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Mosaic: bringing diverse perspectives together

This is the next post in our <a href="http://googleblog.blogspot.com/search/label/diversity">Interface series</a>, which takes a look at valuing people's similarities and differences in the workplace. For more information on how Google fosters an inclusive work environment, visit <a href="http://www.google.com/support/jobs/bin/static.py?page=about.html">Life at Google</a> on our Jobs site. – Ed. Since joining Mosaic, our diversity initiatives group in the <a href="http://maps.google.com/?q=5+Cambridge+Center%2C+Cambridge%2C+MA+%28Google+Cambridge%29">Boston office</a>, we've seen firsthand how even a small group of Googlers dedicated to a cause can make a real difference. Mosaic was created in 2007 when a few Boston Googlers were talking informally over lunch about how to increase the diversity in our rapidly growing office. Since then, we've made great strides in growing our membership and highlighting the creativity and varied experiences of our colleagues. The idea even spread to other Google offices, with several Mosaic chapters opening across the U.S. Over the past year, Mosaic Boston has participated in Google's university recruitment efforts by holding three open houses to encourage traditionally underrepresented students from the Boston area to apply for careers at Google. This past summer, we hosted two enthusiastic interns as part of <a href="http://www.google.com/support/jobs/bin/static.py?page=bold.html">Google's BOLD</a> (Building Opportunities for Leadership & Development) diversity internship program to explore opportunities in the technology industry. We watched their leadership skills grow as they organized events such as a career panel and product demos for high school students through Mosaic. Most recently, we co-hosted a lunch-and-learn with esteemed Harvard Business School professor <a href="http://drfd.hbs.edu/fit/public/facultyInfo.do?facInfo=bio&facEmId=dthomas">David Thomas</a>, co-author of "Breaking Through: The Making of Minority Executives in Corporate America." Down-to-earth and engaging, Professor Thomas presented his findings about minorities and women who had "made it" in corporate America, stressing the need to build wide networks of support, find strong mentors and develop a niche within a company that meshes with one's personal values. His message reminded us of how important it is for Mosaic to provide these opportunities for our own community here at Google. You can <a href="http://www.youtube.com/watch?v=hGPyU1cJAaM">watch the video</a> from his visit on the Authors@Google YouTube channel. As both Googlers and members of Mosaic, we feel empowered and excited to live out our values in our workplace. To us, this means anything from inviting authors to speak and training non-profits on how to use Google Apps, to throwing a Brazilian Carnaval-themed edition of our weekly company meeting complete with <a href="http://www.youtube.com/watch?v=H3B9V0axCpU&feature=channel_page">capoeira performers</a>, caipirinhas, and authentic Brazilian food. We're excited about what Mosaic has accomplished so far and can't wait to see what's next. In the meantime, we continue to be committed to providing personal and professional growth for the members of our diversity group, as well as doing our part to keep Google an inclusive place to work. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhcI2dvP_3npKQntAHj0ZTNvmPcIZP_cKRqtCXn-127SojQ8K_0oDJtT6ZHOCykAstWAlZ9FFE1UzSQhND9qUE_oIedKE99ggCr9HteXb-HzMxXYMkyDtyxnX2Bnhf5_j98svyBLeaEzibu/s1600-h/DSCN2341.JPG" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5322805217330592034" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhcI2dvP_3npKQntAHj0ZTNvmPcIZP_cKRqtCXn-127SojQ8K_0oDJtT6ZHOCykAstWAlZ9FFE1UzSQhND9qUE_oIedKE99ggCr9HteXb-HzMxXYMkyDtyxnX2Bnhf5_j98svyBLeaEzibu/s400/DSCN2341.JPG" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 300px;" /></a>Boston Mosaic team with capoeira performers </div> Posted by Priti Sanghani and Mariam Shaikh, AdWords Account Associates

Mosaic: bringing diverse perspectives together

This is the next post in our Interface series , which takes a look at valuing people's similarities and differences in the workplace. Fo...

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Who Is Now Scolding the "Pharmascolds?"

Ah, there they go again. This week, the Wall Street Journal published an <a href="http://online.wsj.com/article/SB123914780537299005.html">op-ed </a>by David A Shaywitz and Dr Thomas P Stossel whose title says it all, "It's Time to Fight the 'Pharmascolds.'" On the Hooked: Ethics, Medicine and Pharma Blog, Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2009/04/pharmascolds-strike-back-latest-from.html">provided</a> a pithy point by point response to Shaywitz and Stossel, which is very much worth reading. But given the sweeping nature of Shaywitz and Stossel's arguments, and the prominent forum in which they appeared, I thought I could add to the discussion. Shaywitz and Stossel's main point was that "relationships between university researchers and medical product companies are under relentless attack by critics who portray these associations as a morality play in which noble academics struggle to resist the dark, corrupting influence of industry." They castigated <blockquote> the disproportionate influence of a coterie of prominent critics we have previously dubbed 'pharmascolds,' who routinely vilify the medical products industry and portray academics working with it as traitors and sellouts. These critics are pious academics, self-righteous medical journal editors, and opportunistic politicians and journalists. Their condemnation of anyone's legitimate profit -- it's all 'corruption' in their book -- has in fact materially enhanced their own careers. They extrapolate from occasional behavioral lapses in industry -- which is equally, if not more prevalent, in universities -- to demonize the market and portray scientific medicine as an ascetic religion, which it is not. </blockquote> I can't claim to be "prominent," and my career has certainly not been "materially enhanced" so far by my writing on Health Care Renewal, but I am sure some of what my colleagues and I have written puts us at least in the company of more prominent "pharmascolds," in Shaywitz and Stossel's book. However, their arguments seem to be based on a slippery slope, or, on over-generalization of criticism of certain kinds of relationships among certain people and organizations under certain circumstances. In particular, I see nothing wrong, in general, with "relationships" among academics and industry. However, there are specific kinds of conflicts of interest in academic medicine that ought to cause concern. So let me take this opportunity to first postulate a simple definition of conflict of interest in this context, and provide specific examples of the sorts of conflicts that ought to be troubling. Definition: An individual conflict of interest occurs when a person with entrusted responsibility has another interest that may conflict with the proper exercise of that responsibility. Examples of conflicts of interest relevant to academic medicine include: - A physician entrusted to take the best possible care of individual patients receives payments from a drug manufacturer which might bias his or her decisions to use that company's drugs even for patients for whom these drugs would not be the best possible treatment. - A clinical teacher entrusted to honestly impart information, skills, and judgment receives payments from a drug manufacturer which might bias his or her teaching in favor of that company's products - A clinical researcher entrusted to discover and disseminate the truth based on research on human beings receives payments from a drug manufacturer which might bias the design, implementation, analysis or dissemination of studies on humans in favor of that manufacturer's products, or against its competitor's products - An administrator entrusted to uphold the mission of the academic institution receives payments from a drug manufacturer that might bias his or her management decisions in favor of that company's interests, but against the institution's mission - An academic entrusted to provide honest, clear health policy advice receives payments from a drug manufacturer that might bias his or her advice in favor of that company's interests On the other hand, I do not have a problem with true collaboration among academics and industry that does not involve industry paying the academics money, or paying the academics' institutions money for which the individuals receive credit. One can envision all sorts of collaborations that do not involve one party paying the other. Furthermore, I do not necessarily have a problem with industry paying an academic in the course of the conduct of basic science, that is in this case, science that does not involve research done on humans. Shaywitz and Stossel seem most concerned with the damage "pharmascolds" might do to basic and translational research. They warned of dire results from barriers that might mainly be designed to discourage the sorts of conflicts of interest listed above, but would damage the progress of basic science and translational research. For example, they warn <blockquote>each new barrier -- such as the National Institutes of Health's ban on paid consulting for industry -- erected between publicly funded researchers and companies, especially cash-strapped start-ups where many of the breakthroughs occur, slows the progress of potential treatments. </blockquote> There is the germ of an important idea in there. In fact, many medical academics simultaneously wear many hats. So someone who sees patients in practice, and teaches students about clinical medicine may also do bench research in the laboratory. Banning such an individual from receiving consulting payments from drug, biotechnology, device and other companies to prevent bias in his or her patient care or teaching might conceivably adversely affect his or her biomedical research. How to handle such trade-offs has not been widely discussed, but needs to be. But the notion that all relationships among medical academics and industry are meant to promote science and find new cures for disease, but not to market products or influence policy in favor or industry, is at best naive. So Shaywitz and Stossel's dire warnings that seemed based on this notion seem as naive as the notion they attribute to their opponents, that all relationships among academics and industry are evil. Finally, Shaywitz and Stossel did some scolding of their own, addressed to medical academics who do not stand up for their relationships with industry <blockquote>When challenged by reporters, most academic consultants to industry refuse to comment or offer a meek explanation, instead of retorting that industry pays them because they add critically important value. This evasion has only emboldened industry critics, disheartened company employees, and caused even allies to wonder if there really is something to hide. </blockquote>They concluded with plea that academics with industry relationships stand up for these relationships, to wit, <blockquote> For the sake of the many patients whose diseases require innovative treatments -- and for the medical philanthropists determined to make it happen -- it's time for the leaders of the medical products industry to take pride in their purpose and start fighting back. </blockquote> They are entitled to their opinion, of course. However, there is just a whiff of hypocrisy emanating from this. Just below it, Dr Stossel identifies himself as "a professor of medicine at Harvard and a fellow at the Manhattan Institute," which is surely true. But it is also surely incomplete. As we have posted before, Dr Stossel himself has multiple relationships with industry, some of which he has revealed in other venues. As we <a href="http://hcrenewal.blogspot.com/2007/04/can-people-with-conflicts-of-interest.html">wrote in 2007</a>, in a <a href="http://content.nejm.org/cgi/reprint/353/10/1060.pdf">commentary</a> in the New England Journal(1) in which Stossel attacked the rigorous conflicts of interest rules that were once again imposed on the US National Institutes of Health (NIH), Stossel disclosed <blockquote>having received consulting fees from <a href="http://zymequest.com/">ZymeQuest</a>, owning stock options in ZymeQuest and Biogen, and having pending and issued patents, owned by Brigham and Women's Hospital, some of which are licensed to ZymeQuest. </blockquote> In another paean to a laissez-faire approach to conflicts of interest in Perspectives in Biology and Medicine(2), Stossel also disclosed that he <blockquote> is a member of the Board of Directors of Zymequest Inc, and the Scientific Leadership Advisory Board of Merck & Co. The author is a founding scientist of Critical Biologics Corporation and a consultant to Boston Scientific, Inc., and Gerson-Lehrman, Inc. </blockquote> In a commentary in the British Medical Journal(3) arguing once again that concerns with conflicts of interest have gone too far, he disclosed, he <blockquote> is on the boards of directors and owns stock options in ZymeQuest and Critical Biologics Corporations, and his employer has licensed intellectual property to these companies, which may result in his receiving milestone payments, royalties and in the stock options having financial value. He receives fees for speaking to corporations and other organisations on the topic of conflict of interest. He has served on scientific advisory boards for Biogen, Dyax, and Merck. </blockquote> So maybe Dr Stossel should take his own advice, and proudly declare his complex relationships with industry in the course of yet another of his arguments that any criticism of any relationships among medical academics and industry under any circumstances will deprive humanity of future cures of dread diseases. As long as medical academics with relationships to industry, of all kinds and in all contexts, fail to disclose such relationships when they might be germane to the topic at hand, others will continue to wonder if they indeed do have something to hide. References 1. Stossel TP. Regulating academic-industrial research relationships - solving problems or stifling progress? N Engl J Med 2005; 353: 1060-1065. Link <a href="http://content.nejm.org/cgi/content/full/353/10/1060">here</a>. 2. Stossel TP. Regulation of financial conflicts of interest in medical practice and medical research. Perspect Biol Med 2007; 50: 54-71. Link <a href="http://muse.jhu.edu/journals/perspectives_in_biology_and_medicine/v050/50.1stossel.html">here</a>. 3. Stossel TP. Has the hunt for conflicts of interst gone too far? - Yes. Brit Med J 2008; 336: 476. Link <a href="http://www.bmj.com/cgi/content/full/336/7642/476">here</a>.

Who Is Now Scolding the "Pharmascolds?"

Ah, there they go again. This week, the Wall Street Journal published an op-ed by David A Shaywitz and Dr Thomas P Stossel whose title says ...

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Send a video message with Google Latitude

If you're like us, you never tire of finding fun ways to send a simple message (what's the challenge, after all, in just flipping open your phone?). Here's our latest idea: spell out the words with Google Latitude. <object height="344" width="425"><param name="movie" value="http://www.youtube.com/v/h0GA73O_9O4&hl=en&fs=1"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/h0GA73O_9O4&hl=en&fs=1" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" height="344" width="425"></embed></object> After you watch the video, feel free to send your own Latitude message by creating <a href="http://services.google.com/latitudevideo/">a custom video</a> for a friend. You can also check out the <a href="http://googlemobile.blogspot.com/2009/04/google-latitude-ftw.html">Google Mobile Blog</a> to learn about some of the other creative ways people are using Latitude. Posted by Heaven Kim, Product Marketing Manager

Send a video message with Google Latitude

If you're like us, you never tire of finding fun ways to send a simple message (what's the challenge, after all, in just flipping op...

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BLOGSCAN - A Not So Tough Policy on Industry Interactions

BLOGSCAN - A Not So Tough Policy on Industry Interactions

On the Carlat Psychiatry Blog, Dr Daniel Carlat dissected Johns Hopkins' heralded new "tough" policy on interactions with ind...

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Designing lean, green, energy-saving machines

Last week Google hosted a <a href="http://www.google.com/corporate/green/datacenters/summit.html">Data Center Efficiency Summit</a>, bringing together approximately 160 industry leaders to share insights and best practices. Since it was April Fool's Day, we threw in a few jokes to keep the atmosphere fun (<a href="http://www.greenm3.com/2009/04/april-fools-joke-googles-oil-tanker-data-center.html">oil-cooled data center</a>, anyone?), but the topic is serious: How can the IT industry keep growing while also exercising good environmental stewardship? We disclosed for the first time details about the design of our <a href="http://www.google.com/corporate/datacenters">ultra-efficient data centers</a>. We also provided a first-ever video tour of a Google <a href="http://www.youtube.com/watch?v=zRwPSFpLX8I">container data center</a> as well as a <a href="http://www.youtube.com/watch?v=nPjZvFuUKN8">water treatment facility</a>. We detailed how we measure data center efficiency and discussed how we reduced our facility energy use by up to 85%. The engineers who developed our efficient battery backup solution even brought an actual <a href="http://news.cnet.com/8301-1001_3-10209580-92.html">Google server</a> to the event. By the end of the day, we narrowed in on a recurring theme: Reducing resource use through efficiency efforts is not just good for the environment, it saves money too. And it is this economic advantage which makes efficient data centers not just green, but truly sustainable. For a tour of a Google container data center check out the video below or watch the entire summit: <a href="http://www.youtube.com/watch?v=Ho1GEyftpmQ">part 1</a>, <a href="http://www.youtube.com/watch?v=m03vdyCuWS0">part 2</a>, and <a href="http://www.youtube.com/watch?v=91I_Ftsd-7s">part 3</a>. <object height="340" width="560"><param name="movie" value="http://www.youtube.com/v/zRwPSFpLX8I&hl=en&fs=1"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/zRwPSFpLX8I&hl=en&fs=1" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" height="340" width="560"></embed></object> Posted by Jimmy Clidaras, Principal Engineer

Designing lean, green, energy-saving machines

Last week Google hosted a Data Center Efficiency Summit , bringing together approximately 160 industry leaders to share insights and best pr...

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Hedge Fund U

We previously <a href="http://hcrenewal.blogspot.com/2008/12/screamer-who-got-his-way-madoff-case.html">posted</a> about how the Bernie Madoff scandal shed light on problems in the governance and leadership of one major university (which includes a well-known medical school). Yeshiva University, which includes the Albert Einstein College of Medicine, reportedly lost more than $11o million of its investments with Madoff. Not only was Madoff on the university's board of trustees, but also the chairman of the board's investment committee was hedge fund leader Ezra Merkin. Merkin invested the university's money in his own hedge funds, which, in turn, turned over the money to Madoff. This week, Merkin, who like Madoff has left the Yeshiva board, was charged with civil fraud. As <a href="http://online.wsj.com/article/SB123903070566093099.html">reported by the Wall Street Journal</a>, <blockquote> J. Ezra Merkin, a money manager who funneled $2.4 billion from universities and nonprofit organizations into Bernard Madoff's firm, was charged Monday on allegations he "betrayed hundreds of investors" by repeatedly lying to them about how he invested their money. Mr. Merkin, a New York philanthropic leader and the former chairman of finance company GMAC, raised billions of dollars for his three hedge funds, telling clients he was managing the money himself. But instead, according to a civil fraud complaint filed by New York state's attorney general, Andrew Cuomo, Mr. Merkin collected hundreds of millions of dollars in fees over more than a decade while weaving a 'panoply of lies' to conceal that he was channeling much of his clients' funds to Mr. Madoff. 'Merkin held himself out to investors as an investing guru...In reality, Merkin was but a master marketer,' Mr. Cuomo said in the complaint. Mr. Merkin, who met Mr. Madoff in 'the very late 1980s, maybe 1990,' according to his testimony, has emerged as a prominent figure in the Madoff scandal because of his stature among charities, universities, funds and even sophisticated value investors. Many of his clients were entities he courted through his social ties among monied New Yorkers. Mr. Merkin sat on the boards of some charities whose money he managed. The sales pitches for Mr. Merkin's three funds -- Ascot Partners LP, Gabriel Capital Corp. and Ariel Fund Ltd. -- included promises that he actively managed their funds, according to the complaint. Mr. Cuomo said the Ascot fund was formed by Mr. Merkin in 1992 as a 'feeder' fund for Mr. Madoff. It grew to hold $1.8 billion from 300 investors by the end of December 2008. Mr. Madoff pleaded guilty last month to using the money in a Ponzi scheme, where funds from new investors were used to pay existing ones. About 85% of investors in the Ascot fund didn't know their money was flowing largely to Mr. Madoff, Mr. Cuomo's complaint said. In two meetings with Ascot investors in his offices at 450 Park Ave. in Manhattan, it says, Mr. Merkin pointed through a glass partition to a trading area and said his staff 'right here' was doing the work of managing their money. Mr. Merkin collected an annual fee from Ascot's investors amounting to 1% to 1.5% of the fund's total assets, which included the fictitious Madoff returns, Mr. Cuomo's complaint said. By 2008, Mr. Merkin was collecting about $25.5 million a year from managing Ascot -- generating management fees of about $169 million from Ascot from 1995 to 2007, the complaint says. Mr. Merkin told investors that 60% of his Ascot fund was comprised of money that came from his personal family trusts, the complaint alleges. But all told, Mr. Merkin invested personally and through family trusts and foundations $7 million in Ascot through 1998, and less than $2 million over the following 10 years. </blockquote> Seeing how readily Madoff's institutional investors, in particular, the leadership of Yeshiva University were bamboozled, I thought maybe it was time to see who that leadership actually was. Yeshiva's current Board of Trustees is listed <a href="http://www.yu.edu/board/">here on the University web-site</a>, but without any detail about the people whose names appear there. A bit of Google searching revealed that the group included, besides Merkin and Madoff, - Morry J Weiss (chairman), who is <a href="http://spider.mc.yu.edu/news/articles/article.cfm?id=100763">on the advisory board </a>of <a href="http://www.primuscapital.com/">Primus Venture Partners</a>, a private equity firm - Sy Syms (vice chairman), who is <a href="http://www.sec.gov/Archives/edgar/data/724742/000093041308003580/0000930413-08-003580-index.htm">on the board of the Israel Discount Bank of New York</a> - Alan E Goldberg (treasurer), who is <a href="http://www.lindsaygoldbergllc.com/#/team/">co-managing partner and co-founder of Lindsay Goldberg</a>, a private equity firm - Israel A Englander, who is co-founder if <a href="http://iaenglander.com/">I A Englander & Co</a>, a financial derivatives trading firm, and founder of Millennium Partners, a hedge fund (also note that Millennium Partners and Mr Englander personally settled lawsuits in 2005 that charged they used an elaborate scheme using market timing, as per <a href="http://www.nytimes.com/2005/12/02/business/02fund.html">this NY Times story</a>) - Ruth L Gottesman, <a href="http://www.aecom.yu.edu/home/fullstory.asp?id=198">the spouse of David Gottesman</a>, the founder and senior managing director of <a href="http://investing.businessweek.com/businessweek/research/stocks/private/snapshot.asp?privcapId=4613435">First Manhattan Company</a>, an investment adviser, (and also a former chairman of the Yeshiva University board) - Lance L Hirt, another <a href="http://www.lindsaygoldbergllc.com/#/team/">partner at Lindsay Goldberg</a>, a private equity firm (see above) - Michael Jesselson, the president of <a href="http://investing.businessweek.com/businessweek/research/stocks/private/snapshot.asp?privcapId=2567724">Jesselson Capital</a>, an investment company - Henry Kressel, a <a href="http://www.warburgpincus.com/people/ViewEmployee,employeeid,69.aspx">partner and senior managing director of Warburg Pincus</a>, a venture capital company So, before the resignation of Madoff and Merkin, nine of the 40 officers and trustees of Yeshiva University were in finance, all in leadership positions (and the board also included the spouse of another financial leader). Most were not in retail banking or retail stock brokerages, but in the more exotic areas of finance that are most associated with the global economic collapse, including derivative trading, hedge funds, private equity, etc. On one hand, it would appear that a board so heavily stocked with finance leaders ought to have been sophisticated enough to do the due diligence their role required in evaluating the university's investments. On the other hand, perhaps the enrichment with finance people created a clubby atmosphere that discouraged questioning their fellow financiers too closely. That almost 25% of Yeshiva University's board was composed of finance leaders is striking, given that the <a href="http://www.bls.gov/emp/empmajorindustry.htm">US Bureau of Labor Statistics estimates </a>that less than 6% of employed people work in finance. But note that we previously <a href="http://hcrenewal.blogspot.com/2008/12/what-linked-parallel-declines-of.html">found</a> that 50% of the Harvard Fellows (the equivalent of their board of trustees' executive committee), and <a href="http://hcrenewal.blogspot.com/2008/11/leadership-of-elite-american-university.html">69%</a> of Dartmouth College's charter (self-appointed, as opposed to elected by alumni) trustees were leaders in the financial sector. This is somewhat anecdotal evidence, but it suggests that leaders of finance are much more prevalent among the top leadership of elite US institutions of higher education than would be explained by their prevalence in the population. This raises the question of why financial leaders seem to have become so prevalent in academic leadership. This question is important, since this prevalence seems to have increased in a time when the culture of the leadership of the financial sector seemed to become more and more alien to the values that academic leaders ought to support, culminating in a global financial collapse that many blame on the sector leaders' arrogance, greed, and sometimes outright corruption. At least it seems a reasonable hypothesis that some of the problems of academia, and particularly the problems of medical academia, may have been at least enabled by leadership more used to working in an increasingly amoral marketplace than to upholding the academic mission. We hope that there will be more interest in who now leads academia, especially medical academia, how they got there, and what they have wrought.

Hedge Fund U

We previously posted about how the Bernie Madoff scandal shed light on problems in the governance and leadership of one major university (w...

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Have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?

Have we suffered a complete breakdown in the scientific method with regard to EHR and other clinical IT? I read announcements like this with trepidation: <div style="margin-left: 40px;"><a href="http://govhealthit.com/articles/2009/03/31/sebelius-confirmation.aspx" style="font-family: arial;" target="blank">http://govhealthit.com/articles/2009/03/31/sebelius-confirmation.aspx </a> “The goal,” Sebelius said, “is to provide every American with a safe, secure electronic health record by 2014." The nominee also endorsed efforts to use data gleaned from electronic medical records to conduct “comparative effectiveness research" (CER) to provide information on the relative strengths and weaknesses of alternative medical interventions to health providers and consumers.” </div> Recovery Act funds have been allocated to NIH specifically for comparative effectiveness research. NIH has further specified the definition of CER as: <blockquote>"[A] rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy."</blockquote> NIH states that such research may include "the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER." The problems I foresee concern the word "rigorous" as in the above definition. The use of EHR data to reliably detect uncommon (but strong, discrete) early warning signals from a single drug or treatment -- to then be subject to more rigorous study with reasonable controls -- is itself a Medical Informatics "Grand Challenge." An example would be finding VIOXX's association with myocardial infarction earlier than we did, via an EHR-based automated postmarket surveillance process. Doing this is a "grand challenge" due to the nature of EHR data, which is as far from "clinical trials clean" as possible. It is what might be called highly uncontrolled. The statistical methods needed to reliably pull signals out of the muck for even a single drug are still exploratory, the problems formidable if one wants to stay scientifically sound. I wrote about the experimental nature of such efforts a few years ago <a href="http://www.scribd.com/doc/12392184/A-Medical-Informatics-Grand-Challenge-the-EMR-and-PostMarketing-Drug-Surveillance-" target="blank">here</a>, and believe an effort got underway at U. Indiana/Regenstrief to test such methodologies for postmarket surveillance about the same time. Now we have had what appears to be a leap of faith and logic of irrationally exuberant proportions, and probably a deviation from sound science as well. The government has announced enthusiasm for EHR data-based comparative effectiveness research (CER) not to aid science, but to cut costs (implying skipping the rigorous confirmatory phases) through elimination of more costly drugs and treatments deemed less effective or at effectiveness parity compared to less expensive choices. Following this thinking, perhaps in the future a metric will be developed for an "acceptable" improved benefit/cost ratio for expensive drugs that are better than cheaper alternatives? This overconfidence in EHR data is of concern. To detect relatively less concrete (i.e., than major ADE) "outcomes differences" between two or more drugs or treatments via EHR data - did treatment A lower blood pressure more than drug B, did drug C lessen depression more than drug D - rises to the level of "grand overconfidence in computing." To accomplish this task with reasonable scientific certainty from reams of EHR data, originating from different vendor systems, input by myriad people of different backgrounds with differing interpretations of terminologies (students/MD's/RN's etc) under different pressures (time, reimbursement maximization), and so forth, seems a stretch. What will the p values and predictive values be for such studies? Yet our incoming HHS secretary touts such methods? Ironically, the gold standard in medical science is the controlled clinical trial, yet EHR-based comparative effectiveness research itself as a research methodology, now touted by our government, seems to have gotten a pass. Even what I would consider minimum requirements for scientific treatment comparisons, such as well designed and reasonably controlled registries as developed <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=Cardiology%20story">here for interventional cardiology</a>, with hundreds of granular, finely defined and "tuned" data elements, appear to be bypassed in EHR "miracle claims." Such precise registries take months or years to develop, implement, and train users to interact with properly. Further, such registries are not portable and must be created for individual medical domains and subdomains. Uncontrolled EHR data is no substitute for such efforts. The following question arises: Where are the comparative effectiveness studies that compare 1) EHR-based comparative effectiveness studies of drugs and treatments to 2) controlled clinical trials-based comparative effectiveness studies? In other words, where are the meta-clinical trials that compare EHR data mining-based comparative effectiveness research as a methodology, vs. the "traditional" gold standard methodology of controlled clinical trials to compare drugs or treatments? How do we know EHR-based CER studies will not produce GIGO that will cause harm through ham-fisted elimination or defunding of useful treatment options? While there are initial efforts underway to increase understanding of CER, e.g., <a href="http://grants.nih.gov/grants/funding/challenge%5Faward/High_Priority_Topics.pdf#topic_05">"Broad Challenge Area 5</a>" (PDF) of the NIH RC1 Challenge Grants in Health and Science Research, ominously, there is a lot of potential advantage to be had with terabytes of uncontrolled data and a political agenda. I fear that what will come from "comparative effectiveness research" that draws upon uncontrolled EHR data will be politics masquerading as comparative effectiveness research. Good luck to private practitioners and medical innovators. Good luck, pharma. Good luck, patients. This movement towards EHR uncontrolled data alchemy represents a further deviation from medical science towards the Syndrome of Inappropriate Over-Confidence in Computing (a.k.a. SICC Syndrome) writ large. It seems the IT industry has now rendered a scientific approach to HIT and its use obsolete. We see this "post scientific era" phenomenon in the takeover of clinical IT by vendors who contractually demand suppression of sharing of problems, we see it in a remarkably uncritical push for EMR's by 2014 now involving force of government (only financial at present, but will punitive licensure issues and other measures be off the table?) despite a growing body of literature advising caution, we see a consortium of big business/payers/vendors/myriad secondary feeder organizations gunning full blast for this technology without consideration of the possible downsides. Biomedical informatics, a scientific discipline (at least those parts of it not yet compromised by conflicts of interest), as a relevant field is very much a minority player in today's health IT. Even the contributions from experts and pioneers in the field of Biomedical Informatics, in the form of the Jan. 2009 National Research Council's report that "Current Approaches to U.S. Health Care Information Technology are Insufficient" (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=NRC">here</a>) has not had much impact. I see Biomedical Informatics' death as a relevant discipline that anyone of importance pays attention to, not too far down the road as well. -- SS Addendum April 20: We've seen this phenomenon in our economy. WSJ "Information Age" writer L. Gordon Crovitz <a href="http://online.wsj.com/article/SB124018430498933171.html">notes</a>: <blockquote>... In a paper for the scientific journal of the Royal Society back in 1994, Harvard economist Robert Merton wrote that "any virtue can become a vice if taken to extreme, and just so with the applications of mathematical models in finance practice." We know even better now that some risks can be calculated and thus reduced, while some unknowns cannot be turned into probabilities. "The mathematics of the models are precise, but the models are not, being only approximations to the complex, real world."</blockquote> I believe EMR data at best is a very loose approximation to the real world. It contains many "unknowns" regarding quality and reliability that cannot be turned into probabilities no matter how fancy the math. Asking too much of EHR data becomes a vice, not a virtue. -- SS

Have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?

Have we suffered a complete breakdown in the scientific method with regard to EHR and other clinical IT? I read announcements like this with...

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