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Posted on Saturday 7 November 2015

These are some links to articles I’ve reviewed in the recent past – industry funded, professionally-ghost-written, clinical trials of the newer atypical antipsychotics published in highly ranked, peer reviewed, academic journals. There are some other things they share in common [I made it easy with my red highlighting]:
Each article has only one academic author [all of whom have conflicts of interest specific to the drug being studied]. So only five of the forty-four authors are academics. Since the studies were conducted by Contract Research Organizations at multiple Clinical Research Centers all over the world, it is also even possible that none of the forty-four listed authors ever met a one of the subjects involved in these studies.

I’ve been thinking about this ever since we wrote the RIAT 329 article. It felt odd to me that our group was writing about subjects we’ve never seen. But then it occurred to me that it’s the standard in a lot of the Contract Research Organization managed studies. The other thing that occurred to me over and over was that our group had no direct contact with any of the twenty-two authors of the original Paxil Study 329 – only with the sponsoring pharmaceutical company. And reading through the Clinical Study Report, it was obviously written by and analyzed by the sponsor. Even the professional ghost-writer worked off of some version of a summary document prepared by the sponsor. I would suspect that the same is true about the articles above. I guess we’re just so used to the primacy of the sponsors, in spite of the fact that we anachronistically still refer to these articles as "Kane et al" or "Keller et al" [how quaint!].

It just doesn’t seem to register anymore that this class of articles reporting clinical trials is published in academic journals, but it has no real connection to anything "academic." I’ve referred to the authors highlighted in red as "tickets," as if their function is to certify admission to the journals. I recently suggested facetiously in maybe nowhere… that…
It would be fine with me if there were a specific journal for that kind of paper – the Journal of Industry Financed Reviews and Clinical Trials in Psychopharmacology… If the peer reviewed academic journals absolutely need the revenue, they could at least put these articles in a labeled, dedicated section of their publications with a heading [I suggest Industry Financed Reviews and Clinical Trials in Psychopharmacology].
…but maybe I should have taken myself more seriously. I’m beginning to wonder if we are perpetuating the myth that these articles are the productions of an ethical academic author or set of authors. Perhaps we should insist that they be clearly identified as non-academic industrial productions – which is what they are – and published in a section of their own that makes that fact crystal clear. Why not? It’s the truth…
  1.  
    Bernard Carroll
    November 7, 2015 | 8:43 AM
     

    Four of your five examples are from American Journal of Psychiatry (AJP). It has become debatable whether AJP actually is an academic journal. Nowadays it looks like a hybrid of guild journal – trade journal – scientific journal, in that order.

    You ask a good question – whether the token KOLs actually were involved in treating any of the patients in those trials. The modern business of clinical trials is a far cry from the early days of Heinz Lehman with chlorpromazine or of Richard Ball and Leslie Kiloh with imipramine. At least we can say they knew their patients and took clinical responsibility for them. How many of these listed KOL authors can say that? [Free downloads of both articles are available through the PubMed links.]

  2.  
    Mickey
    November 7, 2015 | 9:20 AM
     

    Thanks,

    I would add that if these subjects were actually “patients” and were followed by “clinicians” as well as “raters,” we might learn things that make up for the short-term nature of these trials. We can only know what the rating scales ask, and so our meta·knowledge about these drugs remains static – fixed to the day the clini·metric was created.

    An example: The first patient I ever gave Prozac also happened to be the first patient I ever had that was HIV positive. He was a bright Clinical Psychologist and he wanted to try Prozac. It helped, and he later said [paraphrasing]: “I’m not sure it’s an anti-depressant. I think it’s an anti-broodant. I still think the same things, but I don’t brood about them – get stuck in my gloomy thoughts.” That was long before I heard anything about Prozac and OCD.

    That was a jillion years ago, but I still ask about brooding with depressed patients because, in my subsequent experience, it’s one predictor that the medication is likely to help.

  3.  
    Bernard Carroll
    November 7, 2015 | 10:01 AM
     

    Speaking of meta-knowledge, there is a telling statement in the paper by Ball and Kiloh: “It has certainly been obvious in this department that since the introduction of iproniazid and imipramine the amount of in-patient and out-patient E.C.T. given has fallen sharply.” That is what I call ecological validity.

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