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On the "Wickedness" Of Healthcare IT (And Is CPOE Just a "Typewriter For Orders?")

Large-scale implementation of comprehensive healthcare IT, especially if meaningful ROI on the hundreds of billions of dollars spent is to be attained, is more of a wicked problem than a tractable one, as I have written <a href="http://hcrenewal.blogspot.com/2009/10/washington-post-article-electronic.html#c8760904644296861584">on this site</a> and in a number of presentations (such as this one on <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/EHR_benefit_peril_final.ppt">HIT challenges and perils</a> - PDF). A "<a href="http://en.wikipedia.org/wiki/Wicked_problem">wicked problem</a>" describes a problem that is difficult or impossible to solve because of incomplete, contradictory, and changing requirements that are often difficult to recognize. Moreover, because of complex interdependencies, the effort to solve one aspect of a wicked problem may reveal or create other problems. In the current environment of <a href="http://www.healthbeatblog.org/2008/12/irrational-exuberance-over-electronic-medical-records-.html">irrational exuberance</a>, healthcare IT has been presented as a ready-for-prime-time, "mouse click away from great healthcare", put-it-in-and-reap-the rewards technology. An example of this 'HIsTeria': <div style="text-align: center;">“We have the capacity to transform health with one thunderous click of a mouse after another,” said (former) HHS Secretary Michael Leavitt - <a href="http://www.himss.org/ASP/ContentRedirector.asp?ContentId=65039&type=HIMSSNewsItem">2005 HIMSS Summit</a> </div> "Transform" healthcare via "one thunderous mouse click after another?" On an irrational hyper-ebullience having taken over in healthcare IT, I rest my case. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj5_2X9eOTYBdSsQEmVsYvSq6S7fFAjOLQRoZ_49Ail_dthnUugp-p6NMKf8dOKbb5gorF7UeItBajVHVEoGMZ6wKLwtummpbOeX4eIqlXMJBXe7fXJgqDLTQzWGimEMFKxRSCrjhGc2xyQ/s1600-h/nart0004.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5444488107139424706" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj5_2X9eOTYBdSsQEmVsYvSq6S7fFAjOLQRoZ_49Ail_dthnUugp-p6NMKf8dOKbb5gorF7UeItBajVHVEoGMZ6wKLwtummpbOeX4eIqlXMJBXe7fXJgqDLTQzWGimEMFKxRSCrjhGc2xyQ/s320/nart0004.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 197px; height: 146px;" /></a>Thunderous computing! Oh my! </div> Unfortunately, realizing the capabilities of healthcare IT is not simple. It is in fact devilishly complex. For instance, is CPOE a "typewriter for orders", as it's sometimes represented in this industry to de-emphasize its potential hazards? Far from it. In recent testimony submitted at the HIT Policy Committee, Adoption/Certification Workgroup of HHS on February 25, 2010, a <a href="http://healthit.hhs.gov/portal/server.pt?open=512&objID=1473&&PageID=17117&mode=2&in_hi_userid=11673&cached=true">meeting on HIT safety</a>, Geisinger medical informaticist/CMIO James Walker, MD <a href="http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910718_0_0_18/3Walker_Testimony022510.pdf">wrote</a> (PDF) the following (emphases and red comments mine): <blockquote>... In 2005, <a href="http://www.geisinger.org/">Geisinger</a> was preparing for its first inpatient EHR implementation. Several months into the project, the project director informed the CIO and me that the EHR team’s business analysts were unable to map safe and effective workflows between the new order-entry system and our existing pharmacy system (provided by another vendor). [As an aside, one might question why "business analysts" were attempting a clinical mapping such as this - ed.] They and the project director believed that the only safe approach was to de-install the existing pharmacy system and replace it with the pharmacy system provided by the order-entry vendor—at a cost of several hundred thousand dollars and a nine months’ delay in the project. Pharmacy’s management was pained by the need to remove what was indisputably the best pharmacy system on the market [yet, even so, it needed to be removed and replaced with something that may, or may not, be equivalent in safety, ease of use, customizability, lifecycle maintenance, etc. - ed.] (which they had used very effectively to improve safety and efficiency). Nevertheless, they agreed with the workflow analysis and supported the change. Executive leadership approved the change and we proceeded. Two years later (2007), when I reported this experience to an EHR-safety conference, David Classen noted that the results of the Leapfrog CPOE test in 62 carefully studied hospitals confirmed that this hazard ... appears to be present regardless of which vendors’ products are used. (Classen, in press). [The effects of the disruptions at those 62 carefully studied hospitals might likely increment the "tip of the iceberg" HIT-related injury/death figures <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">cited at the same meeting</a> by FDA official Dr. Jeffrey Shuren- ed.] </blockquote> In other words, any organization that implements a CPOE system needs to throw away whatever IT system is being used in pharmacy, with all of the familiarity and experience of pharmacy staff, and safety improvements that software might have provided because interfacing the systems is (allegedly) impossible and/or impractical. Then, after a learning curve characterized by disruptions in service, it is hoped the new pharmacy system will provide similar benefits to the old, and that the CPOE itself will work well (and not do <a href="http://jama.ama-assn.org/cgi/content/abstract/293/10/1197">this</a>). This disruption, caused by software dependencies in a complex biomedical setting and perhaps other reasons (see below), certainly represents a complex interdependency, the "solution" to which creates new problems, such as: <ul><li>What if the new CPOE vendor-sourced pharmacy system is inferior to the old? </li><li>What does the organization due if the single-source vendor folds, now causing orphaned software over two, not one, critical functions?</li><li>What other software-to-software interdependencies and bottlenecks exist that are not easily remedied by interfaces? CPOE-diagnostic imaging (radiology)? CPOE-laboratory? CPOE-O.R.? CPOE-dietary? CPOE-bed control? And so forth for CPOE and other systems to be installed. </li><li>What happens if the CPOE fails (as <a href="http://hcrenewal.blogspot.com/2005/03/wash-post-on-cedars-sinai-cpoe-failure.html">here</a>)? </li></ul> As to causation of the allegedly irremediable incompatibility between CPOE's and Pharmacy IT, Dr. Walker submitted the following testimony: <blockquote> ... hazards arise due to failures in health IT design, implementation, and maintenance. (While many of these failures are due to a lack of skill or vigilance, many more are due to the interactions of complex healthcare processes and the necessary complexity of IT systems capable of supporting those processes.)</blockquote> While I await the aforementioned Classen in-press paper on 62 hospitals, I take a more saturnine view and would argue that most of the interfacing problems probably have more to do with "lack of skill and vigilance" as opposed to some "organic" problem in interfacing these systems. My view is based on experience in the IT backwater of hospitals and HIT, where bureaucrats and IT personnel largely are working far outside their core competencies; where straightforward software adaptations in complex subspecialties can be <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=Cardiology%20story">completely and repeatedly bungled</a> until appropriate expertise is leveraged; where expert advice may simply be ignored <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=lawsuit">and worse</a>; and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases">other pathologies</a>. (See more on ONC Director Blumenthal's call for correction of the healthcare IT skills problem at "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">ONC Defines a Strategy of Robust HIT Leadership</a>".) The CPOE interface difficulties may also be in part due to vendor strategies of closed and overly complex software and information architectures, and vendor unwillingness to assist in interfacing to "alien" pharmacy IT products through ominous cost structures and halfhearted attempts. These matters could be strategic business decisions in a highly competitive market. (The supposed incompatibilities might actually be another argument supporting open source in healthcare...) ------- In either case regarding interface difficulties, i.e., human-based vs. "organic" IT issues, however, one can see that health IT is no easy "plug and play" affair. There is no predetermined benefit nor ROI. The complexities and "wicked problem" nature of HIT argue that benefits and ROI will not come short term - and never if the technology and its mass implementation are treated as easily tractable, not experimental and "wicked." Finally, CPOE a typewriter for orders? Perhaps, if this is the kind of typewriter being referred to: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjOB2O_L14BVbYlDxrozy5UQLnq7cD2Q7-PXuGUMqJdP-SeJpCIM5bqtjFPr6gXwGDLKkVfriJr-Z9IRr4SMG1KWn-uPscbJozDffBj5eKJZW1_aHu-xaYnYyUSsjPa289XJRCWJy-HqRS9/s1600-h/typewriter.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5444473952079546130" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjOB2O_L14BVbYlDxrozy5UQLnq7cD2Q7-PXuGUMqJdP-SeJpCIM5bqtjFPr6gXwGDLKkVfriJr-Z9IRr4SMG1KWn-uPscbJozDffBj5eKJZW1_aHu-xaYnYyUSsjPa289XJRCWJy-HqRS9/s320/typewriter.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 265px; height: 199px;" /></a>Typewriter for <a href="http://www.flickr.com/photos/pengin/340943701/">Japanese language</a> </div> -- SS <div style="text-align: justify;">For more on HIT challenges see "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" - <a href="http://tinyurl.com/healthITfailure" style="font-style: italic;">http://www.tinyurl.com/healthITfailure</a></div>

On the "Wickedness" Of Healthcare IT (And Is CPOE Just a "Typewriter For Orders?")

Large-scale implementation of comprehensive healthcare IT, especially if meaningful ROI on the hundreds of billions of dollars spent is to...

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Sacks Medical, KV Pharmaceutical Plead Guilty, Mariner Health Care, SavaSeniorCare Settle

The march of legal settlements and guilty pleas by health care organizations just keeps going.  The most recent participants were: Sacks Medical Corp The <a href="http://www.pittsburghlive.com/x/pittsburghtrib/business/s_668630.html">Pittsburgh Tribune-Review reported</a>: <blockquote>A Butler County drug company pleaded guilty in federal court in Pittsburgh to international money laundering and violating federal drug laws in an investigation that involved the now-defunct Monsour Medical Center Research Institute. Sacks Medical Corp. of Evans City was fined $500,000 and ordered to forfeit an additional $500,00 by U.S. District Court Judge Gustave Diamond on Monday. The firm was placed on one year's probation. The research institute was not charged in the investigation. According to federal prosecutors, Sacks in 2004 obtained pharmaceutical drugs at discount prices, which were then resold to other drug wholesalers in violation of the Prescription Drug Marketing Act. Sacks persuaded officials at the Monsour Medical Center in Jeannette to create the research institute, which was nothing more than a shell company, according to the charges. The institute joined two group purchasing organizations and began buying large amounts of medical supplies that should have been designated only for the hospital's use and not resold, according to the charges. Purchases were made from major drug companies, AmerisourceBergen of Valley Forge and McKesson Corp. San Francisco. Monsour then sold the medications to Millenia Hope Healthcare Inc., which was located at Monsour. Millenia then sold the drugs directly to Sacks or to San Med Development Group, which is owned by Sacks, according to prosecutors. Sacks supplied Monsour with the money to buy the discounted drugs. The company then tried to disguise the transaction by wiring the money to a Canadian bank, which in turn wired the money back to Monsour, according to the plea agreement. </blockquote> The novel element here seems to be the charge of international money laundering. KV Pharmaceutical <a href="http://www.businessweek.com/news/2010-02-25/kv-pharmaceutical-unit-to-pay-fine-plead-guilty-update1-.html">Bloomberg reported</a>: <blockquote>KV Pharmaceutical Co. agreed to pay a $25.8 million fine and forfeit $1.8 million to resolve a U.S. Justice Department investigation of its generic pharmaceutical marketing and distribution unit, which will cease operations. That unit, Ethex Corp., will also enter a plea of guilty to criminal charges arising from its actions in 2008, according to a statement issued today by St. Louis-based KV. The agreement requires court approval, the company said. Under the terms of the accord, Ethex will plead guilty to two felony counts stemming from its failure to make and submit to the U.S. Food and Drug Administration a report on its discovery of undistributed pills that 'failed to meet product specifications,' KV said separately in a filing today with the U.S. Securities and Exchange Commission.</blockquote>Note that these first two cases both involved guilty pleas to criminal charges, felonies in the latter case.  Further note, however, that in the latter case, the felony pleas were made by a subsidiary of the corporation, which will then be dissolved, leaving the parent corporation intact.  Although in both cases organizations pleaded guilty to criminal charges, there were no reports that any individuals who worked for or were otherwise involved in these organizations pleaded guilty to any charges. Mariner Health Care, SavaSeniorCare (and Omnicare) Again, from a report <a href="http://www.businessweek.com/news/2010-02-26/doj-says-mariner-health-settles-alleged-kickbacks-update1-.html">by Bloomberg</a>: <blockquote>The U.S. reached a $14 million settlement with nursing home chains Mariner Health Care Inc. and SavaSeniorCare Administrative Services LLC over allegations of kickbacks from a supplier of drugs to nursing home patients. The accord resolves claims that the companies and their principals, Leonard Grunstein, Murray Forman and Rubin Schron, solicited kickbacks from Omnicare Inc., the U.S. Justice Department said in an e-mailed statement. The defendants conspired to have Omnicare pay $50 million in exchange for agreeing to use the supplier for 15 years, the government said last March in a complaint in Boston. The alleged kickback scheme involved Omnicare’s paying $40 million to buy a Mariner unit whose only assets were less than $3 million in accounts receivable, according to the complaint.</blockquote> Note that we discussed another settlement involving Omnicare and kickback allegations <a href="http://hcrenewal.blogspot.com/2009/11/omnicare-ivax-settle.html">here</a>.  It appears, however, that Omnicare paid any additional penalty in this case, despite allegations that it provided the kickbacks. Summary Again, another week, another series of colorful legal settlements and/or guilty pleas and/or convictions involving health care organizations.  Again, although organizations settled or pleaded guilty, no individuals seemed to be held accountable for authorizing, directing, or implementing the actions that lead to these pleas and settlements. So, here we go again ... To repeat, seemingly ad infinitum, these are just the latest in a now long parade of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">settlements</a> and guilty pleas and <a href="http://hcrenewal.blogspot.com/search/label/crime">criminal</a> convictions, sometimes involving charges like <a href="http://hcrenewal.blogspot.com/search/label/bribery">bribery</a>, <a href="http://hcrenewal.blogspot.com/search/label/fraud">fraud</a>, or <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a>,  that serve as reminders of poor behavior by myriad health care organizations. As we have previously noted, these settlements seem to have little deterrent effect on future bad behavior. (Note that many large health care organizations have settled or plead guilty in several major cases since we started commenting on such settlements.) Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts will suffer any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue. I again suggest that to truly reform health care, we need rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health.

Sacks Medical, KV Pharmaceutical Plead Guilty, Mariner Health Care, SavaSeniorCare Settle

The march of legal settlements and guilty pleas by health care organizations just keeps going. The most recent participants were: Sacks Med...

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FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths In Two Years, Probably Just 'Tip of Iceberg'

<div align="left">The Office of the National Coordinator for Health IT held a meeting of the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010. The topic was "HIT safety." The agenda, presenters and presentations are available <a href="http://healthit.hhs.gov/portal/server.pt?open=512&objID=1473&&PageID=17117&mode=2&in_hi_userid=11673&cached=true">at this link</a>. At this meeting FDA testimony was given by Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health. Dr. Shuren noted several categories of health IT-induced adverse consequences known by FDA. This information was striking: He wrote: </div><blockquote><div align="left">... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.</div><div align="left">[I'd call that a likely <a href="http://hcrenewal.blogspot.com/2010/02/health-it-caused-death-injury-extent.html">understatement</a> - ed.] Even within this limited sample, several serious safety concerns have come to light. The reported adverse events have largely fallen into four major categories: (1) errors of commission, such as accessing the wrong patient’s record or overwriting one patient’s information with another’s; (2) errors of omission or transmission, such as the loss or corruption of vital patient data; (3) errors in data analysis, including medication dosing errors of several orders of magnitude; and (4) incompatibility between multi-vendor software applications and systems, which can lead to any of the above.</div></blockquote><div align="left"> This is a technology almost universally touted as inherently beneficial, right up to our most senior elected leaders, who are now pushing this unproven technology under threat of penalty for non-adopters - certainly a precedent, especially in a supposedly democratic country. I have given examples on this blog about how this belief about the universal goodness of healthcare computing is itself inherently idealistic - and unrealistic. Now, here are some very striking, discrete examples of HIT-related adverse consequences, the tip of a larger iceberg, size unknown but quite possibly very large (where's <a href="http://l.yimg.com/eb/ymv/us/img/hv/photo/movie_pix/paramount_pictures/titanic/_group_photos/kate_winslet9.jpg">Kate Winslet</a> when you need her?): (1) Errors of Commission </div><blockquote><div align="left">Example 1: An error occurred in software used to view and document patient activities. When the user documented activities in the task list for one patient and used the “previous” or “next” arrows to select another patient chart, the first patient’s task list displayed for the second patient. Example 2: A nuclear medicine study was saved in the wrong patient’s file. Investigation suggested that this was due to a software error. Example 3: A sleep lab’s workstation software had a confusing user interface, which led to the overwriting and replacement of one patient’s data with another patient’s study.</div><div align="left">[I covered other examples of confusing or "mission hostile" interfaces at an eight part series <a href="http://www.tinyurl.com/hostileuserexper">here</a> - ed.]</div></blockquote><div align="left"> (2) Errors of Omission or Transmission </div><blockquote><div align="left">Example 1: An EMR system was connected to a patient monitoring system to chart vital signs. The system required a hospital staff member to download the vital signs, verify them, and electronically post them in the patient’s chart. Hospital staff reported that, several times, vital signs have been downloaded, viewed, and approved, and have subsequently disappeared from the system. Example 2: An operating room management software application frequently “locked up” during surgery, with no obvious indication that a “lock-up” was occurring. Operative data were lost and had to be re-entered manually, in some cases from the nurse’s recollection. [I experienced <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=Cardiology%20story">similar problems</a>: a decade ago - ed.] Example 3: An improper database configuration caused manual patient allergy data entries to be overwritten during automatic updates of patient data from the hospital information system.</div></blockquote><div align="left"> (3) Errors in Data Analysis </div><blockquote><div align="left">Example 1: In one system, intravenous fluid rates of greater than 1,000 mL/hr were printed as 1 mL/hr on the label that went to the nursing / drug administration area. Example 2: A clinical decision support software application for checking a patient’s profile for drug allergies failed to display the allergy information properly. Investigation by the vendor determined that the error was caused by a missing codeset. Example 3: Mean pressure values displayed on a patient’s physiological monitors did not match the mean pressures computed by the EMR system after systolic and diastolic values were entered.</div></blockquote><div align="left"> (4) Incompatibility between Multi-Vendor Software Applications or Systems </div><blockquote><div align="left">Example 1: An Emergency Department management software package interfaces with the hospital’s core information system and the laboratory’s laboratory information system; all three systems are from different vendors. When lab results were ordered through the ED management software package for one patient, another patient’s results were returned. Example 2: Images produced by a CT scanner from one vendor were presented as a mirror image by another vendor’s picture archiving and communication system (PACS) web software. The PACS software vendor stipulates that something in the interface between the two products causes some images to be randomly “flipped” when displayed.</div></blockquote> <div align="left"> The above is from FDA (2010 internal memo <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">here</a>) and by their own admission under-represents the problems, perhaps massively. Most of these errors are inexcusable from an engineering and quality perspective. Unfortunately, there actually is no comprehensive data on the true magnitude of the problems.</div><div align="center"> </div><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgFEzoM3D2qeDBIM7QqlgIiUHeUjlfgNIs_LNki0ZyN6JKglIVxisfhW8DDYytiw2x5yjHKCzdOtp11Rw3n6liPDe7AMrW6n6qY2TvJpSivredvNhqzCbsqMASEZmDi76t0Z4Rdxh2FzeGF/s1600-h/TipOfIceberg.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5443389824535309074" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgFEzoM3D2qeDBIM7QqlgIiUHeUjlfgNIs_LNki0ZyN6JKglIVxisfhW8DDYytiw2x5yjHKCzdOtp11Rw3n6liPDe7AMrW6n6qY2TvJpSivredvNhqzCbsqMASEZmDi76t0Z4Rdxh2FzeGF/s320/TipOfIceberg.jpg" style="display: block; height: 182px; margin: 0px auto 10px; text-align: center; width: 140px;" /> </a><div align="center">44 injuries and 6 deaths: tip of the iceberg?</div><div align="left">Merely writing about this scarcity can bring opposition. For instance, a recent paper I wrote about lack of data on unintended adverse consequences of HIT and remediation of the data paucity was rejected. (The paucity itself might be considered an 'unintended consequence' of HIT, since secrecy about pros/cons of HIT was not the intention of the medical informatics pioneers.)</div><div align="left">One of the reasons given by an anonymous reviewer justifying rejection of the paper was itself striking: The paper "adds little that is new or that goes beyond what a reader might find in a major city newspaper", the reviewer wrote. Little that is new to whom, exactly? Where are the extant papers on the scarcity of such data?</div><div align="left">I am also highly uncertain as to which "major city newspapers" the reviewer was referring to, as I've rarely if ever read articles in newspapers about the paucity of data on adverse consequences of HIT or the remediation of the paucity. One reason for writing the paper was due to the fact the "major newspapers" - and the medical and medical informatics journals - largely avoid such issues entirely. (The scarcity was noted by organizations such as the Joint Commission, however, in their 2009 <a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm">Sentinel Events Alert on HIT</a> - "There is a dearth of data on the incidence of adverse events directly caused by HIT overall.") This reviewer continued with the frivolous comment that "proposing a classification of sources of unintended consequence and analysis of reasons for undereporting of each type in the resulting classification could be a useful addition to the field."</div><div align="left">Ironically, I actually devoted an entire section of the paper to reasons for under-reporting and scarcity of unintended consequences, broadly speaking, although that this wasn't the paper's main purpose. Its purpose was to point out the dangers inherent in such an information scarcity. It is also hard to granularly classify variants of a phenomenon on which there is scarce data to begin with. Rather than revise the paper, I may simply put it in the public domain and send it to my elected representatives involved in healthcare IT policy. I'd done this with another paper I'd written in 2007 on EMR's and <a href="http://www.scribd.com/doc/12392184/A-Medical-Informatics-Grand-Challenge-the-EMR-and-PostMarketing-Drug-Surveillance-">postmarketing drug surveillance</a> that had received a mysteriously similar "could have read this in any newspaper" critique. In summary, the light is starting to shine on HIT dangers. It is also increasingly recognized by regulators such as FDA that "data scarcity" is a problem of major significance ("tip of the iceberg"), although there are those in this sector who would prefer to keep physicians and patients in the dark on this issue and keep such data scarce.</div><div align="left">Finally, while Shuren presented a number of options regarding FDA involvement in HIT regulation, he wrote that "in light of the safety issues that have been reported to us, we believe that a framework of federal oversight of HIT needs to assure patient safety." This itself represents a major change in the culture of HIT.</div><div align="left">Addendum: the Huffington Post Investigative Fund wrote about this meeting in an article entitled "Experts: Safety Oversight Needed as Patient Records Go Digital" <a href="http://huffpostfund.org/stories/2010/02/experts-safety-oversight-needed-patient-records-go-digital">here</a>.</div>-- SS <div style="font-weight: bold; text-align: justify;"><div style="font-style: italic;"> <div align="left">For more on HIT challenges see "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" - <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/</a></div></div></div>

FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths In Two Years, Probably Just 'Tip of Iceberg'

The Office of the National Coordinator for Health IT held a meeting of the HIT Policy Committee , Adoption/Certification Workgroup on Febru...

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Bring Back the DSI*? - the Avandia Case as Spy Novel

Starting in 2007, we posted quite a bit about the "Avandia case," which centered on whether Avandia (rosiglitazone, by GlaxoSmithKline), a glucose lowering drug for type 2 diabetes, presented excess cardiovascular risks, and how evidence about these risks was handled.  Summary The Nissen and Wolski meta-analysis [Nissen SE, Wolski K. Effects of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356, online <a href="http://content.nejm.org/cgi/content/full/NEJMoa072761">here</a>] was to be the first published article to combine data from all relevant clinical trials of rosiglitazone then available.  Although two major trials of Avandia had been published, its manufacturer, GlaxoSmithKline, had performed many other smaller trials of the drug which remained unpublished.  These results eventually appeared on a <a href="http://www.gsk-clinicalstudyregister.com/">web-site run by GSK</a>. However, this web-site was relatively obscure.  It had not been created voluntarily, but in response to a settlement of legal action that alleged GSK had suppressed clinical research about its antidepresant paroxetine (Paxil). (See Steinbrook R. Registration of clinical trials - voluntary of mandatory. N Engl J Med 2004; 351: 1820-1822, link <a href="http://content.nejm.org/cgi/content/full/351/18/1820">here</a> and our post <a href="http://hcrenewal.blogspot.com/2007/01/not-something-we-want-to-publicise-spin.html">here</a>). Nissen and Wolski found the site, compiled the results of trials on Avandia it contained, and combined their results with those of the few published trials in their meta-analysis. It is to the credit of Nissen and Wolski that they were able to figure out how to do this. It is not to the credit of GSK that they sat on the data from these trials, only put it on this web-site when compelled to do so, did not make any effort to publicize the web-site, and did not publish a meta-analysis done by company scientists that showed qualitatively similar results to that eventually done by Nissen and Wolski (see post <a href="http://hcrenewal.blogspot.com/2007/05/dream-turns-to-nightmare-avandia-and.html">here</a>).   I originally <a href="http://hcrenewal.blogspot.com/2007/06/avandia-spin-cycle-continues.html">thought</a> the case raised two questions:  1 - what are the benefits and harms of rosiglitazone as a treatment of Type 2 diabetes, and therefore for which patients under what circumstances should this drug be used?  2 - what barriers have prevented physicians and patients from getting the best possible answer to the first question, and what can be done about them?   But the immediate response to the Nissen and Wolski meta-analysis was a spin cycle that seemed to obfuscate these questions, and the answers to him (see posts <a href="http://hcrenewal.blogspot.com/2007/06/more-on-avandia-why-we-need-to-call-off.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/06/wall-street-journal-gives-avandia-whirl.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/06/avandia-spin-cycle-continues.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2007/11/silencing-avandia-whistle-blower.html">here</a>)   A Reconsideration   In the last few weeks, several articles about Avandia have appeared in the media, and in medical journals, that reconsider the issues, and in particular, the "Avandia Spin Cycle."  First was a commentary in the European Heart Journal by Dr Steven E Nissen, the first author of the meta-analysis [Nissen SE. The rise and fall of rosiglitazone. Eur Heart J 2010: published online <a href="http://eurheartj.oxfordjournals.org/content/early/2010/02/11/eurheartj.ehq016.long">here</a>.]  Dr Nissen provided a narrative history of the Avandia case from his viewpoint, and summarized it thus: <blockquote>What were the key mistakes and lessons learned from the rosiglitazone affair? 1. The FDA rushed to approve rosiglitazone because of hepatotoxicity concerns about troglitazone, resulting in failure to consider the ‘signals’ suggesting cardiovascular toxicity. 2. An early critic of rosiglitazone was intimidated by company representatives and effectively silenced, a process antithetical to the principals of open scientific discourse. 3. Although early warnings were issued for the risk of heart failure, these warnings went largely unheeded in the face of aggressive marketing and promotion suggesting cardiovascular benefits. 4. No well-designed cardiovascular outcome trials were ever conducted for rosiglitazone, despite evidence suggesting increased cardiovascular risks. The only cardiovascular outcome trial was an open label study driven by a soft endpoint (hospitalization) with low adherence to randomized medications, seriously underpowered, and not completed until 10 years following launch. 5. Although both the FDA and the company were aware of evidence of an increased risk of adverse cardiovascular outcomes, certainly by 2005, neither warned physicians nor the public. 6. When a meta-analysis of rosiglitazone was eventually submitted for publication, the company subverted the editorial review process by stealing a copy of the manuscript and used this advance knowledge inappropriately to unblind an ongoing randomized trial. 7. Approval of diabetes drugs based exclusively upon their glycaemic effects has been short-sighted and scientifically unwise. Drugs that lower blood sugar may have other adverse effects that overcome any inherent benefits. 8. The failure of  50 other PPARs, many for adverse cardiovascular effects, went largely unreported because of negative publication bias. Such knowledge might have warned the medical community about the potential risk of these agents.</blockquote> Meanwhile, the <a href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html">New York Times published </a>conclusions of some internal US Food and Drug Administration (FDA) reports, and of an investigation by the US Senate Finance Committee. FDA safety officials suggested that Avandia should be taken off the market. Some key points from the Senate investigation were: <blockquote>The bipartisan multiyear Senate investigation — whose results are expected to be released publicly on Monday but which were also obtained by The Times — sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly. 'Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,' ....</blockquote>In combination, the Nissen commentary, and the Senate report nicely summarized what I called the "Avandia spin cycle" above.  It appears that research was suppressed, marketing was deceptive, and critics and whistleblowers were intimidated.  Finally, Dr Harlan Krumholz published a commentary about the thiazolidinedione drugs (a group that includes rosiglirazone) in Circulation Cardiovascular Quality and Outcomes [Krumholz HM. A perspective on the American Heart Association Presidential Commission Advisory on thiazolidenedione drugs. Circ Cardiovasc Qual Outcomes 2010; 3 available online, link <a href="http://circoutcomes.ahajournals.org/cgi/rapidpdf/CIRCOUTCOMES.110.936070v1.pdf">here</a>], and <a href="http://www.forbes.com/2010/02/24/diabetes-glaxosmithkline-avandia-business-healthcare-heart-attack.html">an op-ed in Forbes</a>. The latter sums it all up nicely: <blockquote>I want to believe in America's pharmaceutical companies. I want to believe that people in these companies believe that the best strategy for success is to do what is best for patients. I want to believe that they are interested in scientific truth and eager to know of any safety issues and ready to share that information with the public. This week I was disappointed again. Over the years GlaxoSmithKline ( GSK - news - people ) has repeatedly reassured the public about the safety of its blockbuster diabetes drug Avandia. But this weekend the Senate Finance Committee released a report revealing that inside the company Glaxo's own experts and advisors were raising concerns about whether the drug could cause heart problems all along. The report, based on more than 250,000 internal documents, provides a rare and unsettling glimpse into the decision by company executives to deflect safety issues--even as their own experts agreed with conclusions of outside researchers who were warning the public about possible harms. The documents reveal that company researchers were deeply concerned about the cardiovascular safety of the drug as far back as 2003. The pages of the Senate report read like a spy novel: Glaxo receiving confidential documents leaked by a sympathetic academic who consulted for the company; the company embarking on a campaign to intimidate critics who warned about potential safety issues with the drug; and executives pulling strings to release data early from a scientific study that was supposedly controlled by an 'independent' committee of researchers.</blockquote> So, <blockquote>The story here is less about the drug--the Senate report breaks no new ground about Avandia's safety issues (even among experts there remains some controversy)--and more about the ethical behavior of a company. What is clear: Glaxo failed to disclose its own concerns even as it sought to discredit outside researchers who were raising questions about the drug. This type of behavior is eroding the public trust in the pharmaceutical industry.</blockquote>Policy Implications Finally, Dr Krumholz concludes with some solutions with which I heartily agree: <blockquote>The fix is simple: Once a drug is approved, all data relevant to drug safety should be placed in the public domain and independent investigators across the country should be able to use it. There should be big financial penalties for withholding relevant information. Drug studies sponsored by industry must be truly independent--outside of company control. Companies should give outside investigators independence over every aspect of the study. There are too many examples of companies wresting control of clinical studies from their consultant investigators for reasons that seem more related to product promotion than clinical science. And on all sides there should be a commitment to protect against the intimidation of academics who are willing to raise questions about the safety and effectiveness of company products. The free flow of information about the effects of drugs and medical devices will best serve the public's interest.</blockquote>Here in the US, the debate over health care reform has reached a new phase. Today the President is hosting an attempt to get bipartisan discussion of reform going again. Now that there is a new opportunity for discussion, I submit that would be health care reformers ought to think about the underlying causes of our continuing problems with rising costs, declining access, stagnant quality, and demoralized health care professionals. One set of causes that is rarely discussed has to do with the distortion of clinical research by commercial research sponsors with vested interests in the results turning out in favor of their products, and the further distortion of clinical discourse and decision making by the deceptive marketing practices of these same organizations. If we started introducing steps like those suggested by Dr Krumholz into health care reform, maybe we really could decrease costs, increase access, improve quality, and renew professionalism. *Bring Back the DSI? To lighten things up a bit, and to explain the title... When I was in school in the 1960s, I first became a fan of the <a href="http://hardyboys.bobfinnan.com/">Hardy Boys</a> mysteries, then the slightly more mature <a href="http://www.aandc.org/research/biblio_pease_h.htm">Tod Moran series</a>.  While on the <a href="http://www.oceanlinermuseum.co.uk/nieuw_amsterdam.htm">Neiuw Amsterdam</a> (the 1938 version) one day out of Kingston, Jamaica, I viewed <a href="http://www.imdb.com/title/tt0055928/">Dr No</a>, the first James Bond movie, a sophisticated spy thriller, not a spoof like some later entries in the series.  I later read all the classics, like those by <a href="http://www.agathachristie.com/">Agatha Christie</a>, <a href="http://en.wikipedia.org/wiki/Erle_Stanley_Gardner">Earl Stanely Gardner</a>, <a href="http://www.nerowolfe.org/">Rex Stout</a>, <a href="http://en.wikipedia.org/wiki/Ellery_Queen">Ellery Queen</a>, etc.  So it should be no surprise that I, like many other schoolboys and girls, collaborated to form an amateur detective and intelligence agency.  But this was the sophisticated 1960s, so we called it the Department of Scientific Investigation (DSI).  We skulked around New York City and its suburbs looking for spies, saboteurs, and common criminals.  Luckily, we never really found any.  As more realities intruded, I gave up any ideas about becoming an investigator or intelligence agent (although I still read mysteries, spy novels, and thrillers to this day, but mainly on airplanes.)  Once I became a physicians, those days in the DSI seemed very remote (although the title does now seem like it ought to be part of the NIH ;-) ). However, after reading Dr Krumholz's article above, maybe we need to resurrect the DSI.  At least, maybe we health professionals ought to consider how we can become better and more organized watchdogs for the kind of problems revealed in the Avandia case, and in many other cases discussed on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>. But if any of my old DSI colleagues want to set up a reunion, it would be fine with me.  ADDENDUM (25 February, 2010) - see also comments by Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2010/02/avandia-story-failures-of-regulation.html">on the Hooked: Ethics, Medicine and Pharma blog</a>.

Bring Back the DSI*? - the Avandia Case as Spy Novel

Starting in 2007, we posted quite a bit about the "Avandia case," which centered on whether Avandia (rosiglitazone, by GlaxoSmithK...

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The Argument Over Insurance Rate Hikes: A Systemic Problem with Health Care Organizations' Leadership and Governance?

There has been a tremendous amount of news coverage of a large rate increase proposed by Anthem Blue Cross, a subsidiary of WellPoint, in California.  For example, the <a href="http://www.latimes.com/business/la-fi-anthem10-2010feb10,0,2234973.story">Los Angeles Times reported</a> last week, <blockquote>Congress opened an investigation Tuesday into Anthem Blue Cross' impending rate increases in California as President Obama cited the premium hikes -- some as high as 39% -- in his bid to pass national healthcare legislation. The House Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations announced they were examining the increases, which are set to take effect March 1. The subcommittee has scheduled a Feb. 24 hearing in Washington, while an Assembly committee in Sacramento has set a hearing for Feb 23. 'Reports of premium increases up to 39% are deeply troubling,' Rep. Henry A. Waxman (D-Beverly Hills), who chairs the energy committee, said in a statement. 'At a time when millions of Americans are struggling to keep their health insurance, we need to know what possible justification there could be for increases of this magnitude.' Anthem of Woodland Hills is the state's largest for-profit insurer and a unit of Indianapolis health insurance giant WellPoint Inc. At issue are increases in monthly premiums for many of Anthem's estimated 800,000 customers with individual health insurance policies who are not part of group coverage. Anthem began informing individual policyholders last month that prices would go up March 1 and could be adjusted 'more frequently' than typical yearly increases. The company would not say how high the rates could go or how many customers would be affected. Brokers and policyholders said many of the anticipated increases were 30% to 39%, the largest they could recall. The brokers said other insurers also were raising rates by double digits. Anthem maintains that its increases are necessary to meet growing healthcare costs, even as it voices sympathy for policyholders whose premiums are rising.</blockquote>In addition, per again a <a href="http://www.latimes.com/business/la-fi-insure24-2010feb24,0,2866459,print.story">Los Angeles Times article</a> this week, <blockquote>Executives from California health insurance giant Anthem Blue Cross, under fire for scheduled rate hikes of up to 39%, insisted Tuesday that their premiums were fair and legal, and they told lawmakers they expected that the increases would go forward. Appearing before the state Assembly's health committee, the officials said that they believed rate increases for individual health insurance policies, delayed until May 1 while being reviewed by the Department of Insurance, would survive scrutiny by regulators In Sacramento, Anthem's president, Leslie Margolin, told the committee that much of the public frustration over the rate hikes was misdirected and should be aimed at the nation's healthcare system. 'This debate and this inquiry cannot and should not be just about the insurance industry or the delivery system or regulators or legislators or customers or brokers,' Margolin said. 'We have wasted precious time and precious resources doing battle with each other,' she added. 'We must come together collaboratively and strategically to address the distressing symptoms of our troubled system -- rising premiums, for example -- and to address the fundamental underlying causes of our collective failure.'</blockquote> As we have discussed time after time on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, there are multiple fundamental problems with health care in the US (and around the world.) The Anthem President above did not apparently specify what she thought these problems are. We have discussed in particular problems that arise out of abuse and concentration of power in health, particularly problems with the leadership and governance of health care organizations. We have suggested that such problems are major causes of the ever rising costs of, declining access to, and stagnant quality of health care in the US. These problems do not seem to particularly afflict WellPoint more than most other organizations, and certainly do afflict the other organizations with which WellPoint has to deal.  On the other hand, WellPoint has certainly had its own share of issues. These have been sufficient to raise questions about the organization's leadership's transparency, ethics, and management abilities. While WellPoint perhaps should not be singled out for these sorts of problems, the extent they may have contributed to the costs it imposes, and its ability to manage its relationships with other organizations should be a source of skepticism about the idealized pronouncements of its leaders. For a recent example, the Los Angeles Times also just <a href="http://www.latimes.com/business/la-fi-anthem-claims23-2010feb23,0,186309.story">reported</a>, <blockquote>California's largest for-profit health insurer violated state law more than 700 times over a three-year period by failing to pay medical claims on time and misrepresenting policy provisions to customers, the state's insurance commissioner said Monday. Anthem Blue Cross of Woodland Hills could face fines of up to $7 million stemming from the alleged violations from 2006 to 2009. Commissioner Steve Poizner said the insurer repeatedly failed to respond to state regulators in a 'reasonable time' as they investigated complaints over the last year. 'We believe there is evidence to suggest there are serious issues with how Anthem Blue Cross pays claims,' Poizner said at a Sacramento news conference. 'Most disturbing to us is that they don't even respond' to the Department of Insurance 'in a timely way.' </blockquote> Furthermore, WellPoint... <ul><li>settled a RICO (racketeer influenced corrupt organization) law-suit in California over its alleged systematic attempts to withhold payments from physicians (see post <a href="http://hcrenewal.blogspot.com/2005/07/wellpoint-settles-rico-law-suit.html">here</a>).</li><li>subsidiary New York Empire Blue Cross and Blue Shield misplaced a computer disc containing confidential information on 75,000 policy-holders (see story <a href="http://www.nytimes.com/2007/03/14/business/14insure.html">here</a>).</li><li>California Anthem Blue Cross subsidiary cancelled individual insurance policies after their owners made large claims (a practices sometimes called rescission).  The company was ordered to pay a million dollar fine in early 2007 for this (see post <a href="http://hcrenewal.blogspot.com/2007/03/wellpoint-fined-1-million-for-canceling.html">here</a>).  A state agency charged that some of these cancellations by another WellPoint subsidiary were improper (see post <a href="http://hcrenewal.blogspot.com/2007/07/more-than-half-of-wellpoints-policy.html">here</a>).  WellPoint was alleged to have pushed physicians to look for patients' medical problems that would allow rescission (see post <a href="http://hcrenewal.blogspot.com/2008/02/wellpoint-halts-attempts-to-have.html">here</a>).  It turned out that California never collected the 2007 fine noted above, allegedly because the state agency feared that WellPoint had become too powerful to take on (see post <a href="http://hcrenewal.blogspot.com/2008/07/wellpoint-settles-but-has-it-become-too.html">here</a>). But in 2008, WellPoint agreed to pay more fines for its rescission practices (see post <a href="http://hcrenewal.blogspot.com/2008/07/fines-re-statements-and-more-fines-just.html">here</a>).  In 2009, WellPoint executives were defiant about their continued intention to make rescission in hearings before the US congress (see post <a href="http://hcrenewal.blogspot.com/2009/06/managed-care-executives-will-not-limit.html">here</a>).</li><li>California Blue Cross subsidiary allegedly attempted to get physicians to sign contracts whose confidentiality provisions would have prevented them from consulting lawyers about the contract (see post <a href="http://hcrenewal.blogspot.com/2007/11/physicians-and-contracts-cautionary.html">here</a>).</li><li>formerly acclaimed CFO was fired for unclear reasons, and then allegations from numerous women of what now might be called Tiger Woods-like activities surfaced (see post <a href="http://hcrenewal.blogspot.com/2008/01/more-managed-care-management-mumbo.html">here</a>).</li><li>announced that its investment portfolio was hardly immune from the losses prevalent in late 2008 (see post <a href="http://hcrenewal.blogspot.com/2008/10/if-this-is-how-wellpoint-has-managed.html">here</a>).</li><li>was sanctioned by the US government in early 2009 for erroneously denying coverage to senior patients who subscribed to its Medicare drug plans (see post <a href="http://hcrenewal.blogspot.com/2009/01/wellpoint-sanctioned.html">here</a>).</li><li>settled charges that it had used a questionable data-base (builty by Ingenix, a subsidiary of ostensible WellPoint competitor UnitedHealth) to determine fees paid to physicians for out-of-network care (see post <a href="http://hcrenewal.blogspot.com/2009/02/wellpoint-settles.html">here</a>).  </li></ul>So, WellPoint's subsidiary Anthem President Margolin was right in that her company, or insurance and managed care companies should not be blamed for all of our health care woes.  But I submit that her company should no less have to address concerns about the transparency, honesty, and skill of its management, and how problems in these areas have driven up costs, decreased access, threatened quality, and demoralized health care professsionals  than do leaders of other health care organizations.  At the moment, such concerns are at best peripheral to the ongoing debate on health care reform in the US.  I suggest they ought to be central. ADDENDUM (24 February, 2010) - see also comments <a href="http://covertrationingblog.com/healthcare-reform/why-efficiency-is-bad-for-health-insurance-companies">on the Covert Rationing Blog</a>, and <a href="http://www.joepaduda.com/archives/001749.html">on the Managed Care Matters blog</a>.

The Argument Over Insurance Rate Hikes: A Systemic Problem with Health Care Organizations' Leadership and Governance?

There has been a tremendous amount of news coverage of a large rate increase proposed by Anthem Blue Cross, a subsidiary of WellPoint, in Ca...

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Forgotten First Principles in Healthcare IT

A review of several first principles might serve as a useful addendum to the posting "<a href="http://hcrenewal.blogspot.com/2010/02/health-it-caused-death-injury-extent.html">Health IT Caused Death & Injury, Extent Unknown, But Regulation Bad</a>." <blockquote>First principle: A computer can free professionals from tedious, repetitive work which does not require judgment. It can provide facts and figures with lightning speed, giving domain experts more time to exercise their judgment thoughtfully [<a href="http://www.radioshackcatalogs.com/catalogs_extra/1981_rsc-05/">source</a>].</blockquote> Reality: HIT commonly makes work <a href="http://www.tinyurl.com/hostileuserexper">more tedious for clinicians</a>, and there seems to be a not-so-subtle view in the industry that HIT can -- and should -- <a href="http://hcrenewal.blogspot.com/2010/01/does-ceo-of-google-use-google.html">replace or oversee their judgment</a>, and that clinicians are luddites for not embracing the "platform opportunities." <blockquote>First principle: Clinicians need sysems built upon <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Kling_Design_ICT_table.pdf">user-centric design principles</a> (PDF) that provide cognitive support (per the 2009 <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">National Research Commission report on HIT</a>), not inventory systems of medical data.</blockquote> Reality: the designer-centric Management Information Systems paradigms of the IT industry are widely used in HIT and are inappropriate in medicine with its "unbounded, poorly defined environment" of constant clinician improvisation that makes it appear to function smoothly (per a short article focusing on first principles itself, Nemeth & Cook's "<a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf">Hiding in plain sight: What Koppel et al. tell us about healthcare IT</a>", PDF). <blockquote>First principle: modern medicine is a field unarguably and unalterably having science at it roots, and the approach to tools used within it must itself be based on science.</blockquote> Reality: the HIT industry largely ignores science in favor of premature proclamations of "Mission Accomplished", in the form of self-exalting claims made without or with very little supporting evidence (a.k.a. 'puffery'), while studies that should be taken as a red flag about HIT (e.g., those highlighted at "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009">2009 a pivotal year in HIT</a>" languish in obscurity. These principles are largely common sense, but sense, unfortunately, seems all too uncommon in healthcare in 2010. -- SS

Forgotten First Principles in Healthcare IT

A review of several first principles might serve as a useful addendum to the posting " Health IT Caused Death & Injury, Extent Unk...

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Health IT Caused Death & Injury, Extent Unknown, But Regulation Bad Since it Would Slow Government's Campaign To Spur Widespread Adoption

[Note: the hyperlinks in this posting are very informative, so do check them - ed.] A workgroup of the Healthcare IT Policy Committee, a federal advisory body, will <a href="http://www.healthdatamanagement.com/news/safety_software_ehr_regulation-39799-1.html">hear testimony on the safety of health information technology</a> during a public hearing tomorrow (Feb. 25, 2010) in Washington. On the eve of that hearing, an article "<a href="http://huffpostfund.org/stories/2010/02/fda-considers-regulating-safety-electronic-health-systems" style="font-family: arial;">FDA Considers Regulating Safety of Electronic Health Systems</a>" was published Feb. 23, 2010 by the Huffington Post Investigative Fund, authored by Fred Schulte and Emma Schwartz. The article is bylined with "Reports of Patient Harm Include Six Deaths in Two Years." <blockquote style="font-family:arial;"><a href="http://huffpostfund.org/stories/2010/02/fda-considers-regulating-safety-electronic-health-systems" style="font-weight: bold;">FDA Considers Regulating Safety of Electronic Health Systems</a> Reports of Patient Harm Include Six Deaths in Two Years By <a href="http://huffpostfund.org/users/fred-schulte" title="View user profile.">Fred Schulte</a> and <a href="http://huffpostfund.org/users/emmaschwartz" title="View user profile.">Emma Schwartz</a> Huffington Post Investigative Fund 23 Feb 2010 Concerned about potential safety risks in health information technology, the U.S. Food and Drug Administration may be moving closer to regulating the systems for the first time. In the past two years, the agency has received reports of six patient deaths and several dozen injuries linked to malfunctions in the systems, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in testimony prepared for a government hearing on Thursday. “Because these reports are purely voluntary, they may represent only the tip of the iceberg,” Shuren said. </blockquote> In an environment of HIT <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=koppel_kreda" style="font-family: arial;">"hold harmless" provisions and defects gag clauses</a> causing executives to violate their fiduciary and Joint Commission safety standard obligations, <a href="http://hcrenewal.blogspot.com/2009/10/sham-peer-review-could-this-bad-faith.html" style="font-family: arial;">sham peer review</a> for "disruptive" or "non-team player" physicians, <a href="http://hcrenewal.blogspot.com/2009/12/we-are-unable-to-share-documents.html">suppression of HIT research</a> that could cast it in a negative light, conflicts of interest, <a href="http://hcrenewal.blogspot.com/2010/02/lawsuit-over-health-it-whistleblowing.html" style="font-family: arial;">whistleblower retaliation</a>, and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/" style="font-family: arial;">other dysfunctions</a> in the health IT industry, I think "tip of the iceberg" may be a gross understatement. <blockquote style="font-family:arial;">... Many health policy experts believe that fostering greater use of health information technology, which officials refer to as HIT, will significantly improve the quality of medical care, cut costs and reduce medical errors and waste. The government hopes to have an electronic medical record for every American by 2014. </blockquote> These beliefs about HIT -- as it is designed, implemented and managed today -- are being contradicted by a growing body of literature, such as in a recent review article <a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html" style="font-family: arial;">here</a> broadly reviewing the literature, a new book <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=hitormiss" style="font-family: arial;">here</a> and a collection of 2009 releases <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009" style="font-family: arial;">here</a> that is largely ignored by policy makers. This literature is largely ignored and unknown to policy makers while the relatively sparse literature "proving" the case for HIT is overemphasized, perhaps due to intense lobbying from the very wealthy HIT trade organizations as in the Washington Post <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews" style="font-family: arial;">here</a>. <blockquote style="font-family:arial;">But digital medical systems are not risk-free. Over the past two years, the FDA’s voluntary notification system logged a total of 260 reports of “malfunctions with the potential for patient harm,” including 44 injuries and the six deaths. Among other things the systems have mixed up patients, put test results in the wrong person’s file and lost vital medical information. </blockquote> That "260 reports" is also likely highly understated; there is no regulations nor accepted national reporting system for HIT problems as there is for drugs and other medical devices. Consequently most clinicians have no idea where to even report such problems and mishaps. Further, I have probably heard more than that number of "malfunctions with potential for harm" from just a few of my former students and other contacts now in the trenches in the past year or two, who report secretive "defects lists" <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_27.html" style="font-family: arial;">numbering in the hundreds and even thousands</a> in some organizations. A percentage of items on those lists fall into the "likely to cause harm if uncorrected" category. <blockquote style="font-family:arial;"> In one example cited in the FDA testimony, an operating room management system frequently “locked up” during surgery. Lost data had to be re-entered manually “in some cases from a nurse’s recollection.” Another system failed to display a patient’s allergies properly because of software errors. In another case, results from lab testing done in a hospital emergency room were returned for the wrong patient. None of the patients, hospitals or clinics are identified in the reports. </blockquote> I noted such a "computer crash/data loss" malfunction in HIT systems for <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU" style="font-family: arial;">ICU's</a> and for <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=Cardiology%20story" style="font-family: arial;">Invasive Cardiology labs</a> a decade ago. Nothing seems to have been learned by this industry about <a href="http://www.resilience-engineering.org/" style="font-family: arial;">appropriate software engineering</a> for healthcare. <blockquote style="font-family:arial;">“The FDA recognizes the tremendous importance of HIT and its potential to improve patient care. However, in light of the safety issues that have been reported to us, we believe that a framework of federal oversight of HIT needs to assure patient safety,” Shuren said. He said that to date the agency has “largely refrained” from regulating the industry. Through an FDA spokesman, Shuren declined a request for an interview. The FDA official outlined three possible approaches for tighter scrutiny. The agency could require makers of the devices to register them with the government and to submit reports on safety issues and correct problems that surface. The FDA could track this information “to help improve the design of future products.” In a second scenario, the agency could require manufacturers to report safety concerns and set minimum guidelines to assure the quality of products on the market. In a third approach, the systems could be subject to the broader regulatory actions that new medical products must face before they ever reach the market. Though the FDA didn’t specify which approach it favors, Shuren said that at a minimum the agency could “play an important role in preventing or addressing HIT-related safety issues, thereby helping to foster confidence in these devices.” </blockquote> I think plan #3 is the most consistent with regulation in other healthcare industries (pharma and medical devices), and is most ethical with regard to patient rights. I cannot think of any good reason why the HIT industry should be given special dispensation and accommodated with respect to regulation. <blockquote style="font-family:arial;">The manufacturers of the systems generally have opposed regulation by the FDA, arguing in part that imposing strict controls would slow down the government’s campaign to spur widespread adoption of the technology. Regulation will not necessarily create a “safer” electronic medical record “and might actually limit innovation and responsiveness when it is needed most,” Carl Dvorak, executive vice president of Epic Systems Corporation, a Wisconsin-based company that builds the systems mainly for hospitals and large medical practices, said in his prepared testimony for Thursday’s hearing. The hearing is being held by an advisory group created by the stimulus law. </blockquote> One thing is certain: lack of regulation will NOT create a safer HIT environment. Further, when the FDA has received reports of patient deaths and injuries linked to HIT malfunctions, but the actual number of death and injury cases is truly unknown; and when the number of "near misses" related to IT but averted by luck or by some human in the work chain, that might have easily gone the other way, is also unknown (but likely with a high degree of probability to be much, much larger than "260 per year", the conclusions that: <blockquote>Regulation will not necessarily create a “safer” electronic medical record “and might actually limit innovation and responsiveness when it is needed most... and "imposing strict controls would slow down the government’s campaign to spur widespread adoption of the technology..."</blockquote> ... are simply perverse. They do not reflect any ethical medical values of which I am familiar. <blockquote style="font-family:arial;"> Yet some inside the industry favor stepped-up scrutiny. One major vendor, Cerner Corporation, which has voluntarily reported safety incidents to the FDA in recent years, signaled its support for a rule that would make those reports mandatory. Cerner has reported potential safety concerns because it is the “right thing to do,” a company official said. </blockquote> Indeed. <blockquote style="font-family:arial;">Others inside the industry have argued for approaches that don’t involve FDA oversight. James Walker, chief medical information officer at Pennsylvania’s Geisinger Health System, said in prepared testimony for Thursday's hearing that a “patient safety organization” should be created to collect “automatic, anonymous reporting of potential hazards” in electronic health systems. </blockquote> Such an organization already exists, known as the "FDA." Apparently Walker <a href="http://www.worldcongress.com/speakerBio.cfm?speakerID=34&confcode=nw510" style="font-family: arial;">lacks experience</a> in industries that are regulated by FDA such as the pharmaceutical and medical device industries. IT systems in those industries are regulated and in fact validated, by FDA - e.g., see "<a href="http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf" style="font-family: arial;">General Principles of Software Validation; Final Guidance for Industry and FDA Staff</a>", PDF, introduced with the statement that "this guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices." Creating yet another new organization for validating HIT would be once again accommodating that industry, and calling for one is not explicable on any reasonable logic that I can surmise. <blockquote style="font-family:arial;">The federal government’s Office of the National Coordinator for health information technology also has recognized the need for better surveillance. In January, the office issued a contract to address “undesirable and potentially harmful unintended consequences” of the systems. </blockquote> What took them so long, I ask? <blockquote style="font-family:arial;"> One industry critic said Tuesday that she hoped the FDA would follow through on its concerns. “We need monitoring and reporting systems for problems,” said Sharona Hoffman, a professor at Case Western Reserve University School of Law. “It has to go through the highest level of oversight and regulation. Every American who goes to a doctor will be affected.” </blockquote> I could not agree more. Hoffman co-authored several articles on HIT risks (links can be found <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=other" style="font-family: arial;">here</a>). The oversight cannot be done by a rubber-stamp organization; it cannot be performed by those with conflicts of interest; it should not be performed by those who for years have minimized the problems. <blockquote style="font-family:arial;"> Even those who advocate tighter oversight agree that the technology has the potential to revolutionize health care. </blockquote> No, HIT will not "<a href="http://hcrenewal.blogspot.com/2010/01/syndrome-of-useless-information.html">revolutionize</a>" healthcare. Facilitate incremental improvements, possibly - but only if the IT itself is "done well." I believe the "R" word must be removed from our cultural lexicon about IT. It is an expression of a disease, the irrational overconfidence in computing in fields depending on human cognition and judgment. If the largest single flaw in healthcare provision were lack of information availability and retrieval capabilities, it would be a (somewhat) less risible, less hysterical assertion. <blockquote style="font-family:arial;"> Though officials in some other countries have tightened oversight of the systems, U.S. manufacturers have managed to stave off formal regulation, telling the FDA in May 2008 that their products should be excluded from review partly as a means to speed up their adoption. </blockquote> The EU's evolving stance on HIT regulation is <a href="http://hcrenewal.blogspot.com/2009/06/improving-patient-safety-in-eu-hit.html" style="font-family: arial;">here</a>. <blockquote style="font-family:arial;">But critics argue that tighter scrutiny is needed to protect the public. “Oversight and quality control may slow things down, but it’s absolutely critical,” said Hoffman, the law professor. “Patients' lives are at stake.” </blockquote> Hoffman seems one of the few writing about this industry who understands what the issues are all about. I will repeat the bottom line in bold for all to see: <blockquote style="font-family:arial;"> “Patients' lives are at stake.” </blockquote> It's ironic that this observation comes from a non-physician (she is a professor of law), while too many HIT industry-connected physicians are chattering about regulation "<a href="http://evernote.com/pub/poikonen/PublicPharmacoinformatics#Note/582cbf46-d342-46bc-a39e-3d57e3a31388">stifling innovation</a>." Blood for computers? Perhaps they'd like to return to the era when <a href="http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment" style="font-family: arial;">medical experiments such as this</a> were permissible. Seeking regulatory acquiescence to special accommodations for a technology (HIT) already being pushed by government, which could potentially result in a government-corporatist alliance at the expense of the common person and of medical ethics, is quite troubling. -- SS

Health IT Caused Death & Injury, Extent Unknown, But Regulation Bad Since it Would Slow Government's Campaign To Spur Widespread Adoption

[Note: the hyperlinks in this posting are very informative, so do check them - ed.] A workgroup of the Healthcare IT Policy Committee, a f...

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