Practicing (Clinical Trials) Medicine Without a License

Another story of dubious clinical research, this time <a href="http://www.tampabay.com/news/business/article1012526.ece">reported</a> by the St Petersburg (Florida, US) Times:<br /><br /><blockquote><br />Vladimir Martin called himself 'doctor' and ran 17 clinical trials of new drugs for major pharmaceutical companies before one patient noticed he didn't have a medical license.<br /><br />The patient alerted the St. Petersburg Times, whose resulting story led to a state investigation. On Saturday, <em>Martin, 43, was arrested on charges of practicing medicine without a license.</em> He was later released from the Pinellas County Jail on $10,000 bail. The felony charge carries a maximum sentence of five years in prison and maximum fine of $5,000.<br /><br />The Clearwater man, who changed his last name from Kossatchev after moving to Florida in 2003, went to medical school in the former Soviet Union and practiced in a hospital in his native Ukraine.<br /><br />Ruth Weber, a 74-year-old Clearwater resident, told the Times in April 2008 that <em>the man who called himself Dr. Martin enrolled her in a study for lower-back pain and adjusted the dosage of her medicine</em>. Only licensed physicians are supposed to conduct such activities. Patients in the study were <em>randomly selected to receive a new Johnson & Johnson painkiller called tapentadol, a placebo or the potent narcotic oxycodone.<br /></em><br />Though Dr. Robert Lee Jackson, a Clearwater osteopath, was listed by the FDA as the physician conducting the study, Weber said she never saw Jackson. In weekly visits to <em>Alliance Medical Research Group</em> on Belcher Road, Weber said it was Martin who drew blood, doled out medication and, at one point, doubled her dosage.<br /><br />Martin also conducted electrocardiograms on Weber, although his techniques were so rusty the electrodes kept slipping off, she said. Weber eventually dropped out of the study when she saw no improvement for her back pain.<br /><br />A second woman, Ann Reed, told investigators she also responded to an ad for a drug study trial at Alliance Medical Research. Martin took her blood, listened to her heart and gave her medications, Reed said. Martin sometimes had to stick her four times to draw blood, she said.<br /><br />Like Weber, Reed said she never saw Jackson during her trial, which involved 13 visits between May 2007 and March 2008.<br /><br />Greg Panico, a spokesman for Johnson & Johnson, said the company audited Alliance Medical after the Times' story and submitted its findings to the FDA. He declined to discuss the nature of the report, but said the drug company is no longer working with Alliance Medical.<br /><br />Panico also said data collected in the tapentadol study at that site was not submitted to the FDA.<br /><br />The drugmaker said it reported its findings to the <em><a href="http://www.sterlingirb.com/aboutus.php">Sterling Institutional Review Board</a> in Atlanta</em>, which had been hired by Johnson & Johnson to oversee patient safety during the trial.<br /><br />Despite losing the Johnson & Johnson trial, Martin told investigators in July that he was conducting four other drug studies.<br /></blockquote><br />A little Google searching turned up another example <a href="http://http://clinicaltrials.gov/ct2/show/study/NCT00387010">on ClinicalTrials.gov </a>of a commercially funded clinical study for which the Alliance Medical Research Group enrolled patients. This was a Phase III study sponsored by Cephalon, an "Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain." Note also that Sterling Institutional Review Board appears to be another example of a for-profit, commercial institutional review board.<br /><br />Here we have another example of remarkably bad implementation of commercially sponsored and commercially supervised clinical trials. <br /><br />We have posted a number of times about sloppy and mismanagement of commercially sponsored clinical research, often under the auspices of for-profit contract research organizations (CROs) and for-profit institutional review boards (IRBs). See <a href="http://hcrenewal.blogspot.com/2006/05/saga-of-study-3014-and-safety-of.html">this 2006 vintage post </a>on the infamous study 3014 on Ketek, sponsored by Sanofi Aventis. <br /><br />In my humble opinion, in the contemporary business world, many managers are driven mainly by quarterly profits. However, what works best to boost profits in the short run may not be what works to produce valid clinical research that maximizes the safety of and respect afforded human research subjects. When all the organizations involved in the research, the sponsor, the organization implementing the research, and the organization supervising research ethics are for-profit, the incentives to cut corners are multiplied. Cutting corners can jeopardize the validity of the studies, and the safety and respectful treatment of study subjects.<br /><br />I again submit that making human experimental research into a commercial enterprise, mainly serving the marketing of drugs and devices, may not produce good science, and may not be good for patients. It might be a better idea to leave human research to not-for-profit organizations and health care professionals.<br /><br /><br />Hat tip to <a href="http://pharmagossip.blogspot.com/2009/06/alliance-medical-research-group.html">PharmaGossip</a>.

Practicing (Clinical Trials) Medicine Without a License

Another story of dubious clinical research, this time reported by the St Petersburg (Florida, US) Times: Vladimir Martin called himself ...

Đọc thêm »

Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?

<span style="font-size:100%;">Signs that a leader who alleges himself or herself to be objective and a scientist is, in fact, neither objective nor scientific include:</span><div><span style="font-size:100%;"><br /></span></div><div><ul><li><span style="font-size:100%;">Resorting to <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">ad hominem</a> attacks when questioned or criticized.</span></li><li><span style="font-size:100%;">Deficient familiarity with the current literature.</span></li><li><span style="font-size:100%;">Opining that others' concerns expressed in that literature could be "laughed off."<br /></span></li><li><span style="font-size:100%;">Years-behind view of the situation on the ground.</span></li></ul></div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;">The head of CCHIT, Mark Leavitt, has penned the following at iHealthBeat (emphases and comments in <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">red italic</span> mine):</span></div><div><span style="font-size:100%;"><br /></span></div><div> <blockquote><span style="font-size:100%;"><a href="http://www.ihealthbeat.org/perspectives/2009/health-it-under-arra-its-not-the-money-its-the-message.aspx">June 19, 2009 - Perspectives</a></span></blockquote><blockquote><p class="MsoNormal"><span style="font-size:100%;"><b>Health IT Under ARRA: It's Not the Money, It's the Message</b></span></p> <p class="MsoNormal"><span style="font-size:100%;">by Mark Leavitt</span></p><p style="text-align: left;" class="MsoNormal"><span style="font-size:100%;">... Estimates by the Congressional Budget Office suggest the total incentive payout could reach $34 billion, although with expected savings the net cost is half that. Add to that another $2 billion that the Office of the National Coordinator for Health IT can use on various initiatives in support of the goal of having <span style="font-weight: bold;">an </span><span style="font-weight: bold;">EHR for every American </span>by 2014.</span><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"><br /></span></p><p style="text-align: left;" class="MsoNormal"><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Note the catchy marketing slogan, which carries the implicit message "what manner of people would oppose Mother and Apple Pie?" - ed.]</span></p><p class="MsoNormal"><span style="font-size:100%;">But more important than the money itself is the message implicitly conveyed along with it. Will incentives be perceived as an intrusive, carrot-and-stick manipulation of health care providers' business decisions?<span> </span>Or will health care providers interpret ARRA as the correction of a reimbursement anomaly, welcoming the opportunity to modernize their information management and <span style="font-weight: bold;">transform</span> </span><span style="font-size:100%;">the care they </span><span style="font-size:100%;">deliver. </span><br /></p><p style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0); text-align: left;" class="MsoNormal">[Cybernetic Miracle™ Alert - note the grandiose term "transform", as opposed to "facilitate" or "improve" - ed.]</p><p class="MsoNormal"><span style="font-size:100%;">Some of the early signs have been worrisome.<span> </span>Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, <b>individuals with a deeper-seated "anti-EHR" bent emerged.</b> Their numbers are small, but <b>their shocking claims -- that EHRs kill people, that massive privacy violations are taking place,<br /></b></span></p> <p class="MsoNormal"><span style="font-size:100%;"><b><span style="font-style: italic;"><span style="color: rgb(255, 0, 0);">[As an information scientist, I'm almost embarrassed to post</span> </span></b><a style="font-weight: bold;" href="http://news.google.com/archivesearch?q=hipaa+violation+complaint&btnG=Search&hl=en&ned=us&um=1&scoring=a"><span style="font-style: italic;">this link</span></a><b><span style="font-style: italic;"><span style="font-weight: bold;"> </span><span style="color: rgb(255, 0, 0);">and</span> </span></b><a style="font-weight: bold;" href="http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=link&linkname=pubmed_pubmed&uid=18369111&ordinalpos=1&log$=relatedarticles&logdbfrom=pubmed"><span style="font-style: italic;">this link</span></a><b><span style="font-style: italic;"><span style="color: rgb(255, 0, 0);">, the results of just a few minutes' work with public resources. Thorough, robust searches in </span></span></b></span><a href="http://www.dialog.com/sources/"><span style="font-style: italic; font-weight: bold;">Dialog</span></a><span style="font-size:100%;"><b><span style="font-style: italic;"><span style="color: rgb(255, 0, 0);">'s suite of databases, </span></span></b></span><span style="font-size:100%;"><b><span style="font-style: italic;"><span style="color: rgb(255, 0, 0);">Current Contents, </span></span></b></span><span style="font-size:100%;"><b><span style="font-style: italic;"><span style="color: rgb(255, 0, 0);">Lexis Nexis, SciFinder etc. would show far more -</span> <span style="color: rgb(255, 0, 0);">ed.]</span></span></b></span></p><p></p><p class="MsoNormal"><span style="font-size:100%;"><b>that shady conspiracies </b></span><span style="font-size:100%;"><b>are operating --</b></span><span style="font-size:100%;"><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"><br /></span></span></p><p class="MsoNormal"><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[i.e.,</span><b> </b><a style="font-weight: bold;" href="http://www.ehrstimulustour.com/"><span style="font-style: italic;">HIT industry lobbies</span></a><b> <span style="font-style: italic; color: rgb(255, 0, 0);">- ed.]</span></b></p><p class="MsoNormal"><span style="font-size:100%;">make stimulating copy for the media. Those experienced with EHRs might <b>laugh these stories off</b>, but risk-averse newcomers to health IT</span><span style="font-size:100%;">, both health care providers and policymakers<br /></span></p><p class="MsoNormal"><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[i.e., those who take due diligence and </span><span style="font-style: italic;"><a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html">fiduciary responsibilities</a> </span><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">seriously - ed.]</span></p><p class="MsoNormal"><span style="color: rgb(0, 0, 0);">are easily affected by <span style="font-weight: bold;">fear mongering.</span></span><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"><br /></span></p><p></p></blockquote> <!--EndFragment--> </div><br />That is, <span style="font-weight: bold;">Bah!</span> to the apostates' narratives --<br /><br />-- even though many of these narratives are in the peer-reviewed biomedical science and biomedical informatics literature ...<br /><br /><span style="font-size:100%;"><br /></span><div style="text-align: center;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihjCTKnPgicc5ejVkr4Ex4OyrM2g1xnJVBBk6asH_ruJA_eC4iHj6sCB5fu-41HiMhGkDTur9LhwNe6gwuO0v52VKqj6SzqfXOaz1RsX3hfoxzTCdpc2P22sDi_3uwR5o_PeWW6rWTO05Q/s1600-h/dogbert.gif"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5350412883081586530" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihjCTKnPgicc5ejVkr4Ex4OyrM2g1xnJVBBk6asH_ruJA_eC4iHj6sCB5fu-41HiMhGkDTur9LhwNe6gwuO0v52VKqj6SzqfXOaz1RsX3hfoxzTCdpc2P22sDi_3uwR5o_PeWW6rWTO05Q/s320/dogbert.gif" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 166px; height: 165px;" /></a><span style="font-weight: bold;">Bah!</span><br /></div><span style="font-size:100%;"><br /><br />I'm really tired of amateurish political rhetoric and marketing puffery masquerading as substantive debate on critical issues as above. However, being experienced with EHRs, their design, implementation and lifecycle, and concerned with widespread irrational exuberance over health IT (a facilitative tool that carries risk to patients and medical organizations if not done well) I am not at all "laughing these stories off", and will critique the above in a quite serious manner. </span><span style="font-size:100%;"><br /><br />Indeed, "laughing off" stories from credible sources and personnel (e.g., many AMIA members) about potential harm from an experimental technology affecting patients seems the height of hubris, or blindness of a kind mediated by </span><span class="ResultBody">incomplete knowledge</span><span style="font-size:100%;"> or conflicts of interest.<br /><br />First, binary thinking. It seems those who critique health IT's drawbacks are "</span><span style="font-size:100%;"><b>individuals with a deeper-seated anti-EHR bent</b>." That is, they don't buy into the consensus of the industry "experts" and must therefore be biased and wrong. </span><div><div><br /><div><div><span style="font-size:100%;">I, in fact, am a health IT proponent, but simply abhor poor HIT such as at my series <a href="http://tinyurl.com/b28s74">here</a>, or HIT sold to my organization in an unusable (but "Certified") state as in the Civil Complaint <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf">here</a> (PDF). I believe the rush to <a href="http://www.jamia.org/cgi/content/abstract/13/1/106">national EHR by 2014 is premature</a>, will waste massive amounts of money, and will cause disruption to an already strained healthcare system with resultant adverse effects. I believe far more research remains to be done before our social and technical understanding of "how to do clinical IT well" justifies mass government-mandated cybernetic re-engineering in healthcare. (See literature list below.)</span><div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;">On the issue of ad hominem attacks against questions and critique, I documented those at Healthcare Renewal at</span><span class="Apple-style-span" style="font-size:100%;"> </span><span class="Apple-style-span" style="color: rgb(153, 51, 51);font-size:100%;" ><span class="Apple-style-span" style="letter-spacing: -1px; line-height: 19px;"><b><span class="Apple-style-span">"</span><span class="Apple-style-span" style="color: rgb(0, 0, 0); letter-spacing: normal; line-height: normal;"><span class="Apple-style-span">Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-Certified HIT</span></span><span class="Apple-style-span" style="color: rgb(0, 0, 0); font-weight: normal; letter-spacing: normal; line-height: normal;"><span class="Apple-style-span">" </span><a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2009/06/open-letter-to-mark-leavitt-chairman.html"><span class="Apple-style-span">at this link</span></a><span class="Apple-style-span">. Both I and another physician, David Kibbe, MD, M</span></span></b></span></span><span style="font-size:100%;"><span class="Apple-style-span" style="letter-spacing: -1px; line-height: 19px;"><b><span class="Apple-style-span" style="color: rgb(0, 0, 0); font-weight: normal; letter-spacing: normal; line-height: normal;"><span class="Apple-style-span">BA, <span class="Apple-style-span">Health IT Consultant at American Academy of Family</span><span class="Apple-style-span"> Physicians, were subjected to "nonlinear" commentary.</span></span></span></b></span><br /><br />It also seems Dr. Leavitt is unfamiliar with or deliberately downplaying a growing body of literature on health IT risks and failures. <span style="font-style: italic; color: rgb(255, 0, 0); font-weight: bold;">[Health IT failure never, ever puts patients at risk, as I wrote</span><span style="font-weight: bold;"> </span><a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2009/05/health-it-failure-never-puts-patients.html"><span style="font-style: italic;">here</span></a>, <span style="font-style: italic; color: rgb(255, 0, 0); font-weight: bold;">of course - ed.]</span><br /><br />Examples of this growing body of "unknown" or "ignored" or "downplayed" literature include:<br /></span></div><!--StartFragment--> <!--EndFragment--> <div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;">1. The article "<a href="http://www.jamia.org/cgi/content/full/16/3/291">Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop</a>", </span><span class="Apple-style-span" style="font-size:100%;"><span class="Apple-style-span" style="">Bonnie Kaplan and Kimberly D. Harris-Salamone, Journal of the American Medical Informatics Association 2009;16:291-299. DOI 10.1197/jamia.M2997 - and the references cited.</span></span></div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;">There are more than<b> 70 references</b> at the end of this article (See fulltext at link above), and my comments on the findings and recommendations of the multi-working group informatics workshop that created it are in the post "</span><span class="Apple-style-span" style=";font-family:Helvetica;font-size:100%;" ><span class="Apple-style-span" style="font-family:georgia;"><b>Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop</b>"</span><span class="Apple-style-span" style="font-family:Georgia;"> <a href="http://hcrenewal.blogspot.com/2009/03/health-it-project-success-and-failure.html">at this link</a>.</span></span></div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;">2. This corpus of literature below. These are just examples and not a comprehensive listing:</span></div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;"><blockquote><span style="font-size:100%;">Joint Commission: <a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm">Sentinel Events Alert on HIT</a>, Dec. 2008.<br /><br />National Research Council report. <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">Current Approaches to U.S. Healthcare Information Technology are Insufficient</a>. Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions, Jan. 2009<br /><a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15302.htm"><br />The National Programme for IT in the NHS: Progress since 2006,</a> Public Accounts Committee, January 2009. Summary points <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a>.<br /><br /><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">Common Examples of Healthcare IT Difficulties</a> (my own 10-year-old website). S. Silverstein, MD, Drexel University College of Information Science and Technology.<br /><br /></span><span style=";font-family:times new roman;font-size:100%;" ><a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians</a>, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278 </span><br /><span style="font-size:100%;"><br /><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf">Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems</a>, Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1<br /><br /><a href="http://www.ncbi.nlm.nih.gov/pubmed/18213422">Failure to Provide Clinicians Useful IT Systems: Opportunities to Leapfrog Current Technologies</a>, Ball et al., Methods Inf Med 2008; 47: 4–7,<br /><br /><a href="http://jama.ama-assn.org/cgi/content/extract/301/9/919">IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans’ Medical Centers</a>, JAMA Mar. 4, 2009, p. 919-920.<br /><br /><a href="http://pediatrics.aappublications.org/cgi/content/abstract/116/6/1506">Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System</a>, Han et al., Pediatrics Vol. 116 No. 6 December 2005, pp. 1506-1512<br /><br /><a href="http://jama.ama-assn.org/cgi/content/abstract/293/10/1197">Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors</a>. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203<br /></span><br /><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>. Christopher Nemeth, <em></em>Richard Cook. <em></em>Journal of Biomedical Informatics. 38 (4): 262-3.<br /><span style="font-size:100%;"><br /><a href="http://www.jamia.org/cgi/content/short/15/4/408">Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety</a>, Koppel, Wetterneck, Telles & Karsh, JAMIA 2008;15:408-423<br /><br /><a href="http://www.nytimes.com/2009/03/06/opinion/06coben.html">The Computer Will See You Now</a>, New York Times, Armstrong-Coben, March 5, 2009,<br /><br /><a href="http://iig.umit.at/efmi/badinformatics.htm">Bad Health Informatics Can Kill</a>. Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).<br /><br /><a href="http://archinte.ama-assn.org/cgi/content/short/167/13/1400">Electronic Health Record Use and the Quality of Ambulatory Care in the United States</a>. Arch Intern Med. 2007;167:1400-1405<br /></span><span style="font-weight: bold;"><br /></span><a href="http://www.jamia.org/cgi/content/abstract/13/1/106">Predicting the Adoption of Electronic Health Records by Physicians: When Will Health Care be Paperless?</a> Ford et al., J Am Med Inform Assoc. 2006;13:106-112<br /><br /><a href="http://www.jamia.org/cgi/content/abstract/16/3/274">Resistance Is Futile: But It Is Slowing the Pace of EHR Adoption Nonetheless</a>, Ford et al., J Am Med Inform Assoc. 2009;16:274-281<br /><span style="font-size:100%;"><br /><a href="http://archinte.ama-assn.org/cgi/reprint/165/10/1111.pdf">High Rates of Adverse Drug Events in a Highly Computerized Hospital</a>, Nebeker at al., Arch Intern Med. 2005;165:1111-1116.<br /><br />"<a href="http://articles.icmcc.org/2009/01/23/dutch-ehr-postponed-are-they-in-good-company/">Dutch nationwide EHR postponed: Are they in good company?</a>", ICMCC.org, Jan. 24, 2009<br /><br />“<a href="http://www.ama-assn.org/amednews/2006/12/11/bisa1211.htm">Avoiding EMR meltdown</a>.” About a third of practices that buy electronic medical records systems stop using them within a year, AMA News, Dec. 2006.<br /><br />"The failure rates of EMR implementations are also consistently high at close to 50%", from <a href="http://www.infoclin.ca/assets/emr%20success%20methodologies%20framework%20development%20ishimr%202006%20v2.pdf">Proceedings of the 11th International Symposium on Health Information Management Research</a> – iSHIMR 2006<br /><br />"Industry experts estimate that failure rates of Electronic Medical Record (EMR) implementations range from 50–80%.", from <a href="https://www.advancedmd.com/pressroom/white_papers/commonsense_to_emrs.pdf">A Commonsense Approach to EMRs</a>, July 2006<br /><br /><a href="http://www.taxonomer.com/PublishTxgd001/index.htm">Adverse Effects of Information Technology in Healthcare</a>. This knowledge center presents a collection of information on the adverse effects of information technology in its application to healthcare. It also references sources of information on information security, and related media reports.<br /><br /><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf">Pessimism, Computer Failure, and Information Systems Development in the Public Sector</a>. Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007<br /><br />The literature at my HIT website's "<span style="font-weight: bold;">Other Resources</span>" page (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=other">link</a>)<br /><br /></span>The teachings of the field of <span style="font-weight: bold;">Social Informatics</span> about new Information and Communications Technologies (ICT's) and the unanticipated negative consequences they cause. An introductory essay entitled “<span style="font-weight: bold;">Learning from Social Informatics</span>” by R. Kling at the University of Indiana can be found <a href="http://rkcsi.indiana.edu/archive/SI/Arts/SI_report_Aug_14.doc">at this link</a> (MS-Word file). The book “<span style="font-weight: bold;">Understanding And Communicating Social Informatics</span>” by Kling, Rosenbaum & Sawyer, Information Today, 2005 (<a href="http://www.amazon.com/Understanding-Communicating-Social-Informatics-Communication/dp/1573872288/ref=sr_1_1/102-9749119-8288920?ie=UTF8&s=books&qid=1174318804&sr=8-1">Amazon.com link here</a>) was based on this essay.<br /></blockquote></span></div><div><span style="font-size:100%;"><br /><br /></span></div><div><span style="font-size:100%;">3. The warnings of HIT dangers from the U.S. Joint Commission, the EFMI, as linked above, and others; doubts about cost savings from Wharton and Stanford professors (surely no amateurs). </span></div><div><span class="Apple-style-span" style="color: rgb(51, 51, 51);font-size:100%;" ><span class="Apple-style-span" style="line-height: 19px;"><br /></span></span></div><div><span class="Apple-style-span" style="color: rgb(51, 51, 51); line-height: 19px;font-size:100%;" ><span class="Apple-style-span">In the June 20, 2009 Wall Street Journal article "</span><a href="http://online.wsj.com/article/SB10001424052970204005504574235751720822322.html" style="color: rgb(102, 153, 204);"><span class="Apple-style-span">The Myth of Prevention</span></a><span class="Apple-style-span">", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed </span><a href="http://hcrenewal.blogspot.com/2009/06/wharton-on-healthcare-it-can-i-go-home.html" style="color: rgb(102, 153, 204);"><span class="Apple-style-span">several Wharton professor's doubts</span></a><span class="Apple-style-span"> about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:</span></span></div><div><span class="Apple-style-span" style="color: rgb(51, 51, 51);font-size:100%;" ><span class="Apple-style-span" style="line-height: 19px;"><br /></span></span></div><div><span class="Apple-style-span" style="color: rgb(51, 51, 51);font-size:100%;" ><span class="Apple-style-span" style="line-height: 19px;"> <!--StartFragment--> <blockquote>... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.</blockquote></span></span></div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;">There are also reports of problems from FDA-like agencies of other countries such as Sweden's, whose </span><span class="Apple-style-span" style="color: rgb(51, 51, 51); line-height: 19px;font-size:100%;" ><span class="Apple-style-span">report entitled "</span><span style="font-weight: bold;"><span class="Apple-style-span">The Medical Products Agency’s Working Group </span></span><span style="font-weight: bold;"><span class="Apple-style-span">on Medical Information Systems: Project summary</span></span><span class="Apple-style-span">" (available in English translation at </span><a href="http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf" style="color: rgb(102, 153, 204);"><span class="Apple-style-span">this link</span></a><span class="Apple-style-span"> in PDF) stated:</span></span></div><div><span class="Apple-style-span" style="color: rgb(51, 51, 51);font-size:100%;" ><span class="Apple-style-span" style="line-height: 19px;"><br /></span></span></div><div style="font-family:georgia;"><span class="Apple-style-span" style="color: rgb(51, 51, 51);font-size:100%;" ><span class="Apple-style-span" style="line-height: 19px;"> <!--StartFragment--> <blockquote><div><span class="Apple-style-span" style="color: rgb(51, 51, 51);"><span class="Apple-style-span" style="line-height: 19px;"><p class="MsoNormal"><span class="Apple-style-span">It is becoming more common that electronic patient record systems and other systems are interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems should not be regarded as “purely administrative”; instead they have the characteristic features that are typical for medical devices. They sort, compile and present information on patients’ treatments and should therefore be regarded as medical devices in accordance to the definition.</span></p><p class="MsoNormal"><span class="Apple-style-span">Since the electronic patient record system often replaces/constitutes the user interface of “traditional” medical device systems, the call for 100% accuracy of the presented information is increased. </span><b><span class="Apple-style-span">Patient record systems have crucial impact on patient safety, and this has been proven to be the case after a series of incidents <span style="font-style: italic; color: rgb(204, 0, 0);">[including deaths - ed.]</span> that has been reported to the Swedish National Board of Health and Welfare.</span></b></p> <!--EndFragment--> </span></span></div></blockquote></span></span></div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;">On wonders if Dr. Leavitt would include the Swedish Medical Products Agency, who incidentally have a <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108646.htm">cooperation agreement with our own FDA</a>, under the category of "fearmongers."<br /><br />Finally, stories of HIT mayhem of which Dr. Leavitt seems blissfully unaware are making their way to appropriate political circles. The whistleblowers are afraid to speak out publicly due to fear of job loss or retaliation. However, when the case examples do come out, it may be Dr. Leavitt who will be found to be "fear mongering" about those who care more about patients and their rights than about information technology.</span></div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;"><b>Health IT Under ARRA: It's Not the Money, It's the Message.</b> Indeed.</span></div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;">And Dr. Leavitt's message about those who think critically about health IT seems quite ill informed and mean spirited. </span></div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;">Finally, to get past the <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">ad hominem</a> and other <a href="http://en.wikipedia.org/wiki/List_of_fallacies">logical fallacy</a> nonsense I believe will be coming my way, I'll just admit to any and all of it. I'm an SOB, I'm a disgruntled curmudgeon, I'm an HIT dilettante, my uncle was in the mafia, I kick little cygnet swans in the park to be mean to </span><span style="font-size:100%;">Chucky,</span><span style="font-size:100%;"> the cob (father) , and Princess, the pen (mother). </span><span style="font-size:100%;"> /sarc<br /><br />:-)<br /></span><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;"><br /></span></div><div><span style="font-size:100%;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7_n2tP9xo0-LteaFfG7X7klaFrboNttoMfHWIPtseqS2hofqwvADV7FRi62-G0wyTVtUqur42848Q2a8QeC3UBLRfQSfUnPxraclf5_RItFd2DCOuVQ25bwDjjB6jkSpGIgqMPMnsAyL8/s1600-h/swan_family_june22_2009.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5350396710705376466" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7_n2tP9xo0-LteaFfG7X7klaFrboNttoMfHWIPtseqS2hofqwvADV7FRi62-G0wyTVtUqur42848Q2a8QeC3UBLRfQSfUnPxraclf5_RItFd2DCOuVQ25bwDjjB6jkSpGIgqMPMnsAyL8/s320/swan_family_june22_2009.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 316px; height: 215px;" /></a></span></div><div style="text-align: center;"><span style="font-size:100%;"><span style="font-size:85%;">The Mute Swan family of Towamencin Twp., PA. Click to enlarge. The cygnets have really grown this past month (major cuteness warning if you click <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cygnus.jpg">this picture</a> from June 1!)</span><br /></span></div><div><span style="font-size:100%;"><br /><br />Now that we're hopefully past the expected <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">ad hominem</a>, perhaps the real issues can be addressed.<br /><br />As a final piece of advice to Dr. Leavitt, I can add that dismissing concerns of others, Dogbert-style, is not a way to win friends and influence people.<br /></span><br /></div><div><span style="font-size:100%;">Humor and a little humility work much better.<br /><br />-- SS</span></div></div></div></div></div></div></div>

Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?

Signs that a leader who alleges himself or herself to be objective and a scientist is, in fact, neither objective nor scientific include: Re...

Đọc thêm »

An Original Excuse

The Associated Press just published <a href="http://www.google.com/hostednews/ap/article/ALeqM5iqRyDDIAJ4RAA-ImdqfMw4q86TcQD98UHT7G0">a story </a>about another company which apparently failed to report adverse events associated with its product:<br /><blockquote><br />Complaints about a contact lens solution linked to a 2007 outbreak of eye infections that blinded several people went unreported by the manufacturer for more than a year, government documents show.<br /><br />The documents show <em>Advanced Medical Optics received complaints about the solution more than a year before it was recalled, and failed to promptly report nine complaints as required by law</em>.<br /><br />The company <em>pulled its Complete MoisturePlus off the market in May 2007 after the Centers for Disease Control and Prevention linked the fluid to dozens of cases of a serious infection called Acanthamoeba keratitis</em>.<br /><br />Lawyers for customers suing AMO obtained the documents, which stem from a previously undisclosed inspection by the Food and Drug Administration, through a Freedom of Information Act request. The papers were obtained by The Associated Press.<br /><br />Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP, three had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant. The others suffered permanent vision damage.<br /><br /><em>Beginning in February 2006 and continuing through November, AMO received a series of complaints about users who were diagnosed with the Acanthamoeba infections. But those reports were not disclosed until June 2007</em>, when FDA inspectors came to investigate the company's headquarters following its product recall.<br /></blockquote><br /><br />What is most striking is the company's rationale for not reporting:<br /><blockquote><br />When questioned by FDA inspectors, company officials said <em><strong>they were not obligated to report the complaints because the product's labeling does not say it protects against Acanthamoeba</strong></em>, according to the FDA documents.<br /><br />Kelly Morrison, a spokeswoman for Abbott Laboratories, which acquired AMO in February, said the company 'believed it was reporting customer complaints in compliance with FDA regulations.' She declined to elaborate. Abbott Laboratories is based in North Chicago.<br /></blockquote><br /><br />That is an original excuse. Did the "company officials" really mean to imply that in the absence of a promise to protect against a specific microbiologic organism, patients and physicians should assume that the product could be contaminated with that organism? This completely ignores the company's basic responsibility to supply a product that is uncontaminated with any harmful organisms, and unadulterated with any harmful substances, and hence to be vigilant for any events that suggest that the product could have been contaminated or adulterated.<br /><br />The "company officials'" bizarre excuse suggest a fundamental lack of comprehension of their responsibilities for the health and safety of the patients using their products. This is a particularly weird example of how little many leaders of health care organizations understand about health care.

An Original Excuse

The Associated Press just published a story about another company which apparently failed to report adverse events associated with its produ...

Đọc thêm »

All for Good: Bringing search, scale and openness to community service

While many organizations are doing great work to enable community service locally, it's not simple to search across opportunities from a variety of places to find what's right for you. We have some experience finding relevant information from among many scattered sources, and when we learned that President Obama and the First Lady were making community service <a href="http://www.time.com/time/politics/article/0,8599,1872152,00.html?iid=fb_share">a top priority even before taking office</a>, we thought we could help make a difference.<br /><br />With our mission in mind, a group of <a href="http://googleblog.blogspot.com/2006/05/googles-20-percent-time-in-action.html">"20%" engineers, designers, and program managers</a> from Google and other tech companies began work on <a href="http://www.allforgood.org/">All for Good</a>, a new service to help you find volunteer events in your community, and share those events with your friends.<br /><br />All for Good provides a single search interface for volunteer activities across many major volunteering sites and organizations like <a href="http://www.liveunited.org/">United Way</a>, <a href="http://www.volunteermatch.org/">VolunteerMatch</a>, <a href="http://www.handsonnetwork.org/">HandsOn Network</a> and <a href="http://www.reachoutandread.org/about_find.html">Reach Out and Read</a>. By building on top of the amazing efforts of existing volunteer organizations like these, we hope to amplify their efforts.<br /><br /><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhA2WVFmZPobuFjacpLk0mito4oDevdpk_15F_a2GSzBfTXVDwlZL500HsiAQzgOuBOzJnV8MiVzRvLNpbfYGGh4-ukLsk8YexwCvqKpEcxQaVmDFmE-8KU39YuuOdPBvIjjFrNOrNA6wJX/s1600-h/afg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5350174920223874754" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhA2WVFmZPobuFjacpLk0mito4oDevdpk_15F_a2GSzBfTXVDwlZL500HsiAQzgOuBOzJnV8MiVzRvLNpbfYGGh4-ukLsk8YexwCvqKpEcxQaVmDFmE-8KU39YuuOdPBvIjjFrNOrNA6wJX/s400/afg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 228px;" /></a><br />And in the spirit of open data, All for Good has a data API that anyone can use to search the same data displayed on the All for Good site. All for Good was developed entirely using <a href="http://code.google.com/appengine/">App Engine</a> and <a href="http://www.google.com/base/">Google Base</a>, with the full code repository hosted on <a href="http://code.google.com/hosting/">Google Code Hosting</a>. We'll be inviting developers to contribute to the open source application soon, so stay tuned.<br /><br />Just as releasing the Maps API led to an surge of independent and creative uses of geographic information, we've built All for Good as a platform to encourage innovation in volunteerism, as much as an end product in itself. We hope software developers will use the API or code to build their own volunteering applications, some even better than the All for Good site!<br /><br />And if you want to volunteer your video-creating skills to make a difference, check out <a href="http://www.youtube.com/videovolunteers">YouTube Video Volunteers</a>, a new platform designed to make connections between non-profits with video needs and skilled video makers who can help broadcast their causes through video.<br /><br />All for Good is a new kind of collaboration between the private, public and nonprofits sectors to build free and open technology to empower citizens. Similar to the Open Social Foundation, we helped create a new organization called Our Good Works to make sure that the API, the platform, and social innovation that they inspire are supported for the long term. The leadership includes Reid Hoffman, Chris DiBona, Arianna Huffington and Craig Newmark on the board, and the organization aims to build support volunteerism services like All for Good.<br /><br />Today the First Lady is in San Francisco calling on Americans to improve our communities by rolling up our sleeves and putting our time and talent towards doing good. You can learn more at <a href="http://serve.gov/">serve.gov</a>, where we're proud to power search.<br /><br /><span class="byline-author">Posted by Paul Rademacher and Adam Sah, Engineering Tech Leads</span>

All for Good: Bringing search, scale and openness to community service

While many organizations are doing great work to enable community service locally, it's not simple to search across opportunities from a...

Đọc thêm »

A new landmark in computer vision

Science fiction books and movies have long imagined that computers will someday be able to see and interpret the world. At Google, we think computer vision has tremendous potential benefits for consumers, which is why we're dedicated to research in this area. And today, a Google team is presenting a paper on landmark recognition (think: Statue of Liberty, Eiffel Tower) at the <a href="http://www.cvpr2009.org/">Computer Vision and Pattern Recognition (CVPR) conference</a> in Miami, Florida. In the paper, we present a new technology that enables computers to quickly and efficiently identify images of more than 50,000 landmarks from all over the world with 80% accuracy.<br /><br />To be clear up front, this is a research paper, not a new Google product, but we still think it's cool. For our demonstration, we begin with an unnamed, untagged picture of a landmark, enter its web address into the recognition engine, and <span class="Apple-style-span" style="font-style: italic;">poof</span> — the computer identifies and names it: "Recognized Landmark: Acropolis, Athens, Greece." Thanks computer.<br /><br />How did we do it? It wasn't easy. For starters, where do you find a good list of thousands of landmarks? Even if you have that list, where do you get the pictures to develop visual representations of the locations? And how do you pull that source material together in a coherent model that actually works, is fast, and can process an enormous corpus of data? Think about all the different photographs of the <a href="http://images.google.com/images?q=golden%20gate%20bridge">Golden Gate Bridge</a> you've seen — the different perspectives, lighting conditions and image qualities. Recognizing a landmark can be difficult for a human, let alone a computer.<br /><br />Our research builds on the vast number of images on the web, the ability to search those images, and advances in object recognition and clustering techniques. First, we generated a list of landmarks relying on two sources: 40 million GPS-tagged photos (from <a href="http://picasaweb.google.com/">Picasa</a> and <a href="http://www.panoramio.com/">Panoramio</a>) and online tour guide webpages. Next, we found candidate images for each landmark using these sources and <a href="http://images.google.com/">Google Image Search</a>, which we then "pruned" using efficient image matching and unsupervised clustering techniques. Finally, we developed a highly efficient indexing system for fast image recognition. The following image provides a visual representation of the resulting clustered recognition model:<br /><br /><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgfCuAeLMg9C8JTj9ko8qyuRzlzYsNWPiqPxHXI2h86xZVdWo5_71MvMkEwLSeSj2-pE6dn_Ie7qHZvkhyphenhyphenF7U0K6dXMIBdo5fweTVm8m0RhkZdbTOJr2nroDPk_7ixn-9JVdQZp08KN7QLR/s1600-h/Acropolis+Cluster.png"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5350151754492326706" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgfCuAeLMg9C8JTj9ko8qyuRzlzYsNWPiqPxHXI2h86xZVdWo5_71MvMkEwLSeSj2-pE6dn_Ie7qHZvkhyphenhyphenF7U0K6dXMIBdo5fweTVm8m0RhkZdbTOJr2nroDPk_7ixn-9JVdQZp08KN7QLR/s400/Acropolis+Cluster.png" style="display:block; margin:0px auto 10px; text-align:center;cursor:pointer; cursor:hand;width: 370px; height: 400px;" /></a><br /><div style="text-align: center;"><span class="Apple-style-span" style=" font-style: italic; font-size:10px;">In the above image, related views of the Acropolis are "clustered" together, allowing for a more efficient image matching system.</span><br /></div><br />While we've gone a long way towards unlocking the information stored in text on the web, there's still much work to be done unlocking the information stored in pixels. This research demonstrates the feasibility of efficient computer vision techniques based on large, noisy datasets. We expect the insights we've gained will lay a useful foundation for future research in computer vision.<br /><br />If you're interested to learn more about this research, check out the <a href="http://www.google.com/googleblogs/pdfs/google_landmark_recognition.pdf">paper</a>.<br /><br /><span class="byline-author">Posted by Jay Yagnik, Head of Computer Vision Research</span>

A new landmark in computer vision

Science fiction books and movies have long imagined that computers will someday be able to see and interpret the world. At Google, we think ...

Đọc thêm »

Bungled Brachytherapy, Computer Interfaces and Other Mysteries At The Philadelphia Veterans Administration Hospital

The Philadelphia VA Hospital has had some problems with <a href="http://en.wikipedia.org/wiki/Brachytherapy">brachytherapy</a> (implantation of small radioactive pellets for prostate cancer) recently. Multiple procedures were bungled, including wrong placement and incorrect dosages.<br /><div><br /></div><div>In this story, there apparently is a computer involved. From the New York Times article "<a href="http://www.nytimes.com/2009/06/21/health/21radiation.html?pagewanted=1&_r=1">At VA Hospital, a Rogue Cancer Unit</a>", June 20, 2009:</div><div><br /></div><div><div color="#333333" style="font: 15.0px Georgia; line-height: 22.0px; margin: 0.0px 0.0px 15.0px 0.0px;"></div><blockquote><div color="#333333" style="font: 15.0px Georgia; line-height: 22.0px; margin: 0.0px 0.0px 15.0px 0.0px;">... The hospital suspended the brachytherapy program on June 11 last year. By then, 45 substandard implants had been found.</div><div style="color: #333333; font: 15.0px Georgia; line-height: 22.0px; margin: 0.0px 0.0px 15.0px 0.0px;">Two days later, the Joint Commission, which helps set standards in the hospital industry, surveyed the Philadelphia V.A. and on the next day accredited the hospital. “This organization is in full compliance with applicable standards,” the Joint Commission said.</div><div style="color: #333333; font: 15.0px Georgia; line-height: 22.0px; margin: 0.0px 0.0px 15.0px 0.0px;">The commission said that it had no indications of the problems in the brachytherapy program when it arrived at the hospital and that its surveys are not detailed enough to have uncovered the flawed implants.<b><i><span class="Apple-style-span" style="color: red;"> [Or, apparently, flawed computers - ed.]</span></i></b></div><div color="#333333" style="font: 15.0px Georgia; line-height: 22.0px; margin: 0.0px 0.0px 15.0px 0.0px;">Soon after, the N.R.C. sent its own inspectors to Philadelphia. And the more the inspectors looked, the more they found. All told, 57 of the implants delivered too little radiation to the prostate, either because the seeds missed the prostate or were not distributed properly inside the prostate. Thirty-five other cases involved overdoses to other parts of the body. An unspecified number of patients were both underdosed in the prostate and overdosed elsewhere.</div><div style="color: #333333; font: 15.0px Georgia; line-height: 22.0px; margin: 0.0px 0.0px 15.0px 0.0px;">From December 2006 to November 2007, the nuclear commission found, 16 patients received seed implants in Philadelphia <b>even though computer interface problems prevented medical personnel from determining whether those treatments had been successful.</b> The V.A.’s radiation officials knew of the problem but took no action, the nuclear commission charges.</div><div style="color: #333333; font: 15.0px Georgia; line-height: 22.0px; margin: 0.0px 0.0px 15.0px 0.0px;"><br /></div></blockquote></div>I am uncertain how "computer interface problems" (in the <a href="http://www.philly.com/philly/news/homepage/20090621_Feds_see_wider_woes_in_VA_s_cancer_errors.html">Philadelphia Inquirer</a>, they were referred to as "glitches") prevented medical personnel from determining treatment success over several years. I would be most interested in hearing more about these "interface problems."<br /><div><br /></div><div>Here are some questions:</div><div><br /></div><div><ul><li>Did these problems involve the VistA system?</li><li>What was interfaced to what, exactly?</li><li>Who did the interfacing?</li><li>What regulatory authorities validated the interfaces and systems? </li><li>If no regulatory agency was involved, why not?</li></ul></div><div><div><br /></div><div>I have some familiarity with odd events at the Philadelphia VA Hospital. (Not including the fact that I spent a few months there as a medical intern in the early 1980's). In the mid 1990's I took my father there for evaluation for increased service-related disability. He had been treated for skin lesions in the Army in WW2 and after by the VA with <a href="http://en.wikipedia.org/wiki/Fowler%27s_solution">Fowler's solution</a> (an arsenical) and as a consequence of this (even then-outdated and dangerous) treatment, had developed widespread basal cell carcinomatosis over a major portion of his body, with chronic bleeding and discomfort. I accompanied my father to the exam but did not identify myself as an MD, only as his son.</div><div><br /></div><div>My father was seen in an evaluation by several physicians and students (arsenic-caused basal cell carcinomatosis is quite rare now) in my presence, and he was then handed his (paper) chart to take with him back to the main desk. I told my dad I wanted to look at the note. The note by a physician who'd seen him stated (paraphrasing):</div><div><br /></div><div><blockquote>"Mr. Silverstein said he'd taken more than the prescribed dose of arsenic for years, and even shared it with his wife."</blockquote></div><div><br /></div><div>My father and I were shocked and dumbfounded. He'd said no such thing, and being a retired pharmacist of 40+ years, thought anyone making such a statement would have had to have been insane. (My mother had even harsher words when she heard about this.)</div><div><br /></div><div>Needless to say, I was upset. I confronted the physician who wrote the note, but that physician would not change it, bizarrely claiming that they remembered my father telling that story in a visit<i> several years prior. </i>Needless to say, such a claim violated all the precepts of medical information integrity of which I was familiar.</div><div><br /></div><div>In an initial attempt to counteract this disability exam sabotage, I actually crossed out the statement in the chart, writing "this is untrue" or words to that effect and signed my <i>own</i> name. </div><div><i><br /></i></div><div>The head of the Philadelphia VA Hospital would not return my calls on this matter.</div><div><br /></div><div>That is, until <a href="http://rockefeller.senate.gov/press/record.cfm?id=291882">Jesse Brown, then Secretary of the Department of Veterans' Affairs</a>, inquired directly a few days later.<br /><br />Unknown to the VA examiners, my father had been sent for the disability exam <b>after reporting problems to Sen. Jay Rockefeller's office about prolonged delays in having his case heard</b>.  Sen. Rockefeller's staff had set up the exam!<br /><br />Sen. Rockefeller's staff was rather upset at the story I reported upon my return to New Haven about the bizarre chart fabrication at my father's VA disability exam, and apparently relayed the story up the chain of command, as it were. </div><div><br /></div><div>After that, the head of the Philadelphia VA Hospital <b>really, really</b> wanted to speak to me and called me at Yale several times. He wanted to set up a phone conference between me, himself, and the doctors who'd seen my father. I told his administrative assistant that there was "nothing to talk about", and that the false statement in my father's chart would be removed. <b>Period.</b></div><div><br /></div><div>I think it was. My father's increased disability was granted in the end, but what was going on here with disability exams was never fully investigated to my knowledge (having done disability exams myself years prior for the regional transit authority, police, fire etc. in Philadelphia, I suspected an "incentive" program to deny vets a disability determination). If I had not examined my father's chart, we might have never known a reason for his being turned down. </div><div><br /></div><div>A culture of honesty and accountability seemed lacking then, and seems lacking now.</div><div><br /></div><div>Let's hope the investigation of these brachytherapy failures and "computer interface problems" is a bit more thorough than in my father's situation.</div><div><br /></div><div>-- SS</div><div><br /></div></div>

Bungled Brachytherapy, Computer Interfaces and Other Mysteries At The Philadelphia Veterans Administration Hospital

The Philadelphia VA Hospital has had some problems with brachytherapy (implantation of small radioactive pellets for prostate cancer) recen...

Đọc thêm »

Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices. And, Can We Drop the "Massive Cost Savings" Fable?

Here is some sense on healthcare IT from the European Union, echoing a number of themes I've written about at Healthcare Renewal and my <a href="http://www.tinyurl.com/hit-misadventure">academic site</a> on HIT difficulties and failures.<br /><br />These themes revolve around the consideration of healthcare information systems (increasingly used to mediate many aspects of medical care delivery) as medical devices requiring regulation by transparent and impartial authorities - i.e., without conflicts of interest; the importance of regulation due to the adverse consequences caused by ill designed and/or poorly implemented HIT; the need for validation and postmarketing surveillance of the performance of these systems; and vendor accountability.<br /><br />From the <a href="http://www.lakemedelsverket.se/english/">Swedish Medical Products Agency</a>:<br /><span style="font-weight: bold;"><br /></span><blockquote><a href="http://www.lakemedelsverket.se/english/All-news/NYHETER---2009/Improving-patient-safety-in-the-EU-Many-Medical-Information-Systems-should-be-classified-as-Medical-Devices/">Improving patient safety in the EU: Many Medical Information Systems should be classified as Medical Devices </a><br /><br /><span class="datetext">Thursday, June 18, 2009</span><br /><br />Correctly functioning Information Technology (IT) systems for health care is a prerequisite for ensuring patient safety. However, applicable regulation is rarely applied, mainly due to the lack of useful guidelines on how to classify the IT-systems <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[guidelines whose formulation has been resisted for many years by the HIT industry, I might add - ed.]</span> A national working group in Sweden has prepared a guidance report that will help increase compliance with the Medical Device regulation in the EU, thus improving patient safety.<br /><br />An increasing number of serious incidents, with IT-systems involved, have been reported from the health care sector in recent years <span style="font-style: italic; font-weight: bold; color: rgb(255, 0, 0);">[but largely covered up in part due to contractual gag clauses on HIT sales and resultant violations of healthcare leadership fiduciary responsibilities - </span><span style="font-style: italic; font-weight: bold;">see <a href="http://www.hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html">this link</a></span> - <span style="font-style: italic; font-weight: bold; color: rgb(255, 0, 0);">ed.]</span> In most of these cases, existing regulatory regimes have not been applied, either by manufacturers or by health care providers. As a result, the assessment of safety issues has become unclear because the manufacturer’s responsibility is vague. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[It's not vague; it's contractually absent - ed.]</span><br /><br />For this reason, in 2008 the Swedish Medical Products Agency (MPA) initiated a national working group with the aim of providing guidelines for the classification of IT-systems intended to be used in health care. The working group has now prepared a report, intended to serve as guidance for both manufacturers and end-users. At present, there are no guidelines of this kind in Sweden, or the rest of Europe.<br /><br />“Many parties, including the European Commission, have expressed interest in our work. We believe that it will improve the quality and safety of medical information systems. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Finally -ed.] </span>A common approach to product classification is key” says Lennart Philipson, Scientific Director.<br /><br />One important conclusion from the working group is that the Medical Device Directives is the most suitable regulation to be applied.<br /><br />“Our market surveillance of medical information systems will be based on the conclusions in the report from now on. If a system falls within the definition of a medical device, the requirements for CE-marking <span style="font-weight: bold; font-style: italic;">[<span style="color: rgb(255, 0, 0);">Conformité Européene, a</span> <a href="http://www.biz-services-savvy.com/ce-mark.html">branding mark</a> <span style="color: rgb(255, 0, 0);">- ed.]</span></span><span style="color: rgb(255, 0, 0);"> </span>shall be applied” says Mats Ohlson, Chairman of the working group.<br /><br />Manufacturers need to adapt to applicable standards when it comes to quality systems, risk management and usability. They will also need to establish post-market surveillance routines to regularly assess products on the market.<br /><br />The working group consisted of members from the Swedish Medical Products Agency, the National Board of Health and Welfare, the Swedish Association of Local Authorities and Regions, Swedish Medtech, the Swedish Standards Institute, Swedish Electrical Standardization and notified bodies through Intertek Semko.</blockquote><br />A report entitled "<span style="font-weight: bold;">The Medical Products Agency’s Working Group </span><span style="font-weight: bold;">on Medical Information Systems: Project summary</span>" is available in English translation at <a href="http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf">this link</a> (PDF).<br /><br />Download and read the entire report.<br /><br />Highlights:<br /><br /><blockquote><p>A general opinion of the health care providers represented in this Working group is that from a patient safety point of view, i<span style="font-weight: bold;">t is desirable that stand alone software and systems intended to, directly or indirectly, affect diagnosis, health care and treatment of an individual patient <span style="font-style: italic; color: rgb(255, 0, 0);">[what I have referred to a "mediating aspects of care" - ed.]</span> </span>shall be regulated under a <span style="font-weight: bold;">Product Safety Regulation</span>.<span style="font-weight: bold;"> </span><br /></p><p>The Working group has not been able to define any other appropriate regulation than the Medical Device Directive when it comes to the definition of such systems. Adherence to the Medical Device Directive is important so that manufacturers and clients can work with the same intentions. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[I would add that the intentions are not exactly the same; the manufacturers' intentions are, by necessity, to maximize profits - ed.]</span> This project report serves as one step towards the clarification regarding which conditions that shall apply.<br /><br />The Working group believes that <span style="font-weight: bold;">software intended for a medical purpose must be regarded as a "device" <span style="color: rgb(255, 0, 0); font-style: italic;">[indeed - ed.] </span></span>and expressions such as "project", "service" and similar must be avoided describing a Medical Information System. This approach has advantages since a product safety regulation, such as the Medical Device Directive, can be applied and the product will have:<br /><br />• a defined intended use<br />• defined and documented specifications<br />• a manufacturer with a clear responsibility until the delivery is accepted<br />• a controlled ”Post Market” surveillance<br /><br />Furthermore, the Working group believes:<br /><br />• that the Medical Device Directive shall be applicable for software and systems that fulfills the definition of a medical device<br />• that the manufacturer of the intended systems shall follow the appropriate<span style="font-weight: bold;"> </span><span style="font-weight: bold;">validation method</span> <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[e.g., as in the pharma industry's IT - ed.]</span> in the Medical Device Directive<br />• that the level of risk shall be assessed, motivated and control the classification and verification method<br />• that applicable standards shall be followed for design, verification and validation regarding software and information systems that are medical devices<br />• that there is no legal requirement that manufacturers of devices in the lowest device classes must have certification for their operational processes to fulfill the Medical Device Directive. The Medical Products Agency has in these cases no mandate to formally demand certification, such as for instance ISO 13485. However, in reality it is still necessary to have some form of a functional quality management system to manage a proper design process for software systems <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[due to the fact that patients, ethical issues, and human rights issues are involved - ed.]</span> as well as the necessity to fulfill the Post Market Requirements including Vigilance reporting.<br />• that the prerequisite for a successful and fair application of the regulation assumes that health care providers demands that such systems shall be CE‐marked and be regarded as medical devices<br />• that a controlled and standardised verification method when performing installation work in a user’s network, supported by the manufacturer, is an essential supplement to the manufacturer’s CE‐marking and a prerequisite for an acceptable safety level when using the device.</p><p><br /></p> </blockquote>This section gets to the heart of the matter regarding electronic medical records:<p></p><blockquote><p><br /></p><p><span style="font-weight: bold;">8.2.3 Electronic patient records </span><br /></p><p>Electronic patient record systems are <span style="font-weight: bold;">more than an archive for just documents</span>, they also have features for compiling and transferring information to be used for decision making. <span style="font-weight: bold;">Patient records are the basis for documentation and planning of diagnosis, therapy and follow‐up, especially when it comes to drug prescriptions and recommendations. <span style="color: rgb(255, 0, 0); font-style: italic;">[These caveats include CPOE systems as well - ed.]</span></span><br /></p><p>It is becoming more common that electronic patient record systems and other systems are interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems <span style="font-weight: bold;">s</span><span style="font-weight: bold;">hould not be regarded as “purely administrative”</span>; instead they have the characteristic features that are typical for medical devices. They sort, compile and present information on patients’ treatments and should therefore be regarded as medical devices in accordance to the definition.</p><p>Since the electronic patient record system often replaces/constitutes the user interface of “traditional” medical device systems, the call for 100% accuracy of the presented information is increased. Patient record systems have crucial impact on patient safety, <span style="font-weight: bold;">and this has been proven to be the case after a series of incidents that has been reported to the Swedish National Board of Health and Welfare. </span><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[It would be interesting to know more about this "series of incidents" - ed.]</span></p></blockquote><p> </p><br />Finally, in the June 20, 2009 Wall Street Journal article "<a href="http://online.wsj.com/article/SB10001424052970204005504574235751720822322.html">The Myth of Prevention</a>", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed <a href="http://hcrenewal.blogspot.com/2009/06/wharton-on-healthcare-it-can-i-go-home.html">several Wharton professor's doubts</a> about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:<br /><br /><blockquote>... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection. </blockquote><br /><br />HIT can be a facilitator (not a replacement or revolutionary tool) to physicians, if done well, and not overdone to the point of costing far more than <a href="http://hcrenewal.blogspot.com/2006/10/70-million-for-electronic-medical.html">entire new hospitals or hospital wings</a>. There is no replacement for a physician with a strong background in the preclinical and clinical sciences, ethics, critical thinking, and the scientific method. Computers are not a miracle. They can help provide facts, but cannot fundamentally turn a poor physician into a Marcus Welby. Verghese on that issue:<br /><br /><blockquote>To come back to my favorite painting: a computer cannot take the place of the doctor in Fildes’s painting <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">["The Doctor", 1891, see below - ed.];</span> an electronic medical record (EMR) may or may not save money (it won’t be anywhere as much as is projected) but what it will do is ensure that we doctors, nurses, therapists, particularly in hospitals will be spending more and more time focused on the computer, communicating with each other, ordering and getting tests, buffing and caring for our virtual patient—the iPatient is my term for this phenomenon—while the patient in the bed wonders where everybody is. Having worked exclusively for the last seven years or so in hospitals that have electronic medical records (EMR), I have felt for some time that the patient in the bed has become an icon for the real focus of our attention, the iPatient. Yes, electronic medical records help prevent medication errors <b><i><span class="Apple-style-span" style="color:#FF0000;">[only when done well, see<span class="Apple-style-span" style="color: rgb(0, 0, 0); "> <a href="http://jama.ama-assn.org/cgi/content/abstract/293/10/1197">Koppel</a></span><span class="Apple-style-span" style="color: rgb(0, 0, 0); font-style: normal; font-weight: normal; "> <b><i><span class="Apple-style-span" style="color:#FF0000;">- ed.]</span></i></b> and are a blessing in so many ways, but they won’t hold the patient’s hand for you, they won’t explain to the family what is going on.</span></span></i></b></blockquote><blockquote><br /></blockquote><br /><div style="text-align: center;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjAE7RytgExhui-vW_XuPeuePNenYs0LVWL85fksBIphZhtsoPXzESdZdoVldOUoYuqqKqVmW2uGDV82HsTUkchsibY6aJzv3lvyeIhU5gKvh6fyafpDfR-TSGIoJXE0TzeNEDmvD4qZiuk/s1600-h/the_doctor.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5349443605127209442" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjAE7RytgExhui-vW_XuPeuePNenYs0LVWL85fksBIphZhtsoPXzESdZdoVldOUoYuqqKqVmW2uGDV82HsTUkchsibY6aJzv3lvyeIhU5gKvh6fyafpDfR-TSGIoJXE0TzeNEDmvD4qZiuk/s320/the_doctor.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 320px; height: 214px;" /></a><span style="font-size:85%;">"The Doctor", 1891 (Sir Luke Fildes, 1843-1927)</span><span style="font-size:85%;"><span style="font-family:arial;"></span></span><br /></div><br /><br />I will go a step further. It is now clear that the promises of massive savings from electronic medical records, usually originating from vendors based on hearsay or cherry-picked, favorable but flawed studies that dismiss a <a href="http://hcrenewal.blogspot.com/2009/03/reader-on-why-we-have-busywork.html">growing body</a> of <span style="text-decoration: underline;"></span><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=other">other literature</a> (such as in Cerner CEO Neil Patterson's hyper-ebullient piece <a href="http://nealpatterson.cernerblog.com/2009/02/26/the-abcs-of-systemic-healthcare-reform.aspx">here</a>), have been <a href="http://hcrenewal.blogspot.com/2009/05/machinery-behind-healthcare-reform-how.html">deliberately manufactured</a> by a lobby of industry pundits.<br /><br />It is only now that I more fully comprehend the origins of and motivations behind the "we will revolutionize medicine" fervor exhibited by HIT company CEO's, such as I experienced and wrote about starting back in the 1990's. From my 1999 essay "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/informaticsmd/infordef1.htm">What is Medical Informatics, and Why is it an Important Specialty</a>":<br /><br /><p></p><blockquote><p>... A letter I had written <span style="font-style: italic; font-weight: bold; color: rgb(255, 0, 0);">[in Feb. 1999 - ed.]</span>, "<a href="http://web.archive.org/web/19991005222815/http://www.healthcare-informatics.com/issues/1999/02_99/postmark.htm">Broken Chord</a>" published in the journal <a href="http://www.healthcare-informatics.com/">Healthcare Informatics</a>, further amplifies the skills and experience issue. The letter addressed issues of skills, insights, and roles of MIS personnel in healthcare settings. I described a Microsoft Healthcare Users Group conference attended predominantly by healthcare MIS staff and vendors, where I observed a panel discussion moderated by the CEO of HBOC<b><i><span class="Apple-style-span" style="color:#FF0000;"> [before he was found to be cooking the books - ed.]</span></i></b> and composed of several other industry CEO's. The panel was discussing how they would revolutionize healthcare through their leadership in information technology. </p><p> During the Q&A period I asked the audience how many really felt they would revolutionize medicine through their leadership in IT. Several hundred--almost all in the audience--raised their hands. I then asked how many had ever taken care of patients or examined any textbook of medicine, such as Harrison's Textbook of Internal Medicine or the Merck Manual. A minority of hands went up. This suggested, in my view, a striking deficiency of knowledge, experience and insight on the part of the de facto clinical information technology leadership, complicated by rather cavalier attitudes regarding the essential role of clinical expertise. </p></blockquote><br />I believed what I was hearing to be <span style="font-weight: bold; font-style: italic;">irrational</span><span style="font-style: italic;"> </span>exuberance, not <span style="font-style: italic; font-weight: bold;">manufactured</span> exuberance.<br /><br />Quality improvements are possible under the most controlled of environments, such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=Cardiology%20story">here</a> (such projects are not easily portable, unfortunately). Massive cost savings? When organizations are spending upwards of $100 million just for system implementation, not including ongoing lifecycle costs, massive savings projections from HIT are risible.<br /><br />One would think that after Madoff, <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/06/19/AR2009061900078.html?hpid=moreheadlines">Stanford</a> and other recent financial confidence scandals, that bright people would be more skeptical of "massive returns, always and forever" promises, but that does not appear to be the case. With regard to mass savings, I make the prediction that in 2014, as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=UK">in the UK today</a>, our government, healthcare management, and medical professionals will realize, Madoff style, that they've been had.<br /><br />So, Health IT Industry executives, pundits, and consultants, can we drop the grandiose "we will revolutionize medicine!" and "massive savings" myths, and focus on facilitating clinicians and on quality improvement, please?<br /><br />-- SS<div><br /></div><div>6/22/09 <b>Addendum</b></div><div><b><br /></b></div><div>The U.S. Food and Drug Administration (FDA) and Sweden's Medical Products Agency are <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108646.htm">no strangers</a>.</div>

Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices. And, Can We Drop the "Massive Cost Savings" Fable?

Here is some sense on healthcare IT from the European Union, echoing a number of themes I've written about at Healthcare Renewal and my ...

Đọc thêm »