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Failed Leaders of Citigroup as Leaders of Health Care

When we began this blog, I never dreamed I would do so much writing about finance and the financial services sector of the economy, but,...  The Governance of Citigroup The discussions and revelations generated by the global financial collapse/ great recession continue to provide insights into the ongoing health care crisis.  Let me start with a small item <a href="http://online.wsj.com/article/BT-CO-20100419-714975.html">from the Dow Jones Newswire</a> this week: <blockquote>The California Public Employees' Retirement System said it opposes the re-election of two Citigroup Inc. (C) directors, in part because of their roles in the recent financial crisis. The nation's largest public pension fund, which owns about 61.2 million Citigroup shares, plans to cast 'withhold' votes for board nominees Andrew Liveris, chairman and chief executive of Dow Chemical Co. (DOW), and Judith Rodin, Rockefeller Foundation president, at the annual shareowners meeting Tuesday. Both served on the company's audit and risk committee before the financial crisis. During the crisis, the banking giant accepted a total federal government infusion of $45 billion, which it has repaid. 'It's time for new blood in the boardroom,' said Anne Simpson, the senior portfolio manager who heads the Calpers corporate governance program....</blockquote> Let me back up a bit. The near-failure of global banking giant Citigroup, prevented only by a massive US government bail-out, was one of the central components of the global financial collapse. We <a href="http://hcrenewal.blogspot.com/2010/04/very-well-paid-boob-on-harvard.html">noted</a> recently how Mr Robert Rubin, one of the key leaders of Citigroup was accused of "being asleep at the switch," "irresponsibility and misjudgment," and being a "very well paid boob" after his testimony at hearings by the committee investigating the collapse. We also noted his link to health care. As senior member of the Harvard Corporation, Rubin is one of six top stewards of the US' oldest and arguably most presigious university, containing one the country's most prestigious medical schools and teaching hospitals. Although all those who were members of the Citigroup at the time it collapsed have not been hauled in front of the committee, there has been considerable discussion of their responsibility for the company's failures. For example, in 2008, soon after the government rescue of Citigroup began, the Wall Street Journal published <a href="http://online.wsj.com/article/SB122757194671054783.html">an editorial</a>: <blockquote>"Citi never sleeps," says the bank's advertising slogan. But its directors apparently do. While CEO Vikram Pandit can argue that many of Citi's problems were created before he arrived in 2007, most board members have no such excuse. Former Treasury Secretary Robert Rubin has served on the Citi board for a decade. For much of that time he was chairman of the executive committee, collecting tens of millions to massage the Beltway crowd, though apparently not for asking tough questions about risk management. Chairman Sir Win Bischoff has held senior positions at Citi since 2000. Six other directors have served for more than 10 years -- including former CIA Director John Deutch, Time Warner Chairman Richard Parsons, foundation executive Franklin Thomas, former AT&T CEO C. Michael Armstrong, Alcoa Chairman Alain Belda, and former Chevron Chairman Kenneth Derr. When taxpayers are being asked to provide the equivalent of $1,000 each in guarantees on Citi's dubious investments, how can these men possibly say they deserve to remain on the board? While other banks can claim to be victims of the current panic, Citi is at least a three-time loser. The same directors were at the helm in 2005 when the Fed suspended Citi's ability to make acquisitions because of the bank's failure to adhere to regulatory and ethical standards. Citi also needed resuscitation after the sovereign debt disaster of the 1980s, and it required an orchestrated private rescue in the 1990s.</blockquote> Last year, as reported <a href="http://www.bloomberg.com/apps/news?pid=email_en&sid=atMfWxz6KwLo#">by Bloomberg</a>, <blockquote>Citigroup Inc. investors should vote against re-electing four of 14 board members, including John Deutch and Michael Armstrong, to improve management of the company’s risks, a shareholder advisory group said. Deutch, former U.S. Central Intelligence Agency director, Armstrong, former AT& T Inc. chief executive officer, and Alain Belda, chairman of Alcoa Inc., should be opposed 'for poor risk oversight,' RiskMetrics Group Inc.’s ISS Governance Services said today. Xerox Corp. CEO Anne Mulcahy shouldn’t be re-elected because she sits on more than three boards, which may limit her effectiveness, the group said. 'The pattern of chronic oversight failure at Citi and the magnitude of the corresponding shareholder losses warrant removal from the board of directors most responsible for risk oversight,' RiskMetrics said in the statement.</blockquote> Furthermore, <blockquote>'Despite the fact that the board has many incumbent directors that have been successful in their respective fields and have been on the board for some time, their track record taken as a whole is dismal given that the company is currently surviving on federal assistance,' RiskMetrics said. </blockquote> Rick Conrad, of the <a href="http://seekingalpha.com/article/132209-citigroup-shareholders-meeting-lessons-in-corporate-governance">Seeking Alpha blog</a>, thus berated the CEO of Citigroup at its 2009 shareholders meeting, <blockquote>Mr. Armstrong, who has been a director since 1989 is no longer part of the Audit Committee, as of this year, continues his 'service' to our Company on the Nomination as well as the Compensation Committee. Much as this company has suffered under an illusion of prosperity, it appears to continue to suffer under an illusion of competence. John [Deutch] has served on the Audit Committee of our Company since 1997 and hence, likely drank the Kool-Aid as to the Illusion of Prosperity. I note that the audit and risk management committee has many members who, like Mr Deutch and MrArmstrong presided over this seemingly out of control disaster. Andrew Liveris since 2005 on Audit Ann Mulcahy since 2007 on Audit Dr Judith Rodin since 2004 on both Executive and Audit Committees.</blockquote> Overlaps Among Citigroup's Board and Health Care Organizations' Leadership So there seems to be good reason to believe that the board of Citigroup at the time the firm collapsed were a collective example of inattentive goverance and poor stewardship. We have previously documented overlaps among poor governance and leadership of finance, and the governance and leadership of health care, suggesting that the poor leadership and governance of the latter may be in part a result of infection from the former. So I looked for overlaps among the Citigroup board and health care organizational leadership. A list of the membership of the failed board comes from the <a href="http://www.citigroup.com/citi/fin/data/ar08cp.pdf">2008 Citigroup proxy statement</a>.  The biographies provided therein, supplemented with some Google searching, produced the following overlaps: - C Michael Armstrong - is also Chairman, Johns Hopkins Medicine, Health Systems and Hospital - Alain J P Belda - was a Trustee and member of the Corporation of Brown University (including the Warren Alpert Medical School) (see <a href="http://www.brown.edu/Administration/News_Bureau/2002-03/02-146.html">link</a>).  (He stepped down prior to 2009 at an unknown time.) - Sir Winfried Bischoff, Chairman of the Board - is a director of Eli Lilly and Co. - Kenneth T Derr - is a director of the University of California San Francisco Foundation. - John M Deutch - no overlap found - Roberto Hernandez Ramirez - no overlap found - Andrew N Liveris - is a Trustee of Tufts University (including the School of Medicine and Tufts- New England Medical Center) - Anne M Mulcahy - in 2009, was appointed to the Board of Directors of Johnson and Johnson (see <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=25859">link</a>) - Vikran S Pandit, CEO - is a Trustee of Columbia University (including the College of Physicians and Surgeons and Columbia University Medical Center) - Richard D Parsons - is a Trustee of Howard University (including the College of Medicine and Howard University Hospital) - Judith Rodin - is President of the Rockefeller Foundation - Robert E Rubin - is a member of the Harvard Corporation (including Harvard Medical School and multiple Harvard teaching hospitals), and a Trustee of Mount Sinai Medical Center - Robert L Ryan - was a director of UnitedHealth Group, is a Trustee of Cornell University (including Weill Cornell Medical College, and Weill Cornell Medical Center), and was a Senior Vice President and CFO of Medtronic - Franklin A Thomas - no overlaps found Summary So in summary, of 14 board members, 2 are trustees of major medical centers (<a href="http://hcrenewal.blogspot.com/search/label/Johns%20Hopkins%20University">Johns Hopkins</a> and <a href="http://hcrenewal.blogspot.com/search/label/Mount%20Sinai%20Hospital">Mount Sinai</a>), 6 were or are trustees or equivalent of universities that include medical schools and medical centers (<a href="http://hcrenewal.blogspot.com/search/label/Brown%20University">Brown</a>, <a href="http://hcrenewal.blogspot.com/search/label/Tufts%20University">Tufts</a>, <a href="http://hcrenewal.blogspot.com/search/label/Columbia%20University">Columbia</a>, Howard, <a href="http://hcrenewal.blogspot.com/search/label/Harvard">Harvard</a> and <a href="http://hcrenewal.blogspot.com/search/label/Weill%20Cornell%20Medical%20College">Cornell</a>), one is a trustee of such a university's foundation (University of California San Francisco Foundation), 2 are or would be board members of pharmaceutical corporations (<a href="http://hcrenewal.blogspot.com/search/label/Eli%20Lilly">Eli Lilly</a> and <a href="http://hcrenewal.blogspot.com/search/label/DePuy">Johnson</a> and <a href="http://hcrenewal.blogspot.com/search/label/Janssen">Johnson</a>), one was a board member of a commercial managed care organization/ health insurance company (<a href="http://hcrenewal.blogspot.com/search/label/UnitedHealth">UnitedHealth</a>), one was a former top executive of a medical device company (<a href="http://hcrenewal.blogspot.com/search/label/Medtronic">Medtronic</a>), and one is the President of a large charitable foundation which historically has supported multiple medical and public health initiatives (Rockefeller Foundation).  Only 3 of 14 did not have a major leadership role of a health care organization.   Most of these health care organizations have been involved with cases we have discussed on Health Care Renewal (see links above). Given the seriousness of the failure of Citigroup, one has to wonder why so many of the directors who presided over it still have such influential positions in health care organizations? As we have <a href="http://hcrenewal.blogspot.com/2010/02/university-president-but-no-longer.html">pointed out</a>, as the world economy was driven to near ruin by "masters of the universe," some of the same also became leaders of academia and academic medicine in their spare time. Maybe this made sense 10 or 20 years ago, but why does it still make sense? On the other hand, now that we understand how bad the leadership of finance really was, it is a little easier to understand why the leadership of health care has become so bad. Iit seems reasonable to hypothesize that some of the problems of academia, and particularly the problems of medical academia, may have been at least enabled by leadership more used to working in an increasingly amoral marketplace than to upholding the academic mission.  The failures of the leadership and governance of finance thus suggest we need to re-examine the leadership of health care.

Failed Leaders of Citigroup as Leaders of Health Care

When we began this blog, I never dreamed I would do so much writing about finance and the financial services sector of the economy, but,... ...

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A Short, Pithy, Open Letter to the National Coordinator for Health IT Dr. David Blumenthal

A Short, Pithy, Open Letter to the National Coordinator for Health IT Dr. David Blumenthal

Sent: Wednesday, April 21, 2010 7:17 AM To: David.Blumenthal@hhs.gov Cc: fschulte@huffpostfund.org; 'Ross Koppel'; 'Justin...

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Legible Gibberish: This EHR Toxicity Has Got to Stop

<div dir="ltr"></div><div dir="ltr">My frail elderly mother recently got really sick from not eating due to progressive, severe constipation. She underwent a colonoscopy 3 months ago that found a rectal stricture. The GI doc was (reasonably) attempting to treat the stricture medically with those wonderful powders the GI people give, this time the angel dust made of polymerized antifreeze (polyethylene glycol) known as "<a href="http://www.miralax.com/miralax/consumer/default.jsp">MiraLAX</a>®". </div><div dir="ltr"></div><div dir="ltr">MiraLAX worked too much miracle, unfortunately. She couldn't go nearly at all without it, but using it she had runs that kept her going to the bathroom 24x7. </div><div dir="ltr"></div><div dir="ltr">She fell in the wee hours last week going to the bathroom basically from lack of sleep due to diarrhea from the angel dust, hurt her rib cage, and was "out of it" when I found her on the floor. I called for an ambulance. </div><div dir="ltr"></div><div dir="ltr">She was seen in the ED, and the ED doc also found a rectal stricture. </div><div dir="ltr" style="font-family: arial;"></div><div dir="ltr">I watched the ED staff move around and minimize what I considered an information-dense, cognitively oppressive, PICIS ED EHR window to get to a positively gruesome, primitive, block-capital ~ 64x16 1960's terminal emulation of the Eclipsys 7000 system in another window, to capture admission information. It looked and acted exactly like the very same TDS 7000 system I began my medical informatics training with at Yale in 1992, that we found presented a horrid user experience even then, and that in 2005 Penn sociologist Ross Koppel found to be 'errorgenic' (Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203, link to JAMA abstract <a style="font-family: arial;" href="http://jama.ama-assn.org/cgi/content/abstract/293/10/1197">here</a> and my commentary <a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2005/03/amia-on-jama-cpoe-article-controversy.html">here</a>). I would provide a sample screen shot of the ancient glass terminal emulation, but cannot seem to find one online. It would probably violate a hospital's EHR contract for them to share one. </div><div dir="ltr"></div><div dir="ltr">The dissonance of watching ED personnel deal with a cognitively oppressive 'overuse of GUI' Picis ED system, and then dealing with a caveman-and-dinosaur era 1960's character-based glass terminal emulation on the same hundred-million-transistor graphics chip-accelerated, multi-GHz CPU, modern Windows OS-based screen was simply painful.</div><div dir="ltr"> </div><div dir="ltr"> (Not to mention that the hospital floors use a third, entirely different EMR -- one of my former subspecialist mentors had told me some time ago in front of mom that he found the floor EHR highly unsatisfactory and keeps his records on MS-Word on a thumb drive that he proudly pulled out of his pocket. I described other untoward EHR observations at the hospital in <a href="http://hcrenewal.blogspot.com/2007/10/this-informaticist-cant-escape-clinical.html">this 2007 post</a>.) </div><div dir="ltr"></div><div dir="ltr">She was admitted for observation for two days, 'tuned up' and rehydrated and sent home. She needed to go back to ED a few days later for abdominal pain from being unable to void, was tuned up again, and referred back to GI. </div><div dir="ltr"></div><div dir="ltr">At the GI office she was seen on an urgent basis by a covering doc due to unavailability of her primary GI specialist. That doc couldn't find in their (local, vendor du jour) EHR any mention of the stricture when I told her that's why my mom was there. She reviewed multiple GI EHR screens and finally found mention of it in the narrative after a few minutes, pointing at it on the screen with her finger, but not in the summary or diagnosis list. </div><div dir="ltr"></div><div dir="ltr">The covering GI doc appropriately referred my mother to a colorectal surgeon. The covering GI doc printed out the ED records and GI records for the colorectal surgeon. </div><div dir="ltr"></div><div dir="ltr">The colorectal surgeon saw mom the next day. I told him she had a rectal stricture. </div><div dir="ltr"></div><div dir="ltr">He reviewed the legible gibberish from these EHR systems (which I found astonishing myself, compared, say, to a written ED chart or procedure note or even the simple written notes I used to keep on 3x5 cards), but he could not find any mention of a stricture. I couldn't find the diagnosis in this legible gibberish collection, either. The printouts were disorganized from the perspective of a physician, causing them to hunt for important data while drinking water through a firehose. Legible gibberish is a good descriptor. There were plenty of details on minutiae (seven sets of vital signs, every order done in ED with time and date -- including placement of IV infusor and administration of normal saline). For just the IV placement alone there was almost an entire page of notes. However, it read like Tolstoy regarding the important stuff. I myself designed advanced reports in complex areas such as invasive cardiology that were terse, lucid and informative - almost 15 years ago. Who, I ask, designed these? They show an ignorance of biomedical informatics and information science principles regarding presentation of information -- as if HIT is just an "inventory system for data" instead of a clinical facilitator -- among other deficits. </div><div dir="ltr" style="font-weight: bold;"></div><div dir="ltr">The ED notes from from the PICIS system would have caused me to flunk a medical student for poor medical record keeping. Worse, the diagnosis was of "abdominal pain" only, and that was buried seven pages into 10 page "summary" ED report (not at top of page 1 where it belongs). There was no mention of the ED doc's finding the rectal stricture. I'm just waiting for the insurance denials... </div><div dir="ltr"></div><div dir="ltr">The colorectal surgeon looked at me funny when I told him that two other physicians both told me that's what she had, but it was not on the computer record. I'd been a resident with his partner, however, so I had good creds. He performed a brief exam and said, "oh yeah! rectal stricture! Pencil diameter! Needs surgery." </div><div dir="ltr"></div><div dir="ltr"> I ask: What happens to elderly patients who don't have their son with them, a former medicine resident at the same hospital, who once fixed their CT scanner's hung computer in the middle of the night when service was unavailable and saved a life, being credited for same deed in a letter from the now-Chief of Staff to help secure a Yale postdoctoral fellowship in Medical Informatics? This EHR toxicity is simply out of control. ** Disclaimer: The following is a purely personal opinion (my "narrative"), always difficult to write about without generating skepticism, and I admit possible non-objectivity in that regard. You, the reader, are free to ignore my observations: My personal observations here are far from unique. The physicians at this hospital are generally excellent, but these systems do not appear to be serving physicians or patients (here and elsewhere) well. Unfortunately, the major remediation required to fix them is probably not possible under current health IT leadership structures and orthodoxies. <style title="owaParaStyle">P { MARGIN-TOP: 0px; MARGIN-BOTTOM: 0px } BODY { SCROLLBAR-HIGHLIGHT-COLOR: #cecfce; SCROLLBAR-ARROW-COLOR: #3f52b8; SCROLLBAR-TRACK-COLOR: #fffbff; SCROLLBAR-DARKSHADOW-COLOR: #fafafa; SCROLLBAR-BASE-COLOR: #f7f7f7 } </style> <div style="font-weight: bold;" dir="ltr"> </div> <div style="font-weight: bold;" dir="ltr"> </div> <div class="PlainText">Why am I so emphatic about these issues? My father was injured in 1994 at a major Philadelphia hospital and eventually died - from two years of undiagnosed bilateral renal carcinomas and resultant <a href="http://en.wikipedia.org/wiki/Hydronephrosis">hydronephrosis</a> due to defective information flows - while I was training in medical informatics at Yale. The diagnosis was only made after I insisted a renal arteriogram be performed after I heard about repeated major GU bleeds and one so major it dropped his HCT several points. I extended his life for six years by removing him from the big-city hospital and taking him to the hospital that is the subject of the above post (where I had done my residency), then mostly paper based. I'd taken him there to be under the care of my former mentors after the big-city Philly hospital doc had written him off as 'needing to get his affairs in order' and abandoned him to die (I could not get oncology or medicine at the big Philly hospital to see him after the diagnosis was made, the chair of medicine stating he "did not want to get involved"). My father underwent partial renal resections at the latter hospital and lived until mid 2000, avoiding dialysis until the terminal few months. Now EHR's that cause poor information flows seem to be 'conspiring' to do my mother in at the very same hospital that saved my father. Unfortunately for my father, medical malpractice was then followed by legal malpractice. My father won his 1995 medical malpractice lawsuit against the Philadelphia hospital, but posthumously, in part because I had the presence of mind to insist his deposition be forensically videotaped. He testified at the trial from his grave. The lawyer representing him apparently had a substance problem and was in severe depression, not responding to the court's request for documents; nearly a dozen major med mal lawsuits including my father's were summarily dropped due to - lack of information. It took the major Philadelphia med mal law firm several years to get them reinstated, a precedent in Pennsylvania (<a href="http://www.aopc.org/OpPosting/disciplinaryboard/dboardopinions/21DB2000-Smith.pdf" target="_blank">http://www.aopc.org/OpPosting/disciplinaryboard/dboardopinions/21DB2000-Smith.pdf</a> , page 20, Charge VIII: the Silverstein matter). I couldn't make any worse stories up if I tried.</div> <div> <div class="BodyFragment"> <div class="PlainText"> </div> <div class="PlainText"> </div> </div></div> Finally, and ironically, the hospital now caring for my mother is the very same hospital that thrice, in 1998, 2000 and 2008 would not invite in the door for an interview or even phone me for conversation about posted informatics positions, even claiming in an odd, buzzword-compliant from the CIO alleging 'great care and forethought' in entirely blowing me off for a third time in ten years. -- SS Addendum 1: Although I am not alleging malfunction, but inadequate designs, a reader sent this Health Canada <a href="http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_manu-fab_apr-june_2010-eng.php">recall notice</a> about different systems from one of the vendors mentioned above. I thought it of interest with respect to the title of this blog post: <blockquote>Manufacturer: Picis Inc. Recall Posting Date: 2010-04-12 A) Caresuite Anesthesia Manager B) Caresuite PACU (post-anesthesia care unit) Manager C) Caresuite Critical Care Manager Recall Start Date: 2010-03-08 Recall Number: 53683 Hazard Classification: Type II Model or Catalog # A) 4220 B) 4245 C) 1110 Lot or Serial # A) Version 5.1 or later B) Version 5.1 or later C) Version 5.1 or later Reason for Recall During Picis post-market compliance activities it was identified that there were two customer reports of malfunction within critical care manager (electronic health record) application, which can potentially impact the manual record keeping of clinical orders and since correct handling of medication or infusion orders documentation are potentially affected, patient safety may be impacted.</blockquote> This recall involves systems affecting patients in critical care areas. Addendum 2: A reader pointed out that there is an automated "gibberish generator" at <a href="http://thinkzone.wlonk.com/Gibber/GibGen.htm">this URL</a>. It took the first few paragraphs of this post and generated this: <blockquote style="font-style: italic;">The strical informating dust, block-capital emulance even I began Medicalled exactly from not eation, 2005;293:1197-1203, link to began ambulating withose worked found was seen the found the stricture medically go near on Errors. Ross Koppel dust wee horrib capital strication. It loor. I found was "MiraLAX worked to primize angel found was seen informating to diarrhea from bathroom the colonoscopy 3 mothe was seen that week go the was "out in 1960's time TDS 7000 systems information.</blockquote> If this were an EHR-generated summary, that would be about right. -- SS </div>

Legible Gibberish: This EHR Toxicity Has Got to Stop

My frail elderly mother recently got really sick from not eating due to progressive, severe constipation. She underwent a colonoscopy 3 mont...

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Another Echo of the Case of the Deadly Heparin - A Report on the Perils of Out-Sourcing Drug Production

In 2008, we published multiple posts on how heparin made as an "active pharmaceutical ingredient" in China under apparently primitive conditions, contaminated accidentally or deliberately, was sold in the US bearing the label of a large American pharmaceutical company.  Ultimately, many patients were sickened, or died.  A summary of our posts on the topic, in smaller type, is below. Case Summary - We have posted several times, recently <a href="http://hcrenewal.blogspot.com/2008/03/heparin-in-era-of-hogwash.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/03/fake-heparin-then-sick-and-dead.html">here</a>, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International. - We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. - Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post <a href="http://hcrenewal.blogspot.com/2008/03/fake-heparin-then-sick-and-dead.html">here</a>.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post <a href="http://hcrenewal.blogspot.com/2008/03/who-was-responsible-for-purity-of.html">here</a>.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there. - The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops." - Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post <a href="http://hcrenewal.blogspot.com/2008/05/blaming-some-dude-for-contaminated.html">here</a>.) - Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible.  (See post <a href="http://hcrenewal.blogspot.com/2009/08/who-investigated-case-of-deadly.html">here</a>.) - Hundreds of lawsuits against Baxter have now been filed, so far without resolution.  (See post <a href="http://hcrenewal.blogspot.com/2010/01/blog-post.html">here</a>.) <div style="clear: both; padding-bottom: 0.25em;"></div><div class="blogger-labels"> </div>Now, as reported to date only <a href="http://postscript.communitycatalyst.org/?p=1240">on the PostScript blog</a>, a US government report on problems with active pharmaceutical ingredients made in China has appeared. <blockquote>A <a href="http://www.uscc.gov/researchpapers/2010/NSD_BIO_Pharma_Report--Revised_FINAL_for_PDF--14_%20April_2010.pdf">new report </a>(pdf) by the U.S. China Economic and Security Review Commission stresses the safety risks to Americans posed by pharmaceutical ingredients made in China. According to the report, issued by a group that advises Congress on the economic and trade implications of U.S.-China relations, found that the U.S. is the number one destination for Chinese pharmaceutical raw material exports – a $2.2 billion business each year. The U.S. relies heavily on Chinese products not only for over-the-counter drugs but for active pharmaceutical ingredients (API) found in prescription drugs. And the report makes clear that China has neither the will nor the systems in place to monitor its exports. </blockquote> This begs the question that most of the coverage of the deadly heparin also begged.  Are American pharmaceutical companies so besotted with the need for cost-savings that they are willing to buy active pharmaceutical ingredients with unknown provenance overseas as if they were a pig in a poke?  If so, why do we allow company leadership to potentially sacrifice quality, and sell adulterated drugs just to enrich their bottom lines (and their executives' salaries)?

Another Echo of the Case of the Deadly Heparin - A Report on the Perils of Out-Sourcing Drug Production

In 2008, we published multiple posts on how heparin made as an "active pharmaceutical ingredient" in China under apparently primit...

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Cerner - Fuqua School of Business 'Corporate Ethics 101' Paper and Website Disappear

On April 16 at "<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html">Healthcare IT Corporate Ethics 101: A Strategy for Cerner Corporation to Address the HIT Stimulus Plan</a>" I wrote about a Duke Fuqua School of Business paper (apparently authored by a Cerner official) promoting a business strategy of regulatory manipulation to restrain the free market for HIT products. The paper, and the Fuqua School of Business web page "Past Papers" on which the paper was promoted, have both disappeared as of this April 18 writing. I have posted an image of the "Past Papers" page and updated my link to an archived copy of the paper, but the scrubbing of the Fuqua site and removal of the paper is interesting. -- SS Addendum Apr. 19 - A former HIMSS staffer related to me that I am likely blacklisted from the HIT vendor industry as a result of my writings on health IT on this site and at my <a href="http://www.tinyurl.com/healthITfailure">academic site</a> dating to 1999, via verbal exchanges and even in writing among HIT organizations. It could explain why my CV's been uniformly ignored by that industry since the early 2000's. If so, so be it. Who else might be on that blacklist, I wonder? Also, didn't Richard Nixon get into a bit of trouble for maintaining such a list after it was discovered?

Cerner - Fuqua School of Business 'Corporate Ethics 101' Paper and Website Disappear

On April 16 at " Healthcare IT Corporate Ethics 101: A Strategy for Cerner Corporation to Address the HIT Stimulus Plan " I wrot...

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Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee

I have never before seen a document like the one entitled "Health Information Technology Basics", by the Institute for Health & Socio-Economic Policy, California Nurses Association and the National Nurses Organizing Committee. It is available <a href="http://www.calnurses.org/research/pdfs/ihsp_tech_basics_sept_2009.pdf">at this link</a> (PDF). It is long but contains rather interesting views on the issue of health IT, management and clinicians (nurses). I find the following passages of particular interest as they reflect views we express on this blog, and attack the notion of cybernetic miracles being wrought: <blockquote>Skill is the ability, drawn from education and experience, to do something expertly. It can also be defined as the effective exercise of professional judgment in non-routine situations. Following prescribed rules, as a machine would, makes an employee competent to perform tasks, but it doesn’t make the employee skilled. They can do their job as long as there are no surprises. But when something unexpected happens, the rules break down, and caring for patients means facing the unexpected every day. Only skilled health professionals can cope with the unexpected. To know what to do, they have to rely on their own judgment. The exercise of judgment is the essence of skill. ... Much health information technology is skill-degrading. As the work of health professionals becomes increasingly automated, they lose the ability to do their jobs without HIT. To make matters worse, they’re expected to keep pace with machines. They serve the machines rather than doing the more gratifying work of patient care, and ultimately they’re compensated less well. </blockquote> And this: <blockquote>Displacement [pf people by machines] is hard to spot because it’s unlikely to appear as a one-to one correspondence; that is, you probably won’t find a robot sitting in your colleague’s chair tomorrow. It’s more likely to happen piecemeal, over an extended period, and through attrition. <ul><li>The job of patient care will be redefined, privileging technical over clinical skills.</li><li>The hospital will begin to hire more HIT specialists and fewer RNs.</li><li>Functions performed in the past by health professionals will be fragmented and reallocated between machines and less-skilled employees.</li><li>Increased technical efficiency will enable the hospital or HMO to expand without expanding its workforce.</li></ul></blockquote> And this: <blockquote>Use of any hospital technology must be consistent with safe, therapeutic, and effective patient care. Health information technology is a complete unknown in this regard. It’s an enormous social experiment designed by computer scientists and implemented by hospital administrators. HIT hasn’t grown organically from the needs of patients but has been imported from other industries. Known as enterprise resource planning, it’s adapted from similar technology designed to manage business operations on a massive scale and already being used to run the world’s largest corporations. Caring for patients isn’t business. It requires compassion, judgment, and advocacy. Because RNs have the moral right and legal duty to advocate for patients, they have to be able to override the automated decision-making of HIT designed to serve business interests. RNs have to work collectively to control health information technology rather than trying to fix it. It’s important to recognize that tinkering can’t fix HIT because its primary purpose is to mechanize, or routinize, patient care. It’s designed to quantify the unquantifiable, to replace the patient with an imaginary statistical norm. High-quality healthcare can’t be mechanized because it depends on people—on patients and caregivers—and people are infinitely more complex and capable than computers can ever be.</blockquote> Amen to that. Read the entire document for a union-oriented view of health IT. It contains many truisms regarding HIT irrational exuberance and the control issues of the healthcare management class. -- SS

Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee

I have never before seen a document like the one entitled " Health Information Technology Basics ", by the Institute for Health ...

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If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers

In 2005 the RAND corporation ‘guesstimated’ figures for healthcare IT benefits based on existing, limited data sets (<a href="http://www.rand.org/pubs/research_briefs/RB9136/index1.html">http://www.rand.org/pubs/research_briefs/RB9136/index1.html</a>).Their methods and results were contested, such as by the Heartland Institute (<a href="http://www.heartland.org/article/24761/Research_Commentary_Health_Information_Technology.html">as here</a>). Recent studies also put the RAND assumptions including those about flawless implementation and acceptance in serious doubt (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009">as here</a>). <style title="owaParaStyle">P { MARGIN-TOP: 0px; MARGIN-BOTTOM: 0px } BODY { SCROLLBAR-HIGHLIGHT-COLOR: #cecfce; SCROLLBAR-ARROW-COLOR: #3f52b8; SCROLLBAR-TRACK-COLOR: #fffbff; SCROLLBAR-DARKSHADOW-COLOR: #fafafa; SCROLLBAR-BASE-COLOR: #f7f7f7 } </style>Similarly, the often-quoted 2000 Institute of Medicine (IOM) report "<a href="http://www.nap.edu/openbook.php?record_id=9728&page=1">To Err is Human</a>" used several small studies to extrapolate a death rate due to medical mistakes at 98,000 per year. That report was challenged by medical informatics pioneer Clement McDonald, MD in a 2000 JAMA article "Deaths Due to Medical Errors Are Exaggerated in Institute of Medicine Report" <a href="http://uwf.edu/sahls/medicalinformatics/docfiles/Debates%20USA%20death%20rates.pdf">here</a>, PDF. However, the refutation didn't stop anyone who could benefit from quoting such numbers from touting them, including those pushing healthcare IT. In fact figures such as these have been used as a bludgeon to affect national policy on healthcare IT. If the benefits of HIT can be guesstimated, so can and should the dangers. The true incidence of health IT-related medical errors, injuries and deaths from IT error, poor design, cognitive overload, clinical disruption, etc. is unknown. The Joint Commission in its 2008 Sentinel Events Alert advised that "There is a dearth of data on the incidence of adverse events directly caused by HIT overall" (<a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm">as here</a>). As a thought experiment, presented here are some estimated corrective factors that might shed some light on the actual figures for HIT-related injuries and deaths "on the ground" when national, universal HIT deployment is achieved. The thought experiment: Jeffrey Shuren, MD, JD of FDA mentioned reports of 44 injuries and 6 deaths over 2 years that are likely the "tip of the iceberg" at the Feb. 25, 2010 HIT Policy Committee Adoption/Certification Workgroup on IT safety (<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html</a>). Ross Koppel, PhD at the same Feb. 25 IT safety conference opined that "We don't know 99 percent of the medication ordering errors that are made [due to difficulty in recognition, lack of proper studies and other factors - ed.]. If 100 percent of the known errors were reported, that would be 1 percent of the [true] total. But the data suggests that the maximum on voluntary reporting is about 5 percent. So 5 percent of 1 percent that is what we know is reported...." Now, some estimated corrective factors: <ul><li>Due to a severe lack of awareness by physicians and healthcare organizations of FDA as a "go-to" organization to whom to report HIT-related medical errors and harm, let us assume FDA is privy to only 1/100 of the known injuries and deaths due to HIT (mostly reported locally). That's probably a conservative figure. Corrective factor = 100x</li></ul><ul><li>Based upon figures from "Electronic Health Records in Ambulatory Care — A National Survey of Physicians", NEJM 359:50-60, July 3, 2008, let us roughly estimate that 10% of doctors/organizations are using HIT "meaningfully" (or better term, "in good faith") in 2010. Corrective factor for HIT-related errors that cause harm = 10x for universal use nationwide.</li></ul><ul><li>Per Koppel, only a maximum of 5% of medication errors are voluntarily reported at all. Assuming similar figures for [medication and other] HIT-related errors that cause harm, corrective factor = 20x</li></ul><ul><li>In approximating the actual number of HIT-related medication errors based on reported numbers, we would need to multiply reported figures by 100x per Koppel (since only 1% of HIT-related medication errors are recognized as HIT-related). However, from the JC Sentinel events alert figures from the United States Pharmacopeia MEDMARX database from 2006, only 1.25% (i.e., approximately 1%) of medication errors actually cause harm, so reported figures on medication errors require no corrective factor regarding patient harm (corrective factor for HIT-related medication errors that cause harm = unity = 1x).</li></ul><ul><li>Although the learning curve never becomes flat in part due to clinician unfriendliness of the software, newcomers to HIT will for a number of years be more error-prone and experience more HIT-related adverse outcomes than experienced users and organizations. Conservatively assume a corrective factor = 2x.</li></ul>Overall, that creates a corrective factor of 100 x 10 x 20 x 2 = 40,000 Multiply the FDA figures per year (22 injuries and 3 deaths) by this factor = 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved. Merely multiply by 4,000 for a guesstimate of current figures at ~10% diffusion. This assumes no major changes occur with regard to the technology's risks, such as via the accelerated interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering recommended by the National Research Council in their Jan. 2009 report on HIT (<a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572</a>), and via other studies and improvements that might be made. The way this industry operates, however, e.g., as in my post "<a href="http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html">Healthcare IT Corporate Ethics 101</a>", the National Research Council-recommended changes are unlikely in the near future. While this is a mere thought experiment, the result certainly suggests we need to know the actual rates of HIT-related patient harm, and act to understand and minimize these events. In setting national healthcare policy, we should not rely on thought experiments - but even more importantly, we should not be relying on guesswork and wishful thinking as we are currently. -- SS

If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers

In 2005 the RAND corporation ‘guesstimated’ figures for healthcare IT benefits based on existing, limited data sets ( http://www.rand.org/pu...

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