Click Here

  • 1.  ttttttt

    Purple Flower
    Posted Tue December 03, 2019 03:05 PM
    I have tried three times to post this message. The system accepts my attachment, but will not post the message below: CONTINUED UNDECLARED PUBLICATION BIAS AT THE MEDICAL JOURNALS IN SUPPORT OF LIMITING BREAST CANCER SCREENING NOW INCLUDES THE CLEVELAND CLINIC Much to my disappointment and concern, it turns out that there is no ethical oversight for medical journals. As authors we have to declare all conflicts of interest that might influence what we submit for publication, but it turns out that many (? most) journals have no similar oversight. For the most part this is probably a good thing since it should allow journals to be academically free to publish without restrictions. In theory this should facilitate the discussion of new ideas that might run contrary to "conventional wisdom" and allow the various fields of medicine to advance. Unfortunately, this also leads to major problems for which there appears to be no solution. Journals (their editors and unclear other forces) can have undeclared biases that lead to their selective publication of information, and, certainly, with regard to breast cancer screening, the publication of misinformation (1 ). Since the media often report on publications in some of the journals, this means that misinformation can be passed on and have a major effect on public health with little oversight. This is clearly a problem surrounding breast cancer screening. As I wrote in 2005 (2 ), there were at least four journals that had an undeclared bias against breast cancer screening, particularly for women ages 40-49, and they, repeatedly, rejected papers in support, to the point where I know of several experts who ceased to submit papers to these journals. One of the journals that repeatedly rejected studies in support of screening was the "Journal of the National Cancer Institute". This was doubly ironic because it could be said that the JNCI has perpetrated one of the biggest deceptions in medical publishing. The JNCI was sold to Oxford University Press in 1998 and, as is written in fine print at the bottom of a long list of indexing and abstracting sites, states, " JNCI is published monthly by Oxford University Press and is not affiliated with the United States National Cancer Institute. " (3 ). Unfortunately, the media and the public are likely unaware of this fact, and many (? most) still think that articles in the JNCI have the imprimatur of the NCI, when this is false. For years the Journal of the American Medical Association (JAMA) had a similar, undeclared, publication bias although this may be changing under new leadership. The Annals of Internal Medicine had a similar bias. Perhaps the most striking, undeclared publication bias that continues today is at the New England Journal of Medicine. A quick review of publications at the NEJM dating back to 1993 reveals 21 publications (not including Letters or Book Reviews) that denigrated screening. Over the same time period, 4 articles were neutral; with only 2 articles in 17 years were somewhat supportive. I have had at least 4 papers rejected without scientific comment by the NEJM (published elsewhere). One was a fundamental analysis of the statistical power of the RCT's which was fundamental and proven correct. Our major, and unique, paper on "failure analysis" was rejected by the NEJM (4 ), as was at least one major paper from the landmark Swedish Two County Randomized, Controlled Trial (personal communication from Laszlo Tabar). Unfortunately, the Cleveland Clinic Journal of Medicine now has to be added to the list of journals that appear to have undeclared publication bias with regard to breast cancer screening. This past spring, I was made aware of a CCJM paper that quoted me and then proceeded to misrepresent what I had written (5). In addition, it made unsupportable, disparaging claims about breast cancer screening. In response I wrote an article entitled: UNTANGLING THE WEB: "Alternative Facts" and Actual Facts in Breast Cancer Screening (see attached). My paper was accepted for publication at the CCJM with the comment from an editor "It is very well crafted,", but I was required to reduce its length which I did. Following my resubmission, I was then sent an edited, prepublication, galley for my review. Having gotten as far as galley's I was astonished when, a short time later, I received an email telling me that the CCJM had changed their minds and would not publish my article and that I would only be allowed a short Letter to the Editor. Not only had I never had anything like this happen, but I have never heard of it happening to anyone else. When I raised my concern, they responded that they had published an overview of screening that covered the issues that I had raised (6). I reviewed that paper and was surprised to find that it relied heavily on the, scientifically, discredited Canadian National Breast Screening Studies (CNBSS) (7). I sent the editor a line by line critique of the 2015 paper explaining how that paper also provided, fundamentally misleading, information that was corrected by my paper. I pointed out that if that was the only paper they had published on the subject, then they had misinformed their readers. When they still refused to honor their commitment (not to mention providing accurate information to their readers). I wrote to the Head of the Cleveland Clinic, Tomislav Mihaljevic, MD, who had an assistant review my concerns and he responded "I found no evidence of Cleveland Clinic Journal of Medicine censorship, collusion, defamation, deception, unethical practice or lack of editorial integrity." Astonished I responded: "CENSORSHIP: No censorship? Simply stating it does not make it so. In fact, the decision to accept my, scientifically valid paper, and then to, abruptly, stop publication without any scientific criticism is clearly nothing but "censorship". Otherwise, you could have provided me with substantive arguments that refute what I have written. The only reason to not publish it, particularly after having published the "nonscience" by Kim et al, and the earlier paper by Batur and Walsh, both of which promote misinformation, is that the Journal wants to "censor" the facts and prevent its readers from having those facts. COLLUSION: I cannot speak to "collusion", but you provided no information on who, actually, brought pressure to bear on the Journal to terminate the publication of my paper. DEFAMATION: In fact, the paper by Kim et al, in the Journal, that triggered my paper, was, absolutely, "defamatory". The authors wrote: "Both of these authors [referencing me as one of the "authors"] defend the position that the goal of screening is to minimize cause specific mortality, irrespective of overdiagnosis, overtreatment, or false-positive results." In fact, I have never stated, or even suggested this, and I have never supported such a claim that implies that I do not care about adverse effects on women. This is false and defamatory as is the claim in the last sentence of the paragraph that I was not concerned with the "harms" to women from screening. Furthermore, the claim of "overdiagnosis" has been manufactured. If it exists, "overdiagnosis" is the fault of pathologists not mammography. "Overtreatment", which exists in all of medicine, is not the fault of mammography, but rather the responsibility of oncologists. "False positives" are generally expected to mean that women are told that they have breast cancer when they do not. In fact, the use of "false positives" in the context of screening is chosen to be pejorative. These are not women who are falsely told that they have cancer, but, rather, are women recalled from screening for a few extra pictures or an ultrasound and most are told that everything is fine and that they do NOT have breast cancer. DECEPTION: In fact there was clear "deception" both in the Kim et al paper which deceived the readers about my motives, and in misrepresenting the actual facts about breast cancer screening, as well as in the paper by Batur and Walsh which is full of deception about screening. The latter placed great emphasis on the Canadian National Breast Screening Studies ignoring the fact that these trials were major outliers among the RCT of screening and have been shown to be completely compromised and unreliable. This is clear in the imbalances in assignment due to the corrupted, unblinded and nonrandom, allocation process which violated the fundamental rules for RCT's. Furthermore, these studies of mammography screening used demonstrably poor-quality mammography. If an RCT of therapy showed no benefit from an obsolete therapeutic agent would you conclude that there was no benefit from any therapy? No "DECEPTION"? The journal accepted a completely documented paper for publication; requested and received an edited version that was in galleys; and then withdrew the agreement based on a false claim. No deception? UNETHICAL PRACTICE: I guess you may have a different definition of "unethical". It is difficult to state that there was no "unethical practice" at a journal that, having provided misinformation to its readers, first accepted material that clarified the facts, only to reverse itself with no justification, with the only explanation being an effort to prevent the facts from being published. Does this really sound "ethical" to you? EDITORIAL INTEGRITY: No lack of "editorial integrity"? What else would you call it when a journal accepts a paper for publication, has the author edit it as requested, and then rejects it prior to publication with no scientific support for the rejection? What do you consider "editorial integrity"? The argument for stopping publication was the claim that the Journal had provided its readers with a thorough review of the topics when, in fact it had not. The executive editor decided (I suspect under pressure) that my comments would not support the ideas that the Journal and the Clinic, apparently, want to promulgate, which is reduced breast cancer screening. It is pretty hard to argue that supporting demonstrably false arguments while rejecting facts is not a major lack of "editorial integrity". You wrote: "It is my opinion that it does not fit the intended purpose or style of our journal." In fact, I copied the style of the Kim et al paper that had been published by the Journal. They referenced the satirical essay by Swift. I invoked the poem by Scott that perfectly describes the complex twining of misinformation to build a false case against breast cancer screening. Otherwise, what is that "purpose" and "style" to which you refer? Is it to provide readers with defamatory and scientifically unsupportable information?" I never received a response to the above. I have had papers turned down before. That is expected in academics, but this was clearly an effort by the Cleveland Clinic Medical Journal to censor information for its readers. This is the kind of undeclared publication bias that I wrote about in 2005 that continues today and is the reason that the "alternative facts", that have been created by the publication of scientifically unsupportable material, has caused confusion among women and their physicians about breast cancer screening. There is no "Inspector General" overseeing medical journals that could look at these policies, objectively, and correct them. I think most of us expect that specialty journals are likely to provide information that is supportive of the specialty, but I certainly expected the major general medical journals to provide accurate and unbiased information. It is important for physicians to realize that they are receiving filtered information that reflect the undeclared publication bias of these journals, and when the media repeat information in these articles, they disseminate misinformation to the public. I hope that you will alert your clinical colleagues. I would suggest that there needs to be some group at each journal to provide an "inspector general" function that could provide oversight to try to require that journals stop publishing scientifically unsupportable information and to require the publication of legitimate, scientifically justified analyses. REFERENCES 1. Kopans DB. More misinformation on breast cancer screening. Gland Surg. 2017 Feb;6(1):125-129. 2. Kopans DB. Bias in the medical journals: a commentary. AJR Am J Roentgenol. 2005 Jul;185(1):176-7. 3. http://www.oxfordjournals.org/our_journals/jnci/about.html accessed 11/26/2019 4. Webb ML, Cady B, Michaelson JS, Bush DM, Calvillo KZ, Kopans DB, Smith BL. A failure analysis of invasive breast cancer: most deaths from disease occur in women not regularly screened. Cancer. 2014 Sep 15;120(18):2839-46. 5. Kim MS, Nishikawa G, Prasad V. Cancer screening: A modest proposal for prevention. Cleve Clin J Med. 2019 Mar;86(3):157-160. 6. Batur P, Walsh JM. Annual mammography starting at age 40: More talk, less action? Cleve Clin J Med. 2015 May;82(5):272-5. 7. Kopans DB. The Canadian National Breast Screening Studies are compromised and their results are unreliable. They should not factor into decisions about breast cancer screening. Breast Cancer Res Treat. 2017 Aug;165(1):9-15.