In an earlier entry, I was critical of what I call the “press release” variety of medical reporting in which the news report is based heavily or entirely on a press release by individuals or institutions who have a financial or other vested interest in shaping the presentation. In many, if not the majority, of these the difference between informing and marketing is not discernible to me. It is therefore only fair to give credit for what I think is an example of excellent medical reporting. As described below, I was also impressed at the value added to conventional newspaper reporting by its associated Internet capabilities. The article provides an example of the pre-publication embargo system used by some major medical journals with what I think are both positive and negative implications.
The Article and Report.
On Tuesday, February 8, New York Times reporter Denise Grady published an article, “Lymph Node Study Shakes Pillar of Breast Cancer Care.” My sometimes faulty memory tells me I saw her article Monday evening on the New York Times website. The article Ms. Grady reported on was officially published in the February 9 issue of JAMA, the Journal of the American Medical Association: “Axillary Dissection vs No Axillary Dissection in Woman With Invasive Breast Cancer and Sentinel Node Metastasis, ” by Armando E. Giuliano and coauthors; vol. 305:569, 2011. I received my personal copy of the Journal on Wednesday the 9th.
I spent over two hours studying this seven page paper. It was heavy going for me and would have been largely impenetrable to a layperson. It goes against my grain to be paternal, but there is no way for a layperson to understand the significance of the research or how it might relate to them without help. In fact, even I needed some help to put things in perspective, and I confess some of that help came from Denise Grady.
To summarize the paper in an obscenely brief manner, 891 women with breast cancer that had already metastasized as far as the lower lymph nodes in her axilla (armpit) were randomized to 2 different treatment plans. Half the women went on to what was then the standard treatment of extensive removal of all the lymph nodes in their axilla. The other half had no additional surgery beyond the biopsy of the low sentinel node that showed the metastatic cancer. All of the women had a lumpectomy and radiation to the breast, and almost all had additional adjuvant or prophylactic chemotherapy. The patients were followed for as long as eight years. There was no difference in the survival or cancer recurrence rate in either group.
One of the reasons this research is important is that axillary dissection or extirpation is fraught with both short-term and long-term complications. It has replaced radical mastectomy as the thing women fear most about breast surgery for cancer. It’s one thing to pay that price if you think you live longer or better as a result, but by definition, unnecessary surgery is never medically indicated. (Should it be paid for?)
It would be fun for me, and take me back to my research years, to go through the study with you line by line discussing its design, it’s statistical analysis, and the interpretation of its results. These elements are critically important to the validity, and equally important for the applicability of its results. I have never seen a perfect clinical study, nor was this one. However, in my opinion this was excellent research that can be relied on, indeed acted upon.
Ms. Grady obviously had access to this research before I did: indeed before virtually all other physicians and women with breast cancer. She used the time well and interviewed a variety of people including the authors of the study and the editorial that accompanied its publication. She interviewed other breast cancer experts from prestigious institutions. In the New York Times Readers Comments section that accompanied the article, a variety of questions about the study and its applicability arose. Ms. Grady was able to use her panel of experts to expand her reporting in “Question and Answer,” and “Reader’s Comment” sections. Although I usually cringe at some of the commentary in such “Reader’s Blogs,” there was obviously tremendous value added in this instance. I certainly profited from this use of internet-facilitated reporting. The hyperlinks in the text are also useful to define the many medical terms and direct attention to other sources of reliable information.
At least one other group of physicians and patients benefited from advance knowledge of the results of this research. As a participating institution in the research, the Memorial Sloan Kettering Cancer Center in New York knew the results and had already changed its surgical practice six months ago sparing its patients from what it now believes to be unnecessary surgery. (I have to assume that that prestigious institution did not change its protocols until after the results had been fully analyzed.) I ask myself now, who else was the recipient of the good news? Did we know about it in Kentucky? Why not? It would be interesting to do the math and calculate the number of women and their surgeons who might have appreciated the option of axilla-sparing breast surgery. There will probably always be unavoidable delay between the conduct of research, its interpretation by the researchers, the time necessary to write and submit a manuscript, the time required for editorial review and potential acceptance by a journal, and the time it takes to get ink on the page. However, unnecessary delay, like unnecessary surgery, is never defensible. I ask myself, and you, how much delay was attributable to editorial policy at a major medical journal designed to enhance the reputation of that journal? Is it possible that some women were harmed by that policy? I hope the answer to both these questions is “none.”
Who Should Use?
According to Ms. Grady, not all physicians agree with my (and that of the real experts) assessment of the quality and applicability of this research. Some were still planning to root out additional lymph nodes and tissue from the axilla of their patients under the outdated philosophy that one must try “to get it all.” I have always been a pretty conservative physician myself. A line from Alexander Pope always stuck a with me. “Be not the first by whom the new are tried, nor yet the last to leave the old aside.” There is undeniable wisdom in that aphorism. Nonetheless, there comes a point when caution transforms into stubbornness, or even worse, negligence. In a medical system where every physician has been King (or Queen), there is a systemic drag on improving the quality of medical care. Should all people with cancer who fit the description of those in this study now be spared axillary dissection? That is not for me to say. What I can say is that it is possible to drag one’s feet too long. In the mid 1990s I did a study of all people in Kentucky who had breast surgery for cancer in a single year. There were many interesting, indeed even scandalous findings. Not surprisingly the majority of surgeries were done in a limited number of hospitals and outpatient surgery centers. In all but one major facility, the most extensive surgery done for cancer was a simple mastectomy. However, in one self-proclaimed prestigious hospital, radical mastectomies were still being performed. Were women getting state of the art care in that hospital? I think not.
Does Research Matter?
If the general public knew how little information there was to support much of what we physicians do or that it even worked at all, it would go nuts. There would be no opposition to fundamental comprehensive healthcare reform to lower costs and improve quality. We can do better. For example, in this current study, the overall 5-year survival of these women with metastatic breast cancer in their axilla was 92%. In fact, one of the problems with this study was that its designers assumed a five year survival rate of about 60 to 75% based on previous experience. (That estimate was necessary to decide how many patients to enroll and for how long.) The fact that today’s patients did so much better than expected is due to improved radiation and chemotherapy. These improvements were possible only because of systematic clinical research that incrementally compared one form of treatment with another acceptable one. The irony is that several major centers refused to participate in the present multi-center study because they thought it would be unethical to give their patients the option. I hope no institution in Kentucky felt that way, but I have not been able to find that any participated. In my view, when reasonable doubt exists that a treatment might be inferior to another, or indeed might not work at all, it is unethical not to participate in an available clinical study. The alternative is that ineffective or suboptimal treatments persist forever under the cover of “standard of care.”
I wish to thank the authors of this study, and Ms. Grady who reported it for their excellent work!
Peter Hasselbacher, MD
17 Feb 2011