healthy4u: Veterans Affairs

What Does the Blumsohn - Procter and Gamble -Sheffield University Affair Say About the Fitness of the Latest VA Secretary Candidate?

Introduction - New Leadership for the US Department of Veterans Affairs After reports of problems with access, manipulation of data about waiting times, and most recently "a corrosive culture," the US Department of Veterans Affairs, the country's large government run health system, has had a massive leadership overhaul.  President Obama's nominee to head the agency is now Robert A McDonald, former CEO of Procter and Gamble. The choice of a former CEO or a large corporation was called "unorthodox" <a href="http://www.bostonglobe.com/news/nation/2014/06/29/bob-mcdonald-former-chief-obama-nominee-lead-veterans-affairs/zVA9EH7PlMNWaTU7Yyp8NP/story.html">by the Boston Globe</a>, but many saw merit in a business leader running the VA.  As reported by the Globe, House Speaker John Boehner said that as a "private sector" leader,  Mr McDonald is the "kind of person who is capable of implementing the kind of dramatic systemic change that is badly needed and long overdue at the VA."  The Chairman of Boeing, also a member of the P&G board, hailed Mr McDonald as the person who "navigated Procter & Gamble through the difficult post-financial-crisis years, where he expanded business in developing markets and made substantial progress improving the efficiency of the company’s internal operations...." On the other hand, a <a href="http://www.washingtonpost.com/politics/federal_government/obamas-choice-for-va-will-find-fixing-it-is-harder-than-selling-soap/2014/07/01/84cf28d6-0139-11e4-b8ff-89afd3fad6bd_story.html">column in the Washington Post</a> suggested that expertise in "selling Tide and Pantene" might not be relevant to fixing the VA. Yet aside from a <a href="http://ringoffireradio.com/2014/07/obama-nominates-former-corporate-exec-as-veteran-affairs-secretary-2/">single article</a> on the Ring of Fire web site, all news coverage and discussion so far has ignored Mr McDonald previous experience in health care leadership, but also that his relevant track record ought to raise questions about his fitness for the VA position. Procter and Gamble and Health Care According to Mr McDonald's <a href="http://www.pg.com/en_US/downloads/company/executive_team/bios/pg_executive_bio_bob_mcdonald.pdf">official P&G biograpy</a>, after various roles in various countries, before becoming CEO,  <blockquote class="tr_bq">Bob returned to the U.S. as the Vice Chairman of Global Operations (2004 to 2007) and later P&G’s Chief Operating Officer (2007 to 2009).</blockquote> Although not widely known as a pharmaceutical company, P&G actually had a subsidiary that made prescription drugs, which Mr McDonald sold off in 2009 (see this <a href="http://online.wsj.com/news/articles/SB125111032092353427">Wall Street Journal report</a>.)  As we noted <a href="http://hcrenewal.blogspot.com/2014/05/abort-retry-fail-lancet-avoided-much.html">here</a>, its products still include over the counter pharmaceuticals (e.g., Pepto-Bismal, Metamucil, Prilosec OTC).  Also, while Procter & Gamble does not make it very obvious, it has owned MDVIP, a company that employs physicians to provide concierge medical services, since 2010, although as Cincinnati.com just <a href="http://www.cincinnati.com/story/money/business/2014/05/02/pg-sells-concierge-medicine-unit/8622903/">reported</a>, it will soon sell this unit to private equity.  So during Mr McDonald's tenure, his company was to some extent a pharmaceutical company, and a health care provider. The Blumsohn - Procter and Gamble - Sheffield University Case Furthermore, on Mr McDonald's watch as Vice Chairman of Global operations and Chief Operating Officer, there was a case involving Procter and Gamble that raised multiple concerns about the ethics of its pharmaceuticals operations.  We first posted about the case in 2005 (<a href="http://hcrenewal.blogspot.com/2005/12/another-challenge-to-integrity-of.html">here</a>).  For all relevant posts, look <a href="http://hcrenewal.blogspot.com/search/label/Actonel">here</a>. In 2009 we <a href="http://hcrenewal.blogspot.com/2009/12/british-medical-journal-interviews-dr.html">described the case</a> thus, <blockquote class="tr_bq">The case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.</blockquote> We previously <a href="http://hcrenewal.blogspot.com/2009/09/reappearance-of-ghost-of-seasons-past.html">summarized</a> the case's events <blockquote><ul><li>Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (<a href="http://www.actonel.com/index.jsp">Actonel</a>, made by Procter & Gamble Pharmaceuticals [P&G]) under a <a href="http://www.fraudinscience.org/PG/contract.pdf">contract</a> between P&G and the University.</li><li>Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.</li><li>Despite numerous requests, (like <a href="http://www.fraudinscience.org/PG/20050525mckay.pdf">this one</a>), P&G <a href="http://www.fraudinscience.org/PG/20030619email.htm">refused access </a>to this data <a href="http://www.fraudinscience.org/PG/attorneyreq.pdf">repeatedly</a>. Blumsohn was concerned that he and Eastell could be accused of scientific fraud if they continued to make presentations and write articles and abstracts without access to the data which they were supposedly writing about.</li><li>Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially <a href="http://www.fraudinscience.org/PG/20030909audio.htm">related to a graph shown to him that omitted 40% of patient data</a>.</li><li>Blumsohn objected to <a href="http://www.fraudinscience.org/PG/20030424email.htm">P&G arranging for papers and abstracts to be written by a professional writer</a>, but with Blumsohn listed as first author. Blumsohn was concerned that such ghost-written documents were mainly meant to convey "key messages" in support of P&G's commercial interests.</li><li><a href="http://www.fraudinscience.org/PG/20030910audio.htm">Eastell warned Blumsohn </a>not to aggravate P&G, because the company was providing a grant to the University which "is a good source of income."</li><li>After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including <a href="http://www.fraudinscience.org/PG/20040526eastell.pdf">Eastell</a>, medical school Dean <a href="http://www.fraudinscience.org/PG/20050708weetman.pdf">Tony Weetman</a>, University Vice-Chancellor <a href="http://www.fraudinscience.org/PG/20050814bouche.pdf">Robert Boucher</a>, and the Head of the University's Department of Human Resources, <a href="http://www.fraudinscience.org/PG/20050627boucha.pdf">Ms R Valerio</a>.</li><li>Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then <a href="http://www.fraudinscience.org/PG/gag.doc">offered him a severance agreement </a>if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.</li></ul></blockquote><blockquote>So the case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.</blockquote> Although this case occurred in the UK, it involved actions by the US based Procter and Gamble.  While many of the events in the case occurred before 2004, from 2004 to 2009 it became clear that Procter and Gamble was not going to go easy on Dr Blumsohn.  For example, <a href="http://scientific-misconduct.blogspot.com/2007/03/advice-to-p-pharmaceuticals-how-not-to.html">according to Dr Blumsohn</a>, in 2006, P&G released some scientific data relevant to the case, but not complete enough data to be meaningful.  In 2007, there was still shady business going on involving scientific abstract submissions apparently made in Dr Blumsohn's name by P&G operatives. Since Procter and Gamble never made any known attempt to apologize, explain its conduct, or ameliorate Dr Blumsohn's plight during 2004 - 2009, as one of the most senior leaders of Procter and Gamble, seemingly with direct authority over its pharmaceutical operations in the UK during that time period, Mr McDonald ought to be held accountable for the company's misbehavior described above.  To my knowledge, though, no one at P&G, including Mr McDonald, has ever admitted responsibility or been made accountable in any way.   Summary Since Mr McDonald recently was an executive of a company that sold prescription and non-prescription pharmaceuticals, and provided direct health care, confirmation as Veterans Affairs secretary could be regarded as a transit through the revolving door, and hence open to question.  Since Mr McDonald got $15,928,015 in total compensation during his last year as CEO (2012-13) (see the company's 2013 proxy statement), and had accumulated 2,247,593 shares of stock or equivalent by 2013, worth approximately $179 million at today's price of $79.67, his ability to understand the needs of the often poor veterans whom the VA serves is also open to question.  More importantly, while Mr McDonald held high executive positions at Procter and Gamble, the company was involved in a dodgy affair involving conflicts of interest, manipulation of research, and attempted silencing of whistle blowers.  In my humble opinion, given that these events occurred directly on his watch, his fitness to run a huge health care system ought to be in question unless his responsibility for these events is disproved. The widespread huzzahs for Mr McDonald as potential VA leader based mainly on his exalted status as CEO of a big corporation show that many in the US still see corporate CEOs as aristocracy.  True health care reform would hold health care leaders accountable, particularly for upholding the health care mission and putting patients' and the public's health ahead of revenue generation and especially personal profit. ADDENDUM (7 July, 2014) - Link to McDonald's official P&G biography fixed.  ADDENDUM (8 July, 2014) - This post has been re-posted <a href="http://www.nakedcapitalism.com/2014/07/obama-va-robert-macdonald-procter-gamble-scandal.html">on Naked Capitalism</a>, and <a href="http://www.openhealthnews.com/story/2014-07-07/robert-mcdonald-fit-be-va-secretary">on Open Health News</a>.

What Does the Blumsohn - Procter and Gamble -Sheffield University Affair Say About the Fitness of the Latest VA Secretary Candidate?

Introduction - New Leadership for the US Department of Veterans Affairs After reports of problems with access, manipulation of data about wa...

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Sham Peer Review Issue Goes Mainstream. WaPo: VA Physicians Fear Sham Peer Review

The paper's words this time, not mine: From the Washington Post, "VA docs concerned about retaliation", June 12, 2014, <a href="http://www.washingtonpost.com/blogs/federal-eye/wp/2014/06/12/va-docs-concerned-about-retaliation/">http://www.washingtonpost.com/blogs/federal-eye/wp/2014/06/12/va-docs-concerned-about-retaliation/</a>: <blockquote class="tr_bq">Retaliation from management is a real concern among <a href="http://www.va.gov/">Department of Veteran Affairs </a>(VA)  employees ...  James Martin, a physician and a representative of the American Federation of Government Employees National VA Council, told the gathering  that sham peer reviews are a problem in the department. In a later interview, he elaborated, saying, “orchestration of facts” related to issues involving contact with patients [in other words, fabricating stories about substandard patient treatment by physicians, cherry-picking minor incidents and exaggerating them, etc. - ed.] is an issue at some facilities.” Sham reviews, he explained, can be used when management wants to replace or punish a doctor. Retaliation against employee whistleblowers was again the subject of discussion during Thursday’s <a href="http://veterans.house.gov/hearing/an-examination-of-bureaucratic-barriers-to-care-for-veterans">hearing</a> of the House Veterans Affairs Committee.</blockquote> Further amplifying the point: <blockquote class="tr_bq"> ... During the hearing, Republicans Jeff Miller (Fla.) and Dan Benishek (Mich.), both of whom spoke to the NAVAPD conference, asked Robert L. Jesse, the department’s acting under secretary for health, about reports that VA employees were instructed not to talk with members of Congress. Benishek, a physician and former VA employee, said agency doctors have told him they are “reprimanded and have this retribution if they try to change the system.” </blockquote> Read the whole article at the link above. Then, read more on sham peer review at the American Association of Physicians and Surgeons (AAPS) resource site at <a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/</a>. A typical scenario is described like this: A conscientious doctor reports a quality care problem or patient safety problem to the hospital administration. This might be anything from an anesthesiologist falling asleep during surgery to a malfunctioning piece of equipment which places patients at risk for harm. <blockquote class="tr_bq">Instead of fixing the problem, some hospitals misuse the peer review process to attack and silence the physician whistleblower. The hospital administration and unethical physician collaborators then search for some pretext upon which to attack the physician whistleblower. This might involve the hospital bringing trumped up charges against the physician or it might involve bringing totally false and/or fabricated charges against the physician. The truth and the facts do not matter in a sham peer review in the hospital since the hospital controls the entire process. The hospital then goes through the motions of providing a hearing to the accused physician, which they call “fair,” yet the outcome of the hearing is predetermined. The physician’s due process rights are often utterly trampled. At the conclusion of the process, the physician’s privileges to practice at the hospital are terminated. The physician is reported to the National Practitioner Data Bank, and the physician’s career is essentially over. Once a physician receives a negative report in the National Practitioner Data Bank, it is unlikely that physician will ever work in any hospital again anywhere in the nation. </blockquote> Sham peer view affects all physicians, not just public-sector ones. It does not help patients when physicians, their supposed advocates, are cowering in fear over destruction of their careers for being "whistleblowers" (for which a better term might be "corporate integrity agents"). Finally, I think this fear helps explain the relatively low levels of complaints about bad health IT, on which hospital executives invest billions of dollars and their reputations. -- SS

Sham Peer Review Issue Goes Mainstream. WaPo: VA Physicians Fear Sham Peer Review

The paper's words this time, not mine: From the Washington Post, "VA docs concerned about retaliation", June 12, 2014, http://...

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EHR Exceptionalism Debunked: Care Quality Variances Among VA Hospitals, Perhaps The Most Wired Hospitals in the World, Suggest the True Value of Information Technology in Healthcare Has Been Grossly Exaggerated

The Wall Street Journal somehow managed to get access to internal VA patient care quality data and published the following article: <blockquote class="tr_bq"> <a href="http://online.wsj.com/articles/veterans-affairs-hospitals-vary-widely-in-patient-care-1401753437">http://online.wsj.com/articles/veterans-affairs-hospitals-vary-widely-in-patient-care-1401753437</a></blockquote><blockquote>Veterans Affairs Hospitals Vary Widely in Patient Care Internal Records Show Facilities Such as Phoenix Have Far Higher Death Rates Than Peers Thomas M. Burton and Damian Paletta June 3, 2014 The Phoenix facility at the heart of the crisis at the Department of Veterans Affairs is among a number of VA hospitals that show significantly higher rates of mortality and dangerous infections than the agency's top-tier hospitals, internal records show. The criticism that precipitated last week's resignation of VA Secretary Eric Shinseki has focused largely on excessive wait times for appointments across the VA's 150-hospital medical system. But a detailed tabulation of outcomes at a dozen VA hospitals made available to The Wall Street Journal illustrates a deeper challenge: vastly disparate treatment results and what some VA doctors contend is the slippage of quality in recent years at some VA facilities. Some of the discrepancies are stark, especially for an agency known for offering high-quality care in 50 states.</blockquote> Yet, these are highly wired hospitals, perhaps the most highly wired in the world, with one EHR, VistA CPRS, allegedly among the best EHRs in the world developed over decades, and allegedly used by 100% of the clinicians. How can this be?  <blockquote class="tr_bq">... Scott McRoberts, spokesman for the Phoenix VA Health Care System, said on Monday the database "is an internal measurement system to benchmark our improvement, and is not for public consumption." The rate of potentially lethal bloodstream infections from central-intravenous lines was more than 11 times as high among patients at the Phoenix facility than it was at top VA hospitals, data from the year ended March 31, 2014, show. ... The findings come from a nonpublic VA database called Strategic Analytics for Improvement and Learning, known as SAIL. SAIL tracks procedure outcomes and ranks VA hospitals on a scale of five stars, the best, to one star, the lowest. ... In other examples of variations in care, the Atlanta VA Medical Center, a two-star hospital for quality, has more than three times the rate of central-IV infections than the average of five-star VA hospitals. Houston's VA hospital, ranked as a two-star hospital, had a 47% higher acute-care mortality rate than the five-star hospital rate.</blockquote> A 47% higher acute-care mortality rate? Hospitals are willing to go into tens of millions of dollars of debt and knowingly endanger patients (see e.g. "In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red" at <a href="http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html">http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html</a>), and even attempt to stifle clinician conversation on drawbacks (e.g. see "Words that Work" at <a href="http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html">http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html</a>), to attain this technology on the stated reason of "improving patient safety" and "saving money." Former ONC Chair Blumenthal stated explicitly in the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", Blumenthal and Tavenner (10.1056/NEJMp1006114, July 13, 2010): <div class="PlainText" style="font-family: arial;"> </div><blockquote dir="ltr" style="font-family: arial; margin-right: 0px;"><div class="PlainText">... EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. </div></blockquote> There is no doubt expressed there. The industry itself has convinced the Federal Government to spend tens of billions of taxpayer dollars on this technology via HITECH incentives, and to start penalizing non-adopters via Medicare cuts.  The Government has bought into the hyper-enthusiasm hook, line and sinker, when the same money might have been spent elsewhere such as on care of the underserved...or on our Veterans. Yet the data from a highly-computerized organization like the VA show that these systems cannot be all they are made out to be.  They do not automatically "improve caregivers' decisions and patients' outcomes." This is an on its face observation. They are simply a tool, and in absence of appropriate human staffing, expertise, and conducive work environment, they mean significantly "less than advertised" in terms of improving care quality and outcomes.  Finally, as the VA has gotten busier due to factors such as the return of veterans from recent wars, one must also ask if the loss of productivity, cognitive burden, and other factors caused by needing to interact with a computer rather than paper has made the computer systems more of an impediment to good care rather than a facilitating tool. I think it's time the Government start to reform the industry hype surrounding this technology with far more sober predictions that would facilitate far more cautious implementations. No "revolutions" are happening soon, at least not due to information technology in healthcare. Finally, note that EHR oversell and exceptionalism has been going on for decades.   Donald A. B. Lindberg M.D. (<a href="http://www.nlm.nih.gov/od/roster/lindberg.html">http://www.nlm.nih.gov/od/roster/lindberg.html</a>), Medical Informatics pioneer and Director of the U.S. National Library of Medicine at NIH, observed in 1969 that: <blockquote class="tr_bq"> "The [second] reason for the dearth of significant success of computers in medicine has been the flagrant and consistent "over sell" of capability on the part of manufacturers and computer enthusiasts."  </blockquote> Read his full quote by clicking on the page below, from Morris Collen's book "<a href="http://www.amazon.com/History-Medical-Informatics-United-States/dp/0964774305">A History of Medical Informatics in the United States: 1950 to 1990</a>." <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/AVvXsEjrRIuVMu4XQOTRYpbyXb2-IXrnM019VAdbzcR3D8wVVCDQtXDkhG6UlZTWtBpmUKH7s4QnIHjxuyp65kccko4iKwx6nGV3Cxu8kZ75Fss742dcTMln77zZw4tJOu25MXPfH9Oq1F-i5egc/s1600/collen168.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjrRIuVMu4XQOTRYpbyXb2-IXrnM019VAdbzcR3D8wVVCDQtXDkhG6UlZTWtBpmUKH7s4QnIHjxuyp65kccko4iKwx6nGV3Cxu8kZ75Fss742dcTMln77zZw4tJOu25MXPfH9Oq1F-i5egc/s1600/collen168.jpg" width="263" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Informatics pioneer Dr. Donald Lindberg's 1969 observations on health IT oversell.  Click to enlarge.</td></tr></tbody></table> Sadly, nothing has changed in health IT, at least since the year we landed on the Moon. -- SS

EHR Exceptionalism Debunked: Care Quality Variances Among VA Hospitals, Perhaps The Most Wired Hospitals in the World, Suggest the True Value of Information Technology in Healthcare Has Been Grossly Exaggerated

The Wall Street Journal somehow managed to get access to internal VA patient care quality data and published the following article: http://o...

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"Texas VA Run Like a ‘Crime Syndicate,’ Whistleblower Says" - Can Reports About the Benefits of EHRs at the VA Healthcare System Be Trusted?

More and more is leaking out about alleged executive malfeasance at the Veteran's Administration healthcare system in the U.S. This article just appeared: <blockquote class="tr_bq">Texas VA Run Like a ‘Crime Syndicate,’ Whistleblower Says May 27, 2014 <a href="http://www.thedailybeast.com/articles/2014/05/27/exclusive-texas-va-run-like-a-crime-syndicate-whistleblower-says.html">http://www.thedailybeast.com/articles/2014/05/27/exclusive-texas-va-run-like-a-crime-syndicate-whistleblower-says.html</a> For years, employees at a Texas VA complained that their bosses were cooking the books. For years, the VA insisted there was no widespread wrongdoing. New whistleblower testimony and internal documents implicate an award-winning VA hospital in Texas in widespread wrongdoing—and what appears to be systemic fraud. Emails and VA memos obtained exclusively by The Daily Beast provide what is among the most comprehensive accounts yet of how high-level VA hospital employees conspired to game the system. It shows not only how they manipulated hospital wait lists but why—to cover up the weeks and months veterans spent waiting for needed medical care. If those lag times had been revealed, it would have threatened the executives’ bonus pay. What’s worse, the documents show the wrongdoing going unpunished for years, even after it was repeatedly reported to local and national VA authorities. That indicates a new troubling angle to the VA scandal: that the much touted investigations may be incapable of finding violations that are hiding in plain sight.  “For lack of a better term, you’ve got an organized crime syndicate,” a whistleblower who works in the Texas VA told The Daily Beast. “People up on top are suddenly afraid they may actually be prosecuted and they’re pressuring the little guys down below to cover it all up.”</blockquote> Read the linked article in its entirety.  It contains document images of altered electronic orders, the EHR system apparently being used for "creative storytelling" to allow for "good metrics", and an employee "performance plan" evaluation submitted by a whistleblower containing perverse incentives: <blockquote class="tr_bq"><a href="https://www.documentcloud.org/documents/1174555-4-performanceobjs.html" target="_blank">... The VA’s 2012 performance plan</a>, provided to The Daily Beast by the whistleblower, contains five critical elements to evaluate success, each one containing multiple sub-criteria. But critical element No. 5, the “Results Driven” component that contains the “wait time” criteria, is worth 50% of the overall score. That’s as much as all the other elements combined.</blockquote> I won't delve into the gory details of the article further...read it yourself...but I do raise the following issues: 1.  The VA EHR system VistA CPRS has been touted as among the best EHR's in the world, based on reports that come out of the VA. <ul><li>Can these reports on the benefits and safety of VistA CPRS be trusted, considering what may be going on systemically regarding altered data related to "making the numbers" and getting bonuses? </li></ul><ul><li>It is well known that EHRs slow clinicians down, through annoying alerts and reminders and other decision support, cryptic and complex order-entry processes, and the general need to navigate multiples screens and templates to perform what used to take seconds on pen and paper.   Is it also possible that the inability of the VA system to meet its care obligations in a timely manner is related to adverse effects on productivity of the EHR system itself?</li></ul> 2.  EHR audit trails are an automatically-generated log of user activities, such as viewing, printing, altering or deleting an electronic document or other data.  They are the only way to authenticate an electronic record as complete and unaltered, since all paper/handwriting cues are gone in the computer world. <ul><li>It may be of interest to investigate the electronic audit trails generated by the VA electronic health records (EHRs)... or the lack thereof, for as I understand it those audit trails are often only active for VIPs ("very important persons") in the VA VistA CPRS EHR system. </li></ul><ul><li>Even worse, in the commercial sector hospitals admit they can alter or delete the EHR system audit trails - see my post at <a href="http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html">http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html</a>.  It's likely the same applies in the VA, and it would be of concern that any audit trails of test and visit scheduling or other activities could be undergoing a "disappearing act" in the wake of this scandal, in addition to the actual test/scheduling data itself.</li></ul> It is unfortunate that this scandal sheds doubt on claims made about activities, including EHR use, at the VA hospitals.  I myself have taught my students that the VA model has been a model for others to emulate, at least as far as EHRs are concerned. ------------- As an important aside: I am personally familiar with very odd events at the VA, namely in 1995.  At <a href="http://hcrenewal.blogspot.com/2009/06/computer-and-other-mysteries-at.html">http://hcrenewal.blogspot.com/2009/06/computer-and-other-mysteries-at.html</a> regarding the computer-related radiation brachytherapy debacle at the Philadelphia VA Hospital I wrote [and I am adding some additional comments now in brackets]: <blockquote class="tr_bq">... I have some familiarity with odd events at the Philadelphia VA Hospital. (Not including the fact that I spent a few months there as a medical intern in the early 1980's). In the mid 1990's I took my father there for evaluation for increased service-related disability. He had been treated for skin lesions in the Army in WW2 and after by the VA with <a href="http://en.wikipedia.org/wiki/Fowler%27s_solution">Fowler's solution</a> (an arsenical) and as a consequence of this (even then-outdated and dangerous) treatment, had developed widespread basal cell carcinomatosis over a major portion of his body, with chronic bleeding and discomfort. I accompanied my father to the exam but did not identify myself as an MD, only as his son. [I was on vacation and was rather casually dressed.  I looked like any other schlep bringing his elderly veteran father in for care.] My father was seen in an evaluation by several physicians and students (arsenic-caused basal cell carcinomatosis is quite rare now) in my presence, and he was then handed his (paper) chart to take with him back to the main desk.  [As we were walking] I told my dad I wanted to look at the note. The note by a physician who'd seen him stated (paraphrasing): <blockquote class="tr_bq">"Mr. Silverstein said he'd taken more than the prescribed dose of arsenic for years, and even shared it with his wife."</blockquote> My father and I were shocked and dumbfounded. He'd said no such thing, and being a retired pharmacist of 40+ years, thought anyone making such a statement would have had to have been insane. (My mother had even harsher words when she heard about this.) [Along the lines of, "ARE THEY CRAZY???"] Needless to say, I was upset. I [identified myself and] confronted the physician who wrote the note, but that physician [a relatively young woman] would not change it, bizarrely claiming that they "remembered my father telling that story in a visit several years prior." Needless to say, such a claim violated all the precepts of medical information integrity of which I was familiar.  [I wondered to myself, "what type of utter imbecile would even say such a thing to a Yale physician/medical informatics faculty member?"] In an initial attempt to counteract this disability exam sabotage, I actually crossed out the statement in the chart, writing "this is untrue" or words to that effect and signed my own name. The head of the Philadelphia VA Hospital would not return my calls on this matter. That is, until <a href="http://en.wikipedia.org/wiki/Jesse_Brown">Jesse Brown, then Secretary of the Department of Veterans' Affairs</a>, inquired directly a few days later. Unknown to the VA examiners, my father had been sent for the disability exam after reporting problems to Sen. Jay Rockefeller's office about prolonged delays in having his case heard.  Sen. Rockefeller's staff [specifically, Ms. Charlotte Moreland, <a href="http://votesmart.org/public-statement/25153/retirement-of-charlotte-moreland">http://votesmart.org/public-statement/25153/retirement-of-charlotte-moreland</a>, who my mother had befriended through many telephone conversations] had set up the exam! Sen. Rockefeller's staff was rather upset at the story I reported upon my return to New Haven about the bizarre chart fabrication at my father's VA disability exam, and apparently relayed the story up the chain of command, as it were. After that, the head of the Philadelphia VA Hospital really, really wanted to speak to me and called me at Yale several times. He wanted to set up a phone conference between me, himself, and the doctors who'd seen my father. I told his administrative assistant that there was "nothing to talk about", and that the false statement in my father's chart would be removed. Period. I think it was. My father's increased disability was granted in the end, but what was going on here with disability exams was never fully investigated to my knowledge (having done disability exams myself years prior for the regional transit authority, police, fire etc. in Philadelphia, I suspected an "incentive" program to deny vets a disability determination). If I had not examined my father's chart, we might have never known a reason for his being turned down. A culture of honesty and accountability seemed lacking then, and seems lacking now.</blockquote> In retrospect, it seems there may indeed have been an "incentive program" for, in essence, limiting positive disability determinations by sabotage, thus causing negative determinations on benefits. Ironically, among other experiences, it was the impoverished experiences at the Phila. VA as an intern in 1981, with a decade of computer experience under my belt at that time, that led me to pursue a career in Medical Informatics. With inadequate staff and resources, especially at night when a medical student and I and a minimum of nurses covered something like 50 patients - and at that early stage of my career I am honestly admitting that I did not know what I was doing, really - and large amounts of time wasted on paperwork, I thought there had to be a better way via computing. I never expected that computers in medicine could become a tool for "creative data alteration" for executive enrichment, an impediment to good care, and a risk in and of itself, as was outed by a whistleblower recently in Athens, Georgia as at <a href="http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html">http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html</a>. -- SS May 28, 2014 Addendum:   Also see "How VA Clinics Falsified Appointment Records" at <a href="http://www.huffingtonpost.com/2014/05/28/va-clinics-falsified-records_n_5402547.html">http://www.huffingtonpost.com/2014/05/28/va-clinics-falsified-records_n_5402547.html</a> -- SS

"Texas VA Run Like a ‘Crime Syndicate,’ Whistleblower Says" - Can Reports About the Benefits of EHRs at the VA Healthcare System Be Trusted?

More and more is leaking out about alleged executive malfeasance at the Veteran's Administration healthcare system in the U.S. This arti...

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A very short observation on EHRs and the Veterans Administration healthcare scandal

As has been in the news lately, it has been revealed that U.S. veterans' medical care was being delayed at a number of Veteran's Administration-run hospitals, perhaps many others as well not yet known. A timeline for the Veterans Administration medical scandal is here:  <a href="http://www.usatoday.com/story/news/politics/2014/05/21/veterans-healthcare-scandal-shinseki-timeline/9373227/">http://www.usatoday.com/story/news/politics/2014/05/21/veterans-healthcare-scandal-shinseki-timeline/9373227/</a> <blockquote class="tr_bq">The Obama administration is facing a serious scandal in which government officials are alleged to have falsified data to hide how long veterans were waiting to see doctors at VA hospitals. The controversy has led to calls for the resignation of Veterans Affairs Secretary Eric Shinseki, who has served for five years. Here is a timeline of events leading up to the current situation, which President Obama on Wednesday called "intolerable" and "disgraceful."</blockquote> I will not comment on the issues per se. I will only make this pithy observation: The VA system possesses the best electronic medical records systems in the world, VistA CPRS, and is unhampered by EHR sellers' issues and agendas as the VA created it themselves over decades.  You can even download VistA CPRS and explore it with fictitious patients and medical data from test servers set up for that purpose, at <a href="http://www.ehealth.va.gov/EHEALTH/CPRS_demo.asp">http://www.ehealth.va.gov/EHEALTH/CPRS_demo.asp</a>. EHR's and other clinical IT, according to not-very-impartial organizations such as the industry trade group HIMSS, the sellers themselves, and a whole cadre of pundits highly invested in the technology and its implementation, are purportedly going to "revolutionize" medicine (rather than the somewhat less grandiose purpose of merely facilitating clinicians in providing better care). The "revolution" includes reducing the need for human resources, increasing efficiency, saving gobs of money, and according to one billionaire, allowing a small group of doctors to remotely manage the care for an entire city's patients.  (See my Jan. 20, 2014 post "Computers + a few docs can manage 'an entire city', and other cybernetic miracles" at <a href="http://hcrenewal.blogspot.com/2014/01/computers-few-docs-can-manage-entire.html">http://hcrenewal.blogspot.com/2014/01/computers-few-docs-can-manage-entire.html</a>; I am not making that up.) Yet here we have the VA, highly computerized - but instead of being the medical utopia promised by the information technology hyperenthusiasts, the VA is unable to even guarantee patients a two-week waiting period for care, with delays leading to possible patient injuries and deaths. Thus, to those who promote the meme that spending hundreds of billions of dollars on this technology will 'revolutionize' medicine, increase "efficiency", reduce errors, reduce costs etc. and realize all the other fantastical claims made for the technology, I say, "sure, and I have a bridge for sale in Brooklyn." <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/AVvXsEhA3XNDg0DloxZAjRbNKM7INHWPOgAkdnazZOqRu1PYqgvv-QgjncHQDCyIeejK7jIGyQsOoDh3TpeQ_Ql6ezFNIzIRgUrTKTdWiX2D2Mz6CQ4ha5K74uE8Ww7Cxk3WU6zaY3gLwkbB-kH2/s1600/Brooklyn_Bridge_Postdlf.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="161" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhA3XNDg0DloxZAjRbNKM7INHWPOgAkdnazZOqRu1PYqgvv-QgjncHQDCyIeejK7jIGyQsOoDh3TpeQ_Ql6ezFNIzIRgUrTKTdWiX2D2Mz6CQ4ha5K74uE8Ww7Cxk3WU6zaY3gLwkbB-kH2/s1600/Brooklyn_Bridge_Postdlf.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">This bridge at <a href="https://www.google.com/search?q=40.7057%C2%B0+N%2C+73.9964%C2%B0+W">40.7057° N, 73.9964° W</a> is for sale to the highest-bidding hospital.  Its purchase, plus a few hundreds of millions of dollars of IT thrown into the bargain, will revolutionize healthcare at the lucky hospital with the winning bid.</td></tr></tbody></table>  -- SS

A very short observation on EHRs and the Veterans Administration healthcare scandal

As has been in the news lately, it has been revealed that U.S. veterans' medical care was being delayed at a number of Veteran's Adm...

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Another Revolving Door Variant: From Academia with Millions in Medtronic Royalties, to the White House, to the Health Care Service Corp

The revolving door spins, and where it will stop, nobody knows... In October, 2010, we noted questions about how Dr Stephen Ondra got to be a <a href="https://www.va.gov/opa/bios/docs/ondra.pdf">Senior Policy Adviser for the US Department of Veterans Affairs</a>. A veteran who was a neurosurgery professor at Northwestern University, Dr Ondra had received millions of dollars in royalties from device manufacturer Medtronic, whose CEO supported his appointment to the government position  (see this <a href="http://hcrenewal.blogspot.com/2010/10/toxic-and-dangerous-watchdog-vs.html">post</a>).  As soon as he was appointed, he publicly opposed a nominee for US Surgeon General who had been critical of the medical device industry, and its financial ties to doctors. After going to Washington, Dr Ondra apparently also served in the Executive Office of the President, in the White House, but <a href="http://triblocal.com/lake-forest/community/stories/2012/04/northwestern-memorial-hospital-names-stephen-l-ondra-chief-medical-officer/">returned</a> to Northwestern University in 2012.  However, he did not stay there for long. This month, a <a href="http://www.forbes.com/sites/brucejapsen/2013/02/07/obama-advisor-ondra-hired-as-top-doc-at-blue-cross-plan/">post</a> on Forbes indicated he is moving on again, and back to the corporate side of health care. <blockquote class="tr_bq">the nation’s fourth-largest health insurance company is naming a key former health advisor to President Obama as its top doctor. Dr. Stephen Ondra, will become senior vice president and chief medical officer at Health Care Service Corp., the Chicago-based parent company of Blue Cross plans in Illinois, Texas, Oklahoma and New Mexico. The plan has more than 13 million health plan members and is looking to grow even more, announcing last year a proposed partnership with the Blue Cross plan in Montana.</blockquote> Health Care Service Corp is a mutual insurance company, that is, a company owned by its policy-holders rather than stock holders.  However, that does apparently not make it any more ascetic than a typical for-profit insurance company, at least in terms of generosity towards its top hired executives.  As Crain's Chicago Business <a href="http://www.chicagobusiness.com/article/20120515/NEWS03/120519922/blue-cross-parents-ceo-pay-climbs-to-12-9-million">reported</a> in 2012, <blockquote class="tr_bq">New federal regulations intended to force health insurers to spend less on administration didn't keep the parent of Blue Cross & Blue Shield of Illinois from paying CEO Patricia Hemingway Hall more than $12.9 million in 2011, a 61 percent raise. The Health Care Service Corp. chief executive's total compensation last year dwarfed the $8 million she received in 2010, according to a filing with the Illinois Department of Insurance. The 2011 increase was fueled by an $11.8 million bonus, which was 69 percent above her 2010 bonus of $7 million. Ms. Hall wasn't alone in getting a big raise at Health Care Service, whose insurance business booked net income of more than $1 billion in 2011, for the second straight year. The 10 highest-paid executives at the Chicago-based mutual company — which operates Blue Cross plans in Illinois and three other states — earned a collective $41.7 million, 65 percent more than the $25.3 million they were paid in 2010.</blockquote>  If Dr Ondra's new position puts him among the latter group of executives, he too stands to make millions a year.  So to recap Dr Ondra's career so far, in 2010 he was a medical school professor who had earned millions in royalties from Medtronic.  He then went to top leadership positions in the US Veterans Department and Executive Office of the President.  He returned briefly to Northwestern University, only to leave again for a top executive position in for-profit insurance company Health Care Service Corp, where he is likely to make millions more. Thus Dr Ondra is our latest interesting example of the "<a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a>" phenomenon in health care.  He started as an erstwhile academic physician but with a very major financial relationship with a medical device company.  He then went through the door the first time into the US government, and then a second time from the government to a for-profit insurance company, with just a brief stop-over in academia. By the way, it appears that all of this is quite legal.  It does again raise questions about whether health care leaders in government with previous relationships with industry might still feel undue sympathy to the interests of industry, as might government leaders who can expect future jobs in industry. Moreover, this case, like previous cases we have discussed,  indicates how leadership in academic health care, corporate health care, and the government tend to blend together.  Leaders of one type of organization have more and more in common with leaders of the other types of organizations than they do with their lesser ranked colleagues, and certainly than with other health care constituencies.  So the more the revolving door revolves, the more we wonder about the <a href="http://hcrenewal.blogspot.com/search/label/corporatism">corporatism</a> of health care, about how health care seems to be increasingly run by an amorphous group of academic/ corporate/ government leaders whose loyalties may be more to each other than to academic and professional values, patients' and the public's health, and government of, by and for the people.

Another Revolving Door Variant: From Academia with Millions in Medtronic Royalties, to the White House, to the Health Care Service Corp

The revolving door spins, and where it will stop, nobody knows... In October, 2010, we noted questions about how Dr Stephen Ondra got to be ...

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"Toxic and Dangerous?" - The Watchdog vs Medtronic's Man at the VA

An odd story that appeared earlier this month linked several people we have discussed on Health Care Renewal. On one hand, we <a href="http://hcrenewal.blogspot.com/2009/07/polly-want-million-plus.html">posted </a>about how Dr David Polly, a spine surgeon at the University of Minnesota, testified before the US Congress in support of research on treatments of bone injuries afflicting US soldiers.  He did not then reveal that he had been paid more than one million dollars for consulting by Medtronic, the manufacturer of a bone growth product used to treat such injuries, also the source of payments of his expenses for the trip to Washington.  At the time, we suggested this case was a reminder to be skeptical about academics who are really stealth health policy advocates for industry. On the other hand, in a <a href="http://hcrenewal.blogspot.com/2010/06/deferred-prosecution-agreements-end-so.html">post</a> about renewed payments by makers of artificial joints to orthopedic surgeons after the US government advocated a series of deferred prosecution agreements as a cure for such apparent conflicts of interest, we quoted Dr Charles Rosen, "Nothing will change until someone goes to jail. It’s a big game." The link between them appeared in two related articles.  First, the Minneapolis Star-Tribune <a href="http://www.startribune.com/business/104458368.html?elr=KArksUUUoDEy3LGDiO7aiU">reported</a> on the appointment of another Medtronic consultant to a top leadership post in the US Department of Veterans Affairs: <blockquote>In a Sept. 28 letter to Veterans Affairs Secretary Eric Shinseki, Sen. Charles Grassley asks whether Dr. Stephen Ondra's 'policy advice and decisions at the VA are vulnerable to potential conflicts of financial interest' given his prior relationship with the Fridley-based medical technology giant. Ondra and Medtronic mutually severed their financial relationship in July 2008. But just prior to that, Medtronic paid him $3.6 million in royalties related to spine-surgery instruments, according to financial disclosure forms he submitted to the VA.</blockquote>It appears that Medtronic lobbied hard for the appointment of its former consultant: <blockquote>While noting that Ondra is not a Medtronic employee, Grassley characterized the surgeon's relationship with the company as 'unambiguous and substantial.' Further, Grassley notes that Ondra 'was able to penetrate the political establishment at its highest level to obtain a senior position at the VA' because of his previous ties to the company.</blockquote>The details are: <blockquote>Ondra's candidacy for his current post was supported by Medtronic Chief Executive William Hawkins III, who wrote a letter of recommendation to Secretary of Defense Robert Gates on his behalf. This was at the suggestion of Dr. S. Ward Casscells III, who was then assistant secretary of defense for health affairs, according to a series of internal e-mails obtained by the Star Tribune. 'I have known Dr. Casscells for many years and was comfortable in approaching him on this topic,' Hawkins wrote in a Jan. 16, 2009 e-mail to the then-head of Medtronic's $3.5 billion spine device business, Steve La Neve. (La Neve left that position earlier this year in a corporate reorganization.) La Neve replied a day later that Ondra wanted to meet with him or with Hawkins before a reference letter was sent, 'so that it can capture his work on appropriate industry-physician relationships and transparency.'</blockquote>(It is not clear whether the last sentence above is meant to be an ironic pun about regulatory capture.) A <a href="http://www.pharmalot.com/2010/10/the-medtronic-consultant-and-the-toxic-critic/">post</a> on Pharmalot explains what Dr Ondra's first priority was once he got his government job: <blockquote>Within a few days, however, Ondra objected to the proposed nomination of another spine surgeon, Charles Rosen, as US Surgeon General. Why? As founder of the Association of Medical Ethics, Rosen publicly questioned consulting ties between doctors and device makers and, for his trouble, allegedly suffered retaliation by members of the American Academy of Orthopaedic Surgeons (see <a href="http://freepdfhosting.com/505a7ce28c.pdf">this</a>). In a January 21, 2009 email exchange with Davd Polly, a University of Minnesota professor who was another Medtronic consultant, Ondra acknowledged never having heard of Rosen, but reacts viscerally to a recent story in The Orange County Register that details Rosen’s self-appointed role as a watchdog. 'Since this individual is toxic and dangerous I would leave nothing to chance,' he responds to Polly, who had forwarded the newspaper story to Ondra. Polly, by the way, is a nationally known spine surgeon who came under congressional scrutiny for his work several years ago for the device maker, something that Rosen had criticized (look here). 'This moment in history is too important to our country to let such a disreputable and dangerous person continue his self-promotion crusade,' Ondra continues. 'I would encourage you and any other physicians and citizens to weigh in on this to HHS and public health.'</blockquote>Got that?  Medtronic pays Dr Ondra millions.  Medtronic pushes for Dr Ondra's appointment to a top VA leadership position.  Once in that position, Dr Ondra confers with another million dollar Medtronic consultant, and then works to block the appointment as Surgeon General of a known foe of the cozy web of conflicts of interest that afflicts medicine.  Thus do conflicts of interest work to promote the capture of government by special interests.  The Pharmalot post concluded with this opinion: <blockquote>'It’s obvious that Dr. Ondra benefited from his relationship with Medtronic. And since he worked to kill off the nomination of Chuck Rosen, Medtronic’s main critic, I can see how Medtronic benefited from Dr. Ondra,' says Paul Thacker, a former Grassley staff investigator and US Army specialist. 'What I don’t understand is how I and other veterans have benefited from all this back-door dealing. What’s in it for us?'</blockquote>That is a good question. It appears that nothing was in it for veterans, or the US public. But everything was in it for Medtronic and the doctors it pays so well.  I would submit that it is the readiness of big health care corporations to create conflicts of interest that seduce physicians to put their loyalties to their corporate sponsors ahead of the public interest that is toxic and dangerous. This convoluted story suggests the urgent need for full disclosure of all relationships between physicians and others who make decisions and wield influence in health care on one hand, and health care organizations on the other hand.  If physicians want their health policy efforts to be met with anything other than guffaws and cynical eye rolls, they need to seriously consider swearing off the sorts of cushy corporate relationships that Dr Ondra and Dr Polly embraced.

"Toxic and Dangerous?" - The Watchdog vs Medtronic's Man at the VA

An odd story that appeared earlier this month linked several people we have discussed on Health Care Renewal. On one hand, we posted about h...

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$4 Billion Military EMR "AHLTA" to be Put Out of Its Misery? Also, Does the VA Have $150 Million to Burn on IT That Was Never Used?

I have heard from numerous reliable sources that the military's $4 billion+ EMR known as "Armed Forces Health Longitudinal Technology Application" (<a style="font-weight: bold;" href="http://dhims.health.mil/userSupport/ahlta/about.aspx">AHLTA</a>) is to be declared a failure, and replaced. I'd written about AHLTA's considerable problems at the post "If The Military Can't Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?" at <a href="http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html" target="_blank">http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html</a> . From that post: <blockquote> [AHLTA has been described as] difficult for physicians to use. Intolerable. Slow. Unreliable. Frequently crashes. Near mutiny. Morale. Affecting patient care, decreasing patient load. Can it get worse? Yes ... When the Army's Surgeon General observes that clinicians "spend as much or more time working around the system as they do with the system", and that the superusers are not enthusiastic about the system, and a Congressional hearing is held entitled "where do we go from here?" (it's clear to this author that they have no clue), one should start to very critically question basic assumptions about health IT. </blockquote> One wonders if anyone responsible for AHLTA ever read my now decade-old site on health IT dysfunction, now at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">this link</a> at Drexel University, or its many hyperlinks to additional resources. Meanwhile, the VA is having its own problems as noted on the HISTalk blog: <blockquote> [<a href="http://histalk2.com/2010/06/29/news-63010/">HISTalk News 6/30/1</a><a href="http://histalk2.com/2010/06/29/news-63010/">0</a>] Back in <a href="http://histalk2.com/2010/03/16/news-31710/" target="_blank">March</a>, I dug out a juicy nugget from an internal VA report: it was scrapping a $150 million patient scheduling system without ever bringing it live. The GAO weighs in with its <a href="http://www.gao.gov/new.items/d10579.pdf" target="_blank">official report</a> (warning: PDF), pegging the cost at $127 million and saying “VA has not implemented any of the planned system’s capabilities and is essentially starting over.” The contractor that developed the system with “a large number of defects” walks away with $65 million. GAO finds much to criticize about the VA’s involvement: lack of competitive bidding, sloppy specs, unreliable status reports, and lack of action by project oversight groups when the project started tanking. </blockquote> The linked PDF report from the U.S. Government Accountability Office (<a href="http://www.gao.gov/">GAO</a>), entitled "<a href="http://www.gao.gov/new.items/d10579.pdf">INFORMATION TECHNOLOGY - Management Improvements Are Essential to VA’s Second Effort to Replace Its Outpatient Scheduling System</a>", reveals errors that cause me to question whether the project leadership ever passed their introductory undergraduate IT courses (assuming they had any). From that report: <blockquote>VA’s efforts to successfully complete the Scheduling Replacement Project were hindered by weaknesses in several key project management disciplines and a lack of effective oversight that, if not addressed, could undermine the department’s second effort to replace its scheduling system: <ul><li>VA did not adequately plan its acquisition of the scheduling application and did not obtain the benefits of competition.</li><li>VA did not ensure requirements were complete and sufficiently detailed to guide development of the scheduling system.</li><li>VA performed system tests concurrently, increasing the risk that the system would not perform as intended, and did not always follow its own guidance, leading to software passing through the testing process with unaddressed critical defects.</li><li>VA’s project progress and status reports were not reliable, and included data that provided inconsistent views of project performance.</li><li>VA did not effectively identify, mitigate, and communicate project risks due to, among other things, staff members’ reluctance to raise issues to the department’s leadership.</li><li>VA’s various oversight boards had responsibility for overseeing the Scheduling Replacement Project; however, they did not take corrective actions despite the department becoming aware of significant issues. </li></ul> The impact of the scheduling project on the HealtheVet initiative cannot yet be determined because VA has not developed a comprehensive plan for HealtheVet that, among other things, documents the dependencies among the projects that comprise the initiative. </blockquote> <style title="owaParaStyle">P { MARGIN-TOP: 0px; MARGIN-BOTTOM: 0px } BODY { SCROLLBAR-ARROW-COLOR: #3f52b8; SCROLLBAR-DARKSHADOW-COLOR: #fafafa; SCROLLBAR-BASE-COLOR: #f7f7f7; SCROLLBAR-HIGHLIGHT-COLOR: #cecfce; SCROLLBAR-TRACK-COLOR: #fffbff } </style><div dir="ltr">My question is: </div> <div dir="ltr"> </div> <div dir="ltr">By what miracle of God will the military's AHLTA's and the VA's scheduling system "replacements" be any better than what now exists? Through reliance on commercial EMR vendors and management consultant "experts", perhaps? If so, I wish the military and VA the best of luck. They will need it. The problems with computing in complex settings such as medicine are pervasive, far beyond the military. It is increasingly clear that the leadership of the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem">healthcare IT ecosystem</a> (and probably even the broader IT ecosystem) consists of recycled incompetents, never held accountable for project failures, even massive ones, instead moving on to wreak mayhem elsewhere. This has certainly been my own experience in both the hospital and pharma sectors. Competent experts who actually try to do meaningful work (a.k.a. "rock the boat" or "non-team players" in the parlance of the incompetent and/or the power seekers) have become hopelessly marginalized - or unemployed. See the post "<a href="http://hcrenewal.blogspot.com/2010/06/edwin-lee-on-tiger-we-are-now-riding.html">Edwin Lee on the Tiger We Are Now Riding</a>" by Roy Poses. Our economy and even society is falling apart as a result of these leadership problems; Lee's post "Lightweight oil executives produce worthless disaster plans" as linked above is <a href="http://en.wikipedia.org/wiki/Pathognomonic">pathognomonic</a> of these failures. Writes Lee: <blockquote>... This week the executives of the other major oil companies (besides BP) presented their oil spill contingency plans to Congress. Several things were immediately evident: the plans were all grossly inadequate and carelessly done, they were all developed by the same outside consulting firm and they were essentially carbon copies of BP’s nearly useless plans. In other words, they were empty “cover your ass” documents rather than serious contingency plans. Some people may find this surprising. From my experience, it’s what we can and should expect from the vast majority of large, public institutions because of a universal and deeply flawed process for selecting their leaders. ... Those who are chosen to lead fit a mold: mediocre, short term thinkers with similar work experiences, outlooks, temperaments and personal incentives. Disaster response, creative thinking and fundamental changes are outside their limited range of interests or competencies. </blockquote> </div> Here is the major problem in a nutshell: no real accountability where it matters. What follows from this is a first principle: Recycled incompetents will never produce good information systems. Major health IT commercial vendor CEO's have been reported as making statements that health IT usability -- one of AHLTA's major deficiencies - "will be part of certification over her dead body" (as described in my post at <a href="http://www.blogger.com/redir.aspx?C=bbea8e4243b540e08b9cb5507a83da5b&URL=http%3a%2f%2fhcrenewal.blogspot.com%2f2010%2f05%2fdid-epic-ceo-judy-faulkner-of-epic.html" target="_blank">http://hcrenewal.blogspot.com/2010/05/did-epic-ceo-judy-faulkner-of-epic.html</a>). Why don't we recycle physicians with track records of killing patients? Better yet, make them Chairs of clinical departments? The answer is obvious, but the IT culture seems immune to such considerations. The UK's National Programme for IT in the NHS (NPfIT) is AHLTA on a national scale: <blockquote>The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a>. Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) are <a href="http://www.connectingforhealth.nhs.uk/about/foi">here</a> (released under the UK’s Freedom of Information Act), and a summary of 16 key points is <a href="http://www.computerweekly.com/blogs/tony_collins/2009/06/16-key-points-in-gateway-revie.html">here</a>.</blockquote> My prediction is this: I do not believe health IT has advanced enough beyond the experimental stage for clinically efficacious, safe, cost effective mass dissemination. Further, I do not believe that the human capital necessary to make such dissemination happen in a clinically efficacious, safe, cost effective manner exists in the IT industry. Talent management in that industry -- based on cheap, just-in-time, "programming language/platform du jour", "smart people cannot or should not learn but should be declared obsolete", and Bart Simpson-style attitudes about ability and expertise -- does not allow the needed human capital to exist. A remarkable and revealing example comes from an article about health IT leadership a number of years ago in the journal “<a href="http://www.healthcare-informatics.com/">Healthcare Informatics</a>”: <blockquote style="font-family: arial;"> I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the <a href="http://www.goodmangroup.com/">Goodman Group</a> in <st1:place st="on"><st1:city st="on">San Rafael</st1:city>, <st1:state st="on">California</st1:state></st1:place> about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of <a href="http://www.hersher.com/">Hersher Associates</a>, <st1:place st="on"><st1:city st="on">Northbrook</st1:city>, <st1:state st="on">Illinois</st1:state></st1:place>, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman.</blockquote> The "management improvements" sought by the VA may simply not be possible, until the IT field undergoes something comparable to the "Flexner report" that the medical professions and their educational programs underwent a century ago. And perhaps until health IT leadership personnel begin to lose their homes and fortunes in court to harmed patient plaintiffs, to the point where the leadership start begging competent, marginalized professionals who actually know what they're doing to save their sorry asses. -- SS 7/6 addendum: For more on the topic of dinosaur-era attitudes about Medical Informatics that lead to such debacles, see my July 5, 2010 post "<a href="http://hcrenewal.blogspot.com/2010/07/jurassic-attitudes-about-medical.html">Jurassic Attitudes about Medical Informatics: in the U.S. Navy?</a>"

$4 Billion Military EMR "AHLTA" to be Put Out of Its Misery? Also, Does the VA Have $150 Million to Burn on IT That Was Never Used?

I have heard from numerous reliable sources that the military's $4 billion+ EMR known as " Armed Forces Health Longitudinal Techno...

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Philadelphia VA Hospital Brachytherapy Debacle: For The Want of One Competent and Industrious IT Person

This post should perhaps be subtitled "The Theatre of the Absurd." At Healthcare Renewal and other sites I've often commented on the remarkable accommodation given to IT personnel in hospitals, even when these personnel make capricious decisions that are contrary to the support of the mission of healthcare organizations, or contrary to the mission itself. I <a href="http://hcrenewal.blogspot.com/2009/03/health-it-project-success-and-failure.html">wrote that</a> many HIT problems observationally appeared due to ill-informed, capricious edicts of overempowered (relative to clinical leadership) MIS leaders, sanctioned by equally ill-informed executive leadership, for which the IT personnel were rarely held accountable. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">Endangerment of ICU patients</a> via PC's entirely inappropriate for a biohazards environment, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=Cardiology%20story">chaos in a critical procedure area</a> from IT complacency and incompetence, payment of millions of dollars for <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf">HIT with gross defects rendering it unusable</a> by clinicians without consultation of in-house medical informatics expertise, and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=pharma">denial of access for hundreds of drug discovery scientists</a> to the informatics tools their own leaders said were essential to new drug discovery are just a few of the situations I've personally observed due to IT department whimsy. Remarkably, none of these situations nor others reported from numerous sources resulted in repercussions against the teflon-coated IT deities (other than, in some cases, generous promotions), thereby obstructing remediation of the attitudinal and competency problems that created the scenarios. If physicians had it this good, they'd be chopping off wrong limbs, removing the wrong organs, and failing to diagnose and treat with impunity. At my June 2009 posting regarding an unfolding clinical debacle of national import at the Philadelphia VA hospital entitled "<a href="http://hcrenewal.blogspot.com/2009/06/computer-and-other-mysteries-at.html">Bungled Brachytherapy, Computer Interfaces and Other Mysteries At The Philadelphia Veterans Administration Hospital</a>" I wrote: <blockquote>... I am uncertain how "computer interface problems" (in the <a href="http://www.philly.com/philly/news/homepage/20090621_Feds_see_wider_woes_in_VA_s_cancer_errors.html">Philadelphia Inquirer</a>, they were referred to as "glitches") prevented medical personnel from determining treatment success over several years. I would be most interested in hearing more about these "interface problems."</blockquote> That question has now been answered, and I am disappointed (but not surprised) at the results. Having rewritten a poor interface between a gamma scintillation camera and a PDP-11 computer in medical school during a nuclear medicine rotation at Boston City Hospital, allowing endusers to identify ROI's (regions of interest) with a light pen for automated calculation of intensities, I thought perhaps some arcane coding or driver configuration was the culprit at the VAMC Philadelphia. That was not the case: <a href="http://www.philly.com/inquirer/front_page/20090719_VA_radiation_errors_laid_to_offline_computer.html?viewAll=y">VA radiation errors laid to offline computer</a>By Marie McCullough and Josh Goldstein Philadelphia Inquirer July 19, 2009... It is not surprising, then, that NRC and VA investigators spent considerable time delving into why the calculations weren't done for more than a year at the Philadelphia VA. Their investigative reports blamed a "computer interface problem" - the same terminology Kao used during his testimony last month at a congressional hearing. The implication was that some intractable technology breakdown was behind the lapse in care [i.e., some cryptic problem requiring magical incantations and byzantine scripts that mere mortals could not understand nor remedy - ed.] In fact, technology had little to do with the breakdown, as James Bagian discovered when he led an inquiry at the Philadelphia VA and the veterans' health system's 12 other brachytherapy programs. Bagian, a Philadelphia-born physician and former astronaut who is now the national VA's patient-safety director, discovered that the "interface problem" was nothing more than the disconnected computer. Here's what else his inquiry found: The computer was initially unplugged so that another medical device could use the network port. Then, various departments dithered and ducked a request for an additional network port, which was finally installed - after a year. ["Various departments dithered and ducked?" Which departments, exactly? See below - ed.] Some doctors, physicists, and other professionals at the VA acknowledged it was "clinically inappropriate" to omit the post-implant calculations. Some said they had informed their "chain of command." When asked why they didn't tell the hospital's patient-safety officer, they said "it had not occurred to them to do so." ["Had not occurred to them to do so?" I've seen situations where physicians and scientists were afraid of IT leaders, due to the latter's often overinflated political influence and proficiency in playing games of political intrigue. Did this occur here, I wonder? - ed.] So, it appears that for the want of one network connection, installed by one competent, industrious, non-complacent IT person, a national scandal has erupted that has injured many patients. First, I ask the following questions regarding the "various departments" that "dithered and ducked" the responsibility to install an additional network connection in the brachytherapy suite: <ul><li>Was the job the responsibility of the Department of Medicine? The doctors and nurses? Could they have done so? </li><li>Perhaps it was the responsibility of the Public Relations Department (who now have to pick up the pieces?)</li><li>Was it the reponsibility of the Facilities Department? </li><li>Was it the responsibility of the Housekeeping Department?</li><li>Or, was it the responsibility of the IT Department and CIO? </li></ul> (If you need help answering these questions, stop reading now.) I also ask: <ul><li>Why was the IT department's failing to perform this task kept low profile through use of cryptic "interface problem" language that implied complex IT problems, as opposed to simple people problems? </li><li>Who originated this language?</li><li>Did they believe the truth could remain hidden? </li><li>Why do we use the term "medical malpractice" to describe negligence in medical care, not "provider glitch?" Why the different standards? </li></ul> I can visualize what went on behind the scenes in the IT department, refrains I have heard before - "we don't have the resources ... we need to hold more meetings to consider the issues ... it's the vendor's responsibility ... it's the network group's job, not the hardware group ... putting a new network outlet in there will cause packet storms and interfere with system XYZ ... we need to get consensus .... you [doctors] can't understand the complexities of the problem, but don't worry, we'll make it better ... hey, the docs don't need it anyway ..." What would happen to, say, the Facilities Department if a plumbing problem led to failure of a piece of vital equipment in the OR's, and they failed to repair it for a year? This is not to excuse the multiple layers of complacency among clinicians, safety staff, and others for toleration of this network denial situation and the lack of QC on the procedures themselves, but at the heart of this debacle is this attitude, which seems common in hospital IT departments: <blockquote style="font-style: italic;">"Doctors and nurses toil in hospitals so IT personnel can have comfy jobs and nifty computers."</blockquote> Perhaps on this occasion, IT leaders and personnel may end up on the witness stand and be held accountable, and perhaps lose their jobs instead of being promoted. However, even this is doubtful, and it has taken a congressional investigation led by Sen. Arlen Specter to get even this far, to simply find out that the mysterious "interface glitches" were a lack of a network jack due to laziness and complacency. Finally, I point out that it is hospital IT personnel upon whom clinicians will depend for acquisition and implementation of the HIT tools the President of the United States said are essential to changing the culture of healthcare. As I have written, before the IT profession can change the culture of healthcare (in a positive manner, that is), its own culture must change. IT personnel in hospitals must become part of the clinical team and support the mission of clinicians, not the other way around. July 22 addendum:<div> </div><div>I note again that multiple people failed here, including executives, physicians, safety officers, etc. I believe responsibility needs to be fairly assigned. However, IT needs to be included. I've witnessed or heard about too many HIT incidents where IT personnel and leadership remained scot-free when their behavior and attitudes were contributors or root causes.<div>As per my letter to the editor published in JAMA on July 22, "<a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</a>", IT privilege and accommodation must stop. HIT is not business IT used for widget inventory or payroll. As the VA incident shows, patient lives and well being are at stake.July 24 addendum:More on this from a blog on medical physics, "The Sharp End of the Photon", <a href="http://www.drflounder.com/archives/406">here</a>:<blockquote>... the errors in the placement of the radioactive seeds went undiscovered for so long because post-implant dosimetry was not performed. This involves CT scanning the patient, finding the positions of the seeds and calculating the ultimate dose the patient received. In the NRC report, the explanation was that a problem with the interface between the CT scanner and the treatment planning computer prevented transferring the CT images.</blockquote>A "problem with the interface", indeed.Also provided is a link to testimonies from witnesses at the house.gov website, which are <a href="http://veterans.house.gov/hearings/hearing.aspx?newsid=438">here</a>.Notable is the absence of any testimony from IT leadership. The only allusion to IT is in testimony by the doctor who performed the procedures who stated:<blockquote>"There should be a method of categorizing systematic problems by level of urgency so that serious problems, such as those involving failures of medical equipment or transfer of patient-related data, will receive immediate attention from the proper personnel and be quickly resolved."</blockquote>Perhaps, but not in this case. A simple phone call to IT should have been adequate to resolve this particular simple problem. -- SS </div></div>

Philadelphia VA Hospital Brachytherapy Debacle: For The Want of One Competent and Industrious IT Person

This post should perhaps be subtitled "The Theatre of the Absurd." At Healthcare Renewal and other sites I've often commented ...

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

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

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

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

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"There is Always a Hidden Agenda" - Alleged Cover Up of Research Abuses at the VA

In January, we <a href="http://hcrenewal.blogspot.com/2005/01/those-government-health-care-blues.html">posted the story </a>of malfeasance at the Stratton Veterans Affairs (VA) Medical Center in Albany. Today, <a href="http://www.nytimes.com/2005/02/06/nyregion/06vets.html?hp&ex=1107752400&amp;en=1f9bb82504a0e363&ei=5094&partner=homepage">the NY Times published a major piece of investigative reporting </a>on the affair, which now appears to be larger and more troubling than it did last month. Then, the focus was on research coordinator Paul Kornak. Kornak was apparently hired despite having lost medical licenses in several states due to forged credentials, and a felony fraud conviction in Pennsylvania. Although Kornak apparently never completed medical training, the Stratton VAMC allowed him to perform physical examinations and identify himself as "doctor." The FDA found that Kornak had falsified patients' medical records in several drug studies, allowing patients to enroll in studies even though they should have been excluded. Kornak plead guilty to fraud and negligent homicide for the death of one patient in a chemotherapy study. However, problems at Stratton predated Kornak's arrival. In the 1990's, two pharmacists repeatedly complained of major violations of research protocols, including enrollment of patients without consent, enrollment of patients who should have been excluded, and giving patients treatments not included in protocols. In response, the pharmacists were targeted by VA internal investigations, although none ever found any wrong-doing. An investigation of research at the hospital, conducted by Dr. Thomass Ferro, was allegedly rigged by administrators to find nothing wrong. Said Dr. Ferro, "there is always a hidden agenda to exonerate or convict in these internal investigations. In this case it was to exonerate." So Ferro did a cursory investigation, and even after he then "watered down" his finidings, his superiors edited his report to remove even "minor discrepancies." Furthermore, how the VA responded on the national level to the problems at Stratton was even more troubling. When problems there first were noticed in 2003, the new VA Chief of Research and Development, Dr. Nelda Wray, ordered a nation-wide review of VA research. She halted research altogether at Fargo, ND, where there were problems with the Institutional Review Board. She ordered credentials checks on and ethics training for all researchers. But by2004, Dr. Wray, in turn was accused of ethics problems, and was <a href="http://www.biomedcentral.com/news/20040326/03">forced out of her position</a>. Her lawyer charged the investigation was "an easy and convenient way to stop sorely needed reforms." Some major points: - The response of the VA to staff complaints about research at the Stratton VAMC was apparently to punish the whistle-blowers, and cover up the complaints. This is all too reminiscent of the cases of physicians punished for complaining about quality, detailed in the landmark investigative series in the Pittsburgh Post-Gazette, <a href="http://www.post-gazette.com/pg/03299/234499.stm">The Cost of Courage</a>. - This response allowed wrong-doing to continue, resulting in, according to a court of law, the death of at least one patient. - Thus, this case suggests how bad leadership of a medical organization can not only harm the research process, or suppress research results, but also directly harm patients. - Furthermore, the allegations made by Dr. Wray's lawyers, if true, suggest that the problems go much deeper, or higher than the administration of one VA hospital. Coupled with all the other stories we have been reporting, about not only the VA, but the NIH and the FDA at the federal level, about numerous for-profit companies, and not-for-profit hospitals and managed care organizations, this underscores how we need to get serious about restoring integrity to the leadership of health care organizations.

"There is Always a Hidden Agenda" - Alleged Cover Up of Research Abuses at the VA

In January, we posted the story of malfeasance at the Stratton Veterans Affairs (VA) Medical Center in Albany. Today, the NY Times published...

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Those Government Health Care Blues

A few recent examples of mismanagement in the government health care sector: Cuts in Ontario The province of Ontario, Canada planned to lower hospital expenses by moving more patients into improved primary and community care settings. The improvements are not complete, the care as not yet been transferred, yet as <a href="http://www.thestar.com/NASApp/cs/ContentServer?pagename=thestar/Layout/Article_Type1&c=Article&cid=1106088611550&call_pageid=970599119419">the Toronto Star reports</a>, the province is pushing cuts in the hospital budgets now. As <a href="http://www.thestar.com/NASApp/cs/ContentServer?pagename=thestar/Layout/Article_Type1&c=Article&cid=1106088611555&call_pageid=970599119419">this editorial </a>suggests, the result is likely to be drastic nursing shortages and longer queues for care. An IT Flop in the UK The UK is spending 6.2 billion pounds sterling to improve its health care information technology (IT). An early, key project was a system to improve general practitioners' (GPs) abilities to refer patients to specialists. By now, this 196 million pounds sterling system was supposed to have scheduled over 200,000 patient referrals. In reality, it has handled 63. It turns out that very few GPs were familiarized with the system, which lead to an "information vacuum." Furthermore, the system was apparently not designed to handle such situations as patients who needed referrals to more than one professional for treatment. (See reports in the Manchester Guardian <a href="http://politics.guardian.co.uk/publicservices/story/0,11032,1393356,00.html">here</a> and <a href="http://politics.guardian.co.uk/publicservices/story/0,11032,1394028,00.html">here</a>.) US VA Researcher Busted A former cancer researcher at the Stratton Veterans Affairs (VA) Medical Center just plead guilty to negligent homicide, and several other charges, as <a href="http://www.newsday.com/news/local/state/ny-bc-ny--drugtrials0118jan18,0,969450.story?coll=ny-region-apnewyork">reported by Newsday</a>. Paul Kornak had proclaimed himself to be a doctor, although he never completed medical school. He was hired by the VA despite a previous criminal record stemming from forgery of a previous medical licensing application. <a href="http://timesunion.com/AspStories/story.asp?storyID=324713&category=REGIONOTHER&BCCode=HOME&newsdate=1/19/2005">Per the Albany Times-Union</a>, co-workers alleged that they were punished after trying to report irregularities in the cancer research program he ran to hospital administrators. An attempt by hospital pharmacists to involve the Federal Bureau of Investigation was stymied when VA officials told the FBI that one of the pharmacists was under investigation, although he was never charged with doing anything wrong. Kornak was finally tripped up when his commercial sponsor, Ilex Oncology, found more "irregularities" in his reports. The moral of the stories is that government is not immune to health care mismanagement. Maybe more transparency, accountability, and involvement of medical professionals and the public could prevent some of these problems.

Those Government Health Care Blues

A few recent examples of mismanagement in the government health care sector: Cuts in Ontario The province of Ontario, Canada planned to lowe...

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Can They Think Outside of the "Proverbial Federal Box?"

A couple of brief anecdotes illustrating what happens when large organizations run health care.... <a href="http://www.denverpost.com/Stories/0,1413,36~53~2639623,00.html">In Colorado, there is indignation </a>over the Department of Veterans Affairs (VA) cancellation of plans to build a new hospital integrated with the University of Colorado medical center. Apparently, there was a lot of initial discussion about an innovative, cooperative building, but, as Lawrence Biro, director of the VA Rocky Mountain Health Care Network put it, VA architects are not used to designing integrated facilities. "That's the way VA hospitals are built." As for all the local discussions about the cooperative building, "This is out of my control. Planning of hospitals is driven from Washington." As Colorado Governor Bill Owens said, "apparently the VA can't think outside of the proverbial federal box." <a href="http://www.miami.com/mld/miamiherald/10584453.htm">In Florida, a fed-up physician is suing </a>several managed care organizations (MCOs) about how they reimburse out of network physicians. Setting aside the merits of the suit, a telling remark was made by the spokesperson of Neighborhood Health, Bruce C. Rubin, "we've been paying a certain percentage of Medicare for years. It's standard procedure." Thus some Florida MCOs decide how to reimburse simply by paying a fixed proportion of what Medicare pays. So it seems they also can't think outside of the proverbial federal box. Is it any surprise that large organizations don't make decisions outside of the box? But didn't a lot of people once argue that managed care innovation would reduce health costs while improving quality and access? And didn't others argue that the only way to save US health care is to nationalize health insurance? (The euphemism is "single-payer.")

Can They Think Outside of the "Proverbial Federal Box?"

A couple of brief anecdotes illustrating what happens when large organizations run health care.... In Colorado, there is indignation over th...

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Your Health Care Tax Dollars at Work?

Doctors hear again and again about how the health care they provide is too expensive, but we hear little about how large health core organizations drive up the costs of care. Here are some miscellaneous stories about dubious spending decisions by government bureaucrats in a variety of health care organizations.... Golden Parachutes for the TB Sanitarium District Board Cook County, in Illinois, may be the last to have a separate agency to care of tuberculosis patients. The Cook County Tuberculosis Sanitarium Board, circa 1947, no longer has any sanitariums, but runs four TB clinics. Independent from local public health agencies, it has the power to levy real estate taxes to support itself. It has been charged in the past with some dubious management practices, such as failing to bill insured patients for its services, continuing to levy taxes when its reserve funds exceed its annual budget (<a href="http://www.aegis.com/news/ct/2004/CT040708.html">per the Chicago Tribune</a>), and paying for its Board Chairman's health insurance despite legal prohibitions (<a href="http://www.suntimes.com/output/news/cst-nws-tb04.html">per the Sun-Times</a>). As a recent political battle swirled over whether to fold the agency into the Cook County Bureau of Health, the TB Sanitarium Board voted to award "golden parachutes," <a href="http://www.suntimes.com/output/news/cst-nws-tb05.html">according to the Chicago Sun-Times</a>, to outgoing employees and board members, only to have judge hand out a temporary restraining order against it. Federal Investigations of the Failed Bay Pines VA Medical Center Computer System The Justice Department and the Veterans Affairs Inspector General have opened criminal and civil investigations of how Department of Veterans Affairs managers had spent over $200 million on the Core FLS computer system, a system which never worked, reported <a href="http://www.usatoday.com/tech/news/2004-12-22-va-system-scrutiny_x.htm">USA Today </a>and the <a href="http://www.sptimes.com/2004/12/22/Southpinellas/Bay_Pines_system_draw.shtml">St. Petersburg Times</a>. The Core Financial and Logistic System, developed by BearingPoint (formerly KPMG Consulting), flunked its trial at the Bay Pines VA Medical Center. P<a href="http://news.tbo.com/news/MGBEUE7Y6XD.html">er the Tampa Tribune</a>, "CoreFLS was intended to keep better track of hospital supplies and improve financial management. Instead, it led to supply shortages that delayed surgeries and spurred complaints." More Charges About NIH African Nevirapine Study A former NIH physician has charged publicly that a study of nevirapine to block maternal-fetal HIV transmission was so sloppily done as to be invalid, but was kept in operation because NIH officials were "so heavily invested in the trial's outcome." Dr. Jonathan Fishbein also charged that the NIH is trying to fire him because he blew the whistle on this study's problems, but the NIH says he performed poorly during his probabitionary period. (AP report available <a href="http://washingtontimes.com/national/20050104-102727-7319r.htm">here</a>, as well as many other places.) This story, including the apparent role of political considerations in decisions to keep the research study running, was previously discussed on Health Care Renewal <a href="http://hcrenewal.blogspot.com/2004/12/politics-and-nih-nevirapine-study-in.html">here</a>.

Your Health Care Tax Dollars at Work?

Doctors hear again and again about how the health care they provide is too expensive, but we hear little about how large health core organiz...

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