healthy4u: stealth lobbying

Is the Meaningful Use Stage 2 Final Rule invalid?

Here are a few reasonable questions I decided to elevate as a post of its own. In the face of the discovery of industry influence over comments submitted to ONC regarding Meaningful Use Stage 2, as I documented at my post earlier today "<a href="http://hcrenewal.blogspot.com/2012/08/health-it-vendor-epic-uses-clients-as.html">Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?</a>" (<a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing" target="_blank">ghost writing</a>, in effect, by those with obvious conflicts of interest): <ul><li> Is the MU Stage 2 Final Rule invalid due to the influence the industry had on the submitted "public" comments and opinions, supposedly by and of the submitters, which are now demonstrably tainted?</li><li> Should an investigation be opened?</li></ul> After all, as I pointed out on Aug. 29 in "<a href="http://hcrenewal.blogspot.com/2012/08/the-scientific-justification-for.html" target="_blank">The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology</a>", not only is MU2 based on an admitted "nevertheless, we believe" justification (that is, lack of scientific rigor), but now it appears the legislation is based on stealth lobbying and resultant regulatory capture, ONC in essence doing the seller's bidding. Tens of billions of taxpayer dollars are at issue here. -- SS

Is the Meaningful Use Stage 2 Final Rule invalid?

Here are a few reasonable questions I decided to elevate as a post of its own. In the face of the discovery of industry influence over comme...

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Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?

<div style="text-align: left;">Note: Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at <a href="http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html">http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html</a>.</div> ----------------------- From the Histalk blog in the 8/31/12 news <a href="http://histalk2.com/2012/08/30/news-83112/" target="_blank">at this link</a>: <blockquote class="tr_bq">Epic not only submitted MU Stage 2 comments to ONC, it even helpfully distributed them to their customers so they could submit the same comments under their own names. <a href="http://dclunie.blogspot.com/2012/08/why-onc-whimped-out-annotated.html" target="_blank">David Clunie</a> noticed this and lists the hospitals who sent in the boilerplate, including University of Miami, which submitted the same comments five times without noticing the “Remove Before Submitting” headline that prefaced Epic’s explanation of why its customers should share its opinions with Uncle Sam.</blockquote> From the primary source linked in the Histalk note: <blockquote class="tr_bq"><a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0147" target="_blank">Epic via University of Michigan Health System Meaningful Use Workgroup</a> also the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0241" target="_blank">same Epic comments from University of Miami</a> (who liked them so much they <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0241" target="_blank">submitted it twice</a> and then a <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0326" target="_blank">third time</a> and then a <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0313" target="_blank">fourth</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0299" target="_blank">fifth</a> time) and again from the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0123" target="_blank">Martin Health System</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0137" target="_blank">Metro Health Hospital</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0306" target="_blank">The Methodist Hospitals</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0404" target="_blank">Fairview Health Services</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0358" target="_blank">Sutter Health</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0338" target="_blank">Parkview Health System</a> and the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0284" target="_blank">Everett Clinic</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0255" target="_blank">Dayton Childrens'</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0254" target="_blank">UMDNJ</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0243" target="_blank">NYU Langone Medical Center</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0142" target="_blank">Hawaii Pacific Health</a> and finally as submitted by <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0285" target="_blank">Epic themselves</a> - others like the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0158" target="_blank">Community Health Network</a> just stated they had read and agreed with Epic's comments - Imaging - concur that DICOM is not needed for that objective and PACS images do not need to be duplicated - concerned about single sign on if two systems - View, Download and Transmit to 3rd Party - images are not in the EHR but the PACS - patients would need DICOM viewers - size of the images is a problem - disks are better (also if you look at some copies of this, there are some pretty funny "remove before submitting to ONC" notes that say things like which versions support what and how much it would cost to retrofit, etc.; how embarrassing, both for Epic and their lackeys at these institutions)</blockquote> I certainly admire David Clunie's endurance at being able to slog through all of that and appreciate his shedding some sunlight on the "remove before submitting" notes, but - I don't think it's funny at all. Among other things, it represents taint of the submissions via <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing" target="_blank">ghostwriters</a> (unattributed authors) with obvious <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest" target="_blank">conflicts of interests</a>, topics often addressed at HC Renewal. Here's an example I verified, the submission to the government from Dayton Children's Hospital: <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/AVvXsEirxuPSNKvfNLmw5qDGu4JlMVP-MPi6cFKz36m3M_3lZOGY90p1U3Tw36P-mHfyXcyEVGviytPAI6tSdBcvjEgKryW9vAZbve_nooHA5H5vj4Fhdgt7Zn83CBGGrHw6qAX9nedacFQbfZxS/s1600/remove_before_submitting.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="348" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEirxuPSNKvfNLmw5qDGu4JlMVP-MPi6cFKz36m3M_3lZOGY90p1U3Tw36P-mHfyXcyEVGviytPAI6tSdBcvjEgKryW9vAZbve_nooHA5H5vj4Fhdgt7Zn83CBGGrHw6qAX9nedacFQbfZxS/s400/remove_before_submitting.bmp" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">"Informational Comments for Organizations Using EPIC (remove before submitting to ONC)" - click to enlarge.  At least here they say they are "in total agreement" with EPIC's concerns and recommendations.  </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td></tr></tbody></table> Another example - University of Miami: <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/AVvXsEgOJPENnCLi6R2iGZR_GWK9akDzTBYxtYsy5YZi0rONJsZqF8FSCNxjVeO1MUYeGQLEHOqG8vndOhgb2rUn9OWCSMUNLLXGrtAjJAE9CNRdd4WLijC4RFOjLwEvXwoV4B2pF_awkyAzyTLl/s1600/miami.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="392" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgOJPENnCLi6R2iGZR_GWK9akDzTBYxtYsy5YZi0rONJsZqF8FSCNxjVeO1MUYeGQLEHOqG8vndOhgb2rUn9OWCSMUNLLXGrtAjJAE9CNRdd4WLijC4RFOjLwEvXwoV4B2pF_awkyAzyTLl/s400/miami.bmp" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">A danger of dealing with incompetents:  they neglect to tidy up for you - click to enlarge.  (Corollary question: note the line "Our [Epic's - ed.] comments stem from the fact the we believe ..."  So - what opinions belong to the 'public commenting organization', and which to the company?  Likely the whole thing belongs to the latter's ghostwriters, but can anyone really tell?  That's the problem with tainted submissions.)</td></tr></tbody></table> Others is the links above I checked such as Martin and Methodist have the same boilerplate about the "chart search feature."  Some retain the "reminder" to remove; in others it has been erased.  However, the boilerplate remains. I actually find the "advice" from EPIC in the latter document stunning regarding a "chart search feature" (e.g., search note text, and probably also ad hoc clinical searches such as 'find my patients whose blood sugars have been > 100 in the past month').  These are "features" critical to quality care that should have been present decades ago ** [see note below].  Emphasis mine: <blockquote class="tr_bq">... Focus certification on the minimum floor set of capabilities required to complete meaningful use objectives. </blockquote> Is this a tacit admission "certification" is a sham?  Is this in patients' best interests? and <blockquote class="tr_bq">Informational Comments for Organizations Using Epic (remove before submitting to ONC) We’ve heard your requests for a chart search feature, and our desire to see this certification criterion removed does not mean we don’t want to develop such a feature. In a future version of Epic, we want to develop the best possible chart search feature based on your input. However, if this criterion stays in the Final Rule, we worry we’ll have to divert attention from future chart search features you’ve requested to focus on a simplified, less valuable version of the feature to meet certification. </blockquote> In my opinion, this translates to: "we are already overextended, so help us stymie the experts' and government's efforts to make it a criteria for certification, and to hell with your doctors and nurses who need a search feature right now." Can you imagine in 2012 a word processor, database or operating system without a search feature?  That's the kind of antediluvian IT the clinicians have to put up with.  And this industry speaks of "innovation?" It would come as no surprise - to me, at least - if other health IT sellers were engaged in similar activities. I am unable to judge whether stealth lobbying by sellers using their clients, which enables the sellers to then line their pockets through favorable government legislation based on echoed comments of clients, is legal or ethical.  My belief, however,  is that it is at best a questionable practice.  It is certainly inherently unfair e.g., anti-competitive in regard to smaller health IT companies who might be able to meet more stringent MU2 certification criteria, and unfair to private citizens who have no such captive mouthpieces at their beck and call.  While perhaps not as bad as possible 'Combination in Restraint of Trade' as in my April 2010 post "Healthcare IT Corporate Ethics 101" (<a href="http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html" target="_blank">link</a>), this situation should probably be brought to the attention of health IT watchdogs such as Sen. Grassley. This May 2012 post might also be of interest:  <a href="http://hcrenewal.blogspot.com/2010/05/did-epic-ceo-judy-faulkner-of-epic.html" target="_blank">Did EPIC CEO Judy Faulkner of Epic declare that 'healthcare IT usability would be part of certification over her dead body'?</a>  ONC never responded to the questions I raised in the post. Another question:  why did ONC apparently turn a blind eye towards these "accidental inclusions"?  Yet another question:  is the MU2 Final Rule invalid due to the influence the industry clearly had on the submitted "public" comments, which can now reasonably be viewed as tainted? -- SS Addendum: I've informed the Senator via his email and staff voicemail lines.  I've also created a short URL to more conveniently access this post:  <a href="http://www.tinyurl.com/epic-stealth">http://www.tinyurl.com/epic-stealth</a> Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at <a href="http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html">http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html</a>. -- SS Note: ** For instance, I had  implemented a robust search feature of clinical notes, all comment fields and the comprehensive clinical, genetic and genealogical dataset in the Yale-Saudi Clinical Genetics EHR - in 1995.

Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?

Note: Also see the followup Sept. 5, 2012 post " Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule? " at ...

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Polly Want a Million (Plus)

We have frequently posted about attempts to justify financial relationships among physicians and medical academics on one hand, and pharmaceutical, biotechnology, device and other health care corporations, on the other. Some defenders of such relationships now have gone so far as to start their own society, whose meeting was covered and commented on by fellow "pharmascolds," including <a href="http://carlatpsychiatry.blogspot.com/2009/07/acre-meeting-welcome-to-anger-village.html">Dr Daniel Carlat </a>and <a href="http://brodyhooked.blogspot.com/2009/07/carlats-take-on-acre-some-ruminations.html">Dr Howard Brody</a>. The usual justification of these relationships is that they are necessary for "innovation" and the onward progress of medical science, education, and care. I have yet to see any logic or evidence to back up these assertions, nor have I seen anyone defend these relationships who does not also have personal financial relationships of their own with health care corporations. (See examples <a href="http://hcrenewal.blogspot.com/2008/01/logical-fallacies-and-discussion-of.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/04/can-people-with-conflicts-of-interest.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2009/07/again-logical-fallacies-in-defense-of.html">here</a>.) Meanwhile, cases of individual physicians and academics whose lucrative relationships with industry seem to generate huge conflicts of interest continue to surface. The latest example ferreted out by investigators working for US Senator Charles Grassley (R - Iowa) is that of Dr David Polly. (Recall that Dr Polly was one of the strongest defenders of Dr Thomas Kuklo, who was accused of falsifying clinical research results in a way that seemed to favor the product of his own corporate benefactor [see post <a href="http://hcrenewal.blogspot.com/2009/05/breach-of-trust.html">here</a>].) The main points were <a href="http://online.wsj.com/article/SB124882216054688233.html">reported</a> by David Armstrong and Thomas M Burton in the Wall Street Journal, <blockquote>In May 2006, University of Minnesota spine surgeon David Polly urged a Senate committee to fund research into the severe arm, leg and spine injuries suffered by soldiers in Iraq and elsewhere. Dr. Polly told the committee he was testifying on behalf of the American Academy of Orthopaedic Surgeons and referenced his prior work caring for soldiers as a surgeon at the Walter Reed Army Medical Center. What Dr. Polly didn't disclose during his testimony was that his trip to Washington was paid for by Medtronic Inc., the big medical-device maker whose bone growth product, called Infuse, has been used to treat soldiers, according to company records. Dr. Polly and colleagues in Minnesota subsequently received a $466,644 Department of Defense grant for a two-year study beginning in February 2007 to evaluate Infuse in cases where an injury is also infected, according to the university. Dr. Polly was paid $1.14 million by Medtronic for consulting services from 2004 to 2007. Details of Dr. Polly's consultant billing were provided by Medtronic to Sen. Charles Grassley, an Iowa Republican who has been scrutinizing the relationship between academics and industry. </blockquote> Although there have now been many reported cases of medical academics who collected large payments from health care corporations, the services they provided in exchange for the money have not always been very clear. Defenders of financial relationships among physicians and medical academics and industry have argued that most payments were for valuable research, education, or health care activities. However, Senator Grassley's office provided the details of Dr Polly's invoices, and several of the news articles so far described what he did for the money. Per the Wall Street Journal article, <blockquote>In total, Dr. Polly billed Medtronic for more than $50,000 in lobbying-related costs. He made trips to Washington in 2005 and 2006 and called on several members of Congress, according to the records. According to billing records, Dr. Polly's billing rate was $4,750 for an eight-hour day in 2007, and he billed as many as 13,000 minutes a quarter -- or 216 hours over three months. In some months, he conducted at least some Medtronic business on nearly every day. His consulting log indicates that on one occasion he spent one minute to wake up a Medtronic executive, although he listed 'no charge' for that service. He did bill Medtronic for the 30 minutes he spent in the car with that executive after waking him up. </blockquote> An accompanying post on the Wall Street Journal Health Blog provided <a href="http://blogs.wsj.com/health/2009/07/29/what-a-doctor-did-that-was-worth-1-million-to-medtronic/">more information</a>: <blockquote>Did you ever wonder what doctors do to earn big consulting contracts from medical device companies and pharmaceutical concerns? Records released by Medtronic to Sen. Charles Grassley, a longtime critic of the ties between academics and and health-care companies, provide a rare and detailed glimpse into the daily billings of a consultant — in this case, spine surgeon David Polly of the University of Minnesota. Polly collected more than $1 million in four years of work for Medtronic, according to the records, which you can take a look at <a href="http://s.wsj.net/public/resources/documents/UMinnLetter.pdf" target="blank">here</a>. The services he provided were many, but among them, Polly was paid to write articles for medical journals; write a chapter in a book and a book outline; recruit patients for publicity efforts; attend Medtronic national sales meetings; travel to conferences in Japan, Paris and elsewhere; lead training and educational sessions for physicians; and lobby Congress. Polly also billed for at least two phone calls with Medtronic CEO William Hawkins as well as charging the company $2,000 when Mr. Hawkins visited an operating room. In October, 2003, he billed the company $12,000 for attending a medical meeting of the North American Spine Society, at $4,000 a day. There are also scores of entries for work billed in five-minute increments, usually to send email or return phone calls. The bill for each five-minute charge? $49.48 a pop. </blockquote> So did the $1.2 million Medtronic spent on Dr Polly's services inspire any "innovation?" Did it lead to any scientific progress or improved health care? I am not sure. It is clear, however, that a good chunk of this money went to support marketing, advocacy, and lobbying. The items in bold italics above were clearly in support of marketing, advocacy and lobbying, not science, medical education, or patient care. (To give Dr Polly the benefit of a doubt, some other items listed above could have been related to research, education, or patient care, although this is not indisputable.) So the case of Dr Polly corroborates my deep skepticism of the financial relationships among physicians and medical academics on one hand, and corporations that sell health care goods and services on the other. We "pharmascolds," - a preferable term might be health care skeptics - suspect that many of these relationships are really about stealth marketing and advocacy. The companies often pay to market their products and services, or advocate positions to the companies' advantage, but prefer that their salespeople and advocates are cloaked in academic guises, and wreathed in the rarefied aura of respected academic institutions. (Note that some of us are just as skeptical about relationships among academic institutions and other health care not-for-profit organizations on one hand, and such corporations on the other, for analogous reasons.) While the leadership of our formerly distinguished medical academic institutions remains infiltrated, if not dominated by people earning many thousands of dollars from health care corporations, I must remain skeptical about how much of these institutions supposedly academic output is actually stealth marketing and stealth health policy advocacy. At the very least, medical academics, medical academic institutions, and other health care not-for-profits or NGOs should reveal in detail what payments they get from companies selling health care products or services, and how these payments could relate to the companies' marketing or lobbying efforts. In the US, some such disclosure would be mandated by the proposed "Sunshine" legislation now being considered by the US Congress. (By the way, note that this problem is hardly confined to the US, and needs global, not just American attention.) However, physicians (at least physicians in full-time private practice, academic positions, and employed by mission-oriented not for profit organizations) should go further, and consider whether receiving industry money is worth the ongoing damage it does to our professionalism and our professional reputations. Medical schools, universities, health care foundations, disease advocacy groups, and other health care not-for-profits and NGOs should also go further, and consider whether receiving industry money is worth the ongoing damage it does to their missions, and their institutional reputations. See also comments by Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=15588">on the University Diaries blog</a>.

Polly Want a Million (Plus)

We have frequently posted about attempts to justify financial relationships among physicians and medical academics on one hand, and pharmace...

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The Machinery Behind Healthcare Reform: How the HIT Lobby is Pushing Experimental and Unsafe Technology on Unconsented Patients and Clinicians

(To those who linked here from "<a href="http://www.thehealthcareblog.com/the_health_care_blog/2009/05/microsoft-google-in-healthy-competition---cnet-news.html">The Health Care Blog</a>", see my footnote at the end of this post. Also, I suggest readers at least peek at each and every hyperlink I've placed in this essay. It takes time, but it's illuminating - ed.) <div><div> In many past posts on Healthcare Renewal I have commented on a bewildering healthcare and IT industry blindness to a growing body of literature and experiences of those "in the trenches" that throw doubts upon Utopian views of health IT as a panacea for healthcare's problems. Those responsible for this literature advise caution and the highest levels of scientific rigor in the large scale adoption of clinical information technology if that technology is to actually improve healthcare, myself included. We know the difficulties and risks. Bad healthcare informatics wastes money and distracts clinicians. <a href="http://iig.umit.at/efmi/badinformatics.htm">Bad healthcare informatics can kill</a>. "Primum non nocerum" is a critical ideology in health IT. I first wrote about these observations <a href="http://www.tinyurl.com/hit-misadventure">a decade ago</a> and was merely standing on the shoulders of those who preceded me with their own critical thoughts and observations regarding cybernetic miracles in medicine. I've also been puzzled about the sudden lurch by the current administration to commit tens of billions of dollars to national HIT, along with eventual penalties for resistance, within the ridiculously short time frame of 2014 and with little public discussion. The provisions seemed to simply "appear" in H.R. 1 EH, a.k.a. the Economic Recovery Act of 2009. I wrote about this <a href="http://hcrenewal.blogspot.com/2009/02/illusions-of-hope-over-experience.html">here</a>. Finally, I was curious about the timing of a remarkable set of reports from highly respected U.S. organizations on HIT issues, such as a Dec. 2008 Sentinel Events Alert from the <a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm">Joint Commission</a> and a Jan. 2009 report from the <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">U.S. National Research Council</a>. What motivated their release? The answers to these questions have become bit clearer via a remarkable article from the Washington Post. It reveals an administration heavily influenced by - no surprise - powerful industry lobbyists. (I thought this administration had pledged a different mode of government conduct, but as has been said, campaigning is done with poetry, and governing is done with prose.) Here is an interesting explanation of how medicine has been cross-occupationally invaded by the IT industry, probably ten or more years before that industry really has the depth of understanding, depth of talent and capabilities to make useful, usable, safe, and cost effective national health IT a reality: <blockquote><a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">The Machinery Behind Health-Care Reform</a> How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records By Robert O'Harrow Jr. Washington Post Staff Writer Saturday, May 16, 2009 When President Obama won approval for his $787 billion stimulus package in February, large sections of the 407-page bill focused on a push for new technology that would not stimulate the economy for years. The inclusion of as much as $36.5 billion in spending to create a nationwide network of electronic health records fulfilled one of Obama's key campaign promises -- to launch the reform of America's costly health-care system. But it was more than a political victory for the new administration. It also represented a triumph for an influential trade group whose members now stand to gain billions in taxpayer dollars. A Washington Post review found that the trade group, the Healthcare Information and Management Systems Society (HIMSS), had worked closely with technology vendors, researchers and other allies in a sophisticated, decade-long [lobbying] campaign to shape public opinion and win over Washington's political machinery ... At the center of those efforts is the Healthcare Information and Management Systems Society. Started a half-century ago, it represents 350 companies and about 20,000 members. Corporate members include government contractors such as Lockheed Martin and Northrop Grumman, health-care technology giants such as McKesson, Ingenix and GE Healthcare, and drug industry leaders, including the Pharmaceutical Research and Manufacturers of America. With financial backing from the industry, they started advocacy groups, generated research to show the potential for massive savings and met routinely with lawmakers and other government officials.</blockquote> A lot of voices were left out of that trade group's lobbying, including the open source EHR proponents following the traditions of the <a href="http://www.va.gov/cprsdemo/">VistA effort</a>, as one can learn about in the book "<a href="http://www.amazon.com/Medical-Informatics-Electronic-Collaboration-Innovation/dp/0763739251">Medical Informatics 20/20</a>" by VA pioneers Goldstein, Groen et al. These traditions are largely alien to the commercial IT sector as evidenced by the mission hostile clinical IT products they put out (see my series on that issue <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-idiots-part-1.html">starting here</a>) and even known <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf">grossly defective software</a> for use on live patients. The HIMSS trade group's massive conflicts of interest also seem to have blinded it to the longstanding concerns of many experts in medical informatics, social science and related fields that <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">current approaches to health IT are insufficient</a> and may impair healthcare quality initiatives (let's be frank about what that really means - it means patient harm). The creation of advocacy groups backed by industry financing also seems eerily similar to many stories on HC Renewal and other blogs about the pharmaceutical industry, as does "generated research." That "research" may also have been industry funded, and it is my belief the impartiality and soundness of such research needs to be critically and impartially re-examined. <blockquote>Their proposals made little headway in Congress, in part because of the complexity of the issues and questions about whether the technology and federal subsidies would work as billed. </blockquote>In other words, Congress was doing its job regarding lobbying by proponents of an experimental technology in which they had a major financial stake. Until... <blockquote>As the downturn worsened last year, advocates helped persuade Obama's advisers to dust off [i.e., uncritically accept lock, stock and barrel - ed.] electronic records legislation that had stalled in Congress -- legislation that the advocates had a hand in writing, the Post review found. Their sudden success shows how the economic crisis created a remarkable opening for a political and financial windfall: the enactment of a sweeping new policy with no bureaucratic delays and virtually no public debate about an initiative aimed at transforming a sector that accounts for more than a sixth of the American economy.</blockquote> Let me add that while the advocates "had a hand" in writing the legislation [i.e., they wrote the legislation - ed.], researchers and critical thinkers regarding the downsides of health IT industry in its present state seem to have had little voice in this legislation. <blockquote>"It was perhaps a once-in-a-generation opportunity to make something happen," said H. Stephen Lieber, the trade group's president. Obama "identified the vehicle that he could use to move his policy agenda forward without the crippling policy debate."</blockquote> I find this simply outrageous. The reason for policy debates in healthcare and especially healthcare IT is to avoid crippling or killing patients. Lieber is not a clinician. Who is he to cheer (and perhaps to have spearheaded) the short circuiting of "policy debate" on health IT? According to his <a href="http://www.himss.org/Content/files/SLieber_bio.pdf">bio</a>, he holds an MA from the School of Social Service Administration at the University of Chicago, a BA in Psychology from the University of Arkansas, and has completed additional course work at the graduate schools of business at both universities and at the Keller Graduate School of Management. <blockquote>... Many technology advocates, including health policy specialists, say that networked electronic patient records that can be transmitted instantly would make health care more efficient and provide valuable insights about costs and care.... Some advocates also say the savings could amount to tens of billions of dollars each year from reduced paperwork, faster communication and the prevention of harmful drug interactions. An equally important benefit, they say, could be to enable researchers to determine the most effective procedures for an ailment. Such an approach would rely on unprecedented data-mining into medical records and the practices of doctors, a kind of surveillance that also would enable insurers to cut costs by controlling more precisely the care that patients receive [Leading to rationing to increase profits? - ed.]</blockquote> These assertions have never been proven in a scientifically robust manner. Further, there is a growing body of literature expressing significant doubts about these predictions of cybernetic miracles from health IT (see short partial lists of examples <a href="http://hcrenewal.blogspot.com/2009/03/reader-on-why-we-have-busywork.html">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=other">here</a>) that has largely been ignored - in the worst traditions of pseudoscience and scientific fraud - by the industry and its lobbyists. In fact, the latter assertion - comparative effectiveness research based on EHR data - may have moved from scientific possibility (e.g., better detection of major adverse drug and therapy events) to anti-scientific pipe dream, as in my essay "<a href="http://hcrenewal.blogspot.com/2009/04/have-we-suffered-complete-breakdown-in.html">Have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?</a>" I am not even considering massive potential for abuses created by online national health records. <blockquote>"Finally, we're going to have access to millions and millions of patient records online," said Blackford Middleton, a physician, Harvard professor and chairman of the Center for Information Technology Leadership, whose studies have concluded the health-care system could save $77.8 billion each year through the universal use of information technology networks. "This is the biggest step for health-care information technology in this country's history." But others said the case was far from being so clear. Some observers said the projected savings are overly optimistic and that launching such vast computer networks under tight deadlines is risky, a lesson learned by the Bush administration when it botched a variety of homeland security systems rushed into place after the Sept. 11 terrorist attacks. </blockquote> While I respect Blackford Middleton as a former leader of the EHR company from which I selected the EHR for Christiana Care Health System in the late 1990's, I also respect those "others" who say the case is far from clear. It is through science and an open political process that such debates need to be resolved, not through lobbying and utopianism. The potential for adverse, unexpected consequences in such a major social re-engineering effort are simply too great for cavalier attitudes or utopianism. We are already seeing adverse consequences - just the most recent examples are <a href="http://hcrenewal.blogspot.com/2009/05/dangerous-health-it-mismanagement-spin.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/05/medical-cyber-piracy.html">here</a>. Industry "roll out HIT no matter what, patient and clinician <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">informed consent</a> be damned" attitudes also teeter on the precipice of human rights violation. In fact, the corporatization of health IT and the treatment of health IT as if it were any other IT not involving third parties with special rights (i.e., patients) may have already resulted in serious breaches of hospital executive fiduciary responsibilities towards safety and (in the U.S.) of their Joint Commission safety standards obligations as well; see my essay <a href="http://hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html">here</a>. <blockquote>Some proponents said they worry that an over-reliance on technology as a solution could distract the health-care system from difficult questions about quality of care. They said efforts to find a quick technological fix will likely run up against complex cultural challenges.</blockquote> The latter quote sounds like me, stating the obvious. Allow me to translate the applied, real world meaning of "cultural challenges." It means increased political infighting between stakeholders, power grabs, distractions and chaos on the medical floor and in the medical office, and other social and political upheavals within medicine that will likely distract from the ability of already harried clinicians to provide care. <blockquote>"I would like to believe that the effective use of technology to augment health care will lead to substantial savings and improvements in the quality of care," said Mark Frisse, a physician and professor of biomedical informatics at Vanderbilt University, who leads an electronic health record program in Nashville. "But the evidence does not consistently bear this out."</blockquote> Dr. Frisse is quite correct, although I would add that the evidence that does not bear out these beliefs is many, many times stronger than that which, say, caused VIOXX to be pulled off the market. <blockquote> "HIMSS has a very effective grass roots advocacy program that reaches all levels of government," Dave Roberts, a senior executive, said in the group's literature... HIMSS has a "strategic alliance" with the Center for Information Technology Leadership, a nonprofit that produces research reports -- which HIMSS prints and distributes to Congress and elsewhere.</blockquote> I agree with that description. Missing from the description, and one I would not add, is a "scientific organization." <blockquote>After volunteering on John Kerry's presidential campaign in 2004, [now-chairman of the board of HIMSS and their ally, the Center for Information Technology Leadership] Middleton said he was recruited as an Obama volunteer last year and provided information about electronic records to the candidate's health-care policy group. Middleton said he worked with several campaign officials, including David Blumenthal, a colleague at Partners HealthCare and a Harvard professor, who was Obama's health-care adviser and is now the administration's national coordinator for health technology. "We didn't have to go very far to get our information," said one senior Obama adviser, who was not authorized to speak publicly and discussed the campaign on the condition of anonymity. Blumenthal "taught all the rest of us everything we know."</blockquote> He may have taught them "everything they know", but he apparently did not teach them everything that is important to know. Obama's team has seemingly thrown a significant body of literature on HIT drawbacks and risks under the bus. This is the essence of scientific naïveté and quackery. <blockquote>Middleton said he provided many of those details. "I sent them a LOT of stuff, many papers and most of the reports. I probably spoke or communicated with David Blumenthal, David Cutler (the health economist on the team), or Dora Hughes about every other week during the heat of the campaign," Middleton said in an e-mail. </blockquote> While Blumenthal goes on in the article to minimize Middleton's influence, I can only wonder if any of the HIT industry lobbyists sent "<a href="http://iig.umit.at/efmi/badinformatics.htm">this stuff</a>" to the campaign. <blockquote>The stimulus bill suggests that the government will recoup about a third of the spending allocated for electronic health records over the next decade, an assumption that some health-care observers question, in part because of a critical analysis by the Congressional Budget Office last year. The CBO, then led by Orszag, examined the industry-funded study behind the $77.8 billion assertion, among other things, and concluded that it relied on "overly optimistic" assumptions and said much is unknown about the potential impact of health information technology.</blockquote> I can add that not only is there much unknown about the potential, but there is much unknown about the true difficulties of making it all actually work as promised. See <a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf">this seminal short article</a> on why this is so. This is a spectacularly poor way to run major national initiatives costing tens of billions of dollars and upon which patient wellbeing rides. Blindly. <blockquote>Joseph Antos, a health-care policy specialist who has examined the legislation, said the risks of the technology plan are high because of the haste with which it is being implemented and the special interests seeking to profit from it. "This is the real way things get done [and the "real" way true disasters such as our recent world wide financial chaos get initiated - ed.]," said Antos, of the American Enterprise Institute, a Washington think tank. "The stimulus bill looked like a bonanza to an awful lot of people." [I tend to take "awful lot of people" quite literally in this case.]</blockquote> Haste is an understatement. A more reasonable timeframe might have been <a href="http://www.jamia.org/cgi/content/abstract/13/1/106">2024</a>, not 2014. I can add that if this initiative blows up as it has in the UK, then the only triumph will be the financial triumph of the trade group and its apparatchiks. The losers will be the administration, patients, clinicians, and everyone else in the healthcare system. [6/29/09 addendum: it's worse than I thought. The UK's NPfIT in the NHS was suspected to have been doomed from the start, but proceeded anyway; see "<a href="http://www.computerweekly.com/blogs/tony_collins/2009/06/16-key-points-in-gateway-revie.html">16 key points in Gateway Reviews on NHS IT scheme</a>" and the <a href="http://www.connectingforhealth.nhs.uk/about/foi">Gateway Reviews themselves</a>, released under a UK FOI request - ed.] In all seriousness, and with recognition of the harshness of this observation, I add that the patients who might die as a result of hastily and poorly designed and implemented health IT under this rushed "real way" initiative, will have in effect been murdered by this lobby. -- SS Footnote: It is interesting to watch the "circling of the wagons" that is starting over the WaPO story. It is in fact predictable that ad hominem, distortion of views, etc. will follow. For example, Matthew Holt of The Health Care Blog, <a href="http://www.thehealthcareblog.com/the_health_care_blog/2009/05/microsoft-google-in-healthy-competition---cnet-news.html">who writes</a> (emphases mine): <blockquote>I draw your attention to a troika of articles, all of which show how things can be slightly misinterpreted. First, who knew that Blackford Middleton was either the most influential health policy wonk out there, or single-handedly responsible for the Haliburtonization of health IT? If you read <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?sub=AR">the WaPo article about it</a>, it looks as though there was some kind of terrible conspiracy to impose an evil fraud in terms of unnecessary health IT spending on the taxpayer. And for example MedinfomaticsMD over at Health Care Renewal (who appears to have jumped from the position that some health IT installations have real problems to the less tenable one that all EMRs kill) is just one <a href="http://hcrenewal.blogspot.com/2009/05/machinery-behind-healthcare-reform-how.html">going loopy about it</a>.</blockquote> "Loopy?" Merriam-Webster: <blockquote><a href="http://www.merriam-webster.com/dictionary/loopy">Loopy</a>: 1 : having or characterized by loops 2 : <a class="lookup" href="http://www.merriam-webster.com/dictionary/crazy">crazy</a>, <a class="lookup" href="http://www.merriam-webster.com/dictionary/bizarre">bizarre</a> <div class="run_on" mwref="http://www.m-w.com/mwref">— loop·i·ly <a class="audio" href="http://www.merriam-webster.com/cgi-bin/audio.pl?loopi01v.wav=loopily%27" onclick=" popWin('/cgi-bin/audio.pl?loopi01v.wav=loopily'); return false; "><img alt=" Listen to the pronunciation of loopily" src="http://www.merriam-webster.com/images/audio.gif" title=" Listen to the pronunciation of loopily" /></a> \-pə-lē\ adverb </div><div class="run_on" mwref="http://www.m-w.com/mwref">— loop·i·ness <a class="audio" href="http://www.merriam-webster.com/cgi-bin/audio.pl?loopi02v.wav=loopiness%27" onclick=" popWin('/cgi-bin/audio.pl?loopi02v.wav=loopiness'); return false; "><img alt=" Listen to the pronunciation of loopiness" src="http://www.merriam-webster.com/images/audio.gif" title=" Listen to the pronunciation of loopiness" /></a> \-pē-nəs\ noun</div></blockquote><div class="run_on" mwref="http://www.m-w.com/mwref"> </div> Ad hominem (<a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">link</a>) is no substitute for a logical argument, in fact it is a logical fallacy. Further, an over the top statement that I've "jumped to a less tenable position that all EMR's kill" is quite disappointing from someone who clearly has the intellect to know how amateurishly political an attack that is on a physician-informaticist in this field for almost two decades. One who is trying to take a strong pro-patient, ethical stance while balancing the need to develop safe and effective health IT along <a href="http://www.jamia.org/cgi/content/abstract/13/1/106">more reasonable timelines</a>, and without the behind-the-scenes corporate influence we write about at Healthcare Renewal. -- SS 2012 Addendum:  see the end of my post regarding my keynote presentation to the Health Informatics Society of Australia <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">at this link</a> for more on Matthew Holt's apparent disdain for my positions regarding HIT ethcs.</div></div>

The Machinery Behind Healthcare Reform: How the HIT Lobby is Pushing Experimental and Unsafe Technology on Unconsented Patients and Clinicians

(To those who linked here from " The Health Care Blog ", see my footnote at the end of this post. Also, I suggest readers at leas...

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