Propofol and Other Drug Questions: Was Michael Jackson a UPMC Patient at the Same Time as Samuel Sweet?

At my Sept. 24, 2011 post "<a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence</a>" I wrote a detailed summary of a civil medical malpractice Complaint regarding possible electronic chart alteration. As I pointed out, that Complaint made EMR metadata visible to laypeople for the first time that I am aware.<br /><br />A new docket has appeared in that case entitled "<span style="font-weight: bold;">Interrogatories to Defendant</span>" from Attorney/physician Deborah Maliver dated Sept. 27, 2011.<br /><br />This document is <span style="font-weight: bold;">publicly downloadable</span> from the Pittsburgh Prothonotary Office Civil Docket site <a href="https://dcr.alleghenycounty.us/SelectCaseID.asp?filename=Welcome.htm&NoLoginRequired=yes" target="_blank">at this link</a>, case #<span>GD-09-019407, </span><span>document #55, or at my cached version <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/lawsuits/Sweet_second_omnibus_discovery_request_vol1025000001C2.pdf">at this link</a> (PDF)</span>.<br /><span><br />It brings up questions of even greater concern to me as a physician, those of mysterious drug orders for powerful sedatives such as propofol, fentanyl and etomidate. Apparently the metadata makes it difficult to account for what could be questioned as "over-generous" dispensing of those drugs.<br /><br />(This is ironic, since the trial of the doctor who administered this drug to deceased singer Michael Jackson has itself <a href="http://www.washingtonpost.com/national/after-jurors-hear-of-michael-jacksons-promise-pain-manslaughter-trial-moves-into-2nd-day/2011/09/28/gIQA037n3K_story.html">just gotten underway</a>.)<br /><br />Here is the first interrogatory request listing numerous drugs:<br /><br /><br /></span><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhz5UUn1fAdqG_C4hgdKbsZVqd8nSvaKZ-Qzu4FIOmkQwUaBnawjjlNLqYhEhlZ4JzBH7dv6EOtqPw01aQI-_eN2D5PNICxR-BX3ZRVqPDx8r37ZrUyUOqTQWsnTTx2od_CB4JegU-H1zu_/s1600/req_drugs.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5657422163070212418" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhz5UUn1fAdqG_C4hgdKbsZVqd8nSvaKZ-Qzu4FIOmkQwUaBnawjjlNLqYhEhlZ4JzBH7dv6EOtqPw01aQI-_eN2D5PNICxR-BX3ZRVqPDx8r37ZrUyUOqTQWsnTTx2od_CB4JegU-H1zu_/s320/req_drugs.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 205px;" /></a><span style="font-size:85%;">Question 1. Request for full metadata on these drugs<span style="font-weight: bold;"> (click to enlarge)</span><br /></span></div><span><br /><br />See Exhibit "A" from the new Interrogatory docket below, as produced in discovery earlier, and download the new Interrogatory in its entirety to see the questions asked about the other metadata:<br /><br /></span><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEifbEyA4JmFHLDEi9l7jeLeR49Edosxc81jdxE8L2ehKi0mo1XxAte2xJaH6Q9QY5MPjfgexHoFATqrU53bjf2ofDh3OsrQA00GJ4BRNAfAxpn1AZ6CXLa4QqK4KI0UHnQKWgWnGAnwkkjb/s1600/propofol.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5657414336191328802" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEifbEyA4JmFHLDEi9l7jeLeR49Edosxc81jdxE8L2ehKi0mo1XxAte2xJaH6Q9QY5MPjfgexHoFATqrU53bjf2ofDh3OsrQA00GJ4BRNAfAxpn1AZ6CXLa4QqK4KI0UHnQKWgWnGAnwkkjb/s320/propofol.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 381px; height: 221px;" /></a><span style="font-size:85%;">Exhibit "A". McKesson drug cabinet dispenser audit trail. Five 100-ml vials of <a href="http://en.wikipedia.org/wiki/Propofol">propofol</a> in a row from May 14-May 15? <a href="http://en.wikipedia.org/wiki/Lorazepam">Lorazepam</a> (ativan), propofol and <a href="http://en.wikipedia.org/wiki/Etomidate">etomidate</a> on May 15-16 at a time when a patient had a deteriorating respiratory status? (These drugs suppress the respiratory drive.) <span style="font-weight: bold;">Click to enlarge.</span><br /></span></div><span><br /><br />Question 4 is particularly disturbing:<br /><br /></span><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlvErAEhoZ4kZTtYw4FQaahTK0l6pLTMpEiGMrkaERDnxCmpUGzhHHC3yqQ8hOCkcCri22GT_FK9t8Gneg1k4seXSmeUfX3Qvl1o0beyx6fHzz6sc5JX5rKEJNBiUXW_R7seh8HF8Np26H/s1600/do_not_appear.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5657423242222664578" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlvErAEhoZ4kZTtYw4FQaahTK0l6pLTMpEiGMrkaERDnxCmpUGzhHHC3yqQ8hOCkcCri22GT_FK9t8Gneg1k4seXSmeUfX3Qvl1o0beyx6fHzz6sc5JX5rKEJNBiUXW_R7seh8HF8Np26H/s320/do_not_appear.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 380px; height: 147px;" /></a><span style="font-weight: bold;font-size:85%;" >(click to enlarge)</span><br /><br /><div style="text-align: left;"><br />Apparently none of these drugs appeared in the eMAR system, the electronic medication administration record. Where did they go? I hope the full audit trails will show a definitive final disposition of these drugs.<br /><br />One would hope a highly computerized medical center could keep track of its inventory of drugs of powerful potential for abuse with 100% certainty, <a href="http://en.wikipedia.org/wiki/Chain_of_custody">chain-of-custody</a> style (that means, 0% guesswork):<br /><br /><b></b><blockquote><b>Chain of custody</b> (CoC) refers to the chronological documentation or paper trail, showing the <span style="font-weight: bold;">seizure, custody, control, transfer, analysis, and disposition</span> of evidence, physical or electronic.</blockquote><br /></div></div><span>This is of concern to me as a former Occupational Medicine physician (in the transit industry) and a physician in general. I've seen drug abuse result in train wrecks - literally. Drug abuse/failure to be able to track disposition in a hospital would represent a prima facie <span style="font-weight: bold;">public health menace.</span><br /><br />There are also questions about whether users of the EMR signed in or used the accounts of other individuals, which is another weakness of the EMR. No handwriting to evaluate...<br /><br />-- SS<br /><br /><span style="font-weight: bold;">10/24/11 Addendum:</span><br /><br />Here is a horrible example of what can go wrong when drugs of abuse potential are not tracked with the utmost of rigor:<br /><br /><blockquote>Star Tribune/Minneapolis<br /><br /><a href="http://www.startribune.com/local/minneapolis/132140228.html">Abbott Northwestern patient left 'writhing in pain' sues</a><br /><br />"Hi, love," Sarah May Casareto greeted Larry V. King as he lay on a gurney before surgery. As they wheeled down the hall, he recalled in court records, she told him that he'd have to "man up" because they couldn't give him a lot of medication.<br /><br />The next 57 minutes of surgery were excruciating, according to a lawsuit filed Tuesday in Hennepin County District Court that accuses the drug-addicted former nurse of skimming his narcotics, which left him "writhing in pain" during a medical procedure for kidney stones last year at a Minneapolis hospital.<br /><br />Casareto, of Forest Lake, entered an Alford plea of guilty Sept. 1 to a fifth-degree controlled substance crime for possessing Fentanyl, a high-powered painkiller, and was sentenced to probation in connection with the Nov. 8 incident at Abbott Northwestern Hospital. The plea enabled Casareto to maintain her innocence while acknowledging ample evidence to convict her.<br /><br />The suit, which seeks at least $50,000 in damages, alleges that she was "negligent and careless" in her care for King, 57, of Bloomington. The suit also names Abbott as a defendant.<br /><br />It contends that Abbott "knew or should have known [before the procedure] that Casareto was exhibiting drug-seeking behavior and that she had become dependent upon narcotic pain medications." It also notes that Abbott officials knew that she had failed "on at least six different occasions" to properly handle patients' pain medication obtained from the hospital pharmacy.<br /><br />King's attorney, Tony Nemo, <span style="font-weight: bold;">called the lawsuit reflective of "a growing problem" that should draw closer scrutiny to drug diversion, or the theft of medications intended for patients.</span><br /><br />"One of the things I know Mr. King is hoping is that this case may cause Twin Cities hospitals to reveal procedures and protocols to, if not prevent, at least minimize this problem in the future," he said.</blockquote><br />I wonder if information technology problems regarding tracking of drugs with abuse potential existed.<br /><br />Read the whole article at the above link.<br /><br /></span><span>-- SS</span>

Propofol and Other Drug Questions: Was Michael Jackson a UPMC Patient at the Same Time as Samuel Sweet?

At my Sept. 24, 2011 post " UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and fa...

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Using Logical Fallacies to Scold "Pharmascolds"

I first became dimly aware of how dysfunctional health care had become in the US after seeing, up close and personal, a case of attempted suppression of medical research because its content offended vested interests.  (See "Academic Freedom and the Corporate University" by Jennifer Washburn <a href="http://www.aaup.org/AAUP/pubsres/academe/2011/JF/Feat/wash.htm">here</a>.)  We have since blogged frequently about <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of research</a>, other threats to <a href="http://hcrenewal.blogspot.com/search/label/free%20speech">free speech</a> and <a href="http://hcrenewal.blogspot.com/search/label/academic%20freedom">academic freedom</a> in health care, and the larger <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, which undermines discussion of many of the threats to core values in health care.<br /><br /><strong>A Case Illustrating "How Academic Orthodoxy is Enforced?"</strong><br /><br />Thus, I am always on the lookout for new cases which illuminate these issues.  So a recent <a href="http://www.forbes.com/sites/davidshaywitz/2011/09/18/how-academic-orthodoxy-is-enforced/">post</a> on the well-known Forbes blog site by David Shaywitz, identified only as a "contributor," caught my attention:<br /><blockquote>an elite coterie of self-righteous academics seek <em>not to level the playing field but to dominate it, imposing their particular world view on everyone else</em>. Of course, conservatives, among others, have long alleged this is the true nature of American colleges– where tolerance and open-mindedness is said extend from the left all the way to … the far left. But we now have the opportunity to see this <em>play out at the professional level as well</em>.</blockquote><br />This sounds somewhat familiar. The FIRE (Foundation for Individual Rights in Education) <a href="http://www.thefire.org/">web-site</a> boasts a huge case file of attacks on free speech in academia. Most of them did not involve professional schools, or academic medicine in particular. Note, however, that FIRE is avowedly non-partisan, and while many attacks they deplore seemed to be on the free speech of those on the right, quite a few were also on those on the left.<br /><br />So what was the nature of this illuminating case?<br /><blockquote>Those who wonder <em>how academic orthodoxy is enforced in practice</em> need look no further than the response to a recent lecture given at Case Western University by Dr. Tom Stossel, the American Cancer Society Professor of Medicine at Harvard, and Director of the Translational Medicine Division of the Brigham and Women’s Hospital, where he is also an attending physician. (Disclosure: Stossel was an academic colleague of mine back when I was in Boston, and we have co-written a number of commentaries over the years; we also coined the term, Pharmascolds.)<br /><br />Stossel’s lecture, from what I’ve heard, was well-attended — so good for him. But <em>the real news was the three sentence email received by members of the Case Western faculty prior to Stossel’s lecture — a nastygram sent by a colleague at the neighboring Cleveland Clinic</em>.<br /><br />Subject line: 'Re: Medicine Grand Rounds — Tuesday September 13th' (i.e. Stossel’s talk).<br /><br />Body of the email (in full): 'This guy is an embarrassment to the medical profession. Can’t believe you would have him provide Grand Rounds. Your trainees deserve better.'</blockquote><br /><strong>Enforcement or Just Argument?</strong><br />Unless there is more too it, however, this case would not seem to fit in the category of attempts at suppression of free speech or academic freedom. After all, the folks from FIRE often note that the best response to speech or writing with which one disagrees is more speech or writing. The case above seems to involve two people who disagree, Dr Stossel, and whoever wrote the email. Disagreement is what free speech is all about. Per the FIRE web-site <a href="http://thefire.org/cases/freespeech/">section</a> on free speech:<br /><blockquote>Freedom of speech is a fundamental American freedom, and nowhere should it be more valued and protected than at America's colleges and universities. <em>The 'marketplace of ideas' upon which a university depends for its intellectual vitality cannot flourish when students or faculty members must fear punishment for expressing views that might be unpopular with the public at large or disfavored by university administrators. </em></blockquote><br />For this case to be an example of someone trying to "enforce academic orthodoxy," there needs to be an action, or at least threat of an action to silence one of these two people, or to punish one of them for what he or she already said. <br /><br />So I looked for the next part of this case. But there appears to be a problem. There is no more to the case than what appears above:<br /><blockquote>And <em>there you have it</em> — watch and learn kids! - here’s how A-list academics do it, in three steps and three sentences.</blockquote><br />So Mr Shaywitz appeared to be arguing that somehow the email sent about Dr Stossel is a threat to free speech. However, unless the email came from some academic official who could punish Dr Stossel or his audience at Case Western University, the threat to free speech is not apparent. <br /><br />So we need to find out who wrote the three-sentence email, and whether he or she had the power to enforce his or her opinions as orthodoxy.  Who wrote the email?<br /><blockquote>The author of this email? Dr. Steven Nissen, perhaps America’s most quoted Pharmascold.</blockquote><br />Dr Nissen is <a href="http://my.clevelandclinic.org/staff_directory/staff_display.aspx?doctorid=1185">Chief</a> of Cardiovascular Medicine at the Cleveland Clinic. Although he appears to have an appointment at the Case Western Reserve Medical School, the chair of <a href="http://www.cwrumedicine.org/divisions/cardiovascular-medicine">cardiovascular medicine </a>there is Dr Dan Simon. Maybe Dr Nissen did not agree with Dr Stossel, but there is no obvious way he could "enforce" his dislike, or otherwise turn it into "orthodoxy."<br /><br />Dr Stossel's speech may be obnoxious to Dr Nissen. And Dr Nissen's written email may be obnoxious to Dr Stossel, and to Mr Shaywitz. However, neither side has enforced its orthodoxy on, or suppressed the speech of the other. <br /><br /><strong>Logical Fallacies</strong><br /><br /><u>Relativist Fallacy</u><br />If Dr Nissen could enforce orthodoxy by merely writing an email, then Dr Stossel presumably could do so by giving his talk, and Mr Shaywitz could also do so by publishing his post. Implying that only Dr Nissen, with whom Mr Shaywitz disagreed, enforced orthodoxy appears to be an example of the <a href="http://www.nizkor.org/features/fallacies/relativist-fallacy.html">relativist fallacy</a>, the fallacy that a claim may be true for others, but not for the person making it.<br /><br />Thus the central premise of the blog post appeared to be based on a logical fallacy.  This suggests one should be highly skeptical that the goal of the published work was really the defense of free speech.  <br /><br /><u>Straw Man Fallacy</u><br /><br />It did begin with a paean to free speech that even FIRE staff might like, but then posed an interesting contrast:<br /><blockquote>When you think about the arguments raised by the Pharmascolds, critics who worry about university/industry interactions, constriction of academic freedom is typically cited as a key concern. To the Pharmascolds, industry represents an inherently corruptive influence on students and trainees, and threatens to impose a restrictive and biased world view upon them.<br /><br />While this 'Pharmascolds as defenders of academic freedom' narrative has certainly enjoyed considerable traction (likely related to the enabling role of journalists in this dynamic), there’s another competing narrative to consider.</blockquote><br />It appears that Mr Shaywitz really does not agree with the "Pharmascolds," a group in which he believes Dr Nissen fits.  Mr Shaywitz did not explain who the Pharmascolds other than Dr Nissen are. He did not provide evidence in support of his summary of their views.  So, at least in this blog post, the Pharmascolds appear to be straw men, and Mr Shaywitz thus appeared to be using the <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw man fallacy</a> to support his argument.<br /><br /><u>A Second Relativist Fallacy</u><br /><br />Moreover, Mr Shaywitz did not try to challenge the truth of the "Pharmascolds'" supposed views. Rather, he offered a "competing narrative." That is a surprising form of argumentation for someone who seemed to be appealing to conservatives. The notion that there is no truth, only competing narratives, is straight out of post-modernism, a school of thought with which conservatives rarely identify. Mr Shaywitz's casting of his argument as a better, but still "competing narrative," thus appears to be another use of the <a href="http://www.nizkor.org/features/fallacies/relativist-fallacy.html">relativist fallacy</a>. <br /><br />So this extraordinary blog post in Forbes appears to be less a reasoned defense of free speech and academic freedom and more an attempt to once again discredit the "Pharmascolds," and hence to discredit anyone who is skeptical of the influence of pharmaceutical companies and other commercial vested interests on academic medicine. But like the <a href="http://hcrenewal.blogspot.com/2009/04/who-is-now-scolding-pharmascolds.html">last attempt </a>to mock the "Pharmascolds," this one was based on primarily on logical fallacies.<br /><br /><strong>Summary</strong><br /><br />We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples <a href="http://hcrenewal.blogspot.com/2011/03/once-more-with-feeling-another-defense.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/11/there-you-go-again-richard-epstein-says.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2009/09/latest-version-of-argument-that-we-are.html">here</a>.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests.<br />I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts.  While David Shaywtiz was identified only as a "contributor" on his Forbes post, and as an "adjunct scholar" on the <a href="http://www.aei.org/article/104155">version</a> on the American Enterprise Institute site, his <a href="http://blogs.forbes.com/people/davidshaywitz/">profile</a> on the Forbes site notes that he really is Dr David Shaywitz, trained as a "physician-scientist," who now "works at a biopharmaceutical company in San Francisco." His <a href="http://davidshaywitz.wordpress.com/">own blog</a> identifies him as "currently <em>Director of Strategic and Commercial Planning at Theravance</em>, a publicly-held drug development company in South San Francisco."  So perhaps Dr Shaywitz disagrees with the "Pharmascolds" because their skepticism may be perceived as threatening the vested interests of Dr Shaywitz's company? Perhaps the campaign against the "Pharmascolds" is yet another example of stealth health policy advocacy by those with vested interests that might be threatened by skepticism about ties among physicians, academic medicine, and industry?<br /><br />Physicians and the public need to stay extremely skeptical about much of published health policy advocacy, particularly when the arguments appear illogical, or the interests of the advocates are not clear.

Using Logical Fallacies to Scold "Pharmascolds"

I first became dimly aware of how dysfunctional health care had become in the US after seeing, up close and personal, a case of attempted su...

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UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence

The world of electronic medical records is very secretive.<br /><br />Vendors will not allow their programs or data structures to be examined, even by the academic community. Their products, medical devices, are not vetted by regulatory agencies such as the FDA for quality.<br /><br />Patients and clinical personnel are supposed to take the word of the seller that these systems are fit for purpose and of high quality.<br /><br />A window into the internal working of EMR's was initiated Down Under just this year, in the form of a detailed internal analysis of an ED EMR product from America slated for roll-out in public hospitals in one of Australia's most populous states. Dr. Jon Patrick of the University of Sydney performed this work. He was not happy with what he found, in terms of software engineering, human computer interaction, and other issues related to fitness for purpose. See <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116">here</a> and <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">here</a>.<br /><br /><span style="font-size: 100%;">(</span><span style="font-size: 100%;">For more on healthcare IT difficulties, see "</span><span style="font-size: 100%; font-weight: bold;">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</span><span style="font-size: 100%;">" at this link: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/</a>.)</span><br /><br />One component of the healthcare IT "ecosystem" many have been unable to see, which is perhaps even more carefully guarded than the program code and data structures, is the <span style="font-weight: bold;">metadata on EMR use.</span><br /><br /><span style="font-style: italic; font-weight: bold;">A remarkable development has now changed that metadata secrecy - a public civil lawsuit court docket.</span><br /><br />Metadata is "data about data." In this context, that means data about who accessed the EMR, what they did, when they did it, from where they did it, etc. Perhaps it should be deliberately misspelled as "<span style="font-weight: bold;">meat</span>data."<br /><br />It allows the "legible gibberish" (see my Feb. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html" target="_blank">Electronic Medical Records: Two Weeks, Two Reams</a>" for more on that term) produced by the clinical side of EMR to be better weaved into meat, that is, a medical narrative that is essential to truly understanding a case.<br /><br />I noted the unfortunate case of Samuel Sweet at the University of Pittsburgh Medical Center (UMPC), as reported by Sean Hamill in the Pittsburgh Post-Gazette:<br /><span style="font-size: 130%;"><br /></span><blockquote><span style="font-size: 130%;"><a href="http://www.post-gazette.com/pg/11262/1175874-114.stm" style="font-weight: bold;" target="_blank">Trial to begin in wrongful death claim</a></span><br /><span style="font-weight: bold;">Monday, September 19, 2011</span><br /><span style="font-weight: bold;">By Sean D. Hamill, Pittsburgh Post-Gazette</span><br /><br />As far as Samuel Sweet was concerned, he only had a headache. It was a bad one, but nothing more, maybe something his chiropractor could fix with a little adjustment.<br /><br />But three days after being admitted to UPMC Presbyterian for what his family was told was a treatable amount of bleeding on the brain, and six hours after his family saw him laughing and chatting about the Penguins' playoff chances, early in the morning of May 16, 2009, Mr. Sweet died unexpectedly.<br /><br />Why he died is the subject of a civil case his family filed a few months later ... [Plaintiff's attorney] Ms. Maliver <span style="color: red; font-style: italic; font-weight: bold;">[actually Dr. Maliver, as she holds both the JD and MD degrees - ed.]</span> said UPMC's timeline came into question in early August 2011, when UPMC <span style="font-weight: bold;">finally turned over -- after two years of discovery</span> <span style="color: red; font-style: italic; font-weight: bold;">[i.e, they turned them over at the last minute, a few weeks before trial was scheduled to begin - ed.]</span> -- 1,200 pages of "results detail sheets" which show not only when something was written in Mr. Sweet's electronic chart, but who wrote it and how. <span style="color: red; font-style: italic; font-weight: bold;"><br /><br />[The patient died when there was a delay in treatment due to marked difficulty in putting a breathing tube into his lungs (a difficult intubation) when he developed respiratory failure. The defendants possibly never expected someone to actually comb through the 1,200 pages of "results detail sheets" on such a short time frame, but, apparently, the plaintiff's attorney took on the challenge - ed.]</span><br /><br />So, for example, Ms. Maliver alleges that the results detail sheets show that during the 21 minutes before Mr. Sweet was said to stop breathing, none of the information in his chart is straight from the computer monitors that would tell what his vital signs were during that period.<br /><br />But the results detail sheets <span style="font-weight: bold;">also show something more troubling</span>, Ms. Maliver said.<br /><br />She said she found evidence that three days after Mr. Sweet died, Dr. Richard Simmons, UPMC Presbyterian's head of quality assurance, tried to put a "Diff Intub" <span style="color: red; font-style: italic; font-weight: bold;">[difficult to intubate, due to anatomy - ed.] </span>red-letter warning on Mr. Sweet's electronic medical record. That effort showed up on the results details sheets, according to Ms. Maliver.<br /><br />Such a warning would tell <span style="color: red; font-style: italic; font-weight: bold;">["alert" would be a more precise term - ed] </span>anyone who opened the record that Mr. Sweet was difficult to intubate.<span style="font-weight: bold;"><br /></span></blockquote>As a result of this newspaper story, the defendants filed a complaint with the judge, who ordered a <span style="font-weight: bold;">six month delay in further proceedings</span>. The complaint and decision is <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/lawsuits/sweet_v_upmc_delay.pdf">at this link</a> (PDF).<br /><br />In further investigating what I considered a remarkable story, I came across a public docket Dr. Maliver filed on behalf of her clients in the case, "<span style="font-weight: bold;">PLAINTIFF'S MOTION AND SUPPORTING BRIEF TO AMEND COMPLAINT TO SEEK PUNITIVE DAMAGES</span>".<br /><br />As I mentioned previously, this is a<span style="font-weight: bold;"> remarkable development</span> that has opened a window on metadata secrecy.<br /><br />This is freely and publicly downloadable from the Pittsburgh Prothonotary Office Civil Docket site <a href="https://dcr.alleghenycounty.us/SelectCaseID.asp?filename=Welcome.htm&NoLoginRequired=yes" target="_blank">at this link</a>, case #GD-09-019407 , document #40 of 09/02/2011. (I have also cached the document at this link: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/lawsuits/complaint_punitive_damages_vol101400000177.pdf" target="_blank">http://www.ischool.drexel.edu/<wbr></wbr>faculty/ssilverstein/cases/<wbr></wbr>lawsuits/complaint_punitive_<wbr></wbr>damages_vol101400000177.pdf</a> .)<br /><br />As I mentioned in the aforementioned post, I found the hospital attorney's explanation of apparent tampering somewhat troubling:<br /><br /><blockquote><span style="font-weight: bold;">Dr. Simmons wasn't trying to alter the record, [attorney for the defendants] Mr. Conti said</span>; instead he was in Mr. Sweet's medical record as part of the "peer review" process, assessing what happened in Mr. Sweet's case.<br /><br />As part of that, he was in the medical record three days after Mr. Sweet died trying to figure out <span style="font-weight: bold;">how one would create a warning about a patient's difficult intubation </span><span style="color: red; font-style: italic; font-weight: bold;">[in effect, altering the record, at the very least through creation of a confusing audit trail - ed.]</span>, Mr. Conti said.<br /><br /></blockquote>The public nature of the "<span style="font-weight: bold;">PLAINTIFF'S MOTION AND SUPPORTING BRIEF TO AMEND COMPLAINT TO SEEK PUNITIVE DAMAGES</span>" document makes it possible for the public to look at some of the actual metadata to see for themselves what might have occurred.<br /><br />Again, this is remarkable and is the first time I am aware of when the public (and the academic Medical Informatics community, of which I am a part) gets to "peek behind the curtain" of an EMR's metadata.<br /><br />Let's take a look.<br /><br />I will summarize relevant part of the Motion and intersperse testimony and metadata from the actual record of Mr. Sweet (again, from a now-public court document).<br /><br />The purpose of the Motion was to seek punitive damages:<br /><blockquote><br /><span style="font-weight: bold;">A. SEEKING PUNITIVE DAMAGES</span><br /><br />(1) This is a civil action for medical malpractice in which the Plaintiff alleges in essence that Samuel Sweet, a relatively healthy man of only 62 years of age, needlessly suffocated to death in the intensive care unit at UPMC after undergoing a routine cerebral angiogram when, the following day, physicians recklessly and prematurely pulled out his breathing tube and then could not get it back in when it became obvious Mr. Sweet would die without it.<br /><br />(2) This case is listed for trial on September 19, 2011, and discovery has just concluded.<br /><br />(3) In light of the evidence adduced in discovery, the Plaintiff seeks to amend the Complaint to re-characterize Defendant Murugan's and Defendant actions and inactions as willful, wanton, reckless and not merely negligent. The Plaintiff similarly seeks to amend the ad damnum clause against these defendants to include a request for punitive damages because of their shocking and reckless disregard for Mr. Sweet's welfare <span style="font-weight: bold;">and their attempts to alter the appearance of the medical records, in full awareness of Mr. Sweet's brain death, so as to obscure what really </span><span style="font-weight: bold;">happened. </span></blockquote><br />It is the last part of count A.(3) I will address here, a quite serious charge involving medical record evidence spoliation, which is specifically forbidden in Pennsylvania by the <span style="text-decoration: underline;"> </span><a href="http://www.portal.state.pa.us/portal/server.pt/document/495911/hb1802_pdf" target="_blank">Medical Care Availability and Reduction of Error (MCARE) Act of 2002</a> (PDF, see Section 511, "<span style="font-style: italic; font-weight: bold;">Preservation and accuracy of medical records</span>", pg. 18-19) and other regulations.<br /><br />Of importance, the Motion continues:<br /><br /><blockquote>... (15) UPMC has a special warning system that is intended to serve the very purpose of alerting all medical providers of a patient with a difficult airway. The way it works <span style="color: red; font-style: italic; font-weight: bold;">[as UMPC defendants testified under oath - ed.]</span> is the attending physician, writes up the problem list for the patient and <span style="font-weight: bold;">need only put difficult airway in the list, and this will trigger a special yellow banner to pop up on the patient's computer files for all to see every </span><span style="font-weight: bold;">time the chart is opened</span> and every time any page is viewed.<br /><br />Not only that, <span style="font-weight: bold;">but then the words "difficult airway"appear in red text within the yellow banner</span>, and this puts the viewers on notice to check the anesthesia record as to how intubation was done successfully in the past, so they can replicate the successful technique.</blockquote><br />This patient was extubated after a procedure to check for brain bleeding, but by late at night it became obvious he could not breathe adequately on his own, and needed to be re-intubated.<br /><br />Let's see how a chart appears with, and without the banner about a patient being difficult to intubate (due to their mouth and air-passage anatomy):<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjepsPEUxRQrIrssZIL9cYrrRT64dcuyXhRbKbQi66MSYxU8mDE0bByXZDP5P_R8jSj67Kg5i3nthaFPW9qjmFJsoflVAiHZy832W8ZaaRUEd9mjs7k0xCbtpLxZfaI-7SqJ1moanOTSFNW/s1600/banners.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656026922887887554" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjepsPEUxRQrIrssZIL9cYrrRT64dcuyXhRbKbQi66MSYxU8mDE0bByXZDP5P_R8jSj67Kg5i3nthaFPW9qjmFJsoflVAiHZy832W8ZaaRUEd9mjs7k0xCbtpLxZfaI-7SqJ1moanOTSFNW/s320/banners.jpg" style="cursor: pointer; display: block; height: 222px; margin: 0px auto 10px; text-align: center; width: 379px;" /></a><span style="font-size: 85%;">Real Electronic Medical Record screen of Mr. Sweet lacking warning banner, above; fictitious chart showing banner, below.<span style="color: red; font-style: italic; font-weight: bold;"> [Why wasn't it the fictitious patient chart that was fiddled with? - ed.]</span> <span style="font-weight: bold;">Click to enlarge.</span></span></div><br /><br />Such a warning apparently did <span style="font-weight: bold;">not</span> appear in Mr. Sweet's EMR chart, and that along with other failed communication (which can be read in the Motion) led to the re-intubation difficulties, and ultimately death. (I should note that it's possible the clinicians did flag the "difficult intubation" condition, but that the EHR lost the data through relational integrity problems, i.e., the information became "orphaned" from the patient's records, although still existing in the system somewhere.)<br /><br /><blockquote>(27) ... not one person knew that there was a note from anesthesiology containing a road map for success, that included the use of a "Fast-Track LMA device", neither of which was ever brought in for Mr. Sweet that night when he needed the tube to be put back in.<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh2z4gOB0Q3lp2hrp57VVP_Ftbvf5LPbbQvUHMjDDu1mX33eJ8EiengqExqOgqRYD5ZMDuu_QwjIlW-r_0nEM5_2PsnWw-sGt9TK9jBUPZzbXIhYB6g4TsERT83SUa3nuPidqpgYhu2T7Hp/s1600/exhibit_E_how_banner_gets_there.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656022205793766226" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh2z4gOB0Q3lp2hrp57VVP_Ftbvf5LPbbQvUHMjDDu1mX33eJ8EiengqExqOgqRYD5ZMDuu_QwjIlW-r_0nEM5_2PsnWw-sGt9TK9jBUPZzbXIhYB6g4TsERT83SUa3nuPidqpgYhu2T7Hp/s320/exhibit_E_how_banner_gets_there.jpg" style="cursor: pointer; display: block; height: 254px; margin: 0px auto 10px; text-align: center; width: 320px;" /></a><span style="font-size: 85%;"><span style="font-weight: normal;">Exhibit E. Under Oath. "A designation of difficult intubation automatically appears on a patient's banner bar if it is entered as a problem on the Problem List by the user selecting it from a drop-down menu list." <span style="font-style: italic;">(I tend to have doubts the problem list is that intelligent, but this is what was testified.)</span> <span style="font-weight: bold;">Click to enlarge.</span></span></span></div><br /><br />Sworn testimony indicates nobody took the appropriate actions to enable the alert to appear on the EMR screens:<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEix2t2DuFqy6bgmlNvyHCD75TVDQxgRh3bEDxsbSjAjSTPB6W7bH1r-GzRLh6CCmB0iRTGYJ7EVUq70C7plb19dATP-Z1uqLc0VKTudlwi6R6jl8O3ohUU-ruV8wyeW01CvZnhakp5DwW2u/s1600/no_one_ordered_alert.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656031663479819794" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEix2t2DuFqy6bgmlNvyHCD75TVDQxgRh3bEDxsbSjAjSTPB6W7bH1r-GzRLh6CCmB0iRTGYJ7EVUq70C7plb19dATP-Z1uqLc0VKTudlwi6R6jl8O3ohUU-ruV8wyeW01CvZnhakp5DwW2u/s320/no_one_ordered_alert.jpg" style="cursor: pointer; display: block; height: 231px; margin: 0px auto 10px; text-align: center; width: 326px;" /></a><span style="font-size: 85%;">Admitted under oath. Nobody did what it would take to make a "difficult intubation" alert appear on Mr. Sweet's chart.<span style="font-weight: bold;"> Click to enlarge.</span><br /></span></div><br />As a result of this missing data, the "syndrome of overconfidence in computers", and the toxic effect of poorly done health IT impairing clinician-clinician communications, physicians seeing this patient when he was under duress admit under oath they did not know of this intubation problem:<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjJqIMyDrvvOYbOYgTR2iCeVPSBmx7qgbxzuBv3AN90MydUlouZIDByaCo-zMAazRMr6ApCuVu57Na1lGGVfh7U-jKTFixEFoUh0E-W9OmJB7aG8BB5u50dU0ryXhbPmIAQD4Hk_c_Znh6F/s1600/kaura_didn%2527t_know.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656032339134827378" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjJqIMyDrvvOYbOYgTR2iCeVPSBmx7qgbxzuBv3AN90MydUlouZIDByaCo-zMAazRMr6ApCuVu57Na1lGGVfh7U-jKTFixEFoUh0E-W9OmJB7aG8BB5u50dU0ryXhbPmIAQD4Hk_c_Znh6F/s320/kaura_didn%2527t_know.jpg" style="cursor: pointer; display: block; height: 256px; margin: 0px auto 10px; text-align: center; width: 363px;" /></a><span style="font-size: 85%;">Dr. Kaura didn't know. <span style="font-weight: bold;">Click to enlarge.</span></span></div><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbTxrAmyhpOQeGV7mPEdKXcMLBlI3Hk0uCJELiaUn752ZsI9DZzNAkeVrpjX3jy2JJT6WnBNGnAL_4_f5JbEV7fUIwos_upTAr1MZWH4g4C1VOzJpo93bAVUzw1OSuzJw1MdA3MR5C-nFR/s1600/sappington_didnt_know.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656032394544316706" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbTxrAmyhpOQeGV7mPEdKXcMLBlI3Hk0uCJELiaUn752ZsI9DZzNAkeVrpjX3jy2JJT6WnBNGnAL_4_f5JbEV7fUIwos_upTAr1MZWH4g4C1VOzJpo93bAVUzw1OSuzJw1MdA3MR5C-nFR/s320/sappington_didnt_know.jpg" style="cursor: pointer; display: block; height: 112px; margin: 0px auto 10px; text-align: center; width: 344px;" /></a><span style="font-size: 85%;">Dr. Sappington didn't know. <span style="font-weight: bold;">Click to enlarge.</span></span></div></blockquote><br />This is bad enough. The post-mortem chart fiddling issues I am addressing here begin with this:<br /><blockquote><br />C. (39) In the present case, after rounds of complex discovery battles, it became apparent that UPMC altered the records ... in this case, much of the record alteration was conducted by quality assurance officer, one Dr. Richard Simmons.<br /><br />(40) Once the brain death of Mr. Sweet was known, a wave of record alteration and supplementation occurred, largely though not exclusively at the behest of Dr. Simmons ...<br /><br />(41) For example, after Mr. Sweet was dead, when it could obviously not benefit his medical care, Dr. Simmons entered Mr. Sweet's computerized medical record, clearly looking into whether there had been a proper yellow-banner warning created through a problem list (which, of course, there was not). </blockquote><br />Again, these are serious charges. Why would the plaintiff attorney raise these charges? Let's look at some metadata:<br /><br /><blockquote style="font-weight: bold;"><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh9ry71dCSwp2Rt4JWNQ5UkIjlPIHVAiZDix555U1xxV52g2vf-tAtv2UvtKNySvIgOrvQmWRPz3yy2bNnAnLLKSderTTx9WNWEqnGwXR8ouK_MvUDDspG-TypMgdiHxpsqw34qeSfN130u/s1600/Exhibit_K_simmons_postmortem_gap_audit_trail.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656353477734292466" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh9ry71dCSwp2Rt4JWNQ5UkIjlPIHVAiZDix555U1xxV52g2vf-tAtv2UvtKNySvIgOrvQmWRPz3yy2bNnAnLLKSderTTx9WNWEqnGwXR8ouK_MvUDDspG-TypMgdiHxpsqw34qeSfN130u/s320/Exhibit_K_simmons_postmortem_gap_audit_trail.jpg" style="cursor: pointer; display: block; height: 272px; margin: 0px auto 10px; text-align: center; width: 363px;" /></a><span style="font-size: 85%;"><span style="font-weight: normal;">Exhibit K, showing quality assurance officer Dr. Simmons fiddling with Mr. Sweet's chart on May 19th several times during the day, as well as on the 22nd. Note circled entries. <span style="font-weight: bold;">Note the gap</span> (labeled) and the time of the last entry on the 19th, 15:23. Also note all these dates are post mortem by several days; death was on the 16th. Also note the times of entry, and the part of the chart accessed in the second round of accesses on May 19th - including "problem list" at 15:02. <span style="font-weight: bold;">Click to enlarge. </span></span></span></div></blockquote><br />I note that we are left to wonder what happened between access round two by the QA Officer on May 19 beginning 15:01 PM, and round three on May 22 at 14:03 PM. (Where are data for May 19th after 15:23 and May 20th and 21st, I wonder as well? This was not a weekend but midweek ...)<br /><br />The Motion continues:<br /><br /><blockquote>(42) Thereafter, even though Mr. Sweet was now long dead and such action could do him no good, <span style="font-weight: bold;">Dr. Simmons tried to create a problem list</span> that had originally been omitted by Defendant. He listed a difficult airway as the problem (even though obviously Mr. Sweet's problem list would have included many things, such as having undergone an angiogram and a minor cerebral bleed). <span style="font-weight: bold;">In other words, Dr. Simmons tried to take the action necessary to make the computer show the yellow banner warning that was missing. </span></blockquote><br />Here's more metadata seemingly supporting this statement. It's clear that nobody, including especially someone in Dr. Simmons' role should have been doing ANYTHING to the data that would or could raise suspicion of alterations via the metadata, such as times. Surely a presumably competent senior physician in a peer review role would have known this.<br /><br />(I also note, <span style="color: #330033;"> </span><span style="color: #330033; font-weight: bold;">shouldn't the record have been electronically "locked" by several days after death</span>, thus causing <span style="font-weight: bold;">any </span>changes after the lock to appear in the normal "give us the legal medical record" outputs, not just in metadata?):<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiXp5-CufdtW2vq7LB8vCaVfHom0JtTXDV4aQpAqfn9WpAwEh4uEHsJCT5GZRUll_IaBglaLLenJxJiiYFuMXZIYfEuHHqueKq7gggilXdJUmrS5VBRzhV3SWMAA20QxXpgKn0oiOp_tBY7/s1600/problem_history.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656028439347558466" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiXp5-CufdtW2vq7LB8vCaVfHom0JtTXDV4aQpAqfn9WpAwEh4uEHsJCT5GZRUll_IaBglaLLenJxJiiYFuMXZIYfEuHHqueKq7gggilXdJUmrS5VBRzhV3SWMAA20QxXpgKn0oiOp_tBY7/s320/problem_history.jpg" style="cursor: pointer; display: block; height: 266px; margin: 0px auto 10px; text-align: center; width: 353px;" /></a><span style="font-size: 85%;">Exhibit L. Metadata showing Dr. Simmons on <span style="font-weight: bold;">May 19th </span>in the drop-down menu to make a problem list - then retracting it (<span style="font-style: italic;">"active --> cancelled"</span>) shortly afterwards. (I note the apparent cancellation time of 3:24 PM, i.e., 15:24,<span style="font-weight: bold;"> is just after the final May 19th entry of 15:23</span> on Exhibit K, when the several-day "gap" begins. I also note the patient died on <span style="font-weight: bold;">May 16th</span>. Curious... ) <span style="font-weight: bold;">Click to enlarge.</span></span></div><br />But problems apparently occurred:<br /><blockquote><br />(43) It did not work. The yellow banner would not appear retroactively onto the otherwise completed record although he did succeed in altering the original record to look like there had always been a problem list. Further, during review of the "detail sheets," the Plaintiff discovered that Dr. Simmons, having failed to create a banner warning, <span style="font-weight: bold;">tried to then delete or undo what he had attempted</span>, but could not get it out of the computer tracking system. See Exhibit L hereof. </blockquote><br />Let's look at the next part of Exhibit L:<span style="font-weight: bold;"><br /></span><span style="font-weight: bold;"><br /></span><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgaar_8PLLPXJLjGIzHH8Vm6yaDQ_dcQUYcVqGXQ32HqWFrGRq9qvujhEgYkCTpMluJRAYZw9G4BfyNajfWv5Y-43H7pOVC-FEmtX9nzkWWOQC_uzlq5WzqwyCLHrYtA2-I16YWUb1_CkiY/s1600/problem_list.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656029408970613938" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgaar_8PLLPXJLjGIzHH8Vm6yaDQ_dcQUYcVqGXQ32HqWFrGRq9qvujhEgYkCTpMluJRAYZw9G4BfyNajfWv5Y-43H7pOVC-FEmtX9nzkWWOQC_uzlq5WzqwyCLHrYtA2-I16YWUb1_CkiY/s320/problem_list.jpg" style="cursor: pointer; display: block; height: 414px; margin: 0px auto 10px; text-align: center; width: 311px;" /></a><span style="font-size: 85%;"><span style="font-weight: bold;">Note the postmortem date of 5/19/2009 on this "problem list", and the attempted cancellation, presented as evidence.</span> </span><span style="font-size: 85%;"><span style="font-weight: bold;">Note the time of the Problem list addition - 3:02 PM (i.e., 15:02</span> as in exhibit K above). </span><span style="font-size: 85%;">Canceled as above at 3:24. Someone in Dr. Simmons' position should not have been fiddling with the problem list, knowing (or should have known, or should have made it his business to know) that footprints of fiddling in the metadata would, at the very least, <span style="font-style: italic;">raise eyebrows</span>. <span style="font-weight: bold;">Click to enlarge.</span></span></div><br />This does not look like the metadata that would be generated by peer review that I myself would perform ...<br /><br />In summary, this unique Motion containing actual EMR metadata is, in my personal view, suspect for 1) imprudent post-death fiddling with the EMR records at best, and/or 2) attempts to alter the EMR to unjustly protect those who caused harm to come to this patient at worst.<br /><br />I do not know which occurred, but hospital attorney Conti's excuse that "Dr. Simmons was in the medical record three days after Mr. Sweet died trying to figure out <span style="font-weight: bold;">how one would create a warning about a patient's difficult intubation</span>"<span style="color: red; font-style: italic; font-weight: bold;"> [that is, entering new data not present before - ed.]</span> could be either:<br /><br /><ul><li>A sign of lack of computer and legal savvy of a senior clinician/UPMC Presbyterian's head of quality assurance, but whose intentions were pure, as explained above; or</li><li>The confabulations of an attorney caught with his pants down.</li></ul><br />My personal opinion?<br /><br />Want to buy a bridge in Brooklyn, members of the jury and Your Honor?<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiub9uKGChN-bDJ46C8KLfqBpWMWV6CdN9TlYfMpMyYp4Qox50KotMPgBYNpTjYAaGOtMYY8vagPv_yayC-bgcmQryqP2jxMMiABdM-ERAKVF72cDuUCVUVPaHzF0gRsLH3qPHe28asMV1Z/s1600/brooklyn-bridge.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656030708798404066" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiub9uKGChN-bDJ46C8KLfqBpWMWV6CdN9TlYfMpMyYp4Qox50KotMPgBYNpTjYAaGOtMYY8vagPv_yayC-bgcmQryqP2jxMMiABdM-ERAKVF72cDuUCVUVPaHzF0gRsLH3qPHe28asMV1Z/s320/brooklyn-bridge.jpg" style="cursor: pointer; display: block; height: 210px; margin: 0px auto 10px; text-align: center; width: 280px;" /></a><span style="font-size: 85%;">NY bridge for sale. Cheap.</span></div><br /><br />The following also does not favorably influence my interpretation of the metadata:<br /><blockquote><br />(44) It is noteworthy that, prior to producing these results detail sheets that indicated such changes, UPMC attempted to file a motion for a protective order to bring all further discovery to a halt (a motion which was denied) even though the discovery deadline had not yet arrived. </blockquote><br />Obviously, this is not for me to decide and will need to await court adjudication, but as a Medical Informatics specialist and someone with some investigative experience regarding computers and medicine, I am not happy with the looks of this.<br /><br />I report, you decide.<br /><br />There were other allegations in this plaintiff's Motion, <span style="font-style: italic;">again based on clinical IT metadata</span>, regarding: unaccounted-for drugs of potential abuse (e.g., sedative <a href="http://en.wikipedia.org/wiki/Propofol">propofol</a>, the drug that <a href="http://www.foxnews.com/entertainment/2009/07/28/officials-believe-jacksons-doctor-gave-drug-killed-michael-jackson/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%25253A+foxnews%25252Fentertainment+%28FOXNews.com+-+Entertainment%29">killed Michael Jackson)</a>, the entry of fictitious data (such as vital signs, timing and medication administration by others including nurses), dictations coerced out of junior staff by senior personnel that might have been "spun" favorably to the medical center, etc., but those are the subject of later posts.<br /><br />I again repeat the six-month delay in this case could potentially leave various problems with this EMR system unexposed and unremediated. This could unnecessarily expose the public to six more months of risk.<br /><br /><b>Addendum:</b> if UPMC or the vendor take issue with posting of this material due to IP or other issues such as health IT gag clauses (which by the way are signed by hospital executives in violation of Joint Commission Safety Standards per my 2009 <a href="http://jama.ama-assn.org/content/302/4/382.1.extract">JAMA letter here</a> and longer essay <a href="http://hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html">here</a>), contact the Prothonotary Office in Pittsburgh, not me.<br /><br />-- SS<br /><br /><span style="font-size: 85%;"><span style="font-size: 100%;"><span style="font-weight: bold;">Addendum:</span></span><br /><br />What type of person was Mr. Sweet? This type:</span><br /><blockquote><span style="font-size: 85%;"><br /></span><span style="font-size: 85%;">Samuel E. Sweet Jr.</span><br /><span style="font-size: 85%;">Cheswick</span><br /><span style="font-size: 85%;"><br /></span><span style="font-size: 85%;">Samuel E. Sweet Jr., 62, of Cheswick, died Saturday, May 16, 2009, at UPMC Presbyterian Hospital. He was born Dec. 9, 1946, in New Kensington, son of the late Samuel E. Sweet Sr. and Marjorie (Secrist) Sweet. He was a resident of Cheswick for 33 years. He worked for the Army Corps of Engineers at Lock No. 2 of the Allegheny River and served in the Marine Corps during the Vietnam Era. He was a member of Hoboken Presbyterian Church, Blawnox Sportsmen Club, Blawnox "A" Club and the Springdale VFW. He enjoyed gardening and cutting grass. Survivors include his wife, Janet A. Sweet; sons, Samuel E. "Chip" (Michele) Sweet III, of Natrona, and William E. (Tracy) Sweet, of Edgewood; granddaughters, Kristin Ruff, of South Carolina, and Virginia Sweet, of Natrona; brother, John Thomas (Debbie) Sweet, of Warren; and nieces and nephews. Friends received from 2 to 6 p.m. Monday only, at the THOMAS M. SMITH FUNERAL HOME AND CREMATORY LTD., 930 Center Ave., Blawnox, followed by a funeral service at 7 p.m. in Hoboken Presbyterian Church, 921 North Ave., Blawnox, PA 15238. In lieu of flowers, the family respectfully suggests memorial contributions to Hoboken Presbyterian Church.<span style="font-style: italic;"><br /></span></span></blockquote>-- SS<br /><br style="font-weight: bold;" /><span style="font-weight: bold;">Addendum: </span><br /><br />This case <a href="https://dcr.alleghenycounty.us/DisplayImage.asp?gPDFOH=vol1089%20%20%20%20%20%20%20%20%20%20%20%20%20000002FF&CaseID=GD-09-019407&DocketType=PETOR&SeqNumber=79" target="_blank">was settled before going to trial</a> for <b>$1,375,000</b>.<br /><br />-- SS<br /><span style="font-size: 85%;"><span style="font-style: italic;"><br /></span></span>

UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence

The world of electronic medical records is very secretive. Vendors will not allow their programs or data structures to be examined, even ...

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HHS rule would give government everybody’s health records?

I really don't like the sound of this in the Washington Examiner. It contains many warnings of the kind I've written about here at HC Renewal regarding EHR systems, data privacy, confidentiality and security, coding madness, and (especially in the proposed rule) computational alchemy - a belief that one can turn unreliable data into "gold":<br /><br /><a href="http://washingtonexaminer.com/opinion/op-eds/2011/09/obamare-hhs-rule-would-give-government-everybody-s-health-records"></a><blockquote><a href="http://washingtonexaminer.com/opinion/op-eds/2011/09/obamare-hhs-rule-would-give-government-everybody-s-health-records">HHS rule would give government everybody’s health records</a><br />By: Rep. Tim Huelskamp<span class="Apple-style-span" style="border-collapse: separate; color: rgb(0, 0, 0); font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px;font-family:'Times New Roman';font-size:16px;" ><span class="Apple-style-span" style="color: rgb(102, 102, 102); line-height: 19px; text-transform: capitalize;font-family:Helvetica,arial,sans-serif;font-size:10px;" ></span></span><br />09/23/11 3:29 PM<br />OpEd Contributor<br /><br />It’s been said a thousand times: Congress had to pass President Obama’s health care law in order to find out what’s in it. But, despite the repetitiveness, the level of shock from each new discovery never seems to recede.<br /><br />This time, America is learning about the federal government’s plan to collect and aggregate confidential patient records for every one of us.<br /><br />In a proposed rule from Secretary Kathleen Sebelius and the Department of Health and Human Services (HHS), the federal government is demanding insurance companies submit detailed health care information about their patients.<br /><br />(See Proposed Rule: Patient Protection and Affordable Care Act; Standards Related to Reinsurance, Risk Corridors and Risk Adjustment, Volume 76, page 41930. Proposed rule docket ID is HHS-OS-2011-0022 <a href="http://www.gpo.gov/fdsys/pkg/FR-2011-07-15/pdf/2011-17609.pdf">http://www.gpo.gov/fdsys/pkg/FR-2011-07-15/pdf/2011-17609.pdf</a>)<br /><br />The HHS has proposed the federal government pursue one of three paths to obtain this sensitive information: A “centralized approach” wherein insurers’ data go directly to Washington; an “intermediate state-level approach” in which insurers give the information to the 50 states; or a “distributed approach” in which health insurance companies crunch the numbers according to federal bureaucrat edict.<br /><br />It’s par for the course with the federal government, but abstract terms are used to distract from the real objectives of this idea: no matter which “option” is chosen, government bureaucrats would have access to the health records of every American - including you.<br /><br />There are major problems with any one of these three “options.” First is the obvious breach of patient confidentiality. The federal government does not exactly have a stellar track record when it comes to managing private information about its citizens.<br /><br />Why should we trust that the federal government would somehow keep all patient records confidential? In one case, a government employee’s laptop containing information about 26.5 million veterans and their spouses was stolen from the employee’s home.<br /><br />There's also the HHS contractor who lost a laptop containing medical information about nearly 50,000 Medicare beneficiaries. And, we cannot forget when the USDA's computer system was compromised and information and photos of 26,000 employees, contractors, and retirees potentially accessed. <span style="font-weight: bold; font-style: italic;">[<span style="color: rgb(255, 0, 0);">I've written about this issue</span> <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">frequently</a> <span style="color: rgb(255, 0, 0);">on this blog - ed.]</span></span><br /><br />The second concern is the government compulsion to seize details about private business practices. Certainly many health insurance companies defended and advocated for the president’s health care law, but they likely did not know this was part of the bargain.<br /><br />They are being asked to provide proprietary information to governments for purposes that will undermine their competitiveness. Obama and Sebelius made such a big deal about Americans being able to keep the coverage they have under ObamaCare; with these provisions, such private insurance may cease to exist if insurers are required to divulge their business models.<br /><br />Certainly businesses have lost confidential data like the federal government has, but the power of the market can punish the private sector. A victim can fire a health insurance company; he cannot fire a bureaucrat.<br /><br />What happens to the federal government if it loses a laptop full of patient data or business information? What recourse do individual citizens have against an inept bureaucrat who leaves the computer unlocked? Imagine a Wikileaks-sized disclosure of every Americans’ health histories. The results could be devastating - embarrassing - even Orwellian.<br /><br />With its extensive rule-making decrees, ObamaCare has been an exercise in creating authority out of thin air at the expense of individuals’ rights, freedoms, and liberties.<br /><br />The ability of the federal government to spy on, review, and approve individuals’ private patient-doctor interactions is an excessive power-grab.<br /><br />Like other discoveries that have occurred since the law’s passage, this one leaves us scratching our heads as to the necessity not just of this provision, but the entire law.<br /><br />The HHS attempts to justify its proposal on the grounds that it has to be able to compare performance. No matter what the explanation is, however, this type of data collection is an egregious violation of patient-doctor confidentiality and business privacy. It is like J. Edgar Hoover in a lab coat.<br /><br />And, no matter what assurances Obama, Sebelius and their unelected and unaccountable HHS bureaucrats make about protections and safeguards of data, too many people already know what can result when their confidential information gets into the wrong hands, either intentionally or unintentionally.<br /><br /><span style="font-style: italic;">Republican Tim Huelskamp represents the first congressional district of Kansas.</span></blockquote><br />While the word "de-identified" is in the proposed rule, I don't have great confidence in such assurances (for instance, see my Oct. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html">Health IT Vendors Trafficking in Patient Data?</a>").<br /><br />I don't believe additional commentary is needed.<br /><br /><span style="font-size:85%;"><span style="font-style: italic;">Hat tip - <a href="http://www.drudgereport.com/">Drudge Report</a>.</span></span><br /><br />-- SS

HHS rule would give government everybody’s health records?

I really don't like the sound of this in the Washington Examiner. It contains many warnings of the kind I've written about here at ...

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My doctor will now need to code for when I get bitten by George or Martha Goose

The bureaucrats always seem to find new ways to waste precious medical resources and capital to justify their existence.<br /><br />Here's the latest twist:<br /><br />I regularly feed swans, ducks and geese at my local park. In fact, I don't seek them out; the geese in particular come to me when they see me on the trail. They know me for years.<br /><br />They have tremendous vision, so I can't escape them.<br /><br />Per the WSJ, medical coding is about to become so hypergranular (could the reason be that bureaucrats needed work to do?) as to be reasonably considered insane:<br /><a href="http://online.wsj.com/article/SB10001424053111904103404576560742746021106.html#printMode"><br /></a><blockquote><a style="font-weight: bold;" href="http://online.wsj.com/article/SB10001424053111904103404576560742746021106.html#printMode">Walked Into a Lamppost? Hurt While Crocheting? Help Is on the Way </a> <span style="font-weight: bold;"><br /><br />New Medical-Billing System Provides Precision; Nine Codes for Macaw Mishaps</span> <span style="font-weight: bold;"><br /><br />Wall Street Journal</span> <span style="font-weight: bold;">Sept. 13, 2011</span><br /><br />... Billing experts who translate doctors' work into codes are gearing up to start using the new system in two years. They say the new detail is welcome in many cases. But a few aspects are also causing some head scratching.<br /><br />Some codes could seem downright insulting: R46.1 is "bizarre personal appearance (<a href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=bizarre%20personal%20appearance">see code</a>)," while R46.0 is "very low level of personal hygiene (<a href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=very%20low%20level%20of%20personal%20hygiene">see code</a>)."<br /><br />It's not clear how many klutzes want to notify their insurers that a doctor visit was a W22.02XA, "walked into lamppost, initial encounter" (or, for that matter, a W22.02XD, "walked into lamppost, subsequent encounter").<br /><br />Why are there codes for injuries received while sewing, ironing, playing a brass instrument, crocheting, doing handcrafts, or knitting—but not while shopping, wonders Rhonda Buckholtz, who does ICD-10 training for the American Academy of Professional Coders, a credentialing organization.<br /><br />... Much of the new system is based on a World Health Organization code set in use in many countries for more than a decade. Still, the American version, developed by the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services, is considerably more fine-grained.<br /><br />The WHO, for instance, didn't see the need for <span style="font-weight: bold;">72 codes about injuries tied to birds. But American doctors whose patients run afoul of a duck (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=duck">see codes</a><span style="font-weight: bold;">), macaw (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=macaw">see codes</a><span style="font-weight: bold;">), parrot (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=parrot">see codes</a><span style="font-weight: bold;">), goose (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=goose">see codes</a><span style="font-weight: bold;">), turkey (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=turkey">see codes</a><span style="font-weight: bold;">) or chicken (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=chicken">see codes</a><span style="font-weight: bold;">) will be able to select from nine codes for each animal,</span> notes George Alex, an official at the Advisory Board Co., a health-care research firm.<span style="font-weight: bold;"><br /><br />There are 312 animal codes in all</span>, he says, compared to nine in the international version. There are separate codes for <span style="font-weight: bold;">"bitten by turtle"</span> and <span style="font-weight: bold;">"struck by turtle."</span> (<a href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=Turtle">See codes</a>.)</blockquote><p></p>Examples:<br /><br /><blockquote>W6151XA Bitten by goose, initial encounter<br />W6151XD Bitten by goose, subsequent encounter <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Killer Goose?]</span><br />W6151XS Bitten by goose, sequela<br />W6152XA Struck by goose, initial encounter<br />W6152XD Struck by goose, subsequent encounter<br />W6152XS Struck by goose, sequela<br />W6159XA Other contact with goose, initial encounter<br />W6159XD Other contact with goose, subsequent encounter<br />W6159XS Other contact with goose, sequela</blockquote><br />Sometimes my favorite Canada Goose couple, George and Martha, and their annual young'uns will overextend their beaks when being fed and nip my finger. They've never broken my skin (geese have no teeth, just ridges) but if they do ... my doctor is likely to have to code for "bitten by Canada Goose."<br /><br />I wonder if CDC will then send out the Goose Patrol. George and Martha, be careful, or your goose may be cooked!<br /><br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj6XkUrBC9v9JI3_z1vZzaD7SRS3KZiDFUT-QxmGIJVfx14pvYTdMWaWBuiRvBLLM_aU6CWXdgVj7NOne0qYYqD6YPhmK9OJB_WY6eZc2j5PfNTPXUDySG-yaA_7Zckgu2ahU-YstxIQoCT/s1600/george.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5655569935392590242" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj6XkUrBC9v9JI3_z1vZzaD7SRS3KZiDFUT-QxmGIJVfx14pvYTdMWaWBuiRvBLLM_aU6CWXdgVj7NOne0qYYqD6YPhmK9OJB_WY6eZc2j5PfNTPXUDySG-yaA_7Zckgu2ahU-YstxIQoCT/s320/george.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 296px;" /></a><span style="font-size:85%;">George, I'm going to feed you, but don't W6151XD</span><span style="font-size:85%;"> me (bite me) or the Feds will be after you ...</span><span style="font-size:85%;"> (click to enlarge photos) </span></div><br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjAe5L0wj033ueltsLPJXXnedf8mLjn-omiaw3gaLKiIY7YktgdknAW7yyAC9ujlx2KRCCRwOtKbwFxYWjvcVtTH8DOBRqtpCJYUpc4tHAOtGRIb6HzKaxaFfvx5oPN5GP1xEtX8Q4LpIGq/s1600/younguns.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5655571722736097122" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjAe5L0wj033ueltsLPJXXnedf8mLjn-omiaw3gaLKiIY7YktgdknAW7yyAC9ujlx2KRCCRwOtKbwFxYWjvcVtTH8DOBRqtpCJYUpc4tHAOtGRIb6HzKaxaFfvx5oPN5GP1xEtX8Q4LpIGq/s320/younguns.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 240px;" /></a><span style="font-size:85%;">Young'uns, you better watch out, too!</span><br /><br /></div><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjXo-FQb8mopRZE3moes-vRbr89rKLIhAWuRbW5gtrl9g76tMCsgDOOC7Tvpnys1OuKbk0LV0OpPg_vy6Y2OvXwi-58bqNM7LGveqzUfOxO67TBlY5wiLXBu_O9DEwWvw9Dap1zJmbJWpH_/s1600/molly.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5655632407985125138" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjXo-FQb8mopRZE3moes-vRbr89rKLIhAWuRbW5gtrl9g76tMCsgDOOC7Tvpnys1OuKbk0LV0OpPg_vy6Y2OvXwi-58bqNM7LGveqzUfOxO67TBlY5wiLXBu_O9DEwWvw9Dap1zJmbJWpH_/s320/molly.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 240px;" /></a><span style="font-size:85%;">This guy has already done a W6152XA and W6152XD to me with his wings, leaving me with a W6152XS (bruise on my leg</span><span style="font-size:85%;">) when I didn't feed him before the Canadas! You can just tell he's looking to create coding mayhem from that expression on his face.</span><br /></div><br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEip1c7cDSM2ESwSl6Ktg6ILHijLkMH7uUEingai21n_-yBr43pxwUQDqLpdEkOnYZywmE5xzdiDllY9M-Hiiof6RNCnKe0xqyNHAVEKs8h943Y_4ggHNiRktvDK5GHMS8H9sPnx40mInWr5/s1600/duck.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5655571946029411026" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEip1c7cDSM2ESwSl6Ktg6ILHijLkMH7uUEingai21n_-yBr43pxwUQDqLpdEkOnYZywmE5xzdiDllY9M-Hiiof6RNCnKe0xqyNHAVEKs8h943Y_4ggHNiRktvDK5GHMS8H9sPnx40mInWr5/s320/duck.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 240px;" /></a><span style="font-size:85%;">Is there an ICD-10 code for "foot bitten by cute little Mallard duckie?"<br /></span></div><span style="font-size:100%;"><br /></span><span style="font-size:100%;"><span style="font-size:100%;"><br />What a perverse waste of resources this coding mania represents...</span></span><br /><span style="font-size: 100%;"><span style="font-size: 85%;"><br /><span style="font-style: italic;">Hat tip: </span><a href="http://www.galen.org/" style="font-style: italic;">The Galen Institute</a><span style="font-style: italic;">/Grace-Marie Turner</span></span></span><br /><br />-- SS

My doctor will now need to code for when I get bitten by George or Martha Goose

The bureaucrats always seem to find new ways to waste precious medical resources and capital to justify their existence. Here's the late...

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Johnson and Johnson Pleads Guilty - a Reminder of the "Lost Decade" of Nesiritide

It was just a <a href="http://www.bloomberg.com/news/2011-07-09/j-j-s-scios-unit-charged-in-misbranding-of-natrecor-drug-1-.html">short article</a> in Bloomberg about yet another misstep by Johnson and Johnson....<br /><blockquote>Johnson & Johnson (JNJ)’s Scios unit <em>agreed to pay an $85 million fine and plead guilty to misbranding the heart drug Natrecor, </em>the U.S. said.<br /><br />Scios was charged in July with <em>misbranding the medicine because its labeling lacked adequate directions for use.</em> Under a plea agreement reached after months of negotiation with prosecutors, Scios will be placed under <em>organizational probation</em> for three years in addition to paying the fine....</blockquote><br />Although the case did involve a guilty plea, the fine actually seemed small compared to some others we have seen lately. The article made it sound like this was just a technical mis-step in labeling.<br /><br /><strong>A Darker History</strong><br /><br />However, another brief paragraph hinted at a more complex background:<br /><blockquote>Natrecor, given intravenously, was one of the first drugs for congestive heart failure when it was approved in 2001, and in 2004 it generated $230 million in revenue. Sales plummeted to less than $100 million in 2006 after reviews of its use in less than 1,000 patients tied the medicine to worsening kidney function and higher death rates. </blockquote><br />Of course, to a physician, the first sentence makes no sense. Digitalis was probably the first effective drug for heart failure, and its use was described in the 18th century. To the rest we should pay heed. <br /><br /><strong>A Lack of Evidence for Benefit Outweighing Harm</strong><br /><br />In fact, in 2005, Dr Eric Topol wrote a commentary in the New England Journal that discussed Natrecor's (nesiritide's) troubled history.(1) <br /><br />Here are the main points:<br />- Nesiritide was first tested on seriously ill, hospitalized patients with congestive heart failure.<br />- The drug improved one measure of physiogic function, the pulmonary capillary web pressure. However, patients given nesiritide had a not statistically significant increase in mortality, and a later significant decrease in kidney function.<br />- Nesiritide was thus only approved for short-term use in acutely ill heart failure patients (in 2001).<br />- However, its manufacturer, Scios, a Johnson and Johnson subsidiary, vigorously promoted it for out-patient "tune ups," a use for which there was no evidence that its benefits outweighed its harms.<br />- This use, however, was very lucrative for the company at a price of $500 per dose. So,<br /><blockquote>outpatient nesiritide use has become widespread, fulfilling sales objectives for the manufacturer and bringing in revenue for physicians. The overall sales figure for nesiritide is projected to be $700 million for 2005, nearly double last year's tally; it represents payment for more than 1.4 million treatments. Given that nearly 10 times as much drug is used for serial administration in outpatients as for the one-time use in hospitalized patients, much of this growth clearly stems from the off-label 'tune-up' application.</blockquote><br />At that time, Dr Topol summarized the case thus:<br /><blockquote>The nesiritide story reflects some recurring themes: in other recent cases, too, major safety problems have been uncovered after a drug has been approved. Nesiritide was approved on the basis of a single trial in which surrogate end points were assessed three hours after administration. In cardiovascular medicine, we learned long ago that <em>therapies directed at surrogate end points — such as the suppression of premature ventricular contractions or, for inotropic agents, an improved ejection fraction — can be associated with excess deaths</em>. With the low threshold set for regulatory approval, the FDA did not demand appropriate warnings on the label regarding an increased risk of death or worsened renal function and did not require the performance of trials that would have provided definitive verification of the safety and efficacy of nesiritide.<br /><br />We practice medicine in an era in which there is one pharmaceutical-company representative for every five physicians and in which <em>companies will stretch the limits in their marketing of drugs.</em> The boundary lines that previously separated industry from the FDA and academia have unfortunately become blurred. </blockquote><strong>No Evidence of Benefit in 2011, the End of the "Lost Decade"</strong><br />Finally, in 2011, a larger study of the drug appeared.(2) It did not show that nesiritide increased mortality at 30 days, but neither did it decrease it. Essentially, it showed that the drug had no clinically important advantage over standard therapy. In an accompanying commentary, Dr Topol used the nesiritide case as an example of a "lost decade" due to "deficient clinical development of certain pharmaceutical agents."(3)<br /><blockquote>The FDA, without a prospective plan or capability to force the sponsor to perform a fitting trial after approval, <em>unwittingly created a monster</em>. Physicians, who prescribed nesiritide without definitive knowledge of efficacy or safety, particularly for off-label use such as for tune-up clinics, were <em>treating patients without an adequate evidence base</em>. The manufacturer in this case was the <em>chief culprit because it widely promoted nesiritide in the early years after its approval but was unwilling to appropriate the resources to design and execute a compelling trial. </em></blockquote><br /><strong>Summary</strong><br />The sorry nesiritide case now seems to be staggering towards its conclusion with little fanfare (although the Bloomberg article noted that the legal proceedings related to it are not over.  There is a pending civil False Claims suit brought by the US Department of Justice.)<br /><br />So, 10 years after the drug was widely marketed to patients for whom it would do no good, the "chief culprit" has had a pay a small financial price, relative to the revenue it received, for an offense tangential to the lost decade created for patients and physicians who thought that nesiritide might be worth using. As usual in such cases, no individual who authorized, directed or implemented the "monster" that was the dubious nesiritide marketing campaign has suffered any negative consequences.<br /><br />This was just the latest in a long series of legal misadventures by the once revered Johnson and Johnson. Its most recent guilty plea for a marketing offense was only a month ago (see post <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">here</a>.) That blog post listed five other recent adverse legal results related to the company's marketing. <br /><br />Of course, as long as the company's leaders seem immune to any sort of negative consequences for its bad behavior, and as long as its board seems happy to pay millions to the executives who preside over these messes, why should the bad behavior stop? Do we expect multi-millionaire executives to actually worry about the ethics and morals of what they are doing? - not in an era when "greed is good," at least until the whole economy collapses from the aggregated greed of its leaders.<br /><br />For physicians, the nesiritide case should remind us not to deploy a test or treatment without good evidence that it actually does patients more good than harm, even if we really hope it does, and even if the company that markets it really hopes so too.  <br /><br />For all of us, the case should remind us that if there are short-term monetary rewards but no penalties for unethical behavior, unethical behavior will continue.<br /><strong>References</strong><br /><br />1. Topol E. Nesiritide - not verified. N Engl J Med 2005; 353: 113-116. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMp058139">here</a>. <br />2. O'Connor CM, Starling RC, Hernandez AF et al. Effects of nesiritide in patients with acute decompensated heart failure. N Engl J Med 2011; 365: 32-43. Link <a href="http://www.nejm.org/doi/full/10.1056/nejmoa1100171">here</a>. <br />3. Topol EJ.  The lost decade of nesiritide.  N Engl J Med 2011; 365: 81-82.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMe1103116">here</a>.

Johnson and Johnson Pleads Guilty - a Reminder of the "Lost Decade" of Nesiritide

It was just a short article in Bloomberg about yet another misstep by Johnson and Johnson.... Johnson & Johnson (JNJ)’s Scios unit agre...

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NPfIT Programme goes "PfffT"

More on the travails of the UK's moribund National Programme for IT in the NHS.<br /><br />It's officially gone "PffffT"...<br /><blockquote><br /><a style="font-weight: bold;" href="http://www.guardian.co.uk/society/2011/sep/22/nhs-it-project-abandoned">NHS told to abandon delayed IT project</a><br />Denis Campbell, health correspondent<br />The Guardian, Wednesday 21 September 2011<br /><br />£12.7bn computer scheme to create patient record system is to be scrapped after years of delays<br /><br />The NHS has spent billions of pounds on a computerised patient record and booking system, which has never worked properly.<br /><br />An ambitious multibillion pound programme to create a computerised patient record system across the entire NHS is being scrapped, ministers have decided.<br /><br />The £12.7bn National Programme for IT is <span style="font-weight: bold;">being ended after years of delays, technical difficulties, contractual disputes and rising costs</span>.</blockquote><br />And failure to read and comprehend sites like "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</a>" (extant since ca. 1999) and this very blog...<br /><blockquote><br />Health secretary Andrew Lansley, Cabinet Office minister Francis Maude and NHS chief executive Sir David Nicholson have decided it is better to discontinue the programme rather than put even more money into it. The axe may be wielded , with ministers likely to criticise the last Labour government for initiating the project but doing too little to ensure it delivered its objectives.<br /><br />An announcement has been expected for months after the National Audit Office cast serious doubt on the wisdom of ploughing further money into the scheme and David Cameron told MPs in May that he was considering that advice. Whitehall sources confirmed the decision had been made because of coalition cost-cutting and the ongoing problems.<br /><br />"It was meant to be a very helpful thing for NHS staff and patients but instead has become this <span style="font-weight: bold;">amazingly</span> <span style="font-weight: bold;">top-heavy, hideously expensive programme</span>. The problem is, <span style="font-weight: bold;">it didn't deliver</span>", said a Department of Health source.</blockquote><br />We, of course, in the United States will learn from all this and our "National Program for IT in the HHS" will go splendidly...<br /><br /><blockquote>"It was too ambitious, the technology kept changing, and loads and loads of money has been put into it. It's wasted a <span style="font-weight: bold;">lot of money that should have been spent on nurses and improving patient care, and not on big international IT companies."</span></blockquote><br />Perhaps they do read Healthcare Renewal after all, because I've written exactly that in numerous posts...<br /><br /><blockquote>The move comes after ministers received fresh advice from the Cabinet Office's major projects authority, which assesses the value for money of major public spending schemes. It concluded "there can be no confidence that the programme has delivered or can be delivered as originally conceived", recommending ministers "dismember the programme and <span style="font-weight: bold;">reconstitute it under new management and organisation arrangements".</span></blockquote><br />How about with <span style="font-weight: bold;">leaders with domain-specific expertise, too</span>, as I wrote at my Aug. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/08/are-computers-in-medicine-narcotic-why.html">Are computers in medicine narcotic? Why did the National Programme for IT fail?</a>" At that post I sadly observed that:<br /><br /><blockquote>... [NPfIT] also failed because of collective ignorance of these domains <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[e.g., healthcare informatics, social informatics, etc. - ed.] </span>among its leaders, and among those who chose the leaders. For instance, as I wrote <a href="http://hcrenewal.blogspot.com/2009/12/uk-mp.html">here</a>:<br /><br /><span style="font-family:arial;"></span><blockquote><span style="font-family:arial;">The Department of Health has announced the two long-awaited senior management appointments for the National Programme for IT ... </span><span style="font-family:arial;">The Department announced in February that it was recruiting the two positions as part of a revised governance structure for <span style="font-weight: bold;">handling informatics</span> in the Department of Health.</span> <span style="font-family:arial;"><br /><br />Christine Connelly will be the first Chief Information Officer for Health and will focus on developing and delivering the Department's overall information strategy and integrating leadership across the NHS and associated bodies including NHS Connecting for Health and the NHS Information Centre for Health and Social Care.</span><span style="font-family:arial;">Christine Connelly was previously </span><span style="font-weight: bold;font-family:arial;" >Chief Information Officer at Cadbury Schweppes</span><span style="font-family:arial;"> with direct control of all IT operations and projects. She also spent over </span><span style="font-weight: bold;font-family:arial;" >20 years at BP where her roles included Chief of Staff for Gas, Power and Renewables, and Head of IT for both the upstream and downstream business</span><span style="font-family:arial;">.</span><br /><br /><span style="font-family:arial;">Martin Bellamy will be the Director of Programme and System Delivery. He will lead NHS Connecting for Health and focus on enhancing partnerships with and within the NHS.</span> <span style="font-family:arial;">Martin Bellamy has worked for the</span><span style="font-weight: bold;font-family:arial;" > Department for Work and Pensions since 2003. His main role has been as CIO of the Pension Service</span><span style="font-family:arial;">.</span></blockquote><br />Excuse me. Cadbury Schweppes (candy and drink?) The Pension Service? As national leaders for healthcare IT?<br /><br />Instead of sobriety, attitudes about health IT seem to universally be "sure, the experts think you shouldn’t ride a bicycle into the eye of a hurricane, but we have our own theories." (See <a href="http://hcrenewal.blogspot.com/2008/12/open-letter-to-president-barack-obama.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/05/htrea-parallel-world-of-hit.html">here</a>.)<br /><br />The domain of health IT needs a very stiff period of detox and rock-solid sobriety before it can achieve the (non-revolutionary) benefits of which it is capable.<br /></blockquote><br />Riding bicycles into eyes of hurricanes, I'm sorry to say, really is not a good idea.<br /><br />Back to the current Guardian article:<br /><br /><blockquote>Its highly critical verdict said: "The project has not delivered in line with the original intent as targets on dates, functionality, usage and levels of benefit have been delayed and reduced. <span style="font-weight: bold;">It is not possible to identify a documented business case for the whole of the programme. </span>Unless the work is refocused, it is hard to see how the perception can ever be shifted from the faults of the past and allowed to progress effectively to support the delivery of effective healthcare."</blockquote><br />That is a stark assessment. I think we in the U.S. remain deluded as to the true complexity of a scheme for national health IT, using today's systems.<br /><br /><blockquote>Health minister Simon Burns, who is responsible for the NHS, said recently: "The nationally imposed system is neither necessary nor appropriate to deliver this. <span style="font-weight: bold;">We will allow hospitals to use and develop the IT they already have and add to their environment either by integrating systems purchased through the existing national contracts or elsewhere</span>."<br /><br />Providers of NHS care such as hospitals and GP surgeries will now be told to strike IT deals locally and regionally to get the best programmes they can afford.<br /></blockquote><br />Common sense regarding the need for some degree of local control in healthcare, in a country with socialized medicine yet.<br /><br /><blockquote>It is still unclear how much money the government has agreed to pay contractors in recent negotiations over cancellation fees for scrapping the project.<br /></blockquote><br />Let's just say, the amount will not be peanuts.<br /><br /><blockquote>Lansley told the the Daily Mail: "Labour's IT programme let down the NHS and wasted taxpayers' money by imposing a top-down IT system on the local NHS, which didn't fit their needs.<br /><br />"<span style="font-weight: bold;">We will be moving to an innovative new system driven by local decision-making</span>. This is the only way to make sure we get value for money from IT systems that better meet the needs of a modernised NHS." <span style="font-weight: bold;">Serious doubts about the project's future were confirmed this year when the cross-party House of Commons public accounts committee said it was "unworkable" and that, despite huge investment, had failed to deliver.</span></blockquote><br />Sadly, I knew and predicted this years ago. And I'm not even British, although I have spoken to many <a href="http://en.wikipedia.org/wiki/Amateur_radio_call_signs_of_Great_Britain">G-prefixed ham radio operators</a> over the years.<br /><br />This is one prediction I am not happy to see come true.<br /><br />You can guess the next prediction of mine that I hope also doesn't occur.<br /><br />-- SS

NPfIT Programme goes "PfffT"

More on the travails of the UK's moribund National Programme for IT in the NHS. It's officially gone "PffffT"... NHS told ...

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