In the last two days, I have written two posts about articles in the Journal of Pediatric Surgery which, in my mind, raised ethical questions in the presentation of clinical data. The topic was surgery undertaken to to repair a condition called pectus excavatum (sunken chest). The major article contended that there had been an exceptionally positive record of this procedure, as measured by clinical studies.
Helen Haskell is the mother of Lewis Blackman, a boy who died from complications of the procedure on November 6, 2000. When Helen read the March 2002 article, she wrote a thoughtful letter to the JPS. Here, with her permission, are excerpts from her letter of May 13, 2002 to Jay Grosberg, MD, Editor in Chief:
You may imagine my surprise when I read the opening sentence in the results section of this article, "There were no deaths either after the MIRPE or the MRR." Lewis was a healthy child who died as a result of complications of the pain management regimen for the MIRPE procedure. Pain management has been a major problem for this procedure. While there were certainly standard of care issues involved in his death, that surely can be the case with any surgical complication, in any institution. This outcome can by no stretch of the imagination be considered irrelevant to a discussion of complications of this surgery.
The retrospective chart review in this study was structured so as to terminate four weeks before Lewis' surgery. While this may technically provide a rationale for failing to mention what can hardly be considered an inconsequential complication, it cannot help but raise questions about the intention of the authors, three of whom were intimately aware of Lewis' case. Furthermore, other serious complications that occurred at MUSC [Medical University of South Carolina] within the review period have also been omitted. . . . There is, however, no indication in the text that the list of complications in anything but complete. For those looking for information, such omissions are fundamentally misleading. An outcome review cannot pick and choose its findings.
The question is whether your intent is to allow your journal to function as a forum for competing advertisement or as a serious scientific publication. It is time for an open published debate, based on standardized and complete of data, on the pros and cons of the . . . procedure.
This is an elective procedure usually performed on healthy children, often for entirely cosmetic reasons. You will search a long way before you find a parent who will knowingly vounteer his child for an experiment. Pediatric surgeons should be equally unwilling to volunteer their patients.
Helen received a reply from the editor saying the article had been "peer reviewed by three editorial consultants." He acknowledged that "the patients in the study . . . preceded the date of your son's experience," but "based on the information you have provided, the content of [the] manuscript would not be altered."
As noted by Rosemary Gibson and Janardan Prasad Singh in The Treatment Trap (page 122, with my emphasis):
The people on the front lines who lie down on the gurney are the forgotten ones. The only shield they have is the wisdom to know the difference between solid evidence and commercial promotion. That wisdom may come from their own due diligence or a stroke of luck in finding good people whose sole purpose is their best interest.
The way I see it, the authors of this article and the editors of the JPS were not characterized by the last nine words in the previous sentence.
You may imagine my surprise when I read the opening sentence in the results section of this article, "There were no deaths either after the MIRPE or the MRR." Lewis was a healthy child who died as a result of complications of the pain management regimen for the MIRPE procedure. Pain management has been a major problem for this procedure. While there were certainly standard of care issues involved in his death, that surely can be the case with any surgical complication, in any institution. This outcome can by no stretch of the imagination be considered irrelevant to a discussion of complications of this surgery.
The retrospective chart review in this study was structured so as to terminate four weeks before Lewis' surgery. While this may technically provide a rationale for failing to mention what can hardly be considered an inconsequential complication, it cannot help but raise questions about the intention of the authors, three of whom were intimately aware of Lewis' case. Furthermore, other serious complications that occurred at MUSC [Medical University of South Carolina] within the review period have also been omitted. . . . There is, however, no indication in the text that the list of complications in anything but complete. For those looking for information, such omissions are fundamentally misleading. An outcome review cannot pick and choose its findings.
The question is whether your intent is to allow your journal to function as a forum for competing advertisement or as a serious scientific publication. It is time for an open published debate, based on standardized and complete of data, on the pros and cons of the . . . procedure.
This is an elective procedure usually performed on healthy children, often for entirely cosmetic reasons. You will search a long way before you find a parent who will knowingly vounteer his child for an experiment. Pediatric surgeons should be equally unwilling to volunteer their patients.
Helen received a reply from the editor saying the article had been "peer reviewed by three editorial consultants." He acknowledged that "the patients in the study . . . preceded the date of your son's experience," but "based on the information you have provided, the content of [the] manuscript would not be altered."
As noted by Rosemary Gibson and Janardan Prasad Singh in The Treatment Trap (page 122, with my emphasis):
The people on the front lines who lie down on the gurney are the forgotten ones. The only shield they have is the wisdom to know the difference between solid evidence and commercial promotion. That wisdom may come from their own due diligence or a stroke of luck in finding good people whose sole purpose is their best interest.
The way I see it, the authors of this article and the editors of the JPS were not characterized by the last nine words in the previous sentence.
3 comments:
Your posts are very well appreciated by me. This raises the essence of professionalism, where the public cedes authority to a profession to police itself and hold itself to high standards of performance and truthfulness. To my mind, there should be severe penalties for this, no other way to say it, LYING. Your muckraking is outstanding, and sorely lacking in medicine.
I am an adult patient with pectus excavatum planning on getting nussed next week.
I have serious doubts as a trained economist, although the cosmetic side of things is important to me, I also know about the problems with asymmetric information and medical care in the US.
Do you think I should go through with it? I don't have any medical symptoms - I'm not sick, I can walk and have a high quality of life.
Sorry, but I am not qualified to answer this.
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