healthy4u: pseudo-evidence based medicine

Pseudo-Evidence Based Medicine Should be a Global Health Concern

We have frequently advocated for <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a> (EBM) , that is, medicine based on judicious use of the best available evidence from clinical research, critically reviewed and derived from systematic search, combined with biomedical knowledge and understanding of patients' values and preferences.  However, EBM risks being turned into <a href="http://hcrenewal.blogspot.com/search/label/pseudo-evidence%20based%20medicine">pseudo-evidence based medicine</a> due to systematic manipulation and distortion of the clinical research evidence base.  Dr Wally Smith wrote about pseudo-evidence based medicine, which he defined as "the practice of medicine based on falsehoods that are disseminated as truth," in the British journal Clinical Governance (Smith WR. Pseudoevidence-based medicine: what it is, and what to do about it. Clinical Governance 2007; 12: 42-52. Also see <a href="http://hcrenewal.blogspot.com/2007/02/threat-of-pseudoevidence-based-medicine.html">this post</a>).   Now it appears that this issue is causing concern in the Cochrane Collaboration, the main voluntary international group promoting EBM.  An article from December, 2011 in the Indian Journal of Medical Ethics outlined why we need to question the trustworthiness of the global clinical evidence base.  (See Tharyan P. Evidence-based medicine: can the evidence be trusted.  Ind J Med Ethics 2011; 8: 201-207.  Link <a href="http://www.issuesinmedicalethics.org/194ed203.html">here</a>.)  It merits further review. The Role of Vested Interests Dr Tharyan, its author, emphasized that a major threat to the integrity of the clinical research data base is the influence on clinical research of those with vested interests in marketing particular products, e.g., drugs, devices, etc. <blockquote>The motives for conducting research are often determined by considerations other than the advancement of science or the promotion of better health outcomes. Many research studies are driven by the pressure to obtain post-graduate qualifications, earn promotions, obtain tenured positions, or additional research funding; many others are conducted for financial motives that benefit shareholders, or lead to lucrative patents. </blockquote> The Importance of Pervasive <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">Conflicts of Interest</a> Early on, the author discussed how the distortion of the clinical research data base arises from the pervasive web of conflicts of interest in medicine and health care: <blockquote>This hijacked research agenda perpetuates further research of a similar nature that draws more researchers into its lucrative embrace, entrenching the academic direction and position statements of scientific societies and academic associations. Funders and researchers are also deterred from pursuing more relevant research, since the enmeshed relationship between academic institutions and industry determines what research is funded (mostly drugs at the expense of other interventions), and even how research is reported; thus hijacking the research agenda even further away from the interests of science and society.</blockquote> The article then goes on to show how the influence of vested interests may distort the design, implementation, analysis, and dissemination of research. <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">Distortion of Research Design and Implementation</a> The Research Question Dr Tharyan noted <blockquote>The majority of clinical trials conducted world-wide are done to obtain regulatory approval and a marketing licence for new drugs. These regulations often require only the demonstration of the superiority of a new drug over placebo and not over other active interventions in use. It is easier and cheaper to conduct these trials in countries with lower wages, lax regulatory requirements, and less than optimal capacity for ethical oversight. It is therefore not surprising that the focus of research does not reflect the actual burden of disease borne by people in the countries that contribute research participants, nor address the leading causes of the global burden of disease. Some 'seeding' trials, conducted purportedly for the purpose of surveillance for adverse effects, are often only a ploy to ensure brand loyalty among participating clinician-researchers.</blockquote> Insufficient Sample Size The article stated, <blockquote>Many trials do not report calculations on which the sample size was estimated, often leading to sample sizes insufficient to detect even important differences between interventions (for primary, let alone secondary outcomes) </blockquote> I would add that such small trials are particularly bad at detecting important adverse effects of the interventions being promoted. Excessively Stringent Enrollment Criteria As Dr Tharyan wrote, <blockquote>Most RCTs funded by industry and academia are designed to demonstrate if a new drug works, for licensing and marketing purposes. In order to maximise the potential to demonstrate a 'true' drug effect, homogenous patient populations; placebo controls; very tight control over experimental variables such as monitoring, drug doses, and compliance; outcomes addressing short term efficacy and safety; and methods to minimise bias required by regulatory agencies are used to demonstrate if, and how, the drug works under ideal conditions. </blockquote> The problem is that very few patients in clinical practice resemble those enrolled in such trials, so the generalizability of the trials' results is actually dubious. Ideally, clinicians practicing evidence-based medicine could refer to trials that include patients similar to those for whom they care. <blockquote>Practical or pragmatic clinical trials are designed to provide evidence for clinicians to treat patients seen in day-to day clinical practice, and evaluate their effectiveness under 'real-world' conditions. These trials use few exclusion criteria and include people with co-morbid conditions, and all grades of severity. They compare active interventions that are standard practice, and in the flexible doses and levels of compliance seen in usual practice. They utilise outcomes that clinicians, patients, and their families consider important, such as satisfaction, adverse events, return to work, and quality of life). Recommendations exist on their design and reporting , but such trials are rare.</blockquote> Comparisons to Placebo, not the Other Interventions Clinicians Might Realistically Consider Per the article, <blockquote>Industry sponsored trials rarely involve head-to head comparisons of active interventions, particularly those from other drug companies, thus limiting our ability to understand the relative merits of different interventions for the same condition. </blockquote> The result may thus be a number of studies showing particular interventions appear to be better than nothing, but few if any studies that would help clinicians decide which intervention would be best for a particular patient. Inappropriate Comparators However,when studies are done comparing the intervention of interest to other active interventions, the details of the choice of comparators are often managed so that the comparators are likely to appear to be worse. <blockquote>Even if active interventions are compared in industry-sponsored trials, the research agenda has devised ways in which the design of such trials is manipulated to ensure superiority of the sponsor’s drug. If one wants to prove better efficacy, then the comparator drug is a drug that is known to be less effective, or used in doses that are too low, or used in non-standard schedules or duration of treatment. If one wants to show greater safety, then the comparator is a drug with more adverse effects, or one that is used in toxic doses. Follow up, also, is typically too short to judge effectiveness over longer periods of time. </blockquote> Meaningless Outcomes A favorite tactic used in the design of trials influenced by vested interests is to choose outcomes that are likely to show results favorable to the product being promoted, but have no meaning for patients or clinicians. There are three ways this is commonly done. The first is to use rating scales that are very sensitive to small perturbations, but not meaningful in terms of how patients feel or function: <blockquote>The choice of outcome measures used often ensures statistically significant results in advance, at the expense of clinically relevant or clinically important results. Outcomes likely to yield clinically meaningless results include the use of rating scales (depression, pain, etc.). These scales yield continuous measures usually summarised by means and standard deviations, rather than the dichotomous measures clinicians use such as: clinically improved versus not improved. These rating scales, however extensively validated, are hardly ever used in routine clinical practice. A difference of a few points on these scales results in statistically significant differences (low p values), that have little clinical significance to patients. </blockquote> Another is to use surrogate outcomes, <blockquote>Other outcomes commonly used are surrogate outcomes; outcomes that are easy to assess but serve only as proxy indicators of what ought to be assessed, since the real outcome of interest may take a long time to develop. These are mostly continuous measures that require smaller sample sizes (blood sugar levels, blood pressure, lipid levels, CD4 counts, etc.). These measures easily achieve statistical significance but do not result in meaningful improvements (reduction in mortality, reduction in complications, improved quality of life) in patients’ lives, when the interventions are used (often extensively) in clinical practice.</blockquote> Finally, there are composite outcomes, <blockquote>The use of composite outcomes, where many outcomes (primary, secondary and surrogate outcomes) are clubbed together (e.g.: mortality, non-fatal stroke, fatal stroke, blood pressure, creatinine values, rates of revascularisation) as a single primary outcome, can also mislead. Such trials also require smaller sample sizes, and increase the likelihood of statistically significant results. However, if the composite outcome includes those of little clinical importance (lowered blood pressure, or creatinine values), the likelihood of real benefit (reduction in mortality, or strokes, or hospitalisation) and the potential for harm (increase in non-fatal strokes or all-cause mortality) are masked.</blockquote> Distortion of Analysis Relative Instead of Absolute Risks A favorite trick is to emphasize relative risks rather than absolute risks. For example if a trial reduces the risk of a bad outcome from 2 of 10,000 patients (0.02%) to 1 of 10,000 patients (0.01%), the relative risk reduction is 50%, but only 1 of 10,000 patients experienced a benefit. <blockquote>The use of estimates of relative effects of interventions, such as relative risks (RR) and odds ratios (OR) with their 95% confidence intervals, provides estimates of relative magnitudes of the differences and whether these exclude chance, as well as if these differences were nominal or likely to be clinically important. However, even relative risks can be misleading since they ignore the baseline risk of developing the event without the intervention. The absolute risk reduction (ARR) is the difference in risk of the event in the intervention group and the control group, and is more informative since it provides an estimate of the magnitude of the risk reduction, as well the baseline risk (the risk without the intervention, or the risk in the control group). Systematic enquiry demonstrates that on average, people perceive risk reductions to be larger and are more persuaded to adopt a health intervention when its effect is presented as relative risks and relative risk reduction (a proportional reduction) rather than as absolute risk reduction; though this may be misleading.</blockquote> Sub-Group Analysis <blockquote>Another statistical trick used to present favourable outcomes for interventions is the use of spurious subgroup analyses, where observed treatment effects are evaluated for differences across baseline characteristics ( such as sex, or age, or in other subpopulations). While they are useful, if limited to a few biologically plausible subgroups, specified in advance, and reported as a hypothesis for confirmation in future trials; they are often used in industry-sponsored trials to present favourable outcomes, when the primary outcome(s) are not statistically significant.</blockquote>A major statistical point is that the more ways one subdivides the study population, the more likely it is to find a difference between those receiving different interventions by chance alone. Distortion of Dissemination Poor Exposition As noted by Dr Tharyan, <blockquote>Evidence also shows that the published reports are not always consistent with their protocols, in terms of outcomes, as well as the analysis plan, and this again is determined by the significance of the results. Harms are very poorly reported in trials compared to results for efficacy; and are also often suppressed or minimised. </blockquote> <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">Ghost-Writing</a> Also, those with vested interests may try to ensure maximally favorable dissemination by employing ghost-writers, <blockquote>Other tactics used to influence evidence-informed decision making include ghost-writing, where pharmaceutical companies hire public-relations firms who 'ghost-write' articles, editorials, and commentaries under the names of eminent clinicians; a strategy that was detected by one survey in 75% of industry-sponsored trials, where the ghost author was not named at all, and in 91% when the ghost author was only mentioned in the acknowledgement section. Detecting such conflicts of interest is difficult, since they are rarely acknowledged due to the secrecy that shrouds the nexus between academia and industry in clinical trials. Industry-sponsored trials often place various constraints on clinical investigators on publication of their results; these publication arrangements are common, allow sponsors control of how, when, and what is published; and are frequently not mentioned in published articles. </blockquote>Ghost-writers under the direct control of those with vested interests could more efficiently bias their writing in favor of their sponsors than could even academics constrained by contractual obligations to sponsors. <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">Suppression of Research</a> When all else fails, the most crude example of distorted dissemination is suppression of studies that despite all the manipulations noted above fail to produce favorable results for the product being promoted: <blockquote>A considerable body of work provides direct empirical evidence that studies that report positive or significant results are more likely to be published; and outcomes that are statistically significant have higher odds of being fully reported, particularly in industry funded trials.</blockquote> By the way, the latest demonstration of suppression of research was a study by Turner et al (Turner EH, Knoepflmacher D, Shapley L. Publication bias in antipsychotic trials: an analysis of efficacy comparing the published literature to the US Food and Drug Administration database. PLoS Medicine 2012; 9(3): e1001189. Link <a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001189">here</a>) It showed that of 24 trials of atypical antipsychotics registered in the US FDA database, 15/20 (75%) of the published trials were positive, that is, had results in favor of the sponsors' drugs according to the FDA review, but only 1/4 (25%) of the unpublished trials were positive. In other words, 15/16 of positive trials were published, but only 5/8 non-positive ones were. Summary Thus, Dr Tharyan provided a nice summary of many of the ways that the clinical research data base can be manipulated or distorted to serve vested interests. Such distortions risk the transformation of evidence-based medicine into pseudo-evidence based medicine. We have repeatedly discussed (see links above) most of these issues. Because we are located in the US, and speak mainly English, this blog may have given the impression that the lack of trustworthiness of the clinical research evidence base is primarily a US problem. The article by Tharyan emphasizes, however, that it is a global problem. While this problem now seems to have the attention of the Cochrane Collaboration, it seems to be relatively anechoic in global health circles. It appears to be no more prominent on the agendas of <a href="http://hcrenewal.blogspot.com/search/label/global%20health">global health</a> organizations than is <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">health care corruption</a> (look <a href="http://hcrenewal.blogspot.com/2011/12/corruption-kills-so-why-is-health-care.html">here</a>.) Yet the two issues are highly related. Most of the distortions in the global clinical evidence database may be driven by conflicts of interest. Conflicts of interest are risk factors for corruption. Distortions of the global clinical research data base that lead to use of expensive, but ineffective or dangerous interventions when other options would work as well or better leads to needless suffering and death, and by unnecessarily raising the costs of care, decreases access, especially for the poor. Also note that conflicts of interest may be one reason that all these problems remain so <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> (look <a href="http://hcrenewal.blogspot.com/2011/11/will-freeze-of-global-fund-finally-put.html">here</a>). True global health care reform requires addressing health care corruption, but also conflicts of interest and their role in the distortion and manipulation of the clinical research data base. I still live in hope that that some academic health care institutions, professional societies, health care charities and donors, and patient advocacy groups will gain enough fortitude to stand up for accountability, integrity, transparency, and honesty in health care.

Pseudo-Evidence Based Medicine Should be a Global Health Concern

We have frequently advocated for evidence-based medicine (EBM) , that is, medicine based on judicious use of the best available evidence from clinical research, critically reviewed and derived from sy…

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23 Mar 2012

BLOGSCAN - Wandering in the Wilderness

BLOGSCAN - Wandering in the Wilderness

On the 1 Boring Old Man blog, "Mickey," the anonymous blogger, a retired academic psychiatrist, posted about how he figured out the extent that health care dysfunction affected psychiatry while wander…

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01 Jan 2011

Has Ghostwriting Infected The "Experts" With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?

I could have titled this piece "have the deceivers been themselves deceived?" Recent revelations have shown that biomedical ghostwriting is a scourge that some physicians and scientists -- who are clearly lacking ethics, insight and perhaps an understanding of psychiatric defense mechanisms such as rationalization -- engage in all too often, as it taints the corpus of worldwide scientific literature. (I covered the issues related to ethical and justified claims of provenance for scientific writing in my post "Wyeth: Ghostwritten Papers Fake, But Accurate" <a href="http://hcrenewal.blogspot.com/2009/07/wyeth-ghostwritten-papers-fake-but.html">here</a> along with a discussion of why lay leadership of biomedical R&D organizations was not a good idea. Such leaders cannot vouch for the scientific fairness and accuracy emanating from their own organizations.) One should examine the evidence in a first-person manner. The New York Times has made available <a href="http://documents.nytimes.com/design-write-medical-writing">secret documents and emails</a> secured by Senator Grassley on Wyeth's ghostwriting practices. These documents were unsealed by a judge in a personal injury lawsuit and chronicle Wyeth's use of a medical writing company to prepare articles for publication in medical journals. Wyeth said all the articles are "scientifically accurate" and that "it is a common practice in the pharmaceutical industry to work with such firms" (and, by implication, to falsify claimed authorship). As justification for clearly unethical practices, this is a rather poor argument, being a classic logical fallacy known as the <a href="http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html">Appeal to Common Practice</a>: <blockquote>Description of Appeal to Common Practice The Appeal to Common Practice is a fallacy with the following structure: 1. X is a common action. 2. Therefore X is correct/moral/justified/reasonable, etc. </blockquote> That said, these documents raise an important question of a systemic nature: Have the scientific ghostwriting deceivers themselves been deceived regarding biomedical reality by these practices? Might they genuinely believe they are contributing to the scientific literature based on their own erroneous notions, the latter based upon a scientific literature contaminated by other ghostwriters? To illustrate this point, in the New York Times online document pool, we discover that Dr. Gloria Bachmann, Associate Dean for Women's Health and Professor of OB/GYN and Medicine at UNDNJ-Robert Wood Johnson Medical School was presented with a tidy ghostwritten article entitled "The Importance of Treating Vasomotor Symptoms" (in peri- and post-menopausal women) by authors "TBD" (to be decided): <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpfNVCXAffsmRekuHW9VznAj01upkonEa1MGa1YXaE0kCPu-e15jPxm9VsodoXfxp9S1NiSu6TM4owNzlhKT0NYCSUZ8lPts5OVOeQYqs7qWDpAMgOTFhebLVgYBwKDqhApnSnMUARZmCH/s1600-h/Picture+1.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5366869892151207106" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpfNVCXAffsmRekuHW9VznAj01upkonEa1MGa1YXaE0kCPu-e15jPxm9VsodoXfxp9S1NiSu6TM4owNzlhKT0NYCSUZ8lPts5OVOeQYqs7qWDpAMgOTFhebLVgYBwKDqhApnSnMUARZmCH/s320/Picture+1.jpg" style="cursor: pointer; display: block; height: 427px; margin: 0px auto 10px; text-align: center; width: 323px;" /></a>(Original ghostwritten draft. Authors "TBD." Click to enlarge)</div> about which Bachmann wrote the following in an email to the true authors' organization: <blockquote>"Outline is excellent as written. I would like to try for publication as a review article in Obstetrics and Gynecology. We would have to change the title to "Vasomotor Symptoms: Evidence Based Treatment Options" or a title that emphasizes the data driven writing style."</blockquote> Here is an image of the email: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEglfJCs7MUOzFBfvlngFeXxR74ABCDQpvIgv0XBujGInP40VytV7Zb83dmtpdB4ASnVE4s8wKK0HGkjLGaKrhQCTtKw36K9KB5bCk0XpWuxD0KjtNOYDJqbPJx2j8DdpHGVWOKPMwh-GXcW/s1600-h/Picture+3.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5366872232373912850" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEglfJCs7MUOzFBfvlngFeXxR74ABCDQpvIgv0XBujGInP40VytV7Zb83dmtpdB4ASnVE4s8wKK0HGkjLGaKrhQCTtKw36K9KB5bCk0XpWuxD0KjtNOYDJqbPJx2j8DdpHGVWOKPMwh-GXcW/s320/Picture+3.jpg" style="cursor: pointer; display: block; height: 359px; margin: 0px auto 10px; text-align: center; width: 300px;" /></a>(Approval email. Click to enlarge)</div> She found the content OK and agreed to review it. Apparently, only minor changes were made. (Bachmann should have received accreditation in the acknowledgments section for reviewing the article, and/or a position far down the authorship hierarchy if she actually added some material). Instead, the reverse occured. The published document appeared with Bachmann as first (and only) author after Bachmann submitted it to a medical journal under her name, itself unethical. See what "Authors TBD" morphed into in the image below: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFwtod-h29l228wXBF4RE3uSG0PYu6LVv4SFOcQixGn7VEiT3hjC8M7BiUjk_Mhc-O5J9M3YQ-Eq2NVKyv0xMDShshemCGrvFRFN-mIgVzzvBAqqnd13qHvn4aTtfEVPGBseZrOH1o4DRU/s1600-h/Picture+4.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5366873203094683218" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFwtod-h29l228wXBF4RE3uSG0PYu6LVv4SFOcQixGn7VEiT3hjC8M7BiUjk_Mhc-O5J9M3YQ-Eq2NVKyv0xMDShshemCGrvFRFN-mIgVzzvBAqqnd13qHvn4aTtfEVPGBseZrOH1o4DRU/s320/Picture+4.jpg" style="cursor: pointer; display: block; height: 341px; margin: 0px auto 10px; text-align: center; width: 283px;" /></a>(Article submission cover page. Click to enlarge)</div> Here is how the true authors, medical writers for DesignWrite, the medical writing and communications company retained by Wyeth to write the article, received credit: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgUALG8sej3YfhGCix3j59Kc4gm8mh5HQONCBaHcw9SFHKfBrbMpmQgVbZft7UNEl6C0qfLtdrcS_hG824AYKI4rn-_RN5CP9l95qL2pKcZE8A1XDIh0NeSNfbcxy94nydJfP9IhCgVbhAF/s1600-h/Picture+5.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5366880395546903266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgUALG8sej3YfhGCix3j59Kc4gm8mh5HQONCBaHcw9SFHKfBrbMpmQgVbZft7UNEl6C0qfLtdrcS_hG824AYKI4rn-_RN5CP9l95qL2pKcZE8A1XDIh0NeSNfbcxy94nydJfP9IhCgVbhAF/s320/Picture+5.jpg" style="cursor: pointer; display: block; height: 353px; margin: 0px auto 10px; text-align: center; width: 292px;" /></a>(How the "ghosts" received credit for writing the paper. Click to enlarge)</div> Unbelievable. Bachmann has since stated that she believed she was adding to science by engaging in this deceit. From the New York Times: <blockquote>The article, a nearly verbatim copy of the DesignWrite draft, appeared in 2005 in The Journal of Reproductive Medicine, with Dr. Bachmann listed as the primary author. It described hormone drugs as the “gold standard” for treating hot flashes and was less enthusiastic about other therapies. The acknowledgments thanked several medical writers for their “editorial assistance,” not disclosing that those writers worked for DesignWrite, which charged Wyeth $25,000 to generate the article. Dr. Bachmann, who has 30 years of research and clinical experience in menopause, said she played a major role in the publication by lending her expertise. Her e-mail messages do not reflect contributions she may have made during phone calls and in-person meetings, she said. ["May have made?" This gossamer excuse is embarrassing to me, as an academic myself - ed.] “There was a need for a review article and I said ‘Yes, I will review the draft and make sure it is accurate,’ ” Dr. Bachmann said in an interview Tuesday. “This is my work, this is what I believe, this is reflective of my view.”…</blockquote> She is quite off base regarding scientific authorship and "this being her work", but what also needs examination is her "lending her expertise" and her agreeing with the paper as "reflective of her view." The paper itself lists many references, for example these: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhb5ny2qG6A2_7kvtL75s-NPLznznSWCsp03R60pgtjzZnLAZnT0LA6smWFhVSm_79qRKWNRlErRDYz1vjpEdLaazL7TAwr3DQ5mREFpuYkp7yhX5mO_v4oLYdKZot4aFGWM-ZQuVUCOG42/s1600-h/Picture+2.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5366874937593524210" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhb5ny2qG6A2_7kvtL75s-NPLznznSWCsp03R60pgtjzZnLAZnT0LA6smWFhVSm_79qRKWNRlErRDYz1vjpEdLaazL7TAwr3DQ5mREFpuYkp7yhX5mO_v4oLYdKZot4aFGWM-ZQuVUCOG42/s320/Picture+2.jpg" style="cursor: pointer; display: block; height: 351px; margin: 0px auto 10px; text-align: center; width: 290px;" /></a>(References: click to enlarge)</div> Here is, then, the dilemma, another major problem posed by ghostwriting: How many of the cited references, which contributed to Bachmann's beliefs regarding these drugs, were themselves ghostwritten and potentially biased, or otherwise influenced by drug companies? For that matter, how many studies with different ("negative") conclusions on these subjects were suppressed from publication by industry pressure?  Bachmann's own "expert opinions" about these matters may be based upon false or misleading information she's read in other journals, the percentage of which are genuine vs. ghostwritten or industry-influenced being an unknown at this point in time. While I believe Bachmann is most likely rationalizing away the unethical nature of attribution without fair and justifying contribution, perhaps fueled by additional motives of academic portfolio building and perhaps present and future potential pecuniary gain, it is possible she is being genuine about agreeing with the "science" in the paper. However, her agreement may be predicated upon her own tainted expertise -- tainted by reading ghostwritten or industry-influenced articles in her area of specialty. Will we ever be able to peel back all the layers of the ghostwriting onion to get to the core of impartial and objective scientific articles related to drugs and medical devices? Perhaps not, but the practice must stop going forward. Tainted literature creates tainted scientific knowledge, the carriers of which may then further taint the knowledge base (with the best of intentions and with firm belief in the fairness and accuracy of their activities, of course). Practitioners of evidence-based medicine may be unwittingly practicing "evidence-tainted medicine", or "pseudo-evidence based medicine" as described by others on this blog. Such are the systemic risks of the scourge of ghostwriting. -- SS Aug. 31, 2012 Addendum: I was made aware of the following 2011 paper thanks to a post by Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2012/08/ghostwriting-still-no-consequences-for.html">on the Hooked: Ethics, Medicine and Pharma blog</a>:  "<a href="http://psychrights.org/research/Digest/Science4Sale/WhyDoesAcademiaAllowGhostwritingLeoLacasse2011.pdf" target="_blank">Why Does Academic Medicine Allow Ghostwriting?  A Prescription for Reform</a>" by Jonathan Leo, Jeffrey R. Lacasse, and Andrea N. Cimino The paper also observes: <blockquote class="tr_bq">Due to its secretive nature, it is difficult to quantify how many invisible corporate authors haunt the medical literature.</blockquote> The paper is worth reading in its entirety and as of this writing is available free at the link above. -- SS

Has Ghostwriting Infected The "Experts" With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?

I could have titled this piece "have the deceivers been themselves deceived?"Recent revelations have shown that biomedical ghostwriting is a scourge that some physicians and scientists -- who are clea…

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06 Aug 2009

Pseudo-Evidence Based Medicine Threatens Health Care Reform Based on "What Works"

As I <a href="http://hcrenewal.blogspot.com/2009/07/what-health-care-reformers-dont-discuss.html">posted</a> yesterday, the increasingly noisy debate about health care reform in the US has not dealt much with the issues we often discuss on Health Care Renewal. These include problems in how health care organizations are led which threaten physicians' and other health care professionals' core values using tactics including perverse incentives, deception, and intimidation. Last night, however, President Obama held a news conference mostly devoted to health care issues, in which he stressed the importance of changing not just how health insurance works, but how health care decisions are made. As Newsweek's "The Gaggle" blog <a href="http://blog.newsweek.com/blogs/thegaggle/archive/2009/07/23/obama-presser.aspx">reported</a>, <blockquote> Can I guarantee that there are going to be no changes in the health care delivery system? No. The whole point of this is to try to encourage changes that work for the American people and make them healthier. The government already is making some of these decisions. More importantly, insurance companies right now are making those decisions. And part of what we want to do is to make sure that those decisions are being made by doctors and medical experts based on evidence, based on what works, because that's not how it's working right now. </blockquote> So what the President seems to be advocating is making health care more evidence-based, perhaps in the formal sense of evidence-based medicine. As a card-carrying evidence-based medicine advocate, I certainly agree, but let me reiterate that evidence-based medicine is not just medicine based on some sort of evidence. As Dr David Sackett, and colleagues wrote [Sackett DL, Rosenberg WM, Muir Gray JA, Haynes RB, Richardson WS. Evidence-based medicine; what it is and what it isn't. BMJ 1996; 312: 71-72. Link <a href="http://www.bmj.com/cgi/content/full/312/7023/71">here</a>. ] <blockquote> Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. </blockquote> Furthermore, <blockquote> Evidence based medicine is not 'cookbook' medicine. Because it requires a bottom up approach that integrates the best external evidence with individual clinical expertise and patients' choice, it cannot result in slavish, cookbook approaches to individual patient care. External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision. </blockquote> One can find other definitions of EBM, but nearly all emphasize that the approach is designed to appropriately apply results from the best clinical research, critically reviewed, to the individual patient, taking into account that patient's clinical characteristics and personal values. So far, so good. I believe the proper application of "real" (as described above) evidence-based medicine has the potential to improve patient outcomes while moderating health care costs. However, we have pointed out how problems arising from concentration and abuse of power in health care threaten the evidence-based medical ideal. First, there are major problems with the development of the sort of clinical research evidence required by the EBM process. We have discussed how clinical research is frequently <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> by those with vested interests in producing results that favor the products or services that they sell. The critical review process inherent in EBM is meant to cope with less than optimally designed and implemented research. However, the process was designed to cope with honest mistakes and inevitable trade-offs, not deliberate manipulation by vested interests. Worse, we have discussed how vested interests may engineer the <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of research </a>when manipulation fails to produce the desired results. The EBM process assumes that the research on which decisions should be based is an unbiased sample of research that was done (and done to advance science, not commercial or ideological interests). When research whose results are unwanted by vested interests is suppressed, the resulting distortion of the evidence base may irretrievably bias the EBM process. Finally, we have posted about how vested interests have distorted the discussion, dissemination, and teaching of the results of clinical research. They may develop systematic <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing </a>campaigns, often employing supposed "<a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a>," who are paid on the side by marketers, and using "<a href="http://hcrenewal.blogspot.com/search/label/medical%20education%20and%20communication%20companies">medical education and communication companies</a>"as marketing fronts whose publication strategies include deceptive tactics such as "<a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">ghost-writing</a>." Thus, a rising tide of "<a href="http://hcrenewal.blogspot.com/search/label/pseudo-evidence%20based%20medicine">pseudo-evidence based medicine</a>" threatens to overwhelm even the most conscientious physicians trying to practice evidence-based medicine. So, while I applaud President Obama's advocacy of reforming health care to emphasize what the best evidence suggests really works, I do not think this effort will get far unless we deal with the rising tide of pseudo-evidence based medicine. As a minimum, we need full and detailed disclosure of all the relationships among vested interests and medical research and education, and a much greater role for research and education that is not subsidized by corporations bent on using research and education to market their products and services.

Pseudo-Evidence Based Medicine Threatens Health Care Reform Based on "What Works"

As I posted yesterday, the increasingly noisy debate about health care reform in the US has not dealt much with the issues we often discuss on Health Care Renewal. These include problems in how health…

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23 Jul 2009

Some Good Sense on Pharma

Some Good Sense on Pharma

See some very sensible posts on Medical Rants about the current controversies in the pharmaceutical world. One cites a New Yorker article about how Merck hoisted itself on its own petard by over-selli…

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25 Jan 2005

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