place where one algorithm fits all should be our watchword, particularly in an area so intrinsically subjective as mental illness. And when those algorithms are overdetermined by layers of conflict of interest, it’s time for radical change…
  1.  
    May 3, 2013 | 3:50 PM
     

    I am one in your audience, recommending your blog to friends in the community of (ex)users and survivors of psychiatry, in teaching and clinical practice, who don’t mind reading a foreign language. The blog is very good, honest, humane, open.
    I’m busy catching up, after a sojourn in Oslo, pleased to read your take on Kraepelin, thankfull for many pertinent links.
    Also, I like to be reminded of an America populated by ordinary, decent human beings. This is easy to forget as the USA is viewed by many, here in Europe too, with (increasing, I think) disappointment, sceptisism, mistrust, disgust on account of failures of policy, ingrained social inequality, injustice, war…
    We have knowledge needed to alleviate unnecessary suffering. What’s sorely lacking is thinking and acting beyond private interests and prejudices – justice – for all. “Unequal health, the scandal of our times” and “Injustice”, by Daniel Dorling, hereby recommended.

  2.  
    wiley
    May 3, 2013 | 3:56 PM
     

    The job of reforming researchers, journals, and bigpharma are bigger than both of them. The Open Knowledge movement, though, is running apace. Inter-disciplinary efforts are required to even put a dent in the mess that is the Faustian bargain between science and industry.

    http://blogs.library.duke.edu/scholcomm/2010/09/13/what-is-open-science/

  3.  
    PaulRobert
    May 4, 2013 | 12:55 AM
     

    FYI, Dr Ben Goldacre gave a ‘phone interview (approx 13 minutes) with an Australian journalist. He doesn’t say anything that, I presume, would be much of a surprise to you but it’s good that he’s being widely heard: “Medicine is broken, says Bad Pharma author Ben Goldacre. In this audio interview, he talks about giving the public tools to hold the medical industry to account.”

  4.  
    PaulRobert
    May 4, 2013 | 12:56 AM
     
  5.  
    Gad Mayer
    May 4, 2013 | 3:50 AM
     

    I am one of your devoted readers. I am a psychiatrist. I live in Israel and work in a public hospital. I have learned a lot from following your blog. I like the way you think about things and I enjoy your perspective, a perspective that comes from having a long experience, being a good observer, and being able to think about things flexibly (as opposed to rigid dogmatism). There’s one thing that I would like, that would improve my use of your blog, and I don’t know how easy it is to create post-hoc: a keyword search.
    Keep up the great work,
    Gaddy

  6.  
    May 4, 2013 | 3:59 PM
     

    I agree, Gad Mayer, searching 1boringoldman.com is a bear. I use Google with this syntax:

    site:1boringoldman.com keyword keyword keyword

  7.  
    May 12, 2013 | 2:47 AM
     

    Rectify is the story of a man who was sentenced to death for a crime he didn’t commit, and spent 19 years on death row before getting out. Much like in my own real life case, the local politicians refuse to admit he’s innocent even after DNA testing points towards someone else. In fact, there was so much about this show that mirrored my own life I began to wonder how much of my story had crept into the script.

  8.  
    May 12, 2013 | 2:49 AM
     

    The main character is a man named Daniel. When you look at his eyes, you’re looking into the eyes of a man who has seen Hell. There are moments when he looks like he’s about to begin screaming at any second, and never stop. The first time you see this is in episode one, when he’s about to leave the prison. The guard is treating him like a human being, and it’s evident this hasn’t happened in an extremely long time. You see the confusion on his face as he wrestles with suddenly being treated decently by the same people who have treated him like an animal for years. He can’t quite process it. I know that look well. As he’s about to leave the prison, the guard helps him tie his necktie, as he can no longer remember how to do it himself.

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