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Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style

At my Sept. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html" style="font-family: arial;">The Dangers of Critical Thinking in A Politicized, Irrational Culture</a>" I wrote: <blockquote style="font-family:arial;">... It's the EMR "anecdotalists" (as opposed to the "<a href="http://www.blogger.com/redir.aspx?C=dc7b9da405614c5dbab920a23075d904&URL=http%3a%2f%2fonline.wsj.com%2farticle%2fSB122910977401502369.html%3fmod%3dloomia%26loomia_si%3dt0%3aa16%3ag2%3ar3%3ac0.0175368%3ab0" target="_blank">Markopolists</a>") who say that "anecdotes" of HIT-related injury are meaningless. They deem reports of safety issues and HIT-related misadventures and risk as simply "anecdotal", and that "anecdotes don't make evidence" (or "anecdotes don't make data").</blockquote> For "anecdotes" of patient harm due to medical devices even from the most reliable of sources to be counted as "evidence" of device risk, apparently, the stories need to be blessed with Statistical Holy Water. The Holy Water must also be of a brand approved by the academic pundits. For me, this is no longer merely a professional debate. My elderly relative became one of those "anecdotes" in May last year. I address the casual, Dogbert-style, waving-of-the-hand "Bah!" dismissal of health IT harm "anecdotes" at numerous other posts as well, such as "<a href="http://hcrenewal.blogspot.com/2011/01/ehr-problems-no-theyre-merely.html" style="font-family: arial;">EHR Problems? No, They're Merely Anecdotal</a>" and "<a href="http://hcrenewal.blogspot.com/2010/09/health-it-on-anecdotalism-and.html" style="font-family: arial;">Health IT: On Anecdotalism and Totalitarianism</a>". <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjC3R-neGSEVG6YHlF2_aqr3l_TIiwnLOVuprTMHik2msljNENb9cbk8yfkczzdbnzm3vXf5s1MSAybYAwwEdk4qPThRR8mDgKozEtleyGagJOM7rQY7xomFQXq1-z5nKatfhw-Fhc5m5MN/s1600/dilbert_bah.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5588746392800329890" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjC3R-neGSEVG6YHlF2_aqr3l_TIiwnLOVuprTMHik2msljNENb9cbk8yfkczzdbnzm3vXf5s1MSAybYAwwEdk4qPThRR8mDgKozEtleyGagJOM7rQY7xomFQXq1-z5nKatfhw-Fhc5m5MN/s320/dilbert_bah.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 122px; height: 102px;" /></a>Bah! Your Health IT adverse events reports are anecdotes, and anecdotes don't make data! </div> In those posts I also mention how Australian informatics professor Dr. Jon Patrick had essentially hit the flaws of this argument out of the Southern hemisphere with a short editorial in the journal "Applied Clinical Informatics" entitled "<a href="http://aci.schattauer.de/en/contents/archive/issue/1124/manuscript/15463/show.html" style="font-family: arial;">The Validity of Personal Experiences in Evaluating HIT</a>." That essay is free at the link and is worth reading. Interestingly and thankfully, the "anecdotes are meaningless" crowd have now lost, and lost big - Supreme Court style. In fact, the U.S. Supreme Court has shown far more common sense than many esteemed academics and industry pundits. As noted in <a href="http://pipeline.corante.com/archives/2011/03/25/the_supreme_court_slams_big_pharma_not_exactly.php" style="font-family: arial;">this post</a> at Derek Lowe's pharmaceutical industry "In the Pipeline" blog, the company that made "Zicam", a zinc-based over-the-counter cold remedy, tried to defend shareholder suits that the company withheld case reports of Zicam causing permanent loss of smell via arguing that such reports "did not reach a level of statistical significance", i.e., were "anecdotal." The case went to the U.S. Supreme Court. The Supreme Court would have none of that argument: <blockquote>"Matrixx’s [Zicam's manufacturer - ed.] premise that statistical significance is the only reliable indication of causation is flawed. Both medical experts and the Food and Drug Administration rely on evidence other than statistically significant data to establish an inference of causation. It thus stands to reason that reasonable investors would act on such evidence. </blockquote> The full court decision is at this link: <a href="http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf" style="font-family: arial;">http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf</a> (PDF file), but a passage I consider key to this issue is as follows: <blockquote style="font-style: italic;">... We conclude that the materiality of adverse event reports cannot be reduced to a bright-line rule ... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context. </blockquote> This is common sense incarnate. It applies not just to drugs, but to medical devices, to health IT, and to other domains as well. In essence, it is saying that adverse events reports, especially repeated ones, from trustworthy sources are not to be lightly dismissed, but should serve at the very least as red flags that there may be a systemic problem requiring further investigation. One wonders how and if public healthcare IT vendors will begin disclosing "anecdotal" reports of their products causing patient harm to their own stockholders. One also wonders if the academic anecdotalists (up to the level of the chair of the <a href="http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__onc/1200" style="font-family: arial;">Office of the National Coordinator for Health Information Technology</a> at HHS) will cease their unfettered dismissal of health IT AE reports as mere "anecdotes" and therefore let's roll out this 100% beneficent technology nationwide ASAP: <blockquote style="font-family:arial;">"Nothing [ONC has] found would give them any pause that a policy of introducing EMR's could impede patient safety." - David Blumenthal </blockquote> That sounds a bit like the refrain of the makers of Zicam. One might also wonder if the anecdotalists merely lack common sense, or are using this form of epistemological dementia to obscure conflict of interest. On a final note, my favorite comment at the aforementioned "In the Pipeline" blog story is this by anonymous commenter "<a href="http://pipeline.corante.com/archives/2011/03/25/the_supreme_court_slams_big_pharma_not_exactly.php#486785">Still Scared of Dinosaurs</a>": <blockquote>One of the most important ideas real statisticians must get into their heads is "Thou shalt not worship the 0.05 threshold". The whole concept of "statistical significance" for AEs is idiotic and the fact that Matrixx based any part of their defense on it indicates that their stupidity did not end when they named the company.</blockquote> Perhaps this Dilbert cartoon is apropos to the Supreme Court decision: <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpWvtHM2V4woNCenRHGJBsn5bL2lnegSGbsn6NLY-al4u1RXF9vsMrbkECBhDJvRAGg2DNSe298h2dNiNetm9f54jUTxDwmFFYPchyphenhyphenaKz8y8mP16rRDeGIIMIHPsg-utiJIN9ZGOjkrfS6/s1600/dogbert.gif"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5588746949773253554" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpWvtHM2V4woNCenRHGJBsn5bL2lnegSGbsn6NLY-al4u1RXF9vsMrbkECBhDJvRAGg2DNSe298h2dNiNetm9f54jUTxDwmFFYPchyphenhyphenaKz8y8mP16rRDeGIIMIHPsg-utiJIN9ZGOjkrfS6/s320/dogbert.gif" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 138px; height: 135px;" /></a> -SS Addendum: I thought it appropriate to share these thoughts with the leadership of the <a href="http://www.jointcommission.org/">Joint Commission</a>, the organization that accredits healthcare organizations in the United States: <div style="direction: ltr;" id="divRpF355968"></div><blockquote><div style="direction: ltr;font-family:arial;" id="divRpF355968">From: Scot Silverstein Sent: Sunday, March 27, 2011 10:41 AM To: MGiuntoli, Anita; Chassin, Mark; Schyve, Paul; Legaspi, Shirley Cc: Ross Koppel; 'David Kreda' Subject: Re: MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL. </div> <div> <div face="Arial" size="13px" style="direction: ltr; color: rgb(0, 0, 0);"> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;">Not a complaint this time [about health IT failure - ed.], but an observation. The JC has noted health IT risks in the Sentinel Events Alert "<a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF">Safely implementing health information and converging technologies</a>" of 2008. The company that made "Zicam", a zinc-based over-the-counter cold remedy, tried to defend shareholder suits that the company withheld case reports of Zicam causing permanent loss of smell via arguing that such reports "did not reach a level of statistical significance", i.e., were "anecdotal." The case went to the U.S. Supreme Court. The Supreme Court would have none of that argument: <blockquote style="font-family:arial;"> "Matrixx’s [Zicam's manufacturer] premise that statistical significance is the only reliable indication of causation is flawed. Both medical experts and the Food and Drug Administration rely on evidence other than statistically significant data to establish an inference of causation. It thus stands to reason that reasonable investors would act on such evidence. </blockquote> The full court decision is at this link: <a href="http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf" target="_blank">http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf</a> (PDF file), but a passage I consider key to this issue is as follows: <blockquote style="font-family:arial;">... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context.</blockquote> This is common sense incarnate. It applies not just to drugs, but to medical devices, to health IT, and to other domains as well. </div> <div dir="ltr" style="font-family: arial;"> </div> <div dir="ltr" face="arial">I believe JC should start to pay serious attention to "anecdotal reports" of health IT-caused patient injury, and consider reliable reporting of these events as an Accreditation standard. </div> <div dir="ltr" face="arial"> </div> <div dir="ltr" style="font-family: arial;">As I noted in my July 2009 JAMA letter to the editor "<a href="http://jama.ama-assn.org/content/302/4/382.1.extract" target="_blank">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</a>" in response to Koppel and Kreda's <a href="http://jama.ama-assn.org/content/301/12/1276.extract" target="_blank">JAMA article</a> on HIT industry practices, "hold harmless" and "gag" clauses must go, and be replaced with proactive reporting of healthcare IT-related "events." </div> <div style="font-family: arial;" dir="ltr"> </div> <div dir="ltr" style="font-family: arial;">Scot Silverstein</div> <div dir="ltr"> </div></div></div></blockquote>-- SS

Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style

At my Sept. 2010 post " T he Dangers of Critical Thinking in A Politicized, Irrational Culture " I wrote: ... It's the EMR ...

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The Institute of Medicine Releases Reports on Practice Guidelines and Systematic Reviews Which Generate Few Echoes

Two days ago, the prestigious US Institute of Medicine <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=13058">released </a>two reports on important health care issues, clinical practice guidelines and systematic reviews.  <a href="http://iom.edu/Reports/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx">Systematic reviews</a> of the relevant clinical research have been advocated by evidence-based medicine proponents as the appropriate basis for clinical and policy decisions.  <a href="http://iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx">Clinical practice guidelines</a> have been advocated by many health researchers, policy makers, and clinicians as the best way to encapsulate the evidence to inform clinical and policy decision making.  Both reports suggested series of standards for how systematic reviews and clinical practice guidelines should be developed.  These topics are of general importance to clinicians, health services researchers, and health policy makers.  The <a href="http://www.iom.edu/">Institute of Medicine</a>, part of the US National Academy of Sciences, is one of the most authoritative sources of opinion on medicine and health care.  Therefore, one would think that these reports would have gotten wide notice, and would hardly required Health Care Renewal to create some echoes. However, a Google News search today produced only six "hits" relevant to these reports, including the original press release.  All are in specialized medical/ health care news outlets.  None are in the national media, and none are from major medical/ professional journals or societies.  Let me suggest a theory about why these two major reports have generated so few echoes so far.  Let me quote from the <a href="http://iom.edu/~/media/Files/Report%20Files/2011/Clinical-Practice-Guidelines-We-Can-Trust/Clinical%20Practice%20Guidelines%202011%20Report%20Brief.pdf">summary</a> of the report on clinical practice guidelines: <blockquote>Most guidelines used today suffer from shortcomings in development. Dubious trust in guidelines is the result of many factors, including failure to represent a variety of disciplines in guideline development groups, lack of transparency in how recommendations are derived and rated, and omission of a thorough external review process. To be trustworthy, clinical practice guidelines should: • Be based on a systematic review of the existing evidence; • Be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups; • Consider important patient subgroups and patient preferences, as appropriate; • Be based on an explicit and transparent process that minimizes distortions, biases, and conflicts of interest; • Provide a clear explanation of the logical relationships between alternative care options and health outcomes, and provide ratings of both the quality of evidence and the strength of recommendations; and • Be reconsidered and revised as appropriate when important new evidence warrants modifications of recommendations. Additionally, as reflected in the committee’s standards for developing trustworthy clinical practice guidelines, guideline development groups optimally comprise members without conflict of interest. The committee recognizes that in some circumstances, a guideline development group may not be able to perform its work without members who have conflicts of interest—for example, relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the guideline. Therefore, the committee specifies that members of the guideline development group who have a conflict of interest should not represent more than a minority of the group.</blockquote> So it seems that the report on clinical practice guidelines emphasized two issues highly relevant to Health Care Renewal, the need for <a href="http://hcrenewal.blogspot.com/search/label/transparency">transparency</a> in guideline development, and the need to avoid <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> affecting the development process. The two first <a href="http://iom.edu/~/media/Files/Report%20Files/2011/Clinical-Practice-Guidelines-We-Can-Trust/Clinical%20Practice%20Guidelines%202011%20Insert.pdf">standards</a> for guidelines are about transparency and minimization of conflicts of interest.  Similarly, the report on systematic reviews also included fairly tough <a href="http://www.iom.edu/~/media/Files/Report%20Files/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews/Standards%20for%20Systematic%20Review%202010%20Insert.pdf">standards</a> to minimize conflicts of interest. We on Health Care Renewal go on and on about the need to maximize transparency in health care, and particularly in health care leadership and governance, and about the need to disassemble the now pervasive web of conflicts of interest that has entangled health care.  However, as we know, these are not popular topics among the leadership of health care, which includes many individuals who have greatly benefited from lack of transparency and pervasive conflicts of interest.  We know these topics make these leaders, and many of those who report to, or work or associate with them very uncomfortable. So unfortunately, I am not surprised that the two new and likely authoritative reports from the Institute of Medicine, despite that organization's prestige, have started off relatively <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.  It also unfortunately likely that they will remain relatively anechoic.  In 2009, the IOM issued an authoritative <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">report on conflicts of interest</a> in medicine and health care which suggested fairly tough standards to decrease such conflicts and their influence (also see post <a href="http://hcrenewal.blogspot.com/2010/12/health-professionals-for-new-century.html">here</a>).  Since 2009, I just found 53 citations to that report in the medical literature using the ISI Web of Science, for a rate of 27/year.  In 1999, the IOM issued a report on medical errors, "To Err is Human."  Since then, it has received 1374 citations, a rate of 115/year.  As we noted above, the topic of conflicts of interest seems to make the powers that be in health care very uncomfortable.  In contrast, "To Err is Human" was widely interpreted to mean that physicians make a lot of dangerous errors, and the best way to decrease them is to impose more controls by bureaucrats, managers, and executives (even if that was not its intent).  Thus, that report could be twisted to fit the talking points of the powers that be, and hence has been anything but anechoic. So while Health Care Renewal is hardly a powerful tool for creating publicity, I thought we should try to get the word out about the new IOM reports on clinical practice guidelines and systematic reviews.  Every little bit helps. Meanwhile, the deathly quiet reception these reports have gotten so far emphasizes the need to combat the anechoic effect.  As long as the powers that be can command billions of dollars to influence the health care conversation through their marketing, public relations, and lobbying departments, expect the discussion not to question what they do, and how they benefit from the status quo to the financial and health detriment of patients and the population. We will not be able to truly reform health care until we can speak openly about what threatens health care values and what needs to be done about these threats.

The Institute of Medicine Releases Reports on Practice Guidelines and Systematic Reviews Which Generate Few Echoes

Two days ago, the prestigious US Institute of Medicine released two reports on important health care issues, clinical practice guidelines an...

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A Jury Finds Johnson and Johnson's Risperdal Marketing "Willfully Deceptive," but What Will It Take to Change Company Leadership?

For Johnson and Johnson, it's deja vu all over again, as <a href="http://www.goupstate.com/article/20110324/ARTICLES/103241022/1083/ARTICLES?Title=Spartanburg-jury-says-maker-of-drug-Risperdal-deceptive">reported </a>by the Spartansburg (SC) Herald Journal: <blockquote>A Spartanburg jury decided that Johnson & Johnson and a subsidiary violated South Carolina's Unfair Trade Practices Act, but the company will wait until damages are determined next month before it decides whether to appeal the jury's decision.</blockquote> Also, <blockquote>The jury decided Tuesday the company willfully violated the act by sending a 2003 letter to doctors that attorneys for the state said sought to minimize the risk of hyperglycemia — or high blood sugar — and diabetes reported by patients using Risperdal. The letter was sent to about 700,000 doctors nationwide — 7,200 of those in South Carolina. The jury decided that warning labeling included with the drug was also willfully deceptive.</blockquote> This is not the first such lawsuit involving Risperdal, <blockquote>South Carolina's lawsuit was the fourth state lawsuit to go to trial. In West Virginia, claims involving Risperdal were dismissed with prejudice last December following the company's appeal. In October, a jury in Louisiana awarded almost $258 million in civil penalties to the state. Janssen will appeal that decision. In a jury trial in Pennsylvania in June, a judge dismissed the state's case against Janssen.</blockquote> Note that we posted about the Louisiana verdict <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>. The hits, they just keep on coming for Johnson and Johnson, which has been recalling a dizzying array of products due to manufacturing problems.  A new recall was just <a href="http://blogs.wsj.com/health/2011/03/24/jj-recall-watch-360000-surgical-wound-drainers/">announced today</a>, and there have been 20 separate recalls since mid-2009. Just eight days ago we <a href="http://hcrenewal.blogspot.com/2011/03/despite-recalls-legal-settlements.html">contrasted</a> the opulent compensation given the Johnson and Johnson CEO in 2010 (about $29 million) with the company's poor financial performance, seeming inability to make pure, unadulterated, safe products as manifested by multiple recalls, and ethical problems as indicated by legal settlements and guilty pleas. Today we have added another recall, and a jury verdict against the company finding its marketing was deceptive.  So the cognitive dissonance evoked by comparison of executive pay and corporate dysfunction continues.  Is there any degree of organizational dysfunction that could possibly induce a health care corporate CEO to feel shame for continuing to extract millions from the flailing beast?  Is there any degree of disconnection between executive compensation and corporate performance that could possibly induce complacent corporate boards to feel shame for enriching the hired executives who presided over the mess? Probably not.  The events surrounding the global financial collapse suggested that somehow expecting corporations to regulate themselves was at best foolishly naive (e.g., see <a href="http://economistsview.typepad.com/economistsview/2011/03/wall-streets-performance-enhancement-scandals.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+EconomistsView+%28Economist%27s+View+%28EconomistsView%29%29">here</a>).  Presumably former US Federal Reserve Chair Allan Greenspan <a href="http://www.huffingtonpost.com/2010/04/09/financial-crisis-panel-gr_n_531647.html">really thought</a> that markets could regulate themselves, and that fraud could not exist because markets in his idealized view would punish it themselves, <blockquote>he didn't believe that fraud was something that needed to be enforced or was something that regulators should worry about....</blockquote> But then he later admitted:  <blockquote>Those of us who have looked to the self-interest of lending institutions to protect shareholder's equity – myself especially – are in a state of shocked disbelief</blockquote>We do not yet seem to be at the point that will we generate enough "shocked disbelief" about the misbehavior of current health care organizations to realize that they will not police themselves, and a true health care reform movement will have to figure out how to reasonably regulate them.  (I submit that perusing the archives of Health Care Renewal will suggest that we should have been at that point years ago.) If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

A Jury Finds Johnson and Johnson's Risperdal Marketing "Willfully Deceptive," but What Will It Take to Change Company Leadership?

For Johnson and Johnson, it's deja vu all over again, as reported by the Spartansburg (SC) Herald Journal: A Spartanburg jury decided th...

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Despite Poor Financial Results, Diminishing Pipeline, Multiple Settlements of Legal Cases, Outgoing Pfizer CEO Got Over $24 Million

It is the season for share-holders' meetings of big US publicly held corporations, and as the proxy statements prepared for these meetings, prepare for more eye-popping, jaw-dropping examples of executive compensation.  Pfizer's 2010 CEO Compensation The AP (<a href="http://online.wsj.com/article/AP710553746b304ba0b503426028084ebd.html">via the Wall Street Journal</a>) just noted the compensation given to Jeffrey Kindler, the outgoing (in 2010) CEO of Pfizer, Inc, the world's largest pharmaceutical company: <blockquote>Former Pfizer Inc. Chairman and CEO Jeffrey B. Kindler may have left the world's largest drugmaker abruptly last December, but he didn't leave empty-handed thanks to a compensation package valued almost $22 million. Kindler received a 60 percent increase last year over his 2009 compensation, according to an Associated Press analysis of a Pfizer regulatory filing Tuesday. The New York-based drugmaker gave Kindler a salary and performance-related bonus totaling $4.9 million, a $4.5 million severance payment and more than $12 million in stock and option awards. The company also will continue his health coverage for 12 months 'at active employee rates,' the filing said.</blockquote> In fact, perusal of the new <a href="http://www.pfizer.com/files/annualreport/2010/proxy/proxyfinancial2010.pdf">2011 Pfizer proxy statement</a> shows that Kindler, who stepped down on 5 December, 2010, made even more based on Pfizer's own calculations, $24,688, 849. Curiously, Ian Read, the CEO after 5 December, and previously Group President, Worldwide Pharmaceutical Business, received $17,396,112, despite only being CEO for 26 days. Pay for What Kind of Performance? These opulent pay packages stand in contrast to Pfizer's performance under Kindler and its financial results in 2010: <blockquote>Kindler was ousted by Pfizer's board unexpectedly Dec. 6 after four years of languishing share prices and several failures of promising drugs in late testing, including a successor to cholesterol fighter Lipitor, the world's top-selling drug. Pfizer will lose U.S. patent protection in November for Lipitor.</blockquote> Also, <blockquote>Pfizer's 2010 net income fell 4 percent to $8.26 billion, or $1.02 per share. Revenue totaled $67.81 billion, up 36 percent, thanks to $18.1 billion from sales of Wyeth products. Its stock price slipped 4 percent to close 2010 at $17.31, while the Standard & Poor's 500 index climbed 12.8 percent.</blockquote> Furthermore, the compensation given the former and current CEO also stood in sharp contrast to Pfizer's amazing track record of recent unethical behavior.   Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here</a>).  Pfizer was involved in three other major cases from then to early 2010, including two involving settlements of fraud charges, and one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post <a href="http://hcrenewal.blogspot.com/2010/03/settlement-and-conviction-round-up.html">here</a>).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post <a href="http://hcrenewal.blogspot.com/2010/12/drug-companies-are-now-no-1-when-it.html">here</a>).  Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post <a href="http://hcrenewal.blogspot.com/2011/02/pharmacia-or-maybe-pfizer-settles-only.html">here</a>).   Just yesterday a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see <a href="http://www.bloomberg.com/news/2011-03-22/pfizer-reaches-asbestos-settlement-that-may-end-quigley-unit-s-bankruptcy.html">this story</a> in Bloomberg). Despite Pfizer's recent dismal financial performance, clotted drug pipeline, and unfortunate ethical/ legal track record, the company's board compensation committee reported thus: <blockquote>The Committee believes that Pfizer’s executive compensation program implements and achieves the goals of our executive compensation philosophy. Pfizer’s executive compensation philosophy, which is set by the Committee, is to align each executive’s compensation with Pfizer’s short-term and long-term performance and to provide the compensation and incentives needed to attract, motivate and retain key executives who are crucial to Pfizer’s long-term success.</blockquote>Who Provided "Stewardship" of Pfizer? So I had to ask: who were these people who thought that compensation of over $24 million was somehow "aligned" with declining profits, declining revenues, little output of new drugs, and multiple legal settlements of charges like fraud and violating the RICO act? Here is a list of Pfizer's board of directors in 2010, and some relevant affiliations, taken from <a href="http://www.pfizer.com/about/leadership_and_structure/meet_board.jsp">Pfizer's web-site</a>, and where indicated, elsewhere (color coding to be explained below) - Dennis A. Ausiello, M.D. - Jackson Professor of Clinical Medicine at Harvard Medical School and Chief of Medicine at Massachusetts General Hospital since 1996. Member of the Institute of Medicine.... Director of TARIS BioMedical, Inc. (<a href="http://www.researchamerica.org/ausiello_dennis">per Research!America bio</a>) advisor to drug delivery and biosensing start-up companies Entra, BIND Biosciences, and Seventh Sense Biosystems, Inc., to drug-discovery startup companies Promedior and Pulmatrix, to Proventys, an evidence-based medicine delivery system, and to Ore Pharmaceuticals and Polaris, investment and venture capital companies working in the biotech and device area. - Michael S. Brown, M.D. - Distinguished Chair in Biomedical Sciences since 1989 and Regental Professor since 1985 at the University of Texas Southwestern Medical Center at Dallas. Member of ... the Institute of Medicine,.... Director of Regeneron Pharmaceuticals, Inc. - M. Anthony Burns - Chairman Emeritus since 2002, Chairman of the Board from 1985 to 2002, Chief Executive Officer from 1983 to 2000, and President from 1979 to 1999 of Ryder System, Inc., a provider of transportation and logistics services. Life Trustee of the University of Miami. - Robert N. Burt - Retired Chairman and Chief Executive Officer of FMC Corporation, a chemicals manufacturer, and FMC Technologies Inc., a machinery manufacturer.... Life Trustee of the Rehabilitation Institute of Chicago - W. Don Cornwell - Chairman of the Board and Chief Executive Officer of Granite Broadcasting Corporation from 1988 until his retirement in August 2009 and Vice Chairman until December 2009. (per <a href="http://www.wallacefoundation.org/AboutUs/directors_and_staff/Pages/BioWDonCornwell.aspx">Wallace Foundation web-site</a>) He previously served as vice president, investment banking division, of Goldman Sachs. - Frances D. Fergusson, Ph.D. - President Emeritus of Vassar College since 2006 and President from 1986 to 2006. Served on the Mayo Clinic Board for 14 years, the last four years as its Chairman, and as President of the Board of Overseers of Harvard University from 2007 through 2008. - William H. Gray III - Co-Chairman of GrayLoeffler, LLC (formerly the Amani Group), a business advisory and consulting firm. Chairman of the Amani Group from 2004 through September 2009. Currently Director of ... J. P. Morgan Chase & Co. - Constance J. Horner - Guest Scholar from 1993 until 2005 at The Brookings Institution.... - James M. Kilts - Founding Partner, Centerview Partners Management, LLC, a private equity firm, since 2006. (Per <a href="http://www.centerviewpartners.com/overview.aspx?xitm=2&yitm=1">Centerview Partners web-site</a>) Centerview Partners' investment banking advisory business serves some of the largest companies globally in a broad range of industries, with particular expertise in Food & Consumer Products, Financial Institutions, General Industrials, Healthcare, Media & Entertainment .... The firm has executed many significant transactions in recent years, including: Altria's $113 billion spin-off of Philip Morris International, its $62 billion spin-off of Kraft and its $11.7 billion acquisition of UST... Facet Biotech's $722 million sale to Abbott Labs; OSI Pharmaceuticals' $4.0 billion sale to Astellas Pharma; - George A. Lorch - Chairman Emeritus of Armstrong Holdings, Inc., a global manufacturer of flooring and ceiling materials,.... - John P. Mascotte - Retired President and Chief Executive Officer of Blue Cross and Blue Shield of Kansas City, Inc.,... - Suzanne Nora Johnson - Retired Vice Chairman, Goldman Sachs Group, Inc.,... Director of American International Group, Inc., .... Board member of the American Red Cross, The Brookings Institution, ... and the University of Southern California. (per <a href="http://www.milkeninstitute.org/events/gcprogram.taf?EventID=GC08&SPID=3058&function=bio">Milken Institute web-site</a>) on the board of numerous not-for-profit organizations, including ... RAND Health .... She is on the Advisory Board of Councilors of Harvard Medical School - Ian C. Read - President and Chief Executive Officer since December 2010. - Stephen W. Sanger - Chairman of General Mills, Inc. Currently Director of ... Wells Fargo & Company. - William C. Steere, Jr. - Chairman Emeritus of Pfizer Inc. since 2001. Currently Director of Health Management Associates, Inc. Director of the New York University Medical Center ...; and Member of the Board of Overseers of Memorial Sloan-Kettering Cancer Center. Of Pfizer's 14 directors (excluding its CEO), seven have or had leadership positions at teaching hospitals, academic medical centers, medical schools or their parent universities. Three have or had leadership positions at other influential non-profit health care organizations.  Two had leadership positions at potentially competing pharmaceutical or biotechnology companies. Two had leadership positions at companies that finance pharmaceutical, biotechnology and other health related companies. One had a leadership position at a health insurance company. One had a leadership position at a for-profit hospital operating company. Four had leadership positions in financial services corporations, including some that were implicated in the global financial collapse, and/or required massive federal bail-outs to avoid collapse. It seems that every time we look at the boards of directors or trustees who are supposed to provide stewardship to a troubled health care organization, we see a similar pattern.  Just as we <a href="http://hcrenewal.blogspot.com/2011/03/despite-recalls-legal-settlements.html">recently said</a> about the Johnson and Johnson board, ....   Summary   So here we have the latest striking case that indicates the confluence of forces that can lead to health care dysfunction. Not only has the compensation given to health care leaders got so large that it is per se a cause of increased health spending, but also, and more importantly, such compensation often provides perverse incentives that perpetuate mismanagement, raising costs and lowering quality. This situation appears to be enabled by governance (or "stewardship") by individuals who are often fellow members of the CEOs' club, and hence who may feel more sympathy with the executives they are supposed to supervise than the stockholders whose financial interests they are supposed to protect, or the public whom the companies' products and services are supposed to benefit. Moreover, these individuals often have conflicts of interest which may mitigate against objective scrutiny of the executives they are supposed to oversee. Finally, these individuals often may come from corporate cultures which do not espouse the values that we in health care are supposed to uphold. (See this post and its links for other examples of the sorts of people who are supposed to provide stewardship to health care organizations.) So to repeat once more- I strongly believe that there needs to be much more investigation, academic, journalistic, and perhaps legal, of the identity, nature, and culture of the leaders of health care, and their relationships. A few bloggers cannot do it all. Obviously, the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a> mitigates against medical and health care academics looking into their own leaders. However, failing to understand who is leading our march to the brink of health care failure ought not to be something such academics would want on their conscience. Finally, and obviously, health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses. ADDENDUM (23 March, 2011) - See also <a href="http://gooznews.com/?p=2622">comments</a> by Merrill Goozner on the GoozNews blog.

Despite Poor Financial Results, Diminishing Pipeline, Multiple Settlements of Legal Cases, Outgoing Pfizer CEO Got Over $24 Million

It is the season for share-holders' meetings of big US publicly held corporations, and as the proxy statements prepared for these meetin...

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Millions to Health Insurance CEOs, But Blame Everyone Else for Rising Health Care Costs

The revelations about the huge golden parachute given the outgoing CEO of ostensibly non-profit Massachusetts Blue Cross Blue Shield induced some public discussion about the disconnect between executive compensation and the mission of health care organization (see most recent post <a href="http://hcrenewal.blogspot.com/2011/03/some-dare-call-it-corruption.html">here</a>).  Several other recent stories should generate more discussion on these issues.  First, new proxy statements revealed the compensation of executives of two large for-profit health care insurers/ managed care companies.  In alphabetical order, Cigna As reported by the AP, <a href="http://abcnews.go.com/Business/wireStory?id=13169800">via ABC news</a>, the CEO got a big raise: <blockquote>Cigna Corp. CEO David M. Cordani's total compensation more than doubled in 2010, his first year as leader of the nation's fourth-largest health insurer, and a period in which the company's earnings, revenue and enrollment all climb. Cordani, 45, received compensation valued at $15.1 million last year from the Philadelphia managed-care company, according to an Associated Press analysis of a regulatory filing Friday. That included a $1 million salary, a performance-related bonus totaling more than $7.3 million and stock and option awards adding up to $6.7 million.</blockquote> In 2009, Cordani's compensation was $6.5 million, but he did not serve for the entire year. Note that according to the <a href="http://www.sec.gov/Archives/edgar/data/701221/000089322009000604/w73121fdef14a.htm">2009 proxy</a>, the previous CEO, H Edward Hanway, received $12,236,740 in total compensation in 2008, his last year as CEO. What was the rationale for the huge rise in Cordani's compensation from 2009 to 2010? (And implicitly, the fairly large increase compared to Hanway's compensation in his last year?) <blockquote>The company said in its proxy statement filed with the Securities and Exchange Commission that Cigna 'effectively executed on its growth strategy under Cordani's leadership last year. 'Revenue rose significantly in 2010, reflecting strong premium growth in (Cigna's) ongoing business segments,' the proxy said. Cigna earned about $1.35 billion, or $4.89 per share, on $21.25 billion in revenue in 2010. That was up from $1.3 billion, or $4.73 per share, on $18.41 billion in revenue in 2009. The insurer's medical membership climbed 4 percent to 11.4 million people compared to the final quarter of 2009, when it fell more than 5 percent. That helped raise premiums and fees in health care, the insurer's largest segment.</blockquote> Also, <blockquote>Cigna shares climbed 4 percent to close 2010 at $36.66, while the Standard & Poor's 500 index rose 12.8 percent.</blockquote> So to recap, Cigna's current CEO's total compensation doubled in a year while earnings and the stock price rose about 4%. WellPoint Also reported by AP, <a href="http://www.washingtonpost.com/business/wellpoint-ceo-compensation-rose-to-134-million-last-year-despite-slide-in-profit/2011/03/18/ABaEq1r_story.html">via the Washington Post</a>, the CEO got a small raise (but ended up with compensation similar to Mr Cordani's above): <blockquote>The president and CEO of health insurer WellPoint Inc. received a 3 percent boost in total compensation in 2010 even as the company’s profit and enrollment numbers slipped during a transitional year for U.S. health care companies. The Indianapolis-based insurer awarded Angela Braly a total pay package worth $13.4 million up from $13.1 million in 2009. Wellpoint disclosed the compensation — which includes salary, bonus and other awards — in a filing with federal financial regulators late Friday.</blockquote> On the other hand, the company did not do so well financially: <blockquote>The insurer’s profit fell sharply last year compared with 2009, when the sale of its NextRx subsidiary contributed $2.2 billion in after-tax income. Medical enrollment also slid 1 percent last year to 33.3 million members.</blockquote> So what was the rationale for even a small raise (over an already huge compensation package)? <blockquote>In the company’s filing, Wellpoint’s board of directors highlighted accomplishments by management, including reducing general expenses by 3 percent. </blockquote> Also, <blockquote>A Wellpoint spokeswoman stressed Friday that the company’s pay formula rewards executives for improving enrollee health, boosting share prices and meeting other pre-set goals. 'For the CEO, almost 90 percent of total target compensation is based on company performance and is tied to meeting established goals,' Kristin Binns said in a statement.</blockquote>So while Cigna did slightly better financially than last year, its CEO's total compensation doubled to well over $10 million, and while WellPoint did slightly worse financially than last year, its CEO's total compensation increased, again remaining well over $10 million.  It seems that the leaders of top health care organizations will continue to get richer, no matter how well their organizations performed financially, let alone what effect they had on patients' and the public's health. So What Drives Up Health Care Costs? Just to distract from CEOs getting increases in their already huge compensation that seem disproportionate to any reasonable measure of their companies' financial performance, health care insurers continued to deny any responsibility for the rise in health care costs. For example, the San Francisco Chronicle published <a href="http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2011/03/19/MNCE1I3D1T.DTL">a story </a>entitled, "Insurer Wants Focus on What Drives Up Health Costs," which had a familiar ring: <blockquote>When health insurers notify members that rates are going up - often in the punishing double-digits - they typically blame rising medical costs. They say the problem really isn't theirs; it's all the other pieces of the health-care puzzle that drive up costs that must be passed on to customers.</blockquote>Don't blame you, don't blame me, blame that fella behind the tree. It went on to name all the usual suspects (color-coded for comparison below): <blockquote>Insurers say their costs grow in part because of new medical technologies and the rising price of pharmaceutical products and medical equipment. The consolidation of hospitals and doctors into large networks also makes it hard to keep prices low, as do waste, fraud and malpractice, they say. The system also lacks incentives for hospitals and doctors to curb costs. For example, they can charge twice by repeating tests and procedures, and by readmitting patients. Insurers also say they lose money with policies people buy on their own, as opposed to group coverage from employers. Because the individual policies are more expensive, healthier people tend to avoid them, leaving insurers with a sicker pool. Poor reimbursement from government programs such as Medi-Cal also forces insurers to raise private insurance prices to make up the slack, they say. Finally, as people get older and fatter, they gobble up more health care resources. 'When you're looking at growth in premiums, the largest engine of that growth are those medical costs,' said Charles Bacchi, executive vice president of the California Association of Health Plans, which represents health insurers. He said critics who claim that insurers raise prices to increase profits and pad executive salaries are wrong, and that insurers' average profit margin has remained at 3 to 5 percent for years.</blockquote> First, note that the executive compensation, the administrative costs, the marketing, public relations and lobbying costs all come off the top of revenues before any profits are generated, and before any possible dividends get paid to stock-holders.   I suspect that the insurance industry spokespeople immediately switch the topic to profits and investors' results to distract from those who really make money from health insurance companies, the top executives, and all those managers, bureaucrats, marketers, public relations people, and lobbyists who never touch patients and never deliver any care.  As Wendell Potter has written, many people like to blame government bureaucrats for health care's problems. They may deserve some blame, but not any more, and perhaps less than corporate bureaucrats and executives. Recall further what Wendell Potter described in <a href="http://wendellpotter.com/deadlyspin/">Deadly Spin</a>. All those health insurance corporate public relations people were earning good salaries in part based on their ability to distract the public and policy-makers from the insurance companies' roles in health care dysfunction. Potter wrote (p. 110): <blockquote>Rather than admit responsibility for the failures, insurance executives pointed the finger of blame at their customers, the 'consumers' of health care, and, of course, the providers of care. In introducing the concept of their new silver bullet - consumer driven health care - insurance executives claimed that the 'real drivers of health care costs' (one of my CEO's favorite expressions) were the people who sought care when they really didn't need it and the doctors and hospitals who were all too willing to provide this unnecessary care. Sure, the aging population and expensive new technology were also factors, but the main culprits were people who just didn't realize how expensive health care had become.</blockquote> Note the similarities among the "real drivers of health care costs" promulgated by the corporate PR people and the defense of the health insurers' role mounted above (some of the more obvious color-coded). Note that the defenses never explain why the insurance companies seem unable to negotiate prices down, and why they all use the physician payment schedule derived from the recommendations of the secretive <a href="http://hcrenewal.blogspot.com/search/label/RUC">RUC</a>. For some final irony, the Chronicle found an academic who was not too hard on the health insurance companies: <blockquote>Glenn Melnick, a health economist at the University of Southern California, sympathizes with many of the insurers' arguments. He blamed rising costs mainly on higher prices charged by hospitals and doctors, which account for the largest portion of health care spending.</blockquote> The reporter did not note Prof Melnick's full title, <a href="http://www.usc.edu/schools/sppd/faculty/detail.php?id=21">Professor and Blue Cross of California Chair in Health Care Finance</a>. Oops. So in summary, health care costs continue rising, access keeps declining, and there is no evidence of improvements in quality. Large health care organizations blame each other for the problems, but nearly all of them continue to make their top executives extremely rich. Although the amounts diverted to these executives cannot solely account for the rise in health care costs, the perverse incentives given those who lead health care are likely a major cause of the problems. A health care system run by leaders who are comfortable becoming extremely rich while the health care crisis worsens is a likely recipe for dysfunction. We now know commercial health insurers deploy well paid public relations departments to use stealthy if not downright deceptive means to distract those who want to address what really causes health care dysfunction (see <a href="http://hcrenewal.blogspot.com/2011/02/wendell-potters-deadly-spin.html">this post</a>.) It is likely that all large health care organizations use similar stealth advocacy strategies. These strategies have successfully distracted the conversation away from problems with health care leadership and governance, at least until now. As we have <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">said before</a>, far too often the leaders of not-for-profit health care institutions seem more interested in padding their own bottom lines than upholding the institutions' missions. They often seem entirely unaware of their duty to put those missions ahead of their own self-interest. Like the financial services sector in the era of "greed is good," health care too often seems run by <a href="http://hcrenewal.blogspot.com/2009/12/compensation-madness-insiders-hijacking.html">"insiders hijacking established institutions for their personal benefit."</a> True health care reform would encourage leadership of health care who understand health care and care about its mission, rather than those who see a quick way to make a small fortune. Furthermore, we need an open discussion of the real issues related to health care dysfunction, not one stifled by the anechoic effect, spun by corporate PR, and dominated by "third parties" whose conflicts of interest are hidden.

Millions to Health Insurance CEOs, But Blame Everyone Else for Rising Health Care Costs

The revelations about the huge golden parachute given the outgoing CEO of ostensibly non-profit Massachusetts Blue Cross Blue Shield induced...

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How Academic and Government "Anecdotes Are Not Data" Ideologues Kill People

I'm already receiving comments that, regarding Prof. Jon Patrick's <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116">detailed exposé of the dangers of ill-suited-for-purpose ED EHR's</a>, Patrick's observations are: <blockquote style="font-family:arial;">... not really valid because they're not peer reviewed; they're just anecdotal. </blockquote> Only an egghead could pen such words. <div style="font-family: arial; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgnm-VeDoSTOA0VFdXBJX1y4Hq8pyCu-Tdm0vp3ZLcnb9DtRWE04U4A6roR74FqyefhpAs64e6m1Y1Ocu48BU5nS9CfQ6F-yD9M_OLUguFELqMVXZDWL5mUM2Y4mz-owegR86ENRfQJEsN1/s1600/egghead.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5586993306053914498" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgnm-VeDoSTOA0VFdXBJX1y4Hq8pyCu-Tdm0vp3ZLcnb9DtRWE04U4A6roR74FqyefhpAs64e6m1Y1Ocu48BU5nS9CfQ6F-yD9M_OLUguFELqMVXZDWL5mUM2Y4mz-owegR86ENRfQJEsN1/s320/egghead.jpg" style="display: block; margin: 0px auto 10px; width: 134px; cursor: pointer; height: 121px; text-align: center;" /></a>I always get hives immediately after eating strawberries. But without a scientifically controlled experiment with all the right peer review, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives. </div> I'd already written about anecdotalist refrains at my Mar. 7, 2011 post "<a href="http://hcrenewal.blogspot.com/2011/03/australian-ed-ehr-study-putting-lie-to.html" style="font-family: arial;">Australian ED EHR Study: Putting the Lie to the Line "Your Evidence Is Anecdotal, Thus Worthless" Used by Eggheads, Fools and Gonifs.</a>" In that essay I cite Dr. Patrick himself on "anecdotal evidence", regarding which he hit the ball out of the Southern Hemisphere in an editorial in "<a href="http://aci.schattauer.de/en/contents/archive/issue/1124/manuscript/15463/show.html" style="font-family: arial;">Applied Clinical Informatics</a>" entitled "The Validity of Personal Experiences in Evaluating HIT." Aside from the fact that eggheads also don't seem to care about the issues of faulty peer review, especially in profitable biomedical sectors, such as at "<a href="http://hcrenewal.blogspot.com/2010/12/lancet-emphasizes-threats-to-academic.html">The Lancet Emphasizes the Threats to the Academic Medical Mission</a>" with its embedded links, and "<a href="http://hcrenewal.blogspot.com/2009/08/has-ghostwriting-infected-experts-with.html">Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?</a>", there's this simple fact: <blockquote>Public health catastrophe warnings from responsible sources don't need peer review, they need investigation.</blockquote> Yes, there were those pesky, off-narrative journalistic reports that the Japanese nuclear reactors were not entirely safe, that Bernie Madoff was a fraud, that mortgages for everyone was not a good idea, that the O-rings couldn't stand sub-freezing temperatures, that the the foam that broke off the Columbia launch tank caused a danger, and that the Titanic didn't have enough lifeboats, but they weren't peer reviewed...so we ignored them. Saved us a lot of money, too. <div style="text-align: center; font-family: arial;"></div> -- SS Addendum: At my post "<a href="http://hcrenewal.blogspot.com/2011/03/real-medical-informatics-what-does.html" style="font-family: arial;">Real" Medical Informatics: What Does a Problem List of Typical Health IT Look Like, Part 2</a>", I opined: <blockquote style="font-family:arial;">If the purpose of Medical Informatics is the improvement of healthcare (as opposed to career advancement of a small number of academics through publishing obscure articles about HIT benefits while ignoring downsides in rarified, echo-chamber peer reviewed journals), then: <ul><li>Who are the "real" medical informatics specialists, and; </li></ul><ul><li>Who are the poseurs?</li></ul> ... researchers like Jon Patrick who address real-world issues of great import to patients on HIT risks, and further go public on the web with their work without the full blessings of some dusty journal (and those like Ross Koppel who also directly address the downsides, and others who make available to the public material such as on blogs like <a href="http://www.emrupdate.com/">this</a> and <a href="http://hcrenewal.blogspot.com/">this</a>, papers <a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT">like this</a> and sites <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">like this</a>) are the former. Those who deem only "peer reviewed" articles worthy of daylight, and everything else - especially and particularly reports of downsides - "anecdotal" (the <a href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html">anecdotalists</a>) are the latter.</blockquote> I stand by this assertion. Finally, I ask: at what point does ignoring work such as Prof. Patrick's, if patient harm is caused by the system he reviewed, constitute reckless endangerment and perhaps <a href="http://en.wikipedia.org/wiki/Criminal_negligence" style="font-family: arial;">criminal negligence</a> by hospital and government officials? -- SS Addendum Mar. 23: As if on cue, this story appeared in the WSJ: <blockquote style="font-family: arial;"> March 23, 2011 <a href="http://online.wsj.com/article/SB10001424052748703410604576216481092750122.html">Japan Ignored Warning of Nuclear Vulnerability </a> TOKYO—Japanese regulators discussed in recent months the use of new cooling technologies at nuclear plants that could have lessened or prevented the disaster that struck this month when a tsunami wiped out the electricity at the stricken Fukushima Daiichi power facility. However, they chose to ignore the vulnerability at existing reactors and instead focused on fixing the issue in future ones, government and corporate documents show. There was no serious discussion of retrofitting older plants with the alternative technology</blockquote> I guess the "vulnerability reports" just weren't peer reviewed, therefore meaningless - or not reviewed by the "right" peers. This sounds like our own FDA, ONC office and Institute of Medicine (via the <a href="http://hcrenewal.blogspot.com/2011/03/committee-on-patient-safety-and-health.html" style="font-family: arial;">Committee on Patient Safety and Health Information Technology</a>), "choosing to ignore" health IT "vulnerabilities" (such as the <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116" style="font-family: arial;">aforementioned</a>) and focusing on future issues such as comparative effectiveness research, "the common good", etc. instead. I call this attitude "reckless endangerment" and hope plaintiff attorneys are paying close attention. -- SS

How Academic and Government "Anecdotes Are Not Data" Ideologues Kill People

I'm already receiving comments that, regarding Prof. Jon Patrick's detailed exposé of the dangers of ill-suited-for-purpose ED EHR...

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"Real" Medical Informatics: What Does a Problem List of Typical Health IT Look Like, Part 2

At my Mar. 15, 2011 post "<a href="http://hcrenewal.blogspot.com/2011/03/what-does-problem-list-of-typical.html">What does a "problem list" of typical health IT look like?</a>" I displayed a chart by Jon Patrick at U. Sydney on the ill-suited nature of an American EHR system for use in Emergency Dept. settings. That system had been mandated for rollout in public ED's in the entire Australian state of New South Wales. As it turns out, that chart was just preliminary. A new chart is up entitled "Analysis of Problems Defined by ED Directors", divided into four sections: <blockquote>1. Workarounds and Abandonments (27 elements) 2. Functions Lost from the Pre-FirstNet System or Desirable Functions (31 elements) 3. Processes with Added Risk to the Integrity of the EMR (11 elements) 4. General Problem List - What is the Potential for Resolution? (60 elements)</blockquote> The entire chart can be viewed at this link (best with browsers other than MS Internet Explorer): <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116">http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=120&Itemid=116</a> . It is lengthy, detailed and - stunning. Prof. Patrick concludes (emphases mine): <blockquote>Reviewing this compendium of difficulties and obstacles created for staff makes it entirely unsurprising that the patient throughput of most EDs dropped by 50% on the day FirstNet was introduced and now some years later throughputs are only just beginning to recover as staff have been able to instigate work practices to minimise the worst aspects of the system. [A spectacular waste of clinician energy - ed.] The workarounds and abandonments give an expression of the frustration of staff and their strategy for retaining equilibrium in their work practices despite FirstNet's presence. In a number of cases we have seen the practice guidelines of NSWHealth surrendered by the imperatives of the technology with the imposition of the HSS. It is astounding that practices defined from years of clinical experience can be discarded so whimsically. [As I have written, the IT industry has invaded the healthcare sector, and this is the absolutely non-whimsical result - ed.] Fortunately, in the case of one pathology laboratory, patient safety was put ahead of the technological imperative lest it jeopardise the registration of the laboratory. The described function-losses with FirstNet compared to the pre-FirstNet systems, and the functionality needs expressed by the staff indicate that they are acutely aware of the value of good technology and have a strong desire to be equipped with something that works properly without creating unacceptable risks to patients and a draconian reduction in their efficiency. The risks posed by the system to maintaining the integrity of the medical record is something that staff are acutely concerned about as they feel it fails to fulfil their legal obligations.Emergency Departments are too important to have to endure these stressful and unproductive conditions. [This is a first principle, as as such is not open to debate - ed.] It is time that the knowledge and experience of the Directors and their staff were listened to and taken seriously [actually, six decades or so into the "computer revolution", I'd say that time was long ago - ed.] for the sake of improving our hospitals's use of technology. After all we have to ask: What business would commit to an interloping "integrated" system whose services are being necessarily dismembered piecemeal as a matter of survival by the users? This is a system whose pieces are not used by the staff, but rather are shadow mirrored by them, not for redundancy but primacy. Who would want a system that is progressively de-activated by the staff to overcome the hazards and operational inefficiencies it has introduced? [My answer: those who profit handsomely, and at no liability to themselves, from this arrangement. I leave it to the reader to decide who might fit in that category - ed.] </blockquote> As a physician and medical informatics specialist myself, I would not want my ED care or that of my family interfered with by such IT. Several questions: <ul><li>How did a government for an entire state of a major country come to allow themselves to believe an EHR system such as this would improve conditions in the most mission critical section of their hospitals, the ED's?</li></ul><ul><li>What testing and validation of the software was done by officials and representatives of said government, and who were they, exactly?</li></ul><ul><li>What experience and background did the validators possess?</li></ul><ul><li>How were clinician complaints during implementation, which has apparently been underway for several years now, handled?</li></ul><ul><li>What other countries are going down the same path?</li></ul><ul><li>Why is not all health IT subject to the same type of government regulator-led validation as this system was put under by a private academic researcher? (Note that the U.S., pharma IT validation is led by the FDA, but that same agency has essentially shied away from healthcare IT validation.) </li></ul><ul><li>Would a country buy software as ill suited to purpose for, say, mitigating disaster risk in their nuclear power facilities? </li></ul> Finally, I ask: If the purpose of Medical Informatics is the improvement of healthcare (as opposed to career advancement of a small number of academics through publishing obscure articles about HIT benefits while ignoring downsides in rarified, echo-chamber peer reviewed journals), then: <ul><li>Who are the "real" medical informatics specialists, and; </li></ul><ul><li>Who are the poseurs?</li></ul> I opine that researchers like Jon Patrick who address real-world issues of great import to patients on HIT risks, and further go public on the web with their work without the full blessings of some dusty journal (and those like Ross Koppel who also directly address the downsides, and others who make available to the public material such as on blogs like <a href="http://www.emrupdate.com/">this</a> and <a href="http://hcrenewal.blogspot.com/">this</a>, papers <a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT">like this</a> and sites <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">like this</a>) are the former. Those who deem only "peer reviewed" articles worthy of daylight, and everything else - especially and particularly reports of downsides - "anecdotal" (the <a href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html">anecdotalists</a>) are the latter. -- SS

"Real" Medical Informatics: What Does a Problem List of Typical Health IT Look Like, Part 2

At my Mar. 15, 2011 post " What does a "problem list" of typical health IT look like? " I displayed a chart by Jon Patr...

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