the bully pulpit…

Posted on Tuesday 10 January 2017

A Bully Pulpit is a conspicuous position that provides an opportunity to speak out and be listened to. This term was coined by President Theodore Roosevelt, who referred to the White House as a "bully pulpit", by which he meant a terrific platform from which to advocate an agenda.

In 1980, New England Journal of Medicine editor Arnold Relman saw something ominous coming up ahead, and wrote an editorial [The new medical-industrial complex] warning that there was a threat to the integrity of academic medicine from a growing medical industry. And by 1984, the NEJM instituted a policy against publishing any editorials or review articles by authors with industry Conflicts of Interest. But by 1999 things had changed dramatically, a story I summarized in a narrative…. At the time, the new editor, Jeffrey Drazen, was embroiled in a controversy over his own ties to industry [see New England Journal of Medicine Names Third Editor in a Year, FDA censures NEJM editor, Medical Journal Editor Vows to Cut Drug Firm Ties].

Flash Forward
In the summer of 2015, Drazen published an editorial suggesting that the NEJM rescind Relman’s policy and allow experts with COI to write reviews and editorials, introducing a three part series by one of his staff reporters explaining why this was really a good idea:
The suggestion was met with a swift flurry of negative responses from some of medicine’s solidest citizens:
And I couldn’t seem to keep my mouth shut about it either [a contrarian frame of mind… , wtf?…, wtf? for real…, a narrative…, not so proud…, unserious arguments seriously…, the real editors speak out…, got any thoughts?…, not backward…], mostly amplifying on what the others said. I’ll have to add that it felt almost personal. The New England Journal of Medicine was my own very first medical subscription ever, and I read it cover-to-cover for years. It was part of my coming of age as a physician, articles embedded in my own scientific and ethical infastructure. And I felt that Jeffrey Drazen was betraying that history. Who was he to do that? Over the year and a half since that series came out, he’s been on my radar. But the New England Journal of Medicine isn’t one of the journals I follow regularly, so it only came up when there was a loud blip, like his particularly obnoxious editorial, Data Sharing – the one where he warned us about "data parasites" [see notes from a reluctant parasite…].

Then, someone sent me a link to this month’s The Large Pharmaceutical Company Perspective about several heroic PHARMA adventures. I noticed it was from a series called The Changing Face of Clinical Trials, so I ran down the rest of the series and read them all. And then I found some other NEJM Clinical Trial Offerings offerings in 2016. 

    The Changing Face of Clinical Trials
  1. June 2, 2016 | J. Woodcock and Others
    With this issue, we launch a series of articles that deal with contemporary challenges that affect clinical trialists today. Articles will define a specific issue of interest and illustrate it with examples from actual practice, as well as bring additional history and color to the topic.
  2. June 2, 2016 | L.D. Fiore and P.W. Lavori
    Investigators use adaptive trial designs to alter basic features of an ongoing trial. This approach obtains the most information possible in an unbiased way while putting the fewest patients at risk. In this review, the authors discuss selected issues in adaptive design.
  3. August 4, 2016 | I. Ford and J. Norrie
    Investigators use adaptive trial designs to alter basic features of an ongoing trial. This approach obtains the most information possible in an unbiased way while putting the fewest patients at risk. In this review, the authors discuss selected issues in adaptive design.
  4. August 4, 2016 | I. Ford and J. Norrie
    In pragmatic trials, participants are broadly representative of people who will receive a treatment or diagnostic strategy, and the outcomes affect day-to-day care. The authors review the unique features of pragmatic trials through a wide-ranging series of exemplar trials.
  5. September 1, 2016 | S.J. Pocock and G.W. Stone
    When the primary outcome of a clinical trial fails to reach its prespecified end point, can any clinically meaningful information still be derived from it? This review article addresses that question.
  6. September 8, 2016 | S.J. Pocock and G.W. Stone
    When a clinical trial reaches its primary outcome, several issues must be considered before a clinical message is drawn. These issues are reviewed in this article.
  7. October 6, 2016 | D.L. DeMets and S.S. Ellenberg
    Randomized clinical trials require a mechanism to safeguard the enrolled patients from harm that could result from participation. This article reviews the role of data monitoring committees in the performance of randomized clinical trials.
  8. November 3, 2016 | M.A. Pfeffer and J.J.V. McMurray
    Ethical issues can arise in the design and conduct of clinical trials. Using the trials that set the stage for our current treatment of hypertension, the authors show how the changing treatment landscape raised ethical problems as these trials were undertaken.
  9. January 5, 2017 | M. Rosenblatt
    The former chief medical officer of a large pharmaceutical company addresses the issue of complexity and how it affects the performance of clinical trials.
    The Final Rule
  • September 16, 2016 | D.A. Zarin and Others
    The final rule for reporting clinical trial results has now been issued by the Department of Health and Human Services. It aims to increase accountability in the clinical research enterprise, making key information available to researchers, funders, and the public.
    History of Clinical Trials
  1. June 2, 2016 | L.E. Bothwell and Others
  2. July 14, 2016 | A. Rankin and J. Rivest
  3. August 11, 2016 | L.E. Bothwell and S.H. Podolsky
  4. Clinical Trials, Healthy Controls, and the IRB
    September 15, 2016 | L. Stark and J.A. Greene
When I got down to the next ones about Data Sharing, I went back even further because I was waking up to something I had kind of forgotten – a bit of relevant sleight of hand that should have been on the front burner, but somehow got lost in the shuffle. What I realized was that the series I started this post with, Revisiting the Commercial–Academic Interface, didn’t just come out of the blue. It was part of a story that was larger – one that I’ll remind us of in the next post. But first here are the articles on Data Sharing:
    Data Sharing
  1. Collaborative Clinical Trials
    March 3, 2011 | A.J. Moss, C.W. Francis, and D. Ryan
  2. Pragmatic Trials — Guides to Better Patient Care?

    May 5, 2011 | J.H. Ware and M.B. Hamel
  3. October 4, 2012 | R.J. Little and Others
  4. October 24, 2013 | M.M. Mello and Others
  5. November 27, 2014 | B.L. Strom and Others
  6. December 25, 2014 | S. Bonini and Others
  7. January 8, 2015 | D.A. Zarin, T. Tse, and J. Sheehan
  8. January 15, 2015 | J.M. Drazen
  9. Adaptive Phase II Trial Design
    July 7, 2015 | D. Harrington and G. Parmigiani
  10. August 4, 2015 | The Academic Research Organization Consortium for Continuing Evaluation of Scientific Studies — Cardiovascular (ACCESS CV)
  11. August 4, 2015 | The International Consortium of Investigators for Fairness in Trial Data Sharing
  12. August 4, 2015 | H.M. Krumholz and J. Waldstreicher
  13. January 21, 2016 | Dan L. Longo, and Jeffrey M. Drazen
  14. August 4, 2016 | E. Warren
  15. September 22, 2016 | F. Rockhold, P. Nisen, and A. Freeman
  16. September 22, 2016 | B. Lo and D.L. DeMets
  17. September 22, 2016 | R.L. Grossman and Others
  18. October 27, 2016 | B.L. Strom and Others
And so on to the reminder in the next post[s] – how Data Transparency got turned into Data Sharing – and why I called this the bully pulpit…

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