healthy4u

Citizen participation that scales: a call to action

At Google we hold weekly <a href="http://en.wikipedia.org/wiki/Town_hall_meeting">town hall</a>-style meetings with our founders, CEO, and guest speakers, which always feature a Q&A session. Managing Q&A is a unique challenge with an audience of thousands, in offices around the world, who inevitably want to ask more questions than we have time to answer. To help address this challenge, we developed <a href="http://moderator.appspot.com/">Google Moderator</a>, built on <a href="http://code.google.com/appengine/">App Engine</a>. Moderator gives participants a way to submit questions and vote for the ones they want answered. And thanks to the scale that App Engine provides, this application can now support tens of thousands of people at once. This gives everyone the chance to be heard in a way that gives priority to the issues that matter most to the broader group. <a href="http://www.youtube.com/watch?v=hjJm_Hzc6Yg">As you may have heard</a>, the White House is hosting an online town hall meeting on Thursday and has asked people to submit questions for the president and vote on which ones they think he should answer. We think technology can be a force for greater accountability and access between citizens and their elected officials. We're excited that the White House has chosen to use the power of cloud-based applications like Google Moderator and App Engine to scale the president's direct dialogue with the American people. To take part in this experiment in citizen participation, please visit: <a href="http://whitehouse.gov/OpenForQuestions">http://WhiteHouse.gov/OpenForQuestions</a> Posted by Vic Gundotra, Vice President, Engineering

Citizen participation that scales: a call to action

At Google we hold weekly town hall -style meetings with our founders, CEO, and guest speakers, which always feature a Q&A session. Manag...

Đọc thêm »

Health Care Information Technology Vendors' "Hold Harmless" Clause - The Largest IT Industry Abuse Ever?

Dear fellow physicians, nurses and other clinicians: You thought frivolous medical malpractice suits were a problem? Guess what: It's worse. Along with your patients you are nonconsented beta testers and experimental subjects of the health IT industry, and potential victims of the computer industry's arrogance and dysfunction. In the remarkable article <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians</a>, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009;301(12):1276-1278, we learn that: <blockquote style="font-family:arial;">Healthcare information technology (HIT) vendors enjoy a contractual and legal structure that renders them virtually liability-free—“held harmless” is the term-of-art—even when their proprietary products may be implicated in adverse events involving patients. This contractual and legal device shifts liability and remedial burdens to physicians, nurses, hospitals, and clinics, even when these HIT users are strictly following vendor instructions...HIT vendors are not responsible for errors their systems introduce in patient treatment because physicians, nurses, pharmacists, and healthcare technicians should be able to identify—and correct—any errors generated by software faults. [Yes - we're all knowing magicians with the power to read minds, infer incorrect lab values via therapeutic touch, and possess encyclopedic knowledge in our heads at all times. This raises the question: if we are that omniscient to be able to identify and correct software faults with 100 percent accuracy to avoid patient harm, then why do we need electronic medical records at all? - ed.] </blockquote> Also see the Univ. of Pennsylvania press release "Why Are Healthcare Information Manufacturers Free of All Liability When Their Products Can Result in Medical Errors?" <a href="http://sev.prnewswire.com/null/20090324/DC8755624032009-1.html">here</a>. In the new Koppel and Kreda JAMA article we also learn that: <blockquote style="font-family:arial;">HIT implementations are massively complex, and are fraught with delays, errors, resistance, work process redesign, frustration, and outright failure. Healthcare facilities cannot predict the myriad scenarios in which software failures could result in patient harm and liability, and they are not likely to be knowledgeable a priori about frequent vendor updates.</blockquote> We additionally learn that: <blockquote style="font-family:arial;">The significant disparity between buyers and sellers in knowledge and resources [about healthcare IT problems] is profound and consequential. Vendors retain company confidential knowledge about designs, faults, software-operations, and glitches. Their counsel have crafted contractual terms that absolve them of liability and other punitive strictures while compelling users’ non-disclosure of their systems’ problematic, or even disastrous, software faults. [This is simply astonishing. In other words, health IT customers and users have a gag order imposed on them regarding software faults and defects, while clinicians -- through their ingenuity, their labor in finding defect workarounds, and their liability -- serve (as I've written) as captive beta testers and an insurance company for HIT vendors - ed.] </blockquote> These observations are nothing short of astonishing. They do help explain, however, the near silence of hospitals and their executives regarding healthcare IT faults, an observation I made in this 2006 AMIA presentation about the scarcity of such information: <blockquote style="font-family:arial;">Access Patterns to a Website on Healthcare IT Failure (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/content/documents/AMIA2006_poster.pdf">Abstract</a> [pdf], <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/content/documents/FINAL_Healthcare%20IT%20Failure_Oct_19_2006.ppt">Poster</a> [ppt].)</blockquote> The Joint Commission also made this observation in their Dec. 2008 <a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm">Sentinel Events Alert on Health IT</a>: <blockquote>There is a dearth of data on the incidence of adverse events directly caused by HIT overall. </blockquote> The new JAMA article may also explain why HIT is so often done so poorly as to present a mission hostile user experience, as I started to write about a decade ago at my healthcare IT difficulties website <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/">here</a>, as I outlined in an eight part series starting <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-idiots-part-1.html">here</a>, as the American College of Physician Executives noted <a href="http://hcrenewal.blogspot.com/2009/03/health-it-industry-out-of-control.html">here</a>, as the National Research Council noted <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">here</a> ("Current Approaches to US Healthcare IT are Insufficient"), and as many others noted as well: <blockquote style="font-family:arial;">Healthcare IT News (3/10, Merrill) reported, a survey conducted by the American College of Physician Executives found "that although more physician leaders are using healthcare information technology, they still find it clunky and unresponsive to their needs." The survey of 1,000 ACPE members "revealed that the biggest source of frustration is a lack of input from physicians when designing and implementing healthcare information technology systems. Many said involving clinicians at the planning stages would pre-empt many of the problems that crop up later." One respondent noted that "systems are chosen according to administrative criteria rather than what physicians need."</blockquote> Without accountability, a manufacturer is unmotivated to produce quality products at the expense of profits. They become complacent and lazy. This is an excellent reason why major HIT applications are as abhorrent as they are and violate so many fundamental principles of human computer interaction and resilience engineering. It can also explain why talent management within the vendors is biased against hiring medical informatics experts, who would resist intellectual laziness of their non-informatics profit oriented (and unaccountable) counterparts. Koppel and Kreda note that such stipulations defeat patient safety efforts and are contrary to the principles of evidence based medicine. I can add that such stipulations are contrary to the principles of good engineering. These stipulations further instantiate my observation that health IT lacks the rigor of medical science itself, its major Achilles heel. This is one reason why I believe a national HIT initiative at this point in time is going to be, <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">as in the UK</a>, nothing short of an expensive debacle. The existence of "hold harmless" clauses and gag orders raises many questions: <ul><li>Clinical supervisors of other physicians are indeed practicing medicine. Are Health IT vendors in fact practicing medicine by cybernetic proxy via these IT systems? </li><li>Aren't the vendors' own claims of revolutionary healthcare quality improvements mediated via EMR's, alerts and reminders, clinical decision support, etc., malfunctions of which physicians may be held liable, prima facie evidence that the vendors are in fact practicing medicine by proxy? </li><li>Should not these purveyors of cybernetic (i.e., virtual) medical devices be held accountable for their products, as in the pharmaceutical and the non-cybernetic (i.e., physical) medical device industries? </li><li>How did such a situation regarding critical healthcare devices arise?</li><li>In what other healthcare or other technology intensive industries, if any, do similar conditions exist, and what are the repercussions? </li><li>How long has this situation existed?</li><li>Why is it tolerated by clinicians?</li><li>Why is it tolerated by clinical leaders?</li><li>Why is it tolerated by medical professional societies, such as the AMA, the ACPE, etc., supposedly representing their members' interests?</li><li>Why is it tolerated by hospitals and their executive leadership and boards of directors?</li><li>Why is it tolerated by IS departments in hospitals?</li><li>Why is it tolerated by hospital general counsel?</li><li>Are there possible civil tort/RICO (racketeering)/criminal implications regarding patients injured by defective health IT where defects were known but not disclosed?</li><li>Is not such a protective arrangement prima facie evidence that this technology is indeed experimental, with patients and clinicians as unconsented experimental subjects? </li><li>Why is it tolerated by our government?</li></ul> Regarding the last point, the Obama administration has promised an atmosphere of national accountability and responsibility. Why, then, has it simultaneously employed the coercive force of government (payment penalties for HIT non adopters after the absurdly short period of five years from now, 2014) to push an exploratory medical device from an unaccountable industry of unproven ROI at a cost of tens of billions of dollars on to the medical profession? This reality raises another question as I suggested in my <a href="http://hcrenewal.blogspot.com/2009/02/medinformaticsmd-in-wall-street-journal.html">WSJ Letter to the Editor</a> of February 18, 2009. I wrote: <blockquote style="font-family:arial;">Dear Wall Street Journal:You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill. I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.</blockquote> In other words, was the administration misled by the health IT industry? I believe it might have been. As an example, Mr. Obama's healthcare IT policy campaign adviser <a href="http://blogs.wsj.com/health/2009/01/26/allscripts-ceo-urges-one-two-punch-on-electronic-medical-records/">per the WSJ</a> Glen Tullman, CEO of HIT vendor AllScripts and Board member of the industry-created government contractor CCHIT ("Certification Commission for Healthcare IT"), probably didn't tell Mr. Obama his company was selling goods that did not function properly. (Here is a link to my organization's <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf">Civil Complaint against AllScripts</a>, PDF). We apparently cannot know how many other organizations had their own complaints that might not have made it into litigation, due to the aforementioned gag orders. (Ironically, I found out about the lawsuit at my own organization only through an anonymous comment at the HIT gossip site <a href="http://histalk.blog-city.com/news_051607.htm">HISTalk</a>.) Incidentally, by matter of pure speculation, I was not permitted involvement in that implementation despite having been a pioneering CMIO at a larger healthcare system years prior and the only formally educated medical informaticist at my organization. My writings on health IT dysfunction were well known to the IT staff and likely the vendor after a short web search; it would have been in the vendors' interests to keep me away from sales and implementation of known deficient health IT. Again, this is simply speculation. On the other hand, I am aware of major healthcare organizations with "portfolios" of hundreds or thousands of issues and defects awaiting remediation, and CMIO's struggling against cavalier bureaucracies who want the doctors even in critical care areas to live with the problems, and vendors who are not in a hurry to fix their products. Some of the problems rise to the level of critical with regard to patient safety. Under contract, the problems cannot be disclosed to the public, to patients whose care might fall under the aegis of these systems, or to other healthcare organizations seeking the same systems. I hope to be a plaintiff's witness when the inevitable lawsuits for patient injury place such capricious vendor, hospital and IT leadership on the witness stand. Finally, in fairness the JAMA article discusses issues beyond the vendors' control such as misuse or poor training done by the host organization using the IT. Possible remedies to the situation of unaccountability for the outcomes of HIT misdesign, malfunction and other defects are outlined in the article. See it or the press release at the above links if you lack JAMA access. As I've written numerous times on this site, due to the implications and especially now due to the revelation that the scarcity of adverse events information related to HIT is probably by design, I favor stringent health IT regulation <a href="http://hcrenewal.blogspot.com/2009/03/lets-deregulate-pharma-information.html">as in pharmaceutical IT</a>. Whatever happens, however, I know this. For the sake of patient safety: <div style="text-align: left;">This sorry, abusive and inexcusable travesty must end ... now. </div> Finally, to health IT vendors, as my early medical mentor, pioneering cardiovascular surgeon and educator Victor P. Satinsky, MD might have said: If you can't take the heat of the responsibilities of clinical medicine, then get out of our kitchen. -- SS

Health Care Information Technology Vendors' "Hold Harmless" Clause - The Largest IT Industry Abuse Ever?

Dear fellow physicians, nurses and other clinicians: You thought frivolous medical malpractice suits were a problem? Guess what: It's wo...

Đọc thêm »

Two new improvements to Google results pages

Today we're rolling out two new improvements to Google search. The first offers an expanded list of useful related searches and the second is the addition of longer search result descriptions -- both of which help guide users more effectively to the information they need. More and better search refinements Starting today, we're deploying a new technology that can better understand associations and concepts related to your search, and one of its first applications lets us offer you even more useful related searches (the terms found at the bottom, and sometimes at the top, of the search results page). For example, if you search for [<a href="http://www.google.com/search?hl=en&q=principles+of+physics" id="m9yf" title="principles of physics">principles of physics</a>], our algorithms understand that "angular momentum," "special relativity," "big bang" and "quantum mechanic" are related terms that could help you find what you need. Here's an example (click on the images in the post to view them larger): <a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhzKS5-M37xQav-4XE78L8LwbW-7HnyLTXuRR3OR-qgTdAf9myLkGZjTt94kaNY178O1UZLv-Eob_RAhg1X2Y0AHhIQVX8ObBhZYcKUVQYe6PvUyYp3TlgGQtk9r2xpqoLxNkwb39KnNWCS/s1600-h/Picture+5.png"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5316754908836560034" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhzKS5-M37xQav-4XE78L8LwbW-7HnyLTXuRR3OR-qgTdAf9myLkGZjTt94kaNY178O1UZLv-Eob_RAhg1X2Y0AHhIQVX8ObBhZYcKUVQYe6PvUyYp3TlgGQtk9r2xpqoLxNkwb39KnNWCS/s400/Picture+5.png" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 177px;" /></a>Let's look at a couple of examples in other languages. In Russian, for the query [<a href="http://www.google.ru/search?hl=ru&q=%D0%B3%D0%B0%D0%B4%D0%B0%D0%BD%D0%B8%D0%B5+%D0%BD%D0%B0+%D0%BA%D0%B0%D1%80%D1%82%D0%B0%D1%85" id="crp4" title="гадание на картах">гадание на картах</a>] (fortune-telling with cards), the algorithms find the related terms "таро" (tarot), "ленорман" (lenormand) and "тибетское гадание мо" (tibetan divination mo). In Italian, if you search for [<a href="http://www.google.com/search?hl=it&q=surf+alle+canarie" id="pmxj" title="surf alle canarie">surf alle canarie</a>] (surf at the canary islands), we now offer suggestions based on the three most famous Canary Islands: "lanzarote," "gran canaria," and "fuerteventura": <a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjo64eF-Sn4mXoAzWCEIFCKLICLqCektnrO1WwRtayOkxyf_j_JfU6QM6pNOz1r4IygOMF7tfG1HOh12AKW4Y0odjmDh4xZo8Ol1algClS5ngN0SF0DXosHfx1n4Z2DBVC4-dHjWrQGxA2L/s1600-h/Picture+6.png"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5316755205123011730" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjo64eF-Sn4mXoAzWCEIFCKLICLqCektnrO1WwRtayOkxyf_j_JfU6QM6pNOz1r4IygOMF7tfG1HOh12AKW4Y0odjmDh4xZo8Ol1algClS5ngN0SF0DXosHfx1n4Z2DBVC4-dHjWrQGxA2L/s400/Picture+6.png" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 232px;" /></a>We are now able to target more queries, more languages, and make our suggestions more relevant to what you actually need to know. Additionally, we're now offering refinements for longer queries — something that's usually a challenging task. You'll be able to see our new related searches starting today in 37 languages all around the world. And speaking of long queries, that leads us to our next improvement... Longer snippets When you do a search on Google, each result we give you starts with a dark blue title and is followed by a few lines of text (what we call a "snippet"), which together give you an idea of what each page is about. To give more context, the snippet shows how the words of your query appear on the page by highlighting them in bold. When you enter a longer query, with more than three words, regular-length snippets may not give you enough information and context. In these situations, we now increase the number of lines in the snippet to provide more information and show more of the words you typed in the context of the page. Below are a couple of examples. Suppose you were looking for information about Earth's rotation around the sun, and specifically wanted to know about its tilt and distance from the sun. So you type all of that into Google: [earth's rotation axis tilt and distance from sun]. A normal-length snippet wouldn't be able to show you the context for all of those words, but with longer snippets you can be sure that the first result covers all those topics. In addition, the extra line of snippets for the third result shows the word "sun" in context, suggesting that the page doesn't talk about Earth's distance from the sun: <a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi821rOPwKFqRKsUY_YOuXiELw0iY8gjBM8MKT3wwnNK4GH5l3ZjYZrcrBKiMFCivQbK-1WM3PfX1ecap9ukOSbHjH5MxBm_PBFM3JCXDM3bgfpvt3_FsGJDN70_12rINzqPkR00Tkt12Ge/s1600-h/Picture+7.png"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5316755430475690962" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi821rOPwKFqRKsUY_YOuXiELw0iY8gjBM8MKT3wwnNK4GH5l3ZjYZrcrBKiMFCivQbK-1WM3PfX1ecap9ukOSbHjH5MxBm_PBFM3JCXDM3bgfpvt3_FsGJDN70_12rINzqPkR00Tkt12Ge/s400/Picture+7.png" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 242px;" /></a>Similarly, if you're looking for a restaurant review that covers all the parts of the meal, longer snippets can help: <a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgoLwcTE17ciQgnNo6n8wcAj0ORHqwhRaYG21PfcMw-SGlZf7Cfn_XA0QJRTFxsVF9g3P9ljoltEfD9D83tsMHhu93wEkKMfqIBsBXv8I8AXhbsh0iSkdc0wfxIuciX0ehY4pLfTRDsc5fU/s1600-h/Picture+8.png"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5316755749449536610" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgoLwcTE17ciQgnNo6n8wcAj0ORHqwhRaYG21PfcMw-SGlZf7Cfn_XA0QJRTFxsVF9g3P9ljoltEfD9D83tsMHhu93wEkKMfqIBsBXv8I8AXhbsh0iSkdc0wfxIuciX0ehY4pLfTRDsc5fU/s400/Picture+8.png" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 221px;" /></a>But don't just take our word for it — try it out yourself with your favorite long, detailed query. These are just two recent examples of improvements we've made. We are constantly looking for ways to get you to the web page you want as quickly as possible. Even if you don't notice all of our changes, rest assured we're hard at work making sure you have the highest quality search experience possible. Posted by Ori Allon, Technical Lead, Search Quality Team, and Ken Wilder, Snippets Team Engineer

Two new improvements to Google results pages

Today we're rolling out two new improvements to Google search. The first offers an expanded list of useful related searches and the seco...

Đọc thêm »

Supporting students in open source software development

<a href="http://code.google.com/soc/">Google Summer of Code</a>, our program to introduce students to open source software development, is now in full swing for 2009. Over the past four years, we've paired nearly 2,500 "graduates" with more than 2,500 mentors from industry to academia, with some spectacular results: millions of lines of source code produced and over $15M in funding provided to open source development. This year student participants have more than <a href="http://socghop.appspot.com/program/accepted_orgs/google/gsoc2009">150 open source software and technology–related projects</a> to choose from when submitting their applications, from operating systems to content management systems. During the <a href="http://code.google.com/soc/2008/">2008 program</a>, we had more than 975 students successfully complete their projects. Each participant received a $4,500 stipend and an ultra-awesome t-shirt to go along with their newly honed programming skills. We're particularly excited by the social ties our students form through the course of the program, as well. We've connected people in more than 98 countries, and hope to bring people from even more places into the Google Summer of Code community this year. We'll be accepting student applications through April 3, 2009 at 12:00 pm PST. If you're interested in learning more, check out our <a href="http://code.google.com/opensource/gsoc/2009/faqs.html">Frequently Asked Questions</a> or subscribe to our <a href="http://groups.google.com/group/google-summer-of-code-discuss">discussion list</a>. You can also check out the <a href="http://google-opensource.blogspot.com/search/label/gsoc">Google Open Source Blog</a> for regular updates on the program. When you're ready to get started, visit the Google Summer of Code 2009 site to submit your application. Best of luck to all of our applicants! For an overview of the program, check out this video. <object height="344" width="425"><param name="movie" value="http://www.youtube.com/v/vBRRR0BQyz0&hl=en&fs=1"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/vBRRR0BQyz0&hl=en&fs=1" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" width="425" height="344"></embed></object> Posted by Leslie Hawthorn, Program Manager, Open Source Team

Supporting students in open source software development

Google Summer of Code , our program to introduce students to open source software development, is now in full swing for 2009. Over the past ...

Đọc thêm »

JAMA Editors Try Attacking the Messenger

Early this month, yet another story surfaced about allegations of undisclosed conflicts of interest affecting the author of a highly publicized clinical trial. This story has now taken such an odd twist that it seems worth discussing in some detail. Let me first try to present some relevant facts, derived from published articles, mainly peer-reviewed, which do not seem to be in dispute, in chronological order. 2005 - In a multi-author review article on mood disorders in the medically ill, Dr Robert G Robinson, of the University of Iowa, disclosed that he served on the speakers bureau of Forest Laboratories.(1) In an article in Stroke: Clinical Updates, he made a similar disclosure.(2) 28 May, 2008 - Dr Robinson was the first author of an article published in JAMA that described a randomized controlled trial comparing placebo, problem-solving (cognitive talking) therapy, and escitalopram (Lexapro, Forest Laboratories) in the prevention of depression in patients who have had strokes.(3) Patients who received placebo had a higher rate of depression (11 major, 2 minor cases, 22.4%) than patients who received escitalopram (3, 2, 8.5%) or who received problem-solving therapy (5,2, 11.9%). At the end of the article, Dr Robinson disclosed, "over the past 5 years, Dr Robinson reports serving as a consultant to the former Hamilton Pharmaceutical Company and Avanir Pharmaceutical Company," but made no disclosure about any financial relationship with Forest. In a news article published the day before, Dr Robinson was quoted as saying, "I think every stroke patient who can tolerate an antidepressant should be given one to prevent depression," but did not advocate the use of problem solving therapy.(4) 15 October, 2008 - In a letter to JAMA, Lacasse and Leo asked whether Robinson et al had done an analysis directly comparing problem-solving therapy and escitalopram, and noted that the reported incidence data for stroke in the two treatment groups suggest that the difference in treatment results "does not appear to be either clinically or statistically significant."(5) Robinson et al responded that there was no statistically significant differences between the groups.(6) 5 March, 2009 - In a rapid response section in the British Medical Journal, Leo and Lacasse raised their concerns about the interpretation of the results of the 2008 trial, and also stated that "during a subsequent internet search we were surprised to learn that four years previously the lead author had been listed on the speaker's bureau for Forest. The omission, however innocent or mistaken, is disturbing; neither the JAMA article nor subsequent media accounts noted that the lead author had served on the speaker's bureau for the manufacturer of Lexapro."(7) Their citation was to our reference 2. 11 March, 2009 - In a letter to JAMA, Robinson and Arndt reported that the financial disclosure for their 2008 article was incomplete, "resulting from erroneous recollection of the appropriate dates for speaking presentations sponsored by pharmaceutical companies...."(8) Dr Robinson disclosed receiving honoraria for two presentations in 2004, and serving on the Forest Laboratories speakers bureau "in 2004 and perhaps 2005." No editorial comment accompanied this letter. So far, this seems to be a familiar story about an author who seemed to be excessively enthusiastic about a product of the company with whom he had had a financial relationship, but reluctant to disclose this relationship. But wait, 20 March, 2009 - A rather extraordinary editorial was published electronically in JAMA on 20 March, 2009.(9) Let me review its main points, section by section. After acknowledging the attention conflicts of interest now receive, and briefly describing the 2008 study and the subsequent letter by Lacasse and Leo, the editorial stated that JAMA editors had received a communication from Leo on or after 16 October, 2008 which "indicated he had evidence that Robinson had not reported in his article that he had served on the speakers bureaus for pharmaceutical companies." The editorial then devoted several paragraphs explaining the "due diligence" JAMA editors used to investigate this "allegation." They noted the "sensitive nature of these investigations," which required them to conduct them "confidentially," and again insisted "these investigations into undisclosed conflicts of interest are time-intensive and require careful attention." Thus, from the time Leo sent his "allegations," (apparently 16 October, 2008), it took until 31 January, 2009 to get a letter from Robinson et al acknowledging his undisclosed conflicts, and until 11 March, 2009 to publish it, a total of five months. However, the concerns with confidentiality, and the repeated emphasis on the need for unusually painstaking investigation seemed disconnected to the particular case. It is clear that it may take quite a bit of time and effort to investigate some allegations of undisclosed conflicts of interest, especially when the allegations are vague, but the alleged conflicts are severe. However, in this case, it should have taken trivial effort to find Dr Robinson's previous, published disclosures. (It took me about 5 minutes of internet searching to find the two 2005 articles.) Once (easily) discovered, the disclosures in the 2005 articles starkly contrast with the disclosures, or lack thereof in the 2008 article. Furthermore, since these disclosures were already in the public domain, there should have been no concerns with confidentiality. Nonetheless, the editors then asserted: <blockquote> While the confidential investigation of unreported conflicts of interest is under way, we consider involvement of third parties— such as Leo had done by his posting on the BMJ site and by contacting the media—to be a serious ethical breach of confidentiality that not only potentially damages our ability to complete a fair and thorough investigation (of the specific issue that Leo had brought to our attention), but also potentially damages JAMA’s reputation by the insinuation that we would fail to do so. </blockquote> This makes no sense. There was no need for confidentiality, because the allegations were not based on whistle-blowing or confidential information. They were based on published articles, articles which clearly disclosed Dr Robinson's financial ties to Forest Laboratories. Anyone who bothered to do a simple Google search could have found that Dr Robinson's disclosure in his 2008 JAMA article did not agree with his disclosure in several 2005 articles. Lacasse and Leo used no confidential information whatsoever in making their allegations. Actually, they were not making "allegations," but simply pointing out that an author had published statements which were inconsistent. Since Lacasse and Leo were simply pointing discrepancies among published articles, how could they have breached "confidentiality," ethically or not? Second, there was no need for a complex or prolonged investigation. The discrepancies were apparent as soon as one viewed the published articles side by side. The third point was a non sequitur, and a classic example of blaming the messenger for the message. JAMA had published an article. Other journals published other articles. Publishing these articles put them in the public domain. If comparison of these articles in the public domain were to reflect badly on on of their publishers, it would not be the fault of making the comparison. Regardless of the illogical nature of their concerns with non-existent confidentiality, assertions that it takes a long, complex investigation to demonstrate the obvious, and their aspersions on the messenger for the message, the JAMA editors then revealed that: <blockquote> A telephone conversation intended to inform Leo that his actions were inappropriate transformed into an argumentative discussion, as Leo continued to refuse to acknowledge any problems with his actions, even after he was informed that the investigation was completed and was advised to read the upcoming March 11 issue of JAMA (where the letter of explanation and apology from Robinson and the formal correction were in press). </blockquote> Furthermore, the editors proposed punishing Leo, first by effectively banning him from publishing in the pages of JAMA, <blockquote> Leo also was informed that, if his actions represented his apparent lack of confidence in and regard for JAMA, he certainly should not plan to submit future manuscripts or letters for publication. </blockquote> Then, by complaining to his supervisor <blockquote> However, since Leo apparently did not appreciate the serious implications of his actions, despite our attempts to explain, we felt an obligation to notify the dean of his institution about our concerns of how Leo’s actions were potentially damaging to JAMA’s reputation. We sought the dean’s assistance in resolving this issue involving a member of the faculty of his institution, to assure there would be no need to publicly identify that faculty member. No dean wants his or her institution implicated in a publication reflecting improper behavior by a faculty member. </blockquote> Finally, they seemed bitterly offended that the British Medical Journal would publish anything that disagreed with anything printed in JAMA: <blockquote> In addition, we were dismayed that BMJ would post the article by Leo with the allegations against Robinson and the negative insinuations about JAMA, without at least contacting JAMA to verify the veracity of the report. </blockquote> Again, rather than raising unsubstantiated allegations, Leo and Lacasse's letter to the BMJ simply showed the discrepancy between the disclosures in Robinson and colleagues' 2008 JAMA article and those in one of his 2005 articles. Both articles are publicly available. What useful information about the letter above and beyond that provided by viewing the discrepant articles could the JAMA editors have provided? While the JAMA editors castigated Leo for unethical behavior, and sought to punish him for it, they said nothing negative about Robinson. Yet it was Dr Robinson who was supposed to disclose his conflicts to JAMA, but who managed to forget conflicts that he had disclosed before. Why would would it be more unethical to point out publicly available evidence about failure to disclose conflicts of interest than to conceal these conflicts in the first place? This story is saddening. JAMA has published many important and useful articles on conflicts of interest, and other matters relevant to Health Care Renewal. We have probably favorably cited more editorials by JAMA on these topics than those in any other journal. Yet now the journal's leadership seems to have somehow lost their way. Instead of trying to constructively respond to criticism, they now seem intent on punishing the critics. I hope they find their compass soon, before an important medical institution really is irreparably damaged. Note: another detailed analysis of this case is <a href="http://brodyhooked.blogspot.com/2009/03/jama-editors-need-to-come-down-off.html">here</a> in the Hooked: Ethics, Medicine and Pharma blog. <a href="http://online.wsj.com/public/resources/documents/leo_statement_for_WSJ.htm">Here</a> is Professor Leo's response to the JAMA ediorial. ADDENDUM (24 March, 2009) - see also<a href="http://scienceblogs.com/insolence/2009/03/catherine_deangelis_and_jama.php"> the extensive analysis </a>of this case on the Respectful Insolence blog, and the comments <a href="http://scienceblogs.com/effectmeasure/2009/03/jamas_editors_make_sewage_out.php">here</a> on the Effect Measure blog, <a href="http://www.gooznews.com/archives/001359.html">here</a> on Gooznews, and <a href="http://www.kevinmd.com/blog/2009/03/jama-versus-jonathan-leo-debacle.html">here</a> on KevinMD. References 1. Evans DL, Charney DS, Lewis L et al. Mood disorders in the medically ill: scientific review and recommendations. Biol Psychiatry 2005; 58: 175-189. [Link <a href="http://userwww.service.emory.edu/~jdbremn/papers/evans_mooddisorders.pdf">here</a>.] 2. Robinson RG, Zorowitz RD. Pseudobulbar affect and stroke. Stroke: Clinical Updates 2005; XV (Jan-Feb). [Link <a href="http://www.stroke.org/site/DocServer/SCU_-_Jan-Feb_2005.pdf?docID=5161">here</a>.] 3. Robinson RG, Jorge RE, Moser DJ et al. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial. JAMA 2008; 299: 2391-2400. [Link <a href="http://jama.ama-assn.org/cgi/reprint/299/20/2391">here</a>.] 4. Elias M. Study: antidpressants help stroke victims. USA Today, May 27, 2008. 5. Lacasse J, Leo J. Escitalopram, problem-solving therapy, and poststroke depression. JAMA 2008; 300: 1757-1758. 6. Robinson RG, Jorge RE, Arndt S. Escitalopram, problem-solving therapy, and poststroke depression. JAMA 2008; 300: 1758-1759. 7. Leo J, Lacasse J. Clinical trials of therapy versus medication: even in a tie, medication wins. Brit Med J, 2009: 338: b464. [Link <a href="http://www.bmj.com/cgi/eletters/338/feb05_1/b463">here</a>.] 8. Robinson RG, Arnd S. Incomplete financial disclosure in a study of escitalopram and problem-solving therapy for prevention of poststroke depression. JAMA 2009; 301: 1023-1024. [Link <a href="http://jama.ama-assn.org/cgi/content/full/301/10/1023-a">here</a>.] 9. DeAngelis CD, Fontanarosa PB. Conflicts over conflicts of interest. JAMA 2009; 301: [Link <a href="http://jama.ama-assn.org/misc/jed90012pap_E1_E3.pdf">here</a>.]

JAMA Editors Try Attacking the Messenger

Early this month, yet another story surfaced about allegations of undisclosed conflicts of interest affecting the author of a highly publici...

Đọc thêm »

Let's Deregulate Pharmaceutical Information Technology

... after all, a full Electronic Medical Record/Order Entry/Decision Support system is far more complex, with potential for far more immediate patient impact, then pharma's research IT systems. Yet the former is unregulated. <a href="http://www.phrma.org/">PhRMA</a>, you should start lobbying to create your own private Certification Commission For Pharmaceutical IT (CCPIT) now. You can start certifying all your IT by going through a checklist of features, and avoid those pesky FDA inspections just as hospital do! Seriously, my views are identical to that of Hoffman and Podgurski. They expressed their views in the article "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf">Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems"</a>, Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1, and now have summarized and amplified them in the short piece "<a href="http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=3284#">Why Electronic Health Record Systems Require Safety Regulation</a>", Bioethics Forum, Sharona Hoffman and Andy Podgurski, March 20, 2009. Emphases mine: <div style="margin-left: 40px;">...In light of these risks to patient care, federal regulations must establish rigorous quality control mechanisms. Currently, initial approval of EHR systems is conducted by a certification program operated by the Certification Commission for Health Information Technology, a private, industry-based organization. Our review of the certification criteria revealed that they are inadequate to ensure the safety and efficacy of EHR systems . For example, testing is conducted in just one eight-hour period , and the criteria do not explicitly address important issues such as safety and usability. </div> We believe that EHR systems should be scrutinized through a careful premarket approval process, including field testing at several facilities for at least six months. We also recommend local system oversight committees, based on the IRB model , that would oversee field testing and conduct postmarketing monitoring throughout the life of the product. Adverse event reporting would be mandated under this system to ensure that problems are detected and addressed swiftly and that the government intervenes when necessary to safeguard patient welfare. Federal regulations should also require that all EHR systems meet specific quality standards. Audit trails and capture-replay capabilities should be required to facilitate discovery of both system and user errors, much as black boxes allow the reconstruction of conditions that led to aviation incidents . ... Because EHR systems will manage patient care to a significant degree, they must be subject to government oversight akin to the highest level of scrutiny required, in principle, by the Food and Drug Administration for complex medical devices ... Federal regulations should establish appropriate oversight and quality control through EHR system standards, approval processes, and ongoing monitoring requirements. It is only with careful oversight that providers can be assured of investing in high quality EHR products. And it is only with appropriate safeguards that the benefits of this very promising technology will be maximized–that health outcomes will improve and risks as well as costs will decline. I do not think these suggestions are unrealistic. After spending considerable time in pharma, to be consistent I say either we discontinue FDA regulation of pharma clinical IT, or we continue to regulate pharma's IT and add the even more complex provider healthcare IT to the pool of regulated medical devices.-- SS

Let's Deregulate Pharmaceutical Information Technology

... after all, a full Electronic Medical Record/Order Entry/Decision Support system is far more complex, with potential for far more immedia...

Đọc thêm »

BLOGSCAN - The Over-Selling of Seroquel

BLOGSCAN - The Over-Selling of Seroquel

The anonymous blogger on the Clinical Psychology and Psychiatry blog has been hard at work on the story of how research on Seroquel (quetiap...

Đọc thêm »