The Return of PharmaLot

After an unfortunate hiatus (see<a href="http://hcrenewal.blogspot.com/2014/01/pharmalot-sent-down-memory-hole.html"> this post</a>), <a href="http://blogs.wsj.com/pharmalot/">PharmaLot</a> is back.  PharmaLot was one of the premier sources of incisive information on the pharmaceutical industry, is back.  PharmaLot was and now is run by Ed Silverman, and is known for publishing important, but sometimes unpleasant truths.<br /><br />Ed Silverman provided unbiased, insightful reporting.  Notably for the <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> audience, he was not afraid to report on the good, the bad, and the ugly. He was no friend of marketing and public relations smarm.  Often he was first to break stories involving legal settlements, guilty pleas, and miscellaneous misconduct, and in some cases was one of the few to document such stories.<br /><br />For example, when PharmaLot last disappeared, I noted that it provided one of the few accounts of a $21 million fine imposed on Merck by French antitrust regulators (here is the brief <a href="http://www.reuters.com/article/2013/12/19/us-france-fine-idUSBRE9BI0Q420131219">Reuters version</a>.)  PharmaLot reported on a judgement against Actelion for anti-competitive practices in support of its drug for pulmonary artery hypertension.  The only other media report on this was <a href="http://www.sfgate.com/business/article/Actelion-loses-appeal-in-lung-drug-case-5079481.php">in the San Francisco Chronicle</a>, and it was less detailed.  <br /><br />As we have noted endlessly, bad behavior by large health care organizations, including pharmaceutical and biotechnology companies and the various organizations with which they interact, like <a href="http://hcrenewal.blogspot.com/search/label/contract%20research%20organizations">contract research organizations</a>, <a href="http://hcrenewal.blogspot.com/search/label/medical%20education%20and%20communication%20companies">medical education and communication companies (MECCs)</a>, etc has often been <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.  If one likes to get along by going along, it is not a good idea to make too much of a fuss about such issues and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of clinical research</a>, <a href="http://hcrenewal.blogspot.com/search/label/deception">deception</a> in  <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a>, and <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a> including the creation of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interests</a>, much less outright <a href="http://hcrenewal.blogspot.com/search/label/crime">crime </a>and <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">corruption</a>.  Ed Silverman was known to fuss about such issues.<br /><br />So the return of his fearless reporting, and willingness to post controversial interviews and editorials, is a rare ray of light in the gloom.  <br /><br />PharmaLot has just been added back to our blog roll.  Welcome back!<br /><br />PS - It may be too much to hope that the back archives of older versions of PharmaLot can be restored to public view.  We wait with baited breath.  <br /><br />Hat tips to <a href="http://1boringoldman.com/index.php/2014/06/04/oh-how-weve-missed-our-pharmalot/">1BoringOldMan</a>, <a href="http://loathingbioethics.blogspot.com/2014/06/pharmalot-is-back.html">Fear and Loathing in Bioethics</a>

The Return of PharmaLot

After an unfortunate hiatus (see this post ), PharmaLot is back.  PharmaLot was one of the premier sources of incisive information on the ...

Đọc thêm »

Another Sign The EHR Experiment is Producing Undesired (But Predictable) Results: ED EHRs Produce No Efficiency Gains

Adverse results that run counter to the industry meme of healthcare IT exceptionalism are coming fast and furious.  It's hard for me to keep up with it all.<br /><br />In addition to my post today "<b>EHR Exceptionalism Debunked: Care Quality Variances Among VA Hospitals Suggest the True Value of Health IT Has Been Grossly Exaggerated</b>" (<a href="http://hcrenewal.blogspot.com/2014/06/ehr-exceptionalism-debunked-care.html">http://hcrenewal.blogspot.com/2014/06/ehr-exceptionalism-debunked-care.html</a>), here's another.<br /><br />I won't comment on this very much:<br /><br /><blockquote class="tr_bq"><a href="http://www.jwatch.org/na34646/2014/05/30/electronic-charting-less-efficient-paper-charting">http://www.jwatch.org/na34646/2014/05/30/electronic-charting-less-efficient-paper-charting</a><br /><br />May 30, 2014<b> </b><br /><br /><b>Is Electronic Charting Less Efficient Than Paper Charting?</b><br />Daniel J. Pallin, MD, MPH reviewing Ward MJ et al. Ann Emerg Med 2014 Jun.<br /><br />Operational performance was similar before and after computerization at 23 community emergency departments.<br /><br />The federal government has provided $17 billion in incentives to computerize healthcare. The potential benefits include improved error checking, decision support, better billing, and more data for research. However, some research has suggested that going paperless adversely affects productivity.<br /><br />To further examine this issue, investigators measured operational efficiency 6 months before and 6 months after implementation of an electronic health record system at 23 community emergency departments. <b>No significant differences between the two time points were found in all efficiency factors that were measured, including time to provider, lengths of stay, walkouts, patient satisfaction, patients seen per provider per hour, and significant return visits.</b><br /><br />Citation(s):<br /><br />Ward MJ et al. The effect of electronic health record implementation on community emergency department operational measures of performance. Ann Emerg Med 2014 Jun; 63:723. (<a href="http://dx.doi.org/10.1016/j.annemergmed.2013.12.019">http://dx.doi.org/10.1016/j.annemergmed.2013.12.019</a>)</blockquote><br /><i>One might seek to get better results for their $17 billion than, at best, parity to paper.</i><br /><br />Finally, the reader comments at that post suggest ED physicians are the ones helping foot the bill.  As one commenter put it:<br /><br /><blockquote class="tr_bq">"Most quality EM docs won't let a record slow their care up front--especially when quaility metrics are staring us down on time until seen or discharge. <b>So we just chart later and go home later."</b></blockquote><br />We as patients certainly should not find a development like that desirable.<br /><br /><span class="userContent">Note that in my work as a hospital Chief Medical Informatics Officer (CMIO) I recommended simple <b>document imaging solutions</b> for risk-laden ED's (</span><span class="userContent"><span class="userContent">where charts are usually short) </span>to capture and make </span><span class="userContent"><span class="userContent">the paper chart content </span>available anywhere/anytime ... not full-blown digital electronic medical records systems.</span><br /><br />-- SS <br /><br /><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Most quality EM docs won't let a record slow their care up front--especially when quaility metrics are staring us down on time until seen or dischage. So we just chart later and go home later. - See more at: http://www.jwatch.org/na34646/2014/05/30/electronic-charting-less-efficient-paper-charting#sthash.WCiV8FQg.dpuf</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Most quality EM docs won't let a record slow their care up front--especially when quaility metrics are staring us down on time until seen or dischage. So we just chart later and go home later. - See more at: http://www.jwatch.org/na34646/2014/05/30/electronic-charting-less-efficient-paper-charting#sthash.WCiV8FQg.dpuf</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Most quality EM docs won't let a record slow their care up front--especially when quaility metrics are staring us down on time until seen or dischage. So we just chart later and go home later. - See more at: http://www.jwatch.org/na34646/2014/05/30/electronic-charting-less-efficient-paper-charting#sthash.WCiV8FQg.dpuf</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Most quality EM docs won't let a record slow their care up front--especially when quaility metrics are staring us down on time until seen or dischage. So we just chart later and go home later. - See more at: http://www.jwatch.org/na34646/2014/05/30/electronic-charting-less-efficient-paper-charting#sthash.WCiV8FQg.dpuf"</div>

Another Sign The EHR Experiment is Producing Undesired (But Predictable) Results: ED EHRs Produce No Efficiency Gains

Adverse results that run counter to the industry meme of healthcare IT exceptionalism are coming fast and furious.  It's hard for me to ...

Đọc thêm »

Grand Jury: Ventura County, Calif., Mishandled Electronic Health Records Transition

In Ventura County, California, "the function of the Grand Jury is to act as a civil oversight of county and city government, special districts, governing boards, personnel commissions, school districts, and humane officers. It is their responsibility to insure that government is serving the best interests of Ventura County's citizens" (<a href="http://www.ventura.org/grand-jury">http://www.ventura.org/grand-jury</a>).<br /><br />Even under such a grand jury, the need for true Health IT experts (instead of amateurs) seems to have gone unnoticed.<br /><br />A 2013-2014 Ventura County Grand Jury conducted an investigation in response to information received regarding the implementation of a new Electronic Health Records system by the Ventura County Health Care Agency (VCHCA).<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/AVvXsEjVcN68BX3lrwSkNpyg43gOlh2ZVsoEEIOjbxs5z7zfCB1lCwU4wNFXT8RqxVKLzB2fEcZrfszNMExQIeTB9tF1RNAFGAmoObnBIX4D0ZyBaFVRgSV53p-XdqoaG0iNhrumlvUV14Dwx9dr/s1600/grandjury.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjVcN68BX3lrwSkNpyg43gOlh2ZVsoEEIOjbxs5z7zfCB1lCwU4wNFXT8RqxVKLzB2fEcZrfszNMExQIeTB9tF1RNAFGAmoObnBIX4D0ZyBaFVRgSV53p-XdqoaG0iNhrumlvUV14Dwx9dr/s1600/grandjury.jpg" width="246" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Ventura County Grand Jury Final Report "<b>Healthcare Records Processes and Procedures</b>" (full PDF at <a href="http://vcportal.ventura.org/GDJ/docs/reports/2013-14/Healthcare_Records-05.29.14.pdf">http://vcportal.ventura.org/GDJ/docs/reports/2013-14/Healthcare_Records-05.29.14.pdf</a>)</td></tr></tbody></table><br /><br />From the May 29, 2014 Ventura County Grand Jury Final Report "<b>Healthcare Records Processes and Procedures</b>" (full PDF at <a href="http://vcportal.ventura.org/GDJ/docs/reports/2013-14/Healthcare_Records-05.29.14.pdf">http://vcportal.ventura.org/GDJ/docs/reports/2013-14/Healthcare_Records-05.29.14.pdf</a>).  Read the full report.  Any reader of this blog or my Drexel HIT site at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a> will recognize very familiar patterns.<br /><br />Here are some highlights:<br /><br /><blockquote class="tr_bq">In April 2012, VCHCA hired an independent Information Technology (IT) consultant to oversee the EHR implementation; however, he was not authorized to be project manager.</blockquote><br />An "independent IT consultant" who had no formal Medical Informatics expertise is a likely explanation for all that followed.  (Even if he did, his relegation to "internal consultant" was an attempt to seduce failure into rearing her ugly head.)<br /><br /><blockquote class="tr_bq">The Grand Jury found that, beginning with the authorization of the Cerner contract in October 2011, there was a lack of a dedicated and experienced project manager to oversee, track, and report all tasks related to the EHR implementation. T<b>he absence of a recognized standard project plan</b>, as shown in the Project Management Institute’s A Guide to the Project Management Body of Knowledge (PMBOK® Guide), contributed to staff being inadequately prepared for using the new system and to a problematic EHR system implementation by VCHCA.</blockquote><br />Lack of a "recognized standard project plan" was likely the least of the problems. <br /><br /><blockquote class="tr_bq">The Grand Jury found hiring of “contract staff” did not support project needs. The Ventura County Board of Supervisors’ (BOS) approval of additional funds allowed for the hiring of deployment staff. Hiring did not commence until August 2012, and continued after the VCHCA system “go-live” date of July 1, 2013. This indicated a lack of planning and diligence in pursuing the necessary qualified staff.</blockquote><br />Lack of enough "contract IT staff" was likely the least of the problems. <br /><br /><blockquote class="tr_bq">The Grand Jury found that staff training on the new equipment was insufficient, leading to a lack of experience and knowledge with all components of the EHR system. There was a period of inefficient and delayed patient care. <br /><br />Billing processes were significantly impacted, requiring manual intervention, taking additional time.</blockquote><br />These are symptoms of what was likely truly lacking.<br /><br /><blockquote class="tr_bq">The Grand Jury found that VCHCA ordered the user hardware in May and June 2013, too late to allow proper time for configuring of computers, hardware testing, and user familiarization.<br />  <br />The Grand Jury found that VCHCA had until the end of December 2014 to implement the new EHR system to avoid federal penalties.<br /><br />The Grand Jury found that VCHCA had to be on the EHR system for 90 days prior to September 30, 2013, to qualify for full Meaningful Use funding, therefore July 1, 2013 was selected as its go-live date.</blockquote><br />It was all about money.  Still, that was not the likely problem.<br /><br />The problem was likely <b>leadership by healthcare IT amateurs</b>**, lacking formal cross-disciplinary expertise in medicine and clinical computing.<br /><br />Without that expertise, empowered in <b>top leadership roles</b>, these projects will fail or will be seriously impaired, at great cost.<br /><br />If you don't believe me, believe the NIH (<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html</a>).<br /><br />While the 'Grand Jury' investigation of a failed health IT project may be a first, and is not a bad development in my mind, perhaps the members of the Grand Jury need to read a bit more. <br /><br />-- SS <br /><span style="font-size: x-small;"><br /></span><span style="font-size: x-small;">** I am a <b>radio amateur</b>, a formal FCC designation for those licensed to use radio and who have some knowledge, but who are not formal radio telecommunications engineers (unless they have the required formal education, training and experience, of course).</span><br /><br />

Grand Jury: Ventura County, Calif., Mishandled Electronic Health Records Transition

In Ventura County, California, "the function of the Grand Jury is to act as a civil oversight of county and city government, special d...

Đọc thêm »

EHR Exceptionalism Debunked: Care Quality Variances Among VA Hospitals, Perhaps The Most Wired Hospitals in the World, Suggest the True Value of Information Technology in Healthcare Has Been Grossly Exaggerated

The Wall Street Journal somehow managed to get access to internal VA patient care quality data and published the following article:<br /><blockquote class="tr_bq"><br /><a href="http://online.wsj.com/articles/veterans-affairs-hospitals-vary-widely-in-patient-care-1401753437">http://online.wsj.com/articles/veterans-affairs-hospitals-vary-widely-in-patient-care-1401753437</a></blockquote><blockquote><b>Veterans Affairs Hospitals Vary Widely in Patient Care</b><br /><i>Internal Records Show Facilities Such as Phoenix Have Far Higher Death Rates Than Peers</i><br />Thomas M. Burton and Damian Paletta<br />June 3, 2014 <br /><br />The Phoenix facility at the heart of the crisis at the Department of Veterans Affairs is among a number of VA hospitals that show significantly higher rates of mortality and dangerous infections than the agency's top-tier hospitals, internal records show.<br /><br />The criticism that precipitated last week's resignation of VA Secretary Eric Shinseki has focused largely on excessive wait times for appointments across the VA's 150-hospital medical system.<br /><br />But a detailed tabulation of outcomes at a dozen VA hospitals made available to The Wall Street Journal illustrates a deeper challenge: vastly disparate treatment results and what some VA doctors contend is the slippage of quality in recent years at some VA facilities.<br /><br />Some of the discrepancies are stark, especially for an agency known for offering high-quality care in 50 states.</blockquote><br />Yet, these are highly wired hospitals, perhaps the most highly wired in the world, with one EHR, VistA CPRS, allegedly among the best EHRs in the world developed over decades, and allegedly used by 100% of the clinicians.<br /><br />How can this be?  <br /><br /><blockquote class="tr_bq">... Scott McRoberts, spokesman for the Phoenix VA Health Care System, said on Monday the database "is an internal measurement system to benchmark our improvement, and is not for public consumption."<br /><br />The rate of potentially lethal bloodstream infections from central-intravenous lines was <b>more than 11 times as high among patients at the Phoenix facility than it was at top VA hospitals</b>, data from the year ended March 31, 2014, show.<br /><br />... The findings come from a nonpublic VA database called Strategic Analytics for Improvement and Learning, known as SAIL. SAIL tracks procedure outcomes and ranks VA hospitals on a scale of five stars, the best, to one star, the lowest. <br /><br />... In other examples of variations in care, the Atlanta VA Medical Center, a two-star hospital for quality, has more than <b>three times the rate of central-IV infections than the average</b> of five-star VA hospitals. Houston's VA hospital, ranked as a two-star hospital, had a <b>47% higher acute-care mortality rate than the five-star hospital rate.</b></blockquote><br />A 47% higher acute-care mortality rate?<br /><br />Hospitals are willing to go into tens of millions of dollars of debt and knowingly endanger patients (see e.g. "<b>In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red</b>" at <a href="http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html">http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html</a>), and even attempt to stifle clinician conversation on drawbacks (e.g. see "<b>Words that Work</b>" at <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>), to attain this technology on the stated reason of "improving patient safety" and "saving money."<br /><br />Former ONC Chair Blumenthal stated explicitly in <span style="font-size: 100%;">the NEJM article "<span style="font-weight: bold;">The 'Meaningful Use' Regulation for Electronic Health Records</span>", Blumenthal</span> and Tavenner (10.1056/NEJMp1006114, July 13, 2010):<br /><div class="PlainText" style="font-family: arial;"><span style="font-size: 100%;"><br /></span></div><blockquote dir="ltr" style="font-family: arial; margin-right: 0px;"><div class="PlainText"><span style="font-size: 100%;">... EHRs <u><b>will</b></u> improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they <u><b>will demand</b></u> nothing less from their providers. </span></div></blockquote><br />There is no doubt expressed there. <br /><br />The industry itself has convinced the Federal Government to spend tens of billions of taxpayer dollars on this technology via HITECH incentives, and to start penalizing non-adopters via Medicare cuts.  The Government has bought into the hyper-enthusiasm hook, line and sinker, when the same money might have been spent elsewhere such as on care of the underserved...or on our Veterans.<br /><br />Yet the data from a highly-computerized organization like the VA <b>show that these systems cannot be all they are made out to be</b>.  They do not automatically "improve caregivers' decisions and patients' outcomes." This is an on its face observation.<br /><br />They are simply a tool, and in absence of appropriate human staffing, expertise, and conducive work environment, <b>they mean significantly "less than advertised</b>" in terms of improving care quality and outcomes.  <br /><br />Finally, as the VA has gotten busier due to factors such as the return of veterans from recent wars, one must also ask if the loss of productivity, cognitive burden, and other factors caused by needing to interact with a computer rather than paper has made the computer systems more of an impediment to good care rather than a facilitating tool.<br /><br />I think it's time the Government start to reform the industry hype surrounding this technology with far more sober predictions that would facilitate far more cautious implementations.<br /><br />No "revolutions" are happening soon, at least not due to information technology in healthcare. <br /><br />Finally, note that EHR oversell and <i>exceptionalism</i> has been going on for <b>decades.   </b>Donald A. B. Lindberg M.D. (<a href="http://www.nlm.nih.gov/od/roster/lindberg.html">http://www.nlm.nih.gov/od/roster/lindberg.html</a>), Medical Informatics pioneer and Director of the U.S. National Library of Medicine at NIH, observed in 1969 that:<br /><blockquote class="tr_bq"><br />"The [second] reason for the dearth of significant success of computers in medicine has been the <b>flagrant and consistent "over sell" of capability on the part of manufacturers and computer enthusiasts."  </b></blockquote><br />Read his full quote by clicking on the page below, from Morris Collen's book "<a href="http://www.amazon.com/History-Medical-Informatics-United-States/dp/0964774305">A History of Medical Informatics in the United States: 1950 to 1990</a>."<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/AVvXsEjrRIuVMu4XQOTRYpbyXb2-IXrnM019VAdbzcR3D8wVVCDQtXDkhG6UlZTWtBpmUKH7s4QnIHjxuyp65kccko4iKwx6nGV3Cxu8kZ75Fss742dcTMln77zZw4tJOu25MXPfH9Oq1F-i5egc/s1600/collen168.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjrRIuVMu4XQOTRYpbyXb2-IXrnM019VAdbzcR3D8wVVCDQtXDkhG6UlZTWtBpmUKH7s4QnIHjxuyp65kccko4iKwx6nGV3Cxu8kZ75Fss742dcTMln77zZw4tJOu25MXPfH9Oq1F-i5egc/s1600/collen168.jpg" width="263" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Informatics pioneer Dr. Donald Lindberg's 1969 observations on health IT oversell.  Click to enlarge.</td></tr></tbody></table><br /><br />Sadly, nothing has changed in health IT, at least since the year we landed on the Moon.<br /><br />-- SS<br /><br />

EHR Exceptionalism Debunked: Care Quality Variances Among VA Hospitals, Perhaps The Most Wired Hospitals in the World, Suggest the True Value of Information Technology in Healthcare Has Been Grossly Exaggerated

The Wall Street Journal somehow managed to get access to internal VA patient care quality data and published the following article: http://o...

Đọc thêm »

Fool Me Twice? - Boehringer Ingelheim, Medtronic Settle Lawsuits Alleging Deceptive Marketing

It seems like it has been really quiet on the legal settlement front in the US, but maybe corporate executives wanted to wait until things calmed down after the unofficial start of summer to let out news that some people might not think reflected well on them.  So this week it was time to announce two new legal settlements of allegations of bad behavior by corporate health were announced, as we will list in alphabetical order....<br /><br /><b>Boehringer Ingelheim Settles Suits Alleging it Hid Data About Pradaxa Harms</b><br /><br />As <a href="http://www.bloomberg.com/news/2014-05-28/boehringer-pays-650-million-to-end-blood-thinner-cases.html">per Bloomberg</a>,<br /><br /><blockquote class="tr_bq">Boehringer Ingelheim GmbH, the German family-owned drugmaker,<i> agreed to pay $650 million to settle the majority of lawsuits filed over its blood thinner Pradaxa, which has been linked to more than 500 patient deaths.</i></blockquote><br />The major allegations were about deception,<br /><br /><blockquote class="tr_bq"> Patients and their families alleged<i> Boehringer executives knew Pradaxa posed a deadly risk to some consumers when they brought it to the U.S. market in October 2010.</i></blockquote><br />In particular, as we <a href="http://hcrenewal.blogspot.com/2014/02/cant-this-be-avoided-how-corporate.html">discussed</a> in more detail in February, 2014, <br /><br /><blockquote class="tr_bq">Documents made public as part of patients’ Pradaxa suits showed <i>Boehringer officials didn’t disclose to U.S. regulators a data analysis that indicated the blood-thinning drug may have caused more fatal bleeding</i> after it was cleared for sale than in a study used to win approval.  </blockquote><br /><a href="http://www.nytimes.com/2014/05/29/business/international/german-drug-company-to-pay-650-million-to-settle-blood-thinner-lawsuits.html">Per </a>the New York Times, Boehringer Ingelheim executives continued to maintain<br /><br /><blockquote class="tr_bq">that it stood behind the safety and efficacy of Pradaxa and continued to believe that the lawsuits lacked merit, but that settling the case <i>allowed the company to move on.</i> 'Time and again, the benefits and safety of Pradaxa have been confirmed,' said Desiree Ralls-Morrison, senior vice president and general counsel of Boehringer Ingelheim USA.</blockquote><br />This is typical of most legal settlements involving large health care organizations, whether they end lawsuits brought by private parties or by the US government.  The settlements often allow the parties to continue to disagree, do not establish guilt or innocence, but leave one to wonder why executives would pay so much of admittedly other peoples' money just to "move on" without upholding their or their companies' honor, especially when documents revealed and legal findings made in cases prior to settlement remain unchallenged.<br /><br />So this settlement also comes after December, 2013, as we discussed <a href="http://hcrenewal.blogspot.com/2013/12/a-second-order-cover-up-judge-finds.html">here</a>, December, when a judge<br /><br /><blockquote class="tr_bq">ordered Boehringer to pay a $931,000 fine in December for <i>failing to preserve 'countless' files on Pradaxa’s development and marketing. Patients’ lawyers say Boehringer should have placed an effective 'litigation hold' on the documents</i>, forcing employees to preserve them.</blockquote><br />(The above <a href="http://www.bloomberg.com/news/2014-05-28/boehringer-pays-650-million-to-end-blood-thinner-cases.html">per Bloomberg</a>.)  That finding, which the settlement does not dispute, does not fill one with confidence about the openness and transparency of Boehringer Ingelheim managers.<br /><br />Also the settlement does not refute documents released during this litigation which suggested that Boehringer Ingelheim personnel tried to influence, or manipulate a company sponsored research paper to prevent it from contradicting the company's official marketing message that Pradaxa administration does not require monitoring of patients with blood tests (as we discussed <a href="http://hcrenewal.blogspot.com/2014/02/cant-this-be-avoided-how-corporate.html">here</a>).     <br /><br />Note further that this case comes only a few years after a case in which Boehringer Ingelheim settled allegations of deceptive marketing of drugs other than Pradaxa, as we discussed <a href="http://hcrenewal.blogspot.com/2012/10/just-another-day-at-office-boehringer.html">here</a>. <br /><br /><b>Medtronic Settles Suit Alleging Kickbacks to Physicians</b><br /><br />The most extensive and colorful <a href="http://www.startribune.com/business/260978651.html">report</a> was in the Minneapolis Star-Tribune, <br /><br /><blockquote class="tr_bq"><i>Medtronic Inc. will pay the U.S. Justice Department $9.9 million to settle a whistleblower lawsuit that accused the company of paying kickbacks to doctors for using its defibrillators and pacemakers.</i><br /><br />The alleged kickbacks, according to the newly unsealed suit, included '<i>gifts of wine and alcohol</i>' and '<i>trips to strip clubs</i>' paid for by the Fridley-based company. The lawsuit also says Medtronic paid to fly doctors to events in San Francisco, Las Vegas, New Orleans, New York, Minneapolis and other cities that some physicians used as 'a free vacation.'</blockquote><br />More colorful details,<br /><br /><blockquote class="tr_bq">The lawsuit, whose details remained secret until Tuesday, describes Medtronic <i>business plans with names such as 'Project Wildfire' that had sales representatives offer 'cash payments, expensive trips and meals, expensive gifts and entertainment to physicians as kickbacks in exchange for the physicians’ agreement to implant Medtronic devices.'</i><br /><br />The lawsuit alleged that Medtronic '<i>funneled millions of dollars in unrestricted grant money to physicians</i>' to get them to encourage the use of Medtronic defibrillators and pacemakers in patients whose 'mild heart failure symptoms did not meet [Food and Drug Administration] criteria for an implantable device.'<br /><br />Those procedures were not only unnecessary, the suit alleged, but potentially dangerous.<br /><br />The suit describes <i>payments of thousands of dollars in speaking fees to doctors for attending dinners at which they spoke for only a few minutes</i>, if at all. In other cases, <i>Medtronic allegedly prepared entire presentations that physicians offered almost verbatim.</i><br /><br />The suit talks of a plan that 'instructed sales representatives to personally review patient charts in friendly doctor’s offices' and to flag those patients the sales representative 'felt should receive an implant.'</blockquote><br />Note that commercially supplied "unrestricted grant money" is now the lifeblood of many ostensibly academic continuing medical education (CME) programs, but this case suggests that corporate executives may believe they are paying such money to get doctors to use their products.  Note further that many physicians defend their receipt of money in payment of talks they have given on behalf of commercial firms as fair payment for providing unbiased education, but this case suggests that corporate executives may believe they are paying such money for marketing, and/or to get the supposedly unbiased physician speakers to use their products.  <br /><br />Once again, the settlement did not resolve the allegations. <br /><br /><blockquote class="tr_bq"> Medtronic said it <i>did not admit that any of its activities were improper or illegal</i> and that the settlement would bring to a close a long-running review of events dating from 2001 to 2009.</blockquote><br />Also,<br /><br /><blockquote class="tr_bq"> Asked to comment specifically on the strip club allegations and the accusation that it financially facilitated unnecessary implantations, Medtronic<i> reiterated that its $9.9 million payment was not an admission that it had done anything illegal or improper.</i></blockquote><br />See my comments above.  Why would executives with even the slightest ability to feel shame not contest such allegations if they were untrue?  But maybe many of today's corporate health care executives are not capable of feeling shame, and of course they get to pay off these lawsuits with other peoples' money.<br /><br />By the way, this is just one of many Medtronic settlements.  As Bloomberg <a href="http://www.bloomberg.com/news/2014-05-28/medtronic-settles-suit-over-heart-device-kickback-claims.html">summarized</a>,<br /><br /><blockquote class="tr_bq"> Medtronic agreed in 2007 to <i>pay about $130 million to settle consumer suits accusing the device maker of hiding defects in its defibrillators</i>. The company agreed to a <i>$268 million settlement of suits in 2010 over allegations that fractured wires in another line of defibrillators caused at least 13 patient deaths.</i></blockquote><br />In fact, Medtronic has provided our blog with <a href="http://hcrenewal.blogspot.com/search/label/Medtronic">lots of material</a>.  We first <a href="http://hcrenewal.blogspot.com/2006/01/medtronics-payments-to-doctors-too.html">discussed</a> detailed and vivid allegations that Medtronic had been paying off doctors starting in 2003 here in 2006.  Medtronic has been involved in other lawsuits alleging various kinds of deception. <br />-  In 2011, it settled for $23.5 million two other federal lawsuits alleging it paid kickbacks to encourage physicians to implant its devices (look <a href="http://hcrenewal.blogspot.com/2011/12/medtronic-settles-yet-again.html">here</a>).   <br />- In 2008, Medtronic subsidiary Kyphon settled a suit for $75 million and signed a corporate integrity agreement for allegations that it defrauded Medicare through a scheme that lead to excessive hospitalization for patients who received the company's spine surgery device (link <a href="http://hcrenewal.blogspot.com/2008/05/corporate-integrity-agreement-for.html">here</a>)<br />- In 2006, Medtronic subsidiary Sofamor Danek settled for $40 million allegations that it gave kickbacks to doctors in the form of sham consulting fees and lavish trips (look <a href="http://hcrenewal.blogspot.com/2011/12/medtronic-settles-yet-again.html">here</a>). <br /><br />Yet we are now writing at the end of May, 2014, and Medtronic is still settling lawsuits involving vivid allegations of payoffs to physicians, and its executives are still saying nothing to see here, move on.<br /><br /><b>Summary</b><br /><br />These sorts of cases provide evidence that large health care corporations, including not just pharmaceutical companies, but biotechnology and medical device companies, commonly use deceptive and unethical practices to market their products.  Such marketing lets them charge high, even outrageous prices and sometimes results in patients getting expensive treatments that do them no good, or worse, that do more harm than good.  Some of the executives of these companies doubtless got large bonuses, and may have gotten millions in compensation partially because of the sales generated by these practices.  However, they get to walk away from such lawsuits without any personal accountability, just by paying out a few millions, or billions, of the company's, that is, other peoples' money.  They get do pay that money without any other explanation that it eliminates distractions and allows them to move on (with whatever they have already made).<br /><br />The more this goes on, the more health care dysfunction continues, and the more the health care oligarchy prospers.  As we have written many times,<br /><br /><blockquote class="tr_bq">penalties that only appear to be (relatively small) costs of doing business are unlikely to deter future bad behavior. Until the people who actually authorized, directed and implemented the bad behavior have to suffer some negative consequences, expect the bad behavior to continue.  Note that each of the companies discussed above have had their previous ethical lapses discussed in previous Health Care Renewal posts. <br /><br />The continuing march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">settlements</a>, and sometimes <a href="http://hcrenewal.blogspot.com/search/label/crime">criminal</a> convictions involving major health care organizations should be regarded merely as providing a floor to estimates of the extent of bad behavior by large health care organizations. Bad behavior may not be reported, or lead to legal action, and legal action may not lead to settlements or convictions. However, it is amazing how many organizations that were once regarded as exemplary have had to settle, or plead guilty, or been convicted.<br /><br />When it comes to health care's leadership, society seems to have acceded to defining deviancy down. Until we start holding health care leaders to high standards, expect their organizations not to uphold high standards.</blockquote><br />(That version was from 2010, posted <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a> re Medtronic's 2010 settlement. You heard it here first.  Medtronic is still settling, and according to its <a href="http://phx.corporate-ir.net/phoenix.zhtml?c=76126&p=IROL-secToc&TOC=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9vdXRsaW5lLnhtbD9yZXBvPXRlbmsmaXBhZ2U9OTAwMDI5NiZzdWJzaWQ9NTc%3d&ListAll=1">most recent proxy</a>, from 2013, the annual total compensation of its CEO was last reported to be <b><i>$8,975,886</i></b>.) <br /><br /><br />

Fool Me Twice? - Boehringer Ingelheim, Medtronic Settle Lawsuits Alleging Deceptive Marketing

It seems like it has been really quiet on the legal settlement front in the US, but maybe corporate executives wanted to wait until things c...

Đọc thêm »

In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red

At my Nov. 9, 2013 post <style type="text/css">H3 { margin-bottom: 0.08in; }H3.cjk { font-family: "Droid Sans Fallback"; }H3.ctl { font-family: "Lohit Hindi"; }P { margin-bottom: 0.08in;</style>"<b>We’ve resolved 6,036 issues and have 3,517 open issues" </b>(<a href="http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html">http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html</a>) I wrote about "issues" (i.e., "glitches" including potentially injurious or deadly bugs and malfunctions) the organization was having with a new EHR at University of Arizona Health System.<br /><br />Now we know part of the cost of resolving those 9,553 "issues."<br /><br /><blockquote class="tr_bq"><a href="http://azstarnet.com/news/science/health-med-fit/tucson-area-s-largest-area-network-racks-up-nearly-million/article_44d05d04-0acf-5fbc-8561-68d4bef3b577.html">http://azstarnet.com/news/science/health-med-fit/tucson-area-s-largest-area-network-racks-up-nearly-million/article_44d05d04-0acf-5fbc-8561-68d4bef3b577.html</a><br /><b>Tucson area's largest health network racks up nearly $30 million in losses</b></blockquote><div class="publish-meta clearfix"><blockquote><div class="date left"><span class="pubdate">June 01, 2014 </span> •  <span class="byline">By <a class="open-tooltip" href="http://azstarnet.com/users/profile/Emily%20Bregel">Emily Bregel</a>, <a class="open-tooltip" href="http://azstarnet.com/users/profile/Stephanie%20Innes">Stephanie Innes</a></span></div></blockquote><div class="date left"><blockquote><span class="byline"> <style type="text/css">P { margin-bottom: 0.08in; }A:link { }</style> </span><br /><div style="margin-bottom: 0in;">Southern Arizona’s largest health network <b>is $28.5 million in the red so far this fiscal year, and officials say a costly electronic medical records system is largely to blame.</b></div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">The operating loss is unprecedented for the four-year-old University of Arizona Health Network, which includes two local hospitals.</div><div style="margin-bottom: 0in;"></div></blockquote><br />Stellar management was clearly responsible for this wonderful outcome.  When will the layoffs start, I ask? That's the usual managerial solution for financial losses, and in this case I feel particularly worried about employees who did not obey the "suggestion" to only use "<b>Words that Work</b>" about this EHR (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>). <br /><br /><blockquote class="tr_bq"><div style="margin-bottom: 0in;">The electronic records system, from Wisconsin-based Epic Systems, has cost an estimated <b>$115 million</b>, including <b>$32 million in unbudgeted costs for the first eight months of the fiscal year,</b> which ends June 30, financial documents show. The extra costs are due primarily to a delay in getting the system live and funding additional training and support, officials said. It was supposed to be up and running by Sept. 1, but wasn’t operational until Nov. 1.</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">$32 million to fix 9,553 "issues", most likely due to implementation incompetence, plus some that perhaps the seller should have at least been partially responsible for...such as these:</div><div style="margin-bottom: 0in;"><br /></div><blockquote class="tr_bq"><ul><li>Pharmacy Medication Mapping Errors <span style="color: red;"></span></li></ul><ul><li>Microbiology Results Mapping Incorrectly </li></ul></blockquote><blockquote class="tr_bq"><ul><li>Prescription printing bugs</li></ul><ul><li>Errors transmitting prescriptions </li></ul></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">I note that real, live patients were the unwitting experimental subjects in this little software debugging project.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">I also note that $115 million <b>could have paid for an entire new hospital or wing</b> - and these startup costs are just the beginning... </div><div style="margin-bottom: 0in;"><br /></div><blockquote class="tr_bq"><div style="margin-bottom: 0in;">... There are other reasons for the network’s weak finances. UA Health Network officials say uninsured patients aren’t getting health insurance coverage through the federal Affordable Care Act as quickly as they’d anticipated, resulting in $11 million less than expected in patient revenue through February.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">The network also lost federal dollars from a program that helped bridge the funding gap created by Medicaid rate cuts and a rise in uninsured patients. The Safety Net Care Pool, which also included Maricopa Integrated Health System and Phoenix Children’s, pumped $33 million into the UA hospitals for the first six months of the fiscal year. But that infusion ended Dec. 31 to coincide with greater health insurance availability through the Affordable Care Act.</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">It's not like these events were entirely unpredictable.  Perhaps priorities could have been rearranged, rather than dumping millions into a known money pit, the implementation of enterprise clinical information technology?</div><blockquote class="tr_bq"><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">... “The issue is more about where we are going and what things are in place to change the trajectory,” Lynn said. “It was an especially difficult time financially because of Epic, there was no choice in the matter. That period of time has fortunately passed and now we can do much better.”</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">There certainly was "choice in the matter."  I also suggest to Mr. Lynn that the "trajectory" might end up being a ballistic one.</div><div style="margin-bottom: 0in;"><br /></div><blockquote class="tr_bq"><div style="margin-bottom: 0in;">... A financial report presented to the network’s board of directors on April 24 says the Epic system’s higher-than-expected expenses this fiscal year were due to “implementation delays, additional training support and planned schedule reductions.” Some of the expenses were originally supposed to be in the prior fiscal year.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">The report attributes $6.8 million of the current year’s losses to physicians spending enough time training to use the new system that they couldn’t see as many patients between November and January. Schedules were back to normal as of February.</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">One wonders just how much increased stress and pressure there is on clinicians with the new system in place.   </div><div style="margin-bottom: 0in;"><br /></div><blockquote class="tr_bq"><div style="margin-bottom: 0in;">... Implementing the new system has hit the network’s finances hard, but over time it <b>should improve patient safety</b> by cutting down on unnecessary testing and medication errors, among other things, officials say. Eventually it is <b>expected to save money</b> because of its added efficiency.</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">"Should?"  Considering the issues I've outlined at this blog and my Drexel University Healthcare Informatics site (<a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>), this seems a type of wishful-thinking due diligence performed by those who believe in fairy tales and bargain sales of bridges like the one at <a href="http://www.distancesfrom.com/us/Brooklyn-Bridge-latitude-longitude-Brooklyn-Bridge-latitude-Brooklyn-Bridge-longitude/LatLongHistory/24244.aspx"><span id="MC_GMD_lblLatitude">latitude 40.7045096 N, longitude </span></a><span id="MC_GMD_lblLongitude"><a href="http://www.distancesfrom.com/us/Brooklyn-Bridge-latitude-longitude-Brooklyn-Bridge-latitude-Brooklyn-Bridge-longitude/LatLongHistory/24244.aspx">73.99480549999998 W</a>.</span></div><div style="margin-bottom: 0in;"></div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Let me make a realistic projection:  No money will be saved, e.g., see the opinions from Wharton at <a href="http://hcrenewal.blogspot.com/2009/06/wharton-on-healthcare-it-can-i-go-home.html">http://hcrenewal.blogspot.com/2009/06/wharton-on-healthcare-it-can-i-go-home.html</a>.  </div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Another projection:  safety will be adversely affected, e.g., see the <b>ECRI Deep Dive study</b> 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>, the <b>Top Ten Healthcare Technology Risks for 2014</b> at <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> and the FDA Internal Memo on H-IT Risks 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>, to name a few sources repeatedly mentioned here.</div><div style="margin-bottom: 0in;"><br /></div><blockquote class="tr_bq"><div style="margin-bottom: 0in;">At the UA Medical Center’s south campus, the Epic system has taken doctors from paper charts and uncoordinated computer records to having all patient information — from angiogram and CT scan results to billing updates — in one place, accessible via iPhone.</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Try doing medicine on an iPhone screen area...</div><div style="margin-bottom: 0in;"><br /></div><blockquote class="tr_bq"><div style="margin-bottom: 0in;">“This is the future. We have to have electronic medical records,” said Dr. Kwan S. Lee, a cardiologist who is medical director of the UA Medical Center’s south campus.</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">"This is the future!!  We just <i><b><u>have</u> </b></i>to do it!!"  Dr. Lee, I admire your exceptionally well-reasoned and thorough budget justification for putting your healthcare system $30 million in the red.  Congratulations!</div><div style="margin-bottom: 0in;"><br /></div><blockquote class="tr_bq"><div style="margin-bottom: 0in;">... Lee cited a recent case where a patient who had been previously treated at Tucson Medical Center came to the UA Medical Center’s emergency room, having an acute heart attack. The standard of care in such cases is opening the artery within 90 minutes. In a rush against the clock, Lee was able to click on the patient’s record from TMC and see the area where the patient had prior surgery.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">“The patient had consented to share information from Tucson Medical Center and it helped us immensely,” Lee said. “We would have possibly wasted a lot of time. The patient did very well.”</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">A far, far less expensive document image management system could have accomplished exactly the same goal.</div><div style="margin-bottom: 0in;"><br /></div><blockquote class="tr_bq"><div style="margin-bottom: 0in;">One con is that the system is <b>“a little overly complicated”</b> because it tries to be all things to all people, he said.  “It was painful ... <b>A lot of us are technophobes,</b>” he said. “But there was no way we could move forward without adopting it.” </div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">"A little overly complicated?"  Gee, I guess that's why physicians at Athens Regional Medical Center revolted as at <a href="http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html">http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html</a>.  The system was just "a little overly complicated!"</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">"A lot of us are technophobes?"  How about "A lot of us are not EHR hyper-enthusiasts, but pragmatists?" (<a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html</a>).</div><div style="margin-bottom: 0in;"><br /></div><blockquote class="tr_bq"><blockquote class="tr_bq"><div style="margin-bottom: 0in;">Chief Information Officer Critchley agreed, saying that with the infrastructure in place, the system will be improved as needed over time.</div><div style="margin-bottom: 0in;"><b><br /></b></div><b></b><br /><div style="margin-bottom: 0in;"><b>“For better or worse</b>, only when it’s live are you going to get the doctors and staff to engage and do the fine tuning <b>of what it really means</b>, and what they want to see happen,” Critchley said.</div></blockquote></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">This is a political statement at best.  The assumption here is that this technology itself is some sort of miracle worker, just needing "fine tuning" to reveal its miracles.  In fact, most medical inefficiencies and dangers have nothing to do with documentation at all (e.g., see "<b>Is healthcare IT a solution to the wrong problem?</b>" at <a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html</a>).</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;"><b>The only miracle so far has been to put the system $30 million in the red</b>, with more to follow.</div><blockquote class="tr_bq"><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">... The UA Health Network, which began its Epic implementation in 2012, receives a little over $1 million per year in incentive payments, Critchley said.</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">That's nice.   They spent $115 million to qualify for a $1 million annual incentive?  Makes perfect sense to me ...</div><div style="margin-bottom: 0in;"><br /></div><blockquote class="tr_bq"><div style="margin-bottom: 0in;"><b>Adoption of electronic records is voluntary</b>, but hospitals that don’t make the switch by October face Medicare payment cuts of about 1 percent, and increasing reductions each year.</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">At least one reporter reports this factoid accurately.  Hospital and industry execs are fond of misstatements that "EHRs are mandatory."</div><blockquote class="tr_bq"><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Critchley has worked on at least four other Epic installations around the country as part of his consulting work and says <b>the UA Medical Center’s has been the least expensive</b>, with the most aggressive timeline. He has worked on projects that cost more than <b>a half billion dollars</b>.</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">"Least expensive?"  "Half a billion dollars?"  It sounds like first class care for every underserved person in the United States could have been paid for instead of dumping the money into an unproven, experimental computer technology...</div><div style="margin-bottom: 0in;"><br /></div><blockquote class="tr_bq"><div style="margin-bottom: 0in;">At Tucson Medical Center, a $31 million upgrade to its electronic medical records system — also the Epic system — began to reduce expenses <span style="color: red;"><i><b>[overall net expenses, or just on a limited per-account, cherry-picked basis?  I suspect the latter - ed.]</b></i></span> almost immediately after it went live in 2010. TMC is among 3 percent of hospitals nationwide at the highest stage of electronic records adoption, based on an electronic records ranking system.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">“We started to see efficiencies the first day,” said Frank Marini, TMC’s chief information officer. <b>Transcription expenditures dropped by half, as doctors who had previously dictated patient notes instead documented them directly into the electronic record, he said.</b></div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">And they had to type and/or manually edit the results of Dragon or some other VR software.  That's wonderful!  Save money by firing transcriptionists and <i>making the physicians spend their valuable time and attention on clerical work.</i>  Fine business!</div><blockquote class="tr_bq"><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">TMC began its push to upgrade its partial electronic records system in 2009. The hospital’s early investments in infrastructure, starting in 2002, lowered the cost of adopting a comprehensive system, he said.</div></blockquote><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Thus, in fact, overall expense was probably <i><b>several times the $115 million quoted.  Say, perhaps, half a billion dollars?</b></i></div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">To any U. Az healthcare employee reading this - remember, if you are experiencing EHR difficulties, only use Words that Work!</div></div><div class="date left"></div><div class="date left"><span class="byline"><br /></span></div><div class="date left"><span class="byline">-- SS</span></div><div class="comment-count right"></div><div class="comment-count right"></div><div class="comment-count right"></div></div>

In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red

At my Nov. 9, 2013 post " We’ve resolved 6,036 issues and have 3,517 open issues" ( http://hcrenewal.blogspot.com/2013/11...

Đọc thêm »

Sovaldi - a "Revolution" in Clinical Care, or in Marketing and Public Relations?

The continuing public discussion of the sky high price Gilead has set for Sovaldi (sofosbuvir,) its new antiviral drug for hepatitis C, continues to avoid considering the lack of good evidence that the drug is as safe and effective as its proponents claim.<br /><br />We first <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">posted</a> about the Sovaldi debate on March 27, 2014, and its focus on price rather than the quality of the evidence underlying loud claims about the miraculous qualities of the drug.  We suggested that there is no good evidence supporting claims that most hepatitis C patients have very bad outcomes if untreated, treatment prevents most bad outcomes, Sovaldi cures nearly all patients, and Sovaldi has very few side effects.<br /><br />In a subsequent post we wrote that initially, "no one but your humble blogger seemed to be <a href="http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html">publicly skeptical </a>about published assertions that the drug was some sort of modern miracle, and a triumph of medical science."<br /><br />On May 7, we <a href="http://hcrenewal.blogspot.com/2014/05/some-authoritative-skepticism-about.html">noted</a> an assessment by the German Institute for Quality and Efficiency in Health Care (IQWiG) of information submitted by "industry" (presumably Gilead) to the German government.  This assessment found multiple problems with the evidence, including limited generalizability, problems with randomization, lack of information about important outcomes, and lack of ability to quantify benefit.   Also  the US based Institute for Clinical and Economic Review noted that there was little evidence that compared to previous treatments, Sovaldi is better, and no evidence that Sovaldi produces cures in the long term.<br /><br />Nonetheless, the notions that the evidence supporting Sovaldi (and perhaps other similar drugs) is weak, and that the drugs therefore should not yet be considered miracle cures have not seemingly affected the public discussion.  <br /><br /><b>Examples of the Latest Discussion</b><br /><br /><u>Washington Post/ Kaiser Health News</u><br /><br /><br />On May 12, 2014, in an <a href="http://www.kaiserhealthnews.org/stories/2014/may/12/medicare-struggling-with-hepatitis-c-cure-costs.aspx">article</a> on the dilemma the drug's US price of $1000/ pill presents to Medicare, Richard Knox wrote this about a patient with the infection:<br /><br /><blockquote class="tr_bq">Previous drug treatments didn't clear the virus from Bianco's system. But it's <i>almost certain that potent new drugs for hep-C could cure him. </i></blockquote><br />In other words, the article asserted that Sovaldi and similar drugs cure nearly everyone with hepatitis C, even those not cured by previous treatment. <br /><br /> <u>Reuters</u><br /><br />On May 20, 2014, in an <a href="http://www.reuters.com/article/2014/05/20/us-insurance-gilead-sciences-drugcosts-idUSKBN0E029U20140520">article</a> about how US health insurers are balking at the price of Sovaldi, was this statement by the main trade organization for US for-profit health care insurers, America's Health Insurance Plans (AHIP),<br /><br /><blockquote class="tr_bq"><span id="articleText">Sovaldi has <i>shown tremendous results</i>, and it's the kind of medical innovation we need to sustain. </span></blockquote><br /><span id="articleText">In the article's text was the assertion,</span><br /><span id="articleText"></span><br /><br /><blockquote class="tr_bq">The new drug has demonstrated an ability to <i>cure well over 90 percent of patients in just 12 weeks </i>or less with few side effects.<br /><br />Prior to the Sovaldi approval, <i>hepatitis C treatments took 24 or 48 weeks, cured about 75 percent of patients and involved many more pills as well as injectable interferon that causes flu-like symptoms and other side effects that led many people to avoid or discontinue treatment.</i></blockquote><br />In other words, the article asserted that Sovaldi can cure over 90% of patients compared to the cure rate of 75% provided by previously available treatments, and implied Sovaldi has fewer side effects. <br /><br /><u>CNBC</u><br /><br />On May 22, 2014, in an <a href="http://nbr.com/2014/05/22/the-84000-question-will-focusing-on-drug-prices-rein-in-costs/">article</a> on the high costs of new drugs, a quote from Dr Douglas Dieterich, "a liver disease specialist at Mount Sinai Hospital," who "has consulted for pharmaceutical companies, including Gilead," appeared,<br /><br /><blockquote class="tr_bq">I don’t think there’s any question that treating patients with hepatitis C will lower overall health-care costs in the coming 20 years,...<br /><br />If <i>we could get rid of the liver disease in these patients with hepatitis C, prevent them from dying of liver cancer, cirrhosis and liver failure</i>, then there’s no question the cost will be less.</blockquote><br />The implication was that the new drugs can get rid of the disease, that is, cure it, and in doing so prevent early mortality, cirrhosis, and liver failure.<br /><br /><u>CTV</u><br /><br />The discussion of Sovaldi in Canada seems similar. On May 25, 2014, an <a href="http://www.ctvnews.ca/health/hepatitis-c-drugs-show-promise-but-price-is-too-high-for-most-patients-1.1837917">article</a> on the high cost of hepatitis C drugs in Canada from CTV, "Canada's largest private broadcaster," (look<a href="http://www.ctv.ca/About/Corporate-Info/About.aspx"> here</a>) quoted a Canadian physician,<br /><br /><blockquote class="tr_bq"> Dr. Curtis Cooper, director of the viral hepatitis program at the Ottawa Hospital, said the drugs Sovaldi and Galexos <i>offer a revolution for patients with the hepatitis C virus (HCV).</i><br /><br />'It only requires 12 weeks of treatment and (they) are <i>producing cure rates of 90 to even 100 per cent</i>,' he told CTV News.</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><br /><br />And later, addressing the treatment of a particular patient,<br /><br /><blockquote class="tr_bq">We're talking about <i>curative therapies, which could potentially save her from liver failure, save her from liver cancer</i></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Again, the assertions were that the drug cures 90%, maybe 100% if patients, and that cure will prevent liver failure and cancer.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><b>Is There Any Good Evidence?</b></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Again, while there is much discussion, and some outrage over the $1000 per pill price of Sovaldi in the US (in Canada, a bargain at Canadian $650 per pill), all the discussion seems to assume that the pill is really a "revolution" (as per CTV), that provides</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">- cure rates of 90 - 100%, much better than previously available treatments</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">- lower adverse effect rates than than those caused by previously available treatments</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">-  prevention of complications of hepatitis C, including cirrhosis, liver failure, liver cancer, and early death.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">I have found just one recent media article that throws a bit of evidence-based cold water on these claims, and refers to a new systematic review that should be generating a lot of interest, and provoking much more skepticism about the drug, but so far is not.<br /><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><u>The Single Skeptical Article</u><br /><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">On May 22, 2014, a MedPage Today article noted a new systematic review of sofosbuvir (Sovaldi) that had a very different message from the articles above.  In summary,</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq">The <i>evidence base for one of the star hepatitis C drugs is poor and the guidelines for its use are flawed</i>, according to a report obtained by the <a href="http://medicaiddirectors.org/about" target="_blank">National Association of Medicaid Directors</a>.<br /><br />According to the report, studies of sofosbuvir (Sovaldi) are <i>generally of poor quality</i>, mostly directed by the drug's maker, and <i>don't answer key questions, including whether the drug is better and safer than the current standard of care.</i><br /><br />The only available guidelines for its use -- guidelines created by the <a href="http://www.aasld.org/" target="_blank">American Association for the Study of Liver Diseases</a> and the <a href="http://www.idsociety.org/" target="_blank">Infectious Diseases Society of America</a> -- are <i>'methodologically flawed</i>,' according to the report, which was prepared by the<a href="http://www.ohsu.edu/xd/research/centers-institutes/evidence-based-policy-center/" target="_blank"> Center for Evidence-Based Policy</a> at Oregon Health and Science University in Portland (OHSU).<br /><br />In addition, their authors and sponsors had '<i>multiple and significant conflicts of interest</i>,' the report argued.</blockquote><br /><u>The Report from the Center for Evidence-Based Policy </u><br /><br />The report is public, available without cost direct form the Center (email < centerebp@ohsu.edu> ), although not yet directly available on the web.  It directly addresses all four of the major claims made about Sovaldi that we discussed in our <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">first post</a> n the topic.<br /><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">- <i>Most hepatitis C patients have very bad outcomes if untreated</i><br /><br /><br />The report cited the best data about outcome prevalence,<br /><br /><blockquote class="tr_bq">approximately 15% to 25% of people infected with HCV will clear the virus during the acute stage without treatment.  Seventy-five to 85% of infected individuals will develop a chronic HCV infection, and 60% to 70% of patients with chronic infection will develop chronic liver disease.  Over 20 to 30 years, 5% to 20% of infected patients will develop cirrhosis and 1% to 5% will die of cirrhosis or liver cancer.</blockquote><br />Although a majority of chronically infected patients will develop some liver disease, only a minority will develop cirrhosis or liver cancer.<br /><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">- <i>Treatment prevents most bad outcomes</i><br /><br /><br />The report stated,<br /><br /><blockquote class="tr_bq">Because of the slow progression of the disease, clinical trials have not evaluated these patient-important conditions [cirrhosis, hepatocellular carcinoma, decompensated liver disease, liver transplant, or death] as trial outcomes.  Instead a surrogate endpoint of sustained virologic response (SVR) has been used to measure success of treatment.  The SVR is defined as undetectable HCV-ribonucleic acid (RNA) levels.  The standard measure of treatment success has been SVR at 24 weeks post treatment (SVR24).<br /><br />Several long-term studies of patients with chronic HCV infection have shown an association between achieving SVR24 and patient-important clinical outcomes.</blockquote><br />So there is no direct evidence that treatment prevents any of the bad outcomes.  There is only indirect evidence that treatment may reduce the rate of some bad outcomes.  For example,<br /><br /><blockquote class="tr_bq">A 2014 observational study of a VA population found that ... the 5180 (4%) of patients who were able to achieve an undetectable viral load with interferon-based treatment had a 45% reduction in the risk of death ... and 27% reduction in the composite clinical endpoint ... of newly diagnosed cirrhosis, HCC [hepatocellular carcinoma], or liver related hospitalization.</blockquote><br />However, at best, based on an observational analysis that could have been biased, treatment only may have prevented a minority of bad outcomes. <br /><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">- <i>Sovaldi cures nearly all patients</i></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /><br />As we noted earlier, there have been only two randomized controlled trials published that compared sofosbuvir with anything else.  One compared it to placebo, and one was the trial we discussed earlier that compared it sofosbuvir with ribavirin to pegylated interferon with ribavirin.  (Look <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">here</a>.)   <br /><br /><blockquote class="tr_bq">All other studies were designed to refine drug dose, drug combination or duration of treatment.</blockquote><br />Also,<br /><br /><blockquote class="tr_bq">All studies were rated as having a high risk of bias.  No study was judged to have good applicability....  The overall summary judgement for each of the published studies yielded a rating of poor.</blockquote><br />Furthermore, the review found even more problems with the only study that compared sofosbuvir to active treatment (peg-interferon) than we did.  In particular, that study did not compare sofosbuvir with ribavirin to the current standard regimen of PEG plus weight-based ribavirin.  Instead, it compared it to a regimen that included low dose ribavirin.  By comparing sofosbuvir plus a higher dose or ribavirin, an active drug, to a peg-interferon plus a lower dose of ribavirin, the study design seemed designed to artificially enhance the efficacy of the sofosbuvir containing regimen.   Furthermore, the study did not assess the measure of sustained viral response at 24 weeks currently accepted as the best surrogate variable.  Instead it used SVR at 12 weeks, which may be correlated with SVR24 but is often higher. Thus this choice of endpoint seemed designed to increase the apparent efficacy of the regimens it evaluated.  <br /><br />So sofosbuvir has so far been compared to another active anti-viral regimen against hepatitis C in only one study.  That study was poorly designed and implemented, and its problems seemed likely to enhance the apparent efficacy of sofosbuvir.  Nonetheless, that one study did not show that sofosbuvir was more efficiacious, or safer than peg-interferon.<br /><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">-<i> Sovaldi has very few side effects.</i><br /><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div>The review had this summary,<br /><br /><blockquote class="tr_bq">The FDA compiled reports of adverse events from four trials....  There were no treatment-related deaths reported [note that we found there were deaths in the one trial that compared sofosbuvir to PEG, look <a href="http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html">here</a>].<br /><br />Approximately 78% of patients receiving placebo, 88% of patients on SOF + RBV treatment and 95% of patients receiving PEG + SOF +RBV reported a side effect from treatment.  The most common side effects were fatigue, anemia, nausea, rash, headache, insomnia and pain....</blockquote><br />Thus it seems likely that Sovaldi has a lot of side effects, and whether it has fewer than standard treatment is unclear.  Furthermore,<br /><br /><blockquote class="tr_bq">studies on sofosbuvir were small, included populations that were healthier than the general hepatitis C population, were of short duration and had limited follow-up.  In many of the studies, the manufacturer was responsible for recording and reporting adverse events.  In general, reporting of adverse events is often incomplete and discrepancies between clinical trial reports and publications are common....  All of these factors would lead to a <i>bias in under-reporting the true nature of adverse events.</i></blockquote><br />Thus there is no good evidence that sofosbuvir has few side effects, or is dramatically safer than older treatments.<br /><br /><b>Summary</b><br /><br />While there continues to be concern, if not outrage, that the latest treatment for hepatitis C is priced at $1000 per pill, most of those expressing concern seem to assume that the pill is a wonder drug, promising nearly everyone a cure without major side effects.  However, as we first noted in March, 2014, there is no strong evidence to that effect.  In fact, now three skeptical looks at the evidence by people with more resources and perhaps more expertise than we possess have shown similar conclusions.<br /><br />It is a tribute to the power of the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a> that there has been almost no recognition by physicians and other health professionals, journalists, and most amazingly, insurance companies who stand to lose billions paying for Sovaldi, that there is little good evidence that Sovaldi works, much less is superior to previous treatments.  Instead, even America's Health Insurance Plans thought the drug had "tremendous results," not very different from the assertion by the drug's manufacturer that the drug provides "a finite cure," (as reported by Reuters).  One might think that the insurance companies have enough money to invest in some real evidence-based medicine experts who could provide a skeptical assessment of the pricy new drugs and devices for which these companies may pay.  Is it that the commercial insurers are so now so dominated by generic managers who know nothing about health care, medicine, or biomedical science, much less evidence-based medicine that they are unable to resist the marketing and public relations hype?<br /><br />The Sovaldi case is a signal example of how our health care system is awash in marketing hype and public relations buzz that has swamped rational skeptical thinking about logic and evidence.  That marketing and PR is ever enriching managers while it will send the rest of us, health care professionals included, to the poor house.  And all the money we spend will not buy us the promised miracles and triumphs.<br /><br />As we have said until blue in the face, true health care reform would bring some skeptical thinking and regard for evidence and logic into the health policy discussion.   <br /><br />

Sovaldi - a "Revolution" in Clinical Care, or in Marketing and Public Relations?

The continuing public discussion of the sky high price Gilead has set for Sovaldi (sofosbuvir,) its new antiviral drug for hepatitis C, cont...

Đọc thêm »