healthy4u

Lessons Unlearned: Health IT Failure, Act 2

The following appeared on the <a href="http://histalk2.com/2009/08/13/news-81309/">HISTalk site on 8/14/2009</a> from a writer with the screen name UCSFWatch: <blockquote>From UCSFWatch: “Re: UCSF CIO’s e-mail. The GE Centricity Enterprise project is in full stop mode.” The attached and unverified e-mail from CIO Larry Lotenero says this: “The medical center’s Senior Management Group has engaged Kurt Salmon Associates (KSA) to assist us with a review of our IT clinical strategy. We are doing the review because we are dissatisfied with our progress to implement clinical applications to support the care of our patients. KSA will arrange interviews with many of you to capture your insights for the strategy planning. They will be on-site to begin their interviews on August 18. If KSA contacts you, I ask that you be as flexible as possible with your schedule to accommodate this process. We expect to receive a final report before November. For now, all activities associated with developing the GE clinical system should immediately be put on hold. Despite this action, we remain fully focused on our goal to complement our excellent clinical care providers with equally excellent clinical applications as soon as possible.”</blockquote> If true (as it likely is), I find this remarkable. I would have to refer to it as "UCSF Healthcare IT Failure, Act 2" for reasons just below. I find it remarkable that this resource- and money-wasting scenario (with possible adverse patient care repercussions) can occur: <ul><li>In a state that's in a severe economic crisis, </li></ul><ul><li>At an organization that failed severely in a HIT and administrative IT merger just ten years ago (in the failed, late 1990's attempted merger between UCSF and Stanford's medical centers, see the 2000 stories "UCSF/Stanford: Marriage was rough; divorce is expensive" <a href="http://sanfrancisco.bizjournals.com/sanfrancisco/stories/2000/04/24/focus4.html">here</a> and <a name="thousand">"A thousand MIS personnel cannot merge two healthcare systems" </a><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=A%20thousand%20MIS%20personnel%20cannot%20merge%20two%20healthcare%20systems">here</a>),</li></ul><ul><li>With an EHR product, Centricity, that is the descendant of Logician that others have implemented successfully (including myself, speaking from experience), </li></ul><ul><li>With GE, a major global high technology vendor, presiding over this new failure at a major academic medical center, </li></ul><ul><li>With ample preventive material available in books, journals on the web about such failures (e.g., at the many pages and links <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=other">here</a>, as just a few examples). </li></ul> This last point raises additional questions: <ul><li>Do IT managers at UCSF and GE actually read the HIT literature and the web, I wonder? Have they ever done a Google search on "<a href="http://www.google.com/search?q=healthcare+IT+difficulties">healthcare IT difficulties</a>" or "<a href="http://www.google.com/search?q=healthcare+IT+failure">healthcare IT failure</a>", or related concepts? </li></ul><ul><li>Do they think the materials found via such searches frivolous, useless, or not credible? </li></ul> Finally, it is quite remarkable that the best UCSF can do is hire yet another expensive management consulting firm to try to remediate this failure. What are UCSF IT personnel paid to do, exactly? Perhaps AMIA, AHRQ, HHS and others in the administration need to focus less on new research on figuring why these situations occur, and devote resources to ensuring modern knowledge of HIT failure scenarios already extant is leveraged. If not, we're likely (as I fear) to have a lot of UCSF Act 2's in the next few years, as organizations attempt to implement HIT by 2014 so as to not be penalized by HIT provisions in the ARRA act. Perhaps (again, if the HISTalk note is true), we need to bring back the likes of "Neutron Jack" (Jack Welch, well known for laying off less than stellar divisions at GE), and perhaps the Governator needs to "terminate" the roles of the leadership of this project. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjPKkFydtEwFSr1xBQrpGpQ_rZYsdiD6F7MGLodU3tmu7YRQHKigYF5fE_f-l8aVkiaW81KYuuZbwQSi6qo71toXjZCFGzMVjC5QxlTQ2rfEu1HvcW-x5YwgBtcIjACGBue6sIbAOKycrC1/s1600-h/the-terminator.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5371329041525853522" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjPKkFydtEwFSr1xBQrpGpQ_rZYsdiD6F7MGLodU3tmu7YRQHKigYF5fE_f-l8aVkiaW81KYuuZbwQSi6qo71toXjZCFGzMVjC5QxlTQ2rfEu1HvcW-x5YwgBtcIjACGBue6sIbAOKycrC1/s320/the-terminator.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 157px; height: 200px;" /></a>Gov. Schwarzenegger had a way with those who fiddled around destructively with computers... </div> <div>See other disappointing stories about events at UCSF on this blog at <a href="http://hcrenewal.blogspot.com/search?q=ucsf">this link</a>. <div> </div><div>-- SS</div></div>

Lessons Unlearned: Health IT Failure, Act 2

The following appeared on the HISTalk site on 8/14/2009 from a writer with the screen name UCSFWatch: From UCSFWatch : “Re: UCSF CIO’s e-m...

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Sharing with Google Groups

As more and more businesses and organizations "<a href="http://googleblog.blogspot.com/2009/08/going-google-with-google-apps.html">go Google</a>," we find that many of the features we develop based on feedback from large enterprises end up benefiting all of our users. We recently <a href="http://googleenterprise.blogspot.com/2009/08/sharing-with-groups.html">rolled out improvements</a> to the way <a href="http://groups.google.com/">Google Groups</a> interacts with several of our applications. Now, sharing <a href="http://calendar.google.com/">calendars</a>, <a href="http://sites.google.com/">sites</a> and <a href="http://docs.google.com/">documents</a> with multiple people is easy — instead of adding people one at a time, you can simply share with an entire Google Group. As an example, imagine you're organizing a local intramural softball team tournament. You use Google Docs to keep track of the rosters for each team as well as each team's performance. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbakI1Me2G_drSp9BSWu7u8GOiivtNEGEbOS1_TgpAN9OxHB-zFoSxzwTs1L08VV-3KDAa48TzTk5pomxJsCqODfMtWmClAGwRSStbSYU2MIWibFPzuBbC2zP0P5C8DjxKs9Ow9ComgGc9/s1600-h/1.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5371055130392786930" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbakI1Me2G_drSp9BSWu7u8GOiivtNEGEbOS1_TgpAN9OxHB-zFoSxzwTs1L08VV-3KDAa48TzTk5pomxJsCqODfMtWmClAGwRSStbSYU2MIWibFPzuBbC2zP0P5C8DjxKs9Ow9ComgGc9/s400/1.png" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 345px;" /></a> You want all the players, but only the players, to have editing access. You already have a Google Group set up with the tournament participants, so you simply share the spreadsheet with the group itself, granting the group members permission to edit. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgHJuGFxJv_l3vkDlwx5Lz27K154bxvH8V6kx3GuyGEsUUsjtok6EYWZVAnW2GT-PWhHxiOj3miC6hiABykkf7e38TvO2tSMTkV-Si7X9A99oxri9Xl1smqot0SPME4nmQBN7DMFulvfi8u/s1600-h/2.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5371055141565926946" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgHJuGFxJv_l3vkDlwx5Lz27K154bxvH8V6kx3GuyGEsUUsjtok6EYWZVAnW2GT-PWhHxiOj3miC6hiABykkf7e38TvO2tSMTkV-Si7X9A99oxri9Xl1smqot0SPME4nmQBN7DMFulvfi8u/s400/2.png" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 280px; height: 218px;" /></a> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhjIP3Ars5gkI-tqkhWjbpy1rG4dBtA6UrSzy1lL9TLPp5xP3qwFjP7aryVdsxjEqTE0bKYWLcVYH65XrlbV_moQu2xp7WVI_xakazcbzXp07-gCBZ9PF0hy4ye9gdYXVqc3bCNkV3gJCH7/s1600-h/3.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5371055143333679058" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhjIP3Ars5gkI-tqkhWjbpy1rG4dBtA6UrSzy1lL9TLPp5xP3qwFjP7aryVdsxjEqTE0bKYWLcVYH65XrlbV_moQu2xp7WVI_xakazcbzXp07-gCBZ9PF0hy4ye9gdYXVqc3bCNkV3gJCH7/s400/3.png" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 274px;" /></a> Now, when people join or leave the Google Group, they will automatically gain or lose editing access to the spreadsheet. It's that easy. This was a feature that people wanted to "just work" — and now it does. Go ahead and try it out with your sites, calendars and documents! Posted by Jeffrey Chang, Associate Product Manager, Google Groups

Sharing with Google Groups

As more and more businesses and organizations " go Google ," we find that many of the features we develop based on feedback from l...

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New features and languages for Google Insights for Search

Since <a href="http://adwords.blogspot.com/2008/08/announcing-google-insights-for-search.html">launching</a> Google Insights for Search a year ago, we've been providing daily insight into what the world is searching for. Whether you're an advertiser looking to <a href="http://analytics.blogspot.com/2009/02/tips-and-tools-for-expanding-keywords.html">expand keyword lists</a>, an economist <a href="http://googleresearch.blogspot.com/2009/04/predicting-present-with-google-trends.html">analyzing economic trends</a> or just looking to settle a <a href="http://www.google.com/insights/search/#q=batman%2Csuperman%2Cspiderman&cmpt=q">popularity contest</a>, Google Insights for Search can help provide the answers. Looking at search trends helps you understand when, where and how the world's interests have changed. Simply type in search terms to see how search query volume has evolved over time, in which geographic regions search interest is greatest and other related searches. Today, we are proud to announce that Insights for Search is now available in 39 languages around the world. We're also introducing a <a href="http://googleresearch.blogspot.com/2009/08/on-predictability-of-search-trends.html">forecasting feature</a> for <a href="http://www.google.com/support/insights/bin/topic.py?hl=en&topic=13975">some queries</a> based on an extrapolation of the historical trends and search patterns. And to help you visualize these changes and trends, we've also added an <a href="http://www.google.com/insights/search/#q=Twitter&date=today%2012-m&cmpt=q">animated map</a> so you can watch how search interest changes over time in different locations. You can check out some of these cool features in our video below. <object height="344" width="425"><param name="movie" value="http://www.youtube.com/v/4lq98ulKNgg&hl=en&fs=1&"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/4lq98ulKNgg&hl=en&fs=1&" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" width="425" height="344"></embed></object> Visit <a href="http://www.google.com/insights/search">Google Insights for Search</a> and see what the world is searching for. You can also keep on top of the latest trends by adding a customizable <a href="http://www.google.com/ig/adde?moduleurl=google_insightsforsearch_relatedsearches.xml&source=imag&up__results_type=RISING&up__property=empty&up__search_term=hybrid&up__location=empty&up__category=0&up__time_range=3-m&up__max_results=10">gadget</a> to your <a href="http://www.google.com/ig">iGoogle</a> page or embedding a gadget directly on your website. Posted by Hal Varian, Chief Economist and Yossi Matias, Head of Israel R&D Center

New features and languages for Google Insights for Search

Since launching Google Insights for Search a year ago, we've been providing daily insight into what the world is searching for. Whether...

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A University Leader's Goal: "Taking New Biotechnology ... to Market?"

An <a href="http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/08/17/BA3R197K8C.DTL">article</a> from the San Francisco Chronicle noted how the new Chancellor of the <a href="http://www.ucdavis.edu/index.html">University of California - Davis (UC-Davis)</a>, Linda Katehi, is already contending with controversy. One brief section about her goals for the campus caught my eye. The article noted that Dr Katehi (who has a doctorate in engineering) holds 16 patents, then: <blockquote> Now Katehi wants to transfer that entrepreneurship to the campus she'll lead. 'The campus is in a wonderful position to become a major force in improving and strengthening the economy of the state,' Katehi told The Chronicle, adding that she'll help UC Davis to become more aggressive in taking new biotechnology and agriculture products to market. </blockquote> So it would seem that Dr Katehi's goals are making UC-Davis more entrepreneurial, strengthening the California economy, and marketing selling biotechnology products. All of that would make some sense if UC-Davis were a biotechnology company. However, it is not. UC-Davis, of course, is a major academic campus of the University of California system, with multiple graduate and professional schools, including a medical school. Its <a href="http://strategicplan.ucdavis.edu/mission_vision_distinction.html#mission">mission</a> is: <blockquote> Through a distinctive tradition of core-discipline excellence, interdisciplinary collaborations and productive partnerships, UC Davis teaches students to think critically, objectively and creatively and to be lifelong learners, engaged leaders and productive citizens; pursues research to advance knowledge and to address state, national and global challenges; and serves the public through the generation, broad dissemination and application of knowledge. </blockquote> The statement does mention "application" as well as dissemination of knowledge. It seems quite a stretch, though, for that one word to justify putting a priority on entrepreneurship, economic development, and marketing biotechnology products. In fact, Dr Katehi's goals seem to be far removed from, if not in conflict with the university's mission. This is just a recent example of how the leaders of academic institutions seem to be forgetting or radically deconstructing their academic missions, and in particular, how leaders of academic medicine seem to think that their job is to sell drugs and devices. Consider how Dr David Korn, then Senior Vice President, Division of Biomedical and Health Sciences Research of the of the Association of American Medical Colleges (AAMC), wrote that medical schools and their parent universities must confront "societal demands that they become engines of economic development," so that they must "create a precarious equipoise between the world and values of commerce and those of traditional public service." Furthermore, the government and the public, " impatient for new medicinal products, disease preventions, and cures," "fail to understand or too easily forget that in our capitalistic economy the pathway by which research invention becomes beneficial application is often totally dependent on venture capital, the availability of which commonly demands the active participation of the academic inventors in the commercial venture; put simply, no participation, no money. It is this demand, more than any other cause, that has driven the dramatic increase in medical faculty entrepreneurship." [Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-7. Link <a href="http://jama.ama-assn.org/cgi/content/full/284/17/2234">here</a>.] Thus, nine years ago, Dr Korn, and the AAMC seemed to have acquiesced to a radical restructuring of the academic medical mission to put entrepreneurship, and the development and marketing of commercial products ahead of teaching, research and patient care. This fundamental change of the focus on academic medicine seems to have been accepted, if not embraced by other academic leaders, like Dr Katehi. It does seem to correlate with some notable changes in how academic medical leaders think and act: devaluing the education mission and demanding that faculty put a priority on bringing in money (see post <a href="http://hcrenewal.blogspot.com/2007/04/medical-schools-to-faculty-show-me.html">here</a>); , forming their own, often highly lucrative financial relationships with health care corporations (see post <a href="http://hcrenewal.blogspot.com/2007/10/medical-school-leaders-conflicts-of.html">here</a>); acquiescing to faculty becoming "key opinion leaders" and thus supporting marketing of drugs and devices (see post <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">this link</a>); allowing continuing medical education to serve marketing purposes (see link <a href="http://hcrenewal.blogspot.com/search/label/continuing%20medical%20education">here</a>); allowing drug and device company sponsors of clinical research to suppress and manipulate the research (see link <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">here</a>); etc, etc. Thus it seems to underlie many of the most dysfunctional aspects of our current health care system. I find it hard to believe that the public really would want existing respected academic institutions to be turned into biotechnology companies, without any plans to replace their academic roles, and that it wanted faculty members to turn into product developers and salespeople. (Yes, there may be good reason for faculty who do basic science, but not clinical research to consult for health care corporations, in certain instances. But that is a relatively minor, and somewhat separate point.) In my humble opinion, one goal of meaningful health care reform would be to refocus academic medicine on its academic mission, and let drug and device companies alone develop and market their products.

A University Leader's Goal: "Taking New Biotechnology ... to Market?"

An article from the San Francisco Chronicle noted how the new Chancellor of the University of California - Davis (UC-Davis) , Linda Katehi,...

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Senate Investigates Hospital Group Purchasing Organizations

Almost four years ago, we <a href="http://hcrenewal.blogspot.com/2005/11/investigation-of-novation.html">posted</a> about the strange world of hospital group purchasing organizations (GPOs). These organization purchase large volumes of medical products for member hospitals, but a "safe harbor provision" in federal law allows them to charge the vendors, not the hospitals for their services. In fact, it is legal for hospitals to share in fees the vendors give these organizations, and to award contracts to vendors who pay the largest fees. Our 2005 post focused on allegations about the operations of a single GPO, <a href="http://www.novationco.com/">Novation.</a> We noted "several cases in which Novation's actions seemed to have denied hospitals access to the best products, or have increased, rather than ratcheted down the cost s of supplies and equipment." Now, the US Senate is investigating a group of the largest GPOs. <a href="http://www.nytimes.com/2009/08/14/health/policy/14purchasing.html">According to the New York Times</a>, <blockquote> Lawmakers eager to broaden health care coverage while holding down costs are examining the institutional market for medical supplies, a largely unseen $60 billion-a-year realm where things like bedpans and heart implants change hands. Senators from committees like finance, judiciary and aging are investigating the practices of companies that represent big networks of hospitals, nursing homes and other institutions. These group purchasing organizations select 'preferred' manufacturers and negotiate the prices of medical products, which are a closely held secret. They then use a variety of carrots and sticks to make sure their hospitals buy those brands at the contracted price. The senators are concerned that these groups’ practices may be inflating health costs at taxpayer expense. Much of the cost is borne by the government, as it reimburses hospital expenses through the Medicare program. On Wednesday, the senators sent letters to the seven biggest group purchasing organizations, known as G.P.O.’s, demanding detailed information about their business practices, including how they are paid, what services they perform besides picking brands and negotiating prices, and how their revenues are affected when an affiliated hospital buys supplies on its own instead of using the group contract. The senators also asked for copies of contracts, something not normally made public. For years, there have been complaints that the buying process is opaque and unfair. The purchasing companies’ operating expenses are usually paid by the manufacturers sitting across the bargaining table, leaving them open to accusations of steering huge blocks of institutional business to the vendors willing to pay the most. The group purchasing organizations deny this, saying they award contracts on the merits and help hospitals get good deals, saving the government money. The savings are hard to verify, because the market’s opacity makes price comparisons nearly impossible. Normally, Medicare’s law against kickbacks would bar vendors from paying the companies that award them contracts, but Congress granted the industry a special 'safe harbor' many years ago, in the belief that volume purchasing saved money. The senators seem to want to test that belief and perhaps change or abolish the safe harbor, something that would turn the industry on its head. Some of the group purchasing organizations have been in the spotlight before. Premier and Novation were the subject of articles in The New York Times in 2002, which prompted Congressional hearings and the issuance of an industry code of conduct. But Senate aides said they were still hearing reports of possible abuse.... </blockquote>What I wrote about group purchasing organizations four years ago still seems apt. <blockquote> In summary, although GPOs were ostensibly set up simply to save hospitals money when purchasing supplies and equipment, these organizations have turned into huge, complicated and opaque entities whose actions are hidden, but which seem to be conveying large amounts of money back and forth among suppliers, hospitals, and the GPOs themselves. It is not at all clear that the GPOs save the hospitals money, nor get them the best possible supplies for the money they spend. The leaders of the hospitals, including some of the countries most prestigious teaching hospitals, that own Novation and other GPOs ought to explain what these organizations really are doing, and particularly how they are supporting the hospitals' missions. Again, this is another example of how opaque and unaccountable hospital leadership may be. But, the less transparent and accountable are health care leaders, the more the health care mission is at risk. </blockquote> Finally, I applaud the Senators for taking this up at this time. To have meaningful health care reform, we need to address issues such as the opacity and unaccountability of the leadership of health care organizations, particularly not-for-profit hospitals that are supposed to put their patient care (and academic, if applicable) missions ahead of enhancing their financial surpluses and their executives' compensation. ADDENDUM (19 August, 2009) - See interesting comments on this post, including some important information from the trade organization for group purchasing organizations.

Senate Investigates Hospital Group Purchasing Organizations

Almost four years ago, we posted about the strange world of hospital group purchasing organizations (GPOs). These organization purchase lar...

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Growing open government with Transparency Camp West

(If you're interested in meeting the team of Googlers working to strengthen the public sector and civic engagement through technology, check out our <a href="http://googlepublicsector.blogspot.com/2009/08/hello-world.html">Public Sector blog</a>. -Ed.) Organizing public sector information isn't easy, and companies like Google rely on the good work of open government advocates to access useful data. Last weekend more than 150 developers, NGOs, wonks, activists and government representatives from as far away as Russia and Israel gathered at our <a href="http://maps.google.com/?q=Google%20Inc.@37.423156,-122.084917&hl=en">Mountain View campus</a> for <a href="http://transparencycamp.org/">Transparency Camp West</a> to discuss efforts to make governments more transparent and accessible to the public. Sponsored by the <a href="http://www.sunlightfoundation.com/">Sunlight Foundation</a>, a non-partisan organization founded in 2006, Transparency Camp allowed open government advocates to freely swap ideas about a wide range of topics: voting, journalism, public transit, healthcare, citizen engagement and more. The theme of openness also extended to the Sunlight Foundation's board meeting on Saturday. While most organizations hold their board meetings in private, the Sunlight Foundation opened their board meeting not only to staff, but also to members of the public. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEijxdHmobJyroNWs5Jm_ZnBKRNvreutmWKpNrVy3moY6aEF4zG6ntp8PMxc4FZAzDYZghTJmnTmUN3znp0CSFuiCJPig6gWnkrNb5FHFRAOFHUHEYBoHzdRSbEEbw2OL7CEarcsZp0UovWG/s1600-h/IMG_1651.JPG" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5369855161033368850" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEijxdHmobJyroNWs5Jm_ZnBKRNvreutmWKpNrVy3moY6aEF4zG6ntp8PMxc4FZAzDYZghTJmnTmUN3znp0CSFuiCJPig6gWnkrNb5FHFRAOFHUHEYBoHzdRSbEEbw2OL7CEarcsZp0UovWG/s400/IMG_1651.JPG" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 267px;" /></a>The "un-conference" format let attendees decide session topics </div> At Google we're inspired by efforts to connect people to the political process, to useful public information and to their governments — and we're eager to participate. To hear more about the different kinds of bottom-up change proposed at Transparency Camp, head to the <a href="http://google-opensource.blogspot.com/2009/08/let-sunshine-in-transparency-camp-west.html">Google Open Source blog</a> for a summary by Clay Johnson from the Sunlight Foundation. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhio1WH5043k2_0L23kj0K3DWvkKcUeSxXKRqfojKnmq4aQ0A8SRDKJ3C1Dip1MEWuUVrx-4DI0kiiMMPjsLS8EBsotVtRYytj4ia179gOSryITRxwMaisjlij2fqS0LRT2wJ1NwypVARXn/s1600-h/IMG_1603.JPG" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5369855498157078226" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhio1WH5043k2_0L23kj0K3DWvkKcUeSxXKRqfojKnmq4aQ0A8SRDKJ3C1Dip1MEWuUVrx-4DI0kiiMMPjsLS8EBsotVtRYytj4ia179gOSryITRxwMaisjlij2fqS0LRT2wJ1NwypVARXn/s400/IMG_1603.JPG" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 267px;" /></a>This and previous photo courtesy of Heather Bussing </div> Posted by Chris DiBona, Open Source Programs Manager

Growing open government with Transparency Camp West

(If you're interested in meeting the team of Googlers working to strengthen the public sector and civic engagement through technology, c...

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Who Investigated the Case of the Deadly Contaminated Heparin?

A year and a half ago, we posted quite a bit about the case of the deadly contaminated heparin. In retrospect, what is most amazing is how quickly this case fell off the radar screen. Summary of the Case of the Deadly Contaminated Heparin Here is a 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 <a href="http://www.baxter.com/">Baxter International</a>. - 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, <a href="http://www.spl-pharma.com/">Scientific Protein Laboratories LLC</a>, which in turn obtained it from a factory in China operated by <a href="http://www.spl-pharma.com/changzhou.htm">Changzhou SPL</a>, which in turn was owned by Scientific Protein Laboratories and by <a href="http://www.techpool.com.cn/english/index.asp">Changzhou Techpool Pharmaceutical </a>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>.) Since we last posted about the case, three prominent articles by one research group appeared that addressed how contamination of the heparin with oversulfated chondroitin sulfate lead to adverse reactions, some fatal (1-3). An editorial in the New England Journal of Medicine congratulated all the scientists on quickly figuring out the nature of the problem, "allowing heparin to come clean," but did not comment on what the case might mean for drug regulation, or the leadership of health care organizations.(4) The case was used to illustrate the difficulties of national regulation of an increasingly out-sourced pharmaceutical industry.(5) Dr Jerry Avorn did call for more effective, better funded and up to date pharmaceutical regulation.(6) At the time, I thought that the most striking feature of this case, beyond the deaths of many real patients, was how every leader involved tried to dodge accountability for it. Now, in August, 2009, I have been unable to discover whether any of them subsequently took accountability for it. And in this post global financial collapse world, I would now add that the case also exemplifies the adverse effects of the single-minded pursuit of short-term profit and economic efficiency. However, in retrospect, the most distressing aspect of this case is its lack of repercussions, specifically, the lack of any inquiry into how the oversulfated chondroitin sulfate got into the supposedly pure heparin given to patients, and how such adulteration of pharmaceuticals could be prevented in the future. Allegations of Conflicts of Interest Affecting the Scientific Investigation of the Case This week, however, the case has an eerie echo. The Wall Street Journal just <a href="http://online.wsj.com/article/SB125003545637224263.html">reported</a> allegations that the US FDA official involved in the case has conflicts of interest. <blockquote>The investigation of Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner. In its complaint, Amphastar alleges that its competitor had special access to Dr. Woodcock at critical times in the prolonged approval process, which is ongoing. Amphastar points out that Dr. Woodcock co-authored a scientific paper with scientists at Momenta Pharmaceuticals Inc. while both companies were battling to win FDA approval of their generic blood thinners. Amphastar contends that Dr. Woodcock's collaboration with Momenta is a conflict of interest and has asked that she recuse herself from the entire matter at the FDA. Both Amphastar and Momenta, which is based in Cambridge, Mass., submitted applications seeking FDA approval of their generic versions of Lovenox heparin sold by Sanofi-Aventis SA. Amphastar applied in 2003, two years before Momenta. Lovenox, a low-molecular-weight heparin, is a blockbuster biologic drug that brought in $3.5 billion in world-wide sales last year. </blockquote>The specific allegations were: <blockquote>Amphastar, in letters sent to the FDA in April and June, cited some public contacts and email between Dr. Woodcock and one of Momenta's founders, Massachusetts Institute of Technology biological engineering professor Ram Sasisekharan, beginning in February 2007. Among those contacts were their attendance at an international medical conference in Thailand in November 2007. Mainly, however, Amphastar points to Dr. Sasisekharan's appointment to lead an FDA task force in early 2008, which put him and Momenta in regular contact with the agency. That task force was investigating tainted Chinese-made heparin, a crisis that led to nearly 100 deaths. Drs. Woodcock and Sasisekharan, along with other Momenta scientists, then co-authored two medical journal articles last year identifying the cause of the contaminated Chinese heparin imports, a finding that won scientific -- as well as Wall Street -- kudos for Momenta. It is unusual for FDA officials to co-author journal articles with industry researchers.... In April 2008, after the tainted-heparin article was published, an investment report from Morgan Stanley cited Momenta's FDA connection as a 'game-changer,' and Momenta's stock jumped 17% in a day. </blockquote>So, Dr Woodstock arranged for the scientific investigation of the contaminated heparin to be carried out mainly by people employed by or with financial relationships with <a href="http://www.momentapharma.com/">Momenta Pharmaceuticals</a>. The (actually three) articles published as a result of this investigation (1-3), disclosed most of these relationships, but seemed to minimize the relationship of the senior author of all three articles, Dr Ram Sasiskekharan, to the company. Although he was actually a co-founder of the company, and has been on the <a href="http://ir.momentapharma.com/directors.cfm">board of directors </a>of the company since 2001, none of the articles mentioned the former relationship, and only one specifically mentioned the latter. Although the two New England Journal of Medicine articles referred to Momenta Pharmaceuticals' abilities to analyze "complex mixtures, including heparin," none mentioned that the company is developing two anticoagulant products, M-enoxaparin and M118, which could compete with heparin (as described in the company's <a href="http://ir.momentapharma.com/index.cfm">investor relationships web-page</a>). On the other hand, the Nature Biotech article(3) noted that Dr Sasiskekharan and one other author have "served as scientific advisors to Scientific Protein Laboratories," and a third author was a scientific advisor to Baxter International. The relationship between Dr Sasiskekharan and SPL was noted by two of the New England Journal articles(1-2). Questions Raised So the complaint about Dr Woodcock by Amphastar raises multiple questions about the investigation of the case of the deadly contaminated heparin. <ul><li>Why did the FDA put the scientific investigation of Baxter International/ Scientific Protein Laboratories / Changzhou SPL contaminated heparin in the hands of multiple employees, and the co-founder and board member of Momenta Pharmaceuticals, a company that applied to market a product to compete with heparin?</li><li>Was the nature of this apparent conflict clear to the federal agencies that also funded the investigation, which included the National Institutes of Health (NIH) and the Centers for Disease Control (CDC)?</li><li>Did the federal agencies involved also realize that several of the investigators, including the apparent senior investigator, also had ties to two companies (Baxter International and Scientific Protein Laboratories) involved in the production of the contaminated heparin?</li><li>If the federal agencies did not know of the conflicts, why not? And what will they do about them now?</li><li>If the federal agencies did know of all the conflicts, why did they allow such a conflicted group of scientists to investigate one of the most important cases of drug adulteration of the new century?</li></ul>Although there has now been a scientific investigation into the nature of the contamination of the deadly heparin, there has not been any formal inquiry of which I am aware into the actions, decisions and events that allowed the case to unfold. Now that the case seems to involve not only questionable business management decisions, but also a conflicted scientific investigation, maybe someone in authority will see to it that such an investigation occurs. Finally, the case of the deadly contaminated heparin now becomes another illustration of how the complex web of conflicts of interest that pervades our health care system may muddle efforts to protect the public from adulterated medicines, one of the more fundamental public health responsibilities of the government. Hat tip to and see further <a href="http://www.margaretsoltan.com/?p=16272">comments</a> by Prof Margaret Soltan in the University Diaries blog. References 1. Kishimoto TK, Viswanathan K, Ganguly T, Elankumaran S, Smith S, Pelzer K et al. Contaminated heparin associated with adverse clinical events and activation of the contact system. N Engl J Med 2008; 358: 2457-67. [Link <a href="http://content.nejm.org/cgi/content/abstract/NEJMoa0803200v2">here</a>.] 2. Blossom DB, Kallen AJ, Patel PR, Elward A, Robinson L, Gao G et al. Outbreak of adverse reactions associated with contaminated heparin. N Engl J Med 2008; 359: 2674-84. [Link <a href="http://content.nejm.org/cgi/content/full/359/25/2674">here</a>.] 3. Guerrini M, Becaati D, Shriver Z, Naggi A, Viswanathan K, Bisio A et al. Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events. Nature Biotech 2008; 26: 669-675. [Link <a href="http://www.nature.com/nbt/journal/v26/n6/full/nbt1407.html">here</a>.] 4. Schwartz LB. Heparin comes clean. N Engl J Med 2008; 358: 2505-9. [Link <a href="http://content.nejm.org/cgi/content/full/358/23/2505">here</a>.] 5. Schweitzer SO. Trying times at the FDA - the challenge of ensuring the safety of imported pharmaceuticals. N Engl J Med 2008; 358: 1773-7. [Link <a href="http://content.nejm.org/cgi/content/full/358/17/1773">here</a>.] 6. Avorn J. Coagulation and adulteration - building on science and policy lessons from 1905. N Engl J Med 2008; 358: 2429-31. [Link <a href="http://content.nejm.org/cgi/content/full/358/23/2429">here</a>.]

Who Investigated the Case of the Deadly Contaminated Heparin?

A year and a half ago, we posted quite a bit about the case of the deadly contaminated heparin. In retrospect, what is most amazing is how q...

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