More Hospices Pretending Patients are Terminally Ill

In the US, we have been engaged in an experiment involving handing over an ever increasing proportion of direct patient care to for-profit corporations, and non-profit organizations that act increasingly like for-profit corporations (as opposed to mission oriented non-profit organizations or individual health care professionals).  The results have been particularly striking for the care of one of the most vulnerable patient groups, the chronically ill.  <br /><br />Over the last months, a number of stories about the hospices enrolling patients who are not terminally ill have accumulated.  Keep in mind that hospices are supposed to provide compassionate palliative care to the terminally ill.  While they are supposed to make such patients as comfortable and free of pain as is possible, they are not supposed to otherwise aggressively treat other medical problems (based on the assumption that such treatment would benefit dying patients.)  However, such treatments could benefit, or even save the life of patients who are not dying.  (See posts <a href="http://hcrenewal.blogspot.com/2012/03/gentivas-odyssey-healthcare-settles.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/07/prepare-them-to-die-for-profit-hospices.html">here</a>.)<br /><br /><strong>Hospice of the Bluegrass</strong><br /><br />Back in March, there was very brief <a href="http://www.kentucky.com/2012/03/27/2128086/hospice-of-the-bluegrass-agrees.html">report</a> on Kentucky.com that the non-profit Hospice of the Bluegrass "agreed to pay the federal government $685,000 for submitting claims to Medicare to receive reimbursements for services it provided <em>patients who did not qualify for Medicare services</em>,..."  Note that the main requirement for Medicare payments for hospice services is that the patients receiving these services have no more than six months of survival expected. <br /><br />However, then in June a detailed <a href="http://www.kentucky.com/2012/06/23/2235773/hospice-of-the-bluegrass-does.html">investigative report </a>also on Kentucky.com recounted numerous conflicts of interest affecting that hospice's board,<br /><blockquote>The non-profit Hospice of the Bluegrass has spent more than $1.82 million since 2005 on business deals with several of its board members and the spouses of its executives.</blockquote><br />In particular,<br /><blockquote>On its tax returns from 2005 to 2010, Hospice reported paying at least:<br /><br />■ $540,178 for political lobbying and legal representation to the law firm of McBrayer, McGinnis, Leslie & Kirkland. One of the firm's partners and co-owners, Lisa English Hinkle, was a Hospice board member and a former board chairwoman. Hinkle rotated off the board at the end of 2011. She was preceded on the board by another partner in the firm, James Frazier.<br /><br />■ $837,999 for insurance to the firm of Powell-Walton-Milward, whose managing director, John Milward, is a Hospice board member. His brother Greg Milward, who also works at the insurance firm, previously was on the Hospice board and was board chairman in 2007.<br /><br />■ $392,042 for printing to Pat Byrne Printing, owned by the husband of Deede Byrne, Hospice's chief clinical officer.<br /><br />■ $22,506 for heating and air conditioning to Gary Merckle, husband of Carol Ruggles, Hospice's chief financial officer.<br /><br />■ $28,577 for advertising to the Lexington Herald-Leader while then-editor Marilyn Thompson sat on the board.</blockquote><br />The article also noted that the hospice CEO seems very well-paid given the context,<br /><blockquote>CEO Gretchen Marcum Brown, whose 2010 compensation was $238,650 in base pay, $10,570 in bonus pay and $84,978 in other reportable compensation. The other compensation included Hospice's payment into Brown's deferred-compensation account, from which she can draw in the future.<br /><br />Hospice also paid for a membership in Brown's name at The Club at Spindletop Hall, which offers swimming, tennis and dining.</blockquote>Such a pay package may provide incentives to maximize revenue by maximizing enrollment, regardless of whether enrolled patients really should be in hospice.<br /><strong>Hospice Family Care</strong><br /><br />As<a href="http://www.bizjournals.com/phoenix/news/2012/05/31/hospice-family-care-sold-after-37m.html"> reported</a> by the Phoenix Business Journal in May,<br /><blockquote>Hospice Family Care Inc. has agreed to pay the federal government $3.7 million to settle civil allegations that the Mesa-based company <em>violated the False Claims Act by submitting false bills to Medicare.</em></blockquote><br />Also,<br /><blockquote>The U.S. Attorney’s Office had alleged that Hospice Family Care submitted claims for payment to Medicare for <em>patients who were either completely or partially ineligible for hospice</em>,...</blockquote><br />So this settlement is partly for charges that the hospice enrolled patients who were not terminally ill.<br /><br />Note that in this particular case, the government made an effort to punish the owners of the company, who found a way to evade such punishment:<br /><blockquote>However, on the day the U.S. Attorney’s Office announced that settlement, Hospice Family Care’s owners closed on a deal to sell the company.</blockquote><br />So,<br /><blockquote>Neither the company’s attorney, Frederick Petti, nor government officials would disclose the name of the buyer.<br /><br />“Unfortunately, I can’t provide that information because it’s not in the public domain,” said Assistant U.S. Attorney Bill Solomon.<br /><br />The company’s co-owners, Nancy Smith and Nancy Turner, deferred all comments to Petti.<br /><br />'Believe me, if my clients weren’t in the process of selling this company, we would have fought this to the bitter end,' Petti said. 'We would have prevailed. This is a business decision.'<br /><br />He emphasized that the settlement agreement was not an admission of guilt.<br /><br />Smith and Turner agreed to be excluded from Medicare and Medicaid and all other federal health care programs for seven years, effective immediately. However, Petti said the company’s new owners will not be affected by that settlement agreement and will be free to accept reimbursement from government payers.</blockquote>Such maneuvers obviously reduce any deterrent effect of settlements like this on bad behavior, and particularly on the behavior of enrolling patients who are not terminally ill in hospice.<br /><strong>Harden Healthcare</strong><br /><br />Then in June the Wichita (Kansas) Eagle <a href="http://www.kansas.com/2012/06/21/2382557/whistleblower-suit-leads-to-61.html">reported</a>,<br /><blockquote>A Kansas hospice care provider and its Texas-based parent company will pay $6.1 million to resolve allegations that they <em>submitted false claims to the federal Medicare program</em>. The case arose from a whistleblower lawsuit filed by a nurse more than six years ago, the U.S. Justice Department said Thursday.<br /><br />Justice officials said in a news release that they hope the settlement with Wichita-based Hospice Care of Kansas LLC and Fort Worth-based Voyager HospiceCare Inc. will serve as a warning to other hospice providers.<br /><br />Prosecutors alleged the companies submitted false claims to the federal health care program for the elderly and disabled between 2004 and 2008 for patients who weren’t expected to die in less than six months, a requirement for the benefits in question.</blockquote><br />Note that this report makes very explicit the allegation that the hospice was enrolling patients who were not terminally ill. Further note that while the beginning of the report makes it appear that the company that owns the hospice is regional, it actually is larger<br /><blockquote>The agreement includes no admission or determination of wrongdoing, Harden Healthcare, the owner of Voyager HospiceCare and Hospice of Kansas, said in a statement.</blockquote><br />Harden Healthcare, <a href="http://www.bizjournals.com/austin/news/2012/05/25/harden-healthcare-tops-private-firms.html">according to </a>the Austin (Texas) Business Journal, is the largest private employer in that city, with over 3800 employees and revenues of over $810 million. <br /><br /><strong>Hospice of the Comforter</strong><br /><br />The Orlando Sentinel reported in late August,<br /><blockquote>The federal government is taking over a whistleblower lawsuit against the Altamonte Springs-based Hospice of the Comforter — a suit that alleges the nonprofit <em>routinely over-billed Medicare for patients who didn't qualify as terminally ill, sometimes keeping them in hospice care for as long as five years.</em></blockquote><br />These are allegations of course, but it turns out that both sides of the action agree on certain facts of interest,<br /><blockquote>Both sides agree that <em>Hospice of the Comforter officials discharged a large number of Medicare patients after the federal government began scrutinizing the ballooning number of hospice patients nationwide.</em><br /><br />In fact, Stone said, the initial sampling by government auditors showed Hospice of the Comforter had an error rate of 18 percent, just slightly over the 15-percent rate the government allowed and therefore triggering a second, more intense review.<br /><br />That phase, in January 2010, revealed a <em>troubling 77 percent denial rate</em>, Stone said — meaning that Medicare officials believed the hospice was improperly billing the government in 77 percent of the cases it reviewed. According to the government, hospice care should be limited to patients certified by a hospice physician as having six months or less to live.<br /><br />Meanwhile, though, <em>an internal hospice committee did its own review of patients, discharging more than 133 of them and noting they were, 'no longer terminally ill,</em>' the lawsuit states. Some had been designated 'FOB' for 'Friends of Bob [Wilson, the CEO of the hopsice],' and Wilson later insisted some be readmitted and their care billed to Medicare, the lawsuit says.</blockquote><br />Let me just note that for someone truly terminally ill, the way to become no longer terminally ill is to die. <br /><br />A <a href="http://articles.orlandosentinel.com/2012-09-08/news/os-scott-maxwell-hospice-adventist-medicare-fraud--20120908_1_medicare-fraud-settlement-adventist-hospitals-health-care-fraud">column</a> in the Orlando Sentinel suggested that the hospice CEO had a strong personal incentive to enroll patients who were not terminally ill,<br /><blockquote>there are facts not in dispute — such as <em>Wilson's financial incentive to keep his patient counts high: bonuses of $50,000 every three months on top of his base salary of $120,000</em>.</blockquote>Again, maintaining lucrative compensation could be an inducement for hospice executives to sanction enrollment of patients who were not really terminally ill.<br /><strong>Summary</strong><br /><br />Hospices arose to provide compassionate care for among the most vulnerable of patients, the terminally ill.  Hospices began as mission oriented non-profit organizations, often affiliated with hospitals or religious groups.  However, the generous payments for hospice care provided by Medicare and commercial insurance, and the increasingly laissez faire supposedly "market-based" health care context lead to the growth of for-profit hospices, and the emulation of their management by ostensibly non-profit organizations.  <a href="http://articles.orlandosentinel.com/2012-09-08/news/os-scott-maxwell-hospice-adventist-medicare-fraud--20120908_1_medicare-fraud-settlement-adventist-hospitals-health-care-fraud">In the Orlando Sentinel</a>, Scott Maxwell used the example of the Hospice of the Comforter to assert<br /><blockquote>you've been duped when it comes to waste, fraud and abuse in America's health-care system.<br /><br />Politicians love to rant about it. They often do so when explaining why they're about to cut your benefits.<br /><br />They're right that fraud happens. But the individual scammers they portray as the problem are nothing compared to the <em>systemic white-collar fraud perpetrated by corporations — and, yes, faith-based nonprofits.</em><br /><br /><em>This is America's dirty little health-care secret.</em><br /><br />We all know health-care costs are soaring. But <em>we have done little to address the organized fleecing — often because the fleecers are either campaign donors or nonprofits wrapped in a cloak of altruism.</em><br /><br />In this country, you can go to prison for stealing a TV. But if companies get caught stealing millions from taxpayers, the fines are simply viewed as the cost of doing business.</blockquote><br />We have made similar assertions about systemic misbehavior in the US health care system, and how failure of local through national government to impose any penalties on the individuals who authorize, direct or implement bad behavior just allow the problem to get worse. However, the consequences of increasing hospice enrollment (hence short-term revenue, and hence the compensation of top hospice executives) by enrolling patients who are not terminally ill go well beyond just increasing health care costs. As we have <a href="http://hcrenewal.blogspot.com/2012/03/gentivas-odyssey-healthcare-settles.html">said before</a>, enrolling patients into hospice who are not already really doomed to die soon denies them the possibility of treatment for new acute illnesses and worsening of chronic illnesses, which then could hasten their deaths. (Pretending those patients were terminally ill could have fooled their relatives into thinking those deaths were inevitable, instead of results of bad practice and potentially fraud.) <br /><br />So the pattern of fraud now increasingly documented to be taking place in for-profit and even non-profit hospices is particularly reprehensible. It preys on vulnerable patients, and may cost some patients their lives who otherwise might have lived for a long time. This is a prime example of what goes wrong when our main health care policy seems to be based on letting the good times roll. <br /><br />I hope that the realization that enrollment of patients who are not terminally ill into hospices can result in their untimely death may lead to some reconsideration of our experiment in lightly regulated, "market based" health care. Those who directly care for patients ought to be motivated by professional values, not short-term revenue.

More Hospices Pretending Patients are Terminally Ill

In the US, we have been engaged in an experiment involving handing over an ever increasing proportion of direct patient care to for-profit c...

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A Message for Xerox: Americans Not 'Resistant to Change'; They Are Resistant to Reckless Change That Endangers Them

A press release from Xerox Healthcare Provider Solutions:<br /><br /><blockquote class="tr_bq"><span class="articleDate">Jul 31, 2012</span><br /><span class="articleDate"></span><a href="http://news.xerox.com/pr/xerox/Xerox-Surveys-Americans-Electronic-Health-Records.aspx" target="_blank">Only 26 Percent of Americans Want Electronic Medical Records, Says Xerox Survey</a></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">The subtitle is a rhetorical question: </div><div class="MsoNormal"><b><br /></b></div><blockquote class="tr_bq"><div class="MsoNormal"><b>When it comes to healthcare, are Americans resistant to change?</b></div></blockquote><div class="MsoNormal"><b><span style="color: #1f497d;"> </span></b></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span class="articledate">This is analogous to the refrain of calling physicians and nurses "Luddites" regarding their not happily and passively accepting today's clinical IT.  I addressed that issue at my post on pragmatist clinicians v. health IT hyper-enthusiasts <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">at this link.</a></span></div><div class="MsoNormal"><br /></div><blockquote class="tr_bq"><div class="MsoNormal"><span class="articledate">Jul 31, 2012</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="color: #1f497d;"> </span></div><div class="MsoNormal">ROCHESTER, N.Y. – Americans routinely use electronic files to manage their finances, communicate with friends and family and even take college courses – but when it comes to medical records – <b>only 26 percent want them digital</b>. The findings come from the third annual Electronic Health Records (EHR) online survey of 2,147 U.S. adults, conducted for Xerox (NYSE: XRX) by Harris Interactive in May 2012. </div><div class="MsoNormal"><br /></div><div class="MsoNormal"></div><div class="MsoNormal">According to the survey, <b>only 40 percent of respondents believe digital records will deliver better, more efficient care</b>. That response fell two percent from last year’s survey, and matches the response reported in 2010. <b>Overall, 85 percent of respondents this year expressed concern about digital medical records.</b></div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">Americans have a healthy skepticism of putting their private information online to be <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy" target="_blank">hacked</a>, of the <a href="http://www.tinyurl.com/hostileuserexper" target="_blank">disruptive effects</a> of today's commercial health IT on their clinicians, and the costs of doing so.  This likely comes from common sense, reading and observation.<br /><br />As one reader of this blog wrote: <br /><br /><blockquote class="tr_bq">Xerox kindly shared all three years of their annual Electronic Health Records (EHR) online surveys by Harris Interactive. The media, industry and government unrelentingly promote health technology as the latest, greatest best stuff. But the public ain’t buying it. They want smart phones, but they don’t want <b>EHRs</b>. </blockquote></div><div class="MsoNormal"><br />The Xerox article paternalistically continues:<br /><br /></div><div class="MsoNormal"></div><blockquote class="tr_bq"><div class="MsoNormal">“We continue to see a<b> resistance to change</b> from <b>consumers</b> – meaning providers need to continue to educate Americans on the value of EHRs,” said <a href="http://www.blogger.com/redir.aspx?C=128f7c1b39b042a884df5a17e3807ff8&URL=http%3a%2f%2fwww.acs-inc.com%2fthot_chadharris.aspx" target="_blank">Chad Harris</a>, group president, Xerox Healthcare Provider Solutions.</div></blockquote><div class="MsoNormal"><br /><span style="color: black;">(Note the use of the 'EHR' acronym.  As I've written, the acronyms 'EHR' and 'EMR' are anachronisms used to describe what are no longer innocuous filing systems, but greatly intrusive <b>enterprise clinical resource and workflow control systems</b>.  I think the public increasingly understands that.)</span><br /><br /></div><div class="MsoNormal">This patriarchal statement by Chad Harris about "resistance to change" by "healthcare consumers" needing re-education is, in a word, <i>depraved</i>, because I think the person uttering the sentence knows better.  Let's define depraved:</div><div class="MsoNormal"><br /></div><blockquote class="tr_bq"><div class="MsoNormal"><a href="http://www.thefreedictionary.com/depraved" target="_blank">Depraved</a> (adj.):  morally bad or debased; corrupt; perverted</div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">This statement implies is that health IT is a perfected technology without significant flaws, whose benefits are well-proven and whose drawbacks and risks are well understood.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Unfortunately, none of those are true.  From my May 2012 post on ONC's embarrassing "<a href="http://hcrenewal.blogspot.com/2012/05/oncs-health-data-palooza-title-of.html" target="_blank">Health Data Palooza</a>", worth repeating here, with hyperlinks:</div><div class="MsoNormal"><br /></div><div style="font-family: inherit;"><ul><li><span style="font-size: small;">There is a markedly unscientific "irrational exuberance" pushing clinical IT into wide use at a dangerously rapid pace. This exuberance is contradicted by a growing body of literature that shows the benefits are likely far less than stated, e.g., by way of example, the ad-hoc set at </span><span style="font-size: small;"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist;</a></span><span style="font-size: small;"></span> </li><li><span style="font-size: small;">The technology remains experimental, its rollout is a human subjects experiment on a massive scale lacking nearly all the protections of other human subjects experimentation and for IT in mission critical settings (e.g., informed consent, formal quality control/validation/regulation, formal postmarket surveillance and reporting) due to extraordinary legal and regulatory special accommodations afforded the technology and its purveyors; </span></li><li><span style="font-size: small;">Defects of in-use systems are rampant, inappropriately turning patients and clinicians into software alpha and beta testers (e.g., as in the voluntary FDA MAUDE database, <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html</a> which contains information for just one HIT vendor, Cerner, who voluntarily reports such issues);</span> </li><li><span style="font-size: small;">The technology is unsupportive of clinician cognitive needs (2009 National Research Council study, which also stated that accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering will be essential to perfect this technology);</span> </li><li><span style="font-size: small;">The roles of <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">scientific discovery and anecdote</a> have been turned on their heads. RCT's of clinical IT are nearly non-existent and lower-level evidence (e.g., weak observational, pre-post, </span><span style="font-size: small;">qualitative</span><span style="font-size: small;">, and other study types) are cited as "scientific proof" of efficacy and safety justifying hundreds of billions of dollars of taxpayer (or is it Chinese loan?) expenditures.  Yet, risk management-relevant case reports of harmful events and near misses, crucial to help organizations and regulatory agencies understand risks are dismissed as "anecdotal" (e.g., Blumenthal: "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said, while ONC issued an article based on questionable research methods entitled </span><span style="font-size: small;">"<a href="http://content.healthaffairs.org/content/30/3/464.full.html">The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results</a>" </span><span style="font-size: small;">extolling the virtues of HIT, written about at <a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html">http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html</a>).</span> </li><li><span style="font-size: small;">Risks are definite, with known patient injury and death, but the magnitude is admittedly unknown as admitted by JC (2008 Sentinel Event Alert), FDA (2010 Internal memo on HIT risks and statements of Jeffrey Shuren MD JD about known harms likely being "the tip of the iceberg"), IOM (2011 report on HIT risk), ECRI Institute (Top ten healthcare technology hazards for 2011 and 2012), NORCAL Mutual Insurance Company 2009 report on EHR risks, others;</span> </li><li><span style="font-size: small;">Existence of severe impediments to information diffusion about risks explicitly admitted by FDA (2010 memo), IOM (2011 report), others; </span></li><li><span style="font-size: small;">Usability of commercial products in real world settings is often poor (e.g., NIST 2011 study on usability), promoting "use error" (user interface designs that engender users to make errors of commission or omission, where many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc.) </span></li><li><span style="font-size: small;">These systems promote capture and display of clinically irrelevant information in the interest of charge capture, and result in <a href="http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html" target="_blank">reams of "legible gibberish"</a> with many negative characteristics that make it difficult for other clinicians and reviewers to establish a cohesive, definitive narrative of clinical events and timelines.</span></li></ul></div><div class="MsoNormal"><br /></div><div class="MsoNormal"></div><div class="MsoNormal">The article continues: </div><div class="MsoNormal"><br /></div><blockquote class="tr_bq"><div class="MsoNormal">Despite consumers’ misgivings of the value of EHRs, caregivers <i style="color: red;"><b>[largely hospitals and healthcare systems who force it on their staffs and owned physician practices - ed.]</b></i> are quick to adopt digital technology.  <i style="color: red;"><b>[Thanks to incentives and looming penalties - ed.]</b></i> When asked how their healthcare provider recorded medical information during their last visit to a doctor or hospital, 60 percent of respondents – who have visited a doctor or hospital – reported that the information was entered directly into a tablet, laptop or in-room computer station versus 28 percent who reported the information was taken via handwritten notes. </div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">As the numbers don't justify the practice, even if the numbers as stated are valid, my response is:<br /><br /><i>So what? </i></div><div class="MsoNormal"><br /></div><div class="MsoNormal"></div><blockquote class="tr_bq"><div class="MsoNormal">To help caregivers do more with this patient information, Xerox is working with researchers at PARC, A Xerox Company, to explore EHRs as a gateway to a variety of healthcare innovation <b>possibilities</b>. The resulting technology tools <b>will </b>simplify back-office and front-line processes, reduce errors, and free up caregivers to spend more time and attention on day-to-day patient care.</div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">The "possibilities" <b>will</b><b> </b>accomplish all these things?   </div><div class="MsoNormal"><br /></div><div class="MsoNormal">Not only does that not follow logically, but where's the data, or is this simply wishful thinking? </div><div class="MsoNormal"><br /></div><div class="MsoNormal">The latter "possibility that <b>will </b>come true" - "free up caregivers to spend more time and attention on day-to-day patient care" - is the most laughable.   These systems do anything but, as for example <a href="http://hcrenewal.blogspot.com/2012/09/realizing-ehr-potential-or-avoiding.html" target="_blank">here</a> regarding the the time costs of data acquisition and the time costs of data input.  I have yet to see serious studies that consistently demonstrate any time savings at all for clinicians.  Quite the reverse, actually.<br /><br />Of course, the mandatory marketing puffery: </div><blockquote class="tr_bq"><div class="MsoNormal"><br /></div><div class="MsoNormal"></div><div class="MsoNormal">“A big part of PARC’s healthcare work for Xerox is using <a href="http://www.blogger.com/redir.aspx?C=128f7c1b39b042a884df5a17e3807ff8&URL=http%3a%2f%2fwww.parc.com%2fservices%2ffocus-area%2fethnographyservices%2f" target="_blank">ethnography</a> and other social science methods to observe and analyze actual work practices – not just what people say they do,” said <a href="http://www.blogger.com/redir.aspx?C=128f7c1b39b042a884df5a17e3807ff8&URL=http%3a%2f%2fnews.xerox.com%2fpr%2fxerox%2felectronic.aspx%3ffid%3d181957%26id%3dE0C30430" target="_blank">Steve Hoover</a>, CEO, PARC, A Xerox Company. “If there’s one thing that this survey tells us, coupled with our own experiences, it’s that you should never develop or deploy technology outside of the human context.”</div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">Precisely what is being done now, and on a national scale in the 'National Program for IT in the HHS.'</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Xerox, either you're part of the solution or part of the problem.</div><div class="MsoNormal"><br />Which is it? </div><div class="MsoNormal"><br /></div><div class="MsoNormal"><b><span style="font-family: 'Calibri','sans-serif';"> </span></b></div>-- SS

A Message for Xerox: Americans Not 'Resistant to Change'; They Are Resistant to Reckless Change That Endangers Them

A press release from Xerox Healthcare Provider Solutions: Jul 31, 2012 Only 26 Percent of Americans Want Electronic Medical Records, Says Xe...

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How Many Legal Settlements Does it Take... to Lead to Real Change in Johnson and Johnson Leadership?

And the latest Johnson & Johnson settlement is (as <a href="http://www.businessweek.com/news/2012-08-30/j-and-j-will-pay-181-million-to-settle-risperdal-ad-claims">described </a>in Bloomberg/ BusinessWeek):<br /><blockquote><em>Johnson & Johnson (JNJ) will pay <strong>$181 million</strong> to resolve claims by 36 states that it improperly marketed and advertised the antipsychotic drugs Risperdal and Invega</em>.<br /><br />J&J and its Janssen unit settled <em>claims that it promoted the drugs from 1998 through 2004 for uses not approved by the U.S. Food and Drug Administration</em>. New York Attorney General Eric Schneiderman said today the accord is <em>the largest multistate consumer protection-based pharmaceutical settlement.</em><br /><br />'This landmark settlement holds the companies accountable for practices that put patients in danger, and serves as a warning to other pharmaceutical giants that they must play by one set of rules,' Schneiderman said in a statement.<br /><br /><em>J&J agreed it won’t promote the drugs for off-label uses or tout them falsely</em>.</blockquote><br /><strong>Specific Bad Behaviors</strong><br /><br />The allegations were of the sorts of behavior that should make health professionals cringe,<br /><blockquote>Using speaker programs on unapproved uses,<em> sham consulting programs for physicians, and lucrative agreements with doctors who prescribed off-label,</em> J&J 'sought to enhance Risperdal’s off-label market penetration across a wide range of diagnoses and patient populations, according to Florida’s complaint. </blockquote><br />So reading slightly between the lines, the behaviors included various ways to pay physicians ("sham consulting," "lucrative agreements") for prescribing drugs, providing physicians monetary incentives to violate the most core of their core values, putting the individual patient's welfare and needs ahead of personal enrichment. Why these were not labeled kickbacks or bribes is not obvious.<br /><br /><strong>No Individuals Pay any Penalty</strong><br /><br />Nonetheless, as in nearly every other legal action by state or federal law enforcement against a big pharmaceutical company or other big health care company, the entire settlement involved no penalties to any individuals who may have authorized, directed or participated directly in the misbehavior. In fact, <br /><blockquote>The company, based in New Brunswick, New Jersey, settled 'to resolve the concerns of the attorneys general under state consumer protection laws and to avoid unnecessary expense and a prolonged legal process,' it said in a statement.<br /><br /><em>J&J didn’t admit wrongdoing or pay a fine or penalty</em>. </blockquote><br />The tough law enforcers claimed<br /><blockquote>The agreement 'sends a message to all pharmaceutical companies that these practices will not be tolerated,' Florida Attorney General Pam Bondi said in a statement. </blockquote><br />Of course, there was another part to the settlement. The company promised not to do these sort of bad things again,<br /><blockquote>Bondi said Janssen agreed to several steps over five years. They include having policies to ensure that financial incentives aren’t given to encourage off-label marketing; sales and marketing employees can’t develop the medical contents of responses to health-care providers; and it must describe the effectiveness and risks of drugs in a balanced manner. </blockquote><br />Should we believe them? Their record is not promising. <br /><br />Earlier this year Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians about the very same drug at issue in this suit, Risperdal (look <a href="http://hcrenewal.blogspot.com/2012/04/once-more-with-feeling-johnson-and.html">here</a>). That was just the latest in a remarkable string of legal cases suggesting an ongoing pattern of unethical and illegal behavior by this very large health care corporation. As we <a href="http://hcrenewal.blogspot.com/2012/03/despite-recalls-legal-settlements-and.html">wrote </a>recently, this included<br />- Convictions in two different states in 2010 for misleading marketing of Risperdal, as noted above<br />- A guilty plea for misbranding Topamax in 2010<br />- Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary<br />- A guilty plea for marketing Risperdal for unapproved uses in 2011 (see <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">this link</a> for all of the above)<br />- Accusations that the company, which makes smoking cessation products, participated along with tobacco companies in efforts to lobby state legislators (see post <a href="http://hcrenewal.blogspot.com/2011/09/smart-alecs-strange-bedfellows.html">here</a>)<br />- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post <a href="http://hcrenewal.blogspot.com/2011/09/johnson-and-johnson-pleads-guilty.html">here</a>)<br />- More recently, in 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">here</a>).<br />- Most recently, there are reports that the company is in negotiation with the US Department of Justice to settle other lawsuits about the marketing of Risperdal, perhaps for as much as $1.8 billion (see this <a href="http://www.businessweek.com/news/2012-03-12/j-and-j-said-to-face-u-dot-s-dot-demand-to-raise-risperdal-settlement-offer">BusinessWeek story</a>.)<br /><br />One might think that the leadership on whose watch this all occurred would be in disgrace. There has been, however, no major changes in leadership of the company. The CEO who was in power during the time when these settlements, and much of the behavior leading to them, will be retiring, after earning huge compensation, and with a retirement package valued somewhere between $143 and $197 million (see this <a href="http://hcrenewal.blogspot.com/2012/03/despite-recalls-legal-settlements-and.html">post</a>). Rather than disgrace, he recently was put on the committee responsible for investigating JP Morgan Chase's $5.8 billion dollar trading loss (as reported by Bloomberg, <a href="http://www.nj.com/business/index.ssf/2012/08/jjs_weldon_to_help_review_jpmo.html">via NJ.com</a>).<br /><br /><strong>Summary</strong><br /><br />As we have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">noted again and again and again</a>, many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved. <br /><br />These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look <a href="http://hcrenewal.blogspot.com/2012/08/duchess-of-wellpoint-abdicates-likely.html">here</a>). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "<a href="http://www.washingtonpost.com/blogs/election-2012/wp/2012/09/04/patrick-it-is-time-for-democrats-to-grow-a-backbone/">grow a backbone</a>" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care.<br /><br />As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.

How Many Legal Settlements Does it Take... to Lead to Real Change in Johnson and Johnson Leadership?

And the latest Johnson & Johnson settlement is (as described in Bloomberg/ BusinessWeek): Johnson & Johnson (JNJ) will pay $181 mill...

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Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?

At my Aug. 31, 2012 post "<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>" I wrote that healthcare IT vendor EPIC was advising customers in what to write in their "Public comments" regarding the proposed <i>Meaningful Use Stage 2 Final Rule, </i>the requirements of which permit financial incentives to be received by a user if met by an EHR.<br /><br />It appears they may have been successful.<br /><br />Note their apparent boilerplate "recommendations" regarding <b>§ 170.314(a)(9) - Electronic notes</b>.  This comes from the numerous filings with the accidentally unredacted "Informational Comments for Organizations Using Epic (remove before submitting to ONC)" note, and others without.   Pay specific attention to the <b style="color: #3d85c6;">"Tertiary Recommendation</b><b style="color: #3d85c6;">"</b>:<br /><br /><blockquote class="tr_bq"><b style="color: #cc0000;">Major Concern</b><br /><br />As detailed in our introduction, we are significantly concerned that the scope of the certification program is endangering some of the goals of Meaningful Use by introducing unnecessary overhead and burden.<br /><br />As electronic notes are not proposed as a Meaningful Use objective with the rationale that electronic notes are already in common use, we do not think certification on this criterion is necessary, and suggest removal. Introducing unnecessary certification criteria creates expense for ONC, certifying bodies, and EHR developers, and does not provide significant value to the marketplace.<br /><br style="color: #3d85c6;" /><b style="color: #3d85c6;">Recommendation</b><br />Keep consistent with CMS and remove this criterion from the Final Rule.<br /><br /><b><span style="color: #3d85c6;">Secondary Recommendation</span></b><br />If this criterion is retained in the Final Rule, we suggest that the criterion should be an optional certification for the same reasons, and we make the following suggestions:<br /><br />We agree with your assessment that having notes be searchable provides increased value over notes that are part of a scan or other formats that are not able to be searched. Our experience shows that note search capabilities is complex with potential for innovation in how information is found and displayed. Prioritization of such capabilities is best left to the marketplace. Search is not essential to meet the not-proposed objective drafted by CMS. Focus certification on the minimum floor set of capabilities required to complete meaningful use objectives. Therefore, we suggest that search capabilities be excluded from certification.<br /><br /><b style="color: #3d85c6;">Tertiary Recommendation</b><br /><b>If this criterion is retained in the Final Rule and is not made optional, a reasonable requirement for certification would be the ability to <u>search for a free-text string within a particular open note</u>. </b>Other search capabilities should be left as competitive differentiators within the marketplace. Specific certification requirements could interrupt innovative ways to do effective chart search and information display.<br /><br /><h3><b style="color: red;">Informational Comments for Organizations Using Epic (remove before submitting to ONC) </b></h3>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.<br /><br /><b>Our comments<i style="color: red;"> [presumably, those above - ed.]</i></b> stem from the fact that we believe that you prefer we focus our attention on the more sophisticated chart search feature you have requested in a future version. </blockquote><br />The <i>ability to search for a free-text string within an already open [on-screen] <b>note</b></i> is not of very much value (near useless perhaps?) compared to the ability to search an open patient's<b> record</b> for all notes that contain a string, or <b>across</b> <b>a set of many records</b>, for free-text strings or other values. Think Windows 7 "Search programs and files" at the Start menu, the MS Win XP add-on <a href="http://www.microsoft.com/en-us/download/details.aspx?id=23" target="_blank">Windows Search 4.0 for Windows XP</a>, or MacOS's <a href="http://en.wikipedia.org/wiki/Spotlight_%28software%29" target="_blank">Spotlight</a>.<br /><br />(Is there, I ask, a commercial EHR that <b>cannot</b> search for a free-text string within a "particular open note"?  Further, any web browser can search screen contents for text strings, I add, so if the EHR is using a browser, that feature comes as a freebie.)<br /><br />Now note from the MU Stage 2 NPRM (Proposed Rule as in the Notice of Proposed Rulemaking) that appeared in the Federal Register on Mar. 7, 2012.  The relevant passage about note searching is highlighted in <b style="color: #6aa84f;">green</b>:<br /><br /><blockquote class="tr_bq"><div><span style="font-size: small;"><b><span style="font-size: small;">DEPARTMENT OF HEALTH AND HUMAN SERVICES </span></b><br /><b><span style="font-size: small;">Office of the Secretary <br /> 45 CFR Part 170 <br /> RIN 0991-AB82 <br /> Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology <br /> </span></b><span style="font-size: small;"><b>AGENCY: </b></span><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services. </span></span><br /><b><span style="font-size: small;"></span></b><span style="font-size: small;"><b>ACTION: </b></span><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">Proposed rule. </span></span><br /> <br /> § 170.314(a)(9) - Electronic notes<br /> <br /> </span><span style="font-size: small;">• </span><b><u><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">Electronic notes </span></span></u></b><br /><table border="1" cellpadding="7" cellspacing="0" dir="ltr" style="width: 237px;"><tbody><tr><td height="16" valign="top"><b><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;"><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;">MU Objective </span></span></b><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;"><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;"></span></span><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;"><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;">Record electronic notes in patient records. </span></span></td></tr><tr><td height="16" valign="top"><b><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;"><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;">2014 Edition EHR Certification Criterion </span></span></b><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;"><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;"></span></span><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;"><span style="font-family: Times New Roman,Times New Roman; font-size: x-small;">§ 170.314(a)(9) (Electronic notes) </span></span></td></tr></tbody></table></div><div dir="ltr"></div><div dir="ltr"></div><div dir="ltr"><span style="font-size: small;"><br />The HITSC recommended a certification criterion similar to the 2014 Edition EHR certification criterion we propose at § 170.314(a)(9) (with specific reference to "physician, physician assistant, or nurse practitioner" electronic notes) to support the MU objective and measure recommended by the HITPC. CMS has not proposed the MU objective and measure for Stage 2, but has requested public comment on whether the objective and measure should be incorporated into Stage 2.<br /> <br /> <span style="color: #6aa84f;"><span style="color: black;">Consistent with our discussion in the preamble section titled "Explanation and Revision of Terms Used in Certification Criteria," we have replaced the terms "modify" and "retrieve" in the recommended criterion with "change" and "access," respectively. </span><b>Additionally, we are providing the</b></span><b style="color: #6aa84f;"> following clarifications</b><span style="color: #6aa84f;"> <b>for the electronic "search" capability.</b> </span><b style="color: #6aa84f;">"Search" means the </b><span style="color: #38761d; font-size: small;"><b style="color: #6aa84f;">ability to search free text and data fields of electronic notes. <u>It also means the ability to search the notes that any licensed health care professional has included within the EHR technology, including the ability to search for information across separate notes rather than just within notes</u></b><span style="color: #6aa84f;">.</span> <b><span style="color: #6aa84f;">We believe that this certification criterion would encompass the necessary capabilities to support the performance of the MU objective and measure as discussed in the MU Stage 2 proposed rule.</span></b> </span></span></div></blockquote><br />Note the robust "search" capability proposed - <span style="font-size: small;"><span style="font-size: small;"><b>the ability to search the notes that any licensed health care professional has included within the EHR technology, including the ability to search for information across separate notes rather than just within notes</b>.</span></span><br /><br /><span style="font-size: small;"><span style="font-size: small;">Now, finally, note the Final Rule:</span></span><br /><br />On pg. 300 of final rule at <a href="http://www.ofr.gov/OFRUpload/OFRData/2012-21050_PI.pdf">http://www.ofr.gov/OFRUpload/OFRData/2012-21050_PI.pdf</a> it says:<br />  <br /><blockquote class="tr_bq">Stage 2 Measures:<br /><br />Enter at least one electronic progress note created, edited and signed by an eligible professional for more than 30 percent of unique patients with at least one office visit during the EHR reporting period.<br /><br />Enter at least one electronic progress note created, edited and signed by an authorized provider of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) for more than 30 percent of unique patients admitted to the eligible hospital or CAH's inpatient or emergency department during the EHR reporting period.<br /><div style="color: #6aa84f;"><br /></div><b style="color: #6aa84f;">Electronic progress notes must be text-searchable.</b> Nonsearchable notes do not qualify, but this does not mean that all of the content has to be character text. Drawings and other content can be included with searchable text notes under this measure.</blockquote><br />pg. 553:<br /><br /><blockquote class="tr_bq">Enter at least one electronic progress note created, edited, and signed by an eligible professional for more than 30 percent of unique patients with at least one office visit during the EHR reporting period. <br /><br />Enter at least one electronic progress note created, edited and signed by an authorized provider of the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) for more than 30 percent of unique patients admitted to the eligible hospital or CAH’s inpatient or emergency department during the EHR reporting period. <br /><div style="color: #6aa84f;"><br /></div><b style="color: #6aa84f;">Electronic progress notes must be text-searchable. </b>Nonsearchable notes do not qualify, but this does not mean that all of the content has to be character text. Drawings and other content can be included with searchable notes under this measure.</blockquote><br /><span style="font-size: small;"><span style="font-size: small;">It would appear, and readers, please correct me if I am mistaken, that the very short criteria specified here - <b style="color: #6aa84f;">"Electronic progress notes must be text-searchable"</b> </span></span><b><span style="color: #b45f06;"></span>- </b><span style="font-size: small;"><span style="font-size: small;">would be satisfied by "</span></span><b>the ability to search for a free-text string within a particular open note" </b>per the vendor-authored <b style="color: #3d85c6;">Tertiary Recommendation, </b><span style="color: black;">shown <u>supra</u>.</span><br /><br />I've searched the MU Stage 2 Final Rule (Adobe Acrobat can do that, but I probably could have used Windows search itself depending on document length)<b> seeking terms from the NPRM such as <span style="color: #b45f06;"><span style="color: #6aa84f;">"search",</span> "</span></b><span style="font-size: small;"><span style="font-size: small;"><b><span style="color: #b45f06;"><span style="color: #6aa84f;">information across", "notes", "free-text"</span> </span>etc.  </b>However, I cannot find anything approaching the NPRM </span></span><span style="font-size: small;">§ 170.314(a)(9)</span><span style="font-size: small;"> clarification regarding the meaning of "electronic search capability."</span><br /><br /><span style="font-size: small;">I ask:  what was the role of the </span><b style="color: #3d85c6;">Tertiary Recommendation</b> received by ONC from multiple EPIC user organizations?<br /><br />-- SS

Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?

At my Aug. 31, 2012 post " Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ign...

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Realizing EHR potential, or avoiding patient endangerment?

I noted an interesting comment posted in the comment thread of Bob Wachter's post <a href="http://community.the-hospitalist.org/2012/09/03/putting-the-a-back-in-soap-notes-time-to-tackle-an-epic-problem/" rel="bookmark" title="Putting the “A” Back in SOAP Notes: Time to Tackle An Epic Problem">"Putting the “A” Back in SOAP Notes: Time to Tackle An Epic Problem</a>." <br /><br />The comment by Dr. Christine Sinsky reads (there seems to be no way to link directly to it):<br /><br /><blockquote class="tr_bq">Great post Bob.  Ambulatory records are equally in need of brevity and clarity. These notes are often 6 pages of mostly nonsensical boiler plate, formatted on a billing template, leaving the reader asking your question: “but what is going on with the patient?”<br /><br />After 10 years with our clinic’s EHR (McKesson HAC) and 9 years with our hospital EHR (Cerner), the most important issues I’ve encountered have been<br /><br />• <b>The time costs of data acquisition:</b> Remember the graphic on a clipboard at the foot of the bed? It was a concise and convenient source of information that has not been reproduced in our EHR. It is now a laborious process to unearth this same information. I/Os and daily weights have become lost data points.<br /><br />• <b>The time costs of data input:</b> One night on call I did a time trial on six of my admissions: it took an average of 73 seconds to record the admitting orders on paper vs 17 minutes to enter the same orders electronically. And in the electronic world I find myself at higher risk of forgetting the orders I meant to write, as the rigid sequence mandated by the EHR is not always the logical clinical sequence in my mind, and it requires parking orders in my mind until I finish marching through laborious tick boxes.<br /><br />• <b>Diminished situational awareness. </b>Nurses, doctors and others have a more myopic view of the patient, as it is harder to see trends and to see the big picture. Nurses may only know the meds and the orders that pertain to their shift for example.<br /><br />• <b>Barriers to synthesis</b>: I find it harder to synthesize the diverse sources of data for a patient when each data bit is tucked away in hard to reach electronic silos, often down long navigational pathways. Sometimes one has to scroll both vertically and horizontally (without freeze frames, so the column and row headings disappear while you scroll) creating a cognitive nightmare.<br /><br />EHRs will continue to be an important tool going forward; improved usability and a better alignment with clinical workflows are needed if we are to fully realize their potential.</blockquote><br />I thought the bullet list not at all surprising, and added the following comment in reply to amplify an implied but unstated point:<br /><br /><blockquote class="tr_bq"><i>Re: “EHRs will continue to be an important tool going forward; improved usability and a better alignment with clinical workflows are needed if we are to fully realize their potential.”</i><br /><br />You just described what could indisputably be called serious impediments to care. 73 seconds to 17 minutes? Loss of easily accessed data on I/O and daily weights? Diminished situational awareness?<br /><br />Perhaps it’s time clinicians stopped sugar coating their statements with PC <i style="color: red;"><b>[politically correct - ed.]</b></i> niceties such as "... <b>if we are to <u>fully realize their potential</u></b>”, and were more forceful with a more apt <b>“improved usability and a better alignment with clinical workflows are needed</b><b> if we are to</b><b> <u>avoid patient endangerment</u>.”</b></blockquote><br />Disruptive effects like these, in my view, lend more import towards speaking of the latter than of the former.<br /><br />-- SS <b><br /></b>

Realizing EHR potential, or avoiding patient endangerment?

I noted an interesting comment posted in the comment thread of Bob Wachter's post "Putting the “A” Back in SOAP Notes: Time to Tack...

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Who Really Makes Brand-Name Pharmaceuticals?

A striking illustration of the hazards to patients' and the public's health from health care organizational leaders using fashionable management techniques to maximize short-term revenue <a href="http://www.reuters.com/article/2012/08/28/us-china-pharmaceuticals-idUSBRE87R0OD20120828">appeared</a> in Reuters.  <br /><br /><b>Background: The Contaminated Heparin from China</b><br /><br />The particular issue got public notice after US patients started to get sick and die after being infused with heparin, the common anti-coagulant drug. As we have discussed repeatedly starting in 2008 (look <a href="http://hcrenewal.blogspot.com/search/label/heparin">here</a>, and see the summary at the end of the post), Baxter International was selling contaminated heparin under its label which was made in unregulated workshops in China, and then transmitted through a complex chain of Chinese and US companies.  What helped to further obscure the problem was what Baxter was buying was called the active pharmaceutical ingredient (API), which actualy means it was buying the active drug from poorly documented foreign sources.  In other words, it had entirely outsourced the manufacturing of a drug it sold as if it had been made by Baxter in the US.<br /><br /><b>Continued Outsourcing to Questionable Drug Manufacturers</b><br /><br />Reuters reported on a new investigation of outsourcing of drug manufacturing to China.  The main point was:<br /><blockquote>Four years ago, Beijing promised to clean up its act following the deaths of at least 149 Americans who received contaminated Chinese supplies of the blood-thinner heparin. But an examination by Reuters has found that <i>unregulated Chinese chemical companies making active pharmaceutical ingredients (API) are still selling their products on the open market with few or no checks.</i><br /><br />Interviews with more than a dozen API producers and brokers indicate drug ingredients are entering the global supply chain after being made with no oversight from China's State Food and Drug Administration (SFDA), and with no Good Manufacturing Practice (GMP) certification, an internationally recognized standard of quality assurance.<br /><br /><i>'There is falsification of APIs going on, we know it,'</i> said Lembit Rago, coordinator for Quality Assurance and Safety in Medicines with the World Health Organisation (WHO).</blockquote><br />In fact, the article made the point that the majority of drugs sold worldwide are the product of outsourced, often unregulated, and potentially contaminated and adulterated manufacturing:<br /><blockquote><i>'Illegal ingredients in bulk are a big problem, but nobody talks about it,'</i> said Guy Villax, chief executive of Hovione, an API supplier based in Portugal with factories there and in China, the United States and Ireland.<br /><br /><i>About <b>70 to 80 percent of all active drug ingredients</b> - the biologically active component in medicines - originate in China and India</i>, estimate industry experts, with China accounting for the lion's share. Its export market in these products is worth $22 billion in annual sales, according to the China Chamber of Commerce for Import and Export of Medicines and Health Products.<br /><br />'If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty,' said Villax.</blockquote><b>How Dodgy Manufacturers Continue to Operate</b><br /><br />Apparently, a particular problem in China is that APIs, that is, the particular drugs in question, can be made by chemical as opposed to officially designated "pharmaceutical" companies, and these chemical companies are not regulated,<br /><blockquote>A key regulatory weakness in China is<i> the distinction between pharmaceutical and chemical companies. While the former are regulated by the SFDA, the latter, making everything from sweeteners to solvents, are not. Yet many chemical companies also churn out drug ingredients</i>, exploiting a loophole by describing the products as chemicals, which they are, rather than the more specific designation of APIs.</blockquote><br />For example, the article recounted how an unregulated chemical company was apparently a source for a well-known branded pharmaceutical sold by two big pharmaceutical companies headquartered in developed countries,<br /><blockquote>[A]company, <i>Jinan Hongfangde Pharmatech (JHP), of Jinan city in Shandong province, had a product list showing at least five patented products for sale. They included tiotropium bromide, a blockbuster lung drug co-promoted by Boehringer-Ingelheim and Pfizer Inc and sold under the name Spiriva,...</i></blockquote><br />Both Boehringer-Ingelheim and Pfizer spokespeople claimed that they only bought drugs from known sources, but then it would be pointless for Jinan Hongfangde Pharmatech to manufacture tiotropium bromide. <br /><br /><b>The Use of Brokers</b><br /><br />More questions were raised by the pharmaceutical company's apparently common practice of buying drugs through brokers,<br /><blockquote>The rise of the Internet has facilitated exports of drug ingredients. An online search brings up websites offering hundreds of Chinese API sellers. Those not GMP-certified or SFDA-registered are not necessarily substandard, but buyers lack independent quality assurance.<br /><br />The pervasive presence of brokers in the supply line is another risk. <i>Pharmaceutical companies looking to source APIs in China typically hire middlemen to help them navigate the language, red tape and protocol. That system helps Chinese companies making substandard APIs avoid detection.</i></blockquote><br />The reason corporate executives choose to buy drugs in China rather than having their companies manufacture them themselves seems to be to reduce costs. A <a href="http://www.in-pharmatechnologist.com/Ingredients/Substandard-APIs-will-be-made-as-long-as-Pharmas-keep-buying-them-says-WHO">post</a> on the In-Pharma blog quoted Lembit Rago, the same WHO official quoted by Reuters, thus,<br /><blockquote>There are Chinese manufacturers supplying APIs of high quality to multinational companies, but there are also companies producing APIs of poor or not defined quality.</blockquote>So,<br /><blockquote><i>As long as there are customers for substandard APIs they will be produced and sold</i>.</blockquote><br />The cheapest Chinese drugs, of course, come from the most questionable manufacturers, and that may not be apparent to companies who use brokers to facilitate purchases.<br /><blockquote><i>'Any number of foreign pharmaceutical companies go no further than looking for API suppliers at CPhI (an international pharmaceutical fair) based only on price</i>,' [manaing director of Samsara Biopharma Consulting Robert] Walsh said.<br /><br />Reuters spoke to brokers who said <i>an API made by an unregulated chemical company would cost less than one from a company that had a GMP certificate</i>.<br /><br />'Different (API) grades have different prices. Sometimes we accept an order sheet and we happen to find a factory that can do it cheaper than our factory, we will outsource to them and make a bigger margin,' said one broker based in China who sources for a South African outsourcing firm.<br /><br />In China <i>there are few legal repercussions for broker firms who relabel or misrepresent products, and tracing counterfeit and substandard APIs is extremely difficult.</i><br /><br /><i>'There are a lot of brokers who are relabeling (APIs) which means you can't trace where the API comes from and that adds to the risk,'</i> said the WHO's quality assurance expert Rago.<br /><br />Andre, the Belgian drug detective, estimates he has uncovered <i>fraud or misrepresentations in as many as 25 percent of cases where he has been hired to audit factories all over China</i>. 'If you can substitute an API that is expensive to make and manufactured at a high level with something that costs much less, then that can happen,' Andre said. 'It's impossible to give an exact number, but it's not rare. It's a minority, but not tiny minority.'</blockquote><b>Use of Substandard Raw Materials</b><br /><br />Meanwhile, a <a href="http://www.pharmalot.com/2012/09/using-cooking-oil-to-make-antibiotics-in-china/">post</a> on PharmaLot suggested that the supposedly regulated Chinese "pharmaceutical" companies may implement questionable manufacturing practices,<br /><blockquote>A subsidiary of the Joincare Pharmaceutical Group reportedly <i>used reprocessed cooking oil – otherwise known as ‘gutter’ oil – to make a widely used antibiotic in China</i>. If the term gutter oil is unfamiliar, this refers to reprocessed oil made from kitchen waste dredged from gutters behind restaurants. The State Food and Drug Administration is now investigating the charge after media reports over the past several days, China Daily reports.<br /><br />Why might gutter oil be purchased to produce antibiotics? <i>The oil is cheaper than the more expensive soybean oil used to make 7-aminocephalosporinic acid, or 7-ACA, a chemical for produce cephalosporins.</i> Joincare produces 25 percent of the total amount of the chemical, although up to a dozen other drugmakers may have purchased gutter oil from various suppliers, according to various Chinese media reports. For its part, Joincare reportedly denied using gutter oil.<br /><br />The companies reportedly bought the recycled cooking oil from a company called Huikang Grease Co., which is facing prosecution over its alleged processing and selling of thousands of tons of gutter oil in 2010 and 2011. The Shanghai Daily reported that Huikang received around $22.5 million for roughly 14,700 tons of gutter oil sold to Jiaozuo Joincare Biological Product, a unit of Joincare.</blockquote><br /><b>Summary</b><br /><br />There is increasing evidence that a substantial proportion, probably the majority of drugs sold by big pharmaceutical companies based in developed countries were actually made by often poorly regulated firms based elsewhere, often China or India. To put it more directly, most so called pharmaceutical companies in the US and other developed countries have outsourced the actual manufacturing of drugs. Thus, most companies that appear to be pharmaceutical manufacturing companies are really just pharmaceutical marketing and development companies. (And not so much the latter, look here:  Light DW, Lexchin JR. Pharmaceutical R&D; what do we get for all that money? Brit Med J 2012; 345: 22-25.  Link <a href="http://www.bmj.com/content/345/bmj.e4348">here</a>.) Pharmaceutical companies appear to be abandoning their core essence, but are content to market drugs  under their logos without telling the patients who take them the real source of these products.  This would appear to be a big scandal, but one that stays curiously <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.<br /><br />I have yet to see any discussion with pharmaceutical executives about why their companies hardly make drugs anymore. In the absence of such discussion, I can only speculate that most likely, this is first a product of <a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>. Drug company executives, like most organizational leaders, have fallen under the spell that says their only goal should be to increase short-term revenues. It may be cheaper to buy drugs from perhaps dodgy outsourced suppliers rather than manufacturing them them themselves. Continuing stories like those above, and that of the contaminated Chinese heparin suggest that these outsourced drugs are cheap for a reason. It appears that to save money short-term, pharmaceutical executives may be abandoning their most central mission, to provide pure, unadulterated drugs.<br /><br />The continuing story of outsourced pharmaceutical manufacturing provides yet more evidence that current management dogma may be literally toxic. Once again, I suggest that true health care reform requires leadership of health care organization who put patients' and the public's health ahead of short-term revenue (and the personal enrichment that may result).<br /><br />It is likely that a number of policy changes will be needed to reduce the threats posed by contaminated or adulterated outsourced pharmaceuticals.  There is one simple step that ought to be taken quickly to at least make the problem more transparent.  In the US, most manufactured products have a label disclosing the country of origin.  In parallel with that, all pharmaceutical containers, and all pharmaceutical labels and marketing materials ought to disclose the country in which the active pharmaceutical ingredient was manufactured, and the name and location of the company responsible for that manufacture.  <br /><br /><br /><span style="color: blue; font-size: x-small;">Appendix - Heparin Case Summary</span><br /><br /><span style="color: blue; font-size: x-small;">- We have posted several times, recently <a href="http://hcrenewal.blogspot.com/2011/06/first-contaminated-heparin-case-verdict.html">here</a></span><span style="color: blue; font-size: x-small;"> about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late in 2007, hundreds of such reactions, and 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.</span><br /><br /><span style="color: blue; font-size: x-small;">- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. (See posts <a href="http://hcrenewal.blogspot.com/2008/02/in-middle-of-all-those-pigs-in-china.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/03/heparin-in-era-of-hogwash.html">here</a>.)</span><br /><br /><span style="color: blue; font-size: x-small;">- We found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post </span><a href="http://hcrenewal.blogspot.com/2008/03/fake-heparin-then-sick-and-dead.html"><span style="color: blue; font-size: x-small;">here</span></a><span style="color: blue; font-size: x-small;">.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post </span><a href="http://hcrenewal.blogspot.com/2008/03/who-was-responsible-for-purity-of.html"><span style="color: blue; font-size: x-small;">here</span></a><span style="color: blue; font-size: x-small;">.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.</span><br /><br /><span style="color: blue; font-size: x-small;">- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."</span><br /><span style="font-size: x-small;"><br /><span style="color: blue;"></span></span> <span style="color: blue; font-size: x-small;">- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post </span><a href="http://hcrenewal.blogspot.com/2008/05/blaming-some-dude-for-contaminated.html"><span style="color: blue; font-size: x-small;">here</span></a><span style="color: blue; font-size: x-small;">.)  Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post </span><a href="http://hcrenewal.blogspot.com/2010/10/more-contaminated-heparin-but-who-leads.html"><span style="color: blue; font-size: x-small;">here</span></a><span style="color: blue; font-size: x-small;">).  A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post </span><a href="http://hcrenewal.blogspot.com/2011/02/fda-to-scientific-protein-laboratories.html"><span style="color: blue; font-size: x-small;">here</span></a><span style="color: blue; font-size: x-small;">).</span><br /><br /><span style="color: blue; font-size: x-small;">- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible. (See post </span><a href="http://hcrenewal.blogspot.com/2009/08/who-investigated-case-of-deadly.html"><span style="color: blue; font-size: x-small;">here</span></a><span style="color: blue; font-size: x-small;">.)</span><br /><br /><span style="color: blue; font-size: x-small;">- Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post </span><a href="http://hcrenewal.blogspot.com/2010/01/blog-post.html"><span style="color: blue; font-size: x-small;">here</span></a><span style="color: blue; font-size: x-small;">.)  Efforts to make documents to be used in these cases public so far have not succeeded (see post </span><a href="http://hcrenewal.blogspot.com/2010/08/proprietary-information-confidentiality.html"><span style="color: blue; font-size: x-small;">here</span></a><span style="color: blue; font-size: x-small;">).</span><br /><br /><span style="color: blue; font-size: x-small;">- A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post </span><a href="http://hcrenewal.blogspot.com/2010/04/another-echo-of-case-of-deadly-heparin.html"><span style="color: blue; font-size: x-small;">here</span></a><span style="color: blue; font-size: x-small;">.)</span><br /><br /><span style="color: blue; font-size: x-small;">-  Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post </span><a href="http://hcrenewal.blogspot.com/2010/07/more-about-what-we-dont-know-about.html"><span style="color: blue; font-size: x-small;">here</span></a><span style="color: blue; font-size: x-small;">.)</span><br /><br /><span style="color: blue; font-size: x-small;">-  In February, 2011, a congressional investigation of the case was announced, but results are so far unavailable (see post <a href="http://hcrenewal.blogspot.com/2011/02/three-years-later-congressional.html">here</a>.)</span><br /><br /><span style="color: blue; font-size: x-small;">-  In June, 2011, a jury returned the first verdict in a civil case about the contaminated heparin, awarding money from Baxter International and Scientific Protein Laboratories to the estate of a man who apparently died due to tainted heparin (see post <a href="http://hcrenewal.blogspot.com/2011/06/first-contaminated-heparin-case-verdict.html">here</a>).</span>

Who Really Makes Brand-Name Pharmaceuticals?

A striking illustration of the hazards to patients' and the public's health from health care organizational leaders using fashionabl...

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"MetroHealth, Explorys use huge patient database to revolutionize medical research"

As I have written in the past, beware claims of "revolutions" where healthcare or medical research are involved.  As in a slide in my recent <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">presentation</a> to the Health Informatics Society of Australia on healthcare IT trust, I asked:<br /><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgZx4YeKPPlUpYdQHrz-L-Iu_RzvWcGlVYGDmgAVoiQq9tfEitVSmBehI6oQQIvzhqWY-qLj_kqUYEZUvzoy-V2DbPQdsAbN0OyQ-4ohoRVIzRPX1iXmJLhLMxk_QQCo5NeMxZnyrpn1nbJ/s1600/slide1.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="240" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgZx4YeKPPlUpYdQHrz-L-Iu_RzvWcGlVYGDmgAVoiQq9tfEitVSmBehI6oQQIvzhqWY-qLj_kqUYEZUvzoy-V2DbPQdsAbN0OyQ-4ohoRVIzRPX1iXmJLhLMxk_QQCo5NeMxZnyrpn1nbJ/s320/slide1.jpg" width="320" /></a></div><br /><br />In that same talk, I pointed out the "revolutions" usually have downsides, and IT always produces winners and losers (per the empirical research of <a href="http://rkcsi.indiana.edu/" target="_blank">Social Informatics</a>).  <br /><br />I also asked "<i>have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?</i>" in a 2009 post on uncontrolled EHR data and comparative effectiveness studies <a href="http://hcrenewal.blogspot.com/2009/04/have-we-suffered-complete-breakdown-in.html" target="_blank">at this link</a>.   <br /><br />In the Aug. 29, 2012 article "<a href="http://www.cleveland.com/healthfit/index.ssf/2012/08/metrohealth_and_explorys_are_u.html" target="_blank">MetroHealth, Explorys use huge patient database <b>to revolutionize </b>medical research</a>"  in The Plain Dealer (Ohio), the following claims are proffered.  I am assuming regarding this article, as in newspaper articles I make contributions to, that the researchers were involved in its provenance and content:<br /><br /><blockquote class="tr_bq">Large databases of electronic medical records hold great promise for medical research. In theory they can provide doctors access to huge amounts of anonymous patient data, allowing large-scale population studies without the cost and hassle of patient recruitment, review boards and staff training.<br /><br />Now, a team of data experts at MetroHealth Medical Center and the Cleveland Clinic Innovations spinoff company <a href="https://www.explorys.com/about-us">Explorys</a> has shown just how powerful such medical records can be: In three months, they've replicated a major medical study that took a Norwegian team 14 years to research and report. And they've done it at a fraction of the cost, with a sample about 40 times as large.<br /><br />The local effort, led by MetroHealth Chief Medical Informatics Officer <a href="http://www.metrohealth.org/physiciandirectory/PhysicianDetail.aspx?ID=029298">Dr. David Kaelber</a>, was possible because of Explorys' database of 14 million electronic medical records gathered from 12 major health systems. </blockquote><br />14 million records gathered from 12 major health systems, which may in fact be using disparate EHR systems or versions, is almost indisputably <b>not</b> controlled data.<br /><br />A comparison to a more rigorous study was conceptualized and performed:<br /><br /><blockquote class="tr_bq">Most of all though, he [Kaelber] needed to prove that it worked -- that he could get exactly the same results as traditional research studies that required more time and resources.<br /><br />Enter the <a href="http://atvb.ahajournals.org/content/31/6/1439.abstract?sid=9212fce2-301c-4e47-9c70-545442fdc21e">Norwegian study</a>. In 1994, a group of researchers started registering 26,714 people in the northern region's largest city, Tromso. It was part of a much longer study on the population's heart disease risk. They recorded height, weight and other measures of obesity, then followed participants for 13 years, recording any blood clots they had.<br /><br />Their conclusion: the combination of obesity and a tall stature significantly increases risk of blood clots, especially in men. </blockquote><br />The same hypothesis was tested with the uncontrolled EHR data, with claims that (obviously) the time and expense were lower, at least in the instant sense (costs of EHR implementation and maintenance in 12 major health systems could be in the billions of dollars at a time when a health system can easily spend $100 million each over just a few years as Bob Wachter points our <a href="http://community.the-hospitalist.org/2012/09/03/putting-the-a-back-in-soap-notes-time-to-tackle-an-epic-problem/" target="_blank">here</a> - one hundred million dollars for UCSF):<br /><br /><blockquote class="tr_bq">... The sample: 959,030 patients with medical records in the Explorys platform. The method: using software to search for blood clots in the health and claims records contained in the database, and then looking for patterns in those patients' height and weight. The result: Exactly the same as the Tromso study.<br /><br />"And actually the statistical significance of our study was much, much higher because our sample size was 40 times greater," Kaelber said. Kaelber and his team published their results online in July in the <a href="http://jamia.bmj.com/" target="_blank">Journal of the American Medical Informatics Association</a>.</blockquote><br />The conclusion to the article <a href="http://jamia.bmj.com/content/early/2012/07/01/amiajnl-2011-000782.abstract" target="_blank">here</a> (<b>subscription required</b>) was:<br /><br /><blockquote class="tr_bq">With the right clinical research informatics tools and EHR data, some types of very large cohort studies can be completed <i style="color: #e06666;"><b>[and, by implication, trusted and acted upon at local, regional or societal levels - ed.]</b></i> with minimal resources. </blockquote><br /><span class="commentBody" data-jsid="text">This data was, and I don't think this can be refuted, poorly controlled.  There are limits to what "data cleansing" and standardization can accomplish with such data. In methodologies like this, confounders are too numerous to list comprehensively, but just a few - missing data; variability in observations (inter- and intra-observer variability); data originating from different vendor systems with different terminology and definitions, input by myriad people of different backgrounds with differing interpretations of terminologies (students/MD's/RN's etc); different pressures creating bias (time, reimbursement maximization, litigation avoidance); to name just a few.</span><br /><br /><span class="commentBody" data-jsid="text">Several questions: </span><br /><br /><ul><li><span class="commentBody" data-jsid="text">What is the likelihood these results were themselves a chance outcome? Correlation is not proof, especially where n=1. </span></li></ul><ul><li><span class="commentBody" data-jsid="text">How do we reliably identify <i>ante hoc</i> the "</span>types of very large cohort studies" that we can complete?</li></ul><ul><li><span class="commentBody" data-jsid="text">What is the likelihood that such techniques are generalizable to all studies (such as comparative effectiveness research, currently a governmental initiative), especially where issues and confounders might be subtle?</span></li></ul><ul><li><span class="commentBody" data-jsid="text">Related to generalizability <u>supra</u>, where are the scientific studies that prove methodologies like this are valid and reliable for other than, say, low-granularity epidemiological purposes?  Put more colloquially - how do we know what these efforts attempt to do, in what is almost indisputably a radical deviation from controlled-trial norms, is not "computational alchemy" (i.e., attempting to turn lead into gold)?</span></li></ul><ul><li><span class="commentBody" data-jsid="text"></span><span class="commentBody" data-jsid="text">Is there rigorous data on attempted studies like this<i> </i>that<i> failed to correlate</i> with more traditional research?</span>  Unless the latter is studied and/or attempted and some sense gained of whether a radical approach using uncontrolled data such as this does not fail to a concerning extent, <b>then claims of "revolutions" need to be postponed.</b></li></ul><span class="commentBody" data-jsid="text"> <br /> Worst case scenario: large dataset, radical analytics and a political agenda can lead to undesired outcomes.  We need to know what we are doing.</span><br /><br /><span class="commentBody" data-jsid="text">More on these issues in a 2009 article I authored <a href="http://www.jpands.org/vol14no2/silverstein.pdf" target="_blank">here</a>. </span><br /><br /><span class="commentBody" data-jsid="text">I have invited Dr. Kaelber to comment on the questions I raise. </span><br /><br /><b>Note:  </b>I am not challenging this specific study per se, which is an experiment, but <b>am</b> challenging the generalizability of this type of "from data rags to information riches" methodology, as I've done in other posts on similar topics. Not to mention, the overconfidence as expressed in the press, which is what the public including our lawmakers and people responsible for resource allocation read.  I think it's highly premature to write of "revolutionizing medical research."<br /><br />Sep. 4, 2012<br /><br />Here is the reply from Dr. Kaelber -<br /><br /><blockquote class="tr_bq">We actually cover many of the points you raise in the discussion of the article.<br /><br />I think it is important if we are focusing on a scientific discussion of a scientific article to focus on the primary source - the scientific article itself, and not a secondary source - the reporting of the scientific article.<br /><br />One of the major points in the discussion (quoted from the published manuscript) is that we feel that there are three keys to using pooled, standardized, normalized, and de-identified EHR data, including:<br /><br />1. Understanding data sources - understanding of the characteristics of the underlying EHR data sources, including a data dictionary and ontologies used.<br /><br />2. Corroborating data findings - internal and/or external methods to corroborate retrospective EHR cohort study data and/or findings. For example, manual chart review of a sample of the EHR data (internal validation), or other studies demonstrating similar results (external validation), ideally coupled with a biologically plausible hypothesis.<br /><br />3. Clinical data versus research data - recognizing that retrospective EHR data were typically collected for clinical and not research purposes. Therefore, depending on the type of data, the quality may not meet typical research standards. In some cases, the large quantity of clinical data may help mitigate the fact that it was not collected with the higher precision and accuracy that can occur as part of a prospective research study.<br /><br />As I was also quoted in the Plain Dealer article as saying this is like a new type of power drill for those who have been used to using hand drills for retrospective (electronic or paper) chart reviews. To be used appropriately, researchers need to understand the opportunities and disadvantages of using of the new tool and be trained on how to use it.<br /><br />I would also add that, again, as was stated in the introduction for the published paper that clinical research informatics as a field is in its infancy and we need more people involved in the field, more tools for people in the field, and more experience of people using tools in the field to really understand both the contributions and limitations for electronic health record data to advance clinical research.<br /><br />I hope these comments are of some interest/use.<br /><br />-David </blockquote><br />My thoughts are that use of of experimental EHR-based methodologies like this, that could have significant social implications, requires significant caution and validation.  I think we are in agreement on that point.  The methodology of use of EHR data from myriad sources needs to be shown valid, as well as proven <i>not to be invalid</i>, before the findings of "new" studies that are not attempting to duplicate prior ones are translated to the bedside or beyond.<br /><br />The disadvantages include, among other issues (and perhaps most important) the spread of premature over-optimism about health IT such as in newspapers.  That problem has, I believe, contributed greatly to the prevalent <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">hyper-enthusiasm</a> and <i>"there's little supportive data - <b>nevertheless, we believe </b>- so let's spend $15+ billion dollars"</i> attitudes about current health IT as I wrote about, for instance, <a href="http://hcrenewal.blogspot.com/2012/05/oncs-health-data-palooza-title-of.html" target="_blank">here</a> (ONC's 'Data Palooza') and <a href="http://hcrenewal.blogspot.com/2012/08/the-scientific-justification-for.html" target="_blank">here</a> (on MU Stage 2 justifications).<br /><br />Finally, I would question whether increasing the quantity of data could ever reliably compensate for lack of quality (unless, perhaps  the additions were themselves of high quality).  Adding low quality data to already low quality data should not produce better results, it seems to me.<br /><br /><span class="commentBody" data-jsid="text">-- SS</span> <br /><br />

"MetroHealth, Explorys use huge patient database to revolutionize medical research"

As I have written in the past, beware claims of "revolutions" where healthcare or medical research are involved.  As in a slide in...

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