|Subject:||Fraudulent Science: What's Retracted, What Is Not|
|Date:||Wed, 02 May 2012 09:31:09 -0400|
Alliance for Human Research Protection (AHRP)
Advancing Honest and Ethical Medical Research
Critics who deplore the commercialization of medical research have raised concerns about scientific fraud and misconduct that are undermining the integrity of the medical-scientific literature, and the practice of "evidence-based medicine"--- which relies on published journal reports. Recent analyses of retractions of published peer-reviewed journal reports provide supportive evidence for those critics.
Retractions from journals are not routine occurrences--journal editors are extremely reluctant to retract articles, a tacit acknowledgment of their own gate-keeping failure--and fear of reprisals from the sponsors of those retracted trial reports. Many journals don’t even have retraction policies, and the ones that do publish critical notices of retraction long after the original paper appeared—without providing explicit information as to why they are being retracted.
Judging by analyses showing that the number of retractions during the past ten years has skyrocketed, it is reasonable to conclude that the self-regulating peer review system suffers from serious underlying defects.
Indeed, the frequency of retractions prompted Ivan Oransky and Ivan Marcus to establish a blog (2010) called "Retraction Watch." Another website that tracks the PubMed database—by Neil Saunders, an Australian scientist—found that since 1977, the number of retractions increased by a factor of 30, while publications increased fourfold.
An article in the Science section of The New York Times, "A Sharp Rise in Retractions Calls for Reform" (April 16, 2012)  highlighted the concerns raised by two science journal editors--Dr. Ferric Fang, editor in chief of Infection and Immunity Journal, and Dr. Arturo Casadevall, editor in chief of mBio, who are spearheading a call for reform after their search for retracted reports in 17 journals found 740 retractions between 2001 and 2009.  The frequency of retraction varied among the journals: NEJM, Cell, Science and Nature had the highest number of retractions between 2001 and 2010.
Drs. Fang and Casadevall reached the conclusion that not only were retractions rising at an alarming rate, but that retractions were just a manifestation of a much more profound problem — “a symptom of a dysfunctional scientific climate.” They presented their concerns before National Academies of Sciences committee on science, technology and the law in March.
They describe some of the corrosive pressures that academic scientists face since the culture in academia was transformed into a competitive, secretive business environment where quantity is rewarded—not quality. “What people do is they count papers, and they look at the prestige of the journal in which the research is published, and they see how many grant dollars scientists have, and if they don’t have funding, they don’t get promoted...It’s not about the quality of the research.”
Medical journals have similarly come to be evaluated by their quantifiable "impact factor"--much like the popular media ratings. The greater the number of hits (citations to a journal article) the greater its influence, and the higher the journal’s "impact factor." Journals with high impact have tremendous appeal and commercial value for pharmaceutical companies. Thus, it should not come as a surprise that dubious research reports are more likely to be submitted for publication to "high impact" journals. Even if a report is retracted its impact survives through numerous subsequent articles that cite it as authoritative.
Other retraction analyses :
In 2006, a letter to the editor, "Top Journals' Top Retraction Rates," Shi V. Liu noted that top journals brag about their "high" impact as a commercial strategy to boost circulation and increase their attractiveness to authors. However, "the “easiness” of these later retracted papers being published in high profile may indicate a real lack of some true scientific criteria for systematically and adequately evaluating manuscripts by these top journals. In fact, as some readers pointed out, some of these top journals base their selection on sensation rather than on science." Scientific Ethics,[3-6]
In October 2011, the journal Nature [4-3] reported that published retractions had increased tenfold over the past decade, while the number of published papers had increased by just 44%.
Dr. Grant Steen's analysis in the Journal of Medical Ethics (2011) [5-4] found that retracted papers were cited over 5,000 times, with 93% of citations being research related. This suggests that misinformation promulgated in retracted papers can influence subsequent research.
Dr. Steen analyzed 180 retracted primary studies: 70 of the studies were retracted for fraud, of which 41% were clinical trials involving human subjects ( Steen refers to them as “freshly derived human material”). Over 28 000 subjects had been enrolled, and 9,189 patients were treated. Subsequently, over 400,000 subjects were enrolled in 851 secondary studies which cited a retracted paper—in these secondary studies, 70, 501 patients were treated. These estimates, he notes are conservative because only patients enrolled in published clinical studies were counted.
It is worth noting that the results of most negative clinical trials are never published—neither are they disclosed anywhere, except in sponsors’ confidential files and FDA marketing submissions. Those confidential files are pried open ONLY in the course of litigation--until then, commercial stakeholders are shielded by a solid curtain of confidentiality. When post marketing reports link a drug, a medical device or vaccine to serious harm, they are vigorously dismissed as anecdotal, claiming--"there is no scientific evidence” from clinical trials. The evidence and the bodies have been buried without a trace.
False, misleading, and outright fraudulent research reports published in medical journals cause enormous harm: they divert scientists and resources into unproductive lines of investigation, and worst of all, they misinform clinicians about the safety and efficacy of treatments, encouraging them to prescribe inappropriate--even potentially lethal—medical treatments for patients. In other words, false claims in medical journals can be a matter of life and death. Indeed, more than 200,000 Americans are killed every year due to adverse effects of prescription drugs that had not been disclosed in journal reports.
In his recently published book, Pharmageddon (2012, U. of California Press) Dr. David Healy argues that the presumed integrity of medical journals is the cornerstone for evidence-based medicine, and medical practice guidelines are formulated on the basis of published journal findings--which are invoked as scientific evidence. And, he argues, that those "evidence-based" guidelines have supplanted physicians' professional judgment and reliance on experience and close observation of individual patients and their needs.
In an editorial in Infection and Immunity,  Drs. Fang and Casadevall state: "without access to raw data, it is unrealistic to expect that even careful and highly motivated reviewers can detect all instances of falsification or fabrication." But these good doctors fail to point out WHY they don't have access to the data, or WHO prevents access to the raw data? Neither do they suggest the obvious, that without access to the data, the peer review exercise itself lacks authenticity.
Peer review is clearly not a reliable gate keeping mechanism for insuring the integrity of scientific journals--a major flaw is that reviewers do not actually review the raw data because it is withheld by commercial sponsors. And the influence those sponsors exert on the science and practice of medicine, is ubiquitous.
In her article in COUNTERPUNCH, Martha Rosenberg cites several rogue journal authors who were sentenced to prison, yet their fraudulent reports continue to pollute the literature. She asks: "If going to prison for research fraud is not enough reason for retraction, what is?"
The Alliance for Human Research Protection calls upon all medical journals to adopt a publication policy to deter the submission of reports that misrepresent findings, withhold negative data, or make false, unsubstantiated claims. This is in line with the publication policy adopted by NATURE publications, which have a uniform publication standard:
"A condition of publication in a Nature journal is that authors are required to make materials, data and associated protocols promptly available to others without undue qualifications...Supporting data must be made available to editors and peer-reviewers at the time of submission for the purposes of evaluating the manuscript.”
Specifically, for the publication of clinical trials, the Alliance for Human Research Protection recommends that all medical journals require submission of the sponsor’s formal Clinical Study Report which contains the most complete materials, data and associated protocols required by regulatory authorities of the European Union, Japan and the United States (FDA). Inaccuracies, deletions, or alterations in these reports can have regulatory and legal sanctions.
1. Carl Zimmer, A Sharp Rise in Retractions Calls for Reform, The New York Times, April 16, 2012.
2. Ferric C. Fang, Arturo Casadevall, RP Morrison, Retracted Science and the Retraction Index, Infection and Immunity, 2011.
3. Liu, S. V. Top Journals'Top Retraction Rates, Scientific Ethics 1:91–93, 2006;
4. Richard Van Noorden, Science Publishing: The Trouble With Retractions, Nature, 2011.
Retractions in the medical literature: how many patients are put at risk by flawed research? J Med Ethics 37:688-6924.
6. Martha Rosenberg, Big Pharma's Ghostweriters: Why Are These Fraudulent Papers Unretracted? COUNTERPUNCH, April 27-29, 2012.