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Confused Thinking about New Cholesterol Guidelines - Were Conflicts of Interest to Blame?

For years, clinical practice guidelines promulgated by prominent health care organizations have been hailed with accolades as received wisdom.  However, there is increasing reason to be skeptical of such guidelines.  Many guidelines are not based on rigorous application of the principles of <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine,</a> and often seem to arise from the personal opinions of their authors.  This is particularly troublesome when those authors  have conflicts of interest, and when the organizations that sponsor guideline development have institutional conflicts of interest.  Back in 2011, an Institute of Medicine panel advocated standards for guideline development, including strict limits on conflicted panel members, to make their results more trustworthy.  However, as we noted <a href="http://hcrenewal.blogspot.com/2012/11/what-if-institute-of-medicine-wrote.html">here</a>, those standards have been largely ignored.    Therefore, it is good news that the just released, long awaited guidelines on the treatment of blood cholesterol from the American College of Cardiology (ACC) and American Heart Association (AHA)(1)  they provoked controversy rather than adulation.  However, connecting some dots reveals that the guideline development process and the defenses of the guidelines by its developers were even more confused than they first seemed.  That confusion may be explained by conflicts of interest affecting guideline development of the sort that the IOM report wanted eliminated.  . The New Cholesterol Guidelines - Background A striking feature of the guidelines was a new approach to drug treatment for primary prevention, that is, for patients who do not already have heart disease or other atherosclerosis.   Such drug based primary prevention has been controversial, although drug treatment for people with high cholesterol who also have documented coronary heart disease, secondary prevention, is well-established. The new cholesterol treatment guideline suggested drug treatment, essentially limited to statin medications, for patients believed to be at elevated risk of developing coronary artery disease or other forms of atherosclerotic disease, even in the absence of elevated cholesterol levels.   <blockquote class="tr_bq">Adults 40 to 75 years of age with LDL–C [so called "bad cholesterol"] ]70 to 189 mg/dL, without clinical ASCVD* [atherosclerotic cardiovascular disease] or diabetes and an estimated 10-year ASCVD risk ≥7.5% should be treated with moderate- to high-intensity statin therapy.</blockquote> Also, <blockquote class="tr_bq">It is reasonable to offer treatment with a moderate intensity statin to adults 40 to 75 years of age, with LDL–C 70 to 189 mg/dL, without clinical ASCVD* or diabetes and an estimated 10-year ASCVD risk of 5% to [less than] ... 7.5% </blockquote> Previously, guidelines and other recommendations for the treatment of cholesterol for primary prevention, that is, for patients without known atherosclerotic cardiovascular disease, suggested treatments according to the level of cholesterol or its components.   Less controversially, the guidelines recommended treatment for patients with existing ASCVD, very high LDL-C, and diabetes. The new guidelines raise some  questions: - Given the past controversy, how good is the evidence supporting cholesterol lowering drug treatment in primary prevention? - What is the evidence supporting deciding on drug treatment for primary prevention on predicted risk of atherosclerotic cardiovascular disease? - Can physicians make good enough risk predictions to use this approach? Evidence Supporting Drug Treatment of Cholesterol in Primary Prevention - Do Benefits Outweigh Harms? The reason that cholesterol lowering drug use for primary prevention has been controversial is the lack of clear evidence that such drug use leads to benefits to patients that outweigh its harms.  A central principle of evidence based medicine is that only treatments whose benefits clearly outweigh their harms should be prescribed.  . A recent commentary by Abramson et al in the British Medical Journal in October, 2013 outlines the issues.(2)  There is no good evidence that statins used in primary prevention increase overall survival, or decrease overall incidence of adverse events, defined as death, hospital admission, prolongation of admission, cancer or permanent disability. Individual trials and meta-analyses do show that statins lead to a small reduction in the rate of cardiovascular events.  For example, the authors' re-analysis of data from a patient level meta-analysis showed that of 140 low-risk primary prevention patients treated for five years, one patient would avoid a major coronary event or stroke. However, it is not clear that this small likelihood of benefit offsets the likelihood of adverse events due to treatment.  The data about the harms of statins in primary prevention is not very clear, partially because the relevant randomized controlled trials featured "reporting of adverse events ... [that was] generally poor, 'with failure to provide details of severity and type of adverse events or to report on health-related quality of life." In summary, Abramson et al wrote, <blockquote class="tr_bq">statin therapy prevents one serious cardiovascular event per 140 low risk people (five year risk ... [less than] 10%) treated for five years.  Statin therapy in low risk people does not reduce all cause mortality or serious illness and has about an 18% risk of causing side effects that range from minor and reversible to serious and irreversible.  Broadening the recommendations in cholesterol lowering guidelines to include statin therapy for low risk individuals will unnecessarily increase the incidence of adverse effects without providing overall health benefit.</blockquote> However, the new guideline focused on the ability of statins to prevent ASCVD,  <blockquote class="tr_bq">The RCTs identified in the systematic evidence review indicated a consistent reduction in ASCVD events from 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) therapy in secondary and primary prevention populations....</blockquote>However, the new guideline ignored the absence of evidence that statin treatment prolonged life, prevented serious illness overall, or improved health status, function or quality of life. Furthermore, the guideline seemed unreasonably optimistic about the harms of statins.  In particular, it ignored evidence about harms other than diabetes, myopathy (serious muscle disease), and stroke.  Yet there is evidence suggesting that statins at least might cause "liver dysfunction, acute renal failure, and cataracts; cognitive symptoms, neuropathy, and sexual dsyfunction; decreased energy and exertional fatigue; and psychiatric symptoms, including depression, memory loss, confusion, and aggressive reactions" as summarized by Abramson and colleagues. Thus the new guidelines did not make a new and improved case that statin treatment for primary prevention has benefits that outweigh its harms.  One could argue that this is their fatal flaw and thus all the rest of the guidelines' discussion about which patients should get primary prevention was pointless. Dr Abramson and his co-author, Dr Rita Redberg, did get to repeat their arguments about why statin use for primary prevention is not justified in a NY Times <a href="http://www.nytimes.com/2013/11/14/opinion/dont-give-more-patients-statins.html">op-ed,</a> but otherwise the fundamental problem with the guideline's argument for aggressive use of statins went unnoticed. Evidence Supporting Making Decisions about Statin Treatment as Primary Prevention According to Patients' Risks of Developing Atherosclerotic Cardiovascular Disease The guidelines suggested statin therapy for patients judged to have at least a 7.5% risk of ASCVD.  As noted above, there is no evidence that statin therapy in primary prevention in general increases survival, reduces serious events overall, improves health status, quality of life, or function, or has benefits that clearly outweigh its harms.  I could not find any reference in the guidelines to clear evidence about the effects of statin treatment in primary prevention for this sub-group of patients.  In the supplemental guideline on risk assessment,(3) there was this  <blockquote class="tr_bq">After deliberation, the Work Group endorsed the existing and widely employed paradigm of matching the intensity of preventive efforts with the individual’s absolute risk.. The Work Group acknowledges that none of the risk assessment tools or novel risk markers examined in the present document have been formally evaluated in randomized controlled trials of screening strategies with clinical events as outcomes.</blockquote> The wording is confusing, but might be stating that a strategy of using statins only for patients predicted to have a risk greater than 7.5% has not been assessed in a clinical trial.  (It might also, however, be stating that the specific method recommended by the guideline to assess this risk has never been tested in a clinical trial, see below.) The apparent lack of evidence in support of the specific strategy advocated by the guideline to use statins for primary prevention in patients whose risk of ASCVD exceeded the designated threshold did not otherwise attract any notice. Evidence Supporting the Ability of Physicians to Assess Risk of ASCVD Accurately Enough to Implement the Recommended Strategy The supplemental guideline stated that previously published methods of risk prediction would not be suitable for the new proposed approach, <blockquote class="tr_bq">As part of its deliberations, the Work Group considered previously published risk scores with validation in NHLBI cohort data as 1 possible approach. However, a number of persistent concerns with existing risk equations were identified including nonrepresentative or historically dated populations, limited ethnic diversity, narrowly defined endpoints, endpoints influenced by provider preferences (e.g., revascularizations), and endpoints with poor reliability (e.g., angina and heart failure [HF]). </blockquote> Since the recommended strategy requires an estimation of risk, the lack of availability of acceptable risk assessment methods would appear to be another fatal flaw.  However,  <blockquote class="tr_bq">Given the inherent limitations of existing scores, the Work Group judged that a new risk score was needed to address some of the deficiencies of existing scores, such as utilizing a population sample that approaches, to the degree possible, the ideal sample for algorithm development and closely represents the U.S. population.</blockquote> So the question now becomes: did the guideline provide sufficient evidence that the new risk prediction tool developed as part of guideline development predicts sufficiently well to be used to make decisions as recommended by the guidelines? Note that developing, validating, and publishing a new risk score normally would be considered to be tasks that are part of research, not guideline development.  Nonetheless, the guideline developers decided to take on these tasks as part of guideline development, which precluded independent publication of the the results of this research after peer review.  This makes it more difficult for others to critically evaluate the results of the research concerning the new risk score.  But let me attempt to do so. The work group went ahead to develop a new multivariate prediction model for ASCVD.  This means they used statistical methods to find variables, that is, patients' clinical or demographic characteristics, that independently could predict the outcome of interest, and then combined these variables in an equation (or algorithm) to make risk predictions for individual patients.  Such multivariate models to make diagnoses or, as in this case, prognostic predictions have been the subject of considerable research since at least the 1970s.  However, they have not been as useful as their initial advocates hoped. The issues turn out to be a bit complex.  I must digress into an area in which I previously did research. It is quite easy to develop multivariate diagnostic or prediction models.  The statistical analytic tools can almost always find multiple patient characteristics that independently correlate with the outcome of interest.  The problem is that such correlations can be based on random associations, or biases produced by idiosyncrasies in the particular data set used for model development.  That a new model can diagnose or predict accurately for patients who were not in the original data set thus is not assured, and should be considered to be merely a hypothesis. Models developed on one group of patients often do not work when tried prospectively on new patients, probably because the initial development group was somehow not completely representative of all the patients of interest.  For example, a model may have been developed using patients from a particular hospital which attracts different sorts of patients than found in other hospitals in which the model might be used.  .Therefore, before one has confidence in such a multivariate model, one must verify that the model predicted or diagnosed well not only in the group of patients from which it was derived, but prospectively on other patients like those on whom it would be used in clinical practice. The supplemental guidelines did assert that the new model was prospectively tested, <blockquote class="tr_bq"> The equations were also assessed in external validation studies using data from other available cohorts</blockquote> However, it did not specify what these cohorts were. There is some data buried in Appendix 4 of the supplemental guideline on the performance of the model.  They did not distinguish results from derived from prospective validation from those from model derivation. <blockquote class="tr_bq"> In summary, discrimination and calibration of the models were very good. C statistics ranged from a low of 0.713  (African-American men) to a high of 0.818 (African-American women). Calibration chi-square statistics ranged from a low of 4.86 (nonHispanic White men) to a high of 7.25 (African-American women).</blockquote> These two sentences do not provide strong evidence that the model would predict well when used prospectively. The C-statistic is an overall measure of the ability of the model to discriminate between patients who will go on to develop the diseases of interest and those who will not.  The statistic is formally equal to the probability that were two patients, one who developed disease, and another who did not, selected randomly, the model would predict disease more strongly for the patient who actually got it.  Thus, at best, for 20% of random pairs of African-American women, one who got disease, one who did not, the model would give a more pessimistic prediction for the women who would not get disease.  This is good, but not great discrimination ability.  (If this result referred to data from model derivation, not prospective validation, it is likely to be over-optimistic.) Furthermore, since the guideline would be used to make decisions based on the absolute risk, its calibration is also important.  Calibration is the measure of whether the model predictions of risk are close to reality.  To assess calibration, one ought to assess the whole range of predictions made by the model.  Given that the guidelines suggest a 7.5% risk threshold, it would be particularly important to determine whether patients given predictions above and below that value really have risks above and below that value. Unfortunately, the two sentences above are not helpful in this regard.  The chi-square statistic presented is a measure of overall calibration, but does not show calibration for groups of patients given predictions with particularly interesting values, like above or below 7.5% Note that the supplemental guideline on risk assessment includes a statement that details about the model validation done "internally and externally" are in a <a href="http://circ.ahajournals.org/content/early/2013/11/11/01.cir.0000437738.63853.7a/suppl/DC1">Full Panel Report Data Supplement</a>.  The download of that supplement so far does not seem to work Setting that aside for a moment, the published guidelines do not provide good evidence that the risk prediction tool the guidelines recommend should be used to assess ASCVD risk in order to make decisions on statin use for individual patients in primary prevention. The lack of a sufficiently accurate method to predict risk seems to a fatal flaw for a strategy that requires risk prediction. Controversy in the Media It turns out that I was not the first person to identify this problem. In fact, it appears that during the internal review process for the guidelines, major questions had already been raised about the risk prediction model's calibration. However, these questions did not seem to have been conveyed to the guideline authors, and hence were never addressed. As <a href="http://www.nytimes.com/2013/11/18/health/risk-calculator-for-cholesterol-appears-flawed.html">reported</a> by the New York Times on November 17, 2013, <blockquote class="tr_bq">The problems were identified by two Harvard Medical School professors whose findings will be published Tuesday in a commentary in The Lancet, a major medical journal. The professors, Dr. Paul M. Ridker and Dr. Nancy Cook, had pointed out the problems a year earlier when the National Institutes of Health’s National Heart, Lung, and Blood Institute, which originally was developing the guidelines, sent a draft to each professor independently to review. Both reported back that the calculator was not working among the populations it was tested on by the guideline makers. That was unfortunate because the committee thought the researchers had been given the professors’ responses, said Dr. Donald Lloyd-Jones, co-chairman of the guidelines task force and chairman of the department of preventive medicine  at Northwestern University.</blockquote> The article by Ridker and Cook was indeed published. on November 19, 2013(4).  It suggested major problems with the calibration of the risk assessment model, <blockquote class="tr_bq">Another concern for clinicians is whether the new prediction algorithm created by the ACC/AHA correctly assesses the level of vascular risk. To be useful, prediction models must not only discriminate between individuals with and without disease, but must also calibrate well so that predicted risk estimates match as closely as possible the observed risk in external populations. We calculated predicted 10-year risks of the same atherosclerotic events using the new ACC/AHA risk prediction algorithm and compared these estimates with observed event rates in three large-scale primary prevention cohorts, the Women's Health Study, the Physicians' Health Study, and the Women's Health Initiative Observational Study. As shown in figure 1, in all three of these primary prevention cohorts, the new ACC/AHA risk prediction algorithm systematically overestimated observed risks by 75–150%, roughly doubling the actual observed risk. As shown in figure 2, similar overestimation of risk was observed in two external validation cohorts used by the guideline developers themselves, an issue readily acknowledged in the report. Thus, on the basis of data from these five external validation cohorts, it is possible that as many as 40–50% of the 33 million middle-aged Americans targeted by the new ACC/AHA guidelines for statin therapy do not actually have risk thresholds that exceed the 7·5% threshold suggested for treatment. Miscalibration to this extent should be reconciled and addressed in additional external validation cohorts before these new prediction models are widely implemented. It is possible, for example, that the five external validation cohorts are more contemporary than the cohorts used in the risk prediction algorithm and thus reflect secular improvements in overall health and lifestyle patterns in the USA over the past 25 years. </blockquote> Note that Figure 1 of the Ridker and Cook article showed the calibration of the model in the patient cohorts newly tested by these authors, focusing in particular on whether patients predicted to have risks of cardiovascular disease just over the 7.5% threshold actually had rates of such disease greater than 7.5%.  They clearly did not   Note also that Figure 2 showed calibration of the model when the guideline authors attempted to test it on new patient cohorts, apparently the data found in the so far inaccessible Full Panel Report Data Supplement.  Again, the model overestimated risk for patients just over the crucial threshold. So the guideline developers knew that their model overestimated risk, buried this information in supplemental data, did not admit or perhaps appreciate how it threatened the credibility of their guidelines, and somehow were not given the internal review that suggested this was a fatal flaw of the proposed guidelines .  The Guideline Developers' Responses The media controversy over the accuracy of the prediction model incorporated into the new guidelines provoked responses from the guideline developers, but these responses were at best confused.  .   First, as reported by the NY times, <blockquote class="tr_bq">In a response on Sunday, Dr. [Sidney C] Smith of the guidelines committee said the concerns raised by Dr. Cook and Dr. Ridker 'merit attention.' <div itemprop="articleBody"> But, he continued, 'a lot of people put a lot of thought into how can we identify people who can benefit from therapy.' Further, said Dr. Smith, who is also a professor of medicine at the University of North Carolina and a past president of the American Heart Association, 'What we have come forward with represents the best efforts of people who have been working for five years.'</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Note that this response includes two logical fallacies.  First, it contained a <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw man argument</a>.  It appeared to respond to accusations no one made.  Nobody accused the guideline developers of being lazy, not putting in much effort, or not devoting much thought to the effort.  The response also included an implied <a href="http://www.nizkor.org/features/fallacies/appeal-to-authority.html">appeal to authority</a>: big experts came up with these guidelines so their opinions should be credited, even in the presence of data to the contrary.   </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Also, as <a href="http://www.cnn.com/2013/11/18/health/cholesterol-calculator/">reported</a> by CNN,</div><blockquote class="tr_bq"><div class="cnn_storypgraphtxt cnn_storypgraph9">However, 'I can't speak to whether the calculator is valid or not,' Dr. Robert Eckel, co-chair of the American Heart Association committee that wrote the new guidelines and the association's past president, told CNN. 'That needs to be determined.'</div><div class="cnn_storypgraphtxt cnn_storypgraph9"> </div><div class="cnn_storypgraphtxt cnn_storypgraph10">'We trusted that the calculator worked,' he said. 'We trusted that the calculator is valid.'</div></blockquote><div class="cnn_storypgraphtxt cnn_storypgraph10"> </div><div class="cnn_storypgraphtxt cnn_storypgraph10">This was confusing.  Maybe Dr Eckel meant it to be another appeal to authority, the authority in question being that of the work group that developed the risk prediction model.  </div><div class="cnn_storypgraphtxt cnn_storypgraph10"> </div><div class="cnn_storypgraphtxt cnn_storypgraph10">Furthermore, again according to CNN,</div><div class="cnn_storypgraphtxt cnn_storypgraph10"> </div><blockquote class="tr_bq"><div class="cnn_storypgraphtxt cnn_storypgraph10">Researchers apparently did not receive the professors' responses, Dr. Donald Lloyd-Jones, chairman of the committee that developed the equation, told the Times.</div><div class="cnn_storypgraphtxt cnn_storypgraph10">  </div><div class="cnn_storypgraphtxt cnn_storypgraph18">But Lloyd-Jones told reporters Monday, 'There's nothing wrong with these equations.'</div><div class="cnn_storypgraphtxt cnn_storypgraph18"> </div><div class="cnn_storypgraphtxt cnn_storypgraph19">Committee members were aware there could be 'overestimation of risk in some populations,' he said.</div></blockquote><div class="cnn_storypgraphtxt cnn_storypgraph19"> </div><div class="cnn_storypgraphtxt cnn_storypgraph19">In addition,</div><div class="cnn_storypgraphtxt cnn_storypgraph19"> </div><blockquote class="tr_bq"><div class="cnn_storypgraphtxt cnn_storypgraph19"> 'Our risk assessment guideline doesn't tell you what to do. ... It just evaluates risk,' he said.</div></blockquote><div class="cnn_storypgraphtxt cnn_storypgraph19"> </div><div class="cnn_storypgraphtxt cnn_storypgraph19">I am not sure this even rises to the level of a logical fallacy.  It appears to be pure denial.  The whole point of the risk assessment tool was to determine whether a patient's risk is above or below the thresholds suggested by the treatment guideline, and thus to tell you what to do.  There clearly is something wrong with "these equations."  Using them appears to vastly overestimate risk, and thus implementation of the guideline would probably lead to vast over treatment of real people  . </div><div class="cnn_storypgraphtxt cnn_storypgraph19"> </div>Thus, after promulgating guidelines that seemed hardly based on evidence, when challenged, the guideline developers' response was confused and illogical.    What About the Issue of Benefits versus Harms? The other problems that I identified above, lack of evidence that primary prevention provides benefits that clearly outweigh harms, and lack of evidence that a strategy based on risk assessment would provide benefits that outweighs harms, did not get media coverage, and so did not provoke a response from the developers.  However, I  did find that one of the members of the guideline panel implied her approach to the benefits versus harms issue in a Medscape news <a href="http://www.medscape.com/viewarticle/814526">article</a>.   Dr Noel Bairey Merz gave a talk at the 2013 American Heart Association meeting about primary prevention for women, first saying <blockquote class="tr_bq">Although the randomized clinical trial evidence supporting primary prevention with statin therapy in women is not perfect, 'the absence of data means negative data.' That is the argument formulated by Dr Noel Bairey Merz (Cedars Sinai Medical Center, Los Angeles, CA), who spoke today here at the American Heart Association 2013 Scientific Sessions.   'How confident are we that statins do not save lives in the week before a heart attack, but they do save lives the week after a heart attack, for women and men?'</blockquote> Also, <blockquote class="tr_bq">in the overall JUPITER study of 18 000 patients, there was no treatment benefit when women were studied as a subgroup. Merz argues that JUPITER is powered for the total sample size only, not for women alone. In addition, the statistical test for heterogeneity revealed the interaction by sex was not statistically significant. 'Pretty much all the subgroups fall beyond the statistically significant range,' said Merz. 'So should we withhold treatment for women, who now are the majority of victims of cardiovascular disease, because of low precision and a trial that was not designed to address or answer this question?'</blockquote> So Dr Merz seemed to assume that statins work for particular patients in the absence of evidence that they do not work, maybe implying a general assumption that all treatments are beneficial until proven otherwise.  This stands a central precept of evidence-based medicine, and perhaps the ancient dictum to physicians to do no harm, on their heads. <div class="cnn_storypgraphtxt cnn_storypgraph19">Unwarranted Enthusiasm for (Over) Treatment and Conflicts of Interest The new cholesterol guidelines, and those who developed them, seem enthused about the treatment of cholesterol with statin drugs for primary prevention in the absence of evidence that such treatment produces benefits that outweigh its harms.  They also seem enthused about basing treatment decisions on a statistical prognostic model that has not been shown to be accurate, and in fact which appears to be biased towards promoting excess treatment in the context in which it would be used.   The excess enthusiasm occurred in spite of evidence, and at times in spite of logic.  One possible reason that the guideline developers got so enthused that they seemed unable to think straight appears to be their own conflicts of interest, as first publicly noted in a <a href="http://www.pharmalive.com/cholesterol-guidelines-panelists-and-their-conflicts-of-interest">post</a> on Pharmalot. Reviewing the disclosure forms provided with the guidelines revealed more detail. Of the 13 people on the main treatment guideline panel who were not NHLBI staffers serving ex-officio, 7 had financial relationships with pharmaceutical companies that manufacture statins: - Jennifer Robinson, co-chair, research funded by AstraZeneca and Merck; - C Noel Bairey Merz, consulting for Abbott, Bristol-Myers Squib Novartis, and Pfizer; - Robert H Eckel, consulting for Merck, Pfizer and Abbott; - Anne Carol Goldberg, consulting for Abbott and Merck, research funded by Abbott, Merck, and Novartis; - J Sanford Schwartz, consulting for Abbott, Merck and Pfizer, research funded by Pfizer; - Karol Watson, consulting for Abbott, AstraZeneca, Merck and Pfizer, research funded by Merck; - Peter W F Wilson, consulting for and research funded by Merck. Of the 10 expert reviewers for this panel, 3 had financial relationships with pharmaceutical companies that manufacture statins -  William Virgin Brown, consultant for Abbott, Bristol-Myers Squibb, and Pfizer; -  Matthew Ito, consultant for Kowa; - Robert S Rosenson, consultant for Novartis and Pfizer. Of the 11 people on the risk prediction panel who were not NHLBI staffers serving ex-officio, 5 had financial relationships with pharmaceutical companies that manufacture statins -David C Goff Jr, co-chair, research funded by Merck; - Raymond Gibbons, consultant for AstraZeneca; - Jennifer Robinson, research funded by AstraZeneca, and Merck; - J Sanford Schwartz, consulting for Abbott, Merck and Pfizer, research funded by Pfizer [although these relationships were not listed as relevant to this panel, but found in the listing for the panel above]; - Peter W.F Wilson, consultant for and research funded by Merck. Also, in the Abramson and Redberg NY Times op-ed, the authors noted <blockquote class="tr_bq">both the American Heart Association and the American College of Cardiology, while nonprofit entities, are heavily supported by drug companies </blockquote> As noted on Pharmalot, the prevalence of conflicted panel members did not appear to conform to the <a href="http://www.iom.edu/Activities/Quality/ClinicPracGuide.aspx">standards for the development of trustworthy guidelines</a> recently published by the Institute of Medicine: <blockquote class="tr_bq">whenever possible, guideline development group members should not have conflicts of interest… and the chair or co-chairs should not be a person(s) with conflicts of interest.</blockquote> Also, <a href="http://www.latimes.com/science/sciencenow/la-sci-sn-statins-risk-calculator-wrong-20131118,0,3734255.story">noted</a> by the Los Angeles Times was this comment from Dr John Abramson, lead author of the commentary on statins in primary prevention(4), <blockquote class="tr_bq">'There is overtreatment that’s been built into the risk calculator, and this is a warning sign about the overtreatment that’s built into the guidelines themselves and the conflicts of interest in the organizations that are overseeing the production of these guidelines,' said Dr. John Abramson, a Harvard University cardiologist who has argued that statins offer little value for people with a 10-year risk level of heart attack or stroke of less than 20%. 'There aren’t brakes being put on the enthusiasm and overreaching of the experts.' 'There are statin believers, and when you hear these experts talk, they’re talking emotionally, not scientifically,' Abramson added. 'The experts are using emotion, not science.'</blockquote> As Joe Collier  observed, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."(5) This difficulty giving clear advice, when amplified by a guideline for a common problem supported by prestigious non-profit organizations, and promoted by vigorous public relations, could lead to "more than 45 million middle-aged Americans who do not have cardiovascular disease being recommended for consideration of statin therapy" (per Ridker and Cook[4]) unnecessarily, likely resulting in millions suffering unneeded side effects, and billions in costs.   Summary Guidelines for management of a very common problem promulgated by a major medical society and a major disease oriented non-profit organization suggested a strategy that would vastly increase drug treatment of currently healthy patients.  The strategy appears not to have been based on good evidence.  When some of the problems with this evidence were pointed out, the guideline developers responded with illogic.  Apparently many of the guideline developers have financial relationships with the drug companies that would most profit from increases in drug treatment as recommended by the guidelines  Implementation of the new guidelines might results in millions of people in the US receiving unneeded drugs, with resultant side effects and costs. . Do we need more examples of how conflicts of interest are causing the poor outcomes and excess costs that are wrecking our health care system?  Do we need more excuses not to eliminate conflicts of interest from guideline development?  Do we need more delay implementing the standards provided by the Institute of Medicine report on trustworthy guidelines?  Do we need more excuses not to drastically reduce conflicts of interest affecting academic medicine, medical societies, and disease specific non-profits, specifically starting with the earlier (and so far generally disregarded) Institute of Medicine <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">report on conflicts of interest in medicine</a>? While we in the US argue incessantly in the details of minor reforms of our supposed free health care market, we ignore the rot at its foundations.  True health care reform would attack the conflicts of interest that have put money, not patients at the center of health care. </div> References 1.  Stone NJ, Robinson J, Lichtenstein AH,  et al.  2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.  Circulation 2013.  Link <a href="http://circ.ahajournals.org/content/early/2013/11/11/01.cir.0000437738.63853.7a">here</a>. 2.  Abramson JD, Rosenberg HG, Jewell N et al.  Should statins be prescribed to people at low risk of cardiovascular disease. Brit Med J 2013; 347: 15-17.  Link <a href="http://www.bmj.com/content/347/bmj.f6123">here</a>. 3.  Goff Jr DC, Lloyd-Jones DM, Bennett G, et al.  2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk.  Journal of the American College of Cardiology (2013), doi: 10.1016/j.jacc.2013.11.005.  Link <a href="http://content.onlinejacc.org/data/Journals/JAC/0/11005.pdf">here</a>. 4.  Rikder PM, Cook NR. Statins: new American guidelines for prevention of cardiovascular disease.  Lancet 2013;   Link <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2962388-0/fulltext">here</a>. 5.   Collier J. The price of independence. Br Med J 2006; 332: 1447-9.  Link <a href="http://bmj.bmjjournals.com/cgi/content/full/332/7555/1447">here</a>

Confused Thinking about New Cholesterol Guidelines - Were Conflicts of Interest to Blame?

For years, clinical practice guidelines promulgated by prominent health care organizations have been hailed with accolades as received wisdo...

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WHEN IS DISCLOSURE NOT DISCLOSURE?

<div class="MsoNormal">WHEN IS DISCLOSURE NOT DISCLOSURE? <o:p></o:p> </div><div class="MsoNormal">Hint: When it is made by the Chairman of the DSM-5 Task Force.<o:p></o:p> </div><div class="MsoNormal">Here is a case study in conflict of interest (COI). A remarkable <a href="http://archpsyc.jamanetwork.com/article.aspx?articleID=1780020&utm_source=Silverchair%20Information%20Systems&utm_medium=email&utm_campaign=JAMAPsychiatry%3AOnlineFirst11%2F20%2F2013">confession</a> has just appeared by a group of 5 prominent academics, writing in the journal JAMA Psychiatry. Having been outed to the Editors, they now admit to concealing pertinent financial information. One of the five is David J. Kupfer, MD, chairman of the DSM-5 Task Force and past chairman of the department of psychiatry at The University of Pittsburgh. The others are from Pittsburgh, Minnesota, and Chicago.<o:p></o:p> </div><div class="MsoNormal">With millions in funding from NIMH, these folks have been developing new approaches to testing for anxiety and depression. The technical details are not important for this story. What matters is that they have clearly set their sights on a large market for diagnostic screening, epidemiological research, and clinical practice. They have recently published promotional reports talking up three products and projecting major applications – but before taking care of the nuts and bolts of scale development.<o:p></o:p> </div><div class="MsoNormal">Their major <a href="http://archpsyc.jamanetwork.com/article.aspx?articleid=1389370">report</a> in JAMA Psychiatry contained a disclosure to the effect that they might at some time in the future consider commercial development of their depression scale. This disclosure was phony. We now know that, in lieu of frankly disclosing a major COI, they opted for a disingenuous, dissembling statement that was economical with the truth.<o:p></o:p> </div><div class="MsoNormal">I thought the content of their report was sub-par, and the journal published a <a href="http://archpsyc.jamanetwork.com/article.aspx?articleid=1707797&resultClick=3">letter</a> from me to that effect. They <a href="http://archpsyc.jamanetwork.com/article.aspx?articleid=1707798&resultClick=3">responded</a> to my criticism with hand waving, and they tried to impugn me for bias related to my own (disclosed) COI. This foolish, ad hominem tactic aimed to divert attention from the substance of my critique – for which they had no adequate response.<o:p></o:p> </div><div class="MsoNormal">As I am not a person who suffers fools or insults gladly, their evasive response caused me to do some checking. I quickly learned that the gang of five are shareholders in a private corporation. Before their paper was accepted by JAMA Psychiatry, the corporation was incorporated in Delaware and soon after registered to do business in Illinois. Those facts were not disclosed in the original report or in the published letter of Reply to me. These omissions were acknowledged in the notice of Failure to Report that appeared on-line today.<o:p></o:p> </div><div class="MsoNormal">It gets worse. Other things that I learned – and that I communicated to the journal – make it clear that the corporate train had left the station in advance of the letter of Reply. For instance, a professional operations and management executive (Mr. Yehuda Cohen) had joined the corporation. He had established the corporate <a href="http://www.adaptivetestingtechnologies.com/">website</a>, where he was featured as a principal, along with the gang of five. The website also displayed a professionally crafted Privacy Policy, dated ahead of the letter of Reply. This document identified what appears to be a commercial business address for the corporation. The notice of Failure to Disclose is silent on these facts.<o:p></o:p> </div><div class="MsoNormal">So, the published notice of Failure to Disclose still withholds pertinent information, which makes a mockery of the weasel words that they have not released any tests for commercial or professional use. Not yet, they haven’t. But they are under way, make no mistake. This prevarication creates the impression of a habitual lack of transparency. Considering that I gave the journal all this information, one has to be surprised that JAMA Psychiatry went along with this prevarication. Plus, would it have killed them to apologize for their foolish attempt to smear me, as I requested? In correspondence with me, the Editor in Chief of JAMA didn’t want to go there, and he refused to publish my letter that detailed the facts, citing the most specious of grounds. The Editor of JAMA Psychiatry has ducked for cover when I faulted him for publishing the ad hominem material in the first place.<o:p></o:p> </div><div class="MsoNormal">This deplorable episode casts a pall on the repeated assurances by Dr. Kupfer that COI issues were <a href="http://www.medscape.com/viewarticle/777132">under control</a> in the DSM-5 process. If the chairman of the DSM-5 Task Force doesn’t have his own act together, then what are his assurances worth? The new instruments proposed by this corporation bear an eerie resemblance to cross-cutting dimensional measures that were promoted for DSM-5 but that didn’t make the final cut. As far as I know, Dr. Kupfer didn’t declare his interest in this corporation for scrutiny vis à vis DSM-5.<o:p></o:p> </div><div class="MsoNormal">Another lesson is that even Failure to Report notices can be weasel documents. I fault the Editors of JAMA Psychiatry, Joseph Coyle, MD, and of JAMA, Howard Bauchner, MD, for the non-rigorous standard they applied to the notice of Failure to Disclose. They acquiesced in another dissembling response.<o:p></o:p> </div><div class="MsoNormal">Yet another lesson is that all authors are accountable for the accuracy of disclosure statements. Some of these authors might claim they relied on the lead author and president of the corporation, Robert Gibbons, PhD, a statistician at The University of Chicago, to make sure everything was kosher. Big mistake – just like the infamous case of the Nemeroff-led Cyberonics – vagus nerve stimulation<a href="http://hcrenewal.blogspot.com/2006/08/money-and-medical-journals.html"> review</a> that failed to disclose that the academic authors (ahem) were paid consultants of the corporation. When your name is on the byline, be sure you cover the bases for your own protection, and don’t squawk when you are called out. <o:p></o:p></div><div class="MsoNormal">Finally, where is NIMH in all of this? Since when are public NIMH funds to be treated as commercial seed money? Who actually owns the algorithms and data bases on which the Gibbons corporation relies for its commercial aspirations? Why are they not publicly accessible? Is Thomas Insel on top of this?<o:p></o:p></div><div class="MsoNormal"> </div> <div class="MsoNormal"> </div>

WHEN IS DISCLOSURE NOT DISCLOSURE?

WHEN IS DISCLOSURE NOT DISCLOSURE? Hint: When it is made by the Chairman of the DSM-5 Task Force. Here is a case study in conflict of intere...

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Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications "Only a Matter of Time" in Open Letter

I've written previously about substantial problems nurses at Affinity Medical Center, Ohio (<a href="http://www.affinitymedicalcenter.com/">http://www.affinitymedicalcenter.com/</a>) and other organizations are having with EHRs, and how hospital executives were ignoring their complaints.  The complaints have been made openly, I believe, in large part due to the protection afforded by nurses' unions. See for example my July 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" at <a href="http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html">http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html</a> (there are links there to still more examples), and my June 2013 post  "Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday" at <a href="http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html">http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html</a>, along with links therein to other similar situations. Particularly see my July 2013 post "How's this for patient rights? Affinity Medical Center manager: file a safety complaint, and I'll plaster it to your head!" at <a href="http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html">http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html</a>, where a judge had to intervene in a situation of apparent employee harassment for complaints about patient safety risks. Here's the latest at Affinity Medical Center - an open letter to the Chief Nursing Officer (CNO) dated August 15, 2013.  Images and text below: <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhNZ-FVI6yOi6hzHqgyu1v0xQ66Ur33TUGeYYQ1WxrjwfDtDaHq0FZT49Ifs2gDJV7cOKk19pjmGlSkWErY-onGyNoIgZBxjK7moDu912SBF-3CteKp60XUgswug_ZUZdFAPKSoWfBoMiBp/s1600/affinity_page1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhNZ-FVI6yOi6hzHqgyu1v0xQ66Ur33TUGeYYQ1WxrjwfDtDaHq0FZT49Ifs2gDJV7cOKk19pjmGlSkWErY-onGyNoIgZBxjK7moDu912SBF-3CteKp60XUgswug_ZUZdFAPKSoWfBoMiBp/s400/affinity_page1.jpg" width="307" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Page 1 - click to enlarge (text is below) </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjJq3QEnDSUGKCbaNAVv4MmaUcRUmTfAq8x5C8fTNcZcSCHccvXACji_yBjfHDfGHUZNMNu0SuXW4AwwFt4XJPFxcwgrYvrvnFQHLNgCiYfnL76YcOVrsNaWFZhTnhVIInNHzTQdzt0AUJo/s1600/affinity_page2.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjJq3QEnDSUGKCbaNAVv4MmaUcRUmTfAq8x5C8fTNcZcSCHccvXACji_yBjfHDfGHUZNMNu0SuXW4AwwFt4XJPFxcwgrYvrvnFQHLNgCiYfnL76YcOVrsNaWFZhTnhVIInNHzTQdzt0AUJo/s400/affinity_page2.jpg" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Page 2 - click to enlarge (text is below) </td></tr></tbody></table> The letter to the CNO states (emphases and comments in red italics are mine): <blockquote class="tr_bq">August 15, 2013 Mr. Osterman, Nurses at Affinity Medical Center are pleased to see that you have responded to our request and provided additional Cerner education classes, but education was only one of many concerns. [I note that education cannot compensate for the toxic effects of bad health IT that is poorly designed and/or poorly implemented, and that it's legally the responsibility of a hospital to ensure all apparatuses implemented and the environment of care are themselves safe - ed.] Since the implementation nurses throughout the hospital have brought many serious concerns to the attention of both yourself and other supervisors.  When nurses have reported these concerns they have been either ignored or dismissed. It is distressing that Affinity would so blatantly disregard the concern of their RN staff surrounding issues that concern patient safety.  It is clear to direct-care RNs that many of the problems that exist with Cerner are a direct result of the failure to include nurses in the planning stages. [Exclusion of enduser domain experts from health IT development, in 2013, is grossly negligent IMO - ed.] Some of the concerns that nurses have brought to the attention of management include: <ul><li>Medication errors/scanning issues - perhaps the biggest concern of all RNs </li><li>RNs unable to access patient records for hours at  a time</li><li>Incorrect descriptors and inaccurate drop-down menus</li><li>Incorrect calculations in the I&O [fluid input and output, especially important in very ill patients - ed.] and MAP [mean arterial pressure, used to calculate drip rates of potent drugs that raise or lower blood pressure in critical care, among other things - ed.] portions of the chart  </li><li>Inaccurate medication times and the inability of RNs to ensure medications are scheduled correctly</li><li>Endless loops of computer prompts that are unable to be dismissed by RNs in an emergency  </li></ul> [It should be apparent that these 'issues' - some due to fundamental design flaws - are quite serious in terms of the harm they can cause, even with the exceptional and stressful RN hyper-vigilance their presence necessitates- ed.]   These threats to patient safety cannot continue.  It is only a matter of time before a communication error or a medication error lead to a serious complication for a patient.  These types of errors have the ability to harm every patient and must be addressed immediately.  [This is not theoretical or unlikely.  Such an error led to my own mother's crippling injuries and death, and to injuries and deaths in numerous other cases of which I am aware through my legal work - ed.] We ask that you set up a meeting with a delegation of RNs from our Facility Bargaining Council to discuss the concerns that nurses have documented on 'Technology Despite Objection' forms [complaint forms about use of technology with objections - ed.] and make a plan to fix these life-threatening problems. You may set up a meeting by contacting Pam Gardner, RN at [redacted] or our National Representative  Michelle Mahon, RN.  [For the National Nurses United labor union, <a href="http://www.nationalnursesunited.org/">http://www.nationalnursesunited.org/</a>, with close to 185,000 members nationwide - ed.]  We look forward to hearing from you.</blockquote> The letter is followed by the signatures of about 70 nurses. I am informed by a Union rep in mid-November 2013, 3 months after the date of this letter, that (emphasis mine): <blockquote class="tr_bq"><div class="MsoNormal">Nurses there are continuing to document the problems and concerns that they are experiencing.  I have attached a letter sent to the CNO at Affinity signed by nearly 70 RNs.  This is a pretty significant number of nurses especially in light of the fact that managers stole the circulating letter two times to prevent nurses from signing on.  The response to this letter was…….nothing.  The nurses have been ignored yet again. [Ellipsis in the original, I did not redact - ed.]  </div></blockquote><div class="MsoNormal"></div> It is clear the administration of this healthcare system has been explicitly put on notice of likely if not imminent danger to patients by multiple qualified experts, its own RNs.  If they do not act and patient harm occurs, it is my belief criminal negligence charges could be merited. I also highly doubt patients are informed of these EHR system 'issues' and have been afforded the opportunity to give informed consent to the use of these computer systems in their care, or to go elsewhere for treatment. These problems are repeating themselves over and over across this country and others, but many clinicians, especially those not protected to some degree by a labor union, do not speak out due to fear of retaliation. Let's hope the nurses who signed this letter don't get their complaints plastered to their foreheads, as some were threatened with as in the aforementioned post. -- SS

Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications "Only a Matter of Time" in Open Letter

I've written previously about substantial problems nurses at Affinity Medical Center, Ohio ( http://www.affinitymedicalcenter.com/ ) and...

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No Dogs to Bark - Failure to Connect the Events Foreshadowing the Fall of the Upstate President

In <a href="http://en.wikipedia.org/wiki/Silver_Blaze">Silver Blaze</a>, Sherlock Holmes noted the important clue of the watchdog that did not bark.  In health care, nowadays watchdogs are absent, so who is expected to bark?  So, when cases of failed leadership of health care organizations appear, in retrospect they often appear to have been foreshadowed by various events which caused no reaction..  Last week we <a href="http://hcrenewal.blogspot.com/2013/11/engaging-excellence-while-engaging.html">posted</a> about the president of the State University of New York (SUNY) - Upstate Medical University who resigned his job after revelations that he was receiving hundreds of thousands of dollars in income from outside organizations which he had not properly disclosed, and which could have constituted conflicts of interest.  Only days later, on November 20, 2013, James T Mulder, the Syracuse Post-Standard journalist who had done much of the relevant reporting, published an <a href="http://www.syracuse.com/news/index.ssf/2013/11/post_933.html">article</a> summarizing previous events that in retrospect should have suggested that there were serious ongoing problems within SUNY - Upstate leadership.  Claims that the University Fired Physician Whistle-blowers - the Case of Dr Stewart According to the summary article, <blockquote class="tr_bq">Critics of [SUNYH - Upstate Medical University President Dr David R] Smith ... [said]  he ruled with an iron first and did not tolerate opposing views. 'It became clear once he knew who dissenters were, things would happen,' said Dr. James Holsapple, a former Upstate neurosurgeon who now practices and teaches in Boston, Mass.'Dissidents would not be tolerated.' Holsapple cited the case of Dr. William Stewart, a <a href="http://www.syracuse.com/news/index.ssf/2011/04/upstate_fires_whistleblower_do.html">neurosurgeon fired by Upstate </a>in 2011. Stewart contends he was fired because he filed a complaint with the state Health Department, alleging misconduct by two other Upstate doctors. That complaint led to an investigation by the state which issued a report critical of Upstate. Upstate contends Stewart was let go because he refused to cooperate with an investigation into a breach of confidential information, including patient records. Holsapple calls the incident a ' ... clear example of Smith taking out a critic.' In a pending lawsuit in federal court, Holsapple has accused Upstate of retaliating against him for speaking out against what he calls dangerous medical practices and other unethical activities at the Syracuse teaching hospital. Upstate has denied his accusations and called them 'baseless.'</blockquote> In fact, Mr Mulder's <a href="http://www.syracuse.com/news/index.ssf/2011/04/upstate_fires_whistleblower_do.html">article</a> from April, 2011 about Dr Stewart's case noted that Dr Stewart <blockquote class="tr_bq">said his complaint ' ... made me an enemy of the regime.'</blockquote> Although Upstate accused Dr Stewart, <blockquote class="tr_bq"> ... because he refused Upstate’s request that he cooperate in an investigation into an intentional breach of confidential information, including private patient care records.</blockquote> Dr Stewart contended that he knew how to handle confidential information, <blockquote class="tr_bq">Stewart served 20 years as a member of the state Board for Professional Medical Conduct, which takes disciplinary action — including license revocation and suspension — against doctors. He chaired that board for three years in the late 1980s. Stewart said he never disclosed any private patient information. 'I took the Hippocratic oath when I graduated from medical school,' he said. Stewart said physicians are required by state law to report suspected cases of medical misconduct. Failure to do so is considered misconduct under the law. Stewart said that’s why he filed a complaint with the Health Department, alleging that a resident neurosurgeon training at Upstate was allowed to perform complex spine surgery without proper supervision because the neurosurgeon who was supposed to be doing the operation was in another operating room with a different patient.</blockquote> Furthermore, Dr Stewart alleged that Upstate sought to intimidate him, <blockquote class="tr_bq">Stewart said two private investigators hired by Upstate visited his office in December, but he refused to talk to them.</blockquote> Claims that the University Fired Physician Whistle-blowers - the Case of Dr Holsapple The case that caused Dr Holsapple to file a lawsuit against Upstate had some interesting similarities, but also some uniquely colorful aspects, as documented in an <a href="http://www.syracuse.com/news/index.ssf/2011/02/doctors_lawsuit_says_upstate_f.html">article</a> from February, 2011, by Mr Mulder.  Dr Holsapple also alleged a major quality of care problem at Upstate, <blockquote class="tr_bq"> The suit charges Holsapple’s problems began in 2007 when he objected to a plan to have a single neurosurgeon supervise two spine surgeries in separate operating rooms at the same time. Holsapple thought the plan was risky for patients. At the time death rates following spine surgery at Upstate were five times higher than normal, the suit said. The suit contends Dr. Ross Moquin, a neurosurgeon no longer at Upstate, was overseeing the two surgeries, according to the suit. While Moquin was with one patient, Dr. Walter Hall, then chair of the department of neurosurgery, and a resident doctor in training, began surgery on the second patient, the suit says. Neither Hall nor the resident were qualified to finish the operation, but Hall told the resident to complete the surgery because Moquin was busy with the other patient, according to the suit. Holsapple’s suit contends the patient suffered complications. It also accused the hospital of creating fraudulent documentation about the operation and billing fraud. </blockquote> Some of these charges appear to have been independently corroborated, at least, <blockquote class="tr_bq">That same two-room spine surgery case was cited in a recent state Health Department <a href="http://www.health.state.ny.us/"></a>investigation. In a 68-page report issued in August, the Health Department said Upstate did not provide surgical services in a way 'that assures protection of the health, safety and rights of patients ... .'</blockquote> Nonetheless, Dr Holsapple argued that the hospital punished him for his whistleblowing, <blockquote class="tr_bq">The suit says Hall stripped Holsapple of his job as residency coordinator in 2007 without any explanation, cutting his annual pay by $82,500. Hall also removed Holsapple as the department’s quality officer, according to the suit.</blockquote> Dr Holsapple also contended that the hospital attempted to harass him after he left, and did so, as Dr Stewart also argued, using private investigators, <blockquote class="tr_bq">Holsapple contends Upstate continued the retaliation after he left. He said Upstate sent two investigators to his home in South Boston in November to intimidate and harass him and his wife.</blockquote> The lawsuit suggested that Dr Holsapple was qualified to complain about quality issues, <blockquote class="tr_bq">Upstate hired Holsapple as an assistant professor of neurosurgery in 1994 after he completed his residency training there. In his suit he says he served as the quality improvement officer for the neurosurgery department, on the SUNY faculty senate and on the hospital’s medical executive committee alongside top Upstate executives, department chairs and other officials.</blockquote> It also suggested that perhaps Dr Hall, the chairman of neurosurgery whose conduct figured in Dr Holsapple's complaint, was not so qualified to sit in judgment of Dr Holsapple, <blockquote class="tr_bq">The following year nursing staff discovered images of Nazi artifacts within the computerized medical records of Hall’s patients, the suit says. Holsapple said in an interview the images were photographs of tank medals and other Nazi paraphernalia displaying the swastika. The suit says a hospital investigation confirmed the Nazi images belonged to Hall and he was forced to resign as chair of the neurosurgery department. Holsapple said in an interview Hall told hospital officials he bought and sold the Nazi memorabilia and stored the images on his computer. 'Some of the Jewish faculty were disturbed these icons were finding their way into the computer system,' Holsapple said.</blockquote> A Cheating Scandal and Probation by an Accrediting Agency Mr Mulder' November 10, 2013, summary article also reported, <blockquote class="tr_bq">The medical school was embroiled in a cheating scandal in 2011. An Upstate investigation found more than 100 fourth-year medical students cheated on quizzes in a medical literature course. Last year the medical school was placed on probation by the Liaison Committee on Medical Education, an accrediting group. That group criticized the school for having an erratic learning environment. It also said the medical school's curriculum was out of sync, student complaints were being ignored and the dean was ineffective. Upstate fixed the problems and was taken off probation earlier this year.</blockquote> Mr Mulder's article jogged by hazy memory into the recollection that I had seen several other examples of problems at SUNY - Upstate, but since the articles that illustrated them seemed to appear in isolation, I had just dumped them into the pile of  documents to be filed. A hurried search then revealed articles on the two whistle-blowers, and the cheating and probation issues above, and... A Costly Merger? I found a <a href="http://www.syracuse.com/news/index.ssf/2011/02/will_proposed_merge_between_up.html">story</a> from February 21, 2011, also authored by Mr Mulder, that suggested a merger proposed for Upstate University Hospital would lead to a big increase in health care prices, <blockquote class="tr_bq"> The cost to replace a hip, treat a heart attack and provide many other routine hospital services covered by Medicare is about 46 percent higher at Upstate University Hospital than at Community General Hospital. Some experts fear a proposal to merge Upstate and Community into one hospital with one payment rate will raise Community’s prices to Upstate’s level and increase overall health care costs in Central New York. </blockquote> So, <blockquote class="tr_bq">MVP Healthcare, a health insurer, is worried about potential price increases at Community. 'We need to know if the charges for services provided by Community General Hospital would increase as a result of the merger,' said Gary Hughes, a spokesman for the insurer. 'If the rates increase, we would be concerned how the merger would affect health care costs in the region, how that would affect the business community and individuals.' At a recent public forum on the proposed acquisition, Dr. Douglas Tucker, of MVP, said blending Upstate’s high rates with Community’s could be 'catastrophic,' especially for patients with high-deductible plans who have to pay big upfront costs before their insurance coverage kicks in. SEIU Local 1199, the union representing Community General workers, shares that concern. The union wants Community General to remain as a lower cost, private sector community hospital. The union also wants to remain at Community to preserve its members pensions and benefits. It does not want to see Community workers become state employees, who are represented by different unions.</blockquote> Note that although the merger did occur in 2011, I could not find any documentation about its effects on costs since. Summary In the last two years, SUNY - Upstate Medical University has been accused of seeking a merger mainly to drive up its prices, and of independently driving out and attempting to intimidate two separate physicians for blowing the whistle about health care quality concerns.  The department chairman whose work was criticized by one of the physicians, and who subsequently drove him to leave was himself forced out of his leadership position over allegations of Nazi photographs found within his computerized patient files.  University students were involved in a big cheating scandal, and the university was placed on probation by its accrediting agency.  These stories generated lots of concerned and sarcastic comments online.  However, I could find nothing to suggest that they lead to any official investigations by SUNY leadership, state government, accrediting agencies (other than as listed above), Medicare, medical societies, etc  I could find nothing to suggest that any actions were taken by students or faculty at the school, or by independent watchdogs or other members of civil society.  Yet in retrospect the sequence of events suggested major problems with the leadership of SUNY - Upstate Medical University.  The existence of these problems seems to have been confirmed by the revelations that the university president was accepting hundreds of thousands of dollars of outside income which he failed to properly disclose to the university, and which could have constituted major conflicts of interest.  The seriousness of the leadership problems was just underscored by the recent decision of the state Comptroller to audit the institution's contracts (look <a href="http://www.sfgate.com/news/article/NY-to-audit-hospital-where-president-is-quitting-4968340.php">here</a> for AP story), and the sudden resignation of the university senior vice president for administration and finance who apparently was receiving pay, admittedly which he had disclosed, from the same organizations who were paying the president (see story by Mr Mulder <a href="http://www.syracuse.com/news/index.ssf/2013/11/another_top_upstate_medical_administrator_steps_down_amid_pay_investigation.html">here</a>.)  One obvious conclusion is that bad leadership leads to lots of bad consequences. Another is that here in these United States we lack any effective watchdogs who can spot major leadership problems at important health care organizations before they lead to bad outcomes.    In particular, our the leadership of our academic medical organizations do not seem to get any organized scrutiny from student, faculty or alumni groups, from government agencies, from accrediting organizations, from medical societies, or from community based civil society organizations  or health care watchdog groups.  Hoping that overworked local reporters or volunteer bloggers will not only be able to spot evidence of trouble in a timely way, and then make it visible enough to generate action is whistling past the cemetery.  <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3FJQhVA_VvgKlI6r4vWn-rEAr0R_KgWXO4Z1Wcnfc7m0e1Su8SeV2CghNSraFdQ0mtzwkO4f95rm8aKkzQkQwr_SQMPTK6IVqxAcjR-6Wid-vW-3G3RK2MErMyrVNE5hfTQFGFif3NpFO/s1600/Ahnold.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3FJQhVA_VvgKlI6r4vWn-rEAr0R_KgWXO4Z1Wcnfc7m0e1Su8SeV2CghNSraFdQ0mtzwkO4f95rm8aKkzQkQwr_SQMPTK6IVqxAcjR-6Wid-vW-3G3RK2MErMyrVNE5hfTQFGFif3NpFO/s1600/Ahnold.jpg" /></a></div>    IMHO, concerned citizens, hopefully including those in and in training for the health professions, need to set up organized civil society watchdog groups to hold health care leadership accountable, and to push for involvement by government, accrediting organizations, medical societies, etc.

No Dogs to Bark - Failure to Connect the Events Foreshadowing the Fall of the Upstate President

In Silver Blaze , Sherlock Holmes noted the important clue of the watchdog that did not bark. In health care, nowadays watchdogs are absent...

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"We’ve resolved 6,036 issues and have 3,517 open issues": Extolling EPIC EHR Virtues at University of Arizona Health System

The public may believe that, in healthcare, only the Obamacare insurance exchange website has lots of bugs.  On those, see my Oct. 10. 2013 post "Drudge Report, Oct. 10, 2013, 9 AM EST: All that needs to be said about government, computing and healthcare" at <a href="http://hcrenewal.blogspot.com/2013/10/drudge-report-oct-10-2013-9-am-est-all.html">http://hcrenewal.blogspot.com/2013/10/drudge-report-oct-10-2013-9-am-est-all.html</a>. Another pillar of the Affordable Care Act, electronic medical records (promoted with incentives for adopters and with penalties for non-adopters via the HITECH section of the 2009 economic recovery act or ARRA) are pretty damn bad themselves.  Only, those systems don't make it hard to find insurance.  Through bugs and other features of bad health IT, they directly interfere with safety and provision of quality care: <blockquote class="tr_bq">Bad Health IT ("BHIT") is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  </blockquote> At my Oct. 20, 2010 post "Medical center has more than 6000 'issues' with Cerner CPOE system in four months - has patient harm resulted?" (<a href="http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html">http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html</a>) I observed: <blockquote class="tr_bq">From the October 2010 "News for Physicians affiliated with Munson Medical Center" newsletter, a large medical center in Northern Michigan, about more than six thousand "issues" with their Cerner CPOE. ... One wonders how many of those 6,000, and how many of the 600 remaining "issues" <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">fall into categories of</a> "likely to cause patient harm in short term if uncorrected" or "may cause in patient harm in medium or long term." I note that Cerner CPOE is not a new product, nor are similar products from other vendors also afflicted with long lists of "issues." That there could be more than 6,000 "issues" at a new site suggests deep rooted, severe problems with CPOE specifically and health IT design and implementation processes in general. </blockquote> Here's another such multi-"issue"-laden EHR, this at University of Arizona Health Network.  Image of frequent periodic "EHR Update" below. <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhgZkzPXU8Sfpv_3NWc4TPK2B79BvEEnxLU1_Y6OAXuVdcPoJYfHmde-XQXkeW7gO1iLUDVxRtzTpO7be0qDVU4nCD88O45plTy_9168SBdVJ2EiVBb9yChYToK_5OQJfDRSOyh6NF-HqUv/s1600/U_Az2.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhgZkzPXU8Sfpv_3NWc4TPK2B79BvEEnxLU1_Y6OAXuVdcPoJYfHmde-XQXkeW7gO1iLUDVxRtzTpO7be0qDVU4nCD88O45plTy_9168SBdVJ2EiVBb9yChYToK_5OQJfDRSOyh6NF-HqUv/s1600/U_Az2.jpg" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">"We’ve resolved 6,036 issues and have 3,517 open issues."</td></tr></tbody></table><div class="separator" style="clear: both; text-align: center;"></div> [Ignore the 'kewl dark sunglasses' worn by the hipsters at the top of this announcement.  Not sure if this has something to do with EPIC, but I consider the wearing of dark sunglasses by clinicians or any other staff in a hospital setting - where people are sick and/or dying - to be in exceptionally bad taste.] The text starts: <blockquote class="tr_bq">ISSUES UPDATE as of 4:00 p.m., Nov. 8 We’ve resolved 6,036 issues and have 3,517 open issues.</blockquote> That's a total of nearly ten thousand "issues."  As of now, that is.  "Issue" is a euphemism for "glitch" a.k.a. "software defect" and/or "implementation error", see <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>. These "issues" are  in a supposedly "mature" product for which this organization has spent enormous sums of money, that has undergone "innovation" for several decades now - in an environment free from regulation, I might add. Many of the "issues" reduce patient safety, and could or already may have resulted in patient harm.  Such items on this listing, seen below, which is updated frequently, include: <ul></ul><blockquote class="tr_bq"><ul><li>Pharmacy Medication Mapping Errors – Making good progress: watch for further notices.  [Perhaps these should have been tested and fixed before go-live? - ed.]</li></ul><ul><li>Microbiology Results Mapping Incorrectly [does that mean "mapping" to the wrong patient? - ed.]  – all known errors fixed, monitoring and working on enhancements. [As above, perhaps these should have been tested and fixed before go-live? - ed.]</li></ul><ul><li>Prescription printing - output for prescription printing has been fixed</li></ul><ul><li>Refill requests for providers will be routed to the CLIN SUPPORT In Basket pool for the provider’s department.  This was a decision made by UAHN leadership. [Not sure why this is being done; perhaps for approval by managers? - ed.]  </li></ul><ul><li>Errors transmitting prescriptions will also be sent to the CLIN SUPPORT In Basket.  [Errors transmitting prescriptions? That's not reassuring regarding data integrity.  See ECRI report below  - ed.]</li></ul></blockquote><ul></ul> This is not to mention that all of the "reminders" that follow are a distraction to clinical personnel, who cannot be expected to remember all of them. Bad as this is, at my April 1, 2012 post "University of Arizona Medical Center, $10 million in the red in operations, to spend $100M on new EHR system" (<a href="http://hcrenewal.blogspot.com/2012/04/university-of-arizona-medical-center-10.html">http://hcrenewal.blogspot.com/2012/04/university-of-arizona-medical-center-10.html</a>) I observed that: <blockquote class="tr_bq">... $100 million+ is probably enough to pay for AN ENTIRE NEW HOSPITAL or hospital wing ... or a lot of human medical records professionals. </blockquote> To add more bitter icing to this cake, I wrote about a campaign for clinicians to speak only in wonderful terms about the new U. Arizona Health System EHR at my Oct. 3, 2013 post "Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As 'Advised' At The University Of Arizona Health Network."  I observed the following about the "words that work" is the shameless 'suggested' script: <blockquote class="tr_bq">• Efficient - see aforementioned links as well as "Common Examples of Healthcare IT Difficulties" at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a> • Convenient - as above.  According to whom?  Compared to what?  Pen and paper? • Improves patient safety and quality - see IOM report post at <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a> .  We as a nation are only now studying safety of this technology, and the results are not looking entirely convincing, e.g. ECRI Deep Dive Study of health IT safety at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>.  171 health IT mishaps in 36 hospitals, voluntarily reported over 9 weeks, with 8 reported injuries and 3 reported possible deaths is not what I would call something that "improves patient safety and quality" without qualifications. • The Cadillac of its kind - according to whom? • Patients at hospitals using this system love it -  Do most patients even know what it, or any EHR, looks like?  Have they provided informed consent to its use? • Exciting - clinician surveys such as by physicians at <a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html</a> and by nurses at <a href="http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html">http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html</a> shed doubt on that assertion. • The best thing for our patients - again, according to whom? • Sophisticated new system - "New"?  Not so much, just new for U. Arizona Health.  "Sophisticated", as if that's a virtue?  Too much "sophistication" is in part what causes clinician stress and burnout, raising risk</blockquote> Considering the near 10,000 issues, the new ECRI Institute report "Top Ten Technology Hazards in Healthcare", 2014 edition comes to mind (<a href="https://www.ecri.org/Press/Pages/2014_Top_Ten_Hazards.aspx">https://www.ecri.org/Press/Pages/2014_Top_Ten_Hazards.aspx</a>).  Named in that report, as has been the case for the past several years, is healthcare IT.  This year's problem description is: <blockquote class="tr_bq">#4. Data Integrity Failures in EHRs and other Health IT Systems</blockquote> "Data integrity failures" include "issues" (per the bad health IT description) such as: data loss, data corruption, data attributed to the wrong patient, etc. <blockquote class="tr_bq"> ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research to healthcare to discover which medical procedures, devices, drugs, and processes are best to enable improved patient care. As pioneers in this science for 45 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. Strict conflict-of-interest guidelines ensure objectivity. ECRI Institute is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO is listed as a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services. For more information, visit <a href="http://www.ecri.org/">www.ecri.org</a>.</blockquote> ECRI also produced the 2012 Deep Dive Study of Health IT Risk (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>), where in a volunteer study at 36 member PSO hospitals, 171 health IT "mishaps" were reported in just 9 weeks, 8 of which caused patient injury and 3 of which may have contribute to patient death. In summary, The University of Arizona Health System, with components in the red, is spending hundreds of millions of dollars on an EHR system, that has had decades to mature. Yet, they are finding 10,000 "issues" already, a number of which reduce patient safety and are unresolved, with many more likely to be found. They are also 'advising' their staff to speak in glowing, unsubstantiated terms to patients about an EHR system that has 10,000 issues, and not seeking patient consent to its use in mediating and regulating their care - or giving elective patients the information that might allow them to choose another less "buggy" hospital. If (when) patient harm results from such cavalier hospital (mis)management, the juries are going to just love the dark sunglasses, I bet. -- SS

"We’ve resolved 6,036 issues and have 3,517 open issues": Extolling EPIC EHR Virtues at University of Arizona Health System

The public may believe that, in healthcare, only the Obamacare insurance exchange website has lots of bugs. On those, see my Oct. 10. 2013...

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"Engaging Excellence" while Engaging Secret Paychecks - The Rise and Fall of the Upstate Medical University President

Yet another leader of a big health care organization seems to have acquired the excessively entitled CEO syndrome. Another Brilliant, Fearless Leader When Dr David R Smith was appointed President of Upstate Medical University, a part of the State University of New York (SUNY) system located in Syracuse, he got the usual rave reviews from the school's board of trustees, <a href="http://www.suny.edu/sunyNews/News.cfm?filname=2006-06-27BOTApprovesSmith.htm">according to a university press release</a>: <blockquote class="tr_bq">'David Smith rose to national prominence through his leadership ability, experience in children’s medicine, public health policy, and as the chancellor of the Texas Tech University system. We are very pleased to have a one of the country’s foremost educators and health-care professionals lead Upstate Medical University,' said Board Chairman Thomas F. Egan. 'The State University of New York continues to enjoy an excellent record of success in attracting top academic and administrative talent from all over the country.' 'My colleagues and I are very impressed by Dr. Smith’s tremendous record of success and pleased that the Upstate Medical University search committee and University Council have brought Dr. Smith to New York. I am confident that Dr. Smith will excel as the next president of Upstate Medical Center,' said Ryan.</blockquote> By 2012, Dr Smith's <a href="http://www.upstate.edu/president/biography.php">official presidential biography on the university web-site</a> trumpeted, <blockquote class="tr_bq">Since coming to Central New York, Dr. Smith has reenergized the Upstate campus in a time of dwindling State resources with an aggressive program of patient revenue and research growth. The Upstate campus has emerged as one of the true economic engines of the region. There are now over 9,200 State, research and contract jobs on campus and an all-funds budget that exceeds $1.3 billion. Dr. Smith has built upon a vigorous expansion and renewal of campus facilities with 'The Upstate Initiative' which is achieving $600 million worth of bricks-and-mortar projects. Included in that is a long-awaited repurposing of several neglected properties within the City of Syracuse. At the start of his presidency, Dr. Smith launched the Engaging Excellence campaign as his invitation to the entire SUNY Upstate community to achieve and recognize work of the highest standard. The centerpiece of Engaging Excellence was the development of a 10-year strategic plan for purposeful campus growth. </blockquote>They must have used a thesaurus to generate all those superlatives. As we have mentioned in discussions of the <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">outsize compensation</a> now routinely given to the leaders of big health care organizations, the boards of trustees or directors that govern such institutions almost always seem to think their presidents and CEOs are brilliant, or at least, like the children of Lake Woebegone, above average (look <a href="http://hcrenewal.blogspot.com/2013/08/the-long-con-charitable-hospitals-make.html">here</a> for recent example).  Such leaders usually command <a href="http://hcrenewal.blogspot.com/search/label/public%20relations">public relations</a> teams whose job is to continually reinforce impressions of their brilliance.  Of course, anyone who starts an "excellence" campaign has to be excellent, doesn't he? Yet not every leader can be above average, much less excellent or brilliant.  In fact, the need for such leaders to have public relations apparati constantly touting their excellence suggests the opposite.   Secret Paychecks In any case, Dr Smith thus seemed to be collecting all the usual accolades acquired by top health care leaders, and appeared poised to take on an even bigger position when it all came to a crashing halt. As <a href="http://www.timesunion.com/local/article/SUNY-president-got-349-295-on-side-4958828.php">reported</a> first by the Albany (NY) Times-Union, <blockquote class="tr_bq">The president of the State University of New York's upstate medical campus ruined his chance to become the 18th president of Pennsylvania State University and has been placed on leave after SUNY leaders learned he has been padding his state pay without authorization, two state officials familiar with the matter said. SUNY headquarters is reviewing all sources of compensation for SUNY Upstate Medical University President David R. Smith and is threatening more severe measures, according to a letter obtained by the Times Union on Tuesday. Smith, who is based in Syracuse, was put on paid leave Tuesday. Penn State trustees were close to announcing that Smith would be the next president at the home of the Nittany Lions, according to the people familiar with the search. Instead, the public announcement planned for last Friday was canceled after questions about Smith's compensation in New York arose. A search firm working for Penn State, which also works for SUNY, found out about extra pay Smith arranged through outside companies linked to his school, the people familiar with the situation said. The search firm contacted SUNY officials about Smith's additional income. Several members of his executive team at Upstate Medical — the biggest employer in the Syracuse region — may also have been receiving unapproved extra pay from the outside companies, according to the sources. Smith, a pediatrician, became president of Upstate Medical in 2006 after five years as chancellor of Texas Tech University. SUNY pays Smith $625,000, including $315,000 in salary plus a $60,000 housing stipend approved by the SUNY trustees, plus $250,000 from the SUNY Research Foundation. Smith is a member of the Research Foundation's board of directors. </blockquote> However, in addition to that <blockquote class="tr_bq">Smith's outside money has been coming from two companies during recent years that are linked to SUNY Upstate: Medbest Medical Management Inc. and Pediatrics Service Group LLP. Officials with the companies did not respond to emails and calls on Tuesday. Smith's unapproved arrangements added substantially to his pay, according to a Nov. 1 letter to Smith from SUNY Chancellor Nancy Zimpher. In the letter, she alerts Smith to a recent review of his income and says he accepted $349,295 from the outside sources without Zimpher's approval.</blockquote> I could not find a web-page for the Pediatric Services Group LLC. Medbest did not list Dr Smith as a member of its <a href="http://medbest.org/pages/page.cfm?pageid=3">administrative team</a>. A Conflict of Interest? As <a href="http://www.syracuse.com/news/index.ssf/2013/11/union_upstate_medical_pay_investigation_shows_institution_needs_to_be_more_trans.html">reported</a> by the Syracuse Post-Standard, it does not appear that the interests of Upstate are precisely aligned with those of at least one of the companies that was paying Dr Smith on the side, Medbest. <blockquote class="tr_bq">Susan Kent, president of the New York State Public Employees Federation, which represents 1,430 workers at Upstate, said Upstate has been hiring non-union nurses employed by MedBest to fill jobs traditionally filled by union nurses. 'It's being done in a very sneaky backdoor fashion,' Kent said. 'We see it as their (Upstate's) way of trying to drive down wages and not use public sector workers.' MedBest, headquartered at 251 Salina Meadows Parkway in Liverpool, provides billing and other practice management services for doctors affiliated with Upstate. It also provides staffing. On its website, the company says it employs more than 500 people. </blockquote> Also, <blockquote class="tr_bq">Bobbi Stafford, a registered nurse and PEF representative at Upstate, said Upstate has been filling positions formerly held by union nurses with MedBest nurses in outpatient clinics to save money on retirement costs and other benefits. 'It's just a matter of time before they (MedBest employees) weasel their way into the hospital,' she said. Kent said using MedBest may not be a savings to Upstate if the intent of the arrangement is to increase the pay of Upstate administrators. </blockquote> The implication is that while outsourcing nursing services may cut how much the university pays nurses, the financial gain may be used as a rationale to increase payments to administrators, and not, for example, to decrease costs to patients.. Thus the revelations about the Upstate Medical University President's sources of income raise not only questions about his honesty, since he did not see fit to reveal these payments until the search firm found them, and about whether they are conflicts of interest. Ending the "Distraction" Supposedly to end the "distraction" causes by pondering such questions, Dr Smith just announced he will resign his executive position, <a href="http://blog.timesunion.com/capitol/archives/199003/suny-upstate-president-resigns-amid-compensation-review/">according to</a> the Albany Times-Union, <blockquote class="tr_bq">To avoid further distraction for the University from its important mission, I intend to submit my resignation as president of SUNY Upstate Medical Center, so that this great institution can move on to even greater success. </blockquote> Summary This case provides another reason to be very skeptical of the hype now that constantly emerges from health care organizations' public relations and communications departments about their managements', particularly their top managements' brilliance. Consider waiting for real results before believing in the next Excellent program to Excellently Promote Excellence.   Furthermore, I wonder if Dr Smith had come to believe all the hype about him.  Top leaders of big organizations often seem to exist in a bubble created by people who keep telling them what they want to hear, and protect them from anything that might discomfit them.  Many of the bubble keepers are dependent on the leaders for their own exalted administrative pay.  Other bubble keepers who are members of governing boards supposedly entrusted with stewardship of the organization may want to bask in the reflected glory of a brilliant leader renowned for encouraging "excellence," and also certainly to do not want to be seen as supporting an average or mediocre leader. In this bubble, it must be very hard not to take on a sense of entitlement.  I can only speculate that such a sense of entitlement may lead to feeling entitled to receive enough money from whatever the source to get close to the magic $1 million a year figure that CEOs now seem to regard as the minimum acceptable. How many more examples do we need of the currently "toxic" culture that surround the leadership of health care organizations  (to borrow a term from Prof Alan Sager, look <a href="http://www.golocalprov.com/news/rhode-island-non-profit-hospital-ceos-criticized-for-big-paychecks/">here</a>) to motivate action to change this culture, and how such organizations are lead.  Breaking up market dominant organizations, and thus dispersing the power of their leadership, and finding ways to make leaders accountable for putting patients' and the public's health first would be true health care reform.  Hat tip to <a href="http://www.margaretsoltan.com/?p=41906">University Diaries</a>.

"Engaging Excellence" while Engaging Secret Paychecks - The Rise and Fall of the Upstate Medical University President

Yet another leader of a big health care organization seems to have acquired the excessively entitled CEO syndrome. Another Brilliant, Fearle...

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A New, and Huge ($2.2 Billion) Settlement for Johnson and Johnson, but "No Individuals were Charged with Wrongdoing"

The march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements </a>made by big health care organizations has resumed with a bang.  As reported in most major media outlets, giant drug/ device/ biotechnology company Johnson and Johnson has made a big settlement with the US Department of Justice. The Basics of the Settlement As <a href="http://www.businessweek.com/news/2013-11-04/j-and-j-settlement-over-risperdal-said-to-be-announced-later-today">reported</a> by Bloomberg / Businessweek, <blockquote class="tr_bq"><div class="">Johnson & Johnson agreed to resolve criminal and civil probes into the marketing of Risperdal, an antipsychotic drug, and other medicines by paying more than $2.2 billion, one of the largest U.S. health-fraud penalties. </div><div class=""> </div>J&J’s Janssen unit will plead guilty to a misdemeanor criminal charge over misbranding Risperdal for uses not approved by the Food and Drug Administration, including treating elderly patients with dementia. Under a plea agreement announced today, Janssen will pay a $334 million fine and forfeit $66 million. Janssen also settled civil claims that it marketed Risperdal without approval for the elderly, children and the mentally disabled, and that it paid kickbacks to physicians and to Omnicare Inc., the largest pharmacy for nursing homes. The civil accord covered off-label marketing of Risperdal; Invega, another antipsychotic; and Natrecor, a heart drug.</blockquote> This settlement covered conduct that health care professionals ought to find particularly disturbing, including marketing Risperdal for elderly people with dementia without an approved indication, despite evidence that it could be particularly harmful to those patients; marketing Risperdal to adolescent boys without an indication, again despite evidence that it could be particularly harmful to those patients; and using kickbacks to market Risperdal. Promoting Risperdal for Dementia Despite Increased Risk of Death This issue was best <a href="http://online.wsj.com/news/articles/SB10001424052702303936904579177630737380104">summarized</a> by the Wall Street Journal, <blockquote class="tr_bq">Prosecutors alleged that J&J's Janssen Pharmaceuticals unit promoted Risperdal to elderly patients suffering from dementia, despite no approval for that use. Prosecutors also alleged that J&J's 'ElderCare' sales force pushed Risperdal for use in these elderly patients, and sales representatives' bonus awards failed to distinguish prescriptions for schizophrenia or the unapproved dementia use. In 2005, the FDA required the label warn that elderly patients suffering from dementia-related psychosis were at a higher risk of death.</blockquote> The New York Times <a href="http://www.nytimes.com/2013/11/05/business/johnson-johnson-to-settle-risperdal-improper-marketing-case.html">added</a>, <blockquote class="tr_bq"><div itemprop="articleBody"> Johnson & Johnson officials tried to expand the market for Risperdal to older dementia patients soon after the drug was approved in 1993 to treat symptoms of psychiatric disorders, <a href="http://www.justice.gov/opa/documents/jj/janssen-info.pdf" title="The Justice Department filing (PDF). ">according to federal court filings</a>. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">The drug, whose generic name is risperidone, was primarily tested in schizophrenia patients, and the Federal Drug Administration repeatedly rejected efforts by the company to expand the drug’s use to older dementia patients, according to the filings. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">But Johnson & Johnson, federal officials said, actively pursued the market for geriatric patients. The company created a dedicated sales force, ElderCare, to promote the drug and others to doctors who primarily treated older patients. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">The drug, the company claimed, could address symptoms that made treating these patients a challenge, especially in a nursing home setting, including agitation, confusion, hostility and impulsiveness. The company’s sales brochures highlighted these symptoms and minimized the fact that the drug was approved to treat schizophrenia, according to federal documents.</div><div itemprop="articleBody"> </div><div itemprop="articleBody"> Federal officials said the company knew that Risperdal posed serious health risks for older adults, like an increased risk of strokes, but it played them down. The drug’s label was later updated to warn against the use of the drug in older patients with dementia.</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">So the allegations were that the company pursued an elaborate and deceptive strategy to promote the drug for elderly dementia patients despite knowledge that the drug was particularly risky for such patients. </div> Promoting Risperdal for Adolescent Boys Despite Increased Risk of Gynecomastia Again, per the WSJ, <blockquote class="tr_bq">Prosecutors also alleged that J&J promoted Risperdal for use by boys suffering from mental disabilities despite knowing that use could raise levels of a hormone stimulating breast development.</blockquote> The NYT added, <blockquote class="tr_bq"><div itemprop="articleBody">Federal prosecutors also say, as part of the civil settlement, that Johnson & Johnson promoted the use of Risperdal in people with mental disabilities and children, even though the company did not receive F.D.A. approval to market to children until 2006. Janssen told its sales representatives to visit child psychologists and mental health facilities that mainly focused on children, promoting the drug as a safe treatment for disorders like attention deficit hyperactivity disorder and obsessive-compulsive disorder, the government said. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Johnson & Johnson knew that children were susceptible to certain health risks from taking Risperdal, including the possibility that boys could develop breasts through elevated production of the hormone prolactin, federal officials said. </div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Again, the allegations were that the company pursued an elaborate deceptive strategy to market the drug for children despite knowledge that the drug was particularly risky for such patients.  </div><div itemprop="articleBody"> </div><div itemprop="articleBody">No Executives were Discomfited by the Disposition of This Case</div><div itemprop="articleBody"> </div><div itemprop="articleBody">The company took pains to emphasize that the settlement only required a single guilty plea to a misdemeanor by a company subsidiary, and did not involve any other admissions of guilt, or any penalties to specific human beings.  For example, per Bloomberg/ Business Week,</div><div itemprop="articleBody"> </div><blockquote class="tr_bq">'Today we reached closure on complex legal matters spanning almost a decade,' Michael Ullmann, J&J’s general counsel, said in a statement. 'This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world.' While Janssen 'accepts accountability' for the actions described in the misdemeanor plea, the civil settlement 'is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations,' J&J said.</blockquote> So why give up a perfectly good $2.2 billion (minus $400 million fine and forfeiture by the Janssen subsidiary for the single misdemeanor)?  Was "closure" all that valuable? In addition, in the NY Times we found , <blockquote class="tr_bq">Ernie Knewitz, a spokesman for Johnson & Johnson, noted that the misdemeanor charge was being entered on behalf of the company and no individuals were charged with wrongdoing. 'Mr. Gorsky [current CEO] has been an outstanding Johnson & Johnson leader for more than 20 years,' he said. </blockquote>Would you expect someone who works for Mr Gorsky to say otherwise?  Yet it was on Mr Gorsky's watch that much of the alleged bad conduct actually happened.  <blockquote class="tr_bq">Alex Gorsky was promoted to chief executive officer of J&J in April 2012, in part because of his record of generating sales as leader of Janssen Pharmaceuticals. </blockquote> Furthermore, the Inquirer noted that Mr Gorsky was deposed in one of the many civil lawsuits filed by patients against Johnson and Johnson. <blockquote class="tr_bq">The 60-page transcript of Gorsky's deposition in one of the Philadelphia suits was part of the publicly available court record. In the transcript, McCormick walks Gorsky through discussions from 2001 with Joseph Biederman, a Harvard medical school professor and a Massachusetts General Hospital pediatric psychiatrist who gained fame - and criticism - for advocating the use of pharmaceuticals to treat children with perceived mental illness. That was before the U.S. Food and Drug Administration approved, in still-limited ways, drugs such as Risperdal for children. In a one-page letter dated Dec. 7, 2001, Biederman requested $500,000 to start what became the Johnson & Johnson Center for the Study of Pediatric Psychopathology. Gorsky said in the deposition that he approved that payment. Gorsky was asked whether he had been hoping Biederman and, by extension, Massachusetts General Hospital and Harvard, would help J&J to get wider diagnosis and treatment for child and adolescent mental disorders. 'I think our goal was to, yes, have better diagnostic criteria for children who are in need of treatment and to have better therapeutic options for children who are in need of treatment,' Gorsky said. Also in the transcript, McCormick discussed with Gorsky a document called the 'Annual Report 2002: The Johnson & Johnson Center for Pediatric Psychopathology at Massachusetts General Hospital.' Biederman was the director of the center, and one of the goals of its research, according to the report, was that 'it will move forward the commercial goals of J&J.'</blockquote> Thus this testimony seems to imply that current Johnson and Johnson CEO Gorsky was involved in making large payments to an important key opinion leader (KOL) who was supposed to use his academic gravitas to "move forward the commercial goals" of Johnson and Johnson, specifically by promoting Risperdal for children. Yet, as we discussed above, neither Mr Gorsky nor any other person at Johnson and Johnson who might have authorized, directed, or implemented the alleged conduct which was the subject of the settlement, conduct which Johnson and Johnson of course denies was misconduct, suffered any negative consequences. Mr Gorsky's total compensation as CEO in 2012 was $10,977,109 according too the <a href="http://www.investor.jnj.com/secfiling.cfm?filingID=1193125-13-104341">company's 2013 proxy statement</a>. The retiring CEO, William Weldon, on whose overall watch the alleged events occurred, received $29,838,259 that year.  We last discussed their compensation and its contrast with the company's ethical track record <a href="http://hcrenewal.blogspot.com/2013/07/johnson-and-johnson-settles-suit.html">here</a>. These payments also occurred despite all the other settlements Johnson and Johnson has had to make because of allegations about its marketing of Risperdal.  As described by Bloomberg/ Businessweek, <blockquote class="tr_bq">The settlement won’t resolve suits brought by attorneys general in Arkansas, Louisiana and South Carolina, where the company has appealed or has said it will appeal judgments over Risperdal sales. Judges or juries in those states have ordered J&J to pay a total of about $1.8 billion in damages and fines over Risperdal marketing campaigns that were found to have misled doctors and patients about the drug’s health risks and effectiveness. In 2012, a judge in Arkansas ordered the drugmaker to pay $1.2 billion in fines over Risperdal marketing. That verdict came three months after J&J decided to end a trial in Texas over the drug’s sales with a $158 million settlement. The Arkansas judge also awarded the state $180 million in attorney fees, J&J said in an August regulatory filing. The company is appealing the judgment. In June 2011, a judge in South Carolina ordered J&J to pay $327 million in penalties for deceptively marketing the medicine. Ten months earlier, jurors in Louisiana ordered the drugmaker to pay almost $258 million to state officials over J&J’s Risperdal marketing campaign in the state. A Louisiana judge later ordered the drugmaker to pay an additional $73.3 million in attorney fees and costs. </blockquote> The payments further occurred despite a previous settlement involving another drug whose marketing was at issue in the current settlement, according to Bloomberg / Businessweek, <blockquote class="tr_bq">In October 2011, J&J’s Scios unit pleaded guilty to a misdemeanor violation over Natrecor and paid an $85 million criminal fine. </blockquote> Finally, the compensation was given despite other legal actions not having to do with Risperdal, Invega or Natrecor, as we most recently summarized, - A guilty plea for misbranding Topamax in 2010 (look <a href="http://hcrenewal.blogspot.com/2010/05/sunday-settlement-and-guilty-plea.html">here</a>) - Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary (look <a href="http://hcrenewal.blogspot.com/2011/04/johnson-and-johnson-runs-afoul-of.html">here</a>)  - Accusations that the company, which makes smoking cessation products, participated along with tobacco companies in efforts to lobby state legislators (see post <a href="http://hcrenewal.blogspot.com/2011/09/smart-alecs-strange-bedfellows.html">here</a>) Summary The latest settlement in the parade is another marker of the sort of conduct that big health care organizations have exhibited to increase revenue, and to use that revenue as a rationale for making their top insiders very rich.  The particular conduct alleged here could have put patients at risk, partly by deceiving health care professionals.  Yet in their wisdom, top US law enforcement saw fit not to try to hold any individuals accountable for this conduct, and allowed the company to deny any misconduct other than a single misdemeanor by a subsidiary.  This occurred despite the company's history of multiple legal settlements and findings of guilt in various courtrooms. Yet none of these actions has resulted in any negative consequences for any individual within the company.  No one who authorized, directed, or implemented bad behavior will pay any penalty, even were the bad behavior to have lead to significant personal enrichment. As we have said ad infinitum, and <a href="http://hcrenewal.blogspot.com/2012/09/how-many-legal-settlements-does-it-take.html">on the occasion of a previous Johnson and Johnson settlement</a>, many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved. These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look <a href="http://hcrenewal.blogspot.com/2012/08/duchess-of-wellpoint-abdicates-likely.html">here</a>). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "<a href="http://www.washingtonpost.com/blogs/election-2012/wp/2012/09/04/patrick-it-is-time-for-democrats-to-grow-a-backbone/">grow a backbone</a>" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care. As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior. Addendum - Other Comments See also similar sentiments <a href="http://1boringoldman.com/index.php/2013/11/04/an-ending/">from 1BoringOldMan</a>, <blockquote class="tr_bq"> J&J closes out the escrow fund set aside for this settlement. Alex Gorsky goes to his West Point Anniversaries and Boy Scout Board meetings an ongoing success story [<a href="http://1boringoldman.com/index.php/2012/09/18/shoveling/" target="_blank">shoveling…</a>]. And what was this all about? </blockquote><div><blockquote><div align="right">This is the way the world ends</div><div align="right"> This is the way the world ends</div><div align="right"> This is the way the world ends</div><div align="right"> Not with a bang but a whimper</div></blockquote></div> and in a <a href="http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=4012">press release from Public Citizen</a>, <blockquote class="tr_bq">Until more meaningful penalties and the prospect of jail time for company heads who are responsible for such activity become common, companies will continue defrauding the government and putting patients’ lives in danger.</blockquote>

A New, and Huge ($2.2 Billion) Settlement for Johnson and Johnson, but "No Individuals were Charged with Wrongdoing"

The march of legal settlements made by big health care organizations has resumed with a bang. As reported in most major media outlets, gian...

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