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Why Trust Drug Company Executives After One Admits Commercially Sponsored Clinical Research Is All About "Competitive Advantage?"

Mickey, the semi-anonymous blogger on 1BoringOldMan, wrote a <a href="http://1boringoldman.com/index.php/2013/09/12/right-on-the-money/">righteously angry post</a> in support of transparent clinical research.  As we have noted frequently, clinical trials done on human subjects are often <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> to increase the likelihood of results favorable to commercial sponsors, or <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a> when even such manipulation does not produce the desired results. Note that such suppression and manipulation degrade the scientific value of the studies, impede the <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a> process to rationally apply clinical research evidence to improve the health of patients and the public, and violate the trust of research subjects who volunteer to participate based on the assumption that clinical research is meant to improve patient care and public health, and contribute to science, not just secure commercial advantage.   A European initiative to combat suppression of clinical research has been opposed by a lawsuit from US pharmaceutical manufacturers AbbeVie, spun off from Abbott Laboratories, and Intermune.  The European Medicines Agency had been willing to to make public unpublished patient level data from commercially sponsored clinical trials.  The lawsuit has shut down the process, and is meant to shut it down permanently, claiming that the clinical data, obtained from volunteer research subjects, includes "trade secrets." As <a href="http://1boringoldman.com/index.php/2013/09/12/right-on-the-money/">summarized </a>by Mickey, their motivation seems to be to conceal how pharmaceutical manufacturers and other commercial sponsors of human research use this research for promotional, rather than scientific purposes. An AbbeVie lawyer asserted that some adverse effects data should be kept confidential, and that "internal tactical decisions on how we are going to run a study, engage with regulators, and confront and solve problems and challenges we have uncovered during clinical trials" should also be kept secret because revealing them could "give other companies a tremendous competitive advantage," never mind whether keeping secrets could undermine science, decrease the study's usefulness to aid clinical and policy decision making, and break the implicit contract between researchers and study subjects. It is becoming more obvious that many drug company executives, and other leaders of large health organizations, may care more about "competitive advantage" than patients, science or the public good, as Mickey points out.  So much for that advertising puffery  about drug development to improve patient health.  Thus it may be ridiculous to think that these executives they will negotiate to improve transparency of clinical research in good faith when doing so could decrease such advantage, again no matter what the effect on patients, public health, or science. On this case there is an opportunity to speak out, Dr David Healy has a <a href="http://www.change.org/petitions/richard-gonzalez-of-abbvie-and-daniel-welch-of-intermune-drop-your-legal-action-blocking-access-to-ema-clinical-trial-data?utm_source=guides&utm_medium=email&utm_campaign=petition_lonely">petition up on Change.org</a> to oppose the AbbeVie and Intermune lawsuit which might get some notice if there are enough signatures.

Why Trust Drug Company Executives After One Admits Commercially Sponsored Clinical Research Is All About "Competitive Advantage?"

Mickey, the semi-anonymous blogger on 1BoringOldMan, wrote a righteously angry post in support of transparent clinical research. As we hav...

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A New And Quite Perverse Hospital Ploy to Defend Medical Malpractice - Blame the Dead Patient? Two Examples

I did not think hospitals would ever get to the level of perversity, in defense of EHRs and EHR-related malpractice, seen herein. Just a few days ago I came across the following article on a web search. It is an astonishing story of a 49 year old man who died in part because an ED physician in a Suffern, NY hospital did not know how to use the EHR that had life saving diagnostic information within, and the hospital attempted to BLAME THE PATIENT for not "explaining his medical history thoroughly enough" to the ED doctor. You read that correctly. Ironically and sickeningly, yesterday my dead mother and I just had something similar done to us by a suburban Philadelphia hospital, Abington Memorial, as below: <blockquote class="tr_bq">Family Awarded $3.4 Million After ER Misses Aneurysm</blockquote><blockquote><a href="http://blogs.lawyers.com/2012/02/family-awarded-3-4-million-after-er-misses-aneurysm/">http://blogs.lawyers.com/2012/02/family-awarded-3-4-million-after-er-misses-aneurysm/</a> Posted February 17, 2012 in Medical Malpractice by writer <a href="http://blogs.lawyers.com/author/kasea/">Aaron Kase</a> It’s gospel in health care– if you have chest pains, get to the emergency room, especially if you have a history of heart problems. But an inexperienced ER doctor in New York thought his patient’s complaints weren’t serious, and sent him home with muscle relaxers. The result was deadly. A Rockland County jury Wednesday awarded $3.4 million to the family of Michael McKenzie, who was discharged from the Good Samaritan Hospital in Suffern in 2007 after complaining of chest pains and other symptoms consistent with a serious heart problem. The hospital determined that McKenzie, 49, was not having a heart attack, then ER doctor Michael Kane diagnosed him with a muscle strain and sent him home with muscle relaxers. Two days later, McKenzie was found dead in his house by his 10-year-old son, killed by an aortic aneurysm. The hospital should have found the aneurysm, argued Anthony DiPietro, the attorney for McKenzie’s family.”They just blew it,” says DiPietro, who headquarters his practice in New York City. “He had textbook signs of an aortic dissection [bleeding into the wall of the main artery that carries blood from the heart]: Chest pain, back pain, shortness of breath, sudden onset, woke him up from sleep, and he wasn’t doing any activities when it happened.” Compounding the hospital’s error, McKenzie had a history of heart problems that should have pointed them toward the correct diagnosis. In 2003, he had been diagnosed with a dilated aortic root, or enlarged artery, with is a huge red flag for a future rupture. Good Samaritan knew about the dilated root because they had noted it in his chart during a heart procedure McKenzie had undergone the year before his death. But the doctor, who had been at the hospital less than a month and was working unsupervised, never knew about McKenzie’s history. Why not? Because he didn’t know how to use the hospital’s electronic medical records system.</blockquote> That's beyond pathetic, but it gets worse.  Far worse: <blockquote class="tr_bq">“He admitted it as part of his deposition,” DiPietro says. “They equivocated. First they said the system wasn’t working [an apparent attempted mistruth - ed.], but then he said he really didn’t know how to use it yet.” According to a local news report, the doctor was certified in obstetrics and gynecology at the time, and didn’t receive his certificate in emergency medicine until the following year. The hospital argued that the aneurysm wasn’t present when McKenzie visited their ER–despite the fact that his certificate of death stated it had been present for days. The hospital also claimed that McKenzie was responsible for his own death because he didn’t explain his medical history thoroughly enough– the same history that was documented in the hospital’s own records. </blockquote> Let me repeat that for emphasis: The - hospital - also - claimed - that - McKenzie - was - responsible - for - his - own - death - because - he - didn’t - explain - his - medical - history - thoroughly  - enough– the - same - history - that - was-  documented - in - the - hospital’s - own - records. A hospital dares blame a likely frightened-out-of-his-wits patient presenting to their ED with chest pain, back pain, shortness of breath, of sudden onset that woke him up from sleep, for his own death?    That, readers, is the most perverse hospital behavior I have ever encountered since entering medicine in 1977 (actually 1972-3 in summer NSF programs at Hahnemann Hospital in Philadelphia). Not to mention, of course, that said patient cannot defend himself, because he's dead and buried... <blockquote class="tr_bq">In fact, in a highly unusual move, the judge in the case allowed doctors to recount conversations they had with McKenzie to the jury, statements usually prohibited under New York’s “Dead Man’s Statute” designed to keep hearsay out of the courtroom.  </blockquote> It's a very special hearsay indeed when the hear-sayers know the patient is in his grave and cannot respond. <blockquote class="tr_bq">The tilted playing field notwithstanding, the jury nevertheless found the hospital negligent and awarded $3.4 million to McKenzie’s widow, two adult daughters and now 14-year-old son. The money couldn’t come soon enough– the widow, now sole provider for her son, recently lost her job and their home went into foreclosure. “Hopefully this will allow them to keep the house,” DiPietro says.</blockquote> The ironically-named hospital planned an appeal: <blockquote>A Good Samaritan spokesperson said the hospital plans to appeal.</blockquote> I will attempt to find if the dockets are publicly accessible. So, to recap, an ED doc didn't know how to use an EHR that contained lifesaving diagnostic information misses an aneurysm, the patient dies, and the defense attempts to blame the patient for his own death for (allegedly) not telling the doctor thoroughly enough about his own medical condition, i.e., the frightened, in-severe-pain patient didn't know medicine but should have - doesn't everyone? ------------------- I could almost not believe this story, thinking maybe it was exaggerated - until just a few days later I EXPERIENCED THE SAME ISSUE MYSELF, PERSONALLY. As substitute plaintiff in the death of my mother in 2011 due to a 2010 medication reconciliation failure at Abington Memorial Hospital, as mentioned on this blog and in the press (e.g., Bloomberg News, <a href="http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html">http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html</a> and Kaiser Health News, <a href="http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx">http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx</a>), the hospital responded (finally) to the points raised in the Complaint filed in October 2011, after exhausting many procedural delay tactics. The are attempting to blame my mother, who I took to the ED while she was in process of nearly having a stroke, and me as well for her injuries. From their Sept. 9, 2013 filing: <blockquote class="tr_bq">... 41. The injuries allegedly sustained by [substitute] Plaintiffs decedent [my dead mother - ed.] were caused in whole or in part or the same may have been contributed to by the actions of the Plaintiffs decedent [my dead mother - ed.], and accordingly, any claim for damages is barred or the damages recoverable herein must be reduced in accordance with the provisions of the Pennsylvania Comparative Negligence Act, as may be applied to facts disclosed in discovery.</blockquote> They're apparently claiming (quite falsely, as I was there) that my mother, brought to the ED by me with a headache and suffering cerebral ischemia, never advised the doctors and nurses about her heart medication Sotalol (which was in their ED and floor EHR's from prior visits - just as in the aneurysm case above) that they summarily terminated, leading to disaster, so that her injuries and death are her own fault.  Of course, my mother is dead, so only I can speak for her. They also attempt to blame me for my mother's harm and death, a layperson (I have not practiced medicine in over 21 years): <blockquote class="tr_bq">54. Upon information and belief, Scot Silverstein’s actions and/or omissions may have been the cause or one of the causes of the harm suffered by the Decedent and/or her Estate.</blockquote><blockquote>55. Upon information and belief Scot Silverstein may be contributorily or comparatively negligent for any harm to the decedent and/or her Estate.</blockquote> They also falsely claim I never informed medical staff about my mother's heart medication, nothwithstanding their own medication reconciliation (verification) policy calls for a best-effort complete re-verification of medications from all available sources at every transition of care, such as when she went from ED to ICU, and then ICU to floor, when I was not present.  Such resources would include, among others:  1) me, via telephone (not used);  2) the patient (apparently this resource was not used); 3) past EHR visit med lists showing the heart medication (also, apparently not used).  As the Abington Hospital filing was signed and verified by their VP "Patient Advocate" / Director of Risk Management <a href="http://www.corporationwiki.com/Pennsylvania/Abington/regina-sturgis/81813980.aspx">Regina Sturgis</a>, considering these cases, I must ask the question if the practice of "blaming the harmed or dead patient" for their harm is a risk management strategy taught in the seminars these folks attend. Blaming dead patients or their families for harm from medical misadventures is absolutely horrifying.  It shows disrespect for the dead and is depraved, especially coming from a hospital, I think any prospective patient would agree. -- SS

A New And Quite Perverse Hospital Ploy to Defend Medical Malpractice - Blame the Dead Patient? Two Examples

I did not think hospitals would ever get to the level of perversity, in defense of EHRs and EHR-related malpractice, seen herein. Just a few...

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N.S.A. Able to Foil Basic Safeguards of Privacy on Web, Including Medical Records - Yet Another Reason To Be Concerned About What You Tell Your Physician

There's already a major issue with privacy and protection of medical records in electronic form.  See the multiple blog posts at this query link:  <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a> Now this from the New York Times: <blockquote class="tr_bq"><a href="http://www.nytimes.com/2013/09/06/us/nsa-foils-much-internet-encryption.html?pagewanted=all&_r=1&">N.S.A. Able to Foil Basic Safeguards of Privacy on Web</a> By NICOLE PERLROTH, JEFF LARSON and SCOTT SHANE September 5, 2013 The <a class="meta-org" href="http://topics.nytimes.com/top/reference/timestopics/organizations/n/national_security_agency/index.html?inline=nyt-org" title="More articles about National Security Agency, U.S.">National Security Agency</a> is winning its long-running secret war on encryption, using supercomputers, technical trickery, court orders and behind-the-scenes persuasion to undermine the major tools protecting the privacy of everyday communications in the Internet age, according to newly disclosed documents. The agency has circumvented or cracked much of the encryption, or digital scrambling, that guards global commerce and banking systems, protects sensitive data like trade secrets and medical records, and automatically secures the e-mails, Web searches, Internet chats and phone calls of Americans and others around the world, the documents show.  </blockquote> But don't worry, your electronic medical records are secure, and will NEVER be used for political purposes by your adversaries... <blockquote class="tr_bq"><div itemprop="articleBody">Beginning in 2000, as encryption tools were gradually blanketing the Web, the N.S.A. invested billions of dollars in a clandestine campaign to preserve its ability to eavesdrop. Having lost a public battle in the 1990s to insert its own “back door” in all encryption, it set out to accomplish the same goal by stealth. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">The agency, according to the documents and interviews with industry officials, deployed custom-built, superfast computers to break codes, and began collaborating with technology companies in the United States and abroad to build entry points into their products. The documents do not identify which companies have participated. </div></blockquote> At least we may have gotten faster PC's as a side result of the research that supported these efforts. <blockquote class="tr_bq">... the agency used its influence as the world’s most experienced code maker to covertly introduce weaknesses into the encryption standards followed by hardware and software developers around the world. Some of the agency’s most intensive efforts have focused on the encryption in universal use in the United States, including <a href="https://www.globalsign.com/ssl-information-center/what-is-ssl.html" title="More about SSL">Secure Sockets Layer</a>, or SSL; <a href="http://gadgetwise.blogs.nytimes.com/2011/05/17/vpn-for-the-masses/" title="More about VPN">virtual private networks</a>, or VPNs; and the protection used on fourth-generation, or 4G, smartphones. Many Americans, often without realizing it, rely on such protection every time they send an e-mail, buy something online, consult with colleagues via their company’s computer network, or use a phone or a tablet on a 4G network.  </blockquote> Might as well just send them a copy of all your communications to spare them the effort... <blockquote class="tr_bq">... Ladar Levison, the founder of Lavabit, wrote <a href="http://lavabit.com/">a public letter</a> to his disappointed customers, offering an ominous warning. “Without Congressional action or a strong judicial precedent,” he wrote, “I would strongly recommend against anyone trusting their private data to a company with physical ties to the United States.” </blockquote> Hey, how about let's ALL have our medical records stored by health IT companies providing ASP (Application service provider, <a href="http://en.wikipedia.org/wiki/Application_service_provider">http://en.wikipedia.org/wiki/Application_service_provider</a>) offsite EHR hosting services to hospitals and clinics... From the site "techdirt.com": <blockquote class="tr_bq">Allegedly <a href="http://www.theguardian.com/world/2013/sep/05/nsa-gchq-encryption-codes-security" target="_blank">the NSA and GCHQ (UK Government Communications Headquarters) have basically gotten backdoors into various key security offerings used online</a>, in part by controlling the standards efforts, and in part by sometimes covertly introducing security vulnerabilities into various products. They haven't "cracked" encryption standards, but rather just found a different way in. The full report is worth reading ... (<a href="http://www.techdirt.com/articles/20130905/12295324417/nsa-gchq-covertly-took-over-security-standards-recruited-telco-employees-to-insert-backdoors.shtml">http://www.techdirt.com/articles/20130905/12295324417/nsa-gchq-covertly-took-over-security-standards-recruited-telco-employees-to-insert-backdoors.shtml</a>).</blockquote> Half facetiously: unless you're a real nobody, if you, say, contracted V.D. from that sexy prostitute at that Vegas Convention, you perhaps better not tell your doctor about it. Maybe this is what it will take to get the government to start taking electronic medical record privacy, confidentiality and security more seriously. Our legislators, like everyone else, have a stake in the game. -- SS

N.S.A. Able to Foil Basic Safeguards of Privacy on Web, Including Medical Records - Yet Another Reason To Be Concerned About What You Tell Your Physician

There's already a major issue with privacy and protection of medical records in electronic form. See the multiple blog posts at this qu...

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Market Fundamentalism and the Denial of Conflicts of Interest, and of Worse Offenses

While we often point out the pervasiveness of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> in medicine and health care, and the likely ill effects of this state of affairs, it seems that the powers that be in health care tend to airily dismiss conflicts of interest as at most a minor problem that needs management (e.g., look <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">here</a>.)  How Market Fundamentalist Ideology Nullifies the Concept of Conflicts of Interest On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2013/09/why-theres-no-such-thing-as-conflict-of.html">discussed</a> how application of the reigning orthodoxy in economics, sometimes called neoliberalism, market fundamentalism, or <a href="http://hcrenewal.blogspot.com/search/label/economism">economism</a>, can be used to dismiss the concept of conflicts of interest. Basically, supporters of market fundamentalism et al seem to assume that all markets are idealized free markets, and that free markets are like a super computer combining all human thought to provide wisdom in the form of price information.  Furthermore, since the market is based on supposedly rational choices made by free individuals, one cannot go back to question such choices.  So when, for example, an academic physician makes the "free choice" to accept thousands of dollars from a drug company as a "market consultant," and then also gives talks about clinical topics that happen to favor that drug company's products, such choices cannot be questioned.  Therefore, the notion that these choices constitute a conflict of interest, and that the choice to accept the drug company money in particular might increase the likelihood of abuse of the physician's entrusted responsibility to make the best decisions for individual patients, and to teach other physicians honestly and without bias, essentially makes no sense within this framework. Dr Brody further enlarged on the internal contradictions within the ideology of neliberalism/ market fundamentalism/ economism, in <a href="http://theeconomismscam.blogspot.com/2013/09/more-on-inherent-contradictions-of.html">another post</a> on his Economism Scam blog. Of course, the ideology seems to ignore the possibilities that 1) people's choice may not be free, may not be rational, and may not be based on coldly rational cognition and the best possible knowledge; and 2) one person's economic choice may limit another person's choices, or directly harm another person.  By Extension, Fraud and Corruption Denialism Furthermore, not only does neoliberalism et al seem to deny the existence of meaningful conflicts of interest, it also could be used to deny the meaningful existence of deceptive marketing, of market domination through oligopoly or monopoly, and then of outright fraud, bribery, and extortion.  See for example how former US Federal Reserve chairman Alan Greenspan seemed to deny the existence of fraud, which he asserted would always be nullified by the ideal market.  As we posted <a href="http://hcrenewal.blogspot.com/2011/10/another-month-another-series-of-adverse.html">here</a>, according to an <a href="http://www.stanfordalumni.org/news/magazine/2009/marapr/features/born.html">article</a> in Stanford Magazine,  Greenspan told Ms Brooksley Born, the federal regulatory agency head who tried to develop some effective regulation of financial derivatives, <blockquote class="tr_bq">'Well, you probably will always believe there should be laws against fraud, and I don’t think there is any need for a law against fraud,' she recalls. Greenspan, Born says, believed the market would take care of itself.</blockquote> By further extension, market fundamentalism could be used to deny the evils of chattel slavery. The Conflicted as Defenders of Conflicts of Interest Finally, notice that neoliberalism/ market fundamentalism/ economism ideology seems to have conveniently been adopted by pundits, both in economics and in medicine and health policy who may be personally profiting from conflicts of interest on one hand, and whose conflicts seem to arise from payments from large corporations whose management seem to be personally profiting even more so.  For example, we have discussed examples of how defenders of existing financial relationships - which in my humble opinion are actually conflicts of interest - employ logical fallacies to make their points.  Some of these defenders seem to have obvious conflicts of their own (for example, <a href="http://hcrenewal.blogspot.com/2013/03/doctors-dubious-excuses-for-taking.html">this post</a> included examples of physicians rationalizing their financial ties to drug companies,  and <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">this post</a> included fallacies employed by a current medical school leader, but former extremely well paid biotechnology company executive.).  On the other hand, I have yet to find a logical, reality-based defense of these conflicts of interest made by anyone who demonstrably does not have such conflicts of their own.   Summary Human beings have been wrestling with corruption since the dawn of history.  There are ancient arguments against bribery in the Bible  (e.g., in the Old Testament, in Exodus and Deuteronomy), and fraud (e.g., in Leviticus, the Proverbs, and the Gospel of Mark).  One can argue that a fundamental purpose of civilization is to reduce self-serving misbehavior such as bribery, fraud, and extortion, and other varieties of corruption.  The notion that free markets make the concepts of fraud, and of conflicts of interest (that are risk factors for corruption - look <a href="http://hcrenewal.blogspot.com/2012/03/another-cautionary-tale-about-conflicts.html">here</a>) meaningless is nothing more than school playground sophistry. To truly reform health care, we need to return it from its current Wild West mentality to a state more resembling civilization.  We need to reject silly notions that free markets erase the concepts of conflict of interest, or of fraud, or of other aspects of corruption.

Market Fundamentalism and the Denial of Conflicts of Interest, and of Worse Offenses

While we often point out the pervasiveness of conflicts of interest in medicine and health care, and the likely ill effects of this state o...

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Study Explains Errors Caused by EHR Default Values - With Only Four Reports of "Temporary" (By the Grace of God) Patient Harm

From Health Data Management and the <a href="http://patientsafetyauthority.org/Pages/Default.aspx">Pennsylvania Patient Safety Authority</a>: <blockquote class="tr_bq"><a href="http://www.healthdatamanagement.com/news/ehr-electronic-health-records-default-values-errors-46559-1.html">Study Explains Errors Caused by EHR Default Value</a> <div id="article-meta"><div class="name">Joseph Goedert </div><div class="date">Sept. 5, 2013 </div></div> <div id="article-teaser">A new study analyzes errors related to “default values” which are standardized medication order sets in electronic health records and computerized physician order entry systems.</div><div id="article-teaser"> </div>The Pennsylvania Patient Safety Authority, an independent state agency, conducted the study. “Default values are often used to add standardization and efficiency to hospital information systems,” says Erin Sparnon, an analyst with the authority and study author. “For example, a healthy patient using a pain medication after surgery would receive a certain medication, dose and delivery of the medication already preset by the health care facility within the EHR system for that type of surgery.” These presets are the default value, but safety issues can arise if the defaults are not appropriately used. Sparnon studied 324 verified safety reports, noting that 314, or 97 percent, resulted in no harm. Six others were reported as unsafe conditions that caused no harm and four reports caused temporary harm involving some level of intervention.</blockquote><div id="article-content"> One might ask:  how many unreported or yet-to-be-reported EHR/CPOE cases involved, or will involve, permanent harm? <blockquote class="tr_bq">Sept. 9, 2012 Addendum:  We learn this from Healthcare IT News (<a href="http://www.healthcareitnews.com/news/ehr-adverse-events-data-cause-alarm">http://www.healthcareitnews.com/news/ehr-adverse-events-data-cause-alarm</a>):  "Sparnon said two of the reports involved temporary harm that required initial or prolonged hospitalization."  I note that hospitalization, especially prolonged hospitalization, exposes the patient to still more risk. </blockquote> Regarding the "temporary harms", one which includes "default times" as opposed to doses: <blockquote class="tr_bq">The four cases requiring intervention involved accepting a default dose of a muscle relaxant that was higher than the intended dose, giving an extra dose of morphine [keep playing with 'extra doses' of drugs like morphine enough, and you're going to kill someone  - ed.] because of an accepted default administration time that was too soon after the last dose, having a patient’s temperature spike after a default stop time automatically cancelled an antibiotic [do this enough, and you're going to get sepsis and septic shock to deal with - ed.] and rising sodium levels in a patient because confused wording made nurses believe that respiratory therapy was administering an ordered antidiuretic. [Apparently the 'default'- ed.]</blockquote> More on the errors: <blockquote class="tr_bq">The most common types of errors in the study were wrong time (200), wrong dose (71) and inappropriate use of an automated stopping function (28). </blockquote> Any of these, especially the latter two, could have caused harm depending on degree...and to those Risk Management majors out there, eventually will. <blockquote class="tr_bq"> “Many of these reports also showed a source of erroneous data and the three most commonly reported sources were failure to change a default value, user-entered values being overwritten by the system and failure to completely enter information which caused the system to insert information into blank parameters,” Sparnon says. </blockquote> Hence my claim that the term "EHR" is anachronistic, and that these systems now are really cybernetic command-and-control mediators and regulators of care (via cybernetic proxy). <blockquote class="tr_bq">“There were also nine reports that showed a default needed to be updated to match current clinical practice.”</blockquote> The need for a constant, rigorous updating process (which will in the real world likely always be 'behind'), among many others, is a factor that makes the idealistic belief/promise that "health IT will save money and increase safety" (let alone "revolutionize" medicine) unpersuasive. I note that the "default values" risk is only one of many, many "features" of EHRs and other clinical IT that cause risk and error.  This issue is but one layer of a very, very large and multi-layered onion (cf. AHRQ Health IT Hazards Manager, <a href="http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf">http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf</a>, for example). And this, at the same time that the The HIT Policy Committee, a body of industry stakeholders who advise federal officials, on Sept. 4 adopted final recommendations on health IT risk consistent with an attitude of health IT exceptionalism that included: <blockquote class="tr_bq">"HIT should not be subject to FDA [or any - ed.] premarket requirements" and "Vendors should be required to list products which are considered to represent at least some risk if a non-burdensome approach can be identified."  </blockquote> If not, no list? ... And what, exactly, is a "non-burdensome" approach, one might ask?  (See <a href="http://www.healthdatamanagement.com/news/health-information-technology-regulation-fda-onc-fcc-46557-1.html">www.healthdatamanagement.com/news/health-information-technology-regulation-fda-onc-fcc-46557-1.html</a>)</div>  ------------------ Perhaps the penalty for health IT hyperenthusiasts**, short of the Biblical penalty of one of their loved ones suffering the fate of a guinea pig in a medical experiment, should be to be compelled to fly some third rate air carrier with a safety record of "we only had a few near-crashes last month." -- SS ** [See definition of health IT hyperenthusiast at Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality' at <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html]</a>

Study Explains Errors Caused by EHR Default Values - With Only Four Reports of "Temporary" (By the Grace of God) Patient Harm

From Health Data Management and the Pennsylvania Patient Safety Authority : Study Explains Errors Caused by EHR Default Value Joseph Goedert...

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Setback for Sutter after $1B EHR crashes (in followup to post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals")

At my July 12, 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" (<a href="http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html">http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html</a>) I reproduced a California Nurses Association warning about rollout of an EHR at Sutter: <blockquote class="tr_bq">RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals Introduction of a new electronic medical records system at Sutter corporation East Bay hospitals has produced multiple problems with safe care delivery that has put patients at risk, charged the California Nurses Association today. Problems with technology are not unique to health care ...  [What is unique to healthcare IT is the complete lack of regulation - ed.] In over 100 reports submitted by RNs at Alta Bates Summit Medical Center facilities in Berkeley and Oakland, nurses cited a variety of serious problems with the new system, known as Epic. The reports are in union forms RNs submit to management documenting assignments they believe to be unsafe. Patient care concerns included computerized delays in timely administration of medications and contact with physicians, ability to properly monitor patients, and other delays in treatment.  Many noted that the excessive amount of time required to interact with the computer system, inputting and accessing data, sharply cuts down on time they can spend with patients with frequent complaints from patients about not seeing their RN.  [Note: patients are not given the opportunity for informed consent about the risks, nor opt-out of EHR use in their care - ed.]</blockquote> In related posts I'd observed such concerns being ignored by hospital management.  See header of the aforementioned post. Now we have this:  a major system crash. <blockquote class="tr_bq">Healthcare IT News <a href="http://www.healthcareitnews.com/news/setback-sutter-after-1b-ehr-system%20crashes">Setback for Sutter after $1B EHR crashes</a> <div class="top">'No access to medication orders, patient allergies and other information puts patients at serious risk'</div><div class="top">SACRAMENTO, CA | August 28, 2013</div><div class="top"></div><div class="top">The nearly $1 billion electronic health record system at Sutter Health in Northern California crashed early this week, leaving nurses and clinical staff unable to access any patient information for a full day. he Epic EHR was down Aug. 23 due to a planned upgrade for eight hours during which nurses and other clinical users could read medication orders and patient histories but had to record new data on paper to then be re-entered into the system later, according to reports from the California Nurses Association, part of National Nurses United, the largest nurses union in the U.S. Then, on the morning of Aug. 26 at approximately 8 a.m., the system crashed completely, at which time nurses, physicians and hospital staff had no access to patient information, including what medications patients were taking or required to take and all vital patient history data.    The Epic EHR went dark at several Sutter Health locations, including Alta Bates Summit Medical Center, Eden Medical Center, Mills-Peninsula Hospital, Sutter Delta, Sutter Tracy, Sutter Modesto and numerous affiliated clinics. "This incident is especially worrisome," said Bonnie Castilla, RN, CNA legislative director, in a news release. "No access to medication orders, patient allergies and other information puts patients at serious risk.  These systems should never be relied upon for protecting patients or assuring the delivery of the safest care."  [This is no exaggeration.  My mother was nearly killed by such a problem when caused by an EHR defect (<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1729552">link</a>) that I averted at the last minute by happenstance of showing up at the right time, while she recuperating from another EHR-related disaster - ed.]   </div></blockquote><blockquote class="tr_bq"><div class="top">Some RNs also reported that Sutter failed to provide adequate support during the blackout and didn't implement adequate backup planning.   "All information such as medication administration records and patient histories was outdated by two to three days," said Mike Hill, Alta Bates Summit RN, in a news release. "There were no orders that could be seen of any kind through the day so nurses called for what they needed." Kevin Sweat, an emergency room RN at Eden Medical Center, a Sutter affiliate, also weighed in on the blackout, saying that in his 12 years as an RN he has never seen a system crash like this.     </div></blockquote>Worse, clinicians must now serve their Cybernetic Master to perfection, or be whipped (apparently to improve morale): <blockquote class="tr_bq">... "We have been on Epic for 5 months now, and we can no longer have incorrect orders, missing information or incorrect or missing charges. Starting on September 1st, errors made in any of the above will result in progressive discipline," according to another hospital memo sent to staff. </blockquote> In the setting of dire warnings by the nurses of EHR dangers several months back that were likely largely ignored, if any patient was harmed or killed as a result of this latest fiasco, the corporate leadership has literally begged to be sued for negligence, in my view. However I'm sure a press release soon will claim that "<a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised">patient care has not been compromised</a>." Of course this includes now and moving forward, even with informational gaps all over the place. -- SS Aug. 29, 2013 additional thought: The punishment for not being a 'perfect' user of this EHR is the ultimate "blame the user" (blame the victim?) game, considering the pressures of patient care in hospitals in lean times - partly due to EHR expense! - and EHRs that have not been formally studied for usability and are poorly designed causing "use error" (that is, a poor user experience promotes even careful users to make errors).  Cf. definition of bad health IT: <blockquote class="tr_bq"> Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.</blockquote> The study of usability is getting underway only now via NIST but will likely be done in an industry-friendly way due to health IT politics. -- SS Aug. 29, 2013 addendum There have been numerous comments over at HisTalk (at <a href="http://histalk2.com/2013/08/27/news-82813/">http://histalk2.com/2013/08/27/news-82813/</a>) defending the outage as not EPIC's fault.   From the point of view of clinicians - and more importantly, patients - it doesn't matter what component of the hospital's entire "EHR" (an anachronistic term used for what is now a complex enterprise clinical resource and clinician command-and-control system) went down.  Aside from all the EPIC issues the nurses have been complaining about (see earlier July 12, 2013 post linked above), the larger problem is that IT malpractice occurred.  The term "malpractice" is used in medical mishaps; I see no reason why it does not apply to major outages of mission critical healthcare information technology systems. IT malpractice in healthcare kills. These are the types of nurses I'd want caring for me and mine.  Letting this kind of snafu go "anechoic" does not promote proper management remedial education on Safety 101 and on health IT risk, two areas of education that management appears to desperately need in hospitals. -- SS

Setback for Sutter after $1B EHR crashes (in followup to post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals")

At my July 12, 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals...

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Calling Dr. Moe, Dr. Larry and Dr. Curly: Advocate Medical Breach of Four Million Patient Records, and No Encryption

At my Oct. 2011 post "Still More Electronic Medical Data Chaos, Pandemonium, Bedlam, Tumult and Maelstrom: But Don't Worry, Your Data is Secure" (<a href="http://hcrenewal.blogspot.com/2011/10/still-more-ehr-chaos-pandemonium-bedlam.html">http://hcrenewal.blogspot.com/2011/10/still-more-ehr-chaos-pandemonium-bedlam.html</a>) I thought I'd seen the worst. Yet another post to add to the category of medical record privacy/confidentiality/security (<a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy),</a> however: <blockquote class="tr_bq"><a href="http://www.healthcareinfosecurity.com/advocate-medical-breach-no-encryption-a-6021">Advocate Medical Breach: No Encryption?</a> Computer Theft Raises Questions About Unencrypted Devices By Marianne Kolbasuk McGee, August 27, 2013. The recent theft of four unencrypted desktop computers from a Chicago area physician group practice may result in the second biggest healthcare <a href="http://www.healthcareinfosecurity.com/breach-response-c-324">breach</a> ever reported to federal regulators. But the bigger issue is: Why do breaches involving unencrypted computer devices still occur? According to the Department of Health and Human Services' "wall of shame" website listing 646 breaches impacting 500 or more individuals since September 2009, more than half of the incidents involved lost or stolen unencrypted devices. Incidents involving data secured by encryption do not have to be reported to HHS. ... The four unencrypted but password-protected computers [passwords on PC's are bypassable by smart teenagers - ed.] stolen during a burglary in July from an office of <a href="http://www.healthcareinfosecurity.com/breach-may-affect-4-million-patients-a-6018">Advocate Medical Group</a> in Illinois may have exposed information of about 4 million patients, according to an Advocate spokesman. </blockquote> 4 million is about 1.3 percent of the entire U.S. population (about <a href="https://www.google.com/search?q=us%20population">313.9 million</a> in 2012) ... on just four desktop computers. Try that with paper ... As to the subtitle of the article, "Computer Theft Raises Questions About Unencrypted Devices", I've written on that issue before.  I'd noted questions like that are remarkable considering both MacOS and Windows have built-in, readily available encryption, the latter for a few extra $ for the "deluxe version" (see  <a class="" data-reactid=".r[2a5gp].[1][4][1]{comment10200246430313520_4728545}.[0].{right}.[0].{left}.[0].[0].[0][2].[0].[1]" href="http://en.wikipedia.org/wiki/FileVault" rel="nofollow" target="_blank">http://en.wikipedia.org/wiki/FileVault</a> and <a class="" data-reactid=".r[2a5gp].[1][4][1]{comment10200246430313520_4728545}.[0].{right}.[0].{left}.[0].[0].[0][2].[0].[3]" href="http://en.wikipedia.org/wiki/Bitlocker" rel="nofollow" target="_blank">http://en.wikipedia.org/wiki/Bitlocker</a>).   Perhaps the best explanation in 2013 for unencrypted desktop PC's containing millions of confidential medical records is this picture, symbolic of the apparent attitudes of corporate and IT management on health IT security: <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjnAsw6PW67gX6YJJIVtd1hEp5nCpuf5Re_XG0rDd2AJELzlw8B5pV9bvBxHPXa6DhmesPxvPoc8c_n3Y3u2s3Ki1GxEUgZ_jzbex53lu7i4-pc6eS4SKXr6axDPCCVSmKPpHg_UAPThsnN/s1600/stooges+police300px.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjnAsw6PW67gX6YJJIVtd1hEp5nCpuf5Re_XG0rDd2AJELzlw8B5pV9bvBxHPXa6DhmesPxvPoc8c_n3Y3u2s3Ki1GxEUgZ_jzbex53lu7i4-pc6eS4SKXr6axDPCCVSmKPpHg_UAPThsnN/s1600/stooges+police300px.jpg" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Encryption?  We don't need no encryption.  We got triple protection already!</td></tr></tbody></table> -- SS

Calling Dr. Moe, Dr. Larry and Dr. Curly: Advocate Medical Breach of Four Million Patient Records, and No Encryption

At my Oct. 2011 post " Still More Electronic Medical Data Chaos, Pandemonium, Bedlam, Tumult and Maelstrom: But Don't Worry, Your ...

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