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Experiments on Top of Experiments: Threats to Patients Safety of Mobile e-Health Devices - No Surprise to Me

As noted by columnist Neil Versel at MobiHealthNews.com in a Mar. 14, 2012 post "<a href="http://mobihealthnews.com/16642/beware-virtual-keyboards-in-mobile-clinical-apps/">Beware virtual keyboards in mobile clinical apps</a>": <blockquote>... Remember the <a href="http://mobihealthnews.com/14752/ipad-setback-at-seattle-childrens-is-but-a-minor-growing-pain/">problems Seattle Children’s Hospital had</a> with trying to run its Cerner EMR, built for full-size PC monitors, on iPads? The hospital tried to use the iPad as a Citrix terminal emulator, so the handful of physicians and nurses involved in the small trial had to do far too much scrolling to make the tablet practical for regular use in this manner. [From that post: As CIO magazine <a href="http://www.cio.com/article/693401/iPad_in_Healthcare_Not_So_Fast?page=1&taxonomyId=3114" style="font-style: italic; font-weight: bold;">reported</a> last week, iPads failed miserably in a test at Seattle Children’s Hospital. “Every one of the clinicians returned the iPad, saying that it wasn’t going to work for day-to-day clinical work,” CTO Wes Wright was quoted as saying. “The EMR apps are unwieldy on the iPad.” - ed.]</blockquote> Thank heaven it was a small trial, instead of a typical forced rollout to an entire clinical community. Someone seems to have grasped the experimental nature of the effort. <blockquote>Well, there may be a greater risk than just inconvenience when tablets and smartphones stand in for desktop computers. According to a <a href="http://www.advisory.com/Research/Applications-and-Technologies-Collaborative/Research-Notes/2012/Desktop-Virtualization-based-Support-for-EMRs">report from the Advisory Board Co.</a>, “[A] significant threat to patient safety is introduced when desktop virtualization is implemented to support interaction with an EMR using a device with materially less display space and significantly different support for user input than the EMR’s user interface was designed to accommodate.” The report actually is a couple months old, but it hasn’t gotten the publicity it probably deserves. We are talking about more than user inconvenience here. There are serious ramifications for patient safety, and that should command people’s attention.</blockquote> Unfortunately, far too little about health IT safety commands people's attention. It's merely assumed that either 1) health IT is inherently beneficent, or 2) the risks are deliberately ignored for - I'm sorry to note - profit and career advancement. <blockquote>How many CIOs or even end users have considered another one of the unintended consequences of running non-native software on a touch-screen device, that the virtual, on-screen keyboard can easily take up half the display? “Pop-up virtual keyboards obscure a large portion of the device’s display, blocking information the application’s designer intended to be visible during data entry,” wrote author Jim Klein, a senior research director at the Washington-based research and consulting firm.</blockquote> How many CIO's have considered unintended consequences of such experiments-on-top-of-experiments (i.e., handheld or other <a href="http://liliputing.com/">lilliputian computing devices</a> on top of the HIT experiment itself)? Probably few to none.The typical hospital CIO, usually of an MIS background and generally lacking meaningful backgrounds in research, computer science, medicine, medical informatics, social informatics, human-computer interaction, and other research domains, are usually "turnkey-shrinkwrapped software implementers." In fact, most have backgrounds woefully inadequate for any type of clinical device leadership role. They may even lack a degree of any kind, as major HIT recruiters over the past decade expressed the following philosophy ca. 2000: <blockquote>I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman. (Healthcare Informatics, "Who's Growing CIO's".) </blockquote> I wonder just how many CIO's "from the school of hard knocks" were put into action by those groups.Back to the MobiHealthNews.com article: <blockquote>... Klein said that users have two choices to deal with a display that’s much smaller than the software was designed for. The first is to zoom out to view the whole window or desktop at once, but then, obviously, users have to squint to see everything, and it becomes easy to make the wrong selection from drop-down menus and radio buttons. Or, users can zoom in on a small part of the screen. “This option largely, if not completely, eliminates the context of interaction from the user’s view, including possible computer decision-support guidance and warnings, a dangerous trade-off to be sure,” Klein wrote. In either case, the virtual keyboard makes it even more difficult to read important data that clinicians need to make informed decisions about people’s health and to execute EMR functions as designed. </blockquote> Good observations. Two points: 1. As far back as the mid 1990's in my teaching of postdoctoral fellows in my role as Yale faculty in Medical Informatics, due to the limited screen real estate I uniformly presented the following 'diagram' regarding my beliefs about handheld devices (then commonly known as PDA's) as tools for significant EHR interaction: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjVMVEfJo24MJ3wXp2mGdSG0a6b8-BqYhD_GLkpVQx3mZEIaLzoPbqJfCtuecBWCAcs69jKszwLMr2LTwmG4EQs1N4lTeajI3qz_cuQ2wWPtxTaKptcKVcDh592Jl5DrpcBJPHKf6rx8kAU/s1600/newton1.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5724577116776466994" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjVMVEfJo24MJ3wXp2mGdSG0a6b8-BqYhD_GLkpVQx3mZEIaLzoPbqJfCtuecBWCAcs69jKszwLMr2LTwmG4EQs1N4lTeajI3qz_cuQ2wWPtxTaKptcKVcDh592Jl5DrpcBJPHKf6rx8kAU/s320/newton1.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 229px; height: 280px;" /></a>Mid 1990's wisdom: small handhelds as desktop replacements at the bedside - just say "no" </div> This was before today's hi-res screens on small devices, but the limited real estate and its ramifications were obvious to critical thinkers who knew both medicine and medical informatics, even in the mid 1990's. Similarly, experiments with <a href="http://en.wikipedia.org/wiki/HP_95LX">HP95</a> handheld PC's running DOS failed miserably in a similar time frame at the hospital where I later became CMIO. (One benefit: I did get to salvage two of the devices from the trash bin for my obsolete computer collection!): <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVMRrjhASBRH5lRnhwzIxshslXFHRLzCcjmQ0SHaIBLvUmmRBW-yZf9Sq0JR40fEuhoyeP6De6UHtLhpnakM5OjO0VVy6c-IK7_Qi_LuGxGjUi2qK_PDO-_Lbwry6olvL2upAzQZtzm-MH/s1600/hp95.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5724587323294093218" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVMRrjhASBRH5lRnhwzIxshslXFHRLzCcjmQ0SHaIBLvUmmRBW-yZf9Sq0JR40fEuhoyeP6De6UHtLhpnakM5OjO0VVy6c-IK7_Qi_LuGxGjUi2qK_PDO-_Lbwry6olvL2upAzQZtzm-MH/s320/hp95.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 206px; height: 202px;" /></a>HP95LX - full DOS computer equivalent to an IBM PC (except, of course, for screen size). </div> Therefore, IMO the Advisory Report findings of 2012 merely verify what was obvious almost two decades ago. Small devices are adjuncts only, suitable for limited uses (and only after extensive RCT's with informed consent even then, in my view). 2. Another issue that arises is more fundamental. The article notes: <blockquote>“It seems clear that running even a well-designed user interface on a device significantly different than the class of devices it was intended to be run on will lead to additional medical errors,” Advisory’s Klein commented.</blockquote> The critical thinking person's question is: who knows if the "class of device" the app was "intended to run on" is itself appropriate or optimal? Commercial clinical IT (with the exception of devices that require special resolutions, pixel densities, contrast ratios etc., such as PACS imaging systems) is usually designed for commercially available hardware. That means the same size/type of computer monitor you obtain at Best Buy or Wal Mart. Is that sufficient? Is that optimal? As in my Feb. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/ehr-workstation-designed-by-amateurs.html">EHR Workstation Designed by Amateurs</a>", who really knows? <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgGjUWJ42opoFiFJ-oGcxn43ThiXoL1qi3xC_ooaqqxhXa4vOfQn1_HVv-NgDxS1vm5Eg4Okwjtj7Jb1cXbhL-KwIT7Q5p4MJ_7zj9XOIdvTLd4eareH_CtREmBTy2sCBAOwlr4XGOxBAZK/s1600/EHR_workstation.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5724589665949685282" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgGjUWJ42opoFiFJ-oGcxn43ThiXoL1qi3xC_ooaqqxhXa4vOfQn1_HVv-NgDxS1vm5Eg4Okwjtj7Jb1cXbhL-KwIT7Q5p4MJ_7zj9XOIdvTLd4eareH_CtREmBTy2sCBAOwlr4XGOxBAZK/s320/EHR_workstation.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 379px; height: 229px;" /></a><div style="text-align: center;">Click to enlarge. A workstation in an actual tertiary-care hospital ICU, 2011. How many things are wrong here besides the limited display size? See aforementioned post "<a href="http://hcrenewal.blogspot.com/2012/02/ehr-workstation-designed-by-amateurs.html">EHR Workstation Designed by Amateurs</a>". </div> These systems are not robustly cross-tested in multiple configurations, such as multiple-large screen environments vs. single screen, for example. In summary, performing an experiment with small devices on top of another experiment - the use of cybernetic intermediaries (HIT) in healthcare that is already known to pose patient risk - is exceptionally unwise. It would be best to decide what the optimal workstation configuration is, as applicable to different clinical environments, in limited RCT's with experts in HCI strongly involved, before putting patients at additional risk with lilliputian information devices that only a health IT <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html">Ddulite</a> could love. <blockquote>Ddulites: Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures. </blockquote> -- SS

Experiments on Top of Experiments: Threats to Patients Safety of Mobile e-Health Devices - No Surprise to Me

As noted by columnist Neil Versel at MobiHealthNews.com in a Mar. 14, 2012 post " Beware virtual keyboards in mobile clinical apps ...

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Pseudo-Evidence Based Medicine Should be a Global Health Concern

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

Pseudo-Evidence Based Medicine Should be a Global Health Concern

We have frequently advocated for evidence-based medicine (EBM) , that is, medicine based on judicious use of the best available evidence fr...

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An Example of How the Complex Takes Control - A Board Dominated by Hired Managers Levitates Its Hired CEO's Pay

The Indianapolis Star <a href="http://www.indystar.com/article/20120320/BUSINESS03/303180001/Big-raises-those-who-lead-area-s-large-hospital-groups">published</a> the latest story about anti-gravity health care <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a>.  The report emphasized how the largest hospital systems in the metropolitan area raised CEO pay faster than any reasonable metric: <blockquote>CEO pay is up, sharply in some cases, at Indianapolis' four large hospital groups, as the systems have grown and dumped more responsibilities on their top leaders. Total pay for those CEOs rose anywhere from 15 percent to 53 percent from 2008 to 2010. While experts say the pay is in line with executive compensation at other large hospital groups, the rate of the increases far outpaces the minimal wage gains that area health-care workers (1.7 percent) and hourly workers (3.1 percent) have seen over the same time. The rising CEO pay comes at one of the shakiest financial periods ever for hospitals, as they struggle with cuts in reimbursements for care from federal Medicare and Medicaid programs and private insurers.</blockquote> CEO Pay Up More than Revenue Pay at specific health care systems also rose faster than revenue. At the Indiana University Health System: <blockquote>At the top of the best-paid list: IU Health's President and Chief Executive Daniel F. Evans Jr., who pulled down $2.08 million in compensation in 2010, up 17 percent from 2008. Subtracting Evans' retirement payouts, which vary year to year, his base pay jumped 19 percent since 2008.</blockquote> However, <blockquote>From 2008 to 2010, IU Health has seen revenue grow 10 percent to $2.46 billion,...</blockquote> At St Vincent Hospital and Health Care <blockquote>Close behind comes Vincent Caponi, CEO of St. Vincent Hospital and Health Care Center, who took in $1.86 million in 2009-10, a two-year jump of 44 percent, or 64 percent when retirement is removed.</blockquote> However, <blockquote>Revenue over the two years rose 28 percent at St. Vincent,...</blockquote> At Franciscan Alliance, <blockquote>Robert Brody of Franciscan Alliance earned $1.27 million in 2010 (53 percent more than in 2008),...</blockquote> However, over that period revenue only rose 17%. At Community Health Network, <blockquote>Bryan A. Mills, the relatively new CEO of Community Health Network, received $1.35 million, or 15 percent more than his predecessor, William Corley, collected in 2008. (Corley retired in 2009.)</blockquote>while revenue only rose 4%. The Usual Talking Points At this point, it should come as no surprise that hospital leadership trotted out the same old talking points to account for the ever upward trajectory of CEO pay as used in other areas and to account for the pay of leaders of other kinds of health care organizations (look <a href="http://hcrenewal.blogspot.com/2011/09/more-repeats-of-talking-points.html">here</a>). These included... We Pay What Everyone Else Pays It was easy to find a professional compensation consultant to repeat this one: <blockquote>Jim Otto, senior principal in Atlanta for the Hay Group, a consultant on executive benefits, said pay to top hospital CEOs in Indianapolis appears in line with rising compensation, including retirement benefits and bonuses, being paid nationally to most large-system hospital executives.</blockquote> CEOs Work Hard and Are Brilliant So we read: <blockquote>At IU Health, formerly Clarian Health Partners, where Evans has been CEO since 2002, 'The system's grown significantly. It makes us think twice about the difficulty of running such a system. We literally cover the entire state of Indiana. And much of that has been under Dan's oversight,' said Charles Golden, an IU Health board member and chair of its compensation committee.</blockquote> Also, <blockquote>Golden says Evans 'has done a really superb job. Almost everything favorable to our system has been positive in his time.'</blockquote> Here is the version pertaining to St Vincent's <blockquote>Caponi 'is on an airplane and out of town a good bit, running a much bigger area' for Ascension, said Bill Estes, chairman of St. Vincent's board. 'That's the way we justify (higher CEO pay) and feel comfortable with that.'</blockquote> High Pay is Needed to Attract Competent, if not Brilliant People From Mr Otto, the compensation consultant: <blockquote>Large hospital groups make certain they pay similar to their peers to remain competitive. One reason for rising pay, Otto says: 'These aren't easy jobs. They are not easy to fill. The candidate pool isn't terribly large.'</blockquote> Furthermore, Mr Golden, from the IU Board, added, <blockquote>'Unless you want to default to mediocrity, I suppose you can do that (cut CEO pay),' he said. 'But I don't think that's where we are going. I don't think these (hospital) systems will get any easier to manage.'</blockquote> Talking Points Sans Justification As in previous cases, no one that reporter Jeff Swiatek could find provided any specifics to back up these talking points. It is striking that those who stewarded all the major hospital systems in this one area felt the need to raise executive pay substantially faster than the rate of rise of revenue, that is from 1.7 times to 3.75 times the rate of revenue rise. Why Are Hospital Boards So Nice to CEOs? In the interests of full disclosure, I noticed this article because reporter Jeff Swiatek chose yours truly, plus fellow blogger Dr Howard Brody (look <a href="http://brodyhooked.blogspot.com/">here</a>) to comment for it. <blockquote>'Whenever the nonprofit sector starts acting more like the for-profit sector, I start to get worried,' said Dr. Howard Brody, director of the Institute for the Medical Humanities. 'It just becomes crony capitalism. If one executive gets paid $3 million instead of $1 million, then every executive wants $3 million. It just becomes a vicious cycle of inflation of CEO benefits.'</blockquote> Also, I suggested: <blockquote>Put more noncorporate members on hospital boards because they'd be less inclined to endorse large compensation packages that are more typical of for-profit companies. 'Boards are populated by wealthy executives, who themselves are getting increasing compensation, rather than by community representatives or patient representatives,' Poses said.</blockquote>Could the Composition of the Board Explain Excess Deference to the CEO? I made the above comments after hearing approximations of the compensation given out by the hospital systems, but without any knowledge of the composition of the boards that approved that compensation. I am guessing that Dr Brody also was not told anything about board composition when he suggested the possibility of crony capitalism. However, now that the article is out, I think it makes sense to look at the composition of at least one of the boards involved. I chose IU Health, since it is the largest of the systems, paid the most to its CEO, and was kind enough to list board members' brief biographies on a <a href="http://iuhealth.org/about-iu-health/board-of-directors/">web-page</a>.  Here they are, listed with their primary affiliations, and some notable other affiliations. - Judge Sarah Evans Barker, former federal district court judge. - Dr D Craig Brater, "dean of the Indiana University School of Medicine and director of IU Medical Center." Also on  the <a href="http://www.springmillvp.com/people/advisors.html">Board of Advisors</a> of <a href="http://www.springmillvp.com/">Spring Mill Venture Partners</a>, "an early stage venture capital firm focused on investing in high-growth information technology and life sciences companies;" recipient of consulting and travel money from Pfizer (<a href="http://projects.propublica.org/docdollars/">per ProPublica</a>); and who was listed as having "a financial interest/relationship or affiliation in the form of: Consultant for AstraZeneca Pharmaceuticals; BioGen, Inc.; Forest Laboratories; Merck & Co., Inc.; Pfizer Inc.; and Pharmacia and Upjohn Company" <a href="http://www.cmecorner.com/programs_printer.asp?ProductID=178&audience=">per CMECorner</a>. - William R Cast, "CEO of NoMore Clipboard, an online, patient-controlled personal health record management system." - Thomas W Chapman, "president and CEO of The HSC Foundation in Washington, DC, the parent corporation for two subsidiaries, The HSC Pediatric Center and Health Services for Children with Special Needs. He was previously senior associate vice president for Network Development and Professor of Health Services Management and Policy at George Washington University Medical Center in Washington, DC." - Bishop Michael J Coyner, "Bishop of the Indiana Area United Methodist Church" - J Scott Davison, "chief financial officer for OneAmerica and its affiliated companies," and member of the board of directors for Indiana Bond Bank." - Daniel F Evans Jr - CEO of IU Health, also member of the board of Lakeland Financial Corp, (<a href="http://www.bloomberg.com/apps/news?pid=conewsstory&tkr=1000L:US&sid=aunsp4S2I2z0">per Bloomberg</a>) - Charles E Golden, "retired from Eli Lilly and Company in 2006 as executive vice president and CFO and a member of the board of directors. He was previously a corporate vice president of General Motors...." He is also currently on the boards of <a href="http://www.unilever.com/aboutus/companystructure/nonexecutivedirectors/">Unilever</a>, which makes health care related products, and <a href="http://ir.hill-rom.com/directors.cfm">Hill-Rom</a>, which makes medical devices and supplies. - David W Goodrich, "retired in 2005 as president and CEO of Central Indiana Corporate Partnership, Inc." - V William Hunt, "chairman of Hunt Capital Partners, LLC, a venture capital and consulting firm based in Indianapolis. Until August 2001, he was the vice chairman and president of ArvinMeritor Inc...." - Dr James E Lingeman, "long-standing member of the IU Health Methodist Hospital medical staff," but also according to a 2009 American Urologic Association Education and Research <a href="http://www.auanet.org/content/media/whitepaper.pdf">paper</a>, Consultant or Advisor to, and Meeting Participant or Lecturer for Boston Scientific Corp and Lumenis, scientific investigator for Boston Scientific and Olympus, investor in Beck Analytical Laboratories and Midstate Mobile Lithotripsy, and having "Other" financial relationships with Beck and Midstate. - Angela Barron McBride, " distinguished professor and university dean emerita at Indiana University School of Nursing" - Michael A McRobbie, "Indiana University President," also on the board of OneAmerica (look <a href="http://www.oneamerica.com/wps/wcm/connect/oa/oneamerica/home/news+center/press+releases/michael+a.+mcrobbie+elected+to+oneamerica+board+of+directors">here</a>). - Anne Nobles, "senior vice president for Enterprise Risk Management and chief ethics and compliance officer for Eli Lilly and Company." When considering the composition of this board, note that members of non-profit organizations' boards generally are said to have three duties, as <a href="http://www.boardsource.org/Knowledge.asp?ID=3.364">per BoardSource</a>: - The Duty of Care: "a board member owes the duty to exercise reasonable care when he or she makes a decision as a steward of the organization." - The Duty of Loyalty: "a board member must give undivided allegiance when making decisions affecting the organization. This means that a board member can never use information obtained as a member for personal gain, but must act in the best interests of the organization." - The Duty of Obedience: "The duty of obedience requires board members to be faithful to the organization's mission. They are not permitted to act in a way that is inconsistent with the central goals of the organization." The Duties of Care and Obedience require board members to exercise prudent and reasonable supervision over hired managers, and provide these managers reasonable pay and incentives.  However, boards dominated by hired managers may put the interests of such managers ahead of their organizations' missions.  So of the 14 members of the IU Health board, 8 are current or retired top level corporate executives or corporate board members, 4 of which have such leadership positions at financial service companies, (two at OneAmerica). In addition, 5, including 4 apparently ex-officio members, had or have top leadership positions in academic institutions. The board also included one Methodist Bishop and one federal judge. All but two board members are thus current or former top level hired managers of for-profit corporations or non-profit organizations. Thus this board is largely populated by executives who are likely to be wealthy. Thus it is similar to many other <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20directors">boards of health care corporations</a> (e.g., look <a href="http://hcrenewal.blogspot.com/2010/12/on-interconnectedness-of-leadership-of.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/12/boards-who-ought-to-be-accountable-for.html">here</a>) and <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20trustees">non-profit organizations</a>  (e.g., look <a href="http://hcrenewal.blogspot.com/2010/04/failed-leaders-of-citigroup-as-leaders.html">here</a>,  <a href="http://hcrenewal.blogspot.com/2009/10/board-of-trustees-or-social-club-for.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2009/04/hedge-fund-u.html">here</a>) which we have discussed.  It stands to reason that boards dominated by hired managers will feel comfortable with and look kindly on the hired managers whom they are supposed to supervise, and view their compensation sympathetically.  Thus such boards may not exercise the Duties of Care and Obedience. Furthermore, the Duty of Loyalty requires boards not to be affected by conflicts of interest.    However, many of the IU Health board members have financial relationships that could be considered conflicts of interest. Two have or had executive positions at the same pharmaceutical company, Eli Lilly, one of whom also was on the board of medical device and supply company. In addition, both of the doctors on the board have or had significant disclosed financial relationships with drug, device, or biotechnology firms.  Again, it is like other boards affected by such conflicts that we have discussed.  Again, such boards may not exercise the Duty of Loyalty.   Summary   Combined with other examples of the composition of boards of for-profit health care corporations, and non-profit health care organizations, the latest example suggests the complex has taken control.  Nearly every board we have scrutinized is dominated by hired managers of other companies, and salted with conflicts of interest.  It seems likely that such boards will put the interests of hired managers ahead of those of the shareholders of for-profit corporations, and ahead of the missions of non-profit organizations.    The complex that has taken control looks like a confederation of hired managers.  In 2003, five years before the fall of Lehman Brothers ushered in the global financial collapse, John C Bogle <a href="http://www.vanguard.com/bogle_site/sp20030611.html">warned</a> of the "grotesque transformation" of capitalism into an oligarchy of hired managers: <blockquote>The root causes of the disease in our system are deep, and the remedies that are required to cure it will not be easy to come by. For what we have witnessed in the failure of corporate governance in America has been, as journalist William Pfaff described it, 'a pathological mutation in capitalism.' He was right on the mark. The classic system—owners capitalism—had been based on a dedication to serving the interests of the corporation’s owners, maximizing the return on their capital investment. But a new system developed—managers capitalism—in which 'the corporation came to be run to profit its managers, in complicity if not conspiracy with accountants and the managers of other corporations.' Why did it happen? 'Because,' in Mr. Pfaff’s words, 'the markets had so diffused corporate ownership that no responsible owner exists. This is morally unacceptable, but also a corruption of capitalism itself.'</blockquote>This plague of managers' capitalism seems not to have spared health care, and to have infected the non-profit as well as public for-profit sphere. To stave off the coming dystopia, we must return the control of for-profit corporations, including health care corporations, to their owners, and stewardship of non-profit organizations to those who will put their missions ahead of self-interest.

An Example of How the Complex Takes Control - A Board Dominated by Hired Managers Levitates Its Hired CEO's Pay

The Indianapolis Star published the latest story about anti-gravity health care executive compensation . The report emphasized how the lar...

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Human Subjects Experimentation Directives Ignored in the Grand Health IT Experiment?

The following represents some very inconvenient truths that have long been ignored.Health IT is an experimental technology. The literature in 2012 remains conflicting on benefits and risks (the latter which is acknowledged, but whose magnitude is uncertain). At NIH study sections, for example, research proposals that involve health IT (even modifications to existing applications) are subjected to far more scrutiny around human subjects protections, of both patients and investigators, than the typical wide-scale hospital implementation of enterprise health IT systems. The latter are validated and approved by - nobody. How many of these directives are ignored in the Grand Health IT Experiment? I've bolded the issues that I believe are ignored. See "<a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">Reading list on health IT</a>" for more information on conflicts in the literature: --------------------------------------------- Directives for Human Experimentation <a href="http://ohsr.od.nih.gov/guidelines/nuremberg.html">NUREMBERG CODE</a> <ol><li>The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice [that is, to opt-out - ed.], without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person [information on HIT risk exists, such as on this blog - ed.] which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.</li><li>The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study [such as small scale controlled clinical trials with full informed consent and opt-out provisions- ed.], and not random and unnecessary in nature.</li><li>The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.</li><li>The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.</li><li>No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.</li><li>The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. [The magnitude of HIT risks are unknown - ed.] </li><li>Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.</li><li>The experiment should be conducted only by scientifically qualified persons. [Yet the HIT field is filled with amateurs - ed.] The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.</li><li>During the course of the experiment the human subject should be at liberty to bring the experiment to an end [go back to paper - ed.] if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.</li><li>During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage [go back to paper - ed.], if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.</li></ol> Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182.. Washington, D.C.: U.S. Government Printing Office, 1949.I'd thought these issues were settled after WW2, but apparently not.-- SS

Human Subjects Experimentation Directives Ignored in the Grand Health IT Experiment?

The following represents some very inconvenient truths that have long been ignored. Health IT is an experimental technology. The literature...

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To all physicians: Fools hiring amateurs, to control you and land you in court?

Health IT systems will be/are used to control you - a medical professional - in your treatment of patients, and could land you in court if they contribute to your making a medical mistake. They could also land you in a <a href="http://hcrenewal.blogspot.com/2009/10/sham-peer-review-could-this-bad-faith.html">sham peer review</a> for being a "disruptive" physician if you complain about a poor EHR. Here's an example of who gets hired to run such systems. Note the "Education" and "Qualifications Knowledge, Skills, and Abilities Required" I bolded.This job description is not atypical of many "clinical informatics" job descriptions: <blockquote style="font-family:arial;">HCAClinical Informaticist(Job Number: 25388-35620)https://hca.taleo.net/careersection/0hca/jobdetail.ftl?lang=en&job=1112401&src=JB-11444 <div> <div>More About HCA.....</div> <ul><li>HCA has been Recognized in Computerworld Magazine's Top 100 Workplaces to work for Information Technology Professionals for the 3rd consecutive year, coming in this year at #32.</li><li>HCA has been recognized by the Ethisphere Institute as one of the 2011 World's Most Ethical Companies.</li></ul> </div>Summary of Duties <blockquote>The Clinical Informaticist is accountable for driving successful adoption and clinical process optimization of clinical information systems. This is done through the application Clinical Adoption Methodology, incorporating best practice and evidence-based knowledge. Utilizes the knowledge and skills of clinical practice to determine clinical functions that are suitable for computer application and to ensure the information systems are consistent with professional standards of clinical practice. Acts on behalf of the Director of Applications in absence of said director.</blockquote> Duties Include But Are Not Limited To <ul><li>Facilitates knowledge of current state, desired state, and gap analysis of core clinical processes that are enabled by clinical information technology, being mindful of operational requirements/ constraints and conflicts. Works collaboratively with QA to evaluate outcomes, and opportunities for improvement.</li><li>Maintains a trusting and effective relationship with all customers. Assists clinical managers in identifying information systems needs and project management related to information systems.</li><li>Maintains membership or consultation to appropriate committees, work groups or task forces as needed to facilitate the ongoing process of the design, implementation, and revision of the automated and manual components of the clinical information system. Conducts meetings and presentations, effectively and professionally.</li><li>Maintains a current knowledge of a) trends and issues in health care, nursing practice, healthcare informatics, regulatory/accreditation requirements; b) organizational policies and procedures related to clinical practice and the legal implications of the clinical information system; c) structure and hierarchy of the organization.</li><li>Functionality expertise for clinical applications supporting core patient care processes and their relationship to other organizational information systems.</li><li>Works closely with counterparts in appropriate user organizations to ensure consistent and effective use of technology resources and optimization of installed applications and sustainability.</li><li>Adheres to Code of Conduct and Mission & Value Statement. Understands the personal obligation to report any activity that appears to violate applicable laws, rules regulations or the Code of Conduct itself. Maintains confidentiality, promotes system security to promote compliance.</li><li>As facility-care-area based position must learn and comply with System and facility safety policies and rules; must use appropriate safety equipment and procedures at all times; must immediately report all unsafe conditions to supervisors; must be familiar with all safety features of equipment, tools or materials encompassed by job duties; and must check with supervisors (prior to job performance) if there is a question as to the safe procedure to be used for any job function.</li><li>Participate in special projects as needed and performs other duties as assigned.</li></ul> Qualifications Knowledge, Skills, and Abilities Required <ul style="font-weight: bold;"><li>Membership in an appropriate organization is required (HIMSS, AMIA, for example) that is specifically targeted to informatics in healthcare</li><li>Working knowledge of Microsoft Office products (WORD, EXCEL, PowerPoint, Project Plan, and VISIO)</li><li>Strong oral, written, and interpersonal communication skills; strong analysis/problem solving and critical thinking; strong leadership, facilitation and coaching skills; current knowledge of patient care practices; clinical expertise; ability to work in multi-disciplinary teams.</li></ul> <blockquote style="font-weight: bold;">Preferred:</blockquote> <ul style="font-weight: bold;"><li>Knowledge and skill in selection, implementation, and training of clinical information systems</li><li>Project management skills</li><li>Previous experience utilizing Meditech documentation system</li><li>Previous experience with Quality Improvement initiatives and clinical process re-engineering</li></ul> Education <ul style="font-weight: bold;"><li>BSN or Bachelors degree in other Allied Health Professional degree from an accredited college</li><li>Current (10/08) department incumbents must achieve Bachelors requirement by 12/31/2012</li></ul></blockquote> Wow... BSN, allied health bachelors, or "must achieve Bachelor's by 12/31/12"? Some (at best) MBA-level fool wrote this 'description' for the hiring of some amateur with a BS - or no degree - to perform functions that will seriously affect how you, with 4 years college, four years med school, PGY internship, residency, perhaps fellowship or other post doctoral experience, perform your profession?Your kids may have more professional education and qualifications than your hospital's "health computing experts." Fantastic. I add this:Health IT cannot be made to work properly - ever - when being mismanaged by fools and amateurs.-- SS

To all physicians: Fools hiring amateurs, to control you and land you in court?

Health IT systems will be/are used to control you - a medical professional - in your treatment of patients, and could land you in court if...

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Despite Recalls, Legal Settlements and Guilty Pleas - A $143.5 Million (or Perhaps $197 Million) Golden Parachute for the Former Drug Representative Who Is Now CEO of Johnson and Johnson

After 30 separate product recalls since 2009, and multiple legal settlements and guilty pleas, we <a href="http://hcrenewal.blogspot.com/2012/02/semi-retirement-of-salesman-weldon-to.html">noted</a> that the former pharmaceutical representative who is now the CEO of Johnson and Johnson will be retiring.  The $143.5 Million (or Perhaps $197 Million) Golden Parachute The Wall Street Journal just <a href="http://online.wsj.com/article/SB10001424052702304459804577281560545538288.html">reported</a> his retirement will come with an immense golden parachute: <blockquote>Johnson & Johnson Chairman and Chief Executive William Weldon stands to collect pension benefits and deferred compensation currently valued at $143.5 million after his retirement, according to new details released by the health-care conglomerate. </blockquote> The details were: <blockquote>Mr. Weldon, who will be succeeded as CEO by Vice Chairman Alex Gorsky, stands to collect benefits from two main sources. The present value of his accumulated pension benefits is $48.4 million, portions of which are paid out as a monthly annuity for life, according to Wednesday's filing with the Securities and Exchange Commission. His pension's value places Mr. Weldon well into the top 10% of CEOs of Standard & Poor's 500 companies, said Paul Hodgson, chief communications officer and senior research associate at GMI Ratings, which tracks corporate-governance information. Mr. Weldon also has amassed $95.1 million in nonqualified deferred-compensation plans. This represents parts of his salary and bonus that had been deferred in prior years, as well as company contributions to savings plans. Portions of Mr. Weldon's deferred compensation have been recorded each year as part of his total annual pay. Of the $95.1 million, more than $70 million represents Mr. Weldon's accumulated balance from a legacy cash-incentive plan that J&J has discontinued and replaced with a new executive-compensation plan. This sum would be paid to Mr. Weldon at retirement, J&J said. All deferred compensation is subject to taxes. </blockquote> Actually, an argument that the $143.5 million figure is an major under-estimate <a href="http://shearlingsplowed.blogspot.com/2012/03/wsj-under-estimates-j-ceo-weldons-walk.html">appeared</a> in the Shearlings Got Plowed blog: <blockquote>The MSM reports calculate only the cash values for soon to be Ex-CEO Weldon, not the present value of his stock options, at today's NYSE closing price for J&J of $65.08. So, that -- plus the vesting of his February 2012 JNJ RSUs and Stock Option awards [see page 45 of the link (but such amounts are ommitted from the year end 2011 proxy, on which the WSJ relied)] -- add about $53.47 million to the Weldon walkaway haul.</blockquote> Thus, Mr Weldon's golden parachute may be as big as $197 million. The Board's Justification for the Riches Of course, the Johnson and Johnson board justified the latest additions to Mr Weldon's wealth, as reported by the WSJ: <blockquote>In a regulatory filing Wednesday, the board said Mr. Weldon 'successfully managed our company through a challenging economic environment in 2011,' with solid financial results and advances in J&J's pharmaceutical pipeline. The board added that while J&J made progress in addressing manufacturing-quality issues in 2011, 'continued focus is needed to address critical product supply and quality issues that impact our responsibility of being able to deliver products to patients and customers who need them.' </blockquote> Johnson and Johnson's Recent Record The board's upbeat assessment sharply contrasts with Johnson and Johnson's actual recent record. As we <a href="http://www.blogger.com/profile/00497209843184497847">discussed </a>recently, Johnson and Johnson seems to have lost the ability to manufacture high quality products. It has had to make 30 separate product recalls since 2009. The latest was Liquid Infant Tylenol. (The current WSJ Health Blog list of recalls can be found <a href="http://blogs.wsj.com/health/2012/02/17/jj-recall-watch-mcneil-pulls-liquid-infant-tylenol-on-dosing-system-concerns">here</a>.)  This seems to be more than a "rough patch," which is how the WSJ article described the manufacturing problems. In addition, the WSJ article failed to mention that Johnson and Johnson also has an amazing recent record of ethical lapses and guilty pleas, including: - Convictions in two different states in 2010 for misleading marketing of Risperdal - A guilty plea for misbranding Topamax in 2010 - Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary - A guilty plea for marketing Risperdal for unapproved uses in 2011 (see <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">this link</a> for all of the above) - 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>) - A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post <a href="http://hcrenewal.blogspot.com/2011/09/johnson-and-johnson-pleads-guilty.html">here</a>) - More recently, in 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">here</a>). -  Most recently, there are reports that the company is in negotiation with the US Department of Justice to settle other lawsuits about the marketing of Risperdal, perhaps for as much as $1.8 billion (see <a href="http://www.businessweek.com/news/2012-03-12/j-and-j-said-to-face-u-dot-s-dot-demand-to-raise-risperdal-settlement-offer">this BusinessWeek story</a>.) Meanwhile, an <a href="http://knowledge.wharton.upenn.edu/article.cfm?articleid=2943">article</a> from the Wharton Business School suggested that the problems at Johnson and Johnson stemmed directly from former drug representative Weldon's management approach, which put short term revenues, "making the numbers," ahead of everything else, apparently including good manufacturing practices, or ethical business practices: <blockquote>[University of Michigan Ross School of Business Professor Erik] Gordon argues that CEO Weldon's relentless focus on the bottom line -- the company's website touts its record of 27 consecutive years of adjusted earnings increases and 49 consecutive years of dividend increases -- is the reason for the current woes. 'Bill Weldon sets the priorities and the culture for the company,' says Gordon. And the problems, from overly aggressive marketing to underinvestment in safety and quality systems, reflect 'people trying to get their bonuses, hit their numbers and keep their job.' No doubt the global economic collapse in 2008 put renewed pressure on managers at multinationals like Johnson & Johnson. John Kimberly -- a Wharton management professor and executive director of the Wharton/INSEAD Alliance who has worked with J&J executives in Europe since the late 1990s -- says he detected a shift among those managers starting in 2008. 'I got the sense that there were some things happening at corporate, and that messages were being sent about the need to deliver profitability,' Kimberly notes. 'It seemed as though the people I was working with were feeling pressure from above to pay closer attention to the bottom line. It was a palpable, tangible change.' Wharton's Donaldson gives J&J management credit for the aggressive steps the company is now taking to overhaul its manufacturing processes and plants. But he also notes that the balance between profits and patients is a tricky one. Managers at J&J, he says, 'are juggling a lot of balls. In the credo, they say they put patients first and stockholders further down the line. But there is a red ball that every manager knows about, [which is] profit -- and they don't let that red ball drop.' Figuring out how to serve patients well and still deliver for Wall Street is not easy. 'J&J believes they can do both those things,' Donaldson says. 'But if the weight of one side of that formula gets too heavy, the entire structure collapses.' </blockquote> Summary The ongoing news from the once proud Johnson and Johnson, whose <a href="http://www.jnj.com/wps/wcm/connect/c7933f004f5563df9e22be1bb31559c7/jnj_ourcredo_english_us_8.5x11_cmyk.pdf?MOD=AJPERES">credo</a> famously states: <blockquote>We believe our first responsibility is to doctors, nurses and patients, to mothers and fathers, and all others who use our products and services. In meeting their needs, everything we do must be of high quality. </blockquote>suggests that instead, the company's first responsibility is now to the hired managers, to obey their dictates no matter how they undermine the credo, and most importantly, to pay them so much as to make them some of the most wealthy people in the world. Johnson and Johnson has become exemplary, not of putting patients or health care professionals first, but of <a href="http://hcrenewal.blogspot.com/search/label/managers%27%20coup%20d%27etat">how hired managers took over health care</a>, and turned it to their own advantage. So should we trust Johnson and Johnson to do better, now that another former pharmaceutical representative will be its new CEO? The case of Johnson and Johnson indicates why we need a huge change in how health care organizations are lead. Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Despite Recalls, Legal Settlements and Guilty Pleas - A $143.5 Million (or Perhaps $197 Million) Golden Parachute for the Former Drug Representative Who Is Now CEO of Johnson and Johnson

After 30 separate product recalls since 2009, and multiple legal settlements and guilty pleas, we noted that the former pharmaceutical repr...

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EHRs and test ordering: Health Affairs authors reply to ONC

At my March 9, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/03/increased-lab-ordering-with-ehrs.html">Increased Lab Ordering with EHR's?</a>" I refuted ONC's response to a Harvard-based research study "Giving Office-Based Physicians Electronic Access To Patients’ Prior Imaging And Lab Results Did Not Deter Ordering Of Tests" that may contradict the notion that HIT reduces medical costs. Now the authors themselves have responded to ONC. There are many similar themes in their response. I've bolded them below: <blockquote> <a href="http://healthaffairs.org/blog/2012/03/12/the-effect-of-physicians-electronic-access-to-tests-a-response-to-farzad-mostashari/" rel="bookmark" title="Permanent Link: The Effect Of Physicians’ Electronic Access To Tests: A Response To Farzad Mostashari">The Effect Of Physicians’ Electronic Access To Tests: A Response To Farzad Mostashari</a> March 12th, 2012 by Danny McCormick, David Bor, Stephanie Woolhandler, and David Himmelstein <a href="http://content.healthaffairs.org/content/31/3/488.abstract" target="_blank">Our recent Health Affairs article</a> linking increased test ordering to electronic access to results has elicited heated responses, including <a href="http://www.healthit.gov/buzz-blog/meaningful-use/study-facts/" target="_blank">a blog post by Farzad Mostashari</a>, National Coordinator for Health IT. Some of the assertions in his blog post are mistaken. Some take us to task for claims we never made, or for studying only some of the myriad issues relevant to medical computing. And many reflect wishful thinking regarding health IT; an acceptance of deeply flawed evidence of its benefit, and skepticism about solid data that leads to unwelcome conclusions. <div class="entrytext">Dr. Mostashari’s critique of our paper, will, we hope, open a fruitful dialogue. We trust that in the interest of fairness he will direct readers to our response on his agency’s site. [If not, HC Renewal posts get highly ranked by Google - ed.] Our study analyzed government survey data on a nationally representative sample of 28,741 patient visits to 1187 office-based physicians. We found that electronic access to computerized imaging results (either the report or the actual image) was associated with a 40% -70% increase in imaging tests, including sharp increases in expensive tests like MRIs and CT scans; the findings for blood tests were similar. Although the survey did not collect data on payments for the tests, it’s hard to imagine how a 40% to 70% increase in testing could fail to increase imaging costs. Dr. Mostashari’s statement that “reducing test orders is not the way that health IT is meant to reduce costs” is surprising, and contradicts <a href="http://commonhealth.wbur.org/2011/05/health-technology-blumenthal" style="font-weight: bold;" target="_blank">statements by his predecessor as National Coordinator</a> that electronic access to a previous CT scan helped him to avoid ordering a duplicate and “saved a whole bunch of money.” <a href="http://content.healthaffairs.org/content/24/5/1103.abstract" target="_blank">A Rand study</a>, widely cited by health IT advocates including President Obama, estimated that health IT would save $6.6 billion annually on outpatient imaging and lab testing. <a href="http://content.healthaffairs.org/cgi/reprint/hlthaff.w5.10v1" target="_blank">Another frequently quoted estimate of HIT-based savings</a> projected annual cost reductions of $8.3 billion on imaging and $8.1 billion on lab testing. We focused on electronic access to results because the common understanding of how health IT might decrease test ordering is that it would facilitate retrieval of previous results, avoiding duplicate tests. Indeed, it’s clear from the extensive press coverage that our study was seen as contravening this “conventional wisdom”. Nonetheless, Dr. Mostashari criticizes us for analyzing the impact of physicians’ electronic access to imaging and test results, but not other aspects of electronic health record (EHR) use. We did, however, analyze the relationship of EHRs to test ordering in a subsidiary analysis. While physicians use of a full EHR was associated with a 19% increase in image ordering, as we noted in the paper this finding was not statistically significant. While we cautiously (and properly) interpreted this as a “null” finding, these data are inconsistent with Mostashari’s optimistic view that use of a full EHR reduces costs. He asserts that our 2008 data are passe, and that health IT meeting today’s “meaningful use” criteria definitely saves money. The data we analyzed were the latest available data when we initiated the study. While the proportion of outpatient physicians utilizing health IT has grown since 2008, we are unaware of any “game changing” health IT developments in the past four years that are would produce substantially different results if the study were repeated today. The EHR vendors that dominated the market in 2008 remain, by and large, today’s market leaders, and their products have undergone mostly modest tweaks. Mostashari’s contention that 2012 EHRs – incorporating decision support and electronic information exchange – save money in ways not possible in 2008 should be tested through additional research but remains merely a hypothesis. We hope that some day his predicted savings can be achieved. Dr. Mostashari offers his own explanation for our findings, suggesting that doctors who are inclined to order more tests are also inclined to purchase health IT for viewing test results electronically rather than on paper. He offers no evidence for this assertion and ignores the fact that we explored (and rejected) this explanation by analyzing subgroups of doctors who are unlikely to be the decision maker for IT purchases – e.g. employed physicians, those working in an HMO setting etc. In other words, electronic access to results predicted more test ordering whether or not the ordering physician was responsible for health IT purchases. He incorrectly states that our analysis did not take into account patients’ severity of illness, physicians’ level of training, and the nature of physicians’ financial arrangements. In fact, we reported subsidiary multivariate analyses that included several serious diagnoses; all of our models included physician specialty (which we specified in several different ways); and all models included adjustment for an extensive list of indicators of financial arrangements (e.g. whether the physician owned the practice or was an employee; the type of office; whether the practice was owned by a hospital; whether the physician was a solo practitioner; whether the physician’s compensation was based, in part or whole on “profiling”; and whether the practice was predominantly prepaid). We also performed a series of subsidiary analyses that explored whether physicians with a proclivity to “self refer” patients for imaging tests accounted for our finding; they didn’t. Dr. Mostashari criticizes us for failing to assess whether health IT improved the quality or appropriateness of care. Of course, these were not the topic of our research. Those are different studies for a different time. However, we would note that <a href="http://www.pnhp.org/sites/default/files/docs/AJM-Himmelstein-Hospital-Computing.pdf" target="_blank">other</a> <a href="http://content.healthaffairs.org/content/29/4/639.abstract" target="_blank">large-scale</a> <a href="http://content.healthaffairs.org/content/29/4/647.abstract" target="_blank">studies</a> have found no, or trivial quality improvements associated with HIT outside of a few flagship institutions4-6. Dr. Mostashari’s strongest claim is that observational studies like ours (and most other health policy studies, including some by Dr. Mostashari himself) cannot prove causation. This is surely true. As long time teachers of evidence based medicine we took care to couch our conclusions in cautious terms, stating only that “Computerization, whatever its other benefits, remains unproven as a cost control strategy.” But Dr. Motashari is less cautious, asserting that the case for HIT is closed. The paper he cites to buttress this claim (authored by members of his own agency) culled studies reporting any impact of HIT on virtually any aspect of care, and accepted authors’ claims of benefit without regard to study quality or statistical niceties. Thus, a focus group’s impressions of benefit are accorded the same weight as nationwide studies of Medicare data showing virtually no impact of computerization on quality measures. Reports of a reduction from 70% to 38 % in “missed billing opportunities” or a $7,000 reduction in office supply costs are among the 92% of studies judged “positive”. While the literature review he cites is interesting, nothing in it contradicts our findings. Dr. Mostashari is also correct in reiterating that randomized trials are the best way to assess health IT. In fact, no randomized trial has ever been published that examines patients’ outcomes or costs associated with off-the-shelf health IT systems that dominate the U.S. market. No drug or new medical device could pass FDA review based on such thin evidence as we have on health IT. Yet his agency is disbursing $19 billion in federal funds to stimulate the adoption of this inadequately evaluated technology. Dr. Mostashari is perhaps the only person in our nation who commands the resources needed to mount a well done randomized controlled trial to fairly assess the impact of health IT, and the comparative efficacy of the various EHR options. Finally, Dr. Mostashari’s unbridled faith in technology is mirrored by his belief that ACOs are the next panacea for health costs and quality. That health policy flavor-of-the-month also remains wholly unproven.</div></blockquote><div class="entrytext"></div> I think readers comparing my response to the authors', and who are familiar with the many posts at HC Renewal going back to 2004, will recognize the themes I have bolded in the author's response to HHS. -- SS

EHRs and test ordering: Health Affairs authors reply to ONC

At my March 9, 2012 post " Increased Lab Ordering with EHR's? " I refuted ONC's response to a Harvard-based research study...

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