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Another Key Opinion Leader Confesses

The Milwaukee Journal-Sentinel published <a href="http://www.jsonline.com/features/health/43933562.html">another story </a>in their series on physicians' entanglements with health care corporations. This one tells the story of a single university faculty member who was seduced by pharmaceutical companies, then eventually became disillusioned. <blockquote> [Dr James] Stein, now a professor at the University of Wisconsin School of Medicine and Public Health, was a 29-year-old cardiology fellow in Chicago in 1994 when his faculty mentor asked him to fill in for him at a drug company-funded lecture to a large group of doctors. It would be his first taste of life as a drug company speaker and consultant. Stein got first-class airfare to Dallas. A limousine took him to a luxury hotel for the talk. He walked off the stage, and a doctor from the conference handed him an envelope containing a $500 check. 'I got a pat on the back and he said, 'There's more where that came from, son.' I had no idea what that meant, but I went home and paid off part of my student loans,' Stein said in a presentation at UW this month. Stein's first drug company talk led to more than a decade of work for drug companies before he gave it up for ethical reasons. Now he is speaking out. Over the years, many of the big names in the drug industry would hire Stein to give speeches or serve as a consultant, eventually leading to fees of $2,000 to $3,000 per talk. About a month after his first talk in 1994, Stein was asked by another drug company to give a lecture on cholesterol at a small hospital in Chicago, just as blockbuster statin drugs were coming on the market. 'I was really flattered because over and over again I was told that I was a future thought leader,' he said. 'I did my talk. I got a $750 honorarium and I was hooked.' Stein said he now realizes that the speech at the hospital was just an audition. 'They wanted to know what I would say and how I would deliver,' he said. 'And I think they also wanted to know what I would say about their product.' He joined speakers bureaus for several drug companies. It was a kind of badge of honor, he said. The more companies a doctor spoke for, the more highly he or she was regarded. Stein, now 44, came to UW in 1996. Over the years, he would give talks and do other work for many of the top names in the pharmaceutical industry. For instance, in 2005 Stein did work for six drug makers, according to a disclosure form filed with UW. That year, Pfizer paid him between $10,000 and $20,000 for four days of work as a speaker and advisory board member. LipoScience, a firm that markets a cholesterol test, paid him $10,000 to $20,000 for four days of similar work. Another firm, Schering-Plough, paid him about $12,000 for two days as a lecturer. Although he said he had concerns about the propriety of his work, Stein said he was assured by his superiors there was nothing wrong with it as long as he did it on his own time. Indeed, they said it enhanced the reputation of the university. And, he said, he considered himself an educator, not a salesman. He said he tried to manage any conflicts of interest by disclosing who paid him, controlling the content of what he said and doing the work on personal time. Things started to change rapidly beginning several years ago. Drug companies began referring to the talks as promotional. They wanted him to use their slides; he refused. Then, medical journals and the lay press began printing articles questioning the ethics of the relationships. A 2006 article in a Madison newspaper listed Stein as being among the UW doctors who reported the most money from the drug industry. Stein said he was embarrassed. But, he said, he continued to try to manage his relationships with drug companies. He sent letters to patients disclosing his ties to industry. As of December 2006, he donated all the money from his talks to charity. Why didn't he just stop doing the work? He said he believed he could save more lives lecturing than by working in the emergency room. Stein said he saw no harm in being paid. But he admitted that giving the talks also made him feel important. At the same time, new scientific articles suggested that it is impossible for doctors to be unbiased when they receive gifts or payments from drug companies. 'I have learned that human beings, physicians included, are incapable of recognizing bias in themselves, and even when you try not to be biased it is impossible to avoid it, especially when money is involved,' he said. He said he came to realize that drug and medical device firms were no longer trustworthy partners in medical education. He also said it has become obvious that patients have the least power and drug companies have the most power. 'I was wrong,' he said. Stein said he stands by what he taught. But, he added, 'I was naïve to think I was not influenced by the money and power of the drug and device companies.' As of last December, he said, he stopped all drug company speaking and consulting other than bona fide research. </blockquote> It is nice that a few commercially paid "key opinion leaders" have realized what they were really doing. Maybe, Dr Stein will follow in the footsteps of Dr Daniel Carlat, and try to atone for his previous role in drug marketing disguised as education. (See Dr Carlat's excellent blog <a href="http://carlatpsychiatry.blogspot.com/">here</a>, and his now classic article, "<a href="http://www.nytimes.com/2007/11/25/magazine/25memoir-t.html">Dr Drug Rep</a>.") This compelling narrative reinforces some points about relationships among physicians and health care corporations. Health care corporations do not pay for nothing, and are not charitable organizations. If a company pays a physician to give talks, it is almost certainly because those talks will help market company products or services. Pharmaceutical and device companies have argued that they only pay the best and the brightest physicians as speakers and consultants. But this story (and others, e.g. <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a>) suggest that they recruit young physicians who seem to be malleable and likely to go along with the company line, and groom them to do marketing in the guise of education. The company's money thus helps mold "key opinion leaders." Worse, at many medical schools, being a commercially supported speaker or consult was a badge of honor. Thus, faculty chosen by commercial firms as most tractable and sympathetic to the companies' viewpoints, came to be regarded as the best and the brightest. Why getting money from commercial firms was regarded as indicative of honor and intelligence, rather than gullibility, naivete, or worse, is not clear. I wonder whether it correlated with increasing alignment of the leadership of medical schools with commercial interests, and domination of the very top leadership, that is, the universities' board of directors, by those formerly regarded as Masters of the Universe (but now often seen as stupid, arrogant, greedy, or even corrupt. See posts about how the boards of <a href="http://hcrenewal.blogspot.com/2009/04/investment-bankers-strike-back.html">Dartmouth</a>, <a href="http://hcrenewal.blogspot.com/2008/12/what-linked-parallel-declines-of.html">Harvard</a>, and <a href="http://hcrenewal.blogspot.com/2009/04/hedge-fund-u.html">Yeshiva</a> were disproportionately populated by leaders of [faux] finance). At any rate, this is truly a cautionary tale of seduction of academia into hucksterism. Hat tip to Margaret Soltan <a href="http://www.margaretsoltan.com/?p=12236">at University Diaries</a>. ADDENDUM (30 April, 2009) - See also the <a href="http://carlatpsychiatry.blogspot.com/2009/04/another-hired-gun-repents-this-time.html">comments</a> by Dr Daniel Carlat on the Carlat Psychiatry Blog.

Another Key Opinion Leader Confesses

The Milwaukee Journal-Sentinel published another story in their series on physicians' entanglements with health care corporations. This ...

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11 short films about a browser

(Cross-posted from the <a href="http://chrome.blogspot.com/2009/04/11-short-films-about-browser.html">Google Chrome Blog</a>) For those of us who live and work on the web, the browser is an unsung hero. It's become the most important piece of software on our computer, but rarely is it given proper recognition, let alone fêted. We invited some creative friends to make short movies about our own browser, <a href="http://www.google.com/chrome/index.html?brand=CHNT&utm_campaign=en&utm_source=en-et-ogb&utm_medium=et">Google Chrome</a>, and then watched as they came back with dozens of interesting ways to portray the browser. After finishing his <a href="http://www.youtube.com/watch?v=5535Ts-iOP0">video</a>, artist and illustrator <a href="http://www.christophniemann.com/">Christoph Niemann</a> wrote to us about his approach: "Instead of thinking of what I wanted to show, I tried to think about what I did NOT want to show. I realized that when I use a computer or browse the web these days, the one thing I do NOT think about is... a computer. There was a time when I knew the meaning of every single item in my system folder and had to wisely allocate RAM to an application before burdening it with a complex task. Dealing with a computer has become much simpler these days (if everything works), but much more difficult and complex (especially if it doesn't behave) — almost like dealing with a living creature. I wanted to find a simple metaphor that explains what a browser does, without showing a screen, a keyboard, the letters WWW, pixels, zeroes or ones. Initially I thought of my mom (the browser) who brings me (the user) a plate of spaghetti bolognese (the Internet). But since spaghetti bolognese is not a rewarding thing to draw, let alone animate, I went for the next best metaphor, which can be seen in the animation." Along with Christoph's video, there are great shorts by <a href="http://www.motiontheory.com/">Motion Theory</a>, <a href="http://parkpictures.com/">Steve Mottershead</a>, <a href="http://www.gorobot.com/">Go Robot</a>, <a href="http://notclosed.com/">Open</a>, <a href="http://www.defaultbkk.org/">Default Office</a>, <a href="http://www.huntergatherer.net/">Hunter Gatherer</a>, <a href="http://www.lifelongfriendshipsociety.com/site2/flash.php#/">Lifelong Friendship Society</a>, <a href="http://www.superfad.com/">SuperFad</a>, <a href="http://www.thecollaborativeworksofjeffandpaul.com/">Jeff&Paul</a>, and <a href="http://www.pangra.net/">Pantograph</a>. You can view the individual Chrome Shorts on our <a href="http://youtube.com/googlechrome">YouTube channel</a> as well as a quick compilation below. <object height="295" width="480"><param name="movie" value="http://www.youtube.com/v/xj8tD_XFV3g&hl=en&fs=1"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/xj8tD_XFV3g&hl=en&fs=1" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" height="295" width="480"></embed></object> We're really excited about the imagination and range of their ideas, and we hope you enjoy them. Posted by Ji Lee, Creative Lab

11 short films about a browser

(Cross-posted from the Google Chrome Blog ) For those of us who live and work on the web, the browser is an unsung hero. It's become the...

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Experimental Flu Trends for Mexico

(Cross-posted on the <a href="http://blog.google.org/2009/04/experimental-flu-trends-for-mexico.html">Google.org Blog</a>) In November 2008, we launched <a href="http://www.google.org/flutrends/">Google Flu Trends</a> after finding a close relationship between how many people search for flu-related topics and how many people actually have flu symptoms. Google Flu Trends may be able to detect influenza outbreaks earlier than other systems because it estimates flu activity in near real time. In response to recent inquiries from public health officials, we've been attempting to use Google search activity in Mexico to help track human swine flu levels. <a href="http://www.google.org/flutrends/intl/en_mx/index.html"> Experimental Flu Trends for Mexico</a> is, as you might have guessed, very experimental. But the system has detected increases in flu-related searches in Mexico City (Distrito Federal) and a few other Mexican states in recent days, beginning early in the week of April 19-25. In the United States, we were able to validate our estimates using data from a surveillance system managed by the U.S. Centers for Disease Control and Prevention (CDC). We have not verified our data for Mexico in the same manner, but we've seen that Google users in Mexico (and around the world) also search for many flu-related topics when they have flu-like symptoms. Given the tremendous recent attention to swine flu, our model tries to filter out search queries that are more likely associated with topical searches rather than searches by those who may be experiencing symptoms. While we would prefer to validate this data and improve its accuracy, we decided to release an early version today so that it might help public health officials and concerned individuals get an up-to-date picture of the ongoing swine flu outbreak. As with our existing Flu Trends system, estimates are provided across many of Mexico's states and updated every day. Our current estimates of flu activity in the U.S. are still generally low as would be expected given the relatively low confirmed swine flu case count. However, we'll be keeping an eye on the data to look for any spike in activity. We're keenly aware of the trust our users place in us and our responsibility to protect their privacy. Experimental Flu Trends for Mexico -- like Google Flu Trends -- cannot be used to identify individual users. The patterns we observe are only meaningful across large populations of Google searchers. We hope that this experimental release provides useful information. For updates on swine flu and information on how to stay healthy during a disease outbreak, visit the<a href="http://www.cdc.gov/swineflu/"> CDC's swine flu site</a>. Posted by Jeremy Ginsberg and Matt Mohebbi, Software Engineers

Experimental Flu Trends for Mexico

(Cross-posted on the Google.org Blog ) In November 2008, we launched Google Flu Trends after finding a close relationship between how many ...

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Live stream on YouTube: the President's First 100 Days News Conference

(Cross-posted from the <a href="http://www.youtube.com/blog?entry=KnCjVcOtSsM">YouTube Blog</a>) The first three months of the Obama Administration have brought the new American President unprecedented challenges. Back in November, when he was elected, everyone knew the economy and the Middle East would be critical issues for Obama to attack early on. But like every president before him, he's had to deal with the unexpected as well: who could have predicted pirates off the Somali Coast or swine flu? As citizens and pundits from all political perspectives analyze the President's first 100 days in office today, Obama himself will address the nation tonight on the 100-day anniversary of his inauguration -- and we're going to carry a live stream of the conference from the <a href="http://www.youtube.com/whitehouse">White House YouTube channel</a>. Be sure to tune in at 8pm EDT to watch it live. We're also featuring commentary and analysis from top news organizations on our homepage today. <a href="http://www.youtube.com/watch?v=NZKlUIjQ4kM">Hear Karl Rove</a> grade the President on Fox News. Get <a href="http://www.youtube.com/watch?v=hCv3JFdAcTc">a re-cap</a> from Al-Jazeera on what Obama has accomplished in his opening act. Watch the Washington Post <a href="http://www.youtube.com/watch?v=vhqOFGWRUXY">talk with Americans</a> in DC about their early impressions of the new President. You can join in the conversation by making a video: How is the Obama Administration doing, and what advice would you give the President moving forward? Upload your thoughts to YouTube and add them as a video response to this <a href="http://www.youtube.com/watch?v=geljx1wXdnY">Citizentube video</a>, and we'll feature some of them on our News page tomorrow. Finally, don't forget to come to <a href="http://www.youtube.com/whitehouse">youtube.com/whitehouse</a> at 8pm EDT to watch President Obama address the nation. Posted by Steve Grove, YouTube News & Politics

Live stream on YouTube: the President's First 100 Days News Conference

(Cross-posted from the YouTube Blog ) The first three months of the Obama Administration have brought the new American President unprecedent...

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UPMC as "Proving Ground" for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?

Hospitals as a "Proving Ground" for tests of unproven health IT - upon children? At my post "<a href="http://hcrenewal.blogspot.com/2009/04/business-week-on-health-it-dubious.html">BusinessWeek on Health IT: The Dubious Promise of Digital Medicine</a>" I began to discuss the responses made by health IT vendors and organizations regarding HIT problems and defects, raised in a very serious April 23, 2009 <a href="http://www.businessweek.com/magazine/content/09_18/b4129030606214.htm?campaign_id=rss_daily">BusinessWeek article</a> on these issues. In this post I address the following claims regarding UMPC and a controversial Dec. 2005 article by a UPMC physician in the journal Pediatrics ("<a href="http://pediatrics.aappublications.org/cgi/content/abstract/116/6/1506">Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System</a>", Yong Y. Han et al. -- my comments on this paper at that time were <a href="http://hcrenewal.blogspot.com/2005/12/upi-picks-up-on-pitfalls-of-bad.html">at this link</a>). BusinessWeek wrote: <blockquote>... [HIT vendor Cerner] faced more questions over its technology at the University of Pittsburgh Medical Center (UPMC). In 2005 researchers there [i.e., Han et al. - ed.] found that at the university's Children's Hospital [note that this is a Children's Hospital - ed.], patient deaths more than doubled, to 6.6% of intensive-care admissions, in the five months following the installation of a computerized order-entry system. The research on child patient deaths at the University of Pittsburgh found a "direct association between [computerized records] and increased mortality," according to an article published in December 2005 in the medical journal <cite>Pediatrics</cite>. Digital technology slowed treatment in several ways, the researchers concluded. One example: Doctors and nurses in the intensive-care unit were accustomed to ordering medications and tests while a sick child was en route to the hospital. The Cerner system required that orders be submitted only when the patient arrived, costing crucial time. The authors of the <cite>Pediatrics</cite> article acknowledged that their work clashed with other studies showing that digitization decreases errors and shortens hospital stays [but also is consistent with another body of literature (<a href="http://hcrenewal.blogspot.com/2009/03/reader-on-why-we-have-busywork.html">examples here</a>) that Health IT vendors and others with conflicts of interest simply ignore, as per my numerous HC Renewal posts on the issue. Pharma should only have it as good - ed.] G. Daniel Martich, chief medical information officer at UPMC, says the <cite>Pediatrics</cite> study was flawed. Factors other than the installation of computers, such as the centralization of pharmacy services, also disrupted care, he emphasizes. The problems identified in the 2005 paper have all been resolved, Martich adds. "There were workflow issues," he says. "We learned the hard way because we were pioneers." Over the long run, he says, technology has helped decrease mortality rates and cut medication errors in half at Children's Hospital since 2003 .</blockquote> Again, I emphasize we are considering the healthcare of children in this matter. Here are my observations and questions: <ul><li>Why is the 2005 paper simply being dismissed? This is not a scientific approach to the peer reviewed literature, especially where the deaths of children are concerned. I believed in 2005 and believe now that the red flags raised by this paper may have been "brushed under the carpet" too rapidly. See my <a href="http://hcrenewal.blogspot.com/2005/12/upi-picks-up-on-pitfalls-of-bad.html">2005 post</a> on the matter.</li></ul><ul><li>The implication that the Cerner CPOE was uninvolved in the increased mortality would itself require a very careful observational study to ferret out the exact contributions of its deficits and that of the "centralization" of pharmacy services and other factors. Has such a study been performed and peer reviewed, and has a rebuttal been posted by the original study's authors? Can such a prospective study even be performed after the fact? </li></ul><ul><li>While CMIO G. Daniel Martich claims "the problems in the 2005 paper have all been resolved" [wait - I thought the paper was flawed, yet it illustrated problems now resolved? - ed.], how can patients be assured of this? Where are the studies that show the issues have all been resolved?</li></ul><ul><li>Does the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=granger_speaks_out">damning commentary</a> by the UK's former NHS HIT Director Richard Granger, stories such as patients going untreated for months at a time related to Cerner Millennium Care Records Service ("<a href="http://www.computerweekly.com/blogs/tony_collins/2009/04/if-the-npfit-were-a-jumbo-heav.html">If NPfiT were a jumbo jet heaven help 747 flyers</a>"), an equally damning report in Jan. 2009 on Cerner's EHR products (i.e., "Millenium") as reported by the <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">UK House of Commons Public Accounts Committee</a>, and the impact on the UK's £12.7 billion national Health IT project suggest a systemic problem needing investigation?</li></ul>Martich also makes the fantastic claim that "we learned the hard way because we were pioneers." Pioneers? Pioneers in what, exactly? As a former NIH informatics fellow and then former CMIO myself more than a decade ago, it seems more likely UPHS (as well as the children and their parents, and the pediatricians who held the ultimate responsibility per Koppel and Kreda's <a href="http://hcrenewal.blogspot.com/2009/03/health-care-information-technology.html">Hold Harmless</a> paper in JAMA) learned the "hard way" because the organization ignored the work of the pioneers. There is literature going back fifty years on the challenges of health IT as mentioned in my many posts at HC Renewal, such as <a href="http://hcrenewal.blogspot.com/2009/03/reader-on-why-we-have-busywork.html">here</a>. I began my informatics postdoc in 1992-4 working on CPOE implementation at Yale-New Haven Hospital. I'd learned lessons from the writings of others who'd experienced CPOE difficulties years before that, such as (emphases mine): <blockquote> <div class="ref-cit"><div class="citation">Massaro TA. Introducing physician order entry at a major academic medical center. I: Impact on organizational culture and behavior. Acad Med 1993;68:20–5. [<a class="ref-extlink" href="http://www.pubmedcentral.nih.gov/redirect3.cgi?&&auth=0jaErvytwwQQq76TgXy2EDyit4gLe3fP78UcXhAi7&reftype=pubmed&artid=342045&article-id=342045&iid=134759&issue-id=134759&jid=76&journal-id=76&FROM=Article%7CCitationRef&TO=Entrez%7CPubMed%7CRecord&rendering-type=normal&&http://www.ncbi.nlm.nih.gov/pubmed/8447887">PubMed</a>] Summary: In 1988 the University of Virginia Medical Center began implementation of a medical information system based on mandatory physician order entry. The implementation process was much more difficult than expected. The program experienced considerable delays, and cost much more than was originally estimated. Although there were some legitimate questions concerning the user-friendliness of the new technology, these were less significant than the cultural and behavioral problems encountered. The new system challenged basic institutional assumptions; it disturbed traditional patterns of conduct and forced people to modify established practice routines ... The author describes the problems that occurred and the organizational behaviors on which they were based, analyzes the lessons learned, documents the progress that has been achieved, and outlines the challenges that remain. The center's experience provides insight into the issue of technology-driven organizational transformation in academic medical centers. Recommendations for successful introduction of similar agents of institutional change are presented. and Massaro TA. Introducing physician order entry at a major academic medical center: II. Impact on medical education. Acad Med 1993;68:25–30. [<a class="ref-extlink" href="http://www.pubmedcentral.nih.gov/redirect3.cgi?&&auth=0JyfUmP1NgTDWGmXZYjyGg84htX5bDyZoGiLjMQOj&reftype=pubmed&artid=342045&article-id=342045&iid=134759&issue-id=134759&jid=76&journal-id=76&FROM=Article%7CCitationRef&TO=Entrez%7CPubMed%7CRecord&rendering-type=normal&&http://www.ncbi.nlm.nih.gov/pubmed/8447888">PubMed</a>]: Summary: The introduction [in 1988] of an information technology (IT) system that mandates order entry by physicians had significant and often unexpected effects on medical education at the University of Virginia Medical Center. The system was deactivated briefly after the introduction of laboratory ordering, and frustration with the pharmacy ordering pathways provoked a major confrontation between the residents and medical center management. Changes in responsibilities, patterns, and priorities of work introduced by the system also contributed significantly to the general dissatisfaction. These issues had not been thoroughly considered in the planning stage, but it was only after accommodation was made to these changes that integration of the technology into routine practice could proceed. The author emphasizes the importance of extensive involvement and leadership of attending physicians in the planning and implementation of such a system. He presents a set of recommendations to those considering similar IT initiatives and wishing to reduce the disruptions that may accompany their introduction. With time and experience, however, the housestaff have adjusted to the system and developed facility in using it. Much of the dissatisfaction was derived from the perception that "doctors spend too much time on the computer." In fact, less than 10% of the physicians spent more than an hour each day. However, a small group of residents on call for the busier services were sometimes at the computer for more than four hours each day. </div></div></blockquote><div class="ref-cit-blk" id="r12"><div class="ref-cit"><div class="citation"></div></div></div> The entire thirty year old field of <a href="http://www.amazon.com/Understanding-Communicating-Social-Informatics-Communication/dp/1573872288/ref=sr_1_1/102-9749119-8288920?ie=UTF8&s=books&qid=1174318804&sr=8-1">Social Informatics</a> spells out the dangers of unintended consequences, and books such as Lorenzi and Riley's "<a href="http://www.amazon.com/Managing-Technological-Change-Organizational-Informatics/dp/0387985484/ref=sr_1_1/102-9749119-8288920?ie=UTF8&s=books&qid=1174319044&sr=8-1">Managing Technological Change: Organizational Aspects of Health Informatics</a>", which contains enough information to have allowed avoidance of the issues in the 2005 paper, was first published in 1994. My <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">website on HIT difficulties</a> would have helped avoid these issues as well, and it has been online and nearly unique (and the top hit on queries on 'healthcare IT failure' - <a href="http://www.google.com/search?client=firefox-a&rls=org.mozilla%3Aen-US%3Aofficial&channel=s&hl=en&q=healthcare+IT+failure&btnG=Google+Search">click here</a> - and similar) for a decade. Did anyone in this CPOE project do such a search, read it, and perhaps query its author about the material [of course not - ed.] before spending tens of millions of dollars and putting patients at risk? In other words, was true due diligence performed? Considering this was a Children's Hospital, one would have expected extraordinary levels of due diligence. Pioneers learning the hard way? No. It seems this medical center was a pioneer in ignoring the lessons of the past. I believe a simpler explanation of the difficulties in this CPOE project might be that, like many HIT projects, the project was mismanaged. Perhaps Dr. Martich meant UPMC were pioneers in this particular new CPOE system. As in <a href="http://www.pittsburghlive.com/x/pittsburghtrib/news/s_449506.html">this article in the Pittsburgh Tribune</a>: <blockquote>The University of Pittsburgh Medical Center is taking another step in a quest to commercialize new medical technology. UPMC on Monday signed a three-year deal with health care information technology provider Cerner Corp. to develop and market medicine-related technological advances. Both parties will contribute $10 million in cash, services and intellectual property to the effort. The deal is a smaller version of an April 2005 deal between UPMC and information technology behemoth IBM. As is the case in the IBM deal, UPMC will serve as a built-in proving ground for jointly developed technologies and products, with Cerner marketing the products and UPMC awarded a share of profits. </blockquote>"Proving ground?" I cannot believe I am reading such a claim. A hospital and patients, as I have written before, are not a learning lab for HIT vendors. The appropriate "proving ground" for new medical technology is the controlled clinical trial where participants (in this case, patients and healthcare professionals alike) have freedom of choice whether or not to participate, and a chance to give (or deny) consent after being fully informed of potential risk. Were patients or their parents asked to give consent to the use of HIT (such as <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">here</a>)? Were they even aware they were serving as subjects of a "proving ground?" Likewise for clinicians? It should be kept in mind that in this "proving ground" (i.e., experimental) situation we are dealing with children. Using a hospital as a "proving ground" for unproven HIT on unconsented or coerced subjects (e.g., children, their parents, and the doctors themselves) probably amounts to battery at the very least, is consistent with violations of <a href="http://www.hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html">fiduciary and Joint Commission safety standards</a>, and I am concerned about it representing human rights violations as well. In view of the recent <a href="http://hcrenewal.blogspot.com/2009/03/health-care-information-technology.html">Koppel and Kreda paper </a>in JAMA on "hold HIT vendors harmless" and "defects gag" clauses, this entire arrangement seems incredibly disturbing at the very least. I also believe the conflict of interest represented by a healthcare organization partnering with a vendor to "commercialize new medical technology" on unconsented subjects while sharing profits is a horrendous development, for as I stated, the appropriate settings for such practices are properly conducted, impartial clinical trials. The potential for abuses in the current arrangement seems uncomfortably high. My sentiments seem aligned with IOM's recommendation 4.1 and others on Conflict of Interest as pointed out by fellow HC Renewal blogger Bernard Carroll <a href="http://hcrenewal.blogspot.com/2009/04/institute-of-medicine-report-on.html">at this post</a>: <blockquote style="font-style: italic;">Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research…” (page S-14).</blockquote> One wonders if the individuals involved in the CPOE project had unreported conflicts of interest with the HIT industry. Perhaps, as in pharma, this needs to be explored. Han's 2005 article in Pediatrics suggesting children died as a result of the "experiment" should probably be further explored on the basis of the issues I raise above. I also note Han is no longer at UPMC; perhaps his treatment after publication of this article should also be investigated. In Dec. 2005 on this blog <a href="http://hcrenewal.blogspot.com/2005/12/upi-picks-up-on-pitfalls-of-bad.html">I wrote</a>: <blockquote>... This study is dealing with children, of course, and is perhaps a flag that much more detailed study of these systems, especially in socially-sensitive environments such as pediatrics, need to be performed. For if this study's findings are not just due to serendipity and do reflect some underlying causation, the medical, ethical and legal issues could be enormous.</blockquote> I stand by that assessment. Finally, putting the camera to my statement that medicine is suffering a cross occupational invasion by the IT industry, in Business Week the picture below appeared of a handsome and proud physician in his office: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj-oIKLZJ4F2KpjgSFGAmhgXCSVmJZpLugrudeFHYZ0alW0qEkPlW2imcDR4RTwWTgzqyej890AbRrmGDciR8aIXG-Zgu2c_YZKUcuuddj8UgTULKJcBQPbCl-2QN9BjUSLMNTCTp5vECCP/s1600-h/cerner.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5329929630374426466" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj-oIKLZJ4F2KpjgSFGAmhgXCSVmJZpLugrudeFHYZ0alW0qEkPlW2imcDR4RTwWTgzqyej890AbRrmGDciR8aIXG-Zgu2c_YZKUcuuddj8UgTULKJcBQPbCl-2QN9BjUSLMNTCTp5vECCP/s320/cerner.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 255px; height: 193px;" /></a>Cerner CEO Neal Patterson </div> Oh, wait... That person is not a physician nor does he have any medical experience of which I am aware. He is the CEO of the Cerner HIT company. This picture is the future face of medicine, and it will not be the brightest of futures if this cross occupational invasion continues unopposed by those of a scientific and biomedical mindset much longer. I really do believe it is the time for a Congressional investigation of these issues, and strong consideration of FDA regulation of health IT, a precedent set long ago in the pharmaceutical industry. -- SS Addendum: I note in Dr. Martich's <a href="http://www.ccm.upmc.edu/archive/faculty/bios/martich.html">bio</a> an impressive list of medical credentials; however I find formal Biomedical Informatics and/or computer science training lacking. This is not to attack the person, but the culture of HIT, as this scenario is common in HIT and represents what I refer to as "amateurs" running health IT. I use the term "amateur" not derisively, but in the same sense that I am a <a href="http://www.arrl.org/">radio amateur</a> (albeit licensed after examination at the <a href="http://en.wikipedia.org/wiki/Amateur_radio_licensing_in_the_United_States#Current_license_classes">Extra class</a> and in the "old days", when 20 WPM morse code proficiency was also required). I am not a telecommunications professional. While I have excellent skills in telecommunications theory, hardware, antennas, and operations, I would not consider myself even remotely qualified to, say, run a strategic telecommunications project for a large organization. In medicine, I always believed education was critical. I may have been mistaken.

UPMC as "Proving Ground" for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?

Hospitals as a "Proving Ground" for tests of unproven health IT - upon children? At my post " BusinessWeek on Health IT: The ...

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INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

<div align="left"> INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST Today we saw a new marker laid down in the arena called Conflict of Interest (COI). The Institute of Medicine of the National Academy of Sciences issued a <a href="http://policymed.typepad.com/files/medical-coi-full-report-4-28-09.pdf">report</a> of its Committee on Conflict of Interest in Medical Research, Education and Practice. The report is comprehensive, even exhaustive, running to 353 pages. Gardner Harris in the New York Times <a href="http://www.nytimes.com/2009/04/29/health/policy/29drug.html?_r=1">today</a> calls it “scolding,” “stinging,” and “damning.” The recommendations go well beyond any proposed in the recent past by medical schools or by other professional organizations. The NYT quoted David Rothman, president of the Institute on Medicine as a Profession at Columbia University: “With the I.O.M.’s endorsement, issues that were once controversial now are indisputable. Conflicts of interest in medicine are no longer acceptable.” It will take some time for the field to digest the scope of the IOM recommendations. It will take even longer for the new standards to be implemented. For now, I offer just a few observations. First, if the IOM hopes for maximum credibility then it might ought want to do some housecleaning. A few years ago I fired a shot across the bow of the IOM concerning COI. [Can the Institute of Medicine Review the FDA? Nature Medicine 11, 369 (1 April 2005) doi:10.1038/nm0405-369] Nothing much changed, and in the following years, national scandals erupted involving several of the issues I had highlighted. Prominent IOM members, who were well known to be poster boys for COI, were exposed by Senator Charles Grassley (R-Iowa). Their embarrassing behaviors included incomplete financial disclosures and noncompliance with NIH policy on financial conflict of interest. The exposés included Emory’s Charles Nemeroff and Stanford’s Alan Schatzberg. In both cases, administrative rearrangements have now been implemented. The case of Dr. Nemeroff has been referred by Senator Grassley to the Inspector General of the Department of Health and Human Services. It is perhaps no accident that Dean Claudia Adkison of Emory and Dean Philip Pizzo of Stanford were included as external reviewers of the draft IOM report. Their insights would have been invaluable.</div> <div align="left"> Another ongoing embarrassment for the IOM is Lester Crawford. He was the FDA Commissioner who resigned abruptly in 2005 and later pleaded guilty to criminal conflict of interest. He had been charged with falsely reporting information about his stock holdings in companies he was in charge of regulating. He received a sentence of three years of supervised probation and a fine of about $90,000. He is now senior counsel with a health care lobbying firm in Washington, DC. The Institute of Medicine does not help its image by continuing the membership of such a compromised individual.</div> <div align="left"> As the Emory-Nemeroff and Stanford-Schatzberg cases unfolded it appeared that the respective institutions had themselves contributed to the problems, either through inaction or through studiously nontransparent procedures on disclosure. Stanford, for instance, apparently did not require faculty members to report the proceeds of stock sales, and when challenged the university invoked on-line financial reporting services and SEC filings as a sufficient substitute. Not surprisingly, because Stanford didn’t know about Dr. Schatzberg’s realized gain of some $109,000 from sale of founder’s stock in his biotech start-up company, Corcept Therapeutics, this information was not reported to NIH. Recommendation 4.1 One of the IOM’s recommendations applies particularly to the Stanford-Schatzberg case. Recommendation 4.1 addresses the boundary between academia and commerce in the case of research involving human subjects. Here is the specific language: “Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research…” (page S-14). Last year I posted <a href="http://hcrenewal.blogspot.com/search?q=Schatzberg">several times</a> about this issue in the Stanford-Schatzberg case. It is gratifying now to see the IOM affirm the importance of the boundary. The activities declared off-limits by the IOM include not only “recruiting subjects; obtaining informed consent; assessing the clinical end points;” but also “analyzing data; or writing the results, conclusions, and abstracts for publications reporting the findings of the study.” (page 4-17). In Stanford’s earlier plan for managing the conflict and protecting the integrity of the research, Dr. Schatzberg was free to engage in the latter group of activities. Indeed, his hands were all over the project when it came to responding to scientific critiques, managing the climate of professional opinion, attacking and threatening critics, promoting his company’s interest through review articles and press releases, slipping unpublished and non-peer-reviewed commercial data into academic reviews, and generally conducting commercially slanted public relations through academic outlets. When Stanford adopts the IOM recommendations, such activities will be blocked. As I <a href="http://hcrenewal.blogspot.com/2008/07/managing-conflicts-of-interest-at.html#links">stated</a> last year, “Review articles that assess a field and synthesize data form a crucial part of science that has to be off-limits to Dr. Schatzberg just as much as assessing patients in one of his clinical trials would be.”</div> <div align="left"> We should congratulate the IOM committee members for their work, and we hope to see the field embrace their recommendations. Bernard Carroll. </div><div align="left"></div><div align="left">UPDATE 04-30-2009: The link provided earlier for the IOM report document is no longer operative. Here is where to go now for a copy of the report. This time it will cost you.</div><div align="left"><a href="http://www.nap.edu/catalog.php?record_id=12598">http://www.nap.edu/catalog.php?record_id=12598</a> </div>

INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST Today we saw a new marker laid down in the arena called Conflict of Interest (COI). The...

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Adding search power to public data

Earthquakes are not the only thing that can shake Silicon Valley. After the dot-com bubble burst back in 2000 the unemployment rate of <a href="http://maps.google.com/maps?q=santa+clara+county&oe=UTF-8&rls=org.mozilla:en-US:official&client=firefox-a&um=1&ie=UTF-8&sa=N&tab=wl&ei=OF3vScWjMZfglQeqpOw0&oi=property_suggestions&resnum=0&ct=property-revision&cd=3">Santa Clara county</a> went up to 9.1%. During the last couple of months, it has gone up again: <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhXnH0nWDW7MrhYsjJ1y6JonCDhVbu14yozT0CapUXGI8yv5V3kSwzMaf_BpRiWsL-wwUWB8JNx90dFScyr7DCrEFaODKYvGv0dFxS3A4KAJ1o2IEtfq37obm_-sUAb2RQ7WGj54M7WSwrs/s1600-h/PD1+pic.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5329807839989536210" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhXnH0nWDW7MrhYsjJ1y6JonCDhVbu14yozT0CapUXGI8yv5V3kSwzMaf_BpRiWsL-wwUWB8JNx90dFScyr7DCrEFaODKYvGv0dFxS3A4KAJ1o2IEtfq37obm_-sUAb2RQ7WGj54M7WSwrs/s400/PD1+pic.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 264px;" /></a> We just launched a new search feature that makes it easy to find and compare public data. So for example, when comparing Santa Clara county data to the national unemployment rate, it becomes clear not only that Santa Clara's peak during 2002-2003 was really dramatic, but also that the recent increase is a bit more drastic than the national rate: <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjNo2g7fV944v_OMHRgna5FYAKEc6CBw7KW-CiNXt3CgGZYOH6IWdjJumFxabYIc9_WoMoo5d2vgfMkC2K8zsTNo35pGJ7KV9YYORP986H6b34wMd5XYD4s6oivUyBF4-dXJ-DMwXgmGkGx/s1600-h/pD2.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5329808227408123570" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjNo2g7fV944v_OMHRgna5FYAKEc6CBw7KW-CiNXt3CgGZYOH6IWdjJumFxabYIc9_WoMoo5d2vgfMkC2K8zsTNo35pGJ7KV9YYORP986H6b34wMd5XYD4s6oivUyBF4-dXJ-DMwXgmGkGx/s400/pD2.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 256px;" /></a> If you go to Google.com and type in [unemployment rate] or [population] followed by a U.S. state or county, you will see the most recent estimates: <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgywscoY5AiHe5xkBwjQUJXDGjU3o5CLYrJaXCSdJrNKtBf8H5EmzN6levOGYXV4fMmKjeRHFx5fZSBW4qTX1Igs_pG2I1Kvn-NvGQaVLtR0oIV4bqgneFaAx2BQeXfm6QnE80GDSPEOBEX/s1600-h/PD3.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5329808640034607154" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgywscoY5AiHe5xkBwjQUJXDGjU3o5CLYrJaXCSdJrNKtBf8H5EmzN6levOGYXV4fMmKjeRHFx5fZSBW4qTX1Igs_pG2I1Kvn-NvGQaVLtR0oIV4bqgneFaAx2BQeXfm6QnE80GDSPEOBEX/s400/PD3.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 186px;" /></a> Once you click the link, you'll go to <a href="http://www.google.com/publicdata?ds=usunemployment&met=unemployment_rate&idim=county:CN060850">an interactive chart</a> that lets you add and remove data for different geographical areas. Here's a video showing how it works: <object height="344" width="425"><param name="movie" value="http://www.youtube.com/v/9Qt2n34VEr4&hl=en&fs=1"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/9Qt2n34VEr4&hl=en&fs=1" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" height="344" width="425"></embed></object> The data we're including in this first launch represents just a small fraction of all the interesting public data available on the web. There are statistics for prices of cookies, CO2 emissions, asthma frequency, high school graduation rates, bakers' salaries, number of wildfires, and the list goes on. Reliable information about these kinds of things exists thanks to the hard work of data collectors gathering countless survey forms, and of careful statisticians estimating meaningful indicators that make hidden patterns of the world visible to the eye. All the data we've used in this first launch are produced and published by the <a href="http://www.bls.gov/">U.S. Bureau of Labor Statistics </a>and the <a href="http://www.census.gov/popest/estimates.html">U.S. Census Bureau's Population Division</a>. They did the hard work! We just made the data a bit easier to find and use. Since Google's <a href="http://googleblog.blogspot.com/2007/03/world-in-motion.html">acquisition of Trendalyzer</a> two years ago, we have been working on creating a new service that make lots of data instantly available for intuitive, visual exploration. Today's launch is a first step in that direction. We hope people will find this search feature helpful, whether it's used in the classroom, the boardroom or around the kitchen table. We also hope that this will pave the way for public data to take a more central role in informed public conversations. This is just the beginning. Stay tuned for more. Posted by Ola Rosling, Product Manager

Adding search power to public data

Earthquakes are not the only thing that can shake Silicon Valley. After the dot-com bubble burst back in 2000 the unemployment rate of Santa...

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