healthy4u

Kicking off 2nd annual Google I/O developer gathering

Today is the first day of <a href="http://code.google.com/events/io/">Google I/O</a> — two days of developer talks, fireside chats and demos, all focused on the latest innovations in the web as a development platform. We're excited to have this chance to welcome more than 3,000 developers to the Moscone Center in (unusually) sunny San Francisco for a variety of interactive roundtables and talks on subjects like Android, Google Maps and Google Apps for the Enterprise. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiX-nh8xY-Q55cJ5BV6GeJgtqah1afl0XS_ac-kSc3vD77AmBEEiB-4r1ckj1qKc2ac95Vp_Jk7MkZXzggrE_Gpsf2n6rrUKkKSisrtptrfXawLMuXf0Y6jEvFQN1X2lCtzSW8pu19IL8J6/s1600-h/10135098.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5340565901979996258" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiX-nh8xY-Q55cJ5BV6GeJgtqah1afl0XS_ac-kSc3vD77AmBEEiB-4r1ckj1qKc2ac95Vp_Jk7MkZXzggrE_Gpsf2n6rrUKkKSisrtptrfXawLMuXf0Y6jEvFQN1X2lCtzSW8pu19IL8J6/s400/10135098.jpg" style="display:block; margin:0px auto 10px; text-align:center;cursor:pointer; cursor:hand;width: 300px; height: 400px;" /></a> We'll be back with more news as the conference progresses. In the meantime, you can follow updates on the <a href="http://twitter.com/googleio">@googleio</a> Twitter stream; videos of all sessions will be available on <a href="http://code.google.com/">code.google.com</a> shortly after they conclude. Update @ 3:20PM: Videos from Day 1 of Google I/O are now available on our <a href="http://www.youtube.com/view_play_list?p=41F4CEB92D80C4B7">YouTube playlist</a>. Posted by Emily Wood, Google Blog team

Kicking off 2nd annual Google I/O developer gathering

Today is the first day of Google I/O — two days of developer talks, fireside chats and demos, all focused on the latest innovations in the ...

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Harvard's EMR Justification: We Just Have To Do Something?

I think what I termed "irrational exuberance" over health IT is now devolving into just simple irrationality. I am unfamiliar with the reasoning employed below (in boldface) by the Harvard researcher, Ashish Jha, MD, MPH (who authored the April 2009 EHR usage survey "<a href="http://content.nejm.org/cgi/content/full/360/16/1628" style="font-family: arial;">Use of Electronic Health Records in U.S. Hospitals</a>" in the NEJM). From "<a href="http://www.healthleadersmedia.com/content/232813/topic/WS_HLM2_MAG/Cash-for-Computers.html" style="font-family: arial;">Cash for Computers</a>", HealthLeaders Media, May 11, 2009. First, my opinions: <blockquote style="font-family:arial;"> ... "This forced timeline [by 2014] is a <a href="http://www.jamia.org/cgi/content/abstract/13/1/106">very bad thing</a>. I'm concerned it is going to take an experimental technology and turn it into a train wreck," Silverstein [me - ed.] says. "We need a more gradual process where we can learn from mistakes on a small scale to avoid reproducing them on a large scale ... So now, Silverstein says, healthcare providers are caught between their mission to provide quality care and the financial pressure to install an unproven technology that may threaten the mission. "Health IT, when it's done correctly, can improve healthcare and reduce costs. But health IT when it is not done well has the exact reverse potential," Silverstein says. "It can impair healthcare, decrease quality, and create other adverse effects for patients. That is the missing element in this discussion."</blockquote> Then, Jha's: <blockquote style="font-family:arial;">A need to act Others aren't so pessimistic. Jha [Ashish Jha, MD, MPH, the lead author of the survey, and an associate professor of health policy and management at Harvard] says hospitals will have five years to establish EHR before federal penalties kick in. And because it involves the federal government, Jha says it's more than likely that those deadlines will get pushed back even further [not according to ONC chair and fellow Harvard professor David Blumenthal, who as I noted in <a href="http://www.healthleadersmedia.com/content/232813/topic/WS_HLM2_MAG/Cash-for-Computers.html">this post</a> said HIT timelines were "cemented in law" - ed.] Jha says critics are "missing the point." "I'm not suggesting EHR is going to be a panacea, but the one thing that is absolutely true is there is nothing else out there now that has any more political appeal," Jha says. "Everybody agrees, whether you are a conservative, moderate, or liberal, that we have to do something about healthcare. So the one place where we can all come to agreement is we have to do something about electronic records." </blockquote> $20+ billion and penalties upon already squeezed practitioners and hospitals for non-adoption of expensive, experimental technology is a lot of "doing something.", especially at a time when many are medically uninsured or underserved. I am also not sure about what point critics are "missing." (Note: I am not a critic, but am a gadfly of healthcare IT mis-design, mismanagement and fraud.) It appears that reasoning at Harvard has dropped to the level of "we should do it, because we have to do something." Good intentions trump outcomes. Not to make a comparison between HIT and other types of medical experimentation, but it's likely the PI's of the <a href="http://en.wikipedia.org/wiki/Tuskegee_Study_of_Untreated_Syphilis_in_the_Negro_Male" style="font-family: arial;">Tuskegee Experiment</a> felt the same way. Ironically, Harvard is home to Medical Informatics pioneers such as Dr. Octo Barnett, coauthor of the National Research Council report warning that <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" style="font-family: arial;">approaches to today's HIT are inadequate</a>. -- SS

Harvard's EMR Justification: We Just Have To Do Something?

I think what I termed "irrational exuberance" over health IT is now devolving into just simple irrationality. I am unfamiliar with...

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Health IT Failure Never Puts Patients at Risk

At "<a href="http://hcrenewal.blogspot.com/2009/05/dangerous-health-it-mismanagement-spin.html">Dangerous Health IT Mismanagement, Spin Control and the World's Longest Teething Pains</a>" I commented that executives always find that "patient safety is not compromised" when health IT malfunctions. Here's another hair-raising story from Down Under. Just a wee glitch: <blockquote><h3 class="post-title entry-title" style="font-family: arial;"><a href="http://healthcareitaustralia.blogspot.com/2009/05/power-failure-lasting-36-hours-cripples.html">Power failure lasting 36 hours cripples hospital care</a></h3>By Kate Benson healthcareitaustralia.blogspot.com DOCTORS at more than 100 hospitals in the state could not access patient records or vital test results for up to 36 hours last weekend after a power failure crippled NSW Health's computerised database. Some records were lost, X-ray and pathology results could not be accessed and staff were forced to use whiteboards to keep track of emergency patients after the main server shut down at 9am on Saturday because of a faulty circuit-breaker. Back-up power from the Cumberland Data Centre, which provides computer access to the Greater Western, Greater Southern and Sydney West area health services also failed, plunging some of the busiest hospitals in the state into chaos. Thousands of patients were affected, with doctors and nurses forced to take notes on paper and go to other parts of the hospital to collect hard copies of results, extending treatment times and adding to the confusion. Some staff, who did not want to be named, said the weekend was chaotic and a shambles. One surgeon said it was fortunate no lives were lost. The chief executive of Sydney West Area Health Service, Steven Boyages, said hospital blackouts that lasted more than 30 to 60 minutes were unacceptable, but the Health Minister, John Della Bosca, insisted patients were not put at risk. "At no time was there any threat to patient care or safety," he said yesterday. The Opposition spokeswoman on health, Jillian Skinner, said the blackout was "a serious failure" with great potential for disaster. "Hospitals affected not only lost access to patient records, some lost some patient records altogether … and couldn't access X-rays unless they physically went to the X-ray department for a film copy," she said. "John Della Bosca should explain why the patient records system lost power, why back-up systems also failed, and whether patient safety was compromised." A spokesman for Mr Della Bosca said workers doing routine maintenance at the data centre had triggered the outage. No patients had reported problems connected to the blackout but a full investigation would be launched. "If necessary changes will be implemented to prevent a recurrence," he said. with Louise Hall BLACKED OUT Hospitals at Westmead, Auburn, Blacktown, Nepean, Lithgow, Mount Druitt, Cumberland, Blue Mountains, Dubbo, Bathurst, Orange, Mudgee, Parkes, Bourke, Albury, Queanbeyan and Goulburn were affected.</blockquote> Move along, nothing to see here. Patients were not put at risk. Who needs regulation? It would only stifle innovation. -- SS

Health IT Failure Never Puts Patients at Risk

At " Dangerous Health IT Mismanagement, Spin Control and the World's Longest Teething Pains " I commented that executives alw...

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The FDA Commissioner Divests

Dr Margaret Hamburg, having been confirmed by the US Senate, is the new commissioner of the US Food and Drug Administration (FDA). We posted twice about whether her and her family's financial relationships might be relevant to her nomination. <a href="http://hcrenewal.blogspot.com/2009/03/putting-new-schein-to-fda.html">Here</a> we discussed her position on the board of directors of Henry Schein, Inc a medical supply company. My concern was whether someone who had spent years being ultimately responsible for maximizing the profits of a medical supply company would be able to be a fair, and when necessary, tough regulator of the companies that supply Henry Schein with products to sell. <a href="http://hcrenewal.blogspot.com/2009/03/hedging-future-of-fda.html">Here</a> we discussed Dr Hamburg's husband's leadership of the hedge fund management company, Renaissance Technologies. My concern was whether someone who is part of a family that had gotten rich from buying and selling stocks and financial instruments, of which a likely substantial but unknown fraction were of health care corporations, would again be able to be a fair, and when necessary tough regulator of some of these same companies. At the time, it did not seem that anyone else shared these concerns. As far as I could tell, there was no discussion of them in the press, or at Dr Hamburg's confirmation hearings. However, today the Wall Street Journal <a href="http://online.wsj.com/article/SB124328188115551961.html">reported</a>: <blockquote> The new commissioner of the Food and Drug Administration is among the wealthiest Obama administration appointees, with income of at least $10 million in 2008 thanks mostly to her husband, a hedge-fund executive, according to financial disclosure forms. Margaret Hamburg and her husband, Peter Fitzhugh Brown, must divest themselves of several hedge-fund holdings as well as some of Mr. Brown's inherited drug-company stocks so Dr. Hamburg can take the post as the nation's top food and drug regulator. Mr. Brown is a lieutenant to hedge-fund magnate James Simons The couple's income in 2008 came from stocks, money-market accounts, trusts and funds including several affiliated with hedge-fund sponsor Renaissance Technologies, where Mr. Brown works. The couple controls assets worth between $21 million and $40 million, according to disclosure forms Dr. Hamburg gave the White House. The forms don't reveal exact figures, just ranges. Before her FDA nomination, Dr. Hamburg also served for five years on the board of Henry Schein Inc., a $4 billion firm that distributes medical and dental supplies including vaccines. Her remuneration has been in the form of Schein shares. She will forfeit $100,000 to $250,000 in restricted stock and more than 11,000 unvested stock options, all of which have a strike price above market value. She will also have to sell vested stock, valued between $250,000 and $500,000. Mr. Brown, an expert in artificial intelligence, is vice president and director at Renaissance Technologies. The fund company said recently its total assets were about $18 billion. Mr. Simons was the top-paid hedge-fund manager in 2008, receiving $2.5 billion, according to Alpha magazine. A lengthy review by the Government Ethics Office, which included direct discussions with Renaissance managers, determined that both Dr. Hamburg and her husband will have to get rid of their interest in four Renaissance funds—the Renaissance Institutional Equities Fund, the Renaissance Institutional Futures Fund, Meritage Investors and Topspin Partners. However, the couple will be allowed to retain their interest in Renaissance's Medallion fund. An administration official said Medallion was exempted because its computerized quantitative model trades rapidly and holds shares only briefly, creating the equivalent of 'a very blind trust.' Mr. Brown has already sold his stock in Abbott Laboratories and shares in Johnson & Johnson, Merck & Co. and Medco Health Solutions Inc., which he inherited from his father. </blockquote> So it appears, in retrospect, that the Government Ethics Office also felt that Dr Hamburg's position on the Henry Schein Inc board constituted a conflict of interest. Furthermore, the Office felt that Dr Hamburg's and Mr Brown's holdings in several hedge funds constituted conflicts of interest. So, in retrospect, it is odd that these financial relationships attracted no attention other than that of Health Care Renewal prior to Dr Hamburg's confirmation by the Senate. I do hope that now, having severed significant relationships and sold financial holdings, Dr Hamburg will prove to be a fair, and tough when necessary regulator of companies that have too often misbehaved.

The FDA Commissioner Divests

Dr Margaret Hamburg, having been confirmed by the US Senate, is the new commissioner of the US Food and Drug Administration (FDA). We posted...

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What Influenced a Paean to Karen Ignagne?

As the discussion here in the US about health care reform gathers steam, the Washington Post published a rather uncritical <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/24/AR2009052400551.html">profile</a> of one of the prominent participants, Ms Karen Ignagni, CEO of America's Health Insurance Plans (AHIP), the trade group for the health insurance/ managed care industry. It included some compliments from Princeton Professor and prominent health care economist Uwe Reinhardt: <blockquote> 'Whatever AHIP pays her, it's not enough. She's unbelievably effective,' said Princeton economist Uwe Reinhardt. 'It's just amazing what she's achieved for them against all odds.' Ignagni's total compensation, according to AHIP's most recent filing from 2007, was $1.58 million, which includes $700,000 in base salary, $370,000 in deferred compensation and a bonus. Ignagni won't say how many hours a week she works. The number's so high it's embarrassing, she said. Among successes cited by Reinhardt and others is helping persuade the Bush administration to develop private insurance plans within Medicare that are producing unexpectedly high payments for private insurers. </blockquote> What the Washington Post article did not bother to mention was that in addition to being on the Princeton faculty, Professor Reinhardt is a member of the <a href="http://phx.corporate-ir.net/phoenix.zhtml?c=122199&p=irol-govboard">board of directors </a>of <a href="http://www.amerigroupcorp.com/Pages/Home.aspx">Amerigroup</a>, a health insurance company specializing in providing Medicaid and Medicare managed care (see this <a href="http://hcrenewal.blogspot.com/2009/01/what-ruc-prominent-health-care-policy.html">previous post</a>), and a member of AHIP. Former Amerigroup CEO Jeffrey McWalters was <a href="http://orlando.bizjournals.com/gen/executive.html?excode=406F5DF537D14F3AACA5084EC5142068">on the board of AHIP</a>. According to Amerigroup's<a href="http://ccbn.10kwizard.com/xml/download.php?repo=tenk&ipage=6228231&format=PDF"> 2009 proxy statement</a>, Professor Reinhardt controls (via ownership or options) 144,558 shares of Amerigroup stock, and received $226,531 in compensation from Amerigroup in 2008. Perhaps Professor Reinhardt's enthusiasm for Karen Ignagne's performance as CEO of AHIP derived more from his leadership of Amerigroup than a scholarly analysis. Note also that Professor Reinhardt is a member of the <a href="http://phx.corporate-ir.net/phoenix.zhtml?c=62272&p=irol-govBoard">board of directors </a>of <a href="http://www.bostonscientific.com/">Boston Scientific</a>, a medical device company. Furthermore, per proxy statements from the above companies, Professor Reinhardt is on the board of two funds from H&Q Healthcare Investors, and is a Trustee of Duke University and the Duke University Health System. Professor Reinhardt's leadership roles in US publicly traded corporations are public, but not easily found unless one knows where to look. We had first <a href="http://hcrenewal.blogspot.com/2006/03/economist-puts-down-physicians-cri-du.html">discussed</a> these relationships on Health Care Renewal in 2006. However, many of the more academically tinged biographies of him publicly available omit his leadership roles in the for-profit world. At the moment, biographies of Professor Reinhardt on the <a href="http://wws.princeton.edu/people/display_person.xml?netid=reinhard&all=yes">Princeton web-site</a>, and furnished by the <a href="http://www.princeton.edu/~bioethic/about_us/advisors/reinhardt.html">Princeton Bioethics Forum</a>, the <a href="http://www.commonwealthfund.org/bios/bios_show.htm?doc_id=239402">Commonwealth Fund</a>, and the <a href="http://www.kff.org/about/reinhardt.cfm">Henry J Kaiser Foundation </a>did not note these relationships. This illustrates once more participation in the current health policy debate may be driven by vested interests, rather than ideology, much less dispassionate analysis. Were the participants yo disclose, at least, their financial interests, the debate would become that much clearer. Meanwhile, when listening to the debate, always ask, "cui bono?" (Who benefits?) Hat tip to <a href="http://www.thehealthcareblog.com/the_health_care_blog/2009/05/im-not-sure-thats-how-uwe-meant-it.html">the Health Care Blog</a>.

What Influenced a Paean to Karen Ignagne?

As the discussion here in the US about health care reform gathers steam, the Washington Post published a rather uncritical profile of one o...

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BLOGSCAN - Comparative Effectiveness Research, the Partnership to Improve Patient Care, and PhRMA

BLOGSCAN - Comparative Effectiveness Research, the Partnership to Improve Patient Care, and PhRMA

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody dissected a campaign to redirect comparative effectiveness research by mak...

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"A Breach of Trust"

This new variation on a now old theme first <a href="http://www.nytimes.com/2009/05/13/business/13surgeon.html">appeared in the New York Times</a>: <blockquote> A former surgeon at Walter Reed Army Medical Center, who is a paid consultant for a medical company, published a study that made false claims and overstated the benefits of the company’s product in treating soldiers severely injured in Iraq, the hospital’s commander said Tuesday. An investigation by Walter Reed found that the study cited higher numbers of patients and injuries than the hospital could account for, said the commander, Col. Norvell V. Coots. 'It’s like a ghost population that were reported in the article as having been treated that we have no record of ever having existed,' Colonel Coots said in a telephone interview on Tuesday. 'So this really was all falsified information.' The former Army surgeon, Dr. Timothy R. Kuklo, reported that a bone-growth product sold by Medtronic Inc. had much higher success in healing the shattered legs of wounded soldiers at Walter Reed than other doctors there had experienced, according to Colonel Coots and a summary of an Army investigation of the matter. Dr. Kuklo, 48, now an associate professor at the Washington University medical school in St. Louis, did not respond to numerous e-mail messages and telephone calls to his office and home seeking comment over the last two weeks. Walter Reed officials say he did not respond to their inquiries during their investigation. Army investigators found that Dr. Kuklo forged the signatures of four Walter Reed doctors on the article before submitting it last year to a British medical journal, falsely claiming them as co-authors. He also did not obtain the Army’s required permission to conduct the study. In its March edition, at the Army’s request, the journal retracted the article — something that has gone largely unnoticed outside orthopedic circles. While at Walter Reed and since, Dr. Kuklo has given talks to other doctors around the country about the bone-growth product, a protein called Infuse, according to meeting agendas and published documents. A Medtronic spokeswoman, Marybeth Thorsgaard, confirmed that Dr. Kuklo was a paid consultant to the company and that the company financially supported some of his research at Walter Reed, through a foundation affiliated with the hospital. During his time at Walter Reed Dr. Kuklo was extensively involved in research and writing about various Medtronic products, including editing two books published by the company and conducting three studies that were approved by his Army superiors, according to his list of publications and an Army report. Colonel Coots said Tuesday that the total number of patients Dr. Kuklo reported as having been treated for extensive lower leg wounds at Walter Reed during the study period — 138 soldiers — was greater than the number for which the hospital could find records. 'It is a significant breach of academic protocol,' Colonel Coots said. 'It’s a breach of trust.' </blockquote> This story has several familiar elements, but combines them in some interesting ways. We have <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">discussed</a> how health care corporations, particularly pharmaceutical manufacturers, cultivate "key opinion leaders," and use them to market their products. This may amount to stealth marketing, since KOLs rarely disclose in detail their relationships with corporate sponsors, and instead further their marketing objectives cloaked as academics. We have also <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">discussed</a> how health care corporations, particularly pharmaceutical manufacturers, may sponsor clinical research on their own products. However, such sponsors often manipulate the research projects' design, implementation, analysis, and dissemination so as to favor their products. While the sponsorship may be disclosed, the extent of the sponsors' control over the project may not be. Furthermore, scientific investigators running such projects may have their own personal financial relationships with the sponsors. This case apparently shows how a medical academic can both be a paid "key opinion leader," and manipulative clinical researcher. While many examples of key opinion leaders as stealth marketers, and manipulated research involved pharmaceutical companies, this one involves a medical device company. In addition, this research project was not just manipulated, but allegedly falsified. This variation has at least one other interesting element. Again, from the New York Times, <blockquote>A former Walter Reed colleague, Dr. David W. Polly Jr., who is also a Medtronic consultant, said he believed that Dr. Kuklo’s data was “strong” and the episode had been overblown. </blockquote>According to the <a href="http://www.publicintegrity.org/blog/entry/1366/">Center for Public Integrity Paper Trail blog</a>, <blockquote>A former colleague of Kuklo’s at Walter Reed Army Medical Center, Dr. David W. Polly Jr., took even more expensive trips than Kuklo. Polly went on at least 12 Medtronic-sponsored trips costing about $30,000, including a $10,000 trip to Switzerland. </blockquote> Furthermore, the New York Times <a href="http://www.nytimes.com/2009/05/21/business/21surgeon.html">reported</a>, <blockquote>[Senator Charles] Grassley, the ranking Republican [from Iowa] on the Senate Finance Committee, has been investigating since last year whether Medtronic illegally promoted unapproved uses for Infuse. Medtronic, which has denied that accusation, provided him last year with a list of Infuse consultants. After Dr. Kuklo’s links to Medtronic and Infuse came to light last week in a New York Times article, Mr. Grassley’s staff checked the consultants list and noted that Dr. Kuklo’s name was not on it. In reaction, he wrote a letter to Medtronic’s president and chief executive, William A. Hawkins III, asking why Dr. Kuklo had been omitted. Mr. Grassley entered that letter and the list he had received into The Congressional Record. 'In the future, I hope that instead of not providing me with the name of the physician involved in Infuse, or any other matter that I am looking into, that Medtronic contact me to avoid the situation in which we find ourselves,' Mr. Grassley wrote to Mr. Hawkins. </blockquote>So, as soon as this case came to light, the spinning of public discussion to favor Medtronic and its key opinion leaders began. Thus, this case also involved stealth policy advocacy. Stealth marketing, clinical research manipulation, and stealth advocacy all in one case, we seem to have hit the jackpot. The most recent development, again <a href="http://www.nytimes.com/2009/05/23/business/23surgeon.html">according to the NY Times</a>, is <blockquote> Dr. Timothy R. Kuklo, a former Army physician accused of falsifying research involving injured soldiers, has taken a leave of absence from the Washington University School of Medicine in St. Louis and its affiliated hospitals, the medical school said Friday. Dr. Kuklo, an associate professor of orthopedic surgery, will not be performing operations, conducting research or teaching students, said a medical school spokeswoman, Joni Westerhouse. The university granted the leave, she said, so that Dr. Kuklo 'can focus on responding to queries about his research and consulting.' </blockquote>At least his absence was not ascribed to the need to spend more time with his family or pursue other opportunities. Finally, note that we <a href="http://hcrenewal.blogspot.com/2008/05/corporate-integrity-agreement-for.html">posted</a> last year that Medtronic had submitted to a corporate integrity agreement after the US Department of Justice accused it of defrauding Medicare in connection with activities by its Kyphon subsidiary. So this case additionally suggests that such agreements have little effect on the actual integrity of corporate leaders. Hat tip to and see further commentary by Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=12853">on the University Diaries blog</a>. ADDENDUM (24 May, 2009) - see further comments by Prof Soltan <a href="http://www.margaretsoltan.com/?p=13249">on the University Diaries blog</a>.

"A Breach of Trust"

This new variation on a now old theme first appeared in the New York Times : A former surgeon at Walter Reed Army Medical Center, who is a p...

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