Could the New England Journal of Medicine Be Biased Against Arthroscopic Knee Surgery? Part 2

Abstract

First, let us start by being explicit: the title of this editorial is rhetorical. The New England Journal of Medicine is biased against arthroscopic knee surgery.Last month1Rossi M.J. D'Agostino Jr., R.B. Provencher M.T. Lubowitz J.H. Could the New England Journal of Medicine be biased against arthroscopic knee surgery?.Arthroscopy. 2014; 30: 356-357Abstract Full Text Full Text PDF Scopus (37) Google Scholar we reported that ElAttrache and Lubowitz wrote a letter to NEJM criticizing their publication, “Arthroscopic Partial Meniscectomy Versus Sham Surgery for a Degenerative Meniscal Tear” by Sihvonen et al.2Sihvonen R. Paavola M. Malmivaara A. et al.Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear.N Engl J Med. 2013; 369: 2515-2524Crossref PubMed Scopus (553) Google Scholar To review, ElAttrache and Lubowitz concluded their letter to NEJM as follows:Disturbingly, in the 21st century, the NEJM has published only 4 original scientific articles on knee arthroscopy,2Sihvonen R. Paavola M. Malmivaara A. et al.Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear.N Engl J Med. 2013; 369: 2515-2524Crossref PubMed Scopus (553) Google Scholar, 3Moseley J.B. O'Malley K. Petersen N.J. et al.A controlled trial of arthroscopic surgery for osteoarthritis of the knee.N Engl J Med. 2002; 347: 81-88Crossref PubMed Scopus (1143) Google Scholar, 4Kirkley A. Birmingham T.B. Litchfield R.B. et al.A randomized trial of arthroscopic surgery for osteoarthritis of the knee.N Engl J Med. 2008; 359: 1097-1107Crossref PubMed Scopus (511) Google Scholar, 5Katz J.N. Brophy R.H. Chaisson C.E. et al.Surgery versus physical therapy for a meniscal tear and osteoarthritis.N Engl J Med. 2013; 68: 1675-1684Crossref Scopus (427) Google Scholar all with “negative” results, while refusing to even consider for review submitted Level I evidence demonstrating good results.6Lubowitz J.H. Appleby D. Cost-effectiveness analysis of the most common orthopaedic surgery procedures: Knee arthroscopy and knee anterior cruciate ligament reconstruction.Arthroscopy. 2011; 27: 1317-1322Abstract Full Text Full Text PDF PubMed Scopus (84) Google ScholarCould the New England Journal of Medicine be biased against arthroscopic knee surgery?As we have said in editorials, and specifically last month, we believe “controversy demands debate, not bias.”1Rossi M.J. D'Agostino Jr., R.B. Provencher M.T. Lubowitz J.H. Could the New England Journal of Medicine be biased against arthroscopic knee surgery?.Arthroscopy. 2014; 30: 356-357Abstract Full Text Full Text PDF Scopus (37) Google Scholar, 7Lubowitz J.H. Poehling G.G. Controversy in Arthroscopy: Bring it on.Arthroscopy. 2010; 26: 573-574Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar However, the NEJM decided to restrict academic deliberation. Worse yet is the explanation from the NEJM that the rejection of the ElAttrache and Lubowitz's letter to the editor was because of “lack of space.”Here's what happened next. In the spirit of healthy debate, Dr. Lubowitz wrote a note of appeal, reiterating to the editors of the NEJM that the NEJM was being accused of bias, and inquiring as to whether the NEJM might wish to reconsider their decision to limit the discussion. Lubowitz recommended to the NEJM that they find the space for the letter (of fewer than 175 words), and to address the accusation of bias in press, openly, and in an academic manner.To which, the NEJM replied:With respect to your concern that we are biased against arthroscopic surgery: We carefully evaluate all manuscripts submitted to us, including attention to methodologic strengths and weaknesses. We have not yet seen a carefully conducted sham-controlled trial that has shown a benefit of surgery; we would be pleased to have the opportunity to consider such a trial.Sincerely,Caren SolomonDeputy EditorNew England Journal of MedicineAnd there the matter rests.While we do not condone the NEJM for rejecting controversial academic debate due to “lack of space,” we now understand that they prefer sham-controlled trials. However, we wish to make the following points.1.The recent NEJM article by Sihvonen et al.2Sihvonen R. Paavola M. Malmivaara A. et al.Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear.N Engl J Med. 2013; 369: 2515-2524Crossref PubMed Scopus (553) Google Scholar is not a sham-controlled trial. The title of the article in question, “Arthroscopic Partial Meniscectomy Versus Sham Surgery for a Degenerative Meniscal Tear,” is deceptive and misleading. The control group did not have sham surgery. The control group had knee arthroscopy and lavage, a powerful and effective treatment for diverse pathological knee conditions. Knee arthroscopic surgical lavage is not a sham, and knee arthroscopic surgical lavage is not a placebo.1Rossi M.J. D'Agostino Jr., R.B. Provencher M.T. Lubowitz J.H. Could the New England Journal of Medicine be biased against arthroscopic knee surgery?.Arthroscopy. 2014; 30: 356-357Abstract Full Text Full Text PDF Scopus (37) Google Scholar, 8Krych A.J. Carey J.L. Marx R.G. Dahm D.L. Sennett B.J. Stuart M.J. et al.Does arthroscopic knee surgery work?.Arthroscopy. 2014; 30: 544-545Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar, 9ElAttrache N. Lattermann C. Hannon M. Cole B. New England Journal of Medicine article evaluating the usefulness of meniscectomy is flawed.Arthroscopy. 2014; 30: 542-543Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar2.Ethically, sham surgery is a questionable research method, when safer alternative methods exist for treatment of a control group. Physicians take an oath to do no harm. However, anesthetizing and cutting a research subject, without providing a therapeutic intervention, may be harmful, where the potential risks to the research subject may outweigh the benefits. As above, other control methods (e.g., oral, topical, or injectable analgesics, physical therapy) may be compared with surgical intervention, while at the same time providing a safer risk-to-benefit profile for the research subject. Moreover, there is also the alternative control of no treatment. In our zeal to answer scientific questions, we must not lose sight of the fact that human research subjects are our patients, to whom we swear an oath to do no harm.3.Speaking frankly, sham surgery seems ludicrous. Really, what patient in his or her right mind, no matter how well intentioned to participate in research, would consent to sham surgery? We would not consent to the possibility of anesthesia and sham surgery, nor do we believe our right-minded patients would do so. We have a concern that methods of sham surgical trials result in selection bias,10Ilahi O.A. Selection bias results in misinterpretation of randomized controlled trials on arthroscopic treatment of patients with knee osteoarthritis.Arthroscopy. 2010; 26: 144-146Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar where patients who may not be of entirely sound mind are selected as research subjects, and research performed on such individuals would not be generalizable to mentally healthy patients.Perhaps the NEJM has fallen into a trap set by the US Food and Drug Administration, which according to the Wall Street Journal, encourages sham surgical trials.11Gottlieb S. The FDA wants you for sham surgery. There are better ways to test medical devices than by having patients be placebos who get fake operations. Wall Street Journal February 18, 2014. Accessed March 24, 2014. Available at http://online.wsj.com/news/articles/SB10001424052702304680904579365414108916816Google ScholarWe suspect that those at the FDA and the NEJM who recommend sham surgery are not ethical surgeons, and we agree with Dr. Scott Gottlieb, who writes in the Wall Street Journal,…research that introduces harm or risk with no opportunity for benefit would seem to conflict with the principles governing research on humans. Some of these are reflected in the Declaration of Helsinki, an international treaty concerning the conduct of medical research. Other experiments using sham surgeries are obligating patients to undergo unnecessary anesthetics, radiation, abdominal incisions, endoscopy and injections into the rectum, to mention a few examples. The needless cutting means pain as well as the risks of anesthesia and infection…This can suppress innovation. When a sham trial doesn't produce positive results, the company may have exhausted its resources and have no capital left to refine a good idea into a beneficial product.Instead of clinging to inflexible testing requirements, the FDA should allow trials that are feasible, reflect clinical practice, and are morally defensible. There are methods for evaluating science that don't require such contrived experiments on people. The agency doesn't need to rely on research models that raise the opportunity costs so high that some valuable treatments or devices may never become available to patients.11Gottlieb S. The FDA wants you for sham surgery. There are better ways to test medical devices than by having patients be placebos who get fake operations. Wall Street Journal February 18, 2014. Accessed March 24, 2014. Available at http://online.wsj.com/news/articles/SB10001424052702304680904579365414108916816Google ScholarReaders can draw their own conclusions, but we believe that sham surgical trials may themselves be a sham. The results of sham surgical trials should be interpreted with extreme caution. First, let us start by being explicit: the title of this editorial is rhetorical. The New England Journal of Medicine is biased against arthroscopic knee surgery. Last month1Rossi M.J. D'Agostino Jr., R.B. Provencher M.T. Lubowitz J.H. Could the New England Journal of Medicine be biased against arthroscopic knee surgery?.Arthroscopy. 2014; 30: 356-357Abstract Full Text Full Text PDF Scopus (37) Google Scholar we reported that ElAttrache and Lubowitz wrote a letter to NEJM criticizing their publication, “Arthroscopic Partial Meniscectomy Versus Sham Surgery for a Degenerative Meniscal Tear” by Sihvonen et al.2Sihvonen R. Paavola M. Malmivaara A. et al.Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear.N Engl J Med. 2013; 369: 2515-2524Crossref PubMed Scopus (553) Google Scholar To review, ElAttrache and Lubowitz concluded their letter to NEJM as follows:Disturbingly, in the 21st century, the NEJM has published only 4 original scientific articles on knee arthroscopy,2Sihvonen R. Paavola M. Malmivaara A. et al.Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear.N Engl J Med. 2013; 369: 2515-2524Crossref PubMed Scopus (553) Google Scholar, 3Moseley J.B. O'Malley K. Petersen N.J. et al.A controlled trial of arthroscopic surgery for osteoarthritis of the knee.N Engl J Med. 2002; 347: 81-88Crossref PubMed Scopus (1143) Google Scholar, 4Kirkley A. Birmingham T.B. Litchfield R.B. et al.A randomized trial of arthroscopic surgery for osteoarthritis of the knee.N Engl J Med. 2008; 359: 1097-1107Crossref PubMed Scopus (511) Google Scholar, 5Katz J.N. Brophy R.H. Chaisson C.E. et al.Surgery versus physical therapy for a meniscal tear and osteoarthritis.N Engl J Med. 2013; 68: 1675-1684Crossref Scopus (427) Google Scholar all with “negative” results, while refusing to even consider for review submitted Level I evidence demonstrating good results.6Lubowitz J.H. Appleby D. Cost-effectiveness analysis of the most common orthopaedic surgery procedures: Knee arthroscopy and knee anterior cruciate ligament reconstruction.Arthroscopy. 2011; 27: 1317-1322Abstract Full Text Full Text PDF PubMed Scopus (84) Google ScholarCould the New England Journal of Medicine be biased against arthroscopic knee surgery? As we have said in editorials, and specifically last month, we believe “controversy demands debate, not bias.”1Rossi M.J. D'Agostino Jr., R.B. Provencher M.T. Lubowitz J.H. Could the New England Journal of Medicine be biased against arthroscopic knee surgery?.Arthroscopy. 2014; 30: 356-357Abstract Full Text Full Text PDF Scopus (37) Google Scholar, 7Lubowitz J.H. Poehling G.G. Controversy in Arthroscopy: Bring it on.Arthroscopy. 2010; 26: 573-574Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar However, the NEJM decided to restrict academic deliberation. Worse yet is the explanation from the NEJM that the rejection of the ElAttrache and Lubowitz's letter to the editor was because of “lack of space.” Here's what happened next. In the spirit of healthy debate, Dr. Lubowitz wrote a note of appeal, reiterating to the editors of the NEJM that the NEJM was being accused of bias, and inquiring as to whether the NEJM might wish to reconsider their decision to limit the discussion. Lubowitz recommended to the NEJM that they find the space for the letter (of fewer than 175 words), and to address the accusation of bias in press, openly, and in an academic manner. To which, the NEJM replied:With respect to your concern that we are biased against arthroscopic surgery: We carefully evaluate all manuscripts submitted to us, including attention to methodologic strengths and weaknesses. We have not yet seen a carefully conducted sham-controlled trial that has shown a benefit of surgery; we would be pleased to have the opportunity to consider such a trial.Sincerely,Caren SolomonDeputy EditorNew England Journal of Medicine And there the matter rests. While we do not condone the NEJM for rejecting controversial academic debate due to “lack of space,” we now understand that they prefer sham-controlled trials. However, we wish to make the following points.1.The recent NEJM article by Sihvonen et al.2Sihvonen R. Paavola M. Malmivaara A. et al.Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear.N Engl J Med. 2013; 369: 2515-2524Crossref PubMed Scopus (553) Google Scholar is not a sham-controlled trial. The title of the article in question, “Arthroscopic Partial Meniscectomy Versus Sham Surgery for a Degenerative Meniscal Tear,” is deceptive and misleading. The control group did not have sham surgery. The control group had knee arthroscopy and lavage, a powerful and effective treatment for diverse pathological knee conditions. Knee arthroscopic surgical lavage is not a sham, and knee arthroscopic surgical lavage is not a placebo.1Rossi M.J. D'Agostino Jr., R.B. Provencher M.T. Lubowitz J.H. Could the New England Journal of Medicine be biased against arthroscopic knee surgery?.Arthroscopy. 2014; 30: 356-357Abstract Full Text Full Text PDF Scopus (37) Google Scholar, 8Krych A.J. Carey J.L. Marx R.G. Dahm D.L. Sennett B.J. Stuart M.J. et al.Does arthroscopic knee surgery work?.Arthroscopy. 2014; 30: 544-545Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar, 9ElAttrache N. Lattermann C. Hannon M. Cole B. New England Journal of Medicine article evaluating the usefulness of meniscectomy is flawed.Arthroscopy. 2014; 30: 542-543Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar2.Ethically, sham surgery is a questionable research method, when safer alternative methods exist for treatment of a control group. Physicians take an oath to do no harm. However, anesthetizing and cutting a research subject, without providing a therapeutic intervention, may be harmful, where the potential risks to the research subject may outweigh the benefits. As above, other control methods (e.g., oral, topical, or injectable analgesics, physical therapy) may be compared with surgical intervention, while at the same time providing a safer risk-to-benefit profile for the research subject. Moreover, there is also the alternative control of no treatment. In our zeal to answer scientific questions, we must not lose sight of the fact that human research subjects are our patients, to whom we swear an oath to do no harm.3.Speaking frankly, sham surgery seems ludicrous. Really, what patient in his or her right mind, no matter how well intentioned to participate in research, would consent to sham surgery? We would not consent to the possibility of anesthesia and sham surgery, nor do we believe our right-minded patients would do so. We have a concern that methods of sham surgical trials result in selection bias,10Ilahi O.A. Selection bias results in misinterpretation of randomized controlled trials on arthroscopic treatment of patients with knee osteoarthritis.Arthroscopy. 2010; 26: 144-146Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar where patients who may not be of entirely sound mind are selected as research subjects, and research performed on such individuals would not be generalizable to mentally healthy patients. Perhaps the NEJM has fallen into a trap set by the US Food and Drug Administration, which according to the Wall Street Journal, encourages sham surgical trials.11Gottlieb S. The FDA wants you for sham surgery. There are better ways to test medical devices than by having patients be placebos who get fake operations. Wall Street Journal February 18, 2014. Accessed March 24, 2014. Available at http://online.wsj.com/news/articles/SB10001424052702304680904579365414108916816Google Scholar We suspect that those at the FDA and the NEJM who recommend sham surgery are not ethical surgeons, and we agree with Dr. Scott Gottlieb, who writes in the Wall Street Journal,…research that introduces harm or risk with no opportunity for benefit would seem to conflict with the principles governing research on humans. Some of these are reflected in the Declaration of Helsinki, an international treaty concerning the conduct of medical research. Other experiments using sham surgeries are obligating patients to undergo unnecessary anesthetics, radiation, abdominal incisions, endoscopy and injections into the rectum, to mention a few examples. The needless cutting means pain as well as the risks of anesthesia and infection…This can suppress innovation. When a sham trial doesn't produce positive results, the company may have exhausted its resources and have no capital left to refine a good idea into a beneficial product.Instead of clinging to inflexible testing requirements, the FDA should allow trials that are feasible, reflect clinical practice, and are morally defensible. There are methods for evaluating science that don't require such contrived experiments on people. The agency doesn't need to rely on research models that raise the opportunity costs so high that some valuable treatments or devices may never become available to patients.11Gottlieb S. The FDA wants you for sham surgery. There are better ways to test medical devices than by having patients be placebos who get fake operations. Wall Street Journal February 18, 2014. Accessed March 24, 2014. Available at http://online.wsj.com/news/articles/SB10001424052702304680904579365414108916816Google Scholar Readers can draw their own conclusions, but we believe that sham surgical trials may themselves be a sham. The results of sham surgical trials should be interpreted with extreme caution. Sham Surgery StudiesArthroscopyVol. 30Issue 11PreviewWe read with interest the recent Arthroscopy editorial on potential bias in the New England Journal of Medicine (NEJM).1 We have a significant interest in the field of sham surgery trials and also have some issues with the NEJM publication of the FIDELITY (Finnish Degenerative Meniscal Lesion Study) trial.2 We wrote to the NEJM to raise these issues but were told that we could only comment within 3 weeks of publication of the FIDELITY study. Full-Text PDF