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A Small Echo of the Case of the Adulterated Heparin

A small news item <a href="http://www.bloomberg.com/apps/news?pid=20601103&sid=aaDmNquvTq1o">published by Bloomberg</a> is a reminder of a serious case that was never resolved: <blockquote>Baxter International Inc., which recalled its blood thinner heparin amid reports of allergic reactions and deaths in 2008, faces at least 30 lawsuits in Chicago by injured people or their estates. As many as 300 product-liability complaints may be filed in the Illinois state court, plaintiffs’ attorney Allen Schwartz of Kralovec, Jambois & Schwartz said today in a phone interview. His law firm and two others are working to comply with a judge’s order last year to convert an aggregate lawsuit to individual claims against the Deerfield, Illinois-based company. </blockquote> I have appended a summary of the case at the bottom of the post, with relevant <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> links.   What is most striking about this case is that it involved the deaths of many patients, and serious complications of many others.  While the nature of the contamination of the heparin, and the biology of its adverse effects were elucidated, how the contaminant was introduced into the drug marketed in the US was never clear.  Finally, to date, no individual has been held accountable, and no individual has suffered any negative consequences from a case that was as deadly as a terrorist attack.  The best that the leadership of Baxter International could do was described by Bloomberg thus: <blockquote>'We deeply regret any impact the 2008 heparin contamination situation may have had on patients and family members,' [Baxter International spokesperson Erin] Gardiner said in an e-mailed statement. 'If these lawsuits are similar to those that have already been filed, a large number of claims don’t involve contaminated heparin or in some cases, even Baxter heparin,' she said. </blockquote> Again, the "impact" apparently included death. The deaths and morbidity were due to an adulterated drug sold in the US as pure. Combatting drug adulteration was the reason the US Food and Drug Administration was founded. What amazes even me is that a case with such severe outcomes has received so little attention. To my knowledge, there has never been a formal investigation by any branch of government, or by academia, for that matter, of how the contamination occurred, or who was responsible. Aside from some minor attempts to increase general supervision by the FDA of the manufacture of drugs and drug ingredients in other countries, I am aware of no specific changes in policy or regulation meant to prevent another case of deadly drug adulteration. This is a profound and disturbing example of the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, i.e., that stories that the often rich and powerful insiders who now may lead health care might find offensive produce few echoes. If there is no outrage about drug adulteration leading to patient deaths, how do we ever expect to improve our dysfunctional health care system? 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>.)

A Small Echo of the Case of the Adulterated Heparin

A small news item published by Bloomberg is a reminder of a serious case that was never resolved: Baxter International Inc., which recalled...

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Office of the National Coordinator for Health Information Technology (ONC): A One Man Show?

Generally, transparency in government means that the public it serves knows who that government is. Yet the "<a href="http://healthit.hhs.gov/portal/server.pt?open=512&objID=1200&&PageID=15521&mode=2&in_hi_userid=10741&cached=true">Office of the National Coordinator: Key Personne</a>l" page at HHS shows only this, the name of the Coordinator himself, Dr. David Blumenthal: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh_g_kzFCUbXTD0J8KVCw3KZbIxNPztHZWZCCwaAITR0Zm1ge68SjHIHOM9C8LDGCV8Z6QTLZrBW5vNCGTySjKXalElai8Agpt0t44kISbvYzphTo-P1vjKAISaHvkDuzra1trnE8n7OCiW/s1600-h/onc.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5426614649024801090" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh_g_kzFCUbXTD0J8KVCw3KZbIxNPztHZWZCCwaAITR0Zm1ge68SjHIHOM9C8LDGCV8Z6QTLZrBW5vNCGTySjKXalElai8Agpt0t44kISbvYzphTo-P1vjKAISaHvkDuzra1trnE8n7OCiW/s320/onc.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 357px; height: 180px;" /></a>Only one person works at ONC? click to enlarge </div> What about the others as per the <a href="http://healthit.hhs.gov/portal/server.pt?open=512&objID=1200&&PageID=15520&mode=2&in_hi_userid=10741&cached=true">Org Chart</a>? <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhTWvpRu4RhyphenhyphenFgn1nzBySKFjWWOu0-AvyLsVtXhBZ5Qy586nvodeGsX_fQ2JUo5sdhJsAPMeuUrpCz1w_lFj6tN3fTrjoUcU-WLwaV5hLvwSCXyWl_uRrl0xJjD5edkWBotEjYVfvRPcgUq/s1600-h/onc_orgchart.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5426616307910309138" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhTWvpRu4RhyphenhyphenFgn1nzBySKFjWWOu0-AvyLsVtXhBZ5Qy586nvodeGsX_fQ2JUo5sdhJsAPMeuUrpCz1w_lFj6tN3fTrjoUcU-WLwaV5hLvwSCXyWl_uRrl0xJjD5edkWBotEjYVfvRPcgUq/s320/onc_orgchart.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 320px; height: 244px;" /></a>ONC Org Chart (click to enlarge) </div> In the case of the Office of the National Coordinator for Healthcare IT, there are a number of possibilities for this apparent informational lapse: <ul><li>There is only one person working in this office;</li></ul><ul><li>Only one person is considered "Key Personnel";</li></ul><ul><li>This office, responsible for the national program for health IT and Electronic Medical Records in the U.S. that will "<a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=a559d6ae422c4e049617c4084f967d7b&URL=http%3a%2f%2fweb.archive.org%2fweb%2f20080714203445%2fhttp%3a%2f%2fwww.hhs.gov%2fhealthit%2fvision.html">revolutionize</a>" healthcare through better record keeping, has been careless in updating its Electronic Personnel Records; </li></ul><ul><li>The names are buried somewhere not easy to find, or the identities of the personnel are being entirely withheld from the public to prevent the public from knowing who they are and what their past and present affiliations might be.</li></ul> Why might that be an issue? Pro-IT industry conflicts of interest, qualifications, and anti-physician biases come to mind as just a few possibilities. Where's the transparency? Just asking. -- SS

Office of the National Coordinator for Health Information Technology (ONC): A One Man Show?

Generally, transparency in government means that the public it serves knows who that government is. Yet the " Office of the National C...

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Healthcare IT: A 'goldmine' for fraudsters

Health IT is serving another unexpected purpose: it's becoming a landmine for fraud. In "<a href="http://money.cnn.com/2010/01/13/news/economy/health_care_fraud/index.htm">Health care: A 'goldmine' for fraudsters</a>", CNN senior writer Parija Kavilanz observes that: <blockquote>NEW YORK (CNNMoney.com) -- There's a group of people who really love the U.S. health care system -- the fraudsters, scammers and organized criminal gangs who are bilking the system of as much as $100 billion a year. Health care identity theft dominated all other crimes in the sector last year, according to Louis Saccoccio, executive director of the National Health Care Anti-Fraud Association (NHCAA), an advocacy group whose members include insurers, law enforcement and regulatory agencies.The most common method of health care identity fraud occurs when someone with legitimate access, such as a hospital administrator or a doctor's assistant, sells patients' information to organized criminal groups.Increasingly, criminal groups are hacking into digital medical records so that they can steal money from the $450 billion, 44-million-beneficiary Medicare system -- making the government, by far, the "single biggest victim" of health care fraud, according to Rob Montemorra, chief of the FBI's Health Care Fraud Unit. All the stolen information includes medical insurance data and Social Security numbers, explained James Van Dyke, president of Javelin Strategy & Research, a research firm specializing in trends in security and fraud initiatives.Van Dyke said that, with the information, the fraudster falsely bills Medicare and private insurers for drugs, equipment or treatment that were never prescribed. </blockquote> I have somewhat constrained confidence in the health IT prowess of a government that cannot implement proper processes and information systems to prevent $100 billion per year in Medicare fraud. The fraud is not sophisticated; it is performed in the most simplistic manner via simple submission of fraudulent claims via boiler-room billing companies: <blockquote> To collect the money, the criminals set up shell billing companies that disappear as soon as there's any indication of an investigation, according to the FBI.</blockquote> I have less than stellar confidence that the very same government can oversee a national project for health IT to implement technology that is not just a panacea to healthcare's ills as effectively claimed, but goes far beyond that as an alterative that will <a href="http://web.archive.org/web/20080714203445/http://www.hhs.gov/healthit/vision.html">revolutionize healthcare</a>. -- SS

Healthcare IT: A 'goldmine' for fraudsters

Health IT is serving another unexpected purpose: it's becoming a landmine for fraud. In " Health care: A 'goldmine' for fr...

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Non-Profit Health Care Organization Executives: Pay Them Millions or Lose Them?

CareSource is a US not-for-profit managed care organization for Medicaid patients.  This week, the Dayton (Ohio) Daily News ran an investigative series on its leadership and governance which may provide a larger lesson on the disconnect between the high ideals and high costs of the dysfunctional US health care system.  The main issue uncovered by the investigation was CareSource's generosity to its CEO.  As reported in "<a href="http://www.daytondailynews.com/business/caresource-ceos-compensation-grew-faster-than-revenues-at-nonprofit-485261.html">CareSource CEO's compensation grew faster than revenues at nonprofit</a>," <blockquote>From 2005 to 2008, CareSource more than doubled its total revenues — from $770 million to $1.8 billion. It’s now the nation’s third largest nonprofit Medicaid HMO. But CareSource’s phenomenal revenue growth was no match for the increase in total compensation for Chief Executive Pamela Morris, whose pay more than tripled — from $877,000 in 2005 to $2.9 million in 2008, according to IRS filings. </blockquote>Did Pay Buy Performance? Not only did the CEO's pay grow much faster than the organization she lead, it also seemed disproportionate to what ratings of the organization's performance are available. <blockquote>In America’s Best Health Plans for 2009-2010 — a survey conducted by U.S. News & World Report and the National Committee for Quality Assurance (NCQA) — CareSource ranked 72nd in patient satisfaction and quality of care among 82 HMOs participating in the study. It was the lowest ranking among the four participating Ohio Medicaid plans. </blockquote>"We Don't Want to Lose Her" The chair of the organization's Board of Directors claimed that such pay was necessary to secure the CEO's loyalty, per the Daily News, <blockquote>Ellen Leffak, chairwoman of the CareSource board, said a separate committee of the board sets the top executive salaries with the help of a consultant. The committee monitors what is being paid at both for-profit and non-profit competitors. Leffak said Morris is worth her multimillion-dollar compensation. 'We don’t want to lose her' to another HMO, Leffak said. 'She has provided outstanding service to the organization and we think she should be adequately compensated.' </blockquote> The implication, which perhaps Ms Leffak did not mean to openly convey, was that Ms Morris' dedication to the organization and its not-for-profit mission were less important than her desire for a multi-million dollar paycheck.  (Parenthetically, Ms Leffak also failed to specify how Ms Morris' service was determined to be "outstanding,") Furthermore, The Daily News also reported: <blockquote>CareSource officials say Morris’ pay hike, which included a $1.2 million incentive payout in 2008 from her supplemental retirement plan, is in line with salaries paid top executives with similar experience at its for-profit competitors. Morris is 61 and has been with CareSource for 24 years. </blockquote>The newspaper provided a table of CEO compensation at such for-profit competitors. The best-paid CEO in the table was Heath G Schiesser of Wellcare Health Plans, who received $8,077,718. The article did not mention that not onlyh is Wellcare for profit, but it <a href="http://www.wellcare.com/AboutUs/default">claims</a> to be a "nation-wide" operation.  It also did not mention that in August, 2009, Wellcare paid a fine for findings, which it did not contest, that it paid political contributions in Florida that violated state law (see post <a href="http://hcrenewal.blogspot.com/2009/08/wellcare-did-not-contest-that-its.html">here</a>).  Also, in May, 2009 we <a href="http://hcrenewal.blogspot.com/2009/05/wellcare-settles-accepts-deferred.html">posted</a> about WellCare's submission to a deferred prosecution agreemeent based on charges that it defrauded state programs by inflating its expenses. In 2007, we <a href="http://hcrenewal.blogspot.com/2007/11/health-plans-programs-cancelled-for.html">posted</a> about how the state of Connecticut stopped WellCare from running a plan for poor children after the company refused to reveal what it was paying physicians, and why it was failing to pay for particular services. So WellCare has paid three penalties for three different kinds of unethical behavior in the last two years. To be clear, it was the newspaper that stated Wellcare ought to be a standard of comparison, not Ms Leffak, Ms Morrison, or any CareSource official.  However, the choice of comparison further suggests how money may trump mission. Competing Against Stock Options Meanwhile, the Dayton Daily News published another article ("<a href="http://www.daytondailynews.com/business/critics-question-hospitals-ceo-on-caresource-board-485404.html">Critics question hospitals' CEO on CareSource board</a>) which suggested that the governance of CareSource may have resonated with the notion that the leadership of not-for-profit health care organizations may be more motivated by money than mission. <blockquote>Since the HMO’s inception in 1983, Tom Breitenbach, chief executive of Premier Health Partners, has had a hand in shaping CareSource. He continues today on the governing board of its parent, CareSource Management Group Services. But in recent months, health care officials and providers have raised questions about whether the head of the region’s largest hospital system should sit on the board of the parent organization of the region’s largest source of Medicaid payments. 'How can that not be a conflict of interest?' said Dr. Larry Litscher, a Dayton area urologist. 'They (the CareSource board members) have to determine the reimbursement levels' for hospitals and doctors providing service to CareSource patients. 'How can that not be interpreted as a big advantage for the hospitals?' </blockquote> But beyond the issue of conflict of interest, last year, the Dayton Daily News <a href="http://www.daytondailynews.com/n/content/oh/story/news/local/2009/02/22/ddn022209hospitalsinside.html">reported</a> on Mr Breitenbach's own incentives: <blockquote>In 2001, as Premier Health Partners Chief Executive Tom Breitenbach neared age 55, he was given an executive investment plan in addition to his supplemental retirement benefits that paid him nearly $9 million from 2002 to 2007. The requirements were that Breitenbach assume the risk of the investment and stay on as head of Premier until age 60. In 2001, MedAmerica Health Systems Corp., the parent company of Premier Health Partners and six smaller for-profit subsidiaries, found a novel way to help keep Breitenbach at the helm — they invested some of the supplemental retirement benefits he had accrued over 25 years into an executive option plan of mutual funds, in which Breitenbach assumed all risk. Breitenbach cashed out $6.7 million from the plan in 2003, another $660,000 in 2006 and a final payment of $1.5 million in 2007, for a total of $8.9 million, IRS documents show. </blockquote> Also, according to the MedAmerica Health Systems 2007 Form 990 (available <a href="http://www.guidestar.org/FinDocuments/2007/311/040/2007-311040228-048db0b5-9.pdf">through Guidestar</a>), Mr Breitbach's total compensation was $4,044,915. Again, the reason to pay so well seemed to be the fear that in the absence of for-profit levels of compensation, executives of not-for-profit organizations would quit to seek higher recompense in the for-profit world. <blockquote>In setting compensation levels, local hospital officials say they must compete with for-profit enterprises that can offer top executives hefty stock options, country club memberships and other perks that nonprofits can't. 'For-profit or nonprofit, it really has to do with attracting and retaining talent,' said Pete Luongo, who sits on the compensation committee of Kettering Adventist Healthcare, the parent of Kettering Health Network and its six hospitals. </blockquote>The implication is that not-for-profit health care organizations can and should hire people who care more about the level of compensation offered than the not-for-profit organizations' lofty missions. In this case, CareSource Says its <a href="http://www.caresource.com/en/AboutUs/Pages/OurMission.aspx">mission</a> is: <blockquote>to make a difference in the lives of underserved people by improving their health care. At CareSource, our mission is one we take to heart. In fact, we call our mission our 'heartbeat.' It is the essence of our company, and our unwavering dedication to it is a hallmark of our success. Our Vision is to be an innovative leader in the management of quality public-sector health care programs. </blockquote> Premier Health Partners says its <a href="http://www.premierhealthpartners.org/aboutus.aspx?id=760">mission</a> is: <blockquote>We will build healthier communities with others who share our commitment to provide high-quality, cost-competitive health care services. </blockquote> What cognitive dissonance is created by an organization dedicated to serving the "underserved" and another which espouses "cost-competitive" health care lead by CEOs who can only be retained by making them multi-millionaires.  Summary and Conclusions Leaders of not-for-profit organizations, starting with their boards of trustees, are <a href="http://www.boardsource.org/Knowledge.asp?ID=3.364">supposed</a> to subscribe to the duty of  obedience, "to be faithful to the organization's mission,"  and the duty of loyalty, " give undivided allegiance when making decisions affecting the organization." Presumably, that can be extended to the requirement that the top hired executives of not-for-profit put the mission ahead of their own personal gain.  Thus, boards of trustees who feel that they can only retain hired CEOs by pay so high that they will not be tempted by offers from for-profit corporations have failed in their duty by hiring CEOs who put their personal financial interests ahead of the mission.  I believe that the compensation given to CareSource and Premier Health Care CEOs, and the rationale for it, are not anomalies.  There have been many other reports about leaders of not-for-profit health care organizations compensated enough to make them multi-millionaires, justified mainly by the need to provide pay "competitive" with that available from for-profit corporations  (e.g., see posts <a href="http://hcrenewal.blogspot.com/2009/03/more-gravity-defying-compensation-for.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/03/43-million-dollar-ceo-for-not-for.html">here</a>).  Yet not-for-profit CEOs mercenary enough so that they can only be retained by for-profit levels of pay seem to be exactly the sort of people who should not be running what are supposed to be mission-oriented organizations.  Of course, the problem is only amplified when the same mercenary CEOs sit on each others' boards. When money becomes the only value for health care leaders, the health care system will cost a lot, but provide neither health nor care.  The only way to improve health care is to give it leadership that values health and caring for it more than money.

Non-Profit Health Care Organization Executives: Pay Them Millions or Lose Them?

CareSource is a US not-for-profit managed care organization for Medicaid patients. This week, the Dayton (Ohio) Daily News ran an investiga...

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HealthMemes: A "Healthcare Disruptive Innovation" custom Google search site

In my March 2009 post "<a href="http://hcrenewal.blogspot.com/2009/03/disruptive-innovators-at-healthcare.html">Disruptive Innovators at Healthcare Renewal: Disruptive to whom, exactly?</a>" I wrote about a fascinating site "HealthMemes: Tracking Conversations About the Future of Health" at <a href="http://in3.org/health/" target="blank">http://in3.org/health/</a> that linked to some of the posts here. The site is a blog of the organization <a href="http://www.in3.org/info/" style="font-family: arial;">International Informatics Institute (IN3.ORG)</a> and identifies latest trends in health care disruptive innovations (innovations that go "outside the box"). In that post I opined that: <blockquote>... If there are disruptive innovators, then there must be a whole taxonomy of people who are not disruptive innovators. The taxonomy might go something like this: <ul style="font-family: arial;"><li>disruptive innovator</li><li>soothing, tradition-bound innovator</li><li>disruptive imitator (the antonym of innovator)</li><li>tradition-bound imitator</li><li>disruptive non-contributor</li><li>tradition-bound non-contributor</li><li>disruptive demolisher</li><li>tradition-bound demolisher (perhaps an oxymoron)</li></ul> Disruptive innovators, thus, are disruptive to the interests of a wide variety of others. </blockquote> Now, the site has created a custom Google search that searches over 80 healthcare blogs, news sites and research sources considered "disruptively innovative" and used in the daily Health Memes postings. Healthcare Renewal is one of those sites as are some of our favorite others. The "Healthcare Disruptive Innovation" custom Google search is at <a href="http://in3.org/health/sources.php">http://in3.org/health/sources.php</a> and includes quite an impressive collection of sites. Take a look. -- SS

HealthMemes: A "Healthcare Disruptive Innovation" custom Google search site

In my March 2009 post " Disruptive Innovators at Healthcare Renewal: Disruptive to whom, exactly? " I wrote about a fascinating si...

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Does the CEO of Google Use Google? - And: Platform, Platform, Who's Got The Platform?

<div style="text-align: left;">Over at the WSJ health blog, reporter Jacob Goldstein's Jan. 8, 2010 post "<a href="http://blogs.wsj.com/health/2010/01/08/google-ceo-harvard-surgeon-talk-health-it/">Google CEO & Harvard Surgeon Talk Health IT</a>" quotes Google's CEO:</div><blockquote> "Google’s CEO Eric Schmidt doesn’t know why docs haven’t embraced databases to help them sort through medical information." [Schmidt said] ... So when you show up at the doctor with some set of symptoms, in my ideal world what would happen is that the doctor would type in the symptoms he or she also observes, and it would be matched against the data in this repository [such as <a href="http://www.google.com/search?client=firefox-a&rls=org.mozilla%3Aen-US%3Aofficial&channel=s&hl=en&source=hp&q=dxplain&btnG=Google+Search" style="font-style: italic; font-weight: bold;">DXplain</a>? -- which we learn from a - er, um, Google search - was developed starting in the mid 1980's by medical informatics researchers who actually know this domain, and which offers this explanation and warning: "DXplain uses an interactive format to collect clinical information and makes use of a modified form of Bayesian logic to derive clinical interpretations ... DXplain does not offer definitive medical consultation and should <a href="http://lcs.mgh.harvard.edu/projects/dxplain.html" style="font-style: italic; font-weight: bold;">not be used</a> as a substitute for physician diagnostic decision making"? - ed.] ... Then this knowledge engine would use best practices, and all the knowledge in the world to give physicians some sort of standardized guidance. This is a generalized form of the checklists that you’re talking about … As computer scientists, this is a platform database problem, and we do these very, very well, as a general rule. And it befuddles me why medicine hasn’t organized itself around these platform opportunities. [No - the successful practice of medicine is not a 'platform database' or any other reductionistic information retrieval problem - ed.]</blockquote> I note that IT personnel like to refer to "<a href="http://en.wikipedia.org/wiki/Computing_platform">platforms</a>", "solutions" - a rather presumptuous term, "paradigms", and other buzzwords to mask the fact that what they're referring to are more commonly known as "hardware" and "software" and arrangements thereof. Does this "platform opportunity" view reflect naïveté about the complexities of medicine and medical decision making, or does it reflect something else? Could this "befuddlement" be construed as calling physicians obtuse? Is this yet another example of what I referred to in my post "<a href="http://hcrenewal.blogspot.com/2009/12/utter-arrogance-of-it-industry.html">Healthcare IT Failure and The Arrogance of the IT Industry</a>" and other writings as a cross-occupational invasion of medicine by IT? IT personnel seem to have a propensity to offer healthcare-related opinions far outside their own areas of expertise -- or if in healthcare organizations, edicts - based upon the narrow view of their own relatively linear and deterministic fields. The risk is, especially when coming from high perches, that such opinions and edicts can result in deleterious actions (e.g., government initiatives). In an absurdist <a href="http://en.wikipedia.org/wiki/Reductio_ad_absurdum" style="font-style: italic;">reductio ad absurdum</a>, deliberately made absurdist due to many years of exposure to equally absurd (to those with actual domain experience) "who needs medical school/residency/patient care experience to profess on medical matters?" attitudes: Why don't physicians offer the advice that Google could improve its search algorithms, or Intel and AMD their microprocessors, by utilizing intelligent psittacine platforms <a href="http://www.youtube.com/watch?v=O_Fpad20Zbk">as in this British Broadcasting Company (BBC) video</a> narrated by a true technology expert, Captain James T. Kirk? <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi0_5l5d5WTr3rCF1OxYjWQCMZ58U02amoTE7trho8x12NYbR6UPP8JmpwY2E19FcZ4oaBUwNh8lYLp8IolYKq_ve9YohOpipWKEuhjtnh02FzauX2HbebCWl6zID8haXMeDLA3WwmxHjyu/s1600-h/STChangeling.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5424782084411649186" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi0_5l5d5WTr3rCF1OxYjWQCMZ58U02amoTE7trho8x12NYbR6UPP8JmpwY2E19FcZ4oaBUwNh8lYLp8IolYKq_ve9YohOpipWKEuhjtnh02FzauX2HbebCWl6zID8haXMeDLA3WwmxHjyu/s320/STChangeling.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 157px; height: 112px;" /></a>Kirk did have a (computerized) physician son: <a href="http://en.wikipedia.org/wiki/Nomad_%28Star_Trek%29">Nomad</a>! </div> ---------------- Quite seriously, physician reluctance to "embracing databases" and health IT in general is not about database platforms. I only wish it were so simple. The WSJ seems to understand this. In a Jan. 12, 2009 article by reporter Bret Stephens entitled "<a href="http://online.wsj.com/article/SB10001424052748703652104574652002740167932.html">Can Intelligence be Intelligent?</a>", the observation is made that technology is a mere facilitator, and intelligent, well trained, experienced, critical-thinking people are the enablers of any complex field that requires human judgment. They must be unfettered by machine and bureaucrat: <blockquote> ... Terrifying as the thought may be to many of its current practitioners, the true art of intelligence requires, well, intelligence. That is a function neither of technology nor of "systems" [a.k.a. "platforms" - ed.], which begin as efforts to supplement and enhance the work of intelligence and typically wind up as substitutes for it. It is, instead, a matter of experience, intellect, initiative and judgment, nurtured within institutions that welcome gadflies in their midst.</blockquote> I've left the following comment at the WSJ health blog: <blockquote>Mr Schmidt, If you’d like to learn more about why many physicians are reluctant to embrace clinical IT, you might also do a Google search on “<a href="http://www.google.com/search?client=firefox-a&rls=org.mozilla%3Aen-US%3Aofficial&channel=s&hl=en&source=hp&q=healthcare+IT+failure">healthcare IT failure</a>” and similar terms.</blockquote> Need I say anything more about the irony of that advice? I'd also noted a fixation on "platforms" as solutions to biomedical problems (best when they come in shrinkwrapped, off the shelf, "on the IT roadmap" packages!) in my June 2008 post "<a href="http://www.bio-itworld.com/issues/2008/may/cover-story-merck-informatics.html">An Open Letter to Merck CEO Richard Clark on Merck's Mission to Rediscover the Wheel.</a>" A nonmedical research IT leader, who'd found a move from basic research to clinical IT "quite an eye opening experience" (i.e., a domain in which she had little or no experience but was paradoxically appointed to lead) talked all about "platforms" in <a href="http://www.bio-itworld.com/issues/2008/may/cover-story-merck-informatics.html">Bio-IT World</a>: <blockquote>... We've invested a lot in some core platforms; we need to start translating that into results in the clinic at some point. And so having people who have an understanding of what does that really take to help inform the earlier research directions, the platform directions [i.e., research direction = platform direction - ed.], is a key theme...We already have siloed platforms to show that data, we need to integrate it more than it is... combining the results data from clinical samples with the associated patient data, what's that platform?</blockquote> Platform, platform, platform. Who's got the platform? My comments to that CEO in my Open Letter were that this was the wrong mindset and question, based upon an IT person's focus on information technology. This is as opposed to a focus on information science and on facilitating people in interacting with data and information in order to gain actionable knowledge, i.e., an information science and human-computer interaction-based approach that those in medical informatics thought about long ago. In line with the conclusions of <a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html">Greenhalgh et al</a>. [1] who called for "eschewing sanitized accounts of successful projects" and instead recommending studies of clinical IT in organizations that “tell it like it is” using the de-identified critical fiction technique, I'd written on how conflation of information technology and information science impaired R&D in pharma at my essay "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=pharma">Sure path to R&D failure: Conflation of IT with information science in the pharmaceutical industry</a>." That piece and the aforementioned Open Letter were written before Merck sold itself to Schering-Plough in a "<a href="http://www.biojobblog.com/2009/03/articles/ideas-and-indulgences/the-merckschering-plough-deal-under-the-microscope-why-a-reverse-merger/">reverse merger</a>" due to the <a href="http://www.forbes.com/2009/04/21/merck-schering-earnings-business-healthcare-merck.html">unsustainability of doing business from an empty wagon</a> of new products, a sign of just how well this IT-centric "platformania" has been working out for R&D. In the information science-centered view and approach, the "platform," a.k.a. computer technology, is merely a canvas and facilitator, the artist (clinician or scientist) and the brush wielded by them being the primary enabler of and contributor to the masterpiece. Unfortunately, I don't think anyone is "home" in pharma or in the HIT sector anymore to parse these ideas; in fact I've only recently learned that the people I did work with who could parse these ideas into creative reality were laid off by the very IT people making such statements and asking such questions. IT personnel perhaps need to move away from their reductionist platformania. (Perhaps they are confusing "platforms" with "pixie dust.") Rather, they need to start thinking in terms of facilitating clinicians and scientists through domain specific and individualized-to-need information science and HCI innovation that arises of true cross-disciplinary expertise. They need to leave creation of cybernetic miracles to people such as <a href="http://en.wikipedia.org/wiki/Irwin_Allen">Irwin Allen</a> and <a href="http://en.wikipedia.org/wiki/George_Lucas">George Lucas</a>. And platforms to carpenters. -- SS [1] Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method. Greenhalgh, Potts, Wong, Bark, Swinglehurst, University College London. Milbank Quarterly, Dec. 2009. Available at: <a href="http://eprints.ucl.ac.uk/18821/">http://eprints.ucl.ac.uk/18821/</a>

Does the CEO of Google Use Google? - And: Platform, Platform, Who's Got The Platform?

Over at the WSJ health blog, reporter Jacob Goldstein's Jan. 8, 2010 post " Google CEO & Harvard Surgeon Talk Health IT " ...

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Ode to the Paperless Society

I thought <a href="http://www.aapsonline.org/newsoftheday/00767/comment-page-1#comment-3887">this comment</a> to a piece on "Healthcare IT myths" was worthy of wider distribution. (The <a href="http://www.aapsonline.org/newsoftheday/00767/">full piec</a><a href="http://www.aapsonline.org/newsoftheday/00767/">e</a> is also a worthwhile read by itself; disclosure - my work is cited.) Here is the comment: <blockquote>bill waters iii md says: January 8, 2010 at 3:57 amJames Fallows, in a recent Atlantic Monthly, writes that, unlike paper in any of its forms–which retains images –computer software, disks, and drives contain only magnetic impulses that can dissipate. Furthermore, anything over 5 years old runs the risk of there being no software or hardware which can read it. In the coding cubicle of a famously “wired” hospital, I recently noted scores of pigeonholes containing packs of forms.With the advent of electronic methods to manipulate and store data, business has between 1980 and 2000 quadrupled its production and utilization of paperwork.Hence: ODE TO THE PAPERLESS SOCIETY By Bill Waters, MD Write on the beach, the tide will erase; Write on the dune, the wind will deface; Write on the disk, time will show its hand; Remember now—they’re all just sand.* But papyrus and parchment are so well made The Dead Sea Scrolls will never fade. The vaunted electron will soon turn to vapor And its principal product is still just—paper. ____ *For those in Washington, we’re talking about silicon, get it?</blockquote> There is wisdom in this short piece, as well as a certain charm. -- SS

Ode to the Paperless Society

I thought this comment to a piece on "Healthcare IT myths" was worthy of wider distribution. (The full piec e is also a worthwh...

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