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be ashamed…

Posted on Monday 21 March 2016

Editor Jeffrey Drazen‘s New England Journal of Medicine is back on the front burner once again. You’ll likely recall the series he introduced by reporter Lisa Rosenbaum that argued that there was an inappropriate preoccupation with conflict of interest in general and they specifically pondered lifting the ban on review articles and editorials by authors with COIs:
Then he weighed in on people who are interested in reanalyzing questionable studies [like our paper on Paxil Study 329], suggesting that we are data parasites too lazy to do our own research:
Earlier this month, Drazen’s journal was defending the questions about the Xarelto® eg the defunct test machines [see proceed at your own risk…]. The gist of all these postings [if I may paraphrase] is that the uproar about COI, questionable Clinical Trials, Industry is all a bunch of malarkey, some kind of phoney-baloney political correctness that’s picking on industry and just obstructing progress [okay, maybe a little too sarcastic, but I’m in the ball park]. Now we have another New England Journal of Medicine piece from, once again, reporter Lisa Rosenbaum:
This story has lots of details and liabilities. Here are two excellent summations of all the ins and outs:
A morcellator is a whirling machine [something like a roto-router]. It can be used to "chew up" uterine fibroids through a small incision under visualization, simplifying their removal:
Amy Reed, a 40-year-old anesthesiologist and mother of six, underwent a hysterectomy with intraoperative morcellation for presumptively benign uterine fibroids at Boston’s Brigham and Women’s Hospital… The masses turned out to contain foci of leiomyosarcoma, a rare, aggressive cancer that has a 5-year survival rate of 63% when diagnosed at stage I. Reed’s LMS was stage IV, so her likelihood of surviving 5 years was only about 14%.
The procedure had presumably spread the cancer cells throughout he abdomen. Her husband, a surgical fellow, went ballistic, mounted a campaign, and ultimately the FDA added a black box warning, essentially shutting down the use of the morcellator. Dr. Rosenbaum goes on to develop her thesis that this power of tragedy is overblown and creates a reactionary climate. She gives another example:
Yet disproportionate focus on harms caused by use rather than nonuse is common. In 2004, for instance, the FDA placed a black-box warning on antidepressants for pediatric and adolescent use because of concern that they increased the risk of suicidality, although untreated depression probably poses equal or greater risk. Media stories about adolescents harmed by these medications had frightened parents and physicians. Since then, untreated depression has increased among both adolescents and adults, and some data suggest that adolescent suicide rates have also increased.
ASIDE: That last little bit is a reference to Lu et al [Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study], a study thoroughly covered here and elsewhere that certainly doesn’t suggest that! What it shows is the danger of using a flawed proxy. Referencing it with a quip is a testimonial to why studies like Lu et al shouldn’t be published. They get quoted in perpetuity…

In this piece, Dr. Rosenbaum is essentially arguing, "Oh don’t get so emotional," and "Don’t blow a single case up into a campaign." She might as well say, "Stop being so hysterical!" Maybe she could make that argument fly a little higher if it weren’t for the obvious. All of her examples are in defense of lucrative industry positions and standing in opposition to the FDA‘s decisions. What was once our primo academic medical journal, The New England Journal of Medicine, is going out of its way to regularly become a mouthpiece for the pharmaceutical/medical device industries and their profit-driven motives.

I’ll not go through her arguments in detail, as Dr. Poses does that quite well in his post. What I want to focus on is Dr. Drazen’s leadership of the New England Journal of Medicine. One would have to be in a coma not to know that Medicine and medical care has been invaded by industry and become a "market." Even academic medicine has been pulled into the commercial arena. And there are not many forces aligned on the other side. The New England Journal of Medicine has been one of those forces. It was Editor Arnold Relman who warned us what was coming before most of us even saw it:
The new medical-industrial complex.
by Relman AS.
New England Journal of Medicine. 1980  303[17]:963-70.

The most important health-care development of the day is the recent, relatively unheralded rise of a huge new industry that supplies health-care services for profit. Proprietary hospitals and nursing homes, diagnostic laboratories, home-care and emergency-room services, hemodialysis, and a wide variety of other services produced a gross income to this industry last year of about $35 billion to +40 billion. This new "medical-industrial complex" may be more efficient than its nonprofit competition, but it creates the problems of overuse and fragmentation of services, overemphasis on technology, and "cream-skimming," and it may also exercise undue influence on national health policy. In this medical market, physicians must act as discerning purchasing agents for their patients and therefore should have no conflicting financial interests. Closer attention from the public and the profession, and careful study, are necessary to ensure that the "medical-industrial complex" puts the interest of the public before those of its stockholders.
It was subsequent New England Journal of Medicine Editors Jerome P Kassirer and Marcia Angell who kept that point on the front page [and continue into the present – the real editors speak out…]. And now it’s beyond disheartening to have New England Journal of Medicine Editor Jeffrey Drazen and his reporter Lisa Rosenbaum acting as champions against the Food and Drug Administration. First, they propose that they turn their editorial page and review articles into an infomercial conduit like many of the other journals have done. Then he accuses those of us insisting on Data Transparency in order to hold the jury-rigged industry-funded studies accountable of being parasites capitalizing on other peoples data. Now the journal is chiding the FDA for being too careful with breast implants? What I want to say is, "The New England Journal of Medicine isn’t yours to sell out. It’s ours. I started reading it fifty years ago and it helped shape what’s best about my medical persona – as much as any mentor I encountered along the way. If you think it’s naive to be careful and to stay on the safe side of "Do no harm," go find some other place to do that. I have no idea what forces put you on this road, but they sure aren’t coming from the many former young medical students like me that this journal got off on the right foot. You ought to be ashamed"…
  1.  
    Paul Pierce
    March 22, 2016 | 2:32 PM
     

    I found this line interesting, “the FDA placed a black-box warning on antidepressants for pediatric and adolescent use because of concern that they increased the risk of suicidality, although untreated depression probably poses equal or greater risk.”

    My understanding is that black box warning came from pooled data from RTCs of of antidepressants vs. placebo. This pooled data, if I remember correctly, included studies of conditions other than Major Depressive Disorder, but I imagine the bulk of the studies were looking at MDD. Assuming that’s the case (and, again, I may be wrong), then the black box warning came into existence precisely because the data suggested treating depression with antidepressants carried a higher risk of suicidal thoughts/behaviors than treating the same condition with a placebo.

    Now, if that’s all true, I guess you could say the above quote could still be technically right, since non-treatment and placebo treatment are not the same thing. However, that quote, even if you’re willing to stretch credulity, leaves out the important addendum that while untreated depression in teens and young adults MIGHT carry a higher risk of suicide than treating with an antidepressant, treatment with an antidepressant DOES carry higher suicide risk relative to treatment with a placebo.

    So at best, I think that line of thinking still doesn’t lead back to advocating antidepressant treatment in that population as a means of reducing suicide risk. The logical conclusion would be to advocate for placebo treatment.

  2.  
    Bernard Carroll
    March 22, 2016 | 7:32 PM
     

    Here is my take on the claim by Lu et al in BMJ. There isn’t much need to get into the issues Paul Pierce mentions because Lu et al didn’t really have a credible data set.

  3.  
    Winge D Moncke PhD
    March 23, 2016 | 3:33 AM
     

    For those too rushed to click over to Dr. Carroll’s response to the Lu et al piece, some highlights.

    “So, when we take a hard look at Figure 1, the rate of suicide attempts among adolescents didn’t change for 11 quarters after the end of the black box period. The suicide attempt rate didn’t start to rise until the rate of antidepressant drug prescribing started to rebound. Go figure.”

    When the study came out, Washington Post ran the story, illustrated with the graphs of the adolescent data. I thought it was a mistake at first. Among almost 70 commenters, there was no indication that anyone noticed they were arguing about a finding that wasn’t found.

    “I won’t even bother to critique the special pleading and the tendentious tone of this report. The decision to publish it was not the BMJ’s finest hour.”

    The 2nd author is a recipient of Ostuka (Abilify) money. Go figure.

  4.  
    James O'Brien, M.D.
    March 23, 2016 | 7:19 AM
     

    I’d cite other critiques of Drazen’s work, but I don’t want to be a rebuttal parasite.

  5.  
    Bernard Carroll
    March 23, 2016 | 5:12 PM
     

    James: laughing here.

  6.  
    James O'Brien, M.D.
    March 23, 2016 | 7:38 PM
     

    This thing about trying to claim property rights on pure science has been going on since the genomics companies tried to patent human genes and gene discoveries. It’s not intellectual property if its something happening in nature that you happened to observe.

    Amazingly, this idea has gained traction, even in Europe:

    http://www.genengnews.com/insight-and-intelligenceand153/gene-patents-in-europe-relatively-stable-despite-uncertainty-in-the-u-s/77899385/

    Of course, a wise government who should no better would tell them to go to hell.

  7.  
    James O'Brien, M.D.
    March 23, 2016 | 7:40 PM
     

    or “know better”, depending on your preference for correct English. I thought “no” was safely in the public domain, so you understand…

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