Big Door Keep Revolving - Our Latest Roundup About the Blurred Lines Between the Health Care Industry and the Government Bodies that are Supposed to Regulate and Make Policy Affecting It

The revolving door continues to turn connecting US government bodies that make health policy or regulate health care and the health care industry.  Sometimes these transitions are obvious, sometimes they are obscure.  The press sometimes makes the revolving door the subject, but more often it is just an aside.<br /><br />The latest roundup of transitions through the door includes, in chronological order of media attention...<br /><br /><b>Former White House Press Secretary to Consultancy Serving Health Care Corporations </b><br /><br />As <a href="http://www.washingtonpost.com/blogs/post-politics/wp/2014/04/06/pelosi-suggests-gibbss-obamacare-comments-due-to-business-ties/">reported</a> by the Washington Post in April, 2014, Robert Gibbs was White House Press Secretary until he departed for the private sector,<br /><br /><blockquote class="tr_bq">Since departing the White House in 2011, Gibbs has taken a path familiar to other former White House officials who use their ties to a president to enrich themselves and establish a new career. </blockquote><br />In particular, he<br /><br /><blockquote class="tr_bq">co-founded <a href="http://www.theinciteagency.com/">The Incite Agency</a>, a consulting and media relations firm that advises Fortune 500 companies, <i>including health-care firms</i>.</blockquote><br />The story was apparently generated after the Democratic House Minority Leader openly criticized someone who served in the Democratic President's White House, so the thrust of the story was about how Mr Gibbs has apparently changed his ideas on Obamacare since his White House days,<br /><br /><br /><blockquote class="tr_bq">House Minority Leader Nancy Pelosi (D-Calif.) suggested Sunday that former top Obama aide Robert Gibbs's <a href="http://www.washingtonpost.com/blogs/post-politics/wp/2014/04/03/top-former-obama-aide-obamacares-employer-mandate-wont-survive/">comment that the employer mandate portion of the Affordable Care Act won't survive</a> <i>might be related to Gibbs's business interests.</i><br /><br />'I don't know who his clients are or what his perspective is,' Pelosi told CNN's '<a href="http://sotu.blogs.cnn.com/">State of the Union</a>.' 'But we are celebrating the fact that we have over seven million who have signed up.'</blockquote><br />The Post also noted,<br /><br /><blockquote class="tr_bq">The speech Gibbs gave this past week in Colorado is consistent with how the Harry Walker Agency bills Gibbs as a potential paid speaker. <a href="http://www.harrywalker.com/speaker/Robert-Gibbs.cfm?Spea_ID=1474">On its Web site</a>, pitches Gibbs by noting that he '<i>played a major role in the daily White House policy debates over the shape of healthcare reform</i>.' It suggests that during such speeches, Gibbs 'articulates the future for the Patient Protection and Affordable Care Act.'<br /><br />The pitch concludes by stating that 'The future of Obamacare -- and how it will affect your business -- is yet to be seen, and <i>few are better prepared than Gibbs to guide you through that conversation</i>.'</blockquote>Again, note that this article seemed to be inspired by Rep Pelosi's direct criticism of a fellow Democrat, not by the revolving door transition per se.   <br /><br /><b>President of Global Government and Scientific Affairs at Natural Products Association to Director of the Division of Dietary Supplements at the FDA then Back to Natural Products Association as CEO</b><br /><br />This round trip through the door was noted rather obliquely in a New York Times <a href="http://well.blogs.nytimes.com/2014/04/30/why-dangerous-supplements-linger-on-shelves/">article</a> in late April, 2014, focused on how slowly the FDA has reacted to apparently dangerous "dietary supplements,"<br /><br /><blockquote class="tr_bq">Before joining the F.D.A. in 2011, Dr. [Daniel] Fabricant was a top executive at an industry trade group, the Natural Products Association.</blockquote><br />The article had previously identified Dr Fabricant as<br /><br /><blockquote class="tr_bq">the director of the division of dietary supplement programs in the agency’s Center for Food Safety and Applied Nutrition.</blockquote><br />But,<br /><br /><blockquote class="tr_bq">The F.D.A. <a href="http://www.nutraingredients-usa.com/Regulation/Fabricant-leaves-FDA-replaces-Shaw-as-head-of-NPA">recently announced</a> that Dr. Fabricant is leaving the agency this month to return to the trade group as its chief executive.</blockquote>While the NY Times article thus mentioned as an aside that a government official with major responsibility for regulating dietary supplements had these relationships with the dietary supplement industry, it did not question whether that relationship had anything to do with slow responses by the FDA to reports of toxic dietary supplements.  <br /><br /><b>Spokesman for the Speaker of the House of Representatives to Spokesman for America's Health Insurance Plans</b><br /><br />USA Today briefly but directly <a href="http://onpolitics.usatoday.com/2014/05/12/brendan-buck-health-insurance-lobby-ahip/">noted</a> this in mid-May, 2014,<br /><br /><blockquote class="tr_bq">House Speaker <i>John Boehner’s spokesman, Brendan Buck, has spent a lot of time over the years helping his boss and congressional Republicans criticize President Obama’s health care law</i>.<br /><br /><i>Now Buck is leaving Capitol Hill to be spokesman for America’s Health Insurance Plans</i>, the trade association that represents thousands of health insurance companies.<br /><br />'Brendan’s experience and skill set will allow him to hit the ground running on Day One,' said Karen Ignagni, president and CEO of AHIP. 'He’s an effective communicator who knows how to tackle complex policy issues and skillfully navigate an ever-changing health care and media environment.'</blockquote><br />What made this interesting seems to be how it represented a change of tune on Mr Buck's part.  Note that many people believe that commercial health insurers will benefit from all the new policy holders that Obamacare sends them, so<br /><br /><blockquote class="tr_bq">As the health insurance  industry’s trade group, AHIP supports the law’s mandate that individuals obtain health insurance. The trade group has praised the Affordable Care Act’s ability to expand insurance coverage.</blockquote><br />But never mind that the man in the government for whom Mr Buck previously worked, <br /><br /><blockquote class="tr_bq">Boehner likes to call Obamacare a 'train wreck.'</blockquote><br /><b>FDA Director of the Office of Medical Policy for the Center for Drug Evaluation and Research to Greenleaf Health Consultancy</b><br /><br />This so far has appeared only in a mid-May, 2014,  <a href="http://www.businesswire.com/news/home/20140519006244/en/FDA-Senior-Official---Dr.-Rachel-Sherman#.U30IqXaGee0">press release</a>.   It describe Dr Sherman's career at the FDA,<br /><br /><blockquote class="tr_bq">During her FDA tenure, Sherman was a driving force for innovation, new programs and policy. Sherman was responsible for spearheading and implementing the Sentinel Initiative, the Critical Path Initiative, biosimilars policy and the new Breakthrough Therapy Designation.<br /><br />As <i>Director of CDER’s Office of Medical Policy and Associate Center Director for Medical Policy Sherman was responsible for developing, coordinating, and implementing medical policy programs and strategic initiatives as well as establishing and chairing CDER's Medical Policy Counsel</i> [sic]. This included overseeing the regulation of prescription drug promotion and advertising. <br /><br />Sherman began her career with FDA in the Division of Antiviral Drug Products at CDER in 1989—first as a medical reviewer and then as a clinical team leader. In 1998, she was appointed Deputy Office Director for the Office of Drug Evaluation I. In 1999, she assumed the duties of Deputy Office Director for the newly established Office of Medical Policy in CDER. </blockquote><br />But now she will be "Principal, Drug and Biological Drug Products" for Greenleaf, described as,<br /><br /><blockquote class="tr_bq">Greenleaf Health is a<i> full service regulatory consulting firm that provides strategic guidance to companies regulated by the FDA</i> and those developing innovative solutions to pressing public health challenges around the globe</blockquote><br />Note that Greenleaf was already well populated with FDA officials who had previously transited the big revolving door,<br /><br /><blockquote class="tr_bq">Patrick Ronan, former FDA Chief of Staff and currently president of Greenleaf; Dr. Daniel Schultz, former Director of the Center for Devices ('CDRH') and Radiological Health and currently Greenleaf's Principal for Medical Devices and Combination Products; Michael Chappell, former Associate Commissioner for Regulatory Affairs, and currently Greenleaf's Principal for Regulatory Compliance; Heather Rosecrans, former Director of CDRH's 510(k) staff and currently Senior Vice President for Medical Devices and Combination Products; Linda Carter, formerly Associate Director of CDER's Office of Evaluation I and currently Vice President of Drug and Biological Drugs; and Taryn Fritz Walpole, former FDA Deputy Chief of Staff, and currently Chief Operating Officer and Senior Vice President for Regulatory Affairs</blockquote><br />So maybe it has become so routine for middle and upper level FDA managers to go to work for consultancies that help industry to deal with the FDA that no journalist found this revolving door transition interesting.<br /><br /><b>Summary</b><br /><br />Again, there appears to be constant traffic among health care corporations and the government bodies that regulate them and make policy that affects them.  The traffic may be so heavy and routine that it no longer appears to be news, unless accompanied by an ironic detail or two.<br /><br />However, as we have said many times before, the constant interchange of health care insiders among government, large health care corporations, and the consultancies, marketing, public relations, lobbying and legal firms which represent them certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry.<br /><br />However, those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for?<br /><br /><br /><div itemprop="articleBody"></div>Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.<br /><br />Real heath care reform would require multi-year cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.    <br /><br />

Big Door Keep Revolving - Our Latest Roundup About the Blurred Lines Between the Health Care Industry and the Government Bodies that are Supposed to Regulate and Make Policy Affecting It

The revolving door continues to turn connecting US government bodies that make health policy or regulate health care and the health care ind...

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EHR Story for Mother's Day 2014: Even The Formerly Simple Act Of Giving IV Fluids in ICU's Can Kill Babies. But's Let's Be Objective and Happy!

<div style="text-align: center;"><span style="font-size: x-small;">[Note to the humorless:  this post is satirical and sardonic to make a very serious point about the perversity of downplaying/ignoring health IT risks, issues too often ignored by those who know better.  If you don't like satire, don't read it.]</span> </div><br />I've been critiqued for posting in too gloomy a manner for some's taste, even those who like me are in the Medical Informatics field.  For example, in the Feb. 2013 Kaiser Health News article "<b>Health Technology’s ‘Essential Critic’ Warns Of Medical Mistakes</b>" at <a href="http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx">http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx</a>:<br /><br /><blockquote class="tr_bq">... <u>Many say he comes on too strong</u>. Even admirers cringed when he began blogging about the 2011 death of his mother, which he blames in a lawsuit on a computer error that allegedly caused Abington Memorial Hospital to overlook a key medication. (Both he and the hospital said they couldn’t comment on a pending suit.) Personalizing his campaign, some thought, made him seem <u>less objective</u>.</blockquote><br />Of course, if a close relative of these unnamed "many" were killed by, say, a drunk driver (something this unobjective group of mothers takes seriously:  <a href="http://www.madd.org/">http://www.madd.org/</a>), or if their child were abducted and decapitated (<a href="http://en.wikipedia.org/wiki/Murder_of_Adam_Walsh">http://en.wikipedia.org/wiki/Murder_of_Adam_Walsh</a>), or if something like this event (<a href="https://www.youtube.com/watch?v=55XJivhjB4U">https://www.youtube.com/watch?v=55XJivhjB4U</a>) happened, their response would surely be "oh well, stuff happens, let's all be 'objective', not 'personalize' things, not advocate with our personal stories, and above all, <b>be happy!   </b><br /><br /><div class="separator" style="clear: both; text-align: center;"> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgz2Sc_Ep0eHVvzgNTK2PPqnYAKho1OUX3pg4Y8MMphHPtZ3nKt71CbjXSeq3PvKwzIPeU6vw8CW5WskPOtYVfQe2bYtIbV9DW-T1KShF-n_EMiMdFwTzT_HR-m58p4oHUhj1JuMVtKbhpg/s1600/smiley.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgz2Sc_Ep0eHVvzgNTK2PPqnYAKho1OUX3pg4Y8MMphHPtZ3nKt71CbjXSeq3PvKwzIPeU6vw8CW5WskPOtYVfQe2bYtIbV9DW-T1KShF-n_EMiMdFwTzT_HR-m58p4oHUhj1JuMVtKbhpg/s1600/smiley.jpg" /></a></div><br />I really do admire the unnamed "many" for their ability to detach, so am presenting the following story of "anecdotal" patient harm to a child in a pediatric ICU in the spirit of happiness, joy, and Mother's Day love!<br /><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj1nVbtntosQYTim-y3sdm6vTMvInD2jgP1ZlsrcxGevCVfigNMgPvzd8HUqh4qznVDYUP4YCPDpMpgcXg4RaT3XCIO4RjdDTdAPL_aExrCYK3A5ePMQZwv8cEk2lGgbZspCOR74YLbtkRd/s1600/vintage_housewife_cook.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj1nVbtntosQYTim-y3sdm6vTMvInD2jgP1ZlsrcxGevCVfigNMgPvzd8HUqh4qznVDYUP4YCPDpMpgcXg4RaT3XCIO4RjdDTdAPL_aExrCYK3A5ePMQZwv8cEk2lGgbZspCOR74YLbtkRd/s1600/vintage_housewife_cook.jpg" width="175" /></a></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiBVdvcXC2vRHlGd1UhzTgr2F7Ut7bWo3S_ppYkE1Ji-F5AMjm1uHvJx2apITS82nBcYMZDHEVDUwW7IUVMpLLc22Y-7Q318dPGia2NwyjsGojNmzNO4Hpsovvd2f9c42UgYEeaEuEq755A/s1600/smiley1.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><br /></a></div><br />Here's the event we should all be happy about, reported via FDA - I note the FDA's said these devices are not "sufficiently risky" to warrant a high level of their attention even though they secretly admitted in an internal memo that there's no way to really know te true level of risk and harm (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>), so clearly they're all a <b>really jolly bunch:</b><br /><br /><blockquote class="tr_bq"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=117690">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=117690</a><br /><br /><b>FDA MedSun report</b><br /><br />Type of device: medical device data system<br />Device brand name: PowerChart<br />Device manufacturer's name: Cerner Corporation<br />Date of this report: (mm/dd/yyyy) 03/04/2014<br /><br />Describe the event or problem:     <br /><b><br />Medication Error. </b>This event was related to Health Information Technology. Specifically, the manner in which the system processed an order for free water replacement. Order was intended to be 20ml/hr for 6 hours for a total of 120ml. It was a 1000 ml bag so first they put 20ml/hr which would have defaulted the infuse over time to 50 hrs.<b> They tried to change the infuse over to 6 hours which then changes the ml/hr rate to 167 ml/hr. </b>They did not notice this had changed. </blockquote><br />Well, that's WONDERFUL!!  :-)  that the computer recalculates the flow rate for them when they change the infusion time, by paternalistically assuming that's what they wanted to do - <b>change the</b> <b>RATE</b> of infusion - when what they actually did is manually <b>change the TIME</b> (duration) of infusion.  <br /><br />How LOVELY of some programmer to have given them this FANTASTIC convenience!!<br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi8yEnZHeor2UZZlhUf4qKrE_4fxFfxrQna0eHhEQagUgU-_a9j1wpRZEfLCAMhkhyphenhyphenOsXIplxq3wLZU4cE3m0rrvjUniE-RugNfZbwUtYsoZXALSsI9k4Grh7jfb78Uc0hHnW_Eh6NGrjDg/s1600/behappy.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi8yEnZHeor2UZZlhUf4qKrE_4fxFfxrQna0eHhEQagUgU-_a9j1wpRZEfLCAMhkhyphenhyphenOsXIplxq3wLZU4cE3m0rrvjUniE-RugNfZbwUtYsoZXALSsI9k4Grh7jfb78Uc0hHnW_Eh6NGrjDg/s1600/behappy.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Aren't computers wonderful!!!</td></tr></tbody></table><br />Even the following should not be cause for ardent technophiles to wipe the smile from their downside-ignoring faces!! <br /><br /><blockquote class="tr_bq">... They did not realize that they <b>needed to go into details tab</b> to show the time frame so the patient got 167ml/hr instead of 20ml/hr for 6 hours. </blockquote><br />How obvious!!!  Every doctor, nurse, medical student and janitor knows from time immemorial knows you have to <b>go into the detail tab to show the time frame!</b>  (Smile)<br /><br /><blockquote class="tr_bq">... Order was verified by pharmacy and administered at that rate via peripheral IV. After approximately 1L of fluid had infused, patient showed seizure activity.  PICU (pediatric ICU) team called to bedside. <b>Treatment provided for seizures and critical sodium and potassium. </b></blockquote><br />Awww ...  some seizures and critical sodium and potassium levels in the PICU.  Awww.....too bad!!!  We should be happy anyway!  For if this child died...the sacrifice would have been WORTH IT for the betterment of electronic medical records worldwide, and the parents no doubt would be flattered and joyous about their contribution to computing science.  After all, how better to figure out how to make this technology work??<br /><br />After all, it takes a few broken eggs to make an omelette, and a few bumps in the road (like grave mounds) should be of little concern.<br /><br />Because, remember ... w.e. c.a.r.e! <br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiyOy_d372Rp11w3A5pCQBf6qnkp-yS-f-doYNL_pYtAkTMY8Rzj24CbQOHIUMcYdrEvM8d38R1Y1DKCwpakFqeoc3ZHv67S5PpRuDwz-sq_fpE3DstFh_OLkzQGej3MaZbuWAuHH8BQPTe/s1600/words+that+work.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiyOy_d372Rp11w3A5pCQBf6qnkp-yS-f-doYNL_pYtAkTMY8Rzj24CbQOHIUMcYdrEvM8d38R1Y1DKCwpakFqeoc3ZHv67S5PpRuDwz-sq_fpE3DstFh_OLkzQGej3MaZbuWAuHH8BQPTe/s1600/words+that+work.jpg" width="155" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><b>i c.a.r.e!!!!</b>  As at U. Arizona Healthcare System, let's only use Happy Words with our patients about these systems! (click to enlarge, see <a href="http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html">http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html</a> )</td></tr></tbody></table><br />Further, we should use<b> </b>only <b>Words That Work </b>to describe the wonders of these systems in their current state!!!<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjgAtZ_SQ0RVtQt8McdXxf2OEPLie5Sk706vuqci5i-jIWHJpJS0iZa7s09yVFO41Bbwq4GvWWpzRRMw9AxeldgzFHxb18eCHSaTtZn73KyFqrypUR2XyQHFf_UhSsRPXw0U5t4WQSm3fFv/s1600/flowers.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjgAtZ_SQ0RVtQt8McdXxf2OEPLie5Sk706vuqci5i-jIWHJpJS0iZa7s09yVFO41Bbwq4GvWWpzRRMw9AxeldgzFHxb18eCHSaTtZn73KyFqrypUR2XyQHFf_UhSsRPXw0U5t4WQSm3fFv/s1600/flowers.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Some flowers from Cerner CEO Patterson to momma to make up for her little baby having seizures and critically deranged potassium and sodium levels from those big, bad doctors' EHR mistake!</td></tr></tbody></table><br /><blockquote class="tr_bq">... The Cerner powerchart software system has functionality for continuous medications/fluid ordering that does not prevent <b>"user error." </b></blockquote><br />Ut oh ... Looks like I'm going to have to be a sourpuss for just a moment and re-introduce the nasty, ill-tempered, non-objective idea of what the dastardly National Institute of Technology and Standards (NIST) calls "use error" (as opposed to "user error", A.K.A. "Blame the User",  <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html</a>):<br /><br /><blockquote class="tr_bq">... The EUP (EHR usability protocol) emphasis should be on ensuring that <b>necessary and sufficient usability validation and remediation</b> has been conducted so that <b>use error</b> [3] is minimized.<br /><br />[3] <span style="font-weight: bold;">“Use error”</span> is a term used very specifically to refer to user interface designs that will engender users to make errors of commission or omission. <b>It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed</b>, e.g., poorly written messaging <span style="color: red; font-style: italic; font-weight: bold;">[or lack of messaging, e.g., no warnings of potentially dangerous actions - ed.]</span>, <u><b>misuse of color-coding conventions</b></u> [see below], omission of information, etc. <span style="font-style: italic; font-weight: bold;"><span style="color: red;"></span></span><br /><span style="font-style: italic; font-weight: bold;"><span style="color: red;"></span></span></blockquote><br />Awwwwww....aren't I just mean and non-objective?<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh8h7Y65reXdJO632szxyY2e3UhlY3P8xr5VhF4vPIz_8cTZXCU_8L4DKIks0v0LLVJwWrKKd9BzQKa7OJpJv5NXGJkqpvjMd7xKU1mjfEaUD6F7MkhesXaq0Gw_4wHcv1DTduyxsr3atPO/s1600/frown.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="165" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh8h7Y65reXdJO632szxyY2e3UhlY3P8xr5VhF4vPIz_8cTZXCU_8L4DKIks0v0LLVJwWrKKd9BzQKa7OJpJv5NXGJkqpvjMd7xKU1mjfEaUD6F7MkhesXaq0Gw_4wHcv1DTduyxsr3atPO/s1600/frown.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><br /></td></tr></tbody></table><br />That mean doctor Silverstein's just not happy and objective!!  Bad, bad, bad man!<br /><br /><blockquote class="tr_bq">... When the provider orders the fluid, example is D5W, the screen opens to a "continuous details" ordering window. Within the screen, the ordering provider is presented with a preselected bag volume and type of fluid with a brownish background. They have the ability to modify bag volume <b>but it was made this color to discourage that change by Cerner. </b></blockquote><br />Golly gee!  There's something to be happy about once again!  <b><u>Brown, the universally-understood color</u>, in any language, means "Warning, do not change this value, it could kill someone!!!"</b> See how GOOD this technology really is!!!  Why use alerts and confirmation dialogs when a mere COLOR like brown suffices!!<br /><blockquote class="tr_bq"><br />... The rate and "infuse over" fields <b>are a yellow color to show that they need to be completed. </b>The intent <span style="color: #cc0000;"><b><i>[of the programmer, clearly an expert in human-computer interaction and communication by color and smoke signals - ed.]</i></b></span> is for an ongoing continuous fluid and not to limit the time. <i></i></blockquote><br />Golly Gee Times Two!  Yellow, the absolutely universal color for <b>"Warning, you need to complete this to prevent killing someone!"  </b><br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiB07i36jmKHcewYx3Gz9u_Dn1b_sU77r5meRSlFySibvF182tqSVyjtTqOuue6t6pDz1RWP6W580szZKrms1eEmRSb_RIpzZGgVfKNduKoAx7uHGW2dKivEC1nq0UCSXHoKm4H1Q_gHPfw/s1600/yellow-light.jpeg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="133" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiB07i36jmKHcewYx3Gz9u_Dn1b_sU77r5meRSlFySibvF182tqSVyjtTqOuue6t6pDz1RWP6W580szZKrms1eEmRSb_RIpzZGgVfKNduKoAx7uHGW2dKivEC1nq0UCSXHoKm4H1Q_gHPfw/s1600/yellow-light.jpeg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Yellow!  Don't you just think every time you see this color that "warning, you need to complete data entry to avoid killing someone?  Who needs WORDS?</td></tr></tbody></table><br />It's all so CLEAR!!!! <br /><br /><blockquote class="tr_bq">... Providers can misinterpret this field to mean the length of time they want the order to infuse over, <b>when the <u>system intent for that field is to be the system-calculated length of time until the next bag supply will need to be sent</u> to maintain the continuous infusion.  </b></blockquote><br />See how simple!!!!   Isn't it OBVIOUS!!!!<br /><blockquote class="tr_bq"><br />The completed fields turn white. <b>Cerner <u>does not have an intermittent fluid administration order</u> <span style="color: red;"><i>[who the hell needs that, says Cerner and the hospital executives who bought this package for the PICU!! Never a need for that in ICU's!! - ed] </i></span>so providers are <u>expected</u> to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. </b>If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, <b>they may inadvertently order a higher rate than intended.</b></blockquote><br /><br />Ha ha!  Those silly doctors can't even figure out a simple thing like that!!  What stooges they are!!<br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhT3rcoW8Gw85QLLLUqEtmVvyIqCGPmTDBoLqWmwLa5zC0a-4ORhr7iLkFrSZBeA02TCfVLzn5pqH7WxtywG0kyZt54ExddyyuDE_UjALynE545TJIgb5SaosZIC6vFUiC9jt6yhyphenhyphenPpqf5i/s1600/three-stooges.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="156" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhT3rcoW8Gw85QLLLUqEtmVvyIqCGPmTDBoLqWmwLa5zC0a-4ORhr7iLkFrSZBeA02TCfVLzn5pqH7WxtywG0kyZt54ExddyyuDE_UjALynE545TJIgb5SaosZIC6vFUiC9jt6yhyphenhyphenPpqf5i/s1600/three-stooges.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">NYUK NYUK NYUK ... Hey Moe!!  Those silly doctors and nurses cannot understand the simple fact that <b>Cerner does not have an intermittent fluid administration order so providers are expected to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. </b>If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, <b>they may inadvertently order a higher rate than intended.</b>  </td></tr></tbody></table><br />See how much FUN health IT problems can be?  After all, in this ANECDOTAL case, all that happened was: <br /><br /><blockquote class="tr_bq">The device(s) may have caused or contributed to: Potential for patient harm, Serious Injury </blockquote><br />But nobody died of this particular problem (that we know of), so this technology is SAFE!!!!<br /><br /><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgNHrlprFiMwMg8w-uhH23RA1KLiJ7O5qDqdj547Mc40zYY4nDhmNEqZ_d5163YRafaQ34simadB6lLrldXAktiWpOZNGbn2kctTetmpIBNH6FhjjBEO7ZIqwQm9Lgo68p7sjlS1Z5FofgT/s1600/Happy-Mothers-Day.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="268" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgNHrlprFiMwMg8w-uhH23RA1KLiJ7O5qDqdj547Mc40zYY4nDhmNEqZ_d5163YRafaQ34simadB6lLrldXAktiWpOZNGbn2kctTetmpIBNH6FhjjBEO7ZIqwQm9Lgo68p7sjlS1Z5FofgT/s1600/Happy-Mothers-Day.png" width="320" /></a></div><br /><br />Happy mother's day!!!<br /><br />--------------------<br /><br />Additional not-so-funny thought:  depending on brown, yellow etc. instead of clear, written alerts/warnings, plus the fact that the system likely "knew" the weight of the child and should have alerted that the infusion of a liter was a very dangerous thing, reflect <b>Bad Health IT </b>on its face:<br /><br /><blockquote class="tr_bq"><span style="font-family: inherit;"><span style="font-size: small;"><span style="color: black;"><b>Bad Health IT</b> ("BHIT") is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.   </span></span></span></blockquote><br />Had I been a pre-marketing tester of this system working for FDA, those fluid-ordering characteristics would have been changed before the system would have been released to market.<br /><br />Oh, wait ... there is no premarketing testing process for health IT, and FDA, via advice from the FDASIA committees as in the linked FDA-related post above, writes that none is really needed.<br /><br />And who wants to damage TRUE INNOVATIONS like this - turning something that takes 5 seconds for a clinician to write, "<b>D5W, 20 ml/hr x 6 hrs</b>" (meaning dextrose 5% in water, 20 milliliters per hour for 6 hours) into a <i>cryptic and muddled exercise</i> with tabs, colors and numerous caveats - via regulation? <br /><br />-- SS<br /><br />

EHR Story for Mother's Day 2014: Even The Formerly Simple Act Of Giving IV Fluids in ICU's Can Kill Babies. But's Let's Be Objective and Happy!

[Note to the humorless:  this post is satirical and sardonic to make a very serious point about the perversity of downplaying/ignoring heal...

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Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.

Bad health IT is defined at my Medical Informatics academic site (<a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>) as follows:<br /><br /><blockquote class="tr_bq"><span style="color: black; font-family: Arial; mso-bidi-font-weight: bold;"><b>Bad Health IT</b> ("BHIT") is health IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.<span style="mso-spacerun: yes;"> </span></span></blockquote><br />Health IT is unregulated, and Bad Health IT <i>results in patient injuries and deaths</i>.   This is unarguable from the data cited in this post and related posts I've linked to.  The levels of harm are unknown.<br /><br />At my April 9, 2014 post "<b>FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it</b>" (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>) I observed how the FDA bent over backwards to avoid regulating Electronic Medical Records systems and other healthcare IT systems:<br /><br />To recap that post:<br /><br />Out of one side of their mouth FDA wrote this:<br /><br /><blockquote class="tr_bq">... products with health management heath IT functions, <b>includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.</b><br /><br />Products with health management health IT functions are of<b> sufficiently low risk</b> and thus, [even] if they <b><u>meet the statutory definition of a medical device</u>, FDA does not intend to focus its oversight on them.</b></blockquote><br />While out of the side of their mouth that was not intended for public viewing, discovered by investigative reporter Fred Schulte, they wrote this:<br /><br /><div style="margin-left: 40px;"><span style="font-family: inherit;"><span style="font-size: 100%;">...In summary, the <b>results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology</b>. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. <b>The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and <u> impedes a more comprehensive understanding of the actual problems and implications</u>.</b></span></span><br /><span style="font-family: inherit;"><span style="font-size: 100%;"><b> </b></span></span> </div>FDA is thus claiming "we know what we non-publicly concluded it is not possible to know, and Health IT is not worth regulating ... even in face of dangers we do know" (e.g., see the alarming ECRI Institute data at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>).<br /><br /><b>Note that everyone who needs medical care</b> (which is. essentially, <i><u>everyone</u></i>) is increasingly exposed to these electronic products with health management heath IT functions, against their will and without any informed consent processes.  The only people exposed to E-cigarettes are <u><i>those who willingly buy and consume them</i></u>.<br /><br />With E-cigarettes, however:<span class="source"> </span><br /><br /><blockquote class="tr_bq"><span class="source">CBS/AP</span>  April 24, 2014<b> </b><br /><b>FDA: Ban sales of electronic cigarettes to minors </b><br /><br /><a href="http://www.cbsnews.com/news/fda-ban-sales-of-electronic-cigarettes-to-minors/">http://www.cbsnews.com/news/fda-ban-sales-of-electronic-cigarettes-to-minors/</a><br /><br /><b>WASHINGTON --</b> The federal government wants to ban sales of electronic cigarettes to minors and require health warning labels and approval for new products under regulations being proposed by the Food and Drug Administration. </blockquote><br />Wonderful.  How thoughtful.  (E-cigarettes are plastic or metal tubes, usually the size of a cigarette, that heat a liquid nicotine solution instead of burning tobacco. That creates vapor that users inhale.)<br /><blockquote class="tr_bq"><br />While the proposal being issued Thursday won't immediately mean changes for the popular devices, the move is aimed at eventually taming the fast-growing e-cigarette industry.<br /><br />The agency said the proposal sets a foundation for regulating the products but the rules don't immediately ban the wide array of flavors of e-cigarettes, curb marketing in places like TV or set product standards.<br /><br />Any further rules "will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits," Commissioner Dr. Margaret Hamburg said.</blockquote><div dir="LTR" id="article-entry"><br />(Perhaps the E-cigarette industry hasn't figured out who to pay off yet?)<br /><br /><blockquote class="tr_bq">... "By being able to regulate e-cigarettes, we'll get a lot more information about what's in them, how they're made and we're already studying e-cigarettes in terms of how they're being used and what are their implications for health," Hamburg told CBS News.<br /><br />"At the present time, when we can't regulate cigarettes, <b>it's like they wild, wild West"</b> she said. <b>"Companies can do anything they want. They can market in ways that they want</b>. ... Unless they make a therapeutic claim that it is a product for actual cessation of nicotine use, we can't regulate them. If they make a therapeutic claim, we can regulate them as a medical product."</blockquote><br />The "Wild, wild west" is a perfect descriptor of the health IT market.  And claims of benefits?  How about some <b>'Words that Work?'  </b>(<a href="http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html">http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html</a>) <br /><br /><blockquote>Hamburg stressed to CBS News that, "Until we have the authority to regulate e-cigarettes, we cannot provide the information that the American public wants about the relative risk and safety of these products. ... <b>We cannot put in place certain restrictions that might be appropriate with respect to how the products are made, the kind of flavorings, the kind of marketing, etc. </b>So we see this as really a crucial first step."</blockquote><br />The health IT industry has special accommodations in that regard that the E-cigarette company lawyers need to closely examine.<br /><blockquote class="tr_bq">Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn't contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. However, there's not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it's unclear how safe they are.</blockquote><br />It's undeniably unclear how safe clinical IT devices are, either.  The ECRI Institute, for instance, found 171 mishaps in 9 weeks at 36 hospitals voluntarily reported, leaving 8 patients harmed and possibly three of them dead.   (A likely far more than serous problem than GM cars with defective ignitions that killed ~13 in a decade...)   The FDA found many injuries and several deaths in their own self-admitted limited dataset as well.  (See <b>FDA Internal Memo on HIT risk</b> at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>).<br /><br /><blockquote class="tr_bq">... Companies also will be required to submit applications for premarket review within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. That would mean companies would have to submit an application for all e-cigarettes now being sold.</blockquote></div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">There is no premarket review of clinical IT of the types categorized by FDA as "with health management heath IT functions" as above, even if those devices meet the statutory requirements as a medical device that falls under the Food, Drug & Cosmetic Act.  These systems increasingly mediate and regulate every transaction of healthcare.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">E-cigarettes, however, are a major concern that are being reviewed in earnest?</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Unbelievable.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">-- SS<br /><br /><span style="font-size: x-small;">DISCLAIMER:  I neither use tobacco products in any form nor E-cigarettes, never did, and have no conflicts of interest of any kind with either the tobacco or E-cigarette industries.</span></div>

Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.

Bad health IT is defined at my Medical Informatics academic site ( http://cci.drexel.edu/faculty/ssilverstein/cases/ ) as follows: Bad Healt...

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Healthcare IT Amateur Kathleen Sebelius Resigns - Good Riddance

The Secretary of the U.S. Department of Health and Human Services (HHS) is resigning.<br /><br />Press reports say she is resigning in large part due to the Exchange Website debacle.<b>   </b>This from the New York Times:<b><br /></b><br /><blockquote class="tr_bq"><b>Health Secretary Resigns After Woes of HealthCare.gov</b><br /><a href="http://www.nytimes.com/2014/04/11/us/politics/sebelius-resigning-as-health-secretary.html?_r=0" target="_blank">http://www.nytimes.com/2014/<wbr></wbr>04/11/us/politics/sebelius-<wbr></wbr>resigning-as-health-secretary.<wbr></wbr>html?_r=0</a><br /><br />... Officials said Ms. Sebelius, 65, made the decision to resign and was not forced out <span style="color: red;"><b><i>[Yeah, right - SS]</i></b></span>. But the frustration at the White House over her performance had become increasingly clear, as administration aides worried that the crippling problems at HealthCare.gov, the website set up to enroll Americans in insurance exchanges, <b>would result in lasting damage to the president’s legacy.</b></blockquote><br />It's not as if there's no literature out there on how to create good health IT.  Doing so is not a state secret.  Simple (and free, unlike the hundreds of millions spent on incompetent <a href="http://en.wikipedia.org/wiki/Beltway_bandits">beltway-bandit</a> 'consultants') Google searches on the term <a href="https://www.google.com/search?q=%22healthcare+IT+failure%22">"healthcare IT failure"</a> or similar return ample resources that could have prevented the "lasting damage to the president's legacy."<br /><br />Way to go, Ms. Ex-Secretary.  Another health IT amateur bites the dust, as my early computer mentor, Philadelphia's George Washington High School math instructor Fred Holzwarth (<a href="http://www.historicbuckscounty.org/nths/HISTORIA/PDF/Historia_Nov2005.pdf">http://www.historicbuckscounty.org/nths/HISTORIA/PDF/Historia_Nov2005.pdf</a>) would have said.<br /><br />However, even worse ... far worse ...<br /><br />Under this Secretary of the Department of Health and Human Services, the principal watchdog agency over medicine and medical device safety under her aegis, the FDA, found that:<br /><br /><blockquote class="tr_bq">... products with health management heath IT functions, <b>includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.</b><br /><br />Products with health management health IT functions are of<b> sufficiently low risk</b> and thus, if they <b>meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.</b> </blockquote><br /><div style="margin-bottom: 0in;">Thus, patients are condemned to injury and death, probably at ECRI Deep Dive study levels [1], for the foreseeable future (see my post on that FDA decision at my April 9, 2014 post <a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html"> <style type="text/css">P { margin-bottom: 0.08in; }</style></a><b>"FDA on health IT risk: reckless, or another GM-like political coverup?"</b> at <a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>).</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">This is especially outrageous at the time massive investigations are ongoing about the 13 deaths caused by apparent coverups of a faulty General Motors <i>ignition switch.</i></div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">It was your FDA agency, Ms. Ex-Secretary.  You own that decision.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Good Riddance, indeed.  </div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">The person at this link: <a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html</a> would certainly agree, if she were alive; she is not thanks to the very devices your FDA just perversely found to be of "sufficiently low risk."</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">-- SS</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Note:</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;"><span style="font-size: x-small;">[1]  In 9 weeks in 36 PSO-member hospitals, 171 IT mishaps sufficient to cause harm were voluntarily reported; 8 injuries occurred, some severe, and 3 deaths may have been the result.  See <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>.</span></div>

Healthcare IT Amateur Kathleen Sebelius Resigns - Good Riddance

The Secretary of the U.S. Department of Health and Human Services (HHS) is resigning. Press reports say she is resigning in large part due t...

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FDA on health IT risk: reckless, or another GM-like political coverup? "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it."

In my Sept. 16, 2013 post <b>"An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT" </b>(<a href="http://hcrenewal.blogspot.com/2013/09/an-open-letter-to-david-bates-md-chair.html">http://hcrenewal.blogspot.com/2013/09/an-open-letter-to-david-bates-md-chair.html</a>) I wrote: <br /><br /><blockquote class="tr_bq">David Bates, Chair, ONC FDASIA Health IT Policy Committee<br />via email<br />    <br />Dear David, I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee's recommendations that health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process.  I believe this recommendation is, quite frankly, negligent. </blockquote><br />The resultant April 2014 report is out: "<b>FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework</b>."  It is available at <a href="http://www.healthit.gov/sites/default/files/fdasiahealthitreport_final.pdf">http://www.healthit.gov/sites/default/files/fdasiahealthitreport_final.pdf</a>.<br /><br />The report is an academic idealist's and industry's dream.  It is a patient's nightmare.<br /><br />Instead of regulation, the report recommends the creation of a nebulous <b>"Health IT Safety Center"</b> (pgs. 16 and 25) as a "public-private entity with broad stakeholder engagement, that includes a governance structure for the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts.<b><i>"  </i>In other words, a toothless organization without true regulatory authority.</b> <br /><br />The recommendations of the Health IT Policy Committee have apparently been taken seriously by FDA.  <br /><br />This FDA announcement recently appeared (FDA is part of HHS):<br /><br /><blockquote class="tr_bq"><a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm390988.htm">http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm390988.htm</a><br /><br /><b><b>HHS News Release</b></b><br /><b><b>For Immediate Release:</b> April 3, 2014</b><br /><br /><b>Proposed health IT strategy aims to promote innovation, protect patients, and avoid regulatory duplication</b><br /><br /><b>HHS today released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework</b>, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.<br /><br />... As proposed in the draft report, posted on the ONC, FDA and FCC websites, there would be three health IT categories, based on function and level of risk, that focus on what the product does, not on the platform on which it operates (mobile medical device, PC, or cloud-based, for example).<br /><br />The first category, products with administrative health IT functions, poses little or no risk to patient safety and as such requires no additional oversight. They include software for billing and claims processing, scheduling, and practice and inventory management.<br /><br />The second category, products with health management heath IT functions, <b>includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.</b><br /><br />Products with health management health IT functions are of<b> sufficiently low risk</b> and thus, if they <b>meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.</b> Instead, the draft report proposes relying primarily on ONC-coordinated activities and private sector capabilities that highlight quality management principles, industry standards and best practices.</blockquote><br />The characterization of these admitted medical devices as <b>"sufficiently low risk"</b> is in my opinion grossly negligent (if not criminal).<br /><br />For instance, GM concealed an ignition flaw that resulted in 13 deaths.<b><i>  Look what's happening now in that sector.  Revelations of corporate wrongdoing and Congressional investigations:</i></b><br /><br /><blockquote class="tr_bq"><a href="http://www.nytimes.com/2014/03/31/business/us-regulators-declined-full-inquiry-into-gm-ignition-flaws-memo-shows.html">http://www.nytimes.com/2014/03/31/business/us-regulators-declined-full-inquiry-into-gm-ignition-flaws-memo-shows.html</a><br /><br />U.S. Agency Knew About G.M. Flaw but Did Not Act<br />By MATTHEW L. WALD<br />MARCH 30, 2014<br /><br />Federal regulators decided not to open an inquiry on the ignitions of Chevrolet Cobalts and other cars even after their own investigators reported in 2007 that they knew of four fatal crashes, 29 complaints and 14 other reports that showed the problem disabled air bags, according to a memo released by a House subcommittee on Sunday.<br /><br />Then in 2010, the safety agency came to the same decision after receiving more reports that air bags were not deploying.<br /><br />The memo also revealed that General Motors approved the faulty design of the switch in 2002 even though the company that made the part, Delphi, warned the automaker that the switch did not meet specifications. This followed a warning the year before — when the Saturn Ion was being developed — but G.M. said that “a design change had solved the problem,” according to the memo.<br />Continue reading the main story<br />Related Coverage<br /><br />The striking new details in the memo bolster the contention that both G.M. and the National Highway Traffic Safety Administration, more than previously acknowledged, <b>ignored or dismissed warnings for more than a decade about a faulty ignition switch that, if bumped, could turn off, shutting the engine and disabling the air bags. General Motors has recalled nearly 2.6 million cars and has linked 13 deaths to the defec</b>t.<b><i> </i></b></blockquote><br />13 deaths, and we get this: <br /><br /><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="362" data-total-count="2158" itemprop="articleBody">A House subcommittee, which gathered more than 200,000 pages of documents from G.M. and 6,000 pages from the agency, will hold a hearing on Tuesday. Mary T. Barra, <b>General Motors’ chief executive, and David Friedman, the acting administrator of the safety agency, are scheduled to testify. Both are also scheduled to testify before a Senate panel on Wednesday.</b></div><div class="story-body-text story-content" data-para-count="362" data-total-count="2158" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="241" data-total-count="2399" itemprop="articleBody"><b>“The problems persisted over a decade, the red flags were many, and yet those responsible failed to connect the dots</b>,” Fred Upton, a Republican of Michigan and the chairman of the House Energy and Commerce Committee, said in a statement.</div><div class="story-body-text story-content" data-para-count="241" data-total-count="2399" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="104" data-total-count="2503" itemprop="articleBody">The most damaging finding in the memo concerned the <b>four fatal crashes that went unheeded by regulators.</b></div><div class="story-body-text story-content" data-para-count="104" data-total-count="2503" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="224" data-total-count="2727" id="story-continues-5" itemprop="articleBody">In a presentation dated Nov. 17, 2007, the safety agency’s investigators reported to its Office of Defects Investigation on the fatal crashes, as well as broad range of complaints and other reports about cars shutting off.</div><div class="story-body-text story-content" data-para-count="224" data-total-count="2727" id="story-continues-5" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="355" data-total-count="3082" itemprop="articleBody">“The panel did not identify any discernible trend and decided not to pursue a more formal investigation,” the House memo said. The findings <a href="http://www.nytimes.com/2014/03/09/business/auto-regulators-dismissed-defect-tied-to-13-deaths.html" title="The report. ">reinforce an analysis</a> by<b> The New York Times published March 8 that found the agency had received more than 260 complaints about Cobalts, Ions and other cars in the recall, citing potentially dangerous shutdowns<i>.</i></b></div></blockquote><br />While GM is being grilled and raked over the coals, the health IT industry is likely going to get the healthcare industry's most generous and unprecedented special regulatory accommodation<b> </b>by FDA<b> due to its products being deemed of "sufficiently low risk"</b> (?) not to merit attention.<br /><br />--------------------------------------------<br /><div><br /></div><b>The FDA statement is particularly reckless, perhaps criminally so, given the following ten points.</b><br /><br />I add that the following are just highlights off the top of my head, and non-inclusive of all known facts on health IT risk:<br /><br />(1)  FDA's own 2010 "Internal Memo on HIT Risk", "not intended for public use" but exposed by Center for Public Integrity investigative reporter Fred Schulte (<a href="http://www.publicintegrity.org/authors/fred-schulte">http://www.publicintegrity.org/authors/fred-schulte</a>) when he was with the Huffington Post Investigative Fund (as described at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2010/08/smoking-gun-internal-<wbr></wbr>fda-memorandum-<span style="font-family: inherit;">of.html</span></a><span style="font-family: inherit;">), stated:</span><br /><span style="font-family: inherit;">  </span><br /><span style="font-family: inherit;"> </span><br /><div style="margin-left: 40px;"><span style="font-family: inherit;"><span style="font-size: 100%;">...In summary, the <b>results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology</b>. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. <b>The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and impedes a more comprehensive understanding of the actual problems and implications. </b></span></span> </div><div dir="ltr"><span style="font-family: Arial; font-size: 100%;"></span></div><br />They then go on to categorize the known risk factors and the impediments to knowing about their occurrence:<span style="font-size: x-small;"><span style="font-family: inherit;"><b> </b></span></span><br /><br /><blockquote class="tr_bq"><span style="font-size: x-small;"><span style="font-family: inherit;"><b>Limitations of the MAUDE search and final subset of MDRs include the following:</b> </span></span><br /><br /><span style="font-size: x-small;"><span style="font-family: inherit;">1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including</span></span><br /><span style="font-size: x-small;"><span style="font-family: inherit;">...(a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;</span></span><br /><span style="font-size: x-small;"><span style="font-family: inherit;">...(b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;</span></span><br /><span style="font-size: x-small;"><span style="font-family: inherit;">...(c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.<br />2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.<br />3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.<br />4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.<br />5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.</span></span></blockquote><br />In other words, FDA does not know the level of risk due to systematic impediments to information diffusion.<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiRf0xG1UixoduxWOjXHN0BAMipTO7-63_YQZ4NKtaFyhMvkpdfo7MwpGBU8O0c6XKxBEM4owWvWl0RBV1amw0nVtJlMCMEwEy-o2fovaDZWLYJRc2uY6hS34Kl-lWLwwl9m-iZySg9o4b5/s1600/memo.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiRf0xG1UixoduxWOjXHN0BAMipTO7-63_YQZ4NKtaFyhMvkpdfo7MwpGBU8O0c6XKxBEM4owWvWl0RBV1amw0nVtJlMCMEwEy-o2fovaDZWLYJRc2uY6hS34Kl-lWLwwl9m-iZySg9o4b5/s1600/memo.jpg" width="243" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="font-size: x-small;">Internal FDA Memo ("not intended for public use") on potential dangers of health IT.  <b>Download the full PDF by clicking <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">here</a></b>.</span></td></tr></tbody></table><br />I think it axiomatic to state that it is, at best, seriously misleading to now state a technology is of "low risk" while internally having admitted that the risk level is not known due to impediments to that knowledge.  That situation has not changed since this memo's internal FDA dissemination, and its disclosure by Schulte.<br /><br /><i><b>This is inexplicable on its face on scientific grounds.</b></i><br /><br />Further, another HHS agency, the Agency for Healthcare Research and Quality (AHRQ, <a href="http://www.ahrq.gov/">http://www.ahrq.gov/</a>) has also taxonomized in detail a rich tapestry of "how health IT can cause harm."  See "<b>AHRQ Health IT Hazards Manager Report</b>" at <a href="http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf">http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf</a> and its contained list of harms on pg. 29, reproduced below.<br /><br />AHRQ has no regulatory authority.  These failure modes are expensive to deal with, thus many will likely only be dealt with by the industry (if at all) <i>after</i> patient harms or near-misses.  Patients, however, are not experimental subjects for the debugging and "improvement" of experimental IT systems. <br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGfJvUqIoCXmUuiiiqJvolkT3Ncg9DoM4VResY7HhOBmbfdZj29hKbwxLRTUbMi7gbaSCfQNdqcKqI6SKWi0JKIyOrHFgBfL3D0-rzEHwfVx6Lm37KilOi8LjiEUBdIzyH9oH47wXprM7H/s1600/ahrq.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="257" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGfJvUqIoCXmUuiiiqJvolkT3Ncg9DoM4VResY7HhOBmbfdZj29hKbwxLRTUbMi7gbaSCfQNdqcKqI6SKWi0JKIyOrHFgBfL3D0-rzEHwfVx6Lm37KilOi8LjiEUBdIzyH9oH47wXprM7H/s1600/ahrq.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">AHRQ Health IT Hazard Manager Report - Hazard Modes of Health IT <b>(click to enlarge)</b></td></tr></tbody></table><br />Surely FDASIA is aware of this.<br /><br /><br /><div>(2)  FDA CDRH Director Jeff Shuren MD, JD's own statement that the known risks are "the tip of an iceberg" <span style="font-size: 100%;">at the<span style="font-weight: bold;"> HIT Policy Committee</span>, <span style="font-weight: bold;">Adoption/Certification Workgroup</span> on February 25, 2010, where the topic was "HIT safety" (The text is available <a href="http://web.archive.org/web/20120320111030/http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf" target="_blank">at this link</a>):</span><br /><br /><div style="margin-left: 40px;">...... In the past two years, we [FDA] have received <span style="font-weight: bold;">260 reports</span> of HIT-related malfunctions with the potential for patient harm – including <span style="font-weight: bold;">44 reported injuries and 6 reported deaths</span>. Because these reports are purely voluntary, they may represent only the<span style="font-weight: bold;"> tip of the iceberg</span> in terms of the HIT-related problems that exist<span style="font-style: italic;"><span style="font-weight: bold;">.</span></span></div></div><div></div><div></div><div></div><div></div><div></div><div><br />Considering the admitted impediments to information diffusion, it's likely even at this point that FDA knew the number of injuries and deaths was far larger than GM's mere 13 ignition defect-related deaths. </div><div><br /></div><div><div>(3)   FDA's <b>MAUDE (Manufacturer and User Facility Device Experience) databas</b>e is a voluntary medical device defects reporting system, but is not specifically purposed for health IT and is almost unknown to typical health IT users as a resource for reporting flaws.  <br /><br />MAUDE reports show health IT devices are <b>literally festooned with an incredible number of flaws</b>, as if they come from dirt-floor-covered software sweatshops with little oversight.<br /><br />These are defects that have made it into live hospital and caregiver devices, and have led to reported harms and death (see <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2011/01/maude-and-hit-risk-<wbr></wbr>mother-mary-what-in.html</a>).<br /><br />The voluntary nature of this MAUDE reporting by just a few HIT sellers, and lack of knowledge of it by health IT users as a resource, cannot fail to lead to the conclusion that the problems are far worse than this limited dataset indicates.<br /><br />(4)  The prestigious U.S. Institute of Medicine of the National Academies (<a href="http://www.iom.edu/">http://www.iom.edu/</a>), perhaps the top scientific authority in this country, also admitted the<b> risk levels of health IT were unknown due to systematic impediments to knowing.</b>  IOM noted this in their <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">late 2011 study on EHR safety</a>:</div></div><div><br /><blockquote>... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, <b><u>little published evidence could be found </u></b><span style="font-weight: bold;"><u>quantifying the magnitude of the risk</u>. </span><br /><br />Several reasons health IT–related safety data are lacking include the <span style="font-weight: bold;">absence of measures and a central repository</span> (or<span style="font-weight: bold;"> linkages</span> among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is <span style="font-weight: bold;">contractual barriers (e.g., nondisclosure, confidentiality clauses)</span> that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “<span style="font-weight: bold;">hold harmless clauses</span>”). The committee believes these types of contractual restrictions <span style="font-weight: bold;">limit transparency, <u>which significantly contributes to the gaps in knowledge of health IT–related patient safety risks</u>. </span></blockquote><br />The IOM did note, contrary to FDA's current finding that these systems are of "<b>sufficiently low risk</b>", that: <br /><br /><blockquote><span style="font-weight: bold;">These barriers to generating evidence pose unacceptable risks to safety.</span><span style="font-style: italic;">[IOM (Institute of Medicine). 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press, pg. S-2.]</span><span style="font-weight: bold;"><br /></span></blockquote><br />Also in the IOM report:<br /><br /><blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the<span style="font-weight: bold;"> ability to generalize the results across the health care system may be limited</span>. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.<br /><br /><b>More worrisome, some case reports suggest that poorly designed health IT can create new hazards</b> in the already complex delivery of care. <u><b>Although the magnitude of the risk associated with health IT is not known</b></u>, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”</blockquote></div><div></div><div><br />IOM could not have stated the reality more explicitly than via their statement "<u><b>the magnitude of the risk associated with health IT is not known."</b></u> </div><div><br />(5)   Surely FDA (and the FDASIA committees responsible for the new Report) are aware of  the ECRI Institute's Deep Dive study results from a study they carried out within their PSO-member hospitals (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2013/02/peering-underneath-<wbr></wbr>icebergs-water-level.html</a>).  I would call 171 voluntarily-reported health IT-related mishaps in 36 hospitals over 9 weeks, with 8 injuries and 3 possible deaths, an alarming study.<br /><br />In fact, in 2014 based on their PSO data, the ECRI Institute identified health IT as #1 of the "Top Ten Technology Risks in Healthcare" (<a href="http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html">http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html</a>):<br /><br /><blockquote class="tr_bq"><span style="font-family: inherit;"><span style="font-size: small;">CONCERN #1: <b>Data integrity failures with health information technology systems</b></span></span><span style="font-family: inherit;"><span style="font-size: small;"> </span></span><br /><br /><span style="font-family: inherit;"><span style="font-size: small;">With the federal government offering financial incentives for hospitals and physician practices to adopt EHR systems, use of these systems more than tripled from 2009 through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice president, technology evaluation and safety, ECRI Institute. <b>“They are managing a lot of</b><b> information, and it’s easy to get something wrong” if the systems are not designed and </b><b>implemented well.</b> While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions,<b> the presence of incorrect data can lead to incorrect</b> treatment, potentially leading to patient harm.</span></span></blockquote><span style="font-family: inherit;"><span style="font-size: x-small;"></span></span></div><div></div><div><br />I certainly would NOT aver that this technology's risk level is of "<b>sufficiently low risk</b>" to not warrant formal regulation by a body skilled in software regulation, as is FDA., e.g., for medical devices and for IT used in pharmaceutical clinical trials data management and drug manufacturing.<br /><br />See for example <b>"General Principles of Software Validation; Final Guidance for Industry and FDA Staff" </b>at <a href="http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm">http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm</a>.<br /><br />(I would <i><b>really</b></i> not enjoy being in a position to have to make such an averment about "<b>sufficiently low risk</b>" under GM ignition investigation-like conditions... )</div><div><br /></div>(6)  Surely FDA (and the FDASIA committees responsible for the new Report) are aware of the data reported by the medical malpractice insurer CRICO, that insures the Harvard medical community (see <a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2014/02/patient-safety-<wbr></wbr>quality-healthcare.html</a>):<br /><br /><blockquote class="tr_bq">... CRICO recently analyzed a year’s worth of medical malpractice claims in its comparative database [from numerous sources] and found <b>147 cases in which EHRs were a contributing factor</b>. Computer systems that don’t “talk” to each other, test results that aren’t routed properly, and mistakes caused by faulty data entry or copying and pasting <b>were among the EHR-related problems found in the claims, which represented $61 million in direct payments and legal expenses.</b>  ... <b>Half of the 147 cases resulted in severe injury.</b> <span style="color: red;"><b><i> [Death numbers are unstated - ed.] </i></b></span></blockquote><br />Note that these numbers were an examination of lawsuits filed; most medical malpractice never gets to the point of an actual filed lawsuit due to the unfavorable economics of the medical malpractice industry.  Perhaps 5% of actual events ever get filed, thus CRICO's data is also a "tip of an iceberg."<br /><br />(7)  Surely FDA (and the FDASIA committees responsible for the new Report) are aware of mass risk introduced by faulty systems such as in the incident in Rhode Island, at Lifespan Healthcare (<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html</a>), where thousands of prescriptions were altered by faulty HIT without physician knowledge.  Suffixes for the long acting version of a drug (e.g., "XL" or "XR") were dropped:<br /><br /><blockquote class="tr_bq">PROVIDENCE, R.I. (WPRI) - Rhode Island State Senator Jamie Doyle says he is <span style="font-weight: bold;">shocked to hear a <a href="http://www.lifespan.org/">Lifespan</a> computer glitch caused thousands of patients to receive the wrong types of medication. </span><span style="font-weight: bold;"><span style="color: red;">[Appx. 2,000 across five Lifespan hospitals according to the Providence Journal, see below, and </span></span><span style="font-weight: bold;"><span style="color: red;">the</span> <a href="http://www.washingtonpost.com/business/ri-senator-wants-investigation-after-up-to-2000-hospital-patients-got-wrong-form-of-medicine/2011/11/03/gIQAufcviM_story.html">WaPo</a></span><span style="font-weight: bold;"><span style="color: red;"> - ed.]</span></span><br /><br />Doyle is now calling for an independent review of all the hospitals Lifespan runs, and a review of the Rhode Island Department of Health.<br /><br />The DOH is investigating after learning patients who were supposed to receive medications taken once a day <b>instead received medications meant to be taken more than once per day.  <span style="color: red;">[In other words, they were taking short acting drugs on a long-acting once a day schedule, thus being massively under-dosed - ed.]</span></b></blockquote><br />(8)  The FDA (and the FDASIA committees responsible for the new Report) surely cannot be unaware of all of the "glitches" reported on in-situ health IT systems, as cataloged at this blog under the tag "glitch" and as of this writing numbering 25 posts, some including patient deaths.  See the results of the query link: <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>.<br /><br />(9) Surely FDA (and the FDASIA committees responsible for the new Report) cannot be unaware that FDA itself had to recall health IT with flaws "serious enough to cause patient death":<br /><br /><blockquote class="tr_bq"><b>FDA recall.  McKesson Anesthesia Care – Patient Case Data May Not Match Patient Data</b>:  <b>Use of this affected product may cause serious adverse health consequences, including death. </b><br /><a href="http://hcrenewal.blogspot.com/2014/03/ehr-recall-use-of-this-affected-product.html">http://hcrenewal.blogspot.com/2014/03/ehr-recall-use-of-this-affected-product.html</a><br /><br /><b>FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"</b> <br /><a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html">http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html</a><br /><br /><b>FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems </b><br /><a href="http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html">http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html</a><br /><br /><b>FDA recall:  An ED EHR "Glitch" That Mangles Prescriptions </b><br /><a href="http://hcrenewal.blogspot.com/2013/08/a-good-way-to-cynernetically-harm-or.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2013/08/a-good-way-to-<wbr></wbr>cynernetically-harm-or.html</a> </blockquote><br />(10)  FDA (and the FDASIA committees responsible for the new Report) are surely not unaware of my own report to its MAUDE database (because the hospital denied my request to issue the report itself) of a fundamental defect in a widely used health IT system, Eclipsys Sunrise, that nearly caused the death of my mother... AFTER she was seriously injured due to a flaw in an ED's EHR that did lead a year later to her death:<br /><br /><blockquote class="tr_bq"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=172955">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=172955</a>2 <br /><br />ECLIPSYS SUNRISE CLINICAL MANAGER       <br />Event Date 06/12/2010<br />Event Type  Injury   Patient Outcome  Hospitalization,Other,Life Threatening,Required Intervention<br />Event Description<br /><br />The eclipsys sunrise clinical manager emr/cpoe is in use at (b) (6) hospital. This system appears to have a serious deficiency: <b>an apparent lack of date constraint validity checking when users are seeking information on prior medication orders and administration. </b>(b) (6), (b) (6) was admitted (b) (6) 2010, for cerebrovascular problems. Famotidine iv was started prophylactically to prevent gastric problems, but was discontinued and changed to protonix a few days later due to suspicion of causing severe agitation and confusion, causing her to pull her lines. Around (b) (6) 2010, patient was transferred to physical therapy floor in the hospital. Hospital considers such a transfer to be a "discharge" and "readmission. " however, patient did poorly, had to be sent back to med-surg floor several days later. Due to having pulled a percutaneous endoscopic gastrostomy tube -peg tube-, she was started on TPN on (b) (6) 2010. In the first bag of tpn solution was 40 mg. Famotidine. Patient's mental status began deteriorating and she began to get very, very agitated and confused once again. Eclipsys sunrise problem/bug was noted when son, a physician informaticist -and author of this report- noted the 40 mg famotidine in the tpn bag, and reported to the floor rn that this was contraindicated. The rn pulled up the medication order and administration records on the eclipsys sunrise clinical manager system to confirm famotidine had been administered previously. Famotidine was shown only as being ordered for tpn on (b) (6), but not prior. The rn selected a date constraint entry box, at which time a calendar widget popped up. The rn set the date constraint back to (b) (6), then (b) (6), then (b) (6) 2010, but the use of the famotidine at that time did not appear. Son of patient demanded the famotidine be stopped anyway, which it was, and that an allergy entry be entered. However, it was fortunate son was a physician and remembered the name of the medicine. In tracing this error today, it was found that the data from admission on (b) (6) to "discharge" to physical therapy floor (b) (6) 2010, was unavailable since it was considered a "prior admission" although the patient had never left the hospital physically. The sunrise system, however, failed to flag the (b) (6) 2010 date constraint entries as 'out of bounds' for the current admission. <b>The validity of the date constraints was not checked, preventing the rn user from realizing he should have called up the prior admissions records. If son of patient had not been a physician, famotidine might have been continued and patient might have suffered more severe consequences than she did after the 40 mg was given in the first tpn bag</b>. As it was, she spent the next three days in a severe delirium and is only slowly recovering. That the eclipsys sunrise ehr did not alert its user that the date constraints they set for seeking medication ordering and administration data were out of bounds -beyond the range of the current "admission" <b>-is a significant and severe oversight and/or bg, and a danger to patients not fortunate enough to have a physician informaticist son closely monitoring their care. </b></blockquote><br />Addendum May 4, 2014:<br /><br />(11)   CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  (But let's spend hundreds of billions of dollars anyway.) <br /><br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgKNTHRZ65twX8W-4VKJyyfOxz-EKIMmIfoipBwryewkc-IKs_JkusXtcujYkfmjqkzRE_1FyX0m7GAS3X-MTb0rq0yeup3rRxjRKLk2xmnWlO6BLlwHE0rJOqULoHziPGyOKQnO3Jkb2La/s1600/CMS_Letter.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgKNTHRZ65twX8W-4VKJyyfOxz-EKIMmIfoipBwryewkc-IKs_JkusXtcujYkfmjqkzRE_1FyX0m7GAS3X-MTb0rq0yeup3rRxjRKLk2xmnWlO6BLlwHE0rJOqULoHziPGyOKQnO3Jkb2La/s1600/CMS_Letter.jpg" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  <b>Click to enlarge.</b></td></tr></tbody></table><br />--------------------------------------------<br /><br />Note that these ten points themselves, all I had time to write about this morning, themselves represent a "tip of the iceberg" regarding health IT risks.<br /><br />In my opinion it's immensely reckless for FDA to make a statement that "products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software<b> ...</b> are of <b>sufficiently low ri</b>sk" so as to not warrant formal regulation that is already in place for other healthcare software sectors.<br /><br />Fortunately, the public gets to comment via this announcement:<br /><br />Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report; Notice to Public of Availability of the Report and Web Site Location; Request for Comments<br /><a href="http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4678">http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4678</a><br /><br />I feel, however, that the decision is a given, and that the health IT industry has such regulatory capture that public comments will be ignored.  (Not that I won't try.)<br /><br />Finally:<br /><br />I ponder what ever happened to the inquiry responses about health IT defects and harm sought by the Senate Finance Committee, as reported in the Washington Post:<br /><br /><blockquote class="tr_bq"><b>Electronic medical records draw frequent criticisms</b><br />By Alexi Mostrous<br />Washington Post Staff Writer<br />Sunday, October 25, 2009 <br /><br /><a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/10/24/AR2009102400967.html?hpid%3Dtopnews&sub=AR">http://www.washingtonpost.com/wp-dyn/content/article/2009/10/24/AR2009102400967.html?hpid%3Dtopnews&sub=AR</a><br /><br />... the Senate Finance Committee has amassed a thick file of testimony alleging serious computer flaws from doctors, patients and engineers unhappy with current systems.<br /><br /><b>On Oct. 16, the panel wrote to 10 major sellers of electronic record systems, demanding to know, for example, what steps they had taken to safeguard patients.</b> "Every accountability measure ought to be used to track the stimulus money invested in health information technology," said <a href="http://projects.washingtonpost.com/congress/members/g000386/" target="">Sen. Charles E. Grassley</a> (Iowa), the panel's ranking Republican. </blockquote><br />The results of that request seem to have gone to the recycle bin.<br /><br />-- SS<br /><br />

FDA on health IT risk: reckless, or another GM-like political coverup? "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it."

In my Sept. 16, 2013 post "An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against...

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Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life.<br /><br />Even self-stated human rights advocates in healthcare won't seem to broach the topic of <b>EHR-related harms</b> and<b> lack of informed consent processes</b> regarding their use in a patient's care, even when authors openly state their concerns for patient and human rights.<br /><br />This is despite known harms at potentially alarming levels as indicated by organizations including the IOM, FDA, ECRI Institute, AHRQ, Harvard Med Mal insurer CRICO, The Joint Commission, NHS in the UK, and others.<br /><br />Forbes contributor Nicole Fisher (<a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a>) published an article in Forbes dated 3/18/2014 and entitled <b>"Electronic Health Records - Expensive, Disruptive And Here To Stay</b>" (<a href="http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/">http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/</a>).<br /><br />You can read the article at the above link.  It focuses on physician distraction and dissatisfaction, poor usability and usefulness, expense, and related issues.  Of course, quotes from HHS figure prominently.<br /><br />Nowhere, however, is mention of EHR-related harms to patients, such as reported by the aforementioned organizations mentioned - as in this very small sample list of posts, which contain links to source:<br /><br /><blockquote class="tr_bq"><b>Patient Safety & Quality Healthcare: "CRICO Malpractice Claims Analysis Confirms Risks in EHRs"</b><br /><a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a><br /><br /><b>Peering Underneath the Iceberg's Water Level: ECRI "Deep Dive" Study of Health IT "Events"</b><br /><a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a><br /><br /><b>Internal FDA memorandum on HIT risks</b><br /><a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a><br /><br /><b>IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care"</b><br /><a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a><br /><br /><b>EHRs and Deadly glitches</b><br /><a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> (multiple posts)<br /><br /><b>Not to forget issues of breach of privacy:</b>  <br /><a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a> (multiple posts)</blockquote><br />Nor are mentioned the issues of the experimental, unregulated nature of this technology, and the lack of any informed consent process regarding patient's rights to decide whether or not to have these systems used in their care.<br /><br />The only mention of "<b>unintended consequences</b>" links to "<a href="http://www.emrandhipaa.com/guest/2014/03/11/unintended-icd-10-consequences-inadequate-clinical-documentation-can-negatively-impact-physician-profiles-icd-10-tuesdays/">Unintended ICD-10 Consequences: Inadequate Clinical Documentation Can Negatively Impact Physician Profiles</a>." <br /><br />This is in my view disappointing, and seems to be yet another extraordinary healthcare IT industry accommodation, remarkable for an author with the following bio (emphases mine):<br /><br /><blockquote class="tr_bq"><a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a><br /><br />Nicole Fisher is the Founder and Principal at HHR Strategies, <b>a health care and human rights focused advising firm.</b> Additionally, she is a Senior Policy Advisor and health policy expert on health economic analyses mainly focusing on Medicare, Medicaid and health reform, <b>specifically as they impact women and children</b>. Nicole runs a Health Innovation and Policy page at Forbes.com highlighting and advising companies, ideas and people that are changing the health care landscape. She is also currently pursuing her PhD at the University of North Carolina in the Health Policy and Management Department. Her writing has appeared in other publications such as Health Affairs, Wall Street Journal, Washington Post, Centers for Medicare & Medicaid Services Journal, Wright on Health, The Health Care Blog and Health Services Research. Before pursuing her PhD in health policy, Nicole earned her Master’s degree in Public Policy from the University of Chicago and her undergraduate degree from the University of Missouri. Her health care and policy work at those institutions <b>had an emphasis on underserved populations, women's and children’s issues</b>. She presides on several Boards for domestic and international health organizations and <b>frequently speaks on health reform and human rights.</b></blockquote><br />One might conclude the computer has more rights than the patient and the clinician via this Forbes piece.<br /><br />Finally, although I am a domain specialist (<a href="http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx">http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx</a>), I am getting rather tired of having to point out the obvious to major media outlets and writers, in essence doing their homework for them.  I'm sure other bloggers feel the same way.  <br /><br />The title of the Forbes piece should have been "<b>Electronic Health Records - Expensive, Disruptive, Deadly."</b><br /><br />To the author of the Forbes piece and other HIT writers, here is the face (and gravestone) of someone injured by this "disruptive" technology.  <b> </b><a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html</a><br /><b><br /></b>A few babies too:  <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a><b></b><br /><b><br /></b>A family man:  <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html</a><br /><br />I know of others from my legal work supporting the EHR-related injured and deceased that I cannot mention.  And I am but one person.<br /><br />If health IT were causing rapes** and child abuse, rather then merely causing mundane severe injuries and equally mundane deaths, would the media would pay more attention? <br /><br />-- SS<br /><br />** I sadly note that EHR's without proper security measures in force actually did enable rape-like behavior in 2011, as at <b>"EHR as Molestation Candidate Selector: What was this Resident looking for in the EHR before 'examining' female patients?"</b> at <a href="http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html">http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html</a>.<br /><br />

Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life. Even self-stated human rights advocates in healthcare won't seem to broach the topic of EHR...

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Clinical Trial Prestidigitation - Making Old Data Look Worse So New Data Looks Better

Prestidigitation, also known as <a href="http://en.wikipedia.org/wiki/Sleight_of_hand">sleight of hand</a> or legerdemain, is a form of stage magic which uses dextrous manipulation and misdirection to distract the viewer from seeing it. <br /><br />The example, <a href="http://www.bloomberg.com/news/2014-02-25/boehringer-kept-pradaxa-analysis-from-fda-records-show.html">reported</a> by Bloomberg on 26 February, 2014, is discussed late because the nature of the trick meant it took me a while before I understood how it was done.<br /><br /><b>Background</b><br /><br />Pradaxa, a new anticoagulant, was approved by the US Food and Drug Administration (FDA) in 2010 for use by patients with atrial fibrillation to prevent strokes.  We <a href="http://hcrenewal.blogspot.com/2014/02/cant-this-be-avoided-how-corporate.html">discussed</a> previously the release of documents during litigation that showed how marketers from its manufacturer, Boehringer - Ingelheim, attempted to manipulate the results of a clinical study of the drug.  The study results initially seemed to suggest that blood tests should be used to monitor therapy with it.  However, that would have contradicted a key marketing message, that Pradaxa was more convenient than warfarin because it did not require blood tests for monitoring.<br /><br />Litigation by patients alleging that Boehringer-Ingelheim concealed the severity of the bleeding risks caused by the drug<br />continues.  The Bloomberg <a href="http://www.bloomberg.com/news/2014-02-25/boehringer-kept-pradaxa-analysis-from-fda-records-show.html">report</a> dealt with how the company responded to requests by the FDA for data about these risks.   <br />  <br /><b>The Question from the FDA</b><br /><br />As per Bloomberg,<br /><br /><blockquote class="tr_bq">In the Pradaxa case, the regulators asked Boehringer to compare fatal bleeding reports received by the FDA against the number of patients using the drug in order to establish a death rate. The request was made to allow the FDA to 'evaluate the need for modifications to the Pradaxa label or future study,' according to a letter made public as part of the court files.<br /><br /> The company reported back that 6.1 of every 10,000 patients who used the drug after approval developed fatal bleeding, the court documents showed. The regulators also asked Boehringer to reanalyze results from an earlier study used to gain approval to see how that rate compared. </blockquote><br />So, in other words, the FDA wanted to assess the rate of bleeding reflected by reports received after the drug had gone on the market (that is, the FDA was evaluating data from post-marketing surveillance.)  To do so, it wanted to calculate the proportion of patients who took the drug who developed fatal bleeding.  Then it wanted to compare this rate to the rate of fatal bleeding found in the previous controlled trials of the drug done by the manufacturer to secure drug approval.  Note that these trials are also considered the major source of clinical research evidence about the benefits and harms of the drug.<br /><br />The major source of clinical evidence about Pradaxa (dabigatran) was the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulation Therapy), sponsored by Boehringer-Ingelheim, published in the New England Journal of Medicine [Connolly SJ, Ezekowitz MD, Yusuf S et al.  Dabigatran versus warfarin in patients with atrial fibrillation.  N Engl J Med  <span class="citation">2009; 361:1139-1151.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa0905561">here</a>.]   The trial reported that the rates of life-threatening bleeding were 1.8% per year for warfarin, 1.45% for high dose dabigatran, and the rates of major bleeding of 3.36% versus 2.21%.  However, the trial report did not include rates of fatal bleeding per se, nor the rates of patients with major bleeding who then died.   </span><br /><br /><b>Presto Chango</b><br /><br />According to Bloomberg, here is how Boehringer-Ingelheim responded to the question from the FDA about the rate of fatal bleeding.<br /><br /><blockquote class="tr_bq"><i>That effort produced two separate analyses</i> by the company, according to the unsealed court documents. One, looking only at <i>people whose primary cause of death was bleeding, found 5.8 of 10,000 patients died per year</i>. The other, which included anyone who <i>had a major bleeding event and died for any reason, found a rate of 19.5 fatal events per 10,000 patients per year,</i> the documents show.<br /><br /> The report sent to the FDA, though, <i>contained only the analysis indicating the death rate from the earlier research was much higher than the numbers seen after approval,</i> according to the court filings. Potentially, such a finding <i>could head off any after-market action by the FDA because the data showed the drug was safer after it was approved and widely used.   </i></blockquote><br />So, to recapitulate, Boehringer-Ingelheim used results from the RE-LY trial to persuade the FDA that its new drug was safe and effective.  However, the company did not include, at least in the results reported publicly, any measure of fatal bleeding in patients given the drug.  It now appears that the rate of major bleeding in patients who subsequently died was high, perhaps high enough to have raised questions about the safety of the drug prior to approval, had it been revealed.<br /><br />However, after the drug had been approved, when the question was about rates of severe bleeding after the drug had been marketed, the company furnished an analysis of data from the clinical trial that now showed a very high bleeding rate. That was the major misdirection, the sleight of hand.. It would make the rate of fatal bleeding in the post-marketing surveillance data appear low.  <br /><br />But apparently this data also kept the eyes of the FDA focused on the question of bleeding in the post-marketing period.  Did no one in the FDA notice that while this high rate of bad bleeding in the trial made the post-marketing surveillance look good, it also raised questions about whether the drug should have been thought to have been safe enough to be approved in the first place?   <br /><br /><br />By the way, Bloomberg also reported that Boehringer-Ingelheim performed a trick for European regulators,  <br /><br /><blockquote class="tr_bq"><i>Selective disclosure of Pradaxa information may have camouflaged a serious safety signal</i>, according to an assessment report from <a href="http://www.ema.europa.eu/ema/" rel="external" title="Open Web Site">European Medicines Agency’</a>s Committee for Medicinal Products for Human Use in August 2012. That agency is the European Union’s drug regulator.<br /><br />Boehringer also didn’t give the EMA the figures showing that real-world bleeding rates were higher when the committee conducted a similar review and published a report in August 2012. The panel’s analysis, which concurred with Boehringer’s, concluded that Pradaxa’s bleeding risks among the general population were 'substantially less' than the rates seen in the study the drugmaker used as the basis for approval. It didn’t have the analysis showing the risk was higher using a different approach, according to the unsealed files. <br /> <br />'If the reporting rate in the post-marketing phase had been higher than in' Boehringer’s study, 'there would clearly have been a safety concern,' agency officials wrote. </blockquote><br /><b>Summary</b><br /><br />We have discussed a variety of ways that companies that sell health care goods (like drugs or devices) and services may <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulate clinical research</a> to make their products look better than they may actually be.  It appears that these companies may hire very clever people who are very knowledgeable about the design of clinical research to game the system to aid marketing, but meanwhile obfuscate the clinical research data that clinicians and patients rely on to make clinical decisions in the best interests of patients, and that policy makers rely on to make decisions in the best interests of the public.  So far, the hands of the corporate marketers seem to be quicker than the eyes of the clinicians, patients, and policy makers. <br /><br />I wonder, though, how those very clever people sleep well at night knowing that their talents for legerdemain are being used to increase revenues and make corporate insiders rich, at the expense of patients, and of patients' health? <br /><br />As I have said before, and most recently in the context of <a href="http://hcrenewal.blogspot.com/2014/02/cant-this-be-avoided-how-corporate.html">discussing</a> the previous example of manipulation of clinical research to support Pradaxa marketing,  I strongly advocate that those who author authoritative systematic reviews, meta-analyses, and clinical practice guidelines base their work on extremely rigorous, skeptical reviews that assume the likelihood that all commercially sponsored published clinical research has been manipulated (and that research that even post manipulation could not be twisted to support marketing many have been <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a>)  Reviews, meta-analyses, and guidelines that were not so based on extremely critical review should also be viewed with a jaundiced eye.  <br /><br />Perhaps it is possible to devise legal and regulatory methods to at least make such manipulation more transparent.  Maybe this case, however, should again suggest that clinical research, that is, research on human beings, should be completely separated from those with vested interests in selling products or services which could be better hyped were the research turn out in their favor. <br /><br />Hat tip to <a href="http://1boringoldman.com/index.php/2014/02/26/foot-in-mouth-disease/">1BoringOldMan</a>.

Clinical Trial Prestidigitation - Making Old Data Look Worse So New Data Looks Better

Prestidigitation, also known as sleight of hand or legerdemain, is a form of stage magic which uses dextrous manipulation and misdirection ...

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